Document Library
Enter your keywords to quickly find the relevant
product and lot specific documentation.
product and lot specific documentation.
There are no documents that match the specified search term.
AlbuTrol®
Product Specific
- Utilisation prévue Utilização prevista Eurotrol AlbuTrol® est un matériel de contrôle du dosage de l’albumine étalonné destiné à un O Eurotrol AlbuTrol® é um controlo de albumina ensaiado destinado a utilização profissional na usage professionnel pour le contrôle de l’exactitude et de la précision du système HemoCue® Albumin 201. verificação da precisão e rigor do sistema HemoCue® Albumin 201. O Eurotrol AlbuTrol® destina-se à Eurotrol AlbuTrol® est destiné à la détermination quantitative de l’albumine. determinação quantitativa da albumina. Résumé et principe Resumo e princípio Eurotrol AlbuTrol® est un matériel de contrôle de qualité à deux niveaux contenant chacun une O Eurotrol AlbuTrol® é um material de controlo de qualidade disponível em dois níveis, cada um com uma concentration connue d’albumine. Eurotrol AlbuTrol® peut être utilisé pour le contrôle périodique de concentração de albumina estabelecida. O Eurotrol AlbuTrol® pode ser utilizado na verificação periódica da AlbuTrol® l’exactitude et de la précision du système HemoCue® Albumin 201. Se référer aux directives locales pour precisão e rigor do sistema HemoCue® Albumin 201. Consulte as diretrizes locais para obter a frequência connaître la fréquence d’utilisation recommandée. de utilização recomendada. AlbuTrol® Level 1 189.001.002 AlbuTrol® Level 2 189.002.002 Réactifs Reagentes Intended use Eurotrol AlbuTrol® est fourni à deux niveaux physiologiquement pertinents. Chaque flacon contient 1,0 ml O Eurotrol AlbuTrol® apresenta-se em dois níveis fisiologicamente relevantes. Cada frasco contém 1,0 ml Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of d’urine humaine contenant de l’albumine. de urina humana com albumina. the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the Mises en garde et précautions Advertências e precauções quantitative determination of albumin. 1. Exclusivement à usage diagnostique in vitro. 1. Apenas para utilização em diagnóstico in vitro. Summary and Principle 2. Avertissement : Eurotrol AlbuTrol® est préparé au départ d’urine humaine et contient du matériel 2. Atenção: O Eurotrol AlbuTrol® é preparado a partir de urina humana e contém material de origem Eurotrol AlbuTrol® is a quality control material available at two levels, each with a known albumin d’origine humaine. Les composants du contrôle, dérivés de matériel d’origine humaine, ont été testés et humana. Os componentes do controlo, derivados de material de origem humana, foram testados, tendo- concentration. Eurotrol AlbuTrol® may be used in the periodic verification of the precision and accuracy of trouvés non réactifs pour l’antigène HBs et les anticorps anti-HCV et anti-VIH. Néanmoins, aucune se estabelecido que eram não reativos para o HBsAg, anti-VHC e anti-VIH. No entanto, nenhum método the HemoCue® Albumin 201 system. Please refer to local guidelines for recommended frequency of use. méthode de test ne peut fournir une garantie totale que les produits dérivés de matériel d’origine de teste consegue oferecer uma garantia completa de que os produtos derivados de materiais de origem humaine sont exempts d’agents infectieux. humana estejam isentos de agentes infecciosos. Reagents Eurotrol AlbuTrol® is provided at two physiologically relevant levels. Each vial contains 1.0 mL of human 3. Ne pas éliminer ce produit avec les ordures ménagères. Consulter les autorités locales responsables de 3. Este produto não deve ser eliminado no lixo doméstico. Consulte as autoridades ambientais locais para urine containing albumin. l’environnement pour connaître la manière de les éliminer. saber qual o procedimento de eliminação adequado. Warnings and Precautions Conservation et stabilité Armazenagem e estabilidade 1. For in vitro diagnostic use only. Eurotrol AlbuTrol® doit être conservé au réfrigérateur à 2–8 °C (36–46 °F). Si le produit est conservé non O Eurotrol AlbuTrol® deve ser conservado no frigorífico a 2 °C – 8 °C (36 °F – 46 °F). Conservado aberto a 2. Caution: Eurotrol AlbuTrol® is prepared from human urine and contains human source material. ouvert à cette température, sa stabilité est garantie jusqu’à la date de péremption indiquée sur les flacons et esta temperatura, a estabilidade é garantida até à data do prazo de validade indicada no frasco e na caixa Components of the control, which are derived from human source material, have been tested and found sur la boîte. Après ouverture, Eurotrol AlbuTrol® est stable pendant 30 jours à 2–8 °C (36–46 °F). exterior de cartão. Após abrir o frasco, o Eurotrol AlbuTrol® permanece estável durante 30 dias, to be non-reactive for HBsAg, anti-HCV and anti-HIV. However, no test method can offer complete Procédure conservando-o a 2 °C – 8 °C (36 °F – 46 °F). assurance that products derived from human source material are free from infectious agents. 1. Pour des performances optimales, le produit doit être traité comme un échantillon provenant d’un patient Procedimento 3. This product should not be disposed of in general waste. Consult local environmental authorities for et en respectant le mode d’emploi du système HemoCue® Albumin 201. 1. Para um desempenho ótimo, o produto deve ser tratado como amostra de um doente, devendo ser proper disposal. 2. Équilibrer le flacon pendant 15 minutes pour le laisser atteindre une température de 15 à 30 C (59– seguidas as instruções de utilização do sistema HemoCue® Albumin 201. Storage and stability 86 °F). 2. Equilibre o frasco durante 15 minutos a uma temperatura de 15 °C a 30 °C (59 °F – 86 °F). Eurotrol AlbuTrol® must be stored in the refrigerator at 2–8 °C (36–46 °F). Stored unopened at this 3. Immédiatement avant utilisation, agiter manuellement le flacon pendant au moins 30 secondes afin de 3. Imediatamente antes da utilização, agite o frasco à mão durante pelo menos 30 segundos, para misturar temperature, stability it is guaranteed until the expiration date as indicated on the vial and the outer box. After bien en homogénéiser le contenu. completamente o conteúdo. opening, Eurotrol AlbuTrol® is stable for 30 days stored at 2–8 °C (36–46 °F). 4. Maintenir le flacon verticalement et tapoter le capuchon pour éliminer le liquide de l’embout compte- 4. Segure o frasco numa posição vertical e bata levemente na tampa, de modo a remover o líquido da gouttes (Figure 1). ponta do doseador (Figura 1). Procedure 5. Ouvrir délicatement le capuchon sans presser le flacon (Figure 2). 5. Abra cuidadosamente a tampa sem apertar o frasco (Figura 2). 1. For optimal performance the product should be treated as a patient sample and instructions for use of the 6. Éliminer la première goutte du liquide de contrôle de qualité. 6. Elimine a primeira gota do líquido de controlo de qualidade. HemoCue® Albumin 201 system should be followed. 7. Appliquer une goutte sur une surface hydrophobe et l’utiliser immédiatement pour procéder à une 7. Aplique uma gota sobre uma superfície hidrófoba e use-a imediatamente para medir, como se indica no 2. Equilibrate the vial for 15 minutes to a temperature of 15 to 30°C (59–86°F). mesure comme décrit dans le mode d’emploi de l’analyseur. manual do utilizador do analisador. 3. Directly before use, shake the vial by hand for at least 30 seconds to completely mix the contents. 8. Après prélèvement de l’échantillon, essuyer le liquide de contrôle de qualité du capuchon coloré avec un 8. Após a colheita da amostra, retire qualquer líquido de controlo de qualidade da tampa colorida com um 4. Hold the vial in an upright position and tap the cap to remove liquid from the dropper tip (Figure 1.). linge propre et reboucher soigneusement le flacon. toalhete limpo e feche bem novamente com a tampa. 5. Open the cap carefully without squeezing the vial (Figure 2.). 9. Le replacer dans les conditions de conservation indiquées après usage. Répéter l’ensemble de la 9. Após a utilização, coloque novamente o frasco nas condições de armazenagem indicadas. O 6. Discard the first drop of the quality control liquid. procédure chaque fois que l’on doit prélever du matériel de contrôle de qualité pendant la durée de procedimento completo tem de ser repetido sempre que retirar o controlo de qualidade da 7. Apply a drop on a hydrophobic surface and use it immediately for measurement as indicated in the conservation du flacon après ouverture. armazenagem, durante todo o prazo de validade subsequente à abertura inicial do frasco. analyzer user manual. 8. After sampling, remove any liquid of the quality control from the colored cap with a clean tissue and recap Limites Limitações properly. 1. Ne pas utiliser le matériel de contrôle de qualité au-delà de la durée de conservation après ouverture du 1. O material de controlo de qualidade não deve ser utilizado após o prazo de validade subsequente à 9. Return to indicated storage conditions after use. The entire procedure has to be repeated every time flacon ou de sa date de péremption. abertura inicial do frasco nem após a data de validade. upon removing the quality control from storage during the entire open-vial time period. 2. Eurotrol AlbuTrol® n’est pas destiné à être utilisé comme calibrateur/standard. 2. O Eurotrol AlbuTrol® não deve ser utilizado como um calibrador / padrão. 3. Les plages de valeurs du produit sont fournies à titre purement indicatif et il appartient à chaque 3. Os intervalos do produto constituem apenas uma diretriz e os laboratórios devem determinar os Limitations laboratoire de déterminer les intervalles en se basant sur son propre système de test et ses propres intervalos com base no seu próprio sistema de análise e limites de tolerância. 1. The quality control material should not be used past open-vial time period or expiration date. limites de tolérance. 2. Eurotrol AlbuTrol® is not to be used as a calibrator / standard. Valores esperados 3. The ranges of the product are intended only as a guideline and laboratories should determine the ranges Valeurs attendues O valor médio de teste referido na folha do ensaio inclusa deriva de análises replicadas em sistemas based on their own test system and tolerance limits. La valeur moyenne du test indiquée sur la fiche de test provient d’analyses répétées sur des systèmes HemoCue® Albumin 201 calibrados de fábrica e é específico de cada lote. HemoCue® Albumin 201 calibrés en usine et sont spécifiques de ce lot du produit. Para mais informações e/ou assistência técnica, contacte: Expected values The mean assay value provided on the enclosed assay sheet is derived from replicate analyses on factory Pour des informations supplémentaires ou une assistance technique, veuillez contacter : Eurotrol B.V. Eurotrol Inc. calibrated HemoCue® Albumin 201 systems and are batch specific. Keplerlaan 20, 6716 BS Ede 850 N Black Branch Rd, Elizabethtown, KY Eurotrol B.V. Eurotrol Inc. For further information and/or technical assistance, please contact: Keplerlaan 20, 6716 BS Ede 850 N Black Branch Rd, Elizabethtown, KY Países Baixos EUA Pays-Bas États-Unis Telefone +31 318 695 777 Telefone +1 502 501 1180 Eurotrol B.V. Eurotrol Inc. E-mail office@eurotrol.com E-mail officeUSA@eurotrol.com Keplerlaan 20, 6716 BS Ede, 850 N Black Branch Rd, Elizabethtown, KY Téléphone +31 318 695 777 Téléphone +1 502 501 1180 Courriel office@eurotrol.com Courriel officeUSA@eurotrol.com www.eurotrol.com The Netherlands USA Phone +31 318 695 777 Phone +1 502 501 1180 www.eurotrol.com Quaisquer incidentes graves que ocorram com o dispositivo têm de ser comunicados ao fabricante e às E-mail office@eurotrol.com E-mail officeUSA@eurotrol.com Tout incident grave survenu en relation avec le dispositif doit être notifié au fabricant et aux autorités autoridades competentes do estado-membro onde o utilizador e/ou o doente se situe. www.eurotrol.com compétentes de l’état membre dans lequel est établi l’utilisateur et/ou le patient. Histórico de revisões Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the Historique des révisions Revisão Data de entrada em vigor Alteração da revisão anterior competent authority of the member state where the user and/or the patient is established. Révision Date d’entrée en vigueur Modification par rapport à la version précédente 01 2010-05-18 Primeira revisão 01 2010-05-18 Première version Revisão da secção "Resultados esperados", mudança de Revision history 02 2011-10-06 Révision de la section «Résultats attendus», modification de la disposição gráfica, correção de símbolos Revision Effective Date Change to previous revision 02 2011-10-06 présentation, correction des symboles Adição da tradução em português, edição dos símbolos, 01 2010-05-18 First revision 03 2017-07-24 Ajout de la traduction en portugais, modification des symboles, nova ID do documento 02 2011-10-06 Revision of section ‘Expected results’, change of layout, correction of symbols 03 2017-07-24 nouveau code d’identification du document Informações de contacto revistas, edição da descrição dos 03 2017-07-24 Addition of Portuguese translation, editing of symbols, new document ID 04 2018-02-28 Révision des informations de contact, modification de la description símbolos, nova ID do documento 04 2018-02-28 Revised contact information, editing of symbol description, new document ID 04 2018-02-28 des symboles, nouveau code d’identification du document Adição da tradução em espanhol, revisão completa das 05 2019-01-23 Addition of Spanish translation, complete revision of IFU including new layout Ajout de la traduction en espagnol, révision complète du mode All trademarks are the property of their respective owners. © 2019, Eurotrol B.V. 05 2019-01-23 05 2019-01-23 Instruções de utilização, inclusive da nova disposição d’emploi y compris nouvelle présentation gráfica Toutes les marques de commerce sont la propriété de leur détenteur respectif. © 2019, Eurotrol B.V. Todas as marcas comerciais são propriedade dos respetivos proprietários. © 2019, Eurotrol B.V. CE Manufacturer Date of manufacture Use-by date Batch code Catalogue number Temperature limit Consult instructions for use Caution In vitro diagnostic medical device Control Prescription use only CE Fabricant Date de fabrication Date de péremption Numéro de lot Référence catalogue Limites de température Consulter le mode d’emploi Avertissement Dispositif médical de diagnostic in vitro Contrôle Disponible uniquement sur prescription CE Fabricante Data de fabrico Prazo de validade Código de lote Número de catálogo Limite de temperatura Consulte as instruções de utilização Atenção Dispositivo médico de diagnóstico in vitro Controlo Utilização apenas sob prescrição CE Fabricante Fecha de fabricación Fecha de caducidad Código de lote Número de catálogo Límite de temperatura Consulte las instrucciones de uso Precaución Producto sanitario de diagnóstico in vitro Control Uso exclusivo bajo prescripción Page 1 of 2 Uso previsto Eurotrol AlbuTrol® es un control de albúmina ensayado destinado al uso profesional para la verificación de la precisión y la exactitud del sistema HemoCue® Albumin 201. Eurotrol AlbuTrol® está diseñado para la determinación cuantitativa de la albúmina. Resumen y principio Eurotrol AlbuTrol® es una solución de control de calidad disponible en dos niveles, cada uno de ellos con una concentración de albúmina conocida. Eurotrol AlbuTrol® puede utilizarse en la verificación periódica de la precisión y la exactitud del sistema HemoCue® Albumin 201. Consulte las directrices locales para conocer la frecuencia de uso recomendada. Reactivos Eurotrol AlbuTrol® se proporciona en dos niveles fisiológicamente relevantes. Cada vial contiene 1,0 ml de orina humana con albúmina. Advertencias y precauciones 1. Usar solamente para diagnóstico in vitro. 2. Precaución: Eurotrol AlbuTrol® está fabricado con orina humana y contiene material de origen humano. Se han analizado los componentes de control derivados de material de origen humano y se ha demostrado que no reaccionan a HBsAg, anti-VHC ni anti-VIH. Sin embargo, ningún método puede garantizar con total seguridad que los productos derivados de material de origen humano no contengan agentes infecciosos. 3. Este producto no debe desecharse con los residuos generales. Póngase en contacto con las autoridades medioambientales locales para obtener información sobre su correcta eliminación. Conservación y estabilidad Eurotrol AlbuTrol® debe conservarse en el frigorífico a 2-8 °C (36–46 °F). Si se conserva sin abrir a esta Figure 1, Figure 1, Figura 1, Figura 1. temperatura, se garantiza la estabilidad hasta la fecha de caducidad indicada en el vial y en el embalaje exterior. Tras la apertura, Eurotrol AlbuTrol® es estable a una temperatura de 2-8 °C (36–46 °F) durante 30 días. Procedimiento 1. Para obtener un rendimiento óptimo, el producto debe tratarse como una muestra de paciente y se deben seguir las instrucciones de uso del sistema HemoCue® Albumin 201. 2. Estabilice el vial durante 15 minutos a una temperatura entre 15 y 30 °C (59–86 °F). 3. Inmediatamente antes de su uso, agite con la mano el vial durante al menos 30 segundos para mezclar totalmente su contenido. 4. Sostenga el vial en posición vertical y golpee ligeramente el tapón para extraer el líquido de la punta del cuentagotas (figura 1). 5. Abra el tapón con cuidado sin apretar el vial (figura 2). 6. Descarte la primera gota de la solución de control de calidad. 7. Aplique una gota sobre una superficie hidrófoba y úsela inmediatamente para medir, tal como se indica en el manual del usuario del analizador. 8. Después del muestreo, elimine cualquier líquido restante de solución de control de calidad del tapón de color con un pañuelo limpio y coloque de nuevo el tapón correctamente. 9. Después de usarlo, vuelva a guardarlo en las condiciones de conservación indicadas. Todo este procedimiento debe repetirse cada vez que se retire el control de calidad de su lugar de almacenaje durante el período completo de tiempo de apertura del vial. Limitaciones 1. La solución de control de calidad no debe usarse tras el vencimiento del período de tiempo de apertura del vial o la fecha de caducidad. 2. Eurotrol AlbuTrol® no debe utilizarse como calibrador/estándar. Figure 1, Figure 1, Figura 1, Figura 1. 3. Los intervalos del producto solo sirven de guía, por lo que los laboratorios deben determinar los AN01236A01 20190123 intervalos en función de su sistema de análisis y sus límites de tolerancia. Valores esperados El valor de ensayo medio facilitado en la hoja de ensayo adjunta se ha obtenido a partir de repeticiones de análisis en sistemas HemoCue® Albumin 201 calibrados en fábrica y son específicos de lote. Para obtener más información y/o asistencia técnica, póngase en contacto con: Eurotrol B.V. Eurotrol Inc. Keplerlaan 20, 6716 BS Ede 850 N Black Branch Rd, Elizabethtown, KY Países Bajos EE. UU. Teléfono +31 318 695 777 Teléfono +1 502 501 1180 Correo electrónico office@eurotrol.com Correo electrónico officeUSA@eurotrol.com www.eurotrol.com Cualquier incidente grave que se produzca en relación con el producto se debe comunicar al fabricante y a la autoridad competente del Estado miembro en el que esté establecido el usuario o el paciente. Historial de revisiones Revisión Fecha de entrada en vigor Cambio respecto a la revisión anterior 01 2010-05-18 Primera revisión 2011-10-06 Revisión de la sección Resultados esperados, modificación del 02 diseño y corrección de los símbolos. 2017-07-24 Incorporación de la traducción al portugués, modificación de 03 símbolos y nueva ID de documento. 2018-02-28 Revisión de la información de contacto, modificación de la 04 descripción de los símbolos y nueva ID de documento. 2019-01-23 Incorporación de la traducción al español y revisión íntegra de 05 las instrucciones de uso, incluido un nuevo diseño. Todas las marcas comerciales son propiedad de sus respectivos propietarios. © 2019, Eurotrol B.V. CE Manufacturer Date of manufacture Use-by date Batch code Catalogue number Temperature limit Consult instructions for use Caution In vitro diagnostic medical device Control Prescription use only CE Fabricant Date de fabrication Date de péremption Numéro de lot Référence catalogue Limites de température Consulter le mode d’emploi Avertissement Dispositif médical de diagnostic in vitro Contrôle Disponible uniquement sur prescription CE Fabricante Data de fabrico Prazo de validade Código de lote Número de catálogo Limite de temperatura Consulte as instruções de utilização Atenção Dispositivo médico de diagnóstico in vitro Controlo Utilização apenas sob prescrição CE Fabricante Fecha de fabricación Fecha de caducidad Código de lote Número de catálogo Límite de temperatura Consulte las instrucciones de uso Precaución Producto sanitario de diagnóstico in vitro Control Uso exclusivo bajo prescripción Page 2 of 2 Instructions for Use - US (302.9 KB)
- 7. Påfør en dråpe på en hydrofob overflate, og bruk den umiddelbart til måling som angitt i brukerhåndboken for For mere information eller teknisk hjælp kontakt da: Predvidena uporaba Warnhinweise und Vorsichtsmaßnahmen 1. Nur als In-vitro-Diagnostikum einsetzen. analysatoren. Eurotrol AlbuTrol® je preizkušena albuminska kontrola, ki je namenjena za uporabo v profesionalnem okolju za 8. Etter prøvetakingen må du fjerne eventuell kvalitetskontrollvæske fra det fargede lokket med et rent papirhåndkle og sette Eurotrol B.V. preverjanje natančnosti in točnosti sistema HemoCue® Albumin 201. Eurotrol AlbuTrol® je namenjen za določanje količine 2. Vorsicht: Eurotrol AlbuTrol® wird aus Humanurin hergestellt und enthält noch humanes Ausgangsmaterial. Die lokket helt på igjen. Keplerlaan 20, 6716 BS Ede, Holland albumina. Bestandteile der Kontrolle, die aus humanem Ausgangsmaterial gewonnen werden, sind negativ auf HBsAg, Anti-HCV und Anti-HIV getestet worden. Aber keine Testmethode kann mit absoluter Sicherheit garantieren, dass Produkte aus 9. Oppbevar den under de angitte forholdene igjen etter bruk. Hele prosedyren må gjentas hver gang kvalitetskontrollen Telefon +31 318 695 777 Povzetek in načela fjernes fra oppbevaringsforholdene, under hele tidsrommet ampullen er åpen. E-mail office@eurotrol.com humanem Ausgangsmaterial keine Infektionserreger enthalten. Eurotrol AlbuTrol® je material za nadzor kakovosti, ki je dostopen v dveh stopnjah, od katerih ima vsak znano koncentracijo 3. Dieses Produkt darf nicht im normalen Haushaltsmüll entsorgt werden. Ordnungsgemäße Entsorgung bei den Begrensninger Enhver alvorlig hændelse, der er opstået i forbindelse med anvendelse af instrumentet, skal indberettes til producenten og albumina. Eurotrol AlbuTrol® se lahko uporablja za redno preverjanje natančnosti in točnosti sistema HemoCue® Albumin Umweltbehörden vor Ort erfragen. 1. Kvalitetskontrollmaterialet skal ikke brukes etter tidsrommet for åpne ampuller eller utløpsdatoen. den relevante myndighed i det medlemsland, hvor brugeren og/eller patienten er bosat. 201. Za priporočeno pogostost uporabe upoštevajte lokalne smernice. 2. Eurotrol AlbuTrol® skal ikke brukes som kalibrator/standard. Lagerung und Stabilität Ændringsoversigt Reagenti 3. Produktområdene er bare veiledende, og laboratorier skal fastsette områdene basert på egne testsystemer og Eurotrol AlbuTrol® muss im Kühlschrank bei 2–8 °C (36–46 °F) gelagert werden. Bei ungeöffneter Lagerung in diesem Ændring Ikrafttrædelsesdato Ændring i foregående ændring Eurotrol AlbuTrol® obstaja v dveh fiziološko relevantnih stopnjah. Vsaka viala vsebuje 1,0 ml človeš kega urina, ki vsebuje toleransegrenser. AlbuTrol® Temperaturbereich ist die Stabilität bis zu dem Ablaufdatum gewährleistet, das auf dem Fläschchen und auf dem Umkarton steht. Nach dem Öffnen ist Eurotrol AlbuTrol® 30 Tage stabil, wenn es bei 2–8 °C (36–46 °F) gelagert wird. Forventede verdier 05 2006-02-10 Revideret helt efter ændring fra HemoCue AlbuTrol til Eurotrol AlbuTrol albumin. 06 2011-09-26 Ændret afsnit om forventede resultater og producent. Tilføjet tekst i afsnittet om Opozorila in previdnostni ukrepi AlbuTrol® Low 108.001.002 AlbuTrol® High 108.002.002 Gjennomsnittlig analyseverdi oppgitt på vedlagte analyseark er avledet av reproduserte analyser på fabrikkalibr erte medicinsk IVD-udstyr 1. Namenjeno le za diagnostično uporabo in vitro. Verfahren HemoCue® Albumin 201-systemer og er batch-spesifikke. 1. Um die optimale Performance zu erreichen, sollte das Produkt wie eine Patientenprobe gehandhabt werden. Außerdem ist 07 2013-12-04 Tilføjelse af ungarsk og kroatisk oversættelse 2. Pozor: Eurotrol AlbuTrol® je pripravljen iz človeškega uina in vsebuje človeški izvorni material. Komponente kontrole, ki Intended Use die Gebrauchsanweisung des Systems HemoCue® Albumin 201 zu befolgen. Hvis du trenger mer informasjon og/eller teknisk hjelp, kan du benytte følgende kontaktinformasjon: 08 2018-02-28 Nyt dokument-ID, redigering af symboler og beskrivelse izvirajo iz človeškega izvornega materiala, so bile testirane, zanje pa je bilo ugotovljeno, da ne reagirajo na HBsAg, proti- Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision 2. Lassen Sie das Fläschchen 15 Minuten lang eine Temperatur zwischen 15 °C und 30 °C (59–86 °F) annehmen. 09 2019-01-23 Komplet ændring af brugsanvisning med layout. Fjernelse af HemoCue® Urine HCV in proti-HIV. Vendar pa nobena testna metoda ne more nuditi popolnega zagotovila, da izdelki, pridobljeni iz and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of 3. Schütteln Sie das Fläschchen direkt vor der Verwendung mindestens 30 Sekunden lang mit der Hand, um den Inhalt Albumin- system fra afsnittet om tilsigtet anvendelse og forventede værdier. Tilføjelse človeškega izvornega materiala, ne prenašajo povzročiteljev okužb. Eurotrol B.V. albumin. vollständig zu durchmischen. af litauisk og russisk oversættelse. 3. Tega proizvoda ne smete odlagati v zabojnike s splošnimi odpadki. Za primerne načine odlaganja proizvoda se posvetujte 4. Halten Sie das Fläschchen aufrecht und tippen Sie auf den Deckel, um Flüssigkeit aus der Tropfspitze zu entfernen Keplerlaan 20, 6716 BS Ede, Nederland z lokalnimi okoljevarstvenimi organi. Summary and Principle (Abbildung 1). Telefon +31 318 695 777 Alle varemærker tilhører deres respektive ejere. © 2019, Eurotrol B.V. Eurotrol AlbuTrol® is a quality control material available at two levels, each with a known albumin concentration. Eurotrol Shranjevanje in obstojnost 5. Öffnen Sie den Deckel vorsichtig, ohne das Fläschchen zusammenzudrücken (Abbildung 2). E-post office@eurotrol.com Käyttötarkoitus AlbuTrol® may be used in the periodic verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® je treba hraniti v hladilniku pri temperaturi 2–8 °C (36–46 °F). Če ga pri tej temperaturi shranjujete 6. Verwerfen Sie den ersten Tropfen Qualitätskontrollflüssigkeit. www.eurotrol.com Eurotrol AlbuTrol® on ammattilaiskäyttöön tarkoitettu ja testattu albumiinin kontrollimateriaali, jonka avulla Please refer to local guidelines for recommended frequency of use. neodprtega, je njegova stabilnost zagotovljena do datuma izteka roka uporabnosti, navedenega na viali ter na zunanji 7. Geben Sie einen Tropfen auf eine hydrophobe Oberfläche und führen Sie unverzüglich eine Messung durch, wie im Eventuelle alvorlige hendelser som har oppstått i forbindelse med enheten, må rapporteres til produsenten og den relevante tarkastetaan HemoCue® Albumin 201 -järjestelmien tarkkuus ja virheettömyys. Eurotrol AlbuTrol® -tuotetta käytetään embalaži. Po odprtju bo Eurotrol AlbuTrol® ostal stabilen 30 dni, če ga shranjujete pri temperaturi 2–8 °C (36–46 °F). Reagents Handbuch für den Analysator beschrieben. myndigheten i medlemslandet der brukeren og/eller pasienten befinner seg. albumiinin kvantitatiiviseen määrittämiseen. Eurotrol AlbuTrol® is provided at two physiologically relevant levels. Each vial contains 1.0 mL of human urine containing 8. Entfernen Sie nach der Entnahme jegliche Qualitätskontrollflüssigkeit mit einem sauberen Tuch vom farbigen Deckel und Postopek verschließen Sie das Fläschchen ordnungsgemäß. Revisjonshistorikk Yleiskuvaus ja toimintaperiaate 1. Za optimalno delovanje morate z izdelkom rokovati kot z vzorcem bolnika in upoštevati navodila za uporabo sistemov albumin. Eurotrol AlbuTrol® -laadunvalvontamateriaalia on saatavana kahdella tasolla, ja kummankin tuotteen albumiinipitoisuus 9. Bewahren Sie das Fläschchen nach dem Einsatz unter den vorgegebenen Lagerungsbedingungen auf. Dieses gesamte Revisjon Ikrafttredelsesdato Endring fra forrige revisjon HemoCue® Albumin 201. Warnings and Precautions Verfahren ist jedes Mal nach der Entnahme des Qualitätskontrollfläschchens aus der Lagerung zu wiederholen, solange tunnetaan. Eurotrol AlbuTrol® -tuotetta voidaan käyttää HemoCue® Albumin 201 -järjestelmän tarkkuuden ja virheettömyyden 2. Prilagodite vialo sobni temperaturi tako, da jo 15 minut pustite stati na temperaturi med 15 in 30 °C (59–86 °F). 05 2006-02-10 Fullstendig revidert etter endring fra HemoCue AlbuTrol til Eurotrol AlbuTrol 1. For in vitro diagnostic use only. der Verwendungszeitraum nach Öffnung nicht abgelaufen ist. määräaikaistarkastuksiin. Tarkista tuotteen suositeltavat käyttövälit paikallisista ohjeistuksista. 3. Vialo tik pred uporabo v roki stresajte vsaj 30 sekund, da se njena vsebina popolnoma premeša. 06 2011-09-26 Revidert avsnittet «Forventede resultater» og produsent. Lagt til setning i avsnittet 2. Caution: Eurotrol AlbuTrol® is prepared from human urine and contains human source material. Components of the Reagenssit 4. Držite vialo v pokončnem položaju in se dotaknite pokrovčka, da odstranite tekočino iz konice kapalke (Slika 1). Einschränkungen «IVD-medisinsk utstyr» control, which are derived from human source material, have been tested and found to be non-reactive for HBsAg, anti- Eurotrol AlbuTrol® -tuotetta toimitetaan kahdella fysiologisesti relevantilla tasolla. Kukin pullo sisältää 1,0 ml ihmisen virtsaa, 5. Previdno odvijte pokrovček, ne da bi stisnili viale (Slika 2). HCV and anti-HIV. However, no test method can offer complete assurance that products derived from human source 1. Das Qualitätskontrollmaterial darf nicht über den Verwendungszeitraum nach Öffnung oder über das Ablaufdatum hinaus 07 2013-12-04 Lagt til ungarsk og kroatisk oversettelse joka sisältää albumiinia. 6. Zavrzite prvo kapljico tekočine za nadzor kakovosti. material are free from infectious agents. eingesetzt werden. 08 2018-02-28 Ny dokument-ID, redigering av symboler og beskrivelse 7. Nanesite kapljico na hidrofobno površino in jo takoj uporabite za merjenje, kot je označeno v uporabniškem priročniku 3. This product should not be disposed of in general waste. Consult local environmental authorities for proper disposal. 2. Eurotrol AlbuTrol® darf nicht als Kalibrator/Standard eingesetzt werden. 09 2019-01-23 Fullstendig revisjon av bruksanvisning, inkludert layout. Fjernet HemoCue® Urine Varoitukset ja varotoimet analizatorja. 3. Die Wertebereiche für dieses Produkt sind nur als Richtwert zu verstehen. Jedes Labor sollte seine Referenzbereiche Albumin-system fra «Tiltenkt bruk» og «Forventede verdier». Lagt til litauisk og russisk 1. Vain in vitro -diagnostiikkaan. Storage and stability 8. Po odvzemu vzorca z barvnega pokrovčka s čisto krpo popivnajte vsakršno tekočino za nadzor kakovosti in pokrovček entwickeln, die auf dem eigenen Testsystem und den eigenen Toleranzgrenzen basieren. oversettelse. 2. Varoitus: Eurotrol AlbuTrol® -tuote on valmistettu ihmisen virtsasta ja sisältää ihmisperäistä materiaalia. Kontrollin Eurotrol AlbuTrol® must be stored in the refrigerator at 2–8 °C (36–46 °F). Stored unopened at this temperature, stability it is ustrezno zaprite. ihmisperäiset komponentit on testattu eivätkä ne reagoi HBsAg-, anti-HCV- ja anti-HIV -vasta-aineisiin. Mikään 9. Po uporabi vrnite vialo na mesto, ki izpolnjuje pogoje shranjevanja. Celoten postopek morate v dovoljenem času odprtja guaranteed until the expiration date as indicated on the vial and the outer box. After opening, Eurotrol AlbuTrol® is stable for Referenzwerte Alle varemerker tilhører de respektive eierne. © 2019, Eurotrol B.V. Der auf dem beiliegenden Test-Blatt genannte mittlere Assay-Wert wurde anhand wiederholter Analysen auf werksseitig testimenetelmä ei kuitenkaan voi antaa täyttä varmuutta, että ihmisperäisessä materiaalissa ei ole tartunnanaiheuttajia. viale ponoviti vsakič, kot odvzamete tekočino za nadzor kakovosti z mesta shranjevanja. 30 days stored at 2–8 °C (36–46 °F). Utilisation prévue 3. Tuotetta ei saa hävittää sekajätteenä. Tarkista oikea hävitystapa paikalliselta ympäristöviranomaiselta. kalibrierten HemoCue® Albumin 201 Systemen ermittelt und ist chargenspezifisch. Procedure Eurotrol AlbuTrol® est un matériel de contrôle du dosage de l’albumine étalonné destiné à un usage Omejitve Für weitere Informationen und/oder technische Unterstützung wenden Sie sich bitte an: Säilytys ja stabiilius 1. Materiala za nadzor kakovosti ne smete uporabljati po poteku dovoljenega časa odprtja viale ali po datumu izteka roka 1. For optimal performance the product should be treated as a patient sample and instructions for use of the HemoCue® professionnel pour le contrôle de l’exactitude et de la précision du système HemoCue® Albumin 201. Eurotrol AlbuTrol® est Eurotrol AlbuTrol® on säilytettävä jääkaapissa 2–8 °C:n (36–46 °F:n) lämpötilassa. Jos tuotetta säilytetään avaamattomana uporabnosti. Albumin 201 system should be followed. destiné à la détermination quantitative de l’albumine. tässä lämpötilassa, se pysyy stabiilina pulloon ja ulkopakkaukseen merkittyyn viimeiseen käyttöpäivämäärään asti. Avattu 2. Eurotrol AlbuTrol®-a se ne sme uporabljati kot sredstvo za umerjanje/standard. 2. Equilibrate the vial for 15 minutes to a temperature of 15 to 30°C (59–86°F). Eurotrol B.V. Résumé et principe Eurotrol AlbuTrol® on stabiili 30 päivän ajan, kun sitä säilytetään 2–8 °C:ssa (36–46 °F:ssa). 3. Razponi izdelka so zgolj smernice, zato morajo laboratoriji opredeliti razpone na podlagi svojega testnega sistema in 3. Directly before use, shake the vial by hand for at least 30 seconds to completely mix the contents. Keplerlaan 20, 6716 BS Ede, Niederlande Eurotrol AlbuTrol® est un matériel de contrôle de qualité à deux niveaux contenant chacun une concentration connue 4. Hold the vial in an upright position and tap the cap to remove liquid from the dropper tip (Figure 1.). Tel. +31 318 695 777 Käyttöohjeet omejitev odstopanj. d’albumine. Eurotrol AlbuTrol® peut être utilisé pour le contrôle périodique de l’exactitude et de la précision du système 5. Open the cap carefully without squeezing the vial (Figure 2.). E-Mail office@eurotrol.com 1. Optimaalisen suorituskyvyn varmistamiseksi tuotetta on käsiteltävä potilasnäytteen tavoin, noudattaen HemoCue® HemoCue® Albumin 201. Se référer aux directives locales pour connaître la fréquence d’utilisation recommandée. Pričakovane vrednosti 6. Discard the first drop of the quality control liquid. www.eurotrol.com Albumin 201 -järjestelmän käyttöohjeita. Povprečna testna vrednost, ki je navedena na priloženi testni poli, je pridobljena iz ponovitev analiz tovarniško umerjenih 7. Apply a drop on a hydrophobic surface and use it immediately for measurement as indicated in the analyzer user manual. Réactifs 2. Anna pullon lämpötilan tasaantua 15 minuutin ajan 15–30 °C:n (59–86 °F:n) lämpötilaan. Alle schwerwiegenden Vorfälle, die in Zusammenhang mit diesem Produkt auftreten, sind dem Hersteller sowie den sistemov HemoCue® Albumin 201 in je odvisna od serije. 8. After sampling, remove any liquid of the quality control from the colored cap with a clean tissue and recap properly. Eurotrol AlbuTrol® est fourni à deux niveaux physiologiquement pertinents. Chaque flacon contient 1,0 ml d’urine humaine 3. Juuri ennen kuin käytät valmistetta, ravista pulloa käsin vähintään 30 sekuntia ja varmista, että valmiste on sekoittunut zuständigen Behörden des Mitgliedsstaats zu melden, in dem der Anwender und/oder der Patient angesiedelt sind. contenant de l’albumine. Za dodatne informacije in/ali tehnično podporo se obrnite na: 9. Return to indicated storage conditions after use. The entire procedure has to be repeated every time upon removing the kokonaan. quality control from storage during the entire open-vial time period. Revisionsprotokoll Mises en garde et précautions 4. Pidä pulloa pystyasennossa ja poista tiputuskärjessä oleva neste napauttamalla korkkia (kuva 1). Revision Gültigkeitsdatum Änderungen gegenüber voriger Revision 1. Exclusivement à usage diagnostique in vitro. 5. Avaa korkki varovasti puristamatta pulloa (kuva 2). Eurotrol B.V. Limitations 6. Hylkää ensimmäinen kontrolliliuostippa. Keplerlaan 20, 6716 BS Ede, Nizozemska 05 2006-02-10 Vollständige Überarbeitung nach dem Wechsel von HemoCue AlbuTrol zu Eurotrol 2. Avertissement : Eurotrol AlbuTrol® est préparé au départ d’urine humaine et contient du matériel d’origine humaine. Les 1. The quality control material should not be used past open-vial time period or expiration date. 7. Tipauta yksi tippa kontrolliliuosta vettähylkivälle pinnalle ja käytä se heti mittaukseen. Noudata analysaattorin käyttöohjeita. Telefon +31 318 695 777 AlbuTrol composants du contrôle, dérivés de matériel d’origine humaine, ont été testés et trouvés non réactifs pour l’antigène HBs 2. Eurotrol AlbuTrol® is not to be used as a calibrator / standard. 8. Kun näyte on otettu, poista mahdolliset kontrolliliuoksen jäämät värillisestä korkista puhtaalla liinalla ja sulje korkki E-mail office@eurotrol.com 3. The ranges of the product are intended only as a guideline and laboratories should determine the ranges based on their 06 2011-09-26 Überarbeitung des Abschnitts „Referenzwerte“ und Hersteller. Angabe zum „In-vitro- et les anticorps anti-HCV et anti-VIH. Néanmoins, aucune méthode de test ne peut fournir une garantie totale que les Diagnostikum“ hinzugefügt produits dérivés de matériel d’origine humaine sont exempts d’agents infectieux. huolellisesti. www.eurotrol.com own test system and tolerance limits. 9. Palauta tuote käytön jälkeen säilytyspaikkaan, joka täyttää tuotetiedoissa ilmoitetut vaatimukset. Samat toimenpiteet on 07 2013-12-04 Übersetzung ins Ungarische und Kroatische hinzugefügt 3. Ne pas éliminer ce produit avec les ordures ménagères. Consulter les autorités locales responsables de l’environnement Vsak resen dogodek, ki se je zgodil v zvezi z napravo, je treba sporočiti proizvajalcu in pristojnemu organu države članice, v Expected values pour connaître la manière de les éliminer. toistettava kontrolliliuoksen koko säilytysajan jokaisella kerralla, kun kontrolliliuos otetaan säilytyspaikasta. kateri živi uporabnik in/ali pacient. 08 2018-02-28 Neue Dokument-ID, Bearbeitung von Symbolen und Beschreibung The mean assay value provided on the enclosed assay sheet is derived from replicate analyses on factory calibrated 09 2019-01-23 Vollständige Überarbeitung der Anleitung einschließlich Layout. Entfernung des Conservation et stabilité Rajoitukset Zgodovina revizij HemoCue® Albumin 201 systems and are batch specific. HemoCue® Urine Albumin Systems aus den Abschnitten „Zweckbestimmung“ und Eurotrol AlbuTrol® doit être conservé au réfrigérateur à 2–8 °C (36–46 °F). Si le produit est conservé non ouvert à cette 1. Laadunvalvontamateriaalia ei saa käyttää, jos avatun pullon käyttöaika tai viimeinen käyttöpäivä on ohi. Revizija Datum začetka veljavnosti Sprememba prejšnje revizije For further information and/or technical assistance, please contact: „Referenzwerte“. Übersetzung ins Litauische und Russische hinzugefügt. température, sa stabilité est garantie jusqu’à la date de péremption indiquée sur les flacons et sur la boîte. Après ouverture, 2. Eurotrol AlbuTrol® -tuotetta ei saa käyttää kalibraattorina tai standardina. 3. Tuotteen käyttötasot on tarkoitettu vain ohjeellisiksi, ja laboratorioiden on määritettävä tasot omien testijärjestelmiensä ja 05 2006-02-10 Popolnoma revidirano po spremembi iz HemoCue AlbuTrol v Eurotrol AlbuTrul Alle Marken sind Eigentum ihrer jeweiligen Inhaber. © 2019, Eurotrol B.V. Eurotrol AlbuTrol® est stable pendant 30 jours à 2–8 °C (36–46 °F). Eurotrol B.V. toleranssirajojensa perusteella. 06 2011-09-26 Revidirano poglavje "Pričakovani rezultati" in proizvajalec. Dodana izjava v Avsedd användning Procédure poglavju "Medicinski pripomoček za in vitro diagnostiko" Keplerlaan 20, 6716 BS Ede, The Netherlands Odotettavissa olevat arvot Eurotrol AlbuTrol® är en analyserad albuminkontroll avsedd för yrkesmässig användning för att 1. Pour des performances optimales, le produit doit être traité comme un échantillon provenant d’un patient et en respectant 07 2013-12-04 Dodana madžarski in hrvaški prevod Phone +31 318 695 777 Oheisessa määritystaulukossa ilmoitettu keskiarvo on peräisin tehdaskalibroiduilla HemoCue® Albumin 201 -järjestelmillä verifieraHemoCue® Albumin 201-systemets precision och noggrannhet. Eurotrol AlbuTrol® är avsett för le mode d’emploi du système HemoCue® Albumin 201. 08 2018-02-28 Nova identifikacijska številka dokumenta, sprememba simbolov in opisov E-mail office@eurotrol.com tehdyistä rinnakkaismäärityksistä, ja ne ovat eräkohtaisia. kvantitativ bestämning av albumin. 2. Équilibrer le flacon pendant 15 minutes pour le laisser atteindre une température de 15 à 30 C (59–86 °F). 09 2019-01-23 Celostna revizija navodil za uporabo, vključno s postavitvijo. Izbris sistema www.eurotrol.com Sammanfattning och princip 3. Immédiatement avant utilisation, agiter manuellement le flacon pendant au moins 30 secondes afin de bien en Lisätiedot ja/tai tekninen tuki: HemoCue® Urine Albumin iz poglavja "Predvideni način uporabe" in "Pričakovane Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent homogénéiser le contenu. Eurotrol AlbuTrol® är en kontrollösning som är tillgänglig i två nivåer; båda med kända albuminkoncentrationer. Eurotrol vrednosti". Dodana litovski in ruski prevod. authority of the member state where the user and/or the patient is established. 4. Maintenir le flacon verticalement et tapoter le capuchon pour éliminer le liquide de l’embout compte-gouttes (Figure 1). AlbuTrol® kan användas för att regelbundet verifiera HemoCue® Albumin 201-systemets precision och noggrannhet.Se lokala Eurotrol B.V. Vse blagovne znamke so last njihovih lastnikov. © 2019, Eurotrol B.V. Revision history rekommendationer för hur ofta kontrollösningen ska användas. 5. Ouvrir délicatement le capuchon sans presser le flacon (Figure 2). Keplerlaan 20, 6716 BS Ede, Alankomaat 6. Éliminer la première goutte du liquide de contrôle de qualité. Puhelin +31 318 695 777 Uso previsto Revision Effective Date Change to previous revision Reagens 7. Appliquer une goutte sur une surface hydrophobe et l’utiliser immédiatement pour procéder à une mesure comme décrit Sähköposti office@eurotrol.com Eurotrol AlbuTrol® es un control de albúmina ensayado destinado al uso profesional para la verificación de la 05 2006-02-10 Revised completely after change from HemoCue AlbuTrol to Eurotrol AlbuTrol Eurotrol AlbuTrol® är tillgängligt i två fysiologiskt relevanta nivåer. Varje ampull innehåller 1,0 ml human urin innehållande precisión y la exactitud del sistema HemoCue® Albumin 201. Eurotrol AlbuTrol® está diseñado para la determinación dans le mode d’emploi de l’analyseur. www.eurotrol.com 06 2011-09-26 Revised section ‘Expected results’ and manufacturer. Added statement in section ‘IVD albumin. cuantitativa de la albúmina. 8. Après prélèvement de l’échantillon, essuyer le liquide de contrôle de qualité du capuchon coloré avec un linge propre et Medical Device’ Laitteeseen liittyvät vakavat ongelmat on ilmoitettava valmistajalle ja käyttäjän ja/tai potilaan oleskelumaan toimivaltaiselle Varningar och försiktighet reboucher soigneusement le flacon. Resumen y principio 07 2013-12-04 Addition of Hungarian and Croatian translation 9. Le replacer dans les conditions de conservation indiquées après usage. Répéter l’ensemble de la procédure chaque fois viranomaiselle. 1. Endast för in vitro-diagnostiskt bruk. Eurotrol AlbuTrol® es una solución de control de calidad disponible en dos niveles, cada uno de ellos con una concentración 08 2018-02-28 New document ID, editing of symbols and description que l’on doit prélever du matériel de contrôle de qualité pendant la durée de conservation du flacon après ouverture. Versiohistoria 2. Försiktighet! Eurotrol AlbuTrol® framställs av human urin och innehåller annat material av humant ursprung. de albúmina conocida. Eurotrol AlbuTrol® puede utilizarse en la verificación periódica de la precisión y la exactitud del 09 yyyy-mm-dd Complete revision of IFU including layout. Removal of HemoCue ® Urine Albumin System Komponenterna i kontrollen, som härrör från material av humant ursprung, har testats och visat sig vara icke-reaktiva med Révision Date d’entrée en vigueur Modification par rapport à la version précédente sistema HemoCue® Albumin 201. Consulte las directrices locales para conocer la frecuencia de uso recomendada. from ‘Intended use’ and ‘Expected values’. Addition of Lithuanian and Russian translation. Limites avseende på HBsAg och antikroppar mot HCV respektive HIV. Ingen testmetod kan dock fullständigt garantera att 1. Ne pas utiliser le matériel de contrôle de qualité au-delà de la durée de conservation après ouverture du flacon ou de sa 05 2006-02-10 Tarkastettu ja muutettu kokonaan, kun HemoCue AlbuTrol vaihdettiin Eurotrol All trademarks are the property of their respective owners. © 2019, Eurotrol B.V. Reactivos produkter som härrör från material av humant ursprung är fria från smittämnen. date de péremption. AlbuTrol -nimikkeeseen. Eurotrol AlbuTrol® se proporciona en dos niveles fisiológicamente relevantes. Cada vial contiene 1,0 ml de orina humana con Toepassing 3. Denna produkt får ej läggas bland hushållsavfall. Kontakta lokala miljömyndigheter för anvisningar om korrekt 2. Eurotrol AlbuTrol® n’est pas destiné à être utilisé comme calibrateur/standard. 06 2011-09-26 Muutettu lukua ‘Odotettavissa olevat tulokset’ ja valmistajan tietoja. Lisätty albúmina. Eurotrol AlbuTrol® is een geanalyzeerd kwaliteitscontrolemateriaal voor professioneel gebruik bij het controleren avfallshantering. 3. Les plages de valeurs du produit sont fournies à titre purement indicatif et il appartient à chaque laboratoire de déterminer lausunto lukuun ‘In vitro -diagnostiikkaan tarkoitettu lääkinnällinen laite’ van de nauwkeurigheid en precisie van het HemoCue® Albumin 201 systeem. Eurotrol AlbuTrol® is bedoeld voor de les intervalles en se basant sur son propre système de test et ses propres limites de tolérance. 07 2013-12-04 Lisätty unkarin- ja kroatiankieliset käännökset Advertencias y precauciones Förvaring och stabilitet kwanititatieve bepaling van albumine. 1. Usar solamente para diagnóstico in vitro. Eurotrol AlbuTrol® måste förvaras i kylskåp vid 2–8 °C (36–46 °F). När den förvaras oöppnad vid denna temperatur Valeurs attendues 08 2018-02-28 Uusi asiakirjatunnus, muokattu symboleja ja kuvauksia 2. Precaución: Eurotrol AlbuTrol® está fabricado con orina humana y contiene material de origen humano. Se han analizado Samenvatting en principe garanteras stabiliteten fram till det utgångsdatum som anges på ampullerna och ytterkartongen. När Eurotrol AlbuTrol® har La valeur moyenne du test indiquée sur la fiche de test provient d’analyses répétées sur des systèmes HemoCue® Albumin 09 2019-01-23 Käyttöoppaan täydellinen tarkistus, asettelu mukaan lukien. Poistettu HemoCue® los componentes de control derivados de material de origen humano y se ha demostrado que no reaccionan a HBsAg, Eurotrol AlbuTrol® is een kwaliteitscontrolemateriaal beschikbaar in twee niveaus, elk met een bekende öppnats är den stabil vid 2–8 °C (36–46 °F) i 30 dagar. 201 calibrés en usine et sont spécifiques de ce lot du produit. Urine Albumin -järjestelmä luvuista ‘Käyttötarkoitus’ ja ‘Odotettavissa olevat arvot’. anti-VHC ni anti-VIH. Sin embargo, ningún método puede garantizar con total seguridad que los productos derivados de albumineconcentratie. Eurotrol AlbuTrol® is bedoeld voor de periodieke controle van de precisie en nauwkeurigheid van het Förfarande Lisätty liettuan- ja venäjänkieliset käännökset. material de origen humano no contengan agentes infecciosos. Pour des informations supplémentaires ou une assistance technique, veuillez contacter : HemoCue® Albumin 201 syteem. Raadpleeg de lokale richtlijnen voor de aanbevolen gebruiksfrequentie. 1. För optimal prestanda ska produkten hanteras som ett patientprov och bruksanvisningen för HemoCue® Albumin 201- Kaikki tavaramerkit ovat omistajiensa yksityisomaisuutta. © 2019, Eurotrol B.V. 3. Este producto no debe desecharse con los residuos generales. Póngase en contacto con las autoridades Reagentia systemet ska följas. Eurotrol B.V. medioambientales locales para obtener información sobre su correcta eliminación. 2. Ekvilibrera flaskan i 15 minuter till en temperatur på 15 till 30 °C (59–86 °F). Uso previsto Eurotrol AlbuTrol® bestaat uit twee fysiologisch relevante niveaus, elk flesje bevat 1.0 mL menselijke urine met albumine. Keplerlaan 20, 6716 BS Ede, Pays-Bas Eurotrol AlbuTrol® è un materiale per il controllo dell’albumina, per uso professionale, per la verifica della Conservación y estabilidad 3. Precis före användning ska ampullen skakas för hand i minst 30 sekunder tills innehållet är helt blandat. Téléphone +31 318 695 777 Waarschuwingen en voorzorgsmaatregelen precisione e dell'accuratezza del sistema HemoCue® Albumin 201. Eurotrol AlbuTrol® è progettato per la determinazione Eurotrol AlbuTrol® debe conservarse en el frigorífico a 2-8 °C (36–46 °F). Si se conserva sin abrir a esta temperatura, se 4. Håll flaskan upprätt och knacka på locket för att få bort vätskan ur droppflaskans spets (figur 1). Courriel office@eurotrol.com garantiza la estabilidad hasta la fecha de caducidad indicada en el vial y en el embalaje exterior. Tras la apertura, Eurotrol 1. Voor in-vitro diagnostisch gebruik. 5. Öppna locket försiktigt utan att klämma ihop flaskan (figur 2). quantitativa dell'albumina. 2. Waarschuwing: Eurotrol AlbuTrol® is vervaardigd uit menselijke urine en bevat materiaal afkomstig van menselijk weefsel. www.eurotrol.com AlbuTrol® es estable a una temperatura de 2-8 °C (36–46 °F) durante 30 días. 6. Kassera den första droppen av kontrollösningen. Riepilogo e principio Componenten van de controlevloeistof die van menselijk weefsel afkomstig zijn, zijn getest en zijn non-reactief voor 7. Applicera en droppe på den hydrofoba ytan och använd den omedelbart för mätning enligt analysatorns bruksanvisning. Tout incident grave survenu en relation avec le dispositif doit être notifié au fabricant et aux autorités compétentes de l’état Eurotrol AlbuTrol® è un materiale per il controllo della qualità disponibile a due livelli, ognuno con una concentrazione di Procedimiento HbsAg, anti-HCV en anti-HIV. Geen enkele testmethode kan echter volledige zekerheid verschaffen dat producten 8. Efter provinsamlingen används en ren torkduk för att ta bort all vätska från kvalitetskontrollens färgade lock och sedan membre dans lequel est établi l’utilisateur et/ou le patient. albumina nota. Eurotrol AlbuTrol® può essere utilizzato per la verifica periodica della precisione e accuratezza del sistema 1. Para obtener un rendimiento óptimo, el producto debe tratarse como una muestra de paciente y se deben seguir las afkomstig van menselijk weefsel geen infectieuze stoffen bevatten. sätts locket noggrant på igen. HemoCue® Albumin 201. Consultare le linee guida locali per la frequenza di utilizzo consigliata. instrucciones de uso del sistema HemoCue® Albumin 201. Historique des révisions 3. Dit product mag niet in het algemene afvalcircuit tercht komen. Raadpleeg de plaatselijke verantwoordelijke instanties voor 9. Efter användning tillämpas återigen de angivna lagringförhållandena. Hela förfarandet måste upprepas varje gång 2. Estabilice el vial durante 15 minutos a una temperatura entre 15 y 30 °C (59–86 °F). verantwoorde afvalverwerking. Révision Date d’entrée en vigueur Modification par rapport à la version précédente Reagenti kvalitetskontrollen har lämnat lagret fram till den tidsgräns som gäller efter att flaskan har öppnats. 3. Inmediatamente antes de su uso, agite con la mano el vial durante al menos 30 segundos para mezclar totalmente su 05 2006-02-10 Entièrement révisé après changement de nom de HemoCue AlbuTrol à Eurotrol Eurotrol AlbuTrol® è fornito a due livelli fisiologicamente significativi. Ogni fiala contiene 1,0 ml di urina umana contenente Opslag en stabiliteit contenido. Begränsningar AlbuTrol albumina. Eurotrol AlbuTrol® dient te worden bewaard in de koelkast bij 2–8 °C (36–46 °F). Indien het product ongeopened wordt 4. Sostenga el vial en posición vertical y golpee ligeramente el tapón para extraer el líquido de la punta del cuentagotas 1. Kontrollösningen ska inte användas efter den tidsgräns som gäller efter att flaskan har öppnats eller efter utgångsdatumet. 06 2011-09-26 Révision de la section «Résultats attendus» et du fabricant. Ajout d’une bewaard bij deze temperatuur is het product gegarandeerd stabiel tot de houdbaarheidsdatum zoals aangegeven op het label Avvertenze e precauzioni (figura 1). 2. Eurotrol AlbuTrol® får ej användas som kalibrerings-/standardlösning. déclaration dans la section «Dispositif médical pour diagnostic in vitro» 5. Abra el tapón con cuidado sin apretar el vial (figura 2). van de fles en doosje. Na openen is het product 30 dagen stabiel, mits het product wordt bewaard bij 2–8 °C (36–46 °F). 1. Esclusivamente per uso diagnostico in vitro. 3. Intervallen för produkten är endast avsedda som riktlinje och laboratoriet ska fastställa intervallen baserat på det egna 07 2013-12-04 Ajout des traductions en hongrois et en croate 2. Attenzione: Eurotrol AlbuTrol® è prodotto da urina umana e contiene materiale di origine umana. I componenti del 6. Descarte la primera gota de la solución de control de calidad. Procedure testsystemet och dess toleransgränser. 08 2018-02-28 Nouveau code d’identification du document, modification des symboles et de leurs controllo, derivati da materiale di origine umana, sono stati analizzati e non è stata individuata reattività HBsAg, anti-HCV e 7. Aplique una gota sobre una superficie hidrófoba y úsela inmediatamente para medir, tal como se indica en el manual del 1. Voor optimale prestaties dient het product te worden behandeld als een patientenmonster en dient de handleiding van het Förväntade värden descriptions anti-HIV. Tuttavia, nessun metodo analitico può offrire la certezza assoluta che i prodotti derivati da materiale di origine usuario del analizador. HemoCue® Albumin 201 systeem gevolgd te worden. Det analyserade medelvärdet som anges i det bifogade analysdokumentet härrör från replikatanalyser av fabrikskalibrerade 09 2019-01-23 Révision complète du mode d’emploi, y compris de sa présentation. Suppression umana siano esenti da agenti infettivi. 8. Después del muestreo, elimine cualquier líquido restante de solución de control de calidad del tapón de color con un 2. Laat de fles gedurende 15 minuten op een tempertatuur van 15 tot 30°C (59–86°F) komen. HemoCue® Albumin 201-system och är batchspecifika. de système HemoCue® Urine Albumin dans les sections «Utilisation prévue» et 3. Il prodotto non deve essere smaltito nei rifiuti generici. Per un corretto smaltimento, consultare le autorità ambientali locali. pañuelo limpio y coloque de nuevo el tapón correctamente. 3. Direct voor gebruik dient het flesje handmatig geschud te worden voor tenminste 30 seconden om de inhoud volledig te «Valeurs attendues». Ajout des traductions en lituanien et en russe. 9. Después de usarlo, vuelva a guardarlo en las condiciones de conservación indicadas. Todo este procedimiento debe mengen. För mer information och/eller teknisk hjälp, kontakta: Conservazione e stabilità repetirse cada vez que se retire el control de calidad de su lugar de almacenaje durante el período completo de tiempo de 4. Houd de fles rechtop en tik tegen de dop om de vloeistof uit de druppelaar te verwijderen (Afbeelding 1.). Toutes les marques de commerce sont la propriété de leur détenteur respectif. © 2019, Eurotrol B.V. Eurotrol AlbuTrol® deve essere conservato in frigorifero a 2–8 °C (36–46 °F). Se il prodotto è conservato chiuso a questa apertura del vial. 5. Open de dop voorzichtig zonder in de fles te knijpen (Afbeelding 2.). Eurotrol B.V. temperatura la stabilità è garantita fino alla data di scadenza indicata sul flaconcino e sulla confezione esterna. Dopo Tilsigtet anvendelse 6. Gooi de eerste druppel van de kwaliteitscontrolevloeistof weg. Keplerlaan 20, 6716 BS Ede, Nederländerna l’apertura, Eurotrol AlbuTrol® è stabile per 30 giorni conservato a 2–8 °C (36–46 °F). Limitaciones Eurotrol AlbuTrol® er en analyseret albuminkontrol, der er beregnet til professionel anvendelse i kontrollen af 7. Breng een druppel op een hydrofoob oppervlak en gebruik het meteen voor analyse volgens de aanwijzingen in de Telefon +31 318 695 777 1. La solución de control de calidad no debe usarse tras el vencimiento del período de tiempo de apertura del vial o la fecha HemoCue® Albumin 201-systemets præcision og nøjagtighed. Eurotrol AlbuTrol® er beregnet til kvantitativ bestemmelse af Procedura gebruiksaanwijzing van het analyse instrument. E-post office@eurotrol.com de caducidad. albumin. 1. Per garantire prestazioni ottimali, il prodotto deve essere trattato come un comune campione del paziente, seguendo le 8. Na gebruik, verwijder de vloeistof van de gekleurde dop met een schone tissue en sluit de fles. www.eurotrol.com 2. Eurotrol AlbuTrol® no debe utilizarse como calibrador/estándar. istruzioni per l'uso del sistema HemoCue® Albumin 201. 9. Sla het product op bij de aanbevolen temperatuur. Herhaal de hele procedure elke keer dat het product uit de opslag wordt Sammendrag og princip 3. Los intervalos del producto solo sirven de guía, por lo que los laboratorios deben determinar los intervalos en función de Eventuell allvarlig incident som uppkommer med produkten ska rapporteras till tillverkaren och behörig tillsynsmyndighet i det 2. Equilibrare il flaconcino per 15 minuti a temperature comprese tra 15 e 30 °C (59 -86 °F). gehaald tijdens de hele periode dat het product in gebruik is. Eurotrol AlbuTrol® er et kvalitetskontrolmateriale, som fås på to niveauer, der hver har en kendt albuminkoncentration. su sistema de análisis y sus límites de tolerancia. land där användaren och/eller patienten befinner sig. 3. Direttamente prima dell'uso, agitare manualmente il flaconcino per almeno 30 secondi per miscelare completamente il Eurotrol AlbuTrol® kan bruges i forbindelse med den regelmæssige kontrol af HemoCue® Albumin 201-systemets præcision Limitatities contenuto. Valores esperados Revideringshistorik og nøjagtighed. De lokale retningslinjer indeholder information om den anbefalede brugshyppighed. 1. Het kwaliteitscontrolemateriaal dient na het verlopen van de houdbaarheidsdatum niet meer gebruikt te worden. 4. Tenere il flaconcino in posizione verticale e picchiettare sul tappo per rimuovere il liquido dalla punta del contagocce El valor de ensayo medio facilitado en la hoja de ensayo adjunta se ha obtenido a partir de repetic Revisie Ingangsdatum Change to previous revision Reagenser m m m 2. Eurotrol AlbuTrol® is niet bedoeld om gebruikt te worden als kalibrator of standaard. (Figura 1.). 05 2006-02-10 Fullständigt reviderat efter ändring av HemoCue AlbuTrol till Eurotrol AlbuTrol Eurotrol AlbuTrol® fås på to fysiologisk relevante niveauer. Hvert hætteglas indeholder 1,0 ml human urin indeholdende 5. Aprire il tappo con cautela senza comprimere il flaconcino (Figura 2.). 3. De waardes die zijn toegekend aan het product dienen enkel als richtlijn; laboratoria dienen zelf ranges vast te stellen m m gebaseerd op hun eigen testsysteem en bijbehorende tolerantie limieten. 06 2011-09-26 Reviderat avsnitt ”Förväntade resultat” och tillverkare. Tillagd angivelse i avsnittet ”Medicinteknisk albumin. 6. Scartare la prima goccia di liquido per il controllo della qualità. produkt för in vitro-diagnostik” 7. Applicare una goccia su una superficie idrofobica e utilizzarla immediatamente per la misurazione come indicato nel Verwachte waardes Advarsler og forsigtighedsregler 07 2013-12-04 Tillägg av ungersk och kroatisk översättning manuale dell'utilizzatore dell'analizzatore. De gemiddelde testwaarde zoals vermeld op de bijgesloten assay sheet is gebaseerd op meerdere metingen met in de fabriek 1. Kun til diagnostisk anvendelse in vitro. 08 2018-02-28 Nytt dokument-ID, redigering av symboler och beskrivning 2. Forsigtig: Eurotrol AlbuTrol® er fremstillet af human urin og indeholder materiale af human oprindelse. Kontrollens 8. Dopo il campionamento, rimuovere dal tappo colorato ogni residuo di liquido per il controllo della qualità usando un panno gekalibreerde HemoCue® Albumin 201 systemen. pulito e tappare di nuovo correttamente. 09 2019-01-23 Fullständig revidering av bruksanvisningen, inklusive layout. Borttagning av HemoCue® Urine bestanddele, der er udledt af materiale af human oprindelse, er blevet testet og konstateret ikke-reaktive for HBsAg, anti- @ m Neem voor meer informatie contact op met: Albumin-systemet från ”Avsedd användning” och ”Förväntade värden”. Tillägg av litauisk och rysk HCV og anti-HIV. Der findes dog ingen testmetode, som kan give fuldstændig sikkerhed for, at produkter af human 9. Dopo l'uso, riportare alle condizioni di conservazione indicate. Per tutta la durata successiva all'apertura del flaconcino è m översättning. oprindelse er fri for smittestoffer. necessario ripetere l'intera procedura dopo aver rimosso il controllo della qualità dalla sede di stoccaggio. Eurotrol B.V. 3. Dette produkt må ikke kasseres sammen med husholdningsaffaldet. Konsultér de lokale miljømyndigheder vedrørende m Alla varumärken tillhör respektive ägare. © 2019, Eurotrol B.V. Limitazioni Keplerlaan 20, 6716 BS Ede, Nederland m m m korrekt bortskaffelse. 1. Il materiale per il controllo della qualità non deve essere utilizzato dopo il periodo di validità successivo all'apertura del Phone +31 318 695 777 Tiltenkt bruk flaconcino o dopo la data di scadenza. E-mail office@eurotrol.com Eurotrol AlbuTrol® er et analysert albuminkontrollmateriale til profesjonell bruk som brukes til verifisering av Opbevaring og stabilitet Eurotrol AlbuTrol® skal opbevares i køleskab ved 2-8 °C (36–46 °F). Stabiliteten er garanteret ved opbevaring uåbnet ved 2. Eurotrol AlbuTrol® non deve essere usato come calibratore/standard. m www.eurotrol.com presisjonen og nøyaktigheten til HemoCue® Albumin 201-systemet. Eurotrol AlbuTrol® er beregnet på kvantitativ 3. I range del prodotto costituiscono esclusivamente linee guida e i laboratori devono determinare range basati sui propri denne temperatur indtil udløbsdatoen, som er anført på hætteglasset og den ydre emballage. Efter åbning er Eurotrol m m bestemmelse av albumin. sistemi analitici e limiti di tolleranza. Elk aan dit product gerelateerd ernstig incident dient te worden gemeld aan de fabrikant of de bevoegde autoriteit van het land AlbuTrol® stabil i 30 dage ved opbevaring ved 2-8 °C (36–46 °F). waar het incident heeft plaatsgevonden en/of waar de patiënt is gevestigd. Sammendrag og prinsipp Risultati previsti m Eurotrol AlbuTrol® er et kvalitetskontrollmateriale som er tilgjengelig på to nivåer, hvert med kjent albuminkonsentrasjon. Procedure Revisie geschiedenis 1. For at opnå optimale resultater skal produktet behandles som en patientprøve, og brugsanvisningen til HemoCue® Il valore medio dei test fornito nel foglietto allegato è derivato da ripetute analisi su sistemi HemoCue® Albumin 201 calibr ati Eurotrol AlbuTrol® kan brukes til periodisk verifisering av presisjonen og nøyaktigheten til HemoCue® Albumin 201-systemet. in fabbrica ed è specifico per il lotto. m m m Revisie Ingangsdatum Change to previous revision Se lokale retningslinjer for anbefalt hyppighet for bruk. Albumin 201-systemet skal følges. 05 2006-02-10 Complete revisie na verandering van HemoCue AlbuTrol to Eurotrol Albutrol. 2. Lad hætteglasset stå i 15 minutter, indtil det har opnået en temperatur på 15-30 °C (59–86 °F). Per ulteriori informazioni e/o assistenza tecnica, contattare: m m 06 2011-09-26 Revisie van de sectie ‘Verwachte waardes’ en manufacturer. Statement in sectie ‘IVD medische Reagenser 3. Ryst hætteglasset med hånden umiddelbart inden brug i mindst 30 sekunder, så indholdet blandes helt. m m m instrumenten’ toegevoegd. Eurotrol AlbuTrol® er tilgjengelig på to fysiologisk relevante nivåer. Hver ampulle inneholder 1,0 ml human urin som 4. Hold hætteglasset lodret, og bank på hætten for at fjerne væske fra pipettespidsen (figur 1). Eurotrol B.V. inneholder albumin. 5. Åbn forsigtigt hætten uden at trykke på hætteglasset (figur 2). Keplerlaan 20, 6716 BS Ede, Paesi Bassi 07 2013-12-04 Toevoeging Hongaarse en Kroatische vertaling. m m 08 2018-02-28 Nieuwe document identificatie, symbolen en omschrijving aangepast. Advarsler og forholdsregler 6. Kassér den første dråbe af kvalitetskontrolvæsken. Telefono +31 318 695 777 1. Kun for bruk ved in vitro-diagnostikk. 7. Placér en dråbe på en vandafvisende overflade, og brug straks dråben til en måling som beskrevet i instrumentets e-mail office@eurotrol.com 09 2019-01-23 Complete revisie IFU en nieuwe layout. Verwijdering van HemoCue® Urine Albumin Systeem uit 2. Forsiktig: Eurotrol AlbuTrol® er tilvirket fra human urin, og inneholder humant kildemateriale. Kontrollkomponenter, som er brugermanual. www.eurotrol.com ‘toepassing’ and ‘verwachte waardes’. Toevoeging van Litouwse en Russische vertaling. tatt fra humant kildemateriale, er blitt testet og funnet å være ikke-reaktive for HBsAg, anti-HCV og anti-HIV. Imidlertid kan 8. Fjern efter målingen eventuel kvalitetskontrolvæske fra den farvede hætte med en ren serviet, og sæt hætten rigtigt på Alle handelsmerken zijn eigendom van hun respectievelijke eigenaars. © 2019, Eurotrol B.V. Ogni incidente grave correlato al dispositivo deve essere segnalato al fabbricante e all'autorità competente dello stato ingen testmetode gi full forsikring om at produkter tatt fra humant kildemateriale er frie for infeksiøse virkestoffer. igen. Anwendungsbereich 9. Sæt materialet tilbage efter brug under de oplyste opbevaringsbetingelser. Hele proceduren skal gentages hver gang membro in cui risiede l'utilizzatore e/o il paziente. 3. Dette produktet må ikke kastes i vanlig avfall. Kontakt lokale miljømyndigheter for å sørge for riktig avfallshåndtering. Eurotrol AlbuTrol® ist ein Referenzmaterial zur Albuminkontrolle für den Einsatz im professionellen Bereich zur kvalitetskontrollen tages frem i hele det tidsrum, hætteglasset er åbent. Cronologia delle revisioni Bestätigung der Präzision und Genauigkeit des Systems HemoCue® Albumin 201. Eurotrol AlbuTrol® dient zur quantitativen Oppbevaring og stabilitet Begrænsninger Revisione Data di entrata in vigore Modifica alla precedente revisione Bestimmung von Albumin. Eurotrol AlbuTrol® må oppbevares i kjøleskapet ved 2–8 °C (36–46 °F). Hvis produktet oppbevares uåpnet ved denne temperaturen, garanteres stabiliteten frem til utløpsdatoen angitt på ampullene og den ytre esken. Etter åpning er Eurotrol 1. Kvalitetskontrolmaterialet må ikke anvendes, når tidsgrænsen for et åbnet hætteglas er nået eller efter udløbsdatoen. 05 2006-02-10 Completamente rivisto dopo variazione da HemoCue AlbuTrol a Eurotrol AlbuTrol Zusammenfassung und Wirkungsweise AlbuTrol® stabilt i 30 dager ved oppbevaring ved 2–8 °C (36–46 °F). 2. Eurotrol AlbuTrol® må ikke anvendes som kalibrator/standard. 06 2011-09-26 Rivisto paragrafo “Risultati previsti” e produttore. Aggiunta frase nel paragrafo Eurotrol AlbuTrol® ist ein Qualitätskontrollmaterial, das es in zwei Level gibt. Jedes Level enthält eine bekannte Albumin- 3. Produktets måleområder skal kun ses som en rettesnor, og laboratoriet skal fastlægge måleområderne på baggrund af “Dispositivo medico IVD” Konzentration. Eurotrol AlbuTrol® wird zur regelmäßigen Bestätigung der Präzision und Genauigkeit des Systems Prosedyre deres egne testsystemer og tolerancegrænser. 07 2013-12-04 Aggiunta della traduzione in ungherese e croato HemoCue® Albumin 201 angewendet. Die empfohlene Anwendungshäufigkeit entnehmen Sie bitte den nationalen 1. For optimal ytelse skal produktet behandles som en pasientprøve, og bruksanvisningen for HemoCue® Albumin 201- Forventede værdier 08 2018-02-28 Nuovo ID del documento, modifica dei simboli e della descrizione Richtlinien. systemet skal følges. 2. Ekvilibrer ampullen i 15 minutter til en temperatur på 15 til 30 °C (59–86 °F). Den gennemsnitlige prøveværdi på det vedlagte prøveark er udledt af gentagne analyser på fabrikskalibrerede HemoCue® 09 2019-01-23 Revisione completa delle Istruzioni per l’uso, incluso il layout. Rimozione del Reagenzien 3. Rist ampullen for hånd i minst 30 sekunder rett før bruk for å blande innholdet godt. Albumin 201-systemer og er specifikke for hver batch. sistema HemoCue® Urine Albumin da “Uso previsto” e “Risultati previsti”. Eurotrol AlbuTrol® gibt es in zwei physiologisch relevanten Level. Jedes Fläschchen enthält 1,0 ml Humanurin mit Albumin. 4. Hold ampullen oppreist, og slå lett på korken for å fjerne væsken fra dryppespissen (figur 1). Aggiunta della traduzione in lituano e russo. 5. Åpne lokket forsiktig uten å klemme på ampullen (figur 2). Tutti i marchi sono proprietà dei rispettivi proprietari. © 2019, Eurotrol B.V. 6. Forkast den første dråpen med kvalitetskontrollvæske. CE CE Manufacturer Producent Date of manufacture Datum van productie Use-by-date Te gebruiken tot en met Batch code Batchcode Catalogue number Referentienummer Temperature limit Temperatuur limiet Caution Opgelet Consult instructions for use Lees de gebruiksaanwijzing In vitro diagnostic medical device In-vitro diagnostisch medisch apparaat Control Kwaliteitscontrole CE CE Hersteller Tillverkare Herstellungsdatum Tillverkningsdatum Verwendbar bis Utgångsdatum Chargenbezeichnung Batchnummer Bestellnummer Katalognummer Temperaturbegrenzungen Temperaturgräns Vorsicht Försiktighet Gebrauchsanweisung beachten Se bruksanvisningen In-vitro-Diagnostikum Medicinteknisk produkt för in vitro-diagnostik Kontrolle Kontroll CE CE Produsent Frabicant Produksjonsdato Date de fabrication Brukes innen-dato Date de péremption Batch-kode Numéro de lot Katalognummer Référence catalogue Temperaturgrense Limites de température Forsiktig Avertissement Se bruksanvisningen Consulter le mode d’emploi Medisinsk utstyr til in vitro-diagnostikk Dispositif médical de diagnostic in vitro Kontroll Contrôle CE CE Producent Valmistaja Produktionsdato Valmistuspäivä Anvendes før Viimeinen käyttöpäivämäärä Batchnummer Eränumero Katalognummer Tuotenumero Temperaturgrænse Lämpötilaraja Forsigtig Varoitus Læs brugsanvisningen Katso ohjeet käyttöoppaasta Medicinsk anordning til in vitro-diagnostik In vitro -diagnostiikkaan tarkoitettu lääkinnällinen laite Kontrol Kontrolli CE CE Produttore Proizvajalec Data di fabbricazione Datum proizvodnje Data di scadenza Rok uporabe Codice del lotto Številka serije Numero di catalogo Kataloška številka Limite di temperatura Omejitev temperature Attenzione Pozor Consultare le istruzioni per l’uso Oglejte si navodila za uporabo Dispositivo medico diagnostico in vitro Medicinski pripomoček za diagnostično uporabo in vitro Controllo Kontrola CE Fabricante Fecha de fabricación Fecha de caducidad Código de lote Número de catálogo Límite de temperatura Precaución Consulte las instrucciones de uso Producto sanitario de diagnóstico in vitro Control Page 1 of 2 Χρήση για την οποία προορίζεται 2. Oprez: Kontrolni uzorak AlbuTrol® tvrtke Eurotrol pripremljen je iz ljudskog urina i sadrži materijale ljudskog porijekla. 3. Непосредственно перед использованием встряхивайте флакон рукой не менее 30 секунд для полного Το Eurotrol AlbuTrol® είναι ένα αναλυόμενο υλικό ελέγχου αλβουμίνης που προορίζεται για επαγγελματική Sastojci kontrolnog uzorka, izvedeni iz materijala ljudskog porijekla, ispitani su, a rezultati pokazuju da su nereaktivni na перемешивания содержимого. χρήση, για την επιβεβαίωση της ακρίβειας και της ορθότητας του συστήματος HemoCue® Albumin 201. Το Eurotrol AlbuTrol® HBsAg, anti-HCV i anti-HIV. Međutim, nijednom se metodom ispitivanja ne može sa stopostotnom sigurnošću utvrditi 4. Держите флакон в вертикальном положении и постучите по колпачку, чтобы удалить жидкость из кончика προορίζεται για τον ποσοτικό προσδιορισμό της αλβουμίνης. sadrže li proizvodi koji potječu od materijala ljudskog porijekla infektivne agense ili ne. капельницы (рисунок 1). 3. Proizvod nije dopušteno odlagati u opći otpad. Obratite se lokalnoj službi za zaštitu okoliša u vezi propisnog odlaganja. 5. Осторожно снимите колпачок, не сжимая флакон (рисунок 2). Περίληψη και αρχή 6. Удалите в отходы первую каплю жидкого препарата контроля качества. Το Eurotrol AlbuTrol® είναι ένα υλικό ελέγχου ποιότητας που διατίθεται σε δύο επίπεδα, κάθε ένα με γνωστή συγκέντρωση Čuvanje i stabilnost 7. Нанесите каплю на гидрофильную поверхность и немедленно используйте ее для измерения, как описано в αλβουμίνης. Το Eurotrol AlbuTrol® μπορεί να χρησιμοποιηθεί για την περιοδική επιβεβαίωση της ακρίβειας και της ορθότητας Kontrolni uzorak AlbuTrol® tvrtke Eurotrol mora se čuvati u hladnjaku na temperaturi od 2 do 8 °C (36–46 °F). Ako se na toj του συστήματος HemoCue® Albumin 201. Ανατρέξτε στις τοπικές οδηγίες για τη συνιστώμενη συχνότητα χρήσης. temperaturi čuva neotvoren, jamči se njegova stabilnost do isteka roka valjanosti koji je označen na bočici i pakiranju. Nakon руководстве по применению анализатора. 8. После отбора пробы удалите остатки жидкого препарата контроля качества с цветного колпачка чистой тканью и otvaranja, kontrolni je uzorak AlbuTrol® tvrtke Eurotrol stabilan 30 dana ako se čuva na temperaturi od 2 do 8 °C (36–46 °F). Αντιδραστήρια тщательно установите колпачок на место. Το Eurotrol AlbuTrol® παρέχεται σε δύο φυσιολογικά σχετικά επίπεδα. Κάθε φιαλίδιο περιέχει 1,0 ml ανθρώπινων ούρων που Postupak 9. После использования верните флакон для хранения в указанных условиях. Всю эту процедуру следует повторять περιέχουν αλβουμίνη. 1. Kako bi se postigli optimalni rezultati, proizvod treba tretirati kao uzorak pacijenta i treba poštovati upute za uporabu каждый раз после извлечения материала контроля качества из места хранения на всем протяжении периода, в sustava HemoCue® Albumin 201. течение которого флакон открыт. Προειδοποιήσεις και προφυλάξεις 1. Αποκλειστικά για in vitro διαγνωστική χρήση. 2. Ekvilibrirajte bočicu 15 minuta na temperaturi od 15 do 30 °C (59–86 °F). 3. Neposredno prije uporabe bočicu protresite rukom najmanje 30 sekundi kako biste potpuno promiješali sadržaj. Ограничения 2. Προσοχή: Το Eurotrol AlbuTrol® παρασκευάζεται από ανθρώπινα ούρα και περιέχει υλικό ανθρώπινης προέλευσης. Τα 1. Материал контроля качества не следует использовать после истечения срока хранения вскрытого флакона или 4. Bočicu držite u uspravnom položaju i dodirnite čep kako biste uklonili tekućinu iz vrha kapaljke (Slika 1). συστατικά του υλικού ελέγχου, τα οποία προέρχονται από υλικό ανθρώπινης προέλευσης, έχουν ελεγχθεί και έχει βρεθεί после даты окончания срока годности. ότι είναι μη αντιδραστικά για το HBsAg, το anti-HCV και το anti-HIV. Ωστόσο, καμία μέθοδος εξέτασης δεν είναι σε θέση να 5. Pažljivo otvorite čep, a da pritom ne stišćete bočicu (Slika 2). 2. Препарат Eurotrol AlbuTrol® не следует использовать для градуировки или в качестве стандарта. 6. Bacite prvu kapljicu tekućine za kontrolu kvalitete. προσφέρει απόλυτη διαβεβαίωση ότι τα προϊόντα που προέρχονται από υλικά ανθρώπινης προέλευσης είναι ελεύθερα 3. Диапазоны применимости препарата даны исключительно в качестве ориентировочных величин; лаборатории 7. Nanesite kapljicu na hidrofobnu površinu i odmah je upotrijebite za mjerenje, kao što je prikazano u priručniku za uporabu λοιμωδών παραγόντων. должны определить диапазоны на основании своей собственной тест-системы и пределов допуска. 3. Αυτό το προϊόν δεν θα πρέπει να απορρίπτεται στα γενικά απόβλητα. Συμβουλευτείτε τις τοπικές περιβαλλοντικές αρχές analizatora. 8. Nakon uzimanja uzorka, s čepa u boji čistom krpicom uklonite svu tekućinu materijala za kontrolu kvalitete te čep pravilno Ожидаемые значения σχετικά με τη σωστή απόρριψη. zatvorite. Среднее значение результата анализа, приведенное на прилагаемом бланке анализа, получено в результате Αποθήκευση και σταθερότητα 9. Nakon uporabe vratiti u navedene uvjete čuvanja. Cijeli je postupak potrebno ponavljati svaki put prilikom uklanjanja многократного исследования в градуированных производителем системах HemoCue® Albumin 201 и зависит от Το Eurotrol AlbuTrol® πρέπει να αποθηκεύεται στο ψυγείο, σε θερμοκρασία 2–8 °C (36–46 °F). Όταν φυλάσσεται κλειστό σε materijala za kontrolu kvalitete iz skladišta tijekom cijelog razdoblja za vrijeme kojeg je bočica otvorena. партии. αυτήν τη θερμοκρασία, η σταθερότητα είναι εγγυημένη έως την ημερομηνία λήψης που αναγράφεται στο φιαλίδιο και το Ograničenja За дополнительной информацией и (или) технической поддержкой обращайтесь по следующему адресу: εξωτερικό κουτί. Μετά το άνοιγμα, το Eurotrol AlbuTrol® είναι σταθερό για 30 ημέρες όταν φυλάσσεται σε θερμοκρασία 2–8 °C 1. Materijal za kontrolu kvalitete ne smije se upotrijebiti nakon dopuštenog razdoblja uporabe otvorene bočice ili isteka roka (36–46 °F). valjanosti. Eurotrol B.V. Διαδικασία 2. Kontrolni uzorak AlbuTrol® tvrtke Eurotrol ne koristi se kao kalibrator/standard. Keplerlaan 20, 6716 BS Ede, Нидерланды 1. Για βέλτιστη απόδοση, θα πρέπει να γίνεται μεταχείριση του προϊόντος ως δείγμα ασθενούς και θα πρέπει να 3. Rasponi proizvoda namijenjeni su samo kao smjernica, a laboratoriji trebaju odrediti vlastite raspone na temelju svojeg Телефон +31 318 695 777 ακολουθούνται οι οδηγίες χρήσης του συστήματος HemoCue® Albumin 201. sustava ispitivanja i dopuštenih odstupanja. Электронная почта office@eurotrol.com 2. Αφήστε το φιαλίδιο να ισορροπήσει επί 15 λεπτά, σε θερμοκρασία 15 έως 30 °C (59–86 °F). www.eurotrol.com 3. Αμέσως πριν από τη χρήση, ανακινήστε το φιαλίδιο με το χέρι επί τουλάχιστον 30 δευτερόλεπτα, ώστε να αναμειχθεί Očekivane vrijednosti Srednje vrijednosti testa na priloženom testnom listu proizlaze iz ponovljenih analiza tvornički kalibriranih sustava HemoCue® Обо всех серьезных происшествиях, которые имели место в связи с использованием этого изделия, следует πλήρως το περιεχόμενο. Albumin 201 te su specifične za određenu seriju. сообщать производителю и компетентным органам государства, в котором находятся пользователь и (или) пациент. 4. Κρατήστε το φιαλίδιο σε όρθια θέση και χτυπήστε ελαφρά το πώμα, για να απομακρύνετε το υγρό από το άκρο του σταγονόμετρου (Εικόνα 1). Za više informacija i/ili tehničku pomoć obratite se: История редакций 5. Ανοίξτε το πώμα προσεκτικά, χωρίς να συμπιέσετε το φιαλίδιο (Εικόνα 2). Редакция Дата вступления в силу Изменение по сравнению с предыдущей редакцией Figure 1, Afbeelding 1, Abbildung 1, Figur 1, Figur 1, Figure 1, Figur 1, Kuva 1, Figura 1, Slika 1, Figura 1, Εικόνα 1, Rysunek 6. Απορρίψτε την πρώτη σταγόνα του υγρού ελέγχου ποιότητας. Eurotrol B.V. 05 2006-02-10 Полностью пересмотрено после замены HemoCue AlbuTrol на Eurotrol 1, Slika 1, 1. Ábra, Рисунок 1, 1 Pav. 7. Εφαρμόστε μια σταγόνα σε μια υδρόφοβη επιφάνεια και χρησιμοποιήστε την αμέσως για μέτρηση, όπως υποδεικνύεται Keplerlaan 20, 6716 BS Ede, Nizozemska AlbuTrol στο εγχειρίδιο χρήσης του αναλυτή. Tel.: +31 318 695 777 06 2011-09-26 Изменены раздел «Ожидаемые результаты» и название производителя. 8. Μετά τη δειγματοληψία, απομακρύνετε τυχόν υγρό από το υλικό ελέγχου ποιότητας από το έγχρωμο πώμα με ένα καθαρό E-pošta: office@eurotrol.com Добавлена фраза в разделе «Медицинское изделие для диагностики in μαντηλάκι και επαναπωματίστε σωστά. www.eurotrol.com vitro» 9. Μετά τη χρήση, επαναφέρετε στις ενδεδειγμένες συνθήκες αποθήκευσης. Όλη η διαδικασία θα πρέπει να επαναλαμβάνεται Svi ozbiljni incidenti koji se dogode u vezi s proizvodom moraju se prijaviti proizvođaču i nadležnom tijelu države članice 07 2013-12-04 Добавлены переводы на венгерский и хорватский языки. κάθε φορά, μετά την αφαίρεση του υλικού ελέγχου ποιότητας από τον χώρο αποθήκευσης, για όλο το χρονικό διάστημα prema sjedištu korisnika i/ili pacijenta. 08 2018-02-28 Обновлен идентификатор документа, изменены символы и описание που το φιαλίδιο θα παραμείνει ανοιχτό. Povijest izmjena 09 2019-01-23 Полностью пересмотрена инструкция по применению, включая разметку Περιορισμοί страниц. Удалено название системы «HemoCue® Urine Albumin» из 1. Το υλικό ελέγχου ποιότητας δεν θα πρέπει να χρησιμοποιείται μετά την παρέλευση του χρονικού διαστήματος διατήρησης Izmjena Datum stupanja na snagu Promjene u odnosu na prethodnu izmjenu разделов «Назначение» и «Ожидаемые значения». Добавлены переводы на του ανοιχτού φιαλιδίου ή της ημερομηνίας λήξης. 05 2006-02-10 Potpuno izmijenjeno nakon prelaska s kontrolnog uzorka AlbuTrol tvrtke HemoCue na kontrolni uzorak AlbuTrol tvrtke Eurotrol литовский и русский языки. 2. Το Eurotrol AlbuTrol® δεν πρέπει να χρησιμοποιείται ως βαθμονομητής / πρότυπο. 3. Τα εύρη τιμών του προϊόντος παρέχονται αποκλειστικά ως κατευθυντήρια οδηγία και τα εργαστήρια θα πρέπει να 06 2011-09-26 Izmijenjeni odjeljci „Očekivani rezultati” i proizvođač. Dodana izjava u odjeljak προσδιορίζουν τα εύρη τιμών, με βάση τα δικά τους συστήματα δοκιμής και όρια ανοχής. „Medicinski proizvod za in vitro dijagnostiku” Все товарные знаки принадлежат их соответствующим владельцам. © 2019, Eurotrol B.V. 07 2013-12-04 Dodan prijevod na hrvatski i mađarski Naudojimo paskirtis Αναμενόμενες τιμές Η μέση τιμή του προσδιορισμού που παρέχεται στο εσώκλειστο φύλο του προσδιορισμού προέρχεται από επαναληπτικές 08 2018-02-28 Nova identifikacijska oznaka dokumenta, uređeni simboli i opis „Eurotrol AlbuTrol®“ yra ištirta albumino kontrolinė medžiaga, skirta profesionaliai naudoti tikrinant „HemoCue® 09 2019-01-23 Potpuno izmijenjene upute za uporabu, uključujući i raspored. Uklonjen sustav Albumin 201“ sistemos tikslumą. „Eurotrol AlbuTrol®“ yra skirta albumino kiekybinei analizei. αναλύσεις σε συστήματα HemoCue® Albumin 201 που έχουν βαθμονομηθεί στο εργοστάσιο και είναι ειδική για κάθε παρτίδα. HemoCue® Urine Albumin iz odjeljaka „Namjena” i „Očekivane vrijednosti”. Santrauka ir principas Για περαιτέρω πληροφορίες ή/και τεχνική βοήθεια, επικοινωνήστε με: Dodan prijevod na litavski i ruski. „Eurotrol AlbuTrol®“ kokybės kontrolės medžiaga būna dviejų lygių, kurių kiekvieno albumino koncentracija yra žinoma. Svi robni žigovi vlasništvo su njihovih vlasnika. © 2019, Eurotrol B.V. „Eurotrol AlbuTrol®“ gali būti naudojama „HemoCue® Albumin 201“ sistemai periodiškai tikrinti. Rekomenduojamas naudojimo Eurotrol B.V. Rendeltetés dažnumas pateikiamas vietinėse rekomendacijose. Keplerlaan 20, 6716 BS Ede, Ολλανδία Αρ. τηλεφώνου +31 318 695 777 Az Eurotrol AlbuTrol® egy professzionális használatra szánt vizsgálati albumin minőség-ellenőrző anyag Reagentai E-mail office@eurotrol.com (kontroll) a HemoCue® Albumin 201 rendszer precizitásának és pontosságának ellenőrzésére. Az Eurotrol AlbuTrol® az „Eurotrol AlbuTrol®“ tiekiama dviejų fiziologiškai susijusių lygių. Kiekviename buteliuke yra 1,0 ml žmogaus šlapimo, kuriame www.eurotrol.com albumin mennyiségének kvantitatív meghatározására szolgál. yra albumino. Οποιοδήποτε σοβαρό περιστατικό που παρουσιάζεται και αφορά τη συσκευή θα αναφέρεται στον κατασκευαστή και στην Összefoglaló és alapelv Įspėjimai ir atsargumo priemonės αρμόδια αρχή του κράτους-μέλους στο οποίο βρίσκεται ο χρήστης ή/και ο ασθενής. Az Eurotrol AlbuTrol® minőség-ellenőrző anyag két, ismert albumin-koncentrációjú szinttel áll rendelkezésre. Az Eurotrol 1. Skirta tik „in vitro“ diagnostikai. AlbuTrol® felhasználható a HemoCue® Albumin 201 rendszer precizitásának és pontosságának rendszeres ellenőrzésére. 2. Dėmesio! „Eurotrol AlbuTrol®“ yra paruošta iš žmogus šlapimo ir jos sudėtyje yra žmogaus medžiagų. Kontrolinės Ιστορικό αναθεωρήσεων Tartsa be a helyi irányelveket az alkalmazás ajánlott gyakoriságára vonatkozóan. medžiagos komponentai yra išskirti iš žmogus medžiagų, jie buvo patikrinti ir reakcija dėl HBsAg, anti-HCV bei anti-ŽIV Αναθεώρηση Ημερομηνία ισχύος Αλλαγή από την προηγούμενη έκδοση buvo neigiama. Tačiau joks tikrinimo metodas negali visiškai užtikrinti, kad produkte, gautame iš žmogaus kilmės Reagensek 05 2006-02-10 Αναθεωρήθηκε πλήρως μετά την αλλαγή από HemoCue AlbuTrol σε Eurotrol AlbuTrol medžiagų, nėra infekcijos sukėlėjų. Az Eurotrol AlbuTrol®-t két élettanilag fontos szinten állítják elő. Mindegyik ampulla 1,0 ml, albumint tartalmazó humán 06 2011-09-26 Αναθεώρηση της ενότητας «Αναμενόμενα αποτελέσματα» και του κατασκευαστή. vizeletet tartalmaz. 3. Šio produkto negalima išmesti su bendrojo pobūdžio atliekomis. Pasikonsultuokite su vietinėmis aplinkosaugos Προσθήκη δήλωσης στην ενότητα «IVD Ιατροτεχνολογικό Προϊόν» tarnybomis, kaip tinkamai utilizuoti. 07 2013-12-04 Προσθήκη μετάφρασης στην Ουγγρική και Κροατική γλώσσα Figyelmeztetések és óvintézkedések 1. Kizárólag in vitro diagnosztikai felhasználásra. Laikymas ir stabilumas 08 2018-02-28 Νέος αναγνωριστικός αριθμός εγγράφου, επεξεργασία των συμβόλων και της „Eurotrol AlbuTrol®“ reikia laikyti šaldytuve 2–8 °C (36–46 °F) temperatūroje. Laikant neatidarytą šioje temperatūroje περιγραφής 2. Figyelem! Az Eurotrol AlbuTrol®-t humán vizeletből állítják elő, és humán eredetű anyagokat tartalmaz. A minőség- ellenőrző anyag humán eredetű összetevőit tesztelték, és azokat nem reaktívnak találták a HBsAg, az anti-HCV és az anti- garantuojama, kad jis išliks stabilus iki galiojimo datos, nurodytos ant buteliuko ir ant išorinės dėžutės. Atidarius „Eurotrol 09 2019-01-23 Πλήρης αναθεώρηση των οδηγιών χρήσης, περιλαμβανομένης της διάταξης. AlbuTrol®“ išlieka stabilus 30 dienų, laikant 2–8 °C (36–46 °F) temperatūroje. HIV vonatkozásában. Azt azonban egyetlen vizsgálati módszerrel sem lehet biztosítani, hogy a humán eredetű anyagokból Αφαίρεση του συστήματος HemoCue® Urine Albumin από τη «Χρήση για την οποία Figure 2, Afbeelding 2, Abbildung 2, Figur 2, Figur 2, Figure 2, Figur 2, Kuva 2, Figura 2, Slika 2, Figura 2, Εικόνα 2, Rysunek készült készítmények mindenféle kórokozótól mentesek. Procedūra προορίζεται» και τις «Αναμενόμενες τιμές». Προσθήκη μετάφρασης στη Λιθουανική 2, Slika 2, 2. Ábra, Рисунок 2, 2 Pav. 3. Ezt a terméket nem szabad az általános hulladékkal együtt megsemmisíteni. Konzultáljon a helyi környezetvédelmi 1. Kad būtų užtikrintos optimalios produkto charakteristikos, jis turi būti traktuojamas kaip paciento mėginys ir reikia laikytis και Ρωσική γλώσσα AN01440A01 20190123 hatósággal az ártalmatlanítás megfelelő módszeréről. „HemoCue® Albumin 201“ sistemos naudojimo instrukcijų. Όλα τα εμπορικά σήματα αποτελούν ιδιοκτησία των αντίστοιχων κατόχων τους. © 2019, Eurotrol B.V. Tárolás és stabilitás 2. Kad susilygintų buteliuko temperatūra, palaikykite 15 minučių 15–30 °C (59–86 °F) temperatūroje. Przeznaczenie 3. Prieš pat naudodami pakratykite buteliuką ranka mažiausiai 30 sekundžių, kad turinys visiškai susimaišytų. Az Eurotrol AlbuTrol® hűtőszekrényben, 2–8 °C-on (36–46 °F) tárolandó. Ezen a hőmérsékleten bontatlan állapotban tárolva Eurotrol AlbuTrol® to oznaczona kontrola albuminy przeznaczona do zastosowania profesjonalnego w celu 4. Laikydami buteliuką vertikaliai pastuksenkite dangtelį, kad skystis ištekėtų iš pipetės galiuko (1 pav.). a készítmény garantáltan stabil marad a tartályon és a külső dobozon feltüntetett lejárati időpontig. A felbontást követően az weryfikacji precyzji i dokładności systemu HemoCue® Albumin 201. Kontrola Eurotrol AlbuTrol® jest przeznaczona do Eurotrol AlbuTrol® 2–8 °C-on (36–46 °F) tárolva 30 napig marad stabil. 5. Atsargiai atidarykite dangtelį nesuspausdami buteliuko (2 pav.). ilościowego oznaczania stężenia albuminy. 6. Pirmą atitikties kontrolės skysčio lašą išmeskite. Eljárás 7. Užlašinkite lašą ant hidrofobinio paviršiaus ir iškart atlikite jo matavimą, kaip nurodyta analizatoriaus naudotojo vadove. Opis i zasada działania 1. Az optimális végeredmény érdekében a készítményt úgy kell kezelni, mint egy betegmintát, és be kell tartani a HemoCue® 8. Po mėginio tyrimo pašalinkite visą atitikties kontrolės skystį nuo spalvoto dangtelio švaria servetėle ir tinkamai uždarykite Eurotrol AlbuTrol® to materiał kontroli jakości dostępny w dwóch stężeniach o znanym stężeniu albuminy. Kontrolę Eurotrol Albumin 201 rendszerre vonatkozó használati utasításokat. dangtelį. AlbuTrol® można stosować do okresowej weryfikacji precyzji i dokładności systemu HemoCue® Albumin 201. W celu 2. A tartályt hagyja 15 percig 15–30 °C (59–86 °F) közötti egyenletes hőmérsékletre melegedni. uzyskania informacji na temat zalecanej częstotliwości stosowania, należy odnieść się do lokalnych wytycznych. 9. Panaudoję grąžinkite į nurodytas laikymo sąlygas. Visą procedūrą reikia pakartoti kaskart, kai atitikties kontrolės tirpalas 3. Közvetlenül felhasználás előtt legalább 30 másodpercig kézzel rázogassa a tartályt, hogy annak tartalma teljesen išimamas iš laikymo aplinkos, visą tinkamumo po buteliuko atidarymo laiką. Odczynniki összekeveredjen. Kontrola Eurotrol AlbuTrol® jest dostarczana w dwóch istotnych fizjologicznie stężeniach. Każda fiolka zawiera 1,0 ml moczu 4. Tartsa a tartályt függőleges helyzetben, majd ütögesse meg a kupakot, hogy eltávolítsa cseppentőbe került folyadékot ( 1. Apribojimai ludzkiego zawierającego albuminę. ábra). 1. Atitikties kontrolės medžiaga neturi būti naudojama praėjus tinkamumo po atidarymo laikui arba galiojimo datai. 5. Óvatosan távolítsa el a kupakot anélkül, hogy a tartályt közben összenyomná (2. ábra). 2. „Eurotrol AlbuTrol®“ negalima naudoti kaip kalibratoriaus / standarto. Ostrzeżenia i środki ostrożności 3. Produkto intervalai pateikiami tik kaip orientacinės reikšmės, laboratorijos turi nustatyti intervalus atsižvelgdami į savo 6. A minőség-ellenőrző folyadék első cseppjét öntse ki, azt ne használja fel. 1. Do stosowania wyłącznie w diagnostyce in vitro. tyrimo sistemą ir leistinų nuokrypių ribas. 2. Przestroga: Kontrola Eurotrol AlbuTrol® jest przygotowana z moczu ludzkiego i zawiera ludzki materiał źródłowy. Składniki 7. Cseppentsen egy csepp folyadékot egy víztaszító felületre, majd azonnal végezze el a mérést az analizátor felhasználói útmutatójának megfelelően. Tikėtinos reikšmės kontroli, które pochodzą z ludzkiego materiału źródłowego, zostały zbadane i okazały się niereaktywne pod względem 8. A mintavétel után egy tiszta törlővel távolítson el minden folyadékot a színes kupakról, majd zárja vissza a tartályt. Vidutinė tyrimo reikšmė, pateikta pridedamame tyrimo lape, yra išvesta iš kartotinių analizių naudojant gamykloje antygenu HBsAg oraz przeciwciał anty-HCV i anty-HIV. Jednak żadna metoda badawcza nie może całkowicie zapewnić, że produkty otrzymane z materiału pochodzenia ludzkiego nie zawierają czynników zakaźnych. 9. Használat után az előírásoknak megfelelően tárolja a készítményt. Mindezen lépéseket a minőség-ellenőrző első sukalibruotas „HemoCue® Albumin 201“ sistemas ir yra būdinga visai partijai. felbontását követően minden alkalommal újra meg kell ismételni, amikor a tartályt újra előveszi és felnyitja a 3. Opisywany produkt nie powinien być wyrzucany razem z odpadami o charakterze ogólnym. W celu prawidłowej utylizacji Norėdami gauti daugiau informacijos ir (arba) techninės pagalbos, kreipkitės į: felhasználhatósági időszakon belül. tych produktów należy skontaktować się z lokalnymi władzami zajmującymi się ochroną środowiska naturalnego. Przechowywanie i stabilność Korlátozások Eurotrol B.V. Kontrolę Eurotrol AlbuTrol® należy przechowywać w chłodziarce w temperaturze 2–8 °C (36–46 °F). Przechowywać 1. Ne használja fel a minőség-ellenőrző anyagot a lejárati időn vagy a felbontás utáni felhasználhatósági időn túl. Keplerlaan 20, 6716 BS Ede, Nyderlandai 2. Az Eurotrol AlbuTrol® nem használható kalibrátorként vagy standardként. Telefonas +31 318 695 777 nieotwartą w tej temperaturze; stabilność jest gwarantowana do daty ważności wskazanej na fiolce i pudełku zewnętrznym. 3. A készítmény tartományai csak tájékoztató jellegűek, az egyes laboratóriumoknak maguknak kell meghatározniuk a El. paštas office@eurotrol.com Po otwarciu kontrola Eurotrol AlbuTrol® jest stabilna przez 30 dni przechowywania w temperaturze 2–8 °C (36–46 °F). tartományokat saját tesztrendszereik és tűréshatáraik alapján. www.eurotrol.com Procedura 1. W celu uzyskania optymalnej wydajności produkt należy traktować jak próbkę pacjenta i postępować zgodnie z instrukcją Várható értékek Apie visus svarbius atvejus, susijusius su prietaiso naudojimu, reikia pranešti gamintojui ir šalies narės, kurioje gyvena A mellékelt vizsgálati lapon található vizsgálati középértékek a gyárilag kalibrált HemoCue® Albumin 201 rendszerek ismételt vartotojas ir (arba) pacientas, kompetentingoms tarnyboms. obsługi systemu HemoCue® Albumin 201. elemzésein alapulnak, és az adott tételkódra vonatkoznak. 2. Odczekać 15 minut w celu doprowadzenia produktu do temperatury 15–30 °C (59–86 °F). Redakcijų istorija 3. Bezpośrednio przed użyciem potrząsać fiolką ręcznie przez co najmniej 30 sekund, aby całkowicie wymieszać zawartość. További tájékoztatásért, illetve műszaki segítségért forduljon a következőhöz: Redakcija Įsigaliojimo data Pakeisti į ankstesnę redakciją 4. Trzymając fiolkę w pozycji pionowej, postukać w zatyczkę, aby usunąć płyn z końcówki kroplomierza (rysunek 1). 05 2006-02-10 Visiškai peržiūrėta pakeitus iš „HemoCue AlbuTrol“ į „Eurotrol AlbuTrol“ 5. Ostrożnie otworzyć zatyczkę, nie ściskając fiolki (rysunek 2). Eurotrol B.V. 6. Usunąć pierwszą kroplę płynu do kontroli jakości. 06 2011-09-26 Peržiūrėtas skyrius „Tikėtini rezultatai“ ir gamintojas. Pridėtas įrašas skyriuje „IVD Keplerlaan 20, 6716 BS Ede, Hollandia 7. Nanieść kroplę na powierzchnię hydrofobową i od razu użyć jej do wykonania pomiaru zgodnie z opisem w instrukcji medicinos prietaisas“ Telefon +31 318 695 777 obsługi analizatora. E-mail office@eurotrol.com 07 2013-12-04 Pridėti vertimai į vengrų ir kroatų kalbas 8. Po pobraniu próbki należy czystą chusteczką usunąć cały płyn do kontroli jakości z kolorowej zatyczki i ponownie nałożyć www.eurotrol.com 08 2018-02-28 Naujas dokumentas ID, simbolių ir aprašymo redagavimas zatyczkę w odpowiedni sposób. 09 2019-01-23 Išsami NI peržiūra, įskaitant išdėstymą. „HemoCue® Urine Albumin“ sistemos Az eszközzel kapcsolatosan bekövetkezett minden jelentősebb eseményről értesíteni kell a gyártót, valamint a felhasználó išėmimas iš skyrių „Naudojimo paskirtis“ ir „Tikėtinos reikšmės“. Pridėti vertimai į 9. Po użyciu produkt należy przechowywać we wskazanych warunkach. Całą procedurę należy powtarzać przez cały okres és/vagy a beteg országában működő illetékes hatóságot. ważności po otwarciu fiolki za każdym razem po wyjęciu materiału do kontroli jakości z miejsca przechowywania. lietuvių ir rusų kalbas. Változatok listája Ograniczenia Visi prekių ženklai yra jų atitinkamų savininkų nuosavybė. © 2019, Eurotrol B.V. 1. Nie wolno stosować materiału do kontroli jakości po upływie terminu ważności po otwarciu lub daty ważności. Változat Hatálybalépés dátuma Módosítás az előző változathoz képest 2. Kontroli Eurotrol AlbuTrol® nie należy używać jako kalibratora/wzorca. 05 2006-02-10 Teljesen felülvizsgálva a HemoCue AlbuTrol-ról Eurotrol AlbuTrol-ra történő 3. Zakresy produktu należy traktować wyłącznie jako wytyczne, a laboratoria powinny określić zakresy w oparciu o własny váltás után system testowy i granice tolerancji. 06 2011-09-26 Változások a várható eredményeket tartalmazó részben és gyártónál. Az „IVD orvostechnikai eszköz” rész új nyilatkozattal egészült ki Oczekiwane wartości 07 2013-12-04 Magyar és horvát fordítással kiegészítve Średnia wartość oznaczenia podana na arkuszu oznaczenia pochodzi z powtórzeń analiz na fabrycznie skalibrowanych systemach HemoCue® Albumin 201 i jest swoista dla partii. 08 2018-02-28 Új dokumentumazonosító, szimbólumok és leírások módosítása 09 2019-01-23 A Használati útmutató teljes átdolgozása, beleértve az elrendezést. A Dane kontaktowe w celu uzyskania dalszych informacji i/lub pomocy technicznej: HemoCue® Urine Albumin rendszer kikerült a „Rendeltetés” és a „Várható értékek” részből. Litván és orosz fordítással kiegészítve. Eurotrol B.V. Minden védjegy a birtokosa tulajdonában van. © 2019, Eurotrol B.V. Keplerlaan 20, 6716 BS Ede, Holandia Tel. +31 318 695 777 Назначение E-mail office@eurotrol.com Eurotrol AlbuTrol® — аттестованный контрольный препарат альбумина, предназначенный для www.eurotrol.com профессионального применения с целью проверки прецизионности и точности системы HemoCue® Albumin 201. Eurotrol AlbuTrol® предназначен для количественного определения альбумина. Każdy poważny incydent, który miał miejsce w związku z wyrobem, należy zgłaszać producentowi i odnośnym władzom państwa członkowskiego, w którym użytkownik lub pacjent ma swoją siedzibę. Краткие сведения и принцип Eurotrol AlbuTrol® — это материал, предназначенный для контроля качества, который выпускается с двумя Historia zmian известными уровнями концентрации альбумина. Eurotrol AlbuTrol® можно применять для периодической проверки Wersja Data wejścia w życie Zmiana w stosunku do poprzedniej wersji прецизионности и точности системы HemoCue® Albumin 201. Частота проверки регламентируется местными 05 2006-02-10 Pełna redakcja po zmianie HemoCue AlbuTrol na Eurotrol AlbuTrol нормативными документами. 06 2011-09-26 Zredagowano część „Wyniki oczekiwane” i producenta. Dodano deklarację w części Реактивы „Wyrób medyczny do diagnostyki in vitro” Препарат Eurotrol AlbuTrol® выпускается с двумя физиологически значимыми уровнями концентрации. Каждый 07 2013-12-04 Dodanie tłumaczenia węgierskiego i chorwackiego флакон содержит 1,0 мл мочи человека, содержащей альбумин. 08 2018-02-28 Nowy identyfikator dokumentu, edycja symboli i opisu 09 2019-01-23 Pełna redakcja instrukcji obsługi, w tym układu. Usunięcie systemu HemoCue® Urine Предостережения и меры предосторожности 1. Только для диагностики in vitro. Albumin z części „Przeznaczenie” i „Oczekiwane wartości”. Dodanie tłumaczenia 2. Внимание! Препарат Eurotrol AlbuTrol® изготовлен из мочи человека и содержит материал человеческого litewskiego i rosyjskiego. происхождения. Полученные из материала человеческого происхождения компоненты этого контрольного Wszystkie znaki towarowe są własnością odpowiednich właścicieli. © 2019, Eurotrol B.V. препарата были исследованы и признаны не содержащими HBsAg и антител к ВГС или ВИЧ. Однако ни один Namjena метод испытаний не может дать полной уверенности в отсутствии возбудителей инфекций в продуктах, для Kontrolni uzorak AlbuTrol® tvrtke Eurotrol testirani je kontrolni uzorak albumina namijenjen za profesionalnu которых исходные материалы получены у человека. uporabu za provjeravanje preciznosti i točnosti sustava HemoCue® Albumin 201. Kontrolni uzorak AlbuTrol® tvrtke Eurotrol 3. Этот препарат не следует утилизировать с обычными отходами. Проконсультируйтесь с местными органами namijenjen je kvantitativnom određivanju albumina. охраны окружающей среды по вопросу правильной утилизации. Sažetak i načela Хранение и стабильность Kontrolni uzorak AlbuTrol® tvrtke Eurotrol materijal je za kontrolu kvalitete dostupan na dvije razine, od kojih svaka sadrži Препарат Eurotrol AlbuTrol® следует хранить в холодильнике при температуре 2–8 °C (36–46 °F). Хранимый при этой poznatu koncentraciju albumina. Kontrolni uzorak AlbuTrol® tvrtke Eurotrol može se koristiti za periodično provjeravanje температуре препарат в невскрытом флаконе имеет гарантированный срок стабильности, указанный на маркировке preciznosti i točnosti sustava HemoCue® Albumin 201. Provjerite lokalne smjernice o preporučenoj učestalosti uporabe. флакона и наружной упаковке. Препарат Eurotrol AlbuTrol® после вскрытия флакона стабилен в течение 30 суток при Reagensi температуре 2–8 °C (36–46 °F). Kontrolni uzorak AlbuTrol® tvrtke Eurotrol nudi se u dvije fiziološki relevantne razine. Svak a bočica sadrži 1,0 ml ljudskog Процедура urina koji sadrži albumin. 1. Для достижения наилучших рабочих параметров следует обрабатывать этот препарат как образец, полученный у Mjere upozorenja i opreza пациента, и выполнять инструкции по применению системы HemoCue® Albumin 201. 1. Samo za uporabu u in vitro dijagnostici. 2. Выдержите флакон в течение 15 минут при температуре 15–30 °C (59–86 °F) для достижения им этой температуры. CE CE Κατασκευαστής Producent Ημερομηνία κατασκευής Data produkcji Ημερομηνία λήξης Data przydatności do użycia Κωδικός παρτίδας Kod partii Αριθμός καταλόγου Numer katalogowy Όριο θερμοκρασίας Granica temperatury Προσοχή Przestroga Συμβουλευτείτε τις οδηγίες χρήσης Zapoznać się z instrukcją obsługi Ιατροτεχνολογικό προϊόν για in vitro διαγνωστική χρήση Wyrób medyczny do diagnostyki in vitro Μάρτυρας Kontrola CE CE Proizvođač Gyártó Datum proizvodnje Gyártás dátuma Rok uporabe Eltarthatósági idő Kod serije Tételkód Kataloški broj Katalógusszám Ograničenje temperature Hőmérséklethatár Oprez Figyelem Pogledajte upute za uporabu Lásd a használati útmutatót Medicinski proizvod za in vitro dijagnostiku In vitro diagnosztikai orvostechnikai eszköz Kontrola Kontroll CE CE Производитель Gamintojas Дата изготовления Pagaminimo data Годен до Panaudoti iki nurodytos datos Номер партии Partijos kodas Каталожный номер Katalogo numeris Предельные значения температуры Temperatūros riba Внимание! Dėmesio Обратитесь к инструкции по применению Žr. naudojimo instrukcijas Медицинское изделие для диагностики in vitro „In Vitro“ diagnostinis medicininis įrenginys Контроль Kontrolinė medžiaga Page 2 of 2 Instructions for Use (670.6 KB)
