cobas® 8000 data manager

Operator's Manual
Version 14
Software version 1.06.09

(01)07613336172728(8012)1.06.09
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

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Manual version Software version Revision date Main changes

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)
y Revision history

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.

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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.

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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.

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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.

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Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

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.

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 Table of contents 9

Table of contents

Document information 2 4 Data cleanup and archiving

Contact addresses 7 Data cleanup 197
Table of contents 9 About the Interface options tab 213
Intended use 11 About uploading data to Roche or to the
Symbols and abbreviations 12 host 216
What is new in publication version 14? 14 Data archiving 217
What is new in manual version 13? 14 About deleting data 223
What is new in manual version 12? 16 Browsing data using the TraceDocViewer 224
What is new in manual version 10? 16 List of TraceDocViewer interface elements 231
What is new in the manual version 9? 17
What is new in the manual version 8? 18 5 Software update installer (SUI)
What is new in the manual version 7? 19 Software update 247
Update procedures 255
Troubleshooting 266
Safety

1 General safety information

Glossary
Introduction 25
Safety classifications 26 6 Glossary
Safety precautions 27 Index 275
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

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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 The cobas® 8000 data manager provides data and
outside US 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 For a list of globally available accessories and
consumables consumables, refer to the cobas® 8000 modular analyzer
series Operator’s Manual.

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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

Symbol Explanation
o List item.
u Cross-reference to another topic.
Tip. Extra information on correct use or useful
q
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.
Figure. Used in figure titles and cross-
w
references to figures.
Table. Used in table titles and cross-references
y
to tables.
Equation. Used in cross-references to
z
equations.
Code example. Used in code titles and cross-
k
references to codes.
y Symbols used in the publication

Symbols used on product

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

Abbreviations The following abbreviations are used:

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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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Abbreviation Definition
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
y Abbreviations

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.

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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 Details have been added for the following options and
functions added 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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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)

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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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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.

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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.

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 Safety

1 General safety information.................................................................................. 23

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Table of contents

General safety information 1

In this chapter 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Operator qualification . . . . . . . . . . . . . . . . . . . . . . . 27
Installation and deinstallation . . . . . . . . . . . . . . . . . 27
Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . 28
Safe and proper use of the data manager . . . . . . 28
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Configuration changes. . . . . . . . . . . . . . . . . . . . . . . 29
Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

1 General safety information

Mechanical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Software and data security . . . . . . . . . . . . . . . . . . . 31
Equipment damage . . . . . . . . . . . . . . . . . . . . . . . . . 32
Delayed results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Delayed results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Disposal of the equipment . . . . . . . . . . . . . . . . . . . . . . 34

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Table of contents
1 General safety information

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 Introduction 25

Introduction
! 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.

1 General safety information

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 26 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
1 General safety information

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.

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 Safety precautions 27

Safety precautions
! To avoid serious or fatal injury, read and
comply with the following safety precautions.

In this section
Operator qualification (27)
Installation and deinstallation (27)
Operating conditions (28)
Safe and proper use of the data manager (28)

Operator qualification

Insufficient knowledge and skills 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.
r Do not carry out operation and maintenance unless
Roche Diagnostics has trained you.
r Carefully follow the procedures specified in the
Operator’s Manual for the operation and maintenance
of the data manager.
r Leave maintenance, installation, or service that is not
described in the Operator’s Manual to Roche Service.

1 General safety information

Installation and deinstallation

Errors in installation Only the Roche Service representative performs

installations.
r Leave installation tasks that are not described in the
Operator’s Manual to Roche Service.

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 28 Safety precautions

Operating conditions

Power interruption A power failure or momentary drop in voltage may

damage the system or lead to data loss.
r The use of an uninterruptible power supply (UPS) is
recommended.
r Ensure regular maintenance of the UPS.
r Perform regular backups of results.
r Do not switch off power while the control unit
accesses the hard disk or storage device.

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.
1 General safety information

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 Warning messages 29

Warning messages
! List of warning messages
Failure to observe warning messages may result in death
or serious injury.
r Before operating the data manager, read the warning
messages carefully.
In this section
Configuration changes (29)

Configuration changes

Non-approved configuration changes Configuration changes have an impact on the results and
the result interpretation and can lead to a patient
receiving the wrong treatment. Configuration changes are
for example changes on the reference ranges, test units,
dilution factors, formulas, or QC ranges.
r Verify all configuration changes before using them in
routine operation.
r Make sure only authorized and properly qualified staff
can make configuration changes.
r Define the user rights so that configuration changes
can only be made with an appropriate user role.

1 General safety information

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 30 Caution messages

Caution messages
! List of caution messages
Failure to observe caution messages may result in minor
or moderate injury.
r Before operating the data manager, read the caution
messages carefully.
In this section
Mechanical safety (30)
Software and data security (31)
Equipment damage (32)
Delayed results (32)

Mechanical safety

Moving parts Contact with moving parts may result in infection and
personal injury.
r Keep all covers closed and in place while the system is
operating.
r Always switch off the system or go to maintenance
mode, if available, before you work with an opened
cover (for example for cleaning or maintenance).
r Do not touch any parts of the system except those
parts specified. Keep away from moving parts during
operation.
1 General safety information

r During operation and maintenance, carefully follow

the instructions.

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 Caution messages 31

Software and data security

Unauthorized access and data loss due to Portable storage media can be infected with and transmit
malicious software and hacker attacks computer malware, which may be used to gain
unauthorized access to data or cause unwanted changes
to software.
The cobas® 8000 data manager is not protected against
malicious software and hacker attacks.
The customers are responsible for IT security of their IT
infrastructure and for protecting it against malicious
software and hacker attacks. Failure to do so may result
in data loss or render the cobas® 8000 data manager
unusable.
r Roche recommends the following precautions:
o Allow connection to authorized external devices
only.
o Ensure that all external devices are protected by
appropriate security software.
o Ensure that access to all external devices is
protected by appropriate security equipment.
Roche strongly recommends the use of a cobas IT
Firewall or Fortigate 400.
o Do not copy or install any software on the
cobas® 8000 data manager unless it is part of the
system software or you are instructed to do so by
Roche Service.
o If extra software is required, contact Roche Service
to ensure validation of the software in question.
o Do not use the USB ports to connect other storage

1 General safety information

devices unless you are instructed to do so by
official user documentation or by Roche Service.
o Exercise utmost care when using external storage
devices such as CDs or DVDs. Do not use them on
public or home computers while connecting to the
cobas® 8000 data manager.
o Keep all external storage devices in a secure place
and ensure that the authorized persons can access
only.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 32 Caution messages

Corrupt data due to a disclosed password The security of the system and its data depends on the
password-protected access. If an unauthorized person
discovers your user ID and password, they could
compromise this security.
r Always enter your password unobserved.
r Do not write down your password anywhere, including
in a contact form, in the address book, or in a file on
the computer.
r Do not disclose your password to anyone. Roche will
never ask you for your password.
r If you ever disclose your password to anyone, change
it immediately afterwards.
r Contact your local Roche affiliate if you think your
account has been compromised.

Equipment damage

Damaged hardware parts Working with damaged hardware parts like hard disks or
storage devices may damage the whole system or lead to
data loss.
r Replace damaged or potentially damaged hardware
parts immediately after the first sign of damage.

Delayed results
1 General safety information

Network communication issues Using non-appropriate network communication protocols

can lead to communication issues and delayed results.
r Use the TCP/IP communication protocol instead of the
RS232 protocol.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Notices 33

Notices
! List of notices
Failure to observe the notices may result in damage to the
equipment.
r Before operating, the data manager, read the notices
contained in this summary carefully.
In this section
Delayed results (33)

Delayed results

Printer communication issues Printer communication issues can lead to delayed results.
r Immediately resolve any printer communication issue.

1 General safety information

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 34 Disposal of the equipment

Disposal of the equipment

Disposal of the data manager components.

Components of your data manager (such as the

computer, monitor, keyboard) which are marked with this
symbol are covered by the European Directive on Waste
Electrical and Electronic Equipment (WEEE, 2002/96/EC).

Prior to disposal, all patient data and information must be

erased according to local regulations.

These items must be disposed of via designated

collection facilities appointed by government or local
authorities.

For more information about disposal of your old product,

contact your city office, waste disposal service, or Roche
Service.

Constraint:
It is left to the responsible laboratory organization to
determine whether control unit components are
contaminated or not. If contaminated, treat them in the
same way as the analytical modules of the cobas® 8000
modular analyzer series.
1 General safety information

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Operation

2 Introduction .............................................................................................................. 37
3 Routine tasks ........................................................................................................... 71
4 Data cleanup and archiving .............................................................................195
5 Software update installer (SUI) .......................................................................245

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 37
Table of contents

Introduction 2

This chapter provides an introduction to the data

manager.

In this chapter 2
Introduction to the cobas® 8000 data manager. . . . . 39
The cobas® 8000 data manager and associated
workflows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Fixing communication after breakdown . . . . . . . . 41
About validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
About the pass-through mode for patient results 44
About the pass-through mode for QC and
calibration results . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Starting the data manager . . . . . . . . . . . . . . . . . . . . . . 45
Working with the interface . . . . . . . . . . . . . . . . . . . . . . 46
About the cobas® 8000 data manager interface
(without sidebar) . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
About default workplaces and user-dependent
workplaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Data manager workplaces overview . . . . . . . . . . . 51
Features accessed via Sidebar . . . . . . . . . . . . . . . . . . . 52
Accessing an application from the sidebar. . . . . . 53
TraceDocViewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
2 Introduction

Saving screenshots. . . . . . . . . . . . . . . . . . . . . . . . . . 54
Creating issue reports . . . . . . . . . . . . . . . . . . . . . . . 55
About the remote support status . . . . . . . . . . . . . . 55
Starting the software update installer (SUI) . . . . . 56
About the host interface connection status
symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Shutting down the data manager. . . . . . . . . . . . . . 57
Restarting the data manager . . . . . . . . . . . . . . . . . 57
Changing an expired password . . . . . . . . . . . . . . . 58
About USB storage devices. . . . . . . . . . . . . . . . . . . 59
Working with tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 38
Table of contents

About sorting tables. . . . . . . . . . . . . . . . . . . . . . . . . 60

Showing and hiding table columns . . . . . . . . . . . . 62
Exporting and printing tables . . . . . . . . . . . . . . . . . 63
Reloading table data . . . . . . . . . . . . . . . . . . . . . . . . 64
About searching for data. . . . . . . . . . . . . . . . . . . . . . . . 65
Searching for Value Sheets . . . . . . . . . . . . . . . . . . . . . . 68
Using the Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . 70
2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Introduction to the cobas® 8000 data manager 39

Introduction to the cobas® 8000 data

manager
The data manager implements data and workflow
management functionality. The data manager provides an
interface between the cobas 8000 instrument, the host,
and the Roche remote service platform (TSN). TSN is
used to access and route remote information to and from
Roche.

It provides enhanced sample tracking, test management,

result traceability, storage and reporting, together with
QC and calibration recommendation management.

Additionally, it has host back up functionality and serves

as a robust storage location for the instrument.

2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 40 The cobas® 8000 data manager and associated workflows

The cobas® 8000 data manager and

associated workflows

cobas 8000 modular analyzer series

cobas 8000 instrument modules

Hardware
Control Unit Data Manager
TSN cobas® link
Software Software
M1 M2 M3 M4

Host Roche

w Data manager architecture.

The data manager acts as the central point between the

cobas 8000 instrument and the host. The data manager
can perform tasks that the host performs traditionally.

Order and patient demographics entry normally take

place at the host level. However, the data manager
provides a backup to these functions when the host is
unavailable.

q The patient data stored on the data manager is

limited to date of birth, gender, first and last name, and
patient ID.

u Working with samples (85)

Orders and related information are sent from the host to

the data manager.

The instrument receives test orders from the data

manager and sends the results back to the data manager.

The remote service platform (TSN) infrastructure provides

2 Introduction

access and routing of information and functionality to and

from Roche. For example, via TSN, the test parameters,
QC target values are distributed.

The data manager serves as backup/restore medium for

instrument.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 The cobas® 8000 data manager and associated workflows 41

2 of the main areas of work that are undertaken on the

data manager are:
• Validation of test results.
• QC management.
In this section
Fixing communication after breakdown (41)
About validation (43)
About the pass-through mode for patient results (44)
About the pass-through mode for QC and calibration
results (44)

Fixing communication after breakdown

If the communication between the data manager and the
control unit is not available any more, you must restart
both computers.

r To fix communication after

breakdown
1 To stop the instrument from processing, choose the
Stop button on the control unit.

2
2 In the Workplace > Data Review menu of the
control unit, delete all open test orders.

3
3 On the data manager in the Day list > Test table,
delete all already started test orders.
I Check that all orders are sent to the data manager.
2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 42 The cobas® 8000 data manager and associated workflows

4
4 Shut down and restart both computers.
I Start the data manager first to avoid
communication errors.

5 Reactivate all open QC test orders.

6
6 To download the test orders again from the host, load
all samples on the instrument again.
I For cobas e flow, you must restart the complete
workflow.

7 Restart the instrument by choosing the Start button.

2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 The cobas® 8000 data manager and associated workflows 43

About validation
If the test was measured after an out of range QC
measurement, the validation includes checking that test
result values lie within the test's validation range.

The data manager provides full rule management,

including repeats, reruns, and reflex, within a short
reaction time due to the data manager's proximity to the
instrument.

The rules that can be defined on the data manager are

range-based, enabling a comprehensive rule system to be
defined. Depending upon how the reference ranges and
rules are implemented, test results can be validated
automatically (for high throughput) or manually.

2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 44 The cobas® 8000 data manager and associated workflows

About the pass-through mode for patient results

If necessary, validation of patient results can be
undertaken on the host rather than on the data manager.
To validate patient results on the host, set the data
manager to pass-through mode ON/operational for
patient results in the cobas 8000 data manager
Service workplace.

If pass-through mode for patient results is operational,

the repeat, reflex, and rerun rule environment can still be
set up on the data manager. The set up on the data
manager increases the performance for repeat, reflex,
and rerun tests.

About the pass-through mode for QC and calibration

results
The data manager provides full QC management,
including QC evaluation, trend analysis, monitoring, all
close to the instrument.

All QC-related tasks are performed on the data manager.

Roche-related information is downloaded automatically
through the TSN.

The instrument measures QC and sends the results

together with traceability information to the data
manager. The data manager stores the QC results and
tracks the system quality by applying QC rules. The data
manager also provides graphical and tabular data reports
of the QC measurements.

Based on the QC evaluation or other appropriate

information, the data manager is able to trigger a
calibration recommendation on the instrument.

Depending on the configuration, the data manager

triggers patient masking for a particular test on a specific
2 Introduction

measuring cell or position on the reagent disk.

Pass-through mode for QC results If necessary, QC validation can be undertaken on the host
rather than on the data manager. In order to validate QC
results on the host, the data manager is set to pass-
through mode ON/operational for QC results.

Pass-through mode for calibration results Calibration data can also be forwarded to the host. In
order to forward calibration data to the host, the data
manager is set to pass-through mode ON/operational for
calibration results.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Starting the data manager 45

Starting the data manager

Start the data manager to get access to your data and
workflows.

Prerequisite If you have to power on the control unit and the data
manager, make sure that you start the data manager first.
This start up procedure avoids communication errors.

r To start the data manager

1
1 Press the Power button of the data manager server.
f The data manager starts up.

q It is not possible for the operator to access the

Windows level or the C:\ drive. If access is required,
contact your Roche Service representative.

2
2 In the logon dialog box, type in your user name and
password.

q For traceability reasons, each user should be

assigned a personal account. It is not recommended
to create a generic account that is used by more than
one user.

2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 46 Working with the interface

Working with the interface

The following section describes the most important tasks
to help you work with the data manager user interface.

In this section
About the cobas® 8000 data manager interface (without
sidebar) (46)
About default workplaces and user-dependent
workplaces (49)
Data manager workplaces overview (51)

About the cobas® 8000 data manager interface (without

sidebar)
This section explains the main interface elements of the
data manager application.

A
B
C
D
E
F
G L

I
2 Introduction

A Title bar D Information bar G Expand (+)/ J Information window

collapse (-) node
B Menu bar E Navigation tree H Subcomponent K Status bar
C Icon bar F Component I Hide/show navigation tree & L Work area
Information window bar

w Main interface elements of the data manager.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Working with the interface 47

Title bar Displays the current workplace and work area title and
contains the buttons for minimizing, maximizing, and
closing the application work area.

Menu bar Provides access to menus with which you operate the
data manager.

Icon bar Is configurable for displaying buttons that provide direct

access to frequently used components and
subcomponents.

Information bar Provides information on the active workplace and the

open element of the corresponding component. In
addition, it displays the operator logged.

Navigation tree Displays the components and subcomponents within a

workplace in hierarchical form.

The node ‘+’ expands the components.

To access the component, choose the node. When you

choose the node, the component expands and the
subcomponents are displayed, and so on.

When a node is expanded, it changes to a collapse node

‘-’. To hide elements that were visible, choose the node.

Double-clicking components also expands and collapses

navigation tree elements.

When you select a component in the navigation tree, the

corresponding information is displayed in the work area.

Hide/show navigation tree bar In the Hide / show navigation tree & Information window
bar, you can enlarge the work area. Clicking the bar hides
the Navigation tree and the Information window panel.
Click the bar again to show them again.

Information window Provides an overview of the current system and warning

messages. The content of the Information window
panel can be customized.

q In the Information window panel, only the number

2 Introduction

of messages with the highest severity level is displayed.

Additional numbers for messages with a lower severity
level are hidden. For more information, you must open the
detail view panel of the corresponding topic.

The highest indication of connection issues is yellow

against all configuration you made in the cobas 8000
data manager Service > Information window
> Connection issues component. The red level is only
shown if a technical problem occurs.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 48 Working with the interface

Status bar Displays the current date and time as well as the number
of records in the active table.
2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Working with the interface 49

About default workplaces and user-dependent

workplaces
The Workplaces menu on the Menu bar is available for
you to choose workplaces. A group of default workplaces
is provided with the data manager.

User-dependent workplaces If necessary, administrators can customize workplaces to

be user-dependent. In that case, the menu contains only
those workplaces that have been assigned to the
respective user.

Default workplaces used in this manual All descriptions and procedures provided in this manual
refer to these default workplaces.

The following workplaces come with data manager by

default:
• cobas 8000 data manager Routine
• cobas 8000 data manager QC Parameters
• cobas 8000 data manager QC Routine
• cobas 8000 data manager Routine Configuration
• cobas 8000 data manager Test Configuration
• cobas 8000 data manager System Configuration
• cobas 8000 data manager Administration

Routine workplace The cobas 8000 data manager Routine workplace is

where you undertake routine tasks, focusing on order and
result management.

QC-related workplaces There are 2 QC-related workplaces.

Use the cobas 8000 data manager QC Parameters

workplace to maintain the parameters used in the QC
according to QC rules.

The cobas 8000 data manager QC Routine workplace

is where you monitor QC. Here, you manage, view, and
release QC values when errors have occurred.

Configuration-related workplaces There are 3 configuration workplaces.

2 Introduction

You maintain the parameters used in routine work using

the cobas 8000 data manager Routine Configuration
workplace.

The cobas 8000 data manager Test Configuration

workplace is used to maintain test-related parameters.

The cobas 8000 data manager System Configuration

workplace to maintain system-related parameters.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 50 Working with the interface

Administration workplace Use the cobas 8000 data manager Administration

workplace to configure workplaces and user accounts.

Service workplace The cobas 8000 data manager Service workplace is

used by Roche Service only.
2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Working with the interface 51

Data manager workplaces overview

Routine QC Parameter QC Routine Administration

Host backup Control material QC Routine Workplaces

Sample overview QC rules User

Day list QC rule assignment

Validation QC data alarm

Test mask overview 4&FRQÀJXUDWLRQ

System status Calibration method rules

Calibration
System alarm
recommendations

w Data manager default workplaces and associated components

5RXWLQHFRQÀJXUDWLRQ 6\VWHPFRQÀJXUDWLRQ 7HVWFRQÀJXUDWLRQ 6HUYLFH

Sample type Organization Test reference ranges Password settings Test status

Component for test

Test groups 6\VWHPFRQÀJXUDWLRQ Instrument groups Validation status
units

Service-related
3URÀOHV Instrument Formulas Data alarms
FRQÀJXUDWLRQ

0DVNLQJSURÀOHV LISA Administration Comment text groups Icons Information window

2 Introduction

Communication FREDVHÁRZWHVW Real-time alarm

623FRQÀJXUDWLRQ Gender
message overview FRQÀJXUDWLRQ

Processing intervals /RJÀOHV Priorities System message

Sample status /RJÀOHV

w Data manager default workplaces and associated components

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 52 Features accessed via Sidebar

Features accessed via Sidebar

The following features can be accessed by clicking the
respective button located in the Sidebar:

TraceDocViewer button

Screenshot button

Issue report button

Remote support status screen

Software update installer (SUI) button

Shut down button

Change expired password button

Host interface connection status symbol

A short function description of the Sidebar buttons is

provided below.

In this section
Accessing an application from the sidebar (53)
TraceDocViewer (54)
Saving screenshots (54)
Creating issue reports (55)
About the remote support status (55)
Starting the software update installer (SUI) (56)
About the host interface connection status symbol (57)
Shutting down the data manager (57)
Restarting the data manager (57)
2 Introduction

Changing an expired password (58)

About USB storage devices (59)

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Features accessed via Sidebar 53

Accessing an application from the sidebar

The Sidebar allows you to display and access the
following screens in the work area of data manager:
• Data manager application
• Control screen of the control unit of the cobas 8000
instrument
• Screen of cobas IT middleware (the Roche Service
representative must configure this screen because it is
not standard)
• E-library access screen (the data manager serves as
front end for the cobas® e-library)
• TraceDocViewer
• Change expired password

w Data manager interface including the Sidebar

2 Introduction

r To access an application from the

sidebar
1 In the Sidebar, choose the panel of the application you
wish to display in the work area.
f The selected application is displayed in the work
area.
f If the control unit is selected, the screen of the
control unit is shared.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 54 Features accessed via Sidebar

TraceDocViewer

TraceDoc is used to manage data archiving. To display

the TraceDocViewer in the work area, choose the
TraceDocViewer button in the Sidebar.

Saving screenshots
You can make screenshots and save them on the data
manager server or on a USB storage device.

r To save a screenshot on a USB flash

drive

1
1 If you want to save the screenshots on a USB flash
drive, insert the USB flash drive in the data manager
USB port.

2 In the Sidebar, choose the screenshot button.

f The current content of the entire screen is
captured and the Save screenshot dialog box is
displayed.

3
3 In the Save screenshot > Save to dialog box,
choose the drive and the folder where you want to
save the screenshot.
2 Introduction

4 Choose the Save button.

f If no USB storage device has been connected, the
screenshot is saved to the dedicated folder on the
data manager server.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Features accessed via Sidebar 55

Creating issue reports

Issue reports are generated for support purposes. An
issue report comprises the following items corresponding
to the issues:
• Screenshot
• Log files
• System messages

r To create an issue report

1
1 If you wish to save the issue report to a USB storage
device, insert it in the USB port.

2 In the Sidebar, choose the Issue report button.

f The content of the whole screen is captured. The
Issue report dialog box opens.

3
3 In the Issue report dialog box, enter a title and a
description of the issue.

4 Choose the Save button.

f The issue report and the corresponding
screenshot, log files, and system reports are
bundled in a zip file.
f If no USB flash drive has been inserted, the zip file
is saved to a dedicated folder on the data manager
server.
2 Introduction

About the remote support status

The Remote support status button is visible when there is

an open and established connection between the data
manager and Roche Service.

The button is not visible when there is no connection. You

can close the connection by clicking the button.

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 56 Features accessed via Sidebar

Starting the software update installer (SUI)

The software update installer (SUI) allows you to update
software on the data manager and the cobas 8000
instrument.

If the software is already updated, only the Roche Service

representative can reinstall previously used software
versions.

The software updates are classed as mandatory and

optional.

The SUI button on the sidebar indicates the status of the

SUI service as follows:
• Blue: SUI service is running (all optional updates are
either installed or confirmed. All mandatory updates
are installed).
• Yellow: software updates pending (optional software
updates that have not yet been confirmed and/or
there are mandatory updates still to install).
• Red: SUI service is not available or an essential
information upload is being performed.

For the control unit The SUI only downloads the software updates to the data
manager. Perform the updates for the instrument on the
control unit.

r To start the software update installer

(SUI)
1 In the Sidebar, choose the software update installer
(SUI) button.

2
2 In the dialog box, enter your user name and password.
2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Features accessed via Sidebar 57

About the host interface connection status symbol

The host information status symbol displays the status of
the host interface connection. The following states are
possible:
• Green: data manager connected to the host.
• Yellow: State unknown.
• Red: data manager not connected to the host.

Shutting down the data manager

q It is recommended that you restart the data manager
once a week.
Always reboot the data manager following a hardware
failure.

Prerequisite Ensure that the instrument is in standby mode before you

shut down the data manager.

r To shut down the data manager

1 In the Sidebar, choose the Shut Down button.

2
2 In the dialog box, choose the Yes button.
f The data manager shuts down. To restart, you
must press the Power button on the data manager
PC.

Restarting the data manager

2 Introduction

As part of the weekly maintenance, restart the data

manager for cleaning up the database memories.

Prerequisite Ensure that the instrument is in standby mode before you

restart the data manager.

j m Remove USB storage devices before restarting the

data manager

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 58 Features accessed via Sidebar

r To restart the data manager

1 In the Sidebar, press <Shift> + Shut down button.

f The Shut down data manager dialog box is
displayed.

2
2 From the drop-down list, choose the Restart
command.
• Choose the OK button.

Changing an expired password

The change expired password button is used to change
an expired password or to set a password at first login.

q When the ORA-28041: Authentication protocol

internal error message is displayed, you have entered
the new password in the wrong dialog box. Always use
the button on the Sidebar to change an expired password
or to set the password at first login.

j m Your password is expired or you are a new user and

you log in the first time to the cobas® 8000 data
manager.

r To change an expired password

1 In the Sidebar, choose the change expired password

button.

2 In the Username field, enter your user name.

2 Introduction

3 In the Old Password field, enter your old password.

4 In the New Password field, enter a new password.

I The password must be between 6 and maximal 12
alphanumeric characters long and must not
contain the user name.

5 In the Confirm New Password field, enter the new

password again.

6 Choose the OK button.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Features accessed via Sidebar 59

About USB storage devices

When you use USB storage devices with the data
manager, for example:
• Backing up purposes
• Making screenshots

Take care when removing the devices.

USB flash drives should only be removed when there are

no write processes (data transfer) taking place. Remove
the USB flash drive a few minutes after the last write
process is completed.

You should always perform a virus scan on any USB

storage device before attaching it to the data manager.
The data manager is unable to perform virus scans.

2 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 60 Working with tables

Working with tables

Tables in the data manager enable you to select and view
data in different ways.

