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Operator’s Manual
Version 7
Document information
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)).
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
4
Intended use The cobas® 8000 data manager provides data and
workflow management for the in vitro diagnostic medical
device cobas® 8000 modular analyzer series.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
5
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.
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.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
6
Contact addresses
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Table of contents 7
Table of contents
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
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
8 Table of contents
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
9
Preface
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® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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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.
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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
11
Online Help
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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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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
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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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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
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
14
! 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
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Operator qualification
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Safety summary
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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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! 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.
! 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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
19
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.
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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Table of contents
Introduction 1
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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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Table of contents
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 25
1 Introduction
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
26 The cobas® 8000 data manager and associated workflows
Host Roche
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 27
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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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.
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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 29
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
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
30 Starting the data manager
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.
2
2 In the logon dialog box, type in your user name and
password.
1 Introduction
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 31
A
B
C
D
E
F
G L
J
1 Introduction
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.
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.
Status bar Displays the current date and time as well as the number
of records in the active table.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 33
Default workplaces used in this manual All descriptions and procedures provided in this manual
refer to these default workplaces.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
34 Working with the interface
Calibration
System alarm
recommendations
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 35
Sample type Organization Test reference ranges Password settings Test status
Service-related
3URÀOHV Instrument Formulas Data alarms
FRQÀJXUDWLRQ
1 Introduction
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
36 Features accessed via Sidebar
Screenshot button
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 37
! 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
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
Saving screenshots
You can make screenshots and save them on the data
manager server or on a USB storage device.
3
3 In the Save screenshot > Save to dialog box,
choose the folder where you want to save the
screenshot.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
40 Features accessed via Sidebar
3
3 In the Issue report dialog box, enter a title and a
description of the issue.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 41
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.
2
2 In the callout, enter your user name and password.
1 Introduction
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
42 Features accessed via Sidebar
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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 43
2
2 From the drop-down list, choose the Restart
command.
1 Introduction
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
44 Working with tables
A G
F
B
C E
w Table elements
u
• About sorting tables (44)
• Showing and hiding table columns (45)
• Exporting and printing tables (46)
• Reloading table data (47)
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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.
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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.
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.
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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.
1 Introduction
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
48 About searching for data
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
Wild card searches In fields, you can use wild cards to select certain kinds of
1 Introduction
Examples:
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 49
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
! 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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
50 About searching for data
• 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)
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Introduction 51
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
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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.
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Introduction 53
1 Introduction
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
54
1 Introduction Using the Online help
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
55
Table of contents
Routine tasks 2
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
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56
Table of contents
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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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Routine tasks 57
cobas®GDWDPDQDJHUZRUNÁRZ
1 Creating a sample
order manually
2 Searching for
samples
4 Deleting a test
from a sample
5 Managing sample
comments
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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Routine tasks 59
2 Routine tasks
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
60 Working with samples
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Routine tasks 61
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
62 Working with samples
! 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
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! 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
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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.
A
D
B
2 Routine tasks
A Sample group box B Test selection group box C Tests table D Patient group box
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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).
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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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.
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.
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
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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.
4
4 From the drop-down list, choose a test or a profile and
confirm with the Apply button.
2 Routine tasks
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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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
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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)
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B
C
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
• First name
Samples table Contains all sample orders matching the selected filter
criteria, as described above.
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Tests table List the details of tests for a selected sample order.
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.
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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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C D
A Samples table B Tests table C Sample comments table D Test comments table
2 Routine tasks
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Samples table Contains all sample orders matching the selected filter
criteria, as described above.
Tests table Lists all tests for a sample order selected in the samples
table.
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.
! 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.
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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2
2 In the samples table, right-click the appropriate
sample and choose the Show sample history
command.
example:
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Top table Displays the validation status and the location of the
sample.
Bottom table Displays the sample order history that includes the
following information for each event:
• Instrument and location
• Event date and time
• Description
2
2 In the samples table, right-click the appropriate
sample and choose the Show sample tracking
command.
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2
2 In the samples table, right-click the appropriate
sample and choose the Delete sample command.
2
2 In the samples table, locate the sample.
3
3 In the tests table, right-click the appropriate test and
2 Routine tasks
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2
2 In the samples table, right-click the sample and
choose the Delete sample command.
2 Routine tasks
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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
5
5 To add further comments choose the Apply button or
the OK button to close the dialog box.
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2
2 In the comments table, double-click the comment you
wish to edit.
3
3 Edit the comment and choose the OK button.
2
2 In the comments table, right-click the appropriate
comment and choose the Delete comment
command.
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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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.
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.
&DOFXODWH5DWLR
+RVW
Final result
• Test-A
• Test-B
• Test-C
• calculated Ratio
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Host
Final result
• Test-A
• Test-A
• Test-A
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.
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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.
Copy calibration
1 2 3
Four (4) ACNs assigned to copy calibration data to
calibration measurement
cobas e pack additional ACNs
2 Routine tasks
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B C
w Validation component
2 Routine tasks
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Tests table Lists all tests for a sample order selected in the samples
table.
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.
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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.
! 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
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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.
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.
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)
! 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.
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2
2 In the tests table, right-click the appropriate test and
choose the Show test details command.
u Related topics
• Viewing cobas e flow test result details after
measurement (93)
! WARNING
Incorrect test results due to validation by
unauthorized or unqualified staff
Validating test results without the necessary expertise
2 Routine tasks
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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.
Test result presentation Test results that are marked for reporting are displayed as
numeric values or as text results.
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.
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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.
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.
u Related topics
• Viewing test details (92)
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Values tab Lists details of the previous test results for the patient
with the corresponding sample order data in a table.
