cobas Synergy Software

Roche cobas Synergy Software, cobas Synergy Workstation User manual

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cobas Synergy software
For use with cobas
®
6800/8800 Systems (software version 1.2.13) and
Microlab
®
STAR IVD
User Assistance Version 3.0
Software version 1.2
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
2
Publication information
Edition notice This publication is intended for operators of the
cobas Synergy software for use with cobas
®
6800/8800
Systems (software version 1.2.13) and Microlab
®
STAR
IVD.
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 of this publication.
Where to find information The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
Microlab
®
STAR IVD.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
For information about the cobas
®
6800/8800 Systems,
refer to the respective User Assistance.
Publication
version
Software version Revision date Change description
1.0 1.0 December 2015 First version
1.1 1.0 May 2016 o New reports added in Operation part
o Retesting of invalid pools added
o Information added and updated for samples with high B19
titer
o Table added for minimum pool size
o Screenshots and texts updated in Configuration part
o Information about Aurora reports deleted
u What is new in publication version 1.1 (14)
2.0 1.1 December 2016 u What is new in publication version 2.0 (12)
3.0 1.2 August 2017 u What is new in publication version 3.0 (11)
y Revision history
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For test-specific information, refer to the Instructions for
Use of the respective tests.
For information about the optional pre-analytical systems,
refer to the respective user documentation.
!
General attention
To avoid serious or fatal injury and to avoid incorrect
results, ensure that you are familiar with the system, the
instructions, and safety information before you use the
system.
r Pay particular attention to all safety precautions and
safety notices.
r Always follow the instructions in this publication.
r Do not use the Microlab
®
STAR IVD in a way that is
not described in this publication.
r Do not use the software 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.
Disclaimer Not every software version applies to all markets. Some
content in this publication is related to products,
configurations, or tests which are not available in all
markets.
Screenshots The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data, 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 © 2015–2017, F. Hoffmann-La Roche Ltd. All rights
reserved.
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
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License information cobas Synergy software is protected by contract law,
copyright law, and international treaties. cobas Synergy
software contains a user license between F. Hoffmann-La
Roche Ltd. and a license holder, and only authorized
users may access the software and use it. Unauthorized
use and distribution may result in civil and criminal
penalties.
Open Source and Commercial Software cobas Synergy software may include components or
modules of commercial or open source software. For
further information on the intellectual property and other
warnings, as well as licenses pertaining to the software
programs included in cobas Synergy software, refer to
the electronic distribution included with this product.
This open source and commercial software and
cobas Synergy software as a whole can constitute a
device regulated in accordance with applicable law. For
more detailed information, refer to the user manual and
labeling.
Please note that the respective authorization is no longer
valid according to the corresponding legislation should
any unauthorized changes be made to cobas Synergy
software.
Trademarks The following trademarks are acknowledged:
Microlab is a registered trademark of Hamilton Bonaduz
AG.
COBAS, COBAS P, COBAS SYNERGY, 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 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 Microlab
®
STAR IVD 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.
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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.
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU
directives.
Issued by CSA Group for Canada and the US.
'Laboratory Equipment' is the product identifier as
shown on the type plate.
CUS
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Contact addresses
For cobas Synergy software:
Stratec Biomedical UK Limited
Centrum Point
Third Avenue
Centrum 100
Burton upon Trent
DE14 2WD
United Kingdom
For Microlab
®
STAR IVD:
HAMILTON Bonaduz AG
Via Crusch 8
CH-7402 Bonaduz
Switzerland
Made in Switzerland
Distributed in the EU by:
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Distributed in the US by:
Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana
USA
Table of contents 7
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
Table of contents
Publication information 2
Contact addresses 6
Table of contents 7
Intended use 9
Symbols and abbreviations 9
What is new in publication version 3.0 11
What is new in publication version 2.0 12
What is new in publication version 1.1 14
Safety
1 General safety information
Introduction 19
Safety classifications 20
Safety precautions 21
Warning messages 24
Caution messages 28
Notices 33
Safety labels on the instrument 36
Safety information for lasers 38
Safety information for disposal 39
Description of cobas Synergy solution
2 Overview of cobas Synergy solution
About the cobas Synergy solution 45
3 Overview of the hardware
Pooling instrument overview 53
Consumables 70
External PC 74
4 Overview of cobas Synergy software
About the data manager 77
About the pooling instrument manager 88
