Roche cobas 8000 Data Manager User manual

Category
Software
Type
User manual
cobas
®
8000 data manager
Operator's Manual version 6
Software version 1.05
cobas® 8000 data manager
Roche Diagnostics
2 Operator's Manual · version 6
Document information
Revision history
Edition notice
This Operator's Manual is for users of the cobas
®
8000 data manager, which is part of
the cobas
®
8000 modular analyzer series. The cobas
®
8000 data manager consists of a
PC which coordinates data in real time between the cobas
®
8000 instrument and the
host (usually the laboratory information system (LIS)).
Every effort has been made to ensure that all the information is correct at the time of
publishing. However, Roche Diagnostics International Ltd. reserves the right to make
any changes necessary without notice as part of ongoing product development.
Manual
version
Software
version
Revision
date
Main changes
1.0 1.0 June 2009 First version of this Operator’s Manual.
1.01 1.01 January
2010
e-module support
1.02 1.02 October
2010
Terminology: "Technical validation" changed to
"Validation", "Instrument flag" changed to "data
alarm".
User Interface: New information window system
message for software update package, buttons
changed.
Golden rule rounding implemented.
Pass-through mode: new chapter in operator
manual.
TraceDoc chapter enhanced and renamed to "Data
cleanup and archiving".
1.03
(Revision 1)
1.03 Jul-2012 Creation of standalone version of data manager
operator’s manual.
Integration of software update installer chapter.
Integration of online help content into print
version.
New glossary for standalone manual.
Update of TraceDoc chapter.
Added description of sequence mode.
Added workflows in chapter pass-through mode
and software update installer.
Version 5 1.04 Feb -2014 Restructured manual.
Added workplace overview chart in chapter
Introduction.
Updated procedures on software update, creating a
calculated test, setting up a non-Roche QC
material.
Data alarms chapter added.
Version 6 1.05 Aug-2014 Updated procedures on software update, creating a
calculated test.
U For more information on the latest changes,
see What is new in this version of the manual?
(p. 13).
Table 1 Revision history
Roche Diagnostics
Operator's Manual · version 6 3
cobas® 8000 data manager
Any customer modification to the cobas
®
8000 data manager will render the warranty
or service agreement null and void.
Intended use
The cobas
®
8000 data manager provides data and workflow management for the in
vitro diagnostic medical device cobas
®
8000 modular analyzer series.
Copyright © 2009-2014, Roche Diagnostics International Ltd. All rights reserved.
License information
The cobas
®
8000 data manager is protected by contract law, copyright laws, and
international treaties. The cobas
®
8000 data manager is licensed for use between F.
Hoffmann-La Roche Ltd and a licensee, and only users authorized there under are
permitted to access and use the software. Un-authorized use and distribution may
result in civil and criminal penalties.
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 please see the CD/ DVD provided with the product.
The product and the cobas
®
8000 data manager as a whole may form a regulated
device in accordance with the applicable laws - please refer to the installation DVD of
the cobas
®
8000 data manager software for details. Please note that the respective
authorization in accordance with the applicable laws lapse in case of any
unauthorized changes to the cobas
®
8000 data manager.
Trademarks
cobas
®
8000 data manager is a trademark and the cobas® 8000 data manager logo is a
trade-mark of Roche. Other product names and trademarks are the property of their
respective owners.
The following trademarks are acknowledged:
COBAS, COBAS C, and LIFE NEEDS ANSWERS trademarks of Roche.
All other trademarks are the property of their respective owners.
Approvals
The cobas
®
8000 modular analyzer series meets the protection requirements specified
in IVD Directive 98/79/EC. Furthermore, the cobas® 8000 data manager is
manufactured and tested according to the following international safety standards:
Compliance is demonstrated by the following labels:
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.
