cobas
®
8000 modular analyzer
series
Operator’s Manual – Version 5.4
Software Version 06-07
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
2
Publication information
Edition notice This publication is intended for operators of the
cobas
®
8000 modular analyzer series.
Publication
version
Software version Revision date Change description
1.0 01–01 2009-06 First version
2.0 02–01 2010-01 e 602 module added
3.0 03–01 2010-10 c 702 module added
4.0 04–01 2013-04 General update including, by way of example:
o New software features such as review of calibrator status,
PT link, rack unloading, change rack priority, reagent
cassette masking
o Revised software features such as download of
applications, calibrators, and QC material
o Hitergent was replaced by EcoTergent
4.0.1 04–01 2013-05 Manual cleaning revised
4.0.2 04–01 2013-06 Cleaning of pipetter probes revised
4.1 04–02 2013-11 o Changed ISE measuring ranges
o Use of different sample tubes on a rack
o Other changes and corrections
4.2 05–01 2014-10 New software features added
u What is new in publication version 4.2? (22)
5.0 06–02 2016-05 Publication redesigned according to the new Roche
documentation concept.
e 801 module added.
u What is new in publication version 5.0? (22)
5.1 06–03 2016-10 o Inclusion of information on the ISE support box
o Inclusion of the addendum "Cleaning rack trays"
o New section about fluorinated greenhouse gas
o Updated cobas link information
o Minor changes throughout the document
u What is new in publication version 5.1? (21)
5.2 06–05 2017-12 o Inclusion of the addendum "Sample foam detection"
o Inclusion of the addendum 1.0 to Operator’s Manual
version 5.1 (specifications of radio equipment)
o Minor changes throughout the document
u What is new in publication version 5.2? (21)
5.3 06–06 2018-12 o Inclusion of the addendum 1.0 to Operator's Manual
version 5.2 (instrument approvals)
o Inclusion of the addendum 1.0 to Safety Guide version 5.2
(cyber security)
o Inclusion of information on extended power off for 2-17
days procedure
o Minor changes throughout the document
u What is new in publication version 5.3? (20)
5.4 06–07 2019-10 o Warning message in Safety guide added about sharps,
rough edges, and/or moving parts.
u What is new in publication version 5.4? (20)
y Revision history
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
3
The cobas
®
8000 modular analyzer series is composed of
2 main components:
• The instrument includes the analytical modules, the
control unit, and other core components.
•The cobas
®
8000 data manager consists of a PC
which coordinates data in real time between the
instrument and the host.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.
Where to find information The Online Help contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
instrument.
The Quick Reference Guide provides you with an
overview of pre-routine and routine tasks on the data
manager and instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
A separate Operator’s Manual is available for the
cobas
®
8000 data manager.
The PC manufacturer’s manual contains all information
about the control unit hardware.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
4
!
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the system and safety information before you
use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not
described in this publication.
r Store all publications in a safe and easily retrievable
place.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Screenshots The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Copyright © 2007–2019, Roche Diagnostics GmbH.
All rights reserved.
License information
cobas
®
8000 modular analyzer series software is
protected by contract law, copyright law, and
international treaties. cobas
®
8000 modular analyzer
series contains a user license between F. Hoffmann-La
Roche Ltd. and a license holder, and only authorized
users may access the software and use it. Unauthorized
use and distribution may result in civil and criminal
penalties.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
5
License agreement for UltraVNC software and
Linux Kernel
UltraVNC and Linux Kernel are pieces of free software for
all commercial uses, which are installed on the control
unit PC.
You can redistribute the software and/or modify it under
the terms of the GNU General Public License (version 2 or
later), as published by the Free Software Foundation. A
copy of the GNU General Public License (version 2) is
stored on the control unit PC. The path for the license is
C:\Program Files\uvnc bvba\UltraVNC.
The software is distributed without warranty. There is no
implied warranty of merchantability or fitness for a
particular purpose. For more information, see the GNU
General Public License at http://www.gnu.org/licenses.