About user management 92
About the User Assistance 93
5 Description of the pooling process
Overview of pooling process 99
Primary pools 100
Secondary pools 101
Individual donor testing (IDT) 104
Aliquots 105
Exclusion lists 106
6 Specifications
List of pooling instrument specifications 109
System operation
7 Workflow overview
Workflow for PP24 and PP96 pooling runs 115
Workflow for PP6 pooling runs 116
Workflow for aliquot runs 117
8 Before operation
Starting up and logging on 121
9 Operation
Basic operational tasks 127
Pooling operations 134
Reporting in the data manager 174
10 After operation
Shutting down the system 183
11 Maintenance
Maintenance intervals 189
Periodic maintenance 190
Regular maintenance 201
Decontamination 202
12 Quick references
Creating a pool 208
Preparing aliquot plates 209
Evaluating pool results 210
Daily maintenance on the pooling
instrument 212
Weekly maintenance on the pooling
instrument 213
Troubleshooting
13 Troubleshooting
Troubleshooting on the Microlab
®
STAR
IVD 219
Troubleshooting on the data manager 233
List of data manager messages 236
Configuration
14 Configuration of pooling instrument manager
Managing users on the pooling instrument
manager 249
8 Table of contents
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
15 Basic configuration of data manager
About basic configuration 257
Configuring targets 260
Configuring tests 263
Configuring primary runs 266
Assigning tests to IDT runs 268
Connecting instruments 270
Additional general settings 273
Processing results automatically 275
Backing up databases 276
Archiving databases 279
16 The Configuration environment
The Configuration environment of the data
manager 285
Configuring LIS export 288
Creating messages 294
17 The Manager environment
The Manager environment of the data
manager 301
Setting system information codes 304
Managing software access 312
Locking tests, reports, and accept methods 324
Entering laboratory details 328
Viewing log files 329
Appendix
18 Key terms
Comparison of key terms 335
19 Glossary
Index 339
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Intended use
cobas Synergy software manages samples to be
processed on pre-analytic instruments as a front-end to
the cobas
®
6800/8800 Systems. The cobas Synergy
solution collects data from pooling and analyzer
instruments which allows the user to review results
against individual samples and samples which have been
pooled, creating output files from the data that can be
sent to a laboratory information system.
cobas Synergy software is intended for use by blood
establishment personnel who are trained in its operation
and are familiar with the associated tests and
instruments.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Symbols used in the publication
Product name Descriptor
cobas Synergy solution solution
cobas Synergy core core
cobas Synergy software software
Microlab
®
STAR IVD
pooling instrument
cobas
®
6800/8800 Systems
analytic system
y Product names
Symbol Explanation
o List item
Search. Used on the search tab.
Table of contents. Used on the table of
contents tab.
History. Used on the history tab to show
previously viewed topics.
Favorites. Used on the favorites tab and on the
content panel.
Enlarge. Button used on images.
Settings. Button used to open the settings
dialog.
Contact. Used in the User Assistance.
Functionality currently unavailable.
y Symbols used in the publication
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Symbols used on product
Abbreviations The following abbreviations are used.
Symbol Explanation
Global Trade Item Number.
Quantity contained in the package.
y Symbols used on product
Abbreviation Definition
AD Amplification and detection
ANSI American National Standards
Institute
ASTM American Society for Testing And
Materials
DIS Donor information system
CSA Canadian Standards Association
EC European Community
EN European standard
IEC International Electrical
Commission
IDT Individual donor testing
IU International unit
IVD In vitro diagnostic
LIMS Laboratory information
management system (another
name for laboratory information
system)
LIS Laboratory information system
n/a not applicable
QC Quality control
QS Quantitation standard
SD Standard deviation
TADM Total Aspiration Dispensing
Monitoring
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
WEEE Waste Electrical and Electronic
Equipment
y Abbreviations
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What is new in publication version 3.0
Analytic system The cobas Synergy software version 1.2 can be used
together with cobas
®
6800/8800 Systems software
version 1.2.13.
Intended use The intended-use section was updated.
u Intended use (9)
Pool details The table was updated to match the information shown in
the different panels of the software.
u List of pool details (147)
Resending test results The software now allows the resending of already d result
on the Results for review panel. The procedure for
reviewing results was updated accordingly.
u Evaluating results for review (157)
Workflows in case of high B19 titer The section was adapted to match the software version of
the analytic system.
u Handling invalid HAV results due to samples with high
B19 titer (171)
Error messages Additional messages were included.
u List of data manager messages (236)
Configuring targets The software now allows to map the result terms per
target. The description of configuring targets was
updated accordingly.
u Configuring targets (260)
Configuring tests The software now allows to configure a sample type per
test, a volume per test, and to map the result terms per
test. The description of configuring tests was updated
accordingly.
u Configuring tests (263)
Screenshots updated Screenshots that are different with the new software
version were replaced.