CUS
®
cobas® 8000 data manager
Roche Diagnostics
4 Operator's Manual · version 6
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
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cobas® 8000 data manager
cobas® 8000 data manager
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cobas® 8000 data manager
Table of contents
Document information 2
Contact addresses 4
Table of contents 7
Preface 13
Safety classification 16
Safety precautions 17
Safety summary 18
Disposal of the equipment 20
Operation data manager
1 Introduction
Introduction to the cobas
®
8000 data manager 27
The cobas
®
8000 data manager and associated
workflows 28
Start up and shutdown procedures 30
Restarting the data manager 31
The cobas
®
8000 data manager interface
(without sidebar) 32
Accessing an application from the sidebar 34
Features accessed via Sidebar 36
Working with the interface 39
2 Routine tasks
Working with samples 47
Working with tests 56
Validating test results manually 63
Results reporting 66
Masking and unmasking tests 67
QC Routine tasks 71
3 QC Configuration
Configuration of QC Parameters 79
4 Test configuration
Working with tests and reference ranges 95
Calculated tests 106
5 General configuration
Overview 113
Managing workplaces 114
Managing users 116
Configuring profiles 119
Masking profiles 121
Configuring data alarms to ‘block QC’ 123
Changing date and time 124
Synchronizing data manager with TSN agent 126
Instrument 127
Configuring SOPs 130
6 Pass-through mode configuration
Introduction 139
Using the pass-through modes 140
Pass-through mode activation 141
Pass-through mode for patient results 142
Pass-through mode for QC results and
calibration results 145
Pass-through mode data flow scenarios 146
7 Data clean-up and archiving
Introduction 153
Data retrieval and storage 154
Data clean-up 155
Uploading data to Roche 158
Data archiving 160
Data purging 163
Browsing data using the TraceDocViewer 164
TraceDocViewer reference 168
8 Software update installer
The software update installation (SUI)
process 181
Update procedures 187
Troubleshooting and recovery 196
9 Data alarms
The meaning of the data alarms 201
Alarms for Routine or STAT samples 208
Alarms for Control and Calibration samples 212
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cobas® 8000 data manager
Software description
10 Routine windows
Host backup 223
Search patient 225
Sample overview 226
Sample comment 231
Sample history 232
Sample tracking 233
Previous results 234
Test comment 235
Test history 236
Test details 237
Request dilution for test: <x> 239
Day list 240
Search criteria 245
Validation 246
Test mask overview 250
Result entry 252
System status 253
System alarms 255
System status 257
System alarm 258
11 QC routine windows
QC Routine 261
Insert comment 265
Result details 266
QC standby bottles 268
12 QC Parameter windows
QC material 271
Insert QC material 276
Copy control 278
Control history 279
Westgard rules 280
Insert Westgard rule / Edit Westgard rule 283
Westgard rules assignment 286
History 287
QC data alarm 288
QC configuration 289
Calibration method rules 290
Insert calibration method rule 291
Calibration recommendations 292
13 Routine configuration windows
Sample type 295
Edit sample type 297
Test groups 298
Insert/edit test group 300
Profiles 301
Profile 302
Assign tests 303
Profile in profile 304
Masking profiles 305
Masking profile 306
SOP configuration 307
Create popup / Popup details and assignment 308
Processing intervals 309
Processing intervals 310
14 Test configuration windows
Tests / reference ranges 315
Test / reference ranges 316
Reference range for <x> 322
Insert Action 324
Text input 325
Limits of detection 326
Component for test units 327
Test units 328
Configuring test measurement units 329
Conversion factor 331
Formula definition 332
Parameters 335
Managing formulas 336
Formula list 341
Log 343
History 344
Settings 345
Comment texts 346
Comment text groups 347
Managing comment texts 349
Comment texts 352
Comment group 353
Comment group assignment 354
15 System configuration windows
Organization 357
Organization 358
System configuration 359
Instrument 364
Tasks 367
Configuration 368
Edit configuration 369
System message 370
XML information 372
Log files 373
Log information 375
Log information per application 376
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cobas® 8000 data manager
16 Administration windows
Workplaces 379
Workplaces 380
Global properties 381
Assignment component - workplace 382
User profile 383
User ID 384
User/Workplaces 385
Assignment user - workplace 386
User / Icons 387
Assignment user - icons 388
User system rights overview 389
Copy authorizations 390
17 Service windows
Password settings 395
Password profile 396
Instrument groups 397
Edit instrument group 398
Assignment instrument group - instrument 399
Data alarms 400
Edit data alarm 401
Icons 402
Icon 403
Gender 404
Gender 405
Priorities 406
Priority 407
Sample status 408
Sample status 409
Test status 410
Test status 411
Validation status 412
Validation status 414
Service-related configuration 416
System messages overview 422
System message parameters 425
Edit parameter 426
Active level 427
Special configuration 428
System information configuration detail 430
Real time alarms configuration 431
Glossary
18 Glossary
Index
Index 439
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cobas® 8000 data manager
Preface
The cobas
®
8000 data manager implements data and workflow management
functions and provides an interface between the cobas® 8000 modular analyzer, the
host, and the Roche TeleService-Net (TSN). Through TSN it enables remote access to
and from Roche and allows information exchange. It provides enhanced sample
tracking, test management, result traceability, storage and reporting, together with
quality control and calibration management. Additionally, it has host backup
functionality and serves as a robust storage location for the instrument.