- Material Safety Data Sheet 1. Identification of substance Product name: AlbuTrol Product code: REF 108.001.002 (Low), 108.002.002 (High) Manufacturer: Eurotrol B.V., Keplerlaan 20, 6716 BS, Ede, The Netherlands. In emergency call +31 318 695777 for further information. 2. Components Human Urine Human Albumin 3. Hazardous characteristics This product is prepared from human urine and contains other human source material. Components of the control, which are derived from human source material, have been tested and found to be non-reactive for HBsAg, anti-HCV and anti-HIV. However, no test method can offer complete assurance that products derived from human source material are free from infectious agents. HANDLE AS A BIOHAZARD, class II (CDC/NIH guidelines). Appearance: Clear liquid, straw color Odour: Urine odor Physical State: Liquid 4. Emergency first aid procedures Inhalation: N/A Skin contact: Normal hygiene Eye contact: Flush with water for >15 minutes in case reagent contacts eyes Ingestion: Get medical attention 5. Actions in case of fire Not flammable. Follow general fire fighting procedures. 6. Actions in case of spill of material In case of spill of material clean with water. 7. Handling and storage Handling: Follow Good Laboratory Practice MSDS 108-R04-20111216 Storage: The product must be stored in the refrigerator at 2 8 °C. After opening the vial, it is stable for 30 days stored at 2 8 °C. 8. Limitation of the exposure / personal protective measures Follow Good Laboratory Practice Page 1 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 9. Physical / chemical characteristics pH N/A Boiling point (°C) N/A Melting point (°C) N/A Decomposition temperature (°C) N/A Flash-point (°C) Not flammable. Spontaneous combustion temp (°C) N/A Combustibility (solid, gas) N/A Explosive characteristics N/A Explosion limits N/A Oxidizing characteristics N/A Vapor pressure (kPa) N/A Vapor density N/A Appearance Clear Liquid Odour Urine Odor Physical state Liquid Solubility in water Soluble 10. Stability and reactive hazard data Expiry date is stated on each dropper bottle. The product must be stored in the refrigerator at 2 8 °C. After opening the vial, it is stable for 30 days stored at 2 8 °C. Conditions to avoid Freezing or boiling the product 11. Toxicological information This product is prepared from human urine and contains other human source material. Components of the control, which are derived from human source material, have been tested and found to be non-reactive for HBsAg, anti-HCV and anti-HIV. However, no test method can offer complete assurance that products derived from human source material are free from infectious agents. HANDLE AS A BIOHAZARD, class II (CDC/NIH guidelines). 12. Ecological Toxicological information According to applicable regulations, this product does not contain chemical ingredients classified as hazardous or in sufficient concentrations to classify the product as hazardous. 13. Waste disposal methods Do not dispose of in general waste. Consult local environmental authorities for proper disposal. 14. Transport information According to DOT and IATA, the product is classified as: MSDS 108-R04-20111216 NON-HAZARDOUS Proper Shipping Name: N/A Technical Name: UN Number: N/A Hazard Class and Packaging Group: N/A Label(s): N/A Packing Instruction (Passenger Aircraft): N/A Packing Instruction (Cargo Aircraft): N/A Page 2 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Shipping Container Type: N/A Sales Unit: 2 dropper bottles per box 15. Valid regulations N/A 16. Other information The opinions expressed herein are those of qualified experts within Eurotrol B.V. We believe that the information contained herein is current as of the date of this Material Safety Data Sheet. Since the use of this information and these opinions and the conditions of use of the product are not within the control of Eurotrol B.V., it is the users' obligation to assure safe use of the product. Date of issue: December 16, 2011 MSDS 108-R04-20111216 Page 3 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet (101.0 KB)
Calibration Verification Fluids
Product Specific
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet - DE (142.8 KB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 # DE,F . ' 3 ! , 1? - - 4'" ! 1? " * 6 . ' 3 6 " . ' 3 5 ' . %% 3 / , 0 !! # ! # $ ' ! ! !' % ! # ! ' < ! ! ! ! " ' ! ' < 3 , & 5 < # # ' ! 1 , , !! # ! # $ ' ! ! !' % ! # ! ' < ! ! ! ! " ' ! ' < 3 & - , , !! # ! # $ ' ! ! !' % ! # ! ' < ! ! ! ! " ' ! ' < 3 , # * 3, ! & % ' 3 ) 1 !! # -7 7 $ ' ! ! .-. + G -2 4 ' #. % . # 7 !' ! . % 2. . % .A + < , 4 != # # .A 1 D F .A 4 != # ! D4 # ! F .A 4 != # ! D, # ! F .A ' #, 7" .A 2 # % $! # 39 %1 % ! 2 , 2 # D ,F . A ! ! # ' # $ & $ ' ! ,' % ! H ,+IB # D ,F . A 8 ! ! $ # != # # ! %> H 2 + A,14IB 2 % J B "+ % < " % , ! 1 # ,' % ! D + F3 3 5 & # ! "3 7' > ' ' ? > * ' )363 @ & ' ' % ! ' ! ' ' " ' 3 ! ' ' % ' ' ! ' ! * ' ' ! )363$ ' K # ' !3 5 " $ Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet - EUR (132.1 KB)
- ! " & # $ % # % ' ()* )* + , -, ( ,, ( . ,,/ 0 " # 1 / + ( 2 3 ! "#$ % 2 3 & ! #$ &% 243 ' ! #$ '% 2 3 (' )* (' ) ! % 3 5/6/ - *7 89:8 5 ; 5 < = ,>: >:? 8@A999 # ! "#$%%% / ; &' ( ) # #%! $#! %%# / * ( ! B :C 1 # 1 $ # $ / .1 ) 4 = 1 .1 ) " # $ % # ()* / + , = D ( ; 1 E #= % $ ( ; 1 E $ # :A .# 1 / $ - ; / $ / ; $ . = 1 ! $ ! $ / " - . ! # / % - 2 1 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 ( 1 # 1 / ! ) / & 2 1 # , 0 ' 6 = ; # FG(H + ; FG(H + .1 ) 4 = 1 .1 # ; + I + ; # ; 1 2 3 = 1 $ ! 1 $/ ( ! ( & = 1 $ ! 1 $/ * = 1 $ ! 1 $/ ) + D % /( # J % / + I)< # < +)+ I + 2 K + + = 1 + + D ( 1 D 4 1 F H D F H D F H D < D $ 2% F( H G :@79L*778 # # # = 1 1 ! M2 (' 2 = 2 (' NE 2% F( H G :*9*L*77? ! ! # 1 ! # M 'L(.;N E Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 I # G ::*: E % = # 1 = 1 F ' ' ( . (= H/ " 4 . $ 1 # 5/6/ + 1 1 !D ! = 1 F = = 1 H/ ( # # = " # 5/6/ $ ! / I O D *7:8 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet - FR (141.4 KB)
- Voorzorgsmaatregelen Eurotrol epoc Calibration Verification Fluids är endast avsett för in vitro-diagnostiskt bruk. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland Forholdsregler I controlli Eurotrol epoc Calibration Verification Fluids sono ottenuti con l’aggiunta di sali in una matrice 1. Uitsluitend bestemd voor in vitro diagnostisch gebruik. Sammanfattning 1. Kun til in vitro diagnostisk brug. tamponata con tampone fisiologico. La tonometria con livelli predeterminati di ossigeno e anidride carbonica 2. Voorkom dat deze producten in het algemene afvalcircuit terecht komen. Volg de ter plaatse geldende Eurotrol epoc Calibration Verification Fluids är ett kvalitetskontrollmaterial i fem olika nivåer, var och en med Symboler som brukes 2. Disse produkter skal bortskaffes i det almindelige affald. Rådfør dig med de lokale miljømyndigheder equilibrati con azoto e le diverse concentrazioni di sali forniscono cinque livelli distinti per ciascun parametro, regels voor verantwoorde afvalverwerking. vedrørende korrekt afskaffelse. simulando dei range clinicamente significativi di equilibrio acido-base ed elettrolitico, funzione respiratoria, kända koncentrationer Obs! Se bruksanvisningen Batch-kode 3. Eurotrol GAS-ISE dient niet gebruikt te worden voor kalibratiedoeleinden. 3. Eurotrol epoc Calibration Verification Fluids må ikke anvendes som en kalibrator. funzione renale, concentrazione di glucosio e di lattato. I controlli Eurotrol epoc Calibration Verification Fluids Reagens non contengono conservanti, correttori di viscosità, né altri additivi in grado di compromettere la misurazione Verwachte resultaten Brukes innen Temperaturgrense Forventede resultater Eurotrol epoc Calibration Verification Fluids ger fysiologiskt relevanta nivåer och levereras i ampuller om degli elettrodi. Toegekende waarden zijn verkregen door middel van metingen op het epoc Blood Analysis System met Medisinsk utstyr til in vitro-diagnostikk Referansenummer Værdierne opnås ved målinger på epoc Blood Analysis System ved hjælp af BGEM testkortene. De tildelte 2,5 mL lösning. Eurotrol epoc Calibration Verification Fluids-kontrollerna framställs genom upplösning gebruikmaking van BGEM test cards. De toegekende waarden zijn beschikbaar in tabelvorm en gerangschikt værdier er tilgængelige fra http://www.epocal.com, der viser hvert væskelotnummer og sensorkonfiguration Conservazione e stabilità av olika salter i en fysiologiskt buffrad matris. Tonometri med i förväg fastställda nivåer av syrgas och Produsent CE-merke naar lotnummer en sensorconfiguratie via http://www.epocal.com. i tabelform. Eurotrol epoc Calibration Verification Fluids può essere conservato a una temperatura di 2-8 °C. Conservato koldioxid balanserade med kväve och olika saltkoncentrationer ger fem distinkta nivåer för varje parameter, Eurotrol epoc Calibration Verification Fluids is een kwaliteitscontrolemateriaal voor professioneel gebruik bij Eurotrol GAS-ISE Metabolytes er beregnet til professionel brug til verifikation af instrumentydeevne. in confezione integra alla suddetta temperatura il prodotto resta stabile fino alla data di scadenza indicata som simulerar de kliniskt relevanta områdena för syrabas- och elektrolytbalans, respiratorisk funktion, epoc Calibration Verification Fluids het controleren van de precisie en nauwkeurigheid van het epoc Blood Analysis System. Let op njurfunktion, glukos- och laktatkoncentration. Eurotrol epoc Calibration Verification Fluids-kontrollerna innehåller inga konserveringsmedel, viskositetsreglerande medel eller andra tillsatser som skulle kunna Bemærk • Værdierne i tabellen gælder kun for det tildelte væskelotnummer, den relevante epoc Blood Analysis sulle fiale e sulla confezione esterna. A temperatura ambiente Eurotrol epoc Calibration Verification Fluids rimane stabile per 1 settimana (fiale sigillate). Una volta portato il prodotto a temperatura ambiente, non refrigerare! Una volta aperta la fiala Eurotrol epoc Calibration Verification Fluids rimane stabile per 30 • De waarden in de tabel zijn alleen toepasbaar voor het aangegeven lotnummer en op zeeniveau en påverka elektrodmätningarna på ett negativt sätt. System sensorkonfiguration og i niveau med havets overflade. gelden alleen voor de aangegeven epoc Blood Analysis System sensorconfiguratie. Förvaring och stabilitet Eurotrol epoc Calibration Verification Fluids • Forkert prøvetagning, opbevaring eller anden forkert håndtering kan forårsage, at aflæsningerne afviger secondi. Eurotrol epoc Calibration Verification Fluids • Onjuiste bemonstering, bewaarcondities of elke andere wijze van foutieve behandeling kunnen meetwaarden geven die afwijken van de doelwaarden. Eurotrol epoc Calibration Verification Fluids kan förvaras vid 2–8 °C. När kontrollen förvaras oöppnad vid fra målværdierne. Procedure 1. Rimuovere il numero necessario di fiale dalla scatola e dalla vaschetta. Lasciar stabilizzare la/e fiala/e per denna temperatur garanteras stabiliteten fram till det utgångsdatum som anges på ampullerna och på • pO2-værdierne i Eurotrol epoc Calibration Verification Fluids varierer i omvendt forhold til • De pO2 waarden van Eurotrol epoc Calibration Verification Fluids variëren omgekeerd evenredig met Indication un minimo di 1 ora alla temperatura più prossima possibile ai 22 °C. ytterkartongen. Eurotrol epoc Calibration Verification Fluids är stabilt i 1 vecka vid rumstemperatur (oöppnade temperaturændringer. For hver °C-temperaturændring mellem 18 og 26 °C ændres pO2 1,5 % i det lave Intended Purpose temperatuurveranderingen. Voor elke °C verandering in temperatuur tussen 18 °C en 26 °C, verandert Eurotrol epoc Calibration Verification Fluids est un matériel de référence étalonné pour le dosage des gaz, 2. Subito prima dell’uso, agitare la fiala energicamente per almeno quindici secondi per riequilibrare i gas ampuller). Produkten får inte kylas på nytt efter att den har antagit rumstemperatur! Efter att ampullen niveau, 1,1 % i det normale niveau og 0,5 % i det høje niveau. For at opnå en høj grad af korrelation med Eurotrol epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite reference de pO2 1,5% bij fysiologisch lage pO2waarden, 1,1% bij fysiologisch normale pO2 waarden en 0,5% bij électrolytes et métabolites sanguins destiné à contrôler la précision et l’exactitude de l’analyseur epoc® con la soluzione. Agitare tenendo la fiala tra il pollice e l’indice. öppnats är Eurotrol epoc Calibration Verification Fluids stabilt i 30 sekunder. værdierne i tabellen skal ampullerne ækvilibreres så tæt på 22 °C som muligt. material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol epoc Calibration fysiologisch hoge pO2 waarden. Om een grote graad van correllatie te verkrijgen met de waarden in de Blood Analysis System. Eurotrol epoc Calibration Verification Fluids est destiné à tester les analytes 3. Far ruotare la fiala delicatamente in modo da depositare di nuovo la soluzione sul fondo del contenitore. • Når ampullen først er åbnet, har stuetemperaturen ingen signifikant indvirkning på pH-værdierne. Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++ *, tabel, moeten de ampullen zo dicht mogelijk bij 22 °C geëquilibreerd worden. Anvisningar suivants : pH, pO2, pCO2, Na+, K+, Ca++, Mg++ *, Cl- *, glucose, lactate, urée*, créatinine* et tCO2. Eurotrol Prima di aprire la fiala, lasciar affiorare tutte le bolle. • Eurotrol epoc Calibration Verification Fluids er følsom over for de fleste af de instrumentrelaterede Cl- *, Glucose, Lactate, Urea*, Creatinine*, and tCO2. Eurotrol epoc Calibration Verification Fluids is also • Na openen heeft de temperatuur geen significante invloed op de pH waarde. 1. Ta fram lämpligt antal ampuller ur lådan och tråget. Låt ampullen/ampullerna jämviktas under minst 1 epoc Calibration Verification Fluids est également conçu pour contrôler l’étalonnage, la température de 4. Proteggere le dita con una garza, una salvietta o dei guanti. faktorer, der kan forårsage uventede analytiske afvigelser. developed to verify calibration, operating temperature and other performance characteristics. • Eurotrol epoc Calibration Verification Fluids is gevoelig voor de meeste instrumentgerelateerde factoren timme till en temperatur så nära 22 °C som möjligt. fonctionnement et les autres caractéristiques de performances. 5. Tenere la fiala con il pallino colorato rivolto verso l’alto. Staccare il collo della fiala nella direzione • Eurotrol epoc Calibration Verification Fluids kontroller indeholder ikke protein og detekterer muligvis derfor *Cl-, Urea, Creatinine and Mg++ are not available in Canada. die onverwachte analytische afwijkingen kunnen veroorzaken. 2. Skaka ampullen kraftigt omedelbart före användning under minst 15 sekunder för att jämvikta gaserna *Cl-, urée, créatinine et Mg ++ ne sont pas disponibles au Canada. opposta a quella del pallino colorato. Per ulteriori dettagli, leggere il foglio illustrativo sul sistema ikke fejl i funktioner, der er følsomme over for disse komponenter. IVD Medical Device • Eurotrol epoc Calibration Verification Fluids controles bevatten geen eiwit en kunnen daarom geen med lösningen. Håll ampullen mellan tummen och pekfingret när du skakar den. Dispositif médical de diagnostic in vitro • Eurotrol epoc Calibration Verification Fluids er meget følsomme over for kontamineret rumluft. Ved di prerottura (OPC [la fiala si rompe in un solo punto]). Eurotrol epoc Calibration Verification Fluids complies with the IVD Directive 98/79/EC for Medical Devices afwijkingen aantonen die gerelateerd zijn aan deze component(en). 3. Snurra ampullen försiktigt så att all lösning sjunker till ampullens botten. Låt eventuella bubblor stiga upp Eurotrol epoc Calibration Verification Fluids est conforme à la directive européenne 98/79/CE relative aux prøvetagning med væsken inden for 30 sekunder er fejlen under 2 % over hele området på alle niveauer*. 6. Eseguire la procedura di campionamento entro 30 secondi seguendo le istruzioni del manuale operativo and carries the CE mark. • Eurotrol epoc Calibration Verification Fluids is zeer gevoelig voor contaminatie met lucht. Wanneer de innan du öppnar ampullen. dispositifs médicaux de diagnostic in vitro et porte le label CE. Pour les Etats-Unis, Eurotrol epoc Calibration Rumluftens indvirkning på pH er ubetydelig. dell’epoc Blood Analysis System. Eurotrol epoc Calibration Verification Fluids complies with the following US codes of Federal Regulations vloeistof binnen 30 seconden wordt bemonsterd, dan is de fout minder dan 2% over het gehele gebied in 4. Skydda fingrarna med gasväv, pappershandduk eller handskar. Verification Fluids est conforme aux codes de réglementations fédérales (CFR) suivants : 42 CFR partie 72 *Tallene er baseret på prøvetagning med åbne ampuller. 7. Per quanto riguarda la frequenza d’uso raccomandata, fare riferimento alle linee guida locali. (CFR): 42 CFR part 72 and 21 CFR parts 606, 640 and 820. alle niveaus*. De invloed van lucht op de pH is te verwaarlozen. 5. Håll ampullen med den färgade pricken uppåt. Bryt av halsen på ampullen i motsatt riktning mot et 21 CFR parties 606, 640 et 820. Eurotrol epoc Calibration Verification Fluids est exclusivement réservé à Dette produkt er blevet fremstillet i overensstemmelse med Eurotrol specifikationer. Precauzioni Eurotrol epoc Calibration Verification Fluids is for in vitro diagnostic use only. *Deze getallen zijn gebaseerd op het testen van geopende ampullen. den färgade pricken. Läs bladet med OPC-anvisningar för mer information. des applications de diagnostic in vitro. 6. Följ inom 30 sekunder provtagningsanvisningarna i drifthandboken till epoc Blood Analysis System. 1. Esclusivamente per uso diagnostico in vitro. Résumé For at få yderligere oplysninger kontaktes: Summary Dit product is vervaardigd volgens de specificaties van Eurotrol. 2. Il prodotto non deve essere smaltito nei rifiuti ordinari. Per un corretto smaltimento, consultare le autorità 7. Se lokala rekommendationer för hur ofta kontrollmaterial skall analyseras. Eurotrol epoc Calibration Verification Fluids est un matériel de contrôle de qualité disponible à cinq niveaux Eurotrol B.V., Holland, Telefon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, Eurotrol epoc Calibration Verification Fluids is a quality control material available in five levels, each with Neem voor informatie contact op met: ambientali locali. Försiktighetsåtgärder ayant chacun une concentration connue. www.eurotrol.com known concentrations. Eurotrol B.V., Nederland, Telefoon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, 3. Eurotrol epoc Calibration Verification Fluids non deve essere utilizzato come calibratore. www.eurotrol.com 1. Endast för in vitro-diagnostiskt bruk. Réactifs Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Holland Reagents Risultati previsti Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland 2. Dessa produkter får ej läggas bland vanligt brännbart avfall. Kontakta lokala miljömyndigheter för Eurotrol epoc Calibration Verification Fluids fournit des concentrations significatives sur le plan physiologique ; Eurotrol epoc Calibration Verification Fluids provides physiological relevant levels, each ampule containing I valori si ottengono mediante misurazione con epoc Blood Analysis System e con schede di analisi BGEM. anvisningar för korrekt avfallshantering. chaque ampoule contient 2.5 ml de solution. Les contrôles Eurotrol epoc Calibration Verification Fluids sont Anvendte symboler m 2.5 mL solution. Eurotrol epoc Calibration Verification Fluids are prepared using salts in a physiologically I valori assegnati sono disponibili sul sito http://www.epocal.com, e sono suddivisi in tabelle, distinte per Gebruikte symbolen 3. Eurotrol epoc Calibration Verification Fluids får ej användas som kalibreringslösning. préparés au moyen de sels dissous dans une matrice tamponnée à pH physiologique. La tonométrie avec buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen m Bemærk, se brugsanvisning Batchkode numero di lotto di liquido e configurazione del sensore. Förväntade resultat des concentrations prédéfinies d’oxygène et de dioxyde de carbone équilibrées avec de l’azote et différentes and different salt concentrations provide five distinct levels for each parameter, simulating clinically significant Opgelet, lees de gebruiksaanwijzing Eurotrol epoc Calibration Verification Fluids è un dispositivo per uso professionale per la verifica delle Lotnummer Resultaten erhålls genom mätningar på epoc Blood Analysis System med användning av BGEM-testkort. concentrations de sels fournit pour chaque paramètre cinq niveaux distincts qui simulent des plages de Anvendes inden Temperaturgrænse ranges of acid-base and electrolyte balance, respiratory function, renal function, glucose and lactate prestazioni dell’analizzatore. De nominella värdena återfinns på http://www.epocal.com, tabellerade för varje enskild batch av produkten valeurs cliniquement significatives d’équilibre acido-basique et électrolytique, de la fonction respiratoire, de concentration. Eurotrol epoc Calibration Verification Fluids contain no preservatives, viscosity adjusters or Te gebruiken voor Bewaartemperatuur In vitro diagnostisk medicinsk udstyr Referencenummer la fonction rénale et des concentrations en glucose et en lactate. Les contrôles Eurotrol epoc Calibration N.B. other additives that might adversely effect electrode measurements. och varje sensorkonfiguration. In Vitro Diagnostisch Medisch Hulpmiddel Referentienummer Eurotrol epoc Calibration Verification Fluids är avsett för professionellt bruk för verifiering av Verification Fluids ne contiennent ni conservateurs, ni modificateurs de viscosité, ni aucun autre additif Fabrikant CE mærke • I valori indicati nella tabella sono applicabili esclusivamente al numero di lotto assegnato al liquido, alla Storage and Stability susceptible d’affecter les mesures réalisées avec l’électrode. configurazione del sensore epoc Blood Analysis System applicata e al livello del mare. Producent CE-merkteken instrumentprestanda. Eurotrol epoc Calibration Verification Fluids can be stored at a temperature of 2–8 °C (35-46 °F). Stored Conservation et stabilité • Qualora il campionamento, la conservazione o la manipolazione non avvengano correttamente, i risultati unopened at this temperature it is guaranteed stable as indicated until the expiry date on the ampules and OBS! potrebbero deviare dai valori target. Eurotrol epoc Calibration Verification Fluids peut être conservé à une température comprise entre 2 et 8 °C outer box. Eurotrol epoc Calibration Verification Fluids is stable for 1 week at room temperature (unopened • Värdena i tabellen gäller endast för den angivna produktbatchen, tillämplig epoc Blood Analysis System (35 - 46 °F). Si le produit est conservé non ouvert à cette température, sa stabilité est garantie jusqu’à la • I valori della pO2 di Eurotrol epoc Calibration Verification Fluids variano inversamente alle variazioni ampules). Do not refrigerate the product after it has been brought to room temperature! After opening the sensorkonfiguration och på en höjd av noll meter över havet. date de péremption indiquée sur les ampoules et sur la boîte. Eurotrol epoc Calibration Verification Fluids est Eurotrol epoc Calibration Verification Fluids di temperatura. Per ogni m O ampule, Eurotrol epoc Calibration Verification Fluids is stable for 30 seconds. Eurotrol epoc Calibration Verification Fluids • Felaktig provtagning eller förvaring eller annan felaktig hantering kan göra att de avlästa resultaten avviker stable pendant une semaine à température ambiante (ampoules non ouvertes). Ne pas réfrigérer à nouveau % % m % från målvärdena. m Procedures le produit après qu’il ait été amené à température ambiante ! Après ouverture de l’ampoule, Eurotrol epoc Käyttötarkoitus • pO2-värdena för Eurotrol epoc Calibration Verification Fluids varierar omvänt mot temperaturen. För varje Calibration Verification Fluids est stable pendant 30 secondes. 1. Remove the appropriate amount of ampules from box and tray. Equilibrate the ampule(s) for a minimum Eurotrol epoc Calibration Verification Fluids on analysoitu verikaasu-, elektrolyytti- ja metaboliittiviitemateriaali Verwendungszweck °C som temperaturen förändras inom området 18–26 °C förändras pO2 1,5 % på den låga nivån, 1,1 % m m of 1 hour to a temperature as close to 22 °C (71.6 °F) as possible. Procédures epoc® Blood Analysis Systemin täsmällisyyden ja tarkkuuden varmistamiseen. Eurotrol epoc Calibration Bei Eurotrol epoc Calibration Verification Fluids handelt es sich um geprüftes Blutgas-, Elektrolyt- und på den normala nivån och 0,5 % på den höga nivån. För att få bästa möjliga korrelation med värdena i m 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to re-equilibrate the 1. Sortir le nombre requis d’ampoules de la boîte et du plateau.Laisser la ou les ampoules s’équilibrer à Verification Fluids on suunniteltu seuraavien analyyttien testaamiseen: pH, pO2, pCO2, Na+, K+, Ca++, Metabolit-Referenzmaterial für die Verifizierung der Präzision und Exaktheit des epoc® Blood Analysis tabellen skall ampullerna jämviktas till en temperatur så nära 22 °C som möjligt. m m gases with the solution. When shaking, the ampule should be held between the thumb and index finger. une température de 15 à 30 °C. Mg++, Cl-, glukoosi, laktaatti, urea, kreatiniini ja tCO2. Eurotrol epoc Calibration Verification Fluids on System. Eurotrol epoc Calibration Verification Fluids wurde für die Testung der folgenden Analyten entwickelt: • När ampullen har öppnats har rumstemperaturen ingen signifikant inverkan på pH-värdena. 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any bubbles to rise 2. Immédiatement avant l’emploi, agiter vigoureusement l’ampoule pendant au moins quinze secondes pour kehitetty myös kalibroinnin, työskentelylämpötilan ja muiden suoritusominaisuuksien varmistamiseen. pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactat, Harnstoff, Kreatinin und tCO2. Eurotrol epoc • Eurotrol epoc Calibration Verification Fluids är känsligt för de flesta instrumentrelaterade faktorer som kan m m m before opening the ampule. Calibration Verification Fluids dient außerdem der Verifizierung von Kalibrierungen, Betriebstemperaturen leda till oväntade analysavvikelser. rééquilibrer les gaz avec la solution. Agiter l’ampoule en la tenant entre le pouce et l’index. IVD-lääkintälaite m m m 4. Protect fingers with gauze, tissue or gloves. und anderen Leistungsmerkmalen. • Eurotrol epoc Calibration Verification Fluids-kontrollerna innehåller inga proteiner och påvisar därför 3. Faire tourner délicatement l’ampoule pour ramener la solution au fond de celle-ci. Laisser remonter les Eurotrol epoc Calibration Verification Fluids on Euroopan IVD-direktiivin 98/79/EC mukainen diagnostinen in m m % mm 5. Hold ampule with the colored dot facing up. Snap off the neck of the ampule in the opposite eventuellt inte felfunktioner som är känsliga för dessa komponenter. bulles avant d’ouvrir l’ampoule. vitro -lääkintälaite, jolla on CE-merkintä. Medizinisches Gerät für die In-vitro-Diagnostik m direction of the colored dot. Please read the OPC instruction leaflet for more details. • Eurotrol epoc Calibration Verification Fluids är mycket känsligt för kontaminering med rumsluft. Vid 4. Se protéger doigts avec de la gaze, un morceau de tissu ou des gants. Eurotrol epoc Calibration Verification Fluids on tarkoitettu vain diagnostiseen in vitro -käyttöön. 6. Within 30 seconds, follow the sampling procedure according to the instructions in the operating manual Eurotrol epoc Calibration Verification Fluids erfüllt die Vorgaben der EU-Richtlinie 98/79/EC über 5. Maintenir l’ampoule avec le point coloré orienté vers le haut. Casser le col de l’ampoule dans la direction provtagning från vätskan inom 30 sekunder är felet mindre än 2 % för alla analyter och alla nivåer*. Yhteenveto of your epoc Blood Analysis System. medizinische Geräte für die In-vitro-Diagnostik und wurde mit dem CE-Zeichen ausgestattet. Eurotrol epoc opposée au point coloré. Consulter le mode d’emploi de l’OPC (ampoule autocassable) pour plus de Q Effekten av rumsluft på pH-värdet är försumbar. Eurotrol epoc Calibration Verification Fluids on laatukontrollimateriaali, jota on saatavana viitenä tasona, 7. Please refer to local guidelines for recommended frequency of use. Calibration Verification Fluids darf nur für die In-vitro-Diagnostik verwendet werden. détails *Värdena baseras på testning med öppen ampull. joista kullakin on tunnettu konsentraatio. m Zusammenfassung 6. Procéder au prélèvement de l’échantillon conformément aux instructions figurant dans le mode d’emploi Precautions Produkten har framställts i enlighet med Eurotrols specifikationer. O M @ m Bei Eurotrol epoc Calibration Verification Fluids handelt es sich um Lösungen zur Qualitätskontrolle mit fünf de l’analyseur epoc Blood Analysis System. Reagenssit 1. For in vitro diagnostic use only. m festgelegten Konzentrationsbereichen. För ytterligare information ber vi er kontakta: 7. Se référer aux directives locales pour connaître la fréquence d’utilisation recommandée. Eurotrol epoc Calibration Verification Fluids tarjoaa fysiologisesti olennaisia tasoja, ja kukin ampulli 2. These products should not be disposed of in general waste. Consult local environmental authorities for Précautions sisältää 2,5 ml liuosta. Eurotrol epoc Calibration Verification Fluids -kontrollit valmistetaan käyttäen suoloja O proper disposal. Reagenzien Eurotrol B.V. 1. Exclusivement pour usage diagnostic in vitro. fysiologisesti puskuroidussa matriisissa. Tonometria ennalta määritellyillä happi- ja hiilidioksiditasoilla 3. Eurotrol epoc Calibration Verification Fluids is not to be used as a calibrator. Eurotrol epoc Calibration Verification Fluids ist für physiologisch relevante Konzentrationsbereiche erhältlich. Nederländerna, Tel. +31 318 695 777, Fax +31 318 695 770, E-post office@eurotrol.com, 2. Ne pas éliminer ces produits avec les ordures ménagères. Consulter les autorités locales responsables tasapainotettuna typellä ja eri suolapitoisuuksilla tarjoaa viisi erillistä tasoa kullekin parametrille ja simuloi m Expected Results Jede Ampulle enthält 2,5 ml Lösung. Die Kontrolllösungen Eurotrol epoc Calibration Verification Fluids www.eurotrol.com de l’environnement pour connaître la manière de les éliminer. kliinisesti merkitseviä happo-emäs- ja elektrolyyttitasapainon, hengitystoiminnan, munuaisten toiminnan, Values are obtained by measurements on epoc Blood Analysis System using BGEM test cards. The werden auf der Grundlage von Salzen in physiologischer Puffermatrix hergestellt. Festgelegte Sauerstoff- m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederländerna 3. Eurotrol epoc Calibration Verification Fluids n’est pas destiné à être utilisé comme calibrateur. glukoosi- ja laktaattikonsentraatioiden alueita. Eurotrol epoc Calibration Verification Fluids -kontrollit eivät assigned values are available from http://www.epocal.com, tabulated for each fluid lot number and sensor und Kohlendioxidkonzentrationen, ins Gleichgewicht gebracht mit Stickstoff und Salzen in verschiedenen sisällä säilöntäaineita, viskositeetinsäätöaineita tai muita lisäaineita, jotka voisivat vaikuttaa haitallisesti m m configuration. Eurotrol epoc Calibration Verification Fluids is intended for professional use in the verification Konzentrationen, erlauben eine Tonometrie in fünf einzelnen Konzentrationsbereichen für jeden Parameter. Résultats attendus Symbolförklaring m elektrodimittauksiin. of the instrument performance. Simuliert werden klinisch signifikante Bereiche für Säure-Basen- und Elektrolythaushalt, Atemfunktion, Les valeurs sont obtenues par le biais de mesures effectuées sur l’analyseur epoc Blood Analysis m m m Nierenfunktion sowie Glucose- und Lactatkonzentration. Die Kontrolllösungen Eurotrol epoc Calibration Batchnummer System en utilisant les cartes de test BGEM. Les valeurs assignées sont disponibles à l’adresse Varastointi ja stabiilius Obs! Se bruksanvisningen M Please Note Verification Fluids enthalten keine Konservierungsmittel, Mittel zur Einstellung der Viskosität oder andere Eurotrol epoc Calibration Verification Fluids -kontrolleja voidaan säilyttää lämpötilassa 2–8 °C. Kun tuotetta http://www.epocal.com, présentées pour chaque numéro de lot de liquide et chaque configuration de capteur. • The values in the table are applicable only to the assigned fluid lot number, the applicable epoc Blood Zusatzstoffe, die einen negativen Einfluss auf die Elektrodenmessungen haben könnten. Utgångsdatum Temperatur begränsning säilytetään avaamattomana tässä lämpötilassa, taataan sen stabiilius ampulleissa ja ulkopakkauksessa Eurotrol epoc Calibration Verification Fluids est destiné à un usage professionnel pour le contrôle des Analysis System sensor configuration and at sea level. ilmoitettuun viimeiseen käyttöpäivään asti. Eurotrol epoc Calibration Verification Fluids on stabiili 1 viikon Lagerung und Haltbarkeit Medicinteknisk produkt för in vitro-diagnostik Katalognummer performances de l’instrument. • Incorrect sampling, storage, or other mishandling may cause the readings to deviate from the target ajan huoneenlämmössä (avaamattomat ampullit). Tuotetta ei saa laittaa jääkaappiin sen jälkeen kun se on Eurotrol epoc Calibration Verification Fluids kann bei einer Temperatur zwischen 2 und 8 °C gelagert werden. values. • The pO2 values of Eurotrol epoc Calibration Verification Fluids vary inversely with temperature changes. Bei einer Lagerung der ungeöffneten Ampullen in diesem Temperaturbereich wird die angegebene Stabilität Tillverkare CE-märkning Remarques • Les valeurs figurant dans le tableau sont uniquement applicables au numéro de lot de liquide tuotu huoneenlämpöön! Ampullin avaamisen jälkeen Eurotrol epoc Calibration Verification Fluids on stabiili 30 sekunnin ajan. Eu o o epoc Ca b a on Ve fica on F u ds For each °C change in temperatures between 18 °C and 26 °C (between 64.5 °F and 79 °F), the der Lösungen bis zum auf den Ampullen und der Umverpackung angegebenen Verfallsdatum garantiert. correspondant, à la configuration de capteur de l’analyseur epoc Blood Analysis System correspondante Bei Raumtemperatur ist Eurotrol epoc Calibration Verification Fluids eine Woche lang stabil (ungeöffnete et au niveau de la mer. Käyttö pO2 changes 1.5% in the low level, 1.1% in the normal and 0.5% in the high level. To obtain a high Ampullen). Nach dem Erreichen der Raumtemperatur darf die Lösung nicht mehr gekühlt werden! Nach • Un prélèvement incorrect, une conservation inadéquate ou toute autre erreur de manipulation risquent 1. Ota sopiva määrä ampulleja laatikosta ja tarjottimelta. Tasapainota ampullia (ampulleja) vähintään 1 degree of correlation with the values in the table, the ampules should be equilibrated as close to 22 °C tunnin ajan mahdollisimman lähelle lämpötilaa 22 °C. O m m (71.6 °F) as possible. dem Öffnung der Ampullen ist Eurotrol epoc Calibration Verification Fluids dreißig Sekunden lang stabil. Eurotrol epoc Calibration Verification Fluids d’avoir pour conséquence un écart entre les mesures obtenues et les valeurs cibles. 2. Ravistelle ampullia juuri ennen käyttöä voimakkaasti vähintään viidentoista sekunnin ajan, jotta kaasut m m O • Once the ampule is opened, room temperature has no significant effect on pH values. Anweisungen für die Verwendung des Produkts • Les valeurs de pO2 d’Eurotrol epoc Calibration Verification Fluids varient en fonction inverse des tasapainottuvat uudelleen liuoksen kanssa. Ravisteltaessa ampullia tulisi pitää peukalon ja etusormen m O O • Eurotrol epoc Calibration Verification Fluids is sensitive to most of the instrument related factors that can 1. Erforderliche Anzahl an Ampullen aus der Packung entnehmen. Ampulle(n) mindestens eine Stunde lang variations de température. Pour chaque variation de 1 °C de la température entre 18 et 26 °C (64.5 - 79 Tiltenkt formål °F), la valeur de pO2 change de 1.5% pour le niveau bas, de 1.1% pour le niveau normal et de 0.5% pour välissä. M O O cause unexpected analytical deviations. bei einer Temperatur äquilibrieren, die möglichst exakt bei 22 °C liegen sollte. Eurotrol epoc Calibration Verification Fluids er referansemateriale for analyse av blodgass, elektrolytter og 3. Pyörittele ampullia varoen, jotta liuos palaa ampullin pohjalle. Anna mahdollisten kuplien nousta ylös m m m m • Eurotrol epoc Calibration Verification Fluids controls do not contain protein and therefore may not detect 2. Unmittelbar vor der Verwendung Ampulle(n) mindestens fünfzehn Sekunden lang kräftig schütteln, um le niveau élevé. Pour obtenir un haut degré de corrélation avec les valeurs du tableau, les ampoules metabolitter, og brukes til å verifisere presisjonen og nøyaktigheten til epoc® Blood Analysis System. Eurotrol doivent être équilibrées à une température aussi proche que possible de 22 °C (71.6°F). ennen ampullin avaamista. m malfunctions sensitive to these components. die Gase ausreichend mit der Lösung zu vermischen. Zum Schütteln, Ampulle(n) zwischen Daumen und epoc Calibration Verification Fluids er utviklet for å teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca++, • Après ouverture de l’ampoule, la température ambiante n’a plus d’effet significatif sur les valeurs du pH. 4. Sormet on suojattava sideharsolla, paperiliinalla tai käsineillä. • Eurotrol epoc Calibration Verification Fluids is very sensitive to room air contamination. When sampling Zeigefinger halten. M Mg++, Cl-, glukose, laktat, urea, kreatinin og tCO2. Eurotrol epoc Calibration Verification Fluids er også • Eurotrol epoc Calibration Verification Fluids est sensible à la plupart des facteurs liés à l’instrument 5. Pidä ampullia niin, että värillinen täplä on ylöspäin. Katkaise ampullin kaula värillisen täplän O m the fluid within 30 seconds, the error is less than 2% over the entire range in all levels**. The effect of 3. Ampulle(n) vorsichtig schwenken, damit sich die Lösung wieder am Boden der Ampulle(n) absetzt. utviklet for å verifisere kalibrering, driftstemperatur og andre resultatdata. susceptibles de produire des écarts analytiques inattendus. vastakkaiselta puolelta. Lue lisäyksityiskohdat OPC-ohjekirjasesta. room air on pH is negligible. Ampulle(n) erst öffnen, nachdem eventuell vorhandene Bläschen an die Oberfläche gestiegen sind. m m • Les contrôles Eurotrol epoc Calibration Verification Fluids ne contiennent pas de protéines et ne sont dès 6. Noudata epoc Blood Analysis Systemin käyttöoppaan ohjeiden mukaista näytteenottomenetelmää 30 O **Numbers are based on open ampule testing. 4. Hände mit Gaze, Lappen oder Handschuhen schützen. IVD-medisinsk utstyr lors pas à même de détecter les dysfonctionnements sensibles à ces composants. sekunnin kuluessa. This product has been manufactured according to Eurotrol specifications. 5. Ampulle(n) mit dem farbig markierten Punkt nach oben halten und Ampullenhals in die gegenüber Eurotrol epoc Calibration Verification Fluids er i samsvar med det europeiske IVD-direktivet 1998/79/EF for in m • Eurotrol epoc Calibration Verification Fluids est extrêmement sensible à la contamination de l’air 7. Noudata paikallisia ohjeita suositellun käyttötiheyden suhteen. liegende Richtung abbrechen. Weitere Hinweise siehe Anleitungsblatt für OPC-Ampullen vitro-diagnostisk medisinsk utstyr og bærer CE-merket. O mm m For further information please contact: (Brechampullen mit One-Point-Cut). Eurotrol epoc Calibration Verification Fluids er bare for in vitro-diagnostisk bruk. ambiant. Lorsque le prélèvement du liquide a lieu dans les 30 secondes, l’erreur est inférieure à 2% sur Varotoimet m m Eurotrol B.V., The Netherlands, Phone +31 318 695 777, Fax +31 318 695 770 6. Testverfahren gemäß Bedienungsanleitung des epoc Blood Analysis System innerhalb von dreißig l’ensemble de la plage de valeurs pour tous les niveaux**. L’effet de l’air ambiant sur le pH est négligeable. 1. Ainoastaan diagnostiseen in vitro -käyttöön. Sammendrag **Ces chiffres sont basés sur le test portant sur une ampoule ouverte. 2. Näitä tuotteita ei tule hävittää yleisjätteen mukana. Kysyttävä neuvoa oikean jätteenhävityksen suhteen E-mail office@eurotrol.com, www.eurotrol.com Sekunden durchführen. Eurotrol epoc Calibration Verification Fluids er et kvalitetskontrollmateriale tilgjengelig på fem nivåer, hvert paikallisilta ympäristöviranomaisilta. O m m Eurotrol Inc., USA, Toll free phone 1-866-234-5754, Main phone 1-978-598-3779, 7. Empfohlene Anwendungsfrequenz siehe entsprechende Leitlinien vor Ort. Ce produit est fabriqué conformément aux spécifications d’Eurotrol. med kjente konsentrasjoner. 3. Eurotrol epoc Calibration Verification Fluids -kontrollia ei tule käyttää kalibraattorina. m O Fax 1-978-598-3780, E-mail officeUSA@eurotrol.com, www.eurotrol.com Vorsichtsmaßnahmen für die Anwendung Reagenser Pour un complément d’information, veuillez contacter: m m m m m m m 1. Nur für die In-vitro-Diagnostik bestimmt. Eurotrol B.V., Pays-Bas, Téléphone +31 318 695 777, Télécopie +31 318 695 770, m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands Eurotrol epoc Calibration Verification Fluids sørger for fysiologisk relevante nivåer, hver ampulle inneholder Odotetut tulokset 2. Produkte nicht mit dem Hausmüll entsorgen. Anweisungen für eine ordnungsgemäße Entsorgung sind Courriel office@eurotrol.com, www.eurotrol.com m m m m 2,5 ml løsning. Eurotrol epoc Calibration Verification Fluids-kontroller er preparert ved hjelp av salter Arvot saadaan mittaamalla epoc Blood Analysis Systemiissä käyttäen BGEM -testikortteja. Kullekin Symbols used beim jeweils zuständigen Umweltamt zu erfragen. Eurotrol Inc., Etats-Unis, Numéro d’appel gratuit 1-866-234-5754, Téléphone principal 1-978-598-3779, O M i en fysiologisk bufret matrise. Tonometri med forhåndsbestemte nivåer for oksygen og karbondioksid neste-eränumerolle ja anturikonfiguraatiolle määrätyt arvot ovat saatavilla internetosoitteesta 3. Eurotrol epoc Calibration Verification Fluids nicht als Kalibrator verwenden. Télécopie 1-978-598-3780, Courriel officeUSA@eurotrol.com, www.eurotrol.com m m balansert med nitrogen og ulike saltkonsentrasjoner sørger for fem distinkte nivåer for hver parameter, slik http://www.epocal.com. Attention, see instructions for use Batch code m m Zu erwartende Ergebnisse at det simuleres klinisk signifikante områder av syre-base- og elektrolyttbalanse, respiratorisk funksjon, Eurotrol epoc Calibration Verification Fluids on tarkoitettu ammattilaisten käyttöön laitteen toimivuuden Use by Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Pays-Bas Temperature limitation Entsprechende Messwerte werden auf der Grundlage von Messungen durch das epoc Blood Analysis renalfunksjon, glukose- og laktatkonsentrasjon. Eurotrol epoc Calibration Verification Fluids-kontroller varmistamiseksi. m m System unter Verwendung von BGEM-Testkarten erzielt. Die entsprechenden Werte sind unter http:// inneholder ingen konserveringsmidler, viskositetsjustering eller andre tilsetningsstoffer som kan innvirke Symboles utilisés O m m In Vitro Diagnostic Medical Device Reference number Huomioitavaa www.epocal.com in Tabellenform für alle Flüssigkeits-Chargennummer und Sensorkonfigurationen negativt på elektrodemålinger. m m m Manufacturer CE mark Attention, consulter le mode d’emploi Numéro de lot • Taulukon arvot soveltuvat vain määrätyille neste-eränumeroille, soveltuvalle epoc Blood Analysis System erhältlich. Eurotrol epoc Calibration Verification Fluids ist für die professionelle Anwendung zur Prüfung der m O Oppbevaring og stabilitet -anturikonfiguraatiolle ja merenpinnan tasolla. Geräteleistung bestimmt. Date de péremption Limites de température m m m m Eurotrol epoc Calibration Verification Fluids kan oppbevares ved en temperatur på 2–8 °C. Oppbevart • Väärä näytteenotto, varastointi tai muu väärä käsittely voi aiheuttaa tavoitearvoista poikkeavia lukemia. Weitere Hinweise uåpnet ved denne temperaturen er produktet garantert stabilt som angitt til utløpsdatoen på ampullene Dispositif médical de diagnostic in vitro Référence • Eurotrol epoc Calibration Verification Fluids -kontrollin pO2 -arvo voi muuttua käänteisesti m m m • Die Werte in den Tabellen beziehen sich lediglich auf die zugeordnete Flüssigkeits-Chargennummer, die og den utvendige boksen. Eurotrol epoc Calibration Verification Fluids er stabil i 1 uke ved romtemperatur lämpötilamuutosten kanssa. Jokaista °C:n lämpötilamuutosta kohden välillä 18 °C - 26 °C pO2 muuttuu zu verwendende Sensorkonfiguration für das epoc Blood Analysis System und Meereshöhe. Fabricant Label CE (uåpnede ampuller). Ikke sett produktet i kjøleskapet etter at det er blitt brakt til romtemperatur! Etter åpning 1,5% matalalla tasolla, 1,1% normaalilla ja 0,5% korkealla tasolla. Jotta saadaan suuri korrelaatioaste Eurotrol epoc Calibration Verification Fluids • Fehler bei der Probenentnahme oder Lagerung oder andere Handhabungsfehler können zu von den av ampullen vil Eurotrol epoc Calibration Verification Fluids være stabile i 30 sekunder. taulukon arvojen kanssa, tulisi ampullit tasapainottaa mahdollisimman lähelle lämpötilaa 22 °C. m m m m Zielwerten abweichenden Messwerten führen. Prosedyrer • Kun ampulli on avattu, ei huoneenlämmöllä ole merkitsevää vaikutusta pH-arvoihin. m m m m Toepassing • Die pO2-Werte von Eurotrol epoc Calibration Verification Fluids variieren invers in Bezug auf • Eurotrol epoc Calibration Verification Fluids on herkkä useimmille laitteisiin liittyville tekijöille, jotka voivat Eurotrol epoc Calibration Verification Fluids is een kwaliteitscontrolemateriaal met toegekende waarden voor Temperaturveränderungen. Für jede Temperaturveränderung um ein °C zwischen 18 °C und 26 °C 1. Ta ut egnet mengde ampuller fra boks og brett. Ekvilibrer ampullen(e) i minimum 1 time til en temperatur så nær 22 °C som mulig. Eurotrol epoc Calibration Verification Fluids aiheuttaa odottamattomia analyyttisiä poikkeamia. m m m m m m m m professioneel gebruik bij het controleren van de precisie en nauwkeurigheid van het epoc® Blood Analysis verändert sich der pO2-Wert um 1,5% im niedrigen, um 1,1% im normalen und um 0,5% im hohen 2. Umiddelbart før bruk rister du ampullen godt i minst 15 sekunder for å re-ekvilibrere gassene med • Eurotrol epoc Calibration Verification Fluids -kontrollit eivät sisällä proteiinia, ja siksi ne eivät mahdollisesti System. Bereich. Um eine möglichst hohe Übereinstimmung mit den Werten in der Tabelle zu erzielen, sollten die havaitse näille komponenteille herkkiä vikoja. m m m m m m løsningen. Hold ampullen mellom tommelen og pekefingeren når du rister den. Tilsigtet formål Eurotrol epoc Calibration Verification Fluids is ontwikkeld om de volgende parameters te testen: pH, pO2, Ampulle(n) bei einer Temperatur äquilibriert werden, die möglichst exakt bei 22 °C liegen sollte. 3. Drei ampullen forsiktig for å la løsningen returnere til bunnen av ampullen. La eventuelle bobler komme • Eurotrol epoc Calibration Verification Fluids on hyvin herkkä huoneilman kontaminaatiolle. Kun neste m m • Nach dem Öffnen der Ampullen hat die Raumtemperatur keine signifikanten Auswirkungen auf den Eurotrol epoc Calibration Verification Fluids er et analyseret blodgas-, elektrolyt- og käytetään 30 sekunnin kuluessa, on virhe alle 2% koko alueella kaikilla tasoilla*. Huoneilman vaikutus pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactaat, Ureum, Creatinine en tCO2. Eurotrol epoc Calibration opp før du åpner ampullen. m pH-Wert. metabolitreferencemateriale til verificering af præcision og nøjagtighed ved epoc® Blood Analysis System. pH:hon on mitätön. Verification Fluids is tevens ontwikkeld om de ijking, werktemperatuur en andere prestatiekenmerken te 4. Beskytt fingrene med gas, papirhåndkle eller hansker. m m m m • Eurotrol epoc Calibration Verification Fluids reagiert sensibel auf die meisten instrumentenbezogenen Eurotrol epoc Calibration Verification Fluids blev fremstillet til at teste følgende analytter: pH, pO2, pCO2, *Luvut perustuvat avoimen ampullin testaamiseen. controleren. 5. Hold ampullen med den fargede prikken vendt opp. Bryt av halsen på ampullen i motsatt retning av m m O Faktoren, die zu unerwarteten Analyseabweichungen führen können. Na+, K+, Ca++, Mg++, Cl-, glukose, laktat, urea, kreatinin og tCO2. Eurotrol epoc Calibration Verification IVD Medisch Hulpmiddel den fargede prikken. Les OPC-instruksjonsheftet for å få mer detaljert informasjon. Tämä tuote on valmistettu Eurotrol-spesifikaatioiden mukaisesti. m m m m m m • Eurotrol epoc Calibration Verification Fluids enthalten kein Protein. Fehlfunktionen mit Empfindlichkeit für Fluids er også udviklet for at verificere kalibrering, driftstemperatur og andre funktionsdata. Eurotrol epoc Calibration Verification Fluids voldoet aan de Europese Richtlijn 98/79/EG betreffende 6. Innen 30 sekunder følger du prøvetakingsprosedyren i henhold til instruksjonene i bruksanvisningen for m m solche Bestandteile können somit eventuell nicht festgestellt werden. IVD medicinsk udstyr m m Medische Hulpmiddelen voor In-vitro diagnostiek en draagt het CE keurmerk. epoc Blood Analysis System. • Eurotrol epoc Calibration Verification Fluids reagiert sehr empfindlich auf Kontamination durch Raumluft. Eurotrol epoc Calibration Verification Fluids er i overensstemmelse med det europæiske IVD-direktiv 98/79/ Eurotrol epoc Calibration Verification Fluids is uitsluitend bestemd voor professioneel in vitro diagnostisch 7. Se lokale retningslinjer for anbefalt hyppighet for bruk. m Bei einer Prüfung der Flüssigkeit innerhalb von dreißig Sekunden liegt die Fehlerquote bei unter 2% in EC om in vitro diagnostisk medicinsk udstyr og bærer CE-mærket. gebruik. @ m m m allen Bereichen und über alle Konzentrationsstufen hinweg. Die Auswirkungen der Raumluft auf den Forholdsregler Eurotrol epoc Calibration Verification Fluids er kun til in vitro diagnostisk brug. Samenvatting pH-Wert sind vernachlässigbar. 1. Bare til in vitro-diagnostisk bruk. m m m m m 2. Disse produktene må ikke kastes i vanlig avfall. Kontakt lokale miljømyndigheter for å sørge for riktig Opsummering m Eurotrol epoc Calibration Verification Fluids is een kwaliteitscontrolemateriaal, verkrijgbaar op vijf niveaus, *Zahlen basieren auf Testwerten mit offenen Ampullen. håndtering. Eurotrol epoc Calibration Verification Fluids er et kvalitetskontrolmateriale, der leveres i fem niveauer, hvert O m m elk met bekende concentraties. Das vorliegende Produkt wurde gemäß Spezifikationen von Eurotrol hergestellt. m m m 3. Eurotrol epoc Calibration Verification Fluids skal ikke brukes som en kalibrator. med kendte koncentrationer. Reagentia Weitere Informationen erhalten Sie bei: m Forventede resultater Reagenser O m m G M O Eurotrol epoc Calibration Verification Fluids is beschikbaar in fysiologisch relevante niveau’s. Elke ampul Eurotrol B.V. Verdier hentes fra målinger med epoc Blood Analysis System ved hjelp av BGEM testkort. De anviste verdiene Eurotrol epoc Calibration Verification Fluids leverer fysiologiske relevante niveauer, hver ampul indeholder m m m m m bevat 2.5 mL vloeistof. Eurotrol epoc Calibration Verification Fluids is samengesteld uit zouten in een Niederlande, Tel. +31 318 695 777, Fax +31 318 695 770 er tilgjengelige fra http://www.epocal.com, tabulert for hvert væskepartinummer og sensorkonfigurasjon. 2,5 ml opløsning. Eurotrol epoc Calibration Verification Fluids kontroller klargøres ved hjælp af salte i en O G M fysiologisch gebufferde matrix. Tonometrie met van te voren bepaalde niveaus van zuurstof-, koolzuur-, E-Mail office@eurotrol.com, www.eurotrol.com fysiologisk buffermatrix. Tonometri med forudbestemte niveauer af oxygen og kuldioxid, der er afstemt m m m stikstofgasmengsels en verschillende zoutconcentraties, resulteren in vijf fysiologisch relevante niveaus voor Eurotrol GAS-ISE Metabolytes er beregnet på profesjonell bruk i verifiseringen av instrumentytelsen. med nitrogen og forskellige saltkoncentrationer, udgør fem tydelige niveauer for hver parameter, som m elke parameter. Hiermee worden klinisch belangrijke gebieden van de zuur-base- en elektrolytenbalans, Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Niederlande Merk m simulerer klinisk signifikante områder for syre-base og elektrolytbalance, åndedrætsfunktion, nyrefunktion, functie van de ademhaling, nierfunctie en glucose- en lactaatconcentratie weergegeven. Eurotrol epoc • Verdiene i tabellen gjelder bare for det anviste væskepartinummeret, den aktuelle sensorkonfigurasjonen O m Verwendete Symbole glukose og laktatkoncentration. Eurotrol epoc Calibration Verification Fluids kontroller indeholder ingen Calibration Verification Fluids controles bevatten geen conserveringsmiddelen, viscositeitsregelaars of m for epoc Blood Analysis System og ved havnivå. m m konserveringsmidler, viskositetsregulatorer eller andre tilsætningsstoffer, der kan påvirke elektrodemålinger andere toevoegingen die de elektroden of metingen nadelig zouden kunnen beïnvloeden. Achtung, siehe Bedienungsanleitung • Feil prøvetaking, oppbevaring eller annen feilhåndtering kan føre til avlesinger som avviker fra m m m m m m m m m Chargennummer negativt. Opslag en stabiliteit Eurotrol epoc Calibration Verification Fluids kan bewaard worden bij een temperatuur van 2–8 °C. Verwendbar bis Temperaturbereich målverdiene. • pO2 -verdiene for Eurotrol epoc Calibration Verification Fluids varierer omvendt i forhold til Opbevaring og stabilitet Eu o o epoc Ca b a on Ve fica on F u ds O O m m m m Medizinisches Gerät für die In-vitro-Diagnostik Referenznummer temperaturendringer. For hver °C-endring i temperaturer mellom 18 °C og 26 °C endres pO2 1,5 % ved Eurotrol epoc Calibration Verification Fluids kan opbevares ved en temperatur på 2-8 °C. Ved opbevaring m m O m % Ongeopend bewaard bij deze temperatuur is het product gegarandeerd stabiel tot de houdbaarheidsdatum lavt nivå, 1,1 % ved normalt nivå og 0,5 % ved høyt nivå. For å oppnå en høy grad av korrelasjon med i uåbnet tilstand ved denne temperatur garanteres stabilitet, som det er angivet indtil udløbsdatoen på % m % m m zoals aangegeven op de ampul en op de buitenverpakking. Na het openen van de ampul is Eurotrol epoc Hersteller CE-Zeichen verdiene i tabellen, må ampullene ekvilibreres så nært til 22°C som mulig. ampullerne og den udvendige pakning. Eurotrol epoc Calibration Verification Fluids er stabil i 1 uge ved m m m m m m m m Calibration Verification Fluids stabiel gedurende 30 seconden. • Når ampullen er åpnet, har romtemperatur ingen signifikant effekt på pH-verdiene. stuetemperatur (uåbnede ampuller). Undlad at nedkøle produktet, efter det har opnået stuetemperatur! Efter m m m m m m m m Procedures åbning af ampullen er Eurotrol epoc Calibration Verification Fluids stabil i 30 sekunder. O m m • Eurotrol epoc Calibration Verification Fluids er følsomme for de fleste instrumentrelaterte faktorer som m O O 1. Haal het benodigde aantal ampullen uit de verpakking. Incubeer de ampul(len) gedurende ten minste één kan føre til uventede analytiske avvik. M O m m Procedurer uur bij een temperatuur die zo dicht mogelijk bij 22 °C ligt. 2. Schud, vlak voor gebruik, de ampul gedurende 15 seconden om de gassen opnieuw in evenwicht te Eurotrol epoc Calibration Verification Fluids • Eurotrol epoc Calibration Verification Fluids-kontroller inneholder ikke protein og kan derfor ikke registrere 1. Fjern den passende mængde ampuller fra æsken og bakken. Ækvilibrer ampullen/ampullerne i mindst 1 m m O m m m m m feilfunksjoner som er følsomme for disse komponentene. time til en temperatur, der er så tæt på 22 °C som muligt. m brengen met de oplossing. De ampul houdt men daarbij tussen duim en wijsvinger. O m m • Eurotrol epoc Calibration Verification Fluids er svært følsomme for kontaminasjon av romluft. Ved 2. Ryst umiddelbart før brug ampullen kraftigt i mindst femten sekunder for at reækvilibrere gasserne med m 3. Zwenk de ampul voorzichtig zodat de vloeistof naar de bodem kan terugkeren. Laat de gasbelletjes Avsedd användning prøvetaking av væsken innen 30 sekunder er feilen mindre enn 2 % over hele området ved alle nivåer*. Q m m % m opløsningen. Når ampullen rystes, skal den holdes mellem tommel- og pegefinger. m m omhoog komen alvorens de ampul te openen. Eurotrol epoc Calibration Verification Fluids är ett analyserat referensmaterial för blodgaser, elektrolyter och m O m Effekten av romluft på pH er ubetydelig. 3. Sving forsigtigt ampullen rundt for at sende opløsningen tilbage til bunden af ampullen. Lad eventuelle m 4. Bescherm de vingers met verbandgaas, tissue of handschoenen. metaboliter, för verifiering av precisionen och noggrannheten hos epoc® Blood Analysis System. Eurotrol *Tallene er basert på testing av åpne ampuller. O m m m m m bobler stige op, før ampullen åbnes. 5. Houd de ampul met de gekleurde stip naar boven gericht. Breek de hals van de ampul af in epoc Calibration Verification Fluids är avsett för testning av följande analyter: pH, pO2, pCO2, Na+, K+, Ca++, m tegenovergestelde richting van de gekleurde stip. Lees ook de bijgevoegde OPC-instructies. Mg++, Cl-, glukos, laktat, urea, kreatinin och tCO2. Eurotrol epoc Calibration Verification Fluids är även avsett Dette produktet er produsert i henhold til Eurotrols spesifikasjoner. 4. Beskyt fingrene med gaze, servietter eller handsker. m 6. Volg binnen 30 seconden de procedure van bemonsteren volgens de instructies in de handleiding van het för verifiering av kalibrering, drifttemperatur och andra prestandaegenskaper. 5. Hold ampullen, så den farvede prik vender opad. Åbn ampullen i den modsatte retning af den m m Hvis du ønsker mer informasjon, kan du ta kontakt: farvede prik. Læs OPC-indlægssedlen for at få flere oplysninger. epoc Blood Analysis System. Medicinteknisk produkt för in vitro-diagnostik Eurotrol B.V., Nederland, Telefon +31 318 695 777, Faks +31 318 695 770, E-Mail office@eurotrol.com, 6. Følg inden for 30 sekunder prøvetagningsproceduren i overensstemmelse med betjeningsvejledningen M @ m m 7. Raadpleeg de plaatselijk geldende richtlijnen voor de aanbevolen gebruiksfrequentie Eurotrol epoc Calibration Verification Fluids uppfyller det europeiska IVD-direktivet 98/79/EG om www.eurotrol.com til epoc Blood Analysis System. m M @ m medicintekniska produkter för in vitro-diagnostik och är CE-märkt. 7. Se de lokale retningslinjer for anbefalet anvendelseshyppighed. m m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Países Baixos Precauţii Eurotrol epoc Calibration Verification Fluids 는 다음의 미국연방규정집(CFR)을 준수합니다. 42 CFR 파트 72 Kasutatud sümbolid Tootmise kuupäev • Eurotrol epoc Calibration Verification FluidsのpO2値は、温度変化と逆方向に変化します。18 ° C～26 ° C の範 请注意 1. Se utilizează exclusiv pentru diagnostic in vitro. 및 21 CFR 파트 606, 640, 820. 囲で温度が1 ° C変化するごとに、pO2は低レベルで1.5%、標準で1.1%、高レベルで0.5%変化します。表に記載 • 表格中的值仅适用于指定的试剂批号和适当的 epoc Blood Analysis System 传感器配置，且仅在海平面 Símbolos utilizados Data de fabrico 2. Aceste produse nu trebuie evacuate pe calea deşeurilor menajere. Consultaţi autorităţile de mediu locale Eurotrol epoc Calibration Verification Fluids 는 체외 진단용으로만 사용해야 합니다. Tähelepanu, lugege kasutusjuhiseid Partii kood の値と高い相関を得るには、 アンプルを可能な限り22 ° C に近い温度に平衡化させる必要があります。 高度处适用。 pentru o evacuare corectă. 요약 Kasutada enne Temperatuuripiirang • アンプルの開封後は、室温はpH値に大きく影響しません。 • 不正确的取样、储存或其他违规操作可导致读数偏离目标值。 Atenção, consultar instruções de utilização Código de lote 3. Eurotrol epoc Calibration Verification Fluids nu trebuie utilizat drept calibrator. Eurotrol epoc Calibration Verification Fluids 는 5가지 수치로 사용할 수 있는 정도 관리 물질로, 각각의 • Eurotrol epoc Calibration Verification Fluidsは、予期せぬ分析のずれの原因となる機器関連のほとんどの要 • Eurotrol epoc Calibration Verification Fluids 的 pO2 值与温度成反比。在 18 °C 和 26 °C 之间 每改变 Prazo de validade Limites de temperatura Rezultate aşteptate In vitro diagnostiline meditsiiniseade Viitenumber 素に対して高い感受性を持ちます。 1°C，pO2 值在低水平时便改变 1.5%，正常水平时便改变 1.1%，高水平时便改变 0.5%。要使检测值与表 농도가 알려져 있습니다. Valorile se obţin prin măsurători efectuate pe epoc Blood Analysis System utilizând carduri de testare BGEM. Tootja CE-märgis • Eurotrol epoc Calibration Verification Fluids対照にはタンパク質は含まれていないため、これらの成分に対 格中的值高度相关，应将安瓿静置至尽量接近 22 °C。 Dispositivo médico para diagnósticos in vitro Número de referência 시약 して感受性の高い機能不全を検出することはできません。 • 打开安瓿后，室温对 pH 值无显著影响。 Valorile atribuite sunt disponibile la http://www.epocal.com, tabelate pentru fiecare număr de lot de lichid şi Fabricante Marca CE configuraţie a senzorului. Eurotrol epoc Calibration Verification Fluids 는 생리학적 관련 수치를 제공하며, 각 앰플에는 2.5mL의 용액이 • Eurotrol epoc Calibration Verification Fluidsは、室内空気の汚染に対して非常に高い感受性を持ちます。30 • Eurotrol epoc Calibration Verification Fluids 对大多数可引起非预期分析偏差的仪器相关因素敏感。 Eurotrol epoc Calibration Verification Fluids este conceput pentru utilizare profesională la verificarea 들어 있습니다. Eurotrol epoc Calibration Verification Fluids 컨트롤은 생리학적으로 완충된 매트릭스에 秒以内に液体のサンプリングを行う場合は、すべてのレベルで全範囲に渡って2%未満の誤差となります。室 • Eurotrol epoc Calibration Verification Fluids 对照品不含蛋白质，因此检测不出对这些成分敏感的故 performanţelor instrumentelor. 소금을 사용하여 준비됩니다. 질소와 균형이 잡힌 산소 및 이산화탄소의 미리 결정된 수치 그리고 각기 다른 Eurotrol epoc Calibration Verification Fluids 内空気のpHへの影響は無視できます。 障。 소금 농도를 사용한 안압측정은 각 매개변수에 대해 5개의 다른 수치를 제공하여, 임상적으로 유의미한 산- *値は開放アンプル試験に基づいています。 • Eurotrol epoc Calibration Verification Fluids 对室内空气污染非常敏感。当在 30 秒内取样时，所有水平 Eurotrol epoc Calibration Verification Fluids Vă rugăm să reţineţi 염기 및 전해질 균형의 범위, 호흡기 기능, 신장 기능, 포도당 및 유산염 농도를 모의시험할 수 있게 합니다. Peruntukan この製品は、Eurotrol仕様に従って製造されました。 范围内的出错率低于 2%*。室内空气对 pH 的影响可以忽略。 • Valorile din tabel sunt valabile numai pentru numărul de lot de lichid atribuit, pentru configuraţia senzorului Eurotrol epoc Calibration Verification Fluids 컨트롤에는 전극 측정에 부정적인 영향을 미칠 수 있는 방부제, *数字基于公开的安瓿检测。 epoc Blood Analysis System în cauză şi la nivelul mării. Eurotrol epoc Calibration Verification Fluids merupakan materi referensi gas, elektrolit dan metabolit darah Propósito previsto 점도 조절기 또는 기타 첨가제가 함유되어 있지 않습니다. yang diuji, untuk memverifikasi ketepatan dan keakuratan epoc Blood Analysis System. Eurotrol epoc 詳細については、下記までお問い合わせください: 本品按 Eurotrol 规格制造。 • Recoltarea, depozitarea incorecte sau alte manipulări defectuoase pot determina abaterea valorilor de Eurotrol B.V., オランダ, 電話 +31 318 695 777, FAX +31 318 695 770, 電子メール office@eurotrol.com, Eurotrol epoc Calibration Verification Fluids es una solución de referencia probada de gases sanguíneos, 보관 및 안정성 Calibration Verification Fluids dirancang untuk menguji analit berikut: pH, pO2, pCO2, Na+, K+, Ca++, la valorile ţintă. electrolitos y metabolitos para verificar la precisión y exactitud de epoc® Blood Analysis System. Eurotrol Eurotrol epoc Calibration Verification Fluids 는 2–8 °C의 온도에서 보관할 수 있습니다. 이 온도에서 개봉하지 Mg++, Cl-, Glukosa, Laktat, Urea, Kreatinina dan tCO2. Eurotrol epoc Calibration Verification Fluids juga www.eurotrol.com 更多信息，请联系： • Valorile pO2 la Eurotrol epoc Calibration Verification Fluids variază invers proporţional cu modificările 않은 상태로 보관하면 앰플 및 외부 상자 겉면에 표시된 유효기간까지 안정적인 상태를 유지할 수 있습니다. Eurotrol B.V., 荷兰, 电话 +31 318 695 777, 传真 +31 318 695 770, 电子邮件 office@eurotrol.com, epoc Calibration Verification Fluids ha sido diseñado para analizar los analitos siguientes: pH, pO2, pCO2, temperatură. Pentru fiecare °C de modificare a temperaturii între 18 °C şi 26 °C, valoarea pO2 se modifică dikembangkan untuk memverifikasi kalibrasi, suhu operasi dan karakteristik kinerja lainnya. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, オランダ Na+, K+, Ca++, Mg++, Cl-, glucosa, lactato, urea, creatinina y tCO2. Eurotrol epoc Calibration Verification cu 1,5% la nivelul inferior, cu 1,1% la nivelul normal şi cu 0,5% la nivelul superior. Pentru a obţine un Eurotrol epoc Calibration Verification Fluids는 실온에서는 1주간 안정적입니다(미개봉 앰플). 제품을 실온에 www.eurotrol.com Fluids se ha desarrollado asimismo con el fin de verificar la calibración, la temperatura de funcionamiento y 노출한 후에는 냉각시키지 마십시오! Eurotrol epoc Calibration Verification Fluids 는 앰플 개봉 후 30초간 Perangkat Medis IVD 使用されている記号 製造年月日 grad ridicat de corelare cu valorile din tabel, fiolele trebuie echilibrate cât mai aproape posibil de 22°C. Eurotrol epoc Calibration Verification Fluids sesuai dengan Directive 98/79/EC IVD untuk Perangkat Medis Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, 荷兰 otros parámetros de rendimiento. 안정적입니다. • După ce fiola a fost deschisă, temperatura camerei nu are niciun efect semnificativ asupra valorilor pH-ului. dan bertanda CE. 注意、取扱説明書を参照してください バッチコード • Eurotrol epoc Calibration Verification Fluids este sensibil la cei mai mulţi factori legaţi de instrumente care 절차 使用的符号 制造日期 Producto sanitario de diagnóstico in vitro Eurotrol epoc Calibration Verification Fluids dimaksudkan untuk penggunaan diagnostik in-vitro saja. 使用期限 温度限界 Eurotrol epoc Calibration Verification Fluids cumple con la Directiva Europea 98/79/CE sobre productos pot determina abateri analitice neaşteptate. 1. 상자 및 트레이에서 적절한 양을 꺼냅니다. 최소 1시간 동안 22 °C에 최대한 근접한 온도로 앰플의 • Probele martor ale Eurotrol epoc Calibration Verification Fluids nu conţin proteine şi, de aceea, nu pot 평형을 맞춥니다. Ringkasan in vitro診断医療機器 参照番号 注意，请参阅使用说明 批号 sanitarios para diagnóstico in vitro y cuenta con la marca CE. detecta disfuncţiile sensibile la aceste componente. 2. 사용 직전에 최소 15초간 앰플을 세게 흔들어 용액과 가스의 평형을 다시 맞춥니다. 흔들 때는 엄지와 Eurotrol epoc Calibration Verification Fluids adalah materi kendali mutu yang tersedia dalam lima kadar, 使用截止日期 Eurotrol epoc Calibration Verification Fluids cumple con las disposiciones siguientes del Código de 温度限制 masing-masing dengan konsentrasi yang diketahui. 製造者 CEマーク Regulaciones Federales (CRF) estadounidense: parte 72 del título 42 del CRF, y partes 606, 640 y 820 • Eurotrol epoc Calibration Verification Fluids este foarte sensibil la contaminarea aerului ambiant. Dacă 검지 손가락으로 앰플 잡아야 합니다. 3. 앰플을 살살 돌려서 용액이 앰플의 바닥으로 되돌아가도록 합니다. 앰플을 개봉하기 전에 거품이 위로 体外诊断医疗器械 参考号 del título 21 del CRF. lichidul se recoltează în interval de 30 secunde, eroarea este mai mică de 2% pe întregul interval, la toate Reagen Eurotrol epoc Calibration Verification Fluids está diseñado para utilizarse únicamente en diagnóstico in vitro. nivelurile*. Efectul aerului ambiant asupra pH-ului este neglijabil. 떠오르도록 합니다. Eurotrol epoc Calibration Verification Fluids menyediakan kadar yang sesuai dengan fisiologi, setiap ampul 制造商 CE 标志 Resumen *Cifrele se bazează pe testarea unei fiole deschise. 4. 거즈, 티슈 또는 장갑으로 손가락을 보호합니다. 5. 채색된 점이 위를 향하게 하여 앰플을 잡습니다. 채색된 점의 반대 방향으로 앰플의 목부분을 툭 berisi larutan 2,5 mL. Eurotrol epoc Calibration Verification Fluids disiapkan dengan menggunakan garam dalam matriks buffer fisiologi. Tonometri dengan kadar oksigen dan karbon dioksida yang telah ditentukan Eurotrol epoc Calibration Verification Fluids Eurotrol epoc Calibration Verification Fluids es una solución de control de calidad disponible en cinco niveles, Acest produs a fost fabricat în conformitate cu specificaţiile Eurotrol. 잘라냅니다. 자세한 내용은 OPC-설명 부분을 참조하십시오. yang diseimbangkan dengan nitrogen dan konsentrasi garam berbeda memberikan lima kadar berbeda cada uno de ellos con concentraciones conocidas. 6. epoc Blood Analysis System 사용 설명서의 설명에 따라 30초 내에 샘플링 절차를 수행합니다. Kullanım Amacı Pentru informaţii suplimentare, vă rugăm contactaţi: untuk masing-masing parameter, yang mensimulasikan rentang kesetimbangan asam-basa dan elektrolit Reactivos Eurotrol B.V., Olanda, Telefon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, 7. 권장되는 사용 빈도에 대해서는 현지 지침을 참조하십시오. yang signifikan secara klinis, fungsi respiratori, fungsi ginjal, konsentrasi glukosa dan laktat. Eurotrol epoc Eurotrol epoc Calibration Verification Fluids, epoc® Blood Analysis System kesinlik ve doğruluk durumunun Eurotrol epoc Calibration Verification Fluids proporciona concentraciones fisiológicamente relevantes en www.eurotrol.com Calibration Verification Fluids tidak mengandung pengawet, pengatur viskositas atau aditif lain yang mungkin doğrulanması için tahlilde kullanılan kan gazı, elektrolit ve metabolit referans materyalidir. Eurotrol epoc 주의사항 ampollas de 2.5 mL de solución. Los controles de Eurotrol epoc Calibration Verification Fluids se preparan con berpengaruh negatif pada pengukuran elektrode. Calibration Verification Fluids şu analitlerin test edilmesi için tasarlanmıştır: pH, pO2, pCO2, Na+, K+, 1. 체외 진단용으로만 사용합니다. una matriz de sales fisiológicamente amortiguada. La tonometría con niveles predeterminados de oxígeno y Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Olanda Ca++, Mg++, Cl-, Glukoz, Laktat, Üre, Kreatinin ve tCO2. Eurotrol epoc Calibration Verification Fluids ayrıca 2. 이 제품을 일반 쓰레기와 함께 폐기하면 안 됩니다. 적절한 폐기 방법에 대해서는 현지 환경부에 Penyimpanan dan Stabilitas dióxido de carbono equilibrados con nitrógeno y distintas concentraciones salinas proporciona cinco niveles kalibrasyon, çalışma sıcaklığı ve diğer performans özelliklerinin doğrulanması için geliştirilmiştir. Simboluri utilizate Data fabricației 문의하십시오. Eurotrol epoc Calibration Verification Fluids bisa disimpan pada suhu 2–8 °C. Stabilitasnya terjamin hingga distintos para cada parámetro, simulando rangos clínicamente significativos de equilibrio acidobásico y de İn Vitro Diagnostik Tıbbi Cihaz 3. Eurotrol epoc Calibration Verification Fluids 를 교정기로 사용해서는 안 됩니다. tanggal kedaluwarsa yang tertera pada ampul dan kotak luarnya jika disimpan dalam keadaan belum dibuka electrolitos, función respiratoria, función renal y concentración de glucosa y lactato. Los controles de Eurotrol Atenţie, consultaţi instrucţiunile de utilizare Codul seriei de fabricaţie Eurotrol epoc Calibration Verification Fluids Tıbbi Cihazlar için İn Vitro Diagnostik (IVD) Direktifi 98/79/EC ile pada suhu ini. Eurotrol epoc Calibration Verification Fluids stabil selama 1 minggu pada suhu kamar (ampul epoc Calibration Verification Fluids no contienen conservantes, reguladores de la viscosidad ni otros aditivos 예상 결과 uyumludur ve CE işaretini taşır. A se utiliza până la data de Limite de temperatură belum dibuka). Jangan simpan produk di refrigerator setelah diletakkan pada suhu kamar! Setelah ampul que podrían influir de forma adversa en las mediciones de electrodos. 값은 BGEM 시험 카드를 사용해 epoc Blood Analysis System 에서 수행된 측정을 통해 획득됩니다. 할당된 Eurotrol epoc Calibration Verification Fluids sadece in vitro diagnostik kullanım içindir. dibuka, Eurotrol epoc Calibration Verification Fluids stabil selama 30 detik. Dispozitiv medical pentru diagnostic in vitro Număr de referinţă 값은 http://www.epocal.com 에서 입수할 수 있으며, 각 유체의 로트 번호와 센서 구성이 표로 작성되어 Almacenamiento y estabilidad Özet 있습니다. Prosedur Eurotrol epoc Calibration Verification Fluids puede almacenarse a una temperatura de 2 a 8 °C. Si se Eurotrol epoc Calibration Verification Fluids her biri bilinen konsantrasyonlara sahip beş düzeyde sağlanan Producător Marca CE Eurotrol epoc Calibration Verification Fluids 는 계기 성능 확인에 전문적으로 사용하도록 고안되었습니다. 1. Keluarkan ampul secukupnya dari kotak dan baki. Lakukan ekuilibrasi terhadap ampul selama minimal 1 almacena sin abrir a esta temperatura, se garantiza su estabilidad hasta la fecha de caducidad indicada en bir kalite kontrol materyalidir. jam pada suhu sebisa mungkin paling mendekati 22 °C. las ampollas y en el embalaje. Eurotrol epoc Calibration Verification Fluids se mantiene estable durante una 참고사항 2. Tepat sebelum digunakan, kocok ampul dengan kuat minimal lima belas detik untuk meng-ekuilibrasi ulang Reaktifler semana a temperatura ambiente (ampollas sin abrir). No refrigere el producto una vez que se ha dispuesto a • 표의 값들은 할당된 유체 로트 번호, 적용가능한 epoc Blood Analysis System 센서 구성 및 해수면에만 gas dengan larutan. Saat dikocok, ampul harus dipegang di antara jempol dan jari telunjuk. Eurotrol epoc Calibration Verification Fluids fizyolojik olarak anlamlı düzeyler sunar ve her ampul 2,5 mL temperatura ambiente! Tras abrir la ampolla, Eurotrol epoc Calibration Verification Fluids permanece estable durante 30 segundos. Eurotrol epoc Calibration Verification Fluids 적용할 수 있습니다. • 부정확한 샘플링, 보관 또는 기타 취급상의 잘못은 판독값이 목표 값에서 벗어나게 하는 요인이 될 수 3. Perlahan goyang-goyangkan ampul untuk mengembalikan larutan ke bagian bawah ampul. Biarkan solüsyon içerir. Eurotrol epoc Calibration Verification Fluids fizyolojik olarak tamponlanmış bir matriks içinde gelembung naik sebelum membuka ampul. tuzlar kullanılarak hazırlanır. Nitrojen ve farklı tuz konsantrasyonlarıyla dengelenmiş, önceden belirlenmiş 있습니다. Procedimientos 4. Lindungi jari dengan kain kasa, tisu atau sarung tangan. oksijen ve karbondioksit düzeyleriyle tonometri her parametre için beş ayrı düzey sağlayarak klinik olarak Σκοπός για τον οποίο προορίζεται • Eurotrol epoc Calibration Verification Fluids 의 pO2 값은 온도 변화와 반대로 변합니다. 18 °C ~ 26 °C의 1. Retire las ampollas necesarias de la caja y la bandeja. Equilibre las ampollas como mínimo durante 1 hora 5. Pegang ampul dengan bagian titik berwarna mengarah ke atas. Patahkan leher ampul berlawanan anlamlı asit baz ve elektrolit dengesi, solunum işlevi, böbrek işlevi, glukoz ve laktat konsantrasyonu aralıklarını Το Eurotrol epoc Calibration Verification Fluids είναι ένα προσδιορισμένο υλικό αναφοράς αερίων, 온도가 1 °C 변할 때마다, pO2 는 낮은 수치에서 1.5%, 정상 수치에서 1.1%, 높은 수치에서 0.5% 변합니다. a una temperatura lo más próxima posible a 22 °C. arah titik berwarna. Baca leaflet petunjuk OPC untuk detail selengkapnya. simüle eder. Eurotrol epoc Calibration Verification Fluids elektrot ölçümlerini olumsuz etkileyebilecek koruyucu ηλεκτρολυτών και μεταβολιτών αίματος, για την επαλήθευση της πιστότητας και της ακρίβειας του συστήματος 표의 값과 높은 정도의 상관관계를 얻으려면 22 °C에 최대한 근접한 온도로 앰플의 평형을 맞춥니다. 2. Inmediatamente antes de su uso, agite la ampolla enérgicamente durante un mínimo de 15 segundos para 6. Dalam 30 detik, ikuti prosedur pengambilan sampel sesuai petunjuk dalam panduan operasi epoc Blood madde, viskozite ayarlayıcı veya başka katkı maddesi içermez. epoc® Blood Analysis System. Το Eurotrol epoc Calibration Verification Fluids σχεδιάστηκε για την εξέταση • 앰플이 개봉되고 나면 실온은 pH 값에 큰 영향을 미치지 않습니다. reequilibrar los gases de la solución. Para ello, sostenga la ampolla entre el dedo pulgar y el dedo índice. Analysis System. των παρακάτω αναλυόμενων ουσιών: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, γλυκόζη, γαλακτικό, • Eurotrol epoc Calibration Verification Fluids는 예상치 못한 분석 편차를 일으킬 수 있는 대부분의 계기 Saklama ve Stabilite 3. Realice movimientos circulares suaves con la ampolla para que la solución vuelva a la parte inferior de 7. Baca panduan setempat untuk frekuensi penggunaan yang disarankan. ουρία, κρεατινίνη και tCO2. Το Eurotrol epoc Calibration Verification Fluids έχει αναπτυχθεί, επίσης, για την 관련 요인에 민감합니다. Eurotrol epoc Calibration Verification Fluids 2–8 °C sıcaklıkta saklanabilir. Bu sıcaklıkta açılmadan esta. Antes de abrir la ampolla, espere a que todas las burbujas suban. επαλήθευση της βαθμονόμησης, της θερμοκρασίας λειτουργίας και άλλων χαρακτηριστικών απόδοσης. • Eurotrol epoc Calibration Verification Fluids 컨트롤은 단백질을 함유하고 있지 않기 때문에 이러한 Tindakan Pencegahan saklandığında stabilitesi ampullerde ve dış kutuda belirtildiği şekilde son kullanma tarihine kadar garanti 4. Proteja sus dedos con una gasa, un pañuelo o guantes. 성분에 민감한 고장을 감지해내지 못할 수도 있습니다. 1. Untuk penggunaan diagnostik in-vitro saja. edilmektedir. Eurotrol epoc Calibration Verification Fluids oda sıcaklığında 1 hafta stabildir (açılmamış 5. Sostenga la ampolla con el punto de color hacia arriba. Rompa el cuello de la ampolla en la IVD ιατροτεχνολογικό προϊόν • Eurotrol epoc Calibration Verification Fluids는 실내 공기 오염에 매우 민감합니다. 30초 내에 유체를 2. Produk ini tidak boleh dibuang bersama limbah umum. Hubungi otoritas lingkungan setempat untuk ampuller). Ürünü oda sıcaklığına getirildikten sonra buzdolabına koymayın! Ampul açıldıktan sonra Eurotrol dirección opuesta al punto de color. Para obtener más información, consulte el folleto de Το Eurotrol epoc Calibration Verification Fluids συμμορφώνεται με την Ευρωπαϊκή οδηγία IVD 98/79/EΚ 샘플링할 때 모든 수치에서 전 범위에 걸친 오차는 2% 미만입니다.* 실내 공기가 pH에 미치는 영향은 petunjuk pembuangan yang sesuai. epoc Calibration Verification Fluids 30 saniye stabildir. instrucciones del sistema de apertura OPC (rotura por el punto) de la ampolla. σχετικά με τα in vitro διαγνωστικά ιατροτεχνολογικά προϊόντα και φέρει τη σήμανση CE. Το Eurotrol epoc 무시할 수 있는 수준입니다. 3. Eurotrol epoc Calibration Verification Fluids tidak untuk digunakan sebagai kalibrator. 6. Antes de 30 segundos, siga el procedimiento de muestreo de acuerdo con las instrucciones del manual de Calibration Verification Fluids προορίζεται μόνο για in vitro διαγνωστική χρήση. İşlemler *번호는 개봉된 앰플 시험을 기준으로 합니다. Hasil yang Diharapkan funcionamiento de epoc Blood Analysis System. Περίληψη 1. Uygun sayıda ampulü kutu ve tepsiden çıkarın. Ampulü/ampulleri 22 °C sıcaklığa mümkün olduğunca 7. Consulte la normativa local sobre la frecuencia de uso recomendada. Το Eurotrol epoc Calibration Verification Fluids είναι ένα υλικό ποιοτικού ελέγχου που διατίθεται σε πέντε 이 제품은 Eurotrol 사양에 따라 제조되었습니다. Nilai diperoleh dari pengukuran pada epoc Blood Analysis System dengan menggunakan kartu uji BGEM. yakın bir sıcaklıkta en az 1 saat dengeleyin. Nilai yang ditetapkan tersedia di http://www.epocal.com, ditabulasi untuk setiap nomor lot cairan dan 2. Kullanımdan hemen önce gazları solüsyonla tekrar dengelemek için ampulü en az on beş saniye kuvvetle Precauciones επίπεδα, το καθένα από τα οποία έχει γνωστή συγκέντρωση. 자세한 사항은 아래 연락처로 문의하십시오. konfigurasi sensor. Eurotrol epoc Calibration Verification Fluids dimaksudkan untuk penggunaan profesional sallayın. Sallarken ampul başparmak ile işaret parmağı arasında tutulmalıdır. 1. Solamente para uso de diagnóstico in vitro. Αντιδραστήρια Eurotrol B.V., 네덜란드, 전화번호 +31 318 695 777, 팩스번호 +31 318 695 770, untuk memverifikasi kinerja instrumen. 3. Solüsyonu tekrar ampulün alt kısmına getirmek için ampulü yavaşça çevirin. Ampulü açmadan önce 2. Estos productos no deben desecharse junto con los residuos generales. Póngase en contacto con las Το Eurotrol epoc Calibration Verification Fluids διαθέτει φυσιολογικά σχετικά επίπεδα, ενώ η κάθε αμπούλα 이메일 office@eurotrol.com, www.eurotrol.com autoridades medioambientales locales para obtener información sobre su correcta eliminación. Harap Diketahui herhangi bir kabarcığın yükselmesini bekleyin. περιέχει 2,5 ml διαλύματος. Τα υλικά ελέγχου Eurotrol epoc Calibration Verification Fluids παρασκευάζονται 4. Parmakları gazlı bez, kağıt mendil veya eldivenlerle koruyun. 3. Eurotrol epoc Calibration Verification Fluids no debe utilizarse como calibrador. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, 네덜란드 • Nilai pada tabel hanya berlaku untuk nomor lot cairan yang ditentukan, konfigurasi sensor epoc Blood με τη χρήση αλάτων σε μια μήτρα φυσιολογικού ρυθμιστικού διαλύματος. Η τονομετρία με προκαθορισμένα 5. Ampulü renkli nokta yukarı bakar şekilde tutun. Ampulün boynunu renkli noktanın karşı yönüne Analysis System yang berlaku dan di permukaan laut. Resultados esperados επίπεδα οξυγόνου και διοξειδίου του άνθρακα τα οποία έχουν εξισορροπηθεί με άζωτο και διαφορετικές doğru kırın. Lütfen daha fazla ayrıntı için OPC talimat broşürünü okuyun. 사용된 기호 제조일 • Pengambilan sampel dan penyimpanan yang keliru, atau salah penanganan lainnya bisa menyebabkan Los valores se obtienen a través de las mediciones de epoc Blood Analysis System mediante las tarjetas de συγκεντρώσεις αλάτων παρέχει πέντε ξεχωριστά επίπεδα για κάθε παράμετρο, προσομοιάζοντας τα κλινικά 6. Sonraki 30 saniye içinde epoc Blood Analysis System çalıştırma kılavuzunuzdaki talimat uyarınca örnek deviasi pembacaan dari nilai target. análisis BGEM. Los valores asignados están disponibles en http://www.epocal.com, expresados por número σημαντικά εύρη τιμών της οξεοβασικής και της ηλεκτρολυτικής ισορροπίας, της αναπνευστικής λειτουργίας, alma işlemini izleyin. 주의, 사용 설명을 참조 배치 코드 • Nilai pO2 Eurotrol epoc Calibration Verification Fluids sangat beragam seiring dengan perubahan suhu. de lote de fluido y configuración del sensor. Eurotrol epoc Calibration Verification Fluids está diseñado para της νεφρικής λειτουργίας, καθώς επίσης και της συγκέντρωσης γλυκόζης και γαλακτικού. Τα υλικά ελέγχου 7. Lütfen önerilen kullanım sıklığı için yerel kılavuz ilkelere başvurun. Untuk setiap perubahan °C pada suhu antara 18 °C dan 26 °C, pO2 berubah sebesar 1,5% di tempat uso profesional para la verificación del funcionamiento del sistema. Eurotrol epoc Calibration Verification Fluids δεν περιέχουν συντηρητικά, ρυθμιστές ιξώδους ή άλλα πρόσθετα 사용 기한 한계 온도 rendah, 1,1% di ketinggian normal dan 0,5% di ketinggian. Untuk mendapatkan derajat korelasi yang Önlemler τα οποία ενδέχεται να επηρεάσουν δυσμενώς τις μετρήσεις με το ηλεκτρόδιο. A tener en cuenta 체외 진단용 의료기기 참조 번호 tinggi dengan nilai di tabel, ampul harus diekuilibrasi pada suhu sebisa mungkin paling mendekati 22 °C. 1. Sadece in vitro diagnostik kullanım içindir. • Los valores de la tabla se aplican únicamente al número de lote del fluido asignado y a la configuración del Φύλαξη και σταθερότητα • Setelah ampul dibuka, suhu kamar tidak berdampak signifikan pada nilai pH. 2. Bu ürünler genel atıkla atılmamalıdır. Uygun atma işlemi için yerel çevresel makamlara başvurun. Το Eurotrol epoc Calibration Verification Fluids μπορεί να φυλαχθεί σε θερμοκρασία 2–8 °C. Εάν φυλαχθεί σε 제조사 CE 마크 sensor epoc Blood Analysis System correspondiente, a nivel del mar. • Eurotrol epoc Calibration Verification Fluids peka terhadap sebagian besar faktor terkait instrumen yang 3. Eurotrol epoc Calibration Verification Fluids bir kalibratör olarak kullanılmamalıdır. • Si se realiza un muestreo, almacenamiento u otra gestión incorrectos, las lecturas pueden desviarse de αυτή τη θερμοκρασία χωρίς να ανοιχθεί, εγγυάται η σταθερότητά του όπως υποδεικνύεται, έως την ημερομηνία bisa menyebabkan deviasi analitis tak terduga. λήξης που αναφέρεται στις αμπούλες και το εξωτερικό κουτί. Το Eurotrol epoc Calibration Verification Fluids Beklenen Sonuçlar los valores asignados. • Eurotrol epoc Calibration Verification Fluids tidak mengandung protein sehingga tidak bisa mendeteksi • Los valores de pO2 de Eurotrol epoc Calibration Verification Fluids varían de forma inversa a los cambios παραμένει σταθερό για 1 εβδομάδα σε θερμοκρασία δωματίου (αμπούλες που δεν έχουν ανοιχθεί). Μην epoc Blood Analysis System’da değerler BGEM test kartları kullanılarak yapılan ölçümlerle elde edilir. kerusakan yang sensitif terhadap komponen ini. ψύχετε το προϊόν μετά τη μεταφορά του σε θερμοκρασία δωματίου! Μετά το άνοιγμα της αμπούλας, το Eurotrol Belirlenen değerler her sıvı lot numarası ve sensör konfigürasyonu için tablo halinde http://www.epocal. de temperatura. Para cada cambio de °C de temperatura entre los 18 °C y los 26 °C, el valor de pO2 • Eurotrol epoc Calibration Verification Fluids sangat sensitif pada kontaminasi udara kamar. Saat cambia un 1.5% en el nivel bajo, un 1.1% en el nivel normal y un 0.5% en el nivel alto. Para obtener epoc Calibration Verification Fluids παραμένει σταθερό για 30 δευτερόλεπτα. Eurotrol epoc Calibration Verification Fluids mengambil sampel cairan dalam 30 detik, kesalahannya kurang dari 2% pada seluruh kisaran di semua com adresinden elde edilebilir. Eurotrol epoc Calibration Verification Fluids ürününün alet performansının una correlación óptima con los valores de la tabla, las ampollas deben equilibrarse a un valor lo más doğrulanmasında profesyonel olarak kullanılması amaçlanmıştır. Διαδικασίες ketinggian*. Efek udara kamar pada pH bisa diabaikan. cercano posible a 22 °C. 1. Αφαιρέστε την κατάλληλη ποσότητα αμπουλών από το κουτί και τον δίσκο. Αφήστε την αμπούλα ή τις *Angka berdasarkan pengujian ampul terbuka Lütfen Dikkat • Una vez que la ampolla se ha abierto, la temperatura ambiente no tiene ningún efecto significativo en αμπούλες να εξισορροπήσουν για 1 ώρα τουλάχιστον σε θερμοκρασία δωματίου, η οποία να πλησιάζει Kasutusotstarve • Tablodaki değerler sadece tahsis edilmiş sıvı lot numarası ve ilgili epoc Blood Analysis System sensör Produk ini sudah diproduksi sesuai spesifikasi Eurotrol. los valores de pH. όσο το δυνατόν περισσότερο τους 22 °C. Eurotrol epoc Calibration Verification Fluids on veregaaside, elektrolüütide ja metaboliitide analüüsimise konfigürasyonu için deniz seviyesinde geçerlidir. • Eurotrol epoc Calibration Verification Fluids es sensible a la mayoría de factores relacionados con los 2. Αμέσως πριν από τη χρήση, ανακινήστε έντονα την αμπούλα για δεκαπέντε δευτερόλεπτα τουλάχιστον, viitematerjal vereanalüüsisüsteemi epoc® Blood Analysis System täpsuse kontrollimiseks. Eurotrol epoc Untuk informasi selengkapnya, silakan hubungi: • Hatalı örnek alma, saklama veya başka şekillerde yanlış kullanım ölçümlerin hedef değerlerden sapmasına instrumentos que pueden causar desviaciones analíticas inesperadas. Calibration Verification Fluids on mõeldud järgmiste analüütide katsetamiseks: pH, pO2, pCO2, Na+, K+, Eurotrol B.V., Belanda, Telepon +31 318 695 777, Faks +31 318 695 770, Email office@eurotrol.com, neden olabilir. ώστε να επανεξισορροπήσετε τα αέρια με το διάλυμα. Κατά την ανακίνηση, θα πρέπει να κρατάτε την • Los controles de Eurotrol epoc Calibration Verification Fluids no contienen proteínas y, por lo tanto, no αμπούλα μεταξύ του αντίχειρα και του δείκτη. Ca++, Mg++, Cl-, glükoos, laktaat, uurea, kreatiniin ja tCO2. Eurotrol epoc Calibration Verification Fluids on www.eurotrol.com • Eurotrol epoc Calibration Verification Fluids pO2 değerleri sıcaklık değişiklikleriyle ters ilişkili olarak değişir. detectan disfunciones relacionadas con estos componentes. 3. Ανακινήστε την αμπούλα με ήπιες κινήσεις, ώστε το διάλυμα να επιστρέψει στον πυθμένα της αμπούλας. mõeldud ka kalibratsiooni, töötemperatuuri ja muude talitlusnäitajate kontrolliks. pO2 18 °C ile 26 °C arasındaki sıcaklıklarda her °C değişim ile düşük düzeyde %1,5, normal durumda • Eurotrol epoc Calibration Verification Fluids es muy sensible a la contaminación del aire ambiente. Si Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Belanda %1,1 ve yüksek düzeyde %0,5 değişir. Tablodaki değerlerle yüksek bir korelasyon derecesi elde etmek için Αφήστε τυχόν φυσαλίδες να ανέλθουν στην επιφάνεια προτού ανοίξετε την αμπούλα. IVD meditsiiniseade se toma una muestra del fluido antes de 30 segundos, el porcentaje de error es inferior al 2% sobre 4. Προστατεύστε τα δάκτυλά σας με γάζα, χαρτομάντιλο ή γάντια. Simbol yang digunakan ampuller 22 °C sıcaklığa mümkün olduğunca yakın bir sıcaklıkta dengelenmelidir. Eurotrol epoc Calibration Verification Fluids vastab IVD meditsiiniseadmete direktiivile 98/79/EÜ ja sellel on Tanggal produksi el rango completo en todos los niveles*. El efecto del aire ambiente sobre el pH es insignificante. 5. Κρατήστε την αμπούλα με την έγχρωμη κουκκίδα στραμμένη προς τα πάνω. Αποσπάστε τον λαιμό CE-märgis. • Ampul açıldıktan sonra oda sıcaklığının pH değerleri üzerine anlamlı bir etkisi yoktur. *Las cifras están basadas en una prueba con una ampolla abierta. της αμπούλας με κατεύθυνση αντίθετη προς την έγχρωμη κουκκίδα. Διαβάστε το φύλλο οδηγιών Eurotrol epoc Calibration Verification Fluids on mõeldud vaid in vitro diagnostiliseks kasutuseks. Perhatian, baca petunjuk penggunaan Kode batch • Eurotrol epoc Calibration Verification Fluids beklenmeyen analitik sapmalara yol açabilecek, aletle ilgili Este producto se ha fabricado de acuerdo con las especificaciones Eurotrol. OPC για περισσότερες λεπτομέρειες. çoğu faktöre duyarlıdır. Gunakan sebelum Batasan suhu Kokkuvõte • Eurotrol epoc Calibration Verification Fluids kontrolleri protein içermez ve bu nedenle bu bileşenlere duyarlı 6. Εντός 30 δευτερολέπτων ακολουθήστε τη διαδικασία δειγματοληψίας σύμφωνα με τις οδηγίες που Para obtener más información póngase en contacto con: Eurotrol epoc Calibration Verification Fluids on kvaliteedikontrolli materjal, mis on saadaval viie teadaoleva Perangkat Medis Diagnostik In-Vitro Nomor referensi arızaları saptamayabilir. αναφέρονται στο εγχειρίδιο λειτουργίας του συστήματος epoc Blood Analysis System που διαθέτετε. Eurotrol B.V., Países Bajos, Teléfono +31 318 695 777, Fax +31 318 695 770, kontsentratsiooniga tasemena. • Eurotrol epoc Calibration Verification Fluids oda havası kontaminasyonuna çok duyarlıdır. Sıvıdan 30 7. Ανατρέξτε τις τοπικές κατευθυντήριες οδηγίες σχετικά με τη συνιστώμενη συχνότητα χρήσης. Produsen Tanda CE Correo electrónico office@eurotrol.com, www.eurotrol.com saniye içinde örnek alırken hata tüm düzeylerin aralığı boyunca %2’nin altındadır*. Oda havasının pH Reaktiivid Eurotrol Inc., EE. UU., Teléfono gratuito: 1-866-234-5754, Teléfono principal 1-978-598-3779, Προφυλάξεις üzerindeki etkisi dikkate alınmayacak kadar küçüktür. Eurotrol epoc Calibration Verification Fluids tagab füsioloogiliselt asjakohased tasemed ja iga ampull 1. Μόνο για in vitro διαγνωστική χρήση. Fax 1-978-598-3780, Correo electrónico officeUSA@eurotrol.com, www.eurotrol.com 2. Τα προϊόντα αυτά δεν θα πρέπει να απορρίπτονται στα κοινά απόβλητα. Συμβουλευτείτε τις τοπικές sisaldab 2,5 ml lahust. Eurotrol epoc Calibration Verification Fluids on valmistatud sooladest füsioloogilises *Rakamlar açık ampulle yapılan testleri temel alır. OPC Leaflet puhversüsteemis. Lämmastiku ja eri soolakontsentratsioonidega tasakaalustatud eelmääratletud hapniku ning Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Países Bajos περιβαλλοντικές αρχές σχετικά με την κατάλληλη απόρριψη. süsihappegaasi tasemetega tonomeetria tagab igale parameetrile viis eri taset, simuleerides happe-aluse Eurotrol epoc Calibration Verification Fluids Bu ürün Eurotrol spesifikasyonlarına göre üretilmiştir. Símbolos utilizados Fecha de fabricación 3. Το Eurotrol epoc Calibration Verification Fluids δεν προορίζεται για χρήση ως βαθμονομητής. Daha fazla bilgi için lütfen irtibat kurun: ja elektrolüütide tasakaalu, hingamisfunktsiooni, neerufunktsiooni ning glükoosi ja laktaadi kontsentratsiooni Αναμενόμενες τιμές kliiniliselt olulisi vahemikke. Eurotrol epoc Calibration Verification Fluids ei sisalda säilitusaineid, viskoossuse Eurotrol B.V., Hollanda, Telefon +31 318 695 777, Faks +31 318 695 770, Atención: consulte las instrucciones de uso Código de lote 用途 E-posta office@eurotrol.com, www.eurotrol.com Οι τιμές λαμβάνονται από μετρήσεις στο σύστημα epoc Blood Analysis System χρησιμοποιώντας τις κάρτες regulaatoreid ega muid lisandeid, mis elektroodide mõõtmist häirida võiksid. Fecha de uso preferente Eurotrol epoc Calibration Verification Fluidsは、epoc® Blood Analysis Systemの精度を検証するための、評価 Limitación de temperatura εξέτασης BGEM. Οι εκχωρημένες τιμές διατίθενται στη διαδικτυακή τοποθεσία http://www.epocal.com, σε Ladustamine ja stabiilsus 分析済みの血液ガス、電解質および代謝物標準物質です。Eurotrol epoc Calibration Verification Fluidsは、以下 Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Hollanda μορφή πίνακα, για κάθε αριθμό παρτίδας υγρού και κάθε διαμόρφωση αισθητήρα. Poducto sanitario de diagnóstico in vitro Número de referencia Toodet Eurotrol epoc Calibration Verification Fluids võib ladustada temperatuuril 2–8 °C. Sellel temperatuuril の分析対象の試験用に製造されました: pH、pO2、pCO2、Na+、K+、Ca++、Mg++、Cl-、 グルコース、乳酸塩、尿素、 Kullanılan semboller Το Eurotrol GAS-ISE Metabolytes προορίζεται για επαγγελματική χρήση κατά την επαλήθευση της απόδοσης Üretim tarihi avamata ladustamisel on toote stabiilsus garanteeritud kuni ampullidel ja välispakendil märgitud クレアチニンおよびtCO2。Eurotrol epoc Calibration Verification Fluidsは、校正、動作温度およびその他の性能 Fabricante Marca CE του οργάνου. aegumiskuupäevani. Eurotrol epoc Calibration Verification Fluids on toatemperatuuril (avamata ampullides) 特性の検証等の用途にも使用されます。 Dikkat, kullanma talimatına bakınız Parti kodu Σημειώστε ότι stabiilne 1 nädala. Pärast toatemperatuurini soojenemist ärge toodet enam külmutage! Pärast ampulli avamist IVD医療機器 Son kullanma tarihi Sıcaklık sınırlaması • Οι τιμές στον πίνακα ισχύουν μόνο για τον εκχωρημένο αριθμό παρτίδας υγρού, την ισχύουσα διαμόρφωση on Eurotrol epoc Calibration Verification Fluids stabiilne 30 sekundit. Eurotrol epoc Calibration Verification Fluidsは、医療機器に関するIVD指令98/79/ECに準拠しており、CEマーク αισθητήρα του συστήματος epoc Blood Analysis System και στο επίπεδο της θάλασσας. İn Vitro Diagnostik Tıbbi Cihaz Referans numarası Protseduurid が貼付されています。 • Η λανθασμένη δειγματοληψία και φύλαξη ή άλλος κακός χειρισμός ενδέχεται να προκαλέσουν απόκλιση 1. Võtke karbist ja aluselt sobiv kogus ampulle. Laske ampulli(de)l vähemalt 1 tunni jooksul tasakaalustada Eurotrol epoc Calibration Verification Fluidsは、in vitro診断専用です。 Üretici CE işareti των μετρήσεων από τις τιμές-στόχους. Eurotrol epoc Calibration Verification Fluids • Οι τιμές pO2 του Eurotrol epoc Calibration Verification Fluids ποικίλλουν αντιστρεπτά με τις μεταβολές temperatuurile 22 °C võimalikult lähedale. 概要 θερμοκρασίας. Για κάθε μεταβολή ενός °C σε θερμοκρασίες μεταξύ 18 °C και 26 °C, η τιμή pO2 2. Vahetult enne kasutamist raputage ampulli jõuliselt vähemalt viisteist sekundit, et gaasid lahuses taas Eurotrol epoc Calibration Verification Fluidsは、いずれも既知の濃度の、5段階のレベルで利用可能な品質管理 μεταβάλλεται κατά 1,5% στο χαμηλό επίπεδο, κατά 1,1% στο φυσιολογικό επίπεδο και κατά 0,5% στο tasakaalustada. Raputamisel tuleb ampulli hoida pöidla ja nimetissõrme vahel. された材料です。 Domeniu de utilizare υψηλό επίπεδο. Για να ληφθεί υψηλός βαθμός συσχέτισης με τις τιμές του πίνακα, οι αμπούλες θα πρέπει 3. Keerutage ampulli ettevaatlikult, et lahus ampulli põhja tagasi viia. Enne ampulli avamist laske mullidel Eurotrol epoc Calibration Verification Fluids este un material de referinţă pentru gazele sanguine analizate, να εξισορροπηθούν (όσο το δυνατόν) πλησιέστερα στους 22 °C. üles tõusta. 試薬 Eurotrol epoc Calibration Verification Fluids pentru electroliţi şi metaboliţi, conceput în scopul verificării preciziei şi acurateţei epoc® Blood Analysis • Μετά το άνοιγμα της αμπούλας, η θερμοκρασία δωματίου δεν έχει σημαντική επίδραση στις τιμές pH. 4. Kaitske sõrmi marlilapi, paberräti või kinnaste abil. Eurotrol epoc Calibration Verification Fluidsは、生理的に適切なレベルを実現し、各アンプルには2.5 mLの溶 System. Eurotrol epoc Calibration Verification Fluids a fost conceput pentru testarea următorilor analiţi: pH, • Το Eurotrol epoc Calibration Verification Fluids είναι ευαίσθητο στους περισσότερους από τους παράγοντες 5. Hoidke ampulli nii, et värviline täpp jääb üles suunatuks. Murdke ära ampulli kael värvilise täpi 液が含まれます。Eurotrol epoc Calibration Verification Fluidsは、生理的緩衝液に食塩を加えて調製します。窒 pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glucoză, lactat, uree, creatinină şi tCO2. De asemenea, Eurotrol που σχετίζονται με το όργανο και μπορούν να προκαλέσουν μη αναμενόμενες αναλυτικές αποκλίσεις. vastaspoolelt. Üksikasju lugege OPC juhise brošüürist. 素およびさまざまな塩分濃度において平衡が維持される事前に規定された酸素および二酸化炭素レベルでの 预期用途 epoc Calibration Verification Fluids este conceput pentru verificarea calibrării, temperaturii de operare şi a • Τα υλικά ελέγχου Eurotrol epoc Calibration Verification Fluids δεν περιέχουν πρωτεΐνες και, συνεπώς, 6. Järgige 30 sekundi jooksul oma vereanalüüsisüsteemi epoc Blood Analysis System kasutusjuhendis 圧測定により、各パラメータに5つの特有のレベルが提供され、酸塩基および電解質の平衡、呼吸機能、腎機能、 Eurotrol epoc Calibration Verification Fluids 是一种已定量的血气、电解质和代谢物标准物质，用于验证 altor caracteristici de performanţă. ενδέχεται να μην ανιχνεύουν δυσλειτουργίες που οφείλονται σε αυτά τα συστατικά. kirjeldatud proovivõtuprotseduuri juhiseid. グルコースおよび乳酸塩濃度について、臨床上重要な範囲がシミュレートされます。Eurotrol epoc Calibration epoc® Blood Analysis System 的精确度和准确度。Eurotrol epoc Calibration Verification Fluids 用于检 • Το Eurotrol epoc Calibration Verification Fluids είναι πολύ ευαίσθητο σε μόλυνση από τον ατμοσφαιρικό 7. Soovituslikku kasutussagedust lugege kohalikest suunistest. Verification Fluidsには、防腐剤、粘度調整剤または電解質の測定に悪影響を及ぼす可能性のあるその他の添加 测以下分析物：pH、pO2、pCO2、Na+、K+、Ca++、Mg++、Cl-、葡萄糖、乳酸、尿素、肌酐、tCO2 Dispozitiv medical pentru diagnostic in vitro αέρα. Κατά τη δειγματοληψία του υγρού εντός 30 δευτερολέπτων, το σφάλμα είναι μικρότερο από 2% σε 物は含まれません。 。Eurotrol epoc Calibration Verification Fluids 还可用于验证校准、操作温度和其他性能特性。 Eurotrol epoc Calibration Verification Fluids respectă Directiva europeană IVD 98/79/EC privind dispozitivele Ettevaatusabinõud medicale pentru diagnostic in vitro şi poartă marca CE. όλο το εύρος τιμών για όλα τα επίπεδα*. Η επίδραση του ατμοσφαιρικού αέρα στο pH είναι αμελητέα. 1. Ainult in vitro diagnostiliseks kasutuseks. 保管および安定性 体外诊断医疗器械 Eurotrol epoc Calibration Verification Fluids se utilizează exclusiv pentru diagnostic in vitro. *Οι αριθμοί βασίζονται σε εξέταση με ανοικτή αμπούλα. 2. Neid tooteid ei tohi kõrvaldada koos üld jäätmetega. Õige kõrvaldamise juhiseid küsige kohalikult Eurotrol epoc Calibration Verification Fluidsは、2～8 ° C の温度で保管することができます。未開封の状態でこ Eurotrol epoc Calibration Verification Fluids 符合体外诊断医疗器械指令 98/79/EC 并带有 CE 标志。 Αυτό το προϊόν παρασκευάστηκε σύμφωνα με τις προδιαγραφές Eurotrol. keskkonnaametilt. の温度で保管した場合、 アンプルおよび外箱に記載の有効期限まで表示通りの安定性が保証されます。Eurotrol Eurotrol epoc Calibration Verification Fluids 仅供体外诊断使用。 Rezumat 3. Eurotrol epoc Calibration Verification Fluids pole mõeldud kasutamiseks kalibraatorina. epoc Calibration Verification Fluidsの安定性は、室温で1週間維持されます(アンプル未開封の場合)。一度室温 Eurotrol epoc Calibration Verification Fluids este un material de control al calităţii disponibil în cinci niveluri, 总结 Για περισσότερες πληροφορίες, επικοινωνήστε με: にした製品を冷蔵しないでください。 アンプルの開封後、Eurotrol epoc Calibration Verification Fluidsの安定性 fiecare având concentraţii cunoscute. Eeldatavad tulemused Eurotrol epoc Calibration Verification Fluids 是一种质控材料，有五个水平，每个水平都具有已知的浓度。 は30秒間維持されます。 Eurotrol B.V. Väärtused saadakse vereanalüüsisüsteemiga epoc Blood Analysis System BGEM-katsekaartide abil Reactivi 试剂 Ολλανδία, Αρ. τηλεφώνου: +31 318 695 777, Αρ. φαξ: +31 318 695 770 mõõtmisel. Määratud väärtused on saadaval veebisaidil http://www.epocal.com, kus on kõigi vedelikupartii 手順 Eurotrol epoc Calibration Verification Fluids oferă niveluri cu relevanţă fiziologică, fiecare fiolă conţinând 2,5 Eurotrol epoc Calibration Verification Fluids 具有生理相关的水平，每安瓿含 2.5 mL 溶液。Eurotrol epoc ml soluţie. Probele martor ale Eurotrol epoc Calibration Verification Fluids sunt preparate utilizând săruri într-o Διεύθυνση ηλεκτρονικού ταχυδρομείου: office@eurotrol.com, www.eurotrol.com numbrite ja anduri konfiguratsioonide tabel. Eurotrol epoc Calibration Verification Fluids on mõeldud 1. ボックスとトレイから適切な量のアンプルを取り出します。アンプルを少なくとも1時間以上、可能な限り22 ° C Calibration Verification Fluids 是通过将盐加入生理缓冲基质中制备而成。预定水平的氧气和二氧化碳（与 professionaalseks kasutuseks instrumendi talitluse kontrollimisel. に近い温度に平衡化させます。 matrice tamponată fiziologic. Tonometria cu niveluri prestabilite de oxigen şi dioxid de carbon echilibrate cu 氮气平衡）含量以及不同的盐浓度使每个参数具有五个不同的水平，从而模拟有临床意义的酸碱与电解质平 azot şi diferite concentraţii saline oferă cinci niveluri distincte pentru fiecare parametru, simulând intervalele Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Ολλανδία Pange tähele 2. 使用する直前に、アンプルを少なくとも15秒以上強く振り、溶液内のガスを再度平衡化させます。アンプルを振 衡、呼吸功能、肾功能、葡萄糖和乳酸浓度范围。Eurotrol epoc Calibration Verification Fluids 不含防腐 る際は、親指と人差し指で保持します。 cu semnificaţie clinică ale echilibrului acid-bază şi electrolitic, funcţiei respiratorii, funcţiei renale, concentraţiei • Tabelis toodud väärtused rakenduvad ainult määratud vedelikupartii numbrile, rakenduvale 剂、粘度调节剂或其他对电极测量有不良影响的添加剂。 de glucoză şi de lactat. Probele martor ale Eurotrol epoc Calibration Verification Fluids nu conţin conservanţi, Σύμβολα που χρησιμοποιούνται vereanalüüsisüsteemi epoc Blood Analysis System anduri konfiguratsioonile ja merepinna tasemel. 3. アンプルをそっと回し、溶液をアンプルの底に戻します。泡があれば、アンプルを開封する前に浮かび上がら Ημερομηνία κατασκευής せます。 储存与稳定性 regulatori de viscozitate şi nici alţi aditivi care ar putea afecta negativ măsurătorile electrozilor. • Väära proovivõtu, ladustamise või muu väärkasutuse tagajärjel võivad lugemid sihtväärtustest erineda. Προσοχή, δείτε τις οδηγίες χρήσης Κωδικός παρτίδας • Toote Eurotrol epoc Calibration Verification Fluids pO2 väärtused muutuvad temperatuurimuutustega 4. ガーゼ、ティシューまたは手袋で手を保護します。 Eurotrol epoc Calibration Verification Fluids 可存储在 2–8 °C 下。以未开封状态储存在此温度下时，可 Păstrare şi stabilitate Ημερομηνία λήξης pöördvõrdeliselt. Temperatuuri iga 1 °C muutus vahemikus 18–26 °C põhjustab pO2 muutuse madalal 5. 色付きのドットを上に向けてアンプルを保持します。アンプルのネックを、色付きのドットと反対の方向に向かっ 保证本品在安瓿和外包装盒上的到期日之前如标示的那样保持稳定。Eurotrol epoc Calibration Verification Περιορισμός θερμοκρασίας Eurotrol epoc Calibration Verification Fluids poate fi păstrat la o temperatură de 2-8 °C. Dacă produsul て折ります。詳細については、OPC説明書リーフレットを参照してください。 Fluids 在室温下可稳定储存 1 周（安瓿未开封）。本品恢复至室温后不得再冷藏！打开安瓿后，Eurotrol tasemel 1,5%, tavapärasel tasemel 1,1% ja kõrgel tasemel 0,5%. Tabelis toodud väärtustega kõrge este păstrat fără a fi deschis la această temperatură, se garantează stabilitatea conform indicaţiilor până In Vitro διαγνωστικό ιατροτεχνολογικό προϊόν Κωδικός προϊόντος korrelatsiooni astme saavutamiseks tuleb ampullid tasakaalustada temperatuurile 22 °C võimalikult 6. 30秒以内に、epoc Blood Analysis Systemの取扱説明書の説明に従って、サンプリング手順を実行します。 epoc Calibration Verification Fluids 只能稳定 30 秒。 la data expirării tipărită pe fiole şi pe cutie. Eurotrol epoc Calibration Verification Fluids este stabil timp de lähedale. 7. 推奨使用頻度については、地域のガイドラインを参照してください。 程序 1 săptămână la temperatura camerei (fiole nedeschise). Nu refrigeraţi produsul după ce a fost adus la Κατασκευαστής Σήμανση CE • Pärast ampulli avamist ei mõjuta toatemperatuur pH väärtusi olulisel määral. 用法注意 1. 从包装盒和托盘中取出适量的安瓿。将安瓿静置至少 1 小时，使其温度尽量接近 22 °C。 temperatura camerei! După deschiderea fiolei, Eurotrol epoc Calibration Verification Fluids este stabil timp de 30 secunde. • Eurotrol epoc Calibration Verification Fluids on tundlik enamikule instrumendiga seotud teguritele, mis 1. in vitro診断専用です。 2. 使用前，剧烈摇晃安瓿至少十五秒以使气体和溶液重新平衡。应使用拇指和食指拿着安瓿进行摇晃。 ootamatuid analüütilisi kõrvalekaldeid tekitada võivad. 2. これらの製品は一般廃棄物として廃棄しないでください。適切な廃棄方法については、地域の環境保護当局 3. 轻轻旋转安瓿以使溶液返回瓶底。打开安瓿之前先让所有气泡上升。 Proceduri Eurotrol epoc Calibration Verification Fluids • Kontrollid Eurotrol epoc Calibration Verification Fluids ei sisalda valku ega pruugi seega tuvastada neile にお問い合わせください。 4. 使用纱布、纸巾或手套保护手指。 1. Scoateţi cantitatea adecvată de fiole din cutie şi tăviţă. Echilibraţi fiola (fiolele) timp de cel puţin 1 oră la o komponentidele tundlikke rikkeid. 3. Eurotrol epoc Calibration Verification Fluidsは標準物質として使用しないでください。 5. 拿着安瓿，彩色点朝上。向彩色点的反方向掰断安瓿的瓶颈。更多详情请参阅 OPC 说明书。 temperatură cât mai apropiată posibil de 22°C. • Eurotrol epoc Calibration Verification Fluids on toaõhu saastumisele väga tundlik. Kui vedelikust võetakse 6. 在 30 秒内，按照 epoc Blood Analysis System 操作手册中的说明执行取样程序。 予想される結果 2. Imediat înainte de utilizare, agitaţi puternic fiola timp de cel puţin cincisprezece secunde pentru a proov 30 sekundi jooksul, jääb viga kõigil tasemetel alla 2%*. Toaõhu mõju pH-le on mittearvestatav. 7. 请参见当地的指南以了解建议的使用频率。 용도 値は、epoc Blood Analysis SystemでBGEMテストカードを使用した測定によって得られました。対応する値は、 reechilibra gazele cu soluţia. Când agitaţi fiola, trebuie să o ţineţi între degetul mare şi arătător. * Arvud põhinevad avatud ampullide katsetamisel. Eurotrol epoc Calibration Verification Fluids 는 검사된 혈액 가스, 전해질 및 대사 기준 물질로, epoc® Blood 溶液ロット番号およびセンサー構成ごとに表形式にまとめられており、http://www.epocal.comから入手するこ 注意事项 3. Rotiţi uşor fiola pentru a readuce soluţia în partea inferioară a acesteia. Lăsaţi orice bule de aer să se Analysis System 의 정밀도와 정확도를 시험하는 데 사용됩니다. Eurotrol epoc Calibration Verification Fluids See toode on valmistatud Eurotrol spetsifikatsioonide järgi. とができます。Eurotrol epoc Calibration Verification Fluidsは、機器性能検証のために専門家が使用することを 1. 仅供体外诊断使用。 ridice înainte de a deschide fiola. 는 다음 분석물을 시험하도록 설계되었습니다. pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, 포도당, 유산염, 想定しています。 2. 这些产品不得弃置到一般废物中。请咨询当地的环保部门以了解如何正确弃置本品。 4. Protejaţi-vă degetele cu un tifon, un şerveţel sau cu mănuşi. Lisateabe saamiseks võtke ühendust. 요소, 크레아티닌 및 tCO2. Eurotrol epoc Calibration Verification Fluids 는 또한 교정, 작동 온도 및 기타 성능 3. Eurotrol epoc Calibration Verification Fluids 不得用作校准品。 5. Ţineţi fiola cu punctul colorat orientat în sus. Rupeţi gâtul fiolei în direcţia opusă punctului colorat. Eurotrol B.V., Holland, Tel +31 318 695 777, Faks +31 318 695 770, E-post office@eurotrol.com, ご注意 • 表に記載の値は、対応するロット番号、適切なepoc Blood Analysis Systemセンサー構成および海抜にのみ 특성을 확인하기 위한 용도로도 개발되었습니다. Citiţi prospectul cu instrucţiuni OPC pentru mai multe detalii. 预期结果 6. În interval de 30 secunde, urmaţi procedura de recoltare conform instrucţiunilor din manualul de utilizare IVD 의료기기 www.eurotrol.com 該当します。 在 epoc Blood Analysis System 上使用 BGEM 检测卡进行检测，从而得出检测值。赋值提供于 http://www. 183.000.005 al epoc Blood Analysis System. Eurotrol epoc Calibration Verification Fluids 는 체외 진단용 의료기기에 대한 유럽 IVD 지침 98/79/EC를 Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Holland • 不適切なサンプリングまたは保管、あるいはその他の不適切な取り扱いは、読み取り値が目標値からずれる原 epocal.com，该网站以表格的形式显示每个试剂批号和每种传感器配置的赋值。Eurotrol epoc Calibration 7. Consultaţi îndrumările locale pentru frecvenţa de utilizare recomandată. 준수하며 CE 마크를 부착하고 있습니다. 因となることがあります。 Verification Fluids 供专业人士用于验证仪器性能。 MSP101033 Rev.1.0 20170626 Instructions for Use (1.3 MB)
