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Roche cobas 8100 AddOnBuffer User manual

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cobas® 8100 automated workflow series
Operator’s Manual
Version 2.9.5
Software version 04-01
cobas® 8100 automated workflow series
Roche Diagnostics
2 Operator’s Manual · Version 2.9.5
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 2.9.5 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
Manual version Software version Revision date Changes
Table 1 Revision history
cobas® 8100 automated workflow series
Roche Diagnostics
4 Operator’s Manual · Version 2.9.5
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.
2.9.3 03-08 January 2019 Added configurable connection throughout the
document
o Thermo Scientificâ„¢ TCAutomationâ„¢ CRA Interface
2.9.4 03-09 March 2019 Updated images:
o The Sample Type dialog box
o The Draw Volume Settings dialog box
o The Function Offline Settings dialog box
Added:
o Bulk loader systems to the configurable connections
o Section Radius of the rotor room Specifications -
ACU module
o Section Performance guarantee of barcode label in
Specifications - BCL module
o Information about barricor tubes
o Information about Function Offline Settings of the
SCM module
o Sections Tube Type Settings and Cap Color Settings
to the description of the Draw Volume Settings
dialog box
Revised:
o The procedure: Assigning samples to color classes
on the SCM module
New user interface of the software of the SCM module
2.9.5 04-01 March 2020 Update to Windows 10 (SW 04-01).
Information from the Addenda 1.0 and 2.0 to
Operator’s Manual version 2.9.4 have been integrated.
u What is new in publication version 2.9.5 (p. 11)
Manual version Software version Revision date Changes
Table 1 Revision history
Roche Diagnostics
Operator’s Manual · Version 2.9.5 5
cobas® 8100 automated workflow series
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 © 2013–2020, 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.
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.
cobas® 8100 automated workflow series
Roche Diagnostics
6 Operator’s Manual · Version 2.9.5
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 distinction between the 2 fluorinated greenhouse gas types is made with a name
label on the front of the ACU module.
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
R-448A 0.260 0.36 1387
Table 2 Fluorinated greenhouse gas detail.
Roche Diagnostics
Operator’s Manual · Version 2.9.5 7
cobas® 8100 automated workflow series
Figure 1 Fluorinated greenhouse gas label on the centrifuge unit inside the ACU module.
A Name label
Type: R-404A Type: R-448A
Name label
Table 3 Name labels of different types of fluorinated greenhouse gas.
A
TYPE
ME30C
CENTRIFUGE UNIT
200V~60Hz
208V~60Hz
S311617
Refrigerant R-404A
260g (0.573 lb)
Design Pressure
High-side 3.45 MPa (500 psi)
1.2 MPA (174 psi)
Koki Holdings Co., Ltd.
Low-side
200V~50Hz
230V~50Hz
2kVA
S102366
VOLT.
POWER
CAT.NO.
MFG.NO.
TYPE
ME30C
CENTRIFUGE UNIT
200V~60Hz
208V~60Hz
S311801
Refrigerant R-448A
260g (0.573 lb)
Design Pressure
High-side 2.8 MPa (406 psi)
0.33 MPA (48 psi)
Koki Holdings Co., Ltd.
Low-side
200V~50Hz
230V~50Hz
2kVA
S102366
VOLT.
POWER
CAT.NO.
MFG.NO.
