Roche cobas 8100 AddOnBuffer User manual

Type
User manual
cobas® 8100 automated workflow series
Operator’s Manual
Version 2.9.3
Software version 03-08
cobas® 8100 automated workflow series
Roche Diagnostics
2 Operator’s Manual · Version 2.9.3
Document information
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
2.5 02-09 February 2016 Added:
o New CLO and USU modules
o New alarm colors
o Alarm History dialog box
o Automatic shut down function
o New options to the Get Log function
2.6 02-12 September 2016 Added RSS module and software
Graphics updated
2.7 03–02 March 2017 Added:
o New IPB 2 module
o STAT port on the IPB module
o 25-position tray for the OBS module
o 100-position tray for the IPB, IPB 2, and OBS
modules
o Primary sample tubes on RSS module
Software update
Table 1 Revision history
Roche Diagnostics
Operator’s Manual · Version 2.9.3 3
cobas® 8100 automated workflow series
2.8 03–06 October 2017 Added:
o Section Results to the description of the Get
Log dialog box
o Function to check the settings of the Test -
Details and Processing Group - Details
dialog boxes
o Function Offline to the AOB module
o Function to recap incomplete samples
o Rack supply for a BRF module connected to a
post analytical system
o Icon for centrifugation error on the Sample
Monitor dialog box
o Properties for aliquot dialog box
o cobas® 6500 urine analyzer series
o Section Automatic masking and unmasking of
online systems
o Section Instrument Masking
o Statement of conformity to the directive
2014/53/EU
o Specifications of radio equipment
The destination for error sample tray for aliquot
errors was changed.
Software update
2.9 03-07 April 2018 Safety information on laser added.
The number of maximum reformatter per system
changed from 8 to 12.
A 2nd DSP module can be added to a 2nd output
station.
The function to exclude a reformatter module
after incomplete reset process.
Automatic masking and unmasking added to the
UCU module.
Software update
2.9.1 03-08 July 2018 Software update
2.9.2 03-08 October 2018 Added configurable connections: throughout the
document
o cobas® pro integrated solutions
o cobas t 711 coagulation analyzer
o Sysmex XN-9100 analyzer
2.9.3 03-08 January 2019 Added configurable connection throughout the
document
o Thermo Scientificâ„¢ TCAutomationâ„¢ CRA
Interface
Manual version Software version Revision date Changes
Table 1 Revision history
cobas® 8100 automated workflow series
Roche Diagnostics
4 Operator’s Manual · Version 2.9.3
Edition notice This publication is intended for operators 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
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.
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.
CAUTION
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.
War ranty 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 © 2013–2019, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged.
Roche Diagnostics
Operator’s Manual · Version 2.9.3 5
cobas® 8100 automated workflow series
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.
System approvals The cobas® 8100 automated workflow series meets the requirements laid down in:
o Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in-vitro diagnostic medical devices.
o 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.
o Directive 2014/30/EU of the European Parliament and Council of 26 February
2014 relating to electromagnetic compatibility (EMC).
o 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.
The full text of the 2014/53/EU declaration of conformity is available at the
following internet address: http://e-labdoc.roche.com.
Compliance is demonstrated by the marks below.
Instrument approvals The cobas® 8100 automated workflow series complies with the emission and
immunity requirements described in standard IEC 61326-2-6 / EN 61326-2-6.
Furthermore, the cobas® 8100 automated workflow series instrument is
manufactured and tested according to the international safety standards
IEC 61010-2-101, IEC 61010-2-020, IEC 60825-1:2007, and IEC 60825-1:2014.
Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the hermetically sealed
refrigeration.
The insulation of the chamber includes foam blown with fluorinated greenhouse gas.
The cobas® 8100 automated workflow series instrument
complies with IVD Directive 98/79/EC.
The cobas® 8100 automated workflow series instrument
complies with RoHS Directive 2011/65/EU.
Issued by TÃœV Rheinland for Canada and the US.
Type Charge weight (kg) CO
2
equivalent (tonne) Global warming potential
R-404A 0.260 1.02 3920
Table 2 Fluorinated greenhouse gas detail.