- epoc Value Assignment Sheet
Calibration Verification Fluids (with BUN)
Product Specific
- Safety Data Sheet according to OSHA HCS 29 CFR 1910.1200(g) Identification 1.1 Product identifier used on the label Eurotrol® epoc® GAS-ISE-Metabolites Eurotrol® epoc® Calibration Verification Fluids Eurotrol® epoc® GAS-ISE-Metabolites (bulk) 1.2 Other means of identification Eurotrol® epoc® GAS-ISE-Metabolites, level 1 REF266.001.010 Eurotrol® epoc® GAS-ISE-Metabolites, level 2 REF266.002.010 Eurotrol® epoc® GAS-ISE-Metabolites, level 3 REF266.003.010 Eurotrol® epoc® GAS-ISE-Metabolites, level 6 REF266.006.010 Eurotrol® epoc® Calibration Verification Fluids REF267.000.005 Eurotrol® epoc® GAS-ISE-Metabolites (bulk), level 1 REF270.001.001 Eurotrol® epoc® GAS-ISE-Metabolites (bulk), level 2 REF270.002.001 Eurotrol® epoc® GAS-ISE-Metabolites (bulk), level 3 REF270.003.001 Eurotrol® epoc® GAS-ISE-Metabolites (bulk), level 4 REF270.004.001 Eurotrol® epoc® GAS-ISE-Metabolites (bulk), level 5 REF270.005.001 Eurotrol® epoc® GAS-ISE-Metabolites (bulk), level 6 REF270.006.001 1.3 Recommended use of the chemical and restrictions on use Eurotrol® epoc® GAS-ISE-Metabolites, Eurotrol® epoc® Calibration Verification Fluids and Eurotrol® epoc® GAS-ISE-Metabolites (bulk) are assayed blood gas, electrolyte and metabolite reference materials, to verify the precision and accuracy of the epoc® Blood Analysis System, measuring the following parameters: pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, glucose, lactate, urea, creatinine and iMg2+. The product should not be used on another device, or as a calibrator. 1.4 Name, address, phone number of the manufacturer and emergency phone number Manufacturer Sales and Distribution Center Eurotrol B.V. Eurotrol Inc. Keplerlaan 20 850 N Black Branch Rd 6716 BS Ede Elizabethtown, KY 42701 The Netherlands USA Mail: office@eurotrol.com officeusa@eurotrol.com Phone: +31 (0) 318 695777 +1 502 5011180 1.5 Emergency phone number In case of an emergency call +1-978-598-3779 for any further information. Hazard(s) Identification 2.1 Classification of the chemical None of the compounds in the mixture of the product are known to constitute to health or physical hazards and are therefore not classified. Page 1 of 5 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Doc.ID: EDE-AW-1017 Revision: 02 2.2 Signal word, hazard statement(s), symbol(s) and precautionary statement(s) This product does not need to be labeled in accordance with §1910.1200 Occupational Safety and Health Standards, as no classified chemicals are part of the mixture of the product. 2.3 Any hazards not otherwise classified that have been identified during the classification process Unknown. Composition/information on ingredients 3.1 Chemical name and concentration of all ingredients which are classified as health hazards in accordance with paragraph (d) of §1910.1200 The mixture contains no ingredients which are classified as health hazards in accordance with paragraph (d) of §1910.1200. First-aid measures 4.1 Description of necessary first aid measures Inhalation: If inhaled, move person to fresh air. If not breathing, give artificial respiration. Skin contact: Wash off with soap and plenty of water. Eye contact: Flush eyes with water as a precaution. Ingestion: Rinse mouth with water. Do not induce vomiting. 4.2 Most important symptoms/effects, acute and delayed To the best of our knowledge, the chemical, physical and toxicological properties have not been thoroughly investigated. 4.3 Recommendations for immediate medical attention and special treatment needed, if necessary No data available. Fire-fighting measures 5.1 Suitable (and unsuitable) extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. 5.2 Specific hazards arising from the chemical No data on specific hazards available. 5.3 Special protective equipment and precautions for fire-fighters Standard precautions and protective equipment should be used. Accidental release measures 6.1 Personal precautions, protective equipment, and emergency procedures No personal precautions, protective equipment and emergency procedures are required. 6.2 Methods and materials for containment and cleaning up In case of spill of material, clean with water. Keep left over waste in suitable, closed containers for disposal. Page 2 of 5 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Doc.ID: EDE-AW-1017 Revision: 02 Handling and storage 7.1 Precautions for safe handling Follow Good Laboratory Practice (GLP). 7.2 Conditions for safe storage, including any incompatibilities Store the product as indicated on the product label. Exposure controls/personal protection 8.1 OSHA permissible exposure limit and any other exposure limit used Not available. 8.2 Appropriate engineering controls Follow Good Laboratory Practice (GLP). No further engineering controls required for using this product. 8.3 Individual protection measures, such as personal protective equipment Eye/face protection: Use equipment for eye protection tested under appropriate government standards as NIOSH Skin protection: Use protective gloves Body protection: Wear protective clothing Respiratory protection: Respiratory protection not required Physical and chemical properties a) Appearance Colorless liquid in a glass ampoule b) Odor Odorless c) Odor threshold No data available d) pH 6.6 – 7.8 e) Melting point/freezing point Similar to water (~0°C) f) Initial boiling point and boiling range Similar to water (~100°C) g) Flash point No data available h) Evaporation rate Similar to water, (~0.3 g·m-2·h-1) i) Flammability (solid, gas) Product is nonflammable j) Upper/lower flammability or explosive limits Not applicable k) Vapor pressure Similar to water (~2.34 kPa at 20° C) l) Vapor density Similar to water (~17 g·m-3) m) Relative density Similar to water (~1 g·mL-1) n) Solubility(ies) Product is an aqueous solution Page 3 of 5 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Doc.ID: EDE-AW-1017 Revision: 02 o) Partition coefficient: n-octanol/water Product is an aqueous solution p) Auto-ignition temperature No data available q) Decomposition temperature No data available r) Viscosity Similar to water (~1.0016 mPa·s) Stability and reactivity 10.1 Reactivity No data available. 10.2 Chemical stability The product has been validated to be chemically stable at least up until the expiration date. 10.3 Possibility of hazardous reactions No data available. 10.4 Conditions to avoid Avoid exposing the product to temperatures outside the storage temperature range. 10.5 Incompatible materials No data available. 10.6 Hazardous decomposition products No data available. Toxicological information 11.1 Likely routes of exposure (inhalation, ingestion, skin and eye contact) No data available. 11.2 Symptoms related to the physical, chemical and toxicological characteristics No data available. 11.3 Delayed and immediate effects and also chronic effects from short- and long-term exposure No data available. 11.4 Numerical measures of toxicity No data available. 11.5 Carcinogenic compounds No data available. Page 4 of 5 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Doc.ID: EDE-AW-1017 Revision: 02 Ecological information 12.1 Ecotoxicity No data available. 12.2 Persistence and degradability No data available. 12.3 Bioaccumulative potential No data available. 12.4 Mobility in soil No data available. 12.5 Other adverse effects No data available. Disposal considerations Do not dispose of in general waste. Consult local environmental authorities for proper disposal. In case of contaminated packaging, disposition of the unused product. Transport information No specific precautions need to be taken for transporting this product. Regulatory information This Safety Data Sheet complies with the following regulations: Guidelines for Importation #1121 Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Other information The information in this Safety Data Sheet are based on our current knowledge. This SDS has been compiled exclusively for this product and is intended exclusively for this product. It guaranties no product characteristics and does not ensure a legal relationship. Since the implementation of the information and the operating conditions of the product given in this SDS are not controlled by Eurotrol B.V., the user is responsible for the safe use of the product. Revision history Revision Effective date Change to previous revision 01 13 Apr 2017 First revision. 02 26 Jul 2017 Updated document to new template. Effective date: 26 Jul 2017 Page 5 of 5 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Doc.ID: EDE-AW-1017 Revision: 02 Safety Data Sheet (469.9 KB)
- Résultats attendus 3. Os valores de pO2 do Eurotrol epoc® Calibration Verification Fluids variam inversamente às 7. Dopo l'uso, smaltire la fiala e l’eventuale liquido residuo. 3. 앰플을 부드럽게 돌려 용액이 앰플 바닥에 오도록 하십시오. 앰플을 열기 전에 거품이 떠오르도록 fremstilles av kjemikalier i en fysiologisk bufret matrise. Tonometri med forhåndsbestemte nivåer for Les valeurs sont obtenues par le biais de mesures effectuées sur le système d’analyse sanguine epoc® alterações de temperatura. Para obter um elevado nível de correlação com os valores da tabela, as I materiali per il controllo della qualità devono essere usati in conformità con le normative locali, regionali oksygen og karbondioksid balansert med nitrogen og ulike saltkonsentrasjoner gir fem distinkte nivåer. en utilisant les cartes de test BGEM. Les valeurs assignées sont disponibles à l’adresse ampolas devem ser equilibradas até um valor o mais próximo possível de 22 °C. e/o nazionali o ai requisiti di accreditamento. 하십시오. Eurotrol epoc® Calibration Verification Fluids inneholder ingen konserveringsmidler, viskositetsjustering http://www.siemens.com/epoc, présentées pour chaque numéro de lot de liquide et chaque configuration 4. O Eurotrol epoc® Calibration Verification Fluids é muito sensível à contaminação pelo ar ambiente. Limitazioni 4. 거즈, 티슈, 장갑을 이용해 손가락을 보호하십시오. eller andre tilsetningsstoffer som kan innvirke negativt på elektrodemålinger. de capteur. Ao efetuar a amostragem no espaço de 30 segundos, o erro é inferior a 2% ao longo de todo o 1. I valori assegnati si applicano esclusivamente al numero di lotto del liquido assegnato, alla Advarsler og forholdsregler Pour des informations supplémentaires ou une assistance technique, veuillez contacter : intervalo, a todos os níveis. O efeito do ar ambiente sobre o pH é negligenciável. configurazione applicabile del sensore del sistema di analisi ematica epoc® e ad un'altitudine a livello 5. 색깔로 표시된 점이 위를 향하도록 앰플을 잡으십시오. 색깔로 표시된 점과 반대 방향으로 앰플의 목 1. Kun for bruk ved in vitro-diagnostikk. Fabricant Distributeur 5. Os controlos Eurotrol epoc® Calibration Verification Fluids não contêm proteínas e, por isso, podem del mare. 부분을 잘라내십시오. 2. Hver ampulle er kun til engangsbruk. Eurotrol B.V., Eurotrol Inc., não detetar avarias sensíveis a estes componentes. 2. Qualora il campionamento, la conservazione o la manipolazione non avvengano correttamente, i 3. Disse produktene må ikke kastes i vanlig avfall. Kontakt lokale miljømyndigheter for å sørge for riktig Keplerlaan 20, 6716 BS Ede, Pays-Bas 850 N Black Branch Rd, Elizabethtown, KY Resultados esperados risultati potrebbero deviare dai valori target. 6. 30초 이내에 epoc® 혈액 분석 시스템의 조작 설명서 지침에 따라 샘플링 절차를 따르십시오. avfallshåndtering. Téléphone : +31 318 695 777 42701, États-Unis Os valores são obtidos pelas medições no sistema de análise ao sangue epoc® com os cartões de teste 3. I valori della pO2 di Eurotrol epoc® Calibration Verification Fluids variano inversamente alle variazioni 7. 사용 후에는 앰플과 남은 유체를 폐기하십시오. 4. Eurotrol epoc® Calibration Verification Fluids skal ikke brukes som en kalibrator. Courriel : office@eurotrol.com Téléphone: +1 (502) 501-1180 BGEM. Os valores atribuídos estão disponíveis em http://www.siemens.com/epoc, tabelados para cada di temperatura. Per ottenere un grado elevato di correlazione con i valori della tabella, le fiale devono Oppbevaring Eurotrol® epoc® Calibration Verification Fluids www.eurotrol.com Courriel : officeUSA@eurotrol.com número de lote de fluido e configuração de sensor. essere stabilizzate ad una temperatura più vicina possibile a +22 °C. 지역, 주 및/또는 연방 정부 규정이나 승인 요구사항에 따라 정도 관리 물질을 사용해야 합니다. Eurotrol epoc® Calibration Verification Fluids kan brukes til utløpsdatoen som angitt på etikettene på Tout incident grave survenu en relation avec le dispositif doit être notifié au fabricant et aux autorités Para mais informações e/ou assistência, contacte: 4. Eurotrol epoc® Calibration Verification Fluids è molto sensibile alla contaminazione con aria 제한 사항 ampullene og den ytre esken, hvis det oppbevares uåpnet ved en temperatur på 2–8 °C (35–46 °F). 267.000.005 compétentes de l’état membre dans lequel est établi l’utilisateur et/ou le patient. Fabricante Distribuidor ambientale. Campionando i liquidi entro 30 secondi, l'errore corrisponde a meno del 2% sull'intero 1. 할당된 값은 할당된 유체 로트 번호, 해당 epoc® 혈액 분석 시스템 센서 구성 및 해발 고도에만 Eurotrol epoc® Calibration Verification Fluids er stabilt i 1 uke når det oppbevares uåpnet ved Historique des révisions Eurotrol B.V., Eurotrol Inc., range per tutti i livelli. L'effetto dell'aria ambientale sul pH è trascurabile. romtemperatur. Ikke sett produktet i kjøleskapet etter at det har oppnådd romtemperatur. Intended Use Revision Effective date Change to previous revision Keplerlaan 20, 6716 BS Ede, Países Baixos 850 N Black Branch Rd, Elizabethtown, KY 5. I controlli Eurotrol epoc® Calibration Verification Fluids non contengono proteine, pertanto non sono in Indikasjoner på forringelse 적용됩니다. Eurotrol epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte Número de telefone: +31 318 695 777 42701, EUA grado di rilevare malfunzionamenti sensibili a tali componenti. Eurotrol epoc® Calibration Verification Fluids skal være en klar, fargeløs væske i en lukket, uskadet and metabolite reference material for the qualitative verification of the precision and 01 14-09-2017 Première version 2. 부정확한 샘플링, 보관 또는 기타 취급 부주의로 판독치가 목표값과 다를 수 있습니다. Email: office@eurotrol.com Número de telefone: +1 (502) 501-1180 Risultati previsti ampulle. Etter at ampullen er åpnet, er produktet stabilt i 30 sekunder, og deretter kan de oppnådde accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for 02 01-02-2018 Mise à jour des adresses et explication des symboles www.eurotrol.com Email: officeUSA@eurotrol.com I valori si ottengono mediante misurazioni sul sistema di analisi ematica epoc® e con schede di analisi verdiene avvike fra de tildelte verdiene. 3. Eurotrol epoc® Calibration Verification Fluids의 pO2 값은 온도 변화와 반비례합니다. 표에 표시된 값과 professional laboratory personnel. Eurotrol epoc® Calibration Verification Fluids is designed to test the 03 12-10-2018 Ajout de nouvelles traductions, nouvelle présentation du mode d’emploi. Quaisquer incidentes graves que ocorram com o dispositivo têm de ser comunicados ao fabricante e às BGEM. I valori assegnati sono disponibili sul sito http://www.siemens.com/epoc e sono suddivisi in Prosedyre following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and Suppression des figures. autoridades competentes do Estado-Membro onde o utilizador e/ou o doente se situe. tabelle, distinte per numero di lotto del liquido e configurazione del sensore. 높은 수준의 상관관계를 가지려면 가능한 한 22°C에 근접하도록 앰플을 평형 시켜야 합니다. 1. Ta esken ut av kjøleskapet, og fjern ønsket antall ampuller fra esken og brettet. La ampullene oppnå tCO2. Histórico de revisões Per ulteriori informazioni e/o assistenza tecnica, contattare: romtemperatur (22 °C, 71,6 °F) før bruk. Toutes les marques de commerce sont la propriété de leur détenteur respectif. © 2018, Eurotrol B.V. 4. Eurotrol epoc® Calibration Verification Fluids는 실내 공기 오염에 매우 민감합니다. 30초 이내에 유체를 Test Summary Revisão Data de entrada em vigor Alteração da revisão anterior Fabbricante Distributore 2. Umiddelbart før bruk rister du ampullen godt i minst 15 sekunder. Hold ampullen mellom tommelen og Eurotrol epoc® Calibration Verification Fluids provides specific values for the pH, pO2, pCO2, Na+, K+, Zweckbestimmung 샘플링하는 경우 모든 레벨의 전체 범위에서 오류는 2% 미만입니다. pH에 실내 공기가 미치는 영향은 Eurotrol B.V., Eurotrol Inc., pekefingeren når du rister den. Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2 on the epoc® Blood Analysis System, and Eurotrol epoc® Calibration Verification Fluids ist ein geprüftes Blutgas-, Elektrolyt- und 01 14-09-2017 Primeira revisão Keplerlaan 20, 6716 BS Ede, Paesi Bassi 850 N Black Branch Rd, Elizabethtown, KY 미미합니다. 3. Drei ampullen forsiktig for å la løsningen returnere til bunnen av ampullen. La eventuelle bobler by comparing the assigned values of the product with the obtained values, the proper functioning of the Metabolit-Referenzmaterial für den Einmal-Gebrauch zur qualitativen Verifizierung der 02 01-02-2018 Endereço atualizado e glossário de símbolos Telefono: +31 318 695 777 42701, Stati Uniti d'America komme opp før du åpner ampullen. analyzer can be verified. Präzision und Genauigkeit des epoc® Blutanalysensystem. Das Produkt ist ein In-vitro-Diagnostikum, 5. Eurotrol epoc® Calibration Verification Fluids 컨트롤에는 단백질이 함유되어 있지 않기 때문에 이러한 03 12-10-2018 Acréscimo de novas traduções, nova composição gráfica das e-mail: office@eurotrol.com Telefono: +1 (502) 501-1180 4. Beskytt fingrene med gas, papirhåndkle eller hansker. Contents das von geschultem Laborpersonal angewendet wird. Eurotrol epoc® Calibration Verification Fluids Instruções de utilização. Remoção de figuras. www.eurotrol.com e-mail: officeUSA@eurotrol.com 구성 요소에 민감한 오작동을 검출할 수 없습니다. 5. Hold ampullen med den fargede prikken vendt opp. Bryt av halsen på ampullen i motsatt retning av Eurotrol epoc® Calibration Verification Fluids provides one ampule of five physiological relevant levels, wurde für die Testung der folgenden Analyten entwickelt: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, Todas as marcas comerciais são propriedade dos respetivos proprietários. © 2018, Eurotrol B.V. Ogni incidente grave correlato al dispositivo deve essere segnalato al fabbricante e all'autorità den fargede prikken. each ampule containing 2.5 mL solution. Eurotrol epoc® Calibration Verification Fluids is prepared using Glukose, Lactat, Harnstoff, Kreatinin und tCO2. 예상되는 결과 competente dello stato membro in cui risiede l'utilizzatore e/o il paziente. 6. Innen 30 sekunder følger du prøvetakingsprosedyren i henhold til instruksjonene i bruksanvisningen chemicals in a physiologically buffered matrix. Tonometry with predetermined levels of oxygen and Testübersicht Uso previsto Cronologia delle revisioni BGEM 테스트 카드를 사용해 epoc® 혈액 분석 시스템에서 측정을 통해 값을 얻습니다. 할당된 값은 각 유체 for epoc® blodanalysesystemet. carbon dioxide balanced with nitrogen and different salt concentrations provided five distinct levels. Eurotrol epoc® Calibration Verification Fluids liefert spezifische Werte für pH, pO2, pCO2, Na+, K+, Eurotrol epoc® Calibration Verification Fluids es un material de referencia de un solo uso Revisione Data di entrata in vigore Modifica alla precedente revisione 7. Etter bruk kaster du ampullen og den gjenværende væsken. Eurotrol epoc® Calibration Verification Fluids contain no preservatives, viscosity adjusters or other Ca2+, Mg2+, Cl-, Glukose, Lactat, Harnstoff, Kreatinin und tCO2 auf dem epoc® Blutanalysensystem. para gases sanguíneos, electrolitos y metabolitos diseñado para realizar una verificación 로트 번호 및 센서 구성에 따라 표로 만든 값을 http://www.siemens.com/epoc에서 확인할 수 있습니다. Kvalitetskontrollmaterialer skal brukes i henhold til lokale og/eller nasjonale forskrifter eller krav til additives that might adversely affect electrode measurements. Durch einen Vergleich der gemessenen Werte mit den Referenzwerten kann die ordnungsgemäße cualitativa de la precisión y la exactitud del sistema de análisis sanguíneo epoc®. Este producto es un 01 14-09-2017 Prima revisione 자세한 정보 및/또는 지원은 다음으로 문의하십시오. godkjenning. Warnings and precautions Funktion des Analysensystems verifiziert werden. dispositivo de diagnóstico in vitro destinado al personal de laboratorio cualificado. Eurotrol epoc® 02 01-02-2018 Aggiornati gli indirizzi e il glossario dei simboli Begrensninger 1. For in vitro diagnostic use only. Inhalt Calibration Verification Fluids se ha diseñado para analizar los parámetros analíticos siguientes: pH, 제조업체 유통업체 03 12-10-2018 Aggiunta di nuove traduzioni, nuovo layout delle istruzioni per 1. De tildelte verdiene gjelder bare for det anviste væskepartinummeret, den aktuelle 2. Each ampule is single use only. Eurotrol epoc® Calibration Verification Fluids besteht aus je einer Ampulle der fünf physiologisch pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucosa, lactato, urea, creatinina y tCO2. l'uso. Rimozione delle figure. Eurotrol B.V., Eurotrol Inc., sensorkonfigurasjonen for epoc® blodanalysesystemet og høyde ved havnivå. 3. These products should not be disposed of in general waste. Consult local environmental authorities relevanten Level, die jeweils 2,5 ml Lösung enthalten. Eurotrol epoc® Calibration Verification Fluids wird Resumen de la prueba Tutti i marchi sono proprietà dei rispettivi proprietari. © 2018, Eurotrol B.V. Keplerlaan 20, 6716 BS Ede, 네덜란드 850 N Black Branch Rd, Elizabethtown, KY 2. Feil prøvetaking, oppbevaring eller annen feilhåndtering kan føre til avlesinger som avviker fra for proper disposal. mithilfe von Chemikalien in einer physiologisch gepufferten Matrix zubereitet. Durch Tonometrie mit Eurotrol epoc® Calibration Verification Fluids proporciona valores específicos de pH, pO2, pCO2, Na+, målverdiene. 4. Eurotrol epoc® Calibration Verification Fluids is not to be used as a calibrator. festgelegten Mengen an Sauerstoff und Kohlendioxid plus Stickstoff und verschiedenen K+, Ca2+, Mg2+, Cl-, glucosa, lactato, urea, creatinina y tCO2 para el sistema de análisis sanguíneo 預期用途 전화 번호: +31 318 695 777 42701, 미국 3. pO2-verdiene for Eurotrol epoc® Calibration Verification Fluids varierer omvendt i forhold til Storage Salzkonzentrationen werden die fünf verschiedenen Level hergestellt. Eurotrol epoc® Calibration epoc®, y, al comparar los valores asignados del producto con los valores obtenidos, se puede Eurotrol epoc® Calibration Verification Fluids 이메일: office@eurotrol.com 전화 번호: +1 (502) 501-1180 temperaturendringer. For å oppnå en høy grad av korrelasjon med verdiene i tabellen må ampullene Eurotrol epoc® Calibration Verification Fluids can be used until the expiry date as indicated on the labels Verification Fluids enthält weder Konservierungsstoffe noch Mittel zur Viskositätsanpassung oder andere comprobar si el analizador funciona correctamente. 是一種分析血氣、電解質和代謝物的一次性使用標準材料，用於定性驗證 epoc® ekvilibreres så nært til 22 °C (71,6 °F) som mulig. on the ampules and outer box, if stored unopened at a temperature of 2-8 °C (35-46 °F). Eurotrol epoc® Zusätze, die die Elektrolytmessungen beeinträchtigen könnten. Contenido www.eurotrol.com 이메일: officeUSA@eurotrol.com 血液分析系統的精密度和準確度。本產品為體外診斷裝置，供專業實驗室人員使用。Eurotrol epoc® 4. Eurotrol epoc® Calibration Verification Fluids er svært følsomme for kontaminasjon av romluft. Ved Calibration Verification Fluids is stable for 1 week when stored unopened at room temperature. Do not Warnhinweise und Vorsichtsmaßnahmen Eurotrol epoc® Calibration Verification Fluids proporciona una ampolla de cinco niveles fisiológicos, cada 장치와 관련해 발생하는 주요 사건은 제조업체 및 회원국의 주무관청에 보고하여 사용자 및/또는 환자를 prøvetaking av væsken innen 30 sekunder er feilen mindre enn 2 % over hele området ved alle refrigerate the product after it has been brought to room temperature. 1. Nur als In-vitro-Diagnostikum einsetzen. una de las cuales contiene 2,5 ml de solución. Eurotrol epoc® Calibration Verification Fluids se prepara Calibration Verification Fluids 專用於檢測以下分析物：pH、pO2、pCO2、Na+、K+、Ca2+、Mg2+、Cl- nivåer. Effekten av romluft på pH er ubetydelig. Indications of Deterioration 2. Die Ampulle ist nur für den einmaligen Gebrauch vorgesehen. utilizando sustancias químicas en una matriz fisiológicamente tamponada. La tonometría con niveles 、葡萄糖、乳酸鹽、尿素、 肌酸酐及 tCO2。 파악하도록 해야 합니다. 5. Eurotrol epoc® Calibration Verification Fluids-kontroller inneholder ikke protein og kan derfor ikke Eurotrol epoc® Calibration Verification Fluids should be a clear, colorless liquid in a closed, undamaged 3. Dieses Produkt darf nicht mit dem normalen Haushaltsmüll entsorgt werden. Ordnungsgemäße predeterminados de oxígeno y dióxido de carbono en equilibrio con nitrógeno y distintas concentraciones 檢測摘要 개정 기록 registrere feilfunksjoner som er følsomme for disse komponentene. ampule. After opening the ampule, the product is stable for 30 seconds, after which the obtained values Entsorgung bei den Umweltbehörden vor Ort erfragen. de sal proporciona cinco niveles distintos. Eurotrol epoc® Calibration Verification Fluids no contiene Eurotrol epoc® Calibration Verification Fluids 能對 epoc® 血液分析系統中的 pH、pO2、pCO2、Na+、 Forventede resultater may deviate from the assigned values. 4. Eurotrol epoc® Calibration Verification Fluids darf nicht als Kalibrator eingesetzt werden. conservantes, reguladores de la viscosidad ni otros aditivos que puedan afectar negativamente a las K+、Ca2+、Mg2+、Cl-、葡萄糖、乳酸鹽、尿素、肌酸酐及 tCO2 表現出特定值， 개정 해당 날짜 이전 개정에 대한 변경사항 Verdier hentes fra målinger med epoc® blodanalysesystemet ved hjelp av BGEM-testkort. De tildelte Procedure Lagerung mediciones de electrodos. 透過比較產品的指定值與測定值，驗證分析儀是否正常運行。 01 verdiene er tilgjengelige på http://www.siemens.com/epoc, tabulert for hvert væskepartinummer og 1. Take the box out of the refrigerator and remove the appropriate number of ampules from the box and Ungeöffnet und bei Lagerung im Kühlschrank bei 2 °C–8 °C kann Eurotrol epoc® Calibration Verification Advertencias y precauciones 2017년 9월 14일 1차 개정 sensorkonfigurasjon. tray. Bring the ampules to room temperature (22 °C, 71.6 °F) prior to use. Fluids bis zu dem Haltbarkeitsdatum verwendet werden, das auf den Ampullenaufklebern und auf dem 1. Solamente para uso de diagnóstico in vitro. 內容物 02 Hvis du trenger mer informasjon og/eller hjelp, kan du benytte følgende kontaktinformasjon: Umkarton angegeben ist. Ungeöffnet und bei Raumtemperatur ist Eurotrol epoc® Calibration Verification 2. Cada ampolla es de un solo uso. 2018년 2월 1일 주소 및 기호 해설 목록 업데이트 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds. When shaking, the Eurotrol epoc® Calibration Verification Fluids 包含五種生理相關濃度的安瓿，每瓶安瓿裝有 2.5 mL Produsent Distributør ampule should be held between the thumb and index finger. Fluids nur 1 Woche haltbar. Das Produkt darf nicht wieder gekühlt werden, nachdem es einmal auf 3. Estos productos no deben desecharse con los residuos generales. Póngase en contacto con las 溶液。Eurotrol epoc® Calibration Verification Fluids 透過在生理緩衝基質中加入化學品製備而成。 03 2018년 10월 12일 새 번역 추가, IFU 새 레이아웃. 그림 삭제. Eurotrol B.V., Eurotrol Inc., 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any bubbles to rise Raumtemperatur gebracht wurde. autoridades medioambientales locales para obtener información sobre su correcta eliminación. 既定濃度的氧氣和二氧化碳（用氮氣平衡）和不同鹽濃度的測定結果表現出五種不同水平。Eurotrol Keplerlaan 20, 6716 BS Ede, Nederland 850 N Black Branch Rd, Elizabethtown, KY before opening the ampule. Anzeichen für Qualitätsprobleme 4. Eurotrol epoc® Calibration Verification Fluids no se debe utilizar como calibrador. 모든 상표는 각 업체의 자산입니다. © 2018, Eurotrol B.V. epoc® Calibration Verification Fluids 不含防腐劑、黏度調節劑或其他可能影響電極測量值的添加劑。 Telefon: +31 318 695 777 42701, USA 4. Protect fingers with gauze, tissue or gloves. Eurotrol epoc® Calibration Verification Fluids ist eine klare, farblose Flüssigkeit in einer geschlossenen, Conservación 警告和注意事項 使用目的 E-post: office@eurotrol.com Telefon: +1 (502) 501-1180 5. Hold ampule with the colored dot facing up. Snap off the neck of the ampule in the opposite direction unbeschädigten Ampulle. Nach Öffnen der Ampulle ist das Produkt 30 Sekunden lang stabil. Danach Eurotrol epoc® Calibration Verification Fluids se puede utilizar hasta la fecha de caducidad que se indica Eurotrol epoc® Calibration Verification Fluidsは、単回使用の、検定済みの血液ガス、 www.eurotrol.com E-post: officeUSA@eurotrol.com of the colored dot. können die gemessenen Werte von den Referenzwerten abweichen. en las etiquetas de las ampollas y la caja exterior si se guarda sin abrir a una temperatura de 2-8 °C. 1. 僅供體外診斷使用。 電解質および代謝産物標準物質であり、epoc®血液分析システムの精密度および正確度の Eventuelle alvorlige hendelser som har oppstått i forbindelse med enheten, må rapporteres til prod- 6. Within 30 seconds, follow the sampling procedure according to the instructions in the operating Verfahren Eurotrol epoc® Calibration Verification Fluids permanece estable durante 1 semana si se guarda sin abrir 2. 每瓶安瓿僅供一次性使用。 usenten og den relevante myndigheten i medlemslandet der brukeren og/eller pasienten befinner seg. manual of your epoc® Blood Analysis System. 1. Nehmen Sie den Karton aus dem Kühlschrank und entnehmen Sie die gewünschte Anzahl Ampullen a temperatura ambiente. No refrigere el producto una vez que este haya alcanzado la temperatura 3. 這些產品不可作為一般廢棄物處置。諮詢當地環保部門瞭解妥善處置的方法。 定性的検証に使用します。本製品は体外診断装置であり、専門のラボ担当者による使用が意図されてい Revisjonshistorikk 7. After use, dispose of the ampule and remaining fluid. aus dem Karton und dem Halter. Lassen Sie die Ampullen vor der Verwendung Raumtemperatur (22 ambiente. 4. Eurotrol epoc® Calibration Verification Fluids 不可用作校準品。 ます。Eurotrol epoc® Calibration Verification Fluidsは、次の分析物の検査用に設計されています: Revisjon Ikrafttredelsesdato Endring fra forrige revisjon Quality control materials should be used in accordance with local, state, and/or federal regulations or °C) annehmen. Indicaciones de deterioro pH、pO2、 pCO2、Na+、K+、Ca2+、Mg2+、Cl-、グルコース、乳酸、尿素、クレアチニンおよび 儲存 01 14.09.2017 Første revisjon accreditation requirements. 2. Unmittelbar vor der Verwendung schütteln Sie die Ampulle mindestens 15 Sekunden lang kräftig. Eurotrol epoc® Calibration Verification Fluids se suministra en forma de líquido transparente e incoloro tCO2。 Halten Sie die Ampulle beim Schütteln zwischen Daumen und Zeigefinger fest. dentro de una ampolla cerrada en perfecto estado. Una vez abierta la ampolla, el producto permanece Eurotrol epoc® Calibration Verification Fluids 在未開封、儲存於 2-8 °C Limitations 検査サマリー 02 01.02.2018 Oppdatert adresse og symbolordliste 3. Schwenken Sie die Ampulle anschließend leicht, damit sich die gesamte Lösung im unteren Teil der estable durante un período de 30 segundos, después del cual los valores obtenidos pueden desviarse de 的情況下可在有效日期前使用，有效日期標示於安瓿和外包裝盒的標籤上。Eurotrol epoc® Calibration 1. The assigned values are applicable only to the assigned fluid lot number, the applicable epoc® Blood Eurotrol epoc® Calibration Verification 03 12.10.2018 La til nye oversettelser, ny utforming av bruksanvisningen. Figurer er Analysis System sensor configuration and sea level altitude. Ampulle sammelt. Lassen Sie vor dem Öffnen der Ampulle eventuelle Luftblasen nach oben steigen. los valores asignados. Verification Fluids 在未開封、儲存於室溫時穩定性可維持 1 週。產品置於室溫環境後請勿再次冷藏。 Fluidsは、epoc®血液分析システムにおいて、pH、pO2、pCO2、Na+、 K+、Ca2+、Mg2+、Cl- fjernet. 2. Incorrect sampling, storage, or other mishandling may cause the readings to deviate from the target 4. Schützen Sie Ihre Finger mit Gaze, einem Tuch oder Handschuhen. Procedimiento 變質說明 5. Halten Sie die Ampulle fest, sodass der farbige Punkt nach oben und zu Ihnen zeigt. Brechen Sie den 1. Saque la caja de la nevera y retire la cantidad necesaria de ampollas de la caja y la bandeja. Deje 、グルコース、乳酸、尿素、クレアチニンおよびtCO2 Alle varemerker tilhører de respektive eierne. © 2018, Eurotrol B.V. values. Eurotrol epoc® Calibration Verification Fluids 應為澄清、無色液體，裝於封閉、 Ampullenhals in die gegenüber liegende Richtung des farbigen Punkts ab. que las ampollas alcancen la temperatura ambiente (22 °C) antes de utilizarlas. について特定の値を示し、本製品に指定された値と実際に得られた値を比較することにより、分析装置 3. The pO2 values of Eurotrol epoc® Calibration Verification Fluids vary inversely with temperature 未損壞的安瓿中。安瓿打開後，產品穩定性僅可維持 30 秒，此後得出的測定值可能會偏離指定值。 Käyttötarkoitus changes. To obtain a high degree of correlation with the values in the table, the ampules should be 6. Führen Sie die Messung entsprechend den Anweisungen im Handbuch Ihres epoc® 2. Justo antes de utilizar una ampolla, agítela enérgicamente durante quince segundos como mínimo. が適切に機能していることを検証することができます。 Eurotrol epoc® Calibration Verification Fluids on kertakäyttöinen verikaasu-, elektrolyytti- ja 使用步驟 equilibrated as close to 22 °C (71.6 °F) as possible. Blutanalysensystem innerhalb von 30 Sekunden durch. Para agitar la ampolla, debe sujetarla entre el dedo pulgar y el dedo índice. 内容 metaboliittitestien vertailumateriaali, jota käytetään epoc®-verianalyysijärjestelmän 1. 從冷藏室中取出包裝盒，從包裝盒和托盤中取出適量數量的安瓿。使用前先將安瓿回復至室溫 (22 °C). 4. Eurotrol epoc® Calibration Verification Fluids is very sensitive to room air contamination. When 7. Entsorgen Sie danach die Ampulle und die restliche Flüssigkeit. 3. Gire la ampolla con cuidado para volver a situar la solución en la parte inferior de la ampolla. Eurotrol epoc® Calibration Verification Fluidsは、 kvalitatiivisen tarkkuuden ja virheettömyyden tarkistamiseen. Tuote on in vitro -diagnostiikkalaite (IVD- Qualitätskontrollmaterial ist unter Berücksichtigung lokaler, föderaler oder nationaler Vorschriften oder Asegúrese de que las burbujas suban antes de abrir la ampolla. 2. 用力搖晃安瓿至少十五秒後立即使用。搖晃時，應用大拇指和食指握住安瓿。 sampling the fluid within 30 seconds, the error is less than 2% over the entire range in all levels. The 5つの生理学的に適切なレベルの1本のアンプルとして提供され、各アンプルには2.5 laite), joka on tarkoitettu asiantuntevan laboratoriohenkilökunnan käyttöön. Eurotrol epoc® Calibration Akkreditierungsanforderungen zu verwenden. 4. Protéjase los dedos con una gasa, un tejido o guantes. 3. 輕輕旋轉安瓿，讓溶液回流到安瓿底部。先讓所有氣泡浮上來，再打開安瓿。 effect of room air on pH is negligible. mLの溶液が含まれます。Eurotrol epoc® Calibration Verification Fluids Verification Fluids on suunniteltu seuraavien analyyttien testaamiseen: pH, pO2, pCO2, Na+, K+, Ca2+, 5. Eurotrol epoc® Calibration Verification Fluids controls do not contain protein and therefore may not Einschränkungen 5. Sujete la ampolla con el punto coloreado mirando hacia arriba. Rompa el cuello de la ampolla en la 4. 用紗布、紙巾或手套來保護手指。 Mg2+, Cl-, glukoosi, laktaatti, urea, kreatiniini ja tCO2. は、生理的干渉マトリックス中で化学薬品を使用して調製されます。窒素および異なる塩濃度で平衡化 detect malfunctions sensitive to these components. 1. Die angegebenen Werte gelten nur für die angegebene Chargennummer, die angegebene dirección opuesta al punto coloreado. 5. 拿起安瓿，將彩色標記點朝上。從彩色標記點的對面折斷安瓿瓶頸。 Testien yleiskuvaus Sensorkonfiguration des epoc® Blutanalysensystem und auf Normalhöhennull. 6. En un plazo de 30 segundos, siga el procedimiento de muestreo de conformidad con las された、事前定義済みのレベルの酸素および二酸化炭素での圧力測定により、5つの特異なレベルが提供 Expected Results 6. 在 30 秒內，按照 epoc® 血液分析系統操作手冊中的採樣步驟進行採樣。 Eurotrol epoc® Calibration Verification Fluids tuottaa spesifiset arvot seuraaviin epoc® - 2. Falsche Verarbeitung, Lagerung oder Handhabung kann dazu führen, dass die Messergebnisse von instrucciones que se proporcionan en el manual de funcionamiento del sistema de análisis sanguíneo されます。Eurotrol epoc® Calibration Verification Fluidsには、 verianalyysijärjestelmällä tehtäviin testeihin: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukoosi, Values are obtained by measurements on epoc® Blood Analysis System using BGEM test cards. The 7. 使用完畢後，丟棄安瓿及剩餘液體。 assigned values are available from http://www.siemens.com/epoc, tabulated for each fluid lot number and den Zielwerten abweichen. epoc®. 電極の測定に悪影響を及ぼす可能性がある防腐剤、粘性調整剤またはその他の添加物は含まれていませ laktaatti, urea, kreatiniini ja tCO2. Analysointilaitteen oikea toiminta tarkastetaan vertailemalla tuotteen 使用品管材料時應遵循當地、州和/或聯邦法規或認證標準。 sensor configuration. 3. Die pO2-Werte von Eurotrol epoc® Calibration Verification Fluids sind umgekehrt 7. Una vez utilizada, deseche la ampolla y el líquido restante. ん。 määritettyjä arvoja saatuihin arvoihin. temperaturabhängig. Um eine möglichst hohe Korrelation mit den Referenzwerten in der Tabelle zu Los materiales de control de calidad se deben utilizar de conformidad con las normativas o los requisitos 限制 For further information and/or assistance please contact: 警告および注意事項 Sisältö erreichen, sollten die Ampullen möglichst genau auf 22 °C temperiert werden. de acreditación locales, autonómicos o estatales. 1. 指定值僅適用於指定的液體批號、相應的 epoc® 血液分析系統傳感器設定和海拔高度。 Manufacturer Distributor 1. 体外診断専用です。 Eurotrol epoc® Calibration Verification Fluids on ampulli, jossa on viisi fysiologisesti relevanttia tasoa. 4. Eurotrol epoc® Calibration Verification Fluids reagiert sehr empfindlich auf Verschmutzungen in der Limitaciones 2. 採樣、儲存不當或其他操作不當可能導致讀數偏離目標值。 Kussakin ampullissa on 2,5 ml liuosta. Eurotrol epoc® Calibration Verification Fluids valmistellaan Eurotrol B.V., Eurotrol Inc., 2. 各アンプルは単回使用専用です。 Keplerlaan 20. 6716 BS Ede, The Netherlands 850 N Black Branch Rd, Elizabethtown, KY Raumluft. Wenn die Lösung innerhalb von 30 Sekunden nach Öffnung verarbeitet wird, liegt der 1. Los valores asignados se aplican únicamente al número de lote del líquido asignado, a la 3. Eurotrol epoc® Calibration Verification Fluids 測出的 pO2 值和溫度變化呈反比。 käyttämällä kemikaaleja puskuroidussa fysiologisessa liuoksessa. Tonometria, jonka happi- ja Fehler über den Gesamtbereich in allen Level bei unter 2 %. Der Einfluss der Raumluft auf den pH- configuración del sensor del sistema de análisis sanguínea epoc® correspondiente y a la altitud del 3. これらの製品は、一般廃棄物として廃棄してはなりません。適切な廃棄については、地域の環境当局 Phone: +31 318 695 777 42701, USA 為使測定值與表格中的指定值具有高度相關性，安瓿應儘可能回復到 22 °C。 hiilidioksiditasot määritettiin etukäteen ja joka oli tasapainotettu typellä ja eri suolapitoisuuksilla, tuotti viisi Wert ist vernachlässigbar. nivel del mar. にお問い合わせください。 E-mail: office@eurotrol.com Phone: +1 (502) 501-1180 4. Eurotrol epoc® Calibration Verification Fluids 對室內空氣污染非常敏感。在 30 秒內進行液體採樣時， toisistaan erottuvaa tasoa. Eurotrol epoc® Calibration Verification Fluids ei sisällä säilöntäaineita, 5. Die Kontrollen Eurotrol epoc® Calibration Verification Fluids enthalten keine Proteine und können 2. Si se realiza un muestreo, almacenamiento u otra gestión de forma incorrecta, las lecturas pueden 4. Eurotrol epoc® Calibration Verification Fluidsは、較正物質として使用しないでください。 viskositeetin säätäjiä tai muita lisäaineita, jotka voisivat haitata elektrodimittauksia. www.eurotrol.com E-mail: officeUSA@eurotrol.com 所有濃度整個範圍的誤差均不超過 2%。室內空氣對 pH 的影響可以忽略不計。 Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and deswegen keine Fehlfunktionen aufdecken, die durch Proteine verursacht werden. desviarse de los valores asignados. 保管 Varoitukset ja varotoimet 5. Eurotrol epoc® Calibration Verification Fluids 對照品不含蛋白質， the competent authority of the Member State where the user and/or the patient is established. Referenzergebnisse 3. Los valores de pO2 de Eurotrol epoc® Calibration Verification Fluids varían inversamente con los Eurotrol epoc® Calibration Verification 1. Vain in vitro -diagnostiikkaan. Die Werte werden durch Messungen auf dem epoc® Blutanalysensystem mit BGEM-Testkarten ermittelt. cambios de temperatura. Para obtener un alto grado de correlación con los valores de la tabla, las 因此可能無法探測對這些成分敏感的功能缺陷。 Revision history Fluidsは、未開封の状態で2～8℃で保管されていた場合、アンプルおよび外箱のラベルに記載の使用期 2. Ampullit ovat kertakäyttöisiä. Die jeweiligen Werte sind unter http://www.siemens.com/epoc in Tabellenform für jede Kontroll- ampollas se deben equilibrar a la temperatura más cercana a los 22 °C que sea posible. 預期結果 Revision Effective date Change to previous revision 限まで使用することができます。Eurotrol epoc® Calibration Verification Fluidsは、 3. Tuotteita ei saa hävittää sekajätteenä. Tarkista oikea hävitystapa paikalliselta Chargennummer und alle Sensorkonfigurationen aufgeführt. 4. Eurotrol epoc® Calibration Verification Fluids es muy sensible a la contaminación del aire ambiente. 使用 BGEM 檢測卡，在 epoc® 血液分析系統上得出測定值。指定值可瀏覽 http://www.siemens.com/epoc ympäristöviranomaiselta. 01 14-09-2017 First revision 未開封の状態で室温で保管されていた場合、1週間安定しています。一度室温になった製品は冷却しない Für weitere Informationen und/oder technische Unterstützung wenden Sie sich bitte an: Al realizar el muestreo del líquido en 30 segundos, el error es inferior al 2% en todos los niveles del 獲取，每個液體批號和傳感器設定均已在表格中列出指定值。 4. Eurotrol epoc® Calibration Verification Fluids -tuotetta ei saa käyttää kalibrointiin. でください。 02 01-02-2018 Updated address and symbols glossary Hersteller Vertrieb intervalo completo. El efecto del aire ambiente en el pH es insignificante. 如需更多資訊或協助，請聯絡： Säilytys Eurotrol B.V., Eurotrol Inc., 5. Los controles de Eurotrol epoc® Calibration Verification Fluids no contienen proteína y, por tanto, 劣化の兆候 03 12-10-2018 Addition of new translations, new layout of IFU. Removal of figures. 製造商 經銷商 Eurotrol epoc® Calibration Verification Fluids -tuote säilyy ampullien etiketteihin ja ulkopakkaukseen Keplerlaan 20, 6716 BS Ede, Niederlande 850 N Black Branch Rd, Elizabethtown, KY puede que no detecten los fallos de funcionamiento sensibles a estos componentes. Eurotrol epoc® Calibration Verification Fluidsは、密閉され、 損傷していないアンプル中では無色透明 Eurotrol B.V., Eurotrol Inc., merkittyyn viimeiseen käyttöpäivämäärään asti, jos se säilytetään avaamattomana 2–8 °C:ssa. Eurotrol All trademarks are the property of their respective owners. © 2018, Eurotrol B.V. Telefon: +31 318 695 777 42701, USA Resultados esperados の液体です。アンプルの開封後、製品は30秒間安定しています。その後は、得られた値が指定された値 Keplerlaan 20, 6716 BS Ede, 荷蘭 850 N Black Branch Rd, Elizabethtown, KY epoc® Calibration Verification Fluids pysyy stabiilina yhden (1) viikon, jos se säilytetään avaamattomana Utilisation prévue E-mail : office@eurotrol.com Telefon : +1 (502) 501-1180 Los valores se obtienen realizando mediciones en el sistema de análisis sanguíneo epoc® con las から乖離する可能性があります。 huoneenlämmössä. Huoneenlämpöön tasattua tuotetta ei saa jäähdyttää. 電話號碼: +31 318 695 777 42701, 美國 Eurotrol epoc® Calibration Verification Fluids est un matériel de référence à usage unique www.eurotrol.com E-mail : officeUSA@eurotrol.com tarjetas de análisis BGEM. Los valores asignados están disponibles en http://www.siemens.com/epoc, 手順 Laadun heikkenemisen merkit étalonné pour l’analyse des gaz, électrolytes et métabolites sanguins destiné à la vérification Alle schwerwiegenden Vorfälle, die in Zusammenhang mit diesem Produkt auftreten, sind dem Hersteller expresados por número de lote de líquido y configuración del sensor. 電子郵件: office@eurotrol.com 電話號碼: +1 (502) 501-1180 1. 冷蔵庫からボックスを取り出し、ボックスおよびトレイから適切な本数のアンプルを取り出します。 Eurotrol epoc® Calibration Verification Fluids -tuotteen kuuluu olla kirkasta, väritöntä nestettä suljetussa qualitative de la précision et de l’exactitude du système d’analyse sanguine epoc®. Le produit est un sowie den zuständigen Behörden des Mitgliedsstaats zu melden, in dem der Anwender und/oder der Para obtener más información o asistencia, póngase en contacto con: www.eurotrol.com 電子郵件: officeUSA@eurotrol.com ja ehjässä ampullissa. Ampullin avaamisen jälkeen tuote on stabiili 30 sekuntia, minkä jälkeen saadut 使用前に、アンプルを室温（22℃）にします。 dispositif de diagnostic in vitro destiné à des techniciens de laboratoire professionnels. Eurotrol epoc® Patient angesiedelt sind. Fabricante Distribuidor 與本裝置相關的任何嚴重事故均應上報製造商以及使用者和/或患者所在成員國的主管機構。 arvot voivat poiketa määritetyistä arvoista. 2. 使用の直前に、アンプルを15秒以上よく振ります。アンプルを振る際は、アンプルを親指と人差し指 Calibration Verification Fluids est destiné à tester les analytes suivants : pH, pO2, pCO2, Na+, K+, Ca2+, Revisionsprotokoll Eurotrol B.V., Eurotrol Inc., 修訂記錄 Käyttöohjeet Keplerlaan 20, 6716 BS Ede, Países Bajos 850 N Black Branch Rd, Elizabethtown, KY で挟むようにして保持します。 Mg2+, Cl-, glucose, lactate, urée, créatinine et tCO2. Revision Gültig ab Änderungen gegenüber voriger Revision 修訂版 生效日期 修訂內容 1. Ota pakkaus jääkaapista ja ota sopiva määrä ampulleja pakkauksesta ja tarjottimelta. Ennen kuin Résumé du test Número de teléfono: +31 318 695 777 42701, Estados Unidos 3. 溶液をアンプルの底部に戻すため、円を描くようにアンプルをゆるやかに回旋させます。気泡があれ 01 14-09-2017 Erste Revision 01 2017 年 9 月 14 日 第一版 käytät ampulleja, odota, että ne ovat huoneenlämpöisiä (22 °C). Eurotrol epoc® Calibration Verification Fluids fournit des valeurs spécifiques pour les paramètres pH, Correo electrónico: office@eurotrol.com Número de teléfono: +1 (502) 501-1180 ば、アンプルを開封する前に、液面まで上昇させます。 2. Ravista ampullia voimakkaasti vähintään 15 sekuntia juuri ennen kuin käytät sitä. Kun ravistat pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urée, créatinine et tCO2 sur le système 02 01-02-2018 Adresse und Symbol-Glossar aktualisiert www.eurotrol.com Correo electrónico: officeUSA@eurotrol.com 02 2018 年 2 月 1 日 更新地址和符號說明 4. ガーゼ、ティッシュまたは手袋で指を保護します。 ampullia, pidä sitä peukalon ja etusormen välissä. d’analyse sanguine epoc® et la comparaison entre les valeurs assignées du produit et les valeurs 03 12-10-2018 Neue Übersetzungen hinzugefügt, neues Layout der Anleitung. Bilder Cualquier incidente grave que se produzca en relación con el dispositivo se debe comunicar al fabricante 03 2018 年 10 月 12 日 新增翻譯、更新使用說明排版。刪除圖表。 5. 色つきのドットを上向きにして、アンプルを保持します。アンプルのネック部分を、色つきのドット 3. Pyöritä ampullia varovasti niin, että liuos laskeutuu takaisin ampullin pohjaan. Jos ampullissa on obtenues permet de contrôler le bon fonctionnement de l’analyseur. entfernt. y a la autoridad competente del Estado miembro en el que esté establecido el usuario o el paciente. とは反対方向に折ります）。 kuplia, odota että ne nousevat, ennen kuin avaat ampullin. 所有商標皆為其各自擁有者的財產。© 2018, Eurotrol B.V. Contenu Alle Marken sind Eigentum ihrer jeweiligen Inhaber. © 2018, Eurotrol B.V. Historial de revisiones 6. epoc®血液分析システムの取扱説明書の指示に従って、30秒以内にサンプリング手順を行います。 4. Suojaa sormet sideharsolla, paperipyyhkeellä tai suojahansikkailla. Eurotrol epoc® Calibration Verification Fluids contient une ampoule de chacun de cinq niveaux Revisión Fecha de entrada en vigor Cambio respecto a la revisión anterior 사용 목적 5. Pidä ampullista kiinni niin, että värillinen täplä on ylöspäin. Napsauta ampullin kaula irti vastakkaiseen Utilização prevista 7. 使用後は、アンプルと残った液体を廃棄します。 physiologiquement importants, chaque ampoule contenant 2,5 ml de solution. Eurotrol epoc® Calibration 01 14-9-2017 Primera revisión suuntaan kuin värillinen täplä. O Eurotrol epoc® Calibration Verification Fluids é um material de referência testado para Eurotrol epoc® Calibration Verification Fluids는 epoc® 혈액 분석 시스템의 정밀도 및 精度管理物質は、国または地方の規則、あるいは認定要件に従って使用する必要があります。 Verification Fluids est préparé à partir de substances chimiques pures dans une matrice de tampon 6. Ota näyte 30 sekunnin kuluessa. Noudata näytteen ottamisessa epoc®-verianalyysijärjestelmän physiologique. La tonométrie avec des taux d’oxygène et de dioxyde de carbone prédéterminés eletrólitos, metabólitos e gasometria, de utilização única, para a verificação qualitativa da 02 1-2-2018 Actualización de la dirección y el glosario de símbolos 制限 정확도를 정성적으로 평가하기 위한 검사 혈액 가스, 전해액, 신진대사 표준물질로 일회용입니다. 이 제품은 käyttöohjeita. équilibrés avec de l’azote et différentes concentrations de sels fournit cinq niveaux spécifiques. Eurotrol precisão e rigor do sistema de análise ao sangue epoc®. O produto é um dispositivo de diagnóstico in 1. 指定された値は、指定された液体ロット番号、該当するepoc®血液分析システムセンサー構成および 03 12-10-2018 Adición de nuevas traducciones y nuevo diseño de las IDU. 7. Hävitä ampulli ja siihen jäänyt neste käytön jälkeen. epoc® Calibration Verification Fluids ne contient ni conservateurs ni modificateurs de viscosité ni aucun vitro, destinado a ser utilizado por técnicos de laboratório. O Eurotrol epoc® Calibration Verification Eliminación de figuras. 체외 진단용 장치로, 전문 연구소에서 사용해야 합니다. Eurotrol epoc® Calibration Verification Fluids는 海抜高度にのみ適用されます。 Laadunvalvontamateriaalien käytössä on noudatettava paikallisia ja/tai kansallisia määräyksiä tai autre additif susceptible d’affecter les mesures réalisées avec l’électrode. Fluids foi concebido para testar os seguintes analitos: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, Todas las marcas comerciales son propiedad de sus respectivos propietarios. © 2018, Eurotrol B.V. 다음 피분석물을 테스트하도록 설계되었습니다. pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, 글루코오스, 2. 不適切なサンプリングまたは保管、あるいはその他の誤った取り扱いは、読み取り値が目標値から逸 hyväksyntävaatimuksia. Mises en garde et précautions glicose, lactato, ureia, creatinina e tCO2. 脱する原因となる可能性があります。 Rajoitukset 1. Exclusivement à usage diagnostique in vitro. Resumo do teste Uso previsto 젖산염, 요소, 크레아틴 및 tCO2. 3. Eurotrol epoc® Calibration Verification FluidsのpO2値は、温度変化に反比例して変化します。 1. Määritettyjä arvoja voidaan käyttää vain määritetyn nesteen eränumerolle, asianmukaisella epoc®- 2. Chaque ampoule est à usage unique. O Eurotrol epoc® Calibration Verification Fluids fornece valores específicos para o pH, pO2, pCO2, Na+, Eurotrol epoc® Calibration Verification Fluids è un set monouso di materiali di riferimento 테스트 요약 表の値と相関性の高い結果を得るには、アンプルを可能な限り22℃の近くで平衡化する必要がありま verianalyysilaitteen anturikokoonpanolla ja asianmukaisella merenpintakorkeudella. 3. Ne pas éliminer ces produits avec les ordures ménagères. Consulter les autorités locales K+, Ca2+, Mg2+, Cl-, glicose, lactato, ureia, creatinina e tCO2 no sistema de análise ao sangue epoc® e, titolati per emogas, elettroliti e metaboliti, per la verifica qualitativa della precisione e 2. Virheellinen näytteenottotapa tai säilytys tai muu varomaton käsitte m responsables de l’environnement pour connaître la manière de les éliminer. comparando os valores atribuídos do produto com os valores obtidos, é possível verificar o dell'accuratezza del sistema di analisi ematica epoc®. Il prodotto è un dispositivo diagnostico in vitro, Eurotrol epoc® Calibration Verification Fluids는 epoc® 혈액 분석 시스템에서 pH, pO2, pCO2, Na+, K+, す。 4. Eurotrol epoc® Calibration Verification Fluids n’est pas destiné à être utilisé comme calibrateur. funcionamento do analisador. destinato a personale di laboratorio professionale. Eurotrol epoc® Calibration Verification Fluids è 4. Eurotrol epoc® Calibration Verification Fluidsは、室内空気の汚染に非常に敏感です。 Ca2+, Mg2+, Cl-, 글루코오스, 젖산염, 요소, 크레아틴 및 tCO2에 대한 특정 값을 제공하고, 이 제품의 O Conservation Conteúdo progettato per il monitoraggio dei seguenti analiti: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucosio, 30秒以内に液体のサンプリングを行った場合、誤差は、すべてのレベルで全範囲にわたって2%未満 m m m Eurotrol epoc® Calibration Verification Fluids peut être utilisé jusqu’à la date de péremption figurant sur O Eurotrol epoc® Calibration Verification Fluids fornece uma ampola de cinco níveis fisiológicos lattato, urea, creatinina e tCO2. 할당된 값과 획득한 값을 비교해 분석기가 올바르게 작동하는지를 확인할 수 있습니다. です。pHに対する室内空気の影響は無視できます。 m mm m les étiquettes des ampoules et sur la boîte extérieure à condition d’être conservé non ouvert à une relevantes, contendo cada ampola 2,5 ml de solução. O Eurotrol epoc® Calibration Verification Fluids é Riassunto del test 내용 5. Eurotrol epoc® Calibration Verification Fluidsコントロールにはタンパク質は含まれていないため、 m m température comprise entre 2 et 8°C. Eurotrol epoc® Calibration Verification Fluids est stable pendant preparado com químicos numa matriz de tampão fisiológico. A tonometria com níveis predeterminados Eurotrol epoc® Calibration Verification Fluids fornisce valori specifici per pH, pO2, pCO2, Na+, K+, Ca2+, これらの成分に敏感な異常が検出されてはなりません。 % m une semaine lorsqu’il est conservé non ouvert à température ambiante. Ne pas réfrigérer à nouveau le de oxigénio e dióxido de carbono equilibrados com azoto e diferentes concentrações de sal fornece Mg2+, Cl-, glucosio, lattato, urea, creatinina e tCO2 sul sistema di analisi ematica epoc® , e consente di Eurotrol epoc® Calibration Verification Fluids는 생리학적 관련 레벨이 다섯 가지인 한 가지 앰플을 cinco níveis distintos. O Eurotrol epoc® Calibration Verification Fluids não contém conservantes, verificare il funzionamento corretto di quest’ultimo confrontando i valori assegnati del prodotto con quelli 予想される結果 produit après qu’il ait été amené à température ambiante. 제공하며, 각 앰플에는 2.5mL의 용액이 들어 있습니다. Eurotrol epoc® Calibration Verification Fluids는 m ajustadores de viscosidade ou outros aditivos que podem afetar adversamente as medições dos pólos. ottenuti. 値は、epoc®血液分析システムでBGEM検査カードを使用した測定により得られます。指定された値は Indications de détérioration m Eurotrol epoc® Calibration Verification Fluids doit se présenter sous la forme d’un liquide limpide et Advertências e precauções Contenuto 생리적으로 버퍼된 매트릭스에서 화학물질을 사용하도록 준비되었습니다. 질소 및 다양한 소금 농도와 、液体ロット番号およびセンサー構成ごとに表にまとめられており、http://www.siemens.com/epocから O incolore dans une ampoule fermée et intacte. Après ouverture de l’ampoule, le produit est stable pendant 1. Apenas para utilização em diagnóstico in vitro. Eurotrol epoc® Calibration Verification Fluids fornisce una fiala con cinque livelli fisiologicamente 取得することができます。 균형을 이룬, 산소 및 이산화탄소 레벨이 사전에 결정된 안력측정은 다섯 가지 구별되는 레벨을 제공합니다. m m G M M 30 secondes ; après ce délai, les valeurs obtenues peuvent s’écarter des valeurs assignées. 2. Cada ampola destina-se apenas a uma única utilização. significativi; ogni fiala contiene 2,5 mL di soluzione. Eurotrol epoc® Calibration Verification Fluids è 詳細またはサポートについては、下記までお問い合わせください: m m m Procédure 3. Estes produtos não devem ser eliminados no lixo doméstico. Consulte as autoridades ambientais ottenuto con l'aggiunta di sostanze chimiche in una matrice tamponata con tampone fisiologico. La Eurotrol epoc® Calibration Verification Fluids에는 전극 측정에 부정적인 영향을 미칠 수 있는 보존제, 점도 製造者 販売者 m m 1. Sortir la boîte du réfrigérateur et prélever le nombre approprié d’ampoules de la boîte et du plateau. locais para saber qual o procedimento de eliminação adequado. tonometria con livelli predeterminati di ossigeno e anidride carbonica equilibrati con azoto e le diverse 조정자 또는 기타 첨가제를 사용하지 않습니다. Eurotrol B.V., Eurotrol Inc., Amener les ampoules à température ambiante (22°C) avant usage. 4. O Eurotrol epoc® Calibration Verification Fluids não deve ser utilizado como calibrador. concentrazioni di sali forniscono cinque livelli distinti. Eurotrol epoc® Calibration Verification Fluids non Keplerlaan 20, 6716 BS Ede, オランダ 850 N Black Branch Rd, Elizabethtown, KY m 2. Immédiatement avant utilisation, agiter vigoureusement l’ampoule pendant au moins quinze Conservação contiene conservanti, correttori di viscosità, né altri additivi che potrebbero compromettere le misurazioni 경고 및 주의 사항 O Eurotrol epoc® Calibration Verification Fluids pode ser utilizado até ao prazo de validade indicado nos degli elettrodi. 電話番号: +31 318 695 777 42701, アメリカ合衆国 secondes. Agiter l’ampoule en la tenant entre le pouce et l’index. m rótulos das ampolas e na embalagem exterior, se for conservado intacto a uma temperatura de 2-8 °C. O Avvertenze e precauzioni 1. 체외 진단용으로만 사용하십시오. Eメール : office@eurotrol.com 電話番号: +1 (502) 501-1180 3. Faire tourner délicatement l’ampoule pour ramener la solution au fond de celle-ci. Laisser remonter m Eurotrol epoc® Calibration Verification Fluids permanece estável durante 1 semana, quando conservado 1. Esclusivamente per uso diagnostico in vitro. www.eurotrol.com Eメール:officeUSA@eurotrol.com les bulles avant d’ouvrir l’ampoule. 2. 각 앰플은 1회용입니다. @ m m 4. Se protéger doigts avec de la gaze, un morceau de tissu ou des gants. intacto à temperatura ambiente. Não coloque o produto no frigorífico após este ter atingido a temperatura 2. Ogni fiala è esclusivamente monouso. 本装置に関連して発生した重大な事象については、製造者および、使用者または患者の所在地である加 3. 이 제품은 일반폐기물로 폐기해서는 안 됩니다. 올바른 폐기 방법은 해당 지역 환경 당국에 m @ m 5. Maintenir l’ampoule avec le point coloré orienté vers le haut. Casser le col de l’ampoule dans la ambiente. 3. Il prodotto non deve essere smaltito nei rifiuti generici. Per un corretto smaltimento, consultare le 盟国の権限のある機関に報告してください。 m m m direction opposée au point coloré. Sinais de deterioração autorità ambientali locali. 문의하십시오. 改訂履歴 m m m 6. Procéder dans les 30 secondes au prélèvement de l’échantillon conformément aux instructions O Eurotrol epoc® Calibration Verification Fluids deve ter um aspeto líquido incolor e límpido numa 4. Eurotrol epoc® Calibration Verification Fluids non deve essere utilizzato come calibratore. 4. Eurotrol epoc® Calibration Verification Fluids는 칼리브레이터로 사용할 수 없습니다. 改訂 発効日 以前の改訂への変更 figurant dans le mode d’emploi du système d’analyse sanguine epoc®. ampola fechada e isenta de danos. Uma vez aberta a ampola, o produto permanece estável durante 30 Conservazione segundos; após este período, os valores obtidos podem desviar-se dos valores atribuídos. Eurotrol epoc® Calibration Verification Fluids può essere utilizzato fino alla data di scadenza indicata 01 14-09-2017 初版 m M 7. Après usage, éliminer l’ampoule et le liquide résiduel. 보관 Le matériel de contrôle de qualité doit être utilisé conformément aux exigences des réglementations Procedimento sulle etichette delle fiale e della scatola esterna, purché conservato in confezione integra a una 02 01-02-2018 住所および記号用語集の更新 mm 1. Retire a caixa do frigorífico e retire o número adequado de ampolas da caixa e da bandeja. Deixe as temperatura compresa fra +2 °C e +8 °C. Eurotrol epoc® Calibration Verification Fluids resta stabile per Eurotrol epoc® Calibration Verification Fluids는 2 ~ 8°C의 온도에서 미개봉 상태로 보관하는 경우 앰플과 locales et/ou nationales ou aux exigences en matière d’accréditation du laboratoire. 03 12-10-2018 新しい翻訳、IFUの新しいレイアウトの追加。図の削除。 O m m Limites ampolas atingirem a temperatura ambiente (22 °C) antes de utilizar. 1 settimana se conservato in confezione integra a temperatura ambiente. Una volta portato il prodotto a 바깥쪽 포장에 표시된 유효기간까지 사용할 수 있습니다. Eurotrol epoc® Calibration Verification Fluids는 2. Imediatamente antes de utilizar, agite vigorosamente a ampola durante pelo menos quinze segundos. temperatura ambiente, non refrigerarlo. すべての商標は、それぞれの所有者の所有物です。© 2018, Eurotrol B.V. 1. Les valeurs assignées sont uniquement applicables au numéro de lot de liquide correspondant, à la Ao agitar a ampola, deve segurá-la entre o polegar e o indicador. Indici di deterioramento 실온에서 미개봉 상태로 보관하는 경우 일주일 동안 안정적입니다. 제품을 실온에서 보관하다가 냉장 Tiltenkt bruk configuration de capteur du système d’analyse sanguine epoc® correspondante et au niveau de la m m m mer. 3. Faça girar cuidadosamente a ampola para devolver a solução ao fundo da ampola. Deixe subir as Eurotrol epoc® Calibration Verification Fluids deve presentarsi come liquido limpido e incolore, in fiala 보관하지 마십시오. Eurotrol epoc® Calibration Verification Fluids er referansemateriale for analyse av blodgass, 2. Un prélèvement d’échantillon incorrect, une conservation inadéquate ou toute autre erreur de possíveis bolhas de ar, antes de abrir a ampola. chiusa e integra. Una volta aperta la fiala, il prodotto resta stabile per 30 secondi, dopo di che i valori elektrolytter og metabolitter til engangsbruk, og brukes til kvalitativ verifisering av 4. Proteja os dedos com gaze, toalhetes ou luvas. ottenuti potrebbero deviare dai valori assegnati. 변질 증상 presisjonen og nøyaktigheten til epoc® blodanalysesystemet. Produktet er en enhet til in vitro- manipulation risquent d’avoir pour conséquence un écart entre les mesures obtenues et les valeurs cibles. 5. Segure a ampola com o ponto colorido voltado para cima. Quebre a parte superior da ampola no Procedura Eurotrol epoc® Calibration Verification Fluids는 미개봉 상태로 손상되지 않은 경우 투명한 무채색 diagnostikk, beregnet for profesjonelt laboratoriepersonell. Eurotrol epoc® Calibration Verification Fluids 3. Les valeurs de la pO2 d’Eurotrol epoc® Calibration Verification Fluids varient en fonction inverse des sentido oposto ao do ponto colorido. 1. Estrarre la scatola dal frigorifero e rimuovere il numero appropriato di fiale dalla scatola e dalla er utviklet for å teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukose, laktat, urea, 6. No espaço de 30 segundos, leve a cabo o procedimento de amostragem, segundo as instruções do vaschetta. Prima dell’uso, portare le fiale a temperatura ambiente (+22 °C). 액체입니다. 앰플을 개봉한 후 이 제품은 30초간 안정적이며, 그 이후에는 획득한 값이 할당된 값과 달라질 kreatinin og tCO2. écarts de température. Pour obtenir un haut degré de corrélation avec les valeurs du tableau, les ampoules doivent être équilibrées à une température aussi proche que possible de 22°C. manual de funcionamento do seu sistema de análise ao sangue epoc®. 2. Subito prima dell'uso, agitare energicamente la fiala per almeno quindici secondi. Agitare la fiala 수 있습니다. Testsammendrag 4. Eurotrol epoc® Calibration Verification Fluids est extrêmement sensible à la contamination de l’air 7. Após a utilização, elimine a ampola e o fluido restante. tenendola tra il pollice e l'indice. Eurotrol epoc® Calibration Verification Fluids gir bestemte verdier for pH, pO2, pCO2, Na+, K+, Ca2+, Os materiais de controlo de qualidade devem ser utilizados segundo a regulamentação ou os requisitos 3. Far ruotare la fiala delicatamente in modo da depositare di nuovo la soluzione sul fondo del 절차 Mg2+, Cl-, glukose, laktat, urea, kreatinin og tCO2 på epoc® blodanalysesystemet, og ved å ambiant. Lorsque le prélèvement du liquide a lieu dans les 30 secondes, l’erreur est inférieure à 2% sur l’ensemble de la plage de valeurs pour tous les niveaux. L’effet de l’air ambiant sur le pH est de acreditação locais, estaduais e/ou federais. contenitore. Prima di aprire la fiala, lasciare affiorare tutte le bolle. 1. 냉장고에서 박스를 꺼내 박스 및 트레이에서 적절한 수의 앰플을 꺼내십시오. 사용 전에 앰플을 sammenlikne de tildelte verdiene til produktet med de oppnådde verdiene kan det verifiseres at négligeable. Limitações 4. Proteggere le dita con una garza, una salvietta o con guanti. analysatoren fungerer som den skal. 1. Os valores atribuídos aplicam-se apenas ao número de lote do fluido atribuído, à configuração do 5. Tenere la fiala con il punto colorato rivolto verso l'alto. Spezzare il collo della fiala nella direzione 실온(22°C)에 놔두십시오. Innhold 5. Les contrôles Eurotrol Calibration Verification Fluids ne contiennent pas de protéines et ne sont dès lors pas à même de détecter les dysfonctionnements sensibles à ces composants. sensor do sistema de análise ao sangue epoc® e à altitude em relação ao nível do mar aplicáveis. opposta a quella del punto colorato . 2. 사용 직전에 15초 이상 앰플을 흔드십시오. 흔들 때 앰플을 엄지와 검지로 잡아야 합니다. Eurotrol epoc® Calibration Verification Fluids inneholder én ampulle med fem fysiologiske relevante 2. A amostragem ou conservação incorretas ou outro erro de manuseamento pode provocar desvios 6. Eseguire la procedura di campionamento entro 30 secondi seguendo le istruzioni riportate nel nivåer, og hver ampulle inneholder 2,5 ml løsning. Eurotrol epoc® Calibration Verification Fluids nas leituras em relação aos valores-alvo. manuale operativo de sistema di analisi ematica epoc®. CE mark Marquage CE Manufacturer Fabricant Date of manufacturer Date de fabrication Use-by-date Date de péremption Batch code Numéro de lot Catalogue number Référence catalogue Temperature limit Limites de température Caution Attention Do not re-use Ne pas réutiliser In vitro diagnostic medical device Dispositif médical de diagnostic in vitro Control Contrôle CE-Kennzeichnung Marca CE Hersteller Fabricante Herstellungsdatum Data de fabrico Verwendbar bis Prazo de validade Chargenbezeichnung Código de lote Bestellnummer Número de catálogo Temperaturbegrenzungen Limite de temperatura Vorsicht Atenção Nicht zur Wiederverwendung Não reutilizar In-vitro-Diagnostika Dispositivo médico de diagnóstico In Vitro Kontrolle Controlo Marca CE Marchio CE Fabricante Fabbricante Fecha de fabricación Data di fabbricazione Fecha de caducidad Data di scadenza Código de lote Codice del lotto Número de catálogo Numero di catalogo Límite de temperatura Limite di temperatura Precaución Attenzione No reutilizar Non riutilizzare Dispositivo médico de diagnóstico in vitro Dispositivo medico diagnostico in vitro Control Controllo CE 符號 CE 마크 製造商 제조업체 製造日期 제조 일자 使用截止日期 유효일 批次代碼 배치 코드 目錄編號 카탈로그 번호 溫度限制 온도 제한 注意 주의 請勿重複使用 재사용 금지 體外診斷醫療裝置 체외 진단용 의료 장비 對照品 컨트롤 CEマーク CE-merke 製造者 Produsent 製造日 Produksjonsdato 使用期限 Brukes innen-dato バッチコード Batch-kode カタログ番号 Katalognummer 温度制限 Temperaturgrense 注意 Forsiktig 再使用不可 Må ikke gjenbrukes 体外診断用医療機器 Medisinsk utstyr til in vitro-diagnostikk コントロール Kontroll CE-merkki Valmistaja Valmistuspäivä Viimeinen käyttöpäivämäärä Eränumero Tuotenumero Lämpötilaraja Varoitus Ei saa käyttää uudelleen In vitro -diagnostiikkaan tarkoitettu lääkinnällinen laite Kontrolli Page 1 of 2 AN01571A01 20181012 Avsedd användning Revisie geschiedenis Istoricul revizuirilor Eeldatavad tulemused 4. Eurotrol epoc® Calibration Verification Fluids er meget følsomme over for kontaminering af rumluften. Eurotrol epoc® Calibration Verification Fluids är ett analyserat referensmaterial för Revisie Ingangsdatum Verandering ten opzichte van vorige versie Revizuire Data intrării în Modificare față de revizuirea anterioară Väärtused on saadud epoc® vereanalüüsisüsteemi näitudest, kasutades BGEMi analüüsikaarte. Når der tages prøver fra væsken inden for 30 sekunder, er fejlraten under 2 % over hele intervallet på 质控品不含蛋白质，因此可能无法检测对这些成分敏感的故障。 engångsbruk för blodgaser, elektrolyter och metaboliter för kvalitativ verifiering av vigoare Määratud väärtuste teave on kättesaadav veebiaadressil http://www.siemens.com/epoc, kus tabelisse on alle niveauer. Rumluftens indvirkning på pH-værdien er ubetydelig. 预期结果 01 14-09-2017 Eerste revisie precisionen och noggrannheten hos blodanalyssystemet epoc®. Produkten används för in vitro- 01 14-09-2017 Prima revizuire kantud iga vedeliku partii number ja sensori konfiguratsioon. 5. Kontroller til Eurotrol epoc® Calibration Verification Fluids indeholder ikke protein og vil derfor muligvis 通过使用 G M 测试卡在 血液分析系统上进行测定以获得结果值。可访问 diagnostik och är avsedd för professionell laboratoriepersonal. Eurotrol epoc® Calibration Verification 02 01-02-2018 Adres en symbolen glossarium aangepast. Lisateabe ja/või abi saamiseks võtke palun ühendust: ikke kunne påvise defekter, som er følsomme over for disse komponenter. 02 01-02-2018 Actualizarea adresei și a glosarului de simboluri m m 获取赋值，此处用表列出了每个液体批号和传感器配置的赋值。 Fluids är avsedd för testning av följande analyter: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukos, 03 12-10-2018 Toevoeging van nieuwe vertalingen, nieuwe layout. Figuren zijn verwijderd. Tootja Edasimüüja Forventede resultater laktat, urea, kreatinin och tCO2. 03 12-10-2018 Adăugarea unor noi traduceri, o nouă aranjare în pagină a IU. Eurotrol B.V., Eurotrol Inc., Værdierne opnås med målinger på epoc® blodanalysesystemet med anvendelse af BGEM analysekort. 如需更多信息和 或帮助，请联系： Alle handelsmerken zijn eigendom van hun respectievelijke eigenaars.© 2018, Eurotrol B.V. Sammanfattning av testet Eliminarea figurilor. Keplerlaan 20, 6716 BS Ede, Holland 850 N Black Branch Rd, Elizabethtown, KY De tildelte værdier fås på http://www.siemens.com/epoc i form af tabeller for hvert væskelotnummer og 制造商 分销商 Kullanım Amacı Eurotrol epoc® Calibration Verification Fluids ger specifika värden för pH, pO2, pCO2, Na+, K+, Ca2+, Toate mărcile comerciale constituie proprietatea titularilor respectivi. © 2018, Eurotrol B.V. Telefon: +31 318 695 777 42701, USA sensorkonfiguration. Eurotrol epoc® Calibration Verification Fluids, epoc® Kan Analiz Sisteminin hassasiyet ve Mg2+, Cl-, glukos, laktat, urea, kreatinin och tCO2 på epoc® blodanalyssystemet. Genom att jämföra E-post: office@eurotrol.com Telefon: +1 (502) 501-1180 Ønskes mere information og/eller hjælp, kontakt da: 荷兰 doğruluğunun kalitatif olarak doğrulanması için tek kullanımlık bir tahlil edilen kan gazı, Χρήση για την οποία προορίζεται produktens nominella värden med de erhållna värdena kan man verifiera att analysatorn fungerar. Το Eurotrol epoc® Calibration Verification Fluids είναι ένα αναλυόμενο υλικό αναφοράς www.eurotrol.com E-post: officeUSA@eurotrol.com Producent Forhandler 电话号码 美国 elektrolit ve metabolit referans materyalidir. Ürün, profesyonel laboratuvar personeli tarafından Innehåll αερίων αίματος, ηλεκτρολυτών και μεταβολιτών, μίας χρήσης, για την ποιοτική επιβεβαίωση Igast seadmega seotud tõsisest juhtumist tuleb teatada tootjale ja selle liikmesriigi pädevale asutusele, Eurotrol B.V., Eurotrol Inc., kullanılması amaçlanılmış bir in vitro diagnostik cihazdır. Eurotrol epoc® Calibration Verification Fluids 电子邮件 @ m 电话号码 Eurotrol epoc® Calibration Verification Fluids ger fem fysiologiskt relevanta nivåer och levereras i en kus on kasutaja ja/või patsiendi elukoht. Keplerlaan 20, 6716 BS Ede, Holland 850 N Black Branch Rd, Elizabethtown, KY ürünü şu analitleri test etmek üzere tasarlanmıştır: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukoz, της πιστότητας και της ορθότητας του συστήματος ανάλυσης αίματος epoc®. Το προϊόν είναι ένα in vitro m 电子邮件 @ m ampull om 2,5 ml lösning. Eurotrol epoc® Calibration Verification Fluids framställs från kemikalier i en διαγνωστικό προϊόν, που προορίζεται για επαγγελματικό εργαστηριακό προσωπικό. Το Eurotrol epoc® Paranduste ajalugu Telefon: +31 318 695 777 42701, USA laktat, üre, kreatinin ve tCO2. 任何与设备有关的严重事故均应向制造商以及用户和 或患者所在成员国的主管部门报告。 fysiologiskt buffrad matrix. Tonometri med i förväg fastställda nivåer av syrgas och koldioxid balanserade Calibration Verification Fluids έχει σχεδιαστεί για την εξέταση των παρακάτω αναλυόμενων ουσιών: pH, Parandus Jõustumiskuupäev Eelmise paranduse muudatus Email: office@eurotrol.com Telefon: +1 (502) 501-1180 Test Özeti 修订历史 med kväve och olika saltkoncentrationer ger fem distinkta nivåer. Eurotrol epoc® Calibration Verification www.eurotrol.com E-mail: officeUSA@eurotrol.com Eurotrol epoc® Calibration Verification Fluids, epoc® Kan Analizi Sisteminde pH, pO2, pCO2, Na+, K+, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, γλυκόζη, γαλακτικό, ουρία, κρεατινίνη και tCO2. 01 14.09.2017 Esimene parandus Fluids innehåller inga konserveringsmedel, viskositetsreglerande medel eller andra tillsatser som skulle Σύνοψη της εξέτασης Enhver alvorlig hændelse, der er opstået i forbindelse med anvendelse af instrumentet, skal indberettes 修订版本 生效日期 相对先前版本的更改 Ca2+, Mg2+, Cl-, glukoz, laktat, üre, kreatinin ve tCO2 için spesifik değerler sağlar ve ürünün tahsis 02 01.02.2018 Uuendatud aadress ja sümbolite seletus kunna påverka elektrodmätningarna på ett negativt sätt. Το Eurotrol epoc® Calibration Verification Fluids παρέχει ειδικές τιμές για τα pH, pO2, pCO2, Na+, K+, til producenten og den relevante myndighed i det medlemsland, hvor brugeren og/eller patienten er 第一次修订 edilmiş değerleri ile elde edilen değerler karşılaştırılarak analizörün uygun çalışması doğrulanabilir. Varningar och försiktighet 03 12.10.2018 Uute tõlgete lisamine, kasutusjuhendi uus kujundus. Jooniste bosat. İçindekiler Ca2+, Mg2+, Cl-, τη γλυκόζη, το γαλακτικό οξύ, την ουρία, την κρεατινίνη και το tCO2 στο σύστημα 更新地址和符号说明 1. Endast för in vitro-diagnostiskt bruk. ανάλυσης αίματος epoc® και με τη σύγκριση των εκχωρημένων τιμών του προϊόντος με τις τιμές που eemaldamine. Ændringsoversigt Eurotrol epoc® Calibration Verification Fluids her ampulde 2,5 ml solüsyon olacak şekilde fizyolojik olarak 2. Ampullerna är endast för engångsbruk. λαμβάνονται μπορεί να επικυρωθεί η σωστή λειτουργία του αναλυτή. Kõik kaubamärgid on nende vastavate omanike omand. © 2018, Eurotrol B.V. Ændring Ikrafttrædelsesdato Ændring i foregående ændring 增加新翻译、新 布局。删除图表。 ilgili beş seviye için birer ampul sağlar. Eurotrol epoc® Calibration Verification Fluids fizyolojik 3. Dessa produkter får ej läggas bland vanligt avfall. Kontakta lokala miljömyndigheter för anvisningar 所有商标均为其各自所有者的财产。 tamponlanmış bir matrikste kimyasallar kullanılarak hazırlanır. Farklı tuz konsantrasyonları ve nitrojenle Περιεχόμενο Przeznaczenie 01 14-09-2017 Første ændring om korrekt avfallshantering. Το Eurotrol epoc® Calibration Verification Fluids περιέχει μία αμπούλα με πέντε φυσιολογικά σχετικά dengelenmiş karbondioksit ve oksijenin önceden belirlenmiş seviyeleriyle tonometri, beş farklı seviye Eurotrol epoc® Calibration Verification Fluids to jednorazowy materiał referencyjny 02 01-02-2018 Opdateret adresse og liste over symboler 4. Eurotrol epoc® Calibration Verification Fluids får ej användas som kalibrator. επίπεδα, με κάθε αμπούλα να περιέχει 2,5 ml διαλύματος. Το Eurotrol epoc® Calibration Verification sağlamıştır. Eurotrol epoc® Calibration Verification Fluids, elektrot ölçümlerini olumsuz etkileyebilecek zawierający oznaczone gazy, elektrolity i metabolity krwi, który służy do ilościowej Lagring 03 12-10-2018 Tilføjelse af nye oversættelser, nyt layout til brugsanvisning. Fjernelse af herhangi bir koruyucu madde, viskozite ayarlayıcı veya diğer katkı maddesi içermez. Fluids παρασκευάζεται με χρήση χημικών ουσιών σε μήτρα ρυθμιστικού διαλύματος φυσιολογικού ορού. weryfikacji precyzji i dokładności systemu analizy krwi epoc®. Jest to wyrób do diagnostyki In vitro Eurotrol epoc® Calibration Verification Fluids kan användas fram till det utgångsdatum som anges på Η τονομετρία με προκαθορισμένα επίπεδα οξυγόνου και διοξειδίου του άνθρακα, εξισορροπημένα με figurer. Uyarılar ve önlemler przeznaczony dla profesjonalnego personelu laboratoryjnego. Eurotrol epoc® Calibration Verification ф ampullernas och ytterkartongens etiketter, om den förvaras oöppnad vid 2–8 °C. Eurotrol epoc® άζωτο και διαφορετικές συγκεντρώσεις αλάτων παρέχει πέντε διακριτά επίπεδα. Το Eurotrol epoc® Alle varemærker tilhører deres respektive ejere. © 2018, Eurotrol B.V. 1. Sadece in vitro diagnostik kullanım içindir. Fluids jest przeznaczony do wykonywania testów pod kątem następujących analitów: pH, pO2, pCO2, ф Calibration Verification Fluids är stabil i en vecka när den förvaras oöppnad vid rumstemperatur. 2. Her ampul sadece tek kullanımlıktır. Calibration Verification Fluids δεν περιέχει συντηρητικά, ρυθμιστές ιξώδους ή άλλα πρόσθετα που μπορεί Na+, K+, Ca2+, Mg2+, Cl-, glukozy, mleczanu, mocznika, kreatyniny i tCO2. Penggunaan yang Dimaksudkan Produkten får inte kylas på nytt efter att den har antagit rumstemperatur. να επηρεάζουν αρνητικά τις μετρήσεις των ηλεκτροδίων. 3. Bu ürünler genel atıkla atılmamalıdır. Uygun şekilde atmak için yerel çevre makamlarıyla irtibat kurun. Opis testu Eurotrol epoc® Calibration Verification Fluids adalah bahan rujukan elektrolit dan metabolit щ O O M Tecken på försämring Προειδοποιήσεις και προφυλάξεις 4. Eurotrol epoc® Calibration Verification Fluids bir kalibratör olarak kullanılmamalıdır. Produkt Eurotrol epoc® Calibration Verification Fluids zapewnia konkretne wartości dotyczące gas darah teruji, sekali pakai untuk verifikasi kualitatif terhadap ketepatan dan akurasi O Eurotrol epoc® Calibration Verification Fluids ska vara en klar, färglös vätska i en sluten, oskadad ampull. Saklama 1. Αποκλειστικά για in vitro διαγνωστική χρήση. następujących analitów: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukozy, mleczanu, mocznika, Sistem Analisis Darah epoc® Produk ini adalah perangkat diagnostik in vitro yang dimaksudkan untuk När ampullen har öppnats är produkten stabil i 30 sekunder. Därefter kan de erhållna värdena skilja sig 2. Κάθε αμπούλα προορίζεται για μία μόνο χρήση. Eurotrol epoc® Calibration Verification Fluids eğer 2-8 °C sıcaklıkta açılmadan saklanırsa ampuller ve kreatyniny i tCO2 w systemie analizy krwi epoc®, a porównanie wartości przypisanych dla produktu z digunakan oleh personel profesional laboratorium. Eurotrol epoc® Calibration Verification Fluids didesain från de nominella värdena. 3. Αυτά τα προϊόντα δεν θα πρέπει να απορρίπτονται στα γενικά απόβλητα. Συμβουλευτείτε τις τοπικές dış kutudaki etiketlerde belirtildiği şekilde son kullanma tarihine kadar kullanılabilir. Eurotrol epoc® uzyskanymi umożliwia sprawdzenie poprawności działania analizatora. untuk menguji analit-analit berikut: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukosa, laktat, urea, O O M O Förfarande Calibration Verification Fluids oda sıcaklığında açılmadan saklandığında 1 hafta boyunca stabildir. Oda περιβαλλοντικές αρχές σχετικά με τη σωστή απόρριψη. Zawartość kreatinin dan tCO2. 1. Ta ut kartongen ur kylskåpet och ta ur lämpligt antal ampuller från kartongen och brickan. Låt 4. Το Eurotrol epoc® Calibration Verification Fluids δεν προορίζεται για χρήση ως βαθμονομητής. sıcaklığına getirilen ürünü buzdolabına koymayın. Każda ampułka produktu Eurotrol epoc® Calibration Verification Fluids zawiera pięć poziomów istotnych Rangkuman Pengujian щ ф ampullerna anta rumstemperatur (22 °C) före användning. Φύλαξη Bozulma Göstergeleri fizjologicznie w 2,5 ml roztworu. Produkt Eurotrol epoc® Calibration Verification Fluids został Eurotrol epoc® Calibration Verification Fluids memberikan nilai-nilai spesifik untuk pH, pO2, pCO2, Na+, 2. Skaka ampullen kraftigt omedelbart före användning i minst 15 sekunder. Håll ampullen mellan Το Eurotrol epoc® Calibration Verification Fluids μπορεί να χρησιμοποιηθεί μέχρι την ημερομηνία λήξης Eurotrol epoc® Calibration Verification Fluids kapalı ve hasar görmemiş bir ampul içinde saydam ve przygotowywany z użyciem soli w macierzy buforowanej fizjologicznie. Tonometria z użyciem wstępnie K+, Ca2+, Mg2+, Cl-, glukosa, laktat, urea, kreatinin dan tCO2 pada Sistem Analisis Darah epoc®, dan tummen och pekfingret när du skakar den. О ф renksiz bir sıvı halinde olmalıdır. Ampulü açtıktan sonra ürün 30 saniye boyunca stabildir ve bundan που υποδεικνύεται στις ετικέτες των αμπουλών και στο εξωτερικό κουτί, εάν φυλαχθεί κλειστό σε ustalonych poziomów tlenu i dwutlenku węgla zrównoważonych azotem i różnymi stężeniami soli dengan membandingkan nilai-nilai produk yang ditentukan dengan nilai-nilai yang didapatkan, 3. Snurra ampullen försiktigt så att all lösning sjunker till ampullens botten. Låt eventuella bubblor stiga θερμοκρασία 2-8 °C. Το Eurotrol epoc® Calibration Verification Fluids παραμένει σταθερό για 1 sonra elde edilen değerler tahsis edilen değerlerden sapma gösterebilir. zapewnia pięć odrębnych poziomów. Produkt Eurotrol epoc® Calibration Verification Fluids nie zawiera fungsionalitas y alat analisis dapat diverifikasikan. щ upp innan du öppnar ampullen. εβδομάδα, όταν φυλάσσεται κλειστό σε θερμοκρασία δωματίου. Μην ψύχετε το προϊόν αφού το έχετε İşlem żadnych konserwantów, regulatorów lepkości ani innych dodatków, które mogłyby niekorzystnie wpływać Isi 4. Skydda fingrarna med gasväv, pappershandduk eller handskar. ф ф 1. Kutuyu buzdolabından çıkarın ve kutu ve tepsiden uygun sayıda ampulü alın. Ampulleri kullanım θερμάνει σε θερμοκρασία δωματίου. na pomiary wykonywane za pomocą elektrod. Eurotrol epoc® Calibration Verification Fluids berisisatu ampul dengan lima tingkatan fisiologis yang 5. Håll ampullen med den färgade pricken uppåt. Bryt av halsen på ampullen i motsatt riktning mot den Ενδείξεις αλλοίωσης öncesinde oda sıcaklığına (22 °C) getirin. Ostrzeżenia i środki ostrożności relevan, masing-masing ampul berisi cairan 2,5 mL. Eurotrol epoc® Calibration Verification Fluids färgade pricken. Το Eurotrol epoc® Calibration Verification Fluids θα πρέπει να είναι διαυγές, άχρωμο υγρό σε κλειστή 2. Kullanımdan hemen önce ampulü en az on beş saniye iyice sallayın. Sallarken ampul baş parmak ile 1. Do stosowania wyłącznie w diagnostyce in vitro. dipersiapkan dengan menggunakan senyawa-senyawa kimia dalam matriks yang disangga secara 6. Följ inom 30 sekunder provtagningsanvisningarna i bruksanvisningen för blodanalyssystemet epoc®. αμπούλα που δεν έχει υποστεί ζημιά. Μετά το άνοιγμα της αμπούλας, το προϊόν παραμένει σταθερό για işaret parmağı arasında tutulmalıdır. 2. Każda ampułka jest przeznaczona do jednorazowego użytku. fisiologis. Tonometrik dengan tingkat yang sudah terlebih dahulu ditentukan untuk oksigen dan karbon 7. Kassera ampullen och återstående vätska efter användning. 30 δευτερόλεπτα, μετά από τα οποία οι λαμβανόμενες τιμές μπορεί να παρεκκλίνουν από τις 3. Solüsyonu tekrar ampulün alt kısmına getirmek için ampulü yavaşça çevirin. Ampulü açmadan önce 3. Opisywane produkty nie powinny być wyrzucane razem z odpadami o charakterze ogólnym. W celu dioksida yang disetimbangkan dengan nitrogen dan konsentrasi garam yang berbeda-beda memberikan ы Kontrollösning ska användas i enlighet med lokala, regionala och/eller statliga förordningar eller εκχωρημένες τιμές. herhangi bir kabarcığın yükselmesini bekleyin. prawidłowej utylizacji tych produktów należy skontaktować się z lokalnymi władzami zajmującymi się lima tingkat berbeda. Eurotrol epoc® Calibration Verification Fluids tidak mengandung zat pengawet, godkännandekrav. Διαδικασία 4. Parmakları gazlı bez, mendil veya eldivenle koruyun. ochroną środowiska naturalnego. penyesuai viskositas atau zat-zat aditif lainnya yang mungkin dapat mengganggu pengukuran elektroda. Begränsningar 1. Βγάλτε το κουτί από το ψυγείο και αφαιρέστε τον κατάλληλο αριθμό αμπουλών από το κουτί και τον 5. Ampulü renkli nokta yukarı bakacak şekilde tutun. Ampulün boyun kısmını renkli noktanın karşı 4. Produkt Eurotrol epoc® Calibration Verification Fluids nie jest przeznaczony do użytku jako kalibrator. Peringatan dan Perhatian 1. De nominella värdena gäller endast för den angivna produktbatchen, tillämplig sensorkonfiguration för δίσκο. Φέρτε τις αμπούλες σε θερμοκρασία δωματίου (22 °C) πριν από τη χρήση. yönüne doğru iterek kırın. Przechowywanie 1. Hanya untuk diagnostik in vitro. blodanalyssystemet epoc® och på en höjd av noll meter över havet. щ 6. 30 saniye içinde epoc® Kan Analizi Sisteminizin çalıştırma kılavuzundaki talimata göre örnek alma 2. Αμέσως πριν από τη χρήση, ανακινήστε την αμπούλα έντονα για τουλάχιστον δεκαπέντε Produkt Eurotrol epoc® Calibration Verification Fluids może być używany do daty ważności wskazanej na 2. Setiap ampul hanya untuk sekali pakai. 2. Felaktig provtagning, förvaring eller annan felaktig hantering kan göra att de avlästa resultaten avviker δευτερόλεπτα. Κατά την ανακίνηση, η αμπούλα θα πρέπει να συγκρατείται ανάμεσα στον αντίχειρα işlemini izleyin. etykietach ampułek i opakowania zewnętrznego, jeśli będzie przechowywany nieotwarty w temperaturze 3. Produk ini tidak boleh dibuang di tempat pembuangan sampah umum. Bicarakan terlebih dahulu från målvärdena. και τον δείκτη. 7. Kullanımdan sonra ampul ve kalan sıvıyı atın. 2–8°C. Produkt Eurotrol epoc® Calibration Verification Fluids jest stabilny przez 1 tydzień, gdy jest dengan para otoritas lingkungan hidup setempat mengenai pembuangan yang semestinya. 3. pO2-värdena för Eurotrol epoc® Calibration Verification Fluids varierar omvänt mot temperaturen. För Kalite kontrol materyalleri yerel, bölgesel ve/veya ulusal düzenlemeler veya akreditasyon gerekliliklerine 3. Περιδινήστε με ήπιες κινήσεις την αμπούλα για να επιστρέψει το διάλυμα στον πυθμένα της przechowywany nieotwarty w temperaturze pokojowej. Jeśli produkt został doprowadzony do 4. Eurotrol epoc® Calibration Verification Fluids bukan untuk digunakan sebagai kalibrator. att få bästa möjliga korrelation med värdena i tabellen skall ampullerna få anta en temperatur så nära αμπούλας. Αφήστε τυχόν φυσαλίδες να ανέλθουν προς την επιφάνεια πριν από το άνοιγμα της göre kullanılmalıdır. temperatury pokojowej, nie należy go zamrażać. Penyimpanan ш 22 °C som möjligt. αμπούλας. Sınırlamalar Oznaki pogorszenia właściwości Eurotrol epoc® Calibration Verification Fluids dapat digunakan hingga tanggal kedaluwarsatenggat yang 4. Eurotrol epoc® Calibration Verification Fluids är mycket känsligt för kontaminering med rumsluft. Vid 1. Tahsis edilen değerler sadece tahsis edilen sıvı lotu numarası, ilgili epoc® Kan Analizi Sistemi sensör 4. Προστατεύστε τα δάκτυλα με γάζα, μαντηλάκι ή γάντια. Produkt Eurotrol epoc® Calibration Verification Fluids powinien być przejrzystą, bezbarwną cieczą w tercantum pada label ampul dan kotak luar jika disimpan dalam keadaan tertutup pada suhu 2-8°C . provtagning från vätskan inom 30 sekunder är felet mindre än 2 % över hela området på alla nivåer. 5. Κρατήστε την αμπούλα με τη χρωματιστή κουκκίδα στραμμένη προς τα επάνω. Αποσπάστε τον konfigürasyonu ve deniz seviyesi rakım için geçerlidir. zamkniętej, nieuszkodzonej ampułce. Po otwarciu ampułki produkt jest stabilny przez 30 sekund, po Eurotrol epoc® Calibration Verification Fluids tetap stabil selama 1 minggu ketika disimpan dalam щ Effekten av rumsluft på pH-värdet är försumbar. αυχένα της αμπούλας προς την αντίθετη κατεύθυνση από τη χρωματιστή κουκκίδα. 2. Hatalı örnek alma, saklama veya diğer yanlış kullanım, ölçümlerin hedef değerlerden sapmasına czym uzyskane wartości mogą odbiegać od wartości przypisanych. keadaan tertutup pada suhu ruang Jangan masukkan produk ke dalam lemari pendingin setelahterpapar 5. Eurotrol epoc® Calibration Verification Fluids-kontrollerna innehåller inga proteiner och påvisar därför neden olabilir. 6. Εντός 30 δευτερολέπτων, ακολουθήστε τη διαδικασία δειγματοληψίας σύμφωνα με τις οδηγίες του Procedura suhu ruang. eventuellt inte felfunktioner som är känsliga för dessa komponenter. εγχειριδίου λειτουργίας του συστήματος ανάλυσης αίματος epoc®. 3. Eurotrol epoc® Calibration Verification Fluids pO2 değerleri sıcaklık değişiklikleriyle ters orantılı olarak 1. Wyjąć pudełko z lodówki i wyjąć odpowiednią liczbę ampułek z pudełka i tacy. Przed użyciem należy Indikasi-Indikasi Kerusakan Förväntade resultat 7. Μετά τη χρήση, απορρίψτε την αμπούλα και το υπόλοιπο υγρό. değişir. Tablodaki değerlerle yüksek bir korelasyon derecesi elde etmek için ampuller 22 °C (sıcaklığa doprowadzić ampułki do temperatury pokojowej (22°C). Eurotrol epoc® Calibration Verification Fluids harus merupakan cairan bening tidak berwarna dalam Resultaten erhålls genom mätningar i epoc® Blood Analysis System med användning av BGEM-testkort. mümkün olduğunca yakın şekilde dengelenmelidir. Τα υλικά ποιοτικού ελέγχου θα πρέπει να χρησιμοποιούνται σύμφωνα με τους τοπικούς, πολιτειακούς 2. Bezpośrednio przed użyciem należy energicznie potrząsać ampułką przez co najmniej 15 sekund. ampul yang tertutup dan tidak rusak. Setelah membuka ampul, produk tetap stabil selama 30 detik, De nominella värdena återfinns på http://www.siemens.com/epoc, tabellerade för varje enskild batch av ή/και ομοσπονδιακούς κανονισμούς ή τις απαιτήσεις πιστοποίησης. 4. Eurotrol epoc® Calibration Verification Fluids oda havası kontaminasyonuna çok duyarlıdır. 30 saniye Podczas potrząsania ampułkę należy trzymać kciukiem i palcem wskazującym. sesudah itu nilai yang diperoleh dapat menyimpang dari nilai-nilai yang ditentukan. produkten och varje sensorkonfiguration. Περιορισμοί içinde sıvıdan örnek alındığında tüm seviyelerde tüm aralık boyunca hata %2'nin altındadır. Oda 3. Delikatnie zamieszać zawartość ampułki, aby sprowadzić roztwór na jej dno. Przed otwarciem Prosedur För mer information eller hjälp kontaktas: havasının pH üzerine etkisi dikkate alınmayabilecek kadar küçüktür. 1. Οι εκχωρημένες τιμές εφαρμόζονται μόνο για τον εκχωρημένο αριθμό παρτίδας του υγρού, την probówki należy poczekać, aż ewentualne pęcherzyki gazu uniosą się na powierzchnię. 1. Keluarkan kotak dari lemari pendingin dan ambil jumlah ampul yang diperlukan dari kotak dan baki. Tillverkare Distributör υφιστάμενη διαμόρφωση του αισθητήρα του συστήματος ανάλυσης αίματος epoc® και το υψόμετρο 5. Eurotrol epoc® Calibration Verification Fluids kontrolleri protein içermez ve bu nedenle bu bileşenlere 4. W celu ochrony palców użyć gazy, chusteczek lub rękawiczek. Biarkan ampul hingga mencapai suhu ruang (22 °C,) sebelum digunakan. Eurotrol B.V., Eurotrol Inc., από τη στάθμη της θάλασσας. hassas bozuklukları saptamayabilir. 5. Przytrzymywać ampułkę w taki sposób, aby kolorowa kropka była skierowana w górę. Odłamać szyjkę 2. Sesaat sebelum digunakan, kocok ampul dengan kencang minimal paling sedikit lima belas detik. Keplerlaan 20, 6716 BS Ede, Nederländerna 850 N Black Branch Rd, Elizabethtown, KY ш ш Beklenen Sonuçlar 2. Η εσφαλμένη δειγματοληψία, φύλαξη ή άλλος εσφαλμένος χειρισμός μπορεί να προκαλέσουν ampułki w kierunku przeciwnym do strony, po której znajduje się kolorowa kropka. Ketika mengocok, ampul harus dipegang dengan menggunakan ibu jari dan jari telunjuk. Telefon: +31 (318) 695 777 42701, USA απόκλιση των μετρήσεων από τις τιμές-στόχο. Değerler BGEM test kartları kullanılarak epoc® Kan Analizi Sisteminde ölçümlerle elde edilir. Tahsis 6. W ciągu 30 sekund wykonać procedurę pobierania próbek zgodnie z instrukcją z podręcznika obsługi 3. Putar ampul dengan lembut unt m m m m О щ E-post: office@eurotrol.com Telefon:+1 (502) 501-1180 3. Οι τιμές pO2 του Eurotrol epoc® Calibration Verification Fluids κυμαίνονται αντίστροφα από τις edilen değerler her sıvı lot numarası ve sensör konfigürasyonu için tablolar halinde systemu analizy krwi epoc®. m m m www.eurotrol.com E-post: officeUSA@eurotrol.com http://www.siemens.com/epoc adresinden elde edilebilir. αλλαγές της θερμοκρασίας. Για την επίτευξη υψηλού βαθμού συσχέτισης με τις τιμές του πίνακα, οι 7. Po użyciu zutylizować ampułkę i resztki płynu. Eventuell allvarlig incident som uppkommer med produkten ska rapporteras till tillverkaren och behörig О щ щ Daha fazla bilgi ve/veya yardım için lütfen irtibat kurun: αμπούλες θα πρέπει να εξισορροπούνται όσο το δυνατόν πλησιέστερα στους 22 °C. Materiały do kontroli jakości powinny być stosowane zgodnie z lokalnymi, regionalnymi i/lub krajowymi m m m tillsynsmyndighet i det land där användaren och/eller patienten befinner sig. ш Üretici Distribütör 4. Το Eurotrol epoc® Calibration Verification Fluids είναι πολύ ευαίσθητο σε μόλυνση του αέρα του przepisami oraz wymogami akredytacyjnymi. Revideringshistorik Eurotrol B.V., Eurotrol Inc., δωματίου. Κατά τη δειγματοληψία του υγρού εντός 30 δευτερολέπτων, το σφάλμα είναι χαμηλότερο Ograniczenia m m m Revidering Giltighetsdatum Ändring av tidigare revidering από 2% στο πλήρες εύρος σε όλα τα επίπεδα. Η επίδραση του αέρα του δωματίου στο pH είναι Keplerlaan 20, 6716 BS Ede, Hollanda 850 N Black Branch Rd, Elizabethtown, KY 1. Przypisane wartości obowiązują wyłącznie w przypadku przypisanego numeru serii płynu, ш 01 2017-09-14 Första revideringen Telefon numarası: +31 318 695 777 42701, Amerika Birleşik Devletleri αμελητέα. odpowiedniej konfiguracji czujnika systemu analizy krwi epoc® i na wysokości poziomu morza. m ш 02 2018-02-01 Uppdaterad adress och symbolförteckning E-posta: office@eurotrol.com Telefon numarası:+1 (502) 501-1180 5. Οι μάρτυρες Eurotrol epoc® Calibration Verification Fluids δεν περιέχουν πρωτεΐνη και συνεπώς 2. Nieprawidłowe pobieranie próbek, przechowywanie lub inne nieprawidłowości związane z obróbką m М www.eurotrol.com E-posta: officeUSA@eurotrol.com ενδέχεται να μην μπορέσουν να εντοπίσουν δυσλειτουργίες που είναι ευαίσθητες σε αυτά τα mogą spowodować, że odczyty będą się różnić od wartości docelowych. 03 2018-10-12 Tillägg av ny översättning, ny layout på bruksanvisningen Borttagning ф Cihazla ilgili olarak oluşan herhangi bir ciddi olay üreticiye ve kullanıcı ve/veya hastanın yaşadığı Üye συστατικά μέρη. 3. Wartości pO2 uzyskiwane przy użyciu produktu Eurotrol epoc® Calibration Verification Fluids av siffror. О Devlet yetkili makamına bildirilmelidir. Αναμενόμενα αποτελέσματα zmieniają się odwrotnie proporcjonalnie do zmian temperatury. W celu uzyskania wysokiego stopnia m Alla varumärken tillhör respektive ägare. © 2018, Eurotrol B.V. Revizyon geçmişi Οι τιμές λαμβάνονται από μετρήσεις με το σύστημα ανάλυσης αίματος epoc®, με τη χρήση καρτών korelacji z wartościami w tabeli ampułki należy doprowadzić do temperatury w miarę możliwości jak m m щ Toepassing Revizyon Yürürlüğe girme tarihi Önceki revizyonda değişiklik εξέτασης BGEM. Οι εκχωρημένες τιμές είναι διαθέσιμες από την ιστοσελίδα najbardziej zbliżonej do 22°C. m m m Eurotrol epoc® Calibration Verification Fluids is een getoetst bloedgas, electroliet en http://www.siemens.com/epoc και παρατίθενται σε πίνακα για κάθε αριθμό παρτίδας υγρού και 4. Produkt Eurotrol epoc® Calibration Verification Fluids jest bardzo wrażliwy na zanieczyszczenia m m m 01 14-09-2017 İlk revizyon ш metaboliet refererentie materiaal, dat eenmalig gebruikt kan worden voor de kwalitatieve διαμόρφωση αισθητήρα. powietrza w pomieszczeniu. Jeśli próbki płynu zostaną pobrane w ciągu 30 sekund, błąd będzie O verificatie van de precisie en nauwkeurigheid van het epoc® Blood Analysis system. Het product is een 02 01-02-2018 Güncellenmiş adres ve semboller sözlüğü Για περαιτέρω πληροφορίες ή/και βοήθεια, επικοινωνήστε με: mniejszy niż 2% w całym zakresie wszystkich poziomów. Wpływ powietrza w pomieszczeniu na pH m m m O in-vitro diagnostische test, bestemd voor professioneel laboratorium personeel. Eurotrol epoc® 03 12-10-2018 Yeni çeviriler eklenmesi, yeni kullanma kılavuzu düzeni. Şekillerin Κατασκευαστής Διανομέας jest pomijalny. m m Calibration Verification Fluids is ontworpen om de volgende variabelen te testen: pH, pO2, pCO2, Na+, çıkarılması. Eurotrol B.V., Eurotrol Inc., 5. Kontrole z produktu Eurotrol epoc® Calibration Verification Fluids nie zawierają białek i dlatego nie m K+, Ca2+, Mg2+, Cl-, glucose, lactaat, ureum, creatinine and tCO2. Tüm ticari markalar ilgili sahiplerinin malıdır. © 2018, Eurotrol B.V. Keplerlaan 20, 6716 BS Ede, Ολλανδία 850 N Black Branch Rd, Elizabethtown, KY wykrywają nieprawidłowości wrażliwych na białka. m m % Samenvatting van de test Αριθμός τηλεφώνου: +31 318 695 777 42701, Η.Π.Α. Wyniki oczekiwane m Destinația de utilizare Ηλεκτρονική διεύθυνσή: office@eurotrol.com officeUSA@eurotrol.com Wartości są uzyskiwane poprzez wykonywanie pomiarów na systemie analizy krwi epoc® z użyciem kart Eurotrol epoc® Calibration Verification Fluids geeft specifieke waardes voor de pH, pO2, pCO2, Na+, K+, m ш Eurotrol epoc® Calibration Verification Fluids este un material de referință pentru gazele www.eurotrol.com Αριθμός τηλεφώνου: +1 (502) 501-1180 testowych BGEM. Przydzielone wartości są dostępne na stronie http://www.siemens.com/epoc, gdzie Ca2+, Mg2+, Cl-, glucose, lactaat, ureum, creatinine and tCO2 op de epoc® Blood Analysis System m m m m m % sanguine analizate, pentru electroliți și metaboliți, pentru o singură utilizare, destinat Οποιοδήποτε σοβαρό περιστατικό που παρουσιάζεται και αφορά τη συσκευή θα αναφέρεται στον udostępniono tabele z numerami serii poszczególnych płynów i konfiguracjami czujników. weer, en de verkregen waardes met de toegekende waardes te vergelijken kan het correcte functioneren verificării calitative a preciziei și acurateței Sistemului de analiză a sângelui epoc® . Produsul este un κατασκευαστή και στην αρμόδια αρχή του Κράτους-Μέλους στο οποίο βρίσκεται ο χρήστης ή/και ο Dane kontaktowe w celu uzyskania dalszych informacji i/lub pomocy: van het apparaat geverifieerd worden. m m G M dispozitiv de diagnostic in vitro destinat utilizării de către personal profesionist de laborator. Eurotrol ασθενής. Producent Dystrybutor Inhoud m m m m щ epoc® Calibration Verification Fluids este conceput pentru testarea următorilor analiți: pH, pO2, pCO2, Ιστορικό αναθεωρήσεων Eurotrol B.V., Eurotrol Inc., Eurotrol® epoc® Calibration Verification Fluids bevat 1 ampul van 5 relevante levels, en in elke ampul zit m О ы ы Na+, K+, Ca2+, Mg2+, Cl-, glucoză, lactat, uree, creatinină și tCO2. Αναθεώρηση Ημερομηνία ισχύος Αλλαγή από την προηγούμενη έκδοση Keplerlaan 20, 6716 BS Ede, Holandia 850 N Black Branch Rd, Elizabethtown, KY 2,5 mL vloeistof. Eurotrol® epoc® Calibration Verification Fluids wordt bereid door chemicaliën in een m Rezumatul testului Numer telefonu: +31 318 695 777 42701, USA fysiologisch gebufferde matrix op te lossen. Tonometrie met een gespecificeerd gasmengsel bestaand uit 01 14-09-2017 Πρώτη αναθεώρηση M G M Eurotrol epoc® Calibration Verification Fluids furnizează valori specifice pentru pH, pO2, pCO2, Na+, K+, Email: office@eurotrol.com Numer telefonu: +1 (502) 501-1180 zuurstof, koolstofdioxide en stikstof en specifieke zout concentraties resulteren in een level. Eurotrol® m m Ca2+, Mg2+, Cl-, glucoză, lactat, uree, creatinină și tCO2 pe Sistemul de analiză a sângelui epoc®, iar 02 01-02-2018 Ενημερωμένη διεύθυνση και γλωσσάρι συμβόλων www.eurotrol.com E-mail: officeUSA@eurotrol.com epoc® Calibration Verification Fluids bevat geen conserveringsmiddelen, materialen die de viscositeit ф funcționarea corectă a analizorului poate fi verificată prin compararea valorilor atribuite ale produsului cu 03 12-10-2018 Προσθήκη νέων μεταφράσεων, νέα διάταξη των οδηγιών χρήσης. Każdy poważny incydent, który miał miejsce w związku z wyrobem, jest zgłaszany wytwórcy i aanpassen, of andere toevoegingen die een negatieve invoed hebben op de metingen van de electrodes m ф щ valorile obținute. Αφαίρεση εικόνων. właściwemu organowi państwa członkowskiego, w którym użytkownik lub pacjent ma swoją siedzibę. van het apparaat. m @ m Conținut Historia zmian Waarschuwingen en voorzorgsmaatregelen Όλα τα εμπορικά σήματα αποτελούν ιδιοκτησία των αντίστοιχων κατόχων τους. © 2018, Eurotrol B.V. m m @ m ю Eurotrol epoc® Calibration Verification Fluids conține o fiolă cu cinci niveluri fiziologice relevante, fiecare 1. Uitsluitend bestemd voor in-vitro diagnostisch gebruik. Wersja Data wejścia w życie Zmiana w stosunku do poprzedniej wersji m m fiolă conținând 2,5 ml soluție. Eurotrol epoc® Calibration Verification Fluids se prepară utilizând Kavandatud kasutus 2. Elke ampul is eenmalig bruikbaar. 