Roche cobas 6000 core unit User manual

Type
User manual

This manual is also suitable for

cobas
®
6000 analyzer series
Operator´s Manual – Version 8.2
Software Version 06-03
cobas
®
6000 analyzer series
Roche Diagnostics
2 Operator´s Manual · Version 8.2
Publication information
Revision history
Edition notice This publication is intended for operators of the cobas 6000 analyzer series.
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:
o Routine operation
o Maintenance
o Safety
o Troubleshooting information
o A software reference
o Configuration information
o Background information
e
See The help system of the instrument on page B-15
The Operator´s Manual contains information about safety, hardware modules and
operating the system as well as maintenance and troubleshooting.
The manual Interlock function cobas c 501 with ISE describes maintenance actions
of the cobas 6000 analyzer series that can only be performed by special trained
person.
Publication
version
Software version Revision date Change description
1.0 01-01 June 2006 First version
1.1 02-01 September 2007 General update
2.0 02-01 – 02-07 March 2008 General update
3.0 03-01 June 2008 General update
4.0 04-01 February 2009 General update
5.0 05-01 March 2010 General update
5.1 05-01 April 2011 Two safety alerts added
6.0 05-02 July 2013 General update
6.0.1 05-02 March 2014 Minor changes concerning
expired reagents and controls
7.0 06-01
(a)
December 2014 General update
7.1 06-01
(a)
January 2015 Minor changes
8.0 06-01
(a)
September 2016 General update
8.1 06-02
(a) (b)
October 2017 Online Help also applies to
software version 06-02.
8.2 06-03
(a) (b) (c)
December 2018 General update including the
addendum 1.0, 2.0, and 3.0.
(a) Also valid for software version 05-02
(b) Also valid for software version 06-01
(c) Also valid for software version 06-02
Roche Diagnostics
Operator´s Manual · Version 8.2 3
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®
6000 analyzer series
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 2001-2018, Roche Diagnostics GmbH. All rights reserved.
License information cobas 6000 analyzer series software is protected by contract law, copyright law, and
international treaties. cobas 6000 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.
License agreement for
UltraVNC software
UltraVNC is a piece of free software for all commercial uses. It is installed on the
control unit PC of the cobas 6000 analyzer series.
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 6000 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 6000 analyzer series, refer to the electronic distribution included with this
product.
This open source and commercial software and cobas 6000 analyzer series as a whole
can constitute a device regulated in accordance with applicable law. For more
detailed information, refer to the user manual and labeling.
Please note that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to cobas 6000
analyzer series.
General attention
To avoid serious or fatal injury, ensure that you are familiar with the system and safety
information before you use the system.
o Pay particular attention to all safety precautions.
o Always follow the instructions in this publication.
o Do not use the instrument in a way that is not described in this publication.
o Store all publications in a safe and easily retrievable place.
cobas
®
6000 analyzer series
Roche Diagnostics
4 Operator´s Manual · Version 8.2
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS INTEGRA, ELECSYS 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 6000 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 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 with the applicable directives 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:
o IEC 61010-1
o IEC 61010-2-101
The instrument complies with the emission and immunity requirements described in
standard IEC 61326-2-6/EN 61326-2-6.
The Operator’s manual meets the European Standard DIN EN ISO 18113-3.
Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the hermetically sealed
refrigeration.
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC on in vitro diagnostic
medical devices
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the
US.
