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cobas c 513

Roche cobas c 513 User manual

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cobas c 513 analyzer
Safety Manual
Version 5.0
Software Version 02-04
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
2
Publication information
Edition notice This publication is intended for operators of the
cobas c 513 analyzer.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version.
Where to find information The User Assistance contains all information about the
product.
The Safety Manual contains important safety
information. You must read the Safety Manual before
operating the system.
The Operator’s Manual focuses on operation and
maintenance. It contains the content below.
• System description
• Routine operation
• Maintenance
• Advanced operation
• Troubleshooting information
• Software description
!
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.
Publication
version
Software version Revision date Change description
1.0 01-01 September 2015 Version 1.0
2.0 02-01 January 2016 Minor revisions.
3.0 02-02 October 2016 Minor revisions.
4.0 02-03 July 2017 Minor revisions.
5.0 02-04 January 2019 Minor revisions.
y Revision history
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
3
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.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Copyright © 2015-2019, Roche Diagnostics GmbH. All rights
reserved.
Trademarks The following trademarks are acknowledged:
COBAS and COBAS C are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.
Approvals The cobas c 513 analyzer 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.
Directive 2011/65/EU of the European Parliament and of
the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.
The following marks demonstrate compliance.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
4
The cobas c 513 analyzer is manufactured and tested
according to the international safety standards below.
• IEC 61010-1
• IEC 61010-2-101
The RFID readers of the cobas c 513 analyzer meet the
requirements laid down in:
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.
The full text of the 2014/53/EU declaration of conformity
is available at the following internet address:
http://e-labdoc.roche.com
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.
Complies with the IVD directive 98/79/EC and the
directive 2011/65/EU on RoHS.
Complies with the IVD directive 98/79/EC.
Complies with the directive 2011/65/EU on RoHS.
Issued by Intertek to prove compliance with safety
standards for Canada and the US.
Type
Charge weight
(kg)
CO
2
equivalent
(tonne)
Global
warming
potential
R-134a 0.160 0.23 1430
y Fluorinated greenhouse gas detail
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
5
License agreement for UltraVNC software on
the control unit
UltraVNC is a piece of free software for all commercial
uses. It is installed on the control unit of the
cobas c 513 analyzer.
You can redistribute the software and/or modify it under
the terms of the GNU General Public License (version 2 or
later), as published by the Free Software Foundation.
A copy of the GNU General Public License (version 2) is
stored on the control unit of the cobas c 513 analyzer.
The pathway for the license is C:\Program Files\uvnc
bvba\UltraVNC.
The software is distributed without warranty. There is no
implied warranty of merchantability or fitness for a
particular purpose. For more information, see the GNU
General Public License at http://www.gnu.org/licenses.
The source code for the software is stored on the control
unit PC of the cobas c 513 analyzer. The pathway for the
source code is C:\DriversAndTools\UltraVNC.
Contact addresses
Inside the European Union and
EFTA member states
Outside the European Union and
EFTA member states
Manufacturer of
cobas c 513 analyzer
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
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
6
T
able of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 7
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
About operator qualification . . . . . . . . . . . . . . . . . . 11
About safe and proper use of the system . . . . . . . 11
Miscellaneous safety precautions overview . . . . . 14
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 17
Reagents and other working solutions . . . . . . . . . 18
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
System status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Reagents and other working solutions . . . . . . . . . 24
External media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Fatigue due to long hours of operation . . . . . . . . . 25
Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Heat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Analyzer damage . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Electromagnetic interference . . . . . . . . . . . . . . . . . 28
Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Emergency stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Safety labels on the system. . . . . . . . . . . . . . . . . . . . . . 31
List of safety labels on the analyzer . . . . . . . . . . . . 31
Location of safety labels on the analyzer . . . . . . . 33
Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 37
Barcode reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Safety information for disposal. . . . . . . . . . . . . . . . . . . 38
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Preface 7
Preface
Use this publication together with the
cobas c 513 analyzer Operator’s Manual.
Intended use
The cobas c 513 analyzer is a fully automated,
standalone clinical chemistry analyzer intended for the
in-vitro quantitative determination of analytes in body
fluids.
