Roche cobas 8000 Data Manager User manual

Type
User manual
cobas
®
8000 data manager
Operator's Manual
Version 9
Software version 1.06.05
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
3
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 1.06.05 · Operator's Manual · Version 9
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Edition notice
This Operator's Manual describes the cobas
®
8000 data
manager software, which is part of the cobas
®
8000
modular analyzer series. The cobas
®
8000 data manager
is the software which coordinates data in real time
between the cobas
®
8000 instrument and the host
(usually the laboratory information system (LIS)).
Every effort has been made to ensure that all the
information is correct at the time of publishing. However,
Roche Diagnostics International Ltd. reserves the right to
make changes necessary without notice as part of
ongoing product development.
Any customer modification to the cobas
®
8000 data
manager renders the warranty or service agreement null
and void.
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.
Intended use
The cobas
®
8000 data manager provides data and
workflow management for the in vitro diagnostic medical
device cobas
®
8000 modular analyzer series.
Copyright © 2009–2018, F. Hoffmann-La Roche Ltd. All rights
reserved.
License information
The cobas
®
8000 data manager is protected by contract
law, copyright laws, and international treaties. The
cobas
®
8000 data manager is licensed for use between
F. Hoffmann-La Roche Ltd and a licensee, and only
operators authorized there under are permitted to access
and use the software. Unauthorized use and distribution
may result in civil and criminal penalties.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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 might contain components
or modules that are Open Source or Commercial Software
programs. For copyright, and other notices and licensing
information regarding such software programs included
with cobas
®
8000 data manager see the CD/ DVD
provided with the product.
The product and the cobas
®
8000 data manager as a
whole may form a regulated device in accordance with
the applicable laws - refer to the installation DVD of the
cobas
®
8000 data manager software for details.
The respective authorization in accordance with the
applicable laws lapses if any unauthorized changes are
made to the cobas
®
8000 data manager.
Trademarks
cobas
®
8000 data manager is a trademark and the
cobas
®
8000 data manager logo is a trade-mark of
Roche. Other product names and trademarks are the
property of their respective owners.
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.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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Approvals
The cobas
®
8000 modular analyzer series meets the
protection requirements specified in IVD Directive
98/79/EC. Furthermore, the cobas
®
8000 data manager
is manufactured and tested according to the following
international safety standards:
The following labels demonstrate compliance:
Complies with the IVD directive 98/79/EC.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Table of contents 7
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
Table of contents
Document information 3
Contact addresses 6
Table of contents 7
Preface 9
What is new in the manual version 9? 10
What is new in the manual version 8? 11
What is new in the manual version 7? 12
How to use this manual 14
Online Help 14
Symbols and abbreviations 15
Safety classification 18
Safety precautions 19
Operator qualification 19
Safe and proper use of the data manager 19
Miscellaneous safety precautions 20
Safety summary 20
Warning messages 21
Electrical safety 21
Caution messages 22
Fatigue due to long hours of operation 22
Malfunction due to interfering
electromagnetic fields 22
Data security 23
Notices 24
Disposal of the equipment 24
Operation
1 Introduction
Introduction to the cobas
®
8000 data
manager 29
The cobas
®
8000 data manager and
associated workflows 30
Starting the data manager 35
Working with the interface 36
Features accessed via Sidebar 42
Working with tables 50
About searching for data 55
Searching for Value Sheets 58
Using the Online Help 60
2 Routine tasks
Quick reference: Main workflow 65
About cobas e flow tests 68
Working with samples 75
Working with tests 107
Validating test results 128
Reporting test results 146
Masking and unmasking tests 150
Reviewing system status 159
Viewing system alarm details 160
QC tasks 161
3 Data cleanup and archiving
Data cleanup 193
About the Interface options tab 206
About uploading data to Roche or to the
host 209
Data archiving 210
About deleting data 216
Browsing data using the TraceDocViewer 217
List of TraceDocViewer interface elements 224
4 Software update installer (SUI)
Software update 241
Update procedures 251
Troubleshooting 262
Glossary
5 Glossary
Index 271
8 Table of contents
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
9
Preface
The cobas
®
8000 data manager implements data and
workflow management functions and provides an
interface between the cobas
®
8000 modular analyzer
series, the host, and the Roche remote service platform
(TSN). Through TSN, it enables remote access to and
from Roche and allows information exchange. It provides
enhanced sample tracking, test management, result
traceability, storage and reporting, together with QC and
calibration management. Additionally, it has host back up
functionality and serves as a robust storage location for
the instrument.