A G
F
B

C E

A Column used to group by E Column

B Table header F Column header
C Row G Grouping bar
D Show/hide group

w Table elements

In this section
About sorting tables (60)
Showing and hiding table columns (62)
Exporting and printing tables (63)
Reloading table data (64)

About sorting tables

2 Introduction

You can define tables for improved data visualization.

Simple sorting A simple way to sort data in a table is by clicking the

column header by which you want to sort. The sort arrow
on the column header points downwards to indicate that
the values are listed in descending order. It points
upwards to indicate that values are listed in ascending
order.

Text entries are sorted alphabetically; numbers are sorted

numerically.

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 Working with tables 61

Group sorting You can group table contents by column entries, for
example, by instrument. Left-click the column header by
which you want to group. Hold down the mouse button
while dragging the column header to the Grouping bar.

The table divides into groups each headed by an entry

from the column by which you are sorting. Each group is
sorted accordingly. For example, if you sort using the
instrument column header, the table is divided into
groups where an instrument heads each group. Each
group contains the corresponding table data (rows) for
each instrument.

You can perform more complex group sorts by dragging a

second column header to the Grouping bar. This
assignment performs a further sort on the groups.

Table groups can be hidden by clicking the - button to

the left of group header and made visible again by
clicking the + button.

To remove the groupings, right-click in the table, and

choose the Reset table settings command on the
shortcut menu. The column headers used to group are
returned to their original positions.

2 Introduction

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 62 Working with tables

Showing and hiding table columns

For any table, you can define which columns are
displayed and which columns are hidden.

r To show or hide a table column

1
1 Right-click anywhere in the table. For example, in the
Host backup component in the tests table, right-
click, and choose the Properties command.

2
2 In the Properties dialog box, from the check box list,
choose all the columns you want to display.

3 Choose the Apply changes button.

f All the selected columns are displayed in the table.
2 Introduction

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 Working with tables 63

Exporting and printing tables

q Insert a USB storage device before exporting the
table. Otherwise, the file is saved to a dedicated folder on
the data manager server where Roche Service user rights
are required in order to access.

r To export a table to MS Excel

1
1 On the data manager USB port, insert the USB flash
drive.

2
2 In the table you want to export, right-click, and choose
the Export table to > Excel file command.

3
3 In the Export table to dialog box, define the folder
where you want to save the table, enter a file name,
and confirm with the Save button.
f If no USB flash drive was inserted, the file is saved
on the data manager server. In this case, only a
Roche Service Representative can access the
folder.

r To print a table
2 Introduction

1
1 In the table you want to print, right-click, and choose
the Export table to > Printer command.

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 64 Working with tables

2
2 In the Print dialog box, define the printer name,
properties, and confirm with the Print button.

Reloading table data

You can reload table data to ensure that the most up-to-
date data is displayed.

r To reload table data

1 In the table you want to update, right-click, and

choose the Reload table command.
f The data in the table is reloaded.
2 Introduction

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 About searching for data 65

About searching for data

The data manager provides a number of different ways to
search or filter data.

Filters Filters are available in the following components of the

cobas 8000 data manager Routine workplace, with
which you can search for data by entering the
appropriate criteria:
• Sample overview
• Day list
• Validation

Search criteria dialog box The following components in the cobas 8000 data
manager Routine workplace provide you with an extra
search facility:
• Day list
• Validation

In the Day list component samples table, or the

Validation component tests table, right-click, and
choose the Edit search criteria (F7) command on the
shortcut menu. The Search criteria dialog box is
displayed.

q To display the Search criteria dialog box, you can

also press F7 on the keyboard.

You then enter/select the appropriate search criteria.

As with any search that you perform, the more criteria

that you enter, the more refined the search results.

After selecting the search criteria, choose the Apply

button. The Search criteria dialog box closes and the
data matching your search criteria is displayed in the
table.

Wild card searches In fields, you can use wild cards to select certain kinds of
2 Introduction

data. For example, all names starting with ‘B’ or all

numbers containing the string ‘234’.

The character ‘%’ stands for any number of characters,

and the character ‘_’ for a single character.

Examples:

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 66 About searching for data

You enter The system finds all entries

D ...beginning with a capital D.
d ...beginning with a lower case d.
%5 ... that end with a 5.
%5% ... that contain a 5.
_5 ... consisting of 2 characters and the second character is 5.
y Wild-card search examples

e-library document searches There are 3 ways of searching for e-library documents
within the data manager:
• HRD search.
• Show e-library document about application
• Show e-library document about control

In the HRD (human-readable data) search function, you

can view e-library documents from anywhere in the data
manager.

On the data manager Help menu, choose the HRD

search command to display the HRD search dialog box.

Enter the appropriate search criteria and choose the

Search button. Documents matching your search criteria
are listed in the table below the search criteria.

In the table, double-click the entry to display the

corresponding document in the Document viewer
dialog box.

To display a submenu containing all e-library documents

associated with a test, choose the Show e-library
document about application command. To access the
e-library shortcut menu right-click on the respective test.

In the submenu, choose an entry to display the

corresponding document in the Document viewer
dialog box.

The Show e-library document about application

command is available in the following components:
2 Introduction

• Sample overview
u Searching for samples in the Sample overview
component (102)
• Day list
u Viewing samples in the Day list component (106)
• Validation
u Viewing tests in the Validation component (122)
• QC Routine
u About the QC Routine component (177)

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 About searching for data 67

The Show e-library document about control

command provides the same functionality with a right-
click on a control in the QC Routine component.

2 Introduction

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 68 Searching for Value Sheets

Searching for Value Sheets

If you need target values for entering a new QC lot at the
LIS, you can download the corresponding Value Sheet
from the cobas® e-library.

For cobas e 801 modules, there are single Value Sheets

for each QC lot, containing all target values (default as
well as reagent lot specific) for each test and reagent lot.
Value Sheets are regularly updated and available via the
cobas® e-library.

For other modules, Value Sheets are included in the

package of the QC material and are also available via the
cobas® e-library.

r To search for Value Sheets on the

cobas® e-library

1
1 Check the kit lot number when opening a package
with a new QC lot.

2
2 At the e-library, search for the kit lot number of the
QC material. You may also search for a bottle lot
number.
2 Introduction

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 Searching for Value Sheets 69

3
3 Select the latest version of the Value Sheet.
• Download the Value Sheet to view it in the PDF
viewer.
• Print the Value Sheet.

4 At the LIS, enter the target values and ranges to the

tests or reagent lots to which the QC material is
assigned to.

5 Start a new QC series and perform QC measurements.

2 Introduction

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 70 Using the Online Help

Using the Online Help

The data manager application provides Online Help for
every work area and dialog box. The Online Help is
displayed in a dedicated panel and provides an index,
search, and bookmarking functionality.

r To open the Online Help

1 There are 2 ways to open the Online Help:

• To display the Online Help, press F1 on the
keyboard.
• To display the Online Help at its table of contents,
from the Help menu, choose the DM help
command.
2 Introduction

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 71
Table of contents

Routine tasks 3

This chapter contains step-by-step descriptions of routine

tasks undertaken using the cobas 8000 data manager
Routine workplace and the cobas 8000 data manager
QC Routine workplace.

In this chapter 3
Quick reference: Main workflow . . . . . . . . . . . . . . . . . 75
About cobas e flow tests . . . . . . . . . . . . . . . . . . . . . . . . 78
Introducing the cobas e flow test. . . . . . . . . . . . . . 78
What is a cobas e flow test? . . . . . . . . . . . . . . . . . . 78
Working with samples . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Identifying sample tubes . . . . . . . . . . . . . . . . . . . . . 86
About sample priority. . . . . . . . . . . . . . . . . . . . . 86
About barcode mode . . . . . . . . . . . . . . . . . . . . . 87
Working in barcode mode . . . . . . . . . . . . . . . . . 87
About non-barcode mode . . . . . . . . . . . . . . . . . 88
Working in non-barcode mode. . . . . . . . . . . . . 88
Deleting rack positions for reassignment in
non-barcode mode. . . . . . . . . . . . . . . . . . . . . . . 89
Creating a sample order manually . . . . . . . . . . . . . 90
Ordering more tests for a sample. . . . . . . . . . . . . . 93
Viewing samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
3 Routine tasks

About the Sample overview component . . . . . 97

Searching for samples in the Sample
overview component . . . . . . . . . . . . . . . . . . . . . 102
About the Day list component . . . . . . . . . . . . . 103
Viewing samples in the Day list component . . 106
Viewing the sample history . . . . . . . . . . . . . . . . 107
Resending sample order data to the host . . . . 108
Viewing sample tracking . . . . . . . . . . . . . . . . . . 109
Deleting a sample order before measurement. . . 111
Deleting a test from a sample. . . . . . . . . . . . . . . . . 112
Deleting a cobas e flow test order during
processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Managing sample comments . . . . . . . . . . . . . . . . . 114
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 72
Table of contents

Working with tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

About the Validation component . . . . . . . . . . . . . . 118
Searching for tests in the Validation component . 121
Viewing tests in the Validation component . . . . . . 122
Viewing test details . . . . . . . . . . . . . . . . . . . . . . . . . 123
Viewing previous test results . . . . . . . . . . . . . . . . . 125
Viewing test history . . . . . . . . . . . . . . . . . . . . . . . . . 126
Ordering more tests in the Validation component 127
Deleting a test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Managing test comments . . . . . . . . . . . . . . . . . . . . 130
About entering a test result manually . . . . . . . . . . 132
Entering a test result manually . . . . . . . . . . . . . . . . 133
Repeating a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Requesting dilution for a test . . . . . . . . . . . . . . . . . 135
Validating test results . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
cobas e flow test result validation . . . . . . . . . . . . . 137
Viewing cobas e flow test result details after
measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Validating a failed cobas e flow test. . . . . . . . . 140
About repeat, rerun, and reflex tests with
cobas e flow tests . . . . . . . . . . . . . . . . . . . . . . . . 142
Repeating a cobas e flow test. . . . . . . . . . . . . . 143
About validating test results manually. . . . . . . . . . 144
Validating test results manually using the
information window . . . . . . . . . . . . . . . . . . . . . . . . . 145
Validating test results manually in the Validation
component. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Validating test results manually by sample . . . . . . 149
Reporting test results. . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Previewing a test result report . . . . . . . . . . . . . . . . 151
Printing a test result report . . . . . . . . . . . . . . . . . . . 153
Masking and unmasking tests . . . . . . . . . . . . . . . . . . . 154
About masking and unmasking tests . . . . . . . . . . 154
About masking a module or submodule on the
control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Masking and unmasking tests by instrument or
module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Masking and unmasking individual tests . . . . . . . 160
Masking and unmasking a cobas e flow test . . . . 161
3 Routine tasks

Masking and unmasking tests by masking

profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Viewing the masking history of a test . . . . . . . . . . 163
Reviewing system status . . . . . . . . . . . . . . . . . . . . . . . . 164
Viewing system alarm details . . . . . . . . . . . . . . . . . . . . 165
QC tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Quality control for cobas e flow tests . . . . . . . . . . 166
About calculated QC . . . . . . . . . . . . . . . . . . . . . 166
About QC result validation of a cobas e flow
test result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Validating calculated QC results . . . . . . . . . . . . 174

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 73
Table of contents

About the QC Routine component. . . . . . . . . . . . . 177

About copy QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
About QC bracketing . . . . . . . . . . . . . . . . . . . . . . . . 182
Viewing QC results . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Validating QC results . . . . . . . . . . . . . . . . . . . . . . . . 186
Acknowledging QC results . . . . . . . . . . . . . . . . . . . 188
Releasing results with QC errors . . . . . . . . . . . . . . 189
Adding comments to QC results . . . . . . . . . . . . . . 191
Resending QC results to the host. . . . . . . . . . . . . . 192
Monitoring QC standby bottles. . . . . . . . . . . . . . . . 193

3 Routine tasks

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 74
Table of contents
3 Routine tasks

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 Quick reference: Main workflow 75

Quick reference: Main workflow

The main workflow includes procedures such as creating
or modifying sample orders, reviewing, validating, and
releasing test results.

cobas®GDWDPDQDJHUZRUNÁRZ

Host cobas® 8000 data manager

Host backup Sample overview Validation QC Routine

1 Creating a sample
order manually

2 Searching for
samples

3 Ordering more tests

for a sample

4 Deleting a test
from a sample

5 Managing sample
comments

6 Entering a test result

manually

7 Searching for tests

8 Viewing test details

9 Managing test
comments

10 Repeating a test

11 Validating test
results
3 Routine tasks

12 Reporting test
results

13 Viewing QC results

14 Validating QC results

15 Releasing results
with QC errors

16 Monitoring QC
standby bottles

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 76 Quick reference: Main workflow

Quick reference: Routine tasks In the following table, the cobas® 8000 data manager
main workflow is summarized.

For detailed information, refer to the corresponding task

described in this publication.

Steps User action

1 Creating a sample order 1. Choose the Host backup component.
manually 2. Enter sample information.
3. Enter patient demographics.
4. Assign test or profile.

2 Searching for samples 1. Choose the Sample overview

component.
2. Enter the appropriate search criteria.

3 Ordering more tests for a 1. Choose the Sample overview

sample component.
2. Right-click the appropriate sample order.
3. Choose the Edit sample command.
4. Assign test or profile.
4 Deleting a test from a sample 1. Choose the Sample overview
component.
2. Choose the appropriate sample order.
3. Right-click the appropriate test order.
4. Choose the Delete test command.
5 Managing sample comments 1. Choose the Sample overview
component.
2. Right-click the appropriate sample order.
3. Choose the Insert sample comment
command.
4. Choose a predefined text or enter free text.
6 Entering a test result 1. Choose the Sample overview
manually component.
2. Choose the appropriate sample order.
3. Choose the appropriate test order.
4. Press the Return key.
5. Enter the test result.
6. Confirm your entry with the Return key.
7 Searching for tests 1. Choose the Validation component.
2. To apply a filter criterion, select the
appropriate check box.
3. To display the Search criteria dialog box,
press the F7 key.
8 Viewing test details 1. Choose the Validation component.
3 Routine tasks

2. Right-click the appropriate test result.

3. Choose the Show test details command.

9 Managing test comments 1. Choose the Validation component.

2. Right-click the appropriate test result.
3. Choose the Insert test comment
command.
4. Choose a predefined text or enter free text.
y Quick reference: Routine tasks

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 Quick reference: Main workflow 77

Steps User action

10 Repeating a test 1. Choose the Validation component.
2. Right-click the appropriate test result.
3. Choose the Repeat test command.

11 Validating test results 1. Choose the Validation component.

2. Right-click the appropriate test result.
3. Press the F8 key.

12 Reporting test results 1. Choose the Validation component.

2. Right-click the appropriate test result.
3. Choose the Show result report command
or the Print result report command.

13 Viewing QC results 1. Choose the QC Routine component.

2. Choose the appropriate filter criterion.

14 Validating QC results 1. Choose the QC Routine component.

2. Choose the appropriate filter criterion.
3. Right-click the appropriate QC result.
4. Choose the Result details command.
5. Choose the available tabs to check the
result status.
15 Releasing results with QC 1. Choose the QC Routine component.
error 2. Choose the appropriate filter criterion.
3. Right-click the appropriate QC result.
4. Choose the Release result command.

16 Monitoring QC standby 1. Choose the QC Routine component.

bottles 2. From the QC type drop-down list, choose
the Standby bottle option.
3. Choose the appropriate filter criterion.
y Quick reference: Routine tasks

3 Routine tasks

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 78 About cobas e flow tests

About cobas e flow tests

This chapter gives a general introduction to the basic
operation of the cobas e flow test functionality.

In this section
Introducing the cobas e flow test (78)
What is a cobas e flow test? (78)

Introducing the cobas e flow test

This chapter gives a general introduction to the
cobas e flow test feature.

Assumptions and dependencies Only the cobas e 801 module supports cobas e flow
tests. The cobas e 602 module, does not support
cobas e flow tests.

What is a cobas e flow test?

The cobas e 801 module supports cobas e flow tests to
improve the turnaround time and minimize the error rate.

A cobas e flow test consists of a pre-defined group of

tests, known as “embedded tests”. These tests are
combined into a sequence or set of sequences connected
by a decision-making algorithm.

Therefore, the operator does not need to order each test

individually, or assess the results of each test to decide
which test to order next. Instead, the operator orders just
one cobas e flow test. The system orders the tests, and
automatically assesses each result to decide on which
tests to order next.
3 Routine tasks

Roche Diagnostics provides the full definition of the

cobas e flow test package. The definition is not editable,
and embedded tests cannot be ordered separately.

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cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 About cobas e flow tests 79

Order cobas eÁRZWHVW 2UGHUHPEHGGHGWHVWV

LIS / MW 'DWD &RQWURO
V\VWHP manager XQLW
cobas eÁRZWHVWUHVXOW (PEHGGHGWHVWUHVXOWV
cobas eÁRZWHVW´$%&µ
Measure
(PEHGGHGWHVW'

>1HJDWLYH@ >3RVLWLYH@

Report Measure
0DLQUHVXOWWHVW' (PEHGGHGWHVW$
(PEHGGHGWHVW)

Report
0DLQUHVXOWWHVW)
6XEUHVXOWWHVW$
6XEUHVXOWWHVW'

w cobas e flow test execution

To obtain a cobas e flow test, download them from the

cobas® 8000 data manager.

The following items also have be installed to be able to

run the cobas e flow test on the cobas e 801 module:
• All required embedded tests on the control unit
• All required calibrators and QC materials on the
control unit before running embedded tests

About cobas e flow tests The cobas e flow test is a pre-defined algorithm of
embedded tests and calculated results to improve the
turn around time and minimize human errors.

About embedded tests Embedded tests are only used within cobas e flow tests.
The operator cannot order embedded tests separately.

How a cobas e flow test works The cobas e flow test contains up to several embedded
tests linked by an automated reflex algorithm, and works
as follows:
• The cobas e flow test can be ordered from the host or
data manager.
• The data manager sends the first selection of
embedded tests to the control unit.
• After receiving the results, the data manager can send
more embedded tests depending on the cobas e flow
test algorithm.
3 Routine tasks

• Embedded test results are validated against defined

ranges in the cobas e flow.
• All results that are marked for reporting are
summarized in the cobas e flow test result overview
as main and subresults.

If one of the embedded tests within a cobas e flow test

fails, the complete cobas e flow test order must be
repeated. It is not possible to finalize the test manually.

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 80 About cobas e flow tests

cobas e flow test example

cobas e flow test example

FREDVHÁRZWHVW • The cobas e flow test defines which embedded tests
are initially sent to the control unit.
• A negative result finishes the cobas e flow test and is
(PEHGGHG7HVW$
reported as the main result. A positive test result
automatically starts further embedded tests.
NEG / POS • The main result is calculated.
• All results are summarized on the data manager.
+RVW Embedded7HVW% However, only relevant results are reported. For those
Main result Embedded7HVW&
Subresult: tests whose results are not reported, only data alarms
• Test-A
are shown.
&DOFXODWHPDLQUHVXOW

+RVW
Main result
Subresults:
• Test-A
• Test-B
• Test-C

Duplicate repeat test example

Duplicate repeat
test • The cobas e flow test defines which embedded tests
are initially sent to the control unit.
• A negative result finishes the cobas e flow test and is
Embedded Test-A
reported as the main result. A positive result
automatically starts a duplicate confirmation test.
NEG / POS • All results that are marked for reporting are
summarized in the result report.
Host Embedded Test-A
Main result Embedded Test-A
Subresult:
• Test-A

Host
Main result
Subresults:
• Test-A
• Test-A
• Test-A

Duo test example

Duo test • The cobas e flow test defines which embedded tests
3 Routine tasks

for the same parameter are sent to the control unit.

The cobas e flow test can order up to 10 embedded
Embedded Test-A
Embedded Test-B tests of the same parameter.
• The main result is calculated.
Calculate main result • All results that are marked for reporting are
summarized for the result report.

Host
Main result
Subresults:
• Test-A
• Test-B

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 About cobas e flow tests 81

Installation

To run a cobas e flow test on a cobas e 801 module, you

must install the following:
• The cobas e flow test on the data manager
• All required embedded tests on the control unit
• All required calibrators and QC materials on the
control unit before running embedded tests

The data manager validates the cobas e flow test main

result against reference ranges if they exist and they fulfill
following rules:
• The cobas e flow test main result has a numeric value
• The cobas e flow test unit is equal to the unit of the
main result.

q No reference range checking for embedded tests.

No result conversion rule is allowed for cobas e flow
tests.

Out of range handling for embedded test If a measured embedded test result in a cobas e flow
results test is marked with an Out of range data alarm, all
subsequent actions for the cobas e flow test are
predefined. You cannot influence a cobas e flow test, for
example by rerunning the marked embedded tests.

3 Routine tasks

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06.09 · Operator's Manual · Version 14
 82 About cobas e flow tests

cobas e flow test results Each cobas e flow test provides a main result and
potentially one or more subresults. Depending on the
embedded test results during execution, a cobas e flow
test can report different result types, units, and/or a
different number of subresults.

cobas eÁRZWHVW´$%&µ

Measure
Embedded test D

>1HJDWLYH@ >3RVLWLYH@

Report Measure
- Main result test D Embedded test A
Embedded test F

Generate
Generated result B1
Generated result B2

Report
- Main result B1
- Subresult: test A
- Subresult: test F
- Subresult: test D
- Subresult: B2

w Example cobas e flow test

The main and subresults of a cobas e flow test can be:

3 Routine tasks

• a measured result of one of its embedded tests

• a generated result of a cobas e flow test

Subresults provide additional information for the user.

Therefore, they can be reported to host systems as
supplementary information, for example, for the following
reasons:
• Traceability
• Archiving of results
• Troubleshooting

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 About cobas e flow tests 83

The following diagram shows an example for a

successfully processed cobas e flow test “HIV Duo” with
its main and subresults:

cobas eÁRZWHVW´+,9'XRµ

0DLQUHVXOW+,9'XR ´5HDFWLYHµ>&2,@

6XEUHVXOWJHQHUDWHGUHVXOW´$QWL+,9µ ´1RQ5HDFWLYHµ>&2,@

6XEUHVXOWJHQHUDWHGUHVXOW´+,9$Jµ ´5HDFWLYHµ>&2,@

6XEUHVXOWHPEHGGHGWHVW´$QWL+,9µ *******

6XEUHVXOWHPEHGGHGWHVW´+,9$Jµ *******

w Example cobas e flow test with main result and subresults

The definition of the cobas e flow test specifies the units

and type of the main result, as well as the units, number,
and types of any subresults. The definition is not
configurable.

The following table shows all possible result types of

cobas e flow test main or subresults including their
units:

Result type Example [unit]

A quantitative value as result of a measured embedded test 2.33 [U/mL]
A qualitative value derived from the measured results “Repeatedly reactive”
(without any unit)
A qualitative value derived from the measured results, plus a corresponding quantitative “Non Reactive”, 1.20 [COI]
value as COI (Cut-off index)
A qualitative value derived from the measured results, plus a corresponding quantitative “Avidity High”, 65 [%]
value
y Result types returned by cobas e flow tests

Generic data alarm When data alarms or errors occur during the
3 Routine tasks

measurement of embedded tests, the data manager flags

the cobas e flow test main result with a generic data
alarm “eFlow.E”. The specific data alarm is visible in the
result message of the embedded test.

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 84 About cobas e flow tests

Cancellation An error in an embedded test may stop the processing of

the cobas e flow test. For example, if there is a sample
short error, no numeric result value can be determined. In
this case, the system cancels any further actions, and
marks the cobas e flow test with the data alarm
“eFlow.E”. Any available test results or subresults are
reported to the host.

After solving the problem, the operator has to reorder the

cobas e flow test from the host or the data manager.

Copying a calibration Identical applications for regular and embedded tests can
use the same calibration data. Master application and
additional application are defined in the application file.
One master application can support one or more
additional applications.

About copy calibration The master calibration result data are automatically
assigned to the corresponding additional application.

How copy calibration works Copy calibration works as follows:

• The instrument always measures the master
calibration.
• The calibration data is copied automatically to the
additional application if available.

Copy calibration

1 2 3
Four (4) ACNs assigned to copy calibration data to
calibration measurement
cobas e pack additional ACNs

Master ACN Master ACN

Additional-1 ACN Additional-1 ACN
Additional-2 ACN Additional-2 ACN
Additional-3 ACN Additional-3 ACN
3 Routine tasks

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Working with samples

In the data manager, it is possible to create sample orders
manually and administer their associated data.

This section considers the day-to-day administration of

samples in the data manager:
• Creating a sample order
• Viewing, evaluating, and validating test results
• Adding tests to, and deleting tests from a sample
• Commenting on a sample result

Sample orders in the data manager have 3 possible

sources:
• Downloaded from the host
• Manually created in the data manager
• Manually created on the control unit and measured by
the instrument

Samples are created manually on the data manager by

using the Host backup component.

Samples are listed in the following components:

• Day list
• Sample overview
• Validation
In this section
Identifying sample tubes (86)
Creating a sample order manually (90)
Ordering more tests for a sample (93)
Viewing samples (96)
Deleting a sample order before measurement (111)
Deleting a test from a sample (112)
Deleting a cobas e flow test order during
processing (113)
Managing sample comments (114)
3 Routine tasks

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Identifying sample tubes

The barcode on the sample tube identifies the sample.
You can process samples without barcode identification
in non-barcode mode.

It is recommended to operate the instrument in barcode

mode to process samples, calibrators, and QC materials.

Ensure the correct assignment of test results to the non-

barcoded samples.

In this section
About sample priority (86)
About barcode mode (87)
Working in barcode mode (87)
About non-barcode mode (88)
Working in non-barcode mode (88)
Deleting rack positions for reassignment in non-barcode
mode (89)

About sample priority

A priority is assigned to each sample.

The following priorities are available:

• Routine: assigned to processed samples with normal
priority.
• STAT (short turnaround time): assigned to emergency
test orders.
• Default: if no information is available, the data
manager assigns this priority automatically.

STAT orders have the highest priority. Inserting a STAT

order on a STAT rack into the STAT port of the core unit
interrupts the process of the routine measurements.The
instrument processes the STAT order immediately. The
instrument processes all STAT orders first before
3 Routine tasks

rescheduling routine test orders.

q If a STAT order is created but the corresponding

sample is placed in a routine rack, that sample order
might be displayed as routine priority on the control unit.
The sample tube placement does not affect the STAT
handling of the data manager. No action is required.

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About barcode mode

In barcode mode, the sample ID barcode on the tube
identifies the sample. The barcode mode allows loading
of sample tubes, QCs, and calibrators randomly.

The control unit and data manager use barcode mode by

default to identify sample tubes.
u For more information on ordering and handling
barcoded samples and samples with unreadable
barcodes, refer to the Operator’s Manual of the
instrument.

! WARNING
Reusing sample IDs may lead to a wrong test result
assignment
Reusing sample IDs may lead to a wrong test result
assignment. The reuse of a sample ID may lead to
incorrect patient results, which may endanger patient
lives.
r Do not reuse sample IDs if they are in the host or the
data manager.
If the defined sample lifetime is expired, the sample ID
can be reused.

