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cobas 8000 Data Manager

Roche cobas 8000 Data Manager User manual

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cobas
®
8000 data manager
Operator's Manual
Version 14
Software version 1.06.09
(01)07613336172728(8012)1.06.09
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
2
Document information
Revision history
Manual version Software version Revision date Main changes
1.0 1.0 Jun-2009 First version of this Operator’s Manual.
1.01 1.01 Jan-2010 E-module support
1.02 1.02 Oct-2010 Terminology: "Technical validation" changed to
"Validation", "Instrument data alarm" changed to
"data alarm".
User Interface: New information window system
message for software update package, buttons
changed.
Rounding rules for immunology test rounding
implemented.
Pass-through mode: new chapter in operator
manual.
TraceDoc chapter enhanced and renamed to "Data
cleanup and archiving".
1.03 (Revision 1) 1.03 Jul-2012 Creation of standalone version of data manager
operator’s manual.
Integration of software update installer chapter.
Integration of Online Help content into print version.
New glossary for standalone manual.
Update of TraceDoc chapter.
Added description of sequence mode.
Added workflows in chapter pass-through mode
and software update installer.
Version 5 1.04 Feb-2014 Restructured manual.
Added workplace overview chart in chapter
Introduction.
Updated procedures on software update, creating a
calculated test, setting up a non-Roche QC material.
Data alarms chapter added.
Version 6 1.05 Aug-2014 Updated procedures on software update, creating a
calculated test.
Forward instrument status
TSN agent upload data points for all heterogeneous
immunoassays
TSN agent split result upload for ISE, CC, and HET-
IA
Version 7 1.06 May-2016 Restructured manual.
Added images to task steps, concepts, and
references.
Added cobas e 801 module with cobas e flow test.
Update QC type for asymmetric QC range.
Version 8 1.06.01 Jan-2017 Calculated QC result validation
Host code assignment for cobas e flow test
Data cleanup options
Sample life time option
Version 9 1.06.05 Nov-2017 Additional information related to cobas e flow tests
New workflow for host code assignment
New options for sending omitted results to the host
New cobas e flow test upload options
y Revision history
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
3
Edition notice
This publication is intended for users of the cobas
®
8000
data manager software.
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 For information on the individual components of the
cobas
®
8000 modular analyzer series see:
The Safety Manual contains important safety
information. You must read the Safety Manual before
operating the instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
The Online Help contains the content of the Operator’s
Manual, Safety Manual and additionally:
• Troubleshooting information
• A software reference
• Configuration information
• Information about basic analytical principles
The PC manufacturer’s manual contains all information
about the hardware.
Version 10 1.06.06 Mar-2018 o Removal of QC standby bottles component
from the cobas 8000 data manager QC
Routine workplace
u What is new in manual version 10? (16)
Version 11 1.06.07 Nov-2018
Version 12 1.06.08 Mar-2019 Data archiving to network storage
u What is new in manual version 12? (16)
Version 13 1.06.09 Mar-2021 Changing expired password.
Automated third party QC materials.
Default profiles for routine and STAT samples
without test orders.
Panels updated related to cobas e flow tests.
Details on some user interface options and functions
added
Screenshots updated
u What is new in manual version 13? (14)
Version 14 1.06.09 May-2021 u What is new in publication version 14? (14)
Manual version Software version Revision date Main changes
y Revision history
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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!
General attention
To avoid incorrect results, ensure that you are familiar
with the instructions and safety information.
r Pay particular attention to all safety notices.
r Always follow the instructions 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.
!
Incident reporting
r Inform your Roche representative and your local
competent authority about any serious incidents
which may occur when using this product.
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 © 2009–2021, F. Hoffmann-La Roche Ltd. All rights
reserved.
License information
cobas
®
8000 data manager software is protected by
contract law, copyright law, and international treaties.
cobas
®
8000 data manager 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.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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License agreement for UltraVNC software UltraVNC is a piece of free software for all commercial
uses. It is installed on the control unit PC of the
cobas
®
8000 modular analyzer series.