This manual provides detailed descriptions of the data
manager features and operational concepts, specific
functions, and administration procedures.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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 (68)
Quality control for cobas e flow tests (161)
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
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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.
u See:
About the QC Routine component (172)
Validating calculated QC results (169)
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 (193)
Defining automatic data cleanup (196)
Sample lifetime option You can assign different time ranges for the sample
lifetime option according to your laboratory workflow.
u See:
About reusing sample IDs (198)
Defining the sample ID lifetime option (203)
Closing all sample orders (205)
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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 (175)
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.
u See:
About cobas e flow tests (68)
Deleting a cobas e flow test order during
processing (103)
Viewing cobas e flow test result details after
measurement (129)
Repeating a cobas e flow test (136)
Validating a failed cobas e flow test (132)
Masking and unmasking a cobas e flow test (156)
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
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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 1.06.05 · Operator's Manual · Version 9
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How to use this manual
q Always keep this Operator’s Manual in a safe, easily
accessible place.
To help you find information quickly, there is a table of
contents at the beginning of the manual and each
chapter. In addition, a complete index can be found at the
end.
Online Help
The cobas
®
8000 data manager has a context-sensitive
Online Help feature to support you in its operation.
Context sensitive means that the help system always
displays information related to the current work area or
software element.
The instrument software offers 2 help features:
• Accessed via menu bar: opens on title page.
• Accessed via F1 key: opens help page related to
current work area.
F1 Help - This help feature displays information related to
the current work area. Use the F1 Help feature if you
require detailed information about this work area.
Hypertext links guide you to additional information and
procedures related to this work area.
q The Operator's Manual is included in the F1 Help
system. This option allows you to search for information
throughout the software reference and the manual. All
cross-references are implemented as hyperlinks.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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 The following symbols are used:
Abbreviations The following abbreviations are used:
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 a user 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 Table. Used in table titles and cross-references
to tables.
y Symbols used for easy recognition of information
Abbreviation Definition
A
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
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
y Abbreviations
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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
D
DM Data manager
E
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
H
HIS Hospital information system
I
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
IVDD In Vitro Diagnostic Directive
L
LIS Laboratory information system
N
n/a Not applicable
P
PC/CC ProCell/CleanCell, system reagents
used on the e 602 and e 801 module
PCCC1 PreciControl ClinChem Multi 1, a
Roche QC material
PCCC2 PreciControl ClinChem Multi 2, a
Roche QC material
Q
QC Quality control
S
SB Standby
SD Standard deviation
SPR Special Reagent
Abbreviation Definition
y Abbreviations
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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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)
W
WEEE European Waste Electrical and
Electronic Equipment Directive
Abbreviation Definition
y Abbreviations
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
18
Safety classification
This section explains how precautionary information is
presented in this manual.
The safety precautions and important user notes are
classified according to the ANSI Z535.6 Standard.
Familiarize yourself with the following meanings and
icons:
Generic hazard statements
The safety alert symbol by itself without a signal word is
used to promote awareness to hazards which are generic
or to direct the reader to safety information provided
elsewhere in the document.
WARNING
!
Warning
r If not avoided, a hazardous situation can be indicated,
which could result in death or serious injury.
CAUTION
!
Caution
r If not avoided, a hazardous situation can be indicated,
which could result in minor or moderate injury.
NOTICE
Notice
r If not avoided, a hazardous situation can be indicated,
which could result in damage to equipment.
q Tip
Indicates additional information on correct use or useful
tips.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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Safety precautions
Generic hazard statements
Particular attention must be paid to the following safety
precautions. If these safety precautions are ignored, the
operator may suffer serious or fatal injury. Each
precaution is important.
Operator qualification
Operators are required to have a sound knowledge of
relevant guidelines and standards as well as the
information and procedures contained in the Operator’s
Manual.
• Do not carry out operation and maintenance unless
Roche Diagnostics has trained you.
• Carefully follow the procedures specified in the
Operator’s Manual for the operation and maintenance
of the data manager.
• Leave maintenance, installation, or service that is not
described in the Operator’s Manual to Roche Service.
Safe and proper use of the data manager
Keep the Operator’s Manual in a safe place to ensure that
it is not damaged and remains available for use. It must
be easily accessible always.
Installation • Only the Roche Service representative performs
installations.
• Leave installation tasks that are not described in the
Operator’s Manual to Roche Service.
Approved parts Use of non-approved parts or devices may result in
malfunction and may render the warranty null and void.
Only use parts and devices approved by Roche
Diagnostics.
Third-party software If you install third-party software not approved by Roche
Diagnostics, the data manager may behave incorrectly.
Do not install any non-approved software.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.05 · Operator's Manual · Version 9
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Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage may
damage the data manager or lead to data loss. Perform
regular backups of measurement results. Operate only
with an uninterruptible power supply. Do not switch off
power while the PC accesses the hard disk or other
storage device.
Safety summary
This safety summary contains the most important and
general warning, caution, and notice messages.
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Roche cobas 8000 Data Manager User manual

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