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cobas® 8000 data manager

Operator’s Manual
Version 7

Software version 1.06


3

Document information

Revision history

Manual version Software version Revision date Main changes


1.0 1.0 Jun-2009 First version of this Operator’s Manual.
1.01 1.01 Jan-2010 E-module support
1.02 1.02 Oct-2010 Terminology: "Technical validation" changed to
"Validation", "Instrument data alarm" changed to
"data alarm".
User Interface: New information window system
message for software update package, buttons
changed.
Rounding rules for immunology test rounding
implemented.
Pass-through mode: new chapter in operator
manual.
TraceDoc chapter enhanced and renamed to "Data
cleanup and archiving".
1.03 (Revision 1) 1.03 Jul-2012 Creation of standalone version of data manager
operator’s manual.
Integration of software update installer chapter.
Integration of online help content into print version.
New glossary for standalone manual.
Update of TraceDoc chapter.
Added description of sequence mode.
Added workflows in chapter pass-through mode
and software update installer.
Version 5 1.04 Feb-2014 Restructured manual.
Added workplace overview chart in chapter
Introduction.
Updated procedures on software update, creating a
calculated test, setting up a non-Roche QC material.
Data alarms chapter added.
Version 6 1.05 Aug-2014 Updated procedures on software update, creating a
calculated test.
Forward instrument status
TSN agent upload data points for all heterogeneous
immunoassays
TSN agent split result upload for ISE, CC, and HET-
IA
Version 7 1.06 May-2016 Restructured manual.
Added images to task steps, concepts, and
references.
Added cobas e 801 module with cobas e flow test.
Update QC type for asymmetric QC range.
y Revision history

Edition notice This Operator's Manual describes the cobas® 8000 data
manager software, which is part of the cobas® 8000
modular analyzer series. The cobas® 8000 data manager
is the software which coordinates data in real time
between the cobas® 8000 instrument and the host
(usually the laboratory information system (LIS)).

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Every effort has been made to ensure that all the


information is correct at the time of publishing. However,
Roche Diagnostics International Ltd. reserves the right to
make changes necessary without notice as part of
ongoing product development.

Any customer modification to the cobas® 8000 data


manager renders the warranty or service agreement null
and void.

Where to find information For information on the individual components of the


cobas® 8000 modular analyzer series see:

The Safety Manual contains important safety


information. You must read the Safety Manual before
operating the instrument.

The Operator’s Manual focuses on routine operation


and maintenance. The chapters are organized according
to the normal operation workflow.

The Online Help contains the content of the Operator’s


Manual, Safety Manual and additionally:
• Troubleshooting information
• A software reference
• Configuration information
• Information about basic analytical principles

The PC manufacturer’s manual contains all information


about the hardware.

Intended use The cobas® 8000 data manager provides data and
workflow management for the in vitro diagnostic medical
device cobas® 8000 modular analyzer series.

Copyright © 2009-2016, F. Hoffmann-La Roche Ltd. All rights


reserved.

License information The cobas® 8000 data manager is protected by contract


law, copyright laws, and international treaties. The
cobas® 8000 data manager is licensed for use between
F. Hoffmann-La Roche Ltd and a licensee, and only
operators authorized there under are permitted to access
and use the software. Unauthorized use and distribution
may result in civil and criminal penalties.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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License agreement for UltraVNC software UltraVNC is a piece of free software for all commercial
uses. It is installed on the control unit PC of the
cobas® 8000 modular analyzer series.

You can redistribute the software and/or modify it under


the terms of the GNU General Public License (version 2 or
later), as published by the Free Software Foundation. A
copy of the GNU General Public License (version 2) is
stored on the control unit PC and on the data manager
server. The path for the license is C:\Program Files\uvnc
bvba\UltraVNC.

The software is distributed without warranty. There is no


implied warranty of merchantability or fitness for a
particular purpose. For more information, see the GNU
General Public License at http://www.gnu.org/licenses.

The source code for the software is stored on the control


unit PC. The path for the source code is
C:\DriversAndTools\UltraVNC.

Open Source and Commercial Software cobas® 8000 data manager might contain components
or modules that are Open Source or Commercial Software
programs. For copyright, and other notices and licensing
information regarding such software programs included
with cobas® 8000 data manager see the CD/ DVD
provided with the product.

The product and the cobas® 8000 data manager as a


whole may form a regulated device in accordance with
the applicable laws - refer to the installation DVD of the
cobas® 8000 data manager software for details. The
respective authorization in accordance with the
applicable laws lapse in case of any unauthorized
changes to the cobas® 8000 data manager.

Trademarks cobas® 8000 data manager is a trademark and the


cobas® 8000 data manager logo is a trade-mark of
Roche. Other product names and trademarks are the
property of their respective owners.

The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, and LIFE NEEDS ANSWERS


are trademarks of Roche.

All other trademarks are the property of their respective


owners.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Approvals The cobas® 8000 modular analyzer series meets the


protection requirements specified in IVD Directive
98/79/EC. Furthermore, the cobas® 8000 data manager
is manufactured and tested according to the following
international safety standards:

The following labels demonstrate compliance:


Complies with the IVD directive 98/79/EC.

Contact addresses

Roche Diagnostics GmbH


Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Table of contents 7

Table of contents

Document information 3 3 Data cleanup and archiving


Contact addresses 6 Data cleanup 147
Table of contents 7 About uploading data to Roche or to the
Preface 9 host 155
What is new in the manual version 7? 9 Data archiving 157
How to use this manual 10 About deleting data 162
Online Help 11 Browsing data using the TraceDocViewer 163
Symbols and abbreviations 11 List of TraceDocViewer interface elements 169
Safety classification 13
Safety precautions 14 4 Software update installer (SUI)
Operator qualification 15 Software update 183
Safe and proper use of the data manager 15 Update procedures 193
Miscellaneous safety precautions 15 Troubleshooting 203
Safety summary 16
Warning messages 16
Electrical safety 16
Glossary
Caution messages 16
Fatigue due to long hours of operation 17 5 Glossary
Malfunction due to interfering Index 209
electromagnetic fields 17
Data security 18
Notices 19
Disposal of the equipment 19

Operation

1 Introduction
Introduction to the cobas® 8000 data
manager 25
The cobas® 8000 data manager and
associated workflows 26
Starting the data manager 30
Working with the interface 31
Features accessed via Sidebar 36
Working with tables 44
About searching for data 48
Searching for Value Sheets 51
Using the Online help 53

2 Routine tasks
Quick reference: Main workflow 57
Working with samples 60
Working with tests 84
Validating test results 106
Reporting test results 116
Masking and unmasking tests 119
Reviewing system status 127
Viewing system alarm details 128
QC tasks 129

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Preface

The cobas® 8000 data manager implements data and


workflow management functions and provides an
interface between the cobas® 8000 modular analyzer
series, the host, and the Roche remote service platform
(TSN). Through TSN, it enables remote access to and
from Roche and allows information exchange. It provides
enhanced sample tracking, test management, result
traceability, storage and reporting, together with QC and
calibration management. Additionally, it has host back up
functionality and serves as a robust storage location for
the instrument.

This manual provides detailed descriptions of the data


manager features and operational concepts, specific
functions, and administration procedures.

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 (132)

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

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cobas e flow test • The cobas e 801 module with the option to run
cobas e flow test is implemented. The cobas e flow
test combines single assay measurements into a
sequence of automatically processed steps.
u See:
About the cobas e flow test (84)
Deleting a cobas e flow test order during
processing (81)
Viewing cobas e flow test result details after
measurement (93)
Repeating a cobas e flow test (104)
Validating a failed cobas e flow test (113)
Masking and unmasking a cobas e flow test (124)

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 easier and perform tasks quicker.

How to use this manual

q Always keep this Operator’s Manual in a safe, easily


accessible place.

To help you find information quickly, there is a table of


contents at the beginning of the manual and each
chapter. In addition, a complete index can be found at the
end.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Online Help

The cobas® 8000 data manager has a context-sensitive


online help feature to support you in its operation.
Context sensitive means that the help system always
displays information related to the current work area or
software element.

The instrument software offers 2 help features:


• Help, accessed via menu bar: opens on title page.
• Help, accessed via F1 key: opens help page related to
current work area.

F1 Help - This help feature displays information related to


the current work area. Use the F1 Help feature if you
require detailed information about this work area.
Hypertext links guide you to additional information and
procedures related to this work area.

q The Operator's Manual is included in the F1 Help


system. This option allows you to search for information
throughout the software reference and the manual. All
cross-references are implemented as hyperlinks.

Symbols and abbreviations

Visual cues are used to help locate and interpret


information in this document quickly. This section
explains formatting conventions used in this document.