01 14-09-2017 Pierwsza wersja m m substanțe chimice într-o matrice tamponată fiziologic. Tonometria cu niveluri prestabilite de oxigen și Eurotrol epoc® Calibration Verification Fluids on ühekordselt kasutatav analüüsitavate 3. Voorkom dat het product in het algemene afvalcircuit terecht komen. Raadpleeg de lokale veregaaside, elektrolüütide ja metaboliitide referentsmaterjal epoc® vereanalüüsisüsteemi m ф Ш dioxid de carbon echilibrate cu azot și săruri în diferite concentrații furnizează cinci niveluri distincte. 02 01-02-2018 Uaktualniono adres oraz słownik symboli milieuautoriteiten voor de juiste afvalverwerking. täpsuse ja õigsuse kvalitatiivseks kontrollimiseks. Toode on in vitro diagnostiline analüsaator, mis on w @ m ф Eurotrol epoc® Calibration Verification Fluids nu conține conservanți, regulatori de vâscozitate și nici alți 4. Eurotrol epoc® Calibration Verification Fluids dient niet gebruikt te worden als kalibrator. 03 12-10-2018 Dodanie nowych tłumaczeń, nowego układu instrukcji użycia. Usunięcie m m @ m aditivi care ar putea afecta negativ valorile măsurate de electrozi. mõeldud professionaalsele laboripersonalile. Eurotrol epoc® Calibration Verification Fluids on mõeldud Opslag järgmiste analüütide analüüsimiseks: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glükoos, laktaat, uurea, rysunków. О ш Avertismente și precauții m Eurotrol epoc® Calibration Verification Fluids kan gebruikt worden tot en met de houdbaarheids datum kreatiniin ja tCO2. Wszystkie znaki towarowe są własnością odpowiednich właścicieli. © 2018, Eurotrol B.V. щ 1. Destinat utilizării exclusiv pentru diagnostic in vitro. m m die is weergegeven op de labels van zowel de ampullen als de doos, zolang het product ongeopend is 2. Fiecare fiolă este destinată unei singure utilizări. Analüüsi kokkuvõte opgeslagen op een temperatuur van 2–8 °C. Eurotrol epoc® Calibration Verification Fluids is stabiel voor Eurotrol epoc® Calibration Verification Fluids pakub pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, Tilsigtet anvendelse m m G m 3. Aceste produse nu trebuie eliminate pe calea deșeurilor menajere. Consultați autoritățile de mediu een week bij kamertemperatuur, indien de ampul niet is geopend. Nadat het product naar glükoosi, laktaadi, uurea, kreatiniini ja tCO2 konkreetseid väärtusi epoc® vereanalüüsisüsteemi jaoks Eurotrol epoc® Calibration Verification Fluids er et analyseret engangsreferencemateriale til щ locale pentru o eliminare corectă. kamertemperatuur is gebracht, mag het niet nogmaals gekoeld opgeslagen worden. blodgasser, elektrolytter og metabolitter til kvalitativ verificering af et epoc® m m m m m m 4. Eurotrol epoc® Calibration Verification Fluids nu trebuie utilizat drept calibrator. ning võrreldes toote määratud väärtusi saadud väärtustega on võimalik kontrollida analüsaatori Indicaties van bederf töökindlust. blodanalysesystems præcision og nøjagtighed. Produktet er en diagnostisk in vitro-anordning, der er Păstrare 预期用途 Eurotrol epoc® Calibration Verification Fluids zou een heldere, kleurloze vloeistof in een gesloten, Sisu beregnet til at blive brugt af uddannet laboratoriepersonale. Eurotrol epoc® Calibration Verification Fluids О Eurotrol epoc® Calibration Verification Fluids poate fi utilizat până la data de expirare înscrisă pe onbeschadigde ampul moeten zijn. Na het openen van de ampul, is het product stabiel voor 30 er udviklet til at teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glukose, laktat, ф etichetele fiolelor și pe cutie, dacă este păstrat nedeschis la temperaturi de 2-8°C. Eurotrol epoc® Eurotrol epoc® Calibration Verification Fluids.sisaldab üht ampulli viie füsioloogiliselt olulise taseme seconden, waarna de verkregen waarden kunnen afwijken van de toegekende waardes. urea, kreatinin og tCO2. 是一种分析血气、电解质和代谢物的一次性参比材料，用于定性验证 Calibration Verification Fluids este stabil timp de o săptămână dacă este păstrat nedeschis la jaoks, igas ampullis on 2,5 ml lahust. Eurotrol epoc® Calibration Verification Fluids valmistamisel on Procedure kasutatud kemikaale füsioloogiliselt puhverdatud maatriksis. Viis erinevat taset tagab tonomeetria Testoversigt 血液分析系统的精确度和准确性。该产品是一种体外诊断设备，适用于专业实验室人员。 temperatura camerei. Nu refrigerați produsul după ce a fost adus la temperatura camerei. щ 1. Neem de doos uit de koelkast, en pak het benodigde aantal ampullen uit de doos. Breng de ampullen Eurotrol epoc® Calibration Verification Fluids leverer specifikke værdier af pH, pO2, pCO2, Na+, K+, 设计用于检测以下分析物： 、 O 、 O 、 、 、 、M 、 Semne de deteriorare eelmääratletud hapniku ja süsinikdioksiidi tasemetega, mis on tasakaalustatud lämmastiku ja erinevate tot kamertemperatuur (22 °C) voor gebruik soolakontsentratsioonidega. Eurotrol epoc® Calibration Verification Fluids ei sisalda säilitusaineid, Ca2+, Mg2+, Cl-, glukose, laktat, urea, kreatinin og tCO2 på epoc® blodanalysesystemet, og ved at 、葡萄糖、乳酸、尿素、肌酐和 O 。 Eurotrol epoc® Calibration Verification Fluids trebuie să fie un lichid limpede, incolor, într-o fiolă închisă, 2. Direct voor gebruik dienen de ampullen krachtig geschud te worden gedurende 15 seconden. Tijdens viskoossuse regulaatoreid ega teisi lisandeid, mis võivad elektroodide näite mõjutada. sammenligne produktets tildelte værdier med de opnåede værdier kan systemets funktion verificeres. nedeteriorată. După deschiderea fiolei, produsul este stabil timp de 30 secunde, după care valorile 检测概要 het schudden kan de ampul het beste tussen de duim en wijsvinger vast gehouden worden. Indhold obținute pot devia de la valorile atribuite. Hoiatused ja ettevaatusabinõud 在 血液分析系统上， 提供 3. Zwenk de ampul rustig, zodat de oplossing terug aan de onderkant van de ampul gebracht wordt. 1. Kasutamiseks ainult in vitro diagnostikas. Eurotrol epoc® Calibration Verification Fluids giver én ampul med fem fysiologisk relevante niveauer. Procedura 、 O 、 O 、 、 、 、M 、 、葡萄糖、乳酸、尿素、肌酐和 O 的特定值， Laat alle gas belletjes naar het oppervlak rijzen voordat de ampul geopend wordt. 2. Iga ampull on ainult ühekordseks kasutamiseks. Hver ampul indeholder 2,5 ml opløsning. Eurotrol epoc® Calibration Verification Fluids klargøres med 1. Scoateți cutia din frigider și scoateți numărul adecvat de fiole din cutie și din tăviță. Aduceți fiolele la 且通过比较产品的赋值和测定值， 可以验证分析仪的功能是否正常。 4. Bescherm vingers tijdens het openen, bijvoorbeeld met een gaasje, tissue of handschoenen anvendelse af kemikalier i en fysiologisk bufferet matrix. Tonometri med forud fastlagte niveauer af ilt og temperatura camerei (22°C) înainte de utilizare. 3. Neid tooteid ei tohi visata olmeprügi hulka. Nõuetekohase hävitamise kohta küsige nõu kohalikelt 5. Houd de ampul met de gekleurde stip naar boven gericht. Breek de nek van de ampul af in de kuldioxid afbalanceret med nitrogen og forskellige saltkoncentrationer giver fem særskilte niveauer. 内装物品 2. Imediat înainte de utilizare, agitați puternic fiola timp de cel puțin cincisprezece secunde. Când agitați keskkonnaasutustelt. tegenovergestelde richting van de gekleure stip. 4. Eurotrol epoc® Calibration Verification Fluids ei ole mõeldud kasutamiseks kalibraatorina. Eurotrol epoc® Calibration Verification Fluids indeholder ingen konserveringsmidler, 包含 个安瓿，每个安瓿含 m 溶液。 fiola, trebuie să o țineți între degetul mare și arătător. 6. Volg binnen 30 seconden na het openen van de ampul de procedure voor het uitvoeren van viskositetsregulatorer eller andre tilsætningsstoffer, som kan påvirke elektrodemålingerne negativt. 是通过在生理缓冲基质中加入化学物质制备而来 3. Rotiți ușor fiola pentru a readuce soluția în partea inferioară a acesteia. Lăsați orice bule de aer să se Säilitamine metingen, zoals beschreven in de handleiding van het epoc® Blood Analysis System. Eurotrol epoc® Calibration Verification Fluids on kasutamiskõlblik kuni ampullide etikettidele ja karbile Advarsler og forsigtighedsregler 。具有用氮气平衡的预定水平氧气和二氧化碳以及不同盐浓度的张力测定提供一种特定水平。 ridice înainte de a deschide fiola. 7. Gooi na gebruik de ampule en overgebleven vloeistof weg. märgitud aegumiskuupäevani, kui seda säilitatakse avamatuna temperatuuril 2–8 °C . Eurotrol epoc® 1. Kun til diagnostisk anvendelse in vitro. 4. Protejați-vă degetele cu un tifon, un șervețel sau cu mănuși. QC materialen dienen in overeenkomst met lokale, nationale en/of federale regulaties en 2. Hver ampul er kun beregnet til engangsbrug. 5. Țineți fiola cu punctul colorat orientat în sus. Rupeți gâtul fiolei în direcția opusă punctului colorat. Calibration Verification Fluids püsib avamatuna ja toatemperatuuril säilitatuna stabiilsena 1 nädal. Ärge 不含防腐剂、粘度调节剂或其他可能对电极测量产生不利影响的添加剂。 accreditatievereisten gebruikt te worden. pange toodet enam külmikusse tagasi, kui sellel on lastud soojeneda toatemperatuurini. 3. Disse produkter må ikke kasseres sammen med husholdningsaffaldet. Konsultér de lokale 6. În interval de 30 secunde, urmați procedura de recoltare conform instrucțiunilor din manualul de 警告和注意事项 Limitaties Riknemise märgid miljømyndigheder vedrørende korrekt bortskaffelse. utilizare al Sistemului de analiză a sângelui epoc® . 仅供体外诊断使用。 1. De waardes de zijn toegekend aan het product zijn enkel geldig voor dat specifieke lotnummer, de 4. Eurotrol epoc® Calibration Verification Fluids er ikke beregnet til at blive anvendt som kalibrator. 7. După utilizare, aruncați fiola și lichidul rămas. Eurotrol epoc® Calibration Verification Fluids peab olema selge värvitu vedelik suletud ja kahjustumata 每个安瓿仅限一次性使用。 toepasselijke sensorconfiguratie van het epoc® Blood Analysis System en op zeeniveau. ampullis. Pärast ampulli avamist on toode stabiilne 30 sekundit, hiljem võivad saadud väärtused Opbevaring Materialele de control al calității trebuie utilizate în conformitate cu reglementările locale, naționale și/sau 2. Incorrecte monsterneming, opslag of ander verkeerd gebruik van het product kan ertoe leiden dat de määratud väärtustest kõrvale kalduda. Eurotrol epoc® Calibration Verification Fluids kan bruges indtil udløbsdatoen, der er angivet på 这些产品不得作为普通废物处置。请咨询当地环保部门进行正确处置。 federale sau cu cerințele de acreditare. vergaarde resultaten af wijken van de toegekende waardes. ampullernes og den ydre emballages etiketter, hvis de opbevares uåbnede ved en temperatur på 2-8 °C. 不得用作校准品。 Limite Protseduur 3. De waardes voor de pO2 van Eurotrol epoc® Calibration Verification Fluids veranderen invers met de 1. Võtke karp külmikust välja ja eemaldage vajalik arv ampulle karbist ja kandikult. Enne kasutamist Eurotrol epoc® Calibration Verification Fluids er stabile i 1 uge, når de opbevares uåbnede ved 储存 1. Valorile atribuite sunt valabile numai pentru lichidul cu numărul de lot atribuit, pentru configurația temperatuur. Om een sterke correlatie te krijgen met de toegekende waardes, dienen de ampullen zo laske ampullidel soojeneda toatemperatuurini (22 °C). stuetemperatur. Produktet må ikke sættes i køleskab igen, når det først har opnået stuetemperatur. 在 的温度下未开封储存时， respectivă a senzorului Sistemului de analiză a sângelui epoc® și la altitudinea nivelului mării. dicht mogelijk tot 22 °C gebracht te worden, voor ze gemeten worden. Tegn på nedbrydning 2. Recoltarea, păstrarea incorectă sau alte manipulări defectuoase pot determina abaterea valorilor de la 2. Vahetult enne kasutamist raputage ampulli tugevasti vähemalt viisteist sekundit. Raputades tuleb 可以在安瓿和外箱标签上注明的过期日期前使用。在室温下未开封储存时， 4. Eurotrol epoc® Calibration Verification Fluids is gevoelig voor vervuiling van lucht uit de omgeving. Als ampulli hoida pöidla ja nimetissõrme vahel. Eurotrol epoc® Calibration Verification Fluids skal være en klar, farveløs væske i en lukket, intakt ampul. valorile țintă. de meting wordt uitgevoerd binnen 30 seconden na het openen van de ampul, zal de afwijking van de 3. Keerutage ampulli õrnalt, et lahus langeks uuesti ampulli põhja. Enne ampulli avamist laske mullidel Efter åbning af ampullen er produktet stabilt i 30 sekunder. Herefter kan de opnåede værdier afvige fra 可稳定 周。将产品置于室温后不得冷藏。 3. Valorile pO2 ale Eurotrol epoc® Calibration Verification Fluids variază invers proporțional cu verkregen waarde minder zijn dan 2%. Het effect van lucht uit de omgeving op de pH is te de tildelte værdier. 变质指标 modificările de temperatură. Pentru a obține un grad ridicat de corelare cu valorile din tabel, fiolele üles tõusta. verwaarlozen. 4. Kaitske sõrmi marli, lapi või kinnastega. Procedure 应该是包装在密封、未损坏安瓿中的透明、无色液体。 trebuie echilibrate cât mai aproape posibil de 22°C. 5. Eurotrol epoc® Calibration Verification Fluids bevat geen proteïnes en kan daarom geen storingen 5. Hoidke ampulli nii, et värviline täpp jääb ülespoole. Murdke ampulli kael katki värvilise täpi 1. Tag æsken ud af køleskabet og tag det nødvendige antal ampuller ud af æsken og bakken. Lad 打开安瓿后，产品可维持 秒的稳定，之后的测量值可能偏离赋值。 4. Eurotrol epoc® Calibration Verification Fluids este foarte sensibil la contaminarea aerului ambiant. van het apparaat detecteren die hieraan gerelateerd zijn. ampullerne opnå stuetemperatur (22 °C) inden anvendelse. Dacă lichidul se recoltează în interval de 30 secunde, eroarea este mai mică de 2% pe întregul vastassuunas. 步骤 Verwachte resultaten 6. Järgige 30 sekundi jooksul proovivõtmise protseduuri vastavalt teie epoc® vereanalüüsisüsteemi 2. Ryst ampullen kraftigt i mindst 15 sekunder umiddelbart inden brug. Under omrystning skal ampullen interval, la toate nivelurile. Efectul aerului ambiant asupra pH-ului este neglijabil. De waardes worden verkregen op een epoc® Blood Analysis System met behulp van BGEM test tööjuhendi juhistele. holdes mellem tommelfinger og pegefinger. 将包装箱从冰箱中取出，从包装箱和托盘中取出适量的安瓿。使用前将安瓿恢复至室温（ ）。 5. Probele martor ale Eurotrol epoc® Calibration Verification Fluids nu conțin proteine și, de aceea, nu cartridges. De toegekende waardes zijn beschikbaar op: http://www.siemens.com/epoc, waar deze 3. Skvulp forsigtigt ampullen for at få opløsningen ned i bunden af ampullen igen. Lad eventuelle bobler pot detecta disfuncțiile sensibile la aceste componente. 7. Pärast kasutamist visake ampull ja järelejäänud vedelik ära. 剧烈摇晃安瓿至少 秒后立即使用。摇晃时，应使用拇指和食指握住安瓿。 getabuleerd zijn voor elk lotnummer en sensor configuratie. Kvaliteedikontrolli materjale peab kasutama vastavalt kohalikele, riiklikele ja/või föderaalsetele stige op, inden ampullen åbnes. Rezultate anticipate 轻轻旋转安瓿，使溶液返回安瓿底部。待所有气泡浮出后再打开安瓿。 Neem voor meer informatie of assistentie contact op met: määrustele või akrediteerimisnõuetele. 4. Beskyt fingrene med gaze, en papirserviet eller handsker. Valorile se obțin prin determinări efectuate pe Sistemul de analiză a sângelui epoc® utilizând carduri de 使用纱布、纸巾或手套保护手指。 Producent Distributeur 5. Hold ampullen, så den farvede prik vender opad. Knæk ampullens hals af i modsat retning af den testare BGEM. Valorile atribuite sunt disponibile la adresa http://www.siemens.com/epoc, prezentate în Piirangud Eurotrol B.V., Eurotrol Inc., farvede prik. 手持安瓿，保持彩色圆点朝上。沿与彩色圆点相反的方向折断安瓿的颈部。 tabel pentru fiecare număr de lot de lichid și configurație a senzorului. 1. Määratud väärtused kehtivad ainult vedeliku määratud partii numbri, rakendatava epoc® Keplerlaan 20, 6716 BS Ede, Nederland 850 N Black Branch Rd, Elizabethtown, KY vereanalüüsisüsteemi sensori konfiguratsiooni ja merepinnale vastava kõrguse korral. 6. Gå i gang med prøvetagningsproceduren inden for 30 sekunder og følg instruktionerne i 在 秒内，按照 血液分析系统操作手册中的取样步骤进行取样。 Pentru informații suplimentare și/sau asistență, vă rugăm să contactați: Telefoon: +31 318 695 777 42701, USA brugermanualen til epoc® blodanalysesystemet. 使用后，丢弃安瓿和剩余的液体。 Fabricantul Distribuitorul 2. Ebaõige proovivõtmine, säilitamine ja muu väärkäitlemine võivad põhjustada näitude kõrvalekaldumist E-mail: office@eurotrol.com Telefoon: +1 (502) 501-1180 sihtväärtustest. 7. Bortskaf ampullen og resterende væske efter brug. 应根据当地、州和 或联邦法规或认证要求使用质量控制材料。 Eurotrol B.V., Eurotrol Inc., www.eurotrol.com E-mail: officeUSA@eurotrol.com 3. Eurotrol epoc® Calibration Verification Fluids pO2 väärtused varieeruvad pöördsuhteliselt Kvalitetskontrolmaterialerne skal bruges i overensstemmelse med lokale, nationale og/eller statslige 限制 Keplerlaan 20, 6716 BS Ede, Țările de Jos 850 N Black Branch Rd, Elizabethtown, KY Elk aan dit product gerelateerde ernstige incident, dient te worden gemeld aan de fabrikant en de bestemmelser eller krav til godkendelse. Telefon: +31 318 695 777 42701, SUA temperatuurimuutustega. Selleks et saavutada kõrge korrelatsioon tabelis olevate väärtustega, tuleb 赋值仅适用于指定的液体批号、适用的 血液分析系统传感器配置和海拔高度。 bevoegde autoriteit van het land waar het incident heeft plaatsgevonden en/of waar de patiënt is ampullide temperatuur viia võimalikult lähedal temperatuurile 22 °C . Begrænsninger E-mail: office@eurotrol.com Telefon: +1 (502) 501-1180 取样、储存不当或其他误操作可能导致读数偏离目标值。 gevestigd. 4. Eurotrol epoc® Calibration Verification Fluids on väga tundlik ruumi õhusaaste suhtes. Kui 1. De tildelte værdier gælder kun for det tildelte væskelotnummer, den aktuelle konfiguration af epoc® www.eurotrol.com E-mail: officeUSA@eurotrol.com 的 O Orice incident grav survenit în asociere cu dispozitivul trebuie raportat fabricantului și autorității vedelikuproov võtta 30 sekundi jooksul, on viga vahemiku kõikidel tasemetel alla 2%. Ruumiõhu mõju blodanalysesystemets sensor samt højden over havoverfladen. competente din Statul membru în care domiciliază utilizatorul și/sau pacientul. pH-le on ebaoluline. 2. Forkert prøvetagning, opbevaring eller anden forkert håndtering kan medføre, at målingerne afviger 值与温度变化成反比。为了获得与表中数值高度相关的值，安瓿应尽可能平衡至接近 。 5. Eurotrol epoc® Calibration Verification Fluids kontrollivahendid ei sisalda valku ega saa seetõttu fra målværdierne. 对室内空气污染非常敏感。在 avastada nende komponentide suhtes tundlikke häireid. 3. PO2-værdierne fra Eurotrol epoc® Calibration Verification Fluids er omvendt proportionale med 秒内对液体进行采样时，在所有水平的整个范围内误差均小于 %。室内空气对 temperaturændringer. For at opnå en større grad af indbyrdes overensstemmelse med værdierne i tabellen skal ampullerne afbalanceres så tæt på 22 °C som muligt. 的影响可以忽略不计。 CE-märkning CE logo Tillverkare Producent Tillverkningsdatum Datum van productie Utgångsdatum Te gebruiken tot en met Batchnummer Batchcode Katalognummer Referentienummer Temperaturgräns Temperatuurlimiet Försiktighet Opgelet Får ej återanvändas Niet hergebruiken Medicinteknisk produkt för in vitro-diagnostik In-vitro diagnostisch medisch apparaat Kontroll Kwaliteitscontrole CE işareti Marcaj CE Üretici Fabricantul Üretim tarihi Data fabricației Son kullanma tarihi Data de expirare Parti kodu Codul seriei de fabricație Katalog numarası Număr de catalog Sıcaklık sınırı Limite de temperatură Dikkat Atenție Tekrar kullanmayın A nu se reutiliza İn Vitro Diagnostik Tıbbi Cihaz Dispozitiv medical pentru diagnostic in vitro Kontrol Probă martor Σήμανση CE CE märgis Κατασκευαστής Tootja Ημερομηνία κατασκευής Valmistamise kuupäev Ημερομηνία λήξης Kõlblik kuni Κωδικός παρτίδας Partii kood Αριθμός καταλόγου Kataloogi number Όριο θερμοκρασίας Temperatuuripiir Προσοχή Ettevaatust Μην επαναχρησιμοποιείτε Mitte kasutada korduvalt Ιατροτεχνολογικό προϊόν για in vitro διαγνωστική χρήση In vitro diagnostiline meditsiiniseade Μάρτυρας Kontroll Znak CE CE-mærkning Producent Producent Data produkcji Produktionsdato Data przydatności do użycia Anvendes før Kod partii Batchnummer Numer katalogowy Katalognummer Granica temperatury Temperaturgrænse Przestroga Forsigtig Nie używać ponownie Må ikke genbruges. Wyrób medyczny do diagnostyki in vitro Medicinsk anordning til in vitro-diagnostik Kontrola Kontrol Tanda CE CE 标志 Manufaktur 制造商 Tanggal manufaktur 生产日期 Gunakan sebelum 使用截止日期 Kode batch 批次代码 Nomor katalog 目录编号 Batasan suhu 温度限制 Peringatan 警示 Jangan gunakan kembali 请勿重复使用 Perangkat Medis Diagnostik In vitro 体外诊断医疗设备 Kontrol 质控品 Маркировка CE Производитель Дата изготовления Срок годности Код партии Номер по каталогу Температурный режим Внимание! Только для одноразового применения Медицинское изделие для диагностики in vitro Контроль Page 2 of 2 AN01571A01 20181012 Instructions for Use (1.8 MB)
- epoc Value Assignment Sheet
CueSee® CO-OX PT
Product Specific
- Eurotrol presents CueSee CO-OX, the perfect CO-OX control. Here are some of the advantages and principles behind it. - The advantages and principles page 1 CO-oximetry is about the 4 main hemoglobin derivatives: The concentrations of these derivatives are measured with • Oxyhemoglobin (O2Hb) which has bound oxygen, CO-oximeters which are multi-wavelength hemoglobin photometers. • deoxygenated hemoglobin (HHb) which is without oxygen, • carboxyhemoglobin (COHb) which forms in red blood cells Here is a graphical representation of the various hemoglobin upon contact with carbon monoxide and has lost the ability to fractions in blood. bind oxygen, • and methemoglobin (MetHb) which is the form in which the iron in the heme group is oxidized and therefore has lost the ability to bind oxygen. - The advantages and principles page 2 The quality control products in the market for CO-oximetry are This is why dyes have major disadvantages: solutions containing dyes which have major disadvantages. Note the difference between the spectrum of real hemoglobin in Because of the differences from real hemoglobin, the results red vs the spectrum of a typical dye-based quality control liquid. of the dye-based solutions are outside of the clinically relevant It’s obvious that the dye shows peaks at different wavelengths ranges, even with negative values, and dyes don’t show the with different heights and some of the slopes are extremely proper sensitivity to detect problems with CO-oximeters, which is different. the main reason for doing quality control! - The advantages and principles page 3 In the example above, if there is a change in wavelength at 530 That same change in wavelength has a major consequence for nanometers on the x-axis, there is hardly any change in the the absorbance of real hemoglobin. absorbance of the dye-based solution. The ideal QC material is a solution with real hemoglobin derivatives, which has the sensitivity these instruments are facing with patient samples. - The advantages and principles page 4 Eurotrol has revolutionized CO-OX QC with CueSee CO-OX, Packaged in the ACU-Drop II, this innovative, dual-chambered with real hemoglobin derivatives all in one sample. device keeps the oxyhemoglobin separated from the methemoglobin to provide a long shelf-life. - The advantages and principles page 5 Just before use, simply push the button to allow the liquids to Then mix, and a sample with clinically relevant levels of all combine. hemoglobin derivatives is ready to use, either from the built-in dropper bottle or by attaching a syringe. - The advantages and principles page 6 A recent study was carried out by more than 500 laboratories that In summary, with CueSee CO-OX: measured CueSee CO-OX on various models of CO-oximeters • You can assess the accuracy and precision of all hemoglobin with impressive results. derivatives in clinically significant ranges Note the SD’s! • It’s compatible with all common CO-oximeters The results were very accurate and precise which is a major • It’s comparable to whole blood providing identical results on accomplishment for CO-oximetry control materials. all CO-oximeters • It’s ideal for quality control, method comparisons, AMR validation and proficiency testing - The advantages and principles page 7 For more information, contact us. Thank you! - The advantages and principles page 8 The Advantages and Principles (2.5 MB)
- Safety Data Sheet 1. Identification of substance Product name: CueSee® CO-OX PT Product code: Level 1: 249.001.001, Level 2: 249.002.001, Level 3: 249.003.001 Level 4: 249.004.001, Level 5: 249.005.001, Level 6: 249.006.001 Level 7: 284.007.001 Manufacturer: Eurotrol B.V., Keplerlaan 20, 6716 BS, Ede, The Netherlands. For US and Canadian customers: In emergency call +1 502 501 1180 for further information (available during office hours). For Rest of the world: In emergency call +31 318 695777 for further information (available during office hours). 2. Hazards identification This product is prepared from bovine material. Cattle used for bleeding is under veterinary control. Cattle have not been mixed with other cattle. No foot-and-mouth disease or rinderpest has been observed in these cattle. However, no test method can offer complete assurance that products derived from bovine source material are free from infectious agents. Appearance: Bloodlike Odour: None Physical State: Liquid 3. Composition/information on ingredients Component Classification Concentration Bovine hemolyzed red blood cells None 100% 4. First aid measures Inhalation: N/A Skin contact: Use normal hygiene. Flush with water for >15 minutes in case reagent contacts the skin. Eye contact: Flush with water for >15 minutes in case reagent contacts eyes Ingestion: Get medical attention EDE-AW-1014 20180605 5. Firefighting measures Not flammable. follow general fire fighting procedures. 6. Accidental release measures In case of spill of material, clean with water. Use an absorbent material to contain/pick up the spilled solution. Place all contaminated disposables into a suitable container, seal, label, and hold for disposal. Page 1 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 7. Handling and storage Handling: Follow Good Laboratory Practice when working with any chemical whether it is considered hazardous or not. Storage: Store as indicated in product insert to maintain proper performance of the product. 8. Exposure control / personal protection Follow Good Laboratory Practice 9. Physical / chemical characteristics pH ~7.4 (neutral) Boiling point (°C) ~100°C/~212°F Melting point (°C) ~0°C/~32°F Decomposition temperature (°C) ~70°C/~212°F Flash-point (°C) Not flammable. Spontaneous combustion temp (°C) N/A Combustibility (solid, gas) N/A Explosive characteristics N/A Explosion limits N/A Oxidizing characteristics N/A Vapor pressure (kPa) N/A Vapor density N/A Appearance Red colored, after activation/mixing Odour None Physical state Liquid Solubility in water Soluble 10. Stability and reactivity No hazardous decomposition products known. Conditions to avoid: heating or freezing of the product 11. Toxicological information This product does not contain components at concentrations of 0.1% or higher that are classified as toxic according to regulation (EC) No 1272/2008 [EU-GHS/CLP]. No foot-and-mouth disease or rinderpest has been observed in the cattle from which this EDE-AW-1014 20180605 material was derived. However, no test method can offer complete assurance that products derived from bovine source material are free from infectious agents. HANDLE AS A BIOHAZARD, class II (CDC/NIH guidelines). 12. Ecological information This product does not contain components at concentrations of 0.1% or higher that are classified as toxic according to regulation (EC) No 1272/2008 [EU-GHS/CLP]. Page 2 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 No foot-and-mouth disease or rinderpest has been observed in the cattle from which this material was derived. However, no test method can offer complete assurance that products derived from bovine source material are free from infectious agents. 13. Disposal considerations Do not dispose of in general waste. HANDLE AS A BIOHAZARD, class II (CDC/NIH guidelines). Consult local environmental authorities for proper disposal. 14. Transport information According to DOT and IATA, the product is classified as: NON-HAZARDOUS Proper Shipping Name: N/A Technical Name: UN Number: N/A Hazard Class and Packaging Group: N/A Label(s): N/A Packing Instruction (Passenger Aircraft): N/A Packing Instruction (Cargo Aircraft): N/A Shipping Container Type: N/A Sales Unit: ACU-DROP II vial, containing 2 x 2 mL of stroma-free bovine hemolysate. 15. Regulatory information -Regulation (EC) No. 1272/2008 [EU-GHS/CLP] -Regulation (EC) No. 1907/2006 [REACH] -US: -Guidelines for importation #1121 16. Other information The opinions expressed herein are those of qualified experts within Eurotrol B.V. We believe that the information contained herein is current as of the date of this Safety Data Sheet. Since the use of this information and these opinions and the conditions of use of the product are not within the control of Eurotrol B.V., it is the users' obligation to assure safe use of the product. Date of issue: June 5, 2018 EDE-AW-1014 20180605 Page 3 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet (87.9 KB)
- CueSee® CO-OX PT Intended purpose Precautions CueSee® CO-OX PT is an unassayed real hemoglobin quality control material 1. For in vitro diagnostic use only. intended for application in External Quality Assessment and Proficiency Testing 2. This is a bovine animal product and does not contain biohazards to humans such Schemes to verify the precision and accuracy of CO-oximeters when measuring as HepB, HepC and HIV. This product is free from TSE. tHb, FO2Hb, FCOHb and FMetHb. CueSee CO-OX PT is for professional use only. 3. This product should not be disposed of in general waste. Consult local environmental authorities for proper disposal. Summary 4. CueSee CO-OX PT is not to be used as a calibrator. CueSee CO-OX PT provides six physiologically relevant levels, each vial containing 2 mL of solution after preparation of the sample. Each level contains different Reference Values concentrations of hemoglobin (tHb) and hemoglobin derivatives (FO2Hb, FCOHb This product was validated using measurements obtained on Radiometer ABL800 and FMetHb). series instruments. They are not assigned values and are provided only to indicate CueSee CO-OX PT is prepared from a stroma-free bovine hemoglobin solution. No concentrations of analytes per level. dyes have been added to mimic hemoglobin fractions. Please note Storage and stability CueSee CO-OX PT has been tested on many commonly used CO-oximeters. CueSee CO-OX PT must be stored at a temperature of 2–8 °C (36–46 °F). Stored Eurotrol cannot guarantee compatibility of this product with all CO-oximeters. unopened at this temperature it is guaranteed stable until the expiration date as This product has been manufactured according to Eurotrol specifications. indicated on the outer box. After preparation of the sample, the product is stable for 15 minutes at room temperature (15-30°C / 59-86°F). Procedure 1. Read all instructions carefully before preparing the sample. See instructions for preparing the ACU-Drop II sample. Visit www.eurotrol.com for a tutorial video on Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands how to prepare an ACU-Drop II sample. For further information please contact: 2. Take the vial out of its packaging and equilibrate the vial to room temperature (15–30°C / 59–86°F) for a minimum of 15 minutes, but not more than 60 minutes. Eurotrol B.V. Eurotrol Inc., USA Note: Do not put vials back into refrigerator once exposed to room temperature. T +31 318 695777 T +1 502 501 1180 3. You must activate the sample by following the diagram and ‘Instructions for E-mail office@eurotrol.com E-mail officeUSA@eurotrol.com preparing an ACU-Drop II sample’ included. Website www.eurotrol.com Website www.eurotrol.com 4. Transfer sample to the test instrument within 15 minutes after activating and mixing the sample. 5. Measure the sample according to the operating instructions of the CO-oximeter. Symbols used 6. Please refer to local guidelines for recommended frequency of use. Attention, see instructions for use Batch code Use-by date Temperature limit Manufacturer Catalogue number AN01446A01 20180228 Instructions for preparing an ACU-Drop® II sample Instruction A - Sampling with Dropper Tip Instruction B - Sampling with Syringe A1 - Press the button firmly until it is B1 - Press the button firmly until it is dropper tip completely pushed in and level with completely pushed in and level with the indentation. the indentation. A2 - Gently rock and swirl at least B2 - Gently rock and swirl at least cap 5 times to mix the content completely. 5 times to mix the content completely. A3 - Hold the ACU-Drop II with cap facing up and flick the cap firmly B3 - Twist the adaptor onto the tip of several times to make sure that no either a luer lock or standard syringe. liquid remains inside the dropper tip. B4 - Hold the ACU-Drop II with cap A4 - Open the flip cap very carefully by facing down and flick the bottom firmly lifting the cap just a little bit to release several times to be sure that all the liquid luer fitting the pressure. settles. Push the adaptor tip attached to -Only with first time use- the syringe firmly into the luer fitting on indentation the button of the ACU-Drop II. button A5 - The first 2 drops should be B5 - Hold the ACU-Drop II with cap dispensed and discarded. facing up and, using both hands on bottom the syringe, withdraw the contents. adaptor view B6 - Hold the adaptor with the ACU-Drop II A6 - The ACU-Drop II is now ready to cap facing down and carefully unscrew the use to apply a sample drop for testing. syringe, leaving the adaptor in the button of the ACU-Drop II. For instructional video go to A7 - After each use, be sure to wipe the B7 - Use the syringe to deliver your sample. www.eurotrol.com/acudrop2 dropper tip and inside of cap to keep After usage, reattach the ACU-Drop II to the them clean. syringe to reuse or discard. Instructions for use (651.8 KB)
- Clinical Chemistry 44:11 2331–2339 (1998) Laboratory Management Lyophilized bovine hemoglobin as a possible reference material for the determination of hemoglobin derivatives in human blood Bart H.A. Maas,1 Anneke Buursma,2 Rob A.J. Ernst,1 Anton H.J. Maas,3 and Willem G. Zijlstra4* We investigated the suitability of a lyophilized bovine Spectrophotometric multicomponent analysis (MCA)5 of hemoglobin (LBH) preparation containing various frac- hemoglobin derivatives (1, 2) has become available in tions of oxyhemoglobin (O2Hb), carboxyhemoglobin routine clinical chemistry through the development of (COHb), and methemoglobin (MetHb) for quality as- multiwavelength hemoglobin photometers (CO-oxime- sessment in multicomponent analysis (MCA) of hemo- ters) of different design, using either the same number of globin derivatives. It was demonstrated that a stable wavelengths as components to be analyzed [exactly de- preparation of these components after reconstitution termined system (3, 4)] or more wavelengths than are yields a hemoglobin solution that is spectrophotometri- strictly necessary (overdetermined system). In addition, cally equivalent with a fresh bovine hemoglobin solu- various procedures are used for hemolysis and for elim- tion. The preparation was found to be stable for at least inating the influence of turbidity. All instruments mea- sure oxyhemoglobin (O2Hb), deoxygenated hemoglobin 1 year when it is kept at 2– 8 °C and for 1 h after (HHb), carboxyhemoglobin (COHb), and methemoglobin reconstitution. We determined the fractions of O2Hb, (MetHb); some also signal the presence of or measure COHb, and MetHb of several LBH preparations, using sulfhemoglobin. the complete spectra of 480 – 650 nm with 2-nm intervals Comparative measurements have shown that most of and absorptivities as determined for pure LBH solu- these instruments are quite reliable when used within the tions. A field trial involving various types of multiwave- specifications of the manufacturers (5– 8). Quality control length hemoglobin photometers showed the suitability is rather difficult. Of course, the instruments can be tested of LBH as a quality-control material. Computer models with stable dye solutions. However, these solutions show of the various common multiwavelength hemoglobin non-identical spectral behavior in comparison with blood. photometers may be useful for establishing more accu- The ideal test material would be a solution of hemoglobin rate target values of LBH preparations for each type of derivatives of known concentration. Such solutions are photometer and for studying the importance of the not stable for sufficient time periods. Therefore, we inves- influence of specific factors such as wavelength selec- tigated whether a lyophilized bovine hemoglobin (LBH) tion, absorptivity values, and interfering dyes. preparation containing various fractions of O2Hb, COHb, and MetHb may be suitable for quality control in MCA of hemoglobin derivatives. Materials and Methods preparation of lbh 1 EURO-TROL b.v., NL-6702 EA Wageningen, The Netherlands. A stroma-free hemoglobin (SFH) solution was prepared 2 Department of Medical Physiology, University of Groningen, NL-9712 according to Sprokholt and co-workers (9, 10). Briefly, KZ Groningen, The Netherlands. 3 Department of Chemical Technology, Technical University Eindhoven, NL-5600 MB Eindhoven,The Netherlands. 4 Department of Pediatrics, University Hospital, NL-9713 GZ Groningen, 5 The Netherlands. Nonstandard abbreviations: MCA, multicomponent analysis; O2Hb, oxy- *Author for correspondence. Fax 31-503-611671; e-mail w.a.kamps@ hemoglobin; HHb, deoxygenated hemoglobin; COHb, carboxyhemoglobin; med.rug.nl. MetHb, methemoglobin; SFH, stroma-free hemoglobin; and LBH, lyophilized Received January 16, 1998; revision accepted August 3, 1998. bovine hemoglobin. 2331 2332 Maas et al.: Lyophilized bovine hemoglobin in MCA of hemoglobin fresh bovine blood was aseptically collected in a 3-L glass human hemoglobin, which had been published previ- vessel containing sodium heparin solution (100 000 ously (11, 12). Because of the dependence of the absorp- units/L; LEO Pharmaceutical Products B.V.). Plasma was tion spectrum of MetHb on the pH of the solution, we separated from blood cells by centrifugation (2000g for 20 recorded the absorptivity as a function of wavelength for min at 4 °C; Jouan K110). Blood cells were suspended in LBH-MetHb at various pH values. The pH of the solu- NaCl solution (154 mmol/L). Leukocytes and platelets tions was measured at 25 °C with an ABL500 blood gas were removed by cotton wool filtration. Red cell concen- analyzer (Radiometer). trates were prepared by centrifugation, and erythroly- The stability of the LBH solutions after reconstitution sates were prepared from these concentrates (Vc) by of mixtures of LBH by adding 0.5 mL of water to the vials adding water (Vw) in the volume ratio Vc/Vw 5 1/4. The was established after storage of the solutions at 25 °C for erythrocyte stromata were separated from the hemoglo- various periods of time. The O2Hb, COHb, and MetHb bin solution by centrifugation and tangential cross-flow fractions of the solutions were measured at 10-min inter- filtration using the Pellicon system with an HVMP filter vals with a Radiometer ABL520 multiwavelength hemo- cassette (Millipore Corp.) in combination with a peristaltic globin photometer. pump (type 603, Watson-Marlow Ltd.). The diluted SFH The shelf life was determined by storage of vials with solution was concentrated by ultrafiltration using the mixtures of LBH at 2– 8 °C. Measurements of reconsti- Pellicon system equipped with a PTGC filter cassette and tuted samples were performed at 15-min intervals with an a rotary vane pump, type 4 GPM (Millipore). Finally, IL282 multiwavelength hemoglobin photometer. erythrocyte remnants were removed by filtration through polycarbonate filters with a pore size of 0.8 mm, and the computer program simulating mca SFH solution was subsequently sterilized using a polycar- A computer program has been developed to calculate the bonate filter with a pore size of 0.22 mm (Millipore). composition of mixtures of hemoglobin derivatives by SFH solutions were equilibrated with O2 and CO to simulating MCA, which is based on the Lambert-Beer obtain O2Hb and COHb, respectively, and treated with an law: oxidizing agent (sodium nitrite) to induce formation of MetHb. The pH of these solutions was adjusted to 7.26 at A 5 «l z c z l (1) 25 °C by the addition of diluted sodium hydroxide or hydrochloric acid solution. Solutions of pure O2Hb, where A, the absorbance, is log Io/I, «l is the millimolar COHb, or MetHb and a series of four mixtures of these absorptivity (L z mmol21 z cm21) at wavelength l, c is the hemoglobin derivatives covering the pathophysiologi- concentration (mmol/L), and l is the lightpath length in cally interesting ranges (FO2Hb, 90 – 40%; FCOHb, 5–20%; centimeters. The equation can be solved for c when A has and FMetHb, 0 – 40%) were lyophilized in 3-mL vacuum- been measured at a fixed wavelength (l) where «l is sealed vials, each vial containing 0.5 mL of material, and known, provided that the lightpath length is known stored at 2– 8 °C in the dark. exactly. For a solution containing several components, Eq. 1 becomes: reconstitution, measurement, and stability of lbh A 5 « l1 z c1 z l 1 « l2 z c2 z l 1 . . . . . .« nl z cn z l (2) For use, the contents of a vial were reconstituted by adding 0.5 mL of demineralized water with a Po2 of ;20 Writing A* for A/l, this becomes for a solution of O2Hb, kPa and proper mixing until a homogeneous solution was COHb, and MetHb: obtained, which takes ;2 min. The intervial precision was determined by measuring five vials of each mixture with A* 5 «lO2Hb z cO2Hb 1 «lCOHb z cCOHb an IL282 multiwavelength hemoglobin photometer. For 1 «lMetHb z cMetHb (3) practical reasons we decided not to use HHb because of its affinity to oxygen, which leads to unpredictable results Measuring A* of the solution at three different wave- after reconstitution. To ascertain that each mixture is free lengths yields a set of three linear equations with three of HHb, five vials of each mixture were reconstituted with unknown concentrations. For an overdetermined system demineralized water with Po2 .100 kPa and measured on of n .3, this set of equations can be written according to an IL282 multiwavelength hemoglobin photometer. Eq. 4 for each wavelength at which e is the error: The absorptivities of pure O2Hb, COHb, and MetHb of LBH were established by measuring the absorbance of A* 1 e 5 « lO2Hb z cO2Hb 1 « lCOHb z cCOHb reconstituted vials of each derivative with an HP8450A reversed-optics spectrophotometer at room temperature 1 « lMetHb z cMetHb (4) (480 – 650 nm with intervals of 2 nm). Calibration of the spectrophotometer was verified with a Corning HT yel- Eq. 4 for all wavelengths used can be summarized as Eq. low filter calibrated by NIST. The absorptivities of LBH 5, in which Se2 (a measure for total error) is minimal derivatives were compared with those of bovine and when (Se2)/cO2Hb is 0, (Se2)/cCOHb is 0, and (Se2)/ Clinical Chemistry 44, No. 11, 1998 2333 cMetHb is 0: The influence of differences in the absorptivities on the Oe 5 O@« 2 l O2Hb z cO2Hb 1 «lCOHb z cCOHb results of MCA of mixtures of LBH derivatives was established by calculations with the general model. The O2Hb, COHb, and MetHb fractions of the four different 1 « lMetHb z cMetHb 2 A*]2 (5) mixtures of LBH derivatives were determined with the This yields a determined system of three equations with general model and the absorptivities of LBH, bovine three unknown concentrations of O2Hb, COHb, and hemoglobin, and human hemoglobin, respectively. The MetHb that can be solved with standard mathematical results obtained with the LBH absorptivities were desig- procedures. nated the true values of the LBH mixtures. The program has been used with a set of absorbance To determine the influence of the specific models on data for wavelengths from 480 to 650 nm with intervals of the results of MCA of mixtures of LBH derivatives, we 2 nm (general model) and specific sets of absorbance data compared the true values of the LBH mixtures with the for wavelengths as applied in the various types of multi- results of calculations with the specific models based on wavelength hemoglobin photometers (specific models). LBH absorptivities. The following specific models, corre- sponding as far as the wavelengths were concerned with multicomponent analysis several common multiwavelength hemoglobin photome- We carried out a series of experiments with the four ters (7), were used: a 4-wavelength model (corresponding mixtures of LBH derivatives to determine the following: to the CO-Oximeter IL282/482, Instrumentation Labora- (a), the influence of the use of different absorptivities tory), a 6-wavelength model (corresponding to the He- (LBH, bovine, and human); (b), the influence of different moximeter OSM3/ABL520, Radiometer), an 8-wave- sets of wavelengths (general model or various specific length model (corresponding to the CO-Oximeter models); and (c), the combined influence of different CCD270, Chiron Diagnostics), and a 17-wavelength absorptivities and different sets of wavelengths. Each of model (corresponding to the CO-Oxylite AVL912). the specific models when used in combination with the The combined influence of specific models and the absorptivities of human hemoglobin was the closest sim- absorptivities of human hemoglobin was determined by ulation of a particular multiwavelength hemoglobin pho- calculating the O2Hb, COHb, and MetHb fractions of the tometer we could make. The results obtained by these four different mixtures of LBH derivatives with the spe- simulations were then compared with those obtained by cific models based on human absorptivities. Thus, we measurements with the corresponding multiwavelength applied to the LBH mixtures the methods as implemented hemoglobin photometers in various hospital laboratories. in the common multiwavelength hemoglobin photome- The absorbance of the four mixtures of LBH deriva- ters. The results were compared with the true values of tives was measured by a similar procedure on the same the LBH mixtures. HP8450A spectrophotometer as had been used for the Finally, a comparison was made of the true values of determination of the O2Hb, COHb, and MetHb absorp- the LBH mixtures with the results obtained with multi- tivities of LBH. wavelength hemoglobin photometers at various hospital Table 1. Intervial precision of four mixtures of LBH. Reconstitution with demineralized water, PO2 '20 kPa Reconstitution with demineralized water, PO2 >100 kPa Mean (n 5 5) SD CV Mean (n 5 5) SD CV F O2Hb, % 90.8 0.16 0.2% 90.8 0.22 0.2% 68.1 0.04 0.1% 68.3 0.07 0.1%a 60.0 0.12 0.2% 60.1 0.07 0.1% 40.2 0.08 0.2% 40.8 0.11 0.3%a F COHb, % 4.8 0.11 2.3% 4.8 0.04 0.9% 10.4 0.11 1.1% 10.2 0.19 1.9% 12.8 0.13 1.0% 13.0 0.08 0.6% 19.3 0.04 0.2% 19.0 0.07 0.4%a F MetHb, % 4.8 0.11 2.4% 4.6 0.12 2.7% 23.1 0.12 0.5% 23.0 0.08 0.4% 28.8 0.09 0.3% 28.9 0.09 0.3% 42.8 0.15 0.3% 42.6 0.11 0.3% a Significantly different from reconstitution with PO2 '20 kPa, according to the unpaired Student t-test (P ,0.01). 2334 Maas et al.: Lyophilized bovine hemoglobin in MCA of hemoglobin Fig. 1. Absorptivities of bovine, human, and lyophilized bovine hemoglobin as a function of wavelength for O2Hb and COHb (left) and deviation of absorptivities of bovine and human hemoglobins from absorptivity of LBH (right). (E), LBH; (———), bovine hemoglobin; (- - - - -), human hemoglobin. laboratories. To this end, a set of vials containing the four Some minute differences were obtained when the recon- mixtures of LBH derivatives was sent to these laboratories stitution was carried out with demineralized water with as unknown test material in a quality assessment trial. The Po2 .100 kPa (Table 1), showing the presence of traces of mean values of the results obtained for each LBH deriv- HHb in some of the LBH mixtures. ative were grouped for the various types of instruments: The left panels of Fig. 1 show the absorptivities of 14 IL282/482, 13 OSM3/ABL520, 17 CCD270, and 4 bovine, human, and lyophilized bovine hemoglobin as a AVL912 multiwavelength hemoglobin photometers. function of wavelength for O2Hb and COHb. The right panels of Fig. 1 show the deviation the absorptivities of Results bovine and human hemoglobin from the LBH. The ab- The intervial precision of the four LBH mixtures, recon- sorptivities of MetHb as a function of wavelengths are stituted with demineralized water with Po2 '20 kPa, is shown in Fig. 2. In the upper panel, the spectrum of LBH shown in Table 1. The SD of each hemoglobin derivative MetHb at pH 7.06 is compared with that of native bovine of each LBH mixture of all samples was ;0.2%, which MetHb at pH 7.28, which is within the range of pH values corresponds to a coefficient of variation (CV) of 0.1– 0.2% of freshly hemolyzed bovine blood. The lower panel in FO2Hb, 0.2–2.3% in FCOHb, and 0.2–2.4% in FMetHb.6 shows a comparison of the absorption spectrum of LBH MetHb at pH 7.26 with that of human MetHb at pH 7.21, which is within the range of pH values of freshly hemo- 6 Fractions of the hemoglobin derivatives are given in percentages: F 5 lyzed human blood. 0.3 5 30%. When the spread in this value is given as 2%, this means that F is between 28% and 32%. The percentage is not used as a relative measure unless In Table 2, the absorptivities of the various derivatives it is explicitly stated, as in the case of CVs. of LBH and of bovine and human hemoglobin at the Clinical Chemistry 44, No. 11, 1998 2335 Table 2. Absorptivities (L z mmol21 z cm21) at room temperature of lyophylized bovine, bovine, and human O2Hb, COHb, and MetHb at wavelengths (nm) used in specific models corresponding with the wavelengths used in particular multiwavelength hemoglobin photometers. Lyophilized bovine Bovine Human MetHb MetHb MetHb pH 7.26 pH 7.28 pH 7.21 O2Hb COHb 25 °C O2Hb COHb 25 °C O2Hb COHb 25 °C IL282/482 CO-Oximeter 535.0 12.80 13.82 6.72 12.86 13.83 6.57 12.81 13.83 6.67 585.2 8.97 5.09 3.86 8.91 5.07 3.67 8.87 5.01 3.78 594.5 2.14 1.90 3.51 2.06 1.86 3.43 2.07 1.82 3.37 626.6 0.20 0.30 3.87 0.21 0.28 3.92 0.16 0.23 3.82 OSM3 Hemoximeter 535.0 12.80 13.82 6.72 12.86 13.83 6.57 12.81 13.83 6.67 560.0 8.66 12.02 4.14 8.68 12.18 3.98 8.77 12.25 4.18 577.0 15.18 11.03 4.01 15.26 11.00 3.78 15.31 11.00 4.00 622.0 0.22 0.35 3.69 0.25 0.34 3.78 0.20 0.29 3.64 636.0 0.17 0.22 3.81 0.15 0.20 3.81 0.11 0.15 3.77 670.0 0.10 0.05 0.46 0.10 0.08 0.47 0.10 0.05 0.46 CCD270 CO-Oximeter 556.96 9.16 11.56 4.35 9.17 11.71 4.18 9.26 11.76 4.38 564.91a 9.16 13.47 3.98 9.20 13.59 3.81 9.30 13.71 4.03 577.56 15.23 10.62 4.01 15.30 10.59 3.78 15.34 10.57 3.99 597.38 1.44 1.47 3.44 1.37 1.43 3.39 1.36 1.39 3.28 605.42 0.63 0.82 3.33 0.58 0.78 3.37 0.55 0.73 3.19 624.56 0.21 0.32 3.80 0.22 0.31 3.86 0.18 0.25 3.75 635.72 0.17 0.22 3.82 0.15 0.20 3.82 0.11 0.15 3.78 650.23 0.09 0.11 1.90 0.12 0.13 2.04 0.10 0.09 1.94 AVL912 CO-Oxylite 530.0 10.39 12.25 7.02 10.41 12.30 6.95 10.35 12.29 6.94 536.0 13.18 14.02 6.65 13.26 14.03 6.49 13.22 14.05 6.61 542.0 14.47 14.08 6.17 14.53 14.02 5.98 14.52 14.04 6.17 548.0 12.94 12.54 5.40 12.97 12.54 5.23 12.99 12.55 5.44 554.0 10.07 11.49 4.63 10.10 11.60 4.47 10.17 11.63 4.66 560.0 8.66 12.02 4.14 8.68 12.18 3.98 8.77 12.25 4.18 566.0 9.47 13.81 3.97 9.52 13.91 3.79 9.61 14.04 4.02 572.0 12.79 13.92 3.98 12.94 13.87 3.78 13.05 13.99 4.01 578.0 15.28 10.29 4.02 15.33 10.26 3.78 15.36 10.24 3.99 584.0 10.40 5.79 3.91 10.33 5.78 3.70 10.28 5.71 3.83 590.0 4.32 2.96 3.67 4.23 2.94 3.54 4.26 2.89 3.56 604.0 0.71 0.90 3.34 0.65 0.86 3.36 0.63 0.81 3.19 612.0 0.37 0.54 3.34 0.39 0.53 3.42 0.35 0.46 3.25 622.0 0.22 0.35 3.69 0.25 0.34 3.78 0.20 0.29 3.64 630.0 0.18 0.27 3.94 0.18 0.25 3.97 0.14 0.20 3.90 640.0 0.15 0.19 3.45 0.14 0.17 3.46 0.10 0.13 3.42 648.0 0.10 0.12 2.23 0.12 0.14 2.36 0.10 0.10 2.24 a Obtained from Chiron Diagnostics; other wavelengths from Mahoney et al. (7). Absorptivity values for LBH were measured with a HP8450A spectrophotometer. The bovine hemoglobin absorptivities are from Zijlstra and Buursma (12), and the human hemoglobin absorptivities are from Zijlstra et al. (11). wavelengths used in common multiwavelength hemoglo- The second column of Fig. 4 shows the true values of bin photometers and in the corresponding specific models the LBH mixtures, i.e., the results of calculating the are consolidated. fractions of O2Hb, COHb, and MetHb of the four LBH Fig. 3 shows the stability after reconstitution of a mixtures with the help of the general model and the mixture of LBH derivatives when stored for 1 h at 25 °C. absorptivities of LBH. The results of the same calculations When vials containing lyophilized LBH derivatives were with the absorptivities of either bovine or human hemo- stored at 2– 8 °C and measured after reconstitution several globin are shown as the differences between these values times over 1.5 years, no changes in the composition of the and the corresponding true values. When the absorptivi- different LBH mixtures were observed. ties of bovine hemoglobin are used, the differences from 2336 Maas et al.: Lyophilized bovine hemoglobin in MCA of hemoglobin Fig. 4. Fractions of O2Hb (FO2Hb), COHb (FCOHb), and MetHb (FMetHb) Fig. 2. Absorptivities of lyophilized bovine MetHb at various pH values of four LBH mixtures as calculated with the general model and in comparison with those of bovine and human MetHb. absorptivities of LBH (true values, second column) and with the The pH of the various solutions was measured at 25 °C. general model with absorptivities of bovine and human hemoglobin. The solid bars represent the values obtained with absorptivities of bovine hemoglobin minus the true values. The shaded bars represent the values the true values are slight (from 20.8% to 1.3%), which is obtained with absorptivities of human hemoglobin minus the true values. in line with the expectation based on Figs. 1 and 2. The values obtained with the absorptivities of human hemo- globin deviate slightly more (from 22.3% to 1.9%). termined systems give a somewhat better agreement. The The open bars in Fig. 5 represent the results obtained shaded bars in Fig. 5 show the results obtained with the when the specific models and the absorptivities of LBH specific models based on the absorptivities of human were used. The bars represent the differences with respect hemoglobin, again with respect to the true values. In to the true values of the four LBH mixtures in the same addition, the results obtained with various multiwave- manner as those in Fig. 4. It seems that the more overde- length hemoglobin photometers at different laboratories are presented by the solid bars. It should be noted that in the calculations underlying the open bars, the only difference with the determination of the true values is the use of a limited set of wave- lengths. The shaded bars show a greater deviation from the true values because in these calculations the use of the absorptivities of human hemoglobin instead of LBH ab- sorptivities comes in addition to the selection of a limited set of wavelengths. These bars are the result of the closest simulation of the multiwavelength hemoglobin photom- eters, for which the actual outcome is presented by the solid bars. The differences between the simulated multi- wavelength hemoglobin photometers, as given by the shaded bars, and the true values are often, but not in all cases, in agreement with the differences between the Fig. 3. Changes in the fractions of O2Hb, COHb, and MetHb during first results of the actual multiwavelength photometers and hour after reconstitution of an LBH mixture. the true values, as presented by the solid bars. Clinical Chemistry 44, No. 11, 1998 2337 Fig. 5. Fractions of O2Hb (FO2Hb), COHb (FCOHb), and MetHb (FMetHb) of four LBH mixtures as calculated with the general model and absorptivities of LBH (true values, second column), as calculated with the various specific models and absorptivities of LBH and human hemoglobin, respectively, and as measured with various multiwavelength hemoglobin photometers. The open bars represent the values calculated with the specific models and the LBH absorptivities minus the true values. The shaded bars represent the values calculated with the specific models and the human absorptivities minus the true values. The solid bars represent the values measured with the various multiwavelength hemoglobin photometers minus the true values. l, wavelength. Discussion For practical reasons we preferred bovine blood as Although a stable solution of a single hemoglobin deriv- starting material. It can be obtained easily, can be pro- ative (MetHb cyanide) has been in general use for at least cessed without the precautionary measures necessary in the last 30 years as an international reference solution handling human blood, and its spectrophotometric prop- (13, 14), the preparation of a stable solution containing erties are only slightly different from those of human known concentrations of various hemoglobin derivatives blood (12). Because we chose a dry material, which must proved to be beset with difficulties. The work of be redissolved by adding water, we had to restrict the Sprokholt and co-workers (9, 10), however, in which mixture to the three components O2Hb, COHb, and hemoglobin was used primarily as an oxygen buffer in MetHb. Ideally, a four-component mixture including blood gas quality-control material, led to a technique for HHb, which would have allowed us to check the oxygen the preparation of an SFH solution containing fractions of saturation measurement simultaneously, would have O2Hb, COHb, and MetHb, which remained constant for been preferable; however, the strict control of Po2 neces- .400 days. On the basis of this experience, we developed sary for the presence of a constant fraction of HHb has, to the present material and tested its potential for quality date, proven to be an insurmountable problem. assessment in spectrophotometric MCA of hemoglobin As is shown in Table 1, there is hardly any difference derivatives. between the solutions obtained after reconstitution of 2338 Maas et al.: Lyophilized bovine hemoglobin in MCA of hemoglobin different vials containing the same mixture of LBH deriv- globin is slight enough to consider LBH a fair substitute atives. Reconstitution with water with a very high Po2 for human hemoglobin in spectrophotometric MCA. shows that there is indeed practically no HHb present in As with the present methods, the results of MCA of the mixtures. Although part of the differences found hemoglobin derivatives are not completely independent between the two reconstitution procedures is statistically of the set of wavelengths used; we therefore investigated significant, the amount of HHb actually present in the the relevance of these differences with the help of our mixtures is negligible for all practical purposes. The computer model, by varying the set of wavelengths while long-term stability of the LBH preparations warrants a keeping absorbances and absorptivities constant. The shelf-life of .1 year when the vials are kept at 2– 8 °C. difference in the results obtained with the specific models After reconstitution, there is ample time for the measure- in comparison with the general model, as illustrated by ments, as shown by Fig. 3. the open bars in Fig. 5, seems to confirm the theoretical Comparison of the absorptivities of LBH with those of expectation that measuring at more wavelengths allows bovine and human hemoglobin, as presented in Figs. 1 better analysis of a multicomponent mixture. However, it and 2 and in Table 2, shows that processing of bovine also appears that the selection of particular wavelengths hemoglobin, i.e., preparation of the stroma-free solution has a distinct influence on the results. and lyophilization, storage, and reconstitution of the Each of the specific models used in combination with solution, has little influence on the absorption spectra of the absorptivities of human hemoglobin was the closest the hemoglobin derivatives. However, it appears that the simulation of a particular multiwavelength hemoglobin affinity of LBH MetHb for the OH2 ion is different from photometer we could make. As shown by the shaded bars that of bovine hemoglobin, as demonstrated by the upper in Fig. 5, the results thus calculated for the four LBH panel of Fig. 2; the best coincidence between the absorp- mixtures are in fairly good agreement with the true tivity spectra of LBH MetHb and bovine MetHb is ob- values, with the exception of the four-wavelength model, in which the results sometimes differ .5% from the true tained at different pH values. The pH that ensues after values. Fig. 5 also shows that the deviation of the results reconstitution of the LBH solution is 7.26, which is within obtained with the various multiwavelength hemoglobin the range of pH values of freshly hemolyzed bovine photometers from the true values (solid bars) is in quite a blood, i.e., the pH at which the absorptivities of bovine few cases not in agreement with the deviation of the hemoglobin have been determined (12). The pH of freshly results of the corresponding specific model from the true hemolyzed human blood is ;7.21; the absorptivities of values. Several properties of the multiwavelength hemo- human blood have therefore been measured at this pH globin photometers are obviously not taken into account value (11). The fairly good agreement between the absorp- in the specific models or are considered in a different way. tivities of LBH MetHb at pH 7.26 and human MetHb at There may be differences in spectral band width, in the pH 7.21, as shown in the lower panel of Fig. 2, was a good absorptivities used, and in the way the fractions of the reason to keep the pH of reconstituted LBH at 7.26, hemoglobin derivatives are calculated from the absor- instead of lowering it to the value that gave best agree- bances. Moreover, the difference in temperature between ment of the absorption spectrum with that of bovine the calculations, which were based on absorbances and hemoglobin. absorptivities measured at room temperature, and the We termed the O2Hb, COHb, and MetHb fractions, multiwavelength hemoglobin photometers, which usu- determined with the general model and with the absorp- ally are at 37 °C, may have played a part. As shown by tivities of the pure LBH solutions, the true values. These Steinke and Shepherd (15), temperature has a small but values have been used as baseline values in Figs. 4 and 5. appreciable influence on the absorption spectra of O2Hb, We realize that this term is only justified within the COHb, and HHb. This influence, however, can hardly perspective of what is presently attainable with spectro- account for much of the difference between calculated photometric methods. Because the method used to obtain and measured values, because the measured absorbances the true values is not different from the one that had been and the absorptivities used in the calculations will be checked thoroughly earlier by means of other, as far as similarly influenced by the differences in temperature. For possible, nonspectrophotometric methods (2), the uncer- MetHb the situation is more complex, because the higher tainty in the true O2Hb, COHb, and MetHb fractions may temperature in the hemoglobin photometers will lower be assumed not to exceed 6 2%.6 the pH, and any difference in OH2 affinity between LBH As shown in Fig. 4, the influence of using the absorp- MetHb and human MetHb might have yielded a less tivities of bovine hemoglobin instead of those determined perfect agreement at 37 °C between the spectra of human for LBH is negligible for all practical purposes, as could be and LBH MetHb than the one shown in the lower panel of expected on the basis of the absorptivity spectra shown in Fig. 2. Figs. 1 and 2. This confirms that the reconstituted LBH Possible differences in the mathematical processing of solution is spectrophotometrically equivalent with fresh the absorbance data even within the same type of multi- bovine hemoglobin. Fig. 4 also shows that the error wavelength hemoglobin photometer have been suggested introduced by using the absorptivities of human hemo- by the work of Gourlain et al. (16) who, in their investi- Clinical Chemistry 44, No. 11, 1998 2339 gation of the interference of methylene blue in MCA of References hemoglobin by various instruments, found that methyl- 1. Zwart A, Buursma A, van Kampen EJ, Oeseburg B, van der Ploeg ene blue affected the OSM3 and the Radiometer ABL520 PHW, Zijlstra WG. A multi-wavelength spectrophotometric method differently. The two instruments contain the same photo- for the simultaneous determination of five haemoglobin deriva- tives. J Clin Chem Clin Biochem 1981;19:457– 63. metric system; therefore, differences in data processing 2. Zwart A, Buursma A, van Kampen EJ, Zijlstra WG. Multicomponent must be responsible for the difference in methylene blue analysis of hemoglobin derivatives with a reversed-optics spectro- interference. In the present investigation we could not photometer. Clin Chem 1984;30:373–9. analyze any differences between these instruments be- 3. Brown LJ. A new instrument for the simultaneous measurement of cause we did not receive the results of the field trial with total hemoglobin, % oxyhemoglobin, % carboxyhemoglobin, % LBH separately for the OSM3 and the ABL520. methemoglobin, and oxygen content in whole blood. IEEE Trans Our attempt to establish more accurate target values Biomed Eng 1980;27:132– 8. for the LBH preparations in the various multiwavelength 4. Fogh-Andersen N, Siggaard-Andersen O, Lundsgaard FC, Wimber- hemoglobin photometers by computer simulation of the ley PD. Diode-array spectrophotometry for simultaneous meas- urement of hemoglobin pigments. Clin Chim Acta 1987;166: measuring systems implemented in these instruments 283–9. was only partly successful. However, this approach may 5. Zwart A, Buursma A, Oeseburg B, Zijlstra WG. Determination of be useful for studying the influence of factors such hemoglobin derivatives with the IL282 CO-oximeter as compared as wavelength selection or differences in absorptivities with a manual five-wavelength method. Clin Chem 1981;27: on MCA of hemoglobin derivatives. The possible inter- 1903–7. ference by contaminating dyes, as described by Gourlain 6. Zijlstra WG, Buursma A, Zwart A. Performance of an automated et al. (16), probably can be studied more easily in six-wavelength photometer (Radiometer OSM3) for routine mea- this way. surement of hemoglobin derivatives. Clin Chem 1988;34:149 – 52. The data for Fig. 5 suggest that our simulation is best 7. Mahoney JJ, Vreman HJ, Stevenson DK, van Kessel AL. Measure- for the OSM3 and the CCD270, although certainly not ment of carboxyhemoglobin and total hemoglobin by five special- perfect. In these cases, when the results obtained with the ized spectrophotometers (multiwavelength hemoglobin photome- corresponding model had been taken as the target values ters) in comparison with reference methods. Clin Chem 1993;39: instead of our true values for the four LBH preparations, 1693–700. the agreement with the results obtained with the actual 8. Sedor FA, Holleman CM. Evaluation of the IL482 CO-Oximeter. Clin instruments would have been better. Chem 1987;33:1942–3. Apart from these considerations, the potential of LBH 9. Sprokholt R. Quality control in blood gas chemistry [Thesis]. as a reference material is shown by the fact that the Utrecht, The Netherlands: University of Utrecht, 1987: 205 pp. fractions as measured with the multiwavelength hemo- 10. Sprokholt R, van Ooik S, van den Camp RAM, Bouma BN, Zijlstra WG, Maas AHJ. Quality control material containing hemoglobin for globin photometers are generally within 6% of the true blood gas and pH measurement: preparation of stroma-free values and that often the agreement is much better. This is hemoglobin solution. Scand J Clin Lab Investig 1987;47(Suppl a promising result in light of the present limitations of 188):69 – 82. spectrophotometric MCA, which include a high sensitiv- 11. Zijlstra WG, Buursma A, Meeuwsen-van der Roest WP. Absorption ity to small differences in wavelength, the varying influ- spectra of human, fetal and adult oxyhemoglobin, deoxyhemoglo- ence of turbidity as a result of different procedures used bin, carboxyhemoglobin, and methemoglobin. Clin Chem 1991; for hemolysis and turbidity control, and the uncertainty in 37:1633– 8. the true values. 12. Zijlstra WG, Buursma A. Spectrophotometry of hemoglobin: ab- sorption spectra of bovine oxyhemoglobin, deoxyhemoglobin, car- boxyhemoglobin, and methemoglobin. Comp Biochem Physiol 1997;118B:743–9. In summary, it has been demonstrated that stable LBH 13. ICSH. Recommendations for reference method for haemoglobi- can be prepared containing constant mixtures of O2Hb, nometry in human blood (ICSH standard 1995) and specifications COHb, and MetHb, which after reconstitution yields a for international haemiglobincyanide reference preparation, 4th hemoglobin solution that is spectrophotometrically equiv- ed. J Clin Pathol 1996;49:271– 4. alent with a solution of fresh bovine hemoglobin. The 14. Zijlstra WG. Standardisation of haemoglobinometry: history and new challenges. Comp Haematol Int 1997;7:125–32. results obtained thus far with an LBH preparation show 15. Steinke JM, Shepherd AP. Effects of temperature on optical its suitability as a quality-control material for photometric absorbance spectra of oxy-, carboxy-, and deoxyhemoglobin. Clin MCA of hemoglobin. Using a computer model of a Chem 1992;38:1360 – 4. particular multiwavelength hemoglobin photometer may 16. Gourlain H, Bunneaux F, Bozzon SW, Gouget B, Levillain P. become a suitable method for more accurately assigning Interferences of methylene blue with CO-Oximetry of hemoglobin target values to a particular LBH mixture. derivatives. Clin Chem 1997;43:1078 – 80. Article Clinical Chemistry (1998) (512.0 KB)
CueSee® Glucose EQAS
Product Specific
- !"""" !"" "" !""#"" !""!"" !"" "" !""$"" !""%"" !""&"" !""'"" !"""" !""" !" "" !"#$#%&' % "%!%()*)+# ,() (-./* '%& '& #%%' )- -# ,+ ,-./*##&$' %%% )- -# -. 0-.''-1.-+%)-+'+-)--.-+ ++- -+)2+-+ ---+++- /)'+ )2+#()-+'-+)2+-.-+3-)-4 56 -.+3-)-4 # 56# 7)- *60 8-9 *60 !/9 /+---- -3-)/# 7.+- ().)-8/ '-:'+%-.+- )-+ '/+)8-.%--.+# # (/ - -'+3-).+;-.++-<'8+;-90 < 1--.-# ! (0 / 7)- *60 8- *)/.- !/ -+3-)'/ 3 4-+ 7.+- =-- * 1% 3. - -.)-.'+# Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 $ / ( 7+ +'- -3-)3#>+1+1--6'-8' )+'-+-# --+'+1+-+-1-%+% 1) -+'+# % -00 ?-. ,3=1/ - . ,''' %+09>'77-++--)'8.-+# & 1( 2/3//4( ,3=1/ - ' 5 3 ( '? @ ;< "--.'-;A9< @ A96@ A, -.'-;A9< @ A96@ A, '+--';A9< @ A96@ A, ,+)'-;A9< * 1# '+1+-';A9< *60 91+-1--/;+-%.+< *60 !:'+-)-+-+ *60 !:'+---+ *60 B:--2-.)-+-+ *60 $''++;8 < *60 $'+-/ *60 0'' -+'%+3 90 -+) B B++ )/+-+ -C- 1--/-3 1 " 4 . -++--)'8.-+# -+)-/+13)''/+# *)2+'+--'+83# 620 ( 0-.''-1.-+%)-+'+-)--.-+ ++- -+)2+-+ ---+++- /)'+ )2+#()-+'-+)2+-.-+3-)-4 56 -.+3-)-4 # 56# 0620 ( 0-.''-1.-+%)-+'+-)--.-+ ++- -+)2+-+ ---+++- /)'+ )2+#()-+'-+)2+-.-+3-)-4 56 -.+3-)-4 # 56# Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 # ,/( -+'+ -.3+#9+-)--+ '' -+'+# ! 6/ ( 0-.B(70(0%)'-+++- -+ *B*?0D0 B> ')-''-.* *60 ()-* >**1 *60 ?29++ 8.-.=' *60 1;+< *60 8-.7+-; ++.0- < *60 8-.7+-;9.0- < *60 )-''-.9-(/' *60 +>- 91-- 90 ;--.< .++-;--. < 70 ,>=>7!7*!,B 7 B (0(7B*E $ 8 ( ()'--+:'++)-)+ C- -:'+3-)-!"#$#F 1-))- --)--++ ) )-+- /)#-)+ )-+- -)+'--+) --+ + )'3-)-) !"#$#%--+)++G 1-.-+++ + )'# -++ H/ % Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Material Safety Data Sheet (119.9 KB)
- GlucoTrol-WB a highly commutable whole blood quality control for glucose point-of-care testing Carla Huizing 1, Bart Jungerius 1, Deb Phaup 2, Bart Maas 1 1 Eurotrol BV, Keplerlaan 20, 6716 BS Ede, The Netherlands; 2 Eurotrol Inc, 563 Main Street, Bolton MA 01740, USA Problem Glucose point-of-care testing (POCT) is mainly performed on fresh whole blood. In whole blood samples, the glucose concentration rapidly decreases due to glycolysis. In Quality Controls (QC's) currently used the loss of glucose is prevented in several ways: addition of glycolysis inhibitors, fixation of the red blood cells, use of a plasma/serum based matrix or even an aqueous matrix. A disadvantage of these matrix alterations is a noncommutability of the QC's with different POCT devices. Our aim was to develop a glucose QC compatible with all glucose POCT devices, with minimal matrix effects: GlucoTrol-WB (Whole Blood). Solution GlucoTrol-WB was produced by separation of the blood cells from the blood plasma. The plasma was spiked with glucose. The cell fraction and plasma fraction were separately stored in a two compartment container at 2-8 °C. Prior to use, the cells were completely mixed with the plasma to reconstitute a whole blood sample (patent pending). Performance of GlucoTrol-WB Comparison to other glucose QCs 3 levels of GlucoTrol-WB were tested on 19 different glucose POCT Of all tested QC's GlucoTrol-WB has devices at Eurotrol and compared to fresh human EDTA blood. the lowest imprecision. 40 12 14 8 mean=1.33 mmol/L mean=5.52 mmol/L mean=21.7 mmol/L CV % 10 sd=0.30 %CV=22.56 Mean=1.84 mmol/L 12 10 sd=0.80 %CV=14.49 Mean=5.52 mmol/L 7 6 sd=2.95 %CV=13.59 GlucoTrol-WB 30 8 SD=0.46 SD=0.80 5 %CV=0.25 %CV=0.14 frequency 8 frequency fre quen cy 6 4 6 20 4 3 4 2 2 2 1 0 0 0 10 0,4 0,6 0,8 1 1,2 1,4 1,6 1,8 2 2,2 2,4 3,5 4 4,5 5 5,5 6 6,5 7 7,5 8 13 14 15 16 17 18 19 20 21 22 23 24 25 glucos e, m m ol/L glucose, mmol/L gluc os e, m m o l/L 0 Human w hole blood GlucoTrol-WB Inhibitor Plasma QC A queous QC Fixed cells 12 14 8 mean=1.84 mmol/L mean=6.49 mmol/L mean=17.9 mmol/L 10 sd=0.46 sd=0.75 7 sd=2.51 %CV=25.00 12 %CV=11.56 6 %CV=14.02 Human whole 8 10 Joint analysis of results of different QCs (normal level) 8 5 blood over 22 Glucose POCT devices frequency frequency 6 4 frequency 6 4 3 4 Advantages of GlucoTrol-WB 2 2 2 1 0 0 0 1 1,2 1,4 1,6 1,8 2 glucos e, m m ol/L 2,2 2,4 2,6 2,8 3 4,5 5 5,5 6 glucose, mmol/L 6,5 7 7,5 8 8 ,5 9 13 14 15 16 17 18 19 glucose, m m ol/L 20 21 22 23 24 25 - compatible with all POCT devices On all tested levels the imprecision (%CV) of GlucoTrol-WB is - no interfering additives comparable with the imprecision of human whole blood. - long shelf life GlucoTrol-WB was also tested on 30 different POCT devices in several Stability laboratories. The results show a low imprecision and a high The shelf life of GlucoTrol-WB is commutability. GlucoTrol-WB at least 8 weeks at 2-8 °C. 140 140 140 During this shelf life the n = 411 n = 434 n = 434 120 100 mean = 1.7 sd = 0.44 % CV = 25.88 120 100 mean = 7.93 sd = 0.94 % CV = 11.85 120 100 mean = 13.24 sd = 1.31 % CV = 9.89 reconstituted blood shows no 25 percentile = 1.4 signs of detoriation 25 percentile = 7.3 25 percentile = 12.4 75 percentile = 2.0 frequency 80 80 75 percentile = 8.4 75 percentile = 14.0 80 frequency frequency 60 60 60 40 40 40 After reconstitution GlucoTrol-WB 20 20 can be used for 5 hours. 20 0 0 0 0 0.3 0.6 0.9 1.2 1.5 1.8 2.1 2.4 2.7 3 3.3 3.6 5.1 5.9 6.7 7.5 8.3 9.1 9.9 10.7 11.3 9 9.5 10 10.5 11 11.5 12 12.5 13 13.5 14 14.5 15 15.5 16 16.5 17 glucose, mmol/L glucos e, mmol/L glucos e, m mol/L Conclusions GlucoTrol-WB: • performance comparable to fresh human whole blood • compatible with all glucose POCT devices • low imprecision • high commutability www.eurotrol.com Scientific Poster - A Highly Commutable Whole Blood Quality Control for Glucose Point-of-Care Testing (52.9 KB)
- CueSee® Glucose EQAS sample shipping dates and deadlines for 2019 Month Week SHIP DATE1 DEADLINE DATE2 SAMPLE CODE January 3 2019-01-14 2019-01-28 2541901 February 7 2019-02-11 2019-02-25 2541902 March 11 2019-03-11 2019-03-25 2541903 April 15 2019-04-08 2019-04-233 2541904 May 19 2019-05-06 2019-05-20 2541905 June 23 2019-06-03 2019-06-184 2541906 July 28 2019-07-08 2019-07-22 2541907 August 33 2019-08-12 2019-08-26 2541908 September 37 2019-09-09 2019-09-23 2541909 October 41 2019-10-07 2019-10-21 2541910 November 45 2019-11-04 2019-11-18 2541911 December 49 2019-12-02 2019-12-16 2541912 1 Samples are shipped on Mondays. Depending on the location in Europe, the samples will be received on Tuesday or later in that week. 2 Within two weeks results should be measured and reported on the website www.CueSee-Online.com Deadlines are on Mondays at 15:00 hours and reports can be obtained afterwards. 3 Deadline on a Tuesday because of Dutch Public Holiday Monday 2019-04-22 4 Deadline on a Tuesday because of Dutch Public Holiday Monday 2019-06-10 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Shipping dates and deadlines for 2019 (35.8 KB)
- CueSee® Glucose EQAS CueSee® Glucose EQAS CueSee® Glucose EQAS Intended Use Beoogd gebruik Usage prévu CueSee® Glucose EQAS is an unassayed glucose quality CueSee® Glucose EQAS is een glucose kwaliteits- CueSee® Glucose EQAS est un matériel non testé de contrôle control material especially designed for application in External controlemateriaal dat speciaal ontwikkeld is voor gebruik in qualité de glucose spécialement conçu pour être utilisé dans Quality Assessment and Proficiency Testing Schemes to verify Externe kwaliteitscontrole programma’s om de precisie en de l’évaluation externe de la qualité et les tests d’aptitude pour the precision and accuracy of blood glucose meters (BGMs). nauwkeurigheid van bloedglucosemeters vast te stellen. vérifier la précision et l’exactitude des glucomètres. Reagents Reagentia Réactifs CueSee® Glucose EQAS contains bovine packed blood cells CueSee® Glucose EQAS bevat geconcentreerde rode CueSee® Glucose EQAS contient des globules rouges de bovin and plasma and is available at various physiologically relevant bloedcellen en plasma van runderen en is beschikbaar in diverse et du plasma et est disponible en différentes concentrations levels. fysiologisch relevante levels. physiologiquement pertinentes. Storage and stability Bewaring en stabiliteit Conservation et stabilité CueSee® Glucose EQAS must be stored at 2-8 °C (35-46 °F). CueSee® Glucose EQAS dient bewaard te worden bij CueSee® Glucose EQAS doit être stocké entre 2 - 8°C Stored unopened at this temperature it is guaranteed stable until 2 - 8°C (35 - 46°F). Indien CueSee® Glucose EQAS ongeopend (35 - 46°F). Conservé fermé à cette température, il est garanti the expiration date as indicated on the label on the box. After bewaard wordt bij deze temperatuur is het gegarandeerd stabiel stable jusqu’à la date de péremption comme indiqué sur reconstitution CueSee® Glucose EQAS is stable for 4 hours at tot de vervaldatum die vermeld staat op het label van de doos. l’étiquette de la boîte. Après reconstitution, CueSee® Glucose 15-30 °C (59-86 °F). Na reconstitutie is CueSee® Glucose EQAS 4 uur stabiel bij EQAS est stable pendant 4 heures à 15 - 30°C (59 - 86°F). Procedure 15 - 30°C (59 - 86°F). Procédures 1. Read all instructions carefully before preparing the sample. Werkwijze 1.Lire attentivement toutes les instructions avant de See instructions for preparing the ACU-Drop® II sample. Visit 1. Lees zorgvuldig alle instructies om het ACU-Drop® II préparer l’échantillon. Regarder les instructions pour www.eurotrol.com for an instructional video for preparing an monster te bereiden. Op www.eurotrol.com kunt u eveneens een préparer l’échantillon ACU-Drop® II. Consulter le site ACU-Drop II sample. instructievideo raadplegen. www.eurotrol.com pour visionner une vidéo éducative pour la 2. Allow the product to stand for 15 minutes at room temperature 2. Laat het product gedurende 15 minuten op kamertemper- préparation de l’échantillon ACU-Drop II. (15 – 30°C / 59 – 86°F). Note: Do not put vials back into atuur tot rust komen (15 - 30°C / 59 - 86°F). Opmerking: 2. Laisser le produit reposer 15 minutes à température ambiante refrigerator once exposed to room temperature. plaats het product niet opnieuw in de koelkast nadat het aan (15 - 30°C / 59 - 86°F). Note: Ne pas replacer les fioles au 3. Follow instructions on the back side of this document carefully kamertemperatuur bloot gesteld werd. réfrigérateur une fois qu’elles ont exposées à température to obtain a homogeneous CueSee® Glucose EQAS sample. 3. Volg zorgvuldig de instructies op de achterzijde van dit document ambiante. NOTE: to avoid excessive foaming make sure that every om een homogeen CueSee® Glucose EQAS staal te bekomen. 3. Suivre attentivement les instructions au dos de ce document afin step is performed slowly and gently. NOTE: om overmatige schuimvorming te voorkomen dient d’obtenir un échantillon CueSee® Glucose EQAS homogène. 4.The sample may be used at 15 - 30 °C (59 - 86 °F) for 4 hours elke stap langzaam en rustig te worden uitgevoerd. NOTE: Pour éviter la formation d’un excès de mousse, after reconstitution. 4.Na reconstitutie kan het monster 4 uur gebruikt worden bij assurez-vous que chaque étape soit réalisée avec Precautions 15 - 30°C (59 - 86°F). douceur. 1. For in vitro diagnostic use only. Voorzorgsmaatregelen 4.L’échantillon peut être utilisé à 15 - 30°C (59 - 86°F) jusqu’à 2. This is a bovine animal product and does not contain 1. Alleen voor in-vitro diagnostisch gebruik. 4 heures après reconstitution. biohazards to humans such as HepB, HepC and HIV. This 2. Dit is een runderbloed product en het bevat geen voor de mens Precautions product is free from TSE. gevaarlijke pathogenen als HBV, HCV en HIV. Het product is 1. Pour le diagnostic in vitro uniquement. 3. This product should not be disposed of in general waste. vrij van TSE. 2. C’est un produit d’origine bovine et il ne contient pas de Consult local environmental authorities for proper disposal. 3. Het product mag niet verwijderd worden met het gewone afval. pathogènes humains comme HBV, HCV, VIH . Ce produit est Expected results Raadpleeg de lokale autoriteiten voor de juiste afvoer. exempt d’ESB. Each lab should establish its own results and report them at Te verwachten resultaten 3. Ce produit ne doit pas être éliminé avec les déchets ordinaires. CueSee® Online (http://www.cuesee-online.com) to obtain peer Voor het verkrijgen van vergelijkbare resultaten en Consulter vos responsables locaux pour une élimination group analysis and summary reports. een overzichtsrapport dient elk laboratorium zijn eigen adéquate. resultaten vast te stellen en te rapporten op CueSee® Online Résultats attendus (http://www.cuesee-online.com). Chaque laboratoire doit établir ses propres résultats et les communiquer en ligne à CueSee® (http://www.cuesee-online.com) pour obtenir une évaluation (peer group) et des rapports de synthèse. For further information or technical assistance, please contact: Voor verdere informatie of technische hulp, neem contact op met: Pour plus d’information ou pour une assistance technique, veuillez contacter: Eurotrol B.V. Eurotrol B.V. Eurotrol B.V. Phone +31 318 695 777 Tel +31 318 695 777 Tél +31 318 695 777 Fax +31 318 695 770 Fax +31 318 695 770 Fax +31 318 695 770 E-mail office@eurotrol.com E-mail office@eurotrol.com E-mail office@eurotrol.com Website www.eurotrol.com Website www.eurotrol.com Website www.eurotrol.com Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Pays-Bas Symbols used Gebruikte symbolen Symboles utilisés Attention, see instructions for use Batch number Opgelet, lees de gebruiksaanwijzing Lotnummer Attention, se référer aux Numéro de lot instructions Use by Temperature limitation Te gebruiken voor Bewaartemperatuur Restriction de température Utilisé par Manufacturer Reference number Fabrikant Referentienummer Numéro de référence INP 254-R01 20150909 Fabricant INP 254-EN-R01 20150903 INP 254-NL-R01 20150909 INP 254-FR-R01 20150903 IFU 254-R02 20160222 Instructions for preparing an ACU-Drop® II sample Instructies voor het bereiden van een ACU-Drop® II monster Instructions pour préparer un échantillon ACU-Drop® II Instruction A - Sampling with Dropper Tip Instruction B - Sampling with Syringe Instructie A - Bemonstering met de Dropper Tip Instructie B - Bemonstering met de spuit Instruction A - Echantillonnage avec le compte- gouttes Instruction B - Echantillonnage à la seringue 1 A1 - Press the button firmly until it is completely pushed in and level with the indentation. B1 - Press the button firmly until it is completely pushed in and level with the indentation. 2 A1 - Duw stevig op de knop tot hij volledig ingedrukt is tot op de hoogte van de inkeping. B1 - Duw stevig op de knop tot hij volledig ingedrukt is tot op de hoogte van de inkeping. A1 - Presser fermement le bouton jusqu’à ce qu’il soit complétement enfoncé jusqu’au B1 - Presser fermement le bouton jusqu’à ce qu’il soit complétement enfoncé jusqu’au niveau de l’échancrure. niveau de l’échancrure. A2 - Gently rock and swirl at least 5 times to mix the liquids completely. B2 - Gently rock and swirl at least 5 times to mix the liquids completely. A2 - Zwenk en draai het product voorzichtig minstens 5 maal om de vloeistoffen volledig te B2 - Zwenk en draai het product voorzichtig minstens 5 maal om de vloeistoffen volledig te mengen. mengen. A2 - Agitez doucement de haut en bas au moins 5 fois pour mélanger les liquides B2 - Agitez doucement de haut en bas au moins 5 fois pour mélanger les liquides complètement. complètement. 5 3 A3 - Hold the ACU-Drop II with cap facing up and flick the cap firmly several times to make B3 - Twist the adaptor onto the tip of either a luer lock or standard syringe. 4 sure that no liquid remains inside the dropper tip. A3 - Houd de ACU-Drop II met het dopje omhoog en tik een aantal keer stevig tegen het B3 - Draai de adapter op de de top van de luer lock of van de standaardspuit. dopje om zeker te zijn dat er geen vloeistof in blijft hangen. 6 A3 - Maintenir l’ACU-Drop II en position verticale et secouer le bouchon pour vous assurer B3 - Placer l’adaptateur sur le bout d’une seringue à verrouillage (Luer Lock) ou d’une qu’aucun liquide ne reste à l’intérieur de la pointe du compte-gouttes. seringue standard. 7 B4 - Hold the ACU-Drop II with cap facing down and flick the bottom firmly several times to be sure that all the liquid settles. Push the adaptor tip attached to the syringe firmly A4 - Open the flip cap very carefully by lifting the cap just a little bit to release the pressure. into the luer fitting on the button of the ACU-Drop II. - Only with first time use - 8 B4 - Houd de ACU-Drop II met het dopje naar beneden en tik een aantal keer stevig tegen A4 - Open voorzichtig het dopje om de druk te laten ontsnappen. - Enkel bij de eerste de bodem om zeker te zijn dat alle vloeistof vrijkomt. Duw de adapter tip op de spuit ingebruikname - stevig in de luer fitting in de onderkant van de ACU-Drop II. A4 - Ouvrez le bouchon rabattable très soigneusement en soulevant le bouchon un peu B4 - Tenir l’ACU-Drop II à l’envers et tapoter quelque fois pour être sûr que le liquide coule. 1 dropper tip pour relâcher la pression. - Seulement lors de la première utilisation - Poussez fermement l’adaptateur dans le trou au fond de l’ACU-Drop II. 2 cap 3 indentation 4 button 5 luer fitting B5 - Hold the ACU-Drop II with cap facing up and, using both hands on the syringe, 6 bottom view A5 - The first 2 drops should be dispensed and discarded. withdraw the contents. 7 adaptor 8 screw cap A5 - De eerste 2 druppels moeten verwijderd worden. B5 - Houd de spuit met beide handen vast met het dopje van de ACU-Drop II omhoog. Zuig met de spuit de inhoud uit de ACU-Drop II. 1 druppel tip 2 dopje A5 - Les 2 premières gouttes doivent être distribuées et éliminées. B5 - Tournez l’ACU-Drop II le bouchon en haut et, en utilisant les deux mains sur la 3 inkeping seringue, retirer le contenu. 4 knop 5 luer fitting 6 onder aanzicht 7 adapter 8 schroefdop A6 - The ACU-Drop II is now ready to use to apply a sample drop for testing. B6 - Hold the ACU-Drop II with cap facing down and carefully unscrew the syringe from the adaptor, leaving the adaptor in the button of the ACU-Drop II. 1 sommet du compte-gouttes B6 - Houd de ACU-Drop II met het dopje naar beneden en draai de spuit voorzichtig van 2 bouchon A6 - De ACU-Drop II is nu klaar voor gebruik waarbij één druppel per test gebruikt dient te 3 échancrure worden. de adapter waarbij u de adapter in de knop van de ACU-Drop II laat zitten. 4 bouton A6 - L’ ACU-Drop II est maintenant prêt à l’emploi pour utiliser une goutte d’échantillon pour B6 - Tenir l’ACU-Drop II l’envers et dévisser doucement la seringue de l’adaptateur, tout 5 luer fitting être testée. en laissant l’adaptateur dans le fond. 6 vue d’en bas 7 adaptateur 8 bouchon à visser B7 - Seal the adaptor with screw cap to discard or re-use the ACU-Drop II. (Possibility for re-use: see specific product instructions for shelf-life after reconstitution.) Use the A7 - After each use, be sure to wipe the dropper tip and inside of cap to keep them clean. syringe to deliver your sample. For instructional video go to : B7 - Sluit de adapter af met de schroefdop om de ACU-Drop II te verwijderen of te A7 - Veeg na elk gebruik de Dropper Tip en het dopje schoon om ze schoon te houden. hergebruiken. (De mogelijkheid voor hergebruik: zie de vervaldatum van het product Voor instructievideo ga naar: na reconstitutie.) Gebruik de spuit om het monster aan te brengen. Pour la vidéo pédagogique aller à: A7 - Après chaque utilisation, assurez-vous d’essuyer l’embout du compte-gouttes et B7 - Sceller l’adaptateur avec le bouchon à visser pour éliminer ou réutiliser l’ACU-Drop II. l’l’intérieur du bouchon pour les garder propres. (La possibilité de réutilisation dépend de la durée de vie du produit après www.eurotrol.com/acudrop2 reconstitution.) Utilisez la seringue pour distribuer votre échantillon. INP ACU-Drop II-EN-R02-20160114 INP ACU-Drop II-NL-R02-20160208 INP ACU-Drop II-FR-R02 20160222 INP ACU-Drop II-R02 20160222 Instructions for Use (785.2 KB)
- Thank you for spending a few minutes to learn about the advantages and principles behind Eurotrol’s CueSee Glucose, a revolutionary whole blood glucose quality control. - The advantages and principles page 1 We’re all aware of the importance of glucose meters today, It is very important that results from all these glucose meters are especially with the rise in diabetes diagnoses. accurate and precise for good glycemic control. With this enormous market potential worldwide for point of care The outcome of Blood Glucose Monitoring is influenced by glucose testing, there is a huge diversity of glucose meters now • pre-analytical factors available. • the performance of the meter and test strips • the technique • variables with the patient and their sample types - The advantages and principles page 2 A good quality management system provides guidance on These QC materials have a much different matrix than fresh handling all these variables for your blood glucose testing patient whole blood and they are not suitable to detect all the program to ensure consistently reliable test results. This includes variables of blood glucose testing. your quality controls. Also, the target values provided with these products yield very Most of the commercial QC materials used consist of just water wide ranges even for that one particular glucose meter. to which glucose, salts and a buffer are added. - The advantages and principles page 3 The ideal test material would be a whole blood sample with As soon as a blood sample is drawn from a patient, the glucose glucose which has the sensitivity these meters are facing with will decrease because of glycolysis in the red blood cells. patient samples. There are various ways to block this process, but the chemicals Making a test material of whole blood with real red blood cells needed interfere with many glucose meters. with any kind of stability is not easy. - The advantages and principles page 4 Eurotrol has revolutionized quality control for blood glucose Just before use, the user simply pushes a button to allow the meters by developing CueSee Glucose. It is a real, whole blood liquids to combine. sample containing no additives. Then mix, and a whole blood sample with glucose is ready to This is accomplished by packaging CueSee Glucose in the use. ACU-Drop II, an innovative, dual-chambered device that keeps the red blood cells separated from the plasma which contains the glucose. - The advantages and principles page 5 Sampling may be done from the built-in dropper bottle or by When comparing results of aqueous control materials with attaching a syringe. CueSee Glucose and fresh human whole blood on various different glucose meters at a glucose concentration at the decision point for diabetes diagnosis, the whole blood samples obviously perform much better. The standard deviation of the aqueous material is double that of the whole blood samples! - The advantages and principles page 6 CueSee Glucose has been widely used in Europe for many years One of the reasons is that this product uniquely shows great for proficiency testing. overall results on many different brands of glucose meters. - The advantages and principles page 7 To summarize, CueSee Glucose is a unique and superior product As with all our quality control products, Eurotrol provides CueSee to validate blood glucose meters. Online, a free online service for comparing your quality control data with peers. It offers the following benefits: • It is compatible with all glucose meters • It is comparable to whole blood providing the same sensitivity as a patient sample • You can assess the performance of all glucose meters over the whole clinically relevant range • It is ideal for quality control, strip lot validations, method comparisons, AMR validation, competency testing and proficiency testing - The advantages and principles page 8 Thank you! With a simple import tool, enter your results and then generate If you would like more information or have any questions, we’re statistics, reports and graphs for your inspections. here to help. CueSee Online is a real enhancement to any quality control Thank you for your interest in CueSee Glucose! program. - The advantages and principles page 9 The advantages and principles (2.9 MB)
CueSee® Glucose-PT
Product Specific
- Instructions for preparing an ACU-Drop® II sample Instruction A - Sampling with Dropper Tip Instruction B - Sampling with Syringe A1 - Press the button firmly until it is B1 - Press the button firmly until it is dropper tip completely pushed in and level with completely pushed in and level with the indentation. the indentation. A2 - Gently rock and swirl at least B2 - Gently rock and swirl at least cap 5 times to mix the content completely. 5 times to mix the content completely. A3 - Hold the ACU-Drop II with cap facing up and flick the cap firmly B3 - Twist the adaptor onto the tip of several times to make sure that no either a luer lock or standard syringe. liquid remains inside the dropper tip. B4 - Hold the ACU-Drop II with cap A4 - Open the flip cap very carefully by facing down and flick the bottom firmly lifting the cap just a little bit to release several times to be sure that all the liquid luer fitting the pressure. settles. Push the adaptor tip attached to -Only with first time use- the syringe firmly into the luer fitting on indentation the button of the ACU-Drop II. button A5 - The first 2 drops should be B5 - Hold the ACU-Drop II with cap dispensed and discarded. facing up and, using both hands on bottom the syringe, withdraw the contents. adaptor view B6 - Hold the adaptor with the ACU-Drop II A6 - The ACU-Drop II is now ready to cap facing down and carefully unscrew the use to apply a sample drop for testing. syringe, leaving the adaptor in the button of the ACU-Drop II. For instructional video go to A7 - After each use, be sure to wipe the B7 - Discard the ACU-Drop II with the www.eurotrol.com/acudrop2 dropper tip and inside of cap to keep adaptor and use the syringe to deliver them clean. your sample. INP AD-II and Adaptor-R01 20171214 Instructions for Use - Preparing an ACU-Drop® II sample (580.5 KB)
- Thank you for spending a few minutes to learn about the advantages and principles behind Eurotrol’s CueSee Glucose, a revolutionary whole blood glucose quality control. - The advantages and principles page 1 We’re all aware of the importance of glucose meters today, It is very important that results from all these glucose meters are especially with the rise in diabetes diagnoses. accurate and precise for good glycemic control. With this enormous market potential worldwide for point of care The outcome of Blood Glucose Monitoring is influenced by glucose testing, there is a huge diversity of glucose meters now • pre-analytical factors available. • the performance of the meter and test strips • the technique • variables with the patient and their sample types - The advantages and principles page 2 A good quality management system provides guidance on These QC materials have a much different matrix than fresh handling all these variables for your blood glucose testing patient whole blood and they are not suitable to detect all the program to ensure consistently reliable test results. This includes variables of blood glucose testing. your quality controls. Also, the target values provided with these products yield very Most of the commercial QC materials used consist of just water wide ranges even for that one particular glucose meter. to which glucose, salts and a buffer are added. - The advantages and principles page 3 The ideal test material would be a whole blood sample with As soon as a blood sample is drawn from a patient, the glucose glucose which has the sensitivity these meters are facing with will decrease because of glycolysis in the red blood cells. patient samples. There are various ways to block this process, but the chemicals Making a test material of whole blood with real red blood cells needed interfere with many glucose meters. with any kind of stability is not easy. - The advantages and principles page 4 Eurotrol has revolutionized quality control for blood glucose Just before use, the user simply pushes a button to allow the meters by developing CueSee Glucose. It is a real, whole blood liquids to combine. sample containing no additives. Then mix, and a whole blood sample with glucose is ready to This is accomplished by packaging CueSee Glucose in the use. ACU-Drop II, an innovative, dual-chambered device that keeps the red blood cells separated from the plasma which contains the glucose. - The advantages and principles page 5 Sampling may be done from the built-in dropper bottle or by When comparing results of aqueous control materials with attaching a syringe. CueSee Glucose and fresh human whole blood on various different glucose meters at a glucose concentration at the decision point for diabetes diagnosis, the whole blood samples obviously perform much better. The standard deviation of the aqueous material is double that of the whole blood samples! - The advantages and principles page 6 CueSee Glucose has been widely used in Europe for many years One of the reasons is that this product uniquely shows great for proficiency testing. overall results on many different brands of glucose meters. - The advantages and principles page 7 To summarize, CueSee Glucose is a unique and superior product As with all our quality control products, Eurotrol provides CueSee to validate blood glucose meters. Online, a free online service for comparing your quality control data with peers. It offers the following benefits: • It is compatible with all glucose meters • It is comparable to whole blood providing the same sensitivity as a patient sample • You can assess the performance of all glucose meters over the whole clinically relevant range • It is ideal for quality control, strip lot validations, method comparisons, AMR validation, competency testing and proficiency testing - The advantages and principles page 8 Thank you! With a simple import tool, enter your results and then generate If you would like more information or have any questions, we’re statistics, reports and graphs for your inspections. here to help. CueSee Online is a real enhancement to any quality control Thank you for your interest in CueSee Glucose! program. - The advantages and principles page 9 The advantages and principles (2.9 MB)
