cobas
®
pro integrated solutions
<ISE | c503 | e801>
User Guide
Publication version 1.1
Software version 01-02
2
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Publication information
Publication version Software version Revision date Change description
1 01-01 2018-09 First version
1.1 01-02 2019-03 Numerous minor additions and improvements
u What is new in publication version 1.1 (14)
y Revision history
Edition notice
This publication is intended for operators of cobaspro
integrated solutions.
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 User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Configuration information
• Background information, for example, about analytical
principles
The Safety Guide contains important safety information.
You must read the Safety Guide before operating the
system.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow.
The Quick Reference Guide gives a brief introduction
to important routine tasks and daily maintenance.
The cobas
®
e‑library provides access to important
updates, Method Sheets, Value Sheets, and other
important documents from Roche.
The PC manufacturer’s manual contains all information
about the control unit hardware.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Privacy notice
User Assistance is also available online on the internet.
You can use it independently from the instrument on
computers or mobile devices with a current HTML5
browser. To obtain the appropriate links and usage
information, contact your Roche representative.
When you use User Assistance online, viewing events
(topics viewed and searches performed) and IP
addresses are logged.
The data collected is for Roche internal use only and is
never forwarded to third parties. It is anonymized, and
after one year it is automatically deleted.
Viewing events are analyzed to improve User Assistance
content and search functionality. IP addresses are used
to classify regional behavior.
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 system 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.
Copyright
© 2018–2019, Roche Diagnostics GmbH.
All rights reserved.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
License information
cobaspro integrated solutions is protected by contract
law, copyright laws, and international treaties.
cobaspro integrated solutions is licensed for use
between Roche Diagnostics GmbH and a licensee, and
only authorized users there under are permitted to
access and use the software. Unauthorized use and
distribution may result in civil and criminal penalties.
License agreement for UltraVNC software
UltraVNC is a piece of free software for all commercial
uses, which is 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pro integrated solutions might contain
components or systems that are open source or
commercial software. For copyright and other notices
and licensing information regarding such software
programs included with cobaspro integrated solutions
please see the following license notifications and
licenses.
The product and cobaspro integrated solutions as a
whole may form a regulated device in accordance with
the applicable laws – please refer to the User Guide and
the labeling for details. Please note that the respective
authorization in accordance with the applicable laws
lapse in case of any unauthorized changes to cobaspro
integrated solutions.
Trademarks
cobas
®
pro is a trademark and the cobas
®
pro logo is a
trademark of Roche.
Other product names and trademarks are the property of
their respective owners.
5
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
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 Service
representative, should you have any such feedback.
Approvals
cobaspro integrated solutions 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 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.
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.
Compliance is provided by means of the Declaration of
Conformity.
The following marks demonstrate compliance:
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.
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
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.
Contact addresses
Inside 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
Authorized
representative
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Outside the European Union and
EFTA member states
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
7Table of contents
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Table of contents
Publication information 2
Contact addresses 6
Intended use 10
Symbols and abbreviations 10
What is new in publication version 1.1 14
Safety
1 Safety
Safety classifications 21
Safety precautions 22
Warning messages 25
Caution messages 35
Notices 37
Product safety labels 39
Safety information for barcode readers 55
Safety interlock 58
Safety information for disposal 61
System overview
2 Overview of the system
About the system 67
Overview of laboratory IT setup 69
About racks and sample containers 74
Sample handling 82
Barcodes on samples 88
3 Overview of the instrument
About the control unit 95
About the sample supply unit 97
About the sample buffer 103
About the ISE analytical unit 105
About the c503 analytical unit
117
About the e801 analytical unit
132
About rack flow 152
About rack priority 157
Optional components 161
4 Overview of the user interface
About the screen areas 165
About the user interface 172
About the status colors 174
Navigating in the user interface 175
About the Alarm dialog box 176
Printing reports 178
List of symbols on reports 180
Taking a screenshot 181
List of system modes 182
About Rack Reception mode 184
Finding help 186
About the User Assistance 188
Searching for QC Value Sheets on the
cobas e‑library
200
5 Overview of reagents and consumables
About reagents and consumables– ISE and
c503
205
About reagents and consumables– e801
211
Quick reference: Reagents and consumables
- ISE 215
Quick reference: Reagents and consumables
– c503
218
Quick reference: Reagents and consumables
– e801
222
6 Specifications
Specifications – system 227
Specifications – control unit 232
Specifications – sample supply unit and
sample buffer 234
Specifications – ISE 236
Specifications – c503
237
Specifications – e801
240
Operation
7 Before operation
Logging on to the system 247