Symbols The following symbols are used:

Symbol Explanation
o List item
u Related topics containing further information
q Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of a user action within a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics.
y Symbols used for easy recognition of information

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Symbol Explanation
p Task. Used in cross-references to tasks.
w Figure. Used in figure titles and cross-
references to figures.
y Table. Used in table titles and cross-references
to tables.
y Symbols used for easy recognition of information

Abbreviations The following abbreviations are used:

Abbreviation Definition
A
ANSI American National Standards
Institute
AU1, AU2, … Analytical Unit 1, 2, … (used in the
user interface only)
C
c module Photometric module (e.g. c 702, c 701
or c 502)
c 502 cobas c 502 module for clinical
chemistry
c 701 cobas c 701 module for clinical
chemistry
c 702 cobas c 702 module for clinical
chemistry
c7-1, c7-2, c7-3 First, second, third module of the
instrument (e.g. c 702, c 701 or
c 502)
Cal., CAL Calibration
Cfas Calibrator For Automated Systems
ClinChem Clinical chemistry
CV Coefficient of Variation (%)
CU Control unit
D
DM Data manager
E
e module Heterogeneous immunoassay
modules (e.g. e 602 or e 801)
e 602 cobas e 602 module for
heterogeneous immunoassay analysis
e 801 cobas e 801 module for
heterogeneous immunoassay analysis
e6-1, e6-2, e6-3 First, second, third module of the
instrument (e.g. e 602 or e 801)
e.g. exempli gratia – for example
H
HIS Hospital information system
I
ID Identification
i.e. id est – that is to say
y Abbreviations

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Abbreviation Definition
ISE Ion Selective Electrode; also used for
ISE module
ISO International Organization for
Standardization
IVD In Vitro Diagnostic
IVDD In Vitro Diagnostic Directive
L
LIS Laboratory information system
N
n/a Not applicable
P
PC/CC ProCell / CleanCell, system reagents
used on the e 602 and e 801 module
PNU Precinorm Universal, a Roche QC
material
PPU Precipath Universal, a Roche QC
material
Q
QC Quality Control
S
SB Standby
SD Standard deviation
SPR Special Reagent
STAT Short Turn-Around Time
Std Standard, commonly used for
calibrator
SU Rack Sampler Unit, the rack
loader/unloader
(SU is used on the Overview menu)
W
WEEE European Waste Electrical and
Electronic Equipment Directive
y Abbreviations

Safety classification

This section explains how precautionary information is


presented in this manual.

The safety precautions and important user notes are


classified according to the ANSI Z535.6 Standard.
Familiarize yourself with the following meanings and
icons:

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Generic hazard statements


The safety alert symbol by itself without a signal word is
used to promote awareness to hazards which are generic
or to direct the reader to safety information provided
elsewhere in the document.

! WARNING
Warning
r If not avoided, a hazardous situation can be indicated,
which could result in death or serious injury.

! CAUTION
Caution
r If not avoided, a hazardous situation can be indicated,
which could result in minor or moderate injury.

NOTICE
Notice
r If not avoided, a hazardous situation can be indicated,
which could result in damage to equipment.

q Tip
Indicates additional information on correct use or useful
tips.

Safety precautions

Generic hazard statements


Particular attention must be paid to the following safety
precautions. If these safety precautions are ignored, the
operator may suffer serious or fatal injury. Each
precaution is important.

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Operator qualification

Operators are required to have a sound knowledge of


relevant guidelines and standards as well as the
information and procedures contained in the Operator’s
Manual.
• Do not carry out operation and maintenance unless
Roche Diagnostics has trained you.
• Carefully follow the procedures specified in the
Operator’s Manual for the operation and maintenance
of the data manager.
• Leave maintenance, installation, or service that is not
described in the Operator’s Manual to Roche Service.

Safe and proper use of the data manager

Keep the Operator’s Manual in a safe place to ensure that


it is not damaged and remains available for use. It must
be easily accessible always.

Installation • Only the Roche Service representative performs


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

Approved parts Use of non-approved parts or devices may result in


malfunction and may render the warranty null and void.
Only use parts and devices approved by Roche
Diagnostics.

Third-party software Not Roche Diagnostics approved installation of any third-


party software may result in incorrect behavior of the data
manager. Do not install any non-approved software.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may


damage the data manager or lead to data loss. Perform
regular backups of measurement results. Operate only
with an uninterruptible power supply. Do not switch off
power while the PC accesses the hard disk or other
storage device.

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Safety summary

This safety summary contains the most important and


general warning, caution, and notice messages.

Warning messages

! WARNING
List of warning messages
r Before operating the data manager, read the warning
messages contained in this summary carefully. Failure
to observe them may result in death or serious injury.

Electrical safety

! WARNING
Electrical shock by electronic equipment
Removing the covers of electronic equipment can cause
electric shock, as there are high-voltage parts inside. In
addition, opening the top cover during operation can also
cause electric shock.
r Do not attempt to work in any electronic
compartment.
r The system is installed, serviced, and repaired by
authorized and qualified Roche personnel only.

Caution messages

! CAUTION
List of caution messages
r Before operating, read the caution messages
contained in this summary carefully. Failure to observe
them may result in minor or moderate injury.

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Fatigue due to long hours of operation

! CAUTION
Fatigue due to long hours of operation
Looking at the monitor screen over an extended period
may lead to eye strain or body fatigue.
r Take a break for 10–15 minutes every hour to relax.
r Avoid spending more than 6 hours per day looking at
the monitor screen.

Malfunction due to interfering electromagnetic fields

! CAUTION
Malfunction of the data manager and incorrect
results due to interfering electromagnetic fields
This data manager has been designed and tested to
CISPR 11 Class A. In a domestic environment, it may
cause radio interference, in which case, you may need to
take measures to mitigate the interference.
r The electromagnetic environment should be evaluated
prior to operation of the device.
r Do not operate the data manager close to sources of
strong electromagnetic fields (for example unshielded
intentional RF sources), as these may interfere with
the proper operation.

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Data security

! CAUTION
Unauthorized access and data loss due to malicious
software and hacker attacks
Portable storage media can be infected with and transmit
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
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.

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Notices

NOTICE
List of notices
r Before operating, read the notices contained in this
summary carefully. Failure to observe them may result
in damage to 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.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Operation

1 Introduction .............................................................................................................. 23
2 Routine tasks ........................................................................................................... 55
3 Data cleanup and archiving .............................................................................145
4 Software update installer (SUI) .......................................................................181

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Table of contents

Introduction 1

This chapter provides an introduction to the data


manager.

In this chapter 1
Introduction to the cobas® 8000 data manager. . . . . 25
The cobas® 8000 data manager and associated
workflows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Fixing communication after breakdown . . . . . . . . 27
About validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
About the pass-through mode for patient results 28
About the pass-through mode for QC and
calibration results . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Starting the data manager. . . . . . . . . . . . . . . . . . . . . . . 30
Working with the interface . . . . . . . . . . . . . . . . . . . . . . 31
About the cobas® 8000 data manager interface
(without sidebar) . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
About default workplaces and user-dependent
workplaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Data manager workplaces overview . . . . . . . . . . . 34
Features accessed via Sidebar . . . . . . . . . . . . . . . . . . . 36
Accessing an application from the sidebar. . . . . . 37
TraceDocViewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
1 Introduction

Saving screenshots. . . . . . . . . . . . . . . . . . . . . . . . . . 39
Creating issue reports . . . . . . . . . . . . . . . . . . . . . . . 40
About the remote support status . . . . . . . . . . . . . . 40
Starting the software update installer (SUI) . . . . . 41
About the host interface connection status
symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Shutting down the data manager. . . . . . . . . . . . . . 42
Restarting the data manager . . . . . . . . . . . . . . . . . 42
About USB storage devices. . . . . . . . . . . . . . . . . . . 43
Working with tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
About sorting tables. . . . . . . . . . . . . . . . . . . . . . . . . 44

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Table of contents

Showing and hiding table columns . . . . . . . . . . . . 45


Exporting and printing tables . . . . . . . . . . . . . . . . . 46
Reloading table data . . . . . . . . . . . . . . . . . . . . . . . . 47
About searching for data. . . . . . . . . . . . . . . . . . . . . . . . 48
Searching for Value Sheets . . . . . . . . . . . . . . . . . . . . . . 51
Using the Online help . . . . . . . . . . . . . . . . . . . . . . . . . . 53
1 Introduction

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 25

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.

1 Introduction

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
26 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 (60)

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


1 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.

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Introduction 27

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


data manager are:
• Validation of test results.
• Quality control (QC).
u
• Fixing communication after breakdown (27)
• About validation (28)
• About the pass-through mode for patient results (28)
• About the pass-through mode for QC and calibration
results (29)

Fixing communication after breakdown


In case that 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 for processing measurements,
choose the Stop button on the control unit.

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

3
3 On the data manager in the Day list > Tests table,
delete all already started test requests.
1 Introduction

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

5 Reactivate all open QC test requests.

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28 The cobas® 8000 data manager and associated workflows

6
6 On the data manager in the Day list > Tests table
reassign all deleted test requests.
I For cobas e flow, you must restart the complete
workflow.

7 Restart the instrument by choosing the Start button.

About validation
Validation includes checking that test result values lie
within the test's validation range or checking if the test
was performed after an out of range QC measurement.

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.

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 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 providing increased
performance for repeat, reflex, and rerun tests.
1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 29

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 quality control-related tasks are performed on the


data manager. Roche-related information is downloaded
automatically through the TSN.

The instrument measures QC samples 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.

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 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 for calibration
results.

1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
30 Starting the data manager

Starting the data manager


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

Precondition If both the control unit and the data manager must be
started, 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 Start button of the data manager server.
f The data manager starts up.

q It is not possible for the user 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.
1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 31

Working with the interface


The following section describes the most important tasks
to help you work with the data manager user interface.
u
• About the cobas® 8000 data manager interface
(without sidebar) (31)
• About default workplaces and user-dependent
workplaces (33)
• Data manager workplaces overview (34)

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

J
1 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.

Title bar Displays the current workplace and work area title and
contains the buttons for minimizing, maximizing, and
closing the application work area.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
32 Working with the interface

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


of the message 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.
1 Introduction

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.

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

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 33

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.


1 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 · Operator's Manual · Version 7
34 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.