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What is new in publication version 2.0
Analytic system The cobas Synergy software version 1.1 can be used
together with cobas
®
6800/8800 Systems software
versions 1.1.09, 1.1.10, or 1.2.12.
Sorting and filtering of tables A new section about sorting and filtering of tables has
been added.
u Sorting and filtering data in tables (86)
User management New sections about the user management have been
added.
u About user management (92)
u Managing users on the data manager (322)
Exclusion lists A new section explaining the exclusion lists has been
added.
u Exclusion lists (106)
Pooling and aliquot workflows A new chapter with a summary about the pooling and
aliquot workflows has been added.
Quick references A new chapter with quick reference information has been
added.
Masking a test order The section about masking a test order has been updated
and expanded.
u About masking a test order (154)
Searching samples A new section about searching samples has been added.
u Searching samples (173)
Workflows in case of high B19 titer The section was moved to the Operation chapter. The
description was extended to differentiate between
different software versions of the analytic system.
New cobas Synergy reports Information about the new cobas Synergy reports has
been added.
• Where is my sample report
• Testing summary report
• Invalid test results report
• Pooler performance report
• Pooler performance export report
u cobas Synergy reports (175)
Handling sample barcode errors A new section about the handling of sample barcode
reading errors has been added.
u Sample barcode reading error (220)
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Data manager messages A list of data manager messages has been added. The list
includes possible causes and recommended actions.
u List of data manager messages (236)
Backing up and archiving databases The sections about backing up and archiving databases
have been updated.
Archiving can be performed online now.
u Backing up databases (276)
u Archiving databases (279)
User Assistance New context links for the Administration tab have been
added to the User Assistance of the data manager.
u About basic configuration (257)
General improvements General improvements have been made throughout this
publication.
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What is new in publication version 1.1
cobas Synergy reports added In the Operation part, new cobas Synergy reports were
integrated in the procedures. All reporting options in the
data manager were summarized in one new section.
Descriptions of reporting in other places were shortened
and instead referenced to the new section.
u Reporting in the data manager (174)
Repeat testing on the analytic system Information was added about repeat testing on the
analytic system in case of invalid results.
u Repeat testing on the analytic system after an invalid
test result (169)
Workflows in case of high B19 titer The section describing workflows in case of samples with
high B19 titer was updated and extended.
Minimum pool size An overview table for the minimum pool size was added.
u Additional general settings (273)
Updates in Configuration part Screenshots and texts in the Configuration part were
updated to reflect changes in the user interface.
u The Configuration environment (283)
u The Manager environment (299)
Aurora reports The chapter describing Aurora reports was deleted
(legacy functionality only). Recommendation not to use
Aurora reports was added.
u Reporting in the data manager (174)
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Safety
1 General safety information.................................................................................. 17
1 General safety information
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Table of contents
General safety information 1
In this chapter
1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operator qualification . . . . . . . . . . . . . . . . . . . . . . . 21
Safe and proper use of the instrument . . . . . . . . . 21
Miscellaneous safety precautions . . . . . . . . . . . . . 23
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Optical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 25
Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Explosion and fire . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Proper identification. . . . . . . . . . . . . . . . . . . . . . . . . 29
Contamination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Collection media and other working solutions . . . 30
Fatigue due to long hours of operation . . . . . . . . . 31
Electromagnetic interference . . . . . . . . . . . . . . . . . 31
IT security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Moving parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Circuit breakers and fuses . . . . . . . . . . . . . . . . . . . 33
Pipetting channels . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Proper loading and handling . . . . . . . . . . . . . . . . . 34
Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Safety labels on the instrument . . . . . . . . . . . . . . . . . . 36
List of safety labels on the instrument. . . . . . . . . . 36
Location of safety labels on the instrument . . . . . 37
Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 38
Safety information for disposal. . . . . . . . . . . . . . . . . . . 39
Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 39
1 General safety information
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cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
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Table of contents
1 General safety information
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
General safety information 19
Introduction
!
General attention
To avoid serious or fatal injury, read this publication
thoroughly before you use the instrument.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument 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.
1 General safety information
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Assistance · Version 3.0
20 Safety classifications
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 to potential
physical injury hazards. Obey all safety messages that
follow this symbol to avoid possible damage to the
components of the cobas Synergy solution, 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.
/