! CAUTION
Processing samples when cleaning the database
r Do not clean up the data manager database manually
while sample processing is taking place.

Working in barcode mode

In the barcode mode, the instrument identifies the sample
orders, QC materials, and calibrators by reading the
barcode on the tubes.
3 Routine tasks

Working in barcode mode allows you to load randomized

sample tubes, QCs, and calibrators.

r To work in barcode mode

1 On the control unit, make sure that barcode mode is

activated.

q For more information about barcode mode, refer

to the Operator’s Manual of the instrument.

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About non-barcode mode

Non-barcode mode enables you to process samples
according to a worklist and rack position rather than by
barcode identification.

With data manager version 1.02.03 or higher, you can

identify sample tubes with no barcode in non-barcode
mode. A Roche Service representative must activate non-
barcode mode in advance. In non-barcode mode, the
samples must be assigned to test orders using worklists.
Worklists are either generated manually or by the host.
u For more information on ordering and handling
samples in non-barcode mode, refer to the Operator’s
Manual of the instrument.

! WARNING
Resetting non-barcode mode sequence numbers
If you change the working mode, the sample is
automatically deleted completely and cannot be viewed
anymore even if the mode is switched back again.
r Clean up the sample database on the instrument and
the data manager (including open test orders) before
resetting the sequence numbers.
(Note: Also consider the data stored on the host).

Working in non-barcode mode

Use a worklist to run samples without barcode
identification.

r To work in non-barcode mode

1
1 On the control unit, in the Barcode Settings dialog
box, deselect the Routine/Stat check box to
deactivate barcode mode.
3 Routine tasks

f The instrument assigns a sequence number to

each sample. The data manager adds a prefix to
this sequence number.
f The prefix is displayed in the Sample ID field in
the following components:
Sample overview
Day list
Validation

q For more information on working in non-barcode

mode, refer to the Operator’s Manual of the
instrument.

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Deleting rack positions for reassignment in non-barcode mode

If necessary, you can reassign a sample order to a new
rack position, for example using a specific sample type or
sample tube.

If you work in non-barcode mode, the control unit assigns

the rack position automatically to the received sample
orders from the host. If you want to place a sample order
to a specific rack position, you must first delete the
assigned rack position.

q You can reassign rack positions as long as the

sample tube is not registered on the instrument.

j m Your Roche Service representative has the non-

barcode mode activated.
m In the cobas 8000 data manager Routine
workplace > Sample overview > Properties
dialog box, the Sample location check box is
selected.

r To delete rack positions for

reassignment

1
1 Choose cobas 8000 data manager Routine
> Sample overview.

2
2 Choose the Reset rack button.
I In the second confirmation dialog box, the value
shown represents the number of all checked
3 Routine tasks

sample orders.
f In the samples table, the rack position assignment
is deleted for all sample orders that are not already
registered on the instrument.

3 You can reassign the rack position on the control unit

by using the Barcode Read Error menu.

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Creating a sample order manually

If the host is unavailable or a sample order has not been
transferred from the host automatically. You can create a
sample order manually in the Host backup component.

A
D

A Sample group box B Test selection group box C Tests table D Patient group box

w Host backup component

q Only active sample orders are displayed in the table.

After the sample lifetime has ended, the sample order is
no longer displayed in the Host backup component.

There are 3 main steps to register a sample order

manually:
• Entering the sample details
• Assigning a patient ID to the sample
• Adding tests to the sample
3 Routine tasks

q You cannot enter new patient IDs on data manager.

You can only select patient IDs that were previously
created on the host.
If a patient is not assigned to a sample order, the system
enters a ‘?’. A patient can be assigned later.

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r To register the sample details

1
1 Choose cobas 8000 data manager Routine > Host
backup.

2
2 In the sample group box, enter the appropriate sample
data and priority of the sample order.
• Sample ID: maximum 22 characters (spaces
before or after the sample ID characters are
removed).

q For any measurements on the cobas e 602

module, it is not permitted to use the Micro-Sample
Cup as cup type. The dimension of this cup causes
problems during sample aspiration.

r To assign a patient ID to the sample

1
1 In the patient group box, choose the Search patient
button to assign a patient to the sample.
I Only available if patient information was
downloaded from the host.

2
2 In the Search patient dialog box, enter the
appropriate search criteria and confirm with the
Apply button.
f Patients matching your search criteria are listed in
the patient table.

3
3 In the patient table, double-click the patient you wish
3 Routine tasks

to assign to the sample.

f The Search patient dialog box closes and the
patient details are entered in the patient group
box.

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r To assign a test to a sample

1
1 If the sample was pre-diluted manually, select the
Pre-dilution check box.

q For pre-diluting the sample, refer to the Method

Sheet of the test. You cannot assign the dilution factor
on the data manager for pre-diluted samples. You
must multiply the test result manually by the dilution
factor you used for the predilution of the sample.

2
2 Choose the Apply button.

3
3 From the drop-down list, choose a test or a profile and
confirm with the Apply button.
• If you order a calculated test, all the required tests
are automatically ordered.

4 Repeat the previous step until you have added all of

the tests that you require for this sample ID.

5
5 To add a sample comment, choose the Comment
button.

6
6 To enter new sample orders, choose the Clear button.

u Related topics
• Managing sample comments (114)
3 Routine tasks

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Ordering more tests for a sample

You can add tests to a sample in the Sample overview
component, the Day list component, or the Validation
component.

q You can only add a test to a running test order on

the data manager if at minimum 1 of the running tests
has the automatic rerun option switched on.

This procedure describes how to add tests to a sample

from the following components:
• Sample overview
• Day list
u Ordering more tests in the Validation
component (127)

r To add tests to a sample from the

Sample overview component

1
1 Choose cobas 8000 data manager Routine
> Sample overview.

2
2 In the sample group box and the patient group box,
enter the search criteria to display the sample.

3 Routine tasks

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3
3 Choose the appropriate sample and perform one of
the following actions:
• In the samples table, right-click the sample and
choose the Edit sample command.
• In the tests table, right-click a test and choose the
Request additional test command.
f The Edit sample dialog box is displayed.

q You cannot edit the following fields:

o Sample type
o Sample ID
o Patient ID
The Edit sample command is not available for closed
sample orders.

4
4 From the drop-down list, choose a test or a profile and
confirm with the Apply button.
• If you order a calculated test, all the required tests
are automatically ordered.

5
5 Repeat the previous step until you have added all of
the tests that you require for this sample ID.
• To close the dialog box, choose the Clear button.

r To add tests to a sample from the Day

list component

1
1 Choose cobas 8000 data manager Routine > Day
list.
3 Routine tasks

2
2 Choose the appropriate sample and perform one of
the following actions:
• In the samples table, right-click the sample and
choose the Edit sample command.
• In the tests table, right-click a test and choose the
Request additional test command.
f The Edit sample dialog box is displayed.

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3
3 From the drop-down list, choose a test or a profile and
confirm with the Apply button.
• If you order a calculated test, all the required tests
are automatically ordered.

4
4 Repeat the previous step until you have added all of
the tests that you require for this sample ID.
• To close the dialog box, choose the Clear button.

u Related topics
• Viewing samples (96)

3 Routine tasks

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Viewing samples
In the cobas 8000 data manager Routine workplace,
you can view samples and their associated information in
the following components:
• Sample overview
• Day list
• Validation

You can search for samples in the Sample overview

component. Searching by the Sample ID field is a quick
way to locate individual samples.

The Day list component provides an overview of the

samples of the current day. Main filters provide a quick
way to find samples.

q For more search criteria, in the Day list component

or Validation component, right-click in the samples table
and choose the Edit search criteria (F7) command on
the shortcut menu or press F7.
u About searching for data (65)

In this section
About the Sample overview component (97)
Searching for samples in the Sample overview
component (102)
About the Day list component (103)
Viewing samples in the Day list component (106)
Viewing the sample history (107)
Resending sample order data to the host (108)
Viewing sample tracking (109)
3 Routine tasks

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About the Sample overview component

The Sample overview component provides information
about the samples and their test results for a specific time
period.

The Sample overview component contains filter options

and 3 tables:
• Samples table (below the search criteria): lists
samples matching the search criteria.
• Targets table (bottom left): shows the module to
which the selected sample order is assigned. The
target indicates where the associated tests were
analyzed.
• Tests table (bottom right): lists the details of tests for
the target module selected in the targets table.

B
D

A Samples table B Targets table C Sample ID reuse group D Tests table

3 Routine tasks

box

w Sample overview component for regular tests

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A Samples table B Targets table C Tests table D e flow subresults table

w Sample overview component for cobas e flow tests

Filter options In the Sample overview component, you can search for
samples either by patient-related criteria or by sample-
related criteria (at the top of the work area). The sample-
related criteria are:
• Sample ID
• Orders from / To
• Priority
• Sample type
• Results pending
3 Routine tasks

The patient demographics criteria are:

• Patient ID
• Name
• First name

The Count of reused sample IDs field (top right)

displays the number of reused sample IDs. To display the
counts of reused sample IDs, choose the Get list button.
The panel lists all reused sample IDs and shows the count
of reuse.

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q The sample ID reuse group box is only displayed if

the function is enabled in the cobas 8000 data
manager System Configuration > System
configuration > Sample lifetime option tab.

Samples table Contains all sample orders matching the selected filter
criteria, as described above.

To perform tasks in the samples table, use the shortcut

menu.

Tests table Lists the details of tests for a selected sample order.

The tests table displays both active and inactive sample

orders. The status is indicated in the Is active column.

To perform tasks in the tests table, use the shortcut

menu.

e flow subresult table For cobas e flow tests, the table lists the subresults of the
selected e flow main result.

Test results display The following table describes how the data manager
displays and prints different test result types, and how it
sends them to the host.

q Test results that are measured outside the technical

limit are displayed as numeric value or as *******
depending on the test result suppression configuration.

Single and embedded tests

Test result type Result Original result Unit
Qualitative Qualitative message Cut-off index COI
e.g., Non-reactive e.g., 2.12
Data alarm w/o value ??? - COI

Value with data alarm Qualitative message Cut-off index COI

e.g., Non-reactive e.g., 2.12
3 Routine tasks

Value with data alarm Qualitative message Cut-off index COI

(23 / 26 / 27) e.g., Non-reactive e.g., 2.12
Confidential result ******* ******* COI

Not reported ******* ******* COI

Quantitative Measurement value - Laboratory unit

e.g., 3.15 e.g., mmol/L
Data alarm w/o value ??? - Laboratory unit
e.g., mmol/L
y Test result for single and embedded tests
Data alarm 23 = ISE < >Test / data alarm 26 = >Test / data alarm 27 = <Test

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Single and embedded tests

Test result type Result Original result Unit
Value with data alarm Measurement value - Laboratory unit
e.g., 3.15 e.g., mmol/L
Value with data alarm Measurement value - Laboratory unit
(23 / 26 / 27) e.g., 3.15 e.g., mmol/L
Confidential result ******* - Laboratory unit
e.g., mmol/L
Not reported ******* - Laboratory unit
e.g., mmol/L
Formula <calculated value> - Laboratory unit
e.g., 1.25 e.g., %
Not reported ******* - Laboratory unit
e.g., %
Quantitative / Qualitative Measurement value Qualitative message Laboratory unit
e.g., 3.15 e.g., Reactive e.g., mmol/L
Data alarm w/o value ??? - Laboratory unit
e.g., mmol/L
Value with data alarm Measurement value Qualitative message Laboratory unit
e.g., 3.15 e.g., Reactive e.g., mmol/L
Value with data alarm Measurement value Qualitative message Laboratory unit
(23 / 26 / 27) e.g., 3.15 e.g., Reactive e.g., mmol/L
Confidential result ******* ******* Laboratory unit
e.g., mmol/L
Not reported ******* ******* Laboratory unit
e.g., mmol/L
y Test result for single and embedded tests
Data alarm 23 = ISE < >Test / data alarm 26 = >Test / data alarm 27 = <Test

cobas e flow tests

Test result type Result Original result Unit
Qualitative Qualitative message - -
e.g., Intermediate
Canceled ??? - -

Quantitative Measurement value - Laboratory unit

e.g., 3.15 e.g., mmol/L
Formula <calculated value> - Laboratory unit
e.g., 1.25 e.g., %
Canceled ??? - Laboratory unit
e.g., %
3 Routine tasks

Quantitative / Qualitative Embedded test Qualitative message cobas e flow test unit
<measurement value> e.g., gray-zone e.g., mmol/L
e.g., 3.15
Formula <calculated value> Qualitative message cobas e flow test unit
e.g., 1.25 e.g., low avidity e.g., mmol/L
Not reported ******* ******* cobas e flow test unit
e.g., mmol/L
Variable <numeric value> Variable <Text from result cobas e flow test unit
e.g., 4.15 message> e.g., mmol/L
e.g., high avidity
y Test result for cobas e flow test

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cobas e flow tests

Test result type Result Original result Unit
Variable <numeric value> - cobas e flow test unit
e.g., 4.15 e.g., mmol/L
- Variable <Text from result cobas e flow test unit
message> e.g., mmol/L
e.g., high avidity
Not reported ******* ******* cobas e flow test unit
e.g., mmol/L
y Test result for cobas e flow test

3 Routine tasks

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Searching for samples in the Sample overview component

Use the filter options to find samples and related
information.

r To search for samples in the Sample

overview component

1
1 Choose cobas 8000 data manager Routine
> Sample overview.

2
2 In the sample group box or the patient group box,
enter the appropriate search criteria.
I For example, to view all STAT samples:
In the sample group box, from the Priority drop-
down list, choose the STAT option and confirm
with the Apply button.
The Orders from field and To field change to the
current day and should be modified appropriately
to view samples ordered from earlier dates.

3
3 In the samples table, locate the sample you wish to
view.
I The instruments associated with the selected
sample are now listed in the targets table (bottom
left).

4
4 In the targets table, choose the module to view the
tests associated with an instrument.
I The associated tests are displayed in the tests
table (right).
When you select a sample, the tests associated
with the first instrument in the targets table are
3 Routine tasks

listed in the tests table.

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About the Day list component

All samples for the current day or a specific time range
can be displayed according to their status.

The Day list component contains filter options and 4

tables:
• Samples table (located below the search criteria): lists
samples matching the filter criteria.
• Tests table (located below the samples table): lists
tests associated with the selected sample.
• Sample comments table (located bottom left): lists
comments associated with the selected sample.
• Test comments table (located bottom right): lists
comments associated with the selected test.

C D
3 Routine tasks

A Samples table B Tests table C Sample comments table D Test comments table

w Day list component for regular tests

q For e flow result, it could happen that the e flow

subresults table covers the main tests table. If this is the
case, move the views so that all results are displayed.

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A Samples table B Tests table C e flow subresults table

w Day list component for cobas e flow tests

3 Routine tasks

Filter options Choose one of the following filter options:

• All samples: lists all sample orders. Be careful when
selecting this filter as the list can be long and it may
take some time to display the table.
• Results pending: lists all sample orders with at least
one test that has no result.
• Validation pending: lists all sample orders with at
least 1 non-validated test result.
• Completed samples: lists all sample orders for
which all of the associated test results have been
completed and validated.

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If you want to perform a more detailed search, press F7 to

display the Search criteria dialog box.

Select the Show all tests for this sample check box to
display all results for the selected sample. If this check
box is cleared, only the pending results are displayed.

Samples table Contains all sample orders matching the selected filter
criteria, as described above.

To perform tasks in the samples table, use the shortcut

menu.

Tests table Lists all tests for a sample order selected in the samples
table.

The tests table displays both active and inactive sample

orders. The status is indicated in the Is active column.

To perform tasks in the tests table, use the shortcut

menu.

e flow subresult table For cobas e flow tests, the table lists the subresults of the
selected e flow main result.

Sample comment and test comment table Lists chronologically all comments added to the sample
order or test result. The Extended column indicates that
the comment exceeds one line.

Double-clicking a table entry displays a dialog box where

you can edit comments and enter new comments.

3 Routine tasks

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Viewing samples in the Day list component

You can view all sample orders and test results for the
current day or a specific time range.

r To view samples in the Day list

component

1
1 Choose cobas 8000 data manager Routine > Day
list.

2
2 Select the filter check box that best matches the
samples you wish to view.
f The corresponding samples are listed in the
samples table beneath the samples filters.

3
3 In the samples table, locate a sample to view
associated tests listed in the tests table.
I To display more search criteria, press F7 or right-
click in the samples table and choose the Edit
search criteria (F7) command on the shortcut
menu.
f The comments associated with the sample are
listed in the sample comment table (bottom left).

4
4 In the tests table, locate a test to view associated test
comments, in the comment table (bottom right).
3 Routine tasks

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Viewing the sample history

The Sample history panel documents all edits made to
the sample order data.

r To view the sample history

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the samples table, right-click the appropriate
sample and choose the Show sample history
command.

3 Routine tasks

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Resending sample order data to the host

If there is a connection loss, you can resend sample order
data to the host.

You can choose which data you want to resend to the

host.
• Resend all current results
• Resend all previously sent results

q If the Sample lifetime option is active, you cannot

resend sample order data to the host for closed sample
orders.

r To resend sample order data to the

host

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2 In the samples table, right-click the appropriate

2
sample order and choose the Resend results
> Resend all current results command.
I You can choose multiple sample orders.
3 Routine tasks

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Viewing sample tracking

The Sample tracking panel provides information about
the history and location of each listed sample order.

The tile color indicates the status of the sample, for

example:

Blue tile No order for sample

Red tile Pending

Yellow tile • There are unreleased results

• There are unreleased results and open orders
• Analysis not yet completed

The Sample tracking panel includes 2 tables in which

the following information is displayed:

Top table Displays the validation status and the location of the
sample.

The value in the Sample location column describes the

current or latest available physical location (rack and
position) of the sample. No defined sample location
message/status means that data manager has no
3 Routine tasks

information on the location. For example, a sample has

been registered manually, but has not yet been scanned
on the instrument.

Bottom table Displays the sample order history that includes the
following information for each event:
• Instrument and location
• Event date and time
• Description

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r To view sample tracking

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the samples table, right-click the appropriate
sample and choose the Show sample tracking
command.
3 Routine tasks

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Deleting a sample order before measurement

If an order has been manually wrongly created, you can
delete it to save sample and reagent resources.

r To delete a sample order before

measurement

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list

2
2 In the samples table, right-click the appropriate
sample and choose the Delete sample command.

3 Routine tasks

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Deleting a test from a sample

If a manual test order is assigned to the wrong sample
order, you can delete it from the sample order.

q If you delete a running test order before the test

results are created, only the regular test results are sent
to the host. Embedded test results from a cobas e flow
test are deleted and not sent to the host.

Tests can be deleted irrespective of their status.

Depending on your user rights, you may not be allowed to

delete tests.

r To delete a test from a sample

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list

2
2 In the samples table, locate the sample.

3
3 In the tests table, right-click the appropriate test and
choose the Delete test command.
3 Routine tasks

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Deleting a cobas e flow test order during processing

If for example an invalid sample type was used, you can
delete a cobas e flow test order at any time during the
process.

If a cobas e flow test order is deleted during processing,

the instrument completes the running test order. Already
measured test results are not shown or sent to the host.
The results that have already been created are then
deleted with the cobas e flow test order. No further
embedded tests are started and no test results are
available on data manager nor sent to the host.

q If you resend an embedded test result from the

control unit to the data manager, the deleted
cobas e flow test cannot be recalculated. The embedded
test results are not forwarded to the host and are marked
in the log file as failed.

r To delete a cobas e flow test order

during processing

1
1 Choose cobas 8000 data manager Routine
> Sample overview.

2
2 In the samples table, right-click the sample and
choose the Delete sample command.
3 Routine tasks

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Managing sample comments

You can add, edit, or delete sample-related observations
by choosing predefined comments or adding comments
as a free text.

You can add 2 types of comments to a sample:

• Pre-configured
• Free text

q For a cobas e flow test order, you cannot add any

comments to subresults. The free text sample comment
must be alphanumeric with a maximum length of 4000
characters. The Extended column indicates that the
inserted comment exceeds one line. Sample comments
are not sent to the host.

r To add a sample comment

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Host backup
• Sample overview
• Day list

2
2 In the samples table, locate the sample to which you
want to add a comment.
I In the Host backup component, you add the
comment as you create a sample.

3
3 To display the Sample comment dialog box, perform
one of the following actions:
• In the Host backup component, choose the
3 Routine tasks

Comment button.
• In the Sample overview component or the Day
list component, in the samples table, right-click
the appropriate sample and choose the Insert
sample comment command.

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4
4 In the Sample comment dialog box, choose one of
the following options to add your comment:
• To display the comments sorted by code, use the
Code drop-down list.
• To display the comments sorted alphabetically, use
the Text drop-down list.
• The Comment text field allows you to enter a
comment as free text.
I The Code drop-down list and Text drop-down list
contain the same comments.

5
5 To add further comments, choose the Apply button or
the OK button to close the dialog box.

r To edit a sample comment

1
1 In the cobas 8000 data manager Routine
workplace, perform one of the following actions to
display the Sample comment dialog box:
• In the Host backup component, choose the
Comment button.
• In the Sample overview component or the Day
list component, in the samples table, right-click
the sample and choose the Insert sample
comment command from the shortcut menu.

2
2 In the comments table, double-click the comment you
wish to edit.

3
3 Edit the comment and choose the OK button.

3 Routine tasks

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r To delete a sample comment

1
1 In the cobas 8000 data manager Routine
workplace, perform one of the following actions to
display the Sample comment dialog box:
• In the Host backup component, choose the
Comment button.
• In the Sample overview component or the Day
list component, in the samples table, right-click
the sample and choose the Insert sample
comment command from the shortcut menu.

2
2 In the comments table, right-click the appropriate
comment and choose the Delete comment
command.

3
3 To close the Sample comment dialog box, choose
the Cancel button.

u Related topics
• Creating a sample order manually (90)
• Searching for samples in the Sample overview
component (102)
• Viewing samples in the Day list component (106)
3 Routine tasks

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Working with tests

The data manager displays tests and test result data.

In the cobas 8000 data manager Routine workplace,

you can work with samples and their corresponding tests
in the following components:
• Sample overview
• Day list
• Validation: (provides more direct access to tests)

This section looks at the main procedures that you

undertake with tests.

In this section
About the Validation component (118)
Searching for tests in the Validation component (121)
Viewing tests in the Validation component (122)
Viewing test details (123)
Viewing previous test results (125)
Viewing test history (126)
Ordering more tests in the Validation component (127)
Deleting a test (129)
Managing test comments (130)
About entering a test result manually (132)
Entering a test result manually (133)
Repeating a test (134)
Requesting dilution for a test (135)

3 Routine tasks

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About the Validation component

The Validation component provides quick access to test
results and their release status.

The Validation component allows you to validate test

results that were not automatically validated. You can add
comments to the test results, validate them manually, and
repeat the order if necessary.

The Validation component contains filter options and 3

tables:
• Tests table (below the filters): contains tests matching
the filter criteria.
• Sample comments table (bottom left): contains
comments associated with the sample of the selected
test.
• Test comments table (bottom right): contains
comments associated with the selected test.

B C

A Tests table B Sample comments table C Test comments table

w Validation component for regular tests

3 Routine tasks

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C D

A Test table B e flow subresult table C Sample comments table D Test comments table
3 Routine tasks

w Validation component for cobas e flow tests

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Filter options Choose one of the following filter options:

• Results pending: lists all tests without results.
• Validation pending: lists all tests that are not yet
validated.
• Processed tests: lists all tests with results that are
complete and validated.
• Search for tests measured within last: activates a
filter if you want to search within a certain period. You
can either select hours or minutes.

You can filter the tests by using the column headers of

the tests table. For example, to view STAT tests: by
dragging-and-dropping the Priority column header
above the tests table, you group the tests by their priority,
and all STAT tests are grouped.

Tests table Lists all tests that fulfill the chosen filter option.

The tests table displays both active and inactive sample

orders. The status is indicated in the Is active column.

To perform tasks in the tests table, use the shortcut

menu.

e flow subresult table For cobas e flow tests, the table lists the subresults of the
selected e flow main result.

Sample comment and test comment table List chronologically all comments added to the sample
order or test result. The Extended column indicates that
the comment exceeds one line.

Double-clicking a table entry displays a dialog box where

you can edit comments and enter new comments.
3 Routine tasks

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Searching for tests in the Validation component

You can use the search criteria to find samples, tests, and
statuses.

Use the Search criteria dialog box to search with test

and sample-specific criteria for tests.

Tests matching the search criteria are displayed in the

Search criteria dialog box.

r To search for tests

1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 To apply a filter criterion, select the check box.

3
3 To display the Search criteria dialog box, press F7 or
right-click and choose the Edit search criteria (F7)
command.

4
4 Enter the search criteria and choose the Apply button.
f The Search criteria dialog box closes and the
tests corresponding to your search criteria are
listed in the tests table.

q A restart of the data manager does not reset the

3 Routine tasks

search criteria you defined.

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Viewing tests in the Validation component

If the result is not automatically released, you can
examine and initiate appropriate actions.

The Validation component allows you to view tests and

their associated information. You can filter by the time
period since they were ordered or by the status:
• Results pending
• Validation pending
• Processed tests

r To view tests in the Validation

component

1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 To apply a filter criterion, select the appropriate filter
check box.
f The corresponding tests are listed in the tests table
beneath the test filters.

q The test filters apply the current day's date by

default. To display more search criteria, press F7 or
right-click in the tests table and choose the Edit
search criteria (F7) command on the shortcut menu.

3
3 To view test details, choose one of the following
options:
• For information associated with a test, in the tests
table, choose the corresponding test.
3 Routine tasks

• For comments associated with the sample of the

selected test, refer to the sample comments table
(bottom left).
• For comments associated with the selected test,
refer to the test comments table (bottom right).

u Related topics
• Searching for samples in the Sample overview
component (102)
• Viewing samples in the Day list component (106)
• Searching for tests in the Validation component (121)

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Viewing test details

You can use the detail panel to check the test results and
view the linked QC data.

The Show test details command provides

comprehensive information about the test, including:
• Sample identification, test selection, date and time,
and patient name
• Test abbreviation and measuring unit
• Reference range, validation range, and critical range
• Test results and associated data
• QC data

r To view test details

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the tests table, right-click the appropriate test and
choose the Show test details command.

q If the test has the Confidential result data alarm,

you can only see the result if you have Read
confidential results access rights. If not, the test
result appears as ‘xxxxx’ or ’*******’.

3 In the Test details panel, data alarms are initiated in

3
the Validation status group box and displayed in the
Data alarms group box. If multiple data alarms are
3 Routine tasks

assigned to a test result, the data alarm with the

highest priority is displayed in the Data alarms group
box.
I The data alarm with the highest priority is printed
on the report, archived in TraceDoc, and displayed
in the DataMessageFlag field of the
corresponding test result.