Data manager workplaces overview

Routine QC Parameter QC Routine Administration

Host backup Control material QC Routine Workplaces

Sample overview QC rules QC standby bottles 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


1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 35

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

Communication FREDVHÁRZWHVW Real-time alarm


623FRQÀJXUDWLRQ Gender
message overview FRQÀJXUDWLRQ

Processing intervals /RJÀOHV Priorities System message

Sample status /RJÀOHV

w Data manager default workplaces

1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
36 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 display

Software update installer (SUI) button

Shut down button

Host interface connection status symbol

A short function description of the Sidebar buttons is


provided below.
u
• Accessing an application from the sidebar (37)
• TraceDocViewer (39)
• Saving screenshots (39)
• Creating issue reports (40)
• About the remote support status (40)
• Starting the software update installer (SUI) (41)
• About the host interface connection status
symbol (42)
• Shutting down the data manager (42)
• Restarting the data manager (42)
• About USB storage devices (43)
1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 37

Accessing an application from the sidebar

! CAUTION
Unauthorized access and data loss due to malicious
software and hacker attacks
Portable storage media can be infected with and transmit
computer malware. This malware may be used to gain
unauthorized access to data or cause unwanted changes
to software.
The 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 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.
o Do not copy or install any software on the data
manager.
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
devices unless you are instructed to do so by
official user documentation or 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
data manager.
o Keep all external storage devices in a secure place
and ensure that authorized persons can access
only.
1 Introduction

! CAUTION
Risk of injuries due to moving parts
Accepting remote access via the data manager sidebar to
the instrument while the instrument is not secured (for
example, with open covers) can result in suddenly moving
parts.
r Ensure that the instrument is secured before you
accept remote access.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
38 Features accessed via 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

w Data manager interface including the Sidebar

r To access an application from the


1 Introduction

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 · Operator's Manual · Version 7
Introduction 39

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 folder where you want to save the
screenshot.

4 Choose the Save button.


f If no USB storage device has been connected, the
screenshot is saved to the dedicated folder on the
1 Introduction

data manager server.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
40 Features accessed via Sidebar

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.

About the remote support status


1 Introduction

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.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 41

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 callout, enter your user name and password.
1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
42 Features accessed via Sidebar

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


If you switch off the instrument, also shut down the data
manager software.

q It is recommended that you restart the data manager


once a week.
Always reboot the data manager following a hardware
failure.

Precondition 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 callout, choose the Yes button.
f The data manager shuts down. To restart, you
would need to press the Start button on the data
manager PC.

Restarting the data manager


1 Introduction

As part of the weekly maintenance, restart the data


manager for cleaning up the database memories.

Precondition Ensure that the instrument is in standby mode before you


restart the data manager.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 43

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.

About USB storage devices


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

You should take care when removing the devices.

USB flash drives should only be removed when there are


no write processes (data transfer) taking place, 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.

1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
44 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

u
• About sorting tables (44)
• Showing and hiding table columns (45)
• Exporting and printing tables (46)
• Reloading table data (47)

About sorting tables


1 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.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 45

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.

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.
1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
46 Working with tables

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.

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.
1 Introduction

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.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 47

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

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.

1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
48 About searching for data

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
1 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:

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 49

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.

! CAUTION
Result misinterpretation due to incorrect e-library
document status
Outdated application information may cause result
misinterpretation.
r Ensure availability of an online connection for
updating HRD to the current status.

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
1 Introduction

document about application command. To access the


e-library shortcut menu right-click on the respective test.

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
50 About searching for data

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:
• Sample overview
u Searching for samples in the Sample overview
component (74)

• Day list
u Viewing samples in the Day list component (76)
• Validation
u Viewing tests in the Validation component (90)
• QC Routine
u About the QC Routine component (129)

The Show e-library document about control


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

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 51

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.
1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
52 Searching for Value Sheets

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.


1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 53

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, and choose DM help
command.

1 Introduction

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
54
1 Introduction Using the Online help

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
55
Table of contents

Routine tasks 2

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 2
Quick reference: Main workflow . . . . . . . . . . . . . . . . . 57
Working with samples . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Identifying sample tubes . . . . . . . . . . . . . . . . . . . . . 61
About sample priority. . . . . . . . . . . . . . . . . . . . . 61
About barcode mode . . . . . . . . . . . . . . . . . . . . . 62
Working in barcode mode . . . . . . . . . . . . . . . . . 62
About non-barcode mode . . . . . . . . . . . . . . . . . 63
Working in non-barcode mode. . . . . . . . . . . . . 64
Deleting rack positions for reassignment . . . . 64
Creating a sample order manually . . . . . . . . . . . . . 65
Ordering more tests for a sample. . . . . . . . . . . . . . 67
Viewing samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
About the Sample overview component . . . . . 70
Searching for samples in the Sample
overview component . . . . . . . . . . . . . . . . . . . . . 74
About the Day list component . . . . . . . . . . . . . 75
Viewing samples in the Day list component . . 76
2 Routine tasks

Viewing the sample history . . . . . . . . . . . . . . . . 78


Viewing sample tracking . . . . . . . . . . . . . . . . . . 78
Deleting a sample order before measurement. . . 79
Deleting a test from a sample. . . . . . . . . . . . . . . . . 80
Deleting a cobas e flow test order during
processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Managing sample comments . . . . . . . . . . . . . . . . . 81
Working with tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
About the cobas e flow test . . . . . . . . . . . . . . . . . . 84
About the Validation component . . . . . . . . . . . . . . 88
Searching for tests in the Validation component . 89

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
56
Table of contents

Viewing tests in the Validation component . . . . . . 90


Viewing test details . . . . . . . . . . . . . . . . . . . . . . . . . 92
Viewing cobas e flow test result details after
measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Viewing previous test results . . . . . . . . . . . . . . . . . 96
Viewing test history . . . . . . . . . . . . . . . . . . . . . . . . . 96
Ordering more tests in the Validation component 97
Deleting a test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Managing test comments . . . . . . . . . . . . . . . . . . . . 99
About entering a test result manually . . . . . . . . . . 101
Entering a test result manually . . . . . . . . . . . . . . . . 102
Repeating a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Repeating a cobas e flow test. . . . . . . . . . . . . . . . . 104
Requesting dilution for a test . . . . . . . . . . . . . . . . . 105
Validating test results . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
About validating test results manually. . . . . . . . . . 106
Validating test results manually using the
information window . . . . . . . . . . . . . . . . . . . . . . . . . 107
Validating test results manually in the Validation
component. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Validating test results manually by sample . . . . . . 111
Validating a failed cobas e flow test. . . . . . . . . . . . 113
Reporting test results. . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Previewing a test result report . . . . . . . . . . . . . . . . 116
Printing a test result report . . . . . . . . . . . . . . . . . . . 117
Masking and unmasking tests . . . . . . . . . . . . . . . . . . . 119
About masking and unmasking tests . . . . . . . . . . 119
About masking a module or submodule on the
control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Masking and unmasking tests by instrument or
module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Masking and unmasking individual tests . . . . . . . 124
Masking and unmasking a cobas e flow test . . . . 124
Masking and unmasking tests by masking
profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Viewing the masking history of a test . . . . . . . . . . 126
Reviewing system status . . . . . . . . . . . . . . . . . . . . . . . . 127
Viewing system alarm details . . . . . . . . . . . . . . . . . . . . 128
2 Routine tasks

QC tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
About the QC Routine component. . . . . . . . . . . . . 129
About copy QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
About calculated QC . . . . . . . . . . . . . . . . . . . . . . . . 134
About QC bracketing . . . . . . . . . . . . . . . . . . . . . . . . 134
Viewing QC results . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Validating QC results . . . . . . . . . . . . . . . . . . . . . . . . 136
Validating calculated QC results. . . . . . . . . . . . . . . 138
Acknowledging QC results . . . . . . . . . . . . . . . . . . . 139
Releasing results with QC errors . . . . . . . . . . . . . . 140
Adding comments to QC results. . . . . . . . . . . . . . . 141
Monitoring QC standby bottles. . . . . . . . . . . . . . . . 142

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Routine tasks 57

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
2 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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
58 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. For more search criteria, choose the F7
key.
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.
2 Routine tasks

8 Viewing test details 1. Choose the Validation component.


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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Routine tasks 59

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 standby bottles


bottles component.
2. Choose the appropriate filter criterion.

y Quick reference: Routine tasks

2 Routine tasks

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60 Working with samples

Working with samples


In the data manager, you can create sample orders 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

Samples 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
u
• Identifying sample tubes (61)
• Creating a sample order manually (65)
• Ordering more tests for a sample (67)
• Viewing samples (69)
• Deleting a sample order before measurement (79)
• Deleting a test from a sample (80)
• Deleting a cobas e flow test order during
processing (81)
• Managing sample comments (81)
2 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.

If possible, operate the instrument in barcode mode to


process samples, calibrators, and QC materials.

Ensure the correct assignment of non-barcode processed


test results to the samples.
u
• About sample priority (61)
• About barcode mode (62)
• Working in barcode mode (62)
• About non-barcode mode (63)
• Working in non-barcode mode (64)
• Deleting rack positions for reassignment (64)

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 requests.
• 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
rescheduling routine test requests.
2 Routine tasks

q If a STAT order is created but the corresponding


sample type 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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62 Working with samples

About barcode mode


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

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
Risk of deleting measurements due to switching
between barcode mode and non-barcode mode
When you switch between barcode and non-barcode
mode, the measurements are deleted. You should only
switch between barcode modes for instrument checks.
r Before you switch the barcode mode, make sure that
you have archived the databases. Consider archiving
and deleting open test requests and the data stored in
the host.

! WARNING
Reuse of sample IDs
r Do not reuse sample IDs as long as they are in the
host or the data manager.

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

Working in barcode mode


In the barcode mode, the instrument identifies the sample
requests, QC materials, and calibrators by reading the
barcode on the tubes.

Working in barcode mode allows you to load randomized


sample tubes, QCs, and calibrators.

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Routine tasks 63

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.

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).

! WARNING
Risk of overwriting patient data if using STAT
2 Routine tasks

samples in non-barcode mode


If non-barcode mode is on, the results from STAT
samples overwrite the results from routine samples that
have the same sequence number.
r Never use STAT samples if working in non-barcode
mode.

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64 Working with samples

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, deactivate barcode mode.
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.

Deleting rack positions for reassignment


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.
2 Routine tasks

j m Your Roche Service representative has the rack and


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

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Routine tasks 65

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 panel, the value shown
represents the number of all checked 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.