Checking for system alarms 248
About pre-routine 249
Updating software components 251
Replacing reagents and consumables 252
Downloading required parameters 275
Performing recommended maintenance 277
Performing calibration and QC 279
Quick reference: Pre-routine workflow 286
Quick reference: Replacing reagents 289
8 During operation
Running patient samples 295
Prioritizing a sample 308
Checking test results 309
Unloading a sample ahead of schedule 314
Unloading racks from the sample supply unit 315
Loading reagents during operation 317
Manually masking and unmasking reagents,
tests, and analytical units 320
Performing calibration 325
Performing QC 330
Quick reference: Running patient samples 334
Quick reference: Checking test results 336
Quick reference: Performing calibration 337
Quick reference: Performing QC 339
9 After operation
About stopping the system 343
Stopping operation 344
Stopping operation after the current run 345
Logging off from the system 346
8 Table of contents
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Quick reference: Post-routine workflow 347
10 Non-routine operation
Orders and results 353
Reagent management 374
Calibration 396
QC 422
Powering the system on or off 438
Saving and backing up data 454
Overview of masking functions 468
Working with a lab automation system 472
Maintenance
11 Overview of maintenance
Maintenance definitions 479
About self-operating maintenance 481
Moving internal sample data to storage
media 484
About system modes for maintenance 485
Canceling maintenance actions 490
About maintenance pipes and maintenance
pipe functions 491
Creating a maintenance type 497
Checking the maintenance due time 500
Checking the maintenance status 501
Creating a maintenance report 502
List of software maintenance actions 504
List of cleaning solutions 511
List of spare parts and replacement intervals 512
List of maintenance videos 514
12 Maintenance
List of maintenance intervals 521
Maintenance logs 523
Daily maintenance 528
Weekly maintenance 533
Every 2weeks maintenance 535
Monthly maintenance 560
Every 3months maintenance 578
Maintenance as required 584
Troubleshooting
13 Introduction to troubleshooting
General troubleshooting information 649
About data alarms and system alarms 651
Data problems without alarm 653
Problems loading reagent packs 657
Problem with a liquid level sensor fixed to
low voltage 663
14 Data alarms
List of data alarms 669
Data alarms for tests 673
Calibration data alarms 710
QC data alarms 722
List of data alarms that generate an
automatic rerun test 726
Configuration
15 System settings
Adding a user 733
List of access rights 735
Rack ranges 741
Test keys and test profiles 750
Reagent warning levels 754
Configuring filters for results 756
About non-24/7 operation 757
16 Application-related settings
Setting up a test 761
Setting up special reagents, diluents, and
wash solutions 782
Updating an application 784
Deleting an application 788
Analytical principles
17 Measurement technology
About ISE technology 793
About photometric technology 798
About the ECL technology 803
18 Test principles
About test principles - ISE 813
About photometric test principles - c503
815
About sample index principles 831
Overview of immunology principles - e801
835
About limit of detection and limit of
quantitation 842
19 Calibration principles
About calibration of ISE tests 845
About calibration of photometric tests 849
Calibration of immunology tests 876
20 Rules for attaching data alarms
About data alarm rules for photometric tests 887
Index
Glossary
9
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
10
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Intended use
The cobaspro integrated solutions is an in-vitro IVD
device used for the quantitation of clinical chemistry,
immunochemistry and Ion Selective Electrolyte
parameters from various biological fluids.
• The system is an in-vitro diagnostic (IVD) medical
equipment.
• The system is not intended to be used for screening
of blood donations.
Intended users
The cobaspro integrated solutions is intended to be
used by trained laboratory technicians.
Symbols and abbreviations
Product names
Except where the context clearly indicates otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobaspro integrated solutions
system
cobaspro ISE analytical unit
ISE analytical unit
cobasc503 analytical unit c503 analytical unit
cobase801 analytical unit e801 analytical unit
cobascpack green
reagent pack
cobasepack green
reagent pack
cobaseflow cobaseflow test
SonicWash sonic wash station
cobas
®
e‑library cobas e‑library
cobas
®
e‑services cobas e‑services
cobas
®
link cobaslink
Sample Cup standard cup
Micro-Sample Cup micro cup
Sample Cup Micro 13/16 micro cup
Roche Standard False Bottom
Tube
false bottom tube
Sarstedt False Bottom Tube Sarstedt false bottom tube
Sarstedt S-Monovette K2 EDTA Sarstedt S-Monovette tube
Sarstedt Micro Tube micro tube
AssayTip tip
AssayCup cup
y Product names
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Product name Descriptor
AssayTip/AssayCup tray tip and cup tray
WasteLiner solid waste box
y Product names
Symbols used in the publication
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 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)
Status indicator is on
Status indicator is flashing
Status indicator is off
Home tab: View the home screen of the User
Assistance
Search tab: Find matching topics in the User
Assistance
System explorer tab: Navigate visually through
the system
Interactive help tab: Use the guided, interactive
help to resolve specific problems
y Symbols used in the publication
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Symbol Explanation
Maintenance tab: Perform maintenance
actions
History tab: Show previously viewed topics
again
Favorites tab: Select topics that have been
added to the favorites list
Zoom button: Enlarge images and videos in the
User Assistance
Play button: Play videos in the User Assistance
y Symbols used in the publication
Symbols used on products
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
Abbreviations
The following abbreviations are used:
Abbreviation Definition
Abs. Absorbance units
ACN Application Code Number
ANSI American National Standards Institute
AU Analytical unit
CC CleanCellM, wash solution for
measuring cells after measurement
CDC Closed Development Channel