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4 To view the test's QC data, choose the Additional

4
data tab.

u Related topics
• Viewing cobas e flow test result details after
measurement (138)
3 Routine tasks

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Viewing previous test results

The Previous results panel provides information about
the previous results of the selected test for a patient. The
previous results are displayed in a table and a graphical
format.

Values tab Lists details of the previous test results for the patient
with the corresponding sample order data in a table.

Graphics tab Provides a graphical representation of the previous test

results for the patient.

The legend explains the different colors used for the

reference, validation, and critical ranges of the test.

The range may depend on the gender, age, diagnosis,

medication, week of pregnancy, or menstrual cycle of the
patient assigned to the sample.

The ranges are defined under cobas 8000 data

manager Test Configuration > Tests / reference
ranges component.

r To view the previous test results

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the tests table, right-click the appropriate test and
choose the Show previous results command.
3 Routine tasks

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Viewing test history

The Test history panel is displayed and shows a table of
all edits made to a test.

Such actions may include rerunning or deleting a test,

and changing the dilution of a test.

r To view the test history

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the tests table, right-click the appropriate test and
choose the Show test history command.
3 Routine tasks

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Ordering more tests in the Validation component

You can add more test orders to an existing sample.

You can order more tests from the following components:

• Sample overview
• Day list
u Ordering more tests for a sample (93)

In the Validation component, you must specify a test that

is associated with the sample to order more tests.

r To order more tests in the Validation

component

1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 In the tests table, right-click the test associated with
the appropriate sample and choose the Request
additional test command.
f The Edit sample dialog box is displayed.

q You are unable to edit the following fields:

o Sample type
o Sample ID
o Patient ID
The Edit sample command is not available for closed
sample orders.

3
3 From the Test drop-down list, choose the test you
3 Routine tasks

want to add to the sample.

f If a calculated test is ordered, all the required tests
are automatically ordered.

4
4 To confirm, choose the Apply button.

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5
5 To order more tests, repeat steps 3 and 4.
• To close the Edit sample dialog box, choose the
Clear button.
3 Routine tasks

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Deleting a test
You can delete an unused or obsolete test from an
existing sample order.

r To delete a test

1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 In the tests table, right-click the appropriate test and
choose the Delete test command.

3 Routine tasks

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Managing test comments

You can add, edit, or delete observations and information
related to a test result. You can use pre-configured
comments or free text.

These procedures describe how you can add, edit, or

delete a comment in the following components:
• Sample overview
• Day list
• Validation

q You can enter up to 4000 alphanumeric characters

as a free text comment. The Extended column indicates
that the inserted comment exceeds one line.

r To add a test comment

1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 In the tests table, right-click the appropriate test and
choose the Insert test comment command.

3
3 In the Test comment dialog box, choose one of the
following options to add your comment:
• To display the comments sorted by code, use the
Code drop-down list.
3 Routine tasks

• To display the comments sorted alphabetically, use

the Text drop-down list.
• The Comment text field allows you to enter a
comment as free text.
I The Code drop-down list and Text drop-down list
contain the same comments.

4 To make further comments, choose the Apply button,

or choose the OK button to close the Test comment
dialog box.

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r To edit a test comment

1
1 To display the Test comment dialog box, perform one
of the following actions:
• In the Sample overview component or Day list
component, in the tests table, right-click the
appropriate test and choose the Insert test
comment command.

2
2 In the comments table, double-click the comment you
wish to edit.

3
3 Edit the comment and choose the OK button.

r To delete a test comment

1
1 To display the Test comment dialog box, perform the
following action:
• In the Sample overview component or Day list
component, in the tests table, right-click the
appropriate test and choose the Insert test
comment command.

2
2 In the comments table, right-click the comment and
choose the Delete comment command.

3 In the dialog box, choose the OK button.

3
f To close the Test comment dialog box, choose
3 Routine tasks

the Cancel button.

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About entering a test result manually

You can manually enter test results that were created
outside the instrument. In the cobas 8000 data
manager Routine workplace, test results can be entered
in the following components:
• Sample overview
• Day list
• Validation

q You cannot enter results for heterogeneous

immunoassays manually.

After the test result has been manually entered, in the

Sample overview component tests table the status in
the following field changes:
• The Test status field changes to In release
• The Validation status field changes to Manual
result

q Manually entered test results are not validated

automatically. They require manual validation.

q You cannot modify a validated test result.

To overwrite a test result, right-click the test and choose
the Repeat test command on the shortcut menu. A new
test result can now be edited manually. The previous test
result is stored in the test details.
u Repeating a test (134)

Color-coding for test results It is possible to configure test result values to be color-
coded. For example, red to indicate that the result is out
of range and green to indicate that the result is within
range. A Roche Service representative sets up the color
codes.
3 Routine tasks

! WARNING
Incorrect patient treatment due to inaccurately
entered results
Inaccurately entered results could lead to inappropriate
treatment of patients.
r Ensure that test results are entered accurately.
r Ensure that test result values are in line with regional
settings, such as the use of the comma or point for
decimal separation.

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Entering a test result manually

You can enter or edit test results manually for clinical
chemistry tests. You cannot enter results for
heterogeneous immunoassays.

r To enter or edit test results manually

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the tests table, locate the test and press the Enter
key.

3
3 In the Result entry > Result field, edit the value of
the test result and confirm with the Enter key. If an
alphanumeric entry is predefined for the test, choose
it from the Result drop-down list.
f In the tests table, in the Result status column, the
result is marked as a Manual result.

q In the Result field, ensure that the value is

consistent with the regional settings.
For example:
If the decimal separator is set to a comma by the
regional settings, a decimal point invalidates the
result. 3 Routine tasks

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Repeating a test
You can repeat a test (if a confirmation of the result is
needed).

q You can request a repeat test regardless of whether

the result has already been validated or not. A dilution
that has already been ordered cannot be deleted. The
option is unavailable for non-Roche tests.

You cannot repeat tests with pending results. You can

order repetition of a test only once.

r To repeat a test

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the tests table, right-click the appropriate test and
choose the Repeat test command.

3
3 In the Day list component or the Validation
component, choose one of the filter options to list the
tests that you can repeat:
• Validation pending
• Processed tests
f The test order you want to repeat is now displayed
in the following components:
Sample overview: (tests table)
3 Routine tasks

Day list: (All samples check box and Results

pending check box)
Validation: (Results pending check box)

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Requesting dilution for a test

You can request a dilution of a test either before or after
you repeat it.

Dilution orders are created in the cobas 8000 data

manager Routine workplace.

You can choose if the dilution factor for a test is

increased or decreased. You can choose all dilution
factors which are available on the control unit. The
selection of the dilution factors is test-specific.

A dilution that has been ordered cannot be deleted.

Before requesting a dilution, refer to the Instructions for
Use of the test. The test is performed automatically on the
instrument with the assigned dilution setting.

! WARNING
Incorrect result assessment due to the use of an
inappropriate dilution factor
Inappropriate dilution factors may be misinterpreted
during result validation or result interpretation.
r Verify manually entered dilution factors before using
them in routine operation.

r To request a dilution for a test

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2 In the tests table, right-click the appropriate test and

3 Routine tasks

2
choose the Request dilution command.

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3
3 From the Request dilution for test: ;$name;
> Dilution factor drop-down list, choose the dilution
factor.
• You can choose all dilution factors which are
available on the control unit. The selection of the
dilution factors is test-specific.

q For information on the dilution factor, refer to the

Instructions for Use of the test.

4
4 Choose the OK button.
f The former test result is removed from the Result
column. In the Requested dilution column, the
dilution factor (Inc, Dec, none, or the factor) is
displayed. The test status is changed to “Repeat”.
3 Routine tasks

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Validating test results

Test results are validated depending on the configured
test validation rules, ranges, and pass-through mode.

In this section
cobas e flow test result validation (137)
About validating test results manually (144)
Validating test results manually using the information
window (145)
Validating test results manually in the Validation
component (147)
Validating test results manually by sample (149)

cobas e flow test result validation

In this section
Viewing cobas e flow test result details after
measurement (138)
Validating a failed cobas e flow test (140)
About repeat, rerun, and reflex tests with cobas e flow
tests (142)
Repeating a cobas e flow test (143)

3 Routine tasks

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Viewing cobas e flow test result details after measurement

After a cobas e flow test order is processed, all results
and subresults that are marked for reporting are shown in
the test details.

If a QC result for an embedded test fails the QC rule, the

cobas e flow test is marked with an eFlow.E data alarm.
In the cobas e flow test subresults panel, the
embedded test which is linked to the failed QC result
shows the specific data alarm.

If the main result of a cobas e flow test is based on a

formula and 1 of the tests within the formula gets a data
alarm with value. The calculated main result is displayed.
Both results are marked with the eFlowE data alarm. The
specific data alarm is displayed on the user interface, in
the report, printout, TraceDoc, and are sent to the host.

Test result presentation Test results that are marked for reporting are displayed as
numeric values or as text results.

Results which were measured on the instrument and are

not marked for reporting are displayed as ’********’. All
data alarms and QC results which are assigned to the
results are shown.

q Test results that are measured outside the technical

limit are displayed as numeric value or as *******
depending on the test result suppression configuration.

Cancelation of a cobas e flow test If the cobas e flow test fails, the main result is displayed
as ’???’ and the eFlow.E data alarm.

Only test results that were measured on the instrument

are displayed in the cobas e flow test subresults panel.

The test results of the cobas e flow test that failed on the
instrument are marked with a data alarm.
3 Routine tasks

For validation support, all data alarms and QC results

which are assigned to a test result are available, even if
the test result is suppressed.

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r To view cobas e flow test result

details after measurement

1
1 Choose cobas 8000 data manager Routine > Day
list.

2
2 In the samples table, locate the sample to view
associated tests in the tests table.

3
3 In the tests table, right-click the selected
cobas e flow test result and choose the Show test
details command.
f The cobas e flow test main result and subresults
are shown with the validation against the
reference range and rules.

4
4 In the Test details panel, data alarms are initiated in
the Validation status group box and displayed in the
Data alarms group box. If multiple data alarms are
assigned to a test result, the data alarm with the
highest priority is displayed in the Data alarms group
box.
I The data alarm with the highest priority is printed
on the report, archived, and displayed in TraceDoc
in the DataMessageFlag field of the
corresponding test result.

5 To view the test's QC results, choose the Additional

5
data tab.

u Related topics
3 Routine tasks

• Viewing test details (123)

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Validating a failed cobas e flow test

You can validate a failed cobas e flow test to determine
the reason for the failure.

The Sample overview component provides a quick and

visual indication of when action should be taken for the
following situations:
• Test result errors
• QC result errors
• Test and system messages

In the tests table, the failed cobas e flow test result is

marked with the generic alarm and the data alarm for the
corresponding test.

The test results field is marked with "???" and the

canceled status is assigned to the cobas e flow test.

Automatic repetition with dilution If an embedded test result violates the test range, in the
cobas e flow test subresults panel the test result is
marked with the >Test data alarm. The test result is
displayed as numeric value or as ******* depending on the
test result suppression configuration.
• The cobas e flow test is marked with the eFlow.E data
alarm.

If predefined, the failed embedded test is repeated with a

dilution. If the test result still violates the test range, both
failed test results are marked with the >Test data alarm in
the cobas e flow test subresults panel. Both test
results are displayed as numeric value or as *******
depending on the test result suppression configuration.
• The cobas e flow test is marked with the eFlow.E data
alarm.

If the repeated embedded test does not violate the test

3 Routine tasks

range anymore, the test result is displayed in the cobas e

flow test subresults panel without a data alarm.
• The cobas e flow test is valid and not marked with
the eFlow.E data alarm. If the embedded test result is
used for main result, the repeated embedded test
result is displayed in the Test details panel. The first
failed embedded test result is displayed in the cobas
e flow test subresults panel with the >Test data
alarm. Both test results are displayed as ******* or as
numeric value depending on the test result
suppression configuration.

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j m Test results with the QC error status can only be

validated after the corresponding QC result has been
released in the cobas 8000 data manager QC
Routine > QC Routine component.

r To validate a failed cobas e flow test

1
1 Choose cobas 8000 data manager Routine
> Sample overview.

2
2 In the sample group box or the patient group box,
enter the appropriate search criteria.
I For example, to view all STAT samples:
In the sample group box, from the Priority drop-
down list, choose the STAT option and confirm
with the Apply button

q The Orders from field and To field change to

the current day and should be modified appropriately
to view samples ordered from earlier dates.

3
3 In the tests table, right-click the selected
cobas e flow test result and choose the Show test
details command.
I If a cobas e flow test includes calculated results,
the data manager is displayed in the Targets
table in addition to the used modules.
f The main result is shown with the validation
against the reference range and rules.

4
4 On the Result data tab, the generic alarm and the
data alarm are displayed.
3 Routine tasks

5
5 In the cobas e flow test subresults panel, check the
Result data tab and Additional data tab for each
embedded test result for data alarms.
I Alarms are always displayed for any test results,
even if the results are suppressed and displayed as
*******.
On the Result data tab, instrument-related data
alarms are displayed.
On the Additional data tab, the test result-related
QC results are displayed.

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About repeat, rerun, and reflex tests with cobas e flow tests
This section describes the general definitions of terms
“repeat, rerun, and reflex”, and how they can be used with
cobas e flow tests.

Repeat, rerun, and reflex tests You can repeat a test in 2 different ways.
• Repeat test: repeats the measurement of the same
test under the same conditions
• Rerun test: reruns the same test with a dilution

It is also possible to trigger a test order according to the

result from another test:
• Reflex test: uses the result of one test to order another
test.

cobas e flow test rules Rules for cobas e flow test:

• You can repeat the whole cobas e flow test manually.
• You cannot repeat an embedded test of a
cobas e flow test.
• You cannot order a rerun with different dilutions for a
cobas e flow test or its embedded tests.
• A test can trigger a cobas e flow test as a reflex test.

q Although the data manager rule engine can use a

test to trigger cobas e flow test as a reflex test, a
cobas e flow test cannot trigger a regular test or a
cobas e flow test as a reflex test.
To trigger a reflex test from a cobas e flow test, program
it on the host system.

Manual and automatic The following table shows which options can be ordered
manually, and which options can be triggered
automatically for cobas e flow tests.

data manager: manual data manager: automatic Host

Repeat Yes No Yes
Rerun No (1) No
3 Routine tasks

No
Reflex Yes o No (as trigger) Yes
o Yes (as reflex test)
y Ordering repeat, rerun and reflex tests for cobas e flow tests
(1) No automatic TS inquiry R2, as per definition, automatic rerun for cobas e flow tests is always Off

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Repeating a cobas e flow test

If the operator repeats a cobas e flow test, the repetition
always starts from the beginning.

A failed cobas e flow test order cannot be restarted from

the point it is failed. It is not possible to repeat embedded
tests.

q It is only possible to choose the Repeat test

command for a cobas e flow test.
The cobas e flow test can be ordered as reflex test based
on an other test result.
The cobas e flow test cannot be repeated with a
manually assigned dilution.

r To repeat a cobas e flow test

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the tests table, right-click the appropriate test and
choose the Repeat test command.
f The new result is displayed in the Day list
component. The new subresults are stored in the
Show test details panel.

3 Routine tasks

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About validating test results manually

You can define rules for test results and QC results so
they can be validated manually.

q Test results with the Control status can only be

validated after the corresponding QC result has been
released in the cobas 8000 data manager QC Routine
> QC Routine component.

Depending on the configured test validation rules,

ranges, and pass-through mode for test results, most test
results can be validated automatically.

If the pass-through mode is switched off, a QC error

blocks the test result from being sent to the host.

If the pass-through mode is switched off, test results

must be validated manually in the following situations:
• A test result falls outside the test's validation range.
• In the cobas 8000 data manager Test
Configuration > Tests / reference ranges
component, the Automatic validation check box is
not selected.
• A data alarm has been set to block automatic
validation.
• Test results were entered manually.

You can manually validate individual test results in the

following components:
• Sample overview
• Day list
• Validation
• Information window

In the Day list component, you can validate test results

on sample order level. All test results available in the
sample order are validated at once.
3 Routine tasks

q No confirmation required
If you press F8, the result is validated without further
confirmation.
o Always make sure that the result is correct before
pressing F8.

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Validating test results manually using the information

window
You can directly access test results awaiting validation by
using the information window.

There are 2 system messages that you can use:

• Tests pending validation (ROUTINE)
• Tests pend. validation (STAT)

Each message indicates the number of test results

awaiting validation.

The Information window panel represents system

messages by colored icons. They provide a quick and
visual indication of when action should be taken for the
following situations:
• Test result errors
• QC result errors
• Test and system messages

The Roche Service representative can configure system

messages to indicate the level of urgency in terms of the
color of its icon:
• Green: no action is required.
• Yellow (warning): action might be required.
• Red: indicate that an event is critical and requires and
immediate attention.

q In the Information window panel, only the number

of messages with the highest severity level is displayed.
Messages with a lower severity level are hidden. For more
information, you must open the detail view panel of the
corresponding message category.

If a data alarm appears, for example, sample short,

sample clot or foam detected, the cobas e flow test is
3 Routine tasks

canceled.

q In the Information window panel, canceled

cobas e flow tests are displayed as warnings.

The test results field is marked with "???" and the

canceled status is assigned to the cobas e flow test.

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j m Test results with a QC error can only be validated after

the corresponding QC result has been released in the
cobas 8000 data manager QC Routine > QC
Routine component. Ensure that the standby QC
results are also checked and validated.

r To validate test results using the

information window
1 In the Information window panel, double-click one
1
of the following system messages:
• Tests pending validation (ROUTINE)
• Tests pend. validation (STAT)
f The dialog box with containing test results
awaiting validation is displayed.

2
2 In the test results table, right-click the appropriate
test, and choose the Show test details command.
I The result detail panel displays failed cobas e flow
tests as ??? and marked with the eFlow.E data
alarm.

3
3 To view the test's QC data, choose the Additional
data tab.
f To close the dialog box, choose the Close button.

4
4 In the tests table, right-click the test and choose the
Validate test result (F8) command or press the F8
key.
3 Routine tasks

f The test is validated and it disappears from the

tests table of the dialog box.

5 Repeat the procedure for any other tests you want to

validate.

q You can validate more than one test at once by

selecting multiple tests from the list.

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Validating test results manually in the Validation

component
You can use the filter options to list the requested results.

q You can validate test results in the Day list

component and the Sample overview component. For
this purpose, you must first select the sample in the
samples table. This option allows you to validate all
results associated with the sample at once.

Validated test results can be viewed in the Validation

component with the Processed tests filter applied. The
check box in the Validated column is selected, indicating
that the test result has been validated.

j m Test results with a QC error can only be validated after

the corresponding QC result has been released in the
cobas 8000 data manager QC Routine > QC
Routine component. Ensure that the standby QC
results are also checked and validated.

r To validate test results in the

Validation component

1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 In the filter group box, select the Validation pending
check box.
f All tests awaiting validation are listed in the tests
3 Routine tasks

table.

3
3 In the tests table, right-click the appropriate test and
choose the Validate test result (F8) command or
press the F8 key.
f The test is validated and disappears from the tests
table.

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4 Repeat the procedure for any other tests you want to

validate.

q You can validate more than one test at once by

selecting multiple tests in the list.
3 Routine tasks

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Validating test results manually by sample

If a test result is not automatically validated, you can
validate the result manually.

In the Day list component, select the Validation

pending check box to display the samples with results
that require validation.

j m Test results with a QC error can only be validated after

the corresponding QC result has been released in the
cobas 8000 data manager QC Routine > QC
Routine component. Ensure that the standby QC
results are also checked and validated.

r To validate test results by sample

1
1 Choose cobas 8000 data manager Routine > Day
list.

2
2 In the filter group box, select the Validation pending
check box.
f All samples requiring validation are listed in the
samples table.

3
3 In the samples table, right-click the sample and
choose the Validate all sample results (F8)
command or press the F8 key.
f The sample results are validated and disappear
from the samples table.
3 Routine tasks

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Reporting test results

You can generate test result reports in the following
components:
• Sample overview
• Day list
• Validation

You can preview a report before printing it or print it

directly.

q You can configure the data manager to print reports

automatically for STAT and routine test results. On the
cobas 8000 data manager System Configuration
> System configuration > Autoprint tab, enter the
appropriate information.

If the sample lifetime option is enabled, the following

information is available on the sample result report:
• Sample lifetime:
• Start date: date and time when the sample was
registered on the data manager first.
• End date: date and time when the sample lifetime
expired.
3 Routine tasks

w Test result report with sample lifetime information

In this section
Previewing a test result report (151)
Printing a test result report (153)

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Previewing a test result report

Before printing a test result report, you can preview and
check it for completeness.

For cobas e flow test orders, the subresults are included

in the report. If the cobas e flow test is canceled, all
existing subresults are contained in the report and the
following information is provided:
• The report states the reason for the failure under the
corresponding test order.
• In the result column, ??? appears instead of the main
result.
• The cobas e flow test is marked as canceled.
• The cobas e flow test result has generic data alarms.

In the report preview, after a test result is validated and

compared to the normal and/or critical reference ranges,
the symbols in the graph column are displayed. The
following symbols are used to indicate the test result
status regarding these ranges:

Symbol Meaning
*()_ The test result is below normal and/or critical range.
_(*)_ The test result does not violate the normal or the critical range.
_()* The test result is above normal and/or critical range.
y Meaning of symbols in the Graph column of the result report

r To show a result report

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation
3 Routine tasks

2
2 In the samples table, right-click the appropriate
sample and choose one of the options in the Show
result report command.
• Single result report
• Single result report (two units)

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3 To print the report, choose the printer button in the

3
toolbar of the print preview panel.
f The report preview shows the repeated and failed
cobas e flow test results and any test comments.
3 Routine tasks

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Printing a test result report

If you have validated the sample order, you can print a
test result report directly without generating an extra
preview report.

After a test result is validated and compared to the

normal and/or critical reference ranges, the symbols in
the graph column are displayed. The following symbols
are used to indicate the test result status regarding these
ranges:

Symbol Meaning
*()_ The test result is below normal and/or critical range.
_(*)_ The test result does not violate the normal or the critical range.
_()* The test result is above normal and/or critical range.
y Meaning of symbols in the Graph column of the result report

r To print a result report

1
1 In the cobas 8000 data manager Routine
workplace, choose one of the following components:
• Sample overview
• Day list
• Validation

2
2 In the samples table, right-click the appropriate
sample and choose one of the options in the Print
result report command.
• Single result report
• Single result report (two units)
f The report is sent directly to the printer. 3 Routine tasks

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Masking and unmasking tests

When a test is masked, you cannot use the test on the

module to which the test is assigned.

In this section
About masking and unmasking tests (154)
About masking a module or submodule on the control
unit (158)
Masking and unmasking tests by instrument or
module (159)
Masking and unmasking individual tests (160)
Masking and unmasking a cobas e flow test (161)
Masking and unmasking tests by masking profile (162)
Viewing the masking history of a test (163)

About masking and unmasking tests

The cobas 8000 data manager Routine > Test mask
overview component provides information about test
masking.

You can request masking or unmasking for a specific test

or for all patient samples. Assign the order at instrument
level, module level, submodule level, or on an individual
test level.

Masked embedded test in cobas e flow test If you start a cobas e flow test that includes a masked
embedded test, the cobas e flow test is canceled with an
eFlow.E data alarm.

For test detail review, right-click on the corresponding

cobas e flow test and choose the Show test details
command.
3 Routine tasks

In the cobas e flow test subresults panel, the masked

embedded test is marked with the data alarm 113:
"Unmeasurable state has occurred. Because of that, the
measurements of embedded test item for e-flow was
masked."

q Before repeating the order, check the status of the

embedded test on the control unit of the cobas® 8000
instrument. For more detail refer to the Operator’s Manual
of the cobas® 8000 instrument.

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Masking and unmasking of ISE tests All ISE tests of a submodule are masked and unmasked
together. To mask the ISE tests of a submodule, the
masking condition for at least one ISE test of the
submodule must be fulfilled. To unmask the ISE tests of a
submodule, the unmasking condition of all ISE tests of the
submodule must be fulfilled.

The Test mask overview component contains 3 tables:

• The left table lists the modules and masking profiles.
• Top table: lists the tests assigned to a module or a
profile.
• Bottom table: lists the masking history of a test.

A
C

A Mask test (tab) / Masking profiles (tab) B Bottom table C Top table

w Test mask overview component

Filter options The Mask test tab contains the modules and
submodules in a hierarchical tree. You can collapse and
expand the tree by clicking the node buttons beside the
instrument, module, or submodules.

When you select the name of the instrument, a module, or

3 Routine tasks

a submodule, the associated tests are displayed in the

table.

When you select the check box beside the name of the
instrument, module, or submodule, you can request
masking or unmasking of the corresponding tests.

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The Masking profiles tab contains masking profiles

configured in the cobas 8000 data manager Routine
Configuration > Mask profiles component.

When you choose the name of a masking profile, the tests

in the profile are displayed in the top table.

When you select the check box beside a masking profile

name, you can request masking or unmasking of the
corresponding tests.

Top table Contains the tests for the instrument, module, or

submodule that is selected in the Mask test tab, or the
Masking profiles tab.

Masking information is provided for each test (for

example, masking status or details of the last status
change).

Tests are color-coded to indicate their masking status as

follows:
• Violet: Test masking
• Orange: Patient masking
• Gray: module masking (module masking can only be
done on the control unit)
• No color: unmasked

To perform tasks in the top table, use the shortcut menu.

Bottom table Contains the masking history of a test selected in the top
table. Each line represents a masking order and contains
information about the order, including the requestor,
masking type, and method.

Test vs. Patient masking There are 2 ways to mask a test:

• Test masking: no samples, no QC measurements, and
no calibrations can be performed.
• Patient masking: the test is masked for patient
samples. Only calibration and QC can be performed.

q
3 Routine tasks

Test masking is bi-directional. Tests masked on the

control unit are reflected in the Test mask overview
component.

Number of masked tests The Information window > Masked tests message
indicates the number of masked tests. Opening the
message displays the Test mask overview component
and provides the same functionality.

Automatic patient masking If a QC error occurs for a test, you can trigger patient
masking automatically.

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You can mask and unmask tests and patient samples at

the following levels:
• Instrument
• Module (for example c 502 or e 602)
• Submodule (for example ISE(1) and ISE(2))
• Masking profile
• Individual test

q Create masking profiles in the cobas 8000 data

manager Routine Configuration > Mask profiles
component.

3 Routine tasks

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158 Masking and unmasking tests

About masking a module or submodule on the control unit

You can mask a module or submodule for specific
circumstances, for example, service actions. To exclude a
module from the routine, you must perform the module
masking on the control unit.

The control unit sends the module masking order to the

data manager. In the cobas 8000 data manager
Routine > Test mask overview component, the
masking status for the module or submodule is displayed.
• All tests assigned to the module or submodule are
masked and displayed with a gray background.

Test orders from the host or manually created on the data

manager are sent to the control unit but not performed on
the masked module. If a test is assigned to more than one
module, the test order is sent and measured on the
available module.

q If in the Masked column the check box is selected

for a cobas e flow, the cobas e flow is additionally test
masked or patient masked for any cobas e 801 modules
3 Routine tasks

and cannot be ordered.