Creating a sample order manually


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

A
D

B
2 Routine tasks

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

w Host backup component

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
66 Working with samples

q Only active sample orders are displayed in the table.


After the lifetime of a sample order 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

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.

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 Sample Cup
Micro as cup type. The dimension of this cup causes
problems during sample aspiration.
2 Routine tasks

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.
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Routine tasks 67

3
3 In the patient table, double-click the patient you wish
to assign to the sample.
f The Search patient dialog box closes and the
patient details are entered in the patient group
box.

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 (81)
2 Routine tasks

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.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
68 Working with samples

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 (97)

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
3 Choose the appropriate sample and perform 1 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
inactive sample orders.

4
4 From the drop-down list, choose a test or a profile and
confirm with the Apply button.
2 Routine tasks

• 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.

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r To add tests to a sample from the Day


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

2
2 Choose the appropriate sample and perform 1 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.

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 (69)

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
2 Routine tasks

• 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.

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70 Working with samples

q For more search criteria, 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 (48)

u
• About the Sample overview component (70)
• Searching for samples in the Sample overview
component (74)
• About the Day list component (75)
• Viewing samples in the Day list component (76)
• Viewing the sample history (78)
• Viewing sample tracking (78)

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.
2 Routine tasks

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Routine tasks 71

B
C

A Samples table B Targets table C Tests table

w Sample overview component

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

The patient demographics criteria are:


• Patient ID
• Name
2 Routine tasks

• First name

The Count of reused sample IDs field (top right)


displays the number of reused sample IDs. To count the
number of reused sample IDs, choose the Get list button.

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.

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72 Working with samples

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

The tests table displays both active and inactive sample


order IDs. The status is indicated in the Is active column.

To perform tasks in the tests table, use the shortcut


menu.

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.

Single and embedded tests


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

Value with data alarm Qualitative message Cutoff index COI


e.g. Non-reactive e.g. 2.12
Value with data alarm ******* ******* COI
(23 / 26 / 27)
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
Value with data alarm Measurement value - Laboratory unit
e.g. 3.15 e.g. mmol/L
Value with data alarm ******* - Laboratory unit
(23 / 26 / 27) 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. %
2 Routine tasks

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
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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Routine tasks 73

Single and embedded tests


Test result type Result Original result Unit
Value with data alarm ******* ******* Laboratory unit
(23 / 26 / 27) 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. %
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
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
2 Routine tasks

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74 Working with samples

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
listed in the tests table.
2 Routine tasks

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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

A Samples table B Tests table C Sample comments table D Test comments table
2 Routine tasks

w Day list component

Roche Diagnostics
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76 Working with samples

Filter options Choose 1 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.

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


display the Search criteria dialog box.

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


order IDs. The status is indicated in the Is active column.

To perform tasks in the tests table, use the shortcut


menu.

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.

Viewing samples in the Day list component


You can view all sample orders and test results for the
2 Routine tasks

current day or a specific time range.

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
r Make sure only authorized and properly qualified staff
can validate test results.

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! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test 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).
2 Routine tasks

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Viewing the sample history


The Sample history callout 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 1 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.

Viewing sample tracking


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

The tile color indicates the status of the sample, for


2 Routine tasks

example:

Blue tile No request for sample

Red tile Pending

Yellow tile • There are unreleased results


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

The Sample tracking callout includes 2 tables in which


the following information is displayed:

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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
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

r To view sample tracking


1
1 In the cobas 8000 data manager Routine
workplace, choose 1 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.

Deleting a sample order before measurement


If an order has been manually wrongly created, you can
2 Routine tasks

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 1 of the following components:
• Sample overview
• Day list

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80 Working with samples

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

Deleting a test from a sample


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

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 1 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
2 Routine tasks

choose the Delete test command.

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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 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 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.

2 Routine tasks

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

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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 1 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
1 of the following actions:
• 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 appropriate sample and choose the Insert
sample comment command.

4
4 In the Sample comment dialog box, choose 1 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.
2 Routine tasks

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.

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r To edit a sample comment


1
1 In the cobas 8000 data manager Routine
workplace, perform 1 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.

r To delete a sample comment


1
1 In the cobas 8000 data manager Routine
workplace, perform 1 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 To close the Sample comment dialog box, choose


2 Routine tasks

3
the Cancel button.

u Related topics
• Creating a sample order manually (65)
• Searching for samples in the Sample overview
component (74)
• Viewing samples in the Day list component (76)

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84 Working with tests

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.
u
• About the cobas e flow test (84)
• About the Validation component (88)
• Searching for tests in the Validation component (89)
• Viewing tests in the Validation component (90)
• Viewing test details (92)
• Viewing cobas e flow test result details after
measurement (93)
• Viewing previous test results (96)
• Viewing test history (96)
• Ordering more tests in the Validation component (97)
• Deleting a test (98)
• Managing test comments (99)
• About entering a test result manually (101)
• Entering a test result manually (102)
• Repeating a test (103)
• Repeating a cobas e flow test (104)
• Requesting dilution for a test (105)

About the cobas e flow test


2 Routine tasks

The cobas e 801 module supports cobas e flow tests to


improve the turnaround time and minimize the error rate.

About cobas e flow tests The cobas e flow test is the name for a group of
embedded tests and calculated results that are
predefined.

About embedded tests Embedded tests are only used within cobas e flow tests.
The operator cannot perform embedded tests outside of
the cobas e flow test.

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How a cobas e flow test works The cobas e flow test consists of several embedded tests
linked by an automated reflex algorithm, and works as
follows:
• You can order a cobas e flow test 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.
• Only results that are marked for reporting are verified
against the reference ranges.
• All results that are marked for reporting are
summarized in the cobas e flow test result overview
as final and subresults.

If 1 of the embedded tests within a cobas e flow test fails


as a result of a data alarm, the complete cobas e flow
test order must be repeated. It is not possible to finalize
the test manually.

Out of range handling for embedded test If a measured embedded test result in a cobas e flow is
results marked with an Out of range data alarm, all following
actions for the cobas e flow are predefined. The user
cannot influence these, for example by rerunning the
marked embedded 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 final result. A positive test result
automatically starts further embedded tests.
NEG / POS • A required ratio is calculated.
• All results that are marked for reporting are
+RVW Embedded7HVW% summarized for the result report.
Final result Embedded7HVW&
2 Routine tasks

&DOFXODWH5DWLR

+RVW
Final result
• Test-A
• Test-B
• Test-C
• calculated Ratio

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86 Working with tests

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 final 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
Final result Embedded Test-A

Host
Final result
• Test-A
• Test-A
• Test-A

Duo test example


Duo test • The cobas e flow test defines which 2 to 10
embedded tests for the same parameter are sent to
the control unit.
Embedded Test-A
Embedded Test-B • The ratio is calculated.
• All results that are marked for reporting are
Calculate Ratio summarized for the result report.

Host
Final result
• Calculated Ratio

Installation
You can download a cobas e flow test to the data
manager. The cobas e flow test includes one or more
embedded tests. The order of installation of embedded
tests on the instrument is not predefined. All applications
must be installed before running a cobas e flow test.

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


must install the following:
2 Routine tasks

• 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

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The data manager validates only results that are marked


for reporting in the cobas e flow test. These results are
summarized in the cobas e flow test result overview.
Unmarked test results are not validated against any user
definable rules.
• You can create a reference range only for the final
result of the cobas e flow test.

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
calibration result data.

How copy calibration works Copy calibration works as follows:


• The master calibration is always measured by the
instrument.
• 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

2 Routine tasks

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88 Working with tests

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 request 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
2 Routine tasks

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Filter options Choose 1 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 for a sample order selected in the samples
table.

The tests table displays both active and inactive sample


order IDs. The status is indicated in the Is active column.

To perform tasks in the tests table, use the shortcut


menu.

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.

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.
2 Routine tasks

Tests matching the search criteria are displayed in the


Search criteria dialog box.

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90 Working with tests

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


search criteria you defined.

Viewing tests in the Validation component


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

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
2 Routine tasks

r Make sure only authorized and properly qualified staff


can validate test results.

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! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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.
2 Routine tasks

3
3 To view test details, choose 1 of the following options:
• For information associated with a test, in the tests
table, choose the corresponding test.
• 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).

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u Related topics
• Searching for samples in the Sample overview
component (74)
• Viewing samples in the Day list component (76)
• Searching for tests in the Validation component (89)

Viewing test details


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

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
r Make sure only authorized and properly qualified staff
can validate test results.

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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
2 Routine tasks

• Reference range, validation range, and critical range


• Test results and associated data
• QC data

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Routine tasks 93

r To view test details


1
1 In the cobas 8000 data manager Routine
workplace, choose 1 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 user rights. If not, the test result
appears as ‘xxxxx’ or ’*******’.

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


3
data tab.

u Related topics
• Viewing cobas e flow test result details after
measurement (93)

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.

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
2 Routine tasks

may lead to incorrect results being used by medical staff.


r Make sure only authorized and properly qualified staff
can validate test results.

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94 Working with tests

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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 and
the specific data alarm are 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.

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 test that failed on the instrument


are displayed as ’********’.
2 Routine tasks

Test results that were created by a formula are


suppressed.

For validation support, all data alarms and QC results


which are assigned to a test result are available, even 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 final result is shown with the validation against
the reference range and rules.

q The cobas e flow test order does not show


which embedded tests were ordered before
measurement. On the Additional data tab, all
available calculated QC results and the related data
alarms are listed for the main result.

4
4 On the Test details panel, right-click the final result
and choose the cobas e flow test subresults
command.
f All the subresults included in the cobas e flow
test are listed, even if they are not marked as
reported to the user.

q On the cobas e flow test subresults


> Additional data tab, the QC results for each
selected embedded test are listed.