Type Charge weight (kg) CO
2
equivalent
(tonne)
Global warming
potential
R-134a 0.102 0.14 1430
Roche Diagnostics
Operator´s Manual · Version 8.2 5
cobas
®
6000 analyzer series
Contact addresses
Inside the European Union and
EFTA member states
Outside the European Union
and EFTA member states
Manufacturer of the
cobas 6000
analyzer series
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
cobas
®
6000 analyzer series
Roche Diagnostics
6 Operator´s Manual · Version 8.2
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Operator´s Manual · Version 8.2 7
cobas
®
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Table of contents
Publication information 2
Contact addresses 5
Table of contents 7
Intended use 9
Symbols and abbreviations 9
What is new in publication Version 8.2? 13
System description Part A
1 General safety information
Safety classifications A–5
Safety precautions A–6
Safety labels of the system A–22
Safety information for barcode readers A–30
Interlock function A–32
Disposal of the instrument A–33
2 Overview modules
Overview A–37
Modules of the cobas 6000 analyzer series A–38
3 Control unit, cobas link and core unit
Control unit A–47
cobas link A–49
Core unit cu 150 A–54
Trays, racks, tubes, and cups A–61
4 c 501 module
Overview A–73
Sampling area components A–76
Reagent area components A–78
Reaction disk area components A–83
Behind the front doors A–92
Rear view A–94
ISE area components A–95
5 e 601 module
Overview A–101
Reagent area components A–103
Reaction area components A–105
Pre-wash area components A–107
Consumables area components A–109
Auxiliary reagents and cleaning solutions A–112
6 Specifications
General system specifications A–117
Control unit A–124
Core unit cu 150 A–124
c 501 module A–125
e 601 module A–128
Operation Part B
7 Software basics
General description of the user interface B–5
The help system of the instrument B–15
Main menus B–24
8 Daily operation
Overview B–33
Starting the analyzer B–34
Preroutine operation B–47
Routine operation B–65
Shutting down the analyzer B–78
9 Orders and results
Overview B–83
Barcode and non-barcode mode B–84
Test Selection screen B–85
Data Review screen B–93
Calib. Review screen B–101
Tracking samples on the analyzer B–103
10 Reagents
Reagent concept – c 501 B–109
Reagent concept – e 601 B–119
Operator-related reagent management B–129
Reagent Setting screen B–130
Reagent Status screen B–135
Reagent Overview button B–146
11 Calibration
Calibration concept B–159
Calibration concept – c 501 B–162
Calibration concept – e 601 B–166
Calibration concept – masking B–169
Overview B–170
Calibration Status screen B–170
Calibration Calibrator screen B–182
Calibration Install screen B–185
System Overview screen B–198
12 QC
QC concept B–201
Overview B–206
QC Status screen B–206
QC Run Status screen B–211
QC Individual screen B–213
QC Cumulative screen B–221
QC Control screen B–222
QC Install screen B–224
Automatic QC measurement B–232
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®
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13 Extended operation
Instrument status B–237
Interlock function: Reset after stop B–239
Masking functions B–240
Backup operation B–244
Data storage B–248
14 Configuration
Application B–255
Description of application parameters B–264
System configuration B–281
Module Set B–291
Calculated Tests (c 501) B–295
Special Wash B–301
Report Format B–310
Saving system parameters B–314
Restoring system parameters B–316
Maintenance Part C
15 General maintenance
Overview C–5
Maintenance pipes C–10
Maintenance types C–18
Maintenance report C–22
Maintenance schedules C–23
Automating instrument care
with maintenance pipes C–32
Background and parallel maintenance C–35
List of maintenance items C–39
List of maintenance checks C–43
16 Maintenance cu 150
Maintenance schedule C–47
Daily maintenance C–48
Monthly maintenance C–51
Every six months maintenance C–56
As needed C–59
17 Maintenance c 501 with ISE
Maintenance schedule C–67
Periodic replacement of parts C–69
Daily maintenance C–70
Weekly maintenance C–79
Monthly maintenance C–86
Every three months maintenance C–100
Every six months maintenance C–103
As needed maintenance C–108
18 Maintenance e 601
Maintenance schedule C–119
Daily maintenance C–120
Weekly maintenance C–123
Every two weeks maintenance C–139
Every three months maintenance C–142
As needed C–145
Troubleshooting Part D
19 Data alarms
Introduction D–7
Data alarm list D–10
Data alarms c 501 (ISE) D–12
Data alarms c 501 (P) D–19
Data alarms e 601 module D–30
Data alarms for calibrations D–40
Data alarms for controls D–52
Data problems without alarm D–57
Rerun list D–60
20 Troubleshooting
General troubleshooting D–65
Instrument troubleshooting D–68
c 501 (ISE) troubleshooting D–72
c 501 (P) troubleshooting D–77
e 601 troubleshooting D–84
Glossary Part E
Index Part F
Notes Part G
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Operator´s Manual · Version 8.2 9
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®
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Intended use
The cobas 6000 analyzer series is a fully automated, random-access,
software-controlled system for immunoassay and photometric analysis intended for
qualitative and quantitative in vitro determinations using a wide variety of tests. The
cobas 6000 analyzer series is a powerful tool for complete diagnostic laboratory
automation. It is optimized for high throughput workloads using a combination of an
ion selective electrode (ISE) and photometric analysis (c 501 module), and an
immunoassay analysis module (e 601 module).
