Roche cobas pro ISE analytical unit User guide

cobas pro ISE analytical unit
Roche
Brand
Roche
Model
cobas pro ISE analytical unit
Type
User guide

This manual is also suitable for

cobas
®
pro integrated solutions
User Guide version 3.0
Addendum
Publication version 1.0
Software version 02-01
2
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Publication information
Publication version Software version Revision date Change description
1.0 02-01 2021-05 Safety Guide: Sections on potential hazard and correct
disposal of new refrigerant gas added
User Guide: Specifications of new refrigerant gas added
y Revision history
Edition notice
This addendum contains supplementary information for
operators of cobas
®
pro integrated solutions.
It is meant to complement version 3.0 of the Safety Guide
and User Guide.
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the system and safety information before
you use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the system in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.
Training
Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Images
The screenshots and hardware images in this publication
have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, such as
tests, results, or path names visible therein must not be
used for laboratory purposes.
Hardware images and screenshots may show an example
for an analytical unit or system configuration.
Copyright
© 2018–2021, Roche Diagnostics GmbH.
All rights reserved.
License information
cobaspro integrated solutions is protected by contract
law, copyright laws, and international treaties. cobaspro
integrated solutions is licensed for use between Roche
3
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Diagnostics GmbH and a licensee, and only authorized
users there under are permitted to access and use the
software. Unauthorized use and distribution may result in
civil and criminal penalties.
Trademarks
cobas
®
pro is a trademark and the cobas
®
pro logo is a
trademark of Roche.
Other product names and trademarks are the property of
their respective owners.
Approvals
cobaspro integrated solutions meets the requirements
laid down in:
Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices.
Commission Delegated Directive (EU) 2015/863 of 31
March 2015 amending Annex II to Directive 2011/65/EU
of the European Parliament and of the Council as regards
the list of restricted substances.
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
To view the full text of the 2014/53/EU declaration of
conformity, go to the Roche DiaLog Global Web Site
(https://dialog1.roche.com/) and choose the eLabDoc
link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
Compliance is provided by means of the Declaration of
Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC on in vitro
diagnostic medical devices
4
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Issued by Intertek for Canada and the US.
Instrument approvals
Furthermore, the instrument is manufactured and tested
according to the following international safety standards:
• IEC 61010-1
• IEC 61010-2-101
The instrument complies with the emission and immunity
requirements described in standard IEC61326-2-6/
EN61326-2-6.
Contact addresses
Inside the European Union and
EFTA member states
Manufacturer of the
instrument
Hitachi High-Technologies
Corporation
1-24-14 Nishi-Shimbashi
Minato-ku, Tokyo 105-8717
Japan
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Outside the European Union and
EFTA member states
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Distributed in USA by: Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana, USA
5
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Safety classifications
The safety precautions and important user notes are
classified according to the ANSIZ535.6-2011 standard.
Familiarize yourself with the following meanings and
icons:
Safety alert
r The safety alert symbol is used to alert you of
potential physical injury hazards. Obey all safety
messages that follow this symbol to avoid possible
damage to the system, injury, or death.
These symbols and signal words are used for specific
hazards:
WARNING!
Warning…
r …indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
CAUTION!
Caution…
r …indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
NOTICE!
Notice...
...indicates a hazardous situation that, if not avoided,
may result in damage to the system.
Important information that is not safety relevant is
indicated with the following icon:
i
Tip...
...indicates additional information on correct use
or useful tips.
6
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Warning messages
List of warning messages
Failure to observe warning messages may result in
death or serious injury.
r Before operating the system, read the warning
messages carefully.
Flammable material
Flammable refrigerant
The cooling unit in the analytical units contains
flammable refrigerant.
r The corresponding analytical unit can be identified by
a Risk of Fire safety label.
r Do not remove any cover of the system except those
specified in the instructions.
r Leave maintenance, installation, or service that is not
described to trained Roche Service representatives.
7
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Safety information for disposal
Disposal information
Collection of fluorocarbons
The cooling units in the analytical units contain
fluorocarbons. In some countries, fluorocarbons must be
disposed of by designated collection facilities.
r For the disposal of the cooling unit, refer to local
regulations and authorities.
u Related topics
• Fluorinated greenhouse gas (8)
8
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
Specifications – system
The following specifications apply to the system.
Fluorinated greenhouse gas
The product contains a fluorinated greenhouse gas in the
hermetically sealed refrigeration. The insulation of the
chamber includes foam blown with fluorinated
greenhouse gas.
Environmentally friendly refrigerant
As of June2021, the cooling units use HFO-1234yf as
new refrigerant. HFO-1234yf is considered a mildly
flammable refrigerant with relatively low burn velocity. It
is much more environmentally friendly than the one
previously used.
If the safety label shown in the table is placed on the rear
side, the analytical unit uses the new refrigerant.
c503 analytical unit
Type Charge weight
(kg)
CO
2
equivalent
(metric tons)
Global warming
potential
Safety label on rear of analytical unit
R-134a
0.160 0.23 1430 No safety label
HFO-1234yf
0.096 0.00038 4
CAUTION
!
CAUTION
ATTENTION
Risk Of Fire Or Explosion.
Dispose Of Properly In Accordance
With Federal Or Local Regulations.
Flammable Refrigerant Used.
Risque d'incendie ou d'explosion.
Éliminer de façon adaptée selon les
règlements fédéraux ou locaux.
Utilisation de fluide frigorigène inflammable.
y Fluorinated greenhouse gas details (c503)
e801 analytical unit
Type Charge weight
(kg)
CO
2
equivalent
(metric tons)
Global warming
potential
Safety label on rear of analytical unit
R-134a
0.170 0.24 1430 No safety label
HFO-1234yf
0.095 0.00038 4
CAUTION
!
CAUTION
ATTENTION
Risk Of Fire Or Explosion.
Dispose Of Properly In Accordance
With Federal Or Local Regulations.
Flammable Refrigerant Used.
Risque d'incendie ou d'explosion.
Éliminer de façon adaptée selon les
règlements fédéraux ou locaux.
Utilisation de fluide frigorigène inflammable.
y Fluorinated greenhouse gas details (e801)
9
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 02-01 · Addendum · Publication version 1.0
To identify the refrigerant used by the serial number of
the analytical unit, refer to eLabDoc on the Roche
DiaLog website:
www.dialog.roche.com
For more information, contact your local affiliate or
Roche Service representative.
Published by:
Roche Diagnostics GmbH
68305 Mannheim
Germany
www.roche.com
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Roche cobas pro ISE analytical unit User guide

cobas pro ISE analytical unit
Roche
Brand
Roche
Model
cobas pro ISE analytical unit
Type
User guide
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