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


5
data tab.
2 Routine tasks

u Related topics
• Viewing test details (92)

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96 Working with tests

Viewing previous test results


The Previous results callout 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 1 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.
2 Routine tasks

Viewing test history


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

The table displays the edits recorded according to each


action performed on the test. Such actions may include
rerunning or deleting a test, and changing the dilution of
a test.

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r To view the test history


1
1 In the cobas 8000 data manager Routine
workplace, choose 1 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.

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 (67)

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 Routine tasks

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98 Working with tests

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
inactive sample orders.

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

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

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

r To delete a test
2 Routine tasks

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.

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Routine tasks 99

Managing test comments


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

You can add pre-configured and free text comments to a


test.

These procedures describe how you can add, edit, or


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

q The free text 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 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 1 of the
following options to add your comment:
• To display the comments sorted by code, use the
2 Routine tasks

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.

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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100 Working with tests

r To edit a test comment


1
1 To display the Test comment dialog box, perform 1 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 callout, choose the OK button.


3
f To close the Test comment dialog box, choose
the Cancel button.
2 Routine tasks

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About entering a test result manually


You can enter outside the instrument created test results
manually 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 results.


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 (103)

q If a test has the Confidential result data alarm, you


can only enter a result manually if you have Read
confidential results user rights.
u Viewing test details (92)
2 Routine tasks

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.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
102 Working with tests

! 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?

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 1 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
2 Routine tasks

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.

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Routine tasks 103

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 1 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 1 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)
Day list: (All samples check box and Results
pending check box)
2 Routine tasks

Validation: (Results pending check box)

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104 Working with tests

Repeating a cobas e flow test


If you repeat a cobas e flow test order, the repetition
always starts from the beginning.

A failed cobas e flow test order cannot be restarted from


the point it failed. You cannot repeat embedded tests.

q You can only choose the Repeat test command for


a cobas e flow test order. The cobas e flow test repeats
the required embedded test that violates a range with the
corresponding dilution factor automatically.
You can assign the cobas e flow test as reflex test to a
test.
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 1 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 > cobas e flow test
subresults panel.
2 Routine tasks

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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.

r To request a dilution for a test


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

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

3
3 From the Request dilution for test: <x> > 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
2 Routine tasks

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”.

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106 Validating test results

Validating test results


Test results are validated depending on the configured
test validation rules, ranges, and pass-through mode.
u
• About validating test results manually (106)
• Validating test results manually using the information
window (107)
• Validating test results manually in the Validation
component (110)
• Validating test results manually by sample (111)
• Validating a failed cobas e flow test (113)

About validating test results manually


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

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
r Make sure only authorized and properly qualified staff
can validate test results.

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
2 Routine tasks

measurement unit and the corresponding test range.

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.

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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 in the sample order available
test results are validated at once.

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.

Validating test results manually using the information


window
You can directly access test results awaiting validation by
2 Routine tasks

using the information window.

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
r Make sure only authorized and properly qualified staff
can validate test results.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
108 Validating test results

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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
2 Routine tasks

corresponding message category.

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


sample clot or foam detected, the cobas e flow test is
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 1 of
1
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 In the Test details panel, right-click and choose the
cobas e flow test subresults command.
• Choose the embedded test with the data alarm. To
validate the data alarm, choose the Result data
tab.

4
4 To view the test's QC data, choose the Additional
data tab.
f To close the dialog box, choose the Close button.
2 Routine tasks

5
5 In the tests table, right-click the test and choose the
Validate test result (F8) command or press the F8
key.
f The test is validated and it disappears from the
tests table of the dialog box.

6 Repeat the procedure for any other tests you want to


validate.

q To validate more than one test at a time, select


multiple tests from the list.

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110 Validating test results

Validating test results manually in the Validation


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

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
r Make sure only authorized and properly qualified staff
can validate test results.

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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.
2 Routine tasks

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.

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Routine tasks 111

r To validate test results in the


Validation component
1
1 Choose cobas 8000 data manager Routine
> Validation.

2
2 In the filter panel, select the Validation pending
check box.
f All tests awaiting validation are listed in the tests
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.

4 Repeat the procedure for any other tests you want to


validate.

q To validate more than one test at a time, select


multiple tests.

Validating test results manually by sample


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

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
2 Routine tasks

r Make sure only authorized and properly qualified staff


can validate test results.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
112 Validating test results

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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 panel, 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
2 Routine tasks

from the samples table.

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Routine tasks 113

Validating a failed cobas e flow test


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

! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
may lead to incorrect results being used by medical staff.
r Make sure only authorized and properly qualified staff
can validate test results.

! WARNING
Incorrect result assessment due to reading the
result without checking the measurement unit
An incorrect test result interpretation can lead to a
patient receiving the wrong treatment. Tests can use
different measurement units (e.g. mg/dL or mmol/L). The
acceptable range depends on the measurement unit.
r When reading the test result, consider the
measurement unit and the corresponding test range.

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.
2 Routine tasks

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
displayed as ******* with the >Test data alarm.
• The cobas e flow is marked with the eflow.E data
alarm.

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114 Validating test results

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 displayed as ******* with the >Test
data alarm in the cobas e flow test subresults panel.
• The cobas e flow is marked with the eflow.E data
alarm.

If the repeated embedded test does not violate the test


range anymore, the test result is displayed in the cobas e
flow test subresults panel without a data alarm.
• The cobas e flow is valid and not marked with the
eFlow.E anymore. If the repeated embedded test is
marked 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 as ******* with the >Test
data alarm.

j m 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.

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
2 Routine tasks

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 final result is shown with the validation against
the reference range and rules.

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Routine tasks 115

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

5
5 Right-click on the main result and choose the cobas
e flow test subresults command.

6
6 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.

2 Routine tasks

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
116 Reporting test results

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.

u
• Previewing a test result report (116)
• Printing a test result report (117)

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, appear ??? instead of the final
result.
• The cobas e flow test is marked as canceled.
The cobas e flow test result has generic data alarms.
2 Routine tasks

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

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Routine tasks 117

r To show a result report


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

2
2 In the samples table, right-click the appropriate
sample and choose the Show result report > Single
result report command.
f You can also create a result report preview by
choosing the Single result report (two units)
option.

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.

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
2 Routine tasks

*()_ 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

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118 Reporting test results

r To print a result report


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

2
2 In the samples table, right-click the appropriate
sample and choose 1 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.
2 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.
u
• About masking and unmasking tests (119)
• About masking a module or submodule on the control
unit (122)
• Masking and unmasking tests by instrument or
module (123)
• Masking and unmasking individual tests (124)
• Masking and unmasking a cobas e flow test (124)
• Masking and unmasking tests by masking
profile (125)
• Viewing the masking history of a test (126)

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 request 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
> cobas e flow test subresults command.
2 Routine tasks

In the cobas e flow test subresults panel, the masked


embedded test is marked with the data alarm 113.

q Unmask the embedded test before you set the


canceled cobas e flow test to repeat and reinsert the
sample rack on the instrument for rerun.

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
120 Masking and unmasking tests

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


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.

The Masking profiles tab contains masking profiles


2 Routine tasks

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.

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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 request and
contains information about the request, 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 Test masking is bi-directional. Tests masked on the


control unit are reflected in the Test mask overview
panel.

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

Automatic patient masking If a QC error occurs for a test, you can trigger patient
2 Routine tasks

masking automatically.

You can mask and unmask tests and patient samples at


the following levels:
• Instrument
• Module (for example c 502 or e 601)
• Submodule (for example ISE(1) and ISE(2))
• Masking profile
• Individual test

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q Create masking profiles in the cobas 8000 data


manager Routine Configuration > Mask profiles
component.

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 to the module or submodule assigned tests are
masked and displayed with a gray background.

Test orders from the host or manually on the data


manager created are sent to the control unit but not
performed on the masked module. If a test is assigned to
2 Routine tasks

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
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 1 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.

2 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 1 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 1 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.
2 Routine tasks

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.

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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 panel, only the Patient
masking option is available for cobas e flow test.

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
2 Routine tasks

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.

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3
3 In the Confirm masking dialog box, choose 1 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.

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.
2 Routine tasks

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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
the alarm and choose the Display alarm command.

2 Routine tasks

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128 Viewing system alarm details

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.

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.
2 Routine tasks

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QC tasks
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.

The cobas 8000 data manager QC Routine workplace


has 2 components:
• QC Routine
• QC standby bottles
u
• About the QC Routine component (129)
• About copy QC (132)
• About calculated QC (134)
• About QC bracketing (134)
• Viewing QC results (135)
• Validating QC results (136)
• Validating calculated QC results (138)
• Acknowledging QC results (139)
• Releasing results with QC errors (140)
• Adding comments to QC results (141)
• Monitoring QC standby bottles (142)

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
2 Routine tasks

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.

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B
C

D
E

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.

The filtering results are displayed in the Control values


table. The following filter options are provided:
• Current QC results only
• QC results for standby bottles only
• Both result types

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


2 Routine tasks

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.

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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
No evaluation level is assigned to the No evaluation
status since it only applies when no rules are available 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,
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.

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) (31)
2 Routine tasks

The Reference values table and the Statistics table


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

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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
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.
2 Routine 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.

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Routine tasks 133

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

Master ACN Master ACN


Additional-1 ACN Additional-1 ACN
Additional-2 ACN Additional-2 ACN
Additional-3 ACN Additional-3 ACN

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$
2 Routine tasks

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

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134 QC tasks

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

The calculated QC result is used for the validation of the


embedded test result in the cobas e flow test.

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.

u Related topics
• Viewing cobas e flow test result details after
measurement (93)

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

Unlike regular QC, when QC bracketing is enabled, the


4&EUDFNHWLQJcheckbox selected release of a test is dependent upon 2 QC measurements.

If a QC result of an embedded test for a cobas e flow test


4&PHDVXUHPHQW fails, the data manager holds the cobas e flow test
results. To release the failed cobas e flow test result, you
must first validate the failed QC result for the embedded
Instrument

5RXWLQHVDPSOHPHDVXUHPHQWV test. After the failed QC result is released, you can


2 Routine tasks

validate the cobas e flow test result.