cobas® 8100 automated workflow series
Roche Diagnostics
6 Operator’s Manual · Version 2.9.3
Contact addresses
Inside the European Union and EFTA member states
Manufacturer of cobas® 8100
automated workflow series
instrument
Authorized representative
Outside the European Union and EFTA member states
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shimbashi Minato-ku, Tokyo 105–8717
Japan
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
Roche Diagnostics
Operator’s Manual · Version 2.9.3 7
cobas® 8100 automated workflow series
Table of contents
Document information 2
Contact addresses 6
Table of contents 7
About the cobas® 8100 automated workflow
series 9
Where to find information 9
User information 9
Conventions used in this document 10
Symbols used on packaging materials 12
System Description
1 General safety information
Safety classifications 17
Safety precautions 18
Safety summary 20
Safety labels on the system 30
Disposal 37
2 Overview of the system
Overview 41
System configuration 52
General specifications 54
Hardware components of the system 55
Sample and holder workflow 71
Sample tubes 74
Sample and holder identification 76
Operating modes 82
Overview of alarms 83
3 About the modules of the instrument
Overview of sample stations 87
Input station 88
Aliquot station 110
Output station 118
RFM module 134
4 About the connection components
About the connection components 141
BRF module 142
RFX module 147
URF module 152
CLO module 156
CLW module 158
CRO module 161
CRW module 164
PXT module 167
UCU module 169
SLL line 172
SLR line 174
TLJ line 176
5 Overview of the control unit PC and software
The control unit PC 181
Overview of the control unit software 182
Overview of key software areas 186
Online Help 194
Operation
6 Safety information for operation
General information 205
Safety messages of the overall system 206
Safety messages for specific modules 209
7 Daily operation
Daily workflow 213
Prepare for system startup 214
System startup 217
Handling samples, sample trays, and tip trays 226
Loading samples 227
Monitoring the processing of samples 235
Monitoring and controlling the system 238
Searching for samples 240
Retrieving samples 242
Error samples 244
Unloading samples 249
Post-operation checks and inspections 256
Full system shutdown 257
System restart 260
Logging off, shutting down, and closing the
control unit software 268
8 Extended operation
Overview of extended operation 271
Backing up and restoring parameters 272
Adding new users and modifying existing
users 274
Adding new tests and modifying existing tests 275
Adding new processing groups and modifying
existing processing groups 276
Adding new sample types and modifying existing
sample types 277
Saving and restoring system profiles 278
Switching between ACU profiles 279
Setting ACU profiles 280
Naming online systems 281
Setting alarm sounds and lights 282
Assigning samples to color classes on the SCM
module 283
Backing up sample images on the SCM
module 286
Roche Diagnostics
8 Operator’s Manual · Version 2.9.3
cobas® 8100 automated workflow series
9 Reports
Reports overview 289
Generating result reports 290
Generating sample summary reports 291
Generating process result reports 292
Generating sample count reports 293
Generating data log reports 294
Maintenance
10 Safety information for maintenance
General information 299
Safety messages of the overall system 300
11 Maintenance actions
Overview 307
Maintenance schedule 310
Maintenance checklist 314
Maintenance of the input station 322
Maintenance of the aliquot station 361
Maintenance of the output station 391
Maintaining the RFM module 406
Maintenance of the connection components 413
General maintenance actions 436
Troubleshooting
12 Troubleshooting
General information about troubleshooting 443
Troubleshooting alarms 444
Troubleshooting problems with the system 447
Troubleshooting problems with modules 457
Troubleshooting problems with connection
components 498
Troubleshooting problems with online
systems 512
13 Limited Operation
Overview of limited operation 515
Masking modules 515
Masking online systems 523
Masking processing groups and tests 525
Appendices
Glossary
14 Glossary
Index
Index 537
Revisions
Roche Diagnostics
Operator’s Manual · Version 2.9.3 9
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 cobas® pro integrated solutions, the
cobas® 6500 urine analyzer series, the STAGO STA-R Evolution®, the STAGO STA-
R Max®, the DiaSorin LIAISON® XL, the Sysmex XN-9000 / Sysmex XN-9100
analyzer, the Thermo Scientificâ„¢ TCAutomationâ„¢ CRA Interface, and post-
analytical units including the cobas p 501, cobas p 701, and cobas t 711 coagulation
analyzer.
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 always.
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. 194).
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 catalog number and
reference name for each item. Contact Roche technical support for the detailed
ordering list.
cobas® 8100 automated workflow series
Roche Diagnostics
10 Operator’s Manual · Version 2.9.3
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 3 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 dialog box
Table 4 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 5 Abbreviations used in this document
Roche Diagnostics
Operator’s Manual · Version 2.9.3 11
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
CLO Connection line type L without power unit
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 / Sysmex XN-9100
analyzers
RSF Restopper module flexible
RSS Restopper (screw) module
S
SCM Sample check module
SLL Simple line type L
SLR Simple line type R
Abbreviation Definition
Table 5 Abbreviations used in this document
cobas® 8100 automated workflow series
Roche Diagnostics
12 Operator’s Manual · Version 2.9.3
Symbols used on packaging materials
STAT Short turnaround time
Originally an abbreviation of Statim, meaning immediately or urgent.
T
TLJ Transport line with junction
U
UCL Universal connection line
UCU Universal connection unit
UL Underwriters Laboratories Inc.