- GlucoTrol-WB a highly commutable whole blood quality control for glucose point-of-care testing Carla Huizing 1, Bart Jungerius 1, Deb Phaup 2, Bart Maas 1 1 Eurotrol BV, Keplerlaan 20, 6716 BS Ede, The Netherlands; 2 Eurotrol Inc, 563 Main Street, Bolton MA 01740, USA Problem Glucose point-of-care testing (POCT) is mainly performed on fresh whole blood. In whole blood samples, the glucose concentration rapidly decreases due to glycolysis. In Quality Controls (QC's) currently used the loss of glucose is prevented in several ways: addition of glycolysis inhibitors, fixation of the red blood cells, use of a plasma/serum based matrix or even an aqueous matrix. A disadvantage of these matrix alterations is a noncommutability of the QC's with different POCT devices. Our aim was to develop a glucose QC compatible with all glucose POCT devices, with minimal matrix effects: GlucoTrol-WB (Whole Blood). Solution GlucoTrol-WB was produced by separation of the blood cells from the blood plasma. The plasma was spiked with glucose. The cell fraction and plasma fraction were separately stored in a two compartment container at 2-8 °C. Prior to use, the cells were completely mixed with the plasma to reconstitute a whole blood sample (patent pending). Performance of GlucoTrol-WB Comparison to other glucose QCs 3 levels of GlucoTrol-WB were tested on 19 different glucose POCT Of all tested QC's GlucoTrol-WB has devices at Eurotrol and compared to fresh human EDTA blood. the lowest imprecision. 40 12 14 8 mean=1.33 mmol/L mean=5.52 mmol/L mean=21.7 mmol/L CV % 10 sd=0.30 %CV=22.56 Mean=1.84 mmol/L 12 10 sd=0.80 %CV=14.49 Mean=5.52 mmol/L 7 6 sd=2.95 %CV=13.59 GlucoTrol-WB 30 8 SD=0.46 SD=0.80 5 %CV=0.25 %CV=0.14 frequency 8 frequency fre quen cy 6 4 6 20 4 3 4 2 2 2 1 0 0 0 10 0,4 0,6 0,8 1 1,2 1,4 1,6 1,8 2 2,2 2,4 3,5 4 4,5 5 5,5 6 6,5 7 7,5 8 13 14 15 16 17 18 19 20 21 22 23 24 25 glucos e, m m ol/L glucose, mmol/L gluc os e, m m o l/L 0 Human w hole blood GlucoTrol-WB Inhibitor Plasma QC A queous QC Fixed cells 12 14 8 mean=1.84 mmol/L mean=6.49 mmol/L mean=17.9 mmol/L 10 sd=0.46 sd=0.75 7 sd=2.51 %CV=25.00 12 %CV=11.56 6 %CV=14.02 Human whole 8 10 Joint analysis of results of different QCs (normal level) 8 5 blood over 22 Glucose POCT devices frequency frequency 6 4 frequency 6 4 3 4 Advantages of GlucoTrol-WB 2 2 2 1 0 0 0 1 1,2 1,4 1,6 1,8 2 glucos e, m m ol/L 2,2 2,4 2,6 2,8 3 4,5 5 5,5 6 glucose, mmol/L 6,5 7 7,5 8 8 ,5 9 13 14 15 16 17 18 19 glucose, m m ol/L 20 21 22 23 24 25 - compatible with all POCT devices On all tested levels the imprecision (%CV) of GlucoTrol-WB is - no interfering additives comparable with the imprecision of human whole blood. - long shelf life GlucoTrol-WB was also tested on 30 different POCT devices in several Stability laboratories. The results show a low imprecision and a high The shelf life of GlucoTrol-WB is commutability. GlucoTrol-WB at least 8 weeks at 2-8 °C. 140 140 140 During this shelf life the n = 411 n = 434 n = 434 120 100 mean = 1.7 sd = 0.44 % CV = 25.88 120 100 mean = 7.93 sd = 0.94 % CV = 11.85 120 100 mean = 13.24 sd = 1.31 % CV = 9.89 reconstituted blood shows no 25 percentile = 1.4 signs of detoriation 25 percentile = 7.3 25 percentile = 12.4 75 percentile = 2.0 frequency 80 80 75 percentile = 8.4 75 percentile = 14.0 80 frequency frequency 60 60 60 40 40 40 After reconstitution GlucoTrol-WB 20 20 can be used for 5 hours. 20 0 0 0 0 0.3 0.6 0.9 1.2 1.5 1.8 2.1 2.4 2.7 3 3.3 3.6 5.1 5.9 6.7 7.5 8.3 9.1 9.9 10.7 11.3 9 9.5 10 10.5 11 11.5 12 12.5 13 13.5 14 14.5 15 15.5 16 16.5 17 glucose, mmol/L glucos e, mmol/L glucos e, m mol/L Conclusions GlucoTrol-WB: • performance comparable to fresh human whole blood • compatible with all glucose POCT devices • low imprecision • high commutability www.eurotrol.com Scientific Poster - A Highly Commutable Whole Blood Quality Control for Glucose Point-of-Care Testing (52.9 KB)
CueSee® HbA1c
Product Specific
- CueSee® HbA1c CueSee® HbA1c Intended Purpose Expected results Toepassing Verwachte resultaten CueSee® HbA1c is an assayed real glycohaemoglobin control intended for professional use in The reported ranges (mean value ± 3 SD) on the enclosed value sheet are derived from CueSee® HbA1c is een beproefd gezuiverd glycohaemoglobine controlemateriaal voor De ranges (gemiddelde waarde ± 3 SD), aangegeven op het bijgesloten waardeformulier, zijn the verification of the precision and accuracy of HbA1c instruments. The purpose of this quality replicate analysis on various methods of randomly selected vials from each batch. professioneel gebruik bij het controleren van de precisie en nauwkeurigheid van HbA1c verkregen van herhaalde analyses van willekeurig geselecteerde flesjes van de betreffende control is to validate the calibration and other performance related characteristics. IFCC values on the enclosed value sheet are determined with an IFCC calibrated HPLC methoden. Deze kwaliteitscontrole is bedoeld om de ijking en andere prestatiegerelateerde batch. analyser [1]. DCCT values are determined as IFCC values and are recalculated to the DCCT eigenschappen te controleren. IFCC waarden op de bijgevoegde waardensheet zijn bepaald met behulp van een IFCC IVD Medical Device units using the conversion factors of the Master Equations [2]. gecalibreerde HPLC analyser [1]. DCCT waarden zijn op gelijke wijze als IFCC waarden The CueSee® HbA1c control complies with the European Directive 98/79/EC on in vitro IVD Medische Instrumenten bepaald en omgerekend naar DCCT waarden met gebruikmaking van de internationale diagnostic medical devices and carries the CE mark. Please Note De CueSee® HbA1c controles voldoen aan de Europese Richtlijn 98/79/EG betreffende omrekenfactoren [2]. 1. As there is no standard method for the assay of HbA1c, actually measured values obtained medische hulpmiddelen voor in-vitro diagnostiek en dragen het CE keurmerk. Summary by the various methods will deviate from the assigned values. Deviations are proportional to Let op CueSee® HbA1c CueSee® HbA1c is a quality control available at three levels, Level 1 (low), Level 2 (normal) and Level 3 (high), each with a known glycohaemoglobin concentration (HbA1c), covering the those observed in fresh blood samples [3]. 2. In respect to fresh blood samples, substantially higher values are obtained by Abbott's IMX Samenvatting CueSee® HbA1c is een kwaliteitscontrole welke verkrijgbaar is op drie niveaus, Level 1 (laag), 1. Aangezien er geen standaardmethode beschikbaar is voor HbA1c, wijken de met verschillende methoden verkregen actuele waarden af van de toegekende waarden. De clinically relevant ranges. CueSee® HbA1c has been prepared from hemolysed and lyophilised and Vision methods. Level 2 (normaal) en Level 3 (hoog), elk met een bekende glycohaemoglobine concentratie, die afwijkingen zijn evenredig met die, waargenomen in verse bloed monsters [3]. human blood. Stabilisers and protectants (cryo/lyo protectant) are added to the matrix. It is 3. Although applicable for many methods we do not recommend or guarantee the use of control de klinisch relevante gebieden bestrijken. CueSee® HbA1c is samengesteld uit een 2. Met betrekking tot verse bloedmonsters worden substantieel hogere waarden gevonden met intended that CueSee® HbA1c should be used in the periodic verification of the precision and material that is frozen after reconstitution. gevriesdroogd humaan hemolysaat. Stabilisatoren en beschermende middelen zijn aan de de Abbott's IMX en Vision methoden. accuracy of HbA1c instruments. Instruments designed to carry out these measurements must This product has been manufactured according to Eurotrol specifications. matrix toegevoegd. CueSee® HbA1c is bedoeld voor de periodieke controle van de precisie en 3. Alhoewel toepasbaar bij vele methoden, bevelen wij het gebruik van controle materiaal dat na meet stringent requirements to warrant appropriate patients treatment. nauwkeurigheid van HbA1c analysers. Analysers, ontworpen voor dit type metingen, dienen aan reconstitutie ingevroren werd niet aan en geven wij hiervoor geen garantie. References stringente eisen te voldoen om een juiste behandeling van patiënten te kunnen garanderen. Dit product is vervaardigd volgens de specificaties van Eurotrol. Reagents 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of CueSee® HbA1c provides three physiologically relevant levels, each vial holding 0.1 mL HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. Reagentia Referenties hemolysed and lyophilised human blood. 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin CueSee® HbA1c bestaat uit drie fysiologisch relevante niveaus. Elk flesje bevat 0.1 mL 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of A1c in human blood and the national standardization schemes in the United States, Japan gevriesdroogd humaan hemolysaat. HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. Storage and stability CueSee® HbA1c should be stored unopened in the refrigerator at 2 - 8 °C. Stored unopened at and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. Bewaren en stabiliteit 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin this temperature it is guaranteed stable until the expiry date, as indicated on the vials and outer 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion CueSee® HbA1c dient ongeopend bewaard te worden in de koelkast bij 2 - 8 °C. Bewaard bij A1c in human blood and the national standardization schemes in the United States, Japan box. After opening the vial and reconstitution of the material, it is stable for 48 hours stored at 2 - of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem deze temperatuur is het gegarandeerd stabiel tot de vervaldatum, aangegeven op de flesjes en and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. 8 °C, when properly stoppered and treated according to these directions. 1994; 40:138-44. het doosje. Na openen van het flesje en reconstitutie van het materiaal is het 48 uur stabiel bij 2 - 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion 8 °C, indien afgesloten met het stopje en behandelend volgens deze procedure. of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem Procedures 1994; 40:138-44. 1. Remove metal cap and lift rubber stopper carefully. Procedures 2. Add 0,1 mL (100 µL) +/- 10 % water. (For Abbott method: add 0.1 mL physiological saline). 1. Verwijder het metalen kapje en breng de rubberstop zorgvuldig omhoog. 3. Replace stopper. 2. Voeg 0,1 mL (100 µL) +/- 10 % water toe. (Bij Abbott methode: voeg 0.1 mL fysiologische 4. Hold vial under an angle of 45° and swirl gently for 30 seconds, avoid contact between fluid zoutoplossing toe). and rubber stopper. Allow vial to stand for 15 minutes. 3. Plaats de rubberstop weer terug op het flesje. 5. Repeat step 4 until a homogeneous solution is obtained. For further information or technical assistance, please contact : 4. Houdt het flesje onder een hoek van 45° en zwenk voorzichtig gedurende 30 seconden; Voor informatie kunt u contact op met: 6. Vial is ready for use and the fluid can be analysed. Eurotrol B.V. vermijd dat de vloeistof in contact komt met de rubberstop. Laat het flesje 15 minuten staan. Eurotrol B.V. 7. Remove stopper and follow the instruction for measuring, according to the instructions in the Phone +31 318 695 777 5. Herhaal stap 4 en 5 totdat een homogene oplossing is verkregen. Tel +31 318 695 777 appropriate manual of the instrument. Fax +31 318 695 770 6. Het flesje is klaar voor gebruik en de vloeistof kan worden geanalyseerd. Fax +31 318 695 770 8. Please refer to local guidelines for recommended frequency of use. E-mail office@eurotrol.com 7. Verwijder de rubberen stop en voer de meting uit volgens de handleiding behorend bij het E-mail office@eurotrol.com www.eurotrol.com instrument. www.eurotrol.com Precautions 8. Raadpleeg de plaatselijk geldende richtlijnen voor de aanbevolen gebruiksfrequentie. 1. For in vitro diagnostic use only. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland 2. Blood Product. Human based material is tested on HBsAg, a-HCV, and a-HIV and found Voorzorgsmaatregelen negative. Handle the product with the same precautions used for patient specimens. Symbols used 1. Uitsluitend bestemd voor in vitro diagnostisch gebruik. Gebruikte symbolen 3. These products should not be disposed of in general waste. Consult local environmental 2. Product van humaan bloed, getest op HbsAG, a-HCV en a-HIV en negatief bevonden. Attention, see instructions for use Batch code Behandel dit product met dezelfde voorzorgsmaatregelen als voor patiëntenmonsters. Opgelet, lees de gebruiksaanwijzing Batchnummer authorities for proper disposal. 4. CueSee® HbA1c is not to be used as a calibrator. 3. Voorkom dat deze producten in het algemene afvalcircuit terechtkomen. Volg de ter plaatse Use by Temperature limitation geldende regels voor verantwoorde afvalverwerking. Te gebruiken voor Bewaartemperatuur 4. CueSee® HbA1c dient niet gebruikt te worden voor kalibratie. In Vitro Diagnostic Medical Device Reference number In Vitro Diagnostisch Medisch Hulpmiddel Referentienummer Manufacturer CE mark Producent CE-merkteken INP 011-GB-R06 20121015 INP 011-NL-R06 20121015 CueSee® HbA1c CueSee® HbA1c CueSee® HbA1c Verwendungszweck Zielwerte Avsett ändamål Förväntade resultat Bruksområde Forventede resultater CueSee® HbA1c ist eine Kontrolle für glykiertes Hämoglobin und dient der Überprüfung von Die Zielwerte (Mittelwert ± 3 SD) auf dem Beipackzettel beruhen auf Mehrfachbestimmungen CueSee® HbA1c är en äkta glycohemoglobinkontroll för professionellt bruk som används för att Det angivna området (medelvärde ± 3 SD) vilket anges i det bifogade analysbladet är beräknat CueSee® HbA1c er en glykert hemoglobinløsning for kontroll av presisjonen og nøyaktigheten til Det angitte området (middelverdien +/- 3 SD) på pakningsvedlegget er beregnet ut fra gjentatte Genauigkeit und Präzision von HbA1c Systemen. Der Zweck dieser Qualitätskontrolle ist die von zufällig ausgewählten Flaschen einer Charge mit unterschiedlichen Messverfahren. bekräfta precision och noggrannhet för HbA1c system. Avsikten med kvalitetskontrollen är att från upprepade analysresultat med olika metoder ur slumpvis valda flaskor från aktuell lot. IFCC HbA1c systemer og er beregnet til profesjonell bruk. Målet med kvalitetskontrollen er å bekrefte analyser med materiale tatt fra tilfeldig valgte flasker fra hver batch, målt med forskjellige Prüfung der Kalibration und anderer Leistungsmerkmale. IFCC-Werte für HbA1c werden mit einem Hochleistungsflüssigkeitschromatographen (HPLC) bekräfta kalibrering och övriga prestandarelaterade egenskaper. värdena på det bifogade analysbladet är bestämda med ett IFCC kalibrerat HPLC instrument [1]. kalibreringen og ytelsen. metoder. IVD Produkte bestimmt, der nach IFCC Standard kalibriert wurde [1]. DCCT-Werte werden als IFCC-Werte (DCCT värden är bestämda som IFCC värden och omräknade till DCCT enheter med en IFCC verdiene som står på vedlegget er bestemt med en IFCC kalibrert HPLC analysator (1). bestimmt und mit dem Umrechnungsfaktor der Meistergleichung umgerechnet in DCCT Direktiv för in-vitro diagnostik, IVD omräkningsfaktor enligt Master Equations [2]). IVD Medical Device DCCT verdiene er bestemt som IFCC verdier og er omregnet til DCCT enheter ved bruk av CueSee® HbA1c erfüllt die Europäische IVD Richtlinie 98/79/EG und trägt das CE-Zeichen. CueSee® HbA1c uppfyller kraven i EU-direktivet 98/79/EC om medicintekniska produkter för in CueSee® HbA1c er produsert i henhold til IVD Medical Device Directive 98/79/EC og er Maßeinheiten [2]. konverteringsfaktorer fra Master Equations (2). vitro diagnostik och är CE-märkt. Anmärkningar CE-merket. Zusammenfassung Bitte beachten: 1. Eftersom det inte finns någon standardmetod för bestämning av HbA1c kan uppmätta värden Bemerk CueSee® HbA1c Qualitätskontrollmaterial ist verfügbar in 3 verschiedenen Sammanfattning Sammendrag Konzentrationsbereichen, Level 1 (niedrig), Level 2 (normal) und Level 3 (hoch) mit bekannten, 1. Da es keine verbindliche standardisierte Methode für die HbA1c-Bestimmung gibt, weichen från olika metoder skilja sig från det beräknade medelvärdet. Skillnaden är proportionell med 1. Siden det ikke finnes noen standardmetode for bestemmelse av HbA1c, vil de målte verdiene die Messwerte der verschiedenen Routineverfahren von den angegebenen Testergebnissen CueSee® HbA1c är en kvalitetskontroll som finns i tre nivåer, Level 1 (låg), Level 2 (normal) och de man ser i färska blodprover [3]. CueSee® HbA1c er en kvalitetskontroll som finnes i 3 nivåer, Nivå 1 (lav), Nivå 2 (normal) og fra forskjellige metoder kunne avvike fra den beregnede middelverdien. Avvikene er jeweils angegebenen HbA1c-Konzentrationen im klinisch relevanten Bereich. Eurotrol HbA1c Level 3 (hög), varje nivå har en känd HbA1c koncentration som täcker ett kliniskt relevant Nivå 3 (høy), hvert nivå med en kjent middelverdi, og som til sammen dekker det relevante Control wird aus hämolysiertem und lyophilisiertem Humanblut hergestellt. Der Matrix sind ab. Die Größe der Abweichung des Messwertes vom Zielwert des Kontrollmaterials spiegelt 2. Avseende färska blodprover kan avsevärt högre värden erhållas med Abbott´s IMX och Vision proporsjonelle til de man ser ved analysering på ferske blodprøver. in der Regel die Abweichung wider, wie sie bei frischen Blutproben von Patienten auftritt.[3] område. CueSee® HbA1c är tillverkad av hemolyserat och frystorkat humant blod. Stabilisatorer metoder. kliniske området . CueSee® HbA1c er tillaget av hemolysert og lyofilisert humant blod. 2. Ved ferske blodprøver vil man observere betydelig høyere verdier når målt på Abbotts IMX og Stabilisatoren und Protektoren (Kryo/Lyo Protektoren) zugesetzt. CueSee® HbA1 dient der och konserveringsmedel "Cryo- and lyoprotectants" har tillsatts. CueSee® HbA1c är avsedd att Stabilisatorer og andre tilsetningsstoffer (cryo/lyo konserveringsmiddel) er tilsatt matriksen. regelmäßigen Überprüfung von Präzision und Genauigkeit von HbA1c Systemen. 2. Bei Analysen mit Abbott IMX und Vision werden mit frischen Patientenproben jedoch deutlich 3. Även om det är tillämpligt för många metoder rekommenderar eller garanteras inte resultaten Vision metoder. höhere Werte gefunden als mit dem Kontrollmaterial. användas för regelbunden verifiering av HbA1c system. vid användning av kontrollmaterial som frysts efter rekonstituering. Eurotrol HbA1c brukes til regelmessig kontroll av presisjonen og nøyaktigheten til HbA1c 3. Selv om frysing av kontrollmateriale er mulig for flere metoder, er dette ikke anbefalt for Reagenzien 3. Die Verwendung von Kontrollmaterial, das nach Rekonstitution eingefroren wurde, wird nicht Denna produkt har tillverkats enligt Eurotrol´s specifikationer. instrumenter. CueSee® HbA1c og vi kan ikke garantere resultatet ved bruk av kontrollmateriale som er blitt Reagens CueSee® HbA1c enthält 3 Flaschen à 0,1 ml hämolysiertes und lyophilisiertes Humanblut. empfohlen und liegt außerhalb der Gewährleistung. fryst etter rekonstituering. CueSee® HbA1c finns i tre fysiologiskt relevanta områden. Varje flaska innehåller 1 mL Referenser Reagenser Lagerung und Stabilität Dieses Produkt wurde gemäß den Eurotrol Spezifikationen hergestellt. hemolyserat och frystorkat humant blod. CueSee® HbA1c er tilgjengelig i 3 fysiologisk relevante nivåer, hvor hver flaske inneholder 0,1 ml Dette produktet er produsert i følge Eurotrol spesifikasjoner. 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of CueSee® HbA1c soll ungeöffnet bei einer Temperatur von 2 - 8 °C im Kühlschrank gelagert Referenzen HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. hemolysert og lyofilisert humant blod. Referanser werden. Unter diesen Bedingungen ist die Flasche bis zu dem auf der Verpackung angegebenen Förvaring och hållbarhet 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of CueSee® HbA1c skall förvaras oöppnad i kylskåp vid 2 - 8 °C. Kontrollen är då hållbar till 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin Oppbevaring og holdbarhet 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of Verfallsdatum haltbar. Nach Öffnen des Flasche und Rekonstitution des Materials, ist die HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. utgångsdatum angivet på flaskan och ytterförpackningen. Efter att flaskan öppnats och A1c in human blood and the national standardization schemes in the United States, Japan CueSee® HbA1c oppbevares uåpnet i kjøleskap ved 2 - 8 °C. Lagret uåpnet ved riktig HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. Kontrolle 48 Stunden bei 2 - 8 °C in der geschlossenen Flasche haltbar. 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin rekonstituerats är kontrollen stabil i 48 timmar vid förvaring vid 2 - 8 °C, förutsatt att flaskan är väl and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. temperatur er løsningen garantert holdbar til utløpsdatoen angitt på pakningen. Etter åpning og Handhabung A1c in human blood and the national standardization schemes in the United States, Japan försluten och hanterad skall enligt föreskrifterna. 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion rekonstituering er løsningen holdbar i 48 timer ved 2 - 8 °C og godt lukket, og forutsatt at de A1c in human blood and the national standardization schemes in the United States, Japan 1. Metallkappe und Gummistopfen vorsichtig entfernen. and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem angitte instruksjoner overholdes. and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. 2. 0,1 ml (100 µL) +/- 10% Wasser zusetzen. (für Abbot HbA1c–Verfahren: 0,1 ml 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion Bruksanvisning 1994; 40:138-44. 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion physiologische Kochsalzlösung). of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem 1. Avlägsna metallkapsylen och tag försiktigt av gummiproppen. Bruksanvisning of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem 3. Flasche mit Gummistopfen verschließen. 1994; 40:138-44. 2. Tillsätt 0,1 mL (100 µL) +/- 10 % vatten (för Abbott´s metoder: tillsätt 0,1 mL fysiologisk 1. Fjern metallkorken og ta forsiktig av gummiproppen. 1994; 40:138-44. 4. Flasche schräg halten (ca. 45°) und vorsichtig 30 Sekunden drehen, ohne dass die koksaltlösning) 2. Tilsett 0,1 ml (100 µL) +/- 10 % vann (for Abbott metode: tilsett 0,1 mL fysiologisk saltvann). Flüssigkeit den Gummistopfen berührt. Flasche 15 Minuten aufrecht bei Raumtemperatur 3. Sätt tillbaka gummiproppen. 3. Sett gummikorken på plass igjen. stehen lassen. 4. Håll flaskan i upprätt högst 45° vinkel och snurra försiktigt i 30 sek, undvik kontakt mellan 4. Hold flasken i en 45 graders vinkel og rotér den forsiktig i 30 sekunder, unngå kontakt mellom 5. Schritt 4 wiederholen bis eine homogene Lösung vorliegt. vätskan och gummiproppen. Låt flaskan stå 15 minuter. løsningen og gummiproppen. La flasken stå i 15 minutter. 6. Der Flascheninhalt kann nun verwendet werden. 5. Repetera steg 4 tills lösningen är homogen. 5. Gjenta trinn 4 til løsningen er homogen. 7. Zu diesem Zweck Gummistopfen entfernen und das Kontrollmaterial unter Beachtung der Für weitere Informationen setzen Sie sich bitte in Verbindung mit: 6. Lösningen är klar att analyseras. För mer information kontakta: 6. Kontrolløsningen er klar til bruk. For ytterligere informasjon, vennligst ta kontakt med: Bedienungsanleitung des jeweiligen Messsystems einsetzen. Eurotrol B.V. 7. Ta av gummiproppen och analysera kontrollösningen enligt bruksanvisningen för Eurotrol B.V. 7. Fjern gummiproppen og følg anvisningene for analysering, i henhold til den aktuelle Eurotrol B.V. 8. Die Häufigkeit der Kontrollmessung hängt von den gültigen Vorschriften eines Landes und Tel +31 318 695 777 instrumentet. Tel. +31 318 695 777 bruksanvisningen. Telefon +31 318 695 777 den Angaben in der Bedienungsanleitung des eingesetzten Messystems ab. Fax +31 318 695 770 8. Följ lokala riktlinjer och instrumentets bruksanvisning angående kontrollfrekvensen. Fax +31 318 695 770 8. Vennligst følg de gjeldende lokale forskriftene og instrumentets bruksanvisning for hvor ofte Faks +31 318 695 770 Vorsichtsmaßnahmen E-Mail office@eurotrol.com E-post office@eurotrol.com kontrollen bør analyseres. E-Mail office@eurotrol.com www.eurotrol.com Varning www.eurotrol.com www.eurotrol.com 1. Nur zum in-vitro diagnostischen Einsatz. 1. Endast för användning in vitro analysera. Forsiktighetsregler 2. Das Blutprodukt humanen Ursprungs wurde auf HBsAg, a-HCV, und a-HIV untersucht und Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Niederlande 2. CueSee® HbA1c är en blodprodukt av humant ursprung testat för HBsAg, a-HCV, och a-HIV Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederländerna 1. Kun for in-vitro diagnostikk. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands negativ befundet. Trotzdem sind bei Einsatz des Materials die gleichen med negativt resultat. Iakttag samma försiktighet vid hantering av kontrolllösningen som vid 2. Forsiktig CueSee HbA1c er et blodprodukt. Materialet er basert på humant blod og testet Vorsichtsmaßnahmen einzuhalten wie bei Patientenproben. Verwendete Symbole ursprung testat patientprover. Använda symboler negativt for HBsAg, a-HCV og a-HIV. Håndter dette materialet som potensielt smittefarlig. Symboler brukt 3. Diese Produkte dürfen nicht als Restmüll entsorgt werden. Wenden Sie sich hinsichtlich der 3. Kontrollen ska hanteras som Iakttag riskavfall. Följ lokala föreskrifter för korrekt 3. Dette materialet skal ikke kastes i vanlig husholdningsavfall. Følg lokale miljøforskrifter for fachgerechten Entsorgung an die lokale Umweltbehörde. Achtung, beachten Sie die Gebrauchsanweisung Chargen-Nummer avfallshantering. Varning, se bruksanvisning Lot nr korrekt avfallshåndtering. Viktig, se bruksanvisning for bruk Batchnummer 4. CueSee® HbA1c kann nicht als Kalibrator eingesetzt werden. 4. CueSee® HbA1c skall inte användas som kalibrator. 4. CueSee® HbA1c skal ikke brukes som kalibrator. Verwendbar bis Lagerungstemperatur Används före Temperaturgränser Brukes innen Temperaturgrenser In Vitro Diagnostikum Referenz-nummer In-vitro diagnostik Artikelnummer Medisinsk utstyr til In-Vitro Diagnostikk Varenummer Hersteller CE-Zeichen Tillverkare CE-märke Produsert av CE merket INP 011-DE-R01 20121128 INP 011-SE-R01 20121128 INP 011-NO-R01 20121122 CueSee® HbA1c CueSee® HbA1c CueSee® HbA1c Anvendelsesområde Forventede resultater Käyttötarkoitus Tavoitearvot Namjena Očekivani rezultati CueSee® HbA1c er en glycohemoglobin kontrol med fastsat værdi beregnet til professionelt Det specificerede område (middelværdi ± 3 SD), der er anført i det vedlagte skema, er opnået CueSee® HbA1c on ammattimaiseen käyttöön tarkoitettu kontrolli, jolla voidaan tarkistaa Oheisessa liitteessä annetut tavoitearvot (keskiarvo ± 3 SD) on saatu useilla perättäisillä Kontrolni uzorak CueSee® HbA1c testirani je kontrolni uzorak stvarnog glikohemoblobina Prijavljeni rasponi (srednja vrijednost ± 3 SD) na priloženom listu s vrijednostima proizlaze iz brug ved verificering af præcision og nøjagtighed af HbA1c instrumenter. Formålet med ved gentagne analyser på tilfældigt udvalgte flasker fra batchet målt med forskellige metoder. glykohemoglobiinin määrittämiseen käytettävien HbA1c -laitteiden tarkkuus, toistettavuus, mittauksilla eri menetelmillä ja satunnaisesti valituilla kontrollipulloilla valmistuserästä. namijenjen za profesionalnu uporabu za provjeravanje preciznosti i točnosti instrumenata za analize ponavljanja provedene na raznim metodama nasumičnog biranja bočica iz skupine. kvalitetskontrollen er at validere kalibreringen og andre funktionsrelaterede egenskaber. IFCC værdierne på det vedlagte skema er bestemt med en IFCC kalibreret HPLC analysator [1]. kalibrointi ja muut toimintaan liittyvät ominaisuudet. IFCC-arvot oheisessa liitteessä on määritetty IFCC-kalibroidulla HPLC-analysaattorilla (1). ispitivanje HbA1c. Svrha kontrole kvalitete je potvrditi kalibraciju kao i ostale značajke koje se Vrijednosti IFCC-a na priloženom listu s vrijednostima određuje kalibrirani analizator DCCT værdierne er bestemt som IFCC værdier og omregnet til DCCT enheder ved brug af DCCT-arvot on määritetty IFCC-arvoina ja muunnettu DCCT-yksiköiksi käyttämällä Master odnose na rad uređaja. Međunarodne federacije kliničkih kemičara (IFCC) HPLC [1]. Vrijednosti DCCT-a određene su IVD Medical Device konverteringsfaktorer fra Master Equations [2]. IVD Medical Device Equations (2) –muuntokertoimia. kao vrijednosti IFCC-a i preračunavaju se u jedinice DCCT-a pomoću faktora pretvorbe Glavne CueSee® HbA1c er i overensstemmelse med European Directive 98/79/EC – Direktiv om CueSee® HbA1c on IVD Medical Device Directive 98/79/EC -direktiivin mukainen ja sillä on Medicinski uređaj za in vitro dijagnostiku jednadžbe [2]. medicinsk udstyr til in vitro-diagnostik og er CE-mærket. Bemærk CE-merkintä. Huomioitavaa Kontrolni uzorak CueSee® HbA1c u skladu je s Europskom direktivom 98/79/EZ o medicinskim 1. Eftersom der ikke findes en referencemetode til bestemmelse af HbA1c, kan faktisk målte 1. Koska HbA1c:n määrittämiseen ei ole olemassa standardimenetelmää, eri menetelmillä uređajima za in vitro dijagnostiku i ima oznaku CE. Molimo zapamtite Sammenfatning værdier opnået ved forskellige metoder afvige fra de fastsatte værdier. Afvigelserne er Yhteenveto mitatut todelliset tulokset voivat poiketa määritetyistä arvoista. Poikkeavuudet ovat 1. Budući da standardna metoda analiziranja hemoglobina HbA1c ne postoji, stvarno izmjerene CueSee® HbA1c er en kvalitetskontrol tilgængelig i tre niveauer, Level 1 (lav), Level 2 (normal) proportionale med dem, der observeres ved analysering af friske blodprøver [3]. CueSee® HbA1c on saatavana kolmea eri tasoa, Level 1 (matala), Level 2 (normaali) ja Level 3 verrannollisia tuoreissa verinäytteissä havaittuihin eroihin (3). Sažetak vrijednosti dobivene raznim metodama odstupat će od zadanih vrijednosti. Odstupanja su og Level 3 (høj), hver med kendt glycohemoglobinkoncentration (HbA1c), som dækker klinisk 2. Ved friske blodprøver opnås betydelig højere værdier med Abbott's IMX og Vision metoder. (korkea), joiden glykohemoglobiinipitoisuus (HbA1c) on tunnettu ja jotka kattavat kliinisesti 2. Suhteessa tuoreisiin verinäytteisiin Abbott IMX- ja Vision –menetelmillä saadaan Kontrolni uzorak CueSee® HbA1c je uzorak za kontrolu kvalitete na tri razine, prva razina proporcionalna onima primijećenima kod svježih uzoraka krvi [3]. relevante områder. CueSee® HbA1c er fremstillet af hæmolyseret og frysetørret humant blod. 3. Selvom materialet kan anvendes til mange metoder, så hverken anbefaler eller garanterer vi merkittävät mittausalueet. CueSee® HbA1c on valmistettu hemolysoidusta ja kylmäkuivatusta huomattavasti korkeampia arvoja. (niska), druga razina (normalna) i treća razina (visoka), svaka s poznatom koncentracijom 2. S obzirom na svježe uzorke krvi, znatno veće vrijednosti dobivene su Abbottovom metodama Stabilisatorer og konserveringsmidler (cryo/lyo konserveringsmiddel) er tilsat. CueSee® HbA1c brug af kontrolmateriale, der har været frosset efter rekonstituering. humaaniverestä, johon on lisätty stabilisointi- ja säilöntäaineita. CueSee® HbA1c on tarkoitettu 3. Emme suosittele kontrollimateriaalin pakastamista liuotuksen jälkeen, vaikkakin se soveltuisi glikohemoglobina (HbA1c) čime su obuhvaćeni svi klinički relevantni rasponi. Kontrolni uzorak IMX i Vision. Control er beregnet til periodisk verificering af HbA1c instrumenter. Dette produkt er blevet fremstillet i overensstemmelse med Eurotrols specifikationer. HbA1c -laitteiden tarkkuuden ja toistettavuuden ajoittaiseen tarkistamiseen. joillekin menetelmille. CueSee® HbA1c pripremljen je iz hemolizirane i liofilizirane ljudske krvi. Stabilizatori i protektivni 3. Iako je primjenjivo za mnoge metode, ne preporučujemo niti jamčimo korištenje kontrolnog Tämä tuote on valmistettu Eurotrol-spesifikaatioiden mukaisesti. agensi (krioprotektant/lioprotektant) dodaju se u matricu. Kontrolni uzorak CueSee® HbA1c uzorka koji je zamrznut nakon rekonstruiranja. Reagenser Referencer Reagenssit namijenjen je korištenju u periodičnom provjeravanju preciznosti i točnosti instrumenata za CueSee® HbA1c produceres i tre fysiologisk relevante niveauer. Hver flaske indeholder 0,1 mL CueSee® HbA1c on saatavana kolmea eri tasoa. Jokainen pullo sisältää 0.1 mL hemolysoitua ja Ovaj proizvod proizveden je u skladu sa specifikacijama tvrtke Eurotrol. 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of Viitteet ispitivanje HbA1c. Instrumenti dizajnirani za mjerenje moraju zadovoljavati stroge uvjete koji hæmolyseret og frysetørret humant blod. HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. kylmäkuivattua humaaniverta. 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of osiguravaju odgovarajuće liječenje bolesnika. Reference Opbevaring og holdbarhed 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin Säilytys ja säilyvyys HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin Reagenssit HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. CueSee® HbA1c skal opbevares i køleskab ved 2 - 8 °C. Ved opbevaring ved denne temperatur A1c in human blood and the national standardization schemes in the United States, Japan Avaamaton CueSee® HbA1c tulee säilyttää jääkaapissa 2 - 8°C. Avaamattomana tässä and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. A1c in human blood and the national standardization schemes in the United States, Japan Kontrolni uzorak CueSee® HbA1c ima tri fiziološki relevantne razine, a svaka bočica sadrži 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin er ikke anbrudte flasker holdbare indtil udløbsdatoen, der er påtrykt flasken og yderpakningen. lämpötilassa säilytettynä kontrolli on käyttökelpoinen rasiassa ja pullon kyljessä ilmoitettuun 0,1 ml hemolizirane i liofilizirane ljudske krvi. Efter anbrud og rekonstituering af materialet er kontrollen holdbar i 48 timer, under forudsætning 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion viimeiseen käyttöpäivään saakka. Pullon avaamisen ja aineksen liuottamisen jälkeen kontrolli on and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. A1c in human blood and the national standardization schemes in the United States, Japan af at flasken er forsvarligt lukket og opbevares ved 2 - 8 °C. of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem käyttökelpoinen 48 tuntia 2 - 8°C:n lämpötilassa säilytettynä, huolellisesti suljettuna ja ohjeiden 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion Čuvanje i stabilnost and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. 1994; 40:138-44. mukaan käsiteltynä. of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem Kontrolni uzorak CueSee® HbA1c treba se čuvati neotvoren u hladnjaku na temperaturi od 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion Procedure 1994; 40:138-44. 2-8 °C. Ako se čuva neotvoren na toj temperaturi ostat će stabilan do isteka roka valjanosti, kao of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem 1. Tag metallåget af og løft gummiproppen forsigtigt. Käyttöohje što je naznačeno na bočicama i pakiranju. Nakon otvaranja bočice i rekonstruiranja materijala, 1994; 40:138-44. 2. Tilsæt 0,1 mL (100 µL) +/- 10 % vand (for Abbott metode: tilsæt 0,1 mL fysiologisk 1. Poista metallikorkki ja kuminen tulppa varovasti. bit će stabilan 48 sati ako se čuva na 2-8 °C, ako je propisno začepljen i ako se njime rukuje u saltopløsning). 2. Lisää 0.1 mL (100 µL) +/- 10 % vettä (Abbot –menetelmä: lisää 0.1 mL fysiologista skladu s ovim uputama. 3. Sæt proppen på igen. keittosuolaliuosta). 4. Hold flasken i en vinkel på under 45° og rotér den forsigtigt i 30 sekunder, undgå at 3. Aseta tulppa takaisin. Postupci kontrolopløsningen kommer i kontakt med gummiproppen. Lad flasken stå i 15 minutter. 4. Pidä pulloa 45°-asteen kulmassa ja heiluta varovasti 30 sekunnin ajan. Vältä nesteen 1. Uklonite metalni poklopac i pažljivo podignite gumeni čep. 5. Gentag trin 4, indtil opløsningen er homogen. koskettamista kumiseen tulppaan. Anna pullon seistä 15 minuuttia. 2. Dodajte 0,1 ml (100 µl) +/- 10% vode. (Za metodu Abbott: dodajte 0,1 ml fiziološke otopine). 6. Flasken er klar til brug og kontrolopløsningen kan analyseres. For yderligere information kontakt venligst: 5. Toista kohtaa 4 kunnes liuos on homogeeninen. Lisätietoa saa: 3. Zamijenite čep. Za više informacija obratite se tvrtki: 7. Tag gummiproppen af og følg instruktionerne for måling i brugsanvisningen til det anvendte Eurotrol B.V. 6. Pullo on valmis käyttöön ja liuos voidaan analysoida. Eurotrol B.V. 4. Bočicu držite pod kutem od 45° i lagano je okrećite 30 sekundi, pazeći da se tekućina i Eurotrol B.V. instrument. Telefon +31 318 695 777 7. Poista tulppa ja suorita mittaus laitteen käyttöohjeessa annettujen ohjeiden mukaisesti. Puh +31 318 695 777 gumeni čep ne dodiruju. Ne dirajte bočicu 15 minuta. Tel +31 318 695 777 8. Følg lokale retningslinjer og brugsanvisningen til instrumentet for anbefaling af hyppighed af Fax +31 318 695 770 8. Noudata paikallisia ja laitteen käyttöohjeessa annettuja ohjeita siitä, kuinka usein Fax +31 318 695 770 5. Ponavljajte četvrti korak dok ne dobijete homogenu otopinu. Faks +31 318 695 770 kontroludførelse. E-mail office@eurotrol.com laadunvarmistus tulee suorittaa. ltä office@eurotrol.com 6. Bočica je spremna za upotrebu, a tekućinu možete analizirati. office@eurotrol.com www.eurotrol.com www.eurotrol.com 7. Uklonite čep i slijedite upute za mjerenje koje se nalaze u uputama za uporabu instrumenta. www.eurotrol.com Forholdsregler Varoitukset 8. Provjerite lokalne smjernice o preporučenoj učestalosti upotrebljavanja. 1. Må kun anvendes til in vitro-diagnostik. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Holland. 1. Ainoastaan diagnostiseen in vitro -käyttöön. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Alankomaat Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nizozemska 2. Blodprodukt. Humant baseret materiale testet negativ for HBsAg, a-HCV og a-HIV. Produktet 2. Verituote. Ihmisperäinen materiaali on testattu eikä sisällä vaarallisia ainesosia, kuten HBsAg, Mjere opreza skal håndteres med samme sikkerhedsforanstaltninger som for patientprøver. Anvendte symboler a-HCV tai a-HIV. Käsittele tuotetta noudattaen kuitenkin samoja varotoimenpiteitä kuin Käytetyt symbolit 1. Samo za upotrebu u in vitro dijagnostici. Korišteni simboli: 3. Dette produkt skal håndteres som smittefarligt materiale. Følg lokale regler for bortskaffelse käsiteltäessä potilasnäytteitä. 2. Proizvod krvi. Materijal ljudskog porijekla testira se na HBsAg, a-HCV i a-HIV, a nalaz je af sådant materiale. Vigtigt, se brugsanvisningen Lotnummer 3. Tätä tuotetta ei saa hävittää tavallisen jätteen mukana. Noudata paikallisia säännöksiä Varoitus, katso käyttöohjeet Eränumero negativan. Rukujte proizvodom na isti način kao i s uzorkom bolesnika. Pažnja, pogledajte upute za upotrebu Serijski kod 4. CueSee® HbA1c må ikke anvendes som kalibrator. oikeasta jätteenkäsittelystä. 3. Proizvode nije dopušteno odlagati u opći otpad. Obratite se lokalnoj službi za zaštitu okoliša Udløbsdato Opbevaringstemperatur 4. CueSee HbA1c -kontrollia ei tule käyttää kalibraattorina. Käytä ennen Säilytyslämpötila radi propisnog odlaganja. Koristiti do Ograničenje temperature 4. Kontrolni uzorak CueSee® HbA1c ne koristi se kao kalibrator. Direktiv om medicinsk udstyr til in vitro-diagnostik Artikelnummer In Vitro Diagnostic Medical Device Tuotenumero Medicinski uređaj za in vitro dijagnostiku Referentni broj Producent CE-mærket Valmistaja CE-merkki Proizvođač Oznaka CE INP 011-DK-R01 20121128 INP 011-FI-R01 20121128 INP 011-HR-R01 20130920 CueSee® HbA1c CueSee® HbA1c Rendeltetésszerű használat Várható eredmények Назначение 3. Данные изделия не следует утилизировать с обычными отходами. A CueSee® HbA1c segítségével a glikohemoglobin szintjét ellenőrizhetik a szakemberek a A mellékelt értéktáblázatban látható tartományok (középérték ± 3 SD) a tételből véletlenszerűen CueSee® HbA1c представляет собой набор аттестованных контрольных образцов Проконсультируйтесь с местными органами охраны окружающей среды по вопросу HbA1c szintet mérő készülékek precizitásának és pontosságának ellenőrzése során. Ennek a kiválasztott ampullák különböző módszerekkel történő ismételt elemzéséből származnak. A гликогемоглобина, предназначенный для профессионального контроля прецизионности и утилизации данных изделий. minőség-ellenőrzésnek a célja a kalibrálás és a működéshez kapcsolódó egyéb jellemzők mellékelt értéktáblázatban látható IFCC értékeket IFCC szerint kalibrált HPLC analizátorral точности инструментов по определению HbA1c. Данный набор образцов для контроля 4. Набор CueSee® HbA1c не предназначен для использования в качестве калибратора. validálása. határozták meg [1]. A DCCT értékeket IFCC értékekként határozzák meg, majd a főegyenletek качества используется с целью подтверждения калибровки и других технических átszámítási tényezőinek segítségével DCCT mértékegységre számítják át [2]. характеристик. Ожидаемые результаты IVD orvostechnikai eszköz Заявленные диапазоны (среднее значение ± 3 СО), приведенные в прилагаемой таблице A CueSee® HbA1c megfelel az in vitro diagnosztikai orvostechnikai eszközökről szóló 98/79/EK Megjegyzés: Медицинское изделие для диагностики in vitro (IVD) значений, получены на основе параллельного анализа произвольно выбранных из партии számú európai parlamenti és tanácsi irányelvnek, továbbá rendelkezik CE-jelöléssel. 1. Tekintve, hogy nincs szabványos módszer a HbA1c vizsgálatára, a különböző módszerekkel Набор CueSee® HbA1c соответствует требованиям Директивы ЕС 98/79/EC по флаконов с применением различных методов. Значения IFCC (Международная федерация Összefoglaló kapott ténylegesen mért értékek eltérhetnek a hozzárendelt értékektől. Az eltérések медицинским изделиям для диагностики in vitro и имеет маркировку CE. клинической химии и лабораторной медицины) в прилагаемой таблице значений A CueSee® HbA1c minőség-ellenőrző eszköz három szintje áll rendelkezésre: Level 1 arányosak a friss vérmintákban megfigyeltekkel [3]. определены с использованием высокоэффективного жидкостного хроматографа, 2. A friss vérminták tekintetében jóval magasabb értékeket adnak az Abbott IMX és Vision Обзор калиброванного по требованиям IFCC [1]. Значения DCCT (Исследование по контролю (alacsony), Level 2 (normál) és Level 3 (magas); valamennyi esetben ismert glikohemoglobin- Набор образцов для контроля качества CueSee® HbA1c содержит образцы с тремя koncentrációval (HbA1c), amelyek lefedik a klinikailag releváns tartományokat. A CueSee® módszerek. диабета и его осложнений) определены как значения IFCC и пересчитаны в единицы 3. Noha több módszer esetében alkalmazható, mégsem tanácsoljuk olyan kontrollanyag уровнями содержания гликогемоглобина: Уровень 1 (низкий), Уровень 2 (нормальный) и DCCT с использованием коэффициентов пересчета основных уравнений [2]. HbA1c hemolizált és liofilizált humán vérből készül. Tartalmaz továbbá stabilizáló és Уровень 3 (высокий). Для каждого из них известна концентрация гликогемоглобина védőanyagokat (krioprotektív anyagokat, valamint a liofilizáláskor fellépő sokkhatást kivédő felhasználását, amelyet a feloldás után lefagyasztottak, és ebben az esetben nem garantáljuk a minőségét. (HbA1c), покрывающая клинически значимый диапазон. Набор CueSee® HbA1c изготовлен Примечание "lioprotektív" anyagokat). A CueSee® HbA1c felhasználható a HbA1c szintet mérő készülékek из гемолизированной и лиофилизированной крови человека. В состав матрицы добавлены 1. Ввиду отсутствия единой стандартной методики анализа HbA1c реальные значения, precizitásának és pontosságának időszakos ellenőrzésére. Az ilyen jellegű méréseket végző A termék az Eurotrol specifikációi alapján készült. стабилизаторы и протективные агенты (от воздействия низких температур и полученные путем применения различных методов, будут иметь отклонения от műszereknek a legszigorúbb követelményeknek kell megfelelniük a megfelelő betegellátás Hivatkozások лиофилизации). Набор CueSee® HbA1c следует использовать для периодического присвоенных значений. Отклонения пропорциональны отклонениям, наблюдаемым в biztosítása érdekében. 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of контроля прецизионности и точности инструментов по определению HbA1c. Инструменты, образцах свежей крови [3]. Reagensek HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. предназначенные для выполнения данных анализов, должны соответствовать жестким 2. Применение методов IMX и Vision компании Abbott на образцах свежей крови приводит A CueSee® HbA1c három élettanilag fontos szintet mutat ki; valamennyi ampulla 0,1 ml 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin требованиям, которые позволяют обосновать предоставление пациентам к получению существенно более высоких значений. hemolizált és liofilizált humán vért tartalmaz. A1c in human blood and the national standardization schemes in the United States, Japan соответствующего лечения. 3. Производитель не рекомендует и не гарантирует эффективность использования Tárolás és stabilitás and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. контрольного материала, замороженного после восстановления, несмотря на то, что Реагенты 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion это допустимо для многих методов. Tartsa a CueSee® HbA1c készítményt bontatlanul a hűtőszekrényben 2–8 °C közötti В состав набора CueSee® HbA1c входят образцы с тремя физиологически значимыми of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem Настоящее изделие изготовлено в соответствии со спецификациями компании Eurotrol. hőmérsékleten. Ezen a hőmérsékleten bontatlan állapotban megőrizve a készítmény garantáltan уровнями содержания гликогемоглобина. Каждый флакон содержит 0,1 мл stabil marad az ampullákon és a külső tároló dobozon feltüntetett lejárat napjáig. Az ampulla 1994; 40:138-44. гемолизированной и лиофилизированной крови человека. Источники felnyitását és az anyag feloldását követően a készítmény 48 óráig stabil marad 2–8 °C 1. Jeppsson JO, Hoelzel W, et al. Approved IFCC Reference Method for the measurement of hőmérsékleten történő tárolás mellett, ha az ampullát megfelelően lezárták és az utasításokat Условия хранения и обеспечение устойчивости HbA1c in human blood. Clin Chem Lab Med 2002;40:78-89. betartották. Набор CueSee® HbA1c следует хранить в закрытом виде при температуре 2–8 °C. При 2. Hoelzel W, Weykamp C, et al. IFCC Reference System for Measurement of Hemoglobin выполнении данных условий хранения образцы сохраняют устойчивость до истечения Eljárások A1c in human blood and the national standardization schemes in the United States, Japan срока годности, указанного на флаконах и на внешней упаковке. После вскрытия флакона 1. Távolítsa el a fémkupakot és óvatosan emelje ki a gumidugót. and Sweden: a method comparison Study. Clin Chem 2004;50:166-174. и восстановления материала он сохраняет устойчивость в течение 48 часов при 2. Adjon hozzá 0,1 ml (100 µl) +/- 10% vizet. (Az Abbott-módszer esetében: adjon hozzá 0,1 ml 3. Weykamp CW, Penders TJ, Muskiet FAJ, van der Slik W. Effect of calibration on dispersion температуре 2–8 °C, при условии, что флакон закрыт пробкой надлежащим образом и что fiziológiás sóoldatot). of glycohaemoglobin values determined by 111 laboratories using 21 methods. Clin Chem с ним обращаются в соответствии с данными инструкциями. 3. Helyezze vissza a dugót. Ha bővebb tájékoztatásra van szüksége, forduljon az Eurotrol munkatársaihoz: 1994; 40:138-44. 4. Tartsa az ampullát 45°-os szögben, és óvatosan mozgassa körkörösen 30 másodpercig, Процедуры Eurotrol B.V. közben ügyeljen arra, hogy a folyadék ne érintkezzen a gumidugóval. Hagyja állni 15 percig. 1. Удалите металлический колпачок и осторожно снимите резиновую пробку. Более подробную информацию можно получить, связавшись с представителями Telefon +31 318 695 777 5. Ismételje meg a 4. lépést mindaddig, amíg homogén oldatot nem kap. 2. Добавьте 0,1 мл (100 мкл) +/- 10% воды. (Для метода компании Abbott: добавьте 0,1 мл компании: Fax +31 318 695 770 6. Ekkor az ampulla felhasználásra kész és a folyadékot analizálni lehet. физиологического раствора). Eurotrol B.V. office@eurotrol.com 7. Távolítsa el a dugót, és kövesse a mérésre vonatkozó utasítást a műszer kézikönyvében www.eurotrol.com 3. Закройте флакон пробкой. тел +31 318 695 777 található útmutatásnak megfelelően. 4. Удерживайте флакон под углом 45° и осторожно вращайте его в течение 30 секунд, факс +31 318 695 770 8. Tartsa be a helyi irányelveket az alkalmazás ajánlott gyakoriságára vonatozóan. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Hollandia избегая контакта между жидкостью и резиновой пробкой. Оставьте флакон в E-mail office@eurotrol.com Óvintézkedések вертикальном положении на 15 минут. www.eurotrol.com Alkalmazott jelölések 5. Повторяйте шаг 4 до получения однородного раствора. 1. Только для диагностики in vitro. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Нидерланды 6. После этого флакон готов к использованию, а жидкость можно анализировать. 2. Препарат крови. Результаты проверки материалов человеческого происхождения на Figyelem, kövesse a használati utasítást! Tételkód 7. Снимите пробку и выполняйте измерения на основе инструкции, предоставленной в поверхностный антиген вируса гепатита В (HBsAg), антиген вируса гепатита С (a-HCV) Условные обозначения и антиген вируса иммунодефицита человека (a-HIV) были получены отрицательные. пособии по применению соответствующего инструмента. Minőségét megőrzi Hőmérsékleti határértékek 8. Выполняйте контрольные измерения в соответствии с требованиями местного Внимание, см. инструкцию по При обращении с изделием придерживайтесь таких же мер предосторожности, как и Код партии законодательства. применению при работе с образцами, взятыми у пациентов. In vitro diagnosztikai orvostechnikai eszköz Hivatkozási szám 3. Данные изделия не следует утилизировать с обычными отходами. Ограничение рабочих Меры предосторожности Срок годности Проконсультируйтесь с местными органами охраны окружающей среды по вопросу температур Gyártó CE-jelölés 1. Только для диагностики in vitro. утилизации данных изделий. Медицинское изделие для диагностики 2. Препарат крови. Результаты проверки материалов человеческого происхождения на Номер по каталогу 4. Набор CueSee® HbA1c не предназначен для использования в качестве калибратора. INP 011-HU-R01-20130918 поверхностный антиген вируса гепатита В (HBsAg), антиген вируса гепатита С (a-HCV) in vitro и антиген вируса иммунодефицита человека (a-HIV) были получены отрицательные. Производитель Маркировка CE При обращении с изделием придерживайтесь таких же мер предосторожности, как и при работе с образцами, взятыми у пациентов. INP 011-RU-R01 20160822 INP 011-R08 20160822 Instructions for Use (2.9 MB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Material Safety Data Sheet - DE (113.2 KB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 4 * 7 + 2 - 3( G %4 $ - + ' +-) - = - ' -) - ) - - ' - )2 3E + - 2 3( % 4 5 ))- - - - + # > +- + ) ) ) -1 ) 2 78 9 3E 7 9 - - ) * # - H E 9 , -. ,) ))- - - : - + ' - ) 29 3 5 ! - 8=- - + )- ) , ' - - &' #- - ) 1# )) ' - ' ) @ -- 1# ) /- '- ! ? - = ' ' - - - ' - -) ) ' '-) - ,A ' - ' ) '-) - - ' ) #- - ) ' -- ) ) ' # /- '- ' ! - -) ' ) )I -+ - )) ) ) ' # A -)) #- J $ 5 5 8 $B A 8 + Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Material Safety Data Sheet - EN (112.8 KB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 ),6.7& % 8 9- ),) )+- )++# )+ ,, + )+ 6.3;8 /7 2 "" # ) )3 )3) + ) !) ),- * ! )+ 02 ) +* ),) # ) !!)- ),- * 2 ) +* , , ) 2 ) ),- * +) )+ + )+ , # ) ! # )5 ) 0++ # . 9- ) @ ?13&=3 @@9 ) Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Material Safety Data Sheet - NO (123.8 KB)
CueSee® Hyperbaric
Product Specific
- !"# $ % &'(') * + ) , & )% ) -" . " /) " 0 12,,,) 3 4 0 12,, % 5 ') / 6 ! 7 " $ 8 9 :6 7 !" " + / / " " " ; / 6 ! $ 7" " " < 6 7 =+ 4+ / /' >++ < ? @ @ // "6/ ? ! A ) 6 /) 4 $ 46! ! ! // /' " # $ ! 5 " .B> = . "6! %6 3 /" 7 " 7 $ C 2 / / ! / 6 / 5 ! / D % . $ : ' 3 7! $ $ !" !+ /' & % ! '' ' 5 / $ /+ $ 7 "7 ' ' $ $ ! 3 7D : 6 ! * + " + : 7 E F< G/ + : H ( )! *! '! + 3 7D : 6 , '* ' /" & !+ GF++ < ? @ @ // "6/ / ? : 6 7 : ( + + // . / : /" ' ( + / 6 . / : /" ' 3 /" + . $ : ' Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet (128.9 KB)
- CueSee® Hyperbaric Intended use Expected values CueSee® Hyperbaric is an assayed, quality control material for professional use in the i-STAT® analyzer verification of the precision and accuracy of the critically high pO2 value range of many The Eurotrol assigned values for the i-STAT® analyzer have been obtained after blood gas analyzers. equilibration of randomly selected ampules from the applicable batch at 25 ± 1 °C before measurement and have been measured on multiple i-STAT® analyzers using Summary and principle multiple types of cartridges. The expected pO2 value for your applicable incubation CueSee® Hyperbaric is available at one level with a known pO2 value in the critically temperature is shown in the value sheet which can be found on high pO2 value range. It is intended that CueSee® Hyperbaric should be used in the www.eurotrol.com/documents. periodic verification of the precision and accuracy of blood gas analyzers. Epoc® system Contents The assigned values for the epoc® System have been obtained after equilibration of CueSee® Hyperbaric provides one level in the critically high pO2 value range, each randomly selected ampules from the applicable batch at 22 ± 1°C before measurement ampule holding 2.5 mL of solution. CueSee® Hyperbaric is prepared using pure salts and have been measured on multiple epoc® readers using multiple lots of cards. The in a physiologically buffered aqueous solution. Tonometry with a predetermined level assigned values can be found at www.siemens.com/epoc. Refer to the epoc® System of oxygen balanced with nitrogen and different salt concentrations provides the distinct Manual for more information on target adjustments for variable ambient temperature assay value for measurement of partial pressure of oxygen. CueSee® Hyperbaric and barometric pressure. contains no preservatives, viscosity adjusters or other additives that might adversely Limitations affect electrode measurements. • The pO2 values of CueSee® Hyperbaric vary inversely with temperature changes. To Storage and stability obtain a high degree of correlation with the assigned values the ampules should be CueSee® Hyperbaric should be stored at a temperature of 2–30 °C (36–86 °F). Stored equilibrated to 22 °C (71.6 °F) for the epoc® System and to 25 °C (77 °F) for the i- unopened at this temperature the product is stable as indicated until the expiration STAT® analyzer. date on the ampules and the outer box. After opening an ampule of CueSee® • The ranges of the product are intended only as guidelines and laboratories should Hyperbaric, the product is stable for 30 seconds. determine the ranges based on their own test system and tolerance limits. Procedure • The assigned values are applicable at sea level and with the applicable cartridge 1. Remove the ampule from box and tray. Equilibrate the ampule for a minimum of 1 types and cartridge lots only. hour to the room temperature where the testing will take place. Note the current • CueSee® Hyperbaric is very sensitive to contamination once opened. When room temperature. sampling the fluid within 30 seconds, the error is less than 2%, based on open 2. Immediately before use, placing the ampule between the thumb and index finger, ampule testing. shake the ampule vigorously for at least fifteen seconds to re-equilibrate the gases • CueSee® Hyperbaric is not to be used as a calibrator. with the solution. • Incorrect sampling, storage, or other mishandling may cause the readings to deviate 3. Swirl the ampule gently to return liquid to the bottom. Allow bubbles to rise to the from the target values. surface before opening the ampule. For further information and/or technical assistance, please contact: 4. Protect fingers with gauze, tissue or gloves. 5. The One Point Cut (OPC) ampule must be opened as illustrated below. 6. Using techniques described in the instrument manufacturer’s system manual, Manufacturer Distributor transfer the sample from the ampule to the card, cartridge or analyzer within 30 Eurotrol B.V. Eurotrol Inc. seconds after opening of the ampule. Gently load the sample from the syringe to Keplerlaan 20, 6716 BS Ede 850 N Black Branch Rd, Elizabethtown, KY test cartridge/card following the sampling procedure of the instrument operating The Netherlands USA instructions. Important: Use of the Quality Control or Calibration Verification Phone: +31 318 695 777 Phone: +1 (502) 501-1180 Mode, depending on instrument manufacturer, may be needed to obtain high E-mail: office@eurotrol.com E-mail: officeUSA@eurotrol.com pO2 results. www.eurotrol.com 7. For i-STAT® instruments, read the pO2 target range from the Eurotrol Value All trademarks are the property of their respective owners. © 2019, Eurotrol B.V. Assignment Sheet according to the corresponding room temperature. For Symbols used epoc® System users, refer to assigned values at www.siemens.com/epoc. 8. Refer to local, state and/or federal regulations or accreditation requirements for Use-by date Batch code frequency of use. In vitro Diagnostic Medical Device Temperature limit Warnings and precautions 1. For in vitro diagnostic use only. Manufacturer Catalogue number 2. This product should not be disposed of in general waste. Consult local environmental authorities for proper disposal. Control Do not re-use 3. Each ampule is singly use only. 4. Caution: US Federal law restricts this device to sale by or on the order of a licensed Prescription use only Consult instructions for use practitioner. Date of manufacture Hold the bottom of the ampule with thumb Cut located below the red dot is the breaking Grasp the top of the ampule with other hand, Press back to break at the cut under the red pointing to the red colored dot. point of the ampule. positioning thumb at the red dot. dot. AN01602A01 20190328 Instructions for Use (309.9 KB)
- epoc Value Assignment Sheet
Lot Specific
- CueSee® Hyperbaric i-STAT CLEW A38/C38/H38/J38 i-STAT CLEW A38/C38/H38/J38 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 639 578 - 762 mmHg pO2 18 °C 64 °F 674 610 - 794 mmHg 19 °C 66 °F 633 567 - 751 19 °C 66 °F 667 599 - 783 20 °C 68 °F 627 556 - 740 20 °C 68 °F 661 588 - 772 21 °C 70 °F 620 546 - 730 21 °C 70 °F 654 578 - 762 22 °C 72 °F 614 535 - 719 22 °C 72 °F 647 567 - 751 23 °C 73 °F 608 524 - 708 23 °C 73 °F 641 556 - 740 24 °C 75 °F 601 514 - 698 24 °C 75 °F 634 546 - 730 25 °C 77 °F 595 503 - 687 25 °C 77 °F 627 535 - 719 26 °C 79 °F 589 493 - 677 26 °C 79 °F 620 525 - 709 27 °C 81 °F 583 482 - 666 27 °C 81 °F 614 514 - 698 MSP101103 Rev.1.0 20170602 28 °C 82 °F 576 471 - 655 28 °C 82 °F 607 503 - 687 29 °C 84 °F 570 461 - 645 29 °C 84 °F 600 493 - 677 30 °C 86 °F 564 450 - 634 30 °C 86 °F 594 482 - 666 164-2-B925 Expiry date 2022/06 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet - Lot 164-2-B925 - CLEW A38 (95.1 KB)
- CueSee® Hyperbaric i-STAT CLEW A38/C38/H38/J38 i-STAT CLEW A38/C38/H38/J38 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 750 661 - 845 mmHg pO2 18 °C 64 °F 781 669 - 853 mmHg 19 °C 66 °F 740 650 - 834 19 °C 66 °F 768 659 - 843 20 °C 68 °F 730 640 - 824 20 °C 68 °F 754 648 - 832 21 °C 70 °F 719 629 - 813 21 °C 70 °F 741 638 - 822 22 °C 72 °F 709 619 - 803 22 °C 72 °F 728 627 - 811 23 °C 73 °F 699 608 - 792 23 °C 73 °F 714 616 - 800 24 °C 75 °F 689 597 - 781 24 °C 75 °F 701 606 - 790 25 °C 77 °F 679 587 - 771 25 °C 77 °F 687 595 - 779 26 °C 79 °F 669 576 - 760 26 °C 79 °F 674 585 - 769 27 °C 81 °F 658 565 - 749 27 °C 81 °F 660 574 - 758 MSP101103 Rev.1.0 20170602 28 °C 82 °F 648 555 - 739 28 °C 82 °F 647 563 - 747 29 °C 84 °F 638 544 - 728 29 °C 84 °F 633 553 - 737 30 °C 86 °F 628 534 - 718 30 °C 86 °F 620 542 - 726 164-2-B649 Expiry date 2019/12 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B649 – CLEW A38 (73.3 KB)
- CueSee® Hyperbaric i-STAT CLEW A38/C38/H38/J38 i-STAT CLEW A38/C38/H38/J38 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 748 665 - 849 mmHg pO2 18 °C 64 °F 752 668 - 852 mmHg 19 °C 66 °F 739 654 - 838 19 °C 66 °F 743 657 - 841 20 °C 68 °F 729 644 - 828 20 °C 68 °F 733 647 - 831 21 °C 70 °F 720 633 - 817 21 °C 70 °F 724 636 - 820 22 °C 72 °F 711 623 - 807 22 °C 72 °F 714 625 - 809 23 °C 73 °F 701 612 - 796 23 °C 73 °F 705 615 - 799 24 °C 75 °F 692 601 - 785 24 °C 75 °F 695 604 - 788 25 °C 77 °F 683 591 - 775 25 °C 77 °F 686 594 - 778 26 °C 79 °F 673 580 - 764 26 °C 79 °F 676 583 - 767 27 °C 81 °F 664 569 - 753 27 °C 81 °F 666 572 - 756 MSP101103 Rev.1.0 20170602 28 °C 82 °F 655 559 - 743 28 °C 82 °F 657 562 - 746 29 °C 84 °F 645 548 - 732 29 °C 84 °F 647 551 - 735 30 °C 86 °F 636 538 - 722 30 °C 86 °F 638 540 - 724 164-2-B732 Expiry date 2020/08 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B732 – CLEW A38 (73.2 KB)
- CueSee® Hyperbaric i-STAT CLEW A38/C38/H38/J38 i-STAT CLEW A38/C38/H38/J38 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 632 567 - 751 mmHg pO2 18 °C 64 °F 655 581 - 765 mmHg 19 °C 66 °F 625 556 - 740 19 °C 66 °F 647 571 - 755 20 °C 68 °F 619 546 - 730 20 °C 68 °F 639 560 - 744 21 °C 70 °F 612 535 - 719 21 °C 70 °F 631 549 - 733 22 °C 72 °F 605 525 - 709 22 °C 72 °F 623 539 - 723 23 °C 73 °F 598 514 - 698 23 °C 73 °F 615 528 - 712 24 °C 75 °F 591 503 - 687 24 °C 75 °F 607 518 - 702 25 °C 77 °F 585 493 - 677 25 °C 77 °F 599 507 - 691 26 °C 79 °F 578 482 - 666 26 °C 79 °F 591 496 - 680 27 °C 81 °F 571 471 - 655 27 °C 81 °F 583 486 - 670 MSP101103 Rev.1.0 20170602 28 °C 82 °F 564 461 - 645 28 °C 82 °F 575 475 - 659 29 °C 84 °F 558 450 - 634 29 °C 84 °F 567 464 - 648 30 °C 86 °F 551 440 - 624 30 °C 86 °F 559 454 - 638 164-2-B905 Expiry date 2022/01 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B905 – CLEW A38 (73.2 KB)
- CueSee® Hyperbaric i-STAT CLEW A37/C37/H37/J37 i-STAT CLEW A37/C37/H37/J37 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 740 673 - 857 mmHg pO2 18 °C 64 °F 743 681 - 865 mmHg 19 °C 66 °F 733 662 - 846 19 °C 66 °F 737 671 - 855 20 °C 68 °F 726 652 - 836 20 °C 68 °F 730 660 - 844 21 °C 70 °F 719 641 - 825 21 °C 70 °F 724 649 - 833 22 °C 72 °F 712 630 - 814 22 °C 72 °F 718 639 - 823 23 °C 73 °F 705 620 - 804 23 °C 73 °F 712 628 - 812 24 °C 75 °F 697 609 - 793 24 °C 75 °F 705 618 - 802 25 °C 77 °F 690 598 - 782 25 °C 77 °F 699 607 - 791 26 °C 79 °F 683 588 - 772 26 °C 79 °F 693 596 - 780 27 °C 81 °F 676 577 - 761 27 °C 81 °F 686 586 - 770 MSP101103 Rev.1.0 20170602 28 °C 82 °F 669 567 - 751 28 °C 82 °F 680 575 - 759 29 °C 84 °F 662 556 - 740 29 °C 84 °F 674 564 - 748 30 °C 86 °F 655 545 - 729 30 °C 86 °F 668 554 - 738 164-2-B732 Expiry date 2020/08 Eurotrol, Inc., One Wall Street, Burlington, MA 01803, USA, T +1 978 598 3779, F +1 978 598 3780, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B732 – CLEW A37 (72.7 KB)
- CueSee® Hyperbaric i-STAT CLEW A37/C37/H37/J37 i-STAT CLEW A37/C37/H37/J37 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 753 689 - 873 mmHg pO2 18 °C 64 °F 767 685 - 869 mmHg 19 °C 66 °F 746 678 - 862 19 °C 66 °F 758 675 - 859 20 °C 68 °F 740 667 - 851 20 °C 68 °F 749 664 - 848 21 °C 70 °F 733 657 - 841 21 °C 70 °F 740 653 - 837 22 °C 72 °F 726 646 - 830 22 °C 72 °F 730 643 - 827 23 °C 73 °F 720 635 - 819 23 °C 73 °F 721 632 - 816 24 °C 75 °F 713 625 - 809 24 °C 75 °F 712 622 - 806 25 °C 77 °F 706 614 - 798 25 °C 77 °F 703 611 - 795 26 °C 79 °F 700 604 - 788 26 °C 79 °F 694 600 - 784 27 °C 81 °F 693 593 - 777 27 °C 81 °F 685 590 - 774 MSP101103 Rev.1.0 20170602 28 °C 82 °F 686 582 - 766 28 °C 82 °F 675 579 - 763 29 °C 84 °F 680 572 - 756 29 °C 84 °F 666 568 - 752 30 °C 86 °F 673 561 - 745 30 °C 86 °F 657 558 - 742 164-2-B743 Expiry date 2020/10 Eurotrol, Inc., One Wall Street, Burlington, MA 01803, USA, T +1 978 598 3779, F +1 978 598 3780, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B743 – CLEW A37 (72.8 KB)
- CueSee® Hyperbaric i-STAT CLEW A37/C37/H37/J37 i-STAT CLEW A37/C37/H37/J37 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 730 644 - 828 mmHg pO2 18 °C 64 °F 725 658 - 842 mmHg 19 °C 66 °F 721 634 - 818 19 °C 66 °F 718 648 - 832 20 °C 68 °F 711 623 - 807 20 °C 68 °F 711 637 - 821 21 °C 70 °F 701 612 - 796 21 °C 70 °F 704 626 - 810 22 °C 72 °F 691 602 - 786 22 °C 72 °F 697 616 - 800 23 °C 73 °F 682 591 - 775 23 °C 73 °F 690 605 - 789 24 °C 75 °F 672 581 - 765 24 °C 75 °F 683 595 - 779 25 °C 77 °F 662 570 - 754 25 °C 77 °F 676 584 - 768 26 °C 79 °F 652 559 - 743 26 °C 79 °F 669 573 - 757 27 °C 81 °F 642 549 - 733 27 °C 81 °F 662 563 - 747 MSP101103 Rev.1.0 20170602 28 °C 82 °F 633 538 - 722 28 °C 82 °F 655 552 - 736 29 °C 84 °F 623 527 - 711 29 °C 84 °F 648 541 - 725 30 °C 86 °F 613 517 - 701 30 °C 86 °F 641 531 - 715 164-2-B822 Expiry date 2021/05 Eurotrol, Inc., One Wall Street, Burlington, MA 01803, USA, T +1 978 598 3779, F +1 978 598 3780, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B822 – CLEW A37 (72.8 KB)
- CueSee® Hyperbaric i-STAT CLEW A37/C37/H37/J37 i-STAT CLEW A37/C37/H37/J37 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 762 665 - 849 mmHg pO2 18 °C 64 °F 754 674 - 858 mmHg 19 °C 66 °F 751 655 - 839 19 °C 66 °F 745 663 - 847 20 °C 68 °F 740 644 - 828 20 °C 68 °F 736 653 - 837 21 °C 70 °F 728 634 - 818 21 °C 70 °F 727 642 - 826 22 °C 72 °F 717 623 - 807 22 °C 72 °F 718 632 - 816 23 °C 73 °F 706 612 - 796 23 °C 73 °F 709 621 - 805 24 °C 75 °F 694 602 - 786 24 °C 75 °F 700 610 - 794 25 °C 77 °F 683 591 - 775 25 °C 77 °F 692 600 - 784 26 °C 79 °F 672 580 - 764 26 °C 79 °F 683 589 - 773 27 °C 81 °F 660 570 - 754 27 °C 81 °F 674 578 - 762 MSP101103 Rev.1.0 20170602 28 °C 82 °F 649 559 - 743 28 °C 82 °F 665 568 - 752 29 °C 84 °F 638 549 - 733 29 °C 84 °F 656 557 - 741 30 °C 86 °F 627 538 - 722 30 °C 86 °F 647 547 - 731 164-2-B649 Expiry date 2019/12 Eurotrol, Inc., One Wall Street, Burlington, MA 01803, USA, T +1 978 598 3779, F +1 978 598 3780, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B649 – CLEW A37 (72.8 KB)
- CueSee® Hyperbaric i-STAT CLEW A38/C38/H38/J38 i-STAT CLEW A38/C38/H38/J38 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 720 639 - 823 mmHg pO2 18 °C 64 °F 731 650 - 834 mmHg 19 °C 66 °F 711 629 - 813 19 °C 66 °F 722 640 - 824 20 °C 68 °F 702 618 - 802 20 °C 68 °F 713 629 - 813 21 °C 70 °F 693 608 - 792 21 °C 70 °F 704 618 - 802 22 °C 72 °F 684 597 - 781 22 °C 72 °F 695 608 - 792 23 °C 73 °F 675 586 - 770 23 °C 73 °F 686 597 - 781 24 °C 75 °F 666 576 - 760 24 °C 75 °F 677 587 - 771 25 °C 77 °F 657 565 - 749 25 °C 77 °F 668 576 - 760 26 °C 79 °F 648 554 - 738 26 °C 79 °F 659 565 - 749 27 °C 81 °F 639 544 - 728 27 °C 81 °F 650 555 - 739 MSP101103 Rev.1.0 20170602 28 °C 82 °F 630 533 - 717 28 °C 82 °F 641 544 - 728 29 °C 84 °F 621 523 - 707 29 °C 84 °F 632 533 - 717 30 °C 86 °F 612 512 - 696 30 °C 86 °F 623 523 - 707 164-2-B822 Expiry date 2021/05 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B822 – CLEW A38 (73.3 KB)
- CueSee® Hyperbaric i-STAT CLEW A37/C37/H37/J37 i-STAT CLEW A37/C37/H37/J37 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 639 568 - 752 mmHg pO2 18 °C 64 °F 653 588 - 772 mmHg 19 °C 66 °F 632 558 - 742 19 °C 66 °F 646 577 - 761 20 °C 68 °F 624 547 - 731 20 °C 68 °F 639 567 - 751 21 °C 70 °F 616 536 - 720 21 °C 70 °F 633 556 - 740 22 °C 72 °F 609 526 - 710 22 °C 72 °F 626 545 - 729 23 °C 73 °F 601 515 - 699 23 °C 73 °F 619 535 - 719 24 °C 75 °F 594 504 - 688 24 °C 75 °F 612 524 - 708 25 °C 77 °F 586 494 - 678 25 °C 77 °F 605 513 - 697 26 °C 79 °F 578 483 - 667 26 °C 79 °F 599 503 - 687 27 °C 81 °F 571 473 - 657 27 °C 81 °F 592 492 - 676 MSP101103 Rev.1.0 20170602 28 °C 82 °F 563 462 - 646 28 °C 82 °F 585 482 - 666 29 °C 84 °F 555 451 - 635 29 °C 84 °F 578 471 - 655 30 °C 86 °F 548 441 - 625 30 °C 86 °F 572 460 - 644 164-2-B905 Expiry date 2022/01 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet – Lot 164-2-B905 – CLEW A37 (96.2 KB)
- CueSee® Hyperbaric i-STAT CLEW A38/C38/H38/J38 i-STAT CLEW A38/C38/H38/J38 Cartridges types: CG8+, EG7+, EG6+, G3+ and CG4+ Cartridges types: G3+ and CG4+ Cartridge lots: A,K,L,M,N,W or Y Cartridge lots: D Temperature Mean Range Unit Temperature Mean Range Unit pO2 18 °C 64 °F 755 673 - 857 mmHg pO2 18 °C 64 °F 748 679 - 863 mmHg 19 °C 66 °F 746 663 - 847 19 °C 66 °F 740 668 - 852 20 °C 68 °F 737 652 - 836 20 °C 68 °F 733 657 - 841 21 °C 70 °F 728 642 - 826 21 °C 70 °F 726 647 - 831 22 °C 72 °F 719 631 - 815 22 °C 72 °F 718 636 - 820 23 °C 73 °F 709 620 - 804 23 °C 73 °F 711 626 - 810 24 °C 75 °F 700 610 - 794 24 °C 75 °F 704 615 - 799 25 °C 77 °F 691 599 - 783 25 °C 77 °F 696 604 - 788 26 °C 79 °F 682 589 - 773 26 °C 79 °F 689 594 - 778 27 °C 81 °F 673 578 - 762 27 °C 81 °F 682 583 - 767 MSP101103 Rev.1.0 20170602 28 °C 82 °F 664 567 - 751 28 °C 82 °F 674 573 - 757 29 °C 84 °F 655 557 - 741 29 °C 84 °F 667 562 - 746 30 °C 86 °F 645 546 - 730 30 °C 86 °F 660 551 - 735 164-2-B743 Expiry date 2020/10 Eurotrol, Inc., 850 N Black Ranch Rd, Elizabethtown KY 42701, USA, T +1 502 501-1180, officeusa@eurotrol.com, www.eurotrol.com Value Sheet – Lot 164-2-B743 – CLEW A38 (73.3 KB)
CueSee® Hypoxic
Product Specific
- CueSee® Hypoxic Intended Use Warnings and Precautions CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control 1. For in vitro diagnostic use only. material for professional use for monitoring blood gas analyzers’ performance of 2. Caution: Animal blood product. Bovine based materials do not carry biohazards for Oxygen partial pressure (pO2). man, such as HepB, HepC and HIV. This product is free of TSE. 3. These products should not be disposed of in general waste. Consult local Test Summary environmental authorities for proper disposal. CueSee® Hypoxic is available in one level with a known pO2 value in the critically low 4. CueSee® Hypoxic is not to be used as a calibrator. pO2 value range. It is intended that CueSee® Hypoxic should be used in the periodic Expected Values verification of the precision and accuracy of blood gas analyzers. Assigned values are established using the following measuring systems: Radiometer ABL835 FLEX blood gas analyzer, Abbott iSTAT® CG4+ system and epoc® Blood Contents Analysis System. For this purpose, randomly selected ampules from the applicable CueSee® Hypoxic provides one level in the critically low pO2 value range, each batch of CueSee® Hypoxic have been equilibrated at 25 ± 1°C before measurement. ampule holding 2.5 mL of solution. CueSee® Hypoxic is prepared from a stroma-free Assigned values are available from http:/www.eurotrol.com/documents, a paper bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh version can be requested via the contact information shown below. whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen Limitations balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or Incorrect handling, storage or sampling may cause the readings to deviate from the other additives that might adversely affect electrode measurements. target values. The pO2 values of CueSee® Hypoxic vary inversely with temperature changes. For Storage and Stability each °C change in temperature between 18 and 26 °C, the pO2 changes ±1.5%. To CueSee® Hypoxic should be stored between 2-8 °C (35-46 °F) in the dark. Stored obtain a high degree of correlation with the values in the value sheet, the ampules unopened at this temperature it is guaranteed stable until the expiration date as should be equilibrated as close to 25 °C as possible. indicated on the outer box. After opening an ampule of CueSee® Hypoxic, it should be CueSee® Hypoxic is sensitive to most of the instrument related factors that can used within 10 minutes. cause unexpected analytical deviations. Procedure For further information and/or technical assistance, please contact: 1. Remove ampule from box. Equilibrate the ampule at room temperature for a minimum of 1 hour, but not more than 8 hours. Note: Do not put ampules back into Manufacturer Distributor refrigerator once exposed to room temperature. Eurotrol B.V. Eurotrol Inc. 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to Keplerlaan 20, 6716 BS Ede 850 N Black Branch Rd, Elizabethtown, KY the Netherlands USA re-equilibrate the gases with the solution. 3. Swirl the ampule gently to return liquid to bottom. Allow bubbles to rise to the Phone: +31 318 695 777 Phone: +1 (502) 501-1180 surface before opening the ampule. E-mail: office@eurotrol.com E-mail: officeUSA@eurotrol.com www.eurotrol.com 4. Protect fingers with an ampule snapper, gauze, tissue or gloves and carefully snap of the neck of the ampule following the illustration below. The QC material should be analyzed within 10 minutes after opening the ampule. Follow the sampling Symbols used procedure according to analyzer operating instructions. Caution Batch code 5. Please refer to local guidelines for recommended frequency of use. Use-by date Temperature limit In vitro Diagnostic Medical Device Catalogue number Manufacturer CE logo 166.001.005 Hold the bottom of the ampule with thumb Cut located below the red dot is the breaking Grasp the top of the ampule with other hand, Press back to break at the cut under the red dot. pointing to the red colored dot. point of the ampule. positioning thumb at the red dot. AN01572A01 20181029 Instructions for Use (537.8 KB)
- How and why Eurotrol’s CueSee® Hypoxic works Thank you for taking the time to learn some of the advantages and principles behind Eurotrol’s CueSee Hypoxic for the validation of low pO2 blood gas measurements. - The advantages and principles page 1 First, we need to go back to the basics of oxygen transport in So, about 98.5% of the oxygen in arterial blood is bound by blood. hemoglobin in the red cells and about 1.5% is physically dissolved in the plasma. As you know, hemoglobin in red blood cells is the primary vehicle for transporting oxygen in the body. Oxygen is also carried On average, hemoglobin increases the total blood oxygen dissolved in the plasma, but to a much lesser degree. capacity seventyfold! - The advantages and principles page 2 The oxygen solubility in blood plasma is described by Henry’s The oxygen binding capacity of Hemoglobin does not follow Law (one of the gas laws) which states: “The solubility of a gas in Henry’s Law and can be best explained with the a liquid is directly proportional to the partial pressure of the gas oxygen-hemoglobin dissociation curve. above the liquid.” In its most simple form, the oxygen-hemoglobin dissociation curve describes the relationship between the partial pressure of oxygen on the x-axis and the oxygen saturation on the y-axis. - The advantages and principles page 3 Each hemoglobin molecule contains 4 heme groups with iron As a result of this cooperative binding, almost all of the cores to which oxygen binds. Therefore, 1 molecule of hemoglobin is saturated with oxygen. As this limit is approached hemoglobin can bind 4 molecules of oxygen. at pressures above 60 mmHg, very little additional binding occurs and the curve levels out, resulting in the S-shape. The shape of the curve results from the fact that when oxygen binds to hemoglobin, it changes the structure of the hemoglobin Now that you have a clear picture on how blood carries oxygen, molecule, making it easier for more oxygen to bind. The binding you can understand that it is impossible to make a Quality of the first molecule is difficult. However, this facilitates the Control material for validating a low pO2 without Hemoglobin. binding of the second, third and fourth. - The advantages and principles page 4 An ampule with an aqueous liquid that is in equilibrium with a An ampule with a real hemoglobin matrix that is in equilibrium pO2 of 15 mmHg will have a very small amount of oxygen with a pO2 of 15 mmHg will contain much more oxygen, most of dissolved, according to Henry’s law. which is bound by Hemoglobin as explained with the oxygen-hemoglobin dissociation curve. As soon as this ampule is opened for sampling, the liquid is contaminated with room air which has a pO2 of 160 mmHg. The reading of such a product would be easily 50-60 mmHg pO2 on a blood gas instrument. - The advantages and principles page 5 As soon as this ampule is opened, the contamination of room air On top of that, changes in pO2 of these liquids, when exposed with a pO2 of 160 mmHg that will dissolve in the water is to a higher pO2, will not happen as fast because the Hemoglobin negligible compared with the oxygen carried by the hemoglobin. will first bind more oxygen to get a higher level of oxygen saturation with hardly any changes in pO2 as explained by the S-shape in the oxygen-hemoglobin dissociation curve. - The advantages and principles page 6 Back in 2008, Eurotrol developed CueSee Hypoxic, the only low In that same year, a study was carried out in more than 1400 pO2 control in the world with a hemoglobin matrix that behaves laboratories that measured both CueSee Hypoxic and an like real blood. aqueous control with a low pO2. The results plotted in the graph clearly show CueSee Hypoxic: - Reports much lower results - Shows very small imprecision, and - Shows identical results on all different instruments. - The advantages and principles page 7 For CueSee Hypoxic with a value of 16 mmHg, all instruments In summary, CueSee Hypoxic is a unique and superior product to reported a target value between 16 +/- 4 mmHg. For blood gas validate low pO2 on blood gas instruments. quality control materials in the low pO2 range, this is quite an accomplishment. It offers the following benefits: - You can assess the accuracy and precision of low pO2 measurements - It’s ideal for method comparisons and AMR validation - It’s comparable to whole blood tonometry, without the use of a tonometer - It is compatible with all common blood gas instruments - True hemoglobin buffering provides a 10-minute open ampule stability - The advantages and principles page 8 As with all our quality control products, Eurotrol provides CueSee Eurotrol’s helpful staff is always available to assist you in placing Online, a free online service for comparing your quality control an order, evaluating a sample or for any questions or feedback data with peers. you might have. With a simple import tool, enter your results and then generate statistics, reports, and graphs that will satisfy any regulatory inspector. CueSee Online is a true enhancement to any quality control program. - The advantages and principles page 9 The Advantages and Principles (2.4 MB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 $ 3 1 ! )? @*A B $0 01)0AC;B @ C;8@ C/ 01)0AC;B @ C;8@ C/ ).00)AC;B @* C;8@ DC/ / .,)0AC;B -" 3 % ).3.0)AC;B -84 ;3.030 02A. 0'1.B -84 #<) .0 ,0.0. -84 #<) .0 00. -84 E<00501,0.0. -84 &))..A:B -84 &).02 -84 4)) 0., E E .. ,2.0 . 0F0 30 020 3 2 + 0 ..00,):10.% -,5.).00).: % 4 . ! 401)) 03 1 0.',0.).0,0 010. ..0"0 .,5.0.""000. ..0"2,).,5.%+,0.) 0.,5.010. 0,0678 01. 0,0 6 %78 % * -.4 . ! 401)) 03 1 0.',0.).0,0 010. ..0"0 .,5.0.""000. ..0"2,).,5.%+,0.) 0.,5.010. 0,0678 01. 0,0 6 %78 % ' )! 0.)."01 .%;. 0 ,00."))0.). % , 4 ! 401E+94+4',)0. ..0"0. -E-?4G4E= ),0))01- -84 +,0 - =--3 -84 ?5; ..:101>) -84 3 A.B -84 :019.0A..140"B -84 :019.0A;140"B -84 ,0))01;0+2) -84 .=0 > ..) 001 % . 0 5. = >0 0."9)0H I > 3 2?052."; ..0"003 01";,0 .A>?B% Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 6 ! +,)00.<)..,0,."F 0"0<). 0,0# $%&%J3 0 , ,0"00,00..",",0.0 "2,% 0,.",0.0"0,.)00.,00.".",) 0,0, "# $%&%'00.,..K3 010...".",)% "0.. 4)0 ' Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Material Safety Data Sheet (112.6 KB)
- Evaluation of Hypoxic QC™ a QC material with a physiological oxygen saturation curve, for the verification of accuracy and precision of low pO2 measurements Bart Jungerius 1, Annette Thomas 2, Wierd Roufs1, Carla Huizing1, Deb Phaup 3, Bart Maas 1 1 Eurotrol BV, Keplerlaan 20, 6716 BS Ede, The Netherlands; 2 WEQAS, Cardiff, UK; Eurotrol Inc, 3 Eurotrol Inc, 563 Main Street, Bolton MA 01740, USA Introduction Existing Quality Control (QC) materials have a poor oxygen buffering. Thus, QC measurements at extremely low pO2 values tend to have large ranges of variation. This study details the performance characteristics of Hypoxic QC™, a ready- to-use pre-tonometered quality control that allows verification of pO2 measurement methods at levels of 15 to 35 mmHg ( 2.0 to 4.5 kPa). Performance and commutability Saturation Curve Hypoxic (under the name of TonomeTrol) has been utilized by the Wales Hypoxic QC was compared External Quality Assessment Scheme (WEQAS) in their program. Results against whole blood of 1457 participants are represented below (in red). For comparison, results tonometry (Zijlstra et al., 2000) for of 1432 participants with a traditional aqueous material are represented (in recovery of partial pressure of blue). Bars represent 1 standard deviation. oxygen (pO2) and oxygen Hypoxic clearly demonstrates superior performance overall as well as per saturation (sO2) values. analyser. Moreover, Hypoxic provides high commutability. • pO2 was measured on a Hypoxic / TonomeTrol 14 Aqueous Siemens RapidLab 855 blood gas analyzer. 12 • sO2 was measured on Ciba- 10 Corning Model 270 CO-Oximeter. 8 • Saturation data on fresh pO2 (kPa) 6 whole blood were adopted from Zijlstra et al, 2000. 4 100 2 90 0 Overall Gem 3000 Gem 4000 Synthesis 1600 series OPTI Phox Nova CCX i-STAT ABL 5 series ABL 6 series ABL 7 series ABL 800 Flex NPT7 ABL 70/77 ABL 80 f lex Rapid Point 400 Rapidlabs 800 Rapidlabs 1200 OMNI Cobas b221 248 348 80 Peer Group 70 60 25 s O2 (%) Open ampoule stability 50 Ampoules were opened 20 40 p O2 = 0.0413x + 20.464 and left open on the table Value (mmHg) prior to measurement on 15 30 a ABL510. Time interval 10 20 varied from 0 to 30 p CO2 = -0.0479x + 12.877 Hypoxic pH 7.4 minutes. 5 10 Hypoxic pH 7.2 pCO2 Whole Blood pH 7.4 pO2 values were stable pO2 0 0 0 10 20 30 40 50 for well over 10 minutes. 0 5 10 15 20 25 30 pO2 (mmHg) Time from opening (minutes) Reference: Zijlstra, Buursma and Van Assendelft: Visible and Near Infrared Absorption spectra of human and animal Heamoglobin. VSP, Utrecht, NL Conclusions Hypoxic / TonomeTrol: • properties similar to fresh patient samples • ideal to assess pO2 accuracy • down to 15 mmHg (2.0 kPa) • ready-to-use on most common BGE analyzers • highly stable pO2 values after opening www.eurotrol.com Evaluation of Hypoxic QC™ (338.4 KB)
- epoc Value Assignment Sheet
Lot Specific
- CueSee® Hypoxic X-Low 16301928 ÌÇ0>3<:Î 166.001.005 Radiometer ABL 835 FLEX Analyte Mean Range Unit pO2 18.8 6.8 – 30.8 mmHg Abbott i-STAT® system CLEW: 38 Cartridge types: CG8+, EG7+, EG6+, G3+ & CG4+ Lots: A, K, L, M, N, W, Y Analyte Mean Range Unit pO2 17 5 – 29 mmHg Cartridge types: G3+ & CG4+ Lot: D Analyte Mean Range Unit pO2 17 5 – 29 mmHg epoc® Blood Analysis System See instrument manufacturer's website for Assigned values AN01183A01 – 20180615 Assigned values are established on the instruments listed. For other instruments mean values and ranges can be established by the end user. Page 1 of 1 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet - Lot 16301928 - (incl CLEW A38 for i-STAT)) (85.8 KB)
- CueSee® Hypoxic X-Low 16301911 ÌÇ0>3+LÎ 166.001.005 Radiometer ABL 835 FLEX Analyte Mean Range Unit pO2 18.6 6.6 – 30.6 mmHg Abbott i-STAT® system CLEW: A37 Cartridge types: CG8+, EG7+, EG6+, G3+ & CG4+ Lots: A, K, L, M, N, W, Y Analyte Mean Range Unit pO2 14 5 – 26 mmHg Cartridge types: G3+ & CG4+ Lot: D Analyte Mean Range Unit pO2 15 5 – 27 mmHg epoc® Blood Analysis System See instrument manufacturer's website for Assigned values AN01183A01 – 20180615 Assigned values are established on the instruments listed. For other instruments mean values and ranges can be established by the end user. Page 1 of 1 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet – Lot 16301911 – (Incl. CLEW A37 for i-STAT) (85.8 KB)
- CueSee® Hypoxic 1 X-Low 16301911 #NAME? 166.001.005 Radiometer ABL 835 FLEX Analyte Mean Range Unit pO2 18.6 6.6 – 30.6 mmHg Abbott i-STAT® system CLEW: A38 Cartridge types: CG8+, EG7+, EG6+, G3+ & CG4+ Lots: A, K, L, M, N, W, Y Analyte Mean Range Unit pO2 17 5 – 29 mmHg Cartridge types: G3+ & CG4+ Lot: D Analyte Mean Range Unit pO2 16 5 – 28 mmHg epoc® Blood Analysis System AN01183A01 – 20180615 See instrument manufacturer's website for Assigned values Assigned values are established on the instruments listed. For other instruments mean values and ranges can be established by the end user. Page 1 of 1 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet – Lot 16301911 - (Incl. CLEW A38 for i-STAT) (176.8 KB)
- CueSee® Hypoxic 1 X-Low 16301851 #NAME? 166.001.005 Radiometer ABL 835 FLEX Analyte Mean Range Unit pO2 21.8 9.8 – 33.8 mmHg Abbott i-STAT® system CLEW: A38 Cartridge types: CG8+, EG7+, EG6+, G3+ & CG4+ Lots: A, K, L, M, N, W, Y Analyte Mean Range Unit pO2 19 7 – 31 mmHg Cartridge types: G3+ & CG4+ Lot: D Analyte Mean Range Unit pO2 19 7 – 31 mmHg epoc® Blood Analysis System AN01183A01 – 20180615 See instrument manufacturer's website for Assigned values Assigned values are established on the instruments listed. For other instruments mean values and ranges can be established by the end user. Page 1 of 1 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet – Lot 16301851 - (Incl. CLEW A38 for i-STAT) (176.8 KB)
- CueSee® Hypoxic X-Low 16301851 ÌÇ0>2SBÎ 166.001.005 Radiometer ABL 835 FLEX Analyte Mean Range Unit pO2 21.8 9.8 – 33.8 mmHg Abbott i-STAT® system CLEW: A37 Cartridge types: CG8+, EG7+, EG6+, G3+ & CG4+ Lots: A, K, L, M, N, W, Y Analyte Mean Range Unit pO2 17 5 – 29 mmHg Cartridge types: G3+ & CG4+ Lot: D Analyte Mean Range Unit pO2 18 6 – 30 mmHg epoc® Blood Analysis System See instrument manufacturer's website for Assigned values AN01183A01 – 20180615 Assigned values are established on the instruments listed. For other instruments mean values and ranges can be established by the end user. Page 1 of 1 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet – Lot 16301851 – (Incl. CLEW A37 for i-STAT) (85.8 KB)
CueSee VeriSTAT® LVM
Product Specific
- CueSee® VeriSTAT LVM Intended Purpose CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite 7. Refer to CLIA regulations, state regulations, accrediting agency requirements as control material suitable for calibration verification of the Abbott i-STAT® POCT well as the i-STAT system manual for frequency of use. analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when Precautions measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, 1. CueSee® VeriSTAT LVM is for use on the Abbott i-STAT analyzer only. TCO2 and Hematocrit. 2. For in vitro diagnostic use only. 3. Consult local environmental authorities for proper disposal. IVD Medical Device CueSee® VeriSTAT LVM complies with the European Directive 98/79/EC on in vitro Reference Values diagnostic medical devices and carries the CE mark. Enclosed values have been obtained by equilibrating randomly selected ampules from CueSee® VeriSTAT LVM complies with the following US codes of Federal Regulations the applicable batch at 25 ± 1 °C (77 ± 2 °F) before measurement. The values have (CFR): 42 CFR part 72 and 21 CFR parts 606, 640 and 820. been obtained on multiple i-STAT instruments using multiple cartridge types. CueSee® VeriSTAT LVM is for professional in vitro diagnostic use only. The value ranges indicate the values for each parameter within which the obtained results must fall. Summary CueSee® VeriSTAT LVM quality control material is a five (5) level product, containing Please Note one (1) ampule per level. Each level of CueSee® VeriSTAT LVM contains known • The values in the table are applicable at sea level for the Abbott i-STAT POCT values of blood gases, electrolytes and metabolites. analyzer with the applicable cartridge types and cartridge lots only. • Incorrect sampling, storage, or other mishandling may cause the readings to deviate Reagents from the target values. CueSee® VeriSTAT LVM provides five (5) physiological relevant levels, each ampule • The pO2 values of CueSee® VeriSTAT LVM controls vary inversely with temperature containing 2.5 mL of solution. CueSee® VeriSTAT LVM quality controls are prepared changes. To obtain a high degree of correlation with the values in the table, the using salts in an aqueous, physiologically buffered matrix. Tonometry with ampules should be equilibrated as close to 25 °C (77 °F) as possible. predetermined levels of oxygen and carbon dioxide balanced with nitrogen and • CueSee® VeriSTAT LVM controls are very sensitive to room air contamination. To different salt concentrations provides five (5) distinct levels for each parameter, minimize the effect of air contamination, sample within 30 seconds of opening. The simulating clinically significant ranges of acid-base and electrolyte balance, respiratory effect of room air on pH is negligible. function, glucose, lactate, urea and creatinine concentrations, within the reportable • The value assignments are performed by using the IVD manufacturer’s supported range of the Abbott i-STAT POCT analyzer. reagents and representative sampling of this product. Individual laboratory means should fall within the corresponding acceptable range; however, laboratory means of Storage and stability the QC may vary from the listed values during the life of the IVD product. Variations CueSee® VeriSTAT LVM must be stored at a temperature of 2-8 °C (35-46 °F). Stored over time and between laboratories may be caused by differences in laboratory unopened at this temperature it is guaranteed stable until the expiration date as technique, instrumentation calibrating methods and reagents. It is recommended that indicated on the ampule and on the outer box. After opening the CueSee® VeriSTAT each laboratory establish its own means and acceptable ranges and use those LVM ampule, the product is stable for 30 seconds. provided only as guides. Procedures This product has been manufactured according to Eurotrol specifications. 1. Take the ampule out of its packaging and equilibrate the ampule to room temperature (20-25 °C/68-77 °F) for a minimum of 1 hour, but not more than 10 For further information please contact: days. Note: Do not put ampules back into refrigerator once exposed to room Eurotrol Inc., Elizabethtown, KY 42701, USA temperature. T: 1-502-501-1108 officeUSA@eurotrol.com 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to www.eurotrol.com re-equilibrate the gases with the solution by holding the ampule between the thumb and index finger. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any bubbles to rise before opening the ampule. Symbols used 4. Protect fingers with gauze, tissue or gloves. Attention, see instructions for use Batch code 5. The One Point Cut (OPC) ampule must be opened as presented below. Use by Storage temperature 6. Using one of the techniques described under “Controls for Blood Gas/Electrolyte/ Metabolites Cartridges” in the Quality Control section of the i-STAT system manual, In vitro Diagnostic Medical Device Reference number transfer sample from the ampule to the test cartridges within 30 seconds of opening the ampule. Manufacturer CE mark Important: Use the Calibration Verification (CalVer) pathway from the Quality Tests Menu. i-STAT is a registered trademark of Abbott Laboratories Hold the bottom of the ampule with thumb Cut located below the red dot is the Grasp the top of the ampule with other Press back to break at the cut under the pointing to the red colored dot. breaking point of the ampule. hand, positioning thumb at the red dot. red dot. AN01532A01 20181203 Instructions for use (267.9 KB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet (123.5 KB)
- The advantages and principles of Eurotrol’s CueSee® VeriSTAT Thank you for taking the time to learn how Eurotrol can contribute to your quality control process with our products and services designed for the Abbott i-STAT analyzer. - The advantages and principles page 1 With CueSee VeriSTAT, you will enhance your ability to assess Eurotrol is a trusted, independent, 3rd party quality control the accuracy and precision of your test results and, ultimately, manufacturer which ensures an unbiased assessment of the provide better patient care. analyzer’s performance. - The advantages and principles page 2 Back in 2008, Eurotrol created the world’s only “all-in-one” CueSee VeriSTAT comes in 3 levels of QC as well as a control for the i-STAT with blood gases, electrolytes, metabolites linearity verification material or LVM. AND hematocrit - all in the same ampule. More recently, CueSee VeriSTAT was launched with the same great all-in-one formulation, but with an added blue dye to make it easier to use. - The advantages and principles page 3 Of note, our LVM consists of 5 distinctly different levels (not CueSee VeriSTAT is produced so consistently that there is simply our QC with 2 levels added) which are optimized to more negligible lot-to-lot variation. Our value assignments yield more evenly cover the reportable ranges of the analyzer. precise target ranges – analysis shows that 58% of our analyte ranges are tighter than the competitor’s analyte ranges. - The advantages and principles page 4 Customers appreciate the longer shelf life of CueSee VeriSTAT CueSee VeriSTAT equilibrates in only 1 hour. No need to wait which is on average 6 months longer than the competition and up half your work day to run your controls. And with its longer room to 2 years from the date of manufacture. This allows you to use temp stability of 10 days, it is much more practical and the same lot number for longer periods of time which enables convenient should your schedule or demands delay the process. you to recognize any shifts in performance. - The advantages and principles page 5 With the use of one point cut technology, our ampules open more Our ampules contain 68% more solution per vial which precisely, decreasing the risk of injury significantly. decreases the possibility of room air contamination when performing QC. - The advantages and principles page 6 Eurotrol also provides CueSee Online, a free online service for Peer data comparison enhances your quality assurance program comparing your quality control data with peers. Simply import in many ways. It can help with customizing your target ranges, your results to generate your statistics along with helpful reports should you wish to. It also is used to help meet the CAP and graphs, which will impress any inspector! standard COM.30450 for verifying new cartridge lots by using VeriSTAT plus CueSee Online’s peer group data. - The advantages and principles page 7 Many of our customers report great savings using Eurotrol is looking forward to adding confidence to your quality CueSee VeriSTAT QC. control process. If you have any questions, would like to place an order or evaluate a sample, please feel free to contact us! Besides the many advantages and cost savings, Eurotrol provides fast, attentive and personal customer service. You will reach a live person - no automated attendants or frustrating menus to deal with. We are always happy to assist you! - The advantages and principles page 8 The Advantages and Principles (2.3 MB)
Lot Specific
- CueSee® VeriSTAT - Linearity Verification Material Expected values for Abbott i-STAT ® H 2020/12 CLEW: A38/C38/H38/J38 All cartridge types, all cartridge lot numbers Kit Level 1 Level 2 Level 3 Level 4 Level 5 Level 1 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range #N/A Unit `X R `X R `X R `X R `X R 22001901 pH 1 6.563 6.500 - 6.625 6.950 6.874 - 7.027 7.226 7.146 - 7.306 7.640 7.551 - 7.729 7.841 7.755 - 7.928 mmHg 111.7 96.3 - 127.1 88.6 75.4 - 101.8 63.6 51.9 - 75.3 36.4 26.6 - 46.3 19.9 11.0 - 28.8 p CO2 kPa 14.85 12.81 - 16.90 11.78 10.03 - 13.53 8.46 6.91 - 10.02 4.85 3.54 - 6.15 2.65 1.46 - 3.83 Level 2 mmHg 72 53 - 92 161 132 - 190 239 196 - 282 332 276 - 389 413 350 - 475 p O2 kPa 9.6 7.1 - 12.2 21.4 17.6 - 25.3 31.8 26.1 - 37.6 44.2 36.7 - 51.7 54.9 46.6 - 63.1 #N/A + Na mmol/L, mEq/L 107 102 - 112 121 117 - 126 142 138 - 147 154 149 - 160 171 165 - 176 22002851 + K mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.5 5.0 - 6.0 6.9 6.4 - 7.4 8.4 7.8 - 9.0 mmol/L 2.16 2.02 - 2.30 1.81 1.69 - 1.93 1.38 1.30 - 1.47 0.39 0.30 - 0.47 0.91 0.84 - 0.97 ++ iCa mEq/L 4.3 4.0 - 4.6 3.6 3.4 - 3.9 2.8 2.6 - 2.9 0.8 0.6 - 0.9 1.8 1.7 - 1.9 Level 3 mg/dL 8.6 8.1 - 9.2 7.2 6.8 - 7.7 5.5 5.2 - 5.9 1.5 1.2 - 1.9 3.6 3.4 - 3.9 Cl - mmol/L, mEq/L 107 101 - 113 73 67 - 79 128 119 - 137 86 80 - 92 102 95 - 108 #N/A tCO2 mmol/L, mEq/L 16 10 - 22 23 14 - 32 28 21 - 35 40 33 - 47 39 29 - 49 22003902 mg/dL 615 541 - 689 484 426 - 542 292 238 - 345 179 145 - 213 24 13 - 36 Glucose/ g/L 6.15 5.41 - 6.89 4.84 4.26 - 5.42 2.92 2.38 - 3.45 1.79 1.45 - 2.13 0.24 0.13 - 0.36 Glu mmol/L 34.1 30.0 - 38.2 26.9 23.7 - 30.1 16.2 13.2 - 19.1 9.9 8.0 - 11.8 1.3 0.7 - 2.0 Level 4 mmol/L 15.99 13.90 - 18.07 11.68 10.14 - 13.23 7.00 5.96 - 8.05 3.85 3.09 - 4.60 0.61 0.09 - 1.13 Lactate/ mg/dL 144.1 125.3 - 162.8 105.3 91.3 - 119.2 63.1 53.7 - 72.5 34.6 27.8 - 41.4 5.5 0.8 - 10.2 #N/A Lac g/L 1.441 1.253 - 1.628 1.053 0.913 - 1.192 0.631 0.537 - 0.725 0.346 0.278 - 0.414 0.055 0.008 - 0.102 22004851 BUN mg/dL 95 79 - 110 78 65 - 91 61 51 - 72 35 27 - 42 6 3 - 10 22004851 mmol/L 33.9 28.3 - 39.4 27.7 23.1 - 32.3 21.9 18.2 - 25.6 12.3 9.6 - 15.0 2.3 1.1 - 3.5 Urea mg/dL 203 170 - 237 166 139 - 194 132 109 - 154 74 58 - 90 14 6 - 21 Level 5 g/L 2.03 1.70 - 2.37 1.66 1.39 - 1.94 1.32 1.09 - 1.54 0.74 0.58 - 0.90 0.14 0.06 - 0.21 Creatinine/ µmol/L 32 0 - 65 434 343 - 525 716 568 - 863 1171 967 - 1375 1767 1510 - 2024 #N/A AN01262A01 - 20171114 Crea mg/dL 0.4 0.0 - 0.7 4.9 3.9 - 5.9 8.1 6.4 - 9.8 13.2 10.9 - 15.6 20.0 17.1 - 22.9 22005902 Hct 1 %PCV 16 12 - 19 27 23 - 31 40 35 - 44 52 47 - 57 62 57 - 67 2 Hct %PCV 16 13 - 20 28 24 - 32 41 37 - 46 54 49 - 60 65 59 - 70 1 K3EDTA 2 K2EDTA Page 1 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material ® Expected values for Abbott i-STAT CLEW: A38/C38/H38/J38 H 2020-12 CG4+ & G3+ gD Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R pH 1 6.575 6.525 - 6.625 6.977 6.927 - 7.027 7.256 7.206 - 7.306 7.676 7.626 - 7.726 7.875 7.825 - 7.925 mmHg 108.5 99.0 - 118.0 84.4 75.9 - 92.9 59.9 51.9 - 67.9 34.1 26.6 - 41.6 18.9 11.9 - 25.9 p CO2 kPa 14.44 13.17 - 15.70 11.23 10.09 - 12.36 7.97 6.91 - 9.03 4.53 3.54 - 5.53 2.51 1.58 - 3.44 mmHg 70 53 - 87 165 140 - 190 247 212 - 282 344 299 - 389 425 375 - 475 p O2 kPa 9.3 7.1 - 11.6 21.9 18.6 - 25.3 32.9 28.2 - 37.6 45.7 39.7 - 51.7 56.5 49.8 - 63.1 mmol/L 16.07 14.07 - 18.07 11.64 10.14 - 13.14 7.05 6.05 - 8.05 3.85 3.10 - 4.60 0.63 0.13 - 1.13 Lactate/ mg/dL 144.8 126.8 - 162.8 104.8 91.3 - 118.4 63.5 54.5 - 72.5 34.7 27.9 - 41.4 5.7 1.2 - 10.2 Lac g/L 1.448 1.268 - 1.628 1.048 0.913 - 1.184 0.635 0.545 - 0.725 0.347 0.279 - 0.414 0.057 0.012 - 0.102 AN01262A01 - 20171114 Page 2 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material Expected values for Abbott i-STAT ® CLEW: A38/C38/H38/J38 H 2020-12 CG8+, EG7+, EG6+, G3+, Crea & CG4+ g A, K, L, M, N, W or Y Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R pH 1 6.575 6.525 - 6.625 6.975 6.925 - 7.025 7.255 7.205 - 7.305 7.679 7.629 - 7.729 7.878 7.828 - 7.928 mmHg 105.8 96.3 - 115.3 83.9 75.4 - 92.4 61.0 53.0 - 69.0 35.2 27.7 - 42.7 18.0 11.0 - 25.0 p CO2 kPa 14.07 12.81 - 15.34 11.16 10.03 - 12.29 8.11 7.05 - 9.18 4.68 3.68 - 5.68 2.39 1.46 - 3.32 mmHg 75 58 - 92 157 132 - 182 231 196 - 266 321 276 - 366 400 350 - 450 p O2 kPa 9.9 7.7 - 12.2 20.9 17.6 - 24.2 30.7 26.1 - 35.4 42.7 36.7 - 48.7 53.2 46.6 - 59.9 Na+ mmol/L, mEq/L 108 104 - 112 122 118 - 126 143 139 - 147 155 150 - 160 170 165 - 175 K+ mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.5 5.0 - 6.0 6.9 6.4 - 7.4 8.4 7.8 - 9.0 mmol/L 2.15 2.02 - 2.28 1.80 1.69 - 1.91 1.38 1.30 - 1.46 0.38 0.30 - 0.46 0.90 0.84 - 0.96 iCa++ mEq/L 4.3 4.0 - 4.6 3.6 3.4 - 3.8 2.8 2.6 - 2.9 0.8 0.6 - 0.9 1.8 1.7 - 1.9 mg/dL 8.6 8.1 - 9.1 7.2 6.8 - 7.6 5.5 5.2 - 5.8 1.5 1.2 - 1.8 3.6 3.4 - 3.9 mg/dL 616 547 - 685 480 426 - 534 282 242 - 322 172 148 - 196 26 17 - 35 Glucose/ g/L 6.16 5.47 - 6.85 4.80 4.26 - 5.34 2.82 2.42 - 3.22 1.72 1.48 - 1.96 0.26 0.17 - 0.35 Glu mmol/L 34.2 30.3 - 38.0 26.6 23.7 - 29.6 15.7 13.4 - 17.9 9.5 8.2 - 10.9 1.4 0.9 - 1.9 Creatinine/ µmol/L 23 0 - 51 421 343 - 499 698 568 - 828 1157 967 - 1347 1740 1510 - 1970 Crea mg/dL 0.3 0.0 - 0.6 4.8 3.9 - 5.6 7.9 6.4 - 9.4 13.1 10.9 - 15.2 19.7 17.1 - 22.3 mmol/L 15.90 13.90 - 17.90 11.73 10.23 - 13.23 6.96 5.96 - 7.96 3.84 3.09 - 4.59 0.59 0.1 - 1.09 Lactate/ mg/dL 143.3 125.3 - 161.3 105.7 92.2 - 119.2 62.7 53.7 - 71.7 34.6 27.8 - 41.4 5.3 0.8 - 9.8 Lac g/L 1.433 1.253 - 1.613 1.057 0.922 - 1.192 0.627 0.537 - 0.717 0.346 0.278 - 0.414 0.053 0.0 - 0.098 AN01262A01 - 20171114 Hct 1 %PCV 16 13 - 19 28 25 - 31 41 38 - 44 53 49 - 57 63 59 - 67 Hct 2 %PCV 17 14 - 20 29 26 - 32 43 39 - 46 55 51 - 60 66 62 - 70 1 K3EDTA 2 K2EDTA Page 3 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material Expected values for Abbott i-STAT ® CLEW: A38/C38/H38/J38 H 2020-12 EC8+, 6+, EC4+, E3+ & G g F, H, J or K Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R pH 1 6.550 6.500 - 6.600 6.924 6.874 - 6.974 7.196 7.146 - 7.246 7.601 7.551 - 7.651 7.805 7.755 - 7.855 p CO2 mmHg 117.6 108.1 - 127.1 93.3 84.8 - 101.8 67.3 59.3 - 75.3 38.8 31.3 - 46.3 21.8 14.8 - 28.8 kPa 15.63 14.37 - 16.90 12.40 11.27 - 13.53 8.95 7.89 - 10.02 5.16 4.16 - 6.15 2.90 1.97 - 3.83 Na+ mmol/L, mEq/L 107 103 - 111 122 118 - 126 142 138 - 146 154 149 - 159 171 166 - 176 K+ mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.5 5.0 - 6.0 6.9 6.4 - 7.4 8.4 7.8 - 9.0 Cl- mmol/L, mEq/L 107 101 - 113 72 67 - 77 127 119 - 135 85 80 - 90 101 95 - 107 mg/dL 610 541 - 679 486 432 - 540 305 265 - 345 189 165 - 213 27 18 - 36 Glucose/ g/L 6.10 5.41 - 6.79 4.86 4.32 - 5.40 3.05 2.65 - 3.45 1.89 1.65 - 2.13 0.27 0.18 - 0.36 Glu mmol/L 33.9 30.0 - 37.7 27.0 24.0 - 30.0 16.9 14.7 - 19.1 10.5 9.2 - 11.8 1.5 1.0 - 2.0 BUN mg/dL 95 80 - 110 77 65 - 89 60 51 - 69 33 27 - 39 6 3 -9 mmol/L 34.1 28.7 - 39.4 27.4 23.1 - 31.7 21.4 18.2 - 24.7 11.8 9.6 - 13.9 2.1 1.1 - 3.2 Urea mg/dL 204 172 - 237 165 139 - 190 129 109 - 148 71 58 - 83 13 6 - 19 g/L 2.04 1.72 - 2.37 1.65 1.39 - 1.90 1.29 1.09 - 1.48 0.71 0.58 - 0.83 0.13 0.06 - 0.19 Hct 1 %PCV 15 12 - 18 27 24 - 30 40 37 - 43 52 48 - 56 62 58 - 66 Hct 2 %PCV 16 13 - 19 29 25 - 32 42 38 - 45 55 50 - 59 65 61 - 69 1 K3EDTA 2 K2EDTA AN01262A01 - 20171114 Page 4 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material ® Expected values for Abbott i-STAT CLEW: A38/C38/H38/J38 H 2020-12 CHEM8+ gH Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R Na+ mmol/L, mEq/L 106 102 - 110 121 117 - 125 142 138 - 146 154 149 - 159 170 165 - 175 K+ mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.5 5.0 - 6.0 6.9 6.4 - 7.4 8.4 7.8 - 9.0 Cl- mmol/L, mEq/L 107 101 - 113 74 69 - 79 129 121 - 137 87 82 - 92 102 96 - 108 mmol/L 2.17 2.04 - 2.30 1.82 1.71 - 1.93 1.39 1.31 - 1.47 0.39 0.31 - 0.47 0.91 0.85 - 0.97 iCa++ mEq/L 4.3 4.1 - 4.6 3.6 3.4 - 3.9 2.8 2.6 - 2.9 0.8 0.6 - 0.9 1.8 1.7 - 1.9 mg/dL 8.7 8.1 - 9.2 7.3 6.8 - 7.7 5.6 5.2 - 5.9 1.6 1.3 - 1.9 3.7 3.4 - 3.9 mg/dL 620 551 - 689 488 434 - 542 278 238 - 318 169 145 - 193 22 13 - 31 Glucose/ g/L 6.20 5.51 - 6.89 4.88 4.34 - 5.42 2.78 2.38 - 3.18 1.69 1.45 - 1.93 0.22 0.13 - 0.31 Glu mmol/L 34.4 30.6 - 38.2 27.1 24.1 - 30.1 15.4 13.2 - 17.7 9.4 8.0 - 10.7 1.2 0.7 - 1.7 tCO2 mmol/L, mEq/L 16 10 - 22 23 14 - 32 28 21 - 35 40 33 - 47 39 29 - 49 Creatinine/ µmol/L 37 9 - 65 447 369 - 525 733 603 - 863 1185 995 - 1375 1794 1564 - 2024 Crea mg/dL 0.4 0.1 - 0.7 5.1 4.2 - 5.9 8.3 6.8 - 9.8 13.4 11.3 - 15.6 20.3 17.7 - 22.9 BUN mg/dL 94 79 - 109 79 67 - 91 63 54 - 72 36 30 - 42 7 4 - 10 mmol/L 33.7 28.3 - 39.0 28.0 23.7 - 32.3 22.4 19.2 - 25.6 12.9 10.7 - 15.0 2.5 1.4 - 3.5 Urea mg/dL 202 170 - 234 168 142 - 194 135 115 - 154 77 64 - 90 15 8 - 21 g/L 2.02 1.70 - 2.34 1.68 1.42 - 1.94 1.35 1.15 - 1.54 0.77 0.64 - 0.90 0.15 0.08 - 0.21 Hct 1 %PCV 15 12 - 18 26 23 - 29 38 35 - 41 51 47 - 55 61 57 - 65 Hct 2 %PCV 16 13 - 19 27 24 - 30 40 37 - 43 53 49 - 57 63 59 - 68 AN01262A01 - 20171114 1 K3EDTA 2 K2EDTA Page 5 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 220-B904 – CLEW A38 (262.7 KB)