4&PHDVXUHPHQW
If you attempt to validate a cobas e flow test result with a
QC bracketing violation, a callout informs you that a QC
bracketing error appeared.
2XWFRPH
manager
Data

The QC result can have 1 of the following statuses:


• OK
• Error
• Missing

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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 automatically Test results can be manually
released released
OK OK Yes Yes
OK Missing No Yes
Missing OK No Yes
Missing Missing No Yes
OK Error No No
Missing Error No No
Error OK No No
Error Missing No No
Error Error No No
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 latest QC result
received following the test results determines whether the
test results are released or not.

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


2 Routine tasks

Copied from value indicates the additional QC results.

Possible filter criteria for the QC status are listed below:


• QC Error
• QC Warning
• Not enough values
• Activate
• Inactivate

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136 QC tasks

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
3 In the Filter options group box:
• 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.

4
4 Choose 1 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.

Validating QC results
In the QC Routine component, you can validate QC
results.
2 Routine tasks

Possible filter criteria for the QC status are listed below:


• QC Error
• QC Warning
• Not enough values
• Activate
• Inactivate

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Routine tasks 137

r To validate QC results
1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

2
2 In the Filter options group box, select 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 1 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.

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.
2 Routine tasks

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138 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
2 In the Filter options group box, select the
Calculated QC check box.
• 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 1 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


2 Routine tasks

type drop-down list, the Last results only option


does not work.

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

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Routine tasks 139

5
5 On the Result details > Data alarms tab, the data
alarm for the failed QC result that is used for the
calculation is displayed. In addition to the data alarm,
the generic alarm for the cobas e flow test is
displayed.

Acknowledging QC results
If a QC result fails, you can use the acknowledge QC
results 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.

! WARNING
Incorrect results due to erroneously acknowledged
QC results
QC results must meet the conditions defined in the
manufacturer’s package insert.
r Do not acknowledge results without checking that
2 Routine tasks

they are within the ranges defined by the


manufacturer.

r To acknowledge QC results
1
1 Choose cobas 8000 data manager QC Routine
> QC Routine.

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140 QC tasks

2
2 On the Control values tab, right-click the appropriate
QC result and choose 1 of the following commands:
f The Acknowledge result command indicates
that the result has been viewed. The
corresponding check box in the Acknowledged
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.

Releasing results with QC errors


To reactivate the automatic test result validation option,
you must manually validate and release the marked 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.

Control lock Indicates that the QC material is locked. Sample results


are blocked due to this lock.

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
2 Routine tasks

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 the QC result is released manually the test results
which have been measured afterwards have to be
validated manually.

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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


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 Release result command.

q To show the tooltip, place the mouse pointer over


a selected check box in the Data alarms column. A
callout 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.

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.
2 Routine tasks

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.

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142 QC tasks

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.

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 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

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.

The QC standby bottles component comprises a table


listing the QC results and a number of criteria by which
you can filter the entries.

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


menu.
2 Routine tasks

q Standby bottles with a QC error must be released in


the QC Routine component.

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Routine tasks 143

r To monitor QC standby bottles


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

2
2 In the filter option panel, choose the search criteria to
select the results that you want to view.
f The results corresponding to the filter selection are
displayed in the table.

3
3 In the Control values table, right-click the
appropriate QC result and choose the 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.

2 Routine tasks

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2 Routine tasks QC tasks

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Table of contents

Data cleanup and archiving 3

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 on an external storage device using the
TraceDocViewer.

In this chapter 3
Data cleanup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
About data cleanup and archiving . . . . . . . . . . . . . 147
Defining automatic data cleanup . . . . . . . . . . . . . . 149
Starting data cleanup manually . . . . . . . . . . . . . . . 150
About reusing sample IDs . . . . . . . . . . . . . . . . . . . . 150
Defining the sample ID lifetime . . . . . . . . . . . . . . . 153
About uploading data to Roche or to the host . . . . . . 155

3 Data cleanup and archiving


Data archiving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
About archiving data . . . . . . . . . . . . . . . . . . . . . . . . 157
List of supported types of external storage
devices for archiving . . . . . . . . . . . . . . . . . . . . . . . . 159
Starting an archive run manually . . . . . . . . . . . . . . 159
About troubleshooting failed archiving runs . . . . 160
About deleting data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Browsing data using the TraceDocViewer . . . . . . . . . 163
About the TraceDocViewer . . . . . . . . . . . . . . . . . . . 163
About browsing data . . . . . . . . . . . . . . . . . . . . . . . . 165
About viewing result details and related data . . . 166
About related data searches . . . . . . . . . . . . . . . . . . 167
About printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
About closing the TraceDocViewer . . . . . . . . . . . . 168
List of TraceDocViewer interface elements. . . . . . . . . 169
Sample details tab . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Used control details tab. . . . . . . . . . . . . . . . . . . . . . 171
Used calibration details tab. . . . . . . . . . . . . . . . . . . 172
Used calibration details ISE tab . . . . . . . . . . . . . . . 174

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Table of contents

Used calibration details immunochemistry tab . . 175


Used reagent details tab . . . . . . . . . . . . . . . . . . . . . 178
3 Data cleanup and archiving

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Data cleanup
In the data manager, you can determine the length of
time that data is retained before it is deleted or for which
period a sample ID can be reused.
u
• About data cleanup and archiving (147)
• Defining automatic data cleanup (149)
• Starting data cleanup manually (150)
• About reusing sample IDs (150)
• Defining the sample ID lifetime (153)

About data cleanup and archiving


The retention period is important since certain categories
of data can accumulate (for example, system messages
and log entries).

! CAUTION
Reduced data manager performance due to
database size.
If data is not deleted regularly, the size of the database
grows. Setting the retention period to 0 results in data not
automatically being cleaned up. The data manager may
start to operate more slowly and may even stop operating
altogether.
r Cleanup and archive data regularly.

3 Data cleanup and archiving


The Roche Service representative defines the retention
period after which TraceDoc deletes the files that are
successfully archived (by default 10 days).

! CAUTION
Archiving data
r For data archiving requirements, refer to local
regulations.

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In the cobas 8000 data manager System


Configuration > System configuration > Cleanup
options group box, you can specify the retention period
for the following data categories:
• System messages and log entries
• Test results
• QC results
• Data alarms

To delete data on the data manager, the following


conditions must be fulfilled:
• The age of the data is greater than its retention period.
• The data has been sent to TraceDoc.

The data manager checks the age of data every 2 hours. If


the data age exceeds the data category retention period
and the data has been sent to TraceDoc, it is deleted from
the data manager.

q Only data that has been sent to TraceDoc and is not


part of open orders (pending results) or active QC
materials is deleted.

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.
3 Data cleanup and archiving

Files on TraceDoc are:


• Sent to the remote service platform (every 2 hours)
• Archived to an external storage device

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 device.

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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)
sent to TraceDoc is deleted
C Data retrieved from the data manager by TraceDoc (every F Data is archived to external storage device regularly (for
10 minutes) example, weekly to a DVD or USB flash drive)

w Data cleanup and archiving

Defining automatic data cleanup


You can define the period after which the data is deleted
on the data manager.

3 Data cleanup and archiving


r To define an automatic data cleanup
1
1 Choose cobas 8000 data manager System
Configuration > System configuration.

2
2 CAUTION!
If the retention period is set to zero “0”, the data of this
category is not deleted in the automatic cleanup. The
size of the database may have a negative impact on
performance issues. 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).

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3 Choose the OK button.


I The cleanup is performed automatically at the next
scheduled cleanup run time.

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 set to zero "0", the data in that
category that is sent to TraceDoc is deleted.

About reusing sample IDs


You can define the lifetime of sample IDs in order to
3 Data cleanup and archiving

reuse them.

Preconditions • Change the value in the Sample ID lifetime in hours


field at the beginning or at the end of the daily routine
only.
• Always assign patient IDs to samples when reusing
sample IDs.

Beginning of sample ID lifetime is one of the following:


• Date and time when the data manager receives an
order from the host.
• Date and time when the operator created an 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.

After the lifetime of a sample ID has ended, the sample ID


is set to inactive.

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The Is active column indicates the state of a sample ID in


the following components:
• Sample overview
• Day list

The Host backup component only displays active sample


IDs.

Test scenario 1 Patient A

Sample order ID

action request
• Repeat
Test request • Rerun
• 5HÁH[
• Test-A
• Test-B Result Test-A Result Test-B Result Test-B

Time [h]
Start of the sample ID lifetime End of the sample ID lifetime

If one of the following requests causes a test result, and


the Sample ID lifetime in hours option is exceeded, it is
assigned to the pre-used sample ID.

3 Data cleanup and archiving


• Repeat
• Rerun
• Reflex

After the lifetime of a sample ID has ended and all test


results are available, you can reuse this sample ID without
having to clean up the database beforehand.

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Test scenario 1 Patient A

Sample order ID

action request
• Repeat
Test request • Rerun
• 5HÁH[
• Test-A
• Test-B Result Test-A Result Test-B Result Test-B

Time [h]
Start of the sample ID lifetime End of the sample ID lifetime

The test result is created after the Sample ID lifetime in


hours option is exceeded. This test result is assigned to
the new patient, who uses the same sample ID.

q All cobas e flow test results are assigned to the


correct cobas e flow, even if the test results are created
after the Sample ID lifetime in hours option is
exceeded.
3 Data cleanup and archiving

! WARNING
Risk of overwriting results if the Sample ID lifetime
in hours field is deactivated
If the Sample ID lifetime in hours field is set to "0" and
a sample ID is reused, the samples are merged, unless
the database has been cleaned up beforehand.
r Never set the Sample ID lifetime in hours field to
"0" 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.

