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Roche cobas 8100 AddOnBuffer User manual

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cobas® 8100 automated workflow series
Operator’s Manual
Software Version 02-06
cobas® 8100 automated workflow series
Roche Diagnostics
2 Operator’s Manual · Version 2.4
Document information
Edition notice This Operator's Manual is for users of the cobas® 8100 automated workflow series.
The cobas® 8100 automated workflow series consists of processing modules,
connection components, and a control unit PC, that combine to create an automated
processing system.
Every effort has been made to ensure that all the information contained in this
document is correct at the time of printing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary without notice as part of ongoing
product development.
Intended use The cobas® 8100 automated workflow series is an automated, software controlled
system for processing patient samples before they go for analysis.
The system is designed to centrifuge patient samples, remove and insert sample tube
caps as required, apply barcode labels to secondary tubes, and prepare aliquots from
primary samples. It can sort samples for online and offline analysis, and temporarily
store samples. The system transports individual samples between modules, and to
connected analyzers.
The cobas® 8100 automated workflow series is intended for use with analyzers that
perform tests in the areas of immunology, clinical chemistry, coagulation, urinalysis,
and hematology.
It is essential that all users read this Operator's Manual thoroughly before using the
system.
Any user modification of the instrument will render the warranty or agreement null
and void.
Manual version Software version Revision date Changes
1.0 01–02 August 2013
1.1 01–02 September 2013 Graphics updated
Minor revisions
1.2 01–03 July 2014 Software updated
2.0 02–01 January 2015 New connection components
and updated DSP module
Software updated
2.1 02–03 March 2015 Added RFX and PXT modules
Graphics updated
Software updated
2.2 02–03 April 2015 Updated RFX module
troubleshooting section
Added power supply
specifications
2.3 02-04 and above June 2015 Added CLW and CRO
modules, and SLL and SLR
lines
Minor revisions
2.4 02-06 October 2015 Added SCM module and
software
Graphics updated
Table 1 Revision history
Roche Diagnostics
Operator’s Manual · Version 2.4 3
cobas® 8100 automated workflow series
Copyright © 2013–2015, Roche Diagnostics GmbH. All rights reserved.
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.
System approvals The cobas® 8100 automated workflow series meets the protection requirements
specified in IVD Directive 98/79/EC.
Compliance is demonstrated by the mark below.
Instrument approvals The cobas® 8100 automated workflow series instrument complies with the emission
and immunity requirements described in standard IEC 61326-2-6:2005.
Furthermore, the cobas® 8100 automated workflow series instrument is
manufactured and tested according to the international safety standards
IEC 61010-2-101:2002, IEC 61010-2-020:2006, and IEC 60825-1:2007.
Contact addresses
Inside the European Union and EFTA member states
Manufacturer of cobas® 8100
automated workflow series
instrument
Authorized representative
The cobas® 8100 automated workflow series instrument
complies with IVD Directive 98/79/EC.
Issued by TÃœV Rheinland for Canada and the US.