This publication has detailed descriptions of features of the cobas 6000
analyzer series and general operational concepts, specification functions and use of
controls, operating techniques, emergency procedures, product labeling and
maintenance procedures.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the following product names
and descriptors are used.
Observe the instructions of the Operator’s Manual for safe operation of the system
o If the system is used in a manner not specified in this Operator’s Manual, the
protection provided by the system may be impaired.
o Keep this 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.
Product name Descriptor
cobas 6000 analyzer series System
cobas c 501 module c 501 module
cobas e 601 module e 601 module
cobas cu 150 module cu 150 module
cobas c pack reagent cassette
cobas e pack reagent cassette
cobas e-library Software
cobas link Software
Sample Cup standard cup
Micro-Sample Cup micro cup
AssayTip/AssayCup tray magazine
WasteLiner solid waste box
cobas
®
6000 analyzer series
Roche Diagnostics
10 Operator´s Manual · Version 8.2
Symbols used in the publication
Symbols used on products
Symbol Explanation
a Start of procedure
End of procedure
o List item
e Cross-reference
Tip
Safety alert
Symbol Explanation
Global Trade Item Number.
Quantity contained in the package.
Quantity contained in the package.
Complies with the directive 2011/65/EU on RoHS.
Disposal of electronic equipment.
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Operator´s Manual · Version 8.2 11
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®
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Abbreviations The following abbreviations are used:
Abbreviation Definition
A
Abs Absorbance
ACN Application code number
ANSI American national standards institute
A.U. Analytical unit (module short name and measuring cell, if applicable)
C
c 501 (ISE) ISE unit of the c 501 module
c 501 (P) Photometric unit of the c 501 module
CLAS 2 Clinical laboratory automation system 2
CSA Canadian standards association
CSF Cerebrospinal fluid
D
DIL Diluent
E
e 601 cobas e 601 module for immunoassay analysis
EC European community
ECL Electrochemiluminescence
EN European standard
F
FBT False bottom tube
H
HbA1c Hemoglobin A1c, glycosylated hemoglobin
HPE High priority elecsys
I
IEC International electrical commission
IS Internal standard (ISE module)
ISE Ion selective electrode
IVD In vitro diagnostic
K
KCL Potassium chloride, reference solution for the ISE unit of the c 501
module
kVA Kilovolt-ampere. unit for expressing rating of AC electrical
machinery.
L
LDL Lower detection limit see analytical sensitivity
LIS Laboratory information system
LLD Liquid level detection
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12 Operator´s Manual · Version 8.2
M
MPA MODULAR PRE-ANALYTICS
N
n/a Not applicable
NaCl Sodium chloride
NG Not good (calibration)
P
PC/CC ProCell M (ProCell) /CleanCell M (CleanCell)
PRE Pretreatment reagent for immunoassays
PSM Process system manager (software)
Q
QC Quality control
R
RCM Reaction calculation mode
REF Reference solution for ISE module
RF Radio frequency
R.M. Result message
RoHS Restriction of Hazardous Substances Directive
R.P. or R. pack cobas e pack (reagent pack)
RRM Rack reception mode
S
SCCS Special cell cleaner solution
SD Standard deviation
SMS Selective mode solution (Detergent for special washes of reagent
probes)
STAT Short turn-around time
Std Standard, commonly used for calibrator
SVGA Super video graphics adapter
T
TPA Tripropylamine
U
UL Underwriters laboratories Inc.