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! CAUTION
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.

Defining the sample ID lifetime


You can assign the time frame in which a sample ID can
be reused.

r To define the sample ID lifetime


1
1 Choose cobas 8000 data manager System
Configuration > System configuration.

2
2 In the Cleanup options > Sample lifetime option
> Sample ID lifetime in hours field, enter the time
(in hours) for which a sample ID can be reused.

3 Data cleanup and archiving


3
3 Choose the OK button.
f The sample IDs can now be reused for the
assigned number of hours. Cleaning up the
database before reuse is not required.

r To deactivate sample ID lifetime


1
1 WARNING!
Risk of overwriting results if Sample ID lifetime in
hours option is deactivated.
If the Sample ID lifetime in hours field is set to zero
"0" and sample IDs are reused, these samples are
merged (unless the database has been cleared
before). If you are reusing sample IDs, do not set the
Sample ID lifetime in hours field to zero "0".
1 Choose cobas 8000 data manager System
Configuration > System configuration.

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2
2 On the Cleanup options tab, fill in zero "0" in the
Sample ID lifetime in hours field and confirm with
the OK button.
3 Data cleanup and archiving

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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.

Sending immunoassay data points to the host 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

3 Data cleanup and archiving


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.

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.

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The Forward instrument status 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
• Post operation
• S.Stop
• E.Stop
3 Data cleanup and archiving

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Data archiving
By default TraceDoc archives data every week to an
external storage device (for example, DVD or USB flash
drive).
u
• About archiving data (157)
• List of supported types of external storage devices for
archiving (159)
• Starting an archive run manually (159)
• About troubleshooting failed archiving runs (160)

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 destination is always the root of the E:\
drive.

3 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. You can
view the next scheduled archive run on the cobas 8000
data manager Service > Service-related
configuration > TraceDoc tab.

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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! CAUTION
Cleanup option set to zero
Setting a cleanup option to zero prevents an automatic
cleanup running for that option.
r The cleanup for that option must be performed
manually by choosing the Start cleanup now button.
After the manual cleanup reset the retention period to
the default values. Otherwise the database is not
cleaned up automatically again.

Identify a time in the week when archiving can best take


place. Examples might be:
• 03:00 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 03:00 Monday example above. The first action


on Monday morning would be to remove the DVD
containing the archive created at 03:00 A.M. Insert an
empty, labeled DVD for the archive run next Monday
morning.
3 Data cleanup and archiving

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List of supported types of external storage devices for


archiving
The following types of external storage devices are
supported by the data manager.
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

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. Remove the archive DVD, insert a new
DVD for the emergency archive run, or connect the
external storage device.
u List of supported types of external storage devices for
archiving (159)

3 Data cleanup and archiving


r To start an archive run manually
1
1 On the data manager PC, insert a CD or DVD, or
connect a USB flash drive.

2
2 Choose cobas 8000 data manager System
Configuration > System configuration.

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3
3 On the TraceDoc tab, choose the Start archiving
button.

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.

TraceDoc archives as much data as possible, even if the


amount of data to be archived is greater than the
available space on the DVD. The remaining 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 device.

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
3 Data cleanup and archiving

archived that TraceDoc received after the emergency


archive.

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

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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.

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-2014
16:00:00 to 11-April-2014 12:59:59.
• A QC material for a test was measured on 5-Apr-2014
at 15:32:37 and a calibration result was created on 30-
March-2014.
• The QC material and the calibration details are not in
the TraceDoc archive. These results are saved in the
previous archive.

3 Data cleanup and archiving

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About deleting data


Data is deleted from TraceDoc based on the length 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
• Sent to Roche
• Older than the value entered in the Purge archived
data older than field
3 Data cleanup and archiving

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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.

u
• About the TraceDocViewer (163)
• About browsing data (165)
• About viewing result details and related data (166)
• About related data searches (167)
• About printing (168)
• About closing the TraceDocViewer (168)

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:

3 Data cleanup and archiving


• On data manager in TraceDoc
• Archived on external storage device

q The TraceDocViewer functions in the same way in


both cases.

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


display resolution of 1400 pixels or more in width, and
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 (36)

TraceDocViewer components

A C

B
3 Data cleanup and archiving

A Search group box B Results group box C Details tab

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.

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.

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To use the TraceDocViewer on a DVD or on another


external storage device, 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.

About browsing data


In the TraceDocViewer, use the Looking for drop-down

3 Data cleanup and archiving


list to browse data. The available data types are:
• Samples
• Subresults (only for cobas e flow)
• QC controls
• Calculated QC results (only for cobas e flow)
• 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

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Additional search criteria are listed beneath the Search


Criteria group box:
• Used module
• Used reagent
• Used calibration
• Used control (QC)

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 check box to
search for master QC results. The calculated QC results
are not displayed.

Display formulas and variables for TraceDoc assigns the application code of the
cobas e flow cobas e flow to test results that are created by a formula
or used as a variable.

Find Workflow button In the Sample Details > SampleResult panel, choose
the Find cobas e flow test button on the appropriate
embedded test to view the corresponding data.
3 Data cleanup and archiving

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.

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q cobas e flow
For cobas e flow, test results are displayed, even if they
are created by calculation. 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 Details: only for cobas e flow
• Used calibration Details
• Used reagent Details
• Subresult Details

q Tab visibility
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.

About related data searches


You can perform searches based on data that is related to

3 Data cleanup and archiving


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 Calibration 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 (163)

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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.

About closing the TraceDocViewer


Choose the Exit button to close the TraceDocViewer
when you are using it on the data manager, archive DVD,
or other external storage device.

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.
3 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.
• Result flag: Optional, in case data alarm flag is
available.
u About the TraceDocViewer (163)
u
• Sample details tab (169)
• Used control details tab (171)
• Used calibration details tab (172)
• Used calibration details ISE tab (174)
• Used calibration details immunochemistry tab (175)
• Used reagent details tab (178)

Sample details tab

3 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.
3 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 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).
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

Used control details tab

SampleResult

3 Data cleanup and archiving


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

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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

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).
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.
3 Data cleanup and archiving

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

Used calibration details tab

CCalibResult

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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
o 1-6Point
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.

3 Data cleanup and archiving


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

CalibratorAbsorbance

CalibratorAbsorbance
Absorbance Mean of measured absorbance values.
DataAlarmFlag Data alarm of the sample.
y CCalibResult > CalibratorBottleAbsorbanceResult > CalibratorAbsorbance

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CalibratorAbsorbance
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

Used calibration details ISE tab

ISECalibResult
3 Data cleanup and archiving

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.
y ISECalibResult

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ISECalibResult
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
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.
ISConc Concentration of Reference.

3 Data cleanup and archiving


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

Used calibration details immunochemistry tab

ECalibResult

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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
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.
3 Data cleanup and archiving

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

Signal
SignalValue1 Measured signal value.
SignalValue2 Measured signal value.
y ECalibResult > CalibratorBottleSignalResult > Signal

ECalibResultDetails

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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.
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

3 Data cleanup and archiving


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.
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

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Used reagent details tab

ReagentSetting

ReagentSetting
ModuleID ID of the module.
SubModuleNo Submodule identification.
ReagentCompartmentTemperature Temperature of the reagent compartment 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
3 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 cassette
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

3 Data cleanup and archiving

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3 Data cleanup and archiving List of TraceDocViewer interface elements

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Table of contents

Software update installer (SUI) 4

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 4
Software update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
About basic requirements . . . . . . . . . . . . . . . . . . . . 183
About the software update installer (SUI). . . . . . . 185
About installation packages . . . . . . . . . . . . . . . . . . 190
About the software update on the control unit . . 191
Update procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
About the update procedure. . . . . . . . . . . . . . . . . . 193

4 Software update installer (SUI)


Selecting the appropriate software release. . . . . . 194
Installing software on the data manager (case 1) 196
Installing software on the control unit (case 2) . . 197
Installing software on the data manager and the
control unit (case 3) . . . . . . . . . . . . . . . . . . . . . . . . . 199
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
About failures during installation of data
manager software. . . . . . . . . . . . . . . . . . . . . . . . . . . 203
Proceeding after installation of control unit
software failed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

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Table of contents
4 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.
u
• About basic requirements (183)
• About the software update installer (SUI) (185)
• About installation packages (190)
• About the software update on the control unit (191)

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

4 Software update installer (SUI)


cannot be used.

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184 Software update

! WARNING
Risk of wrong results if customer information is not
consulted before update
Errors before or during the update procedure may
damage the software installation of the data manager
and/or the control unit. Errors may lead to system
downtime and wrong results.
The system automatically creates a backup before
running the update. If an error occurs during the update
procedure, the system automatically rolls back to that
backup. Once the update has been completed, a rollback
is no longer possible.
r Read the customer letter carefully before beginning
the update procedure.
The customer information on a software release is
available via e-library or in customer letters, received
by fax or e-mail.
r Follow the instructions given.
r Do not perform a software update when the data
manager is in routine use.
r Updates can be optional or mandatory.

Before you start the software installation, the following


requirements must be fulfilled:
• 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
4 Software update installer (SUI)

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.

4 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.
y Status explanation of SUI button

If the SUI button is blue or yellow, choose the SUI button


to view the available software releases.

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E
B

A Software version of data manager and control unit D Compatibility indicator


B Software releases status E Selected software release detail information
C Acknowledge button
4 Software update installer (SUI)

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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! WARNING
Risk of wrong results if customer information is not
consulted before update
Errors before or during the update procedure may
damage the software installation of the data manager
and/or the control unit. Errors may lead to system
downtime and wrong results.
The system automatically creates a backup before
running the update. If an error occurs during the update
procedure, the system automatically rolls back to that
backup. Once the update has been completed, a rollback
is no longer possible.
r Read the customer letter carefully before beginning
the update procedure.
The customer information on a software release is
available via e-library or in customer letters, received
by fax or e-mail.
r Follow the instructions given.
r Do not perform a software update when the data
manager is in routine use.
r Updates can be optional or mandatory.