- CueSee® VeriSTAT - Linearity Verification Material Expected values for Abbott i-STAT ® H 2020-12 CLEW: A37/C37/H37/J37 All cartridge types, all cartridge lot numbers Kit Level 1 Level 2 Level 3 Level 4 Level 5 Level 1 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range #N/B Unit `X R `X R `X R `X R `X R 22001901 pH 1 6.566 6.489 - 6.644 6.951 6.869 - 7.033 7.225 7.140 - 7.310 7.648 7.557 - 7.740 7.873 7.782 - 7.963 mmHg 110.4 90.6 - 130.2 90.0 72.3 - 107.7 64.6 50.9 - 78.4 38.8 27.8 - 49.7 21.1 10.8 - 31.4 p CO2 kPa 14.68 12.05 - 17.31 11.97 9.62 - 14.32 8.60 6.77 - 10.43 5.16 3.70 - 6.62 2.81 1.44 - 4.18 Level 2 mmHg 72 50 - 93 159 130 - 188 228 185 - 272 331 275 - 387 405 340 - 470 p O2 kPa 9.5 6.7 - 12.4 21.1 17.2 - 25.0 30.4 24.6 - 36.2 44.0 36.5 - 51.4 53.8 45.2 - 62.5 #N/B Na+ mmol/L, mEq/L 107 103 - 111 122 118 - 127 143 138 - 147 155 149 - 161 172 166 - 178 22002851 + K mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.4 4.9 - 5.9 6.8 6.3 - 7.3 8.3 7.6 - 8.9 mmol/L 2.15 2.02 - 2.29 1.80 1.68 - 1.91 1.38 1.29 - 1.46 0.39 0.30 - 0.47 0.92 0.84 - 0.99 iCa++ mEq/L 4.3 4.0 - 4.6 3.6 3.4 - 3.8 2.8 2.6 - 2.9 0.8 0.6 - 0.9 1.8 1.7 - 2.0 Level 3 mg/dL 8.6 8.1 - 9.2 7.2 6.7 - 7.7 5.5 5.2 - 5.8 1.5 1.2 - 1.9 3.7 3.4 - 4.0 Cl- mmol/L, mEq/L 108 101 - 114 74 68 - 79 127 118 - 135 85 79 - 91 100 94 - 107 #N/B tCO2 mmol/L, mEq/L 15 9 - 21 22 13 - 31 28 21 - 35 40 33 - 47 39 29 - 49 22003902 mg/dL 617 538 - 696 483 424 - 542 290 236 - 343 176 141 - 211 24 13 - 35 Glucose/ g/L 6.17 5.38 - 6.96 4.83 4.24 - 5.42 2.90 2.36 - 3.43 1.76 1.41 - 2.11 0.24 0.13 - 0.35 Glu mmol/L 34.3 29.9 - 38.6 26.8 23.5 - 30.1 16.1 13.1 - 19.1 9.8 7.8 - 11.7 1.3 0.7 - 1.9 Level 4 mmol/L 15.66 13.39 - 17.93 11.56 10.03 - 13.08 6.80 5.58 - 8.02 3.69 2.93 - 4.46 0.52 0.01 - 1.02 Lactate/ mg/dL 141.1 120.6 - 161.5 104.1 90.4 - 117.9 61.3 50.3 - 72.2 33.3 26.4 - 40.2 4.6 0.1 - 9.2 #N/B Lac g/L 1.411 1.206 - 1.615 1.041 0.904 - 1.179 0.613 0.503 - 0.722 0.333 0.264 - 0.402 0.046 0.001 - 0.092 22004851 BUN mg/dL 89 69 - 110 74 59 - 88 58 48 - 69 34 27 - 40 7 4 - 10 22004851 mmol/L 31.8 24.5 - 39.1 26.3 21.2 - 31.4 20.9 17.2 - 24.5 12.0 9.6 - 14.3 2.5 1.4 - 3.6 Urea mg/dL 191 147 - 235 158 127 - 189 125 103 - 147 72 58 - 86 15 9 - 22 Level 5 g/L 1.91 1.47 - 2.35 1.58 1.27 - 1.89 1.25 1.03 - 1.47 0.72 0.58 - 0.86 0.15 0.09 - 0.22 Creatinine/ µmol/L 30 0 - 61 421 336 - 505 703 572 - 834 1138 944 - 1332 1740 1490 - 1989 #N/B AN01262A01 - 20171114 Crea mg/dL 0.3 0.0 - 0.7 4.8 3.8 - 5.7 8.0 6.5 - 9.4 12.9 10.7 - 15.1 19.7 16.9 - 22.5 22005902 Hct 1 %PCV 16 12 - 19 27 23 - 31 39 35 - 44 52 47 - 57 62 57 - 67 2 Hct %PCV 16 13 - 20 28 24 - 32 41 37 - 45 54 49 - 60 65 60 - 70 1 K3EDTA 2 K2EDTA Page 1 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material ® Expected values for Abbott i-STAT CLEW: A37/C37/H37/J37 H 2020-12 CG4+ & G3+ gD Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R pH 1 6.546 6.496 - 6.596 6.962 6.912 - 7.012 7.248 7.198 - 7.298 7.675 7.625 - 7.725 7.874 7.824 - 7.924 mmHg 104.5 95.0 - 114.0 82.2 73.7 - 90.7 59.2 51.2 - 67.2 35.5 28.0 - 43.0 17.8 10.8 - 24.8 p CO2 kPa 13.90 12.64 - 15.16 10.93 9.80 - 12.06 7.88 6.81 - 8.94 4.72 3.72 - 5.72 2.37 1.44 - 3.30 mmHg 67 50 - 84 163 138 - 188 237 202 - 272 342 297 - 387 420 370 - 470 p O2 kPa 9.0 6.7 - 11.2 21.7 18.4 - 25.0 31.5 26.8 - 36.2 45.4 39.4 - 51.4 55.8 49.2 - 62.5 mmol/L 15.39 13.39 - 17.39 11.53 10.03 - 13.03 6.58 5.58 - 7.58 3.68 2.93 - 4.43 0.51 0.01 - 1.01 Lactate/ mg/dL 138.7 120.6 - 156.7 103.9 90.4 - 117.4 59.3 50.3 - 68.3 33.1 26.4 - 39.9 4.6 0.1 - 9.1 Lac g/L 1.387 1.206 - 1.567 1.039 0.904 - 1.174 0.593 0.503 - 0.683 0.331 0.264 - 0.399 0.046 0.001 - 0.091 AN01262A01 - 20171114 Page 2 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material ® Expected values for Abbott i-STAT CLEW: A37/C37/H37/J37 H 2020-12 CG8+, EG7+, EG6+, G3+, Crea & CG4+ g A, K, L, M, N, W or Y Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R pH 1 6.594 6.544 - 6.644 6.983 6.933 - 7.033 7.260 7.210 - 7.310 7.690 7.640 - 7.740 7.913 7.863 - 7.963 mmHg 100.1 90.6 - 109.6 80.8 72.3 - 89.3 58.9 50.9 - 66.9 35.3 27.8 - 42.8 19.0 12.0 - 26.0 p CO2 kPa 13.31 12.05 - 14.57 10.75 9.62 - 11.88 7.83 6.77 - 8.89 4.70 3.70 - 5.70 2.53 1.59 - 3.46 mmHg 76 59 - 93 155 130 - 180 220 185 - 255 320 275 - 365 390 340 - 440 p O2 kPa 10.1 7.9 - 12.4 20.6 17.2 - 23.9 29.2 24.6 - 33.9 42.5 36.5 - 48.5 51.8 45.2 - 58.5 Na+ mmol/L, mEq/L 107 103 - 111 123 119 - 127 143 139 - 147 156 151 - 161 172 167 - 177 K+ mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.4 4.9 - 5.9 6.8 6.3 - 7.3 8.3 7.7 - 8.9 mmol/L 2.15 2.02 - 2.28 1.79 1.68 - 1.90 1.37 1.29 - 1.45 0.38 0.30 - 0.46 0.90 0.84 - 0.96 iCa++ mEq/L 4.3 4.0 - 4.6 3.6 3.4 - 3.8 2.7 2.6 - 2.9 0.8 0.6 - 0.9 1.8 1.7 - 1.9 mg/dL 8.6 8.1 - 9.1 7.2 6.7 - 7.6 5.5 5.2 - 5.8 1.5 1.2 - 1.8 3.6 3.4 - 3.9 mg/dL 607 538 - 676 478 424 - 532 281 241 - 321 170 146 - 194 24 15 - 33 Glucose/ g/L 6.07 5.38 - 6.76 4.78 4.24 - 5.32 2.81 2.41 - 3.21 1.70 1.46 - 1.94 0.24 0.15 - 0.33 Glu mmol/L 33.7 29.9 - 37.5 26.5 23.5 - 29.5 15.6 13.4 - 17.8 9.4 8.1 - 10.8 1.3 0.8 - 1.8 Creatinine/ µmol/L 27 0 - 55 414 336 - 492 702 572 - 832 1134 944 - 1324 1759 1529 - 1989 Crea mg/dL 0.3 0.0 - 0.6 4.7 3.8 - 5.6 7.9 6.5 - 9.4 12.8 10.7 - 15.0 19.9 17.3 - 22.5 mmol/L 15.93 13.93 - 17.93 11.58 10.08 - 13.08 7.02 6.02 - 8.02 3.71 2.96 - 4.46 0.52 0.0 - 1.02 Lactate/ mg/dL 143.5 125.5 - 161.5 104.4 90.9 - 117.9 63.2 54.2 - 72.2 33.4 26.7 - 40.2 4.7 0.2 - 9.2 Lac g/L 1.435 1.255 - 1.615 1.044 0.909 - 1.179 0.632 0.542 - 0.722 0.334 0.267 - 0.402 0.047 0.0 - 0.092 AN01262A01 - 20171114 Hct 1 %PCV 16 13 - 19 28 25 - 31 41 38 - 44 53 49 - 57 63 59 - 67 Hct 2 %PCV 17 14 - 20 29 26 - 32 42 39 - 45 56 51 - 60 66 62 - 70 1 K3EDTA 2 K2EDTA Page 3 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ® CueSee VeriSTAT - Linearity Verification Material Expected values for Abbott i-STAT ® CLEW: A37/C37/H37/J37 H 2020-12 EC8+, 6+, EC4+, E3+ & G g F, H, J or K Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R pH 1 6.539 6.489 - 6.589 6.919 6.869 - 6.969 7.190 7.140 - 7.240 7.607 7.557 - 7.657 7.832 7.782 - 7.882 p CO2 mmHg 120.7 111.2 - 130.2 99.2 90.7 - 107.7 70.4 62.4 - 78.4 42.2 34.7 - 49.7 24.4 17.4 - 31.4 kPa 16.05 14.79 - 17.31 13.19 12.06 - 14.32 9.36 8.30 - 10.43 5.62 4.62 - 6.62 3.25 2.32 - 4.18 Na+ mmol/L, mEq/L 107 103 - 111 122 118 - 126 143 139 - 147 156 151 - 161 173 168 - 178 K+ mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.4 4.9 - 5.9 6.8 6.3 - 7.3 8.2 7.6 - 8.8 Cl- mmol/L, mEq/L 108 102 - 114 73 68 - 78 126 118 - 134 84 79 - 89 101 95 - 107 mg/dL 615 546 - 684 488 434 - 542 303 263 - 343 187 163 - 211 26 17 - 35 Glucose/ g/L 6.15 5.46 - 6.84 4.88 4.34 - 5.42 3.03 2.63 - 3.43 1.87 1.63 - 2.11 0.26 0.17 - 0.35 Glu mmol/L 34.1 30.3 - 37.9 27.1 24.1 - 30.1 16.8 14.6 - 19.1 10.4 9.0 - 11.7 1.4 0.9 - 1.9 BUN mg/dL 95 80 - 110 76 64 - 88 60 51 - 69 33 27 - 39 7 4 - 10 mmol/L 33.8 28.4 - 39.1 27.2 22.9 - 31.4 21.3 18.1 - 24.5 11.8 9.6 - 13.9 2.5 1.4 - 3.6 Urea mg/dL 203 171 - 235 163 137 - 189 128 109 - 147 71 58 - 84 15 9 - 21 g/L 2.03 1.71 - 2.35 1.63 1.37 - 1.89 1.28 1.09 - 1.47 0.71 0.58 - 0.84 0.15 0.09 - 0.21 Hct 1 %PCV 15 12 - 18 28 25 - 31 40 37 - 43 53 49 - 57 63 59 - 67 2 Hct %PCV 16 13 - 19 29 26 - 32 42 39 - 45 55 51 - 60 66 62 - 70 1 K3EDTA 2 K2EDTA AN01262A01 - 20171114 Page 4 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT - Linearity Verification Material ® Expected values for Abbott i-STAT CLEW: A37/C37/H37/J37 H 2020-12 CHEM8+ gH Kit Level 1 Level 2 Level 3 Level 4 Level 5 g 22001901 g 22002851 g 22003902 g 22004851 g 22005902 g 220-B904 Mean Range Mean Range Mean Range Mean Range Mean Range Unit `X R `X R `X R `X R `X R Na+ mmol/L, mEq/L 107 103 - 111 122 118 - 126 142 138 - 146 154 149 - 159 171 166 - 176 K+ mmol/L, mEq/L 2.5 2.1 - 2.9 3.9 3.5 - 4.3 5.4 4.9 - 5.9 6.8 6.3 - 7.3 8.3 7.7 - 8.9 Cl- mmol/L, mEq/L 107 101 - 113 74 69 - 79 127 119 - 135 86 81 - 91 100 94 - 106 mmol/L 2.16 2.03 - 2.29 1.80 1.69 - 1.91 1.38 1.30 - 1.46 0.39 0.31 - 0.47 0.93 0.87 - 0.99 iCa++ mEq/L 4.3 4.1 - 4.6 3.6 3.4 - 3.8 2.8 2.6 - 2.9 0.8 0.6 - 0.9 1.9 1.7 - 2.0 mg/dL 8.7 8.1 - 9.2 7.2 6.8 - 7.7 5.5 5.2 - 5.8 1.6 1.3 - 1.9 3.7 3.5 - 4.0 mg/dL 627 558 - 696 487 433 - 541 276 236 - 316 165 141 - 189 22 13 - 31 Glucose/ g/L 6.27 5.58 - 6.96 4.87 4.33 - 5.41 2.76 2.36 - 3.16 1.65 1.41 - 1.89 0.22 0.13 - 0.31 Glu mmol/L 34.8 31.0 - 38.6 27.0 24.0 - 30.0 15.3 13.1 - 17.6 9.2 7.8 - 10.5 1.2 0.7 - 1.7 tCO2 mmol/L, mEq/L 15 9 - 21 22 13 - 31 28 21 - 35 40 33 - 47 39 29 - 49 Creatinine/ µmol/L 33 5 - 61 427 349 - 505 704 574 - 834 1142 952 - 1332 1720 1490 - 1950 Crea mg/dL 0.4 0.1 - 0.7 4.8 4.0 - 5.7 8.0 6.5 - 9.4 12.9 10.8 - 15.1 19.5 16.9 - 22.1 BUN mg/dL 84 69 - 99 71 59 - 83 57 48 - 66 34 28 - 40 7 4 - 10 mmol/L 29.9 24.5 - 35.2 25.5 21.2 - 29.8 20.4 17.2 - 23.6 12.2 10.0 - 14.3 2.5 1.5 - 3.6 Urea mg/dL 179 147 - 211 153 127 - 179 122 103 - 142 73 60 - 86 15 9 - 22 g/L 1.79 1.47 - 2.11 1.53 1.27 - 1.79 1.22 1.03 - 1.42 0.73 0.60 - 0.86 0.15 0.09 - 0.22 Hct 1 %PCV 15 12 - 18 26 23 - 29 38 35 - 41 51 47 - 55 61 57 - 65 2 Hct %PCV 16 13 - 19 27 24 - 30 40 37 - 43 53 49 - 57 64 60 - 68 AN01262A01 - 20171114 1 K3EDTA 2 K2EDTA Page 5 of 5 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 220-B904 – CLEW A37 (262.8 KB)
CueSee VeriSTAT® QC
Product Specific
- CueSee® VeriSTAT QC – Level 3 Intended Use CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for Precautions professional use in the verification of the precision and accuracy of the Abbott i-STAT® 1. CueSee® VeriSTAT QC - Level 3 is for use on the Abbott i-STAT analyzer only. POCT analyzer. 2. For in vitro diagnostic use only. It is intended that CueSee® VeriSTAT QC - Level 3 should be used in the periodic 3. CueSee® VeriSTAT QC - Level 3 is not to be used as a calibrator. verification of the precision, accuracy of the Abbott i-STAT POCT analyzer when 4. Consult local environmental authorities for proper disposal measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Reference Values Enclosed values have been obtained by equilibrating randomly selected ampules from IVD Medical Device the applicable batch at 25 ± 1 °C (77 ± 2 °F) before measurement. The values have CueSee® VeriSTAT QC - Level 3 complies with the European Directive 98/79/EC on been obtained on multiple i-STAT instruments using multiple cartridge types. The value in vitro diagnostic medical devices and carries the CE mark. ranges indicate the values for each parameter within which the obtained results must CueSee® VeriSTAT QC - Level 3 complies with the following US codes of Federal fall. Regulations (CFR): 42 CFR part 72 and 21 CFR parts 606, 640 and 820. CueSee® VeriSTAT QC - Level 3 is for professional in vitro diagnostic use only. Please Note • The values in the table are applicable at sea level for the Abbott i-STAT POCT Summary analyzer with the applicable cartridge types and cartridge lots only. CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for • Due to variations in CLEW updates, cartridge type and cartridge lot number, for some professional use in the verification of the precision and accuracy of the Abbott i-STAT® analyte concentrations in CueSee® VeriSTAT QC - Level 3, results may fall outside of POCT analyzer. Each ampule contains 2.5 mL of solution. the i-STAT reportable range. If necessary, it is recommended that the Calibration Verification pathway be used to obtain a numerical result. Reagents • Incorrect sampling, storage, or other mishandling may cause the readings to deviate CueSee® VeriSTAT QC - Level 3 quality controls are prepared using salts in an from the target values. aqueous, physiologically buffered matrix. Tonometry with predetermined levels of • The pO2 values of CueSee® VeriSTAT QC - Level 3 controls vary inversely with oxygen and carbon dioxide balanced with nitrogen and different salt concentrations temperature changes. To obtain a high degree of correlation with the values in the provides distinct levels for each parameter, simulating clinically significant ranges of table, the ampules should be equilibrated as close to 25 °C (77 °F) as possible. acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and • CueSee® VeriSTAT QC - Level 3 controls are very sensitive to room air creatinine concentrations, within the reportable range of the Abbott i-STAT POCT contamination. To minimize the effect of air contamination, sample within 30 seconds analyzer. of opening. The effect of room air on pH is negligible. • The value assignments are performed by using the IVD manufacturer’s supported Storage and stability reagents and representative sampling of this product. Individual laboratory means CueSee® VeriSTAT QC - Level 3 must be stored at a temperature of 2-8 °C (35-46 should fall within the corresponding acceptable range; however, laboratory means of °F). Stored unopened at this temperature it is guaranteed stable until the expiration the QC may vary from the listed values during the life of the IVD product. Variations date as indicated on the ampule and on the outer box. After opening the CueSee® over time and between laboratories may be caused by differences in laboratory VeriSTAT QC - Level 3 ampule, the product is stable for 30 seconds. technique, instrumentation calibrating methods and reagents. It is recommended that each laboratory establishes it’s own means and acceptable ranges and use those Procedures provided only as guides. 1. Take the ampule out of its packaging and equilibrate the ampule to room This product has been manufactured according to Eurotrol specifications. temperature (20-25 °C/68-77 °F) for a minimum of 1 hour, but not more than 10 days. For further information please contact: Note: Do not put ampules back into refrigerator once exposed to room temperature. 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to Eurotrol Inc., Elizabethtown, KY 42701, USA re-equilibrate the gases with the solution by holding the ampule between the thumb T: 1-502-501-1108 officeUSA@eurotrol.com and index finger. www.eurotrol.com 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands bubbles to rise before opening the ampule. Symbols used 4. Protect fingers with gauze, tissue or gloves. 5. The One Point Cut (OPC) ampule must be opened as presented below. Attention, see instructions for use Batch code 6. Using one of the techniques described under “Controls for Blood Gas/Electrolyte/ Use by Temperature limitation Metabolite Cartridges” in the Quality Control section of the i-STAT system manual, transfer sample from the ampule to the test cartridges within 30 seconds of opening In vitro Diagnostic Medical Device Reference number the ampule. Manufacturer CE mark 7. Refer to CLIA regulations, state regulations, accrediting agency requirements as well as the i-STAT system manual for frequency of use. i-STAT is a registered trademark of Abbott Laboratories Hold the bottom of the ampule with thumb Cut located below the red dot is the Grasp the top of the ampule with other Press back to break at the cut under the pointing to the red colored dot. breaking point of the ampule. hand, positioning thumb at the red dot. red dot. AN01539A03 20181203 Instructions for use - Level 3 (268.3 KB)
- CueSee® VeriSTAT QC – Level 2 Intended Use CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for Precautions professional use in the verification of the precision and accuracy of the Abbott i-STAT® 1. CueSee® VeriSTAT QC - Level 2 is for use on the Abbott i-STAT analyzer only. POCT analyzer. 2. For in vitro diagnostic use only. It is intended that CueSee® VeriSTAT QC - Level 2 should be used in the periodic 3. CueSee® VeriSTAT QC - Level 2 is not to be used as a calibrator. verification of the precision, accuracy of the Abbott i-STAT POCT analyzer when 4. Consult local environmental authorities for proper disposal measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Reference Values Enclosed values have been obtained by equilibrating randomly selected ampules from IVD Medical Device the applicable batch at 25 ± 1 °C (77 ± 2 °F) before measurement. The values have CueSee® VeriSTAT QC - Level 2 complies with the European Directive 98/79/EC on been obtained on multiple i-STAT instruments using multiple cartridge types. The value in vitro diagnostic medical devices and carries the CE mark. ranges indicate the values for each parameter within which the obtained results must CueSee® VeriSTAT QC - Level 2 complies with the following US codes of Federal fall. Regulations (CFR): 42 CFR part 72 and 21 CFR parts 606, 640 and 820. CueSee® VeriSTAT QC - Level 2 is for professional in vitro diagnostic use only. Please Note • The values in the table are applicable at sea level for the Abbott i-STAT POCT Summary analyzer with the applicable cartridge types and cartridge lots only. CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for • Due to variations in CLEW updates, cartridge type and cartridge lot number, for some professional use in the verification of the precision and accuracy of the Abbott i-STAT® analyte concentrations in CueSee® VeriSTAT QC - Level 2, results may fall outside of POCT analyzer. Each ampule contains 2.5 mL of solution. the i-STAT reportable range. If necessary, it is recommended that the Calibration Verification pathway be used to obtain a numerical result. Reagents • Incorrect sampling, storage, or other mishandling may cause the readings to deviate CueSee® VeriSTAT QC - Level 2 quality controls are prepared using salts in an from the target values. aqueous, physiologically buffered matrix. Tonometry with predetermined levels of • The pO2 values of CueSee® VeriSTAT QC - Level 2 controls vary inversely with oxygen and carbon dioxide balanced with nitrogen and different salt concentrations temperature changes. To obtain a high degree of correlation with the values in the provides distinct levels for each parameter, simulating clinically significant ranges of table, the ampules should be equilibrated as close to 25 °C (77 °F) as possible. acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and • CueSee® VeriSTAT QC - Level 2 controls are very sensitive to room air creatinine concentrations, within the reportable range of the Abbott i-STAT POCT contamination. To minimize the effect of air contamination, sample within 30 seconds analyzer. of opening. The effect of room air on pH is negligible. • The value assignments are performed by using the IVD manufacturer’s supported Storage and stability reagents and representative sampling of this product. Individual laboratory means CueSee® VeriSTAT QC - Level 2 must be stored at a temperature of 2-8 °C (35-46 should fall within the corresponding acceptable range; however, laboratory means of °F). Stored unopened at this temperature it is guaranteed stable until the expiration the QC may vary from the listed values during the life of the IVD product. Variations date as indicated on the ampule and on the outer box. After opening the CueSee® over time and between laboratories may be caused by differences in laboratory VeriSTAT QC - Level 2 ampule, the product is stable for 30 seconds. technique, instrumentation calibrating methods and reagents. It is recommended that each laboratory establishes it’s own means and acceptable ranges and use those Procedures provided only as guides. 1. Take the ampule out of its packaging and equilibrate the ampule to room This product has been manufactured according to Eurotrol specifications. temperature (20-25 °C/68-77 °F) for a minimum of 1 hour, but not more than 10 days. For further information please contact: Note: Do not put ampules back into refrigerator once exposed to room temperature. 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to Eurotrol Inc., Elizabethtown, KY 42701, USA re-equilibrate the gases with the solution by holding the ampule between the thumb T: 1-502-501-1108 officeUSA@eurotrol.com and index finger. www.eurotrol.com 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands bubbles to rise before opening the ampule. Symbols used 4. Protect fingers with gauze, tissue or gloves. 5. The One Point Cut (OPC) ampule must be opened as presented below. Attention, see instructions for use Batch code 6. Using one of the techniques described under “Controls for Blood Gas/Electrolyte/ Use by Temperature limitation Metabolite Cartridges” in the Quality Control section of the i-STAT system manual, transfer sample from the ampule to the test cartridges within 30 seconds of opening In vitro Diagnostic Medical Device Reference number the ampule. Manufacturer CE mark 7. Refer to CLIA regulations, state regulations, accrediting agency requirements as well as the i-STAT system manual for frequency of use. i-STAT is a registered trademark of Abbott Laboratories Hold the bottom of the ampule with thumb Cut located below the red dot is the Grasp the top of the ampule with other Press back to break at the cut under the pointing to the red colored dot. breaking point of the ampule. hand, positioning thumb at the red dot. red dot. AN01539A02 20181203 Instructions for use - Level 2 (268.6 KB)
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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No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urotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Safety Data Sheet (120.6 KB)
- The advantages and principles of Eurotrol’s CueSee® VeriSTAT Thank you for taking the time to learn how Eurotrol can contribute to your quality control process with our products and services designed for the Abbott i-STAT analyzer. - The advantages and principles page 1 With CueSee VeriSTAT, you will enhance your ability to assess Eurotrol is a trusted, independent, 3rd party quality control the accuracy and precision of your test results and, ultimately, manufacturer which ensures an unbiased assessment of the provide better patient care. analyzer’s performance. - The advantages and principles page 2 Back in 2008, Eurotrol created the world’s only “all-in-one” CueSee VeriSTAT comes in 3 levels of QC as well as a control for the i-STAT with blood gases, electrolytes, metabolites linearity verification material or LVM. AND hematocrit - all in the same ampule. More recently, CueSee VeriSTAT was launched with the same great all-in-one formulation, but with an added blue dye to make it easier to use. - The advantages and principles page 3 Of note, our LVM consists of 5 distinctly different levels (not CueSee VeriSTAT is produced so consistently that there is simply our QC with 2 levels added) which are optimized to more negligible lot-to-lot variation. Our value assignments yield more evenly cover the reportable ranges of the analyzer. precise target ranges – analysis shows that 58% of our analyte ranges are tighter than the competitor’s analyte ranges. - The advantages and principles page 4 Customers appreciate the longer shelf life of CueSee VeriSTAT CueSee VeriSTAT equilibrates in only 1 hour. No need to wait which is on average 6 months longer than the competition and up half your work day to run your controls. And with its longer room to 2 years from the date of manufacture. This allows you to use temp stability of 10 days, it is much more practical and the same lot number for longer periods of time which enables convenient should your schedule or demands delay the process. you to recognize any shifts in performance. - The advantages and principles page 5 With the use of one point cut technology, our ampules open more Our ampules contain 68% more solution per vial which precisely, decreasing the risk of injury significantly. decreases the possibility of room air contamination when performing QC. - The advantages and principles page 6 Eurotrol also provides CueSee Online, a free online service for Peer data comparison enhances your quality assurance program comparing your quality control data with peers. Simply import in many ways. It can help with customizing your target ranges, your results to generate your statistics along with helpful reports should you wish to. It also is used to help meet the CAP and graphs, which will impress any inspector! standard COM.30450 for verifying new cartridge lots by using VeriSTAT plus CueSee Online’s peer group data. - The advantages and principles page 7 Many of our customers report great savings using Eurotrol is looking forward to adding confidence to your quality CueSee VeriSTAT QC. control process. If you have any questions, would like to place an order or evaluate a sample, please feel free to contact us! Besides the many advantages and cost savings, Eurotrol provides fast, attentive and personal customer service. You will reach a live person - no automated attendants or frustrating menus to deal with. We are always happy to assist you! - The advantages and principles page 8 The Advantages and Principles (2.3 MB)
- CueSee® VeriSTAT QC – Level 1 Intended Use CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for Precautions professional use in the verification of the precision and accuracy of the Abbott i-STAT® 1. CueSee® VeriSTAT QC - Level 1 is for use on the Abbott i-STAT analyzer only. POCT analyzer. 2. For in vitro diagnostic use only. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic 3. CueSee® VeriSTAT QC - Level 1 is not to be used as a calibrator. verification of the precision, accuracy of the Abbott i-STAT POCT analyzer when 4. Consult local environmental authorities for proper disposal measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Reference Values Enclosed values have been obtained by equilibrating randomly selected ampules from IVD Medical Device the applicable batch at 25 ± 1 °C (77 ± 2 °F) before measurement. The values have CueSee® VeriSTAT QC - Level 1 complies with the European Directive 98/79/EC on been obtained on multiple i-STAT instruments using multiple cartridge types. The value in vitro diagnostic medical devices and carries the CE mark. ranges indicate the values for each parameter within which the obtained results must CueSee® VeriSTAT QC - Level 1 complies with the following US codes of Federal fall. Regulations (CFR): 42 CFR part 72 and 21 CFR parts 606, 640 and 820. CueSee® VeriSTAT QC - Level 1 is for professional in vitro diagnostic use only. Please Note • The values in the table are applicable at sea level for the Abbott i-STAT POCT Summary analyzer with the applicable cartridge types and cartridge lots only. CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for • Due to variations in CLEW updates, cartridge type and cartridge lot number, for some professional use in the verification of the precision and accuracy of the Abbott i-STAT® analyte concentrations in CueSee® VeriSTAT QC - Level 1, results may fall outside of POCT analyzer. Each ampule contains 2.5 mL of solution. the i-STAT reportable range. If necessary, it is recommended that the Calibration Verification pathway be used to obtain a numerical result. Reagents • Incorrect sampling, storage, or other mishandling may cause the readings to deviate CueSee® VeriSTAT QC - Level 1 quality controls are prepared using salts in an from the target values. aqueous, physiologically buffered matrix. Tonometry with predetermined levels of • The pO2 values of CueSee® VeriSTAT QC - Level 1 controls vary inversely with oxygen and carbon dioxide balanced with nitrogen and different salt concentrations temperature changes. To obtain a high degree of correlation with the values in the provides distinct levels for each parameter, simulating clinically significant ranges of table, the ampules should be equilibrated as close to 25 °C (77 °F) as possible. acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and • CueSee® VeriSTAT QC - Level 1 controls are very sensitive to room air creatinine concentrations, within the reportable range of the Abbott i-STAT POCT contamination. To minimize the effect of air contamination, sample within 30 seconds analyzer. of opening. The effect of room air on pH is negligible. • The value assignments are performed by using the IVD manufacturer’s supported Storage and stability reagents and representative sampling of this product. Individual laboratory means CueSee® VeriSTAT QC - Level 1 must be stored at a temperature of 2-8 °C (35-46 should fall within the corresponding acceptable range; however, laboratory means of °F). Stored unopened at this temperature it is guaranteed stable until the expiration the QC may vary from the listed values during the life of the IVD product. Variations date as indicated on the ampule and on the outer box. After opening the CueSee® over time and between laboratories may be caused by differences in laboratory VeriSTAT QC - Level 1 ampule, the product is stable for 30 seconds. technique, instrumentation calibrating methods and reagents. It is recommended that each laboratory establishes it’s own means and acceptable ranges and use those Procedures provided only as guides. 1. Take the ampule out of its packaging and equilibrate the ampule to room This product has been manufactured according to Eurotrol specifications. temperature (20-25 °C/68-77 °F) for a minimum of 1 hour, but not more than 10 days. For further information please contact: Note: Do not put ampules back into refrigerator once exposed to room temperature. 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to Eurotrol Inc., Elizabethtown, KY 42701, USA re-equilibrate the gases with the solution by holding the ampule between the thumb T: 1-502-501-1108 officeUSA@eurotrol.com and index finger. www.eurotrol.com 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands bubbles to rise before opening the ampule. Symbols used 4. Protect fingers with gauze, tissue or gloves. 5. The One Point Cut (OPC) ampule must be opened as presented below. Attention, see instructions for use Batch code 6. Using one of the techniques described under “Controls for Blood Gas/Electrolyte/ Use by Temperature limitation Metabolite Cartridges” in the Quality Control section of the i-STAT system manual, transfer sample from the ampule to the test cartridges within 30 seconds of opening In vitro Diagnostic Medical Device Reference number the ampule. Manufacturer CE mark 7. Refer to CLIA regulations, state regulations, accrediting agency requirements as well as the i-STAT system manual for frequency of use. i-STAT is a registered trademark of Abbott Laboratories Hold the bottom of the ampule with thumb Cut located below the red dot is the Grasp the top of the ampule with other Press back to break at the cut under the pointing to the red colored dot. breaking point of the ampule. hand, positioning thumb at the red dot. red dot. AN01539A01 20181203 Instructions for use - Level 1 (267.9 KB)
Lot Specific
- ® CueSee VeriSTAT QC g 22103909 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 7.631 7.551 - 7.710 mmHg 30.2 21.0 - 39.3 p CO2 kPa 4.01 2.80 - 5.23 mmHg 133 103 - 163 p O2 kPa 17.7 13.7 - 21.7 + Na mmol/L, mEq/L 161 155 - 167 + K mmol/L, mEq/L 6.1 5.6 - 6.6 mmol/L 0.66 0.57 - 0.76 iCa++ mEq/L 1.3 1.1 - 1.5 mg/dL 2.7 2.3 - 3.0 - Cl mmol/L, mEq/L 124 117 - 131 tCO2 mmol/L, mEq/L 34 27 - 41 mg/dL 45 33 - 57 Glucose/ g/L 0.45 0.33 - 0.57 Glu mmol/L 2.5 1.9 - 3.2 mmol/L 0.71 0.20 - 1.21 Lactate/ mg/dL 6.4 1.8 - 10.9 Lac g/L 0.064 0.018 - 0.109 BUN mg/dL 11 8 - 13 mmol/L 3.8 2.9 - 4.6 Urea mg/dL 23 18 - 27 AN01263A01 - 20171114 g/L 0.23 0.18 - 0.27 Creatinine/ µmol/L 55 27 - 83 Crea mg/dL 0.6 0.3 - 0.9 Hct 1 %PCV 53 48 - 58 2 Hct %PCV 55 50 - 60 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.601 7.551 - 7.651 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 32.3 25.3 - 39.3 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.30 3.36 - 5.23 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 161 156 - 166 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.1 5.6 - 6.6 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 123 117 - 129 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 48 39 - 57 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.48 0.39 - 0.57 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.7 2.2 - 3.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.7 2.9 - 4.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 18 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.18 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 53 49 - 57 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 51 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.660 7.610 - 7.710 pH 1 7.655 7.605 - 7.705 mmHg 28.3 21.3 - 35.3 mmHg 28.0 21.0 - 35.0 p CO2 p CO2 kPa 3.76 2.83 - 4.69 kPa 3.73 2.80 - 4.66 mmHg 131 106 - 156 mmHg 135 110 - 160 p O2 p O2 kPa 17.5 14.2 - 20.8 kPa 18.0 14.7 - 21.3 + Na mmol/L, mEq/L 162 157 - 167 mmol/L 0.71 0.21 - 1.21 + Lactate/ K mmol/L, mEq/L 6.1 5.6 - 6.6 mg/dL 6.4 1.9 - 10.9 Lac mmol/L 0.68 0.60 - 0.76 g/L 0.064 0.019 - 0.109 iCa++ mEq/L 1.4 1.2 - 1.5 mg/dL 2.7 2.4 - 3.0 mg/dL 47 38 - 56 Glucose/ g/L 0.47 0.38 - 0.56 Glu mmol/L 2.6 2.1 - 3.1 Creatinine/ µmol/L 57 30 - 83 Crea mg/dL 0.6 0.3 - 0.9 mmol/L 0.70 0.20 - 1.20 Lactate/ mg/dL 6.3 1.8 - 10.8 Lac g/L 0.063 0.018 - 0.108 1 AN01263A01 - 20171114 Hct %PCV 54 50 - 58 2 Hct %PCV 56 52 - 60 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 160 155 - 165 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.1 5.6 - 6.6 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 125 119 - 131 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.65 0.57 - 0.73 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.1 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.6 2.3 - 2.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 42 33 - 51 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.42 0.33 - 0.51 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.4 1.9 - 2.9 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 34 27 - 41 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 53 27 - 80 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 9 - 13 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.9 3.2 - 4.6 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 23 19 - 27 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.23 0.19 - 0.27 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 52 48 - 56 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 54 50 - 58 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103909 – Level 3 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22102910 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 7.343 7.263 - 7.423 mmHg 41.9 30.3 - 53.5 p CO2 kPa 5.58 4.03 - 7.12 mmHg 92 67 - 117 p O2 kPa 12.2 8.9 - 15.5 + Na mmol/L, mEq/L 135 130 - 140 + K mmol/L, mEq/L 3.6 3.1 - 4.0 mmol/L 1.14 1.05 - 1.23 iCa++ mEq/L 2.3 2.1 - 2.5 mg/dL 4.6 4.2 - 4.9 - Cl mmol/L, mEq/L 100 94 - 106 tCO2 mmol/L, mEq/L 25 18 - 32 mg/dL 141 124 - 158 Glucose/ g/L 1.41 1.24 - 1.58 Glu mmol/L 7.8 6.9 - 8.7 mmol/L 2.06 1.55 - 2.57 Lactate/ mg/dL 18.6 14.0 - 23.2 Lac g/L 0.186 0.140 - 0.232 BUN mg/dL 12 9 - 15 mmol/L 4.3 3.2 - 5.4 Urea mg/dL 26 19 - 32 AN01263A01 - 20171114 g/L 0.26 0.19 - 0.32 Creatinine/ µmol/L 141 104 - 177 Crea mg/dL 1.6 1.2 - 2.0 1 Hct %PCV 34 30 - 38 2 Hct %PCV 35 31 - 40 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.313 7.263 - 7.363 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 46.5 39.5 - 53.5 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 6.19 5.25 - 7.12 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 136 132 - 140 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 99 94 - 104 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 144 130 - 158 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.44 1.30 - 1.58 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.0 7.2 - 8.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.2 3.2 - 5.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 25 19 - 32 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.25 0.19 - 0.32 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 36 33 - 39 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.373 7.323 - 7.423 pH 1 7.373 7.323 - 7.423 mmHg 39.0 32.0 - 46.0 mmHg 37.3 30.3 - 44.3 p CO2 p CO2 kPa 5.19 4.26 - 6.12 kPa 4.96 4.03 - 5.90 mmHg 94 74 - 114 mmHg 89 69 - 109 p O2 p O2 kPa 12.5 9.9 - 15.2 kPa 11.8 9.2 - 14.5 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.07 1.57 - 2.57 + Lactate/ K mmol/L, mEq/L 3.5 3.1 - 3.9 mg/dL 18.7 14.2 - 23.2 Lac mmol/L 1.15 1.07 - 1.23 g/L 0.187 0.142 - 0.232 iCa++ mEq/L 2.3 2.1 - 2.5 mg/dL 4.6 4.3 - 4.9 mg/dL 139 125 - 153 Glucose/ g/L 1.39 1.25 - 1.53 Glu mmol/L 7.7 6.9 - 8.5 Creatinine/ µmol/L 139 104 - 175 Crea mg/dL 1.6 1.2 - 2.0 mmol/L 2.05 1.55 - 2.55 Lactate/ mg/dL 18.5 14.0 - 23.0 Lac g/L 0.185 0.140 - 0.230 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 36 33 - 40 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 134 130 - 138 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 101 96 - 106 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.13 1.05 - 1.21 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.3 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.5 4.2 - 4.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 138 124 - 152 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.38 1.24 - 1.52 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.6 6.9 - 8.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 25 18 - 32 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 142 107 - 177 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.3 3.2 - 5.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 26 19 - 32 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.26 0.19 - 0.32 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 33 30 - 36 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102910 – Level 2 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101910 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 6.942 6.866 - 7.019 mmHg 77.2 61.8 - 92.7 p CO2 kPa 10.27 8.21 - 12.33 mmHg 55 35 - 75 p O2 kPa 7.4 4.7 - 10.0 + Na mmol/L, mEq/L 118 113 - 123 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.40 1.29 - 1.51 iCa++ mEq/L 2.8 2.6 - 3.0 mg/dL 5.6 5.1 - 6.1 - Cl mmol/L, mEq/L 80 74 - 86 tCO2 mmol/L, mEq/L 20 11 - 29 mg/dL 307 259 - 356 Glucose/ g/L 3.07 2.59 - 3.56 Glu mmol/L 17.1 14.4 - 19.8 mmol/L 8.02 7.01 - 9.03 Lactate/ mg/dL 72.3 63.1 - 81.4 Lac g/L 0.723 0.631 - 0.814 BUN mg/dL 58 51 - 65 mmol/L 20.6 18.1 - 23.1 Urea mg/dL 124 108 - 139 AN01263A01 - 20171114 g/L 1.24 1.08 - 1.39 Creatinine/ µmol/L 330 258 - 403 Crea mg/dL 3.7 2.9 - 4.6 1 Hct %PCV 17 13 - 20 2 Hct %PCV 17 14 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.916 6.866 - 6.966 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 82.7 72.7 - 92.7 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 11.00 9.67 - 12.33 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 79 74 - 84 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 305 263 - 347 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.05 2.63 - 3.47 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 16.9 14.6 - 19.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 58 51 - 65 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.6 18.1 - 23.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 123 108 - 138 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.23 1.08 - 1.38 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 17 14 - 20 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 18 14 - 21 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.967 6.917 - 7.017 pH 1 6.969 6.919 - 7.019 mmHg 69.8 61.8 - 77.8 mmHg 70.2 62.2 - 78.2 p CO2 p CO2 kPa 9.28 8.21 - 10.34 kPa 9.34 8.28 - 10.40 mmHg 60 45 - 75 mmHg 50 35 - 65 p O2 p O2 kPa 8.0 6.0 - 10.0 kPa 6.7 4.7 - 8.7 + Na mmol/L, mEq/L 119 115 - 123 mmol/L 8.11 7.19 - 9.03 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 73.1 64.8 - 81.4 Lac mmol/L 1.40 1.29 - 1.51 g/L 0.731 0.648 - 0.814 iCa++ mEq/L 2.8 2.6 - 3.0 mg/dL 5.6 5.2 - 6.1 mg/dL 301 259 - 343 Glucose/ g/L 3.01 2.59 - 3.43 Glu mmol/L 16.7 14.4 - 19.0 Creatinine/ µmol/L 329 258 - 399 Crea mg/dL 3.7 2.9 - 4.5 mmol/L 7.93 7.01 - 8.85 Lactate/ mg/dL 71.4 63.1 - 79.7 Lac g/L 0.714 0.631 - 0.797 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 117 113 - 121 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 81 76 - 86 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.40 1.29 - 1.51 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.8 2.6 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.6 5.1 - 6.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 314 272 - 356 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.14 2.72 - 3.56 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.4 15.1 - 19.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 20 11 - 29 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 332 262 - 403 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.8 3.0 - 4.6 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 58 51 - 65 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.6 18.1 - 23.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 124 109 - 139 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.24 1.09 - 1.39 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 14 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101910 – Level 1 – CLEW A39 (145.3 KB)
- ® CueSee VeriSTAT QC g 22103847 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 7.625 7.550 - 7.700 mmHg 31.5 22.1 - 41.0 p CO2 kPa 4.20 2.94 - 5.45 mmHg 132 102 - 162 p O2 kPa 17.5 13.5 - 21.5 + Na mmol/L, mEq/L 160 154 - 166 + K mmol/L, mEq/L 6.0 5.5 - 6.6 mmol/L 0.66 0.57 - 0.75 iCa++ mEq/L 1.3 1.1 - 1.5 mg/dL 2.6 2.3 - 3.0 - Cl mmol/L, mEq/L 124 118 - 130 tCO2 mmol/L, mEq/L 35 28 - 42 mg/dL 44 32 - 56 Glucose/ g/L 0.44 0.32 - 0.56 Glu mmol/L 2.4 1.8 - 3.1 mmol/L 0.65 0.13 - 1.17 Lactate/ mg/dL 5.9 1.2 - 10.5 Lac g/L 0.059 0.012 - 0.105 BUN mg/dL 10 8 - 12 mmol/L 3.6 2.9 - 4.4 Urea mg/dL 22 17 - 26 AN01263A01 - 20171114 g/L 0.22 0.17 - 0.26 Creatinine/ µmol/L 52 23 - 80 Crea mg/dL 0.6 0.3 - 0.9 Hct 1 %PCV 52 46 - 58 2 Hct %PCV 54 48 - 60 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.600 7.550 - 7.650 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 34.0 27.0 - 41.0 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.52 3.59 - 5.45 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 160 155 - 165 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.1 5.6 - 6.6 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 124 118 - 130 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 47 38 - 56 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.47 0.38 - 0.56 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.6 2.1 - 3.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.7 2.9 - 4.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 18 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.18 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 53 49 - 57 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 51 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.650 7.600 - 7.700 pH 1 7.645 7.595 - 7.695 mmHg 29.1 22.1 - 36.1 mmHg 29.3 22.3 - 36.3 p CO2 p CO2 kPa 3.87 2.94 - 4.80 kPa 3.90 2.97 - 4.83 mmHg 131 106 - 156 mmHg 132 107 - 157 p O2 p O2 kPa 17.4 14.1 - 20.7 kPa 17.6 14.3 - 20.9 + Na mmol/L, mEq/L 161 156 - 166 mmol/L 0.63 0.13 - 1.13 + Lactate/ K mmol/L, mEq/L 6.0 5.5 - 6.5 mg/dL 5.7 1.2 - 10.2 Lac mmol/L 0.67 0.59 - 0.75 g/L 0.057 0.012 - 0.102 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.4 - 3.0 mg/dL 47 38 - 56 Glucose/ g/L 0.47 0.38 - 0.56 Glu mmol/L 2.6 2.1 - 3.1 Creatinine/ µmol/L 54 27 - 80 Crea mg/dL 0.6 0.3 - 0.9 mmol/L 0.67 0.17 - 1.17 Lactate/ mg/dL 6.0 1.5 - 10.5 Lac g/L 0.060 0.015 - 0.105 1 AN01263A01 - 20171114 Hct %PCV 54 50 - 58 2 Hct %PCV 56 52 - 60 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 159 154 - 164 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.0 5.5 - 6.5 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 124 118 - 130 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.65 0.57 - 0.73 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.1 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.6 2.3 - 2.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 41 32 - 50 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.41 0.32 - 0.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.3 1.8 - 2.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 35 28 - 42 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 50 23 - 77 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.6 2.9 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 50 46 - 54 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 52 48 - 56 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103847 – Level 3 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22102849 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 7.362 7.282 - 7.441 mmHg 40.4 29.5 - 51.3 p CO2 kPa 5.38 3.92 - 6.83 mmHg 93 68 - 118 p O2 kPa 12.4 9.1 - 15.7 + Na mmol/L, mEq/L 135 130 - 140 + K mmol/L, mEq/L 3.6 3.2 - 4.0 mmol/L 1.14 1.05 - 1.23 iCa++ mEq/L 2.3 2.1 - 2.5 mg/dL 4.6 4.2 - 4.9 - Cl mmol/L, mEq/L 100 94 - 105 tCO2 mmol/L, mEq/L 25 18 - 32 mg/dL 140 122 - 158 Glucose/ g/L 1.40 1.22 - 1.58 Glu mmol/L 7.8 6.8 - 8.7 mmol/L 2.04 1.52 - 2.55 Lactate/ mg/dL 18.3 13.7 - 23.0 Lac g/L 0.183 0.137 - 0.230 BUN mg/dL 12 9 - 15 mmol/L 4.2 3.1 - 5.3 Urea mg/dL 25 19 - 32 AN01263A01 - 20171114 g/L 0.25 0.19 - 0.32 Creatinine/ µmol/L 140 103 - 176 Crea mg/dL 1.6 1.2 - 2.0 1 Hct %PCV 34 30 - 38 2 Hct %PCV 35 31 - 40 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.332 7.282 - 7.382 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 44.3 37.3 - 51.3 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 5.90 4.97 - 6.83 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 135 131 - 139 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 99 94 - 104 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 144 130 - 158 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.44 1.30 - 1.58 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.0 7.2 - 8.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.3 3.2 - 5.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 26 19 - 32 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.26 0.19 - 0.32 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 36 33 - 39 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.391 7.341 - 7.441 pH 1 7.387 7.337 - 7.437 mmHg 37.0 30.0 - 44.0 mmHg 36.5 29.5 - 43.5 p CO2 p CO2 kPa 4.92 3.99 - 5.85 kPa 4.86 3.92 - 5.79 mmHg 95 75 - 115 mmHg 92 72 - 112 p O2 p O2 kPa 12.6 10.0 - 15.3 kPa 12.2 9.6 - 14.9 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.02 1.52 - 2.52 + Lactate/ K mmol/L, mEq/L 3.6 3.2 - 4.0 mg/dL 18.2 13.7 - 22.7 Lac mmol/L 1.15 1.07 - 1.23 g/L 0.182 0.137 - 0.227 iCa++ mEq/L 2.3 2.1 - 2.5 mg/dL 4.6 4.3 - 4.9 mg/dL 139 125 - 153 Glucose/ g/L 1.39 1.25 - 1.53 Glu mmol/L 7.7 6.9 - 8.5 Creatinine/ µmol/L 139 103 - 174 Crea mg/dL 1.6 1.2 - 2.0 mmol/L 2.05 1.55 - 2.55 Lactate/ mg/dL 18.5 14.0 - 23.0 Lac g/L 0.185 0.140 - 0.230 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 37 33 - 40 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 134 130 - 138 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.13 1.05 - 1.21 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.3 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.5 4.2 - 4.8 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 136 122 - 150 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.36 1.22 - 1.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.6 6.8 - 8.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 25 18 - 32 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 141 105 - 176 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.2 3.1 - 5.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 25 19 - 32 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.25 0.19 - 0.32 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 33 30 - 36 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102849 – Level 2 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101849 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 6.942 6.861 - 7.023 mmHg 78.0 61.5 - 94.5 p CO2 kPa 10.37 8.17 - 12.57 mmHg 53 33 - 73 p O2 kPa 7.1 4.4 - 9.7 + Na mmol/L, mEq/L 118 113 - 123 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.38 1.27 - 1.50 iCa++ mEq/L 2.8 2.5 - 3.0 mg/dL 5.5 5.1 - 6.0 - Cl mmol/L, mEq/L 80 74 - 85 tCO2 mmol/L, mEq/L 20 11 - 29 mg/dL 309 262 - 355 Glucose/ g/L 3.09 2.62 - 3.55 Glu mmol/L 17.1 14.5 - 19.7 mmol/L 8.12 7.12 - 9.12 Lactate/ mg/dL 73.2 64.2 - 82.2 Lac g/L 0.732 0.642 - 0.822 BUN mg/dL 58 50 - 66 mmol/L 20.7 18.0 - 23.4 Urea mg/dL 124 108 - 140 AN01263A01 - 20171114 g/L 1.24 1.08 - 1.40 Creatinine/ µmol/L 334 263 - 406 Crea mg/dL 3.8 3.0 - 4.6 1 Hct %PCV 16 13 - 20 2 Hct %PCV 17 13 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.911 6.861 - 6.961 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 84.5 74.5 - 94.5 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 11.24 9.91 - 12.57 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 79 74 - 84 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 304 262 - 346 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.04 2.62 - 3.46 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 16.9 14.5 - 19.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 59 52 - 66 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.9 18.4 - 23.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 125 110 - 140 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.25 1.10 - 1.40 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 17 14 - 20 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 18 15 - 21 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.967 6.917 - 7.017 pH 1 6.973 6.923 - 7.023 mmHg 70.1 62.1 - 78.1 mmHg 69.5 61.5 - 77.5 p CO2 p CO2 kPa 9.32 8.26 - 10.39 kPa 9.24 8.17 - 10.30 mmHg 58 43 - 73 mmHg 49 34 - 64 p O2 p O2 kPa 7.6 5.7 - 9.6 kPa 6.5 4.5 - 8.5 + Na mmol/L, mEq/L 119 115 - 123 mmol/L 8.04 7.12 - 8.96 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 72.5 64.2 - 80.7 Lac mmol/L 1.38 1.27 - 1.49 g/L 0.725 0.642 - 0.807 iCa++ mEq/L 2.8 2.5 - 3.0 mg/dL 5.5 5.1 - 6.0 mg/dL 307 265 - 349 Glucose/ g/L 3.07 2.65 - 3.49 Glu mmol/L 17.0 14.7 - 19.3 Creatinine/ µmol/L 335 265 - 406 Crea mg/dL 3.8 3.0 - 4.6 mmol/L 8.20 7.28 - 9.12 Lactate/ mg/dL 73.9 65.6 - 82.2 Lac g/L 0.739 0.656 - 0.822 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 117 113 - 121 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 80 75 - 85 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.39 1.28 - 1.50 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.8 2.6 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.5 5.1 - 6.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 313 271 - 355 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.13 2.71 - 3.55 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.4 15.0 - 19.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 20 11 - 29 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 334 263 - 404 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.8 3.0 - 4.6 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 57 50 - 64 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.5 18.0 - 23.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 123 108 - 138 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.23 1.08 - 1.38 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 13 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101849 – Level 1 – CLEW A39 (145.3 KB)
- ® CueSee VeriSTAT QC g 22102822 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 7.347 7.266 - 7.428 mmHg 42.1 30.4 - 53.9 p CO2 kPa 5.60 4.04 - 7.17 mmHg 93 68 - 118 p O2 kPa 12.4 9.1 - 15.7 + Na mmol/L, mEq/L 135 130 - 140 + K mmol/L, mEq/L 3.6 3.1 - 4.0 mmol/L 1.15 1.06 - 1.24 iCa++ mEq/L 2.3 2.1 - 2.5 mg/dL 4.6 4.2 - 5.0 - Cl mmol/L, mEq/L 99 94 - 105 tCO2 mmol/L, mEq/L 25 18 - 32 mg/dL 140 123 - 157 Glucose/ g/L 1.40 1.23 - 1.57 Glu mmol/L 7.8 6.8 - 8.7 mmol/L 2.07 1.56 - 2.59 Lactate/ mg/dL 18.7 14.0 - 23.3 Lac g/L 0.187 0.140 - 0.233 BUN mg/dL 12 9 - 15 mmol/L 4.3 3.2 - 5.4 Urea mg/dL 26 19 - 32 AN01263A01 - 20171114 g/L 0.26 0.19 - 0.32 Creatinine/ µmol/L 139 102 - 176 Crea mg/dL 1.6 1.2 - 2.0 1 Hct %PCV 34 30 - 38 2 Hct %PCV 35 31 - 40 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.316 7.266 - 7.366 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 46.9 39.9 - 53.9 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 6.24 5.31 - 7.17 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 136 132 - 140 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 99 94 - 104 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 143 129 - 157 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.43 1.29 - 1.57 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.9 7.2 - 8.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.3 3.2 - 5.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 26 19 - 32 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.26 0.19 - 0.32 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 35 32 - 38 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 37 34 - 40 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.377 7.327 - 7.427 pH 1 7.378 7.328 - 7.428 mmHg 39.1 32.1 - 46.1 mmHg 37.4 30.4 - 44.4 p CO2 p CO2 kPa 5.19 4.26 - 6.12 kPa 4.97 4.04 - 5.90 mmHg 95 75 - 115 mmHg 91 71 - 111 p O2 p O2 kPa 12.6 10.0 - 15.3 kPa 12.1 9.5 - 14.8 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.06 1.56 - 2.56 + Lactate/ K mmol/L, mEq/L 3.5 3.1 - 3.9 mg/dL 18.5 14.0 - 23.0 Lac mmol/L 1.16 1.08 - 1.24 g/L 0.185 0.140 - 0.230 iCa++ mEq/L 2.3 2.2 - 2.5 mg/dL 4.6 4.3 - 5.0 mg/dL 137 123 - 151 Glucose/ g/L 1.37 1.23 - 1.51 Glu mmol/L 7.6 6.8 - 8.4 Creatinine/ µmol/L 140 105 - 176 Crea mg/dL 1.6 1.2 - 2.0 mmol/L 2.09 1.59 - 2.59 Lactate/ mg/dL 18.8 14.3 - 23.3 Lac g/L 0.188 0.143 - 0.233 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 36 33 - 40 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 134 130 - 138 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.14 1.06 - 1.22 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.3 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.6 4.2 - 4.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 137 123 - 151 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.37 1.23 - 1.51 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.6 6.8 - 8.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 25 18 - 32 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 137 102 - 173 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.3 3.2 - 5.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 26 19 - 32 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.26 0.19 - 0.32 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 33 30 - 36 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 38 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102822 – Level 2 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22103822 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 7.631 7.551 - 7.711 mmHg 30.6 20.6 - 40.7 p CO2 kPa 4.07 2.73 - 5.41 mmHg 129 99 - 159 p O2 kPa 17.2 13.2 - 21.2 + Na mmol/L, mEq/L 159 153 - 165 + K mmol/L, mEq/L 6.0 5.5 - 6.5 mmol/L 0.66 0.57 - 0.74 iCa++ mEq/L 1.3 1.1 - 1.5 mg/dL 2.6 2.3 - 3.0 - Cl mmol/L, mEq/L 122 114 - 129 tCO2 mmol/L, mEq/L 34 27 - 41 mg/dL 44 32 - 56 Glucose/ g/L 0.44 0.32 - 0.56 Glu mmol/L 2.5 1.8 - 3.1 mmol/L 0.66 0.16 - 1.16 Lactate/ mg/dL 6.0 1.5 - 10.5 Lac g/L 0.060 0.015 - 0.105 BUN mg/dL 10 8 - 12 mmol/L 3.7 2.9 - 4.4 Urea mg/dL 22 18 - 26 AN01263A01 - 20171114 g/L 0.22 0.18 - 0.26 Creatinine/ µmol/L 52 25 - 79 Crea mg/dL 0.6 0.3 - 0.9 Hct 1 %PCV 51 46 - 57 2 Hct %PCV 54 48 - 59 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.601 7.551 - 7.651 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 33.7 26.7 - 40.7 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.48 3.55 - 5.41 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 160 155 - 165 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.0 5.5 - 6.5 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 120 114 - 126 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 47 38 - 56 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.47 0.38 - 0.56 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.6 2.1 - 3.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.7 2.9 - 4.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 18 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.18 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 53 49 - 57 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 51 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.661 7.611 - 7.711 pH 1 7.654 7.604 - 7.704 mmHg 28.1 21.1 - 35.1 mmHg 27.6 20.6 - 34.6 p CO2 p CO2 kPa 3.74 2.81 - 4.67 kPa 3.67 2.73 - 4.60 mmHg 128 103 - 153 mmHg 130 105 - 155 p O2 p O2 kPa 17.1 13.7 - 20.4 kPa 17.3 14.0 - 20.7 + Na mmol/L, mEq/L 160 155 - 165 mmol/L 0.66 0.16 - 1.16 + Lactate/ K mmol/L, mEq/L 6.0 5.5 - 6.5 mg/dL 6.0 1.5 - 10.5 Lac mmol/L 0.66 0.58 - 0.74 g/L 0.060 0.015 - 0.105 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.3 - 3.0 mg/dL 45 36 - 54 Glucose/ g/L 0.45 0.36 - 0.54 Glu mmol/L 2.5 2.0 - 3.0 Creatinine/ µmol/L 52 25 - 78 Crea mg/dL 0.6 0.3 - 0.9 mmol/L 0.66 0.16 - 1.16 Lactate/ mg/dL 6.0 1.5 - 10.5 Lac g/L 0.060 0.015 - 0.105 1 AN01263A01 - 20171114 Hct %PCV 53 49 - 57 2 Hct %PCV 55 51 - 59 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 158 153 - 163 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.0 5.5 - 6.5 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 123 117 - 129 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.65 0.57 - 0.73 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.1 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.6 2.3 - 2.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 41 32 - 50 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.41 0.32 - 0.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.3 1.8 - 2.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 34 27 - 41 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 52 25 - 79 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.7 2.9 - 4.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 18 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.18 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 50 46 - 54 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 52 48 - 56 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103822 – Level 3 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101822 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 All cartridge types, all lot numbers CLEW: A39/C39/H39/J39 Units X̄ (Mean) R (Range) pH 1 6.947 6.869 - 7.026 mmHg 76.2 59.8 - 92.7 p CO2 kPa 10.14 7.96 - 12.32 mmHg 53 33 - 73 p O2 kPa 7.1 4.5 - 9.8 + Na mmol/L, mEq/L 118 113 - 124 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.41 1.29 - 1.53 iCa++ mEq/L 2.8 2.6 - 3.1 mg/dL 5.6 5.2 - 6.1 - Cl mmol/L, mEq/L 80 74 - 86 tCO2 mmol/L, mEq/L 19 10 - 28 mg/dL 306 260 - 353 Glucose/ g/L 3.06 2.60 - 3.53 Glu mmol/L 17.0 14.4 - 19.6 mmol/L 8.02 7.04 - 8.99 Lactate/ mg/dL 72.2 63.5 - 81.0 Lac g/L 0.722 0.635 - 0.810 BUN mg/dL 58 51 - 66 mmol/L 20.8 18.0 - 23.7 Urea mg/dL 125 108 - 142 AN01263A01 - 20171114 g/L 1.25 1.08 - 1.42 Creatinine/ µmol/L 332 258 - 405 Crea mg/dL 3.8 2.9 - 4.6 1 Hct %PCV 17 13 - 20 2 Hct %PCV 17 14 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A39/C39/H39/J39 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.919 6.869 - 6.969 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 82.7 72.7 - 92.7 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 10.99 9.66 - 12.32 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 79 74 - 84 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 302 260 - 344 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.02 2.60 - 3.44 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 16.8 14.4 - 19.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 59 52 - 66 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 21.2 18.7 - 23.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 127 112 - 142 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.27 1.12 - 1.42 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 18 15 - 21 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 19 15 - 22 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A39/C39/H39/J39 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.972 6.922 - 7.022 pH 1 6.976 6.926 - 7.026 mmHg 68.8 60.8 - 76.8 mmHg 67.8 59.8 - 75.8 p CO2 p CO2 kPa 9.16 8.09 - 10.22 kPa 9.02 7.96 - 10.08 mmHg 58 43 - 73 mmHg 49 34 - 64 p O2 p O2 kPa 7.7 5.8 - 9.7 kPa 6.5 4.5 - 8.5 + Na mmol/L, mEq/L 120 116 - 124 mmol/L 7.96 7.04 - 8.88 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 71.7 63.5 - 80.0 Lac mmol/L 1.42 1.31 - 1.53 g/L 0.717 0.635 - 0.800 iCa++ mEq/L 2.8 2.6 - 3.1 mg/dL 5.7 5.2 - 6.1 mg/dL 303 261 - 345 Glucose/ g/L 3.03 2.61 - 3.45 Glu mmol/L 16.8 14.5 - 19.2 Creatinine/ µmol/L 334 264 - 405 Crea mg/dL 3.8 3.0 - 4.6 mmol/L 8.07 7.15 - 8.99 Lactate/ mg/dL 72.7 64.4 - 81.0 Lac g/L 0.727 0.644 - 0.810 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A39/C39/H39/J39 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 117 113 - 121 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 81 76 - 86 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.40 1.29 - 1.51 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.8 2.6 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.6 5.2 - 6.1 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 311 269 - 353 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.11 2.69 - 3.53 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.2 14.9 - 19.6 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 19 10 - 28 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 329 258 - 400 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.7 2.9 - 4.5 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 58 51 - 65 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.5 18.0 - 23.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 123 108 - 138 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.23 1.08 - 1.38 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 14 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101822 – Level 1 – CLEW A39 (145.2 KB)
- ® CueSee VeriSTAT QC g 22103909 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 7.638 7.553 - 7.723 mmHg 30.3 20.6 - 40.0 p CO2 kPa 4.03 2.74 - 5.32 mmHg 144 114 - 174 p O2 kPa 19.2 15.2 - 23.2 + Na mmol/L, mEq/L 161 155 - 166 + K mmol/L, mEq/L 6.1 5.6 - 6.6 mmol/L 0.66 0.58 - 0.74 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.6 2.3 - 3.0 - Cl mmol/L, mEq/L 126 118 - 133 tCO2 mmol/L, mEq/L 33 26 - 40 mg/dL 44 32 - 57 Glucose/ g/L 0.44 0.32 - 0.57 Glu mmol/L 2.5 1.8 - 3.2 mmol/L 0.70 0.17 - 1.22 Lactate/ mg/dL 6.3 1.5 - 11.0 Lac g/L 0.063 0.015 - 0.110 BUN mg/dL 10 7 - 12 mmol/L 3.4 2.6 - 4.3 Urea mg/dL 21 15 - 26 AN01263A01 - 20171114 g/L 0.21 0.15 - 0.26 Creatinine/ µmol/L 52 21 - 83 Crea mg/dL 0.6 0.2 - 0.9 Hct 1 %PCV 52 47 - 58 2 Hct %PCV 54 49 - 60 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.603 7.553 - 7.653 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 33.0 26.0 - 40.0 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.38 3.45 - 5.32 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 161 156 - 166 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.1 5.6 - 6.6 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 124 118 - 130 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 48 39 - 57 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.48 0.39 - 0.57 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.7 2.2 - 3.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 9 7 - 11 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.3 2.6 - 4.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 20 15 - 24 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.20 0.15 - 0.24 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 53 49 - 57 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 51 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.673 7.623 - 7.723 pH 1 7.669 7.619 - 7.719 mmHg 27.8 20.8 - 34.8 mmHg 27.6 20.6 - 34.6 p CO2 p CO2 kPa 3.70 2.77 - 4.63 kPa 3.67 2.74 - 4.60 mmHg 141 116 - 166 mmHg 148 123 - 173 p O2 p O2 kPa 18.8 15.4 - 22.1 kPa 19.6 16.3 - 23.0 + Na mmol/L, mEq/L 161 156 - 166 mmol/L 0.72 0.22 - 1.22 + Lactate/ K mmol/L, mEq/L 6.1 5.6 - 6.6 mg/dL 6.5 2.0 - 11.0 Lac mmol/L 0.66 0.58 - 0.74 g/L 0.065 0.020 - 0.110 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.6 2.3 - 2.9 mg/dL 44 35 - 53 Glucose/ g/L 0.44 0.35 - 0.53 Glu mmol/L 2.5 2.0 - 3.0 Creatinine/ µmol/L 48 21 - 74 Crea mg/dL 0.5 0.2 - 0.8 mmol/L 0.67 0.17 - 1.17 Lactate/ mg/dL 6.0 1.5 - 10.5 Lac g/L 0.060 0.015 - 0.105 1 AN01263A01 - 20171114 Hct %PCV 54 50 - 58 2 Hct %PCV 56 52 - 60 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103909 Level 3 Expected values for Abbott i-STAT ® Í6*G)~Î H 2021-02 22103909 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 160 155 - 165 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.1 5.6 - 6.6 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 127 121 - 133 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.66 0.58 - 0.74 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.2 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.6 2.3 - 3.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 41 32 - 50 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.41 0.32 - 0.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.3 1.8 - 2.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 33 26 - 40 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 57 30 - 83 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.6 2.9 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 21 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.21 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 51 47 - 55 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 53 49 - 57 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103909 – Level 3 – CLEW A38 (145.2 KB)
- ® CueSee VeriSTAT QC g 22102910 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 7.346 7.263 - 7.430 mmHg 41.7 30.9 - 52.5 p CO2 kPa 5.54 4.11 - 6.98 mmHg 100 75 - 125 p O2 kPa 13.3 9.9 - 16.6 + Na mmol/L, mEq/L 135 130 - 140 + K mmol/L, mEq/L 3.6 3.2 - 4.0 mmol/L 1.12 1.04 - 1.21 iCa++ mEq/L 2.2 2.1 - 2.4 mg/dL 4.5 4.2 - 4.8 - Cl mmol/L, mEq/L 101 95 - 107 tCO2 mmol/L, mEq/L 24 17 - 31 mg/dL 140 121 - 159 Glucose/ g/L 1.40 1.21 - 1.59 Glu mmol/L 7.8 6.7 - 8.8 mmol/L 2.12 1.60 - 2.64 Lactate/ mg/dL 19.1 14.4 - 23.8 Lac g/L 0.191 0.144 - 0.238 BUN mg/dL 11 8 - 14 mmol/L 3.9 2.8 - 5.0 Urea mg/dL 23 17 - 30 AN01263A01 - 20171114 g/L 0.23 0.17 - 0.30 Creatinine/ µmol/L 137 94 - 180 Crea mg/dL 1.5 1.1 - 2.0 Hct 1 %PCV 34 30 - 38 2 Hct %PCV 35 31 - 40 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.313 7.263 - 7.363 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 45.5 38.5 - 52.5 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 6.05 5.12 - 6.98 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 135 131 - 139 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 145 131 - 159 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.45 1.31 - 1.59 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.0 7.3 - 8.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.9 2.8 - 5.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 23 17 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.23 0.17 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 36 32 - 39 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.377 7.327 - 7.427 pH 1 7.380 7.330 - 7.430 mmHg 38.9 31.9 - 45.9 mmHg 37.9 30.9 - 44.9 p CO2 p CO2 kPa 5.17 4.24 - 6.10 kPa 5.04 4.11 - 5.97 mmHg 100 80 - 120 mmHg 100 80 - 120 p O2 p O2 kPa 13.2 10.6 - 15.9 kPa 13.3 10.6 - 15.9 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.14 1.64 - 2.64 + Lactate/ K mmol/L, mEq/L 3.6 3.2 - 4.0 mg/dL 19.3 14.8 - 23.8 Lac mmol/L 1.13 1.05 - 1.21 g/L 0.193 0.148 - 0.238 iCa++ mEq/L 2.3 2.1 - 2.4 mg/dL 4.5 4.2 - 4.8 mg/dL 137 123 - 151 Glucose/ g/L 1.37 1.23 - 1.51 Glu mmol/L 7.6 6.8 - 8.4 Creatinine/ µmol/L 129 94 - 165 Crea mg/dL 1.5 1.1 - 1.9 mmol/L 2.10 1.60 - 2.60 Lactate/ mg/dL 18.9 14.4 - 23.4 Lac g/L 0.189 0.144 - 0.234 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 37 33 - 40 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102910 Level 2 Expected values for Abbott i-STAT ® Í6*=*dÎ H 2021-03 22102910 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 134 130 - 138 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 102 97 - 107 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.12 1.04 - 1.20 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.2 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.5 4.2 - 4.8 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 135 121 - 149 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.35 1.21 - 1.49 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.5 6.7 - 8.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 24 17 - 31 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 144 109 - 180 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.9 2.9 - 5.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 17 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.17 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 33 30 - 36 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102910 – Level 2 – CLEW A38 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101910 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 6.950 6.875 - 7.025 mmHg 76.1 61.3 - 91.0 p CO2 kPa 10.13 8.15 - 12.11 mmHg 63 43 - 83 p O2 kPa 8.4 5.8 - 11.1 + Na mmol/L, mEq/L 119 114 - 124 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.38 1.27 - 1.49 iCa++ mEq/L 2.8 2.5 - 3.0 mg/dL 5.5 5.1 - 6.0 - Cl mmol/L, mEq/L 80 74 - 86 tCO2 mmol/L, mEq/L 19 10 - 28 mg/dL 308 263 - 352 Glucose/ g/L 3.08 2.63 - 3.52 Glu mmol/L 17.1 14.6 - 19.5 mmol/L 8.09 7.14 - 9.04 Lactate/ mg/dL 72.9 64.4 - 81.4 Lac g/L 0.729 0.644 - 0.814 BUN mg/dL 58 49 - 66 mmol/L 20.6 17.6 - 23.7 Urea mg/dL 124 106 - 142 AN01263A01 - 20171114 g/L 1.24 1.06 - 1.42 Creatinine/ µmol/L 330 253 - 407 Crea mg/dL 3.7 2.9 - 4.6 1 Hct %PCV 17 13 - 20 2 Hct %PCV 17 13 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.925 6.875 - 6.975 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 81.0 71.0 - 91.0 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 10.78 9.45 - 12.11 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 79 74 - 84 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 307 265 - 349 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.07 2.65 - 3.49 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.0 14.7 - 19.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 56 49 - 63 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.1 17.6 - 22.6 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 121 106 - 136 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.21 1.06 - 1.36 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 14 - 20 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.975 6.925 - 7.025 pH 1 6.975 6.925 - 7.025 mmHg 69.7 61.7 - 77.7 mmHg 69.3 61.3 - 77.3 p CO2 p CO2 kPa 9.27 8.21 - 10.34 kPa 9.21 8.15 - 10.28 mmHg 67 52 - 82 mmHg 60 45 - 75 p O2 p O2 kPa 8.9 6.9 - 10.8 kPa 8.0 6.0 - 10.0 + Na mmol/L, mEq/L 120 116 - 124 mmol/L 8.06 7.14 - 8.98 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 72.7 64.4 - 80.9 Lac mmol/L 1.38 1.27 - 1.49 g/L 0.727 0.644 - 0.809 iCa++ mEq/L 2.8 2.5 - 3.0 mg/dL 5.5 5.1 - 6.0 mg/dL 305 263 - 347 Glucose/ g/L 3.05 2.63 - 3.47 Glu mmol/L 16.9 14.6 - 19.3 Creatinine/ µmol/L 324 253 - 394 Crea mg/dL 3.7 2.9 - 4.5 mmol/L 8.12 7.20 - 9.04 Lactate/ mg/dL 73.2 64.9 - 81.4 Lac g/L 0.732 0.649 - 0.814 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101910 Level 1 Expected values for Abbott i-STAT ® Í6*3*FÎ H 2021-03 22101910 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 118 114 - 122 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 81 76 - 86 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.38 1.27 - 1.49 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.8 2.5 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.5 5.1 - 5.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 310 268 - 352 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.10 2.68 - 3.52 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.2 14.9 - 19.5 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 19 10 - 28 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 336 266 - 407 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.8 3.0 - 4.6 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 59 52 - 66 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 21.2 18.7 - 23.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 127 112 - 142 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.27 1.12 - 1.42 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 13 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101910 – Level 1 – CLEW A38 (145.2 KB)
- ® CueSee VeriSTAT QC g 22102822 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 7.350 7.266 - 7.434 mmHg 40.7 30.3 - 51.0 p CO2 kPa 5.41 4.04 - 6.78 mmHg 98 73 - 123 p O2 kPa 13.0 9.7 - 16.4 + Na mmol/L, mEq/L 135 131 - 140 + K mmol/L, mEq/L 3.6 3.2 - 4.0 mmol/L 1.14 1.06 - 1.22 iCa++ mEq/L 2.3 2.1 - 2.4 mg/dL 4.6 4.2 - 4.9 - Cl mmol/L, mEq/L 100 95 - 106 tCO2 mmol/L, mEq/L 24 17 - 31 mg/dL 140 121 - 159 Glucose/ g/L 1.40 1.21 - 1.59 Glu mmol/L 7.8 6.7 - 8.8 mmol/L 2.13 1.61 - 2.65 Lactate/ mg/dL 19.2 14.5 - 23.8 Lac g/L 0.192 0.145 - 0.238 BUN mg/dL 11 8 - 14 mmol/L 4.0 2.9 - 5.1 Urea mg/dL 24 17 - 30 AN01263A01 - 20171114 g/L 0.24 0.17 - 0.30 Creatinine/ µmol/L 136 96 - 177 Crea mg/dL 1.5 1.1 - 2.0 Hct 1 %PCV 34 30 - 38 2 Hct %PCV 35 31 - 40 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.316 7.266 - 7.366 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 44.0 37.0 - 51.0 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 5.85 4.92 - 6.78 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 135 131 - 139 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 145 131 - 159 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.45 1.31 - 1.59 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.1 7.3 - 8.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.9 2.9 - 5.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 17 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.17 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 35 32 - 38 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.383 7.333 - 7.433 pH 1 7.384 7.334 - 7.434 mmHg 38.4 31.4 - 45.4 mmHg 37.3 30.3 - 44.3 p CO2 p CO2 kPa 5.11 4.18 - 6.04 kPa 4.97 4.04 - 5.90 mmHg 97 77 - 117 mmHg 99 79 - 119 p O2 p O2 kPa 12.9 10.3 - 15.6 kPa 13.1 10.5 - 15.8 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.15 1.65 - 2.65 + Lactate/ K mmol/L, mEq/L 3.6 3.2 - 4.0 mg/dL 19.3 14.8 - 23.8 Lac mmol/L 1.14 1.06 - 1.22 g/L 0.193 0.148 - 0.238 iCa++ mEq/L 2.3 2.1 - 2.4 mg/dL 4.6 4.2 - 4.9 mg/dL 137 123 - 151 Glucose/ g/L 1.37 1.23 - 1.51 Glu mmol/L 7.6 6.8 - 8.4 Creatinine/ µmol/L 131 96 - 167 Crea mg/dL 1.5 1.1 - 1.9 mmol/L 2.11 1.61 - 2.61 Lactate/ mg/dL 19.0 14.5 - 23.5 Lac g/L 0.190 0.145 - 0.235 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 36 33 - 40 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 135 131 - 139 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 101 96 - 106 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.14 1.06 - 1.22 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.3 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.6 4.2 - 4.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 135 121 - 149 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.35 1.21 - 1.49 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.5 6.7 - 8.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 24 17 - 31 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 141 106 - 177 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.0 2.9 - 5.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 17 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.17 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 33 30 - 36 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102822 – Level 2 – CLEW A38 (145.2 KB)
- ® CueSee VeriSTAT QC g 22102849 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 7.362 7.279 - 7.445 mmHg 38.8 28.6 - 49.1 p CO2 kPa 5.17 3.80 - 6.53 mmHg 99 74 - 124 p O2 kPa 13.1 9.8 - 16.4 + Na mmol/L, mEq/L 135 130 - 139 + K mmol/L, mEq/L 3.6 3.2 - 4.0 mmol/L 1.12 1.04 - 1.20 iCa++ mEq/L 2.2 2.1 - 2.4 mg/dL 4.5 4.2 - 4.8 - Cl mmol/L, mEq/L 100 95 - 106 tCO2 mmol/L, mEq/L 24 17 - 31 mg/dL 140 122 - 159 Glucose/ g/L 1.40 1.22 - 1.59 Glu mmol/L 7.8 6.7 - 8.8 mmol/L 2.08 1.58 - 2.58 Lactate/ mg/dL 18.7 14.2 - 23.3 Lac g/L 0.187 0.142 - 0.233 BUN mg/dL 11 8 - 14 mmol/L 3.9 2.9 - 5.0 Urea mg/dL 24 17 - 30 AN01263A01 - 20171114 g/L 0.24 0.17 - 0.30 Creatinine/ µmol/L 137 97 - 178 Crea mg/dL 1.6 1.1 - 2.0 Hct 1 %PCV 33 29 - 38 2 Hct %PCV 35 30 - 39 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.329 7.279 - 7.379 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 42.1 35.1 - 49.1 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 5.60 4.67 - 6.53 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 135 131 - 139 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 145 131 - 159 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.45 1.31 - 1.59 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.0 7.3 - 8.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.9 2.9 - 5.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 17 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.17 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 35 32 - 38 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.394 7.344 - 7.444 pH 1 7.395 7.345 - 7.445 mmHg 36.9 29.9 - 43.9 mmHg 35.6 28.6 - 42.6 p CO2 p CO2 kPa 4.91 3.98 - 5.84 kPa 4.73 3.80 - 5.66 mmHg 99 79 - 119 mmHg 98 78 - 118 p O2 p O2 kPa 13.2 10.5 - 15.8 kPa 13.1 10.4 - 15.7 + Na mmol/L, mEq/L 135 131 - 139 mmol/L 2.08 1.58 - 2.58 + Lactate/ K mmol/L, mEq/L 3.6 3.2 - 4.0 mg/dL 18.7 14.2 - 23.2 Lac mmol/L 1.12 1.04 - 1.20 g/L 0.187 0.142 - 0.232 iCa++ mEq/L 2.2 2.1 - 2.4 mg/dL 4.5 4.2 - 4.8 mg/dL 136 122 - 150 Glucose/ g/L 1.36 1.22 - 1.50 Glu mmol/L 7.6 6.8 - 8.3 Creatinine/ µmol/L 132 97 - 168 Crea mg/dL 1.5 1.1 - 1.9 mmol/L 2.08 1.58 - 2.58 Lactate/ mg/dL 18.8 14.3 - 23.3 Lac g/L 0.188 0.143 - 0.233 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 36 33 - 39 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 134 130 - 138 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 101 96 - 106 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.12 1.04 - 1.20 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.2 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.5 4.2 - 4.8 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 136 122 - 150 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.36 1.22 - 1.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.5 6.7 - 8.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 24 17 - 31 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 143 107 - 178 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.0 2.9 - 5.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 17 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.17 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 32 29 - 35 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 30 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102849 – Level 2 – CLEW A38 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101822 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 6.966 6.898 - 7.034 mmHg 72.1 59.8 - 84.3 p CO2 kPa 9.58 7.95 - 11.21 mmHg 60 40 - 80 p O2 kPa 7.9 5.3 - 10.6 + Na mmol/L, mEq/L 118 114 - 123 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.40 1.29 - 1.51 iCa++ mEq/L 2.8 2.6 - 3.0 mg/dL 5.6 5.1 - 6.0 - Cl mmol/L, mEq/L 80 74 - 85 tCO2 mmol/L, mEq/L 19 10 - 28 mg/dL 307 262 - 352 Glucose/ g/L 3.07 2.62 - 3.52 Glu mmol/L 17.1 14.6 - 19.5 mmol/L 8.12 7.11 - 9.14 Lactate/ mg/dL 73.2 64.0 - 82.3 Lac g/L 0.732 0.640 - 0.823 BUN mg/dL 58 49 - 66 mmol/L 20.6 17.5 - 23.6 Urea mg/dL 123 105 - 142 AN01263A01 - 20171114 g/L 1.23 1.05 - 1.42 Creatinine/ µmol/L 324 244 - 404 Crea mg/dL 3.7 2.8 - 4.6 1 Hct %PCV 16 13 - 20 2 Hct %PCV 17 13 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.948 6.898 - 6.998 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 74.3 64.3 - 84.3 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 9.88 8.55 - 11.21 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 79 74 - 84 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 308 266 - 350 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.08 2.66 - 3.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.1 14.8 - 19.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 56 49 - 63 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.0 17.5 - 22.5 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 120 105 - 135 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.20 1.05 - 1.35 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 17 14 - 20 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 18 14 - 21 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.982 6.932 - 7.032 pH 1 6.984 6.934 - 7.034 mmHg 68.6 60.6 - 76.6 mmHg 67.8 59.8 - 75.8 p CO2 p CO2 kPa 9.12 8.06 - 10.19 kPa 9.02 7.95 - 10.08 mmHg 63 48 - 78 mmHg 57 42 - 72 p O2 p O2 kPa 8.3 6.4 - 10.3 kPa 7.5 5.5 - 9.5 + Na mmol/L, mEq/L 119 115 - 123 mmol/L 8.22 7.30 - 9.14 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 74.0 65.7 - 82.3 Lac mmol/L 1.40 1.29 - 1.51 g/L 0.740 0.657 - 0.823 iCa++ mEq/L 2.8 2.6 - 3.0 mg/dL 5.6 5.1 - 6.0 mg/dL 304 262 - 346 Glucose/ g/L 3.04 2.62 - 3.46 Glu mmol/L 16.9 14.6 - 19.2 Creatinine/ µmol/L 315 244 - 385 Crea mg/dL 3.6 2.8 - 4.4 mmol/L 8.03 7.11 - 8.95 Lactate/ mg/dL 72.3 64.0 - 80.6 Lac g/L 0.723 0.640 - 0.806 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 118 114 - 122 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 80 75 - 85 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.40 1.29 - 1.51 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.8 2.6 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.6 5.2 - 6.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 310 268 - 352 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.10 2.68 - 3.52 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.2 14.9 - 19.5 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 19 10 - 28 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 333 263 - 404 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.8 3.0 - 4.6 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 59 52 - 66 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 21.1 18.6 - 23.6 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 127 112 - 142 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.27 1.12 - 1.42 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 13 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101822 – Level 1 – CLEW A38 (145.3 KB)
- ® CueSee VeriSTAT QC g 22101849 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 6.955 6.883 - 7.027 mmHg 74.1 60.8 - 87.4 p CO2 kPa 9.86 8.08 - 11.63 mmHg 58 38 - 78 p O2 kPa 7.7 5.0 - 10.3 + Na mmol/L, mEq/L 118 114 - 123 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.37 1.25 - 1.48 iCa++ mEq/L 2.7 2.5 - 3.0 mg/dL 5.5 5.0 - 5.9 - Cl mmol/L, mEq/L 80 74 - 85 tCO2 mmol/L, mEq/L 20 11 - 29 mg/dL 304 258 - 351 Glucose/ g/L 3.04 2.58 - 3.51 Glu mmol/L 16.9 14.3 - 19.5 mmol/L 8.10 7.15 - 9.06 Lactate/ mg/dL 73.0 64.5 - 81.6 Lac g/L 0.730 0.645 - 0.816 BUN mg/dL 58 50 - 66 mmol/L 20.6 17.8 - 23.5 Urea mg/dL 124 107 - 141 AN01263A01 - 20171114 g/L 1.24 1.07 - 1.41 Creatinine/ µmol/L 327 248 - 407 Crea mg/dL 3.7 2.8 - 4.6 1 Hct %PCV 16 13 - 20 2 Hct %PCV 17 13 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.933 6.883 - 6.983 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 77.4 67.4 - 87.4 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 10.30 8.97 - 11.63 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 79 74 - 84 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 306 264 - 348 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.06 2.64 - 3.48 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.0 14.6 - 19.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 57 50 - 64 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 20.3 17.8 - 22.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 122 107 - 137 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.22 1.07 - 1.37 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 14 - 20 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.977 6.927 - 7.027 pH 1 6.977 6.927 - 7.027 mmHg 69.7 61.7 - 77.7 mmHg 68.8 60.8 - 76.8 p CO2 p CO2 kPa 9.27 8.21 - 10.34 kPa 9.15 8.08 - 10.21 mmHg 60 45 - 75 mmHg 55 40 - 70 p O2 p O2 kPa 8.0 6.0 - 9.9 kPa 7.4 5.4 - 9.4 + Na mmol/L, mEq/L 119 115 - 123 mmol/L 8.07 7.15 - 8.99 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 72.7 64.5 - 81.0 Lac mmol/L 1.36 1.25 - 1.47 g/L 0.727 0.645 - 0.810 iCa++ mEq/L 2.7 2.5 - 2.9 mg/dL 5.5 5.0 - 5.9 mg/dL 300 258 - 342 Glucose/ g/L 3.00 2.58 - 3.42 Glu mmol/L 16.6 14.3 - 19.0 Creatinine/ µmol/L 318 248 - 389 Crea mg/dL 3.6 2.8 - 4.4 mmol/L 8.14 7.22 - 9.06 Lactate/ mg/dL 73.3 65.0 - 81.6 Lac g/L 0.733 0.650 - 0.816 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 118 114 - 122 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 80 75 - 85 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.37 1.26 - 1.48 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.7 2.5 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.5 5.1 - 5.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 309 267 - 351 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.09 2.67 - 3.51 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.1 14.8 - 19.5 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 20 11 - 29 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 337 266 - 407 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.8 3.0 - 4.6 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 59 52 - 66 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 21.0 18.5 - 23.5 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 126 111 - 141 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.26 1.11 - 1.41 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 16 13 - 19 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101849 – Level 1 – CLEW A38 (145.3 KB)
- ® CueSee VeriSTAT QC g 22102822 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 All cartridge types, all lot numbers CLEW: A37/C37/H37/J37 Units X̄ (Mean) R (Range) pH 1 7.354 7.273 - 7.435 mmHg 41.4 31.0 - 51.9 p CO2 kPa 5.51 4.12 - 6.90 mmHg 96 71 - 121 p O2 kPa 12.8 9.4 - 16.1 + Na mmol/L, mEq/L 135 131 - 140 + K mmol/L, mEq/L 3.6 3.2 - 4.0 mmol/L 1.13 1.05 - 1.22 iCa++ mEq/L 2.3 2.1 - 2.4 mg/dL 4.5 4.2 - 4.9 - Cl mmol/L, mEq/L 100 95 - 105 tCO2 mmol/L, mEq/L 25 18 - 32 mg/dL 141 123 - 158 Glucose/ g/L 1.41 1.23 - 1.58 Glu mmol/L 7.8 6.8 - 8.8 mmol/L 2.07 1.56 - 2.58 Lactate/ mg/dL 18.7 14.1 - 23.2 Lac g/L 0.187 0.141 - 0.232 BUN mg/dL 11 8 - 14 mmol/L 4.0 2.9 - 5.1 Urea mg/dL 24 18 - 30 AN01263A01 - 20171114 g/L 0.24 0.18 - 0.30 Creatinine/ µmol/L 136 100 - 171 Crea mg/dL 1.5 1.1 - 1.9 1 Hct %PCV 34 29 - 38 2 Hct %PCV 35 31 - 39 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A37/C37/H37/J37 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.323 7.273 - 7.373 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 44.9 37.9 - 51.9 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 5.97 5.04 - 6.90 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 135 131 - 139 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 144 130 - 158 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.44 1.30 - 1.58 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.0 7.2 - 8.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.0 2.9 - 5.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 18 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.18 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 36 32 - 39 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A37/C37/H37/J37 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.385 7.335 - 7.435 pH 1 7.383 7.333 - 7.433 mmHg 38.4 31.4 - 45.4 mmHg 38.0 31.0 - 45.0 p CO2 p CO2 kPa 5.11 4.18 - 6.04 kPa 5.05 4.12 - 5.98 mmHg 96 76 - 116 mmHg 96 76 - 116 p O2 p O2 kPa 12.8 10.1 - 15.5 kPa 12.7 10.1 - 15.4 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.06 1.56 - 2.56 + Lactate/ K mmol/L, mEq/L 3.6 3.2 - 4.0 mg/dL 18.6 14.1 - 23.1 Lac mmol/L 1.14 1.06 - 1.22 g/L 0.186 0.141 - 0.231 iCa++ mEq/L 2.3 2.1 - 2.4 mg/dL 4.5 4.2 - 4.9 mg/dL 138 124 - 152 Glucose/ g/L 1.38 1.24 - 1.52 Glu mmol/L 7.6 6.9 - 8.4 Creatinine/ µmol/L 135 100 - 170 Crea mg/dL 1.5 1.1 - 1.9 mmol/L 2.08 1.58 - 2.58 Lactate/ mg/dL 18.7 14.2 - 23.2 Lac g/L 0.187 0.142 - 0.232 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 36 33 - 39 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102822 Level 2 Expected values for Abbott i-STAT ® Í6*<6*Î H 2020-05 22102822 CLEW: A37/C37/H37/J37 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 135 131 - 139 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.13 1.05 - 1.21 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.3 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.5 4.2 - 4.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 137 123 - 151 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.37 1.23 - 1.51 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.6 6.8 - 8.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 25 18 - 32 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 136 101 - 171 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.5 1.1 - 1.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.0 2.9 - 5.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 18 - 30 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.18 - 0.30 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 32 29 - 35 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102822 – Level 2 – CLEW A37 (145.1 KB)
- ® CueSee VeriSTAT QC g 22103847 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 7.625 7.540 - 7.710 mmHg 29.5 19.8 - 39.3 p CO2 kPa 3.93 2.63 - 5.22 mmHg 139 109 - 169 p O2 kPa 18.4 14.4 - 22.4 + Na mmol/L, mEq/L 161 155 - 166 + K mmol/L, mEq/L 6.1 5.6 - 6.6 mmol/L 0.66 0.58 - 0.75 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.3 - 3.0 - Cl mmol/L, mEq/L 125 118 - 132 tCO2 mmol/L, mEq/L 32 25 - 39 mg/dL 44 31 - 57 Glucose/ g/L 0.44 0.31 - 0.57 Glu mmol/L 2.5 1.7 - 3.2 mmol/L 0.72 0.18 - 1.26 Lactate/ mg/dL 6.5 1.6 - 11.4 Lac g/L 0.065 0.016 - 0.114 BUN mg/dL 10 7 - 12 mmol/L 3.5 2.6 - 4.3 Urea mg/dL 21 16 - 26 AN01263A01 - 20171114 g/L 0.21 0.16 - 0.26 Creatinine/ µmol/L 51 19 - 82 Crea mg/dL 0.6 0.2 - 0.9 Hct 1 %PCV 52 47 - 57 2 Hct %PCV 54 49 - 60 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.590 7.540 - 7.640 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 32.3 25.3 - 39.3 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.29 3.36 - 5.22 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 160 155 - 165 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.1 5.6 - 6.6 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 124 118 - 130 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 48 39 - 57 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.48 0.39 - 0.57 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.7 2.2 - 3.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 9 7 - 11 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.4 2.6 - 4.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 20 16 - 24 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.20 0.16 - 0.24 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 53 49 - 57 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 51 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.660 7.610 - 7.710 pH 1 7.660 7.610 - 7.710 mmHg 28.2 21.2 - 35.2 mmHg 26.8 19.8 - 33.8 p CO2 p CO2 kPa 3.75 2.81 - 4.68 kPa 3.56 2.63 - 4.49 mmHg 134 109 - 159 mmHg 143 118 - 168 p O2 p O2 kPa 17.8 14.5 - 21.1 kPa 19.0 15.7 - 22.4 + Na mmol/L, mEq/L 161 156 - 166 mmol/L 0.76 0.26 - 1.26 + Lactate/ K mmol/L, mEq/L 6.1 5.6 - 6.6 mg/dL 6.9 2.4 - 11.4 Lac mmol/L 0.66 0.58 - 0.74 g/L 0.069 0.024 - 0.114 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.3 - 3.0 mg/dL 45 36 - 54 Glucose/ g/L 0.45 0.36 - 0.54 Glu mmol/L 2.5 2.0 - 3.0 Creatinine/ µmol/L 46 19 - 72 Crea mg/dL 0.5 0.2 - 0.8 mmol/L 0.68 0.18 - 1.18 Lactate/ mg/dL 6.1 1.6 - 10.6 Lac g/L 0.061 0.016 - 0.106 1 AN01263A01 - 20171114 Hct %PCV 53 49 - 57 2 Hct %PCV 56 51 - 60 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 160 155 - 165 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.1 5.6 - 6.6 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 126 120 - 132 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.67 0.59 - 0.75 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.2 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.7 2.3 - 3.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 40 31 - 49 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.40 0.31 - 0.49 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.2 1.7 - 2.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 32 25 - 39 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 56 29 - 82 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.6 2.9 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 51 47 - 55 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 53 49 - 57 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103847 – Level 3 – CLEW A38 (145.3 KB)
- ® CueSee VeriSTAT QC g 22103822 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 All cartridge types, all lot numbers CLEW: A38/C38/H38/J38 Units X̄ (Mean) R (Range) pH 1 7.636 7.551 - 7.720 mmHg 29.1 20.1 - 38.1 p CO2 kPa 3.87 2.67 - 5.07 mmHg 138 108 - 168 p O2 kPa 18.3 14.3 - 22.3 + Na mmol/L, mEq/L 159 153 - 164 + K mmol/L, mEq/L 6.1 5.5 - 6.6 mmol/L 0.67 0.59 - 0.75 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.4 - 3.0 - Cl mmol/L, mEq/L 123 116 - 130 tCO2 mmol/L, mEq/L 32 25 - 39 mg/dL 45 32 - 58 Glucose/ g/L 0.45 0.32 - 0.58 Glu mmol/L 2.5 1.8 - 3.2 mmol/L 0.71 0.18 - 1.25 Lactate/ mg/dL 6.4 1.7 - 11.2 Lac g/L 0.064 0.017 - 0.112 BUN mg/dL 10 7 - 12 mmol/L 3.4 2.6 - 4.3 Urea mg/dL 21 16 - 26 AN01263A01 - 20171114 g/L 0.21 0.16 - 0.26 Creatinine/ µmol/L 50 18 - 83 Crea mg/dL 0.6 0.2 - 0.9 Hct 1 %PCV 52 47 - 57 2 Hct %PCV 54 49 - 59 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A38/C38/H38/J38 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.601 7.551 - 7.651 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 31.1 24.1 - 38.1 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.14 3.21 - 5.07 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 158 153 - 163 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.0 5.5 - 6.5 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 122 116 - 128 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 49 40 - 58 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.49 0.40 - 0.58 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.7 2.2 - 3.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 9 7 - 11 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.3 2.6 - 4.0 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 20 16 - 24 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.20 0.16 - 0.24 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 52 48 - 56 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 54 50 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A38/C38/H38/J38 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.670 7.620 - 7.720 pH 1 7.669 7.619 - 7.719 mmHg 27.4 20.4 - 34.4 mmHg 27.1 20.1 - 34.1 p CO2 p CO2 kPa 3.64 2.71 - 4.58 kPa 3.60 2.67 - 4.53 mmHg 134 109 - 159 mmHg 142 117 - 167 p O2 p O2 kPa 17.8 14.4 - 21.1 kPa 18.9 15.6 - 22.2 + Na mmol/L, mEq/L 159 154 - 164 mmol/L 0.75 0.25 - 1.25 + Lactate/ K mmol/L, mEq/L 6.0 5.5 - 6.5 mg/dL 6.7 2.2 - 11.2 Lac mmol/L 0.67 0.59 - 0.75 g/L 0.067 0.022 - 0.112 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.4 - 3.0 mg/dL 44 35 - 53 Glucose/ g/L 0.44 0.35 - 0.53 Glu mmol/L 2.5 2.0 - 3.0 Creatinine/ µmol/L 45 18 - 71 Crea mg/dL 0.5 0.2 - 0.8 mmol/L 0.68 0.18 - 1.18 Lactate/ mg/dL 6.2 1.7 - 10.7 Lac g/L 0.062 0.017 - 0.107 1 AN01263A01 - 20171114 Hct %PCV 53 49 - 57 2 Hct %PCV 55 51 - 59 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A38/C38/H38/J38 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 158 153 - 163 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.1 5.6 - 6.6 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 124 118 - 130 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.67 0.59 - 0.75 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.2 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.7 2.4 - 3.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 41 32 - 50 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.41 0.32 - 0.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.3 1.8 - 2.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 32 25 - 39 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 56 30 - 83 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.5 2.8 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 21 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.21 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 51 47 - 55 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 53 49 - 57 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103822 – Level 3 – CLEW A38 (145.2 KB)
