Dimension ENZ I Calibrator Instrcuions for Use DXDCM

DC35

DC35

DC35

DC35

Dimension® clinical chemistry system

Dimension® clinical chemistry system

Dimension® clinical chemistry system

Dimension® clinical chemistry system

ENZ I CAL

ENZ I CAL

ENZ I CAL

ENZ I CAL

LOT

2010-03-01

Assigned Values/Sollwert/Valeurs Attribuées/Valori Assegnati/Valores Asignados

LEVEL 1a

LEVEL 2

LEVEL 3

Units/Einheiten/ Unités/Unità/ Unidades

LDI

539

1066

U/L

LEVEL 1a

LEVEL 2

LEVEL 3

SI*

0.00

9.00

17.80

µkat/L

0

Intended Use The ENZ I CAL is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension® clinical chemistry system. Reagents Contents: 4 vials: (2 vials Calibrator Level 2, 1.5 mL per vial) (2 vials Calibrator Level 3, 1.5 mL per vial)

Do not reuse / Nicht zur Wiederverwendung / Ne pas réutiliser / Non riutilizzare / No reutilizar

EXP CCYY-MM-DD

LDI

Enzyme I Calibrator

Symbols Key Symbolschlüssel Explication des Symboles Interpretazione simboli Clave de los Símbolos

9GD056

ENZ I CAL is a liquid bovine serum albumin based product containing lactate dehydrogenase (chicken heart).

Use By / Verwendbar bis / Utiliser jusque / Utilizzare entro / Fecha de caducidad

Note: Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or Reagent grade water is required for use as Calibrator Level 1 for the LDI method.

Batch Code / Chargenbezeichnung / Code du lot / Codice del lotto / Código de lote Catalogue Number / Bestellnummer / Référence du catalogue / Numero di catalogo / Número de catálogo

a. Purified Water Diluent (Cat. No. 710615901) or Reagent grade water a. Verdünnungsmittel Reinstwasser (Art.-Nr. 710615901) oder Wasser in Reagenzqualität a. Diluant eau purifiée (n° de réf. 710615901) ou eau de qualité réactif a. Diluente in acqua purificata (Num. cat. 710615901) o acqua di grado reagente a. Diluyente Agua Purificada (ref. 710615901) o agua de grado reactivo

Caution, consult accompanying documents / Achtung, Begleitdokumente beachten / Attention voir notice d’instructions / Attenzione, vedere le istruzioni per l'uso / Atención, ver instrucciones de uso

*Système International d’Unités (Units x F = SI)

Authorized Representative in the European Community / Bevollmächtigter in der Europäischen Gemeinschaft / Mandataire dans la Communauté européenne / Mandatario nella Comunità Europea / Representante autorizado en la Comunidad Europea

Assigned Constituent Values: Refer to the enclosed Table of Assigned Values. Traceability

LDI

IFCC LD at 37 °C primary reference method

Risk and Safety Safety data sheets (MSDS/SDS) available on www.siemens.com/diagnostics

Manufacturer / Hersteller / Fabricant / Fabbricante / Fabricante

IVD

Constituent

Precautions: For in vitro diagnostic use Materials Provided: ENZ I CAL Cat. No. DC35 Materials Required But Not Provided: Purified Water Diluent (Cat. No. 710615901) or Reagent grade water.

Contains sufficient for <n> tests / Inhalt ausreichend für <n> Tests / Contenu suffisant pour “n” tests / Contenuto sufficiente per “n” saggi / Contenido suficiente para <n> ensayos

Reagent Preparation: ENZ I CAL is ready for use. No preparation is required.

In Vitro Diagnostic Medical Device / In-Vitro-Diagnostikum / Dispositif médical de diagnostic in vitro / Dispositivo medico-diagnostico in vitro / Producto sanitario para diagnóstico in vitro

Stability Unopened Product: See Expiration Date.

Store at: 2 – 8 °C

Opened Product: Once cap is removed, assigned values are stable for 30 days when recapped immediately after use and stored at 2 – 8 °C.

Temperature Limitation / Temperaturbegrenzung / Limites de température / Limiti di temperatura / Límite de temperatura

Calibration Procedure Refer to the Calibration and Quality Control section in the Operator’s Guide for the Dimension® clinical chemistry system.

Consult Instructions for Use / Gebrauchsanweisung beachten / Consulter les instructions d’utilisation / Consultare le istruzioni per l’uso / Consulte las instrucciones de uso

Symbols Key: See adjacent panel.

Non-sterile / Nicht steril / Non stérile / Non sterile / No estéril

Dimension® is a trademark of Siemens Healthcare Diagnostics Inc. ©2008 Siemens Healthcare Diagnostics Inc. All rights reserved.

CE Mark / CE Zeichen / Marquage CE / Marchio CE / Marca CE Contents / Inhalt / Contenu / Contenuto / Contenido Reconstitution Volume / Rekonstitutionsvolumen / Volume de reconstitution / Volume di ricostituzione / Volumen de reconstitución Level / Konzentration / Niveau / Livello / Nivel 2006-06_EFIGS

Siemens Healthcare Diagnostics Ltd. Sir William Siemens Sq. Frimley, Camberley, UK GU16 8QD

Siemens Healthcare Diagnostics Inc. Newark, DE 19714, U.S.A. www.siemens.com/diagnostics

Siemens Healthcare Diagnostics Ltd. Sir William Siemens Sq. Frimley, Camberley, UK GU16 8QD

Siemens Healthcare Diagnostics Inc. Newark, DE 19714, U.S.A. www.siemens.com/diagnostics

Siemens Healthcare Diagnostics Ltd. Sir William Siemens Sq. Frimley, Camberley, UK GU16 8QD

2008-08 A PN 792035.002-US

Siemens Healthcare Diagnostics Inc. Newark, DE 19714, U.S.A. www.siemens.com/diagnostics

2008-08 A PN 792035.002

Siemens Healthcare Diagnostics Ltd. Sir William Siemens Sq. Frimley, Camberley, UK GU16 8QD

2008-08 A PN 792035.002

Siemens Healthcare Diagnostics Inc. Newark, DE 19714, U.S.A. www.siemens.com/diagnostics

2008-08 A PN 792035.002

2009-08-10