The source code for the software is stored on the control
unit PC. The path for the source code is
C:\DriversAndTools\UltraVNC.
Open Source and Commercial Software
cobas
®
8000 modular analyzer series may include
components or modules of commercial or open-source
software. For further information on the intellectual
property and other warnings, as well as licenses
pertaining to the software programs included in
cobas
®
8000 modular analyzer series, refer to the
electronic distribution included with this product.
This open source and commercial software and
cobas
®
8000 modular analyzer series as a whole can
constitute a device regulated in accordance with
applicable law. For more detailed information, refer to the
user documentation and labeling.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to cobas
®
8000 modular
analyzer series.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS E, COBAS INTEGRA, and LIFE
NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback Every effort has been made to ensure that this publication
fulfills the intended purpose. All feedback on any aspect
of this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
6
Approvals
The cobas
®
8000 modular analyzer series meets the
requirements laid down in:
Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices.
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
To view the full text of the 2014/53/EU declaration of
conformity, go to the Roche DiaLog Global Web Site
(https://dialog1.roche.com/) and choose the eLabDoc
link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
Directive 2011/65/EU of the European Parliament and of
the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.
Compliance is provided by means of the Declaration of
Conformity.
The following marks demonstrate compliance:
Instrument approvals Furthermore, the instrument is manufactured and tested
according to the following international safety standards:
• IEC 61010-1
• IEC 61010-2-101
The instrument complies with the emission and immunity
requirements described in standard IEC 61326-2-
6/EN 61326-2-6.
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC on in vitro
diagnostic medical devices
Issued by Intertek for Canada and the US.
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
7
Contact addresses
Inside the European Union and
EFTA member states
Outside the European Union and
EFTA member states
Manufacturer of the
instrument
Hitachi High-Technologies
Corporation
1-24-14 Nishi-Shimbashi
Minato-ku Tokyo 105-8717
Japan
Manufacturer of
cobas
®
8000 data
manager
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
8
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
9
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
10
Table of contents 11
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
Table of contents
Publication information 2
Contact addresses 7
Table of contents 11
Intended use 17
Symbols and abbreviations 17
What is new in publication version 5.4? 20
What is new in publication version 5.3? 20
What is new in publication version 5.2? 21
What is new in publication version 5.1? 21
What is new in publication version 5.0? 22
What is new in publication version 4.2? 22
Operation
5 Overview of the system
About the system 29
About the data manager 32
About the control unit 33
About the core components 35
About the cobas
®
ISE module 45
About the cobas c 701 module 58
About the cobas c 702 module 73
About the cobas c 502 module 92
About the cobas e 801 module 108
About the cobas e 602 module 129
6 Overview of operation
Overview of the user interface 149
Using the help system 162
Overview of cobas
®
link 168
7 Before operation
Quick reference: Main workflow 179
Starting the instrument 183
Troubleshooting system alarms 206
Preparing the instrument for operation 207
Measuring samples 221
8 Reagents
About reagent statuses 229
Working with reagent masking 232
Reagents of the ISE module 236
Reagents of the c 701 module 246
Reagents of the c 702 module 260
Reagents of the c 502 module 284
Reagents and consumables of the e 801
module 299
Reagents and consumables on the e 602
module 349
9Calibration
Calibration 373
Calibrating tests on the ISE and cobas c
modules 392
Calibrating tests on the cobas e modules 396
10 Quality control
About quality control (QC) 407
About QC types 409
Performing routine QC 411
Performing QC for standby reagents 413
Performing timeout QC 415
Performing QC after calibration 417
Performing manual QC 419
