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cobas 8100 AliquoterModule

Roche cobas 8100 AliquoterModule 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 1.1
Document information
Edition notice This Operator's Manual is for users of the cobas® 8100 automated workflow series.
The co
bas® 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 i
s 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 co
bas® 8100 automated workflow series is a collection of interlinked modules for
processing and transporting patient samples.
The system is designed to centrifuge patient samp
les, 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 co
bas® 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 Operato
r's Manual thoroughly before using the
system.
Any user modification of the instrument will render the warranty or service
agreem
ent 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 co
bas® 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 August 2013
1.1 01-02 September 2013 Graphics updated
Minor revisions
Table 1 Revision history
The cobas® 8100 automated workflow series instrument
complies with IVD Directive 98/79/EC.
Roche Diagnostics
Operator’s Manual · Version 1.1 3
cobas® 8100 automated workflow series
Contact addresses
Manufacturer of cobas® 8100
automated workflow series
instrument
Authorized representative
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
Roche Diagnostics
4 Operator’s Manual · Version 1.1
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Operator’s Manual · Version 1.1 5
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 29
2 Overview of system components
Overview 33
System configuration 38
General specifications 39
Instrument components 40
Sample and holder flow 48
Sample tubes 50
Sample and holder identification 51
Operating modes 54
Overview of alarms 55
3 Modules
Overview of sample stations 59
Input station 60
Aliquot station 76
Output station 85
RFM module 96
4 Overview of the control unit software
Introduction 103
The control unit PC 104
Overview of the control unit software 105
Overview of key windows 108
Online help 115
Operation
5 Safety information for operation
General information 125
Safety messages of the overall system 126
Safety messages for specific modules 128
6 Daily operation
Daily workflow 131
Prepare for system start-up 132
System start-up 134
Handling samples, sample trays, and tip trays 140
Loading samples 141
Monitoring the processing of samples 145
Monitoring and controlling the system 148
Searching for samples 150
Retrieving samples 152
Error samples 154
Unloading samples 158
Post-operation checks and inspections 162
Full system shutdown 163
System restart 166
Logging off, shutting down, and closing the
control unit software 172
7 Extended operation
Overview of extended operation 175
Backing up and restoring parameters 176
Adding new users and modifying existing
users 177
Adding new tests and modifying existing
tests 178
Adding new processing groups and modifying
existing processing groups 179
Adding new sample types and modifying
existing sample types 180
Switching between ACU profiles 181
Setting ACU profiles 182
Setting alarm sounds and lights 183
8 Reports
Reports overview 187
Generating result reports 188
Generating sample summary reports 189
Generating process result reports 190
Generating sample count reports 191
Generating data log reports 192
Maintenance
9 Safety information for maintenance
General information 197
Safety messages of the overall system 198
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cobas® 8100 automated workflow series
10 Maintenance actions
Overview 205
Maintenance schedule 208
Maintenance of the input station 212
Maintenance of the aliquot station 243
Maintenance of the output station 276
Maintenance of the RFM module 289
General maintenance actions 296
Troubleshooting
11 Troubleshooting
General information about troubleshooting 303
Troubleshooting alarms 304
Troubleshooting problems with the system 307
Troubleshooting problems with modules 317
12 Limited Operation
Overview of limited operation 359
Module masking 359
Masking processing groups and tests 364
Glossary
13 Glossary
Index
Index 373
Revisions
Roche Diagnostics
Operator’s Manual · Version 1.1 7
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 co
bas 8100 automated workflow series allows a range of configurable
connections to online analyzers, including the cobas® 6000 analyzer series, the
co
bas® 8000 modular analyzer series, the STAGO STA-R Evolution®, and post-
analytical un
its including the cobas® p 501 and co
bas® 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 troubleshooti
ng 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.
U
For more information, see Online help (p. 115).
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
agree
ment for the system.
Ordering information Spare parts and consumables for the co
bas 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
Roche Diagnostics
8 Operator’s Manual · Version 1.1
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
Table 2 Symbols used in this document
Abbreviation Definition
A
ACU Automatic Centrifuge U
nit 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 an
d the UCL
CLAS 2 Clinical Laboratory Au
tomation System 2
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
Table 3 Abbreviations used in this document
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Operator’s Manual · Version 1.1 9
cobas® 8100 automated workflow series
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
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 3 Abbreviations used in this document
cobas® 8100 automated workflow series
Roche Diagnostics
10 Operator’s Manual · Version 1.1
System Description
1 General safety information ..............................................................................................................13
2 Overview of system components ......................................................................................................31
3 Modules.............................................................................................................................................57
4 Overview of the control unit software ..........................................................................................101
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Operator’s Manual · Version 1.1 13
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 ................................................................................................................................
.29
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14 Operator’s Manual · Version 1.1
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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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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
Roc
he Diagnostics.
o Carefully follow the procedures specified in the Op
erator'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 wit
h 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 representative
s 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
m
alfunction of the system.
U
See Environmental conditions (p. 39).
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 condi
tions 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 m
anual 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 softwa
re. 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
pow
er 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
pe
riod
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
transportati
on to trained and authorized Roche personnel.
U
For information about disposal of the system, see Disposal (p. 29).
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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 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 reinsert used caps.
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1 General safety information cobas® 8100 automated workflow series
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. 29).
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 drawer lock button to stop flashing before you open a loading 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. 29.
/