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 PC and on the data manager
server. The path 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. The path for the source code is
C:\DriversAndTools\UltraVNC.
Open source and commercial software
cobas
®
8000 data manager 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
®
8000 data manager, refer
to the electronic distribution included with this product.
This open source and commercial software and
cobas
®
8000 data manager as a whole can constitute a
device regulated in accordance with applicable law. For
more detailed information, refer to the corresponding
user documentation and labeling.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to cobas
®
8000 data
manager.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS E, 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.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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Approvals
The cobas
®
8000 data manager meets the requirements
laid down in:
Regulation (EU) 2017/746 of the European Parliament
and of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU
regulations.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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Contact addresses
Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm
eLabDoc Electronic user documentation can be downloaded using
the eLabDoc e-service on Dialog:
www.dialog.roche.com
For more information, contact your local affiliate or Roche
Service representative.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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Table of contents 9
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
Table of contents
Document information 2
Contact addresses 7
Table of contents 9
Intended use 11
Symbols and abbreviations 12
What is new in publication version 14? 14
What is new in manual version 13? 14
What is new in manual version 12? 16
What is new in manual version 10? 16
What is new in the manual version 9? 17
What is new in the manual version 8? 18
What is new in the manual version 7? 19
Safety
1 General safety information
Introduction 25
Safety classifications 26
Safety precautions 27
Warning messages 29
Caution messages 30
Notices 33
Disposal of the equipment 34
Operation
2 Introduction
Introduction to the cobas
®
8000 data
manager 39
The cobas
®
8000 data manager and
associated workflows 40
Starting the data manager 45
Working with the interface 46
Features accessed via Sidebar 52
Working with tables 60
About searching for data 65
Searching for Value Sheets 68
Using the Online Help 70
3 Routine tasks
Quick reference: Main workflow 75
About cobas e flow tests 78
Working with samples 85
Working with tests 117
Validating test results 137
Reporting test results 150
Masking and unmasking tests 154
Reviewing system status 164
Viewing system alarm details 165
QC tasks 166
4 Data cleanup and archiving
Data cleanup 197
About the Interface options tab 213
About uploading data to Roche or to the
host 216
Data archiving 217
About deleting data 223
Browsing data using the TraceDocViewer 224
List of TraceDocViewer interface elements 231
5 Software update installer (SUI)
Software update 247
Update procedures 255
Troubleshooting 266
Glossary
6 Glossary
Index 275
10 Table of contents
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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Intended use
Intended use statement for US only
The cobas
®
8000 data manager provides data and
workflow management for the in vitro diagnostic medical
device cobas
®
8000 modular analyzer series.
Intended use statement for EU/EFTA and
outside US
The cobas
®
8000 data manager provides data and
workflow management for the in vitro diagnostic medical
device cobas
®
8000 modular analyzer series.
For cobas e flow tests, measured on cobas e 801
modules, the cobas
®
8000 data manager provides
predefined workflow management and performs result
calculation and reporting.
List of available accessories and
consumables
For a list of globally available accessories and
consumables, refer to the cobas
®
8000 modular analyzer
series Operator’s Manual.
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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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Symbols and abbreviations
Visual cues are used to help locate and interpret
information in this document quickly. This section
explains formatting conventions used in this document.
Symbols used in the publication
Symbols used on product
Abbreviations The following abbreviations are used:
Symbol Explanation
o List item.
u Cross-reference to another topic.
q
Tip. Extra information on correct use or useful
hints.
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.
w
Figure. Used in figure titles and cross-
references to figures.
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.
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number.
Catalog number.
Unique device identifier.
Caution. Consult the instructions for use.
