Roche cobas 8100 AddOnBuffer User manual

Type
User manual
CLAS 2 for cobas® 8100
automated workflow series
Operator’s Manual
CLAS 2 for 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 CLAS 2 (Clinical Laboratory Automation
Series 2).
CLAS 2 consists of connection modules and a controlling computer that together
provide an automated sample-transportation 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 reserves the
right to make any changes necessary without notice as part of ongoing product
development.
Intended use CLAS 2 connection components provide an automated transportation system for
carrying samples from an instrument of the cobas® 8100 automated workflow series
to online analyzers or to online sample-storage units.
It is essential that all users read this Operator’s Manual thoroughly before using the
system.
Any customer modification of the components will render the warranty or service
agreement null and void.
Copyright © 2013
-2014, 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 Clinical Laboratory Automation Series 2 meets the protection requirements specified
in IVD Directive 98/79/EC.
Manual version Software version Revision date Changes
1.0 06-16 August 2013 New manual
1.1 06-16 and above
07-01 and above
August 2014 Minor updates, new tab and new screenshots for
Utility window.
Table 1 Revision history
Clinical Laboratory Automation Series 2 complies with
IVD Directive 98/79/EC.
Roche Diagnostics
Operator's Manual · Version 1.1 3
CLAS 2 for cobas® 8100 automated workflow series
Contact addresses
Manufacturer of CLAS 2 for
cobas® 8100 automated workflow
series
Authorized representative
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shinbashi Minato-ku, Tokyo 105-8717
Japan
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
CLAS 2 for 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
CLAS 2 for cobas® 8100 automated workflow series
Table of contents
Document information 2
Contact addresses 2
Table of contents 5
About CLAS 2 7
Where to find information 7
Customer information 7
Conventions used in this document 7
System description
1 General safety
Safety classifications 13
Safety precautions 14
Safety summary 16
Safety labels on the CLAS 2 components 19
Location of safety labels on the components 20
Disposal 30
2 Overview of system components
Connection components 33
TSM PC 34
Total System Manager software 35
Alarms 43
Operating conditions 44
3 CLAS 2 connection line components
Universal Connection Line (UCL) 47
Sample Buffer Unit (SBU) 53
Turntable Unit (TUS) 55
Transport Line (TL) 56
Connection Line (CL) 58
cobas® 8000 B-Gate Sample Buffer Unit
(SBU-MA(B)) 59
Pitch Exchange Turntable Unit (PET) 61
Connection Line for cobas® 8100 (CL8) 63
Operation
4 Daily operation
General preparation for start-up 69
Starting up CLAS 2 69
Checking the status of CLAS 2 components 70
Changing the status of CLAS 2 components 71
Shutting down CLAS 2 72
5 Extended operation
Managing user accounts 77
Maintenance
6 Maintenance actions
Introduction 85
Troubleshooting
7 Basic troubleshooting
Viewing alarms 91
8 Limited operation
Consequences of non-functioning
components 95
Index
Index 99
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6 Operator's Manual · Version 1.1
CLAS 2 for cobas® 8100 automated workflow series
Roche Diagnostics
Operator's Manual · Version 1.1 7
CLAS 2 for cobas® 8100 automated workflow series
About CLAS 2
CLAS 2 comprises a family of components that provides configurable connections
from a cobas® 8100 automated workflow series instrument to online analyzers,
including the cobas® 6000 analyzer series, the cobas® 8000 modular analyzer series,
the STAGO STA-R Evolution®, and to post-analytical units, including the
cobas® p 501 and cobas® p 701.
To monitor and control the components, operators use Total System Manager (TSM)
software, which runs on a dedicated PC.
Where to find information
For information on the cobas 8100 automated workflow series and how its modules
integrate with the CLAS 2 components, refer to the Operator’s Manual for the
cobas 8100 automated workflow series.
Customer information
Customer training Contact your local Roche Sales representative for any questions or information
regarding training on the system.