- ® CueSee VeriSTAT QC g 22103822 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 All cartridge types, all lot numbers CLEW: A37/C37/H37/J37 Units X̄ (Mean) R (Range) pH 1 7.649 7.567 - 7.731 mmHg 30.5 20.9 - 40.0 p CO2 kPa 4.05 2.78 - 5.32 mmHg 135 105 - 165 p O2 kPa 18.0 14.0 - 22.0 + Na mmol/L, mEq/L 159 153 - 165 + K mmol/L, mEq/L 6.0 5.5 - 6.6 mmol/L 0.66 0.58 - 0.75 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.7 2.3 - 3.0 - Cl mmol/L, mEq/L 122 116 - 128 tCO2 mmol/L, mEq/L 32 25 - 39 mg/dL 44 32 - 56 Glucose/ g/L 0.44 0.32 - 0.56 Glu mmol/L 2.4 1.8 - 3.1 mmol/L 0.63 0.10 - 1.15 Lactate/ mg/dL 5.7 0.9 - 10.4 Lac g/L 0.057 0.009 - 0.104 BUN mg/dL 10 8 - 12 mmol/L 3.5 2.8 - 4.3 Urea mg/dL 21 17 - 26 AN01263A01 - 20171114 g/L 0.21 0.17 - 0.26 Creatinine/ µmol/L 51 24 - 78 Crea mg/dL 0.6 0.3 - 0.9 Hct 1 %PCV 52 46 - 57 2 Hct %PCV 54 48 - 59 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A37/C37/H37/J37 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.617 7.567 - 7.667 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 33.0 26.0 - 40.0 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.39 3.46 - 5.32 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 159 154 - 164 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.1 5.6 - 6.6 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 122 116 - 128 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 47 38 - 56 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.47 0.38 - 0.56 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.6 2.1 - 3.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.5 2.8 - 4.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 21 17 - 25 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.21 0.17 - 0.25 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 52 48 - 56 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 50 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A37/C37/H37/J37 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.681 7.631 - 7.731 pH 1 7.669 7.619 - 7.719 mmHg 27.9 20.9 - 34.9 mmHg 28.0 21.0 - 35.0 p CO2 p CO2 kPa 3.71 2.78 - 4.64 kPa 3.72 2.79 - 4.65 mmHg 130 105 - 155 mmHg 141 116 - 166 p O2 p O2 kPa 17.3 14.0 - 20.6 kPa 18.8 15.4 - 22.1 + Na mmol/L, mEq/L 160 155 - 165 mmol/L 0.65 0.15 - 1.15 + Lactate/ K mmol/L, mEq/L 6.0 5.5 - 6.5 mg/dL 5.9 1.4 - 10.4 Lac mmol/L 0.66 0.58 - 0.74 g/L 0.059 0.014 - 0.104 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.6 2.3 - 2.9 mg/dL 43 34 - 52 Glucose/ g/L 0.43 0.34 - 0.52 Glu mmol/L 2.4 1.9 - 2.9 Creatinine/ µmol/L 51 24 - 77 Crea mg/dL 0.6 0.3 - 0.9 mmol/L 0.60 0.10 - 1.10 Lactate/ mg/dL 5.4 0.9 - 9.9 Lac g/L 0.054 0.009 - 0.099 1 AN01263A01 - 20171114 Hct %PCV 53 49 - 57 2 Hct %PCV 55 51 - 59 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103822 Level 3 Expected values for Abbott i-STAT ® Í6*F6HÎ H 2020-05 22103822 CLEW: A37/C37/H37/J37 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 158 153 - 163 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.0 5.5 - 6.5 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 122 116 - 128 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.67 0.59 - 0.75 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.2 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.7 2.4 - 3.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 41 32 - 50 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.41 0.32 - 0.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.3 1.8 - 2.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 32 25 - 39 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 52 25 - 78 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.6 2.9 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 21 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.21 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 50 46 - 54 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 53 48 - 57 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103822 – Level 3 – CLEW A37 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101849 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 All cartridge types, all lot numbers CLEW: A37/C37/H37/J37 Units X̄ (Mean) R (Range) pH 1 6.962 6.890 - 7.035 mmHg 72.2 58.6 - 85.9 p CO2 kPa 9.61 7.79 - 11.43 mmHg 55 35 - 75 p O2 kPa 7.3 4.6 - 10.0 + Na mmol/L, mEq/L 119 115 - 124 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.36 1.25 - 1.47 ++ iCa mEq/L 2.7 2.5 - 2.9 mg/dL 5.4 5.0 - 5.9 - Cl mmol/L, mEq/L 80 75 - 85 tCO2 mmol/L, mEq/L 19 10 - 28 mg/dL 308 263 - 354 Glucose/ g/L 3.08 2.63 - 3.54 Glu mmol/L 17.1 14.6 - 19.6 mmol/L 8.14 7.12 - 9.16 Lactate/ mg/dL 73.3 64.1 - 82.5 Lac g/L 0.733 0.641 - 0.825 BUN mg/dL 54 47 - 62 mmol/L 19.4 16.7 - 22.1 Urea mg/dL 116 100 - 133 AN01263A01 - 20171114 g/L 1.16 1.00 - 1.33 Creatinine/ µmol/L 326 252 - 399 Crea mg/dL 3.7 2.9 - 4.5 Hct 1 %PCV 17 13 - 20 2 Hct %PCV 17 13 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A37/C37/H37/J37 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.940 6.890 - 6.990 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 75.9 65.9 - 85.9 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 10.10 8.77 - 11.43 kPa #DIV/0! #DIV/0! - #DIV/0! + + Na mmol/L, mEq/L 119 115 - 123 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Cl- mmol/L, mEq/L 80 75 - 85 Cl- mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 309 267 - 351 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.09 2.67 - 3.51 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.1 14.8 - 19.5 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 55 48 - 62 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 19.6 17.1 - 22.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 118 103 - 133 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.18 1.03 - 1.33 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! 2 * = Determined in the K3EDTA mode. Hct %PCV 17 14 - 20 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A37/C37/H37/J37 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.985 6.935 - 7.035 pH 1 6.965 6.915 - 7.015 mmHg 67.7 59.7 - 75.7 mmHg 66.6 58.6 - 74.6 p CO2 p CO2 kPa 9.00 7.94 - 10.07 kPa 8.86 7.79 - 9.92 mmHg 59 44 - 74 mmHg 50 35 - 65 p O2 p O2 kPa 7.9 5.9 - 9.9 kPa 6.7 4.7 - 8.7 Na+ mmol/L, mEq/L 120 116 - 124 mmol/L 8.24 7.32 - 9.16 Lactate/ K+ mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 74.2 65.9 - 82.5 Lac mmol/L 1.36 1.25 - 1.47 g/L 0.742 0.659 - 0.825 ++ iCa mEq/L 2.7 2.5 - 2.9 mg/dL 5.4 5.0 - 5.9 mg/dL 305 263 - 347 Glucose/ g/L 3.05 2.63 - 3.47 Glu mmol/L 16.9 14.6 - 19.3 Creatinine/ µmol/L 323 252 - 394 Crea mg/dL 3.7 2.9 - 4.5 mmol/L 8.04 7.12 - 8.96 Lactate/ Lac mg/dL 72.4 64.1 - 80.7 g/L 0.724 0.641 - 0.807 AN01263A01 - 20171114 Hct 1 %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101849 Level 1 Expected values for Abbott i-STAT ® Í6*2QxÎ H 2020-12 22101849 CLEW: A37/C37/H37/J37 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 119 115 - 123 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 80 75 - 85 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.36 1.25 - 1.47 mmol/L #DIV/0! #DIV/0! - #DIV/0! iCa++ mEq/L 2.7 2.5 - 2.9 iCa++ mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.4 5.0 - 5.9 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 312 270 - 354 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.12 2.70 - 3.54 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.3 15.0 - 19.6 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 19 10 - 28 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 329 258 - 399 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.7 2.9 - 4.5 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 54 47 - 61 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 19.2 16.7 - 21.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 115 100 - 130 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.15 1.00 - 1.30 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! 2 Hct %PCV 17 13 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101849 – Level 1 – CLEW A37 (145.2 KB)
- ® CueSee VeriSTAT QC g 22101822 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 All cartridge types, all lot numbers CLEW: A37/C37/H37/J37 Units X̄ (Mean) R (Range) pH 1 6.967 6.891 - 7.043 mmHg 72.1 58.8 - 85.3 p CO2 kPa 9.58 7.82 - 11.35 mmHg 59 39 - 79 p O2 kPa 7.8 5.2 - 10.5 + Na mmol/L, mEq/L 119 115 - 123 + K mmol/L, mEq/L 2.7 2.3 - 3.1 mmol/L 1.38 1.27 - 1.50 iCa++ mEq/L 2.8 2.5 - 3.0 mg/dL 5.5 5.1 - 6.0 - Cl mmol/L, mEq/L 80 75 - 85 tCO2 mmol/L, mEq/L 19 10 - 28 mg/dL 309 262 - 356 Glucose/ g/L 3.09 2.62 - 3.56 Glu mmol/L 17.1 14.5 - 19.7 mmol/L 8.12 7.14 - 9.09 Lactate/ mg/dL 73.1 64.3 - 81.9 Lac g/L 0.731 0.643 - 0.819 BUN mg/dL 54 46 - 62 mmol/L 19.3 16.6 - 22.1 Urea mg/dL 116 99 - 133 AN01263A01 - 20171114 g/L 1.16 0.99 - 1.33 Creatinine/ µmol/L 325 251 - 400 Crea mg/dL 3.7 2.8 - 4.5 1 Hct %PCV 16 13 - 20 2 Hct %PCV 17 13 - 21 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A37/C37/H37/J37 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 6.941 6.891 - 6.991 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 75.3 65.3 - 85.3 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 10.02 8.69 - 11.35 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 119 115 - 123 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 2.7 2.3 - 3.1 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 80 75 - 85 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 308 266 - 350 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.08 2.66 - 3.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.1 14.8 - 19.4 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 55 48 - 62 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 19.6 17.1 - 22.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 118 103 - 133 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.18 1.03 - 1.33 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 14 - 20 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A37/C37/H37/J37 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 6.993 6.943 - 7.043 pH 1 6.969 6.919 - 7.019 mmHg 66.8 58.8 - 74.8 mmHg 68.8 60.8 - 76.8 p CO2 p CO2 kPa 8.88 7.82 - 9.95 kPa 9.15 8.08 - 10.21 mmHg 63 48 - 78 mmHg 55 40 - 70 p O2 p O2 kPa 8.3 6.4 - 10.3 kPa 7.3 5.3 - 9.3 + Na mmol/L, mEq/L 119 115 - 123 mmol/L 8.17 7.25 - 9.09 + Lactate/ K mmol/L, mEq/L 2.7 2.3 - 3.1 mg/dL 73.6 65.4 - 81.9 Lac mmol/L 1.38 1.27 - 1.49 g/L 0.736 0.654 - 0.819 iCa++ mEq/L 2.8 2.5 - 3.0 mg/dL 5.5 5.1 - 6.0 mg/dL 304 262 - 346 Glucose/ g/L 3.04 2.62 - 3.46 Glu mmol/L 16.8 14.5 - 19.2 Creatinine/ µmol/L 321 251 - 392 Crea mg/dL 3.6 2.8 - 4.4 mmol/L 8.06 7.14 - 8.98 Lactate/ mg/dL 72.6 64.3 - 80.9 Lac g/L 0.726 0.643 - 0.809 1 AN01263A01 - 20171114 Hct %PCV 17 14 - 20 2 Hct %PCV 18 15 - 21 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22101822 Level 1 Expected values for Abbott i-STAT ® Í6*26sÎ H 2020-05 22101822 CLEW: A37/C37/H37/J37 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 119 115 - 123 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 2.7 2.3 - 3.1 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 80 75 - 85 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.39 1.28 - 1.50 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.8 2.6 - 3.0 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 5.5 5.1 - 6.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 314 272 - 356 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 3.14 2.72 - 3.56 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 17.4 15.1 - 19.7 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 19 10 - 28 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 329 259 - 400 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 3.7 2.9 - 4.5 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 53 46 - 60 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 19.1 16.6 - 21.6 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 114 99 - 129 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 1.14 0.99 - 1.29 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 16 13 - 19 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 17 13 - 20 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22101822 – Level 1 – CLEW A37 (145.2 KB)
- ® CueSee VeriSTAT QC g 22102849 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 All cartridge types, all lot numbers CLEW: A37/C37/H37/J37 Units X̄ (Mean) R (Range) pH 1 7.361 7.276 - 7.446 mmHg 40.2 29.6 - 50.9 p CO2 kPa 5.35 3.94 - 6.77 mmHg 96 71 - 121 p O2 kPa 12.8 9.5 - 16.2 + Na mmol/L, mEq/L 136 131 - 140 + K mmol/L, mEq/L 3.6 3.2 - 4.0 mmol/L 1.12 1.04 - 1.20 iCa++ mEq/L 2.2 2.1 - 2.4 mg/dL 4.5 4.1 - 4.8 - Cl mmol/L, mEq/L 100 95 - 105 tCO2 mmol/L, mEq/L 24 17 - 31 mg/dL 140 120 - 159 Glucose/ g/L 1.40 1.20 - 1.59 Glu mmol/L 7.8 6.7 - 8.8 mmol/L 2.04 1.54 - 2.55 Lactate/ mg/dL 18.4 13.9 - 23.0 Lac g/L 0.184 0.139 - 0.230 BUN mg/dL 11 8 - 15 mmol/L 4.1 3.0 - 5.2 Urea mg/dL 25 18 - 31 AN01263A01 - 20171114 g/L 0.25 0.18 - 0.31 Creatinine/ µmol/L 138 102 - 174 Crea mg/dL 1.6 1.2 - 2.0 1 Hct %PCV 34 30 - 38 2 Hct %PCV 35 31 - 40 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A37/C37/H37/J37 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.326 7.276 - 7.376 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 43.9 36.9 - 50.9 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 5.83 4.90 - 6.77 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 135 131 - 139 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 3.6 3.2 - 4.0 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 145 131 - 159 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.45 1.31 - 1.59 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 8.1 7.3 - 8.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 11 8 - 14 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.0 3.0 - 5.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 24 18 - 31 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.24 0.18 - 0.31 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 34 31 - 37 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 35 32 - 38 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A37/C37/H37/J37 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.393 7.343 - 7.443 pH 1 7.396 7.346 - 7.446 mmHg 36.6 29.6 - 43.6 mmHg 36.6 29.6 - 43.6 p CO2 p CO2 kPa 4.87 3.94 - 5.80 kPa 4.87 3.94 - 5.80 mmHg 96 76 - 116 mmHg 97 77 - 117 p O2 p O2 kPa 12.8 10.2 - 15.5 kPa 12.8 10.2 - 15.5 + Na mmol/L, mEq/L 136 132 - 140 mmol/L 2.05 1.55 - 2.55 + Lactate/ K mmol/L, mEq/L 3.6 3.2 - 4.0 mg/dL 18.5 14.0 - 23.0 Lac mmol/L 1.12 1.04 - 1.20 g/L 0.185 0.140 - 0.230 iCa++ mEq/L 2.2 2.1 - 2.4 mg/dL 4.5 4.2 - 4.8 mg/dL 136 122 - 150 Glucose/ g/L 1.36 1.22 - 1.50 Glu mmol/L 7.6 6.8 - 8.3 Creatinine/ µmol/L 138 102 - 173 Crea mg/dL 1.6 1.2 - 2.0 mmol/L 2.04 1.54 - 2.54 Lactate/ mg/dL 18.4 13.9 - 22.9 Lac g/L 0.184 0.139 - 0.229 1 AN01263A01 - 20171114 Hct %PCV 35 32 - 38 2 Hct %PCV 36 33 - 40 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22102849 Level 2 Expected values for Abbott i-STAT ® Í6*<Q/Î H 2020-12 22102849 CLEW: A37/C37/H37/J37 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 135 131 - 139 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 3.6 3.2 - 4.0 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 100 95 - 105 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 1.12 1.04 - 1.20 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 2.2 2.1 - 2.4 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 4.5 4.1 - 4.8 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 134 120 - 148 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 1.34 1.20 - 1.48 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 7.5 6.7 - 8.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 24 17 - 31 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 139 103 - 174 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 1.6 1.2 - 2.0 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 12 9 - 15 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 4.1 3.1 - 5.2 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 25 18 - 31 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.25 0.18 - 0.31 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 33 30 - 36 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 34 31 - 37 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22102849 – Level 2 – CLEW A37 (145.2 KB)
- ® CueSee VeriSTAT QC g 22103847 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 All cartridge types, all lot numbers CLEW: A37/C37/H37/J37 Units X̄ (Mean) R (Range) pH 1 7.640 7.554 - 7.727 mmHg 31.9 21.3 - 42.4 p CO2 kPa 4.24 2.84 - 5.63 mmHg 135 105 - 165 p O2 kPa 18.0 14.0 - 21.9 + Na mmol/L, mEq/L 161 155 - 167 + K mmol/L, mEq/L 6.0 5.5 - 6.6 mmol/L 0.66 0.58 - 0.74 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.6 2.3 - 3.0 - Cl mmol/L, mEq/L 123 117 - 130 tCO2 mmol/L, mEq/L 33 26 - 40 mg/dL 44 32 - 56 Glucose/ g/L 0.44 0.32 - 0.56 Glu mmol/L 2.4 1.8 - 3.1 mmol/L 0.62 0.11 - 1.14 Lactate/ mg/dL 5.6 1.0 - 10.2 Lac g/L 0.056 0.010 - 0.102 BUN mg/dL 10 8 - 12 mmol/L 3.6 2.9 - 4.3 Urea mg/dL 21 17 - 26 AN01263A01 - 20171114 g/L 0.21 0.17 - 0.26 Creatinine/ µmol/L 51 24 - 78 Crea mg/dL 0.6 0.3 - 0.9 Hct 1 %PCV 52 47 - 58 2 Hct %PCV 54 49 - 60 1 K3EDTA 2 K2EDTA page 1 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A37/C37/H37/J37 EC8+, 6+, EC4+, E3+ & G EC8+, 6+, EC4+, E3+ & G F, H, J or K #N/A Units X̄ (Mean) R (Range) Units X (Mean) T h e R (Range) pH 1 7.604 7.554 - 7.654 pH 1 #DIV/0! #DIV/0! - #DIV/0! mmHg 35.4 28.4 - 42.4 mmHg #DIV/0! #DIV/0! - #DIV/0! p CO2 p CO2 kPa 4.70 3.77 - 5.63 kPa #DIV/0! #DIV/0! - #DIV/0! Na+ mmol/L, mEq/L 161 156 - 166 Na+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! K+ mmol/L, mEq/L 6.1 5.6 - 6.6 K+ mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 123 117 - 129 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 47 38 - 56 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.47 0.38 - 0.56 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.6 2.1 - 3.1 mmol/L #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.6 2.9 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 21 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.21 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! Hct 1 %PCV 53 49 - 57 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 55 51 - 59 * = Determined in the K3EDTA mode. 1 K3EDTA 2 K2EDTA AN01263A01 - 20171114 page 2 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A37/C37/H37/J37 CG8+, EG7+, EG6+, G3+, Crea & CG4+ CG4+, G3+ A, K, L, M, N, W or Y D Units X̄ (Mean) R (Range) Units X̄ (Mean) R (Range) pH 1 7.677 7.627 - 7.727 pH 1 7.664 7.614 - 7.714 mmHg 28.9 21.9 - 35.9 mmHg 28.3 21.3 - 35.3 p CO2 p CO2 kPa 3.84 2.91 - 4.77 kPa 3.77 2.84 - 4.70 mmHg 131 106 - 156 mmHg 139 114 - 164 p O2 p O2 kPa 17.4 14.1 - 20.7 kPa 18.5 15.2 - 21.8 + Na mmol/L, mEq/L 162 157 - 167 mmol/L 0.64 0.14 - 1.14 + Lactate/ K mmol/L, mEq/L 6.1 5.6 - 6.6 mg/dL 5.7 1.2 - 10.2 Lac mmol/L 0.66 0.58 - 0.74 g/L 0.057 0.012 - 0.102 iCa++ mEq/L 1.3 1.2 - 1.5 mg/dL 2.6 2.3 - 3.0 mg/dL 42 33 - 51 Glucose/ g/L 0.42 0.33 - 0.51 Glu mmol/L 2.3 1.8 - 2.8 Creatinine/ µmol/L 52 25 - 78 Crea mg/dL 0.6 0.3 - 0.9 mmol/L 0.61 0.11 - 1.11 Lactate/ mg/dL 5.5 1.0 - 10.0 Lac g/L 0.055 0.010 - 0.100 1 AN01263A01 - 20171114 Hct %PCV 54 50 - 58 2 Hct %PCV 56 52 - 60 1 K3EDTA 2 K2EDTA page 3 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com CueSee® VeriSTAT QC g 22103847 Level 3 Expected values for Abbott i-STAT ® Í6*FOEÎ H 2020-11 22103847 CLEW: A37/C37/H37/J37 Chem8+ Chem8+ H #N/A R (Range) xX (Mean) R (Range) T Units X̄ (Mean) Units h e + + Na mmol/L, mEq/L 160 155 - 165 Na mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! + + K mmol/L, mEq/L 6.0 5.5 - 6.5 K mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! - - Cl mmol/L, mEq/L 124 118 - 130 Cl mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! mmol/L 0.66 0.58 - 0.74 mmol/L #DIV/0! #DIV/0! - #DIV/0! ++ ++ iCa mEq/L 1.3 1.2 - 1.5 iCa mEq/L #DIV/0! #DIV/0! - #DIV/0! mg/dL 2.6 2.3 - 3.0 mg/dL #DIV/0! #DIV/0! - #DIV/0! mg/dL 41 32 - 50 mg/dL #DIV/0! #DIV/0! - #DIV/0! Glucose/ Glucose/ g/L 0.41 0.32 - 0.50 g/L #DIV/0! #DIV/0! - #DIV/0! Glu Glu mmol/L 2.3 1.8 - 2.8 mmol/L #DIV/0! #DIV/0! - #DIV/0! tCO2 mmol/L, mEq/L 33 26 - 40 tCO2 mmol/L, mEq/L #DIV/0! #DIV/0! - #DIV/0! Creatinine/ µmol/L 50 24 - 77 Creatinine/ µmol/L #DIV/0! #DIV/0! - #DIV/0! Crea mg/dL 0.6 0.3 - 0.9 Crea mg/dL #DIV/0! #DIV/0! - #DIV/0! BUN mg/dL 10 8 - 12 BUN mg/dL #DIV/0! #DIV/0! - #DIV/0! mmol/L 3.6 2.9 - 4.3 mmol/L #DIV/0! #DIV/0! - #DIV/0! Urea mg/dL 22 17 - 26 Urea mg/dL #DIV/0! #DIV/0! - #DIV/0! g/L 0.22 0.17 - 0.26 g/L #DIV/0! #DIV/0! - #DIV/0! 1 Hct %PCV 51 47 - 55 Hct * %PCV #DIV/0! #DIV/0! - #DIV/0! Hct 2 %PCV 53 49 - 57 * = Determined in the K3EDTA mode. 1 AN01263A01 - 20171114 K3EDTA 2 K2EDTA page 4 of 4 Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 22103847 – Level 3 – CLEW A37 (145.2 KB)
GAS-ISE
Product Specific
- GAS-ISE Eurotrol GAS-ISE Eurotrol GAS-ISE Verwendungszweck Toepassing Eurotrol GAS-ISE ist ein Kontrollmaterial mit Zielwerten zur Überwachung von Genauigkeit sowie Präzision und Richtigkeit von Analysengeräten zur Eurotrol GAS-ISE is een beproefd kwaliteitscontrolemateriaal voor professioneel gebruik bij het controleren van de precisie en nauwkeurigheid van Bestimmung von Blutgasen und/oder Elektrolyten: pH, pO2, pCO2 , cNa+, cK+, cCl-, cLi+, cCa2 + (ionisiert), ctCa (gesamt), ctMg (gesamt), cGlu und cLac. gecombineerde bloedgas- en elektrolytenanalysers: pH, pO2, pCO2 , cNa+, cK+, cCl-, cLi+, cCa2 +, ctCa, ctMg alsmede de glucose- en lactaatconcentratie. Eurotrol GAS-ISE erlaubt auch die Überprüfung der Kalibration, der Meßtemperatur und anderer Teilschritte. GAS-ISE is tevens ontwikkeld om de ijking, werktemperatuur en andere prestatiekenmerken te controleren. IVD Medizinische Hilfsmittel IVD Medische Hulpmiddelen Eurotrol GAS-ISE erfüllt die Richtlinie 98/79/EG Medizinische Hilfsmittel IVD und trägt das CE-Zeichen. Eurotrol GAS-ISE voldoet aan de Europese Richtlijn 98/79/EG betreffende Medische Hulpmiddelen voor In-vitro diagnostiek en draagt het CE keurmerk. Zusam menfassung Samenvatting Eurotrol GAS-ISE Kontrollmaterial ist verfügbar in 3 verschiedenen Konzentrationsstufen, Level 1 (niedrig), Level 2 (normal), Level 3 (hoch) im klinisch Eurotrol GAS-ISE is een kwaliteitscontrolemateriaal dat verkrijgbaar is op drie niveaus (Level 1, Level 2 en Level 3), elk met bekende concentraties. Eurotrol relevanten Bereich. GAS-ISE is bedoeld voor de periodieke controle van de precisie en nauwkeurigheid van verschillende gecombineerde bloedgas- en elektrolyten- analysers. Eurotrol GAS-ISE soll zur regelmäßigen Prüfung der Präzision und Genauigkeit der Blutgasen- und/oder ElektrolytenGeräte eingesetzt werden. Diese Geräte müssen strengen Anforderungen entsprechen als Grundlage für eine sachgerechte Therapie. Reagentia Eurotrol GAS-ISE is beschikbaar in drie relevante niveau's. Elke ampul bevat 2.5 mL vloeistof. Eurotrol GAS-ISE controles worden samengesteld met zouten Reagenzien in een fysiologisch gebufferde matrix. Tonometrie met van te voren bepaalde niveaus van zuurstof-, koolzuur-, stikstofgasmengsels en verschillende Eurotrol GAS-ISE enthält 3 klinisch relevanten Konzentrationen à 2,5 ml Lösung. Eurotrol GAS-ISE wird unter Verwendung von reinen Salzen in zoutconcentraties, resulteren in drie fysiologisch relevante niveaus voor elke parameter. Hiermee worden klinisch belangrijke gebieden van de zuur-base- en physiologischer, gepufferter Matrix hergestellt. Unter Verwendung von Sauerstoff und Kohlendioxid in Stickstoff werden mittels Tonometrie und Susatz der elektrolytenbalans, functie van de ademhaling, glucose- en lactaatconcentratie weergegeven. Eurotrol GAS-ISE controles bevatten geen entsprechenden Salze Kontrollproben in drei verschiedenen Konzentrationen gewonnen. Sie entsprechen 3 verschiedenen klinisch relevanten conserveringsmiddelen, viscositeitsregelaars of andere toevoegingen die elektrode metingen nadelig zouden kunnen beïnvloeden. Konzentrationsbereichen bezüglich Saure-, Basen- und Elektrolythaushalt, der Lungenfunktion, sowie Glucose- und Laktatkonzentration. Eurotrol GAS-ISE Kontrollmaterial enthält keine Konservierungsmittel, Mittel zur Viskostäts-Anpassung oder andere Zusatzstoffe, die einen nachteiligen Bewaren en stabiliteit Effekt auf die Elektroden-Messungen haben könnten. Eurotrol GAS-ISE kan bewaard worden bij een temperatuur van 15-30 °C. Ongeopend bewaard bij deze temperatuur, is het gegarandeerd stabiel tot de houdbaarheidsdatum, aangegeven op de ampul en de buitenverpakking. Na het openen van de ampul is Eurotrol GAS-ISE stabiel gedurende 30 seconden. Lagerung und Stabilität Eurotrol GAS-ISE soll ungeöffnet bei Raumtemperatur (15–30 °C) gelagert werden. Unter diesen Bedingungen ist es bis zu dem auf Ampulle und Procedures Verpackungen angegebenen Verfallsdatum haltbar. Nach Öffnung der Ampulle muß das Kontrollmaterial innerhalb von 30 Sekunden verwendet werden. 1. Incubeer de ampul minstens een half uur bij 25 ± 1 °C. 2. Schud, vlak voor gebruik, de ampul gedurende 15 seconden om de gassen opnieuw in evenwicht te brengen met de oplossing. De ampul houdt men Handhabung daarbij tussen duim en wijsvinger. 1. Ampulle auf 25 ± 1 °C temperieren. 3. Zwenk de ampul voorzichtig zodat de vloeistof naar de bodem kan terugkeren. Laat de gasbelletjes omhoog komen alvorens de ampul te openen. 2. Unmittelbar vor Verwendung muß die Ampulle kräftig, mindestens 15 Sekunden geschüttelt werden, um Gas und Flüssigkeit zu reäquilibrieren. Zum 4. Bescherm de vingers met verbandgaas, tissue of handschoenen. Schütteln soll die Ampulle zwischen Daumen und Zeigefinger gehalten werden. 5. Houd de ampul met de gekleurde stip naar boven gericht. Breek de hals van de ampul af in tegenovergestelde richting van de gekleurde 3. Anschließend Ampulle leicht schwenken, um die gesamte Flüssigkeit in den unteren Teil der Ampulle zu verbringen. Die Flüssigkeit muß Luftblasen frei stip. Zie bijgevoegde OPC instructie. sein. 6. Volg binnen 30 seconden de procedure van bemonsteren volgens de instructies in de handleiding van de bloedgas analyser. 4. Schützen Sie Ihre Finger mit Gaze, Tuch oder Handschuhen. 7. Raadpleeg de plaatselijk geldende richtlijnen voor de aanbevolen gebruiksfrequentie. 5. Halten Sie die Ampulle so, dass sich der rote Punkt oben befindet. Knicken Sie den Hals der Am pulle in die entgegengesetzte Richtung des roten Punktes ab. Weitere Hinweise siehe Anleitungsblatt für OPC-Ampullen (Brechampullen mit One-Point-Cut). Voorzorgsmaatregelen 6. Innerhalb von 30 Sekunden Messungen entsprechend den Angaben in der Gerätebeschreibung durchführen. 1. Uitsluitend bestemd voor in vitro diagnostisch gebruik. 7. Messungen wiederholen entsprechend den jeweils gültigen Vorschriften. 2. Voorkom dat deze producten in het algemene afvalcircuit terecht komen. Volg de ter plaatse geldende regels voor verantwoorde afvalverwerking. 3. Eurotrol GAS-ISE dient niet gebruikt te worden voor kalibratie. Vorsichtsm aßnahmen und Hinweise 1. Eurotrol GAS-ISE nur zur Anwendung in vitro. Verwachte resultaten 2. Das Material nicht als Hausmüll entsorgen. Informieren Sie sich bei der örtlichen Behörde bezüglich der entsprechenden Vorschriften. De waarden van gegeven parameters zijn zijn te vinden op de website www.eurotrol.com. De waarden zijn verkregen met willekeurig geselecteerde ampullen 3. Eurotrol GAS-ISE darf nicht als Kalibrator eingesetzt werden. van elk lot, geïncubeerd bij 25 ± 1 °C en gemeten bij 37 °C. De waarden zijn gemiddelde gebieden, gemiddelde waarden ± 3SD. Deze waarden zijn een leidraad voor het evalueren van de precisie en nauwkeurigheid van de analyser. Zielwerte Die entsprechenden Werte sind unter www.eurotrol.com erhältlich. Sie beruhen auf entsprechenden Messungen zufällig ausgewählter Ampullen des Let op jeweiligen Lots bei 37 °C. Als Sollwerte sind jeweils Mittelwerte ± dreifache Standardabweichung angegeben. Sie helfen bei der Bewertung von Präzision De waarden in de tabel zijn alleen toepasbaar voor het aangegeven lotnummer en op zeeniveau. und Genauigkeit des Analysengeräts. Onjuiste bemonstering, bewaarcondities, etc. kunnen meetwaarden geven die afwijken van de target waarden. De pO2 waarden van Eurotrol GAS-ISE variëren omgekeerd evenredig met de temperatuurveranderingen. Voor elke °C verandering in temperatuur tussen Bitte beachten 18 en 26 °C, verandert de pO 2 1,5% op het lage niveau, 1,1% op het normale en 0,5% op het hoge niveau. Om een grote graad van correllatie te Die Werte in der Tabelle gelten nur für die angegebene Chargennummer und beziehen sich auf NN. verkrijgen met de waarden in de tabel, moeten de ampullen zo dicht mogelijk bij 25 °C geschud worden. Abweichende Handhabung und Lagerung der Kontrollproben können zu fehlerhaften Meßergebnissen führen. Kamertemperatuur heeft geen significante invloed op de pH waarde. (bij het openen van de ampul) Die pO 2 Werte von Eurotrol GAS-ISE sind Temperatur abhängig, sie steigen mit fallender Temperatur und umgekehrt. Zwischen 18 und 26 °C verändert Eurotrol GAS-ISE is gevoelig voor de meeste instrumentgerelateerde factoren die onverwachte analytische afwijkingen kunnen veroorzaken. sich pO2 im niedrigem Bereich 1,5% , im normalen um 1,1% und im hohen um 0,5%. Deshalb muß versucht werden, die Ampulle vor Verwending Eurotrol GAS-ISE controles bevatten geen eiwit en kunnen daarom geen storingen tengevolge hiervan opsporen. möglichst genau auf 25 °C zu temperieren. Die Temperatur der Ampulle hat (jedoch) keinen Einfluß auf den pH. Eurotrol GAS-ISE is zeer gevoelig voor contaminatie met kamerlucht. Dit wordt veroorzaakt door de lage oplosbaarheid van zuurstof in waterige Eurotrol GAS-ISE erfaßt die meisten Geräte bedingten Ursachen, die zu Fehlmessungen führen können. Da es kein Protein enthält, ist es jedoch Eiweiß oplossingen resulterend in een lage buffercapaciteit voor zuurstof. Na 60 seconden open staan geven de controles een afwijking van 5% bij een lage bedingten Störungen gegenüber unempfindlich. pO 2, 1,1% afwijking bij een normale pO2 en van 0,4% bij een hoge pO2. Vergeleken met zuurstof is de oplosbaarheid van koolzuurgas in waterige Bei Luftzutritt verändert sich der pO2 von Eurotrol GAS-ISE rasch. Das ist bedingt durch die geringe Löslichkeit von Sauerstoff in wäßrigen Lösungen mit oplossing veel groter en de concentratie van koolzuurgas in kamerlucht vele malen lager. De fout is minder dan 2% over het gehele gebied op alle folglich geringer Pufferkapazität. 60 Sekunden nach Öffnung , weicht der niederige pO2 um 5% vom Zielwert ab, der normale um 1,1% und der hohe um niveaus (20 – 70 mmHg). De invloed van kamerlucht op de pH is te verwaarlozen. 0,4%. Der Einfluß des Raumluft auf den pO2 ist sehr viel geringer (da die Löslichkeit von CO2 in wäßrigen Lösungen besser ist als die von O2 und der CO 2 -Gehalt der Luft niedriger). Die Abweichung beträgt im gesamtem Bereich (20-70 mmHg) weniger als 2%. Der Einfluß der Raumluft auf den pH ist Dit product is vervaardigd volgens de specificaties van Eurotrol B.V. vernachlässigbar. Dieses Produkt wurde gemäß den Eurotrol Spezifikationen hergestellt. Für weitere Informationen setzen Sie sich bitte mit: Voor verdere informatie kunt u contact opnemen met: Eurotrol B.V., Niederlande, Tel. +31 318 695 777, Fax +31 318 695 770, E-mail: office@eurotrol.com, www.eurotrol.com Eurotrol B.V., Nederland, Tel. +31 318 695 777, Fax +31 318 695 770, E-mail: office@eurotrol.com, www.eurotrol.com Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Niederlande Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland Verwendete Symbole Gebruikte symbolen Achtung, beachten Sie die Gebrauchsanweisung Chargen-Nummer Opgelet, lees de gebruiksaanwijzing Batchnummer Verwendbar bis Lagerungstemperatur Te gebruiken voor Bewaartemperatuur In Vitro Diagnostikum Referenz-Nummer In Vitro Diagnostisch Medisch Hulpmiddel Referentienummer Hersteller CE-Zeichen Producent CE-merkteken INP 013-DE-R04 20130725 INP 013-NL-R06 20130724 GAS-ISE Eurotrol GAS-ISE Intended purpose Eurotrol GAS-ISE is an assayed quality control material intended for professional use in the verification of the precision and accuracy of combined bloodgas and electrolyte analysers: pH, pO2, pCO 2, cNa+, cK+, cCl-, cLi+, cCa2+, ctCa, ctMg, cGlu and cLac. Eurotrol GAS-ISE is also developed to verify calibration, operating temperature and other performance characteristics. IVD Medical Device Eurotrol GAS-ISE complies with the IVD Directive 98/79/EC for Medical Devices and carries the CE mark. Summary Eurotrol GAS-ISE quality control material is available at three levels (Level 1, Level 2 and Level 3), each with known concentrations. It is intended that Eurotrol GAS-ISE should be used in the periodic verification of the precision and accuracy of different combined bloodgas and electrolyte analysers. Reagents Eurotrol GAS-ISE provides three physiological relevant levels, each ampoule holding 2.5 mL solution. Eurotrol GAS-ISE controls are prepared using salts in a physiologically bufferred matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provide three distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose and lactate concentration. Eurotrol GAS-ISE controls contain no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements. Storage and stability Eurotrol GAS-ISE can be stored at a temperature of 15 - 30 °C. Stored unopened at this temperature it is guaranteed stable as indicated until the expiry date on the ampoules and outer box. After opening the Eurotrol GAS-ISE ampoule it is stable for 30 seconds. Procedures 1. Allow the ampoule to adapt to a temperature of 25 ± 1 °C. 2. Immediately before use, shake the ampoule vigorously for at least fifteen seconds to re-equilibrate the gases with the solution. When shaken, the ampoule should be held between the thumb and index finger. 3. Swirl the ampoule gently to return the solution to the bottom of the ampoule. Allow bubbles to rise between shaking and before opening the ampoule. 4. Protect fingers with gauze, tissue or gloves. 5. Hold ampoule with the coloured dot upside. Snap off the neck of the ampoule in the opposite direction of the coloured dot. See enclosed OPC instructions. 6. Follow within 30 seconds the sampling procedure according to the instructions in the operating manual of your bloodgas and electrolyte analyser. 7. Please refer to local guidelines for recommended frequency of use. Precautions 1. For in vitro diagnostic use only. 2. These products should not be disposed of in general waste. Consult local environmental authorities for proper disposal. 3. Eurotrol GAS-ISE is not to be used as a calibrator. Expected results The values for each parameter at the three levels available from www.eurotrol.com. The values are derived from randomly selected ampoules from each lot, incubated at 25 ± 1 °C and measured at 37 °C. The values are mean ranges, mean value ± 3SD. These values are a guide for evaluating the precision and accuracy of the analyser. Please Note The values in the table are applicable only to the assigned lot number and at sea level. Incorrect sampling, storage, etc. may cause the readings to deviate from the target values. The pO2 values of Eurotrol GAS-ISE vary inversely with temperature changes. For each °C change in temperatures between 18 and 26 °C, the pO 2 changes 1,5% in the low level, 1,1% in the normal and 0,5% in the high level. To obtain a high degree of correlation with the values in the table, the ampoules should be equilibrated as close to 25 °C as possible. Room temperature has no significant effect on pH values. (when opening the ampoule) Eurotrol GAS-ISE is sensitive to most of the instrument related factors that can cause unexpected analytical deviations. Eurotrol GAS-ISE controls do not contain protein and therefore may not detect malfunctions sensitive to these components. Eurotrol GAS-ISE is very sensitive to room air contamination. This is caused by the low solubility of oxygen in aqueous solutions which results in low buffering capacity. After 60 seconds opened, controls show 5% deviation at a low pO 2, 1,1% deviation at a normal pO 2 and 0,4% deviation at a high pO2. OPC leaflet Compared to oxygen, the solubility of carbon dioxide in aqueous solution is much higher and the concentration of carbon dioxide in room air is much lower. The error is less than 2% over the entire range in all three levels (20 – 70 mmHg). The effect of room air on pH is negligible. This product has been manufactured according to Eurotrol specifications. For further information please contact: Eurotrol B.V.,The Netherlands, Phone: +31 318 695 777, Fax: +31 318 695 770, E-mail: office@eurotrol.com, www.eurotrol.com Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands Symbols used Attention, see instructions for use Batch code Use by Temperature limitation In Vitro Diagnostic Medical Device Reference number Manufacturer CE Mark INP 013-EN-R06 20130725 INP 013-R02 20130725 Instructions for Use (846.4 KB)
- Material Safety Data Sheet 1. Identification of substance Product name: Eurotrol GAS-ISE Product code: REF 013.001.010, 013.002.010, 013.003.010 Manufacturer: Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands, Phone: +31 318 695777 In emergency call +31 318 695777 for further information. For US and Canadian customers: In emergency call +1-978-598-3779 for further information. 2. Components Water, electrolytes, metabolites and controlled mixture of oxygen, nitrogen and CO2 gases. Product does not contain components at concentrations of 0.1% or higher that are classified as toxic according to regulation (EC) No 1272/2008 [EU-GHS/CLP]. 3. Hazardous characteristics Appearance: Clear liquid Odour: Odourless Physical State: Liquid 4. Emergency first aid procedures Inhalation: N/A Skin contact: May cause irritation; Normal hygiene Eye contact: May cause irritation; Flush with water for >15 minutes in case reagent contacts eyes Ingestion: Ingestion of this product may cause choking, vomiting or nausea. 5. Actions in case of fire Not flammable. Follow general fire fighting procedures. 6. Actions in case of spill of material MSDS 013-R02-20130117 In case of spill of material clean with water. 7. Handling and storage Handling:Follow good Laboratory Practice when working with any chemical whether it is considered hazardous or not. Storage: Store as indicated in product insert to maintain proper performance of the product. Page 1 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 8. Limitation of the exposure / personal protective measures Follow good Laboratory Practice when working with any chemical whether it is considered hazardous or not. 9. Physical / chemical characteristics pH See value sheet Boiling point (°C) ~100°C Melting point (°C) ~0°C Appearance Clear Liquid Odour Odourless Physical state Liquid Solubility in water Soluble Vapour pressure Not established. Vapour density Not established. Flash point Not flammable. 10. Stability and reactive hazard data According to applicable regulations, this product does not contain chemical ingredients classified as hazardous or in sufficient concentrations to classify the product as hazardous. Conditions to avoid Freezing or boiling the product 11. Toxicological information Product does not contain components at levels greater than or equal to 0.1% that are identified as probable, possible, or confirmed to be toxic. Product does not contain components that are identified as probable, possible, or confirmed human carcinogen. 12. Ecological Toxicological information No information is found on environmental toxicity for this solution. 13. Waste disposal methods Do not dispose of in general waste. Consult local environmental authorities for proper disposal. 14. Transport information According to DOT and IATA, the product is classified as: NON-HAZARDOUS Proper Shipping Name: Not regulated Technical Name: UN Number: N/A Hazard Class and Packaging Group: N/A Label(s): N/A MSDS 013-R02-20130117 Packing Instruction (Passenger Aircraft): N/A Packing Instruction (Cargo Aircraft): N/A Shipping Container Type: N/A Sales Unit: 10 ampoules per box, 1 level per box. 15. Valid regulations EU: Regulation (EC) No. 1272/2008 [EU-GHS/CLP] EU: Regulation (EC) No. 1907/2006 [REACH] US: H.R. 5820, Toxic Chemicals Safety Act, 2010 Page 2 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 16. Other information The opinions expressed herein are those of qualified experts within Eurotrol B.V. We believe that the information contained herein is current as of the date of this Material Safety Data Sheet. Since the use of this information and these opinions and the conditions of use of the product are not within the control of Eurotrol B.V., it is the users' obligation to assure safe use of the product. Date of issue: January 17, 2013 MSDS 013-R02-20130117 Page 3 of 3 Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Material Safety Data Sheet (150.7 KB)
Lot Specific
- Product Name : GAS-ISE Reference number : h 013.001.010 Lot number : g 13-1-B722 Expiry date : H 2020-05 IL Radiometer Roche Siemens GEM Series ABL-5 ABL-500, 600 series ABL-700, 800 series AVL OMNI/Cobas b 248 / 348 Rapidpoint 400/405 Rapidlab 800 Target Range Target Range Target Range Target Range Target Range Target Range Target Range Target Range pH 1 7.220 7.191 - 7.249 7.214 7.185 - 7.243 7.214 7.185 - 7.243 7.199 7.170 - 7.228 7.232 7.203 - 7.261 7.217 7.188 - 7.246 7.206 7.177 - 7.235 7.236 7.207 - 7.265 pCO2 kPa 7.44 6.96 - 7.92 7.33 6.86 - 7.81 7.39 6.91 - 7.87 7.47 6.98 - 7.95 7.79 7.28 - 8.29 7.64 7.14 - 8.14 7.93 7.42 - 8.45 7.31 6.83 - 7.78 pCO2 mmHg 55.8 52.2 - 59.4 55.0 51.4 - 58.6 55.4 51.8 - 59.0 56.0 52.4 - 59.6 58.4 54.6 - 62.2 57.3 53.6 - 61.0 59.5 55.6 - 63.4 54.8 51.2 - 58.4 pO2 kPa 8.12 7.23 - 9.01 6.81 6.06 - 7.56 7.80 6.94 - 8.66 9.21 8.20 - 10.23 12.31 11.45 - 13.17 5.39 4.79 - 5.98 8.91 7.93 - 9.89 7.07 6.29 - 7.84 pO2 mmHg 60.9 54.2 - 67.6 51.1 45.5 - 56.7 58.5 52.1 - 64.9 69.1 61.5 - 76.7 92.3 85.8 - 98.8 40.4 36.0 - 44.8 66.8 59.5 - 74.1 53.0 47.2 - 58.8 Weighed in values Roche Cobas C111 Bloodgas instruments* * Target ranges are validated on all bloodgas instruments listed in the table above. Target Range Target Range Target Range Na mmol/L 120.0 117.0 - 123.0 - - - - 114 111 - 117 K mmol/L 3.00 2.70 - 3.30 - - - - 2.9 2.8 - 3.0 Li mmol/L 0.50 0.45 - 0.55 - - - - - - - - Cl mmol/L 80.8 77.0 - 83.0 - - - - 77 74 - 80 Ca++ mmol/L n.a. n.a. - n.a. - - - - 1.88 1.74 - 2.02 tCa mmol/L 2.52 2.47 - 2.57 2.38 2.23 - 2.52 - - - - tMg mmol/L 0.50 0.40 - 0.60 0.52 0.48 - 0.56 - - - - Glucose mmol/L 3.00 2.90 - 3.10 3.04 2.71 - 3.38 3.1 2.8 - 3.4 Lactate mmol/L 7.50 7.20 - 7.80 7.67 6.83 - 8.52 6.4 5.7 - 7.1 Urea mmol/L 0.83 0.50 - 1.10 0.71 0.64 - 0.79 - - - - Value Sheet - Lot 13-1-B722 (190.7 KB)
- Product Name : GAS-ISE Reference number : h 013.002.010 Lot number : g 13-2-B725 Expiry date : H 2020-06 IL Radiometer Roche Siemens GEM Series ABL-5 ABL-500, 600 series ABL-700, 800 series AVL OMNI/Cobas b 248 / 348 Rapidpoint 400/405 Rapidlab 800 Target Range Target Range Target Range Target Range Target Range Target Range Target Range Target Range pH 1 7.452 7.422 - 7.482 7.425 7.395 - 7.455 7.425 7.395 - 7.455 7.411 7.381 - 7.441 7.420 7.390 - 7.450 7.433 7.403 - 7.463 7.427 7.397 - 7.457 7.447 7.417 - 7.477 pCO2 kPa 4.69 4.39 - 5.00 4.73 4.43 - 5.04 4.80 4.49 - 5.11 4.80 4.49 - 5.11 5.01 4.69 - 5.34 4.96 4.64 - 5.28 4.96 4.64 - 5.28 4.67 4.36 - 4.97 pCO2 mmHg 35.2 32.9 - 37.5 35.5 33.2 - 37.8 36.0 33.7 - 38.3 36.0 33.7 - 38.3 37.6 35.2 - 40.0 37.2 34.8 - 39.6 37.2 34.8 - 39.6 35.0 32.7 - 37.3 pO2 kPa 13.40 12.46 - 14.34 12.55 11.67 - 13.42 13.24 12.31 - 14.17 14.03 13.04 - 15.01 16.16 15.03 - 17.29 11.71 10.89 - 12.53 13.57 12.62 - 14.52 12.32 11.46 - 13.18 pO2 mmHg 100.5 93.5 - 107.5 94.1 87.5 - 100.7 99.3 92.3 - 106.3 105.2 97.8 - 112.6 121.2 112.7 - 129.7 87.8 81.7 - 93.9 101.8 94.7 - 108.9 92.4 85.9 - 98.9 Weighed in values Roche Cobas C111 Bloodgas instruments* * Target ranges are validated on all bloodgas instruments listed in the table above. Target Range Target Range Target Range Na mmol/L 140.0 137.0 - 143.0 - - - - 134 130 - 138 K mmol/L 4.50 4.20 - 4.80 - - - - 4.3 4.1 - 4.5 Li mmol/L 0.80 0.75 - 0.85 - - - - - - - - Cl mmol/L 100.4 97.0 - 103.0 - - - - 97 93 - 101 Ca++ mmol/L n.a. n.a. - n.a. - - - - 1.36 1.26 - 1.46 tCa mmol/L 1.72 1.67 - 1.77 1.64 1.54 - 1.74 - - - - tMg mmol/L 0.90 0.80 - 1.00 0.89 0.83 - 0.96 - - - - Glucose mmol/L 6.00 5.90 - 6.10 6.30 5.61 - 6.99 5.9 5.2 - 6.6 Lactate mmol/L 3.00 2.70 - 3.30 3.19 2.84 - 3.54 2.7 2.4 - 3.0 Urea mmol/L 3.33 3.00 - 3.70 3.24 2.90 - 3.58 - - - - Value Sheet - Lot 13-2-B725 (190.9 KB)
- Product Name : GAS-ISE Reference number : h 013.003.010 Lot number : g 13-3-B725 Expiry date : H 2020-06 IL Radiometer Roche Siemens GEM Series ABL-5 ABL-500, 600 series ABL-700, 800 series AVL OMNI/Cobas b 248 / 348 Rapidpoint 400/405 Rapidlab 800 Target Range Target Range Target Range Target Range Target Range Target Range Target Range Target Range pH 1 7.670 7.639 - 7.701 7.623 7.593 - 7.653 7.623 7.593 - 7.653 7.609 7.579 - 7.639 7.596 7.566 - 7.626 7.626 7.595 - 7.657 7.635 7.604 - 7.666 7.646 7.615 - 7.677 pCO2 kPa 2.08 1.94 - 2.22 2.25 2.11 - 2.40 2.35 2.19 - 2.50 2.28 2.13 - 2.43 2.41 2.26 - 2.57 2.39 2.23 - 2.54 2.15 2.01 - 2.29 2.17 2.03 - 2.31 pCO2 mmHg 15.6 14.6 - 16.6 16.9 15.8 - 18.0 17.6 16.5 - 18.7 17.1 16.0 - 18.2 18.1 16.9 - 19.3 17.9 16.7 - 19.1 16.1 15.1 - 17.1 16.3 15.2 - 17.4 pO2 kPa 18.20 17.20 - 19.20 17.87 16.88 - 18.85 18.17 17.17 - 19.17 18.40 17.39 - 19.41 19.65 18.57 - 20.73 16.81 15.89 - 17.74 17.80 16.82 - 18.78 17.09 16.15 - 18.03 pO2 mmHg 136.5 129.0 - 144.0 134.0 126.6 - 141.4 136.3 128.8 - 143.8 138.0 130.4 - 145.6 147.4 139.3 - 155.5 126.1 119.2 - 133.0 133.5 126.2 - 140.8 128.2 121.1 - 135.3 Weighed in values Roche Cobas C111 Bloodgas instruments* * Target ranges are validated on all bloodgas instruments listed in the table above. Target Range Target Range Target Range Na mmol/L 160.0 157.0 - 163.0 - - - - 154 149 - 159 K mmol/L 7.00 6.70 - 7.30 - - - - 6.6 6.3 - 6.9 Li mmol/L 1.20 1.15 - 1.25 - - - - - - - - Cl mmol/L 120.0 117.0 - 123.0 - - - - 118 113 - 123 Ca++ mmol/L n.a. n.a. - n.a. - - - - 0.64 0.55 - 0.73 tCa mmol/L 0.68 0.63 - 0.73 0.63 0.59 - 0.66 - - - - tMg mmol/L 1.50 1.40 - 1.60 1.47 1.36 - 1.58 - - - - Glucose mmol/L 12.50 12.40 - 12.60 12.99 11.56 - 14.42 11.9 10.6 - 13.2 Lactate mmol/L 1.20 0.90 - 1.50 1.27 1.13 - 1.41 1.0 0.9 - 1.1 Urea mmol/L 7.49 7.20 - 7.80 7.32 6.55 - 8.09 - - - - Value Sheet - Lot 13-3-B725 (191.0 KB)
- GAS-ISE Level 3 Value Sheet Product Name : GAS-ISE Reference number : h 013.003.010 Lot number : g 13-3-B722 Expiry date : H 2020-05 IL Radiometer Roche Siemens GEM Series ABL-5 ABL-500, 600 series ABL-700, 800 series AVL OMNI/Cobas b 248 / 348 Rapidpoint 400/405 Rapidlab 800 Target Range Target Range Target Range Target Range Target Range Target Range Target Range Target Range pH 1 7.677 7.646 - 7.708 7.629 7.598 - 7.660 7.629 7.598 - 7.660 7.616 7.586 - 7.646 7.602 7.572 - 7.632 7.632 7.601 - 7.663 7.641 7.610 - 7.672 7.652 7.621 - 7.683 pCO2 kPa 2.00 1.76 - 2.24 2.17 2.03 - 2.31 2.27 2.12 - 2.41 2.20 2.06 - 2.34 2.33 2.18 - 2.49 2.31 2.16 - 2.46 2.05 1.92 - 2.19 2.09 1.96 - 2.23 pCO2 mmHg 15.0 13.2 - 16.8 16.3 15.2 - 17.4 17.0 15.9 - 18.1 16.5 15.4 - 17.6 17.5 16.4 - 18.6 17.3 16.2 - 18.4 15.4 14.4 - 16.4 15.7 14.7 - 16.7 pO2 kPa 18.39 17.38 - 19.40 18.04 17.05 - 19.03 18.36 17.35 - 19.37 18.57 17.55 - 19.59 19.79 18.70 - 20.87 17.00 16.07 - 17.94 17.97 16.98 - 18.96 17.28 16.33 - 18.23 pO2 mmHg 137.9 130.3 - 145.5 135.3 127.9 - 142.7 137.7 130.1 - 145.3 139.3 131.6 - 147.0 148.4 140.2 - 156.6 127.5 120.5 - 134.5 134.8 127.4 - 142.2 129.6 122.5 - 136.7 Weighed in values Roche Cobas C111 Bloodgas instruments* * Target ranges are validated on all bloodgas instruments listed in the table above. Target Range Target Range Target Range Na mmol/L 160.0 157.0 - 163.0 - - - - 153 148 - 158 K mmol/L 7.00 6.70 - 7.30 - - - - 6.6 6.3 - 6.9 Li mmol/L 1.20 1.15 - 1.25 - - - - - - - - Cl mmol/L 120.0 117.0 - 123.0 - - - - 118 113 - 123 Ca++ mmol/L n.a. n.a. - n.a. - - - - 0.64 0.55 - 0.73 tCa mmol/L 0.68 0.63 - 0.73 0.62 0.58 - 0.66 - - - - VAS 013.003-R07 20170609 tMg mmol/L 1.50 1.40 - 1.60 1.46 1.35 - 1.57 - - - - Glucose mmol/L 12.50 12.40 - 12.60 12.59 11.21 - 13.98 11.8 10.5 - 13.1 Lactate mmol/L 1.20 0.90 - 1.50 1.22 1.09 - 1.36 1.1 1.0 - 1.2 Urea mmol/L 7.49 7.20 - 7.80 7.15 6.40 - 7.90 - - - - Eurotrol B.V. P.O. Box 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com ABN AMRO Bank No. 56.18.38.909, BIC ABNANL2A, IBAN NL92ABNA0561838909, Trade register Arnhem 09067367, VAT No. NL009139448B01 Value Sheet – Lot 13-3-B722 (33.1 KB)
- GAS-ISE Level 2 Value Sheet Product Name : GAS-ISE Reference number : h 013.002.010 Lot number : g 13-2-B722 Expiry date : H 2020-05 IL Radiometer Roche Siemens GEM Series ABL-5 ABL-500, 600 series ABL-700, 800 series AVL OMNI/Cobas b 248 / 348 Rapidpoint 400/405 Rapidlab 800 Target Range Target Range Target Range Target Range Target Range Target Range Target Range Target Range pH 1 7.449 7.419 - 7.479 7.422 7.392 - 7.452 7.422 7.392 - 7.452 7.408 7.378 - 7.438 7.417 7.387 - 7.447 7.430 7.400 - 7.460 7.424 7.394 - 7.454 7.445 7.415 - 7.475 pCO2 kPa 4.72 4.41 - 5.03 4.76 4.45 - 5.07 4.83 4.51 - 5.14 4.83 4.51 - 5.14 5.04 4.71 - 5.37 4.99 4.66 - 5.31 4.99 4.66 - 5.31 4.69 4.39 - 5.00 pCO2 mmHg 35.4 33.1 - 37.7 35.7 33.4 - 38.0 36.2 33.8 - 38.6 36.2 33.8 - 38.6 37.8 35.3 - 40.3 37.4 35.0 - 39.8 37.4 35.0 - 39.8 35.2 32.9 - 37.5 pO2 kPa 13.09 12.18 - 14.01 12.27 11.41 - 13.13 12.92 12.02 - 13.82 13.75 12.78 - 14.71 15.93 14.82 - 17.05 11.39 10.59 - 12.18 13.31 12.38 - 14.24 12.03 11.18 - 12.87 pO2 mmHg 98.2 91.3 - 105.1 92.0 85.6 - 98.4 96.9 90.1 - 103.7 103.1 95.9 - 110.3 119.5 111.1 - 127.9 85.4 79.4 - 91.4 99.8 92.8 - 106.8 90.2 83.9 - 96.5 Weighed in values Roche Cobas C111 Bloodgas instruments* * Target ranges are validated on all bloodgas instruments listed in the table above. Target Range Target Range Target Range Na mmol/L 140.0 137.0 - 143.0 - - - - 133 129 - 137 K mmol/L 4.50 4.20 - 4.80 - - - - 4.3 4.1 - 4.5 Li mmol/L 0.80 0.75 - 0.85 - - - - - - - - Cl mmol/L 100.4 97.0 - 103.0 - - - - 97 93 - 101 Ca++ mmol/L n.a. n.a. - n.a. - - - - 1.35 1.25 - 1.45 tCa mmol/L 1.72 1.67 - 1.77 1.60 1.51 - 1.70 - - - - VAS 013.002-R07 20170606 tMg mmol/L 0.90 0.80 - 1.00 0.90 0.83 - 0.97 - - - - Glucose mmol/L 6.00 5.90 - 6.10 6.07 5.40 - 6.74 6.0 5.3 - 6.7 Lactate mmol/L 3.00 2.70 - 3.30 3.07 2.73 - 3.41 2.8 2.5 - 3.1 Urea mmol/L 3.33 3.00 - 3.70 3.11 2.78 - 3.43 - - - - Eurotrol B.V., Postbus 722, 6710 BS Ede, Keplerlaan 20, 6716 BS Ede, The Netherlands, T +31 318 695777, F +31 318 695770, office@eurotrol.com, www.eurotrol.com Value Sheet – Lot 13-2-B722 (31.9 KB)
GAS-ISE Metabolites
Product Specific
- 2. Voorkom dat deze producten in het algemene afvalcircuit terecht komen. Volg de ter plaatse geldende Sammanfattning Symboler som brukes Forholdsregler range clinicamente significativi di equilibrio acido-base ed elettrolitico, funzione respiratoria, funzione renale, regels voor verantwoorde afvalverwerking. Eurotrol GAS-ISE Metabolites är ett kvalitetskontrollmaterial i fem olika nivåer, var och en med kända 1. Kun til in vitro diagnostisk brug. concentrazione di glucosio e di lattato. I controlli Eurotrol GAS-ISE Metabolites non contengono conservanti, 3. Eurotrol GAS-ISE dient niet gebruikt te worden voor kalibratiedoeleinden. koncentrationer Obs! Se bruksanvisningen Batch-kode 2. Disse produkter skal bortskaffes i det almindelige affald. Rådfør dig med de lokale miljømyndigheder correttori di viscosità, né altri additivi in grado di compromettere la misurazione degli elettrodi. Temperaturgrense vedrørende korrekt afskaffelse. Verwachte resultaten Reagens Brukes innen Conservazione e stabilità Toegekende waarden zijn verkregen door middel van metingen op het epoc Blood Analysis System met Eurotrol GAS-ISE Metabolites ger fysiologiskt relevanta nivåer och levereras i ampuller om 2,5 mL lösning. 3. Eurotrol GAS-ISE Metabolites må ikke anvendes som en kalibrator. Eurotrol GAS-ISE Metabolites può essere conservato a una temperatura di 2-8 °C. Conservato in confezione Medisinsk utstyr til in vitro-diagnostikk Referansenummer gebruikmaking van BGEM test cards. De toegekende waarden zijn beschikbaar in tabelvorm en gerangschikt Eurotrol GAS-ISE Metabolites-kontrollerna framställs genom upplösning av olika salter i en fysiologiskt buffrad Forventede resultater integra alla suddetta temperatura il prodotto resta stabile fino alla data di scadenza indicata sulle fiale e sulla naar lotnummer en sensorconfiguratie via http://www.epocal.com. matris. Tonometri med i förväg fastställda nivåer av syrgas och koldioxid balanserade med kväve och olika Produsent CE-merke Værdierne opnås ved målinger på epoc Blood Analysis System ved hjælp af BGEM testkortene. De tildelte confezione esterna. A temperatura ambiente Eurotrol GAS-ISE Metabolites rimane stabile per 1 settimana Eurotrol GAS-ISE Metabolites is een kwaliteitscontrolemateriaal voor professioneel gebruik bij het saltkoncentrationer ger fem distinkta nivåer för varje parameter, som simulerar de kliniskt relevanta områdena værdier er tilgængelige fra http://www.epocal.com, der viser hvert væskelotnummer og sensorkonfiguration (fiale sigillate). Una volta portato il prodotto a temperatura ambiente, non refrigerare! Una volta aperta la fiala controleren van de precisie en nauwkeurigheid van het epoc Blood Analysis System. för syrabas- och elektrolytbalans, respiratorisk funktion, njurfunktion, glukos- och laktatkoncentration. i tabelform. Eurotrol GAS-ISE Metabolites rimane stabile per 30 secondi. Eurotrol GAS-ISE Metabolites-kontrollerna innehåller inga konserveringsmedel, viskositetsreglerande medel Eurotrol GAS-ISE Metabolytes er beregnet til professionel brug til verifikation af instrumentydeevne. Let op Procedure eller andra tillsatser som skulle kunna påverka elektrodmätningarna på ett negativt sätt. GAS-ISE Metabolites - Level 1 • De waarden in de tabel zijn alleen toepasbaar voor het aangegeven lotnummer en op zeeniveau en 1. Rimuovere il numero necessario di fiale dalla scatola e dalla vaschetta. Lasciar stabilizzare la/e fiala/e per gelden alleen voor de aangegeven epoc Blood Analysis System sensorconfiguratie. Förvaring och stabilitet Eurotrol GAS-ISE Metabolites - Level 1 Bemærk • Værdierne i tabellen gælder kun for det tildelte væskelotnummer, den relevante epoc Blood Analysis un minimo di 1 ora alla temperatura più prossima possibile ai 22 °C. • Onjuiste bemonstering, bewaarcondities of elke andere wijze van foutieve behandeling kunnen Eurotrol GAS-ISE Metabolites kan förvaras vid 2–8 °C. När kontrollen förvaras oöppnad vid denna temperatur System sensorkonfiguration og i niveau med havets overflade. 2. Subito prima dell’uso, agitare la fiala energicamente per almeno quindici secondi per riequilibrare i gas meetwaarden geven die afwijken van de doelwaarden. garanteras stabiliteten fram till det utgångsdatum som anges på ampullerna och på ytterkartongen. Eurotrol • Forkert prøvetagning, opbevaring eller anden forkert håndtering kan forårsage, at aflæsningerne afviger con la soluzione. Agitare tenendo la fiala tra il pollice e l’indice. Indication • De pO2 waarden van Eurotrol GAS-ISE Metabolites variëren omgekeerd evenredig met GAS-ISE Metabolites är stabilt i 1 vecka vid rumstemperatur (oöppnade ampuller). Produkten får inte kylas fra målværdierne. 3. Far ruotare la fiala delicatamente in modo da depositare di nuovo la soluzione sul fondo del contenitore. Eurotrol GAS-ISE Metabolites est un matériel de référence étalonné pour le dosage des gaz, électrolytes temperatuurveranderingen. Voor elke °C verandering in temperatuur tussen 18 °C en 26 °C, verandert på nytt efter att den har antagit rumstemperatur! Efter att ampullen öppnats är Eurotrol GAS-ISE Metabolites • pO2-værdierne i Eurotrol GAS-ISE Metabolites varierer i omvendt forhold til temperaturændringer. For Prima di aprire la fiala, lasciar affiorare tutte le bolle. et métabolites sanguins destiné à contrôler la précision et l’exactitude de l’analyseur epoc® Blood Analysis de pO2 1,5% bij fysiologisch lage pO2waarden, 1,1% bij fysiologisch normale pO2 waarden en 0,5% bij stabilt i 30 sekunder. hver °C-temperaturændring mellem 18 og 26 °C ændres pO2 1,5 % i det lave niveau, 1,1 % i det normale 4. Proteggere le dita con una garza, una salvietta o dei guanti. System. Eurotrol GAS-ISE Metabolites est destiné à tester les analytes suivants : pH, pO2, pCO2, Na+, K+, Eurotrol GAS-ISE Metabolites - Level 1 fysiologisch hoge pO2 waarden. Om een grote graad van correllatie te verkrijgen met de waarden in de tabel, moeten de ampullen zo dicht mogelijk bij 22 °C geëquilibreerd worden. Anvisningar Ca++, Mg++*, Cl-*, glucose, lactate, urée*, créatinine* et tCO2. Eurotrol GAS-ISE Metabolites est également niveau og 0,5 % i det høje niveau. For at opnå en høj grad af korrelation med værdierne i tabellen skal ampullerne ækvilibreres så tæt på 22 °C som muligt. 5. Tenere la fiala con il pallino colorato rivolto verso l’alto. Staccare il collo della fiala nella direzione opposta a quella del pallino colorato. Per ulteriori dettagli, leggere il foglio illustrativo sul sistema 1. Ta fram lämpligt antal ampuller ur lådan och tråget. Låt ampullen/ampullerna jämviktas under minst conçu pour contrôler l’étalonnage, la température de fonctionnement et les autres caractéristiques de • Na openen heeft de temperatuur geen significante invloed op de pH waarde. 1 timme till en temperatur så nära 22 °C som möjligt. • Når ampullen først er åbnet, har stuetemperaturen ingen signifikant indvirkning på pH-værdierne. di prerottura (OPC [la fiala si rompe in un solo punto]). Intended Purpose performances. • Eurotrol GAS-ISE Metabolites is gevoelig voor de meeste instrumentgerelateerde factoren die 2. Skaka ampullen kraftigt omedelbart före användning under minst 15 sekunder för att jämvikta gaserna • Eurotrol GAS-ISE Metabolites er følsom over for de fleste af de instrumentrelaterede faktorer, der kan 6. Eseguire la procedura di campionamento entro 30 secondi seguendo le istruzioni del manuale operativo Eurotrol GAS-ISE Metabolites - Level 1 is an assayed blood gas, electrolyte and metabolite reference *Cl-, urée, créatinine et Mg++ ne sont pas disponibles au Canada. onverwachte analytische afwijkingen kunnen veroorzaken. forårsage uventede analytiske afvigelser. dell’epoc Blood Analysis System. material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE med lösningen. Håll ampullen mellan tummen och pekfingret när du skakar den. • Eurotrol GAS-ISE Metabolites controles bevatten geen eiwit en kunnen daarom geen afwijkingen Dispositif médical de diagnostic in vitro • Eurotrol GAS-ISE Metabolites kontroller indeholder ikke protein og detekterer muligvis derfor ikke fejl i 7. Per quanto riguarda la frequenza d’uso raccomandata, fare riferimento alle linee guida locali. Metabolites - Level 1 was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++*, Cl- 3. Snurra ampullen försiktigt så att all lösning sjunker till ampullens botten. Låt eventuella bubblor stiga upp aantonen die gerelateerd zijn aan deze component(en). Eurotrol GAS-ISE Metabolites est conforme à la directive européenne 98/79/CE relative aux dispositifs funktioner, der er følsomme over for disse komponenter. *, Glucose, Lactate, Urea*, Creatinine* and tCO . Eurotrol GAS-ISE Metabolites - Level 1 is also developed innan du öppnar ampullen. Precauzioni 2 • Eurotrol GAS-ISE Metabolites is zeer gevoelig voor contaminatie met lucht. Wanneer de vloeistof binnen 4. Skydda fingrarna med gasväv, pappershandduk eller handskar. médicaux de diagnostic in vitro et porte le label CE. Pour les Etats-Unis, Eurotrol GAS-ISE Metabolites est • Eurotrol GAS-ISE Metabolites er meget følsomme over for kontamineret rumluft. Ved prøvetagning med 1. Esclusivamente per uso diagnostico in vitro. to verify calibration, operating temperature and other performance characteristics. 30 seconden wordt bemonsterd, dan is de fout minder dan 2% over het gehele gebied in alle niveaus*. De conforme aux codes de réglementations fédérales (CFR) suivants : 42 CFR partie 72 et 21 CFR parties 606, væsken inden for 30 sekunder er fejlen under 2 % over hele området på alle niveauer*. Rumluftens *Cl-, Urea, Creatinine and Mg++ are not available in Canada 5. Håll ampullen med den färgade pricken uppåt. Bryt av halsen på ampullen i motsatt riktning mot 2. Il prodotto non deve essere smaltito nei rifiuti ordinari. Per un corretto smaltimento, consultare le autorità invloed van lucht op de pH is te verwaarlozen. 640 et 820. Eurotrol GAS-ISE Metabolites est exclusivement réservé à des applications de diagnostic in vitro. indvirkning på pH er ubetydelig. den färgade pricken. Läs bladet med OPC-anvisningar för mer information. ambientali locali. IVD Medical Device *Deze getallen zijn gebaseerd op het testen van geopende ampullen. Résumé *Tallene er baseret på prøvetagning med åbne ampuller. 6. Följ inom 30 sekunder provtagningsanvisningarna i drifthandboken till epoc Blood Analysis System. 3. Eurotrol GAS-ISE Metabolites non deve essere utilizzato come calibratore. Eurotrol GAS-ISE Metabolites - Level 1 complies with the IVD Directive 98/79/EC for Medical Devices and Dit product is vervaardigd volgens de specificaties van Eurotrol. 7. Se lokala rekommendationer för hur ofta kontrollmaterial skall analyseras. Eurotrol GAS-ISE Metabolites est un matériel de contrôle de qualité disponible à cinq niveaux ayant chacun Dette produkt er blevet fremstillet i overensstemmelse med Eurotrol specifikationer. carries the CE mark. Risultati previsti une concentration connue. Eurotrol GAS-ISE Metabolites - Level 1 complies with the following US codes of Federal Regulations (CFR): Neem voor informatie contact op met: Försiktighetsåtgärder For at få yderligere oplysninger kontaktes: I valori si ottengono mediante misurazione con epoc Blood Analysis System e con schede di analisi BGEM. Eurotrol B.V., Nederland, Telefoon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, 1. Endast för in vitro-diagnostiskt bruk. Réactifs I valori assegnati sono disponibili sul sito http://www.epocal.com, e sono suddivisi in tabelle, distinte per 42 CFR part 72 and 21 CFR parts 606, 640 and 820. Eurotrol B.V., Holland, Telefon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, Eurotrol GAS-ISE Metabolites - Level 1 is for in vitro diagnostic use only. www.eurotrol.com 2. Dessa produkter får ej läggas bland vanligt brännbart avfall. Kontakta lokala miljömyndigheter för Eurotrol GAS-ISE Metabolites fournit des concentrations significatives sur le plan physiologique ; chaque www.eurotrol.com numero di lotto di liquido e configurazione del sensore. anvisningar för korrekt avfallshantering. ampoule contient 2.5 ml de solution. Les contrôles Eurotrol GAS-ISE Metabolites sont préparés au moyen Eurotrol GAS-ISE Metabolites è un dispositivo per uso professionale per la verifica delle prestazioni Summary Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland 3. Eurotrol GAS-ISE Metabolites får ej användas som kalibreringslösning. de sels dissous dans une matrice tamponnée à pH physiologique. La tonométrie avec des concentrations Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Holland dell’analizzatore. Eurotrol GAS-ISE Metabolites - Level 1 is an assayed blood gas, electrolyte and metabolite reference prédéfinies d’oxygène et de dioxyde de carbone équilibrées avec de l’azote et différentes concentrations de material, to verify the precision and accuracy of the epoc® Blood Analysis System. Each ampule contains Gebruikte symbolen Förväntade resultat N.B. m sels fournit pour chaque paramètre cinq niveaux distincts qui simulent des plages de valeurs cliniquement Anvendte symboler m 2.5 mL solution. Resultaten erhålls genom mätningar på epoc Blood Analysis System med användning av BGEM-testkort. • I valori indicati nella tabella sono applicabili esclusivamente al numero di lotto assegnato al liquido, alla significatives d’équilibre acido-basique et électrolytique, de la fonction respiratoire, de la fonction rénale et Opgelet, lees de gebruiksaanwijzing Lotnummer De nominella värdena återfinns på http://www.epocal.com, tabellerade för varje enskild batch av produkten Bemærk, se brugsanvisning Batchkode configurazione del sensore epoc Blood Analysis System applicata e al livello del mare. Reagents des concentrations en glucose et en lactate. Les contrôles Eurotrol GAS-ISE Metabolites ne contiennent Bewaartemperatuur och varje sensorkonfiguration. • Qualora il campionamento, la conservazione o la manipolazione non avvengano correttamente, i risultati Eurotrol GAS-ISE Metabolites - Level 1 controls are prepared using salts in a physiologically buffered matrix. Te gebruiken voor ni conservateurs, ni modificateurs de viscosité, ni aucun autre additif susceptible d’affecter les mesures Anvendes inden Temperaturgrænse Eurotrol GAS-ISE Metabolites är avsett för professionellt bruk för verifiering av instrumentprestanda. potrebbero deviare dai valori target. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt réalisées avec l’électrode. In Vitro Diagnostisch Medisch Hulpmiddel Referentienummer OBS! In vitro diagnostisk medicinsk udstyr Referencenummer • I valori della pO2 di Eurotrol GAS-ISE Metabolites variano inversamente alle variazioni di temperatura. concentrations provide a distinct level for each parameter, simulating clinically significant ranges of acid-base Conservation et stabilité Per ogni grado Celsius di variazione della temperatura tra 18 °C e 26 °C, la pO2 varia dell’1.5% per il and electrolyte balance, respiratory function, renal function, glucose and lactate concentration. Eurotrol GAS- Producent CE-merkteken • Värdena i tabellen gäller endast för den angivna produktbatchen, tillämplig epoc Blood Analysis System Fabrikant CE mærke Eurotrol GAS-ISE Metabolites peut être conservé à une température comprise entre 2 et 8 °C (35 - 46 livello basso, dell’1.1% per il livello normale e dello 0.5% per il livello alto. Per ottenere un grado elevato ISE Metabolites - Level 1 controls contains no preservatives, viscosity adjusters or other additives that might sensorkonfiguration och på en höjd av noll meter över havet. °F). Si le produit est conservé non ouvert à cette température, sa stabilité est garantie jusqu’à la date de di correlazione con i valori della tabella, le fiale devono essere stabilizzate alla temperatura più vicina adversely effect electrode measurements. • Felaktig provtagning eller förvaring eller annan felaktig hantering kan göra att de avlästa resultaten avviker péremption indiquée sur les ampoules et sur la boîte. Eurotrol GAS-ISE Metabolites est stable pendant une possibile ai 22 °C. från målvärdena. Storage and Stability • pO2-värdena för Eurotrol GAS-ISE Metabolites varierar omvänt mot temperaturen. För varje °C som semaine à température ambiante (ampoules non ouvertes). Ne pas réfrigérer à nouveau le produit après • Una volta aperta la fiala, la temperatura ambiente non produce effetti significativi sui valori del pH. Eurotrol GAS-ISE Metabolites - Level 1 can be stored at a temperature of 2–8 °C (35-46 °F). Stored unopened at this temperature it is guaranteed stable as indicated until the expiry date on the ampules and Eurotrol GAS-ISE Metabolites - Level 1 temperaturen förändras inom området 18–26 °C förändras pO2 1,5 % på den låga nivån, 1,1 % på den qu’il ait été amené à température ambiante ! Après ouverture de l’ampoule, Eurotrol GAS-ISE Metabolites est stable pendant 30 secondes. Eurotrol GAS-ISE Metabolites - Level 1 • Eurotrol GAS-ISE Metabolites è sensibile a numerosi fattori correlati all’analizzatore che possono alterare in maniera imprevista i risultati delle analisi. normala nivån och 0,5 % på den höga nivån. För att få bästa möjliga korrelation med värdena i tabellen outer box. Eurotrol GAS-ISE Metabolites - Level 1 is stable for 1 week at room temperature (unopened skall ampullerna jämviktas till en temperatur så nära 22 °C som möjligt. Procédures • Poiché i controlli Eurotrol GAS-ISE Metabolites non contengono proteine, essi non sono in grado di ampules). Do not refrigerate the product after it has been brought to room temperature! After opening the Verwendungszweck 1. Sortir le nombre requis d’ampoules de la boîte et du plateau.Laisser la ou les ampoules s’équilibrer à Käyttötarkoitus rilevare malfunzionamenti sensibili a tali componenti. • När ampullen har öppnats har rumstemperaturen ingen signifikant inverkan på pH-värdena. ampule, Eurotrol GAS-ISE Metabolites - Level 1 is stable for 30 seconds. Bei Eurotrol GAS-ISE Metabolites handelt es sich um geprüftes Blutgas-, Elektrolyt- und Metabolit- • Eurotrol GAS-ISE Metabolites är känsligt för de flesta instrumentrelaterade faktorer som kan leda till une température de 15 à 30 °C. Eurotrol GAS-ISE Metabolites on analysoitu verikaasu-, elektrolyytti- ja metaboliittiviitemateriaali epoc® • Eurotrol GAS-ISE Metabolites è molto sensibile alla contaminazione dell’aria ambiente. Campionando i Referenzmaterial für die Verifizierung der Präzision und Exaktheit des epoc® Blood Analysis System. 2. Immédiatement avant l’emploi, agiter vigoureusement l’ampoule pendant au moins quinze secondes pour Blood Analysis Systemin täsmällisyyden ja tarkkuuden varmistamiseen. Eurotrol GAS-ISE Metabolites liquidi entro 30 secondi, l’errore corrisponde a meno del 2% sull’intera gamma per tutti i livelli*. L’effetto Procedures oväntade analysavvikelser. Eurotrol GAS-ISE Metabolites wurde für die Testung der folgenden Analyten entwickelt: pH, pO2, pCO2, Na+, on suunniteltu seuraavien analyyttien testaamiseen: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, dell’aria ambiente sul pH è trascurabile. 1. Remove the appropriate amount of ampules from box and tray. Equilibrate the ampule(s) for a minimum • Eurotrol GAS-ISE Metabolites-kontrollerna innehåller inga proteiner och påvisar därför eventuellt inte rééquilibrer les gaz avec la solution. Agiter l’ampoule en la tenant entre le pouce et l’index. K+, Ca++, Mg++, Cl-, Glucose, Lactat, Harnstoff, Kreatinin und tCO2. Eurotrol GAS-ISE Metabolites dient 3. Faire tourner délicatement l’ampoule pour ramener la solution au fond de celle-ci. Laisser remonter les glukoosi, laktaatti, urea, kreatiniini ja tCO2. Eurotrol GAS-ISE Metabolites on kehitetty myös kalibroinnin, of 1 hour to a temperature as close to 22 °C (71.6 °F) as possible. felfunktioner som är känsliga för dessa komponenter. außerdem der Verifizierung von Kalibrierungen, Betriebstemperaturen und anderen Leistungsmerkmalen. työskentelylämpötilan ja muiden suoritusominaisuuksien varmistamiseen. 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to re-equilibrate the • Eurotrol GAS-ISE Metabolites är mycket känsligt för kontaminering med rumsluft. Vid provtagning från bulles avant d’ouvrir l’ampoule. Q gases with the solution. When shaking, the ampule should be held between the thumb and index finger. Medizinisches Gerät für die In-vitro-Diagnostik vätskan inom 30 sekunder är felet mindre än 2 % för alla analyter och alla nivåer*. Effekten av rumsluft 4. Se protéger doigts avec de la gaze, un morceau de tissu ou des gants. IVD-lääkintälaite Eurotrol GAS-ISE Metabolites erfüllt die Vorgaben der EU-Richtlinie 98/79/EC über medizinische Geräte für 5. Maintenir l’ampoule avec le point coloré orienté vers le haut. Casser le col de l’ampoule dans la direction m 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any bubbles to rise på pH-värdet är försumbar. Eurotrol GAS-ISE Metabolites on Euroopan IVD-direktiivin 98/79/EC mukainen diagnostinen in vitro die In-vitro-Diagnostik und wurde mit dem CE-Zeichen ausgestattet. Eurotrol GAS-ISE Metabolites darf nur *Värdena baseras på testning med öppen ampull. opposée au point coloré. Consulter le mode d’emploi de l’OPC (ampoule autocassable) pour plus de O M @ m before opening the ampule. -lääkintälaite, jolla on CE-merkintä. für die In-vitro-Diagnostik verwendet werden. détails m 4. Protect fingers with gauze, tissue or gloves. Produkten har framställts i enlighet med Eurotrols specifikationer. Eurotrol GAS-ISE Metabolites on tarkoitettu vain diagnostiseen in vitro -käyttöön. 6. Procéder au prélèvement de l’échantillon conformément aux instructions figurant dans le mode d’emploi m 5. Hold ampule with the colored dot facing up. Snap off the neck of the ampule in the opposite Zusammenfassung de l’analyseur epoc Blood Analysis System. Yhteenveto m @ m m direction of the colored dot. Please read the OPC instruction leaflet for more details. Bei Eurotrol GAS-ISE Metabolites handelt es sich um Lösungen zur Qualitätskontrolle mit fünf festgelegten För ytterligare information ber vi er kontakta: 7. Se référer aux directives locales pour connaître la fréquence d’utilisation recommandée. Eurotrol GAS-ISE Metabolites on laatukontrollimateriaali, jota on saatavana viitenä tasona, joista kullakin 6. Within 30 seconds, follow the sampling procedure according to the instructions in the operating manual Konzentrationsbereichen. Eurotrol B.V. on tunnettu konsentraatio. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Olanda of your epoc Blood Analysis System. Nederländerna, Tel. +31 318 695 777, Fax +31 318 695 770, E-post office@eurotrol.com, Précautions 7. Please refer to local guidelines for recommended frequency of use. Reagenzien Reagenssit www.eurotrol.com 1. Exclusivement pour usage diagnostic in vitro. Eurotrol GAS-ISE Metabolites ist für physiologisch relevante Konzentrationsbereiche erhältlich. Jede Ampulle Eurotrol GAS-ISE Metabolites tarjoaa fysiologisesti olennaisia tasoja, ja kukin ampulli sisältää 2,5 ml Simboli Precautions 2. Ne pas éliminer ces produits avec les ordures ménagères. Consulter les autorités locales responsables enthält 2,5 ml Lösung. Die Kontrolllösungen Eurotrol GAS-ISE Metabolites werden auf der Grundlage von liuosta. Eurotrol GAS-ISE Metabolites -kontrollit valmistetaan käyttäen suoloja fysiologisesti puskuroidussa 1. For in vitro diagnostic use only. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederländerna de l’environnement pour connaître la manière de les éliminer. Attenzione, consultare le istruzioni per l’uso Numero di lotto Salzen in physiologischer Puffermatrix hergestellt. Festgelegte Sauerstoff- und Kohlendioxidkonzentrationen, matriisissa. Tonometria ennalta määritellyillä happi- ja hiilidioksiditasoilla tasapainotettuna typellä ja eri 2. These products should not be disposed of in general waste. Consult local environmental authorities for 3. Eurotrol GAS-ISE Metabolites n’est pas destiné à être utilisé comme calibrateur. ins Gleichgewicht gebracht mit Stickstoff und Salzen in verschiedenen Konzentrationen, erlauben eine Symbolförklaring suolapitoisuuksilla tarjoaa viisi erillistä tasoa kullekin parametrille ja simuloi kliinisesti merkitseviä happo-emäs- Utilizzare entro Limiti di temperatura proper disposal. m Tonometrie in fünf einzelnen Konzentrationsbereichen für jeden Parameter. Simuliert werden klinisch Résultats attendus ja elektrolyyttitasapainon, hengitystoiminnan, munuaisten toiminnan, glukoosi- ja laktaattikonsentraatioiden 3. Eurotrol GAS-ISE Metabolites - Level 1 is not to be used as a calibrator. signifikante Bereiche für Säure-Basen- und Elektrolythaushalt, Atemfunktion, Nierenfunktion sowie Obs! Se bruksanvisningen Batchnummer Les valeurs sont obtenues par le biais de mesures effectuées sur l’analyseur epoc Blood Analysis Dispositivo medico-diagnostico in vitro Numero di riferimento alueita. Eurotrol GAS-ISE Metabolites -kontrollit eivät sisällä säilöntäaineita, viskositeetinsäätöaineita tai Expected Results Glucose- und Lactatkonzentration. Die Kontrolllösungen Eurotrol GAS-ISE Metabolites enthalten keine System en utilisant les cartes de test BGEM. Les valeurs assignées sont disponibles à l’adresse muita lisäaineita, jotka voisivat vaikuttaa haitallisesti elektrodimittauksiin. Utgångsdatum Temperatur begränsning Produttore Marchio CE Values are obtained by measurements on epoc Blood Analysis System using BGEM test cards. The Konservierungsmittel, Mittel zur Einstellung der Viskosität oder andere Zusatzstoffe, die einen negativen http://www.epocal.com, présentées pour chaque numéro de lot de liquide et chaque configuration de capteur. Medicinteknisk produkt för in vitro-diagnostik Katalognummer Eurotrol GAS-ISE Metabolites est destiné à un usage professionnel pour le contrôle des performances de Varastointi ja stabiilius assigned values are available from http://www.epocal.com, tabulated for each fluid lot number and sensor Einfluss auf die Elektrodenmessungen haben könnten. l’instrument. Eurotrol GAS-ISE Metabolites -kontrolleja voidaan säilyttää lämpötilassa 2–8 °C. Kun tuotetta säilytetään configuration. Eurotrol GAS-ISE Metabolites - Level 1 is intended for professional use in the verification of Lagerung und Haltbarkeit Tillverkare CE-märkning avaamattomana tässä lämpötilassa, taataan sen stabiilius ampulleissa ja ulkopakkauksessa ilmoitettuun the instrument performance. Eurotrol GAS-ISE Metabolites kann bei einer Temperatur zwischen 2 und 8 °C gelagert werden. Bei einer Remarques viimeiseen käyttöpäivään asti. Eurotrol GAS-ISE Metabolites on stabiili 1 viikon ajan huoneenlämmössä Lagerung der ungeöffneten Ampullen in diesem Temperaturbereich wird die angegebene Stabilität der • Les valeurs figurant dans le tableau sont uniquement applicables au numéro de lot de liquide Please Note • The values in the table are applicable only to the assigned fluid lot number, the applicable epoc Blood Lösungen bis zum auf den Ampullen und der Umverpackung angegebenen Verfallsdatum garantiert. Bei correspondant, à la configuration de capteur de l’analyseur epoc Blood Analysis System correspondante (avaamattomat ampullit). Tuotetta ei saa laittaa jääkaappiin sen jälkeen kun se on tuotu huoneenlämpöön! Ampullin avaamisen jälkeen Eurotrol GAS-ISE Metabolites on stabiili 30 sekunnin ajan. Eu o o GAS SE Me abo es Leve 1 Analysis System sensor configuration and at sea level. Raumtemperatur ist Eurotrol GAS-ISE Metabolites eine Woche lang stabil (ungeöffnete Ampullen). Nach dem et au niveau de la mer. • Un prélèvement incorrect, une conservation inadéquate ou toute autre erreur de manipulation risquent Käyttö • Incorrect sampling, storage, or other mishandling may cause the readings to deviate from the target Erreichen der Raumtemperatur darf die Lösung nicht mehr gekühlt werden! Nach dem Öffnung der Ampullen ist Eurotrol GAS-ISE Metabolites dreißig Sekunden lang stabil. d’avoir pour conséquence un écart entre les mesures obtenues et les valeurs cibles. 1. Ota sopiva määrä ampulleja laatikosta ja tarjottimelta. Tasapainota ampullia (ampulleja) vähintään 1 values. • Les valeurs de pO2 d’Eurotrol GAS-ISE Metabolites varient en fonction inverse des variations de tunnin ajan mahdollisimman lähelle lämpötilaa 22 °C. O G M m m • The pO2 values of Eurotrol GAS-ISE Metabolites - Level 1 vary inversely with temperature changes. For each °C change in temperatures between 18 °C and 26 °C (between 64.5 °F and 79 °F), the Anweisungen für die Verwendung des Produkts 1. Erforderliche Anzahl an Ampullen aus der Packung entnehmen. Ampulle(n) mindestens eine Stunde lang Eurotrol GAS-ISE Metabolites - Level 1 température. Pour chaque variation de 1 °C de la température entre 18 et 26 °C (64.5 - 79 °F), la valeur 2. Ravistelle ampullia juuri ennen käyttöä voimakkaasti vähintään viidentoista sekunnin ajan, jotta kaasut tasapainottuvat uudelleen liuoksen kanssa. Ravisteltaessa ampullia tulisi pitää peukalon ja etusormen m m O G pO2 changes 1.5% in the low level, 1.1% in the normal and 0.5% in the high level. To obtain a high de pO2 change de 1.5% pour le niveau bas, de 1.1% pour le niveau normal et de 0.5% pour le niveau M m O O M bei einer Temperatur äquilibrieren, die möglichst exakt bei 22 °C liegen sollte. välissä. degree of correlation with the values in the table, the ampules should be equilibrated as close to 22 °C élevé. Pour obtenir un haut degré de corrélation avec les valeurs du tableau, les ampoules doivent être O O G M m m 2. Unmittelbar vor der Verwendung Ampulle(n) mindestens fünfzehn Sekunden lang kräftig schütteln, um Tiltenkt formål 3. Pyörittele ampullia varoen, jotta liuos palaa ampullin pohjalle. Anna mahdollisten kuplien nousta ylös (71.6 °F) as possible. équilibrées à une température aussi proche que possible de 22 °C (71.6°F). m m m die Gase ausreichend mit der Lösung zu vermischen. Zum Schütteln, Ampulle(n) zwischen Daumen und Eurotrol GAS-ISE Metabolites er referansemateriale for analyse av blodgass, elektrolytter og metabolitter, ennen ampullin avaamista. • Once the ampule is opened, room temperature has no significant effect on pH values. • Après ouverture de l’ampoule, la température ambiante n’a plus d’effet significatif sur les valeurs du pH. M Zeigefinger halten. og brukes til å verifisere presisjonen og nøyaktigheten til epoc® Blood Analysis System. Eurotrol GAS-ISE 4. Sormet on suojattava sideharsolla, paperiliinalla tai käsineillä. • Eurotrol GAS-ISE Metabolites - Level 1 is sensitive to most of the instrument related factors that can cause • Eurotrol GAS-ISE Metabolites est sensible à la plupart des facteurs liés à l’instrument susceptibles de O G M m 3. Ampulle(n) vorsichtig schwenken, damit sich die Lösung wieder am Boden der Ampulle(n) absetzt. Metabolites er utviklet for å teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glukose, 5. Pidä ampullia niin, että värillinen täplä on ylöspäin. Katkaise ampullin kaula värillisen täplän unexpected analytical deviations. produire des écarts analytiques inattendus. m m Ampulle(n) erst öffnen, nachdem eventuell vorhandene Bläschen an die Oberfläche gestiegen sind. laktat, urea, kreatinin og tCO2. Eurotrol GAS-ISE Metabolites er også utviklet for å verifisere kalibrering, vastakkaiselta puolelta. Lue lisäyksityiskohdat OPC-ohjekirjasesta. • Eurotrol GAS-ISE Metabolites - Level 1 controls do not contain protein and therefore may not detect • Les contrôles Eurotrol GAS-ISE Metabolites ne contiennent pas de protéines et ne sont dès lors pas à O G M 4. Hände mit Gaze, Lappen oder Handschuhen schützen. driftstemperatur og andre resultatdata. 6. Noudata epoc Blood Analysis Systemin käyttöoppaan ohjeiden mukaista näytteenottomenetelmää 30 malfunctions sensitive to these components. même de détecter les dysfonctionnements sensibles à ces composants. 5. Ampulle(n) mit dem farbig markierten Punkt nach oben halten und Ampullenhals in die gegenüber sekunnin kuluessa. m • Eurotrol GAS-ISE Metabolites - Level 1 is very sensitive to room air contamination. When sampling the IVD-medisinsk utstyr • Eurotrol GAS-ISE Metabolites est extrêmement sensible à la contamination de l’air ambiant. Lorsque liegende Richtung abbrechen. Weitere Hinweise siehe Anleitungsblatt für OPC-Ampullen 7. Noudata paikallisia ohjeita suositellun käyttötiheyden suhteen. O G M mm m m fluid within 30 seconds, the error is less than 2% over the entire range in all levels**. The effect of room Eurotrol GAS-ISE Metabolites er i samsvar med det europeiske IVD-direktivet 1998/79/EF for in le prélèvement du liquide a lieu dans les 30 secondes, l’erreur est inférieure à 2% sur l’ensemble (Brechampullen mit One-Point-Cut). m air on pH is negligible. vitro-diagnostisk medisinsk utstyr og bærer CE-merket. de la plage de valeurs pour tous les niveaux**. L’effet de l’air ambiant sur le pH est négligeable. Varotoimet 6. Testverfahren gemäß Bedienungsanleitung des epoc Blood Analysis System innerhalb von dreißig **Numbers are based on open ampule testing. Sekunden durchführen. Eurotrol GAS-ISE Metabolites er bare for in vitro-diagnostisk bruk. **Ces chiffres sont basés sur le test portant sur une ampoule ouverte. 1. Ainoastaan diagnostiseen in vitro -käyttöön. 7. Empfohlene Anwendungsfrequenz siehe entsprechende Leitlinien vor Ort. Ce produit est fabriqué conformément aux spécifications d’Eurotrol. 2. Näitä tuotteita ei tule hävittää yleisjätteen mukana. Kysyttävä neuvoa oikean jätteenhävityksen suhteen O G M m m m This product has been manufactured according to Eurotrol specifications. Sammendrag paikallisilta ympäristöviranomaisilta. O G M m m m Vorsichtsmaßnahmen für die Anwendung Eurotrol GAS-ISE Metabolites er et kvalitetskontrollmateriale tilgjengelig på fem nivåer, hvert med kjente For further information please contact: Pour un complément d’information, veuillez contacter: 3. Eurotrol GAS-ISE Metabolites -kontrollia ei tule käyttää kalibraattorina. m m m m 1. Nur für die In-vitro-Diagnostik bestimmt. konsentrasjoner. Eurotrol B.V., The Netherlands, Phone +31 318 695 777, Fax +31 318 695 770 Eurotrol B.V., Pays-Bas, Téléphone +31 318 695 777, Télécopie +31 318 695 770, m m Odotetut tulokset E-mail office@eurotrol.com, www.eurotrol.com 2. Produkte nicht mit dem Hausmüll entsorgen. Anweisungen für eine ordnungsgemäße Entsorgung sind Reagenser Courriel office@eurotrol.com, www.eurotrol.com m m m Arvot saadaan mittaamalla epoc Blood Analysis Systemiissä käyttäen BGEM -testikortteja. Kullekin Eurotrol Inc., USA, Toll free phone 1-866-234-5754, Main phone 1-978-598-3779, beim jeweils zuständigen Umweltamt zu erfragen. Eurotrol GAS-ISE Metabolites sørger for fysiologisk relevante nivåer, hver ampulle inneholder 2,5 ml Eurotrol Inc., Etats-Unis, Numéro d’appel gratuit 1-866-234-5754, Téléphone principal 1-978-598-3779, O G M m neste-eränumerolle ja anturikonfiguraatiolle määrätyt arvot ovat saatavilla internetosoitteesta Fax 1-978-598-3780, E-mail officeUSA@eurotrol.com, www.eurotrol.com 3. Eurotrol GAS-ISE Metabolites nicht als Kalibrator verwenden. løsning. Eurotrol GAS-ISE Metabolites-kontroller er preparert ved hjelp av salter i en fysiologisk bufret Télécopie 1-978-598-3780, Courriel officeUSA@eurotrol.com, www.eurotrol.com m m http://www.epocal.com. Zu erwartende Ergebnisse matrise. Tonometri med forhåndsbestemte nivåer for oksygen og karbondioksid balansert med nitrogen m Eurotrol GAS-ISE Metabolites on tarkoitettu ammattilaisten käyttöön laitteen toimivuuden varmistamiseksi. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands og ulike saltkonsentrasjoner sørger for fem distinkte nivåer for hver parameter, slik at det simuleres klinisk Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Pays-Bas Entsprechende Messwerte werden auf der Grundlage von Messungen durch das epoc Blood Analysis m m signifikante områder av syre-base- og elektrolyttbalanse, respiratorisk funksjon, renalfunksjon, glukose- Huomioitavaa Symbols used System unter Verwendung von BGEM-Testkarten erzielt. Die entsprechenden Werte sind unter Symboles utilisés O G M m m m M http://www.epocal.com in Tabellenform für alle Flüssigkeits-Chargennummer und Sensorkonfigurationen og laktatkonsentrasjon. Eurotrol GAS-ISE Metabolites-kontroller inneholder ingen konserveringsmidler, • Taulukon arvot soveltuvat vain määrätyille neste-eränumeroille, soveltuvalle epoc Blood Analysis System -anturikonfiguraatiolle ja merenpinnan tasolla. m m Attention, see instructions for use Batch code erhältlich. Eurotrol GAS-ISE Metabolites ist für die professionelle Anwendung zur Prüfung der Geräteleistung viskositetsjustering eller andre tilsetningsstoffer som kan innvirke negativt på elektrodemålinger. Attention, consulter le mode d’emploi Numéro de lot m O G M m m bestimmt. • Väärä näytteenotto, varastointi tai muu väärä käsittely voi aiheuttaa tavoitearvoista poikkeavia lukemia. Temperature limitation Oppbevaring og stabilitet m m m Use by Date de péremption Limites de température • Eurotrol GAS-ISE Metabolites -kontrollin pO2 -arvo voi muuttua käänteisesti lämpötilamuutosten kanssa. Weitere Hinweise Eurotrol GAS-ISE Metabolites kan oppbevares ved en temperatur på 2–8 °C. Oppbevart uåpnet ved denne m m G M Reference number Jokaista °C:n lämpötilamuutosta kohden välillä 18 °C - 26 °C pO2 muuttuu 1,5% matalalla tasolla, 1,1% In Vitro Diagnostic Medical Device • Die Werte in den Tabellen beziehen sich lediglich auf die zugeordnete Flüssigkeits-Chargennummer, die temperaturen er produktet garantert stabilt som angitt til utløpsdatoen på ampullene og den utvendige Dispositif médical de diagnostic in vitro Référence normaalilla ja 0,5% korkealla tasolla. Jotta saadaan suuri korrelaatioaste taulukon arvojen kanssa, tulisi m zu verwendende Sensorkonfiguration für das epoc Blood Analysis System und Meereshöhe. boksen. Eurotrol GAS-ISE Metabolites er stabil i 1 uke ved romtemperatur (uåpnede ampuller). Ikke sett Manufacturer CE mark Fabricant Label CE ampullit tasapainottaa mahdollisimman lähelle lämpötilaa 22 °C. m m m • Fehler bei der Probenentnahme oder Lagerung oder andere Handhabungsfehler können zu von den produktet i kjøleskapet etter at det er blitt brakt til romtemperatur! Etter åpning av ampullen vil Eurotrol • Kun ampulli on avattu, ei huoneenlämmöllä ole merkitsevää vaikutusta pH-arvoihin. m m m m Zielwerten abweichenden Messwerten führen. GAS-ISE Metabolites være stabile i 30 sekunder. • Eurotrol GAS-ISE Metabolites on herkkä useimmille laitteisiin liittyville tekijöille, jotka voivat aiheuttaa m m m m m • Die pO2-Werte von Eurotrol GAS-ISE Metabolites variieren invers in Bezug auf Temperaturveränderungen. Prosedyrer odottamattomia analyyttisiä poikkeamia. m m m Für jede Temperaturveränderung um ein °C zwischen 18 °C und 26 °C verändert sich der pO2-Wert um 1. Ta ut egnet mengde ampuller fra boks og brett. Ekvilibrer ampullen(e) i minimum 1 time til en temperatur Eurotrol GAS-ISE Metabolites - Level 1 1,5% im niedrigen, um 1,1% im normalen und um 0,5% im hohen Bereich. Um eine möglichst hohe så nær 22 °C som mulig. • Eurotrol GAS-ISE Metabolites -kontrollit eivät sisällä proteiinia, ja siksi ne eivät mahdollisesti havaitse näille komponenteille herkkiä vikoja. m m mm m m Übereinstimmung mit den Werten in der Tabelle zu erzielen, sollten die Ampulle(n) bei einer Temperatur äquilibriert werden, die möglichst exakt bei 22 °C liegen sollte. 2. Umiddelbart før bruk rister du ampullen godt i minst 15 sekunder for å re-ekvilibrere gassene med løsningen. Hold ampullen mellom tommelen og pekefingeren når du rister den. Eurotrol GAS-ISE Metabolites - Level 1 • Eurotrol GAS-ISE Metabolites on hyvin herkkä huoneilman kontaminaatiolle. Kun neste käytetään 30 m m Toepassing sekunnin kuluessa, on virhe alle 2% koko alueella kaikilla tasoilla*. Huoneilman vaikutus pH:hon on m Eurotrol GAS-ISE Metabolites is een kwaliteitscontrolemateriaal met toegekende waarden voor professioneel • Nach dem Öffnen der Ampullen hat die Raumtemperatur keine signifikanten Auswirkungen auf den 3. Drei ampullen forsiktig for å la løsningen returnere til bunnen av ampullen. La eventuelle bobler komme mitätön. m m m m gebruik bij het controleren van de precisie en nauwkeurigheid van het epoc® Blood Analysis System. pH-Wert. opp før du åpner ampullen. *Luvut perustuvat avoimen ampullin testaamiseen. m m O Tilsigtet formål GAS-ISE Metabolites is ontwikkeld om de volgende parameters te testen: pH, pO2, pCO2, Na+, K+, Ca++, • Eurotrol GAS-ISE Metabolites reagiert sensibel auf die meisten instrumentenbezogenen Faktoren, die zu 4. Beskytt fingrene med gas, papirhåndkle eller hansker. Eurotrol GAS-ISE Metabolites er et analyseret blodgas-, elektrolyt- og metabolitreferencemateriale til m m m m m m Tämä tuote on valmistettu Eurotrol-spesifikaatioiden mukaisesti. Mg++, Cl-, Glucose, Lactaat, Ureum, Creatinine en tCO2. GAS-ISE Metabolites is tevens ontwikkeld om de unerwarteten Analyseabweichungen führen können. 5. Hold ampullen med den fargede prikken vendt opp. Bryt av halsen på ampullen i motsatt retning av verificering af præcision og nøjagtighed ved epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites m m • Eurotrol GAS-ISE Metabolites enthalten kein Protein. Fehlfunktionen mit Empfindlichkeit für solche den fargede prikken. Les OPC-instruksjonsheftet for å få mer detaljert informasjon. m m ijking, werktemperatuur en andere prestatiekenmerken te controleren. blev fremstillet til at teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glukose, laktat, urea, Lisätietoja osoitteesta: Bestandteile können somit eventuell nicht festgestellt werden. 6. Innen 30 sekunder følger du prøvetakingsprosedyren i henhold til instruksjonene i bruksanvisningen for kreatinin og tCO2. Eurotrol GAS-ISE Metabolites er også udviklet for at verificere kalibrering, driftstemperatur Eurotrol B.V., Países Baixos, Puhelin +31 318 695 777, Faksi +31 318 695 770, IVD Medisch Hulpmiddel • Eurotrol GAS-ISE Metabolites reagiert sehr empfindlich auf Kontamination durch Raumluft. Bei einer epoc Blood Analysis System. og andre funktionsdata. S-posti office@eurotrol.com, www.eurotrol.com m Eurotrol GAS-ISE Metabolites voldoet aan de Europese Richtlijn 98/79/EG betreffende Medische Prüfung der Flüssigkeit innerhalb von dreißig Sekunden liegt die Fehlerquote bei unter 2% in allen 7. Se lokale retningslinjer for anbefalt hyppighet for bruk. Hulpmiddelen voor In-vitro diagnostiek en draagt het CE keurmerk. Bereichen und über alle Konzentrationsstufen hinweg. Die Auswirkungen der Raumluft auf den pH-Wert IVD medicinsk udstyr m m m m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Alankomaat Eurotrol GAS-ISE Metabolites is uitsluitend bestemd voor professioneel in vitro diagnostisch gebruik. Forholdsregler Eurotrol GAS-ISE Metabolites er i overensstemmelse med det europæiske IVD-direktiv 98/79/EC om in vitro m sind vernachlässigbar. 1. Bare til in vitro-diagnostisk bruk. diagnostisk medicinsk udstyr og bærer CE-mærket. O G M m m Samenvatting *Zahlen basieren auf Testwerten mit offenen Ampullen. Käytetyt symbolit m m 2. Disse produktene må ikke kastes i vanlig avfall. Kontakt lokale miljømyndigheter for å sørge for riktig Eurotrol GAS-ISE Metabolites er kun til in vitro diagnostisk brug. Eurotrol GAS-ISE Metabolites is een kwaliteitscontrolemateriaal, verkrijgbaar op vijf niveaus, elk met håndtering. Das vorliegende Produkt wurde gemäß Spezifikationen von Eurotrol hergestellt. Huomio, katso käyttöohjeet Eräkoodi bekende concentraties. Opsummering O m m G M 3. Eurotrol GAS-ISE Metabolites skal ikke brukes som en kalibrator. Weitere Informationen erhalten Sie bei: Eurotrol GAS-ISE Metabolites er et kvalitetskontrolmateriale, der leveres i fem niveauer, hvert med kendte Käytettävä viimeistään Lämpötilarajoite O m m m Reagentia Forventede resultater Eurotrol B.V. koncentrationer. O G M Eurotrol GAS-ISE Metabolites is beschikbaar in fysiologisch relevante niveau’s. Elke ampul bevat 2.5 mL Verdier hentes fra målinger med epoc Blood Analysis System ved hjelp av BGEM testkort. De anviste verdiene Diagnostinen in vitro -lääkintälaite Niederlande, Tel. +31 318 695 777, Fax +31 318 695 770 Viitenumero m m vloeistof. Eurotrol GAS-ISE Metabolites is samengesteld uit zouten in een fysiologisch gebufferde matrix. er tilgjengelige fra http://www.epocal.com, tabulert for hvert væskepartinummer og sensorkonfigurasjon. Reagenser Tonometrie met van te voren bepaalde niveaus van zuurstof-, koolzuur-, stikstofgasmengsels en verschillende E-Mail office@eurotrol.com, www.eurotrol.com Valmistaja CE-merkki Eurotrol GAS-ISE Metabolytes er beregnet på profesjonell bruk i verifiseringen av instrumentytelsen. Eurotrol GAS-ISE Metabolites leverer fysiologiske relevante niveauer, hver ampul indeholder 2,5 ml zoutconcentraties, resulteren in vijf fysiologisch relevante niveaus voor elke parameter. Hiermee worden opløsning. Eurotrol GAS-ISE Metabolites kontroller klargøres ved hjælp af salte i en fysiologisk buffermatrix. O m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Niederlande Merk m m klinisch belangrijke gebieden van de zuur-base- en elektrolytenbalans, functie van de ademhaling, nierfunctie Tonometri med forudbestemte niveauer af oxygen og kuldioxid, der er afstemt med nitrogen og forskellige en glucose- en lactaatconcentratie weergegeven. Eurotrol GAS-ISE Metabolites controles bevatten geen Verwendete Symbole • Verdiene i tabellen gjelder bare for det anviste væskepartinummeret, den aktuelle sensorkonfigurasjonen saltkoncentrationer, udgør fem tydelige niveauer for hver parameter, som simulerer klinisk signifikante m m m m m m m m m m for epoc Blood Analysis System og ved havnivå. conserveringsmiddelen, viscositeitsregelaars of andere toevoegingen die de elektroden of metingen nadelig områder for syre-base og elektrolytbalance, åndedrætsfunktion, nyrefunktion, glukose og laktatkoncentration. m zouden kunnen beïnvloeden. Achtung, siehe Bedienungsanleitung Chargennummer • Feil prøvetaking, oppbevaring eller annen feilhåndtering kan føre til avlesinger som avviker fra målverdiene. Eurotrol GAS-ISE Metabolites kontroller indeholder ingen konserveringsmidler, viskositetsregulatorer eller Eurotrol GAS-ISE Metabolites - Level 1 O O G M m m m andre tilsætningsstoffer, der kan påvirke elektrodemålinger negativt. m m O m % Opslag en stabiliteit Verwendbar bis Temperaturbereich • pO2 -verdiene for Eurotrol GAS-ISE Metabolites varierer omvendt i forhold til temperaturendringer. For % m % m m Eurotrol GAS-ISE Metabolites kan bewaard worden bij een temperatuur van 2–8 °C. Ongeopend bewaard Medizinisches Gerät für die hver °C-endring i temperaturer mellom 18 °C og 26 °C endres pO2 1,5 % ved lavt nivå, 1,1 % ved Opbevaring og stabilitet Referenznummer Destinazione d’uso m m m m m bij deze temperatuur is het product gegarandeerd stabiel tot de houdbaarheidsdatum zoals aangegeven op normalt nivå og 0,5 % ved høyt nivå. For å oppnå en høy grad av korrelasjon med verdiene i tabellen, må Eurotrol GAS-ISE Metabolites kan opbevares ved en temperatur på 2-8 °C. Ved opbevaring i uåbnet tilstand Eurotrol GAS-ISE Metabolites è un set di materiali di riferimento titolati per emogas, elettroliti e metaboliti, m m m m m m de ampul en op de buitenverpakking. Na het openen van de ampul is Eurotrol GAS-ISE Metabolites stabiel Hersteller CE-Zeichen ved denne temperatur garanteres stabilitet, som det er angivet indtil udløbsdatoen på ampullerne og den ampullene ekvilibreres så nært til 22°C som mulig. destinato a verificare la precisione e l’accuratezza dell’analizzatore epoc® Blood Analysis System. Eurotrol O G M m m m gedurende 30 seconden. • Når ampullen er åpnet, har romtemperatur ingen signifikant effekt på pH-verdiene. udvendige pakning. Eurotrol GAS-ISE Metabolites er stabil i 1 uge ved stuetemperatur (uåbnede ampuller). GAS-ISE Metabolites è indicato per il monitoraggio dei seguenti analiti: pH, pO2, pCO2, Na+, K+, Ca++, m Procedures • Eurotrol GAS-ISE Metabolites er følsomme for de fleste instrumentrelaterte faktorer som kan føre til Undlad at nedkøle produktet, efter det har opnået stuetemperatur! Efter åbning af ampullen er Eurotrol GAS- Mg++, Cl-, glucosio, lattato, urea, creatinina e tCO2. Eurotrol GAS-ISE Metabolites serve inoltre a verificare O G M m m m 1. Haal het benodigde aantal ampullen uit de verpakking. Incubeer de ampul(len) gedurende ten minste één uventede analytiske avvik. ISE Metabolites stabil i 30 sekunder. m m la calibrazione, la temperatura operativa e altre caratteristiche di performance. uur bij een temperatuur die zo dicht mogelijk bij 22 °C ligt. 2. Schud, vlak voor gebruik, de ampul gedurende 15 seconden om de gassen opnieuw in evenwicht te Eurotrol GAS-ISE Metabolites - Level 1 • Eurotrol GAS-ISE Metabolites-kontroller inneholder ikke protein og kan derfor ikke registrere feilfunksjoner som er følsomme for disse komponentene. Procedurer 1. Fjern den passende mængde ampuller fra æsken og bakken. Ækvilibrer ampullen/ampullerne i mindst 1 Dispositivi medico-diagnostici in vitro O m m G M m % m m Q m brengen met de oplossing. De ampul houdt men daarbij tussen duim en wijsvinger. • Eurotrol GAS-ISE Metabolites er svært følsomme for kontaminasjon av romluft. Ved prøvetaking av Eurotrol GAS-ISE Metabolites è conforme alla Direttiva Europea 98/79/CE sui dispositivi medico-diagnostici time til en temperatur, der er så tæt på 22 °C som muligt. O m 3. Zwenk de ampul voorzichtig zodat de vloeistof naar de bodem kan terugkeren. Laat de gasbelletjes væsken innen 30 sekunder er feilen mindre enn 2 % over hele området ved alle nivåer*. Effekten av in vitro e porta il marchio CE. Avsedd användning 2. Ryst umiddelbart før brug ampullen kraftigt i mindst femten sekunder for at reækvilibrere gasserne med O m m m m m omhoog komen alvorens de ampul te openen. romluft på pH er ubetydelig. Eurotrol GAS-ISE Metabolites è destinato esclusivamente ad uso diagnostico in vitro. Eurotrol GAS-ISE Metabolites är ett analyserat referensmaterial för blodgaser, elektrolyter och metaboliter, opløsningen. Når ampullen rystes, skal den holdes mellem tommel- og pegefinger. m 4. 4. Bescherm de vingers met verbandgaas, tissue of handschoenen. för verifiering av precisionen och noggrannheten hos epoc® Blood Analysis System. Eurotrol GAS-ISE *Tallene er basert på testing av åpne ampuller. 3. Sving forsigtigt ampullen rundt for at sende opløsningen tilbage til bunden af ampullen. Lad eventuelle Riassunto 5. Houd de ampul met de gekleurde stip naar boven gericht. Breek de hals van de ampul af in Metabolites är avsett för testning av följande analyter: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glukos, Dette produktet er produsert i henhold til Eurotrols spesifikasjoner. bobler stige op, før ampullen åbnes. Eurotrol GAS-ISE Metabolites è un materiale di controllo fornito in cinque livelli, ciascuno a titolo noto. m m tegenovergestelde richting van de gekleurde stip. Lees ook de bijgevoegde OPC-instructies. laktat, urea, kreatinin och tCO2. Eurotrol GAS-ISE Metabolites är även avsett för verifiering av kalibrering, 4. Beskyt fingrene med gaze, servietter eller handsker. Reagenti 6. Volg binnen 30 seconden de procedure van bemonsteren volgens de instructies in de handleiding van drifttemperatur och andra prestandaegenskaper. Hvis du ønsker mer informasjon, kan du ta kontakt: 5. Hold ampullen, så den farvede prik vender opad. Åbn ampullen i den modsatte retning af den M @ m m Eurotrol GAS-ISE Metabolites fornisce dei livelli fisiologicamente significativi, con un contenuto di 2.5 ml di het epoc Blood Analysis System. Eurotrol B.V., Nederland, Telefon +31 318 695 777, Faks +31 318 695 770, E-Mail office@eurotrol.com, M @ m Medicinteknisk produkt för in vitro-diagnostik farvede prik. Læs OPC-indlægssedlen for at få flere oplysninger. soluzione per ogni fiala. 