Consult instructions for use on this website:
www.dialog.roche.com.
y Symbols used on product
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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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Abbreviation Definition
ACN Application Code Number. Unique
reference number to identify and to
manage downloaded files across the
whole system, e.g. parameter files for
applications, QC materials,
calibrators, etc.
ANSI American National Standards
Institute
AU1, AU2, … Analytical Unit 1, 2, … (used in the
user interface only)
c module Photometric module (e.g. c 702,
c 701, or c 502)
c 502 cobas c 502 module for clinical
chemistry
c 701 cobas c 701 module for clinical
chemistry
c 702 cobas c 702 module for clinical
chemistry
c7-1, c7-2, c7-3 First, second, third module of the
instrument (e.g. c 702, c 701, or
c 502)
Cal., CAL Calibration
Cfas Calibrator For Automated Systems
ClinChem Clinical chemistry
CV Coefficient of Variation (%)
CU Control unit
DM Data manager
e module Heterogeneous immunoassay
modules (e.g. e 602 or e 801)
e 602 cobas e 602 module for
heterogeneous immunoassay analysis
e 801 cobas e 801 module for
heterogeneous immunoassay analysis
e6-1, e6-2, e6-3 First, second, third module of the
instrument (e.g. e 602 or e 801)
e.g. Exempli gratia – for example
HIS Hospital information system
ID Identification
i.e. Id est – that is to say
ISE Ion Selective Electrode; also used for
ISE module
ISO International Organization for
Standardization
IVD In Vitro Diagnostic
IVDR In Vitro Diagnostic Directive
LIS Laboratory information system
n/a Not applicable
PC/CC ProCell/CleanCell, system reagents
used on the e 602 and e 801 module
y Abbreviations
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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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What is new in publication version 14?
Regulatory adaptations The following information was added as part of the
adaptation to the EU regulation 2017/746 on in vitro
diagnostic medical devices:
• Information about incident reporting
• Link to the worldwide list of Roche affiliates
• Download information about electronic user
documentation
What is new in manual version 13?
An overview of the changes compared to the previous
version of the manual is provided below.
Changing expired password On the Sidebar. a new button allows you to change an
expired password or to set the password at first login.
u Changing an expired password (58)
Automated third party QC materials Automated third party QC materials are non-Roche QC
materials where the parameter file is downloaded from
cobas® link. The analyzer handles automated third party
QC results in the same way as QC results from Roche QC
materials providing you observe specific rules for rack
loading and container type.
PCCC1 PreciControl ClinChem Multi 1, a
Roche QC material
PCCC2 PreciControl ClinChem Multi 2, a
Roche QC material
QC Quality control
SB Standby
SD Standard deviation
sFTP Secure File Transfer Protocol
SPR Special Reagent
STAT Short turnaround time
Std Standard, commonly used for
calibrator
SU Rack Sampler Unit, the rack
loader/unloader
(SU is used on the Overview menu)
WEEE European Waste Electrical and
Electronic Equipment Directive
Abbreviation Definition
y Abbreviations
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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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cobas e flow tests The following panels related to cobas e flow tests have
been updated:
u About the Sample overview component (97)
u About the Day list component (103)
u About the Validation component (118)
Details on some user interface options and
functions added
Details have been added for the following options and
functions:
• Show all tests for this sample check box on the
Day list component
• Masking and unmasking of ISE tests
• Refresh button on the QC Routine component
• Impact of QC bracketing on the result release timing
for cobas e flow tests.
• Table of QC bracketing actions updated
• Structuring data on an external storage device when
using the TraceDocViewer,
• The SUI button does not change its color and stays
yellow if a mandatory release was acknowledged.
• Target values for non-Roche QC material can be
negative.
• Make sure that all tests in the Formula input are
used in the formula.
• New default profile function added for routine and
STAT samples without test orders.
• About resending a cobas e flow test result to the host
when the cobas e flow test was deactivated.
• Modifying the result type value might be necessary
after test installation to change the default result type
(qualitative/quantitative) to another value.