This manual provides detailed descriptions of the data manager features and
operational concepts, specific functions and administration procedures.
What is new in this version of the manual?
This section summarizes the new and changed features described in this manual.
Control material o In the QC Parameter workplace the following names are changed.
Control overview tab to QC material overview tab. Field control name to QC
material name. On the shortcut menu, Insert control material to Insert QC
material, and Delete control material to Delete QC material.
U Configuration of QC Parameters (p. 79)
Test configuration o If the value in the Symbolic name field in a calculated test is equal to a Roche or
Development Channel test number, the Roche test cannot be installed to the data
manager. An information is added to the task to enter the Symbolic name for
calculated tests according to the guidelines.
U Creating a calculated test (p. 106)
TSN agent o On the TSN agent tab of the Service-related configuration component, you can
choose new upload filters for patient results that are related to the instrument
module, for example ISE, Clinical chemistry or Immunoassay.
U Uploading data to Roche (p. 158)
TSN agent o On the TSN agent tab of the Service-related configuration component, choose
the Send IA patient results option to send the test results for all heterogeneous
immunoassays (HET-IA) to the TSN agent. If the data point upload option on the
control unit is activated, the data manager forwards the test result with the data
points to the TSN agent. The upload support the ASTM and the HL7 host
protocol. Data points can be sent from the data manager for all e-modules of the
cobas® 8000 modular analyzer.
U Sending immunoassay data points to the host (p. 158)
Forward instrument status o The Forward instrument status option is used to send information about the
instrument status and the test availability to the host automatically. The option
allows the host to know the status of the different modules and to organize the
sample orders turnaround time in the most optimal way.
U Forwarding instrument status to the host (p. 158)
cobas® 8000 data manager
Roche Diagnostics
14 Operator's Manual · version 6
How to use this manual
Q
o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use.
o This Operator’s Manual should be easily accessible at all times.
To help you find information quickly, there is a table of contents at the beginning of
the book and each chapter. In addition, a complete index can be found at the end.
Where to find information
For information on the individual components of the cobas 8000 instrument series
see:
o cobas® 8000 modular analyzer series Operator’s Manual
o cobas® 8000 modular analyzer series Online Help
o cobas
®
8000 data manager Operator’s Manual
o cobas
®
8000 data manager Online Help
Online Help
The cobas
®
8000 data manager has a context sensitive online help feature to support
you in its operation. Context sensitive means that the help system always displays
information related to the current window or software element.
The instrument software offers two help features:
o Help, accessed via menu bar: opens on title page.
o Help, accessed via F1 key: opens help page related to current window
F1 Help - This help feature displays information related to the current window. Use
the F1 Help feature if you require detailed information about this window. Hypertext
links guide you to additional information and procedures related to this window.
Q
The Operator's Manual is included in the F1 Help system. This allows you to search for
information throughout the software reference and the manual. All cross-references are
implemented as hyperlinks.
Symbols and abbreviations
Visual cues are used to help locate and interpret information in this document
quickly. This section explains formatting conventions used in this document.
Symbols The following symbols are used:
Symbol Comment
o List item
P Start of procedure
S End of procedure
Table 2 Symbols used for easy recognition of information
Roche Diagnostics
Operator's Manual · version 6 15
cobas® 8000 data manager
Abbreviations The following abbreviations are used:
U Cross-reference
f Navigation path indication
Q Tip
Safety alert
Electrical and electronic equipment marked with this symbol are
covered by the European directive WEEE.
Symbol Comment
Table 2 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 (c 701 / c 702 / c 502)
c7-1, c7-2, c7-3 First, second, third c 701 / c 702 module of the instrument
Cal., CAL Calibration
Cfas Calibrator For Automated Systems
ClinChem Clinical chemistry
CV Coefficient of Variation (%)
CU Control unit
D
DM data manager
E
e 602 cobas e 602 module for immunoassay analysis
e6-1, e6-2, e6-3 First, second, third e 602 module of the instrument
e.g. exempli gratia – for example
H
HIS Hospital information system
I
ID Identification
i.e. id est – that is to say
ISE Ion Selective Electrode; also used for ISE module
ISO International Organization for Standardization
IVD In Vitro Diagnostic
IVDD In Vitro Diagnostic Directive
L
LIS Laboratory information system
N
n/a not applicable
P
Table 3 Abbreviations
cobas® 8000 data manager
Roche Diagnostics
16 Operator's Manual · version 6
Safety classification
This section explains how precautionary information is presented in this manual.