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

4 Software update installer (SUI)


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.

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).

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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
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.
4 Software update installer (SUI)

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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.

4 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.
4 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.

4 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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192 Software update

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.
4 Software update installer (SUI)

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Software update installer (SUI) 193

Update procedures
This section provides detailed descriptions of the update
procedures.
u
• About the update procedure (193)
• Selecting the appropriate software release (194)
• Installing software on the data manager (case 1) (196)
• Installing software on the control unit (case 2) (197)
• Installing software on the data manager and the
control unit (case 3) (199)

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

4 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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194 Update procedures

! WARNING
Risk of wrong results if customer information is not
consulted before update
Errors before or during the update procedure may
damage the software installation of the data manager
and/or the control unit. Errors may lead to system
downtime and wrong results.
The system automatically creates a backup before
running the update. If an error occurs during the update
procedure, the system automatically rolls back to that
backup. Once the update has been completed, a rollback
is no longer possible.
r Read the customer letter carefully before beginning
the update procedure.
The customer information on a software release is
available via e-library or in customer letters, received
by fax or e-mail.
r Follow the instructions given.
r Do not perform a software update when the data
manager is in routine use.
r Updates can be optional or mandatory.

u see:
Selecting the appropriate software release (194)
Installing software on the data manager (case 1) (196)
Installing software on the control unit (case 2) (197)
Installing software on the data manager and the
control unit (case 3) (199)
4 Software update installer (SUI)

About failures during installation of data manager


software (203)
Proceeding after installation of control unit software
failed (203)

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.

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Software update installer (SUI) 195

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.

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

4 Software update installer (SUI)


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).

u Related topics
• Installing software on the data manager (case 1) (196)
• Installing software on the control unit (case 2) (197)
• Installing software on the data manager and the
control unit (case 3) (199)

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
196 Update procedures

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.
4 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 (203)

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Software update installer (SUI) 197

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.

4 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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198 Update procedures

5
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
4 Software update installer (SUI)

information upload is performed automatically


after confirmation.

u Related topics
• Troubleshooting (203)

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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Software update installer (SUI) 199

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

4 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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200 Update procedures

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.
4 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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Software update installer (SUI) 201

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.
f The essential information upload is performed

4 Software update installer (SUI)


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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202 Update procedures

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 (203)
4 Software update installer (SUI)

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Software update installer (SUI) 203

Troubleshooting
If the installation fails, the data manager and control unit
provide an automatic recovery function to restore the
previous software release.
u
• About failures during installation of data manager
software (203)
• Proceeding after installation of control unit software
failed (203)

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


automatically.

4 Software update installer (SUI)


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 (40)

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.

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204 Troubleshooting

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.

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.

6 If the alarm recurs, contact your Roche Service


representative.
4 Software update installer (SUI)

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
callout informs you that the rollback has been
completed.

u Related topics
• Installing software on the data manager and the
control unit (case 3) (199)

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Glossary

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Glossary 207
across controls - standard deviation

Glossary 5
measurement unit Real scalar quantity, created and
adopted by convention. Any other quantity of the same
across controls Option on a QC rule. It specifies that kind can be compared to express the ratio of the 2
a rule is applied across several QC materials for the quantities as a number. NOTE 1 Measurement units
same test. are designated by conventionally assigned names and
calculated test Test that is done based on a symbols. NOTE 2 For a given quantity, the short-term
calculation of measured test results, algorithms, and unit is often combined with the quantity name, such as
formulas. mass unit or unit mass. NOTE 3 Measurement units of
quantities of dimension one are numbers. The
carry over Contamination of a test by reagents or measurement units are given special names, for
sample of previous test. example, radian, steradian, and decibel, or quotients
comment group Group of comments that can be expressed such as millimole per mole equal to 10-3
assigned to data in specified contexts. and microgram per kilogram equal to 10-9. [ISO/IEG
data alarm Alarm associated with a test result or Guide 99:2007, definition 1.9]
calibration. The abnormal condition of a measurement pass-through mode Operating mode that allows the
is the cause. system software to send results to another system
development channel Option which allows an without any assessment, modification, or validation.
operator to run tests not provided by Roche on the QC Procedures in a laboratory that ensure and prove
system. For such tests, all parameters must be set that test results are technically correct.
manually.
QC bracketing Setting in which a test result must be
diluent Liquid used to dilute samples or to affect an preceded by, and followed by a successful QC result
analytical reaction. before it is released.
dilution factor Ratio of final volume of QC material Substance with known characteristics
sample/aliquot volume. Final volume = aliquot + used to verify correct measurement of instruments.
diluent.
QC result Result of a QC test.
instrument group Group of instruments that are
listed together based on a predefined parameter. QC test Test which is run with QC material.

laboratory information system Computer system rack reception mode Operating mode in which the
that supports the automation of laboratory system remains in operation after the last test result
management. has been generated and until one of the following
conditions occurs: this operating mode was
log file File that contains records of specific events terminated or the system entered the standby mode
that have occurred on a system. regularly.
lower limit The lowest allowed or available value of a reference range Range of test results expected for a
variable. defined group of healthy patients or materials.
masking Temporarily preventing the system from Remote service platform (TSN) Global IT platform
performing activities on or accessing a selected item, provided by Roche to deliver to and receive data from
e.g. module, instrument, test. analyzers. It offers storage and comparison of specific
analyzer data for Roche customers.
Glossary

software update installer Component of cobas®


8000 data manager which enables you to install
software packages.
standard deviation Positive square root of the
variance.

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208 Glossary
test masking - within control

test masking Temporarily preventing the system


from performing a test. Test masking includes QC runs
and calibrations.
Underwriters Laboratories Inc. Independent,
product safety testing and certification organization.
upper limit The highest allowed or available value of
a variable.
within control Option on a QC rule. It specifies that a
rule only applies to one QC material of a test.
Glossary

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Index 209

Index

A – workflows, 26
Day list, 76
Abbreviations, 12 Deleting
Adding – cobas e flow order during processing, 81
– comments to QC results, 141 – sample order before measurement, 79
– comments to sample, 81 – test from sample, 80
– comments to test, 99 Dilution factor, requesting, 105

C E

Calculated QC results eLibrary, 49


– validating, 136, 138
Calibration results
– pass-through mode, 29
H
cobas e flow
he, 129
– Concept, 84
– deleting order during processing, 81
– validating failed test, 113 I
– viewing details after measurement, 93
cobas e-library Installer
– Value Sheets, 51 – software update, 41
Comments Interface, data manager, 31
– adding to QC results, 141 Issue reports, 40
– adding to sample, 81
– adding to test, 99
Contact addresses, 6
M
Copyright, 4
Masking/unmasking
Creating
– tests, 119, 124
– issue reports, 40
– tests by instrument, 123
– tests by profile, 125
D – viewing history of test, 126

Data
– archiving, 157
P
– automatic cleanup, 149
Pass-through mode
– browsing, 165
– patient results, 28
– browsing using TraceDocViewer, 163
– QC results, 29
– clean-up, 147
Printing
– closing TraceDocViewer, 168
– result report, 117
– purging, 162
– TraceDocViewer, 168
– retrieval and storage, 148
– searching, 48
– searching related, 167 Q
– starting TraceDocViewer, 163
– TraceDoc, 145 QC
– uploading to Roche, 155 – QC bracketing, 134
Data manager – standby bottles, 142
Index

– automatic cleanup, 149 QC errors, 140


– filters, 48 QC results, 135
– interface, 31 – evaluation, 139
– introduction, 25 Quality control, 29
– standard tasks, 31 Quick Start Guide, 58
– starting the system, 30
– tables, 44

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210 Index

R – editing, 100
Test results, 107
Reporting, results, 116 – validating, 110
Results – validating manually, 106
– pass-through mode for patient, 28 – validating manually by sample, 111
– pass-through mode for QC, 29 Tests
– printing report, 117 – deleting, 98
– reporting, 116 – entering results manually, 102
– showing report, 116 – managing comments, 99
– viewing details and related data, 166 – masking/unmasking, 119, 124
Reviewing – masking/unsmasking by instrument, 123
– system alarms, 128 – masking/unsmasking by profile, 125
– system status, 127 – printing result report, 117
Routine – repeating, 103
– quality control, 129 – requesting additional, 97
– requesting additional tests for sample, 67
– requesting dilution, 105
S – searching for, 89
– showing result report, 116
Sample comment
– validating results, 110
– adding, 82
– validating results manually, 106, 107
– deleting, 83
– validating results manually by sample, 111
– editing, 83
– viewing, 90
Samples
– viewing details, 92
– deleting test, 80
– working with, 84
– managing comments, 81
TraceDoc
– overview, 74
– purging data, 162
– registering manually, 65
– starting viewer, 163
– requesting additional for tests, 67
TraceDocViewer
– viewing, 69
– browsing data, 163
– working with, 60
– closing, 168
Screen captures, 39
– printing, 168
– saving, 39
Screen sharing
– selecting an application, 38 U
Searching
– criteria dialog box, 48 Updating software, 41
– data, 48
– eLibrary document, 49
– related data, 167
V
– tests, 89
validating manually, 107
– Value Sheets, 51
Validation, 28, 107, 110
– wild card, 48
– Calculated QC results, 136, 138
Software
– cobas e flow, 113
– updating installer, 41
Viewing
Symbols, 11
– masking history of test, 126
System
– QC results, 135
– reviewing alarms, 128
– result details and related data, 166
– reviewing status, 127
– samples, 69
– test details, 92
T – tests, 90
Index

Tables
– group sorting, 45
W
– simple sorting, 44
Wild cards, 48
– working with, 44
Workflow overview, 57
Test comment
Workplaces
– adding, 99
– default, 33
– deleting, 100

Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7