Roche cobas c 311 User manual

Type
User manual
cobas c 311 analyzer
Operator’s Manual
Software version 01-09
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
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 is correct at the time of publishing. However,
Roche Diagnostics reserves the right to change this
publication as necessary and without notice as part of
ongoing product development.
Where to find information The Safety Manual contains important safety
information. You must the read the Safety manual before
operating the instrument.
The Operator’s Manual focuses on routine operation
and maintenance. The chapters are organized according
to the normal operation workflow.
The Online Help contains the content of the Operator’s
Manual and additionally:
• Troubleshooting information
• A software reference
• Configuration information
• Background information
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the instructions and safety information
before you use the instrument.
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.
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.
y Revision history
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
3
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 © 2007-2014, Roche Diagnostics GmbH.
All rights reserved.
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 purpose as mentioned above. 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.
Instrument approvals Compliance is demonstrated by the following marks:
The cobas c 311 analyzer meets the requirements of the
Directive 98/79/EC.
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and
the US.
CUS
®
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
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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 5
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
Table of contents
Publication information 2
Contact addresses 4
Table of contents 5
Intended use 7
Symbols and abbreviations 7
What is new in software version 01-09? 9
Operation
1 Overview of the instrument
About the c 311 analyzer 15
Overview of the hardware 16
Overview of the power switches 24
2 Overview of operation
Overview of the user interface 29
Using the online help 42
Overview of cobas link 48
Overview of the main workflow 55
Quick start guide 56
3 Before operation
Starting from Sleep mode 63
Starting from power-off 70
Troubleshooting system alarms 74
Preparing the analyzer for operation 75
Measuring patient samples 86
4 Reagents
About positions of reagents 91
About statuses of reagents 94
Loading reagent packs 97
Unloading reagent packs 100
Changing ISE reagents 102
Changing sample probe detergents 107
Changing cell detergents 108
Performing a cell detergent prime 110
Defining reagent level alarms 111
5 Calibration
About calibration 117
About calibration methods 118
About recommended calibration 120
About manual calibration 122
Performing recommended calibration 123
Performing manual calibration 125
Checking calibration results 128
Assigning non-barcoded calibrators to
sample disk positions 129
6 Quality control
About quality control (QC) 133
Performing QC for individual tests 137
Performing QC after calibration 140
Performing QC for individual standby
reagents 142
Checking QC results 145
About the handling of QC results 146
Workflows for handling and deleting QC
results 148
Assigning non-barcoded controls to disk
positions 154
7 Orders and results
Workflow for sample processing 159
Ordering tests 161
Loading samples 166
Processing samples 170
Working with sample results 178
Processing reruns 187
Processing open test requests 192
Unloading samples 202
About barcodes 204
8 After operation
Preparing the analyzer for switching off 211
Switching off the analyzer 213
9 Overview of maintenance
Maintenance definitions 221
About Maintenance mode 222
About maintenance pipes and
maintenance pipe functions 225
Checking maintenance due time 233
Checking maintenance status 234
Requesting the Maintenance Report 235
List of maintenance items 237
List of maintenance checks 239
List of spare parts and replacement
intervals 240
10 Periodic maintenance
List of maintenance tasks 245
Daily maintenance 247
Weekly maintenance 256
Monthly maintenance 262
Every two months maintenance 279
Every three months maintenance 284
Every six months maintenance 292
6 Table of contents
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
11 Maintenance as required
Checking and draining the vacuum tank 311
Replacing the sample probe 313
Eliminating clogging of the sample probe 319
Replacing the reagent probe 321
Eliminating clogging of the reagent probe 327
Replacing nozzle tips on cell rinse nozzles 329
Eliminating clogging of the cell rinse
nozzles 332
Appendix
12 Specifications
System specifications 339
Analytical specifications 342
List of sample containers 346
List of barcode specifications 347
13 Glossary
Index 351
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
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Intended use
The cobas c 311 analyzer is an automated, software-
controlled system for clinical chemistry analysis. It is
designed for both quantitative and qualitative in vitro
determinations using a large variety of tests for analysis.
The cobas c 311 analyzer performs photometric assays
and ion-selective electrode measurements and uses
serum/plasma, urine, CSF and supernatant sample types.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the
following product names and abbreviations are used.
Symbols used in the publication
Abbreviations The following abbreviations are used.
Product name Abbreviation
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 01-09 · Operator's Manual · Version 3.0
8
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 01-09 · Operator's Manual · Version 3.0
9
What is new in software version 01-09?
Short description of all major changes in this version.
Detergent for the incubator bath Hitergent is replaced by Ecotergent. This detergent is
indicated as BathDet (water bath detergent) in the
instrument software.
New ISE calibration scheme ISE compensator is replaced by the use of a second
aliquot of ISE Standard High for the purpose of ISE
compensation at full calibration.
The use of ISE Standard High (S3) improves the stability
