Roche cobas c User Manual

Roche Diagnostics
Operator’s Manual · Version 1.2 5
cobas c pack opener Document information
Document information
Revision history
Edition notice Operator’s Manual for users of the cobas c pack opener.
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary without notice as a part of ongoing
product development. Any customer modification to the instrument will render the
warranty or service agreement null and void.
Intended use The cobas c pack opener is a semiautomatic device designed for use with
cobas ® 8000 modular analyzer series and cobas c 513 analyzer. It is intended for
opening the cobas c pack large.
Copyright © 2009-2018, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:
cobas, cobas c , and LIFE NEEDS ANSWERS are trademarks of Roche.
Instrument approvals The cobas c pack opener meets the protection requirements laid down in
IVD Directive 98/79/EC. Furthermore, the device is manufactured and tested
according to the following international standards:
o IEC/EN 61010-1
o IEC 61010-2-101
o IEC 61326-2-6
The Operator's Manual meets the requirements of European Standard EN ISO
18113-3:2011.
Compliance is demonstrated by the following marks:
Manual version Revision date Changes
1.0 August 2009 Initial version
1.1 August 2015 cobas c 513 analyzer was added to
the section Intended use.
1.2 August 2018 Removed cobas c 711 analyzer,
updated intended use, updated
symbols list, updated
Maintenance and
Troubleshooting sections, minor
editorial revisions.
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada
and the US.

Roche cobas c Specifications