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shinbashi Minato-ku, Tokyo 105-8717
Japan
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
cobas® 8100 automated workflow series
Roche Diagnostics
4 Operator’s Manual · Version 2.4
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
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cobas® 8100 automated workflow series
Table of contents
Document information 2
Contact addresses 3
Table of contents 7
About the cobas 8100 automated workflow
series 11
Where to find information 11
User information 11
Conventions used in this document 12
System Description
1 General safety information
Safety classifications 19
Safety precautions 20
Safety summary 22
Safety labels on the system 32
Disposal 39
2 Overview of the system
Overview 43
System configuration 51
General specifications 52
Hardware components of the system 53
Sample and holder workflow 67
Sample tubes 70
Sample and holder identification 71
Operating modes 75
Overview of alarms 76
3 About the modules of the instrument
Overview of sample stations 79
Input station 80
Aliquot station 99
Output station 108
RFM module 119
4 About the connection components
About the connection components 125
BRF module 126
RFX module 131
URF module 136
CLW module 140
CRO module 143
CRW module 146
PXT module 149
SLL line 151
SLR line 153
TLJ line 155
5 Overview of the control unit PC and software
The control unit PC 161
Overview of the control unit software 163
Overview of key software areas 167
Online help 175
Operation
6 Safety information for operation
General information 185
Safety messages of the overall system 186
Safety messages for specific modules 189
7 Daily operation
Daily workflow 193
Prepare for system start-up 194
System start-up 197
Handling samples, sample trays, and tip trays 206
Loading samples 207
Monitoring the processing of samples 212
Monitoring and controlling the system 215
Searching for samples 217
Retrieving samples 219
Error samples 221
Unloading samples 226
Post-operation checks and inspections 230
Full system shutdown 231
System restart 234
Logging off, shutting down, and closing the
control unit software 242
8 Extended operation
Overview of extended operation 245
Backing up and restoring parameters 246
Adding new users and modifying existing
users 248
Adding new tests and modifying existing
tests 249
Adding new processing groups and modifying
existing processing groups 250
Adding new sample types and modifying
existing sample types 251
Saving and restoring system profiles 252
Switching between ACU profiles 253
Setting ACU profiles 254
Naming online systems 255
Setting alarm sounds and lights 256
Assigning samples to color classes on the
SCM module 257
Backing up sample images on the SCM
module 260
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cobas® 8100 automated workflow series
9 Reports
Reports overview 263
Generating result reports 264
Generating sample summary reports 265
Generating process result reports 266
Generating sample count reports 267
Generating data log reports 268
Maintenance
10 Safety information for maintenance
General information 273
Safety messages of the overall system 274
11 Maintenance actions
Overview 281
Maintenance schedule 284
Maintenance checklist 288
Maintenance of the input station 296
Maintenance of the aliquot station 335
Maintenance of the output station 368
Maintaining the RFM module 381
Maintenance of the connection components 388
General maintenance actions 411
Troubleshooting
12 Troubleshooting
General information about troubleshooting 419
Troubleshooting alarms 420
Troubleshooting problems with the system 423
Troubleshooting problems with modules 433
Troubleshooting problems with connection
components 474
Troubleshooting problems with online
systems 487
13 Limited Operation
Overview of limited operation 491
Masking modules 491
Masking online systems 498
Masking processing groups and tests 499
Glossary
14 Glossary
Index
Index 509
Revisions
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cobas® 8100 automated workflow series
About the cobas 8100 automated workflow series
The cobas 8100 automated workflow series is a fully automated system for sample
workflow management. The system provides a modular and flexible approach to the
processing of samples before and after online or offline analysis. The system is
optimized for high-throughput workloads, allowing a range of sample types to be
processed simultaneously and automatically.
The cobas 8100 automated workflow series allows a range of configurable
connections to online systems, including the cobas® 6000 analyzer series, the
cobas® 8000 modular analyzer series, the STAGO STA-R Evolution®, the
Sysmex XN-9000 analyzer, and post-analytical units including the cobas® p 501 and
cobas® p 701.
Where to find information
The following documents can assist you in finding useful information quickly.
Operator's Manual This manual describes operation, maintenance and troubleshooting of the system.
An index at the end of the manual helps you to find information quickly. A glossary
offers detailed explanations for important terms.
q
Observe the Operator's Manual for safe operation of the instrument
o If the instrument is used in a manner not specified in the Operator's Manual, the
protection provided by the instrument can be impaired.
o Keep this manual in a safe place to ensure that it remains easily accessible at all times.
Online help The software of the cobas 8100 automated workflow series offers online help
features. Online help contains extra information about the software, for example, the
purpose of software buttons.
u For more information, see Online help (p. 175).
User information
User training Contact your local Roche sales representative for any questions or information about
training on the system.
Service agreement Contact your local Roche sales representative for further information about a service
agreement for the system.