As soon as you unmask the module on the control unit, all

tests restart measuring at the position they were stopped
because of masking.

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Masking and unmasking tests by instrument or module

If there is a technical problem, you can exclude an
instrument, module, or submodule from the routine
workflow.

r To mask and unmask tests by

instrument, module or submodule

1
1 Choose cobas 8000 data manager Routine > Test
mask overview.

2
2 On the Mask test tab, select the appropriate check
box beside the instrument, module, or submodule.

3
3 In the Confirm masking dialog box, choose one of
the available options.
f The request to mask or unmask the tests is sent to
the control unit.
f If you mask tests, the check box beside the
instrument, module, or submodule, and all of the
corresponding test check boxes are selected.
f If you unmask tests, the corresponding instrument,
module or submodule, and test check boxes are
cleared.
f The tests are color-coded to indicate their masking
status.
3 Routine tasks

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Masking and unmasking individual tests

If there is a test-specific problem or the reagent cassette
for the test is not used often, you can exclude the test
from the routine process.

r To mask and unmask an individual

test

1
1 Choose cobas 8000 data manager Routine > Test
mask overview.

2
2 In the top table, locate the test and choose one of the
following options:
• Select the Masked check box.
• Right-click the test and choose the Request
patient masking or test masking command.

q To display all available tests that were assigned

to an instrument or module, choose the instrument or
module name on the Mask test tab.

3
3 In the Confirm masking dialog box, choose one of
the available options.
f The request to mask or unmask the tests is sent to
the instrument.
f If you mask the test, the corresponding check box
is selected and it is color-coded:
Orange for patient-masking
Violet for test-masking
f If you unmask a test, the corresponding check box
is cleared and the color-coding is removed.
3 Routine tasks

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Masking and unmasking a cobas e flow test

You can order a cobas e flow test when it is masked on
the data manager or host. None of the embedded tests is
processed on the instrument.

Patient masking When you choose the Patient masking option on a

cobas e flow test, all defined sample types (for example,
serum/plasma or urine) of the cobas e flow test are
masked.

Test masking When you choose the Test masking option on an

embedded test, the cobas e flow test is not masked. Only
when you choose the Patient masking option, all regular
tests, embedded tests, and cobas e flow tests are
masked.

q An embedded test that has been masked on the

control unit has no influence on the ability to order a
cobas e flow test. The cobas e flow test is processed as
far as possible. The workflow stays on hold until the
required embedded test is unmasked on the control unit.
Processing of the cobas e flow test is then resumed.

r To mask/unmask a cobas e flow test

1
1 Choose cobas 8000 data manager Routine > Test
mask overview.

2
2 In the test list overview, choose the cobas e flow test
and select the Masked check box.
f On the Confirm masking dialog box, only the
3 Routine tasks

Patient masking option is available for

cobas e flow test.

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Masking and unmasking tests by masking profile

If you want to mask or unmask a defined group of tests,
you can use the masking profile option.

r To mask and unmask tests by

masking profile

1
1 Choose cobas 8000 data manager Routine > Test
mask overview.

2
2 On the Masking profiles tab, select the check box
beside the masking profile that you wish to use.

3
3 In the Confirm masking dialog box, choose one of
the available options.
f The request to mask or unmask the tests is sent to
the instrument.
f If you mask tests, the check box beside the
masking profile and all of the corresponding test
check boxes are selected.
f If you unmask tests, the masking profile check box
and the corresponding test check boxes are
cleared.
f The masked tests are color-coded indicating their
masking status.
3 Routine tasks

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Viewing the masking history of a test

You can use the masking history to view the different
statuses of a test since its installation.

r To view the masking history of a test

1
1 Choose cobas 8000 data manager Routine > Test
mask overview.

2
2 In the top table, locate the test whose masking history
you wish to view.
f The masking history of the test is displayed in the
bottom table.

3 Routine tasks

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164 Reviewing system status

Reviewing system status

In the System status component, you can review
predefined system statuses together with the
corresponding system alarms (by status date).

r To review a system status by date

1
1 Choose cobas 8000 data manager Routine
> System status.

2
2 In the navigation tree, choose instrument or
instrument adapter whose statuses you want to view.

3
3 To view statuses for a specific date, choose the date
from the Status date drop-down list.

4
4 To view the complete information of a system status,
right-click the status in the status table and choose
the Display status command.

5
5 To view the complete information of an alarm
associated with the selected system status, right-click
3 Routine tasks

the alarm and choose the Display alarm command.

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 Viewing system alarm details 165

Viewing system alarm details

The System alarms component lists all alarms with or
without a corresponding system status. System alarms
indicate errors in the system.

The details of system alarms that occurred on the

instrument are not shown in this component but on the
control unit.

After reviewing an alarm, you can send the alarm details

to the remote service platform.

r To view the data manager system

alarm details

1
1 Choose cobas 8000 data manager Routine
> System alarms.

2
2 In the navigation tree, choose the data manager or
instrument to review the corresponding alarms.

3
3 To display alarms for a specific day, choose the day in
the Alarm date drop-down list.
3 Routine tasks

4
4 In the alarms table, right-click the appropriate alarm
and choose the Display alarm command.
f The System alarm dialog box provides
information containing the alarm details.

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166 QC tasks

QC tasks
The cobas 8000 data manager QC Routine workplace
has the following component:
• QC Routine

In the QC Routine component, the measured QC

materials that have been validated against their defined
target values and ranges are displayed. The QC Routine
component also allows you to validate and release the
displayed QC results, and monitor QC standby bottles.

In this section
Quality control for cobas e flow tests (166)
About the QC Routine component (177)
About copy QC (180)
About QC bracketing (182)
Viewing QC results (184)
Validating QC results (186)
Acknowledging QC results (188)
Releasing results with QC errors (189)
Adding comments to QC results (191)
Resending QC results to the host (192)
Monitoring QC standby bottles (193)

Quality control for cobas e flow tests

In order to ensure the accuracy and quality of patient
results, the system validates the results against the status
of their corresponding QC results.

In this section
About calculated QC (166)
About QC result validation of a cobas e flow test
result (171)
3 Routine tasks

Validating calculated QC results (174)

About calculated QC
The data manager calculates the calculated QC value
which is used in cobas e flow tests.

For QC of a cobas e flow test, the following types of QC

results are considered:
• Single QC
• Calculated QC

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Single QC definition Single QC means a single QC result for each measured

embedded test.

cobas eÁRZWHVW Single QC2 (HBSAGQE, MC1): 0.01 [IU/mL]

“HBSAG Q D”
Single QC3 (HBSAGQE, MC1) 0.01 [IU/mL]

w Single QC

Calculated QC definition Calculated QC means QC results for "linked tests" or

"linked kits" within a cobas e flow test. This is provided
by Roche Diagnostics.

Calculated QC3 for “HIV Duo”: 0.650 [COI]

cobas eÁRZWHVW
“HIV Duo” Single QC1 (HIV Ag, MC1): 0.375 [COI]

Single QC4 (Anti HIV, MC2): 0.531 [COI]

w Calculated QC

For details of linked tests and linked kits, see the next
section.

Calculated QC for linked tests or linked kits A cobas e flow test may measure multiple embedded
tests during its execution. The embedded tests can be
specified as a set of combined embedded tests (linked
tests) or combined cobas e packs (linked kits).
Therefore, there are dependencies between embedded
tests or cobas e packs. The definition of the linked tests
or linked kit forces the instrument to measure the tests in
a certain order of pipetting.
3 Routine tasks

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168 QC tasks

The cobas® 8000 data manager can generate a

pipetting sequence calculated QC result using a pre-defined formula based
on a specific cobas e flow test. The calculated result is
based on the single QC results of the embedded tests in
the cobas e flow test. When a cobas e flow test is
ACN 11150 ACN 11151 installed on the cobas® 8000 modular analyzer series,
CMVA IGG CMVA AVI the calculated QC functionality is automatically installed
and enabled with it.

Link However, not all cobas e flow tests have a calculated QC

cobas eÁRZWHVW value. There is only at most one formula for calculated QC
per cobas e flow test. However, more than one
“CMV AVI” ACN 12001
calculated QC value can be reported, depending on the
as “Linked test” assigned measuring cell.

Since the cobas e 801 module has 2 measuring cells, it

pipetting sequence
can happen that different measurements can be
performed on different measuring cells. For example, the
cobas e flow test “HIV Duo” has 2 embedded tests, “HIV
Ag” and “Anti HIV”: the system has to calculate 4
ACN 11014 ACN 11013
calculated QC values, one for each combination of
HIV Ag Anti HIV
module, measuring cell, and QC level (QC lot number).

Link
cobas eÁRZWHVW
´+,9'XRµ$&1
as “Linked kit”
3 Routine tasks

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 QC tasks 169

The following example shows calculated QCs for the

cobas e flow test “HIV Duo” on a cobas e 801 module
with 2 measuring cells, “MC1” and “MC2”:

Calculated QCs for cobas eÁRZWHVW´+,9'XRµ

HPEHGGHGWHVWV´$QWL+,9+,9$Jµ

cobas e 801 module,QVWDOOHGHPEHGGHGWHVWRQPHDVXULQJFHOO0&

+,9$J $QWL+,9 +,9$J $QWL+,9

0& 0& 0& 0&

6LQJOH4&1 6LQJOH4&2 6LQJOH4&3 6LQJOH4&4

Calculated QC1+,9'XR Calculated QC2+,9'XR

+,9$J0&$QWL+,90& +,9$J0&$QWL+,90&

Calculated QC3+,9'XR Calculated QC4+,9'XR

+,9$J0&$QWL+,90& +,9$J0&$QWL+,90&

w Complete example for all combinations for calculated QC for two embedded tests on different modules

The following diagram shows an example result of a

calculated QC including its corresponding single QC
result values.

Calculated QC3 for “HIV Duo”: 0.650 [COI]

(HIV Ag, MC1 - Anti HIV, MC2)

Single QC1 (HIV Ag, MC1): 0.375 [COI]

3 Routine tasks

Single QC4 (Anti HIV, MC2): 0.531 [COI]

w Example calculated QC and corresponding single QC values

For each measurement of linked tests or embedded tests

referred to linked kits during the cobas e flow test
execution, the appropriate calculated QC result must be
used for cobas e flow test validation.

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170 QC tasks

For each QC result that is used by an embedded test in

the cobas e flow test, the data manager performs a
calculation taking into account the following
components:
• QC material
• Module
• Measuring cell

The calculated QC result is displayed in the Test details

panel on the Additional data tab of the cobas e flow
test.

q If one or both of the measured QC results of the

embedded tests is marked with the status Error, the
calculated final QC result is marked with the status Error
as well.

u Related topics
• Viewing cobas e flow test result details after
measurement (138)
• Validating calculated QC results (174)
3 Routine tasks

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 QC tasks 171

About QC result validation of a cobas e flow test result

In order to validate cobas e flow test results (if
configured), the system considers all relevant QC results
(single QC measurements as well as calculated QCs).

The following diagram shows which QC results are

relevant to validating a cobas e flow test.

cobas eÁRZWHVW´$%&µ cobas eÁRZWHVW4&

Measure 0HDVXUHG4&IRU
Embedded test D HPEHGGHGWHVW´'µ
4&/RW1R

>1HJDWLYH@ >3RVLWLYH@

Report Measure &DOFXODWHG4&IRU

- Main result test D Embedded test A cobas eÁRZWHVW´$%&µ
Embedded test F 4&/RW1R

0HDVXUHG4&IRU
HPEHGGHGWHVW´$µ
Generate
4&/RW1R
Generated result B1
Generated result B2
0HDVXUHG4&IRU
HPEHGGHGWHVW´)µ
4&/RW1R

Report
- Main result test B1
- Subresult test A
3 Routine tasks

- Subresult test F
- Subresult test D
- Subresult B2

w Calculated QC and measured QC

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172 QC tasks

The diagram below shows the relevant calculated QC

results and single QC results for a particular example
cobas e flow test result.

cobas eÁRZWHVW´+,9'XRµ

0DLQUHVXOW+,9'XR ´5HDFWLYHµ>&2,@

6XEUHVXOW$QWL+,9 ´1RQ5HDFWLYHµ>&2,@

6XEUHVXOW+,9$J ´5HDFWLYHµ>&2,@

&DOFXODWHG4& IRU´+,9'XRµ >&2,@
+,9$J0&$QWL+,90&
+,9$J0&$QWL+,90&
6XEUHVXOWRIHPEHGGHGWHVW$QWL+,90& ******* 6LQJOH4&+,9$J0& >&2,@

6XEUHVXOWRIHPEHGGHGWHVW+,9$J0& ******* 6LQJOH4&$QWL+,90& >&2,@

w Example QC assignment to patient results

Each measurement of linked tests or embedded tests

referred to linked kits need to be validated against the
appropriate calculated and single QC results.
3 Routine tasks

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 QC tasks 173

The following diagram shows an example for the

cobas e flow test “HIV Duo R (duplicate repeat)” and its
calculated QC results. In order to simplify the diagram,
only a part of the subresults and only one control level are
shown.

cobas eÁRZWHVW
´+,9'XR5GXSOLFDWHUHSHDWµ

0DLQUHVXOW+,9'XR5 ´5HSHDWHGO\5HDFWLYHµ

6XEUHVXOW$QWL+,9 ´5HDFWLYHµ>&2,@

6XEUHVXOW+,9$J ´5HDFWLYHµ>&2,@

&DOFXODWHG4& IRU´+,9'XR5µ >&2,@
+,9$J0&$QWL+,90&
+,9$J0&$QWL+,90&
6XEUHVXOWRIHPEHGGHGWHVW$QWL+,9>@0& ******* 6LQJOH4&+,9$J0& >&2,@

6XEUHVXOWRIHPEHGGHGWHVW+,9$J>@0& ******* 6LQJOH4&4$QWL+,90& >&2,@

•
•
•

6XEUHVXOW$QWL+,9 ´1RQ5HDFWLYHµ>&2,@

6XEUHVXOW+,9$J ´5HDFWLYHµ>&2,@

&DOFXODWHG4& IRU´+,9'XR5µ >&2,@
+,9$J0&$QWL+,90&
+,9$J0&$QWL+,90&
6XEUHVXOWRIHPEHGGHGWHVW$QWL+,9>@0& ******* 6LQJOH4&+,9$J0& >&2,@

6XEUHVXOWRIHPEHGGHGWHVW+,9$J>@0& ******* 6LQJOH4&$QWL+,90& >&2,@

w Example QC for multiple QC assignments to patient results

3 Routine tasks

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174 QC tasks

Validating calculated QC results

In the QC Routine component, you can validate
calculated QC results.

Possible filter criteria for the QC status are listed below:

• All
• OK
• Warning
• Error
• Not enough values
• No evaluation

r To validate calculated QC results

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2 In the QC Type group box, select the Calculated QC

2
check box only.
• From the drop-down lists, choose a time frame or
enter the number of days counting back from the
current date.
• To make your selection as precise as necessary,
use the remaining drop-down lists.

3
3 Choose one of the following filter options:
All results
Last results only
f From the QC type drop-down list, choose the
Current option or the Standby bottle option.
f If the All results option is selected, all QC results,
including previous ones are displayed.
f With the Last results only option, only the latest
3 Routine tasks

results are displayed.

q If the All results option is selected from the QC

type drop-down list, the Last results only option
does not work.

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 QC tasks 175

4
4 In the QC results table, choose the appropriate QC
result and choose the Result details command.

5
5 In the Result details panel, use the available tabs to
check the result status.
I On the Data alarms tab, only the generic data
alarm for the cobas e flow test is displayed.

6
6 On the QC results used for calculation tab, the QC
results of the measured QC materials are displayed.
• Note the details of the failed QC result
• Choose the Close button

7
7 Set the filter criteria to find the corresponding failed
measured QC result.

8
8 In the QC results table, choose the appropriate QC
result and choose the Result details command.
• Check the reason of failure.
• If necessary, start corrective actions.

9
9 On the appropriate QC result, right-click and choose
the Release result command.

10 In the Insert comment dialog box, enter free text or

3 Routine tasks

10
choose a pre-configured comment and confirm with
the OK button.
• Use steps 7–10 to validate any involved QC result
of the calculated QC result.

11
11 In the Filter options group box, choose the required
filter criteria to filter for the appropriate calculated QC
result.

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176 QC tasks

12
12 On the appropriate calculated QC result, right-click
and choose the Release result command.

13
13 In the Insert comment dialog box, enter free text or
choose a pre-configured comment and confirm with
the OK button.
3 Routine tasks

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 QC tasks 177

About the QC Routine component

In the QC Routine component, you can view, evaluate,
and release QC results depending on the settings. The
selection criteria allow you to filter QC results. The more
criteria you enter, the more accurate the result display.

The QC Routine component contains filter options, 3

tables, and the Levey-Jennings chart:
• Reference value table: contains the reference values
for the QC material that is selected in the Control
values tab.
• Statistics table: provides information about the QC
value statistics for the QC material currently selected
on the Control values tab.
• QC results table: contains either the control table, the
Levey-Jennings chart, or both, depending upon the
Table visible check box and Graph visible check
box selections.

B
C

D
E
3 Routine tasks

A Filter options B Reference value C Statistics table D QC results table E Levey-Jennings

table chart

w QC Routine component

Filter options

Enable you to determine the QC results that you want to

view.

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178 QC tasks

The filtering results are displayed in the Control values

table.

Choose the Refresh button to refresh the QC Routine

component after you have made some filter changes.

Viewing calculated QC results To show or hide calculated QC results in the QC result

table and chart, select or clear the Calculated QC check
box.

q In the Instrument column of the Control values

table, calculated QC results are assigned to the data
manager.

Viewing copy QC results To show or hide copy QC results in the QC result table
and chart, select or clear the Copy QC check box.

q The following severity levels may be assigned to a

QC result, by decreasing order of severity:
o Error
o Warning
o Not enough values
o OK
The No evaluation status only applies when no QC rule
is assigned for the test.

Reference values table Contains the reference values for the QC material that is
selected in the Control values tab. The table includes
the target value, allowed deviation, -1s to +1s, -2s to +2s,
-3s to +3s, lower limit, and upper limit.

Statistics table Provides information about the QC result statistics for the
QC material currently selected on the Control values
tab. The details include the number of result values, the
standard deviation, root-mean-square error (RMSE), and
the systematic error value.

Control values tab Contains either the control table or the graphic or both,
3 Routine tasks

depending upon the Table visible check box and Graph

visible check box selections.

To perform tasks in the QC results table, use the shortcut

menu.

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 QC tasks 179

q By using the Table visible check box and the

Graph visible check box you can display the table only,
or the chart only as necessary. You can display graphics
depending on the QC type, for example, symmetric,
asymmetric with target value and asymmetric without
target value.
u About the cobas® 8000 data manager interface (without
sidebar) (46)

The Reference values table and the Statistics table

contain the corresponding values for the result that is
highlighted in the Control values table.

Levey-Jennings chart Provides a graphical representation of QC results for the

QC material selected in the Control values table. It
provides the following functionality:
• Representation of QC results and QC results for
standby bottles (indicated by dots and squares
respectively). When you place the mouse pointer over
a result node of a chart, a tooltip containing
information about the result is displayed.
• Colored indication of when a calibration has taken
place, there has been a reagent change, or both.
• Color coding of the standard deviation ranges (<2s, 2s
to 3s, and >3s).
• You can display multiple charts simultaneously by
making multiple selections in the Control values
table.
• Results are displayed as absolute values or as the
corresponding reference range values.

q If the Levey-Jennings chart displays symmetric QC

results and asymmetric QC results, be aware of wrong QC
result interpretation because of the different range
scaling.

Absolute scale Select the check box to view the QC results as absolute
values. When the check box is cleared, the QC results are
3 Routine tasks

indicated in terms of + or - standard deviations.

Chart limit Select the check box to view the QC results within the
chart limits (+ and - 4 standard deviations). When the
check box is cleared, the maximum and minimum QC
results bound the graph.

Zoom function in the Levey-Jennings chart You can zoom in and out of a chart by left-clicking and
dragging the mouse pointer:
• Left to right over the area you want to zoom into.
• Right to left over the area you want to zoom out of.

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180 QC tasks

About copy QC
This section summarizes the copy QC functionality for
cobas e flow tests.

About copy QC Identical applications for regular and embedded test

measurements can use the same QC data. Master
application and additional application are defined in the
application file. One master application can support one
or more additional applications.

The master QC result is assigned automatically to the

corresponding additional application. In the QC Routine
> Copied from column, the master QC is displayed, from
where the additional application copied the QC results.

q The copy QC feature only supports Roche QC

materials.

About copy QC validation QC rule validations are only performed on master QC

results. The master QC result (with all data alarms,
instrument messages, and comments) is automatically
copied and attached to the additional application.

How copy QC works The copy QC feature works as follows:

• The QC is always measured for master application.
• The master QC result data is copied automatically to
the additional application if available.
• The copy QC feature works for current and standby
reagents.

Copy QC

1 2 3
Four (4) ACNs assigned to copy QC data to additional
QC measurement
cobas e pack ACNs
3 Routine tasks

Master ACN Master ACN

Additional-1 ACN Additional-1 ACN
Additional-2 ACN Additional-2 ACN
Additional-3 ACN Additional-3 ACN

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 QC tasks 181

Test with additional ACN and own QC material

If you install the QC material, any tests related to the QC

FREDVHÁRZWHVW material are automatically assigned. If you install the QC
LQVWDOODWLRQ material that is used for the test with an additional ACN,
this test is assigned to both QC materials automatically.
(PEHGGHG7HVW$

q If the additional ACN has its own QC material, the

(PEHGGHG7HVW%

additional ACN is also measured on the instrument.

0DVWHU4&PDWHULDO 4&PDWHULDOIRU
(PEHGGHG7HVW%
$GGLWLRQDO$&1

Embedded Test-A
- Master ACN
Embedded Test-B Embedded Test-B
- Additional ACN - Additional ACN

3 Routine tasks

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182 QC tasks

About QC bracketing

QC bracketing is activated or deactivated in the cobas

cobas 8000 data manager test 8000 data manager Test Configuration > Tests /
FRQÀJXUDWLRQ
reference ranges component.
Data manager

Tests / reference ranges

4&EUDFNHWLQJcheckbox selected

4&PHDVXUHPHQW
Instrument

5RXWLQHVDPSOHPHDVXUHPHQWV

4&PHDVXUHPHQW

2XWFRPH
manager
Data

q Using QC bracketing has an impact on the result

release timing. The more samples are analyzed within the
QC bracket, the longer it takes to release the result.
For cobas e flow tests, QC bracketing can be enabled
only for the main test but not for the embedded tests.
The system will consider the functionality to release
corresponding embedded tests automatically.

The QC result can have one of the following statuses:

• All
• OK
• Warning
• Error
3 Routine tasks

• Not enough values

• No evaluation

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 QC tasks 183

The table below indicates the outcome and the actions

that can be taken for test results for which QC bracketing
is enabled.

QC measurement 1 QC measurement 2 Test results are Manual validation of sample result

automatically released
OK OK Yes n/a
Not OK OK No Possible, after you have accepted and released the
QC result with the status “Not OK” manually.
OK Not OK No Possible, after you have accepted and released the
QC result with the status “Not OK” manually.
Not OK Not OK No Possible, after you have accepted and released the
QC result with the status “Not OK” manually.
Missing Missing No Not supported
Missing Not OK No Not supported
Not OK Missing No Not supported
Missing OK No Not supported
OK Missing No Not supported
y QC bracketing actions

You can view the status of test results using the Sample
overview component. In the Test details dialog box, the
test result status resulting from the QC bracketing is
displayed.

You can assign more than 1 QC material to a test. If the

QC bracketing option is enabled, the QC validation will be
triggered with the first QC result received following the
test results when it has a valid QC ("closing" bracket).
• The validation of the sample results is only based on
the QC values received with the "opening" bracket.
• The validation of the sample results is only triggered
when the first QC value of the "closing" bracket is
valid.
• The validation of the sample results is not triggered
when the first QC value of the "closing" bracket is not
valid (WARNING, ERROR). 3 Routine tasks

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184 QC tasks

Viewing QC results
The filtering functions allow quick searching through the
QC data.

In the QC Routine component, you can filter QC results.

You can select a combination of filter criteria, such as
instruments, tests, reagent lot number, QC status, and QC
material to view the required results.

In the QC Routine component, the column with the

Copied from value indicates the additional QC results.

Possible filter criteria for the QC status are listed below:

• All
• OK
• Warning
• Error
• Not enough values
• No evaluation

r To view QC results

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2
2 If the selection criteria are not visible, choose the +
button to display the Filter options group box.

3 In the Filter options group box:

3
• From the drop-down lists, choose a time frame or
enter the number of days counting back from the
3 Routine tasks

current date. You can use decimal value for partial

days.
• To make your selection as precise as necessary,
use the remaining drop-down lists.

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 QC tasks 185

4
4 Choose one of the following filter options:
All results
Last results only
f From the QC type drop-down list, choose the
Current option or the Standby bottle option.
f If the All results option is selected, all QC results,
including previous ones are displayed.
f With the Last results only option, only the latest
results are displayed.

q If the All results option is selected from the QC

type drop-down list, the Last results only option
does not work.

3 Routine tasks

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Validating QC results
In the QC Routine component, you can validate QC
results.

Possible filter criteria for the QC status are listed below:

• All
• OK
• Warning
• Error
• Not enough values
• No evaluation

q If one or both of the measured QC results of the

embedded tests receive the status Error, the calculated
final QC result receives the status Error as well.

r To validate QC results

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2
2 In the Filter options group box, choose the required
filter criteria.
• From the drop-down lists, choose a time frame or
enter the number of days counting back from the
current date.
• To make your selection as precise as necessary,
use the remaining drop-down lists.

3
3 Choose one of the following filter options:
All results
3 Routine tasks

Last results only

f From the QC type drop-down list, choose the
Current option or the Standby bottle option.
f If the All results option is selected, all QC results,
including previous ones are displayed.
f With the Last results only option, only the latest
results are displayed.

q If the All results option is selected from the QC

type drop-down list, the Last results only option
does not work.

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 QC tasks 187

4
4 In the QC results table, choose the appropriate QC
result and choose the Result details command.

5
5 In the Result details panel, use the available tabs to
check the result status.
I The Related calculated QC results tab lists all
calculated QC results for which the measured QC
result is used.

3 Routine tasks

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188 QC tasks

Acknowledging QC results
If a QC result fails, you can use the Acknowledge result
option to confirm that you have reviewed the failed QC
result.

After you have filtered the requested results, you must

validate them according to the information provided by
the test manufacturer. Validate the QC result by
acknowledging. If the Acknowledge result option is
selected, a check mark is displayed in the table.

q If you enter a comment for a copied QC result, the

comment is also assigned to the master ACN from which
the copy has been made.
The comment is then added to all other copies of the
master ACN. All comments are stored in the QC result
history file.