Symbols and abbreviations
Product names Except where the context clearly indicates otherwise, the
product names below are used.
Symbols used in the publication
Abbreviations The abbreviations below are used.
Product name Term
cobas c 513 analyzer system system
cobas c 513 analyzer analyzer
cobas c 513 analyzer
software
software
cobas c pack reagent cassette
cobas
®
user assistance
User Assistance
y Product names
Symbol Explanation
o List item
u Related topics containing further information
q Tip. Extra information on correct use or useful
hints.
w Figure. Used in figure titles and cross-references
to figures.
y Table. Used in table titles and cross-references to
tables.
y Symbols used in the publication
Abbreviation Definition
ANSI American National Standards Institute
CAS Canadian Standards Association
CTS Closed Tube Sampling
EC European Community
EN European Standard
y Abbreviations
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
8 Preface
IEC International Electrical Commission
IVD In Vitro Diagnostic
LIS Laboratory Information System
QC Quality Control
RFID Radio Frequency Identification
RoHS Restriction of Hazardous Substances
SD Standard Deviation
UL Underwriters Laboratories
WEEE Waste Electrical and Electronic Equipment
Abbreviation Definition
y Abbreviations
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Introduction 9
Introduction
!
General attention
To avoid serious or fatal injury, read this publication
thoroughly 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 Keep this publication in a safe place to ensure that it
is not damaged and remains available for use.
This publication must always be easily accessible.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
10 Safety classifications
Safety classifications
The safety precautions and important user notes are
classified according to the ANSI Z535.6 standard.
Familiarize yourself with the following meanings and
icons:
!
Safety alert
r The safety alert symbol is used to alert you to 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 which, if not avoided,
could result in death or serious injury.
CAUTION
!
Caution...
r ...indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
NOTICE
Notice...
r ...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:
q Tip...
...indicates additional information on correct use or useful
tips.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Safety precautions 11
Safety precautions
!
To avoid serious or fatal injury, read and
comply with the following safety precautions.
In this section
About operator qualification (11)
About safe and proper use of the system (11)
Miscellaneous safety precautions overview (14)
About operator qualification
Insufficient knowledge and skills As an operator, ensure that you know the relevant safety
precaution guidelines and standards, and the information
and procedures contained in these instructions.
r Do not carry out operation and maintenance unless
Roche Diagnostics has trained you to do so.
r Leave maintenance, installation, or service that is not
described to trained Roche Service representatives.
r Carefully follow the procedures specified in the
instructions for operation and maintenance.
r Follow good laboratory practices, especially when you
work with biohazardous material.
About safe and proper use of the system
Missing personal protective equipment Working without personal protective equipment means
danger to life or health.
r Wear appropriate personal protective equipment,
including, but not limited to, the following items:
o Eye protection with side shields
o Fluid-resistant laboratory coat
o Approved lab gloves
o Face shield if there is a chance of splashing or
splattering
r Follow good laboratory practices and regularly change
lab gloves to minimize the risk of infection and
contamination, especially after contact with waste or
sample material.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
12 Safety precautions
Exposure to chemicals r Avoid exposure to chemicals.
Exposure to infectious waste Failure to place an appropriate waste container at the
waste outlet can lead to exposure to infectious waste
material.
r Always place a waste container at the waste outlet
during operation.
r Check the liquid level sensor is fully inserted into the
liquid waste container.
r Follow good laboratory practices and regularly change
lab gloves to minimize the risk of infection and
contamination, especially after contact with waste or
sample material.
Regular cleaning To prevent inaccurate results and unsafe operation of the
system:
r Regularly clean and/or decontaminate the analyzer as
required. Follow good laboratory practices for
cleaning and decontamination.
r Ensure that the laboratory is regularly cleaned and is
maintained in an orderly manner.
Approved cleaning solutions r Use only approved cleaning solutions for cleaning.
Errors in installation Only trained Roche Service representatives may install
the system.
r Leave installation that is not described to trained
Roche Service representatives.