Ordering information Spare parts and consumables for the cobas 8100 automated workflow series,
including caps, barcode labels, and aliquot tips, must be ordered from Roche
Diagnostics only. When ordering, use the Roche Diagnostics catalogue number and
reference name for each item. Contact Roche technical support for the detailed
ordering list.
cobas® 8100 automated workflow series
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12 Operator’s Manual · Version 2.4
Conventions used in this document
Visual cues and shortened names are used to help you locate and interpret
information in this document quickly. This section explains the formatting
conventions used in this document.
Product names Except where the context clearly indicates otherwise, the product names and
abbreviations below are used in this Operator's Manual.
Symbols The symbols below are used in this Operator's Manual.
Abbreviations The abbreviations below are used in this Operator's Manual.
Product name Abbreviation
cobas® 8100 automated workflow series,
including processing modules, control unit
software, and connection components.
System
cobas® 8100 automated workflow series,
processing modules only.
Instrument
cobas® 8100 automated workflow series,
including the RFM module and CLAS 2
system.
Version 1
cobas® 8100 automated workflow series,
including new bi-directional connection
components.
Version 2
Table 2 Product names used in this document
Symbol Used for
Safety caution symbol
Q Tip
P Start of procedure
S End of procedure
o List item
U Cross-reference
f Path to the active menu or window
Table 3 Symbols used in this document
Abbreviation Definition
A
ACU Automatic centrifuge unit module
ANSI American National Standards Institute
AOB Add-on/output buffer module
AQM Aliquot module
ASCII American Standard Code for Information Interchange
B
BC Barcode
BCL Barcode labeler/tube feeder module
Table 4 Abbreviations used in this document
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cobas® 8100 automated workflow series
BRF Bi-directional reformatter module
C
CE European Conformity marking
CL8 CLAS 2 connection line between the instrument and the UCL
CLAS 2 Clinical laboratory automation system 2
CLW Connection line type L with power unit
CRO Connection line type R without power unit
CRW Connection line type R with power unit
CSA Canadian Standards Association
CU Control unit
D
DSP Destopper module
E
EN European standard
H
HIS Hospital information system
I
IEC International Electrical Commission
IPB Input buffer module
L
LED Light emitting diode
LIS Laboratory information system
LLD Liquid level detection
N
n/a not applicable
O
OBS Output buffer/sorter module
P
PC Personal computer
PXT Power extension module
R
RCL Reformatter connection line
RFID Radio frequency identification
RFM Reformatter module
RFX Reformatter module for Sysmex XN-9000 analyzers
RSF Restopper module flexible
S
SCM Sample check module
SLL Simple line type L
SLR Simple line type R
STAT Short turnaround time
Originally an abbreviation of Statim, meaning immediately or urgent.
T
Abbreviation Definition
Table 4 Abbreviations used in this document
cobas® 8100 automated workflow series
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TLJ Transport line with junction
U
UCL Universal connection line
UL Underwriters Laboratories Inc.
URF Uni-directional reformatter module
W
WEEE European Waste Electrical and Electronic Equipment directive
Abbreviation Definition
Table 4 Abbreviations used in this document
System Description
1 General safety information.............................................................................................................. 17
2 Overview of the system .................................................................................................................... 41
3 About the modules of the instrument.............................................................................................. 77
4 About the connection components................................................................................................. 123
5 Overview of the control unit PC and software.............................................................................. 159
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cobas® 8100 automated workflow series 1 General safety information
Table of contents
General safety information 1
Before you start working with the system, it is essential that you understand the
warnings, cautions, and safety requirements contained in this manual, as well as the
explanations of the safety labels to be found on the system.