of ISE results by eliminating the variation that comes with
the target value assignment of a serum based ISE
compensator. It further eliminates the necessity to enter
new compensator target values for new lots, since the
target values in ISE Standard High (S3) are fixed and lot-
independent.
ISE calibration curves It is possible to inactivate one of the two ISE calibration
curves, for example, ISE-B.
In the ISE Calibration Setting dialog box select the
same calibration curve type for all sample types to
inactivate the second ISE calibration curve.
The inactivated ISE calibration curve is deleted on the
following Calibration dialogs:
• Status submenu
• Calibration Trace dialog box
• Instrument Factor dialog box
• Start Up Setting dialog box
The inactivated ISE calibration curve cannot be applied
and the analyzer does not recommend a calibration for
this test.
u Setting up individual calibration curves for each ISE
sample type (618)
ISE volume reset The button for resetting the ISE reagent volume has been
moved from Reagent > Setting to Reagent > Status.
ISE.E and ISE.N alarms If the ISE.N or ISE.E data alarm is attached to one of the
ISE tests, the analyzer attaches this data alarm to all ISE
results for this sample.
Calibrator update New pop-up messages (Confirmation dialog boxes)
during calibrator update are implemented and previously
existing messages are modified.
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
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Media Eject The Media Eject button is moved from the System
Overview menu to the global buttons.
Windows 7 support This software version can be installed on a control unit
running Windows 7 or Windows XP as operating system.
If the control unit uses Windows 7, cobas link must also
run under Windows 7.
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
Operation
1 Overview of the instrument ................................................................................ 13
2 Overview of operation........................................................................................... 27
3 Before operation ..................................................................................................... 61
4 Reagents.................................................................................................................... 89
5 Calibration...............................................................................................................115
6 Quality control .......................................................................................................131
7 Orders and results................................................................................................157
8 After operation ......................................................................................................209
9 Overview of maintenance..................................................................................219
10 Periodic maintenance.........................................................................................243
11 Maintenance as required ..................................................................................309
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
13
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. . . . . . . . . . . . . . . . . . . . . . . . 15
Overview of the hardware . . . . . . . . . . . . . . . . . . . . . . . 16
Top view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Front view with open front door . . . . . . . . . . . . . . . 20
Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Overview of the power switches. . . . . . . . . . . . . . . . . . 24
Main circuit breaker. . . . . . . . . . . . . . . . . . . . . . . . . 24
Power and maintenance switches . . . . . . . . . . . . . 25
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
14
Table of contents
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
About the c 311 analyzer 15
About the c 311 analyzer
The cobas c 311 analyzer is an automated system for
qualitative and quantitative in vitro diagnostics. The
electrometric (ion-selective electrode/ISE) and the
photometric measurement 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
B
A
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
16 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.
u
• Top view (16)
• Front view (18)
• Front view with open front door (20)
• Rear view (22)
Top view
You can access most of the components of the analytical
unit from the top when opening the top cover.
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.
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 01-09 · Operator's Manual · Version 3.0
Overview of the hardware 17
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 01-09 · Operator's Manual · Version 3.0
18 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.
A Touchscreen monitor D Personal computer
B Keyboard/mouse E Cooling unit
C Height adjusting lever F Front door
A
B
C
D
E
F
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
Overview of the hardware 19
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.
Printer (optional) If a printer is connected, you can print the results.
Cooling unit The cooling unit cools the reagent packs in the
refrigeration compartment.
Front door Some components of the analytical unit are located
behind the front door.
1 Overview of the instrument
Roche Diagnostics
cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0
20 Overview of the hardware
Front view with open front door
You have to open the front door to access some
components of the analytical unit.
Reagent syringe The reagent syringe controls the pipetting of reagent to
the reaction cells.
Sample syringe The sample syringe controls the pipetting of sample to
the reaction cells.
ISE sipper syringe The ISE sipper syringe controls the pipetting of diluted
samples from the reaction cells and the pipetting of ISE
reagents to the ISE unit.
A Reagent syringe E Cell cleaner II
B Sample syringe F Alarm volume knob
C ISE sipper syringe G Water tank
D Cell cleaner I H Drain tube of the vacuum tank
A
B
C
D
E
F
G
H
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Roche cobas c 311 User manual

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User manual

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