Exchange or removal of parts Unauthorized exchange or removal of system parts can
damage the system or stop it from functioning correctly.
r Do not exchange or remove any part of the analyzer
that is not described in the user documentation.
r Leave replacement of parts not described in the user
documentation to trained Roche Service
representatives.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Safety precautions 13
Unsuitable environmental conditions Operation outside of the specified ranges may lead to
incorrect results or malfunction of the system.
r Use the system indoors only, and avoid heat and
humidity outside of the specified range.
r Make sure that the system's ventilation openings
always remain unobstructed.
r To maintain the environmental conditions of the
system, perform maintenance in accordance with the
specified intervals.
r Keep the operating instructions undamaged and
available for use. Operating instructions must be
easily accessible for all users.
u For the allowable environmental conditions, see the
user documentation.
Non-approved spare parts Use of non-approved spare parts or devices may result in
malfunction of the system and may render the warranty
null and void.
r Use only spare parts and devices approved by Roche
Diagnostics.
Non-specified third-party software Installation of third-party software is not approved by
Roche Diagnostics and may result in malfunction.
r Do not install third-party software.
Non-specified consumables Use of non-specified consumables can lead to incorrect
results.
r Do not use consumables that are not intended for use
with the system.
u For a list of supported materials, see the user
documentation.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
14 Safety precautions
Miscellaneous safety precautions overview
Power interruption A power failure or momentary drop in voltage may
damage the system or lead to data loss.
r It is recommended to use an uninterruptible power
supply (UPS).
r Ensure regular maintenance of the UPS.
r Perform regular backup of results and system
parameters.
r Do not switch off power while the control unit
accesses the hard disk or storage device.
Electromagnetic compatibility The cobas c 513 analyzer complies with the standard
IEC 61326-2-6/EN 61326-2-6. It has been designed and
tested to CISPR 11 Class A. In a domestic environment it
may cause radio interference, in which case, you may
need to take measures to mitigate the interference.
The electromagnetic environment should be evaluated
prior to operation of the device.
• Do not operate this instrument in close proximity to
sources of strong electromagnetic fields (for example,
unshielded intentional radio frequency sources), as
they may interfere with proper operations.
• Do not operate the following devices in close
proximity to the instrument:
- Mobile phones
- Transceiver
- Cordless phones
- Other electrical devices that generate strong
electromagnetic fields.
The RFID reader in the cobas c 513 analyzer complies
with the emission requirements described in this part of
the FCC CFR 47, Part 15 Class A.
System not used for an extended period r Follow the extended shutdown procedure in the user
documentation.
r Set the main circuit breaker switches to OFF if you do
not use the system for an extended period.
r Remove and refrigerate any remaining reagents and
controls.
r For further information, contact your Roche Service
representative.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Safety precautions 15
Damage in transit r Do not attempt to relocate or transport the system.
r Leave relocation and transportation to Roche Service
representatives.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
16 Warning messages
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.
In this section
Electrical safety (16)
Biohazardous materials (17)
Reagents and other working solutions (18)
Maintenance (21)
QC (21)
Waste (21)
Electrical safety
Electric shock Removing the covers of electronic equipment can cause
electric shock because there are high-voltage parts
inside.
r Do not attempt to work on any electronic equipment.
r Do not remove any cover of the analyzer except those
covers specified in the instructions.
r Only Roche Service representatives may install,
service, and repair the analyzer.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Warning messages 17
Biohazardous materials
Operator infection and injury Contact with system mechanisms, for example, sample
probes, reagent probes, rinse stations, the reaction cell
rinse unit, or with the system chassis or covers, may result
in personal injury and infection.
r Keep all covers and doors closed and in place while
the system is operating. An interlock system prevents
operation of moving parts when the covers are open.
r Always ensure that the system is powered off, in sleep
mode, or in standby mode, before you work with an
opened cover, for example, for cleaning or
maintenance.
r Do not open the covers while the system is performing
maintenance.
r Make sure the covers are fully open to avoid hitting
your head.
r Do not touch any parts of the analyzer other than
those specified.
r Never reach into the analyzer while parts are moving.
r Carefully observe all instructions given in this safety
manual.
Infectious samples Contact with samples containing material of human origin
may result in infection. All materials and mechanical
components associated with samples containing material
of human origin are potentially biohazardous.
r Follow good laboratory practices, especially when
working with biohazardous material.
r Keep all covers closed while the system is operating.
r Wear appropriate personal protective equipment.
r If any biohazardous material is spilled, wipe it up
immediately and apply laboratory disinfectant.
r If sample or waste comes into contact with your skin,
wash the affected area immediately with soap and
water and apply disinfectant.
