Dimension CHOL Calibrator Instructions for Use DXDCM

DC16

DC16

DC16

DC16

Dimension® clinical chemistry system

Dimension® clinical chemistry system

Dimension® clinical chemistry system

Dimension® clinical chemistry system

CHOL CAL

CHOL CAL

CHOL CAL

CHOL CAL

LOT

2010-07-01

a

a

a

a

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

CHOL

CHOL

LEVEL 1

LEVEL 2

LEVEL 3

Units/Einheiten/ Unités/Unità/ Unidades

72

241

423

mg/dL

LEVEL 1

LEVEL 2

LEVEL 3

SI*

1.9

6.2

11.0

mmol/L

a

EXP CCYY-MM-DD

mg/dL

Conversion Factor (F) Umrechnungsfaktor Facteur de conversion Fattore di conversione Factor de conversión x

0.0259

Reagents Contents: 6 vials: 2 vials (Level 1, 1.0 mL per vial, reconstituted) 2 vials (Level 2, 1.0 mL per vial, reconstituted) 2 vials (Level 3, 1.0 mL per vial, reconstituted)

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

Cholesterol Calibrator is a lyophilized bovine serum albumin base product containing cholesterol. Assigned Constituent Values: Refer to the enclosed Table of Assigned Values.

SI*

Constituent

Traceability

Catalogue Number / Bestellnummer / Référence du catalogue / Numero di catalogo / Número de catálogo

CHOL

NIST SRMa 911 CDCb Abell-Kendall reference method

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

a. NIST-SRM: National Institute of Standards and Technology - Standard Reference Material b. CDC: Centers for Disease Control

Precautions This Product Contains Dry Natural Rubber. This material should be handled using good laboratory practice to avoid skin contact or ingestion.

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

For in vitro diagnostic use Materials Provided: CHOL CAL, Cat. No. DC16

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

IVD

=

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

Manufacturer / Hersteller / Fabricant / Fabbricante / Fabricante

*Système International d’Unités (Units x F = SI units) Units Einheiten Unités Unità Unidades

Intended Use The Dimension® Cholesterol Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Cholesterol (CHOL) method.

Batch Code / Chargenbezeichnung / Code du lot / Codice del lotto / Código de lote

a. The assigned values are traceable to the Centers for Disease Control's Abell-Kendall reference method as recommended by National Cholesterol Education Program (NCEP). a. Die Werte können auf die vom National Cholesterol Education Program (NCEP, Nationales Cholesterinaufklärungsprogramm) empfohlene Abell-Kendall-Referenzmethode des Center for Disease Control zurückgeführt werden. a. Les valeurs attribuées sont issues de la méthode de référence Abell-Kendall du CDC (Centers for Disease Control), selon les recommandation du National Cholesterol Education Program (NCEP). a. I valori assegnati sono rintracciabili sul metodo di riferimento Abell-Kendall dei Centers for Disease Control's come consigliato dal programma NCEP (National Cholesterol Education Program). a. Los valores asignados están referidos al método de referencia de Abell-Kendall en el Centro de Control de Enfermedades de acuerdo con las recomendaciones del Programa Nacional de Educación para el Colesterol (NCEP, por sus siglas en inglès).

CHOL

Cholesterol Calibrator

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

9GD041

Materials Required But Not Provided: 1.0 mL volumetric pipette or equivalent, Purified Water Diluent (Cat. No. 710615901) or reagent grade water. Reconstitution Procedure 1. Remove vials from refrigerator and allow to stand at room temperature (22 – 28 °C) for 10 to 15 minutes. 2. Remove stopper and volumetrically add 1.00 ± 0.01 mL Purified Water (Cat. No. 710615901) or reagent grade water. The water should be at room temperature (22 – 28 °C). 3. Replace stopper, and let stand for 5 minutes. Do not invert the vials. 4. Swirl vials gently for 30 seconds, then gently invert 10 times. 5. Let vials stand on bench top for 10 minutes, then invert gently 10 times. 6. Let vials stand on bench top for 15 minutes. Then invert 10 times and swirl gently. 7. Use immediately or refrigerate at 2 – 8 °C for future use. Prior to use, invert 10 times and swirl gently.

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

mmol/L

Consult Instructions for Use / Gebrauchsanweisung beachten / Consulter les instructions d’utilisation / Consultare le istruzioni per l’uso / Consulte las instrucciones de uso Non-sterile / Nicht steril / Non stérile / Non sterile / No estéril CE Mark / CE Zeichen / Marquage CE / Marchio CE / Marca CE

Storage Store at 2 – 8 °C.

Contents / Inhalt / Contenu / Contenuto / Contenido

Stability Unopened Product: See Expiration Date.

Reconstitution Volume / Rekonstitutionsvolumen / Volume de reconstitution / Volume di ricostituzione / Volumen de reconstitución

Opened Product: Assigned values are stable 24 hours after reconstitution when vials are stoppered and stored at 2 – 8 °C.

Level / Konzentration / Niveau / Livello / Nivel 2006-06_EFIGS

Calibration Procedure Refer to the instruction manual for the Dimension® system. Symbols Key: See adjacent panel.

2009-08-26

Dimension® is a trademark of Siemens Healthcare Diagnostics Inc.

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

2008-04 I PN 792016.001-US

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

2008-04 I PN 792016.001

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

2008-04 I PN 792016.001

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

2008-04 I PN 792016.001

©2008 Siemens Healthcare Diagnostics Inc. All rights reserved.