Roche Cobas 4800 System User Manual

cobas®
4800 System
Document
information
Systeni Manual
Revision history
Instrument approvals
Roche Diagnostics
2
Manual version
Software version Revision date Changes
1.0 2.1
April2013
Table
1
Revsion history
Edition notice
This manual is
for users of the cobas 4800 System.
Every effort has
been made to ensure that all the information contained in this
manual is correct at
the time of printing. However, Roche reserves the right to make
any changes
necessary without notice as part of ongoing product development.
Any customer
modification to the cobas x 480 instrument or cobas z 480 analyzer
will render the warranty or service agreement null and void.
Software updates are done by Roche Service representatives.
The screenshots in this publication have been added exclusively for the
purpose of
ilustration. Configurable and variable data such as parameters, resuits,
path names
etc.
visible therein must not be used for laboratory purposes.
Intended use The
system is intended to be used as a diagnostic or screening system
providing
samplepreparation, amplification and
detection of specific targets from human
samples.
It is important that the operator reads
this manual and the test-specific Operator’s
Manual thoroughly before using the
system.
The system is to be used by laboratory
professionals trained in laboratory techniques
and by instruction on the use of the system.
Copyright
©
2013, Roche
Diagnostics International Ltd. All rights reserved.
Tradernarks The following
trademarks are acknowledged:
COBAS, COBAS Z,
and LIFE NEEDS ANSWERS are trademarks of Roche.
All other
trademarks are the property of their respective owners.
Feedback Every effort has been
made
to
ensure that this manual fulfills the intended purpose as
mentioned above.
All feedback on any aspect of this manual is welcome and will be
considered during updates. Please contact
your Roche representative, should you
have any such feedback.
The instrument and the analyzer meet the
protection requirements laid down in IVD
Directive
98/79/EG.
Furthermore, the analyzer is manufactured and tested according to
the following
international standards:
• lEG 61010-1
• lEG 61010-2-101
• UL61O1O-1
• CAN/CSA
C22.2
No.
61010-1
This manual meets
the European Standard EN ISO 18113-3.
Compliance is
demonstrated by the following marks:
System Manual . Version 1.0

Roche Cobas 4800 System Specifications

General

Brand	Roche
Model	Cobas 4800 System
Category	Analytical Instruments
Language	English