UPS Uninterruptible power supply
W
WEEE Waste Electrical and Electronic Equipment
Abbreviation Definition
Roche Diagnostics
Operator´s Manual · Version 8.2 13
cobas
®
6000 analyzer series
What is new in publication Version 8.2?
This section provides an overview of all major changes in this publication.
Software version This documentation is valid for the software version 05–02, 06-01, 06–02, and 06–03.
Instrument approvals The international standard IEC 61010-2-081 and IEC 61010-2-010 have been deleted
in section Instrument approvals.
CAN/CSA 61010-1 has been deleted.
UL 61010-1 has been deleted.
e
See Instrument approvals on page 4.
Safety information for barcode
readers
The section has been revised.
A new optional laser barcode reader has been added to the description.
The maximum LED radiation output power of the e 601 reagent barcode reader has
increased to 166.9 μW.
e
See Safety information for barcode readers on page A-30.
Correct alignment of sample
tubes on a rack
The specification of the safety precaution about the tube alignment has been changed
to WARNING.
e
See Correct alignment of sample tubes on a rack on page A-66.
ISE calibrations For ISE calibrations, the software now uses separate compensated limit checks for
slope and calibrator S3 concentration.
Maintenance
General maintenance In section Recommended maintenance pipes the descriptions for the following pipes
have been revised:
o Extended power ON (2-17 days – only e 601)
o Extended power OFF (2-17 days – only e 601)
e
For associated topics see:
Extended power ON 2 (2 to17 days – only e 601) on page C-34
Extended power OFF (2 to17 days – only e 601) on page C-34
Maintenance cu 150 As needed maintenance Cleaning rack tray surfaces:
Safety message has been revised.
e
See Cleaning rack tray surfaces on page C-62.
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®
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Roche Diagnostics
14 Operator´s Manual · Version 8.2
Maintenance c 501 with ISE During product surveillance, a risk of personal injury at the edges of the cell cover
above the ultrasonic mixers was found.
A safety message was added to all maintenance actions that involve handling of the
cell cover above the ultrasonic mixers.
e
For associated topics see:
Cleaning the cell covers on page C-81
Cleaning the incubator bath on page C-90
Cleaning the ultrasonic mixers on page C-100
Replacing the photometer lamp on page C-103
Cleaning instrument surfaces Materials required were revised concerning the use of alcohol or bleach.
e
For associated topics see:
Cleaning instrument surfaces on page C-59
Cleaning instrument surfaces on page C-112
Cleaning instrument surfaces on page C-152
Maintenance e 601 The procedures for extended power on and power off have been reworked.
e
See Extended Power OFF procedures on page C-154.
1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 Overview modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-35
3 Control unit, cobas link and core unit . . . . . . . . . . . . . . . . . . . A-45
4 c 501 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-71
5 e 601 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-99
6 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-115
System description
A
Roche Diagnostics
Operator´s Manual · Version 8.2 A-3
cobas
®
6000 analyzer series 1 General safety information
Table of contents
General safety information
Before operating with the cobas 6000 analyzer series it is essential that the warnings,
cautions, and safety requirements contained in this manual, as well as the explanation
of safety labels on the system are read and understood by the user.
