Roche cobas c 311 User manual

Type
User manual
cobas c 311 analyzer
Operator’s Manual – Version 3.1
Software version 01-10
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
2
Publication information
Edition notice This publication is intended for operators of the
cobas c 311 analyzer.
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 Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
Publication
version
Software version Revision date Change description
1.0 01-01 2007-11 First version
1.1 01-04 2009-11 Addendum 3.0 implemented in Online help
2.0 01-06 2010-12 General update
3.0 01-09 2014-10 Documentation redesigned according to the new Roche
documentation concept.
Description of new software features added.
3.0.1 01-09 2016-07 Replacement pages with minor additions:
o UltraVNC licence agreement
o Electromagnetic compatibility statement
o RoHS and Content symbol explanation
3.0.2 01-09 2016-10 Replacement pages with minor additions:
o Fluorinated greenhouse gas
o Safety message for incomplete display of test results in
case the column is too narrow
3.1 01-10 2016-12 Description of new software features added (LCP3).
License information and regulatory information updated.
u What is new in publication version 3.1? (11)
y Revision history
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
3
!
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.
Images The screenshots and hardware images in this publication
have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, 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 © 2007-2016, Roche Diagnostics GmbH.
All rights reserved.
License information cobas c 311 analyzer software is protected by contract
law, copyright law, and international treaties.
cobas c 311 analyzer 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.
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.
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
4
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 c 311 analyzer 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 c 311 analyzer, refer to the
electronic distribution included with this product.
This open source and commercial software and the
cobas c 311 analyzer 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 c 311 analyzer.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, 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 use. 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.
Approvals The cobas c 311 analyzer 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.
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
The following marks demonstrate compliance:
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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The cobas c 311 analyzer complies with the emission
and immunity requirements described in the standard
IEC 61326-2-6 / EN 61326-2-6.
Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the
hermetically sealed refrigeration.
For in vitro diagnostic use.
Complies with the provisions of the applicable EU
directives.
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
CUS
®
Type
Charge weight
(kg)
CO
2
equivalent
(tonne)
Global warming
potential
R-134a 0.102 0.14 1430
y Fluorinated greenhouse gas detail
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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Contact addresses
Inside the European Union and
EFTA member states
Outside the European Union and
EFTA member states
Manufacturer of
cobas c 311
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
Manufactured by: Hitachi High-Technologies
Corporation
Manufactured for: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Table of contents 7
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
Table of contents
Publication information 2
Contact addresses 6
Table of contents 7
Intended use 9
Symbols and abbreviations 9
What is new in publication version 3.1? 11
Operation
1 Overview of the instrument
About the c 311 analyzer 17
Overview of the hardware 18
Overview of the power switches 25
2 Overview of operation
Overview of the user interface 29
Using the online help 42
Overview of cobas link 47
3 Before operation
Overview of the main workflow 57
Quick start guide 58
Starting from Sleep mode 63
Starting from power-off 70
Troubleshooting system alarms 75
Preparing the analyzer for operation 76
Measuring patient samples 88
4 Reagents
About positions of reagents 95
About statuses of reagents 98
Loading reagent packs 101
Unloading reagent packs 104
Changing ISE reagents 106
Changing sample probe detergents 112
Changing cell detergents 113
Performing a cell detergent prime 115
Defining reagent level alarms 116
5 Calibration
About calibration 121
About calibration methods 122
About recommended calibration 124
About manual calibration 126
Performing recommended calibration 127
Performing manual calibration 129
Checking calibration results 132
Assigning non-barcoded calibrators to
sample disk positions 133
6 Quality control
About quality control (QC) 137
Performing QC for individual tests 141
Performing QC after calibration 144
Performing QC for individual standby
reagents 146
Checking QC results 149
About the handling of QC results 150
Workflows for handling and deleting QC
results 152
Assigning non-barcoded controls to disk
positions 159
7 Orders and results
Workflow for sample processing 163
Ordering tests 165
Loading samples 170
Processing samples 175
Working with sample results 183
Processing reruns 194
Processing open test requests 199
Unloading samples 210
About barcodes 212
Preparing a DVD disk 217
8 After operation
Preparing the analyzer for switching off 221
Switching off the analyzer 223
Maintenance
9 Overview of maintenance
Maintenance definitions 235
About Maintenance mode 236
About maintenance pipes and
maintenance pipe functions 239
Checking maintenance due time 247
Checking maintenance status 248
Requesting the Maintenance Report 249
List of maintenance items 251
List of maintenance checks 253
List of tools, materials, and solutions 254
List of spare parts and replacement
intervals 255
10 Periodic maintenance
List of maintenance tasks 259
Daily maintenance 261
Weekly maintenance 270
Monthly maintenance 278
Every two months maintenance 295
Every three months maintenance 301
Every six months maintenance 309
8 Table of contents
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
11 Maintenance as required
Checking and draining the vacuum tank 329
Replacing the sample probe 331
Eliminating clogging of the sample probe 338
Replacing the reagent probe 340
Eliminating clogging of the reagent probe 346
Replacing nozzle tips on cell rinse nozzles 348
Eliminating clogging of the cell rinse
nozzles 351
Appendix
12 Specifications
System specifications 357
Analytical specifications 360
List of sample containers 365
List of barcode specifications 366
List of accessories and consumables 368
13 Glossary
Index 371
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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Intended use
The cobas c 311 analyzer is a fully automated, discrete
clinical chemistry analyzer intended for the in-vitro
quantitative and qualitative determination of analytes in
body fluids.
