Roche cobas c Manual de usuario
cobas c pack opener
Operator’s Manual
Roche Diagnostics
Operator’s Manual · Version 1.2 3
cobas c pack opener
Table of contents
Document information ........................................................................................................5
Contact address .....................................................................................................................6
Conventions used in this manual ........................................................................................7
Other symbols ........................................................................................................................8
Unpacking and assembly ......................................................................................................9
Product description .............................................................................................................12
Operator qualification ........................................................................................................13
Power on and operation .....................................................................................................14
Disposal of the device .........................................................................................................16
Maintenance .........................................................................................................................17
Troubleshooting ...................................................................................................................19
Technical data and specifications ......................................................................................22
Roche Diagnostics
4Operator’s Manual · Version 1.2
cobas c pack opener
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 c513 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:
oIEC/EN 61010-1
oIEC 61010-2-101
oIEC 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 Diagnostics
6Operator’s Manual · Version 1.2
Contact address cobas c pack opener
Contact address
Manufacturer Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Roche Diagnostics
Operator’s Manual · Version 1.2 7
cobas c pack opener Conventions used in this manual
Conventions used in this manual
Visual cues are used to help quickly locate and interpret information in this manual.
This section explains the formatting conventions used in this manual.
The safety precautions and important user notes are classified according to the
ANSI Z535.6 standard. Familiarize yourself with the following meanings and icons:
The following symbols and signal words are used for specific hazards:
Important information that is not safety relevant is indicated by the following
symbol:
The following symbols are also used:
The safety alert symbol (without a signal word) is used to promote awareness of generic
hazards or to direct the reader to safety information provided elsewhere in the document.
WARNING
WARNING
Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
CAUTION
Indicates a hazardous situation which, if not avoided, could result in minor or moderate
injury.
NOTICE NOTICE
Indicates a hazardous situation which, if not avoided, may result in property damage.
Tip
Indicates additional information on correct use of the device or useful tips.
Symbol Used for
aStart of procedure
• List item
eCross-reference
Roche Diagnostics
8Operator’s Manual · Version 1.2
Other symbols cobas c pack opener
Other symbols
On the type plate and packaging label of the device you will find the following
additional symbols that have not been explained so far.
Symbol Meaning
Disposal of electronic equipment.
This device is covered by the European Directive WEEE.
Global Trade Item Number.
Quantity contained in the package.
Fragile, handle with care.
Stacking limit by 4.
Roche Diagnostics
Operator’s Manual · Version 1.2 9
cobas c pack opener Unpacking and assembly
Unpacking and assembly
The cobas c pack opener is delivered in a box. If any part was damaged during
transport, inform your supplier or the carrier immediately.
aUnpacking the cobas c pack opener
1
Open the box as indicated.
e
Refer to the label on the box.
2
Grasp the unit firmly and remove the unit from the box.
3
Place the unit in an upright position on the bench.
4
Pull off the top foam cushion.
5
Separate the unit from the bottom foam cushion.
6
Pull off the plastic foil and remove the desiccant bag from the unit.
7
Place the unit on a stable, vibration-free surface, for example a bench. Do not
place in direct sunlight. Comply with other environmental requirements.
e
Technical data and specifications on page 22
8
Position the unit in a way that its on/off switch and power receptacle can be easily
and quickly accessed whenever needed.
9
Check that the consignment is complete.
CAUTION
Personal injury due to heavy and slippery device
The unit may slip out of your hands.
Always hold the unit firmly.
Roche Diagnostics
10 Operator’s Manual · Version 1.2
Unpacking and assembly cobas c pack opener
If any items are missing, inform your supplier without delay.
A cobas c pack opener
BWaste container
CAdapter for cobas c pack large
Figure 1 cobas c pack opener and components
DPower cord
Figure 2 Optional
A
B
C
B
D
The adapter (C) for using cobas c pack large is part of the standard cobas c pack opener
consignment.
The device is delivered without a power cord (D). A country-specific power cord is
provided separately by Roche.
Keep the original packaging. Transport the cobas c pack opener only in the original
packaging.
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