Consult a physician.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
18 Warning messages
Sharp objects Contact with probes may result in infection.
r When you wipe probes, use several layers of lint-free
cloth and wipe from the top down.
r Take care not to puncture yourself.
r Wear appropriate personal protective equipment.
Take extra care when working with lab gloves. They
can easily be pierced or cut, leading to infection.
r Take care not to touch the tips of the sample or
reagent probes without personal protective
equipment.
Smoke due to electrical malfunction Electrical malfunction can result in the emission of
hazardous smoke. Inhaling smoke emitting from the
analyzer can lead to personal injury.
r If you see smoke coming from the analyzer:
o Avoid inhaling
o Disconnect from power supply
o Contact your Roche Service representative
immediately
Troubleshooting procedures Corrective measures in troubleshooting procedures can
result in exposure to biohazardous materials.
r Always follow the troubleshooting procedures given in
software wizards and/or in the user documentation.
r Wear appropriate personal protective equipment
when implementing corrective measures.
Reagents and other working solutions
Foam, clots, films, or air bubbles Incorrect results may occur due to foam, clots, films, or air
bubbles in reagents or samples.
r Ensure good sample preparation and reagent
handling techniques to avoid the formation of foam,
clots, and air bubbles in all reagents, samples,
calibrators, and controls.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
Warning messages 19
Evaporation of samples or reagents Evaporation of samples or reagents may lead to incorrect
or invalid results. The term reagent applies to all reagent
cassettes and system reagents.
r Sample material may evaporate if left open. Do not
leave samples open for any length of time.
r Open the cover of the reagent disk only when
necessary.
r Reagents may evaporate if the cover of the reagent
disk is left open. Do not leave the cover of the reagent
disk open longer than necessary.
r Do not use improperly stored reagents. Ensure that
reagents are stored according to the Instructions for
Use.
r Do not use expired reagents.
Expired calibrators or controls Use of expired calibrators or controls may lead to
incorrect or invalid results.
r Calibrators and controls may evaporate if left open. Do
not leave calibrators or controls open for any length of
time.
r Do not use improperly stored calibrators or controls.
Ensure that calibrators and controls are stored
according to the Instructions for Use.
r Do not use expired calibrators or controls.
Incorrect reagent volume Incorrect reagent handling may cause an undetectable
loss of reagent. The term reagent applies to all reagent
cassettes and system reagents.
r Always store reagents according to the specified
storage conditions as stated in the Instructions for Use
for the test.
r Do not use a reagent cassette or reagent bottle whose
reagent has spilled.
Overfilling of sample containers Overfilling of sample containers may cause splashing of
the sample during transportation.
r Leave approximately 10 mm clearance between the
sample liquid and the top of the tube or cup.
Roche Diagnostics
cobas c 513 analyzer · Software Version 02-04 · Safety Manual · Version 5.0
20 Warning messages
Incorrect handling of samples Incorrect handling of samples may cause incorrect
results.
r Do not load samples on the analyzer that have an
unusually high viscosity.
r Before you load samples on the analyzer, wait for the
samples to be at room temperature.
Incorrect use of barcode labels Incorrect use of barcode labels may cause incorrect
results.
r Use barcode labels of the correct specification.
r When you attach barcode labels to sample tubes,
ensure they are readable.
r To prevent undetected barcode read errors, use
barcodes with check digits.
r Ensure that all ITF barcode labels used have the same
number of digits.
q For more information about barcode labels, see the
list of barcode specifications in the Operator’s Manual or
User Assistance.
Incorrect loading of sample containers on
racks
Incorrect loading of sample containers may cause
incorrect results.
r Load sample containers of the correct specification on
racks.
r Specify rack ranges for sample types. Load sample
containers and types in the correct rack ranges.
r Only use sample tube types on CTS racks that are
configured on the system.
r Load sample tube types in the correct rack ranges.
q For more information about sample containers, see
the list of sample container specifications in the
Operator’s Manual or User Assistance.
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