Safety classifications ........................................................................................................ A-5
Safety precautions ........................................................................................................... A-6
Operator qualification .............................................................................................. A-6
Commissioning and decommissioning ................................................................. A-6
Relocation and transportation .......................................................................... A-7
Disposal ................................................................................................................ A-7
Operating conditions ................................................................................................ A-7
Power interruption ............................................................................................. A-7
Electromagnetic compatibility .......................................................................... A-8
Safe and proper use of the instrument ................................................................... A-8
Personal protection measures ........................................................................... A-9
Biohazardous materials ...................................................................................... A-9
Electrical safety .................................................................................................. A-11
Mechanical safety .............................................................................................. A-12
Reagents and working solutions ........................................................................... A-13
Skin contact ....................................................................................................... A-13
Fire and burns ................................................................................................... A-13
Incorrect results ...................................................................................................... A-13
Samples ............................................................................................................... A-14
Reagents ............................................................................................................. A-15
Instrument covers ............................................................................................. A-16
Others ................................................................................................................. A-16
Sample loss ............................................................................................................... A-17
Software and data security ..................................................................................... A-18
Unauthorized access ......................................................................................... A-18
Incorrect or corrupt data ................................................................................. A-19
USB storage devices .......................................................................................... A-19
Computer viruses .............................................................................................. A-19
Third-party software ........................................................................................ A-19
Backup ................................................................................................................ A-20
In this chapter
Chapter
1
Roche Diagnostics
A-4 Operator´s Manual · Version 8.2
1 General safety information cobas
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Table of contents
Instrument damage ................................................................................................. A-20
Moving parts ..................................................................................................... A-20
Spillage ............................................................................................................... A-20
Cleaning agents ................................................................................................. A-21
Excessive weight ................................................................................................ A-21
Safety labels of the system ............................................................................................ A-22
Front view ................................................................................................................ A-24
Side view ................................................................................................................... A-26
Top view ................................................................................................................... A-27
Rear view .................................................................................................................. A-29
Safety information for barcode readers ..................................................................... A-30
Interlock function ......................................................................................................... A-32
Disposal of the instrument ........................................................................................... A-33
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Safety classifications
Safety classifications
This section explains how precautionary information is presented in the manual.
The safety precautions and important user notes are classified according to
ANSI Z535.6 Standards. Familiarize yourself with the following meanings and icons:
These symbols and signal words are used for specific hazards:
Important information which is not safety relevant, is indicated with the following
icon:
Safety alert
The safety alert symbol is used to alert you to potential physical injury hazards. Obey all
safety messages that follow this symbol to avoid possible damage to the system, injury, or
death.
WARNING
Warning
Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
Caution
Indicates a hazardous situation which, if not avoided, could result in minor or moderate
injury.
NOTICE
Notice
Indicates a hazardous situation which, if not avoided, may result in damage to the
instrument.
Tip
Indicates additional information on correct use or useful tips.
Roche Diagnostics
A-6 Operator´s Manual · Version 8.2
1 General safety information cobas
®
6000 analyzer series
Safety precautions
Safety precautions
Keep in mind that the hazard warnings in this manual and on the instrument cannot
cover every possible case, as it is impossible to predict and evaluate all circumstances
beforehand.
Just following the given directions may, therefore, be inadequate for operation.
Always be alert and use your common sense.
Operator qualification
As a user, you are required to be a licensed person according to your country’s
specific laws. You must have sound knowledge of relevant safety precaution
guidelines and standards and of 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 to do so.
o Leave maintenance, installation, or service that is not described in the Operator´s
Manual to the Roche service representative.
o Carefully follow the procedures specified in the Operator´s Manual for the
operation and maintenance.
o Follow standard laboratory practices, especially when working with biohazardous
material.
Commissioning and decommissioning
Only the Roche service representatives can perform commissioning.
For installation described in the Operator´s Manual (such as Installing an
application), follow the installation instructions carefully.
Correct grounding of the power supply cord is essential for the correct function of
the analyzer. The system can only be connected to a power supply source with the
specified power supply cord and only by authorized personnel.
o Contact your Roche service representative for any changes to the power supply
cord.
Pay attention to the following safety precautions!
If you ignore them you may be killed or suffer serious injuries.
Each precaution is important.
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Roche cobas 6000 core unit User manual

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User manual
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