If a QC result has to be released manually because of a

QC error, choose the Release result command on the
shortcut menu. You can directly release a QC material
with a QC error without acknowledging it first.

r To acknowledge QC results

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2
2 On the Control values tab, right-click the appropriate
QC result and choose one of the following commands:
f The Acknowledge result command indicates
that the result has been viewed. The
corresponding check box in the Acknowledged
3 Routine tasks

column is selected.
f To add one or more comments to the selected
result, choose the Acknowledge result with
comment option.
f After validating the result, the check box in the
Acknowledged column is automatically selected.
Once a result is validated, you cannot revalidate it.
If the result has a related comment, the
corresponding check box in the Comments
column is also selected.

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Releasing results with QC errors

To reactivate the automatic test result validation option,
you must manually validate and release the failed QC
result.

When a QC result violates an assigned QC rule (severity

level of Error) or has a data alarm, a QC error is attached
to the result. Subsequent test results are blocked, not
automatically validated, not sent to the host and must be
manually released. Before you can manually validate the
test results, you must first release the corresponding QC
result with the QC error.

Result lock Indicates that the QC result has a QC error and the result
was not released manually.

The rules for releasing QC results are applied as follows:

1. You can always release a locked QC material on the
last active QC result. The release of a locked QC
material allows the automatic validation of new test
results again.
2. A QC error occurred and the corresponding test
results are blocked until you have explicitly accepted
(‘Released’) the QC result.
3. If test results that were measured before the failed QC
result is released, these test results have to also be
validated manually.

q If you enter a comment for a copied QC result, the

comment is also assigned to the master ACN from which
the copy has been made.
The comment is then added to all other copies of the
master ACN. All comments are stored in the control
history file.

r To release results with a QC error

3 Routine tasks

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

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2
2 On the Control values tab, right-click the appropriate
QC result and choose the Release result command.

q To show the tooltip, place the mouse pointer over

a selected check box in the Data alarms column. A
panel displays the corresponding information, for
example, 47: Calibration result invalid.

3
3 In the Insert comment dialog box, enter free text or
choose a pre-configured comment and confirm with
the OK button.
3 Routine tasks

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Adding comments to QC results

You can add and edit multiple comments to individual QC
results.

q The free text sample comment must be

alphanumeric with a maximum length of 4000 characters.
The Extended column indicates that the inserted
comment exceeds one line.

r To add comments to QC results

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2
2 On the Control values tab, right-click the appropriate
QC result and choose the Insert comment
command.

3
3 In the Insert comment dialog box, select a pre-
configured comment or manually enter free text in the
Comment text field and confirm with the OK button.

3 Routine tasks

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Resending QC results to the host

If there is a connection loss, you can resend QC results to
the host.

r To resend QC results to the host

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2 In the Control values table, right-click the

2
appropriate QC result and choose the Resend result
command.
I You can choose multiple QC results.
3 Routine tasks

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Monitoring QC standby bottles

You can monitor the QC status of standby bottles based
on the tests performed on them in order to take the
appropriate action.

The result status evaluation of symmetric QC material is

based on the range that is entered in the Tests /
reference ranges component.

The default values are:

• 2 SD for clinical chemistry and ISE tests
• 3 SD for heterogeneous immunoassays

For asymmetric QC material, the QC rule based on its

defined range is evaluated.

If a standby reagent cassette becomes the current

reagent and has a QC error, the test results measured
with this new reagent cassette are not released
automatically when using the validation lock feature. If a
standby calculated QC result becomes current, its validity
and usability are automatically assigned to all test results
that are based on its result.

r To monitor QC standby bottles

1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2
2 In the Filter options group box, do the following:
• From the QC type drop-down list, choose the
Standby bottle option.
• Choose the desired search criteria.
3 Routine tasks

f The results matching the search criteria are

displayed in the Control values table.

3 Right-click the appropriate QC result and choose the

3
Resend result command to resend a result to the
host.
f To acknowledge a QC error, right-click the
appropriate QC result and choose the
Acknowledge error command.

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3 Routine tasks QC tasks

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Table of contents

Data cleanup and archiving 4

This section looks at the data cleanup and archiving as

performed using the data manager and TraceDoc. It also
explains how you can browse data stored in TraceDoc or
archive data using the TraceDocViewer.

In this chapter 4
Data cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
About data cleanup and archiving . . . . . . . . . . . . . 197
Archiving data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Archiving data to a CD/DVD . . . . . . . . . . . . . . . 200
Archiving data to a USB flash drive . . . . . . . . . 200
Archiving data to sFTP server . . . . . . . . . . . . . . 201
Disabling archiving. . . . . . . . . . . . . . . . . . . . . . . 202
Defining automatic data cleanup . . . . . . . . . . . . . . 203

4 Data cleanup and archiving

Starting data cleanup manually . . . . . . . . . . . . . . . 204
About reusing sample IDs . . . . . . . . . . . . . . . . . . . . 205
Defining the sample ID lifetime option . . . . . . . . . 210
Closing all sample orders . . . . . . . . . . . . . . . . . . . . 212
About the Interface options tab . . . . . . . . . . . . . . . . . . 213
About uploading data to Roche or to the host . . . . . . 216
Data archiving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
About archiving data . . . . . . . . . . . . . . . . . . . . . . . . 217
List of supported types of external storage
devices for archiving . . . . . . . . . . . . . . . . . . . . . . . . 219
Starting an archive run manually . . . . . . . . . . . . . . 220
About troubleshooting failed archiving runs . . . . 221
About deleting data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
Browsing data using the TraceDocViewer . . . . . . . . . 224
About the TraceDocViewer . . . . . . . . . . . . . . . . . . . 224
About browsing data . . . . . . . . . . . . . . . . . . . . . . . . 227
About viewing result details and related data . . . 228
About related data searches . . . . . . . . . . . . . . . . . . 229
About printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

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Table of contents

About closing the TraceDocViewer . . . . . . . . . . . . 230

List of TraceDocViewer interface elements. . . . . . . . . 231
Sample details tab . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Used control details tab. . . . . . . . . . . . . . . . . . . . . . 234
Used calibration details tab. . . . . . . . . . . . . . . . . . . 236
Used calibration details ISE tab . . . . . . . . . . . . . . . 238
Used calibration details immunochemistry tab . . 240
Used reagent details tab . . . . . . . . . . . . . . . . . . . . . 243
4 Data cleanup and archiving

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Data cleanup
You can determine the lifetime that data is retained or
how long a sample ID can be reused for the same patient.

In this section
About data cleanup and archiving (197)
Archiving data (199)
Defining automatic data cleanup (203)
Starting data cleanup manually (204)
About reusing sample IDs (205)
Defining the sample ID lifetime option (210)
Closing all sample orders (212)

About data cleanup and archiving

The retention period is important since certain categories
of data can accumulate (for example, system messages
and log entries).

The Roche Service representative defines the retention

period after which cobas® 8000 data manager deletes
the files that are successfully sent to TraceDoc (by default
10 days) and the retention period of data after a
successful archive from TraceDoc. (recommended
1 month).

In the cobas 8000 data manager System

4 Data cleanup and archiving

Configuration > System configuration > Cleanup
options group box, you can specify the retention period
for the following data categories:
• System messages and log entries
• Samples with all related data
• QC results
• Data alarms

If the Enable check box is cleared, the corresponding

data is not deleted even the range is exceeded and the
data are archived in TraceDoc.

If the Include incomplete sample orders check box is

selected, samples with open test orders are included for
deletion.

To delete data on the data manager, the following

conditions must be fulfilled:

Messages and log entries • The age of the data is greater than its retention period.

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Sample data • The age of the data is greater than its retention period.
• The data has been archived in TraceDoc.

QC data • The age of the data is greater than its retention period.
• The data has been archived in TraceDoc.
• No linked sample orders
• No more in use for test result validation

Calibration data • Older than 365 days

The data manager checks the age of data every day on

the defined time. If the data age exceeds the data
category retention period and the data has been archived
in TraceDoc, it is deleted from the data manager.

q The cleanup process is triggered by default at 02:00.

The chosen time should be in a time frame where
generally the lowest load of the system is expected.

Data cleanup and archiving takes place on the data

manager and TraceDoc. TraceDoc is a separate module
within the data manager that has its own independent
database.

Data retrieval and storage Files for archiving are retrieved from the data manager by
TraceDoc every 10 minutes.

Files on TraceDoc are:

• If configured, sent to the remote service platform
(every 2 hours)
4 Data cleanup and archiving

• Archived to external storage

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The TraceDocViewer is a component of TraceDoc and is

used to view the content of TraceDoc. The
TraceDocViewer is also used to view the archived data on
the external storage.

TraceDocViewer

Roche

F
TraceDocViewer
A C E cobas® link
cobas® 8000 data manager TraceDoc

B D

A Data (for example, test results, QC results, data alarms, or D Data older than archive retention period that has been
system messages) archived is deleted
B Data older than the retention period and that has been E Data sent to cobas® link (every 2 hours)
archived in TraceDoc is deleted
C Data archived from the data manager in TraceDoc (every F Data is archived to external storage regularly.
10 minutes)

w Data cleanup and archiving

4 Data cleanup and archiving

Archiving data
You can archive data from the data manager to a
CD/DVD, a USB flash drive, or a network storage (sFTP
server).

In this section
Archiving data to a CD/DVD (200)
Archiving data to a USB flash drive (200)
Archiving data to sFTP server (201)
Disabling archiving (202)

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Archiving data to a CD/DVD

r To archive data to a CD/DVD

1 Choose cobas 8000 data manager Service

> Service-related configuration > TraceDoc.

2
2 Choose the archiving interval.
I Available time frames: week, day.

3 From the Target: drop-down list, choose the

CD/DVD option.
I The default archive destination for a CD/DVD is
E:\ . Other destinations are not supported.

4 Complete the configuration and choose the OK

button.

Archiving data to a USB flash drive

r To archive data to a USB flash drive

4 Data cleanup and archiving

1 Choose cobas 8000 data manager Service

> Service-related configuration > TraceDoc.

2
2 Choose the archiving interval.
I Available time frames: week, day.

3 From the Target: drop-down list, choose the External

USB option.
I The default archive destination for a USB flash
drive is F:\ . Other destinations are not supported.

4 Complete the configuration and choose the OK

button.

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Archiving data to sFTP server

Fingerprint The fingerprint from your sFTP server must contain the
prefix, encryption algorithm, and fingerprint in lowercase.

Prefix|Encryption(512/1024/2048)|Fingerprint
k Fingerprint format

ssh-rsa|1024|22:84:42:39:2f:d9:5a:5c:74:ab:99:c8:f5:4b:ce:0f
k Example fingerprint

j m Sufficient storage space on sFTP server

r To archive data to sFTP server

1 Choose cobas 8000 data manager Service

> Service-related configuration > TraceDoc.

2 Choose the archiving interval.

I Available time frames: week, day, hour.

2
3 From the Target: drop-down list, choose the sFTP
option.
• Enter the URL, user name, password, and
fingerprint for your sFTP server.
I - Ensure that the URL starts with sftp:// .
- Ensure that the fingerprint contains prefix,
encryption algorithm, and fingerprint (in
lowercase).

4 Data cleanup and archiving

4 Complete the configuration and choose the OK
button.

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Disabling archiving
You can disable the data archiving.

r To disable archiving

1 Choose cobas 8000 data manager Service

> Service-related configuration > TraceDoc.

2
2 From the Target: drop-down list, choose the Disable
archiving option.
I If you disable the data archiving, no TraceDoc data
is archived at all.

3 Choose the OK button.

4 Data cleanup and archiving

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Defining automatic data cleanup

You can define the period after which the data is deleted
on the data manager.

r To define an automatic data cleanup

1
1 Choose cobas 8000 data manager System
Configuration > System configuration.

2
2 CAUTION!
If the Enable check box is cleared, the data of this
category is not deleted in the automatic cleanup. The
size of the database may have a negative impact on
the data manager performance. It is not
recommended to disable the automatic cleanup.
2 On the Cleanup options tab, fill in for each data
category the retention period (by default 10 days).

3 To activate the cleanup options, select the

corresponding Enable check boxes.
I If you want to include sample orders with pending
test order or not validated test results in the
cleanup, select the Include incomplete sample
orders check box.

4 Data cleanup and archiving

4 Choose the OK button.
I The cleanup is performed automatically at the next
scheduled cleanup run time.

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Starting data cleanup manually

You can trigger the data cleanup to start immediately
(use this option if the automatic data cleanup failed).

r To start data cleanup manually

1
1 Choose cobas 8000 data manager System
Configuration > System configuration.

2
2 On the Cleanup options tab, choose the Start
cleanup now button.
f Data is deleted for the specified time frame. If a
cleanup option is enabled, the data in that
category that is sent to TraceDoc is deleted.
4 Data cleanup and archiving

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About reusing sample IDs

Use the sample lifetime option to reuse the same sample
ID for a different patient after a defined time period (T0-
T1).

Preconditions • Change the value on the Sample lifetime option tab

at the beginning or at the end of the daily routine only.
• Always assign patient IDs to samples when reusing
sample IDs.

q If you use the sample lifetime option, assign an

appropriate time range that reflects your laboratory
workflow. A short sample lifetime may lead to sample
order cancelations, hands on time for manual
reassignments, or decreasing of the throughput of the
system.

The Is active column indicates the state of a sample ID in

the following components:
• Sample overview
• Day list
• Validation

The Host backup component only displays active sample

orders.

Patient ID A Patient ID F

4 Data cleanup and archiving

Sample order ID B Sample order ID B

Test C Test C
Test D Test D

Test C result
Test E Test E result
Test D result

SP CP SP
time
t0 ts tc (t1 - 5 Min) t1 / t0 ts

A t0 = start of sample lifetime D tc = close time (5 minutes before t1)

B SP = safety period (starts at t0) E CP = close period (5 minutes)
C ts = end of safety period F t1 = end of sample lifetime

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Sample lifetime start Beginning of sample lifetime (t0) is one of the following:
• Date and time when the data manager receives a
sample order from the host.
• Date and time when the operator created a sample
order on data manager.
• If the data manager does not have an order for a
sample, date and time when the sample barcode is
scanned on the instrument.

Sample lifetime period Within the time period (T0-t1), you can reuse the sample
ID for the same patient.

If a sample order is closed, you cannot perform any of the

following actions for the sample or test:
• Edit sample
• Repeat test
• Delete test
• Request additional test
• Request dilution
• Resend results

Closing cobas e flow test orders The data manager closes running cobas e flow test
orders 5 minutes before the sample lifetime ends (t1). The
cobas e flow test is canceled and all available embedded
test results are sent to the host. No new embedded test
order is sent to the control unit. If an embedded test
result is received in the closure period (CP), the data
manager archives the embedded test result in TraceDoc
for comprehensibility only.
4 Data cleanup and archiving

Patient ID A Patient ID F
Sample order ID B Sample order ID B

Test E
Embedded test C Embedded test D Embedded test D result
Test F

Embedded test C result &ORVLQJFREDVHÁRZ

SP CP SP
time
t0 ts tc (t1 - 5 Min) t1 / t0 ts

q You must print and edit the test result into your host
system manually.

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Reusing sample IDs When the sample lifetime ends (t1), the data manager
closes the sample order. You can reuse the same sample
ID for a new patient without having to clean up the
database beforehand.

Patient ID A Patient ID F
Sample order ID B Sample order ID B

Test C Test C
Test D Test D

Test E result

Test C result
Test E
Test D result

SP CP SP
time
t0 ts tc (t1 - 5 Min) t1 / t0 ts

Until you complete the following actions, all test results

with reused sample IDs are stored using temporary
sample IDs:
• On the control unit, delete the sample orders with the
reused Sample IDs.
• Reload the corresponding sample tubes on the
instrument.

This test result is not part of an automatic printout or sent

to the host. The test result is archived in TraceDoc for
comprehensibility.

4 Data cleanup and archiving

This approach ensures that a test result from a closed
sample order is not wrongly assigned to a patient that
reuses the same sample ID. In addition, all affected open
sample orders are closed automatically.

q You must print and edit the test result into your host
system manually.

Nevertheless, you must delete the affected sample order

on the data manager. Recreate the sample order with the
corresponding sample ID and test order on the data
manager or resend the sample order from the host.

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 208 Data cleanup

! WARNING
Risk of overwriting results if the Sample lifetime in
hours field is deactivated
If on the Sample lifetime option tab, the Enable check
box is cleared and a sample ID is reused, the samples are
merged, unless the database has been cleaned up
beforehand.
r Never clear the Enable check box if you are reusing
sample IDs.

! WARNING
Risk of sample mismatch if sample IDs are not
deleted on control unit and host before reuse
Sample IDs that were not deleted on the control unit and
the host before reuse cause a sample mismatch.
r Always delete sample IDs on the control unit and the
host before reusing sample IDs.

! WARNING
Wrong test result assignment
If the sample ID is reused before all test results are
available, the test results can be assigned to the wrong
patient. On the control unit, the samples with reused
sample IDs are displayed as merged. On the data
manager, they are displayed as different samples.
r Before reusing sample IDs, ensure that all entries
related to these sample IDs must be deleted.
4 Data cleanup and archiving

Sample lifetime reporting If the sample lifetime option is enabled, the following
information is available in the sample result report
header:
• Sample lifetime:
• Start date: date and time when the sample was
registered on the data manager first.
• End date: date and time when the sample lifetime
expired.

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4 Data cleanup and archiving

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Defining the sample ID lifetime option

You can assign the time frame after which a sample ID
can be reused.

r To define the sample ID lifetime

option

1
1 Choose cobas 8000 data manager System
Configuration > System configuration.

2
2 On the Sample lifetime option tab, choose from the
Sample lifetime unit drop-down list the unit for
which a sample ID can be reused for the same patient.
• Hours
• Days

3 Enter the value for the time range that is within the
following limits according to the unit you have chosen
from the Sample lifetime unit drop-down list:
• 2–256 hours
• 1–60 days

4 If you want to activate the sample lifetime option,

select the Enable check box.
4 Data cleanup and archiving

5 Choose the OK button.

f The sample IDs can now be reused for the
assigned number of hours or days for the same
patient. Cleaning up the database before reuse is
not required.

r To disable the sample ID lifetime

option

1
1 WARNING!
Risk of overwriting results if on the Sample lifetime
option tab the Enable check box is cleared.
If the Enable check box is cleared and sample IDs are
reused, these samples are merged (unless the
database has been cleared before). If you are reusing
sample IDs, do clear the Enable check box.
1 Choose cobas 8000 data manager System
Configuration > System configuration.

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2
2 On the Sample lifetime option tab, clear the Enable
check box and confirm with the OK button.

u Related topics
• About reusing sample IDs (205)
• Closing all sample orders (212)

4 Data cleanup and archiving

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Closing all sample orders

If you want to reuse all sample barcode IDs, close first all
sample orders first to ensure that no test result is wrongly
assigned.

q This task can only be performed if the sample

lifetime option is enabled.
Perform this task only when the system is in Standby
mode.

If a sample order is closed, you cannot perform any of the

following actions for the sample or test:
• Edit sample
• Repeat test
• Delete test
• Request additional test
• Request dilution
• Resend results

In the cobas 8000 data manager Routine > Sample

overview > Count of reused sample IDs group box,
choose the Get list button to list all sample orders that
reuse sample barcode IDs. The number in the Count of
reuse sample IDs reflects the amount of samples orders
that reuse sample barcode IDs.

r To close all sample orders

4 Data cleanup and archiving

1
1 Choose the cobas 8000 data manager Routine
> Sample overview component.

2
2 In the Count of reused sample IDs group box,
choose the Close all button.
• Confirm the dialog box with the OK button.

u Related topics
• About reusing sample IDs (205)
• Defining the sample ID lifetime option (210)

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 About the Interface options tab 213

About the Interface options tab

Use the Interface options tab to set up your host
connection, pass-through mode option, and system
behaviors.

Host communication

In the LIS connection group box, you can assign you

host connection settings.

Pass-through group box

In the Pass group box, you can choose for with result type
the pass.through mode should be active.
• Patient results
• QC results
• Calibration results

Enable rack and position mode To activate the Rack and position mode, select the check
box.

To configure the data manager to store the rack and

position, the Enable rack and position mode check box
is selected. This option is part of a test selection batch
download from the host to the data manager.

4 Data cleanup and archiving

q Rack and position mode is only used when
processing sample orders without barcodes AND using
batch download of test orders. You must also inform the
instrument that you are using this mode.
u For more information on how to configure the instrument to
use strict rack and position, refer to the Host Manual.

Result upload settings

In the Result upload settings group box, the upload

settings defined on the control unit are displayed.

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cobas e flow test subresults

If the cobas e flow test result reporting check box is

selected, embedded test result used in the cobas e flow
test are sent to the host.

If the Send single QC results for calculated QC check

box is selected, QC results for embedded tests are sent to
the host.

If the Send additional link information for calculated

QC check box is selected, additional information, for
example, used measuring cell for the QC measurement is
sent to the host.

Assigning host code

For cobas e flow tests, you can activate or deactivate the

assignment of host codes for available measurement
units, for example mmol/L, mg/dL, or U/L.

You can send cobas e flow test results to the host for
any available and assigned test unit.

q If the Assign host code by reported lab unit

check box is cleared, you cannot assign a host code to a
cobas e flow test result. If the check box is cleared, the
cobas e flow test main result is sent with the host code
which was entered originally in the Host code field.

Sending immunoassay data points to the host

4 Data cleanup and archiving

If the data point upload option on the control unit is

activated, the data manager sends the test data points for
heterogeneous immunoassays to the remote service
platform. The upload supports the ASTM and the HL7
host protocols. Data points can be sent from the data
manager for all e-modules of the cobas® 8000 modular
analyzer series.

In TraceDoc and on the host (if supported), you can see

the data points for heterogeneous immunoassay test
results.

If the host does not support raw data or data points, clear
the Send raw data / data points to host check box on
the Service-related configuration > Interface
options tab.

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Enable STAT masking mode To activate the STAT masking mode, select the check box.

If you are using a cobas® 8100 automated workflow

series instrument, and more than 5% of your samples
have STAT tests on them, select the check box for the
STAT masking mode option.

If you are using the cobas® 8100 automated workflow

series instrument to sort samples, some of the routine
samples may be upgraded to STAT samples. If there is an
upgraded sample in a rack, all the samples on the rack
are upgraded to STAT. In some installations, if there are
many STAT samples, the routine samples may be delayed.

Forwarding instrument status to the host The availability of instrument, module, and test status
improves the workflow and the turnaround time for
sample orders.

On the Service-related configuration > Interface

options tab, select the Enable instrument status
forwarding check box.

The Enable instrument status forwarding option is

used to send information about the instrument status and
the test availability to the host automatically. This
information allows the host to organize the sample orders
turnaround time in the most optimal way.

Possible statuses of the instrument could be as follows:

• Power Up
• Standby
• Operation

4 Data cleanup and archiving

• Post operation
• S.Stop
• E.Stop

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About uploading data to Roche or to the

host
TraceDoc uploads data to the remote service platform
every 2 hours.

On the cobas 8000 data manager Service > Service-

related configuration > TSN agent tab, you can
determine the data that is uploaded to Roche.

w cobas 8000 data manager Service > Service-related configuration > TSN agent tab

Your Roche Service representative defines the upload

settings.

q For any uploaded data, no indication of patient

identity is transmitted.
4 Data cleanup and archiving

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Data archiving

By default TraceDoc archives data every week to an

external storage.

In this section
About archiving data (217)
List of supported types of external storage devices for
archiving (219)
Starting an archive run manually (220)
About troubleshooting failed archiving runs (221)

About archiving data

The archiving interval reflects the data throughput. High
throughput probably requires archiving weekly while a
lower throughput may only require archiving monthly.

Your Roche Service representative creates the following

settings:
• The next archive runs, indicating when an archive
takes place.
• The archiving interval determining the frequency of
archiving (number of days / weeks / months between
archives).
• The archive target defines the storage location.

4 Data cleanup and archiving

• The interval to delete data that is older than the
archiving interval and archived (the default setting is 1
month).

If an archive fails to run (for example, a DVD was not

inserted), an emergency archive is automatically
scheduled for the same time on the next day.
u Starting an archive run manually (220)

q Your Roche Service representative can configure a

reminder message displayed in the Information window
panel. The default time is 10 hours before the next archive
run starts.
If the archiving destination is available, the message is
not displayed.

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Identify a time in the week when archiving can best take

place. Examples might be:
• 02:00 Monday morning so that archiving is completed
when you arrive at work.
• During the instrument weekly maintenance downtime,
when the instrument must be shut down and
restarted.

Your Roche Service representative can specify the day

and time when archiving takes place.

Ensure that an empty, labeled DVD (if DVD is chosen for

archiving) is in the drive before archiving starts.

Take the 02:00 Monday example above. The first action

on Monday morning would be to remove the DVD
containing the archive created at 02:00 A.M. Insert an
empty, labeled DVD for the archive run next Monday
morning.
4 Data cleanup and archiving

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 Data archiving 219

List of supported types of external storage devices for

archiving
The data manager supports the following types of
external storage devices.
Supported Not supported
CD-R DVD+R
CD-RW DVD+RW
DVD-R DVD-RAM
DVD-RW DVD+R Dual layer media
USB flash drive DVD-R Dual layer media
y Supported types of external storage devices for archiving

4 Data cleanup and archiving

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Starting an archive run manually

If the automatic archiving run fails, you can start an
archive run manually.

In the Information window panel, TraceDoc informs you

that an archive run has failed and an emergency archive
run is scheduled.
u List of supported types of external storage devices for
archiving (219)

r To start an archive run manually

1
1 On the data manager PC, do one of the following
based on your settings:
• Insert a CD or DVD.
• Connect a USB flash drive.
• Ensure that the sFTP server is available.

2
2 Choose cobas 8000 data manager System
Configuration > System configuration.
4 Data cleanup and archiving

3
3 On the TraceDoc tab, choose the Start archiving
button.

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About troubleshooting failed archiving runs

There may be situations when archiving does not run as
planned. For example, if you forget to insert an empty
DVD for a scheduled archive run.

If the archiving fails, the not archived data is archived in

the emergency archive run 24 hours later.

In the Information window panel, TraceDoc informs you

that an archive run has failed and an emergency archive
run is scheduled. Remove the archive DVD, insert a new
DVD for the emergency archive run, or connect the
external storage.

The emergency archive run starts the next day. The

remaining data from the day before and the data that has
come into TraceDoc during the 24-hour period are
archived. No data in TraceDoc is archived twice.

In the example below, the scheduled archive run 2 failed.

An emergency run was performed successfully 24 hours
later. On the scheduled archive run 3, only the data is
archived that TraceDoc received after the emergency
archive.

4 Data cleanup and archiving

w Emergency archive

SA Scheduled archive run

EA Emergency archive run

EAd Data archived by emergency archive run

SA3d Data archived by scheduled archive run 3

If the emergency archive run does not take place (for

example, a DVD was not available), another run is
scheduled for 24 hours later. Emergency archive runs
continue to be scheduled every 24 hours until an
emergency archive run takes place or the next scheduled
archive is due.