• Show intermediate results check box on the Test
details panel.
• Where to display the currently installed versions of the
cobas
®
8000 data manager software.
u About the Day list component (103)
u About masking and unmasking tests (154)
u About the QC Routine component (177)
u About QC bracketing (182)
u About the TraceDocViewer (224)
u About the software update installer (SUI) (248)
Screenshots The following screenshots have been updated:
u Test result report with sample lifetime
information (150)
u cobas 8000 data manager Service > Service-related
configuration > TSN agent tab (216)
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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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What is new in manual version 12?
An overview of the changes compared to the previous
version of the manual is provided below.
Archiving to network storage The system supports data archiving to a network storage.
u Archiving data (199)
What is new in manual version 10?
An overview of the changes compared to the previous
version of the manual is provided below.
QC standby bottles The QC standby bottles component has been removed
from the cobas 8000 data manager QC Routine
workplace. Its functionality has been integrated in the QC
Routine component.
u Data manager workplaces overview (51)
u QC tasks (166)
u Monitoring QC standby bottles (193)
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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What is new in the manual version 9?
An overview of the changes compared to the previous
version of the manual is provided below.
Additional cobas e flow test information Detailed information provided for a better understanding
of the cobas e flow test and its behavior.
u See:
About cobas e flow tests (78)
Quality control for cobas e flow tests (166)
Uploading single QC results for calculated QC Use the Send single QC results for calculated QC
check-box to send single QC results that are used for
calculated QC results to the host.
Send additional linkage information If the Send additional link information for calculated
QC check-box is selected, the following additional
information is uploaded to the host for a cobas e flow
test.
Replacement of deprecated terms Following terms are replaced in the document:
• SOP popup -> SOP callout
• Variables and formulas for cobas e flow tests ->
cobas e flow test generated subresults
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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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What is new in the manual version 8?
An overview of the changes compared to the previous
version of the manual is provided below.
Calculated QC result validation You can filter for calculated QC results and display result
details. You can validate calculated QC results.
Test configuration dialog box The test configuration dialog box only displays test type
related elements.
Host code assignment for cobas e flow test You can activate host codes and assign them to
cobas e flow test results, formulas, and variables.
Test result suppression You can activate or deactivate the display suppression on
reports or TraceDoc for test results that are measured
outside the technical limits.
Data cleanup options You can include incomplete sample orders in the data
cleanup process. You can activate/deactivate cleanup
options according to your laboratory needs via check
boxes.
u See:
About data cleanup and archiving (197)
Defining automatic data cleanup (203)
Sample lifetime option You can assign different time ranges for the sample
lifetime option according to your laboratory workflow.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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What is new in the manual version 7?
An overview of the changes compared to the previous
version of the manual is provided below.
Copy QC Identical applications can share QC data. On the
instrument, it is only necessary to measure the master
application. It is not required to measure the QC material
for additional applications. The master QC result is
assigned automatically to these applications.
u About copy QC (180)
QC chart The 3 types of QC chart can be supported in a single view
or summarized.
• QC range with target value
• Asymmetric QC range with target value
• Asymmetric QC range without target value
New sample types The 3 new sample types are added to the sample type list.
• Hemolysate
• Amniotic fluid
• Processed stool
cobas e flow test • The cobas e 801 module with the option to run
cobas e flow test is implemented. The cobas e flow
test combines single assay measurements into a
sequence of automatically processed steps.
Test definition If you install a test and the host code is already used by
another test, the host code field stays empty. You must
enter the host code manually before starting any
measurements for the test.
Higher uncertainty The test result can only be validated against the higher
uncertainty limit. You can only assign quantitative or
quantitative/qualitative test results to the validation
against the Roche value.
The following limits are no longer available:
• Limit of blank
• Limit of detection
• Limit of quantitation
New layout and structure In response to customer feedback, we have updated the
layout and the structure of this publication to help you
find information more easily and perform tasks more
quickly.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
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