Checking QC results 421
Deactivating tests for QC material 423
Assigning non-barcoded QC material to rack
positions 424
Unloading auto QC racks from the auto QC
compartment 426
11 Orders and results
About sample processing 431
About data distribution 432
About barcode and non-barcode mode 434
Switching between barcode and non-barcode
mode 436
About the Rack Reception mode 438
Ordering tests 439
Working with barcodes 448
Loading samples 451
Processing samples 462
Working with sample results 470
Processing rerun tests 484
Unloading samples manually 489
About the Calibration Review submenu 490
12 After operation
Performing manual finalization on cobas e
modules 495
Performing data backup and archiving 498
Preparing the instrument for powering off 510
Powering off the instrument 511
13 Special operation
Overview of masking functions 527
Operating with a pre-analytical system 530
Operating the instrument in backup operating
mode 533
12 Table of contents
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
Maintenance
14 Overview of maintenance
Maintenance definitions 543
About performing maintenance 545
About modes for maintenance 546
About maintenance pipes and maintenance
pipe functions 558
Checking maintenance due time 567
Checking maintenance status 568
Requesting the maintenance report 569
List of maintenance actions 572
List of maintenance checks 577
List of maintenance schedules for all
modules 581
List of cleaning solutions 584
List of spare parts and replacement
intervals 585
List of maintenance videos 587
15 Maintenance of the core unit and the MSBs
List of maintenance actions on the core unit and
the MSBs 591
Daily maintenance of the core unit and the
MSBs 592
Monthly maintenance of the core unit and the
MSBs 594
Maintenance as required on the core unit and
the MSBs 599
16 Maintenance of the ISE module
List of maintenance actions on the ISE
module 607
Daily maintenance of the ISE module 609
Weekly maintenance of the ISE module 618
Monthly maintenance of the ISE module 621
Every 2 months maintenance of the ISE
module 628
Quarterly maintenance of the ISE module 634
Every 6 months maintenance of the ISE
module 640
Maintenance as required on the ISE
module 644
17 Maintenance of the c 701 and c 702 modules
List of maintenance actions on the c 701 and
c 702 modules 663
Daily maintenance of the c 701 and c 702
modules 665
Weekly maintenance of the c 701 and c 702
modules 673
Monthly maintenance of the c 701 and c 702
modules 684
Quarterly maintenance of the c 701 and c 702
modules 701
Every 6 months maintenance of the c 701 and
c 702 modules 706
Maintenance as required on the c 701 and
c 702 modules 712
18 Maintenance of the c 502 module
List of maintenance actions on the c 502
module 739
Daily maintenance of the c 502 module 741
Weekly maintenance of the c 502 module 748
Monthly maintenance of the c 502 module 755
Quarterly maintenance of the c 502
module 773
Every 6 months maintenance of the c 502
module 777
Maintenance as required on the c 502
module 783
19 Maintenance of the e 801 module
List of maintenance actions on the e 801
module 791
Daily maintenance of the e 801 module 793
Every 2 weeks maintenance of the e 801
module 798
Maintenance as required on the e 801
module 820
20 Maintenance of the e 602 module
List of maintenance actions on the e 602
module 845
Daily maintenance of the e 602 module 846
Weekly maintenance of the e 602 module 850
Every 2 weeks maintenance of the e 602
module 866
Quarterly maintenance of the e 602
module 870
Maintenance as required on the e 602
module 876
Table of contents 13
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
Appendix
21 Specifications
General specifications 895
Specifications of the control unit 901
Specifications of the core components 902
Specifications of the ISE module 904
Specifications of the cobas c modules 906
Specifications of the cobas e modules 909
List of available accessories and
consumables 912
Specifications of barcodes 922
22 Glossary
Index 931
14 Table of contents
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
Table of contents 15
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
16 Table of contents
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
17
Intended use
The cobas
®
8000 modular analyzer series is a fully
automated random-access software-controlled system
for immunoassays and photometric analysis intended for
qualitative and quantitative in vitro determinations using a
wide variety of tests.