In this chapter
Chapter
1
Safety classifications.............................................................................................................19
Safety precautions.................................................................................................................20
Operator qualification...................................................................................................20
Safe and proper use of the system................................................................................20
Miscellaneous safety precautions.................................................................................21
Safety summary ....................................................................................................................22
Warning messages..........................................................................................................22
Electrical safety.........................................................................................................22
Biohazardous materials ...........................................................................................23
Flammable materials ...............................................................................................24
Waste..........................................................................................................................24
False or wrongly reported results...........................................................................24
Lasers.........................................................................................................................25
Caution messages...........................................................................................................25
Mechanical safety.....................................................................................................26
Working solutions....................................................................................................27
Exposure to lasers ....................................................................................................27
Insoluble contaminants in samples........................................................................27
Evaporation of samples ...........................................................................................27
Fatigue due to long hours of operation.................................................................28
Malfunction due to interfering electromagnetic fields .......................................28
Spillage.......................................................................................................................28
Instrument ................................................................................................................28
Sample identification...............................................................................................29
Delayed results .........................................................................................................29
Notices .............................................................................................................................30
Moving parts.............................................................................................................30
Circuit breakers and fuses.......................................................................................30
Spillage.......................................................................................................................30
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Table of contents
Fixed size trays .........................................................................................................30
Software.....................................................................................................................31
Safety labels on the system ..................................................................................................32
Locations of safety labels on the instrument ..............................................................33
Locations of safety labels on the connection components........................................36
Disposal .................................................................................................................................39
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cobas® 8100 automated workflow series 1 General safety information
Safety classifications
Safety classifications
This section explains how precautionary information is presented in this manual.
The safety precautions and important user notes are classified according to the
ANSI Z535.6 Standard. Familiarize yourself with the meanings and icons below.
Safety alert symbol
The safety alert symbol alone promotes awareness of hazards that are generic or directs
the reader to safety information provided elsewhere in the document.
These symbols and signal words are used for specific hazards.
WARNING
Warning
r Indicates a hazardous situation that, if not avoided, could result in death or serious
injury.
CAUTION
Caution
r Indicates a hazardous situation that, if not avoided, could result in minor or moderate
injury.
NOTICE
Notice
Indicates a hazardous situation that, if not avoided, can result in damage to the system.
u For more information about the product safety labels, see Safety labels on the system
(p. 32).
Important information that is not relevant to safety is indicated with the icon below.
q
Tip
Indicates additional information on correct use or useful tips.
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1 General safety information cobas® 8100 automated workflow series
Safety precautions
Safety precautions
Pay attention to the following safety precautions!
If you ignore these precautions, you can suffer minor to moderate injury. Each precaution
is important.
Operator qualification
As a user, you are required to 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 are trained to do so by
Roche Diagnostics.
o Carefully follow the procedures specified in the Operator's Manual for operation
and maintenance.
o Leave maintenance, installation, or service that is not described in the Operator's
Manual to trained Roche Service representatives.
o Follow Good Laboratory Practices, especially when working with biohazardous
material.
Safe and proper use of the system
Personal protective equipment o Wear appropriate protective equipment including, but not limited to, eye
protection with side shields, fluid resistant lab coat, and disposable laboratory
gloves.
o Wear a face shield if there is a chance of splash or splatter.
Installation Only trained, certified Roche Service representatives can perform an installation. The
user is responsible for providing the necessary facilities.
Environmental conditions o Operation outside of the specified ranges can lead to incorrect processing or
malfunction of the system.
u See Environmental conditions (p. 52).
o Use the system indoors only and avoid heat and humidity.
o Make sure that the ventilation openings of the system remain unobstructed at all
times.
o Perform maintenance according to the specified intervals to maintain the
environmental conditions of the system.
o Keep the Operator's Manual in a safe place to ensure that it is not damaged and
remains available for use. The manual must be easily accessible for users.
Approved parts Only use parts and devices approved by Roche Diagnostics. Use of non-approved
parts or devices can result in malfunction of the system and can render the warranty
null and void.
Third-party software Do not install any non-approved third-party software. Installation of any third-party
software that is not approved by Roche Diagnostics can result in incorrect behavior
of the system.
/