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Roche cobas 8100 AddOnBuffer User manual

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cobas® 8100 automated
workflow series
Operator’s Manual
Software Version 01-02
cobas® 8100 automated workflow series
Roche Diagnostics
2 Operator’s Manual · Version 1.0
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 a control unit PC and
workflow modules 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 a collection of interlinked modules for
processing and transporting patient samples.
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 can
transport samples to connected analyzers using CLAS 2 components.
The cobas® 8100 automated workflow series is intended for use with analyzers that
perform tests in the areas of immunology, clinical chemistry, coagulation, urinalysis,
hematology, and serology.
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 service
agreement null and void.
Copyright © 2013, 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.
Manual version Software version Revision date Changes
1.0 01-02 – –
Table 1 Revision history
Online help version Software version Revision date Changes
1.0 01-02 – –
Table 2 Revision history
The cobas® 8100 automated workflow series instrument
complies with IVD Directive 98/79/EC.
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cobas® 8100 automated workflow series
Instrument approvals
Contact addresses
Manufacturer of cobas® 8100
automated workflow series
instrument
Authorized representative
Issued by Intertek 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
D-68305 Mannheim, Germany
cobas® 8100 automated workflow series
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cobas® 8100 automated workflow series
Table of contents
Document information 2
Contact addresses 3
Table of contents 5
About the cobas 8100 automated workflow
series 7
Where to find information 7
User information 7
Conventions used in this document 8
System Description
1 General safety information
Safety classifications 15
Safety precautions 16
Safety summary 18
Safety labels on the instrument 25
Disposal 28
2 Overview of system components
Overview 31
System configuration 35
General specifications 36
Instrument components 37
Sample and holder flow 44
Sample tubes 46
Sample and holder identification 47
Operating modes 50
Overview of alarms 51
3 Modules
Overview of sample stations 55
Input station 56
Aliquot station 71
Output station 80
RFM module 91
4 Overview of the control unit software
Introduction 97
The control unit PC 98
Overview of the control unit software 99
Overview of key windows 102
Online help 108
Operation
5 Safety information for operation
General information 119
Safety messages of the overall system 120
Safety messages for specific modules 122
6 Daily operation
Daily workflow 125
Prepare for system start-up 126
System start-up 128
Handling samples, sample trays, and tip trays 134
Loading samples 135
Monitoring the processing of samples 139
Monitoring and controlling the system 142
Searching for samples 144
Retrieving samples 146
Error samples 148
Unloading samples 152
Post-operation checks and inspections 156
Full system shutdown 157
System restart 160
Log off, shut down, and close
the control unit software 167
7 Extended operation
Overview of extended operation 171
Backing up and restoring parameters 172
Adding new users and modifying existing
users 173
Adding new tests and modifying existing
tests 174
Adding new processing groups and modifying
existing processing groups 175
Adding new sample types and modifying
existing sample types 176
Switching between ACU profiles 177
Setting alarm sounds and lights 178
8 Reports
Reports overview 181
Generating result reports 182
Generating sample summary reports 183
Generating process result reports 184
Generating sample count reports 185
Generating data log reports 186
Maintenance
9 Safety information for maintenance
General information 191
Safety messages of the overall system 192
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cobas® 8100 automated workflow series
10 Maintenance actions
Overview 199
Maintenance schedule 202
Maintenance of the input station 205
Maintenance of the aliquot station 236
Maintenance of the output station 268
Maintenance of the RFM module 281
General maintenance actions 288
Troubleshooting
11 Troubleshooting
General information about troubleshooting 295
Troubleshooting alarms 296
Troubleshooting problems with the system 299
Troubleshooting problems with modules 309
12 Limited Operation
Overview of limited operation 351
Module masking 351
Masking processing groups and tests 356
Glossary
13 Glossary
Index
Index 365
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 analyzers, including the cobas®
6000 analyzer series, the
cobas®
8000 modular analyzer series, the STAGO STA-R Evolution®, 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. When the online help system is displayed it shows information related to the
current window.
U For more information, see: Online help (p. 108).
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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8 Operator’s Manual · Version 1.0
Conventions used in this document
Visual cues are used to help you locate and interpret information in this document
quickly. This section explains the formatting conventions used in this document.
Symbols The symbols below are used in this Operator's Manual.
Abbreviations The abbreviations below are used in this Operator's Manual.
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
Electrical and electronic equipment marked with this symbol are
covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed of in
the municipal waste system.
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
C
CE European Conformity marking
CL8 CLAS 2 Connection Line between the instrument and the UCL
CLAS 2 Clinical Laboratory Automation System 2
CSA Canadian Standards Association
CU Control Unit
D
DSP Destopper module
E
EN European standard
H
HIS Hospital Information System
Table 4 Abbreviations used in this document
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cobas® 8100 automated workflow series
I
IEC International Electrical Commission
IPB Input Buffer module
L
LED Light Emitting Diode
LIS Laboratory Information System
N
n/a not applicable
O
OBS Output Buffer/Sorter module
P
PC Personal Computer
R
RCL Reformatter Connection Line
RFID Radio Frequency Identification
RFM Reformatter Module
RSF Restopper module for Archiving Caps
S
STAT Short Turnaround Time
Originally an abbreviation of Statim, meaning immediately or urgent.
U
UCL Universal Connection Line
UL Underwriters Laboratories Inc.