cobas® 8100 automated workflow series
Roche Diagnostics
8 Operator’s Manual · Version 2.9.5
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
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
Manufactured by
Manufactured for
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shimbashi, Minato-ku, Tokyo 105-8717
Japan
Hitachi High-Technologies Corporation
Roche Diagnostics
Operator’s Manual · Version 2.9.5 9
cobas® 8100 automated workflow series
Table of contents
Document information 2
Contact addresses 8
Table of contents 9
What is new in publication version 2.9.5 11
What is new in publication version 2.9.4 11
About the cobas® 8100 automated workflow
series 12
Where to find information 12
User information 13
Conventions used in this document 13
Symbols used on packaging materials 15
System Description
1 General safety information
Safety classifications 21
Safety precautions 22
Safety summary 24
Safety labels on the system 34
Disposal 41
2 Overview of the system
Overview 45
System configuration 56
General specifications 58
Hardware components of the system 59
Sample and holder workflow 76
Sample tubes 79
Sample and holder identification 81
Operating modes 87
Overview of alarms 88
3 About the modules of the instrument
Overview of sample stations 91
Input station 92
Aliquot station 114
Output station 123
RFM module 139
4 About the connection components
About the connection components 145
BRF module 146
RFX module 151
URF module 156
CLO module 160
CLW module 162
CRO module 165
CRW module 168
PXT module 171
UCU module 173
SLL line 176
SLR line 178
TLJ line 180
5 Overview of the control unit PC and software
The control unit PC 185
Overview of the control unit software 186
Overview of key software areas 190
Online Help 198
Operation
6 Safety information for operation
General information 209
Safety messages of the overall system 210
Safety messages for specific modules 213
7 Daily operation
Daily workflow 217
Prepare for system startup 218
System startup 221
Handling samples, sample trays, and tip trays 230
Loading samples 231
Monitoring the processing of samples 239
Monitoring and controlling the system 242
Searching for samples 244
Retrieving samples 246
Error samples 248
Unloading samples 253
Post-operation checks and inspections 260
Full system shutdown 261
System restart 264
Logging off, shutting down, and closing the
control unit software 272
Roche Diagnostics
10 Operator’s Manual · Version 2.9.5
cobas® 8100 automated workflow series
8 Extended operation
Overview of extended operation 275
Backing up and restoring parameters 276
Adding new users and modifying existing
users 278
Adding new tests and modifying existing tests 279
Adding new processing groups and modifying
existing processing groups 280
Adding new sample types and modifying existing
sample types 281
Saving and restoring system profiles 282
Switching between ACU profiles 283
Setting ACU profiles 284
Naming online systems 285
Setting alarm sounds and lights 286
Assigning samples to color classes on the SCM
module 287
Backing up sample images on the SCM
module 290
9 Reports
Reports overview 293
Generating result reports 294
Generating sample summary reports 295
Generating process result reports 296
Generating sample count reports 297
Generating data log reports 298
Maintenance
10 Safety information for maintenance
General information 303
Safety messages of the overall system 304
11 Maintenance actions
Overview 311
Maintenance schedule 314
Maintenance checklist 318
Maintenance of the input station 326
Maintenance of the aliquot station 365
Maintenance of the output station 395
Maintaining the RFM module 410
Maintenance of the connection components 417
General maintenance actions 440
Troubleshooting
12 Troubleshooting
General information about troubleshooting 447
Troubleshooting alarms 448
Troubleshooting problems with the system 451
Troubleshooting problems with modules 461
Troubleshooting problems with connection
components 502
Troubleshooting problems with online
systems 516
13 Limited Operation
Overview of limited operation 519
Masking modules 519
Masking online systems 527
Masking processing groups and tests 529
Glossary
14 Glossary
Index
Index 539
Revisions
Roche Diagnostics
Operator’s Manual · Version 2.9.5 11
cobas® 8100 automated workflow series
What is new in publication version 2.9.5
Update to Windows 10 The software version 04-01 is functional identical to version 03-09 but has been
designed for Windows 10 computers.
Information from Addendum 1
integrated
The ACU module uses a fluorinated greenhouse gas, either R-404A or R-448A (new).
Check the name label to identify the refrigerant used.
u Fluorinated greenhouse gas (p. 6)
Two graphics showing the centrifuge unit inside the ACU module have been
updated.
u ACU module (p. 103)
Information from Addendum 2
integrated
A warning message about sharp, rough edges has been added.
u Sharps, rough edges, and/or moving parts (p. 24)
What is new in publication version 2.9.4
Bulk loader systems Bulk loader systems added to the configurable connections.
u About the cobas® 8100 automated workflow series (p. 12)
Radius of the rotor room in the
ACU module
Information about the radius of the rotor room added.
u Specifications - ACU module (p. 105)
Performance guarantee of barcode
label
Information about the performance guarantee of barcode labels o f the BCL module
added.
u Specifications - BCL module (p. 116)
Barricor tubes A new caution message added and information about loading barricor tubes.
u Loading routine samples (p. 231)
Changed user interfacer of the
software of the SCM module
The user interface of the software of the SCM module is updated. The update leads to
changes in some procedures.