7. Raadpleeg de plaatselijk geldende richtlijnen voor de aanbevolen gebruiksfrequentie www.eurotrol.com 6. Følg inden for 30 sekunder prøvetagningsproceduren i overensstemmelse med betjeningsvejledningen m Eurotrol GAS-ISE Metabolites uppfyller det europeiska IVD-direktivet 98/79/EG om medicintekniska I controlli Eurotrol GAS-ISE Metabolites sono ottenuti con l’aggiunta di sali in una matrice tamponata con Voorzorgsmaatregelen produkter för in vitro-diagnostik och är CE-märkt. til epoc Blood Analysis System. tampone fisiologico. La tonometria con livelli predeterminati di ossigeno e anidride carbonica equilibrati con 1. Uitsluitend bestemd voor in vitro diagnostisch gebruik. Eurotrol GAS-ISE Metabolites är endast avsett för in vitro-diagnostiskt bruk. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland 7. Se de lokale retningslinjer for anbefalet anvendelseshyppighed. azoto e le diverse concentrazioni di sali forniscono cinque livelli distinti per ciascun parametro, simulando dei Símbolos utilizados Data de fabrico Rezultate aşteptate 요약 Kasutatud sümbolid Tootmise kuupäev • アンプルの開封後は、室温はpH値に大きく影響しません。 请注意 Valorile se obţin prin măsurători efectuate pe epoc Blood Analysis System utilizând carduri de testare BGEM. Eurotrol GAS-ISE Metabolites 는 5가지 수치로 사용할 수 있는 정도 관리 물질로, 각각의 농도가 알려져 • Eurotrol GAS-ISE Metabolites - Level 1 は、予期せぬ分析のずれの原因となる機器関連のほとんどの要素に • 表格中的值仅适用于指定的试剂批号和适当的 epoc Blood Analysis System 传感器配置，且仅在海平面 Atenção, consultar instruções de utilização Código de lote Valorile atribuite sunt disponibile la http://www.epocal.com, tabelate pentru fiecare număr de lot de lichid şi 있습니다. Tähelepanu, lugege kasutusjuhiseid Partii kood 対して高い感受性を持ちます。 高度处适用。 Prazo de validade Limites de temperatura configuraţie a senzorului. 시약 Kasutada enne Temperatuuripiirang • Eurotrol GAS-ISE Metabolites - Level 1 対照にはタンパク質は含まれていないため、これらの成分に対して感 • 不正确的取样、储存或其他违规操作可导致读数偏离目标值。 Eurotrol GAS-ISE Metabolytes este conceput pentru utilizare profesională la verificarea performanţelor Eurotrol GAS-ISE Metabolites 는 생리학적 관련 수치를 제공하며, 각 앰플에는 2.5mL의 용액이 들어 受性の高い機能不全を検出することはできません。 • Eurotrol GAS-ISE Metabolites - Level 1 的 pO2 值与温度成反比。在 18 °C 和 26 °C 之间 每改变 Dispositivo médico para diagnósticos in vitro Número de referência instrumentelor. 있습니다. Eurotrol GAS-ISE Metabolites 컨트롤은 생리학적으로 완충된 매트릭스에 소금을 사용하여 In vitro diagnostiline meditsiiniseade Viitenumber • Eurotrol GAS-ISE Metabolites - Level 1 は、室内空気の汚染に対して非常に高い感受性を持ちます。30秒以 1°C，pO2 值在低水平时便改变 1.5%，正常水平时便改变 1.1%，高水平时便改变 0.5%。要使检测值与表 Fabricante Marca CE Vă rugăm să reţineţi 준비됩니다. 질소와 균형이 잡힌 산소 및 이산화탄소의 미리 결정된 수치 그리고 각기 다른 소금 농도를 Tootja CE-märgis 内に液体のサンプリングを行う場合は、すべてのレベルで全範囲に渡って2%未満の誤差となります。室内空 格中的值高度相关，应将安瓿静置至尽量接近 22 °C。 • Valorile din tabel sunt valabile numai pentru numărul de lot de lichid atribuit, pentru configuraţia senzorului 사용한 안압측정은 각 매개변수에 대해 5개의 다른 수치를 제공하여, 임상적으로 유의미한 산-염기 및 전해질 気のpHへの影響は無視できます。 • 打开安瓿后，室温对 pH 值无显著影响。 epoc Blood Analysis System în cauză şi la nivelul mării. 균형의 범위, 호흡기 기능, 신장 기능, 포도당 및 유산염 농도를 모의시험할 수 있게 합니다. Eurotrol GAS-ISE *値は開放アンプル試験に基づいています。 • Eurotrol GAS-ISE Metabolites - Level 1 对大多数可引起非预期分析偏差的仪器相关因素敏感。 • Recoltarea, depozitarea incorecte sau alte manipulări defectuoase pot determina abaterea valorilor de Metabolites 컨트롤에는 전극 측정에 부정적인 영향을 미칠 수 있는 방부제, 점도 조절기 또는 기타 첨가제가 この製品は、Eurotrol仕様に従って製造されました。 • Eurotrol GAS-ISE Metabolites - Level 1 对照品不含蛋白质，因此检测不出对这些成分敏感的故障。 • Eurotrol GAS-ISE Metabolites - Level 1 对室内空气污染非常敏感。当在 30 秒内取样时，所有水平范围 Eurotrol GAS-ISE Metabolites - Level 1 la valorile ţintă. • Valorile pO2 la Eurotrol GAS-ISE Metabolites variază invers proporţional cu modificările temperatură. 함유되어 있지 않습니다. Eurotrol GAS-ISE Metabolites - Level 1 詳細については、下記までお問い合わせください: 内的出错率低于 2%*。室内空气对 pH 的影响可以忽略。 보관 및 안정성 Pentru fiecare °C de modificare a temperaturii între 18 °C şi 26 °C, valoarea pO2 se modifică cu 1,5% la Eurotrol B.V., オランダ, 電話 +31 318 695 777, FAX +31 318 695 770, 電子メール office@eurotrol.com, *数字基于公开的安瓿检测。 Eurotrol GAS-ISE Metabolites 는 2–8 °C의 온도에서 보관할 수 있습니다. 이 온도에서 개봉하지 않은 상태로 Propósito previsto nivelul inferior, cu 1,1% la nivelul normal şi cu 0,5% la nivelul superior. Pentru a obţine un grad ridicat de Maksud Penggunaan www.eurotrol.com 本品按 Eurotrol 规格制造。 보관하면 앰플 및 외부 상자 겉면에 표시된 유효기간까지 안정적인 상태를 유지할 수 있습니다. Eurotrol GAS- Eurotrol GAS-ISE Metabolites es una solución de referencia probada de gases sanguíneos, electrolitos y corelare cu valorile din tabel, fiolele trebuie echilibrate cât mai aproape posibil de 22°C. metabolitos para verificar la precisión y exactitud de epoc® Blood Analysis System. Eurotrol GAS-ISE ISE Metabolites는 실온에서는 1주간 안정적입니다(미개봉 앰플). 제품을 실온에 노출한 후에는 냉각시키지 Eurotrol GAS-ISE Metabolites - Level 1 merupakan materi referensi gas, elektrolit dan metabolit darah Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, オランダ • După ce fiola a fost deschisă, temperatura camerei nu are niciun efect semnificativ asupra valorilor pH-ului. 마십시오! Eurotrol GAS-ISE Metabolites 는 앰플 개봉 후 30초간 안정적입니다. yang diuji, untuk memverifikasi ketepatan dan keakuratan epoc® Blood Analysis System. Eurotrol GAS-ISE 更多信息，请联系： Metabolites ha sido diseñado para analizar los analitos siguientes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, • Eurotrol GAS-ISE Metabolites este sensibil la cei mai mulţi factori legaţi de instrumente care pot determina Metabolites - Level 1 dirancang untuk menguji analit berikut: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, 使用されている記号 製造年月日 Eurotrol B.V., 荷兰, 电话 +31 318 695 777, 传真 +31 318 695 770, 电子邮件 office@eurotrol.com, Cl-, glucosa, lactato, urea, creatinina y tCO2. Eurotrol GAS-ISE Metabolites se ha desarrollado asimismo abateri analitice neaşteptate. 절차 www.eurotrol.com con el fin de verificar la calibración, la temperatura de funcionamiento y otros parámetros de rendimiento. Glukosa, Laktat, Urea, Kreatinina dan tCO2. 注意、取扱説明書を参照してください バッチコード • Probele martor ale Eurotrol GAS-ISE Metabolites nu conţin proteine şi, de aceea, nu pot detecta 1. 상자 및 트레이에서 적절한 양을 꺼냅니다. 최소 1시간 동안 22 °C에 최대한 근접한 온도로 앰플의 Eurotrol GAS-ISE Metabolites - Level 1 juga dikembangkan untuk memverifikasi kalibrasi, suhu operasi dan disfuncţiile sensibile la aceste componente. 평형을 맞춥니다. 使用期限 温度限界 Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, 荷兰 Producto sanitario de diagnóstico in vitro karakteristik kinerja lainnya. Eurotrol GAS-ISE Metabolites cumple con la Directiva Europea 98/79/CE sobre productos sanitarios para • Eurotrol GAS-ISE Metabolites este foarte sensibil la contaminarea aerului ambiant. Dacă lichidul se 2. 사용 직전에 최소 15초간 앰플을 세게 흔들어 용액과 가스의 평형을 다시 맞춥니다. 흔들 때는 엄지와 参照番号 使用的符号 制造日期 검지 손가락으로 앰플 잡아야 합니다. Perangkat Medis IVD in vitro診断医療機器 diagnóstico in vitro y cuenta con la marca CE. recoltează în interval de 30 secunde, eroarea este mai mică de 2% pe întregul interval, la toate nivelurile*. Eurotrol GAS-ISE Metabolites cumple con las disposiciones siguientes del Código de Regulaciones Federales Efectul aerului ambiant asupra pH-ului este neglijabil. 3. 앰플을 살살 돌려서 용액이 앰플의 바닥으로 되돌아가도록 합니다. 앰플을 개봉하기 전에 거품이 위로 Eurotrol GAS-ISE Metabolites - Level 1 sesuai dengan Directive 98/79/EC IVD untuk Perangkat Medis dan 製造者 CEマーク 注意，请参阅使用说明 批号 *Cifrele se bazează pe testarea unei fiole deschise. 떠오르도록 합니다. bertanda CE. (CRF) estadounidense: parte 72 del título 42 del CRF, y partes 606, 640 y 820 del título 21 del CRF. 使用截止日期 温度限制 4. 거즈, 티슈 또는 장갑으로 손가락을 보호합니다. Eurotrol GAS-ISE Metabolites - Level 1 dimaksudkan untuk penggunaan diagnostik in-vitro saja. Eurotrol GAS-ISE Metabolites está diseñado para utilizarse únicamente en diagnóstico in vitro. Acest produs a fost fabricat în conformitate cu specificaţiile Eurotrol. 5. 채색된 점이 위를 향하게 하여 앰플을 잡습니다. 채색된 점의 반대 방향으로 앰플의 목부분을 툭 Ringkasan 体外诊断医疗器械 参考号 Resumen Eurotrol GAS-ISE Metabolites es una solución de control de calidad disponible en cinco niveles, cada uno de Pentru informaţii suplimentare, vă rugăm contactaţi: 잘라냅니다. 자세한 내용은 OPC-설명 부분을 참조하십시오. Eurotrol GAS-ISE Metabolites - Level 1 merupakan materi referensi gas, elektrolit dan metabolit darah yang Eurotrol GAS-ISE Metabolites - Level 1 制造商 CE 标志 Eurotrol B.V., Olanda, Telefon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, 6. epoc Blood Analysis System 사용 설명서의 설명에 따라 30초 내에 샘플링 절차를 수행합니다. diuji, untuk memverifikasi ketepatan dan keakuratan epoc® Blood Analysis System. Setiap ampul berisi ellos con concentraciones conocidas. www.eurotrol.com 7. 권장되는 사용 빈도에 대해서는 현지 지침을 참조하십시오. larutan 2,5 mL. Reactivos Kullanım Amacı Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Olanda 주의사항 Reagen Eurotrol GAS-ISE Metabolites proporciona concentraciones fisiológicamente relevantes en ampollas de Eurotrol GAS-ISE Metabolites - Level 1 , epoc® Blood Analysis System kesinlik ve doğruluk durumunun 1. 체외 진단용으로만 사용합니다. Kontrol Eurotrol GAS-ISE Metabolites - Level 1 disiapkan dengan menggunakan garam dalam matriks buffer 2.5 mL de solución. Los controles de Eurotrol GAS-ISE Metabolites se preparan con una matriz de sales doğrulanması için tahlilde kullanılan kan gazı, elektrolit ve metabolit referans materyalidir. Eurotrol GAS-ISE Simboluri utilizate Data fabricației 2. 이 제품을 일반 쓰레기와 함께 폐기하면 안 됩니다. 적절한 폐기 방법에 대해서는 현지 환경부에 fisiologi. Tonometri dengan kadar oksigen dan karbon dioksida yang telah ditentukan yang diseimbangkan fisiológicamente amortiguada. La tonometría con niveles predeterminados de oxígeno y dióxido de carbono Metabolites - Level 1 şu analitlerin test edilmesi için tasarlanmıştır: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, 문의하십시오. dengan nitrogen dan konsentrasi garam berbeda memberikan kadar berbeda untuk masing-masing equilibrados con nitrógeno y distintas concentraciones salinas proporciona cinco niveles distintos para Atenţie, consultaţi instrucţiunile de utilizare Cl-, Glukoz, Laktat, Üre, Kreatinin ve tCO2. Codul seriei de fabricaţie 3. Eurotrol GAS-ISE Metabolites 를 교정기로 사용해서는 안 됩니다. parameter, yang mensimulasikan rentang kesetimbangan asam-basa dan elektrolit yang signifikan secara Eurotrol GAS-ISE Metabolites - Level 1 ayrıca kalibrasyon, çalışma sıcaklığı ve diğer performans özelliklerinin cada parámetro, simulando rangos clínicamente significativos de equilibrio acidobásico y de electrolitos, A se utiliza până la data de Limite de temperatură 예상 결과 klinis, fungsi respiratori, fungsi ginjal, konsentrasi glukosa dan laktat. Kontrol Eurotrol GAS-ISE Metabolites - doğrulanması için geliştirilmiştir. función respiratoria, función renal y concentración de glucosa y lactato. Los controles de Eurotrol GAS-ISE 값은 BGEM 시험 카드를 사용해 epoc Blood Analysis System 에서 수행된 측정을 통해 획득됩니다. 할당된 Level 1 tidak mengandung pengawet, pengatur viskositas atau aditif lain yang mungkin berpengaruh negatif Metabolites no contienen conservantes, reguladores de la viscosidad ni otros aditivos que podrían influir de Dispozitiv medical pentru diagnostic in vitro Număr de referinţă İn Vitro Diagnostik Tıbbi Cihaz 값은 http://www.epocal.com 에서 입수할 수 있으며, 각 유체의 로트 번호와 센서 구성이 표로 작성되어 pada pengukuran elektrode. forma adversa en las mediciones de electrodos. Eurotrol GAS-ISE Metabolites - Level 1 Tıbbi Cihazlar için İn Vitro Diagnostik (IVD) Direktifi 98/79/EC ile Producător Marca CE 있습니다. Penyimpanan dan Stabilitas Almacenamiento y estabilidad uyumludur ve CE işaretini taşır. Eurotrol GAS-ISE Metabolytes 는 계기 성능 확인에 전문적으로 사용하도록 고안되었습니다. Eurotrol GAS-ISE Metabolites - Level 1 bisa disimpan pada suhu 2–8 °C. Stabilitasnya terjamin hingga Eurotrol GAS-ISE Metabolites puede almacenarse a una temperatura de 2 a 8 °C. Si se almacena sin abrir Eurotrol GAS-ISE Metabolites - Level 1 sadece in vitro diagnostik kullanım içindir. 참고사항 tanggal kedaluwarsa yang tertera pada ampul dan kotak luarnya jika disimpan dalam keadaan belum dibuka a esta temperatura, se garantiza su estabilidad hasta la fecha de caducidad indicada en las ampollas y en el Özet • 표의 값들은 할당된 유체 로트 번호, 적용가능한 epoc Blood Analysis System 센서 구성 및 해수면에만 pada suhu ini. Eurotrol GAS-ISE Metabolites - Level 1 stabil selama 1 minggu pada suhu kamar (ampul belum embalaje. Eurotrol GAS-ISE Metabolites se mantiene estable durante una semana a temperatura ambiente Eurotrol GAS-ISE Metabolites - Level 1 , epoc® Blood Analysis System kesinlik ve doğruluk durumunun 적용할 수 있습니다. dibuka). Jangan simpan produk di refrigerator setelah diletakkan pada suhu kamar! Setelah ampul dibuka, (ampollas sin abrir). No refrigere el producto una vez que se ha dispuesto a temperatura ambiente! Tras abrir la ampolla, Eurotrol GAS-ISE Metabolites permanece estable durante 30 segundos. Eurotrol GAS-ISE Metabolites - Level 1 • 부정확한 샘플링, 보관 또는 기타 취급상의 잘못은 판독값이 목표 값에서 벗어나게 하는 요인이 될 수 Eurotrol GAS-ISE Metabolites - Level 1 stabil selama 30 detik. doğrulanması için tahlilde kullanılan kan gazı, elektrolit ve metabolit referans materyalidir. Her ampul 2,5 mL solüsyon içerir. 있습니다. Prosedur Procedimientos • Eurotrol GAS-ISE Metabolites 의 pO2 값은 온도 변화와 반대로 변합니다. 18 °C ~ 26 °C의 온도가 1 °C Reaktifler 1. Keluarkan ampul secukupnya dari kotak dan baki. Lakukan ekuilibrasi terhadap ampul selama minimal 1 1. Retire las ampollas necesarias de la caja y la bandeja. Equilibre las ampollas como mínimo durante 1 hora Σκοπός για τον οποίο προορίζεται 변할 때마다, pO2 는 낮은 수치에서 1.5%, 정상 수치에서 1.1%, 높은 수치에서 0.5% 변합니다. 표의 값과 Eurotrol GAS-ISE Metabolites - Level 1 fizyolojik olarak tamponlanmış bir matriks içinde tuzlar kullanılarak jam pada suhu sebisa mungkin paling mendekati 22 °C. a una temperatura lo más próxima posible a 22 °C. Το Eurotrol GAS-ISE Metabolites είναι ένα προσδιορισμένο υλικό αναφοράς αερίων, ηλεκτρολυτών και 높은 정도의 상관관계를 얻으려면 22 °C에 최대한 근접한 온도로 앰플의 평형을 맞춥니다. hazırlanır. Nitrojen ve farklı tuz konsantrasyonlarıyla dengelenmiş, önceden belirlenmiş oksijen ve 2. Tepat sebelum digunakan, kocok ampul dengan kuat minimal lima belas detik untuk meng-ekuilibrasi ulang 2. Inmediatamente antes de su uso, agite la ampolla enérgicamente durante un mínimo de 15 segundos para μεταβολιτών αίματος, για την επαλήθευση της πιστότητας και της ακρίβειας του συστήματος epoc® Blood • 앰플이 개봉되고 나면 실온은 pH 값에 큰 영향을 미치지 않습니다. karbondioksit düzeyleriyle tonometri her parametre için ayrı bir düzey sağlayarak klinik olarak anlamlı asit gas dengan larutan. Saat dikocok, ampul harus dipegang di antara jempol dan jari telunjuk. reequilibrar los gases de la solución. Para ello, sostenga la ampolla entre el dedo pulgar y el dedo índice. Analysis System. Το Eurotrol GAS-ISE Metabolites σχεδιάστηκε για την εξέταση των παρακάτω αναλυόμενων • Eurotrol GAS-ISE Metabolites는 예상치 못한 분석 편차를 일으킬 수 있는 대부분의 계기 관련 요인에 baz ve elektrolit dengesi, solunum işlevi, böbrek işlevi, glukoz ve laktat konsantrasyonu aralıklarını simüle 3. Perlahan goyang-goyangkan ampul untuk mengembalikan larutan ke bagian bawah ampul. Biarkan 3. Realice movimientos circulares suaves con la ampolla para que la solución vuelva a la parte inferior de ουσιών: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, γλυκόζη, γαλακτικό, ουρία, κρεατινίνη και tCO2. Το 민감합니다. eder. Eurotrol GAS-ISE Metabolites - Level 1 elektrot ölçümlerini olumsuz etkileyebilecek koruyucu madde, gelembung naik sebelum membuka ampul. esta. Antes de abrir la ampolla, espere a que todas las burbujas suban. Eurotrol GAS-ISE Metabolites έχει αναπτυχθεί, επίσης, για την επαλήθευση της βαθμονόμησης, της • Eurotrol GAS-ISE Metabolites 컨트롤은 단백질을 함유하고 있지 않기 때문에 이러한 성분에 민감한 viskozite ayarlayıcı veya başka katkı maddesi içermez. 4. Lindungi jari dengan kain kasa, tisu atau sarung tangan. 4. Proteja sus dedos con una gasa, un pañuelo o guantes. θερμοκρασίας λειτουργίας και άλλων χαρακτηριστικών απόδοσης. 고장을 감지해내지 못할 수도 있습니다. 5. Pegang ampul dengan bagian titik berwarna mengarah ke atas. Patahkan leher ampul berlawanan Saklama ve Stabilite 5. Sostenga la ampolla con el punto de color hacia arriba. Rompa el cuello de la ampolla en la • Eurotrol GAS-ISE Metabolites는 실내 공기 오염에 매우 민감합니다. 30초 내에 유체를 샘플링할 때 모든 Eurotrol GAS-ISE Metabolites - Level 1 2–8 °C sıcaklıkta saklanabilir. Bu sıcaklıkta açılmadan saklandığında IVD ιατροτεχνολογικό προϊόν arah titik berwarna. Baca leaflet petunjuk OPC untuk detail selengkapnya. dirección opuesta al punto de color. Para obtener más información, consulte el folleto de 수치에서 전 범위에 걸친 오차는 2% 미만입니다.* 실내 공기가 pH에 미치는 영향은 무시할 수 있는 Το Eurotrol GAS-ISE Metabolites συμμορφώνεται με την Ευρωπαϊκή οδηγία IVD 98/79/EΚ σχετικά με τα in 6. Dalam 30 detik, ikuti prosedur pengambilan sampel sesuai petunjuk dalam panduan operasi epoc Blood stabilitesi ampullerde ve dış kutuda belirtildiği şekilde son kullanma tarihine kadar garanti edilmektedir. instrucciones del sistema de apertura OPC (rotura por el punto) de la ampolla. 수준입니다. vitro διαγνωστικά ιατροτεχνολογικά προϊόντα και φέρει τη σήμανση CE. Το Eurotrol GAS-ISE Metabolites Analysis System. Baca panduan setempat untuk frekuensi penggunaan yang disarankan. Eurotrol GAS-ISE Metabolites - Level 1 oda sıcaklığında 1 hafta stabildir (açılmamış ampuller). Ürünü oda 6. Antes de 30 segundos, siga el procedimiento de muestreo de acuerdo con las instrucciones del manual de *번호는 개봉된 앰플 시험을 기준으로 합니다. sıcaklığına getirildikten sonra buzdolabına koymayın! Ampul açıldıktan sonra Eurotrol GAS-ISE Metabolites funcionamiento de epoc Blood Analysis System. προορίζεται μόνο για in vitro διαγνωστική χρήση. Tindakan Pencegahan 이 제품은 Eurotrol 사양에 따라 제조되었습니다. - Level 1 30 saniye stabildir. 7. Consulte la normativa local sobre la frecuencia de uso recomendada. Περίληψη 1. Untuk penggunaan diagnostik in-vitro saja. Το Eurotrol GAS-ISE Metabolites είναι ένα υλικό ποιοτικού ελέγχου που διατίθεται σε πέντε επίπεδα, το καθένα 2. Produk ini tidak boleh dibuang bersama limbah umum. Hubungi otoritas lingkungan setempat untuk İşlemler Precauciones από τα οποία έχει γνωστή συγκέντρωση. 자세한 사항은 아래 연락처로 문의하십시오. petunjuk pembuangan yang sesuai. 1. Uygun sayıda ampulü kutu ve tepsiden çıkarın. Ampulü/ampulleri 22 °C sıcaklığa mümkün olduğunca 1. Solamente para uso de diagnóstico in vitro. Eurotrol B.V., 네덜란드, 전화번호 +31 318 695 777, 팩스번호 +31 318 695 770, 3. Eurotrol GAS-ISE Metabolites - Level 1 tidak untuk digunakan sebagai kalibrator. yakın bir sıcaklıkta en az 1 saat dengeleyin. 2. Estos productos no deben desecharse junto con los residuos generales. Póngase en contacto con las Αντιδραστήρια 이메일 office@eurotrol.com, www.eurotrol.com Hasil yang Diharapkan 2. Kullanımdan hemen önce gazları solüsyonla tekrar dengelemek için ampulü en az on beş saniye kuvvetle autoridades medioambientales locales para obtener información sobre su correcta eliminación. Το Eurotrol GAS-ISE Metabolites διαθέτει φυσιολογικά σχετικά επίπεδα, ενώ η κάθε αμπούλα περιέχει 2,5 sallayın. Sallarken ampul başparmak ile işaret parmağı arasında tutulmalıdır. 3. Eurotrol GAS-ISE Metabolites no debe utilizarse como calibrador. ml διαλύματος. Τα υλικά ελέγχου Eurotrol GAS-ISE Metabolites παρασκευάζονται με τη χρήση αλάτων σε Nilai diperoleh dari pengukuran pada epoc Blood Analysis System dengan menggunakan kartu uji BGEM. Nilai yang ditetapkan tersedia di http://www.epocal.com, ditabulasi untuk setiap nomor lot cairan dan 3. Solüsyonu tekrar ampulün alt kısmına getirmek için ampulü yavaşça çevirin. Ampulü açmadan önce Resultados esperados μια μήτρα φυσιολογικού ρυθμιστικού διαλύματος. Η τονομετρία με προκαθορισμένα επίπεδα οξυγόνου και Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, 네덜란드 herhangi bir kabarcığın yükselmesini bekleyin. διοξειδίου του άνθρακα τα οποία έχουν εξισορροπηθεί με άζωτο και διαφορετικές συγκεντρώσεις αλάτων konfigurasi sensor. Eurotrol GAS-ISE Metabolites - Level 1 dimaksudkan untuk penggunaan profesional Los valores se obtienen a través de las mediciones de epoc Blood Analysis System mediante las tarjetas de untuk memverifikasi kinerja instrumen. 4. Parmakları gazlı bez, kağıt mendil veya eldivenlerle koruyun. análisis BGEM. Los valores asignados están disponibles en http://www.epocal.com, expresados por número παρέχει πέντε ξεχωριστά επίπεδα για κάθε παράμετρο, προσομοιάζοντας τα κλινικά σημαντικά εύρη τιμών της 사용된 기호 제조일 5. Ampulü renkli nokta yukarı bakar şekilde tutun. Ampulün boynunu renkli noktanın karşı yönüne de lote de fluido y configuración del sensor. Eurotrol GAS-ISE Metabolites está diseñado para uso profesional οξεοβασικής και της ηλεκτρολυτικής ισορροπίας, της αναπνευστικής λειτουργίας, της νεφρικής λειτουργίας, Harap Diketahui doğru kırın. Lütfen daha fazla ayrıntı için OPC talimat broşürünü okuyun. 주의, 사용 설명을 참조 배치 코드 para la verificación del funcionamiento del sistema. καθώς επίσης και της συγκέντρωσης γλυκόζης και γαλακτικού. Τα υλικά ελέγχου Eurotrol GAS-ISE Metabolites • Nilai pada tabel hanya berlaku untuk nomor lot cairan yang ditentukan, konfigurasi sensor epoc Blood 6. Sonraki 30 saniye içinde epoc Blood Analysis System çalıştırma kılavuzunuzdaki talimat uyarınca örnek δεν περιέχουν συντηρητικά, ρυθμιστές ιξώδους ή άλλα πρόσθετα τα οποία ενδέχεται να επηρεάσουν 사용 기한 한계 온도 Analysis System yang berlaku dan di permukaan laut. alma işlemini izleyin. A tener en cuenta δυσμενώς τις μετρήσεις με το ηλεκτρόδιο. • Pengambilan sampel dan penyimpanan yang keliru, atau salah penanganan lainnya bisa menyebabkan 7. Lütfen önerilen kullanım sıklığı için yerel kılavuz ilkelere başvurun. • Los valores de la tabla se aplican únicamente al número de lote del fluido asignado y a la configuración del 체외 진단용 의료기기 참조 번호 Φύλαξη και σταθερότητα deviasi pembacaan dari nilai target. sensor epoc Blood Analysis System correspondiente, a nivel del mar. Önlemler Το Eurotrol GAS-ISE Metabolites μπορεί να φυλαχθεί σε θερμοκρασία 2–8 °C. Εάν φυλαχθεί σε αυτή τη 제조사 CE 마크 • Nilai pO2 Eurotrol GAS-ISE Metabolites - Level 1 sangat beragam seiring dengan perubahan suhu. Untuk • Si se realiza un muestreo, almacenamiento u otra gestión incorrectos, las lecturas pueden desviarse de 1. Sadece in vitro diagnostik kullanım içindir. θερμοκρασία χωρίς να ανοιχθεί, εγγυάται η σταθερότητά του όπως υποδεικνύεται, έως την ημερομηνία λήξης setiap perubahan °C pada suhu antara 18 °C dan 26 °C, pO2 berubah sebesar 1,5% di tempat rendah, los valores asignados. 1,1% di ketinggian normal dan 0,5% di ketinggian. Untuk mendapatkan derajat korelasi yang tinggi dengan 2. Bu ürünler genel atıkla atılmamalıdır. Uygun atma işlemi için yerel çevresel makamlara başvurun. • Los valores de pO2 de Eurotrol GAS-ISE Metabolites varían de forma inversa a los cambios de που αναφέρεται στις αμπούλες και το εξωτερικό κουτί. Το Eurotrol GAS-ISE Metabolites παραμένει σταθερό 3. Eurotrol GAS-ISE Metabolites - Level 1 bir kalibratör olarak kullanılmamalıdır. για 1 εβδομάδα σε θερμοκρασία δωματίου (αμπούλες που δεν έχουν ανοιχθεί). Μην ψύχετε το προϊόν μετά τη nilai di tabel, ampul harus diekuilibrasi pada suhu sebisa mungkin paling mendekati 22 °C. temperatura. Para cada cambio de °C de temperatura entre los 18 °C y los 26 °C, el valor de pO2 cambia μεταφορά του σε θερμοκρασία δωματίου! Μετά το άνοιγμα της αμπούλας, το Eurotrol GAS-ISE Metabolites • Setelah ampul dibuka, suhu kamar tidak berdampak signifikan pada nilai pH. Beklenen Sonuçlar un 1.5% en el nivel bajo, un 1.1% en el nivel normal y un 0.5% en el nivel alto. Para obtener una correlación παραμένει σταθερό για 30 δευτερόλεπτα. • Eurotrol GAS-ISE Metabolites - Level 1 peka terhadap sebagian besar faktor terkait instrumen yang bisa epoc Blood Analysis System’da değerler BGEM test kartları kullanılarak yapılan ölçümlerle elde edilir. óptima con los valores de la tabla, las ampollas deben equilibrarse a un valor lo más cercano posible menyebabkan deviasi analitis tak terduga. Belirlenen değerler her sıvı lot numarası ve sensör konfigürasyonu için tablo halinde http://www.epocal. a 22 °C. Διαδικασίες • Kontrol Eurotrol GAS-ISE Metabolites - Level 1 tidak mengandung protein sehingga tidak bisa mendeteksi com adresinden elde edilebilir. Eurotrol GAS-ISE Metabolites - Level 1 ürününün alet performansının • Una vez que la ampolla se ha abierto, la temperatura ambiente no tiene ningún efecto significativo en los valores de pH. 1. Αφαιρέστε την κατάλληλη ποσότητα αμπουλών από το κουτί και τον δίσκο. Αφήστε την αμπούλα ή τις αμπούλες να εξισορροπήσουν για 1 ώρα τουλάχιστον σε θερμοκρασία δωματίου, η οποία να πλησιάζει Eurotrol GAS-ISE Metabolites - Level 1 kerusakan yang sensitif terhadap komponen ini. doğrulanmasında profesyonel olarak kullanılması amaçlanmıştır. • Eurotrol GAS-ISE Metabolites - Level 1 sangat sensitif pada kontaminasi udara kamar. Saat mengambil Lütfen Dikkat • Eurotrol GAS-ISE Metabolites es sensible a la mayoría de factores relacionados con los instrumentos que όσο το δυνατόν περισσότερο τους 22 °C. sampel cairan dalam 30 detik, kesalahannya kurang dari 2% pada seluruh kisaran di semua ketinggian*. • Tablodaki değerler sadece tahsis edilmiş sıvı lot numarası ve ilgili epoc Blood Analysis System sensör pueden causar desviaciones analíticas inesperadas. 2. Αμέσως πριν από τη χρήση, ανακινήστε έντονα την αμπούλα για δεκαπέντε δευτερόλεπτα τουλάχιστον, Efek udara kamar pada pH bisa diabaikan. konfigürasyonu için deniz seviyesinde geçerlidir. • Los controles de Eurotrol GAS-ISE Metabolites no contienen proteínas y, por lo tanto, no detectan ώστε να επανεξισορροπήσετε τα αέρια με το διάλυμα. Κατά την ανακίνηση, θα πρέπει να κρατάτε την Kasutusotstarve *Angka berdasarkan pengujian ampul terbuka • Hatalı örnek alma, saklama veya başka şekillerde yanlış kullanım ölçümlerin hedef değerlerden sapmasına disfunciones relacionadas con estos componentes. αμπούλα μεταξύ του αντίχειρα και του δείκτη. Eurotrol GAS-ISE Metabolites - Level 1 on veregaaside, elektrolüütide ja metaboliitide analüüsimise • Eurotrol GAS-ISE Metabolites es muy sensible a la contaminación del aire ambiente. Si se toma 3. Ανακινήστε την αμπούλα με ήπιες κινήσεις, ώστε το διάλυμα να επιστρέψει στον πυθμένα της αμπούλας. viitematerjal vereanalüüsisüsteemi epoc® Blood Analysis System täpsuse kontrollimiseks. Eurotrol GAS-ISE Produk ini sudah diproduksi sesuai spesifikasi Eurotrol. neden olabilir. una muestra del fluido antes de 30 segundos, el porcentaje de error es inferior al 2% sobre el Αφήστε τυχόν φυσαλίδες να ανέλθουν στην επιφάνεια προτού ανοίξετε την αμπούλα. Metabolites - Level 1 on mõeldud järgmiste analüütide katsetamiseks: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Untuk informasi selengkapnya, silakan hubungi: • Eurotrol GAS-ISE Metabolites - Level 1 pO2 değerleri sıcaklık değişiklikleriyle ters ilişkili olarak değişir. rango completo en todos los niveles*. El efecto del aire ambiente sobre el pH es insignificante. 4. Προστατεύστε τα δάκτυλά σας με γάζα, χαρτομάντιλο ή γάντια. Cl-, glükoos, laktaat, uurea, kreatiniin ja tCO2. Eurotrol B.V., Belanda, Telepon +31 318 695 777, Faks +31 318 695 770, Email office@eurotrol.com, pO2 18 °C ile 26 °C arasındaki sıcaklıklarda her °C değişim ile düşük düzeyde %1,5, normal durumda *Las cifras están basadas en una prueba con una ampolla abierta. 5. Κρατήστε την αμπούλα με την έγχρωμη κουκκίδα στραμμένη προς τα πάνω. Αποσπάστε τον λαιμό Eurotrol GAS-ISE Metabolites - Level 1 on mõeldud ka kalibratsiooni, töötemperatuuri ja muude www.eurotrol.com %1,1 ve yüksek düzeyde %0,5 değişir. Tablodaki değerlerle yüksek bir korelasyon derecesi elde etmek için της αμπούλας με κατεύθυνση αντίθετη προς την έγχρωμη κουκκίδα. Διαβάστε το φύλλο οδηγιών talitlusnäitajate kontrolliks. ampuller 22 °C sıcaklığa mümkün olduğunca yakın bir sıcaklıkta dengelenmelidir. Este producto se ha fabricado de acuerdo con las especificaciones Eurotrol. OPC για περισσότερες λεπτομέρειες. IVD meditsiiniseade Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Belanda • Ampul açıldıktan sonra oda sıcaklığının pH değerleri üzerine anlamlı bir etkisi yoktur. Para obtener más información póngase en contacto con: 6. Εντός 30 δευτερολέπτων ακολουθήστε τη διαδικασία δειγματοληψίας σύμφωνα με τις οδηγίες που Eurotrol GAS-ISE Metabolites - Level 1 vastab IVD meditsiiniseadmete direktiivile 98/79/EÜ ja sellel on CE- • Eurotrol GAS-ISE Metabolites - Level 1 beklenmeyen analitik sapmalara yol açabilecek, aletle ilgili çoğu Simbol yang digunakan Tanggal produksi faktöre duyarlıdır. Eurotrol B.V., Países Bajos, Teléfono +31 318 695 777, Fax +31 318 695 770, αναφέρονται στο εγχειρίδιο λειτουργίας του συστήματος epoc Blood Analysis System που διαθέτετε. märgis. Correo electrónico office@eurotrol.com, www.eurotrol.com 7. Ανατρέξτε τις τοπικές κατευθυντήριες οδηγίες σχετικά με τη συνιστώμενη συχνότητα χρήσης. Eurotrol GAS-ISE Metabolites - Level 1 on mõeldud vaid in vitro diagnostiliseks kasutuseks. Perhatian, baca petunjuk penggunaan Kode batch • Eurotrol GAS-ISE Metabolites - Level 1 kontrolleri protein içermez ve bu nedenle bu bileşenlere duyarlı arızaları saptamayabilir. Eurotrol Inc., EE. UU., Teléfono gratuito: 1-866-234-5754, Teléfono principal 1-978-598-3779, Προφυλάξεις Kokkuvõte Gunakan sebelum Batasan suhu • Eurotrol GAS-ISE Metabolites - Level 1 oda havası kontaminasyonuna çok duyarlıdır. Sıvıdan 30 saniye Fax 1-978-598-3780, Correo electrónico officeUSA@eurotrol.com, www.eurotrol.com 1. Μόνο για in vitro διαγνωστική χρήση. Eurotrol GAS-ISE Metabolites - Level 1 on veregaaside, elektrolüütide ja metaboliitide analüüsimise içinde örnek alırken hata tüm düzeylerin aralığı boyunca %2’nin altındadır*. Oda havasının pH üzerindeki 2. Τα προϊόντα αυτά δεν θα πρέπει να απορρίπτονται στα κοινά απόβλητα. Συμβουλευτείτε τις τοπικές Perangkat Medis Diagnostik In-Vitro Nomor referensi Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Países Bajos viitematerjal vereanalüüsisüsteemi epoc® Blood Analysis System täpsuse kontrollimiseks. Iga ampull sisaldab etkisi dikkate alınmayacak kadar küçüktür. περιβαλλοντικές αρχές σχετικά με την κατάλληλη απόρριψη. 2,5 ml lahust. Produsen Tanda CE *Rakamlar açık ampulle yapılan testleri temel alır. Símbolos utilizados Fecha de fabricación 3. Το Eurotrol GAS-ISE Metabolites δεν προορίζεται για χρήση ως βαθμονομητής. Atención: consulte las instrucciones de uso Código de lote Αναμενόμενες τιμές Reaktiivid Kontrollid Eurotrol GAS-ISE Metabolites - Level 1 on valmistatud sooladest füsioloogilises puhversüsteemis. Bu ürün Eurotrol spesifikasyonlarına göre üretilmiştir. OPC Leaflet Οι τιμές λαμβάνονται από μετρήσεις στο σύστημα epoc Blood Analysis System χρησιμοποιώντας τις κάρτες Lämmastiku ja eri soolakontsentratsioonidega tasakaalustatud eelmääratletud hapniku ning süsihappegaasi Daha fazla bilgi için lütfen irtibat kurun: Fecha de uso preferente Limitación de temperatura εξέτασης BGEM. Οι εκχωρημένες τιμές διατίθενται στη διαδικτυακή τοποθεσία http://www.epocal.com, σε tasemetega tonomeetria tagab igale parameetrile eri taseme, simuleerides happe-aluse ja elektrolüütide Eurotrol GAS-ISE Metabolites - Level 1 Eurotrol B.V., Hollanda, Telefon +31 318 695 777, Faks +31 318 695 770, Número de referencia μορφή πίνακα, για κάθε αριθμό παρτίδας υγρού και κάθε διαμόρφωση αισθητήρα. tasakaalu, hingamisfunktsiooni, neerufunktsiooni ning glükoosi ja laktaadi kontsentratsiooni kliiniliselt E-posta office@eurotrol.com, www.eurotrol.com Poducto sanitario de diagnóstico in vitro Το Eurotrol GAS-ISE Metabolytes προορίζεται για επαγγελματική χρήση κατά την επαλήθευση της απόδοσης olulisi vahemikke. Kontrollid Eurotrol GAS-ISE Metabolites - Level 1 ei sisalda säilitusaineid, viskoossuse 用途 Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Hollanda Fabricante Marca CE του οργάνου. regulaatoreid ega muid lisandeid, mis elektroodide mõõtmist häirida võiksid. Eurotrol GAS-ISE Metabolites - Level 1 は、epoc® Blood Analysis Systemの精度を検証するための、評価分析 Σημειώστε ότι Ladustamine ja stabiilsus 済みの血液ガス、電解質および代謝物標準物質です。Eurotrol GAS-ISE Metabolites - Level 1 は、以下の分析対 Kullanılan semboller Üretim tarihi • Οι τιμές στον πίνακα ισχύουν μόνο για τον εκχωρημένο αριθμό παρτίδας υγρού, την ισχύουσα διαμόρφωση Toodet Eurotrol GAS-ISE Metabolites - Level 1 võib ladustada temperatuuril 2–8 °C. Sellel temperatuuril 象の試験用に製造されました:pH、pO2、pCO2、Na+、K+、Ca++、Mg++、Cl-、 グルコース、乳酸塩、尿素、 クレアチ Dikkat, kullanma talimatına bakınız Parti kodu αισθητήρα του συστήματος epoc Blood Analysis System και στο επίπεδο της θάλασσας. avamata ladustamisel on toote stabiilsus garanteeritud kuni ampullidel ja välispakendil märgitud ニンおよびtCO2。 • Η λανθασμένη δειγματοληψία και φύλαξη ή άλλος κακός χειρισμός ενδέχεται να προκαλέσουν απόκλιση aegumiskuupäevani. Eurotrol GAS-ISE Metabolites - Level 1 on toatemperatuuril (avamata ampullides) Eurotrol GAS-ISE Metabolites - Level 1 は、校正、動作温度およびその他の性能特性の検証等の用途にも使用 Son kullanma tarihi Sıcaklık sınırlaması των μετρήσεων από τις τιμές-στόχους. されます。 Eurotrol GAS-ISE Metabolites - Level 1 • Οι τιμές pO2 του Eurotrol GAS-ISE Metabolites ποικίλλουν αντιστρεπτά με τις μεταβολές θερμοκρασίας. stabiilne 1 nädala. Pärast toatemperatuurini soojenemist ärge toodet enam külmutage! Pärast ampulli avamist on Eurotrol GAS-ISE Metabolites - Level 1 stabiilne 30 sekundit. IVD医療機器 İn Vitro Diagnostik Tıbbi Cihaz Referans numarası Για κάθε μεταβολή ενός °C σε θερμοκρασίες μεταξύ 18 °C και 26 °C, η τιμή pO2 μεταβάλλεται κατά 1,5% Üretici CE işareti Protseduurid Eurotrol GAS-ISE Metabolites - Level 1 は、医療機器に関するIVD指令98/79/ECに準拠しており、CEマークが貼 στο χαμηλό επίπεδο, κατά 1,1% στο φυσιολογικό επίπεδο και κατά 0,5% στο υψηλό επίπεδο. Για να ληφθεί 1. Võtke karbist ja aluselt sobiv kogus ampulle. Laske ampulli(de)l vähemalt 1 tunni jooksul tasakaalustada 付されています。 Domeniu de utilizare υψηλός βαθμός συσχέτισης με τις τιμές του πίνακα, οι αμπούλες θα πρέπει να εξισορροπηθούν (όσο το temperatuurile 22 °C võimalikult lähedale. Eurotrol GAS-ISE Metabolites - Level 1 は、in vitro診断専用です。 Eurotrol GAS-ISE Metabolites este un material de referinţă pentru gazele sanguine analizate, pentru electroliţi δυνατόν) πλησιέστερα στους 22 °C. 2. Vahetult enne kasutamist raputage ampulli jõuliselt vähemalt viisteist sekundit, et gaasid lahuses taas şi metaboliţi, conceput în scopul verificării preciziei şi acurateţei epoc® Blood Analysis System. Eurotrol GAS- ISE Metabolites a fost conceput pentru testarea următorilor analiţi: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, • Μετά το άνοιγμα της αμπούλας, η θερμοκρασία δωματίου δεν έχει σημαντική επίδραση στις τιμές pH. tasakaalustada. Raputamisel tuleb ampulli hoida pöidla ja nimetissõrme vahel. 概要 Eurotrol GAS-ISE Metabolites - Level 1 は、epoc® Blood Analysis Systemの精度を検証するための、評価分析済 Eurotrol GAS-ISE Metabolites - Level 1 • Το Eurotrol GAS-ISE Metabolites είναι ευαίσθητο στους περισσότερους από τους παράγοντες που glucoză, lactat, uree, creatinină şi tCO2. De asemenea, Eurotrol GAS-ISE Metabolites este conceput pentru 3. Keerutage ampulli ettevaatlikult, et lahus ampulli põhja tagasi viia. Enne ampulli avamist laske mullidel みの血液ガス、電解質および代謝物標準物質です。各アンプルには2.5 mLの溶液が含まれます。 σχετίζονται με το όργανο και μπορούν να προκαλέσουν μη αναμενόμενες αναλυτικές αποκλίσεις. verificarea calibrării, temperaturii de operare şi a altor caracteristici de performanţă. üles tõusta. 预期用途 • Τα υλικά ελέγχου Eurotrol GAS-ISE Metabolites δεν περιέχουν πρωτεΐνες και, συνεπώς, ενδέχεται να μην 4. Kaitske sõrmi marlilapi, paberräti või kinnaste abil. 試薬 Dispozitiv medical pentru diagnostic in vitro ανιχνεύουν δυσλειτουργίες που οφείλονται σε αυτά τα συστατικά. Eurotrol GAS-ISE Metabolites - Level 1 対照は、生理的緩衝液に食塩を加えて調製します。窒素およびさまざまな Eurotrol GAS-ISE Metabolites - Level 1 是一种已定量的血气、电解质和代谢物标准物质，用于验证 epoc® 5. Hoidke ampulli nii, et värviline täpp jääb üles suunatuks. Murdke ära ampulli kael värvilise täpi Blood Analysis System 的精确度和准确度。Eurotrol GAS-ISE Metabolites - Level 1 用于检测以下分析 Eurotrol GAS-ISE Metabolites respectă Directiva europeană IVD 98/79/EC privind dispozitivele medicale • Το Eurotrol GAS-ISE Metabolites είναι πολύ ευαίσθητο σε μόλυνση από τον ατμοσφαιρικό αέρα. vastaspoolelt. Üksikasju lugege OPC juhise brošüürist. 塩分濃度において平衡が維持される事前に規定された酸素および二酸化炭素レベルでの圧測定により、各パラ pentru diagnostic in vitro şi poartă marca CE. Κατά τη δειγματοληψία του υγρού εντός 30 δευτερολέπτων, το σφάλμα είναι μικρότερο από 2% σε メータに特有のレベルが提供され、酸塩基および電解質の平衡、呼吸機能、腎機能、 グルコースおよび乳酸塩濃 物：pH、pO2、pCO2、Na+、K+、Ca++、Mg++、Cl-、葡萄糖、乳酸、尿素、肌酐、tCO2。 6. Järgige 30 sekundi jooksul oma vereanalüüsisüsteemi epoc Blood Analysis System kasutusjuhendis Eurotrol GAS-ISE Metabolites - Level 1 还可用于验证校准、操作温度和其他性能特性。 Eurotrol GAS-ISE Metabolites se utilizează exclusiv pentru diagnostic in vitro. όλο το εύρος τιμών για όλα τα επίπεδα*. Η επίδραση του ατμοσφαιρικού αέρα στο pH είναι αμελητέα. kirjeldatud proovivõtuprotseduuri juhiseid. 度について、臨床上重要な範囲がシミュレートされます。Eurotrol GAS-ISE Metabolites - Level 1 対照には、防腐 *Οι αριθμοί βασίζονται σε εξέταση με ανοικτή αμπούλα. 7. Soovituslikku kasutussagedust lugege kohalikest suunistest. 剤、粘度調整剤または電解質の測定に悪影響を及ぼす可能性のあるその他の添加物は含まれません。 体外诊断医疗器械 Rezumat Eurotrol GAS-ISE Metabolites este un material de control al calităţii disponibil în cinci niveluri, fiecare având Αυτό το προϊόν παρασκευάστηκε σύμφωνα με τις προδιαγραφές Eurotrol. 保管および安定性 Eurotrol GAS-ISE Metabolites - Level 1 符合体外诊断医疗器械指令 98/79/EC 并带有 CE 标志。 Ettevaatusabinõud Eurotrol GAS-ISE Metabolites - Level 1 仅供体外诊断使用。 concentraţii cunoscute. 1. Ainult in vitro diagnostiliseks kasutuseks. Eurotrol GAS-ISE Metabolites - Level 1 は、2～8 ° C の温度で保管することができます。未開封の状態でこの温 Για περισσότερες πληροφορίες, επικοινωνήστε με: 2. Neid tooteid ei tohi kõrvaldada koos üld jäätmetega. Õige kõrvaldamise juhiseid küsige kohalikult 度で保管した場合、 アンプルおよび外箱に記載の有効期限まで表示通りの安定性が保証されます。Eurotrol GAS- 总结 Reactivi Eurotrol B.V. keskkonnaametilt. ISE Metabolites - Level 1 の安定性は、室温で1週間維持されます(アンプル未開封の場合)。一度室温にした製品 Eurotrol GAS-ISE Metabolites - Level 1 是一种已定量的血气、电解质和代谢物标准物质，用于验证 epoc® Eurotrol GAS-ISE Metabolites oferă niveluri cu relevanţă fiziologică, fiecare fiolă conţinând 2,5 ml soluţie. Ολλανδία, Αρ. τηλεφώνου: +31 318 695 777, Αρ. φαξ: +31 318 695 770 3. Eurotrol GAS-ISE Metabolites - Level 1 pole mõeldud kasutamiseks kalibraatorina. を冷蔵しないでください。 アンプルの開封後、Eurotrol GAS-ISE Metabolites - Level 1 の安定性は30秒間維持さ Blood Analysis System 的精确度和准确度。每安瓿含 2.5 mL 溶液。 Probele martor ale Eurotrol GAS-ISE Metabolites sunt preparate utilizând săruri într-o matrice tamponată Διεύθυνση ηλεκτρονικού ταχυδρομείου: office@eurotrol.com, www.eurotrol.com れます。 fiziologic. Tonometria cu niveluri prestabilite de oxigen şi dioxid de carbon echilibrate cu azot şi diferite Eeldatavad tulemused 试剂 concentraţii saline oferă cinci niveluri distincte pentru fiecare parametru, simulând intervalele cu semnificaţie Väärtused saadakse vereanalüüsisüsteemiga epoc Blood Analysis System BGEM-katsekaartide abil 手順 Eurotrol GAS-ISE Metabolites - Level 1 对照品是通过将盐加入生理缓冲基质中制备而成。预定水平的氧气 clinică ale echilibrului acid-bază şi electrolitic, funcţiei respiratorii, funcţiei renale, concentraţiei de glucoză şi Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Ολλανδία mõõtmisel. Määratud väärtused on saadaval veebisaidil http://www.epocal.com, kus on kõigi vedelikupartii 1. ボックスとトレイから適切な量のアンプルを取り出します。アンプルを少なくとも1時間以上、可能な限り22 ° C 和二氧化碳（与氮气平衡）含量以及不同的盐浓度使每个参数具有不同的水平，从而模拟有临床意义的酸碱与 de lactat. Probele martor ale Eurotrol GAS-ISE Metabolites nu conţin conservanţi, regulatori de viscozitate şi numbrite ja anduri konfiguratsioonide tabel. Eurotrol GAS-ISE Metabolites - Level 1 on mõeldud に近い温度に平衡化させます。 电解质平衡、呼吸功能、肾功能、葡萄糖和乳酸浓度范围。Eurotrol GAS-ISE Metabolites - Level 1 对照品 Σύμβολα που χρησιμοποιούνται nici alţi aditivi care ar putea afecta negativ măsurătorile electrozilor. Ημερομηνία κατασκευής professionaalseks kasutuseks instrumendi talitluse kontrollimisel. 2. 使用する直前に、アンプルを少なくとも15秒以上強く振り、溶液内のガスを再度平衡化させます。アンプルを振 不含防腐剂、粘度调节剂或其他对电极测量有不良影响的添加剂。 Προσοχή, δείτε τις οδηγίες χρήσης る際は、親指と人差し指で保持します。 Păstrare şi stabilitate Κωδικός παρτίδας 储存与稳定性 Pange tähele 3. アンプルをそっと回し、溶液をアンプルの底に戻します。泡があれば、アンプルを開封する前に浮かび上がら Eurotrol GAS-ISE Metabolites poate fi păstrat la o temperatură de 2-8 °C. Dacă produsul este păstrat fără a fi • Tabelis toodud väärtused rakenduvad ainult määratud vedelikupartii numbrile, rakenduvale Eurotrol GAS-ISE Metabolites - Level 1 可储存在 2–8 °C 下。以未开封状态储存在此温度下时，可保证本 Ημερομηνία λήξης Περιορισμός θερμοκρασίας せます。 deschis la această temperatură, se garantează stabilitatea conform indicaţiilor până la data expirării tipărită pe 品在安瓿和外包装盒上的到期日之前如标示的那样保持稳定。Eurotrol GAS-ISE Metabolites - Level 1 在 In Vitro διαγνωστικό ιατροτεχνολογικό προϊόν Κωδικός προϊόντος vereanalüüsisüsteemi epoc Blood Analysis System anduri konfiguratsioonile ja merepinna tasemel. 4. ガーゼ、ティシューまたは手袋で手を保護します。 fiole şi pe cutie. Eurotrol GAS-ISE Metabolites este stabil timp de 1 săptămână la temperatura camerei (fiole 室温下可稳定储存 1 周（安瓿未开封）。本品恢复至室温后不得再冷藏！打开安瓿后，Eurotrol GAS-ISE • Väära proovivõtu, ladustamise või muu väärkasutuse tagajärjel võivad lugemid sihtväärtustest erineda. 5. 色付きのドットを上に向けてアンプルを保持します。アンプルのネックを、色付きのドットと反対の方向に向かっ nedeschise). Nu refrigeraţi produsul după ce a fost adus la temperatura camerei! După deschiderea fiolei, • Toote Eurotrol GAS-ISE Metabolites - Level 1 pO2 väärtused muutuvad temperatuurimuutustega Metabolites - Level 1 只能稳定 30 秒 Κατασκευαστής Σήμανση CE て折ります。詳細については、OPC説明書リーフレットを参照してください。 Eurotrol GAS-ISE Metabolites este stabil timp de 30 secunde. pöördvõrdeliselt. Temperatuuri iga 1 °C muutus vahemikus 18–26 °C põhjustab pO2 muutuse madalal 6. 30秒以内に、epoc Blood Analysis Systemの取扱説明書の説明に従って、サンプリング手順を実行します。 程序 Proceduri tasemel 1,5%, tavapärasel tasemel 1,1% ja kõrgel tasemel 0,5%. Tabelis toodud väärtustega kõrge 7. 推奨使用頻度については、地域のガイドラインを参照してください。 1. 从包装盒和托盘中取出适量的安瓿。将安瓿静置至少 1 小时，使其温度尽量接近 22 °C 1. Scoateţi cantitatea adecvată de fiole din cutie şi tăviţă. Echilibraţi fiola (fiolele) timp de cel puţin 1 oră la o korrelatsiooni astme saavutamiseks tuleb ampullid tasakaalustada temperatuurile 22 °C võimalikult 2. 使用前，剧烈摇晃安瓿至少十五秒以使气体和溶液重新平衡。应使用拇指和食指拿着安瓿进行摇晃。 lähedale. 用法注意 temperatură cât mai apropiată posibil de 22°C. 3. 轻轻旋转安瓿以使溶液返回瓶底。打开安瓿之前先让所有气泡上升。 1. in vitro診断専用です。 2. Imediat înainte de utilizare, agitaţi puternic fiola timp de cel puţin cincisprezece secunde pentru a Eurotrol GAS-ISE Metabolites - Level 1 • Pärast ampulli avamist ei mõjuta toatemperatuur pH väärtusi olulisel määral. 2. これらの製品は一般廃棄物として廃棄しないでください。適切な廃棄方法については、地域の環境保護当局 4. 使用纱布、纸巾或手套保护手指。 reechilibra gazele cu soluţia. Când agitaţi fiola, trebuie să o ţineţi între degetul mare şi arătător. • Eurotrol GAS-ISE Metabolites - Level 1 on tundlik enamikule instrumendiga seotud teguritele, mis 5. 拿着安瓿，彩色点朝上。向彩色点的反方向掰断安瓿的瓶颈。更多详情请参阅 OPC 说明书。 ootamatuid analüütilisi kõrvalekaldeid tekitada võivad. にお問い合わせください。 3. Rotiţi uşor fiola pentru a readuce soluţia în partea inferioară a acesteia. Lăsaţi orice bule de aer să se 6. 在 30 秒内，按照 epoc Blood Analysis System 操作手册中的说明执行取样程序。 • Kontrollid Eurotrol GAS-ISE Metabolites - Level 1 ei sisalda valku ega pruugi seega tuvastada neile 3. Eurotrol GAS-ISE Metabolites - Level 1 は標準物質として使用しないでください。 ridice înainte de a deschide fiola. 용도 7. 请参见当地的指南以了解建议的使用频率。 4. Protejaţi-vă degetele cu un tifon, un şerveţel sau cu mănuşi. Eurotrol GAS-ISE Metabolites 는 검사된 혈액 가스, 전해질 및 대사 기준 물질로, epoc® Blood Analysis komponentidele tundlikke rikkeid. 予想される結果 注意事项 5. Ţineţi fiola cu punctul colorat orientat în sus. Rupeţi gâtul fiolei în direcţia opusă punctului colorat. System 의 정밀도와 정확도를 시험하는 데 사용됩니다. Eurotrol GAS-ISE Metabolites 는 다음 분석물을 • Eurotrol GAS-ISE Metabolites - Level 1 on toaõhu saastumisele väga tundlik. Kui vedelikust võetakse 値は、epoc Blood Analysis SystemでBGEMテストカードを使用した測定によって得られました。対応する値は、 1. 仅供体外诊断使用。 Citiţi prospectul cu instrucţiuni OPC pentru mai multe detalii. 시험하도록 설계되었습니다. pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, 포도당, 유산염, 요소, 크레아티닌 proov 30 sekundi jooksul, jääb viga kõigil tasemetel alla 2%*. Toaõhu mõju pH-le on mittearvestatav. 溶液ロット番号およびセンサー構成ごとに表形式にまとめられており、http://www.epocal.comから入手するこ 2. 这些产品不得弃置到一般废物中。请咨询当地的环保部门以了解如何正确弃置本品。 6. În interval de 30 secunde, urmaţi procedura de recoltare conform instrucţiunilor din manualul de utilizare 및 tCO2. Eurotrol GAS-ISE Metabolites 는 또한 교정, 작동 온도 및 기타 성능 특성을 확인하기 위한 용도로도 * Arvud põhinevad avatud ampullide katsetamisel. とができます。Eurotrol GAS-ISE Metabolites - Level 1 は、機器性能検証のために専門家が使用することを想定 3. Eurotrol GAS-ISE Metabolites - Level 1 不得用作校准品。 al epoc Blood Analysis System. 개발되었습니다. See toode on valmistatud Eurotrol spetsifikatsioonide järgi. しています。 7. Consultaţi îndrumările locale pentru frecvenţa de utilizare recomandată. 预期结果 IVD 의료기기 ご注意 在 epoc Blood Analysis System 上使用 BGEM 检测卡进行检测，从而得出检测值。赋值提供于 http:// Precauţii Eurotrol GAS-ISE Metabolites 는 체외 진단용 의료기기에 대한 유럽 IVD 지침 98/79/EC를 준수하며 CE Lisateabe saamiseks võtke ühendust. • 不適切なサンプリングまたは保管、あるいはその他の不適切な取り扱いは、読み取り値が目標値からずれる原 www.epocal.com，该网站以表格的形式显示每个试剂批号和每种传感器配置的赋值。Eurotrol GAS-ISE 1. Se utilizează exclusiv pentru diagnostic in vitro. 마크를 부착하고 있습니다. Eurotrol B.V., Holland, Tel +31 318 695 777, Faks +31 318 695 770, E-post office@eurotrol.com, 因となることがあります。 Metabolites - Level 1 供专业人士用于验证仪器性能。 2. Aceste produse nu trebuie evacuate pe calea deşeurilor menajere. Consultaţi autorităţile de mediu locale Eurotrol GAS-ISE Metabolites 는 다음의 미국연방규정집(CFR)을 준수합니다. 42 CFR 파트 72 및 21 CFR www.eurotrol.com • Eurotrol GAS-ISE Metabolites - Level 1 のpO2値は、温度変化と逆方向に変化します。18 ° C～26 °C の範囲で 179.001.010 pentru o evacuare corectă. 파트 606, 640, 820. 温度が1 ° C変化するごとに、pO2は低レベルで1.5%、標準で1.1%、高レベルで0.5%変化します。表に記載の値 Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Holland 3. Eurotrol GAS-ISE Metabolites nu trebuie utilizat drept calibrator. Eurotrol GAS-ISE Metabolites 는 체외 진단용으로만 사용해야 합니다. と高い相関を得るには、 アンプルを可能な限り22 ° C に近い温度に平衡化させる必要があります。 MSP100976 Rev.2.0 20170626 Instructions for Use - Level 1 (1.4 MB)
- 2. Voorkom dat deze producten in het algemene afvalcircuit terecht komen. Volg de ter plaatse geldende Sammanfattning Symboler som brukes Forholdsregler range clinicamente significativi di equilibrio acido-base ed elettrolitico, funzione respiratoria, funzione renale, regels voor verantwoorde afvalverwerking. Eurotrol GAS-ISE Metabolites är ett kvalitetskontrollmaterial i fem olika nivåer, var och en med kända 1. Kun til in vitro diagnostisk brug. concentrazione di glucosio e di lattato. I controlli Eurotrol GAS-ISE Metabolites non contengono conservanti, 3. Eurotrol GAS-ISE dient niet gebruikt te worden voor kalibratiedoeleinden. koncentrationer Obs! Se bruksanvisningen Batch-kode 2. Disse produkter skal bortskaffes i det almindelige affald. Rådfør dig med de lokale miljømyndigheder correttori di viscosità, né altri additivi in grado di compromettere la misurazione degli elettrodi. Temperaturgrense vedrørende korrekt afskaffelse. Verwachte resultaten Reagens Brukes innen Conservazione e stabilità Toegekende waarden zijn verkregen door middel van metingen op het epoc Blood Analysis System met Eurotrol GAS-ISE Metabolites ger fysiologiskt relevanta nivåer och levereras i ampuller om 2,5 mL lösning. 3. Eurotrol GAS-ISE Metabolites må ikke anvendes som en kalibrator. Eurotrol GAS-ISE Metabolites può essere conservato a una temperatura di 2-8 °C. Conservato in confezione Medisinsk utstyr til in vitro-diagnostikk Referansenummer gebruikmaking van BGEM test cards. De toegekende waarden zijn beschikbaar in tabelvorm en gerangschikt Eurotrol GAS-ISE Metabolites-kontrollerna framställs genom upplösning av olika salter i en fysiologiskt buffrad Forventede resultater integra alla suddetta temperatura il prodotto resta stabile fino alla data di scadenza indicata sulle fiale e sulla naar lotnummer en sensorconfiguratie via http://www.epocal.com. matris. Tonometri med i förväg fastställda nivåer av syrgas och koldioxid balanserade med kväve och olika Produsent CE-merke Værdierne opnås ved målinger på epoc Blood Analysis System ved hjælp af BGEM testkortene. De tildelte confezione esterna. A temperatura ambiente Eurotrol GAS-ISE Metabolites rimane stabile per 1 settimana Eurotrol GAS-ISE Metabolites is een kwaliteitscontrolemateriaal voor professioneel gebruik bij het saltkoncentrationer ger fem distinkta nivåer för varje parameter, som simulerar de kliniskt relevanta områdena værdier er tilgængelige fra http://www.epocal.com, der viser hvert væskelotnummer og sensorkonfiguration (fiale sigillate). Una volta portato il prodotto a temperatura ambiente, non refrigerare! Una volta aperta la fiala controleren van de precisie en nauwkeurigheid van het epoc Blood Analysis System. för syrabas- och elektrolytbalans, respiratorisk funktion, njurfunktion, glukos- och laktatkoncentration. i tabelform. Eurotrol GAS-ISE Metabolites rimane stabile per 30 secondi. Eurotrol GAS-ISE Metabolites-kontrollerna innehåller inga konserveringsmedel, viskositetsreglerande medel Eurotrol GAS-ISE Metabolytes er beregnet til professionel brug til verifikation af instrumentydeevne. Let op Procedure eller andra tillsatser som skulle kunna påverka elektrodmätningarna på ett negativt sätt. GAS-ISE Metabolites - Level 2 • De waarden in de tabel zijn alleen toepasbaar voor het aangegeven lotnummer en op zeeniveau en 1. Rimuovere il numero necessario di fiale dalla scatola e dalla vaschetta. Lasciar stabilizzare la/e fiala/e per gelden alleen voor de aangegeven epoc Blood Analysis System sensorconfiguratie. Förvaring och stabilitet Eurotrol GAS-ISE Metabolites - Level 2 Bemærk • Værdierne i tabellen gælder kun for det tildelte væskelotnummer, den relevante epoc Blood Analysis un minimo di 1 ora alla temperatura più prossima possibile ai 22 °C. • Onjuiste bemonstering, bewaarcondities of elke andere wijze van foutieve behandeling kunnen Eurotrol GAS-ISE Metabolites kan förvaras vid 2–8 °C. När kontrollen förvaras oöppnad vid denna temperatur System sensorkonfiguration og i niveau med havets overflade. 2. Subito prima dell’uso, agitare la fiala energicamente per almeno quindici secondi per riequilibrare i gas meetwaarden geven die afwijken van de doelwaarden. garanteras stabiliteten fram till det utgångsdatum som anges på ampullerna och på ytterkartongen. Eurotrol • Forkert prøvetagning, opbevaring eller anden forkert håndtering kan forårsage, at aflæsningerne afviger con la soluzione. Agitare tenendo la fiala tra il pollice e l’indice. Indication • De pO2 waarden van Eurotrol GAS-ISE Metabolites variëren omgekeerd evenredig met GAS-ISE Metabolites är stabilt i 1 vecka vid rumstemperatur (oöppnade ampuller). Produkten får inte kylas fra målværdierne. 3. Far ruotare la fiala delicatamente in modo da depositare di nuovo la soluzione sul fondo del contenitore. Eurotrol GAS-ISE Metabolites est un matériel de référence étalonné pour le dosage des gaz, électrolytes temperatuurveranderingen. Voor elke °C verandering in temperatuur tussen 18 °C en 26 °C, verandert på nytt efter att den har antagit rumstemperatur! Efter att ampullen öppnats är Eurotrol GAS-ISE Metabolites • pO2-værdierne i Eurotrol GAS-ISE Metabolites varierer i omvendt forhold til temperaturændringer. For Prima di aprire la fiala, lasciar affiorare tutte le bolle. et métabolites sanguins destiné à contrôler la précision et l’exactitude de l’analyseur epoc® Blood Analysis de pO2 1,5% bij fysiologisch lage pO2waarden, 1,1% bij fysiologisch normale pO2 waarden en 0,5% bij stabilt i 30 sekunder. hver °C-temperaturændring mellem 18 og 26 °C ændres pO2 1,5 % i det lave niveau, 1,1 % i det normale 4. Proteggere le dita con una garza, una salvietta o dei guanti. System. Eurotrol GAS-ISE Metabolites est destiné à tester les analytes suivants : pH, pO2, pCO2, Na+, K+, Eurotrol GAS-ISE Metabolites - Level 2 fysiologisch hoge pO2 waarden. Om een grote graad van correllatie te verkrijgen met de waarden in de tabel, moeten de ampullen zo dicht mogelijk bij 22 °C geëquilibreerd worden. Anvisningar Ca++, Mg++*, Cl-*, glucose, lactate, urée*, créatinine* et tCO2. Eurotrol GAS-ISE Metabolites est également niveau og 0,5 % i det høje niveau. For at opnå en høj grad af korrelation med værdierne i tabellen skal ampullerne ækvilibreres så tæt på 22 °C som muligt. 5. Tenere la fiala con il pallino colorato rivolto verso l’alto. Staccare il collo della fiala nella direzione opposta a quella del pallino colorato. Per ulteriori dettagli, leggere il foglio illustrativo sul sistema 1. Ta fram lämpligt antal ampuller ur lådan och tråget. Låt ampullen/ampullerna jämviktas under minst conçu pour contrôler l’étalonnage, la température de fonctionnement et les autres caractéristiques de • Na openen heeft de temperatuur geen significante invloed op de pH waarde. 1 timme till en temperatur så nära 22 °C som möjligt. • Når ampullen først er åbnet, har stuetemperaturen ingen signifikant indvirkning på pH-værdierne. di prerottura (OPC [la fiala si rompe in un solo punto]). Intended Purpose performances. • Eurotrol GAS-ISE Metabolites is gevoelig voor de meeste instrumentgerelateerde factoren die 2. Skaka ampullen kraftigt omedelbart före användning under minst 15 sekunder för att jämvikta gaserna • Eurotrol GAS-ISE Metabolites er følsom over for de fleste af de instrumentrelaterede faktorer, der kan 6. Eseguire la procedura di campionamento entro 30 secondi seguendo le istruzioni del manuale operativo Eurotrol GAS-ISE Metabolites - Level 2 is an assayed blood gas, electrolyte and metabolite reference *Cl-, urée, créatinine et Mg++ ne sont pas disponibles au Canada. onverwachte analytische afwijkingen kunnen veroorzaken. forårsage uventede analytiske afvigelser. dell’epoc Blood Analysis System. material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE med lösningen. Håll ampullen mellan tummen och pekfingret när du skakar den. • Eurotrol GAS-ISE Metabolites controles bevatten geen eiwit en kunnen daarom geen afwijkingen Dispositif médical de diagnostic in vitro • Eurotrol GAS-ISE Metabolites kontroller indeholder ikke protein og detekterer muligvis derfor ikke fejl i 7. Per quanto riguarda la frequenza d’uso raccomandata, fare riferimento alle linee guida locali. Metabolites - Level 2 was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++*, Cl- 3. Snurra ampullen försiktigt så att all lösning sjunker till ampullens botten. Låt eventuella bubblor stiga upp aantonen die gerelateerd zijn aan deze component(en). Eurotrol GAS-ISE Metabolites est conforme à la directive européenne 98/79/CE relative aux dispositifs funktioner, der er følsomme over for disse komponenter. *, Glucose, Lactate, Urea*, Creatinine* and tCO . Eurotrol GAS-ISE Metabolites - Level 2 is also developed innan du öppnar ampullen. Precauzioni 2 • Eurotrol GAS-ISE Metabolites is zeer gevoelig voor contaminatie met lucht. Wanneer de vloeistof binnen 4. Skydda fingrarna med gasväv, pappershandduk eller handskar. médicaux de diagnostic in vitro et porte le label CE. Pour les Etats-Unis, Eurotrol GAS-ISE Metabolites est • Eurotrol GAS-ISE Metabolites er meget følsomme over for kontamineret rumluft. Ved prøvetagning med 1. Esclusivamente per uso diagnostico in vitro. to verify calibration, operating temperature and other performance characteristics. 30 seconden wordt bemonsterd, dan is de fout minder dan 2% over het gehele gebied in alle niveaus*. De conforme aux codes de réglementations fédérales (CFR) suivants : 42 CFR partie 72 et 21 CFR parties 606, væsken inden for 30 sekunder er fejlen under 2 % over hele området på alle niveauer*. Rumluftens *Cl-, Urea, Creatinine and Mg++ are not available in Canada 5. Håll ampullen med den färgade pricken uppåt. Bryt av halsen på ampullen i motsatt riktning mot 2. Il prodotto non deve essere smaltito nei rifiuti ordinari. Per un corretto smaltimento, consultare le autorità invloed van lucht op de pH is te verwaarlozen. 640 et 820. Eurotrol GAS-ISE Metabolites est exclusivement réservé à des applications de diagnostic in vitro. indvirkning på pH er ubetydelig. den färgade pricken. Läs bladet med OPC-anvisningar för mer information. ambientali locali. IVD Medical Device *Deze getallen zijn gebaseerd op het testen van geopende ampullen. Résumé *Tallene er baseret på prøvetagning med åbne ampuller. 6. Följ inom 30 sekunder provtagningsanvisningarna i drifthandboken till epoc Blood Analysis System. 3. Eurotrol GAS-ISE Metabolites non deve essere utilizzato come calibratore. Eurotrol GAS-ISE Metabolites - Level 2 complies with the IVD Directive 98/79/EC for Medical Devices and Dit product is vervaardigd volgens de specificaties van Eurotrol. 7. Se lokala rekommendationer för hur ofta kontrollmaterial skall analyseras. Eurotrol GAS-ISE Metabolites est un matériel de contrôle de qualité disponible à cinq niveaux ayant chacun Dette produkt er blevet fremstillet i overensstemmelse med Eurotrol specifikationer. carries the CE mark. Risultati previsti une concentration connue. Eurotrol GAS-ISE Metabolites - Level 2 complies with the following US codes of Federal Regulations (CFR): Neem voor informatie contact op met: Försiktighetsåtgärder For at få yderligere oplysninger kontaktes: I valori si ottengono mediante misurazione con epoc Blood Analysis System e con schede di analisi BGEM. Eurotrol B.V., Nederland, Telefoon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, 1. Endast för in vitro-diagnostiskt bruk. Réactifs I valori assegnati sono disponibili sul sito http://www.epocal.com, e sono suddivisi in tabelle, distinte per 42 CFR part 72 and 21 CFR parts 606, 640 and 820. Eurotrol B.V., Holland, Telefon +31 318 695 777, Fax +31 318 695 770, E-Mail office@eurotrol.com, Eurotrol GAS-ISE Metabolites - Level 2 is for in vitro diagnostic use only. www.eurotrol.com 2. Dessa produkter får ej läggas bland vanligt brännbart avfall. Kontakta lokala miljömyndigheter för Eurotrol GAS-ISE Metabolites fournit des concentrations significatives sur le plan physiologique ; chaque www.eurotrol.com numero di lotto di liquido e configurazione del sensore. anvisningar för korrekt avfallshantering. ampoule contient 2.5 ml de solution. Les contrôles Eurotrol GAS-ISE Metabolites sont préparés au moyen Eurotrol GAS-ISE Metabolites è un dispositivo per uso professionale per la verifica delle prestazioni Summary Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland 3. Eurotrol GAS-ISE Metabolites får ej användas som kalibreringslösning. de sels dissous dans une matrice tamponnée à pH physiologique. La tonométrie avec des concentrations Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Holland dell’analizzatore. Eurotrol GAS-ISE Metabolites - Level 2 is an assayed blood gas, electrolyte and metabolite reference prédéfinies d’oxygène et de dioxyde de carbone équilibrées avec de l’azote et différentes concentrations de material, to verify the precision and accuracy of the epoc® Blood Analysis System. Each ampule contains Gebruikte symbolen Förväntade resultat N.B. m sels fournit pour chaque paramètre cinq niveaux distincts qui simulent des plages de valeurs cliniquement Anvendte symboler m 2.5 mL solution. Resultaten erhålls genom mätningar på epoc Blood Analysis System med användning av BGEM-testkort. • I valori indicati nella tabella sono applicabili esclusivamente al numero di lotto assegnato al liquido, alla significatives d’équilibre acido-basique et électrolytique, de la fonction respiratoire, de la fonction rénale et Opgelet, lees de gebruiksaanwijzing Lotnummer De nominella värdena återfinns på http://www.epocal.com, tabellerade för varje enskild batch av produkten Bemærk, se brugsanvisning Batchkode configurazione del sensore epoc Blood Analysis System applicata e al livello del mare. Reagents des concentrations en glucose et en lactate. Les contrôles Eurotrol GAS-ISE Metabolites ne contiennent Bewaartemperatuur och varje sensorkonfiguration. • Qualora il campionamento, la conservazione o la manipolazione non avvengano correttamente, i risultati Eurotrol GAS-ISE Metabolites - Level 2 controls are prepared using salts in a physiologically buffered matrix. Te gebruiken voor ni conservateurs, ni modificateurs de viscosité, ni aucun autre additif susceptible d’affecter les mesures Anvendes inden Temperaturgrænse Eurotrol GAS-ISE Metabolites är avsett för professionellt bruk för verifiering av instrumentprestanda. potrebbero deviare dai valori target. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt réalisées avec l’électrode. In Vitro Diagnostisch Medisch Hulpmiddel Referentienummer OBS! In vitro diagnostisk medicinsk udstyr Referencenummer • I valori della pO2 di Eurotrol GAS-ISE Metabolites variano inversamente alle variazioni di temperatura. concentrations provide a distinct level for each parameter, simulating clinically significant ranges of acid-base Conservation et stabilité Per ogni grado Celsius di variazione della temperatura tra 18 °C e 26 °C, la pO2 varia dell’1.5% per il and electrolyte balance, respiratory function, renal function, glucose and lactate concentration. Eurotrol GAS- Producent CE-merkteken • Värdena i tabellen gäller endast för den angivna produktbatchen, tillämplig epoc Blood Analysis System Fabrikant CE mærke Eurotrol GAS-ISE Metabolites peut être conservé à une température comprise entre 2 et 8 °C (35 - 46 livello basso, dell’1.1% per il livello normale e dello 0.5% per il livello alto. Per ottenere un grado elevato ISE Metabolites - Level 2 controls contains no preservatives, viscosity adjusters or other additives that might sensorkonfiguration och på en höjd av noll meter över havet. °F). Si le produit est conservé non ouvert à cette température, sa stabilité est garantie jusqu’à la date de di correlazione con i valori della tabella, le fiale devono essere stabilizzate alla temperatura più vicina adversely effect electrode measurements. • Felaktig provtagning eller förvaring eller annan felaktig hantering kan göra att de avlästa resultaten avviker péremption indiquée sur les ampoules et sur la boîte. Eurotrol GAS-ISE Metabolites est stable pendant une possibile ai 22 °C. från målvärdena. Storage and Stability • pO2-värdena för Eurotrol GAS-ISE Metabolites varierar omvänt mot temperaturen. För varje °C som semaine à température ambiante (ampoules non ouvertes). Ne pas réfrigérer à nouveau le produit après • Una volta aperta la fiala, la temperatura ambiente non produce effetti significativi sui valori del pH. Eurotrol GAS-ISE Metabolites - Level 2 can be stored at a temperature of 2–8 °C (35-46 °F). Stored unopened at this temperature it is guaranteed stable as indicated until the expiry date on the ampules and Eurotrol GAS-ISE Metabolites - Level 2 temperaturen förändras inom området 18–26 °C förändras pO2 1,5 % på den låga nivån, 1,1 % på den qu’il ait été amené à température ambiante ! Après ouverture de l’ampoule, Eurotrol GAS-ISE Metabolites est stable pendant 30 secondes. Eurotrol GAS-ISE Metabolites - Level 2 • Eurotrol GAS-ISE Metabolites è sensibile a numerosi fattori correlati all’analizzatore che possono alterare in maniera imprevista i risultati delle analisi. normala nivån och 0,5 % på den höga nivån. För att få bästa möjliga korrelation med värdena i tabellen outer box. Eurotrol GAS-ISE Metabolites - Level 2 is stable for 1 week at room temperature (unopened skall ampullerna jämviktas till en temperatur så nära 22 °C som möjligt. Procédures • Poiché i controlli Eurotrol GAS-ISE Metabolites non contengono proteine, essi non sono in grado di ampules). Do not refrigerate the product after it has been brought to room temperature! After opening the Verwendungszweck 1. Sortir le nombre requis d’ampoules de la boîte et du plateau.Laisser la ou les ampoules s’équilibrer à Käyttötarkoitus rilevare malfunzionamenti sensibili a tali componenti. • När ampullen har öppnats har rumstemperaturen ingen signifikant inverkan på pH-värdena. ampule, Eurotrol GAS-ISE Metabolites - Level 2 is stable for 30 seconds. Bei Eurotrol GAS-ISE Metabolites handelt es sich um geprüftes Blutgas-, Elektrolyt- und Metabolit- • Eurotrol GAS-ISE Metabolites är känsligt för de flesta instrumentrelaterade faktorer som kan leda till une température de 15 à 30 °C. Eurotrol GAS-ISE Metabolites on analysoitu verikaasu-, elektrolyytti- ja metaboliittiviitemateriaali epoc® • Eurotrol GAS-ISE Metabolites è molto sensibile alla contaminazione dell’aria ambiente. Campionando i Referenzmaterial für die Verifizierung der Präzision und Exaktheit des epoc® Blood Analysis System. 2. Immédiatement avant l’emploi, agiter vigoureusement l’ampoule pendant au moins quinze secondes pour Blood Analysis Systemin täsmällisyyden ja tarkkuuden varmistamiseen. Eurotrol GAS-ISE Metabolites liquidi entro 30 secondi, l’errore corrisponde a meno del 2% sull’intera gamma per tutti i livelli*. L’effetto Procedures oväntade analysavvikelser. Eurotrol GAS-ISE Metabolites wurde für die Testung der folgenden Analyten entwickelt: pH, pO2, pCO2, Na+, on suunniteltu seuraavien analyyttien testaamiseen: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, dell’aria ambiente sul pH è trascurabile. 1. Remove the appropriate amount of ampules from box and tray. Equilibrate the ampule(s) for a minimum • Eurotrol GAS-ISE Metabolites-kontrollerna innehåller inga proteiner och påvisar därför eventuellt inte rééquilibrer les gaz avec la solution. Agiter l’ampoule en la tenant entre le pouce et l’index. K+, Ca++, Mg++, Cl-, Glucose, Lactat, Harnstoff, Kreatinin und tCO2. Eurotrol GAS-ISE Metabolites dient 3. Faire tourner délicatement l’ampoule pour ramener la solution au fond de celle-ci. Laisser remonter les glukoosi, laktaatti, urea, kreatiniini ja tCO2. Eurotrol GAS-ISE Metabolites on kehitetty myös kalibroinnin, of 1 hour to a temperature as close to 22 °C (71.6 °F) as possible. felfunktioner som är känsliga för dessa komponenter. außerdem der Verifizierung von Kalibrierungen, Betriebstemperaturen und anderen Leistungsmerkmalen. työskentelylämpötilan ja muiden suoritusominaisuuksien varmistamiseen. 2. Immediately before use, shake the ampule vigorously for at least fifteen seconds to re-equilibrate the • Eurotrol GAS-ISE Metabolites är mycket känsligt för kontaminering med rumsluft. Vid provtagning från bulles avant d’ouvrir l’ampoule. Q gases with the solution. When shaking, the ampule should be held between the thumb and index finger. Medizinisches Gerät für die In-vitro-Diagnostik vätskan inom 30 sekunder är felet mindre än 2 % för alla analyter och alla nivåer*. Effekten av rumsluft 4. Se protéger doigts avec de la gaze, un morceau de tissu ou des gants. IVD-lääkintälaite Eurotrol GAS-ISE Metabolites erfüllt die Vorgaben der EU-Richtlinie 98/79/EC über medizinische Geräte für 5. Maintenir l’ampoule avec le point coloré orienté vers le haut. Casser le col de l’ampoule dans la direction m 3. Swirl the ampule gently to return the solution to the bottom of the ampule. Allow any bubbles to rise på pH-värdet är försumbar. Eurotrol GAS-ISE Metabolites on Euroopan IVD-direktiivin 98/79/EC mukainen diagnostinen in vitro die In-vitro-Diagnostik und wurde mit dem CE-Zeichen ausgestattet. Eurotrol GAS-ISE Metabolites darf nur *Värdena baseras på testning med öppen ampull. opposée au point coloré. Consulter le mode d’emploi de l’OPC (ampoule autocassable) pour plus de O M @ m before opening the ampule. -lääkintälaite, jolla on CE-merkintä. für die In-vitro-Diagnostik verwendet werden. détails m 4. Protect fingers with gauze, tissue or gloves. Produkten har framställts i enlighet med Eurotrols specifikationer. Eurotrol GAS-ISE Metabolites on tarkoitettu vain diagnostiseen in vitro -käyttöön. 6. Procéder au prélèvement de l’échantillon conformément aux instructions figurant dans le mode d’emploi m 5. Hold ampule with the colored dot facing up. Snap off the neck of the ampule in the opposite Zusammenfassung de l’analyseur epoc Blood Analysis System. Yhteenveto m @ m m direction of the colored dot. Please read the OPC instruction leaflet for more details. Bei Eurotrol GAS-ISE Metabolites handelt es sich um Lösungen zur Qualitätskontrolle mit fünf festgelegten För ytterligare information ber vi er kontakta: 7. Se référer aux directives locales pour connaître la fréquence d’utilisation recommandée. Eurotrol GAS-ISE Metabolites on laatukontrollimateriaali, jota on saatavana viitenä tasona, joista kullakin 6. Within 30 seconds, follow the sampling procedure according to the instructions in the operating manual Konzentrationsbereichen. Eurotrol B.V. on tunnettu konsentraatio. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Olanda of your epoc Blood Analysis System. Nederländerna, Tel. +31 318 695 777, Fax +31 318 695 770, E-post office@eurotrol.com, Précautions 7. Please refer to local guidelines for recommended frequency of use. Reagenzien Reagenssit www.eurotrol.com 1. Exclusivement pour usage diagnostic in vitro. Eurotrol GAS-ISE Metabolites ist für physiologisch relevante Konzentrationsbereiche erhältlich. Jede Ampulle Eurotrol GAS-ISE Metabolites tarjoaa fysiologisesti olennaisia tasoja, ja kukin ampulli sisältää 2,5 ml Simboli Precautions 2. Ne pas éliminer ces produits avec les ordures ménagères. Consulter les autorités locales responsables enthält 2,5 ml Lösung. Die Kontrolllösungen Eurotrol GAS-ISE Metabolites werden auf der Grundlage von liuosta. Eurotrol GAS-ISE Metabolites -kontrollit valmistetaan käyttäen suoloja fysiologisesti puskuroidussa 1. For in vitro diagnostic use only. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederländerna de l’environnement pour connaître la manière de les éliminer. Attenzione, consultare le istruzioni per l’uso Numero di lotto Salzen in physiologischer Puffermatrix hergestellt. Festgelegte Sauerstoff- und Kohlendioxidkonzentrationen, matriisissa. Tonometria ennalta määritellyillä happi- ja hiilidioksiditasoilla tasapainotettuna typellä ja eri 2. These products should not be disposed of in general waste. Consult local environmental authorities for 3. Eurotrol GAS-ISE Metabolites n’est pas destiné à être utilisé comme calibrateur. ins Gleichgewicht gebracht mit Stickstoff und Salzen in verschiedenen Konzentrationen, erlauben eine Symbolförklaring suolapitoisuuksilla tarjoaa viisi erillistä tasoa kullekin parametrille ja simuloi kliinisesti merkitseviä happo-emäs- Utilizzare entro Limiti di temperatura proper disposal. m Tonometrie in fünf einzelnen Konzentrationsbereichen für jeden Parameter. Simuliert werden klinisch Résultats attendus ja elektrolyyttitasapainon, hengitystoiminnan, munuaisten toiminnan, glukoosi- ja laktaattikonsentraatioiden 3. Eurotrol GAS-ISE Metabolites - Level 2 is not to be used as a calibrator. signifikante Bereiche für Säure-Basen- und Elektrolythaushalt, Atemfunktion, Nierenfunktion sowie Obs! Se bruksanvisningen Batchnummer Les valeurs sont obtenues par le biais de mesures effectuées sur l’analyseur epoc Blood Analysis Dispositivo medico-diagnostico in vitro Numero di riferimento alueita. Eurotrol GAS-ISE Metabolites -kontrollit eivät sisällä säilöntäaineita, viskositeetinsäätöaineita tai Expected Results Glucose- und Lactatkonzentration. Die Kontrolllösungen Eurotrol GAS-ISE Metabolites enthalten keine System en utilisant les cartes de test BGEM. Les valeurs assignées sont disponibles à l’adresse muita lisäaineita, jotka voisivat vaikuttaa haitallisesti elektrodimittauksiin. Utgångsdatum Temperatur begränsning Produttore Marchio CE Values are obtained by measurements on epoc Blood Analysis System using BGEM test cards. The Konservierungsmittel, Mittel zur Einstellung der Viskosität oder andere Zusatzstoffe, die einen negativen http://www.epocal.com, présentées pour chaque numéro de lot de liquide et chaque configuration de capteur. Medicinteknisk produkt för in vitro-diagnostik Katalognummer Eurotrol GAS-ISE Metabolites est destiné à un usage professionnel pour le contrôle des performances de Varastointi ja stabiilius assigned values are available from http://www.epocal.com, tabulated for each fluid lot number and sensor Einfluss auf die Elektrodenmessungen haben könnten. l’instrument. Eurotrol GAS-ISE Metabolites -kontrolleja voidaan säilyttää lämpötilassa 2–8 °C. Kun tuotetta säilytetään configuration. Eurotrol GAS-ISE Metabolites - Level 2 is intended for professional use in the verification of Lagerung und Haltbarkeit Tillverkare CE-märkning avaamattomana tässä lämpötilassa, taataan sen stabiilius ampulleissa ja ulkopakkauksessa ilmoitettuun the instrument performance. Eurotrol GAS-ISE Metabolites kann bei einer Temperatur zwischen 2 und 8 °C gelagert werden. Bei einer Remarques viimeiseen käyttöpäivään asti. Eurotrol GAS-ISE Metabolites on stabiili 1 viikon ajan huoneenlämmössä Lagerung der ungeöffneten Ampullen in diesem Temperaturbereich wird die angegebene Stabilität der • Les valeurs figurant dans le tableau sont uniquement applicables au numéro de lot de liquide Please Note • The values in the table are applicable only to the assigned fluid lot number, the applicable epoc Blood Lösungen bis zum auf den Ampullen und der Umverpackung angegebenen Verfallsdatum garantiert. Bei correspondant, à la configuration de capteur de l’analyseur epoc Blood Analysis System correspondante (avaamattomat ampullit). Tuotetta ei saa laittaa jääkaappiin sen jälkeen kun se on tuotu huoneenlämpöön! Ampullin avaamisen jälkeen Eurotrol GAS-ISE Metabolites on stabiili 30 sekunnin ajan. Eu o o GAS SE Me abo es Leve 2 Analysis System sensor configuration and at sea level. Raumtemperatur ist Eurotrol GAS-ISE Metabolites eine Woche lang stabil (ungeöffnete Ampullen). Nach dem et au niveau de la mer. • Un prélèvement incorrect, une conservation inadéquate ou toute autre erreur de manipulation risquent Käyttö • Incorrect sampling, storage, or other mishandling may cause the readings to deviate from the target Erreichen der Raumtemperatur darf die Lösung nicht mehr gekühlt werden! Nach dem Öffnung der Ampullen ist Eurotrol GAS-ISE Metabolites dreißig Sekunden lang stabil. d’avoir pour conséquence un écart entre les mesures obtenues et les valeurs cibles. 1. Ota sopiva määrä ampulleja laatikosta ja tarjottimelta. Tasapainota ampullia (ampulleja) vähintään 1 values. • Les valeurs de pO2 d’Eurotrol GAS-ISE Metabolites varient en fonction inverse des variations de tunnin ajan mahdollisimman lähelle lämpötilaa 22 °C. O G M m m • The pO2 values of Eurotrol GAS-ISE Metabolites - Level 2 vary inversely with temperature changes. For each °C change in temperatures between 18 °C and 26 °C (between 64.5 °F and 79 °F), the Anweisungen für die Verwendung des Produkts 1. Erforderliche Anzahl an Ampullen aus der Packung entnehmen. Ampulle(n) mindestens eine Stunde lang Eurotrol GAS-ISE Metabolites - Level 2 température. Pour chaque variation de 1 °C de la température entre 18 et 26 °C (64.5 - 79 °F), la valeur 2. Ravistelle ampullia juuri ennen käyttöä voimakkaasti vähintään viidentoista sekunnin ajan, jotta kaasut tasapainottuvat uudelleen liuoksen kanssa. Ravisteltaessa ampullia tulisi pitää peukalon ja etusormen m m O G pO2 changes 1.5% in the low level, 1.1% in the normal and 0.5% in the high level. To obtain a high de pO2 change de 1.5% pour le niveau bas, de 1.1% pour le niveau normal et de 0.5% pour le niveau M m O O M bei einer Temperatur äquilibrieren, die möglichst exakt bei 22 °C liegen sollte. välissä. degree of correlation with the values in the table, the ampules should be equilibrated as close to 22 °C élevé. Pour obtenir un haut degré de corrélation avec les valeurs du tableau, les ampoules doivent être O O G M m m 2. Unmittelbar vor der Verwendung Ampulle(n) mindestens fünfzehn Sekunden lang kräftig schütteln, um Tiltenkt formål 3. Pyörittele ampullia varoen, jotta liuos palaa ampullin pohjalle. Anna mahdollisten kuplien nousta ylös (71.6 °F) as possible. équilibrées à une température aussi proche que possible de 22 °C (71.6°F). m m m die Gase ausreichend mit der Lösung zu vermischen. Zum Schütteln, Ampulle(n) zwischen Daumen und Eurotrol GAS-ISE Metabolites er referansemateriale for analyse av blodgass, elektrolytter og metabolitter, ennen ampullin avaamista. • Once the ampule is opened, room temperature has no significant effect on pH values. • Après ouverture de l’ampoule, la température ambiante n’a plus d’effet significatif sur les valeurs du pH. M Zeigefinger halten. og brukes til å verifisere presisjonen og nøyaktigheten til epoc® Blood Analysis System. Eurotrol GAS-ISE 4. Sormet on suojattava sideharsolla, paperiliinalla tai käsineillä. • Eurotrol GAS-ISE Metabolites - Level 2 is sensitive to most of the instrument related factors that can cause • Eurotrol GAS-ISE Metabolites est sensible à la plupart des facteurs liés à l’instrument susceptibles de O G M m 3. Ampulle(n) vorsichtig schwenken, damit sich die Lösung wieder am Boden der Ampulle(n) absetzt. Metabolites er utviklet for å teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glukose, 5. Pidä ampullia niin, että värillinen täplä on ylöspäin. Katkaise ampullin kaula värillisen täplän unexpected analytical deviations. produire des écarts analytiques inattendus. m m Ampulle(n) erst öffnen, nachdem eventuell vorhandene Bläschen an die Oberfläche gestiegen sind. laktat, urea, kreatinin og tCO2. Eurotrol GAS-ISE Metabolites er også utviklet for å verifisere kalibrering, vastakkaiselta puolelta. Lue lisäyksityiskohdat OPC-ohjekirjasesta. • Eurotrol GAS-ISE Metabolites - Level 2 controls do not contain protein and therefore may not detect • Les contrôles Eurotrol GAS-ISE Metabolites ne contiennent pas de protéines et ne sont dès lors pas à O G M 4. Hände mit Gaze, Lappen oder Handschuhen schützen. driftstemperatur og andre resultatdata. 6. Noudata epoc Blood Analysis Systemin käyttöoppaan ohjeiden mukaista näytteenottomenetelmää 30 malfunctions sensitive to these components. même de détecter les dysfonctionnements sensibles à ces composants. 5. Ampulle(n) mit dem farbig markierten Punkt nach oben halten und Ampullenhals in die gegenüber sekunnin kuluessa. m • Eurotrol GAS-ISE Metabolites - Level 2 is very sensitive to room air contamination. When sampling the IVD-medisinsk utstyr • Eurotrol GAS-ISE Metabolites est extrêmement sensible à la contamination de l’air ambiant. Lorsque liegende Richtung abbrechen. Weitere Hinweise siehe Anleitungsblatt für OPC-Ampullen 7. Noudata paikallisia ohjeita suositellun käyttötiheyden suhteen. O G M mm m m fluid within 30 seconds, the error is less than 2% over the entire range in all levels**. The effect of room Eurotrol GAS-ISE Metabolites er i samsvar med det europeiske IVD-direktivet 1998/79/EF for in le prélèvement du liquide a lieu dans les 30 secondes, l’erreur est inférieure à 2% sur l’ensemble (Brechampullen mit One-Point-Cut). m air on pH is negligible. vitro-diagnostisk medisinsk utstyr og bærer CE-merket. de la plage de valeurs pour tous les niveaux**. L’effet de l’air ambiant sur le pH est négligeable. Varotoimet 6. Testverfahren gemäß Bedienungsanleitung des epoc Blood Analysis System innerhalb von dreißig **Numbers are based on open ampule testing. Sekunden durchführen. Eurotrol GAS-ISE Metabolites er bare for in vitro-diagnostisk bruk. **Ces chiffres sont basés sur le test portant sur une ampoule ouverte. 1. Ainoastaan diagnostiseen in vitro -käyttöön. 7. Empfohlene Anwendungsfrequenz siehe entsprechende Leitlinien vor Ort. Ce produit est fabriqué conformément aux spécifications d’Eurotrol. 2. Näitä tuotteita ei tule hävittää yleisjätteen mukana. Kysyttävä neuvoa oikean jätteenhävityksen suhteen O G M m m m This product has been manufactured according to Eurotrol specifications. Sammendrag paikallisilta ympäristöviranomaisilta. O G M m m m Vorsichtsmaßnahmen für die Anwendung Eurotrol GAS-ISE Metabolites er et kvalitetskontrollmateriale tilgjengelig på fem nivåer, hvert med kjente For further information please contact: Pour un complément d’information, veuillez contacter: 3. Eurotrol GAS-ISE Metabolites -kontrollia ei tule käyttää kalibraattorina. m m m m 1. Nur für die In-vitro-Diagnostik bestimmt. konsentrasjoner. Eurotrol B.V., The Netherlands, Phone +31 318 695 777, Fax +31 318 695 770 Eurotrol B.V., Pays-Bas, Téléphone +31 318 695 777, Télécopie +31 318 695 770, m m Odotetut tulokset E-mail office@eurotrol.com, www.eurotrol.com 2. Produkte nicht mit dem Hausmüll entsorgen. Anweisungen für eine ordnungsgemäße Entsorgung sind Reagenser Courriel office@eurotrol.com, www.eurotrol.com m m m Arvot saadaan mittaamalla epoc Blood Analysis Systemiissä käyttäen BGEM -testikortteja. Kullekin Eurotrol Inc., USA, Toll free phone 1-866-234-5754, Main phone 1-978-598-3779, beim jeweils zuständigen Umweltamt zu erfragen. Eurotrol GAS-ISE Metabolites sørger for fysiologisk relevante nivåer, hver ampulle inneholder 2,5 ml Eurotrol Inc., Etats-Unis, Numéro d’appel gratuit 1-866-234-5754, Téléphone principal 1-978-598-3779, O G M m neste-eränumerolle ja anturikonfiguraatiolle määrätyt arvot ovat saatavilla internetosoitteesta Fax 1-978-598-3780, E-mail officeUSA@eurotrol.com, www.eurotrol.com 3. Eurotrol GAS-ISE Metabolites nicht als Kalibrator verwenden. løsning. Eurotrol GAS-ISE Metabolites-kontroller er preparert ved hjelp av salter i en fysiologisk bufret Télécopie 1-978-598-3780, Courriel officeUSA@eurotrol.com, www.eurotrol.com m m http://www.epocal.com. Zu erwartende Ergebnisse matrise. Tonometri med forhåndsbestemte nivåer for oksygen og karbondioksid balansert med nitrogen m Eurotrol GAS-ISE Metabolites on tarkoitettu ammattilaisten käyttöön laitteen toimivuuden varmistamiseksi. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, The Netherlands og ulike saltkonsentrasjoner sørger for fem distinkte nivåer for hver parameter, slik at det simuleres klinisk Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Pays-Bas Entsprechende Messwerte werden auf der Grundlage von Messungen durch das epoc Blood Analysis m m signifikante områder av syre-base- og elektrolyttbalanse, respiratorisk funksjon, renalfunksjon, glukose- Huomioitavaa Symbols used System unter Verwendung von BGEM-Testkarten erzielt. Die entsprechenden Werte sind unter Symboles utilisés O G M m m m http://www.epocal.com in Tabellenform für alle Flüssigkeits-Chargennummer und Sensorkonfigurationen og laktatkonsentrasjon. Eurotrol GAS-ISE Metabolites-kontroller inneholder ingen konserveringsmidler, • Taulukon arvot soveltuvat vain määrätyille neste-eränumeroille, soveltuvalle epoc Blood Analysis System -anturikonfiguraatiolle ja merenpinnan tasolla. m m Attention, see instructions for use Batch code erhältlich. Eurotrol GAS-ISE Metabolites ist für die professionelle Anwendung zur Prüfung der Geräteleistung viskositetsjustering eller andre tilsetningsstoffer som kan innvirke negativt på elektrodemålinger. Attention, consulter le mode d’emploi Numéro de lot m O G M m m bestimmt. • Väärä näytteenotto, varastointi tai muu väärä käsittely voi aiheuttaa tavoitearvoista poikkeavia lukemia. Temperature limitation Oppbevaring og stabilitet m m m Use by Date de péremption Limites de température • Eurotrol GAS-ISE Metabolites -kontrollin pO2 -arvo voi muuttua käänteisesti lämpötilamuutosten kanssa. Weitere Hinweise Eurotrol GAS-ISE Metabolites kan oppbevares ved en temperatur på 2–8 °C. Oppbevart uåpnet ved denne m m G M Reference number Jokaista °C:n lämpötilamuutosta kohden välillä 18 °C - 26 °C pO2 muuttuu 1,5% matalalla tasolla, 1,1% In Vitro Diagnostic Medical Device • Die Werte in den Tabellen beziehen sich lediglich auf die zugeordnete Flüssigkeits-Chargennummer, die temperaturen er produktet garantert stabilt som angitt til utløpsdatoen på ampullene og den utvendige Dispositif médical de diagnostic in vitro Référence normaalilla ja 0,5% korkealla tasolla. Jotta saadaan suuri korrelaatioaste taulukon arvojen kanssa, tulisi m zu verwendende Sensorkonfiguration für das epoc Blood Analysis System und Meereshöhe. boksen. Eurotrol GAS-ISE Metabolites er stabil i 1 uke ved romtemperatur (uåpnede ampuller). Ikke sett Manufacturer CE mark Fabricant Label CE ampullit tasapainottaa mahdollisimman lähelle lämpötilaa 22 °C. m m m • Fehler bei der Probenentnahme oder Lagerung oder andere Handhabungsfehler können zu von den produktet i kjøleskapet etter at det er blitt brakt til romtemperatur! Etter åpning av ampullen vil Eurotrol • Kun ampulli on avattu, ei huoneenlämmöllä ole merkitsevää vaikutusta pH-arvoihin. m m m m Zielwerten abweichenden Messwerten führen. GAS-ISE Metabolites være stabile i 30 sekunder. • Eurotrol GAS-ISE Metabolites on herkkä useimmille laitteisiin liittyville tekijöille, jotka voivat aiheuttaa m m m m m • Die pO2-Werte von Eurotrol GAS-ISE Metabolites variieren invers in Bezug auf Temperaturveränderungen. Prosedyrer odottamattomia analyyttisiä poikkeamia. m m m Für jede Temperaturveränderung um ein °C zwischen 18 °C und 26 °C verändert sich der pO2-Wert um 1. Ta ut egnet mengde ampuller fra boks og brett. Ekvilibrer ampullen(e) i minimum 1 time til en temperatur Eurotrol GAS-ISE Metabolites - Level 2 1,5% im niedrigen, um 1,1% im normalen und um 0,5% im hohen Bereich. Um eine möglichst hohe så nær 22 °C som mulig. • Eurotrol GAS-ISE Metabolites -kontrollit eivät sisällä proteiinia, ja siksi ne eivät mahdollisesti havaitse näille komponenteille herkkiä vikoja. m m mm m m Übereinstimmung mit den Werten in der Tabelle zu erzielen, sollten die Ampulle(n) bei einer Temperatur äquilibriert werden, die möglichst exakt bei 22 °C liegen sollte. 2. Umiddelbart før bruk rister du ampullen godt i minst 15 sekunder for å re-ekvilibrere gassene med løsningen. Hold ampullen mellom tommelen og pekefingeren når du rister den. Eurotrol GAS-ISE Metabolites - Level 2 • Eurotrol GAS-ISE Metabolites on hyvin herkkä huoneilman kontaminaatiolle. Kun neste käytetään 30 m m Toepassing sekunnin kuluessa, on virhe alle 2% koko alueella kaikilla tasoilla*. Huoneilman vaikutus pH:hon on m Eurotrol GAS-ISE Metabolites is een kwaliteitscontrolemateriaal met toegekende waarden voor professioneel • Nach dem Öffnen der Ampullen hat die Raumtemperatur keine signifikanten Auswirkungen auf den 3. Drei ampullen forsiktig for å la løsningen returnere til bunnen av ampullen. La eventuelle bobler komme mitätön. m m m m gebruik bij het controleren van de precisie en nauwkeurigheid van het epoc® Blood Analysis System. pH-Wert. opp før du åpner ampullen. *Luvut perustuvat avoimen ampullin testaamiseen. m m O Tilsigtet formål GAS-ISE Metabolites is ontwikkeld om de volgende parameters te testen: pH, pO2, pCO2, Na+, K+, Ca++, • Eurotrol GAS-ISE Metabolites reagiert sensibel auf die meisten instrumentenbezogenen Faktoren, die zu 4. Beskytt fingrene med gas, papirhåndkle eller hansker. Eurotrol GAS-ISE Metabolites er et analyseret blodgas-, elektrolyt- og metabolitreferencemateriale til m m m m m m Tämä tuote on valmistettu Eurotrol-spesifikaatioiden mukaisesti. Mg++, Cl-, Glucose, Lactaat, Ureum, Creatinine en tCO2. GAS-ISE Metabolites is tevens ontwikkeld om de unerwarteten Analyseabweichungen führen können. 5. Hold ampullen med den fargede prikken vendt opp. Bryt av halsen på ampullen i motsatt retning av verificering af præcision og nøjagtighed ved epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites m m • Eurotrol GAS-ISE Metabolites enthalten kein Protein. Fehlfunktionen mit Empfindlichkeit für solche den fargede prikken. Les OPC-instruksjonsheftet for å få mer detaljert informasjon. m m ijking, werktemperatuur en andere prestatiekenmerken te controleren. blev fremstillet til at teste følgende analytter: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glukose, laktat, urea, Lisätietoja osoitteesta: Bestandteile können somit eventuell nicht festgestellt werden. 6. Innen 30 sekunder følger du prøvetakingsprosedyren i henhold til instruksjonene i bruksanvisningen for kreatinin og tCO2. Eurotrol GAS-ISE Metabolites er også udviklet for at verificere kalibrering, driftstemperatur Eurotrol B.V., Países Baixos, Puhelin +31 318 695 777, Faksi +31 318 695 770, IVD Medisch Hulpmiddel • Eurotrol GAS-ISE Metabolites reagiert sehr empfindlich auf Kontamination durch Raumluft. Bei einer epoc Blood Analysis System. og andre funktionsdata. S-posti office@eurotrol.com, www.eurotrol.com m Eurotrol GAS-ISE Metabolites voldoet aan de Europese Richtlijn 98/79/EG betreffende Medische Prüfung der Flüssigkeit innerhalb von dreißig Sekunden liegt die Fehlerquote bei unter 2% in allen 7. Se lokale retningslinjer for anbefalt hyppighet for bruk. Hulpmiddelen voor In-vitro diagnostiek en draagt het CE keurmerk. Bereichen und über alle Konzentrationsstufen hinweg. Die Auswirkungen der Raumluft auf den pH-Wert IVD medicinsk udstyr m m m m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Alankomaat Eurotrol GAS-ISE Metabolites is uitsluitend bestemd voor professioneel in vitro diagnostisch gebruik. Forholdsregler Eurotrol GAS-ISE Metabolites er i overensstemmelse med det europæiske IVD-direktiv 98/79/EC om in vitro m sind vernachlässigbar. 1. Bare til in vitro-diagnostisk bruk. diagnostisk medicinsk udstyr og bærer CE-mærket. O G M m m Samenvatting *Zahlen basieren auf Testwerten mit offenen Ampullen. Käytetyt symbolit m m 2. Disse produktene må ikke kastes i vanlig avfall. Kontakt lokale miljømyndigheter for å sørge for riktig Eurotrol GAS-ISE Metabolites er kun til in vitro diagnostisk brug. Eurotrol GAS-ISE Metabolites is een kwaliteitscontrolemateriaal, verkrijgbaar op vijf niveaus, elk met håndtering. Das vorliegende Produkt wurde gemäß Spezifikationen von Eurotrol hergestellt. Huomio, katso käyttöohjeet Eräkoodi bekende concentraties. Opsummering O m m G M 3. Eurotrol GAS-ISE Metabolites skal ikke brukes som en kalibrator. Weitere Informationen erhalten Sie bei: Eurotrol GAS-ISE Metabolites er et kvalitetskontrolmateriale, der leveres i fem niveauer, hvert med kendte Käytettävä viimeistään Lämpötilarajoite O m m m Reagentia Forventede resultater Eurotrol B.V. koncentrationer. O G M Eurotrol GAS-ISE Metabolites is beschikbaar in fysiologisch relevante niveau’s. Elke ampul bevat 2.5 mL Verdier hentes fra målinger med epoc Blood Analysis System ved hjelp av BGEM testkort. De anviste verdiene Diagnostinen in vitro -lääkintälaite Niederlande, Tel. +31 318 695 777, Fax +31 318 695 770 Viitenumero m m vloeistof. Eurotrol GAS-ISE Metabolites is samengesteld uit zouten in een fysiologisch gebufferde matrix. er tilgjengelige fra http://www.epocal.com, tabulert for hvert væskepartinummer og sensorkonfigurasjon. Reagenser Tonometrie met van te voren bepaalde niveaus van zuurstof-, koolzuur-, stikstofgasmengsels en verschillende E-Mail office@eurotrol.com, www.eurotrol.com Valmistaja CE-merkki Eurotrol GAS-ISE Metabolytes er beregnet på profesjonell bruk i verifiseringen av instrumentytelsen. Eurotrol GAS-ISE Metabolites leverer fysiologiske relevante niveauer, hver ampul indeholder 2,5 ml zoutconcentraties, resulteren in vijf fysiologisch relevante niveaus voor elke parameter. Hiermee worden opløsning. Eurotrol GAS-ISE Metabolites kontroller klargøres ved hjælp af salte i en fysiologisk buffermatrix. O m Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Niederlande Merk m m klinisch belangrijke gebieden van de zuur-base- en elektrolytenbalans, functie van de ademhaling, nierfunctie Tonometri med forudbestemte niveauer af oxygen og kuldioxid, der er afstemt med nitrogen og forskellige en glucose- en lactaatconcentratie weergegeven. Eurotrol GAS-ISE Metabolites controles bevatten geen Verwendete Symbole • Verdiene i tabellen gjelder bare for det anviste væskepartinummeret, den aktuelle sensorkonfigurasjonen saltkoncentrationer, udgør fem tydelige niveauer for hver parameter, som simulerer klinisk signifikante m m m m m m m m m m for epoc Blood Analysis System og ved havnivå. conserveringsmiddelen, viscositeitsregelaars of andere toevoegingen die de elektroden of metingen nadelig områder for syre-base og elektrolytbalance, åndedrætsfunktion, nyrefunktion, glukose og laktatkoncentration. m zouden kunnen beïnvloeden. Achtung, siehe Bedienungsanleitung Chargennummer • Feil prøvetaking, oppbevaring eller annen feilhåndtering kan føre til avlesinger som avviker fra målverdiene. Eurotrol GAS-ISE Metabolites kontroller indeholder ingen konserveringsmidler, viskositetsregulatorer eller Eurotrol GAS-ISE Metabolites - Level 2 O O G M m m m andre tilsætningsstoffer, der kan påvirke elektrodemålinger negativt. m m O m % Opslag en stabiliteit Verwendbar bis Temperaturbereich • pO2 -verdiene for Eurotrol GAS-ISE Metabolites varierer omvendt i forhold til temperaturendringer. For % m % m m Eurotrol GAS-ISE Metabolites kan bewaard worden bij een temperatuur van 2–8 °C. Ongeopend bewaard Medizinisches Gerät für die hver °C-endring i temperaturer mellom 18 °C og 26 °C endres pO2 1,5 % ved lavt nivå, 1,1 % ved Opbevaring og stabilitet Referenznummer Destinazione d’uso m m m m m bij deze temperatuur is het product gegarandeerd stabiel tot de houdbaarheidsdatum zoals aangegeven op normalt nivå og 0,5 % ved høyt nivå. For å oppnå en høy grad av korrelasjon med verdiene i tabellen, må Eurotrol GAS-ISE Metabolites kan opbevares ved en temperatur på 2-8 °C. Ved opbevaring i uåbnet tilstand Eurotrol GAS-ISE Metabolites è un set di materiali di riferimento titolati per emogas, elettroliti e metaboliti, m m m m m m de ampul en op de buitenverpakking. Na het openen van de ampul is Eurotrol GAS-ISE Metabolites stabiel Hersteller CE-Zeichen ved denne temperatur garanteres stabilitet, som det er angivet indtil udløbsdatoen på ampullerne og den ampullene ekvilibreres så nært til 22°C som mulig. destinato a verificare la precisione e l’accuratezza dell’analizzatore epoc® Blood Analysis System. Eurotrol O G M m m m gedurende 30 seconden. • Når ampullen er åpnet, har romtemperatur ingen signifikant effekt på pH-verdiene. udvendige pakning. Eurotrol GAS-ISE Metabolites er stabil i 1 uge ved stuetemperatur (uåbnede ampuller). GAS-ISE Metabolites è indicato per il monitoraggio dei seguenti analiti: pH, pO2, pCO2, Na+, K+, Ca++, m Procedures • Eurotrol GAS-ISE Metabolites er følsomme for de fleste instrumentrelaterte faktorer som kan føre til Undlad at nedkøle produktet, efter det har opnået stuetemperatur! Efter åbning af ampullen er Eurotrol GAS- Mg++, Cl-, glucosio, lattato, urea, creatinina e tCO2. Eurotrol GAS-ISE Metabolites serve inoltre a verificare O G M m m m 1. Haal het benodigde aantal ampullen uit de verpakking. Incubeer de ampul(len) gedurende ten minste één uventede analytiske avvik. ISE Metabolites stabil i 30 sekunder. m m la calibrazione, la temperatura operativa e altre caratteristiche di performance. uur bij een temperatuur die zo dicht mogelijk bij 22 °C ligt. 2. Schud, vlak voor gebruik, de ampul gedurende 15 seconden om de gassen opnieuw in evenwicht te Eurotrol GAS-ISE Metabolites - Level 2 • Eurotrol GAS-ISE Metabolites-kontroller inneholder ikke protein og kan derfor ikke registrere feilfunksjoner som er følsomme for disse komponentene. Procedurer 1. Fjern den passende mængde ampuller fra æsken og bakken. Ækvilibrer ampullen/ampullerne i mindst 1 Dispositivi medico-diagnostici in vitro O m m G M m % m m Q m brengen met de oplossing. De ampul houdt men daarbij tussen duim en wijsvinger. • Eurotrol GAS-ISE Metabolites er svært følsomme for kontaminasjon av romluft. Ved prøvetaking av Eurotrol GAS-ISE Metabolites è conforme alla Direttiva Europea 98/79/CE sui dispositivi medico-diagnostici time til en temperatur, der er så tæt på 22 °C som muligt. O m 3. Zwenk de ampul voorzichtig zodat de vloeistof naar de bodem kan terugkeren. Laat de gasbelletjes væsken innen 30 sekunder er feilen mindre enn 2 % over hele området ved alle nivåer*. Effekten av in vitro e porta il marchio CE. Avsedd användning 2. Ryst umiddelbart før brug ampullen kraftigt i mindst femten sekunder for at reækvilibrere gasserne med O m m m m m omhoog komen alvorens de ampul te openen. romluft på pH er ubetydelig. Eurotrol GAS-ISE Metabolites è destinato esclusivamente ad uso diagnostico in vitro. Eurotrol GAS-ISE Metabolites är ett analyserat referensmaterial för blodgaser, elektrolyter och metaboliter, opløsningen. Når ampullen rystes, skal den holdes mellem tommel- og pegefinger. m 4. 4. Bescherm de vingers met verbandgaas, tissue of handschoenen. för verifiering av precisionen och noggrannheten hos epoc® Blood Analysis System. Eurotrol GAS-ISE *Tallene er basert på testing av åpne ampuller. 3. Sving forsigtigt ampullen rundt for at sende opløsningen tilbage til bunden af ampullen. Lad eventuelle Riassunto 5. Houd de ampul met de gekleurde stip naar boven gericht. Breek de hals van de ampul af in Metabolites är avsett för testning av följande analyter: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, glukos, Dette produktet er produsert i henhold til Eurotrols spesifikasjoner. bobler stige op, før ampullen åbnes. Eurotrol GAS-ISE Metabolites è un materiale di controllo fornito in cinque livelli, ciascuno a titolo noto. m m tegenovergestelde richting van de gekleurde stip. Lees ook de bijgevoegde OPC-instructies. laktat, urea, kreatinin och tCO2. Eurotrol GAS-ISE Metabolites är även avsett för verifiering av kalibrering, 4. Beskyt fingrene med gaze, servietter eller handsker. Reagenti 6. Volg binnen 30 seconden de procedure van bemonsteren volgens de instructies in de handleiding van drifttemperatur och andra prestandaegenskaper. Hvis du ønsker mer informasjon, kan du ta kontakt: 5. Hold ampullen, så den farvede prik vender opad. Åbn ampullen i den modsatte retning af den M @ m m Eurotrol GAS-ISE Metabolites fornisce dei livelli fisiologicamente significativi, con un contenuto di 2.5 ml di het epoc Blood Analysis System. Eurotrol B.V., Nederland, Telefon +31 318 695 777, Faks +31 318 695 770, E-Mail office@eurotrol.com, M @ m Medicinteknisk produkt för in vitro-diagnostik farvede prik. Læs OPC-indlægssedlen for at få flere oplysninger. soluzione per ogni fiala. 7. Raadpleeg de plaatselijk geldende richtlijnen voor de aanbevolen gebruiksfrequentie www.eurotrol.com 6. Følg inden for 30 sekunder prøvetagningsproceduren i overensstemmelse med betjeningsvejledningen m Eurotrol GAS-ISE Metabolites uppfyller det europeiska IVD-direktivet 98/79/EG om medicintekniska I controlli Eurotrol GAS-ISE Metabolites sono ottenuti con l’aggiunta di sali in una matrice tamponata con Voorzorgsmaatregelen produkter för in vitro-diagnostik och är CE-märkt. til epoc Blood Analysis System. tampone fisiologico. La tonometria con livelli predeterminati di ossigeno e anidride carbonica equilibrati con 1. Uitsluitend bestemd voor in vitro diagnostisch gebruik. Eurotrol GAS-ISE Metabolites är endast avsett för in vitro-diagnostiskt bruk. Eurotrol B.V., Keplerlaan 20, 6716 BS Ede, Nederland 7. Se de lokale retningslinjer for anbefalet anvendelseshyppighed. azoto e le diverse concentrazioni di sali forniscono cinque livelli distinti per ciascun parametro, simulando dei Símbolos utilizados Data de fabrico Rezultate aşteptate 요약 Kasutatud sümbolid Tootmise kuupäev • アンプルの開封後は、室温はpH値に大きく影響しません。 请注意 Valorile se obţin prin măsurători efectuate pe epoc Blood Analysis System utilizând carduri de testare BGEM. Eurotrol GAS-ISE Metabolites 는 5가지 수치로 사용할 수 있는 정도 관리 물질로, 각각의 농도가 알려져 • Eurotrol GAS-ISE Metabolites - Level 2 は、予期せぬ分析のずれの原因となる機器関連のほとんどの要素に • 表格中的值仅适用于指定的试剂批号和适当的 epoc Blood Analysis System 传感器配置，且仅在海平面 Atenção, consultar instruções de utilização Código de lote Valorile atribuite sunt disponibile la http://www.epocal.com, tabelate pentru fiecare număr de lot de lichid şi 있습니다. Tähelepanu, lugege kasutusjuhiseid Partii kood 対して高い感受性を持ちます。 高度处适用。 Prazo de validade Limites de temperatura configuraţie a senzorului. 시약 Kasutada enne Temperatuuripiirang • Eurotrol GAS-ISE Metabolites - Level 2 対照にはタンパク質は含まれていないため、これらの成分に対して感 • 不正确的取样、储存或其他违规操作可导致读数偏离目标值。 Eurotrol GAS-ISE Metabolytes este conceput pentru utilizare profesională la verificarea performanţelor Eurotrol GAS-ISE Metabolites 는 생리학적 관련 수치를 제공하며, 각 앰플에는 2.5mL의 용액이 들어 受性の高い機能不全を検出することはできません。 • Eurotrol GAS-ISE Metabolites - Level 2 的 pO2 值与温度成反比。在 18 °C 和 26 °C 之间 每改变 Dispositivo médico para diagnósticos in vitro Número de referência instrumentelor. 있습니다. Eurotrol GAS-ISE Metabolites 컨트롤은 생리학적으로 완충된 매트릭스에 소금을 사용하여 In vitro diagnostiline meditsiiniseade Viitenumber • Eurotrol GAS-ISE Metabolites - Level 2 は、室内空気の汚染に対して非常に高い感受性を持ちます。30秒以 1°C，pO2 值在低水平时便改变 1.5%，正常水平时便改变 1.1%，高水平时便改变 0.5%。要使检测值与表 Fabricante Marca CE Vă rugăm să reţineţi 준비됩니다. 질소와 균형이 잡힌 산소 및 이산화탄소의 미리 결정된 수치 그리고 각기 다른 소금 농도를 Tootja CE-märgis 内に液体のサンプリングを行う場合は、すべてのレベルで全範囲に渡って2%未満の誤差となります。室内空 格中的值高度相关，应将安瓿静置至尽量接近 22 °C。 • Valorile din tabel sunt valabile numai pentru numărul de lot de lichid atribuit, pentru configuraţia senzorului 사용한 안압측정은 각 매개변수에 대해 5개의 다른 수치를 제공하여, 임상적으로 유의미한 산-염기 및 전해질 気のpHへの影響は無視できます。 • 打开安瓿后，室温对 pH 值无显著影响。 epoc Blood Analysis System în cauză şi la nivelul mării. 균형의 범위, 호흡기 기능, 신장 기능, 포도당 및 유산염 농도를 모의시험할 수 있게 합니다. Eurotrol GAS-ISE *値は開放アンプル試験に基づいています。 • Eurotrol GAS-ISE Metabolites - Level 2 对大多数可引起非预期分析偏差的仪器相关因素敏感。 • Recoltarea, depozitarea incorecte sau alte manipulări defectuoase pot determina abaterea valorilor de Metabolites 컨트롤에는 전극 측정에 부정적인 영향을 미칠 수 있는 방부제, 점도 조절기