The cobas c 311 analyzer is intended to be used by
trained laboratory technicians.
The operational environment for the cobas c 311
analyzer are clinical laboratories, hospital laboratories
and commercial hospitals, as well as private laboratories.
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 c 311 analyzer analyzer
cobas c pack reagent pack
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
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.
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.
y Symbols used in the publication
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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Symbols used on products
Abbreviations The following abbreviations are used.
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
ANSI American National Standards
Institute
COBI Compendium of Background
Information
CSV comma separated values
EC European Community
EFTA European Free Trade Association
EN European standard
IEC International Electrical
Commission
IVD In vitro diagnostic
LIS Laboratory information system
n/a not applicable
QC Quality control
SBS scan before sample stop
SD Standard deviation
WEEE Waste Electrical and Electronic
Equipment
y Abbreviations
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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What is new in publication version 3.1?
Filter function for Reagent Level Check From software version 01-10 on, you can filter the
reagents by type on the Reagent Level Check window.
The filter function allows you to only display diluents and
wash solutions. This function simplifies setting the
reagent level check values for the yellow and purple
alarm.
In addition, separate reagent level check values are now
available for each diluent and wash solution.
u Defining reagent level alarms (116)
Improved Review By Exception data alarm
setting
On Utility > System > Page 4/5 > Review By
Exception, you define which data alarms prevent a test
result from being sent to the Host computer.
In version 01-10, the software has been improved so that
all data alarms are now available on the Review By
Exception window.
Data alarms for serum index checks Seven new data alarms have been implemented in
software version 01-10. These data alarms provide more
detailed information about a possibly problematic serum
condition: lipemic, hemolytic, or icteric samples, or a
combination thereof.
Former software versions attached only the generic
>Index data alarm to results generated from a lipemic,
hemolytic, or icteric sample.
Improved handling of invalid reagent packs In some cases, you must delete an application and
download it again, for example, to change the unit of
measure. You can no longer use reagent packs for this
application that were already in use on the system before
deleting the application.
u Unloading reagent packs (104)
Chapter structure The chapter structure was slightly adapted to be
consistent with other Roche publications. For example,
the chapter Specifications was moved to Part Appendix.
u Specifications (355)
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
Operation
1 Overview of the instrument ................................................................................ 15
2 Overview of operation........................................................................................... 27
3 Before operation ..................................................................................................... 55
4 Reagents.................................................................................................................... 93
5 Calibration...............................................................................................................119
6 Quality control .......................................................................................................135
7 Orders and results................................................................................................161
8 After operation ......................................................................................................219
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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Table of contents
Overview of the instrument 1
Read this chapter to get familiar with the hardware of the
instrument.
In this chapter
1
About the c 311 analyzer. . . . . . . . . . . . . . . . . . . . . . . . 17
Overview of the hardware . . . . . . . . . . . . . . . . . . . . . . . 18
Top view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Front view with open front door . . . . . . . . . . . . . . . 21
Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Overview of the power switches. . . . . . . . . . . . . . . . . . 25
Main circuit breaker. . . . . . . . . . . . . . . . . . . . . . . . . 25
Power and maintenance switches . . . . . . . . . . . . . 26
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
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Table of contents
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
Overview of the instrument 17
About the c 311 analyzer
The cobas c 311 analyzer is an automated system for
qualitative and quantitative in vitro diagnostics. The ion-
selective electrode (ISE) and the photometric
measurement unit provide a wide variety of tests.
The cobas c 311 analyzer consists of the following units:
• Analytical unit
• Control unit
A Analytical unit B Control unit
BA
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
18 Overview of the hardware
Overview of the hardware
The cobas c 311 analyzer is a standalone device. For a
smooth operation, it is important to have access to all
parts of the analyzer.
In this section
Top view (18)
Front view (20)
Front view with open front door (21)
Rear view (23)
Top view
You can access most of the components of the analytical
unit from the top when opening the top cover.
A Sampling area C ISE area
B Reaction area D Reagent area
ACDB
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
Overview of the instrument 19
Sampling area Samples are manually loaded to the sample disk. They are
scanned or placed to a manually assigned position. That
way, they are identifiable and easy to follow. From the
sampling area, samples are pipetted to the reaction or ISE
area.
Reaction area A photometric measuring system measures the
absorbance of the reaction mixture in reaction cells on
the reaction disk.
ISE area An ion-selective electrode measuring system measures
the electromotive force (EMF) in millivolts between the
electrode in the diluted sample solution and the electrode
in the reference solution. The electrodes are selective for
CL
-
, K
+
, and Na
+
.
Reagent area Reagent packs are manually loaded to the reagent disk.
They are scanned and stored in a refrigerated
compartment. From the reagent area, reagents are
pipetted to the reaction area.
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-10 · Operator's Manual · 3.1
20 Overview of the hardware
Front view
You can access most of the components of the control
unit from the front.
Touchscreen monitor The touchscreen monitor displays information. You can
navigate through the software and start the analyzer
functions.
Keyboard/mouse With the keyboard or the mouse, you can navigate
through the software and select or enter information.
Height adjusting lever If you lift the height adjusting lever, you can adjust the
height of the touchscreen monitor.
Personal computer The personal computer monitors the functions and
operational modes of the analyzer. The installed software
has a graphical user interface (GUI) that allows you to
control all analyzer functions.
A Touchscreen monitor D Personal computer
B Keyboard/mouse E Front door
C Height adjusting lever F Cooling unit
A
B
C
D
E
F
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Roche cobas c 311 User manual

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