2
2 In the tests table, right-click the appropriate test and
choose the Show previous results command.
2 Routine tasks
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2
2 In the tests table, right-click the appropriate test and
choose the Show test history command.
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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.
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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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
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2
2 In the comments table, double-click the comment you
wish to edit.
3
3 Edit the comment and choose the OK button.
2
2 In the comments table, right-click the comment and
choose the Delete comment command.
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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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! 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?
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
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Repeating a test
You can repeat a test (if a confirmation of the result is
needed).
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
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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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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
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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! 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
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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.
! 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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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.
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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.
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! 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.
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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.
! 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
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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.
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
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! 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.
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
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
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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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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u
• Previewing a test result report (116)
• Printing a test result report (117)
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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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.
Symbol Meaning
2 Routine tasks
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118 Reporting test results
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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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.
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A
C
A Mask test (tab) / Masking profiles (tab) B Bottom table C Top table
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 check box beside the name of the
instrument, module, or submodule, you can request
masking or unmasking of the corresponding tests.
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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.
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.
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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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124 Masking and unmasking tests
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.
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
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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.
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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126 Masking and unmasking tests
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.
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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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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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.
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130 QC tasks
B
C
D
E
w QC Routine component
Filter options Enable you to determine the QC results that you want to
view.
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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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.
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132 QC tasks
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.
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Routine tasks 133
Copy QC
1 2 3
Four (4) ACNs assigned to copy QC data to additional
QC measurement
cobas e pack ACNs
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.
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
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
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Routine tasks 135
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.
Viewing QC results
The filtering functions allow quick searching through the
QC data.
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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.
Validating QC results
In the QC Routine component, you can validate QC
results.
2 Routine tasks
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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.
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
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.
4
4 In the QC results table, choose the appropriate QC
result and choose the Result details command.
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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.
! 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
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.
Result lock Indicates that the QC result has a QC error and the result
was not released manually.
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2
2 On the Control values tab, right-click the appropriate
QC result and choose the Release result command.
3
3 In the Insert comment dialog box, enter free text or
choose a pre-configured comment and confirm with
the OK button.
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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.
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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
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
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Table of contents
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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)
! 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.
! CAUTION
Archiving data
r For data archiving requirements, refer to local
regulations.
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148 Data cleanup
Data retrieval and storage Files for archiving are retrieved from the data manager by
TraceDoc every 10 minutes.
3 Data cleanup and archiving
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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)
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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150 Data cleanup
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.
reuse them.
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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
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152 Data cleanup
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
! 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.
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.
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154 Data cleanup
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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w cobas 8000 data manager Service > Service-related configuration > TSN agent tab
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
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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Data cleanup and archiving 157
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)
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158 Data archiving
! 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.
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Data cleanup and archiving 159
2
2 Choose cobas 8000 data manager System
Configuration > System configuration.
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160 Data archiving
3
3 On the TraceDoc tab, choose the Start archiving
button.
w Emergency archive
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Data cleanup and archiving 161
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.
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.
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Data cleanup and archiving 163
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)
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164 Browsing data using the TraceDocViewer
TraceDocViewer components
A C
B
3 Data cleanup and archiving
w TraceDocViewer
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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.
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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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
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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.
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.
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168 Browsing data using the TraceDocViewer
About printing
In the TraceDocViewer, choose the Print button to print
the content of the active tab.
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Data cleanup and archiving 169
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)
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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170 List of TraceDocViewer interface elements
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
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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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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172 List of TraceDocViewer interface elements
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
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.
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
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.
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
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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178 List of TraceDocViewer interface elements
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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Data cleanup and archiving 179
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
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3 Data cleanup and archiving List of TraceDocViewer interface elements
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181
Table of contents
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
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182
Table of contents
4 Software update installer (SUI)
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Software update installer (SUI) 183
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)
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
Roche Diagnostics
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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.
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Software update installer (SUI) 185
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
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186 Software update
E
B
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
Software update installer (SUI) 187
! 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
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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188 Software update
Roche Diagnostics
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Software update installer (SUI) 189
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.
Load CD Load software releases from CD, for example, if no internet connection is available.
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190 Software update
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
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Software update installer (SUI) 191
q User rights
An administrator level password is required to install
software on the control unit.
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192 Software update
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.
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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)
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.
Roche Diagnostics
cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
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)
Roche Diagnostics
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Software update installer (SUI) 195
2
2 Log on with your user name and password.
3
3 In the Software Releases panel, choose the
appropriate release.
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)
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196 Update procedures
u Related topics
• Troubleshooting (203)
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Software update installer (SUI) 197
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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.
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.
u Related topics
• Troubleshooting (203)
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Software update installer (SUI) 199
Installing software on the data manager and the control unit (case 3)
Process of performing a combined update for both data manager and control unit.
1
Install update on
data manager
2 3
Data manager update System information
successful?
Yes CU update
Control unitmandatory
update mandatory
No
5
Control unit update
successful?
Yes No
No
Yes
7 6
Retry update of
Rollback of data manager?
No control unit?
Yes
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200 Update procedures
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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.
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.
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
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.
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cobas® 8000 data manager · Software version 1.06 · Operator's Manual · Version 7
202 Update procedures
u Related topics
• Troubleshooting (203)
4 Software update installer (SUI)
Roche Diagnostics
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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)
Roche Diagnostics
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204 Troubleshooting
2
2 Check alarms for error information.
3
3 In the Alarm panel, follow the remedy measures
described.
u Related topics
• Installing software on the data manager and the
control unit (case 3) (199)
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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
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test masking - within control
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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
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
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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