W
WEEE European Waste Electrical and Electronic Equipment Directive
Abbreviation Definition
Table 4 Abbreviations used in this document
cobas® 8100 automated workflow series
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10 Operator’s Manual · Version 1.0
System Description
1 General safety information ..............................................................................................................13
2 Overview of system components ......................................................................................................29
3 Modules.............................................................................................................................................53
4 Overview of the control unit software .............................................................................................95
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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.............................................................................................................15
Safety precautions ................................................................................................................16
Operator qualification...................................................................................................16
Safe and proper use of the system................................................................................16
Miscellaneous safety precautions.................................................................................17
Safety summary ....................................................................................................................18
Warning messages .........................................................................................................18
Electrical safety.........................................................................................................18
Biohazardous materials...........................................................................................19
Flammable materials ...............................................................................................20
Waste.........................................................................................................................20
Caution messages...........................................................................................................20
Mechanical safety.....................................................................................................20
Working solutions...................................................................................................21
Insoluble contaminants in samples.......................................................................21
Evaporation of samples...........................................................................................22
Fatigue due to long hours of operation ................................................................22
Malfunction due to interfering electromagnetic fields.......................................22
Spillage ......................................................................................................................22
Instrument................................................................................................................22
Notices.............................................................................................................................23
Moving parts ............................................................................................................23
Circuit breakers and fuses ......................................................................................23
Spillage ......................................................................................................................24
Software.....................................................................................................................24
Safety labels on the instrument ..........................................................................................25
Locations of safety labels on the instrument..............................................................26
Disposal .................................................................................................................................28
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Table of contents
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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 instrument
(p. 25).
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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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.
Operating conditions o Operation outside of the specified ranges can lead to incorrect processing or
malfunction of the system.
U See Operating conditions (p. 36).
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
operating 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.
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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 shut
down 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 the same room where the system is installed.
o Mobile phone
o Transceiver
o Cordless phone
o Other electrical devices that generate electromagnetic fields
System unused for an extended
period of time
If the system is not to be used for an extended period of time, 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. 28).
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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 instrument (p. 25), particularly Electrical safety (p. 26).
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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cobas® 8100 automated workflow series 1 General safety information
Safety summary
Biohazardous materials
WARNING
Infection by samples and associated materials
Contact with samples containing material of human origin can result in infection. All
materials and mechanical components associated with samples of human origin are
potentially biohazardous.
r Follow Good Laboratory Practices, especially when working with biohazardous
material.
r Keep the top covers and the front doors and drawers closed while the system is
operating.
r Always switch the system to the correct operating mode, as given in the appropriate
procedure, before working with an opened cover, door, or drawer, for example,
cleaning or maintenance.
r Be sure to wear appropriate protective equipment, including, but not limited to, eye
protection with side shields, fluid resistant lab coat, and disposable laboratory gloves.
r Wear a face shield if there is a chance of splash or splatter.
r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If any sample comes into contact with your skin, wash it off immediately with soap and
water and apply a disinfectant. Consult a physician.
WARNING
Biohazardous materials
All in vitro diagnostic equipment, pretreatment systems and patients samples used on this
system should be treated as potentially biohazardous materials.
r Use the personal protective equipment recommended by your facility when handling
any of these components.
r If any potentially biohazardous materials come into direct contact with your skin, wash
them off immediately and apply disinfectant. Consult a physician.
r It is possible to pierce through protective gloves. Therefore use extra caution when
working inside the instrument.
WARNING
Samples
r Avoid direct contact with samples that may be biohazardous.
r If sample spills on the instrument, wear protective clothing including, but not limited to,
a lab coat, disposable laboratory gloves, and eye protection, and wipe it up
immediately.
r Make sure that the samples do not contain clots, dust or other insoluble contaminants.
If insoluble contaminants are contained in a sample, correct measuring values may not
be obtained.
WARNING
Restopper caps
The following instructions apply to all restopper caps, including Archive caps.
r The caps are for protection from evaporation only.
r The caps are not guaranteed to be leakproof.
r Store capped tubes only in an upright position.
r If capped tubes fall, or are accidentally placed on their sides, remove the caps manually
before loading them onto the IPB module.
r Capped tubes should not be stored frozen.
r Do not push the caps into overfilled tubes.
r Do not push the cap into the sample liquid.
r Do not mix samples or re-insert used caps.
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Safety summary
Flammable materials
WARNING
Cleaning with alcohol
If equipment is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired.
r When performing maintenance using isopropyl alcohol, do not bring a flame close to
these liquids as this may result in a person receiving burns.
WARNING
Flammable and explosive materials
Use of dangerous flammables on or around the instrument can result in fire or explosion.
r Do not work in any electric compartment.
r Service and repair can only be performed by authorized and qualified personnel.
Waste
WARNING
Contamination of the environment by liquid and solid waste
The waste of the system is potentially biohazardous.
r Dispose of waste according to the appropriate local regulations.
U For information about the disposal of the system, see Disposal (p. 28).
Caution messages
CAUTION
List of caution messages
r Before operating, read the caution messages contained in this summary carefully.
Failure to observe them can result in minor or moderate injury.
Mechanical safety
CAUTION
Personal injury due to contact with moving parts
r Do not touch any parts of the system other than those specified. Keep away from
moving parts during operation.
r Do not touch the printer of the BCL module during operation.
r Keep the top covers and front doors and drawers closed and in place while the system
is operating unless specifically directed otherwise by the Operator's Manual.
r Switch the system to Stop mode before working with an opened cover, drawer, or door,
unless otherwise directed by the Operator's Manual.
r On the IPB module, the OBS module, and the AOB module, wait for the white light of
the lock release button to stop flashing before you open a loading lane drawer.
r On the RFM module, wait for the white light of the loading lane button to start flashing
before you load empty 5-position racks into the loading lane.
r On the AQM module, do not replace tip trays or empty the solid waste disposal box
during operation.
r During operation and maintenance, proceed according to the instructions given in the
Operator's Manual.
r Do not attempt to disassemble the instrument.
r Observe the system safety labels illustrated from page p. 26 to p. 28.
/