u Assigning samples to color classes on the SCM module (p. 287)
Function Offline Settings On the SCM module, you can set specific module functions to Offline mode.
u Setting specific module functions to Offline mode (p. 525)
Draw Volume Settings Sections Tube Type Settings and Cap Color Settings added to the description of the
Draw Volume Settings dialog box.
cobas® 8100 automated workflow series
Roche Diagnostics
12 Operator’s Manual · Version 2.9.5
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:
o Online systems including
O cobas® 6000 analyzer series
O cobas® 8000 modular analyzer series
O cobas® pro integrated solutions
O cobas® 6500 urine analyzer series
O cobas t 711 coagulation analyzer
O STAGO STA-R Evolution®
O STAGO STA-R Max®
O DiaSorin LIAISON® XL
O Sysmex XN-9000 / Sysmex XN-9100 analyzer
O Thermo Scientificâ„¢ TCAutomationâ„¢ CRA Interface
O Phadiaâ„¢ 250 analyzer
o Post-analytical units including
O cobas p 501
O cobas p 701
o Bulk Loader system
O Bulk Loader Module (BLM) for centrifuge unit cobas p 671 (67x)
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. 198).
Roche Diagnostics
Operator’s Manual · Version 2.9.5 13
cobas® 8100 automated workflow series
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.
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.
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
BD Vacutainer® Barricor Plasma Blood
Collection Tubes
Barricor tube
Table 4 Product names used in this document
Symbol Used for
Safety caution symbol
Q Tip
P Start of procedure
S End of procedure
Table 5 Symbols used in this document
cobas® 8100 automated workflow series
Roche Diagnostics
14 Operator’s Manual · Version 2.9.5
Abbreviations The abbreviations below are used in this Operator's Manual.
o List item
U Cross-reference
f Path to the active menu or dialog box
Symbol Used for
Table 5 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
BLM Bulk Loader Module
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
Table 6 Abbreviations used in this document
Roche Diagnostics
Operator’s Manual · Version 2.9.5 15
cobas® 8100 automated workflow series
Symbols used on packaging materials
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
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 6 Abbreviations used in this document
Symbol Definition
Quantity in the package
Table 7 Symbols used on packaging materials
cobas® 8100 automated workflow series
Roche Diagnostics
16 Operator’s Manual · Version 2.9.5
System Description
1 General safety information.............................................................................................................. 19
2 Overview of the system .................................................................................................................... 43
3 About the modules of the instrument.............................................................................................. 89
4 About the connection components................................................................................................. 143
5 Overview of the control unit PC and software.............................................................................. 183
Roche Diagnostics
Operator’s Manual · Version 2.9.5 19
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.............................................................................................................21
Safety precautions.................................................................................................................22
Operator qualification...................................................................................................22
Safe and proper use of the system................................................................................22
Miscellaneous safety precautions.................................................................................23
Safety summary ....................................................................................................................24
Warning messages..........................................................................................................24
Sharps, rough edges, and/or moving parts...........................................................24
Electrical safety.........................................................................................................24
Biohazardous materials...........................................................................................25
Flammable materials ...............................................................................................26
Waste..........................................................................................................................26
False or wrongly reported results...........................................................................26
Lasers.........................................................................................................................27
Caution messages...........................................................................................................28
Mechanical safety.....................................................................................................28
Working solutions....................................................................................................29
Exposure to lasers ....................................................................................................29
Insoluble contaminants in samples........................................................................29
Evaporation of samples ...........................................................................................29
Fatigue due to long hours of operation.................................................................30
Malfunction due to interfering electromagnetic fields.......................................30
Spillage.......................................................................................................................30
Instrument ................................................................................................................30
Sample identification...............................................................................................31
Delayed results .........................................................................................................31
Notices.............................................................................................................................32
Moving parts.............................................................................................................32
Circuit breakers and fuses.......................................................................................32
Roche Diagnostics
20 Operator’s Manual · Version 2.9.5
1 General safety information cobas® 8100 automated workflow series
Table of contents
Spillage.......................................................................................................................32
Fixed size trays .........................................................................................................32
Software.....................................................................................................................33
Safety labels on the system..................................................................................................34
Location of safety labels on the instrument................................................................35
Locations of safety labels on the connection components .......................................38
Disposal .................................................................................................................................41
/