URF Uni-directional reformatter module
W
WEEE European Waste Electrical and Electronic Equipment directive
Abbreviation Definition
Table 5 Abbreviations used in this document
Symbol Definition
Quantity in the package
Table 6 Symbols used on packaging materials
System Description
1 General safety information.............................................................................................................. 15
2 Overview of the system .................................................................................................................... 39
3 About the modules of the instrument.............................................................................................. 85
4 About the connection components................................................................................................. 139
5 Overview of the control unit PC and software.............................................................................. 179
Roche Diagnostics
Operator’s Manual · Version 2.9.3 15
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.............................................................................................................17
Safety precautions.................................................................................................................18
Operator qualification...................................................................................................18
Safe and proper use of the system................................................................................18
Miscellaneous safety precautions.................................................................................19
Safety summary ....................................................................................................................20
Warning messages..........................................................................................................20
Electrical safety.........................................................................................................20
Biohazardous materials...........................................................................................21
Flammable materials ...............................................................................................22
Waste..........................................................................................................................22
False or wrongly reported results...........................................................................22
Lasers.........................................................................................................................23
Caution messages...........................................................................................................24
Mechanical safety.....................................................................................................24
Working solutions....................................................................................................25
Exposure to lasers ....................................................................................................25
Insoluble contaminants in samples........................................................................25
Evaporation of samples ...........................................................................................25
Fatigue due to long hours of operation.................................................................26
Malfunction due to interfering electromagnetic fields.......................................26
Spillage.......................................................................................................................26
Instrument ................................................................................................................26
Sample identification...............................................................................................27
Delayed results .........................................................................................................27
Notices.............................................................................................................................28
Moving parts.............................................................................................................28
Circuit breakers and fuses.......................................................................................28
Spillage.......................................................................................................................28
Roche Diagnostics
16 Operator’s Manual · Version 2.9.3
1 General safety information cobas® 8100 automated workflow series
Table of contents
Fixed size trays .........................................................................................................28
Software.....................................................................................................................29
Safety labels on the system..................................................................................................30
Location of safety labels on the instrument................................................................31
Locations of safety labels on the connection components .......................................34
Disposal .................................................................................................................................37
Roche Diagnostics
Operator’s Manual · Version 2.9.3 17
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. 30).
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.
Roche Diagnostics
18 Operator’s Manual · Version 2.9.3
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. 54).
o Use the system indoors only and avoid heat and humidity.
o Make sure that the ventilation openings of the system remain unobstructed
always.
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.
Roche Diagnostics
Operator’s Manual · Version 2.9.3 19
cobas® 8100 automated workflow series 1 General safety information
Safety precautions
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage can damage the system or lead to data
loss. The items below are preventative measures.
o Roche recommends that you only operate the system with an uninterruptible
power supply.
o Do not switch off power while the control unit PC accesses the hard disk or
attached external storage devices. To ensure reliable operation, follow the
shutdown procedures provided in this Operator's Manual.
Electromagnetic fields Devices that emit electromagnetic waves can cause the system to malfunction. Do not
operate the devices below in close proximity to where the system is installed.
o Mobile phone
o Transceiver
o Cordless phone
o Other electrical devices that generate strong electromagnetic fields
System unused for an extended
period
If the system is not to be used for an extended period, switch the main circuit breaker
to OFF. Remove, close, and refrigerate any remaining samples.
For further information, call technical support.
Relocation and transportation Do not attempt to relocate or transport the system. Leave relocation and
transportation to trained and authorized Roche personnel.
u For information about disposal of the system, see Disposal (p. 37).
Aliquot tip containers To prevent injury to your hands, carefully open aliquot tip containers.
Roche Diagnostics
20 Operator’s Manual · Version 2.9.3
1 General safety information cobas® 8100 automated workflow series
Safety summary
Safety summary
This safety summary contains the most necessary general warning and caution
messages. Additionally, you can find specific safety information at the beginning of
the Operation Part and the Maintenance Part.
Warning messages
WARNING
List of warning messages
Failure to observe warning messages can result in death or serious injury.
r Before operating the system, read the warning messages contained in this summary
carefully.
Electrical safety
WARNING
Electrical shock by electronic equipment
Removing the covers of electronic equipment can cause electric shock as there are high-
voltage parts inside.
r Do not attempt to work in any electronic compartment.
r Do not remove any cover of the system other than those specified in the Operator's
Manual.
r Only authorized and qualified Roche personnel are to perform installation, service, or
repair of the system.
r Observe the Safety labels on the system (p. 30), particularly Electrical safety (p. 31).
WARNING
Power interruption
On occurrence of momentary power voltage drop due to power interruption or lighting, the
control section of this instrument may become faulty, or the system software, application
software, or data may be damaged.
r Take special care when recovering from power interruption.
WARNING
Circuit breakers and fuses
If any foreign material comes in contact with the circuit board, the ICs or other circuit
elements may be damaged.
r Should any of the instrument circuit breakers or fuses blow, DO NOT attempt to
operate the system before contacting your Roche Service representative.
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Roche cobas 8100 AddOnBuffer User manual

Type
User manual

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