The cobas
®
8000 modular analyzer series is an in vitro
diagnostic (IVD) medical equipment.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Symbols used in the publication
Product name Descriptor
cobas
®
8000 modular analyzer
series
System
cobas
®
8000 data manager
Data manager
cobas
®
ISE module
ISE module
cobas c 702 module c 702 module
cobas c 701 module c 701 module
cobas c 502 module c 502 module
cobas e 801 module e 801 module
cobas e 602 module e 602 module
cobas c pack reagent cassette
cobas e pack reagent cassette
cobas e pack green reagent cassette
cobas e flow cobas e flow test
Self-Contained ISE Support Box ISE support box
Sample Cup standard cup
Micro-Sample Cup micro cup
Sarstedt micro tube cryo cup
AssayTip/AssayCup tray magazine
WasteLiner solid waste box
y Product names
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
y Symbols used in the publication
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
18
Symbols used on products
Abbreviations The following abbreviations are used:
f Result of an action within a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics
p Task. Used in cross-references to tasks
w
Figure. Used in figure titles and cross-
references to figures
y
Table. Used in table titles and cross-references
to tables
z
Equation. Used in cross-references to
equations
Symbol Explanation
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number
Quantity contained in the package
Quantity contained in the package
Orientation of the package during
transportation
Complies with the directive 2011/65/EU on
RoHS
y Symbols used on products
Abbreviation Definition
ACN Application Code Number
ANSI American National Standards Institute
CleanCell (CC) Wash solution for measuring cells after
measurement
y Abbreviations
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
19
CellCln1 Basic reaction cell wash solution
(NaOH-D)
CellCln2 Acid reaction cell wash solution
CFAS Calibrator for automated systems
(C.f.a.s.)
CSV Comma-separated values
CV Coefficient of variation
DIL ISE Diluent
EC European Community
ECL Electrochemiluminescence
ECO-D EcoTergent, additive to the incubation
bath to reduce surface tension
EFTA European Free Trade Association
EN European standard
ICVC Initial cassette volume check
IEC International Electrotechnical
Commission
IS ISE Internal Standard
ISE Ion-selective electrode
ISE COMP ISE Standard High, used as calibrator 3
ISE HIGH ISE Standard High, used as calibrator 2
ISE LOW ISE Standard Low, used as calibrator 1
IVD In vitro diagnostic
LED Light-emitting diode
LIS Laboratory information system
LLD Liquid level detection
MSB Module sample buffer
n/a Not applicable
NACL NaCl solution, used as diluent
NaOHD Wash solution for reagent probes and
reaction cells (D1)
ProCell (PC) Signal generating buffer for the ECL
detection
QC Quality control
RCM Reaction calculation mode
REF ISE Reference Electrolyte solution
RFID Radio-frequency identification
SCCS Additive to prevent reaction cell
carryover in long HbA1c batches (D3)
SD Standard deviation
SmpCln1 Basic sample probe wash solution
SmpCln2 Acid sample probe wash solution
SMS Wash solution for reagent probes and
reaction cells (D2)
Abbreviation Definition
y Abbreviations
Roche Diagnostics
cobas® 8000 modular analyzer series · Software Version 06-07 · Operator's manual · 5.4
20
What is new in publication version 5.4?
This section provides an overview of all major changes in
this publication and the software.
Safety Guide A warning message about Sharps, rough edges,
and/or moving parts has beed added to the Safety
guide.
What is new in publication version 5.3?
This section provides an overview of all major changes in
this publication and the software.
Safety Guide The safety precaution Bubbles or foam inside a cobas
c pack has been renamed to Bubbles or foam inside a
reagent cassette.
The description about Data security has been revised.
Instrument approvals The following standards have been deleted from the
instrument approvals:
• IEC 61010-2-081 and A1
• UL 61010-1
• CAN/CSA C22.2 No. 61010-1CAN/CSA C22.2
No. 61010-2-101CAN/CSA C22.2 No. 61010-2-081
u Instrument approvals (6)
Extended Power off and on The description for extended power-on and power-off
has been reworked.
u Powering on cobas e modules after extended power-
off (192)
u Powering off the instrument (511)
Reagent loader e 801 The description and naming of the status indicator and
reset button has been reworked.
New function, expired ProCell II M bottles are masked
automatically, has been described.
STAT Short turn-around time
SysClean ISE Cleaning Solution/Elecsys SysClean
WEEE Waste Electrical and Electronic
Equipment
Abbreviation Definition
y Abbreviations
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