The examples above refer to a DVD as the archiving

medium. The same applies to any archive medium in
terms of the amount of data to be archived exceeding the
available space on the archive medium.

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An archive does not contain all details If a TraceDoc archive does not contain QC material and
calibration information for all measured samples, an error
message indicates this behavior in TraceDoc.

The TraceDoc archive operates in 2-hour time intervals. If

a QC material or calibration was measured before the
archive run starts, the information is not available in the
TraceDoc archive.

For example:
• The archive covers the time period from 5-Apr-2018
16:00:00 to 11-April-2018 12:59:59.
• A QC material for a test was measured on 5-Apr-2018
at 15:32:37 and a calibration result was created on 30-
March-2018.
• The QC material and the calibration details are not in
the TraceDoc archive. These results are saved in the
previous archive.
4 Data cleanup and archiving

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About deleting data

Data is deleted from TraceDoc based on the period of
time that it has resided on TraceDoc. Data is deleted once
a day.

The default period that data is retained on TraceDoc

before it is purged is 1 month. Your Roche Service
representative can configure the period to match the
requirements of your system.

TraceDoc checks the age of data in its database.

Data is purged if the following conditions are fulfilled:

• Data is archived to external storage.
• Sent to Roche (if configured in Service-related
configuration > TSN agent)
• Older than the value entered in the Purge archived
data older than field

4 Data cleanup and archiving

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 224 Browsing data using the TraceDocViewer

Browsing data using the TraceDocViewer

Use the TraceDocViewer to view trace data.

q If you reinstall a cobas e flow with a different

application name, restart TraceDoc to display the new
name.

In this section
About the TraceDocViewer (224)
About browsing data (227)
About viewing result details and related data (228)
About related data searches (229)
About printing (229)
About closing the TraceDocViewer (230)

About the TraceDocViewer

TraceDocViewer allows you to do the following:
• Browse different data types (traces)
• View related data
• Search for related data
• Print selected data

You can browse data that is stored in one of the following

areas:
4 Data cleanup and archiving

• On data manager in TraceDoc

• Archived on external storage

q The TraceDocViewer functions in the same way in

both cases.

q When accessing data on an external storage device

using the TraceDocViewer, it is recommended to
structure the data in different subfolders (for example per
Year/Month).

To start the TraceDocViewer on the data manager,

choose the button on the sidebar. The
TraceDocViewer is displayed in the panel on the sidebar.

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Sample details are displayed truncated

If the screen resolution is set too low, or the system text

size is set too high, sample details may be truncated.

For optimal results, make sure that you are using a screen
resolution of 1400 pixels or more in width. Additionally
make sure that the Windows text size is set to 100% or
below. To change the screen resolution, choose the
Windows Control Panel > Screen Resolution
> Adjust screen resolution option. To change the text
size settings, in the Screen Resolution panel, choose
the Make text and other items larger or smaller
option.
u Features accessed via Sidebar (52)

TraceDocViewer components

A C

A Search group box B Results group box C Details tab

4 Data cleanup and archiving
w TraceDocViewer

The TraceDocViewer contains 4 main areas:

• Looking for
• Search criteria
• Search results
• Details

Use the Looking for drop-down list and the Search

criteria group box to search for data.

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The result of your search or of subsequent related

searches is listed in the Search results table.

Data for a selected result item is displayed in the Details

panel.

To use the TraceDocViewer on a DVD or another external

storage, you must locate the TraceDocViewer software.

Double-click the TraceDocViewer software to display the

TraceDocViewer.

q TraceDocViewer software
Do not confuse the TraceDocViewer software file with the
TraceDocViewer configuration file.
When the hide extensions for known file type option
(Windows Folder Options) is not selected, then in file
selection dialog boxes:
o The TraceDocViewer software file is displayed as
TraceDocViewer.exe.
o The TraceDocViewer configuration file is displayed as
TraceDocViewer.exe.config.
When the hide extensions for known file type option is
selected, then in file selection dialog boxes:
o The TraceDocViewer software file is displayed as
TraceDocViewer.
o The TraceDocViewer configuration file is displayed as
TraceDocViewer.exe.
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About browsing data

In the TraceDocViewer, use the Looking for drop-down
list to browse data. The available data types are:
• Samples
• Subresults (only for cobas e flow tests)
• QC controls
• Calculated QC results (only for cobas e flow tests)
• Calibrations
• Reagents
• Others (trace types, for example, calibration factors,
instrument factors, or photometer checks)

The criteria that you use to search within a data type are
listed in the Search criteria group box (beneath the
Looking for drop-down list). For example, the available
search criteria for samples are:
• From / To dates
• Sample ID
• Application code
• Application name

Additional search criteria are listed beneath the Search

criteria group box:
• Used module
• Used reagent
• Used calibration
• Used control (QC)

4 Data cleanup and archiving

The availability of different group boxes is dependent
upon the data type that you select. For example, all group
boxes are available for samples data. For the calibration
data type search, use the Used module group box or the
Used reagent group box.

q Search criteria group boxes

The search criteria group boxes are collapsed by default.
Choose the + button to expand a group box and view its
content.

Display calculated QC result From the Looking for drop-down list, choose the QC
controls option. Select the Calculated QC result check
box to search for master QC results. The calculated QC
results are not displayed.

Display cobas e flow test generated TraceDoc assigns the application code of the
subresults cobas e flow to generated subresults.

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About viewing result details and related data

After you have obtained the search results, you can view
the result data.

Choose the appropriate result in the Search results

table to view related data. In the Details group box,
choose the appropriate tab. The available tabs are
dependent upon the data type you used in the search.

q cobas e flow
For cobas e flow, test results are displayed, even if a
calculation was used for creation. The cobas e flow
results are labeled with the linked cobas e flow names.
Embedded tests used within cobas e flow tests are
displayed as single tests and labeled with the
corresponding embedded test names.

For example, if you searched using the samples data type,

the available tabs are:
• Sample details
• Used control details
• Calculated QC result details: only for cobas e flow
• Used calibration details
• Used reagent details
• Subresult details

q Tab visibility
4 Data cleanup and archiving

Depending on the size of your monitor, not all tabs are

visible. Use the 2 arrows located to the right of the tabs to
scroll and view hidden tabs.

cobas e flow test display If you assign the appropriate settings in the Search
criteria group box, the following data for a cobas e flow
test is listed in the Search results table:
• cobas e flow test
• Within the cobas e flow test measured embedded
tests

q Suppressed embedded test results, or generated

subresults are displayed as *******.

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If you choose the cobas e flow test in the Search

results table, all related data is displayed in the
Subresult details tab including used generated
subresults.

If you choose the embedded test that is used as

cobas e flow test main result, details are displayed in the
Sample details tab.

Find cobas e flow button In the Sample details > SampleResult panel, choose
the Find cobas e flow button on the appropriate
embedded test to view the corresponding data.

About related data searches

You can perform searches based on data that is related to
a search result. At the bottom of the Details tabs, one (or
more) search buttons allow you to perform a related data
search.

For example, you have performed a search for samples. In

the Search results table, choose a sample and view-
related data on the Used control details tab. At the
bottom of the tab, choose the Find samples button or
the Find controls button to search for samples or QC
materials that use the current calibration.

The result of the search is listed in the Search results

table.
u About the TraceDocViewer (224)

4 Data cleanup and archiving

About printing
In the TraceDocViewer, choose the Print button to print
the content of the active tab.

q To print related data from other tabs in the Details

group box, choose the tab to make its content visible.

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About closing the TraceDocViewer

Choose the Exit button to close the TraceDocViewer
when you are using it on the data manager, archive DVD,
or another external storage.

When you are using the TraceDocViewer on the data

manager, you can switch from the TraceDocViewer to
another work area using the sidebar. However, it is
advisable to exit the TraceDocViewer when you are not
using it.
4 Data cleanup and archiving

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List of TraceDocViewer interface elements

This section explains the data that can be viewed on the
Details tab of the TraceDocViewer.

The tables explain each of the entries on the

corresponding Details tab.

Test result display The TraceDocViewer displays test results as they are
displayed on the data manager and on reports.
• Test name: Short name of the test.
• Test unit: Laboratory unit which is specified during
installation for displaying test results.
• Test result: Measured test result or value calculated by
a formula.
• Data alarm: Optional, in case data alarm flag is
available.
u About the TraceDocViewer (224)

In this section
Sample details tab (231)
Used control details tab (234)
Used calibration details tab (236)
Used calibration details ISE tab (238)
Used calibration details immunochemistry tab (240)
Used reagent details tab (243)

Sample details tab

4 Data cleanup and archiving

SampleResult

SampleResult
Operator User name.
IsSTAT Indicates STAT sample – false or true.
y SampleResult

Rack

Rack
RackID ID of the sample rack.
Position Sample position on the sample rack.
y SampleResult > Rack

PatientSample

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PatientSample
SampleID ID of the sample.
Sample Type Sample type (can be Amniotic fluid, Cerebrospinal fluid, Hemolysate,
Oral fluids, Others, Processed stool, Serum/Plasma, Supernatant,
Urine, or Whole blood).
DrawingDateTime Date and time when the barcode reader scanned the sample and
the test selection messages were sent to the data manager. The
control unit time is used.
ArrivalDateTime Date and time when the data manager received the test selection
message. The data manager time is used.
OrderingDateTime Date and time when the order was created on the host or on the
data manager. The host sends this date and time in the test order
message to data manager.
y SampleResult > PatientSample

PatientSample - PatientDetails

Rack
Age Age of the patient given in the assigned age unit.
AgeUnit Age unit of the patient (Y = years, M = months, or D = days).
Gender Gender of the patient (F = female, M = male, or U = undefined).
y SampleResult > PatientSample > PatientDetails

CTestResult

CTestResult (also applicable for ETestResult and ISETestResult)

ApplicationCode Application code number (ACN).
ApplicationName Abbreviation of the application.
Result Calculated result value of measurement. [Rounding rules applied].
QualitativeResult Qualitative result value of measurement.
Uom Measurement unit.
4 Data cleanup and archiving

ModuleID ID of module where results have been measured. The control unit
creates an internal ID. The modules and their IDs can be seen on the
Module filter criterion in TraceDocViewer.
SubModuleNo Submodule (for example, measuring cell) identification.
CalibrationID ID of the calibration that was used to calculate this result, also
visible in the calibration trace of the control unit.
DataAlarmFlag Displays the value "0" by default (currently not used)
MeasuringRangeFlag Measuring range data alarm sent by the instrument.
DataMessageFlag Data message alarm (message code) sent by the instrument.
DiluentContainerSetID Internal ID.
DateTimeCreated Result measurement time (when result was available).
ControlGIDFK Displayed only for test results. If the result is from a patient
measurement, the GID references the preceding QC test. TraceDoc
uses this value to make a link to the related QC result.
CalibrationGIDFK The GID references the preceding calibration measurement.
TraceDoc uses this value to make a link to the related calibration
result.
ReagentContainerSetID Internal ID.
IsRerun Indicates whether this result belongs to a rerun test – false or true.
y SampleResult > CTestResult

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CTestResult (also applicable for ETestResult and ISETestResult)

IsMainResult Indicates main result cobas e flow test – false or true.
Only used in ETestResult for cobas e 801 module with the
cobas e flow test.
TestResultGIDFK The GID references the test result that was used for the
measurement. TraceDoc uses this value to make a link to the related
test result.
Only used in ETestResult for cobas e 801 module.
InstrumentReagentGIDFK The GID references the reagent bottle that was used for the
measurement. TraceDoc uses this value to make a link to the related
reagent. The field is not displayed for ISE results.
y SampleResult > CTestResult

ETestResult > RawData

ETestResult > RawData

EffectiveSignal The calculated PMT signal that corresponds to the measured
amount of light of an ECL measurement. It is used for all further
calculations (calibration, QC, test concentrations).
EffectiveVoltage The calculated voltage in the measuring cell during the
measurement. Only used for service purposes.
EffectiveCurrent The calculated current in the measuring cell during the
measurement. Only used for service purposes.
SpikeValue The characteristic about the quality of the PMT signal. Only used for
service purposes.
y SampleResult > ETestResult > RawData

4 Data cleanup and archiving

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Used control details tab

SampleResult

SampleResult
Operator User name.
IsSTAT Indicates a STAT sample – false or true.
y SampleResult

Rack

Rack
RackID ID of the QC rack.
Position QC material position on the QC rack.
y SampleResult > Rack

ControlBottle

ControlBottle
Lot Lot number of QC material.
Code Code of the QC material.
BottleCountNo. Bottle number on the QC material.
Sample Type Sample type (can be Amniotic fluid, Cerebrospinal, Hemolysate, Oral
fluids, Others, Processed stool, Serum/Plasma, Supernatant, Urine, or
Whole blood).
y SampleResult > ControlBottle

CTestResult
4 Data cleanup and archiving

CTestResult
ApplicationCode Application code number (ACN).
Result Calculated result value of measurement. [Rounding rules applied].
QualitativeResult Qualitative result value of measurement.
Uom Measurement unit.
ModuleID ID of module where results have been measured. The control unit
creates an internal ID. The modules and their IDs can be seen on the
Module filter criterion in TraceDocViewer.
SubModuleNo Submodule (for example, measuring cell) identification.
CalibrationID ID of the calibration that was used to calculate this result, also
visible in the calibration trace of the control unit.
DataAlarmFlag Data alarm sent by the instrument.
MeasuringRangeFlag Measuring range data alarm sent by the instrument.
DataMessageFlag Data message alarm (message code) sent by the instrument.
DiluentContainerSetID Internal ID.
DateTimeCreated Result measurement time (when result was available).
y SampleResult > CTestResult

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CTestResult
ControlGIDFK Displayed only for sample results. If the result is from a patient
measurement, the GID references the preceding QC test. TraceDoc
uses this value to make a link to the related QC result.
CalibrationGIDFK The GID references the preceding calibration measurement.
TraceDoc uses this value to make a link to the related calibration
result.
ReagentContainerSetID Internal ID.
IsRerun Indicates whether this result belongs to a rerun test - false or true.
InstrumentReagentGIDFK The GID references the reagent bottle that was used for the
measurement. TraceDoc uses this value to make a link to the related
reagent. The field is not displayed for ISE results.
y SampleResult > CTestResult

4 Data cleanup and archiving

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Used calibration details tab

CCalibResult

CCalibResult
ModuleID ID of the module where the calibration has been performed.
SubModuleNo Submodule (for example, reagent disk) identification.
Reason Reason for calibration - contains one of the following values:
o Manual
o LotChange
o LotTimeout
o Reagent cassette changeover
o Reagent cassette timeout
o QCFailed
o Data manager request
CalibrationID ID of the calibration measurement.
DateTimeCreated Calibration date and time (timestamp from instrument).
ApplicationCode Application code (ACN).
CalibrationSuccessType This attribute indicates if the calibration is valid.
CalibrationResultType Contains one of the following values:
o NoCalibration (calibration has not been executed)
o LotCalibration
o ContainerCalibration
o InheritedLotCalibration(1)
o InheritedItemCalibration(2)
o UserModifiedCalibration
o UnmaskedCalibration
o FailedCalibration
NoOfCalibrators Contains one of the following values:
o Blank
4 Data cleanup and archiving

o 1–6 Point
o Cancel
ReagentContainerSetID Internal ID.
CalibrationGIDPK Internal identifier of the calibration. Patient and QC results reference
the GID.
InstrumentReagentGIDPK Internal identifier of the instrument reagent. Test and QC results
reference the GID.
y CCalibResult
(1) The calibration result of the last valid lot calibration is transferred to a new reagent cassette. This cassette uses the same lot number and was
placed in the reagent disk without calibration.
(2) The lot calibration of the current reagent cassette is transferred to a newly placed reagent cassette with a different lot (only valid for clinical
chemistry tests).

CalibratorBottleAbsorbanceResult

CalibratorBottleAbsorbanceResult
Lot Lot number of the calibrator.
BottleCountNo. Bottle number of the calibrator.
Code Calibrator code.
Level Level of calibrator.
y CCalibResult > CalibratorBottleAbsorbanceResult

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CalibratorAbsorbance

CalibratorAbsorbance
Absorbance Mean of measured absorbance values.
DataAlarmFlag Data alarm of the sample.
FirstAbsorbance Measured absorbance value.
SecondAbsorbance Measured absorbance value.
FirstInitialAbsorbance Measured absorbance value (main wavelength).
SecondInitialAbsorbance Measured absorbance value (main wavelength).
y CCalibResult > CalibratorBottleAbsorbanceResult > CalibratorAbsorbance

CCalibResultDetails

CCalibResultDetails
SD Standard deviation.
S1Absorbance Absorbance of standard 1.
K K factor (calibration slope).
A Nonlinear coefficient A (slope).
B Nonlinear coefficient B (intercept).
C Nonlinear coefficient C.
L Bichromatic absorbance difference of the lipemic index.
H Bichromatic absorbance difference of the hemolysis index.
I Bichromatic absorbance difference of the icterus index.
CalibrationAlarm Indicates which calibration data alarm occurred.
OriginalCalibrationID If there is a calibration which has been transferred, this attribute
indicates the ID of the original calibration.
y CCalibResult > CCalibResultDetails

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Used calibration details ISE tab

ISECalibResult

ISECalibResult
ModuleID ID of the module where the calibration has been performed.
SubModuleNo Submodule (for example, reagent disk) identification.
Reason Reason for calibration - contains one of the following values:
o Manual
o LotChange
o LotTimeout
o Reagent cassette changeover
o Reagent cassette timeout
o QCFailed
o Data managerRequest
CalibrationID ID of the calibration measurement. The control unit generates the ID.
DateTimeCreated Calibration date and time (timestamp from instrument).
ApplicationCode Application code (ACN).
CalibrationSuccessType Indicates if the calibration is valid.
CalibrationResultType Contains one of the following values:
o NoCalibration (calibration has not been executed)
o LotCalibration
o ContainerCalibration
o UserModifiedCalibration
o UnmaskedCalibration
o FailedCalibration
NoOfCalibrators Contains one of the following values:
o 1-3Point
o Cancel
4 Data cleanup and archiving

ISECalibrationGIDPK Internal identifier of the ISE calibration. Test and QC results

reference the GID.
y ISECalibResult

ISECalibResultDetails

ISECalibResultDetails
CalibrationType Type of calibration (Type-A or Type-B) which has been performed.
ISEmfAlarm CalibrationErrorCode.
ISEmf Voltage of reference.
LowEmfAlarm CalibrationErrorCode.
LowEmf Voltage of low standard.
HighEmfAlarm CalibrationErrorCode.
HighEmf Voltage of high standard.
CalibEmfAlarm CalibrationErrorCode.
CalibEmf Voltage of calibrator.
DispSlopeAlarm CalibrationErrorCode.
DispSlope Slope value for display.
ISConcAlarm CalibrationErrorCode.
y ISECalibResult > ISECalibResultDetails

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ISECalibResultDetails
ISConc Concentration of Reference.
CalibConcAlarm CalibrationErrorCode.
CalibConc Concentration of Calibrator.
CarryoverRateAlarm CalibrationErrorCode.
CarryoverRate CarryoverRate.
CalcSlopeValueAlarm CalibrationErrorCode.
CalcSlopeValue Slope value for calculation.
CompensateValueAlarm CalibrationErrorCode.
CompensateValue Compensation factor to adjust slope.
y ISECalibResult > ISECalibResultDetails

4 Data cleanup and archiving

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Used calibration details immunochemistry tab

ECalibResult

ECalibResult
ModuleID ID of the module where the calibration has been performed.
SubModuleNo Submodule (measuring cell) identification.
Reason Reason for calibration - contains one of the following values:
o Manual
o LotChange
o LotTimeout
o Reagent cassette changeover
o Reagent cassette timeout
o QCFailed
o Data managerRequest
CalibrationID ID of the calibration measurement.
DateTimeCreated Calibration date and time (timestamp from instrument).
ApplicationCode Application code (ACN).
CalibrationSuccessType This attribute indicates if the calibration is valid.
CalibrationResultType Contains one of the following values:
o NoCalibration (calibration has not been executed)
o LotCalibration
o ContainerCalibration
o InheritedLotCalibration(1)
o UserModifiedCalibration
o UnmaskedCalibration
o FailedCalibration
NoOfCalibrators Contains one of the following values:
o Full
o Cancel
4 Data cleanup and archiving

CalibrationGIDPK Internal identifier of the calibration. Test and QC results reference

the GID.
InstrumentReagentGIDFK The GID references the reagent bottle which was calibrated.
TraceDoc uses this value to make a link to the reagent.
y ECalibResult
(1) The calibration result of the last valid lot calibration is transferred to a new reagent cassette. This cassette uses the same lot number and was
placed in the reagent disk without calibration.

CalibratorBottleSignalResult

CalibratorBottleSifgnalResult
Lot Lot number of the calibrator.
BottleCountNo. Bottle number of the calibrator.
Code Calibrator code.
Level Level of calibrator.
y ECalibResult > CalibratorBottleSignalResult

Signal

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Signal
SignalValue1 Measured signal value.
SignalValue2 Measured signal value.
y ECalibResult > CalibratorBottleSignalResult > Signal

ECalibResultDetails

ECalibResultDetails
IsQualitative Indicates whether the calibration was quantitative or qualitative.
CalibrationValidityScope Indicates whether the calibration’s validity scope is lot or reagent
container (reagent cassette).
y ECalibResult > ECalibResultDetails

ECalibQuantDetails

ECalibQuantDetails
MissingValue Indicates if a value for calculation is missing.
ReagentExpired Indicates if the reagent has expired.
MinSignal Indicates if a minimum signal value is violated.
MaxSignal Indicates that a maximum signal value is violated.
SystemError Indicates that a system error occurred during the corresponding
calibrator measurement.
CurveParmeters Curve parameters (Master calibration values).
Parameters2Point 2-point calibration parameters, calculated for this calibration (slope
and intercept).
Parameter1Point 1-point calibration parameter, calculated for this calibration
(currently not used for assays).
Monotony Indicates that the monotony criterion is fulfilled for the
corresponding calibrator level.
Deviation Indicates whether the difference between the duplicate
measurements of a calibrator is violated.

4 Data cleanup and archiving

MinAcceptDiff Indicates whether the minimum acceptable difference value has
been violated.
CalibFactor Quotient of the slope of the reagent cassette calibration performed
and the stored lot calibration. If the calibration validity scope shows
Lot, then this value is always 1,000.
y ECalibResultDetails > ECalibQuantDetails

ECalibQualDetails

ECalibQualDetails
MissingValue Indicates if a value for calculation is missing.
ReagentExpired Indicates that the reagent has expired.
MinSignal Minimum signal.
MaxSignal Maximum signal.
SystemError Data alarm indicating that a system error occurred during the
corresponding calibrator measurement.
BorderLimit Upper and lower limits.
y ECalibResultDetails > ECalibResultDetails > ECalibQualDetails

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ECalibQualDetails
Deviation Data alarm that indicates if the difference between the duplicate
measurements of a calibrator is OK or not.
Slope Slope of the calibration curve.
y ECalibResultDetails > ECalibResultDetails > ECalibQualDetails
4 Data cleanup and archiving

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Used reagent details tab

ReagentSetting

ReagentSetting
ModuleID ID of the module.
SubModuleNo Submodule identification.
ReagentCompartmentTemperature Temperature of the reagent storage in °C.
DateTimeCreated Date and time of creation of the reagent setting (Reagent
Registration time). The reagent setting is valid until a new reagent
setting is created.
IsUpdate Current software version - true or false.
y ReagentSetting

ReagentContainerPosition Identifier

ReagentContainerPositionIdentifier
InstrumentReagentGIDPK Internal identifier of the reagent bottle. Test results, QC results, and
calibrations reference the GID.
ReagentContainerCode Code of the reagent.
ReagentLot Lot number of the reagent.
ReagentLotExtension Lot extension (internal number for production) of the reagent.
ReagentCountNo Bottle count number (serial number of the reagent).
ReagentChannel Current, Standby, or Unusable.
ReagentBaseType Contains one of the following values:
o CCReagent
o CCSpecialReagent
o CCDiluent

4 Data cleanup and archiving

o CCDetergent
o ICReagent
o ICReagentInpackCal
o ICDiluent
o ICPreTreatment
o ICBlankCell
o ICPreClean
o ICProbeWash
CC: Clinical chemistry
IC: Immunochemistry
ReagentPosition Position of the reagent container on the reagent rotor/disk.
RemainingDays Number of remaining days on board (based on onboard stability
time).
ReagentContainerSetID Internal ID.
Expiration Expiry date of the reagent lot (year and month).
y ReagentSetting > ReagentContainerPositionIdentifier

RemainingBottleVolume

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RemainingBottleVolume
Volume Volume of the remaining reagent.
VolumeUomName Measurement unit (mL or μL).
Position Position of the reagent in the reagent disk
y ReagentSetting > ReagentContainerPositionIdentifier > RemainingBottleVolume

ApplicationSetting

ApplicationSetting
ApplicationCode Application code (ACN).
y ReagentSetting > ReagentContainerPositionIdentifier > ApplicationSetting

RemainingTest

RemainingTest
NumberOfTests Number of remaining tests.
y ReagentSetting > ReagentContainerPositionIdentifier > RemainingTest
4 Data cleanup and archiving

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Table of contents

Software update installer (SUI) 5

This chapter explains how you update software on the

data manager and the control unit. It also explains how
you manage failed software installation processes.

In this chapter 5
Software update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
About basic requirements . . . . . . . . . . . . . . . . . . . . 247
About the software update installer (SUI). . . . . . . 248
About installation packages . . . . . . . . . . . . . . . . . . 252
About the software update on the control unit . . 253
Update procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
About the update procedure. . . . . . . . . . . . . . . . . . 255

5 Software update installer (SUI)

Selecting the appropriate software release. . . . . . 257
Installing software on the data manager (case 1) 259
Installing software on the control unit (case 2) . . 260
Installing software on the data manager and the
control unit (case 3) . . . . . . . . . . . . . . . . . . . . . . . . . 262
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
About failures during installation of data
manager software. . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Proceeding after installation of control unit
software failed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267

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Table of contents
5 Software update installer (SUI)

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Software update
You can use the software update installer to update
software on the data manager and the control unit.

In this section
About basic requirements (247)
About the software update installer (SUI) (248)
About installation packages (252)
About the software update on the control unit (253)

About basic requirements

The software update installation comprises 2 tools:
• Software update installer (SUI) on the data manager
• Software update on the control unit using the program
update tab

q Key notes
A complete update of the data manager can take up to 2
hours. The time required depends on the size of the
database and the type of software being installed. After
the data manager, the control unit can be updated - so it
might be, that the complete update takes longer.
During this time, the data manager and the control unit

5 Software update installer (SUI)

cannot be used.

Before you start the software installation, the following

requirements must be fulfilled:
• On the data manager, you must be logged in as
DMUser.
• You must have the appropriate user rights at the data
manager to run a software installation.
• You must have the administrator level at the control
unit to install software.
• An internet connection or a CD with the required files
must be available.
To install the software release from a CD, choose the
Load CD button.
• Close any application started from the D: drive.