y Abbreviations
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Abbreviation Definition
CFAS Calibrator for automated systems (also
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 water
EFTA European Free Trade Association
EN European standard
EU European Union
FBT False bottom tube
ICVC Initial cassette volume check
IEC International Electrical Commission
IS ISE Internal Standard solution
ISE Ion-selective electrode
ISEhigh ISEStandardHigh, used as calibrator2
ISElow ISEStandardLow, used as calibrator1
ISES3 ISE standard, used as calibrator3
according to ISE package insert
IVD In-vitro diagnostic
LAS Laboratory automation system
LED Light-emitting diode
LIS Laboratory information system
LLD Liquid level detection
n/a Not applicable
NACL NaCl solution, used as diluent
NaOHD Wash solution for reagent probes and
reaction cells (D1)
PC ProCellIIM, signal generating buffer
solution for the ECL detection
QC Quality control
RCM Reaction calculation mode
REF ISE Reference Electrolyte solution or
reference electrode
RFID Radio-frequency identification
SB Sample buffer
SCCS Special Cell Cleaning Solution
SD Standard deviation
SMS Selective Mode Solution, a wash
solution for reagent probes and reaction
cells (D2)
SSU Sample supply unit
STAT Short turn-around time
y Abbreviations
14
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Abbreviation Definition
SW Software
SysClean ISE Cleaning Solution/SysClean
WEEE Waste Electrical and Electronic
Equipment
y Abbreviations
u Related topics
• Overview of the User Assistance (188)
What is new in publication version 1.1
New topics
The following topics have been added since the last
publication:
u About rack stickers for rack ID ranges (76)
u About transport lines (152)
u List of symbols on reports (180)
u Taking a screenshot (181)
u Moving internal sample data to storage media (484)
u Problem with a liquid level sensor fixed to low
voltage (663)
u About sample containers for whole blood samples
(773)
u Using Sarstedt S-Monovette tubes for the HbA1c test
(773)
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Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Corrections and improvements
Feedback from different sources has been implemented,
including text corrections, terminology changes, and
graphic corrections.
• Table footnotes have been replaced by text within
table cells where possible.
• Part Troubleshooting has been slightly restructured
for alignment between User Guide and User
Assistance.
• Additional utility films and interactive help procedures
have been integrated in the User Assistance
• The glossary has been included. Blue links to the
corresponding glossary definition have been inserted
at the most important places in the text.
Hardware changes
Several illustrations have been revised to reflect
hardware changes, for example:
• Tubings at the water container
• ISE top cover
• c503 reagent manager
• c503 solenoid valve (below reaction disk)
• Instrument labels (rear and side views)
Software features
Descriptions of software features have been revised:
• Update of software components
• Auto calibration
• Support for Sarstedt S-Monovette tubes
• Preventive maintenance and interactive maintenance
• Reinstalling applications after deletion
u Updating software components (251)
u Ordering a calibration for an AutoCal reagent (404)
u Using Sarstedt S-Monovette tubes for the HbA1c test
(773)
u Maintenance definitions (479)
u Deleting an application (788)
16
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
19
Table of contents
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
Safety
In this chapter
1
Safety classifications............................................................. 21
Safety precautions................................................................. 22
About operator qualification................................... 22
About safe and proper use of the system ......... 22
About environmental conditions........................... 23
About installation and deinstallation................... 24
Warning messages................................................................ 25
Biohazardous materials ............................................ 25
Waste............................................................................... 27
Results............................................................................. 28
Electrical safety............................................................ 32
Software and data security...................................... 33
Caution messages ................................................................. 35
Mechanical safety....................................................... 35
Reagents and working solutions........................... 36
Notices ....................................................................................... 37
Spillage ........................................................................... 37
Mechanical overload ................................................. 37
Third-party software .................................................. 38
Product safety labels............................................................. 39
List of product safety labels.................................... 39
Product safety labels – sample supply unit....... 41
Product safety labels – sample buffer................. 42
Product safety labels – ISE ...................................... 43
Product safety labels – c503 .................................
45
Product safety labels – e801 .................................
48
Safety information for barcode readers......................... 55
About the laser barcode reader ............................ 55
About the LED barcode readers ........................... 56
Safety interlock ....................................................................... 58
1 Safety
20
Table of contents
Roche Diagnostics
cobas
®
pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1
About safety interlock of covers............................ 58
Using maintenance mode – c503 .......................
59
Safety information for disposal......................................... 61
Disposal information.................................................. 61
1 Safety
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Roche cobas c 503 User guide
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