The safety precautions and important user notes are classified according to the ANSI
Z535.6 Standard. Familiarize yourself with the following meanings and icons:
Generic hazard statements
The safety alert symbol by itself without a signal word is used to promote awareness to
hazards which are generic or to direct the reader to safety information provided elsewhere
in the document.
WARNING
Warning
r Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
Caution
r Indicates a hazardous situation which, if not avoided, could result in minor or moderate
injury.
NOTICE
Notice
r Indicates a hazardous situation which, if not avoided, could result in damage to
equipment.
Q
Tip
Indicates additional information on correct use or useful tips.
PC/CC ProCell / CleanCell, system reagents used on the e 602 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
Abbreviation Definition
Table 3 Abbreviations
Roche Diagnostics
Operator's Manual · version 6 17
cobas® 8000 data manager
Safety precautions
Generic hazard statements
Particular attention must be paid to the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is
important.
Operator qualification
Operators are required to have a sound knowledge of relevant guidelines and
standards as well as the information and procedures contained in the Operator’s
Manual.
o Do not carry out operation and maintenance unless you have been trained by
Roche Diagnostics.
o Carefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the data manager.
o Leave maintenance, installation or service that is not described in the Operator’s
Manual to Roche Service.
Safe and proper use of the data manager
Keep the Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use. It must be easily accessible at all times.
Installation o Installation must be performed by Roche Service only.
o Leave installation tasks that are not described in the Operator’s Manual to Roche
Service.
Approved parts Use of non-approved parts or devices may result in malfunction and may render the
warranty null and void. Only use parts and devices approved by Roche Diagnostics.
Third-party software Installation of any third-party software that is not approved by Roche Diagnostics
may result in incorrect behavior of the data manager. Do not install any non-
approved software.
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage may damage the data manager or lead
to data loss. Perform regular backups of measurement results. Operate only with an
uninterruptible power supply. Do not switch off power while the PC accesses the
hard disk or other storage device.
cobas® 8000 data manager
Roche Diagnostics
18 Operator's Manual · version 6
Safety summary
This safety summary contains the most important and general warning, caution, and
notice messages.
Warning messages
WARNING
List of warning messages
r Before operating the data manager, read the warning messages contained in this
summary carefully. Failure to observe them may result in death or serious injury.
Electrical safety
WARNING
Electrical shock by electronic equipment
Removing the covers of electronic equipment can cause electric shock, as there are high
voltage parts inside. In addition, opening the top cover during operation can also cause
electric shock.
r Do not attempt to work in any electronic compartment.
r Only authorized and qualified Roche personnel are to perform an installation, service
and repair of the system.
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.
Fatigue due to long hours of operation
CAUTION
Fatigue due to long hours of operation
Looking at the monitor screen over an extended period of time may lead to eye strain or
body fatigue.
r Take a break for 10 to 15 minutes every hour to relax.
r Avoid spending more than 6 hours per day looking at the monitor screen.
Roche Diagnostics
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cobas® 8000 data manager
Malfunction due to interfering electromagnetic fields
CAUTION
Malfunction of the data manager and incorrect results due to interfering
electromagnetic fields
This data manager has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
r The electromagnetic environment should be evaluated prior to operation of the device.
r Do not operate the data manager in close proximity to sources of strong
electromagnetic fields (for example unshielded intentional RF sources), as these may
interfere with the proper operation.
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 additional 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 they can be
accessed by authorized persons only.
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.
cobas® 8000 data manager
Roche Diagnostics
20 Operator's Manual · version 6
Circuit breakers and fuses
NOTICE
Damage to the data manager due to improper use
r Should one of the circuit breakers or fuses blow, do not attempt to operate the data
manager before contacting either Roche Service or technical support.
Disposal of the equipment
Disposal of control unit components
Components of your control unit (such as the computer, monitor, keyboard) which are
marked with this symbol are covered by the European Directive on Waste Electrical and
Electronic Equipment (WEEE, 2002/96/EC).
r Prior to disposal, all patient data and information must be erased according to local
regulations.
r These items must be disposed of via designated collection facilities appointed by
government or local authorities.
r For more information about disposal of your old product, please contact your city
office, waste disposal service or Roche Service.
r 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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Roche cobas 8000 Data Manager User manual

Category
Software
Type
User manual

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