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About the software update installer (SUI)

The software update installer (SUI) is a background
service that continuously checks for software releases
available on cobas® link. The SUI manages the complete
installation process, including download, backup, and
installation checks.
5 Software update installer (SUI)

w SUI button and main panel of the software update installer

SUI button colors The SUI button on the sidebar indicates the status as
follows:

Description
Blue The software update installer is running and all mandatory software releases are installed.
All optional releases are either installed or confirmed.
Yellow Software releases are pending: There are still mandatory releases to be installed.
Or: Optional software releases are not yet confirmed or installed.
Red The software update installer is not running (the connection to cobas® link is not available).
It is normal behavior that the SUI button sometimes turns red for a few minutes, for example, during
startup or essential information upload.
If the SUI button is permanently red, contact your Roche Service representative.

q Do not restart or shut down data manager if SUI Button is Red. You may disrupt the process in
the background

y Status explanation of SUI button

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If the SUI button is blue or yellow, choose the SUI button

to view the available software releases.

E
B

A Software version of data manager and control unit D Compatibility indicator

5 Software update installer (SUI)

B Software releases status E Selected software release detail information
C Acknowledge button

w Main panel with a software release selected

The main panel contains 2 work areas:

• Software releases
• Selected software release

Available software releases for the data manager and for

the control unit, are displayed in the Software releases
panel. Software releases are displayed in bold as long as
they have not yet been installed or acknowledged.

Software releases remain visible for 6 months, regardless

of whether they were installed or not. Contact your Roche
Service representative if you require an older release
again.

Select a software release to display its details in the

Selected software release panel.

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Color coding of software releases Software releases are classified as mandatory or optional.
• Mandatory (orange): We recommend to install as soon
as possible. If you want to install a higher version, all
previous mandatory updates must be installed.
• Optional (blue): These releases are not required to be
installed for certain countries. Consult the customer
letter on whether and, if applicable, by when a release
must be installed.
To confirm that you have noticed a release, choose the
Acknowledge button. The selected release is not
installed on the data manager and the SUI button
status changes from yellow to blue.
The SUI button does not change its color and stays
yellow if a mandatory release was acknowledged.

Required software versions The listed software releases must be installed on the data
manager and the control unit before updating (see
customer letter for details).

Compatibility indicator A small icon indicates whether the selected software

release is compatible with the currently installed version
on the data manager and control unit or not. Move the
pointer over the icon to see more information on the
software version.
• : A green check mark indicates that this release is
available for installation.
• : A yellow caution symbol indicates that this release
requires a compatible version of the data manager or
5 Software update installer (SUI)

control unit that is not already installed.

• : A red cross indicates that this release is not
available for installation. In this case, the software
cannot be updated because the required version is
either missing or the release is already installed.

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Acknowledge button If you do not want to install an update now, choose the
Acknowledge button to confirm that you have noticed it.
The button changes to the Set to New status and the
Acknowledged: status is check-marked ( ).
Furthermore, the SUI button may change its color.

5 Software update installer (SUI)

w Dialog box after the Acknowledge button was chosen

If you want to install this software release later, choose

the Set to New button to reset the Acknowledged:
status ( ). The software release is displayed in bold. The
color of the SUI button changes to yellow and the Set to
New button changes back to the Acknowledge button.

Buttons in the main panel

Button Description

Exit Exit the main panel of the software update installer.

Print Print metadata of the selected software release.

Load CD Load software releases from CD, for example, if no internet connection is available.

y Buttons at the right of the main panel

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About installation packages

In the bottom section of the selected software release
panel, the contents of the software release are displayed.

For the data manager Two different types of software can be included in a
software release:
• Installation package of the current data manager
software version
• Language package

For the control unit Three different types of software can be included in a
software release:
• Installation package of the current control unit
software version
• Language package
• Video package for the Online Help

q Software releases for the control unit

The SUI only downloads the updates to the data manager.
Afterwards the installation itself must be run from the
control unit.
5 Software update installer (SUI)

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About the software update on the control unit

On the control unit, you can use the Utility
> Maintenance > Program Update menu for installing
software. The software updates have previously been
downloaded to the data manager by the SUI.

q User rights
An administrator level password is required to install
software on the control unit.

5 Software update installer (SUI)

w Program update dialog box

The control unit software updates are displayed in the

Program Update dialog box. The 3 check boxes below
the table allow you to install only parts of a complete
software package.

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Note the following points when selecting options:

• Select the check boxes of the appropriate items. For
example, if you want to install video updates only,
select the Video check box.
• Install the relevant language package. Even if you use
English only, you must install the English language
package.

Information entered in the Comment field is printed in

reports.

Installation process After the required software files are downloaded from the
data manager, an essential information upload is
performed automatically. If you want to use previous
settings and data after a successful update, you must
contact Roche Service representative.

If an error occurs during the update procedure, the

system automatically rolls back to the previous version.
u For more information on the essential information
upload, refer to the relevant section in the Operator’s
Manual of the instrument.
5 Software update installer (SUI)

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 Update procedures 255

Update procedures
This section provides detailed descriptions of the update
procedures.

In this section
About the update procedure (255)
Selecting the appropriate software release (257)
Installing software on the data manager (case 1) (259)
Installing software on the control unit (case 2) (260)
Installing software on the data manager and the control
unit (case 3) (262)

About the update procedure

There are 3 cases where you can install software:
1. Install data manager software (case 1).
2. Install control unit software (case 2).
3. Install data manager and control unit software
(case 3).

The update procedure consists of up to 3 main steps:

1. Select the appropriate software release for installation.
This step is common to the installation process cases
1 and 3. The following procedures differ, depending

5 Software update installer (SUI)

on the case.
2. Start the download and installation (this action can
take up to 2 hours depending on the data volume).
Continue with one of the following procedures:
1) Installing software on the data manager (case 1).
2) Installing software on the control unit (case 2).
3) Installing software on the data manager and the
control unit (case 3).
3. Perform a data cleanup and restart the data manager
software.

q Key notes
A complete update of the data manager can take up to 2
hours. The time required depends on the size of the
database and the type of software being installed. After
the data manager, the control unit can be updated - so it
might be, that the complete update takes longer.
During this time, the data manager and the control unit
cannot be used.

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u see:
Selecting the appropriate software release (257)
Installing software on the data manager (case 1) (259)
Installing software on the control unit (case 2) (260)
Installing software on the data manager and the
control unit (case 3) (262)
About failures during installation of data manager
software (266)
Proceeding after installation of control unit software
failed (267)
5 Software update installer (SUI)

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 Update procedures 257

Selecting the appropriate software release

In the software update installer (SUI), you can choose
which software update is required for your laboratory
environment.

The procedure to select the software release is shown in

the installation process cases 1 and 3.

r To select the appropriate software

release (cases 1 and 3)
1 On the Sidebar, choose the button.

2
2 Log on with your user name and password.

3
3 In the Software releases panel, choose the
appropriate release.

5 Software update installer (SUI)

4 In the Selected software release panel, check the
requirements of the release.
• Read the customer letter.

5 Check that the required software version is already

installed.
f The current version is displayed on the top of the
screen, in the System information title box.

q The current software version is displayed in the

following work areas:
o Data manager: Help > About
o Control unit: Utility > Maintenance > Check
> Disk check

6 Continue with one of the following procedures:

• Installing software on the data manager (case 1).
• Installing software on the control unit (case 2).
• Installing software on the data manager and the
control unit (case 3).

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u Related topics
• Installing software on the data manager (case 1) (259)
• Installing software on the control unit (case 2) (260)
• Installing software on the data manager and the
control unit (case 3) (262)
5 Software update installer (SUI)

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Installing software on the data manager (case 1)

You can install software updates on the data manager.
The software update installer runs the installations
automatically.

r To install software on the data

manager (case 1)
1 To install the selected software release, choose the
Install button.

2 Choose the Yes button.

• The SUI runs the required installation processes
automatically, including backup and several
checks.
The progress is indicated in the Installation
status panel as follows:
: The green check mark indicates successfully
performed steps.
: The red cross indicates that an installation
error occurred.

q Red SUI button

During the backup, the connection to cobas® link is
temporarily disabled. The SUI button indicates this
connection loss by turning red.

5 Software update installer (SUI)

3 The data manager automatically restarts after the
installation is completed.

4 After the software is updated and restarted, the Post

installer main window is displayed.
f The data manager reboots after confirming the
dialog box.

5 If the installation was successful, the data manager is

ready for operation.
If the installation failed, a dialog box is displayed.
f The rollback will be executed automatically after
confirmation. After completing the rollback, you
can work with the old software version on the
system.

u Related topics
• Troubleshooting (266)

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Installing software on the control unit (case 2)

You can install software or updates on the control unit
without updating the data manager software.

Control unit software, language package, and video files

can be updated all at once or one after another. The
control unit will be automatically restarted after each
installation.

q The software update installer automatically

downloads available software releases to the data
manager. Therefore, it is not necessary to start a
download process manually.

r To install control unit software

(case 2)

1
1 In the Utility > Maintenance > Check work area,
choose the Program Update button.

2 To display the Program Update panel, choose the

Select button.
f The panel displays the control unit software
versions currently available on the data manager.
5 Software update installer (SUI)

3
3 Note the following points when selecting options:
• Select the check boxes of the appropriate items.
For example, if you want to install video updates
only, select the Video check box.
• Install the relevant language package. Even if you
use English only, you must install the English
language package.

q Check language version

Before starting the installation, make sure to select the
same language version that was used previously. In
the Program Update panel, choose the version.

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 Update procedures 261

4
4 Choose the Execute button.
I Each installation step is displayed in the Program
Update panel.
f The data manager downloads the required
software packages.
f The essential information upload is performed
automatically.
f The control unit reboots automatically after a
successful installation.

5 Choose the OK button.

q
o After an update of the complete package (control
unit software, language package and video files),
the language package and video files can still be
selected. Only the Software check box is disabled.
o No information is displayed after the update
indicating that a language package or video file
has been installed.

6 To check whether the installation on the control unit

was successful, choose the Print > History option.
• Choose the disk check.pdf file.

7 Go to the last page of the pdf file where the currently

installed software version is listed.
f To save the created settings and data, an essential

5 Software update installer (SUI)

information upload is performed automatically
after confirmation.

u Related topics
• Troubleshooting (266)

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 262 Update procedures

Installing software on the data manager and the control

unit (case 3)
You can install software updates on the data manager
and control unit in one procedure.

In this case, the steps from cases 1 and 2 are combined

with some additional steps.

q If running a combined update, the update on the

data manager must be run first.

Installing software on the data manager and the control unit (case 3)
Process of performing a combined update for both data manager and control unit.

1
Install update on
data manager

2 3
Data manager update System information
successful?
Yes CU update
Control unitmandatory
update mandatory
No
5 Software update installer (SUI)

4
Install update
on control unit

5
Control unit update
successful?

Yes No
No
Yes

7 6
Retry update of
Rollback of data manager?
No control unit?

Yes

Automatic rollback of data manager Start data manager

w Workflow for combined updates

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 Update procedures 263

r To install software on the data

manager and the control unit (case 3)
1 To install the selected software release on the data
manager, choose the Install button.
I The time required for updating the data manager
may take up to 2 hours.
After updating the data manager, the control unit
software can be updated.

2 Choose the Yes button.

• The software update installer runs the required
installation processes, including backup and
several checks. The data manager downloads the
files to the control unit.
f The Installation status panel indicates the
progress as follows:
: The green check mark indicates successfully
performed steps.
: The red cross indicates that an installation
error occurred.

q Red SUI button

During the backup, the connection to cobas® link is
temporarily disabled. The SUI button indicates this
connection loss by turning red.

3 The data manager restarts automatically after the

installation is completed.

5 Software update installer (SUI)

4 After the data manager software has been restarted, a
dialog box informs you about the outcome of the
update.
If the installation was successful, perform the update
on the control unit.
If the installation failed, a rollback is executed
automatically after confirmation.
I Before continuing with the software update, install
the required software on the control unit.

5 On the control unit, choose Utility > Maintenance

> Check.

6 Choose the Program Update button.

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7
7 To display the Program Update panel, choose the
Select button.
f This panel displays the software versions currently
available for installation on the control unit.

q The update version for the control unit software

is only visible if the update of the matching version on
the data manager was successful.

8
8 Note the following points when selecting options:
• Select the check boxes of the appropriate items.
For example, if you want to install video updates
only, select the Video check box.
• Install the relevant language package. Even if you
use English only, you must install the English
language package.

q Check language version

Before starting the installation, make sure to select the
same language version that was used previously. In
the Program Update panel, choose the version.

9
9 Choose the Execute button.
I Each installation step is displayed in the Program
Update panel.
f The data manager downloads the required
software packages.
5 Software update installer (SUI)

f The essential information upload is performed

automatically.
f The control unit reboots automatically after a
successful installation.

10 Choose the OK button.

q
o After an update of the complete package (control
unit software, language package, and video files),
the language package and video files can still be
selected. Only the Software check box is disabled.
o No information is displayed after the update
indicating that a language package or video file
has been installed.

11 To check whether the installation on the control unit

was successful, choose Print > History.
• Choose the disk check.pdf file.

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12 Go to the last page of the pdf file where the currently

installed software version is listed.
• Confirm the successful update of the data
manager.
f The data manager reboots.

13 Confirm the successful update on the control unit.

I If the control unit software installation fails, a
dialog box is displayed. A message asks whether
you want to retry installing the control unit
software or roll back.
f If you choose the rollback option, the data
manager is rolled back to the previous software
version too.

14 To save the created settings and data after a

successful update, an essential information upload is
performed automatically.

u Related topics
• Troubleshooting (266)

5 Software update installer (SUI)

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Troubleshooting

If the installation fails, the data manager and control unit

provide an automatic recovery function to restore the
previous software release.

In this section
About failures during installation of data manager
software (266)
Proceeding after installation of control unit software
failed (267)

About failures during installation of data manager

software
If the installation fails, an is displayed in the
Installation status panel.

To roll back to the previous software release, choose the

OK button.

The status of the rollback is indicated at the bottom left.

After a successful rollback, the data manager reboots

5 Software update installer (SUI)

automatically.

q If the rollback to the previous software release fails,

contact your Roche Service representative.
Keep the problem report ready to provide to the Roche
Service representative.
u Creating issue reports (55)

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 Troubleshooting 267

Proceeding after installation of control unit software

failed
This task explains what to do if the update installation on
the control unit fails.

The Confirmation panel indicates an installation failure.

The following reasons may cause installation failures:

• Essential information upload failed.
• The software could not be transferred.
• The software could not be properly installed.

q The control unit automatically restores the previous

version after confirmation.

r To proceed after installation of

control unit software failed
1 Choose the global Alarm button.

2
2 Check alarms for error information.

5 Software update installer (SUI)

3
3 In the Alarm panel, follow the remedy measures
described.

4 Check the hardware installation (power cable and

network connections).

5 Try the update once again.

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6 If the alarm recurs, contact your Roche Service

representative.

q Update of both data manager and control unit

software within the same process:
If the control unit software installation fails, you must
roll back the data manager software, even if its update
was successful.
To restore the data manager, confirm the dialog. A
dialog box informs you that the rollback has been
completed.

u Related topics
• Installing software on the data manager and the
control unit (case 3) (262)
5 Software update installer (SUI)

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across controls - lower limit

Glossary 6
data point During a measurement, on every cobas®
8000 modular analyzer series, the instrument provides
across controls Option on a Westgard rule. It a series of single measuring points (approximately 200
specifies that a rule is applied across several QC values for each test result). With the corresponding
materials for the same test. configuration only, these data points are sent from the
calculated QC A calculated QC is a result calculated control unit to the data manager. Data points are not
by a defined formula. It is needed as a combined QC displayed on the data manager or in TraceDoc.
result for cobas e flow tests. development channel Feature which allows an
calculated test Test for which the result is operator to run tests not provided by Roche on the
calculated on the basis of other measured test results, system. For such tests parameters must be set
with the help of algorithms and formulas. manually.

carryover Contamination of a test by reagents or a diluent Liquid used to dilute samples or to affect an
sample of a previous test. analytical reaction.

cobas e flow test Product name for a test that dilution factor Ratio of final volume of
consists of a pre-defined combination and sequence sample/aliquot volume. Final volume = aliquot +
of embedded tests. The combinations are provided by diluent.
Roche and are not editable by the customer. embedded test Test that is required for calculating a
cobas e flow test result Main and subresults cobas e flow test and can be ordered exclusively by a
reported by cobas e flow test in the form of a cobas e flow test. It cannot be ordered by the host or
calculated, qualitative value, or measured embedded manually by the user.
tests. host A Laboratory Information System (LIS) or other
cobas e pack Product name for the reagent IT solutions (middle ware) which is connected to the
cassettes used for immunology testing on cobas e system.
modules and Elecsys® systems. The cobas e pack is instrument group Group of instruments that are
an integrated reagent carrier consisting of 3 reagent listed together based on a predefined parameter.
bottles.
laboratory information system Computer system
cobas e packs for the cobas e 801 module are that supports the automation of laboratory
delivered with an RFID tag, which contains references management.
to the parameter file. linked tests, Linked kits Roche-internal
dependency rule for certain embedded tests and
The following data is needed for a unique cobas e packs which specifies the sequence of
identification of a cobas e pack: pipetting during the measurement procedure.
• Reagent cassette lot number
Reagent kit that consists of 2 to 10 cobas e packs
• Reagent container code
inclusive. These are logically linked during loading into
• Container count number (bottle sequence number) the instrument by the software via the same reagent
• Reagent expiry date lot number.
comment group Group of comments that can be
LIS Computer system that supports the automation of
assigned to data in specified contexts.
Glossary

laboratory management.
copy QC Feature which allows to copy QC data from
log file File that contains records of specific events
master ACN to the additional ACN of the same type
that have occurred on a system.
(on the same cobas e pack).
lower limit The lowest allowed or available value of a
data alarm Additional piece of information
variable.
associated with a test, QC or calibration result. It is
caused by the abnormal condition of measurement.

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masking - Underwriters Laboratories Inc.

masking Temporarily preventing the system from QC material A substance, material or article
performing activities on, or accessing a selected item, intended by its manufacturer to be used to verify the
for example module, instrument, test. performance characteristics of an in vitro diagnostic
medical device (ISO 15197). Note: A device, material,
measurement unit Real scalar quantity, defined and
solution, or lyophilized preparation intended for use in
adopted by convention, with which any other quantity
the quality control process. It should be similar to, and
of the same kind can be compared to express the ratio
is analyzed along with, patient samples. If different, it
of the two quantities as a number. NOTE 1
should have a recognized, defined response to
Measurement units are designated by conventionally
analytical measurements. QC materials may or may not
assigned names and symbols. NOTE 2 For a given
have known measurand concentration (i.e. assigned
quantity, the short term unit is often combined with the
values) within specified limits (e.g. target value,
quantity name, such as mass unit or unit mass. NOTE 3
standard deviation). They are not used for calibration
Measurement units of quantities of dimension one are
purposes.
numbers. In some cases these measurement units are
given special names, e.g. radian, steradian and QC result Result of a QC test.
decibel, or are expressed by quotients such as
QC test Test which is run with QC material.
millimole per mole equal to 10-3 and microgram per
kilogram equal to 10-9. (ISO/lEG Guide 99:2007, rack reception mode Operation mode in which the
definition 1.9) system remains in operation after the last test result
has been generated and until one of the following
measuring cell A set of hardware components for
conditions occurs: this operating mode was
performing a test. The analytical cobas e 801 module
terminated or the system entered the standby mode
and the cobas e 602 module have 2 measuring cells
regularly.
(“cell” for short).
reference range Range of test results expected for a
pass-through mode Operation mode that allows the
defined group of healthy patients or materials.
system software to send results to another system
without any assessment, modification, or validation. RRM Operation mode in which the system remains in
operation after the last test result has been generated
QC Measure of precision or how well the
and until one of the following conditions occurs: this
measurement system reproduces the same result over
operating mode was terminated or the system entered
time and under varying operating conditions. It is
the standby mode regularly.
designed to detect, reduce, and correct deficiencies in
a laboratory's internal analytical process prior to the software update installer Component of cobas®
release of patient results and improve the quality of 8000 data manager which enables users to install new
the results reported by the laboratory. software packages.
SUI Component of cobas® 8000 data manager which
QC refers to methods to ensure the reliability and
enables users to install new software packages.
consistency of reagents and the results based on
reactions using the reagents, on a per application test masking Temporarily preventing the system
basis. from performing a test. This includes QC runs and
calibrations.
This document distinguishes between 2 types of QC:
test order Record or data structure defining a test to
• Single QC (or measured QC) be performed by the instrument, using an order or lab
• Calculated QC test code that might need to be mapped to an
instrument code.
A single QC is measured on the instrument and refers UL Underwriters Laboratories Inc. is an independent,
to an embedded test or regular test.
Glossary

product safety testing and certification organization.

A calculated QC is calculated with a mathematical Underwriters Laboratories Inc. Independent,

formula and refers to a cobas e flow test. product safety testing and certification organization.

QC bracketing Setting in which a test result must be

preceded by, and followed by, a successful QC result
before it is released.

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 Glossary 273
unit - within control

unit Real scalar quantity, defined and adopted by

convention, with which any other quantity of the same
kind can be compared to express the ratio of the two
quantities as a number. NOTE 1 Measurement units
are designated by conventionally assigned names and
symbols. NOTE 2 For a given quantity, the short term
unit is often combined with the quantity name, such as
mass unit or unit mass. NOTE 3 Measurement units of
quantities of dimension one are numbers. In some
cases these measurement units are given special
names, e.g. radian, steradian and decibel, or are
expressed by quotients such as millimole per mole
equal to 10-3 and microgram per kilogram equal to
10-9. (ISO/lEG Guide 99:2007, definition 1.9)
upper limit The highest allowed or available value of
a variable.
virtual keyboard Keyboard displayed and used on a
touch screen.
within control Option on a Westgard rule. It specifies
that a rule only applies to one QC material of a test.

Glossary

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6 Glossary

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Index

A – retrieval and storage, 198

– searching, 65
Abbreviations, 12 – searching related, 229
Adding – starting TraceDocViewer, 224
– comments to QC results, 191 – TraceDoc, 195
– comments to sample, 114 – uploading to Roche, 216
– comments to test, 130 Data alarms
– cobas e flow tests, 83
Data manager
B – automatic cleanup, 203
– filters, 65
Barcode
– interface, 46
– barcode mode concept, 87
– introduction, 39
– deleting rack position in non-barcode mode, 89
– standard tasks, 46
– non-barcode mode concept, 88
– starting the system, 45
– tables, 60
C – workflows, 40
Day list
Calculated QC – day list component concept, 103
– cobas e flow tests, 167 – viewing cobas e flow test details after measurement,
Calculated QC results 138
– validating, 174, 186 – viewing samples, 106
Calibration results Deleting
– pass-through mode, 44 – cobas e flow order during processing, 113
Cancellation of cobas e flow tests, 84 – sample order before measurement, 111
cobas e 801 module, 78 – test from sample, 112
cobas e flow Dilution factor, requesting, 135
– cobas e flow concept, 78
– deleting order during processing, 113
– repeating, 143
E
– validating failed test, 140
eLibrary, 66
– viewing details after measurement, 138
Embedded tests, 78
cobas e pack, 167
cobas e-library
– Value Sheets, 68 F
Comments
– adding to QC results, 191 Feedback, 5
– adding to sample, 114
– adding to test, 130
Contact addresses, 7
I
Copyright, 4
Information window
Cover, safety information, 30
– validation test results manually, 145
Creating
Installer
– issue reports, 55
– software update, 56
Interface, data manager, 46
D Issue reports, 55

Data
Index

– archiving, 217
M
– automatic cleanup, 203
Masking/unmasking
– browsing, 227
– tests, 154, 160
– browsing using TraceDocViewer, 224
– tests by instrument, 159
– clean-up, 197
– tests by profile, 162
– closing TraceDocViewer, 230
– viewing history of test, 163
– purging, 223

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Mechanical safety, 30 – registering manually, 90

– requesting additional for tests, 93
– requesting additional tests, 93
P – resending to host, 108
– test result validation, 149
Pass-through mode
– viewing, 96
– patient results, 44
– viewing history, 107
– QC results, 44
– viewing tracking, 109
Password
– working with, 85
– changing expired password, 58
Screen captures, 54
Printing
– saving, 54
– TraceDocViewer, 229
Screen sharing
– selecting an application, 53
Q Screenshot disclaimer, 4
Searching
QC, 44 – criteria dialog box, 65
– QC bracketing, 182 – data, 65
– standby bottles, 193 – eLibrary document, 66
QC errors, 189 – related data, 229
QC results, 184 – tests, 121
– evaluation, 188 – Value Sheets, 68
Quick Start Guide, 76 – wild card, 65
Software
– updating installer, 56
R Symbols, 12
System
Reporting, results, 150
– reviewing alarms, 165
Resending
– reviewing status, 164
– sample order, 108
Results
– pass-through mode for patient, 44 T
– pass-through mode for QC, 44
– printing report, 153 Tables
– reporting, 150 – group sorting, 61
– showing report, 151 – simple sorting, 60
– viewing details and related data, 228 – working with, 60
Reviewing Test comment
– system alarms, 165 – adding, 130
– system status, 164 – deleting, 131
Routine – editing, 131
– QC, 166 Test results
– validating, 147
– validating manually, 144
S – validating manually by sample, 149
Tests
Safety classification, 26
– deleting, 129
Sample comment
– entering results manually, 133
– adding, 114
– entering results manually concept, 132
– deleting, 116
– managing comments, 130
– editing, 115
– manual validation concept, 144
Sample overview
– masking/unmasking, 154, 160
– sample overview component concept, 97
– masking/unsmasking by instrument, 159
– searching for samples, 102
Index

– masking/unsmasking by profile, 162

Samples
– printing result report, 153
– closing all, 212
– repeating, 134
– deleting before measurement, 111
– repeating a cobas e flow, 143
– deleting test, 112
– requesting additional, 127
– lifetime concept, 205
– requesting dilution, 135
– managing comments, 114
– searching for, 121
– priority concept, 86

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– showing result report, 151

– validating results manually, 144
– viewing, 122
– viewing details, 123
– viewing history, 126
– viewing previous, 125
– working with, 117
TraceDoc
– purging data, 223
– starting viewer, 224
TraceDocViewer
– browsing data, 224
– closing, 230
– printing, 229

Updating software, 56

Validation, 43
– Calculated QC results, 174, 186
– deleting test, 129
– failed cobas e flow, 140
– manually edited test result, 147
– validation component concept, 118
– viewing tests, 122
– viewing tests details, 123
Viewing
– masking history of test, 163
– previous test results, 125
– QC results, 184
– result details and related data, 228
– sample history, 107
– sample tracking, 109
– samples, 96
– test details, 123
– test history, 126
– tests, 122

Warranty, 4
Wild cards, 65
Workflow overview, 75
Workplaces
– default, 49
Index

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Index Index

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