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cobas 8000 core unit

Roche cobas 8000 core unit User manual

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  • What safety measures should be taken when operating the instrument?
    What is the potential impact of using electromagnetic devices near the instrument?
    Which specific devices should not be used near the instrument?
    Is the instrument compliant with any electromagnetic compatibility standards?
    What is the recommended course of action if electromagnetic interference is suspected?
Addendum
to Operator’s Manual version 4.2
cobas 8000 modular analyzer series
Software Version 05-01
cobas 8000 modular analyzer series
Roche Diagnostics
2 Addendum · 1.0
Document information
Edition notice This addendum contains supplementary information for operators of the
cobas® 8000 modular analyzer series. It is meant to complement the Operator’s
Manual version 4.2.
Every effort has been made to ensure that all the information is correct at the time of
publishing. However, Roche Diagnostics reserves the right to make any changes
necessary without notice as part of ongoing product development.
Copyright © 2009-2015, Roche Diagnostics GmbH.
All rights reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS INTEGRA, ELECSYS and LIFE NEEDS ANSWERS are
trademarks of Roche.
All other trademarks are the property of their respective owners.
Contact addresses
Inside the European Union and
EFTA member states:
Outside the European Union and
EFTA member states:
Document
version
Software
version
Revision date Changes
1.0 05-01 May 2015 Caution message revised. Devices emitting
electromagnetic fields can now be operated
in the same room with the instrument.
4.2.1 05-01 May 2015 Caution message revised. Devices emitting
electromagnetic fields can now be operated
in the same room with the instrument.
Table 1 Revision history
Manufacturer of cobas® 8000
instrument
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shinbashi
Minato-ku, Tokyo 105-8717
Japan
Manufacturer of cobas® 8000
data manager
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Authorized representative Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Manufactured by: Hitachi High-Technologies Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
Addendum · 1.0 3
cobas 8000 modular analyzer series
T
able of contents
General safety information ...................................................................................................4
Caution messages.............................................................................................................4
Electromagnetic devices............................................................................................4
Roche Diagnostics
4 Addendum · 1.0
General safety information cobas 8000 modular analyzer series
Caution messages
General safety information
Caution messages
Electromagnetic devices
CAUTION
Malfunction of instrument and incorrect results due to interfering electromagnetic
fields
This instrument has been designed and tested to IEC 61326-2-6. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
r The electromagnetic environment should be evaluated prior to operation of the device.
r Devices that emit electromagnetic waves may cause the instrument to malfunction. Do
not operate this instrument in close proximity to sources of strong electromagnetic
fields (for example unshielded intentional radio frequency (RF) sources).
r Do not operate the following devices in close proximity to the instrument:
o Mobile phones
o Transceiver
o Cordless phones
o Other electrical devices that generate strong electromagnetic fields
/