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cobas Synergy Software

Roche cobas Synergy Software, cobas Synergy Workstation User guide

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cobas Synergy software
For use with cobas
®
6800/8800 Systems and Microlab
®
STAR IVD
User Guide Version 3.1
Software version 1.2
Roche Diagnostics
cobas Synergy software · Software version 1.2 · User Guide · Version 3.1
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Publication information
Edition notice This publication is intended for operators of the
cobas Synergy software for use with cobas
®
6800/8800
Systems 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
u What is new in publication version 1.1 (15)
2.0 1.1 December 2016 u What is new in publication version 2.0 (13)
3.0 1.2 August 2017 u What is new in publication version 3.0 (11)
3.1 1.2 August 2018 Update done for cobas Synergy software patch 5.
This publication is in accordance with analytic software
versions 1.2.13, 1.2. 14, 1.3.8, and 1.3.9.
u What is new in publication version 3.1 (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 © 2015–2018, F. Hoffmann-La Roche Ltd. All rights
reserved.
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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
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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 3.1 11
What is new in publication version 3.0 11
What is new in publication version 2.0 13
What is new in publication version 1.1 15
System operation
1 Workflow overview
Workflow for PP24 and PP96 pooling runs 21
Workflow for PP6 pooling runs 22
Workflow for PP1 pooling runs 23
Workflow for aliquot runs 24
2 Before operation
Starting up and logging on 27
3Operation
Basic operational tasks 33
Pooling operations 40
Reporting in the data manager 82
4 After operation
Shutting down the system 91
5Maintenance
Maintenance intervals 97
Periodic maintenance 98
Regular maintenance 109
Decontamination 110
6 Quick references
Creating a pool 116
Preparing aliquot plates 117
Evaluating pool results 118
Daily maintenance on the pooling
instrument 120
Weekly maintenance on the pooling
instrument 121
Appendix
7 Key terms
Comparison of key terms 127
8 Glossary
Index 131
8 Table of contents
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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
u Related topics containing further information
q
Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of an action within a task.
c Frequency of a task.
n Duration of a task.
d Materials that are required for a task.
j Prerequisites of a task.
u Topic. Used in cross-references to topics.
p Task. Used in cross-references to tasks.
w
Figure. Used in figure titles and cross-
references to figures.
y Symbols used in the publication
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Symbols used on product
Abbreviations The following abbreviations are used.
y
Table. Used in table titles and cross-references
to tables.
z
Equation. Used in cross-references to
equations.
k
Code example. Used in code titles and cross-
references to codes.
Symbol Explanation
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number.
Quantity contained in the package.
y Symbols used on product
Abbreviation Definition
AD Amplification and detection
ALR Above Linear Range
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
y Abbreviations
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What is new in publication version 3.1
Analytic system The cobas Synergy software version 1.2 can be used
together with cobas
®
6800/8800 Systems software
version 1.2.13, 1.2.14, 1.3.8, and 1.3.9.
Workflow for primary pools of 1 A workflow for primary pools of 1 (PP1) was implemented.
Use the PP1 pooling run workflow when your laboratory is
using the same sample ID on multiple sample tubes with
different sample types from the same donor. For example,
create a primary pool of 1 from the plasma sample tube to
run a plasma PP1 test whereas the other sample tubes
from the same donor are used to run a whole blood IDT
test and a plasma PP6 test.
Reactive primary pools of 1 do not need to be resolved.
The result of a primary pool of 1 is the final result.
Therefore, no secondary pools for reactive primary pools
of 1 are created.
u Refer to the section Overview of pooling process in the
User Assistance
u Refer to the section Primary pools of 1 in the User
Assistance
u Workflow for PP1 pooling runs (23)
u To force an invalid HAV result to be unresolved for an
IDT or PP1 sample p (78)
u Using sample tubes with the same sample ID for
different sample types (79)
u Refer to the section Minimum pool size in the User
Assistance
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.
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
WEEE Waste Electrical and Electronic
Equipment
Abbreviation Definition
y Abbreviations
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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 (53)
Resending test results The software now allows the resending of already
released result on the Results for review panel. The
procedure for reviewing results was updated accordingly.
u Evaluating results for review (63)
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 (77)
Error messages Additional messages were included.
u List of data manager messages (246)
Configuring targets The software now allows to map the result terms per
target. The description of configuring targets was
updated accordingly.
u Configuring targets (270)
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 (273)
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 For details, refer to the cobas Synergy software User
Assistance
User management New sections about the user management have been
added.
u For details, refer to the cobas Synergy software User
Assistance
Exclusion lists A new section explaining the exclusion lists has been
added.
u For details, refer to the cobas Synergy software User
Assistance
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 (60)
Searching samples A new section about searching samples has been added.
u Searching samples (80)
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 (83)
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Handling sample barcode errors A new section about the handling of sample barcode
reading errors has been added.
u For details, refer to the cobas Synergy software User
Assistance
Data manager messages A list of data manager messages has been added. The list
includes possible causes and recommended actions.
u For details, refer to the cobas Synergy software User
Assistance
Backing up and archiving databases The sections about backing up and archiving databases
have been updated.
Archiving can be performed online now.
u For details, refer to the cobas Synergy software User
Assistance
User Assistance New context links for the Administration tab have been
added to the User Assistance of the data manager.
u For details, refer to the cobas Synergy software User
Assistance
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 (82)
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 (76)
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System operation
1 Workflow overview................................................................................................. 19
2 Before operation..................................................................................................... 25
3 Operation................................................................................................................... 31
4 After operation ........................................................................................................ 89
5 Maintenance ............................................................................................................ 95
6 Quick references ..................................................................................................115
1 Workflow overview
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Table of contents
Workflow overview 1
In this chapter
1
Workflow for PP24 and PP96 pooling runs . . . . . . . . . 21
Workflow for PP6 pooling runs. . . . . . . . . . . . . . . . . . . 22
Workflow for PP1 pooling runs. . . . . . . . . . . . . . . . . . . 23
Workflow for aliquot runs . . . . . . . . . . . . . . . . . . . . . . . 24
1 Workflow overview
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Table of contents
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