Service agreement Contact your local Roche Sales representative for further information regarding a
service agreement for the system.
Ordering information Order all replacement parts and consumable materials from Roche Diagnostics.
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 are used to help you locate and interpret information in this document
quickly. This section explains the formatting conventions used in this document.
Symbols
Symbol Used for
Safety caution symbol
Q Tip
P Start of procedure
S End of procedure
Table 2 Symbols used in this document
CLAS 2 for cobas® 8100 automated workflow series
Roche Diagnostics
8 Operator's Manual · Version 1.1
Abbreviations
o List item
U Cross-reference
Electrical and electronic equipment marked with this symbol is
covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed of in
the municipal waste system.
Symbol Used for
Table 2 Symbols used in this document
Abbreviation Definition
A
ANSI American National Standards Institute
C
CE European Conformity marking
CL Connection Line
CL8 Connection Line for cobas® 8100 (not available in the USA)
CLAS 2 Clinical Laboratory Automation System 2
CSA Canadian Standards Association
I
IEC International Electrical Commission
L
LIS Laboratory Information System
P
PC Personal Computer
PET Pitch Exchange Turntable Unit (not available in the USA)
S
SBU Sample Buffer Unit
SBU-MA(B) cobas® 8000 B-Gate Buffer Unit (not available in the USA)
STAT Abbreviation of statim, meaning immediate or urgent.
Also used to mean Short Turn-Around Time
T
TL Transport Line
TSM Total System Manager software
TUS Turntable Unit
U
UCL Universal Connection Line
UL Underwriters Laboratories Inc.
Table 3 Abbreviations
System description
1 General safety....................................................................................................................................11
2 Overview of system components ......................................................................................................31
3 CLAS 2 connection line components ...............................................................................................45
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CLAS 2 for cobas® 8100 automated workflow series 1 General safety
Table of contents
General safety 1
Before you start working with the system, you must 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.............................................................................................................13
Safety precautions ................................................................................................................14
Operator qualification...................................................................................................14
Safe and proper use of the system................................................................................14
Miscellaneous safety precautions.................................................................................15
Safety summary ....................................................................................................................16
Warning messages .........................................................................................................16
Electrical safety.........................................................................................................16
Biohazardous materials...........................................................................................16
Reagents and working solutions............................................................................17
Caution messages...........................................................................................................17
Mechanical safety.....................................................................................................17
Software updates......................................................................................................17
Evaporation of samples...........................................................................................17
Fatigue due to long hours of operation ................................................................18
Transport belts .........................................................................................................18
Malfunction due to interfering electromagnetic fields.......................................18
Notices.............................................................................................................................18
Circuit breakers and fuses ......................................................................................18
Spillage ......................................................................................................................18
Software.....................................................................................................................19
Safety labels on the CLAS 2 components..........................................................................19
Location of safety labels on the components ...................................................................20
Universal Connection Line (UCL) ..............................................................................20
Sample Buffer Unit (SBU) ............................................................................................21
Turntable Unit (TUS) ...................................................................................................23
Transport Line (TL).......................................................................................................24
Connection Line (CL) ...................................................................................................24
cobas® 8000 B-Gate Sample Buffer Unit (SBU-MA(B)) ...........................................25
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Table of contents
Pitch Exchange Turntable Unit (PET)........................................................................27
Connection Line for cobas® 8100 (CL8) .....................................................................29
Disposal .................................................................................................................................30
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CLAS 2 for cobas® 8100 automated workflow series 1 General safety
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 following meanings and icons:
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 Location of safety labels on the
components (p. 20).
Important information that is not relevant to safety is indicated with the following
icon:
Q
Tip
Indicates additional information on correct use or useful tips.
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1 General safety CLAS 2 for 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 approved 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.
Operating conditions o Operation outside of the specified ranges can lead to incorrect processing or
malfunction of the system.
U
See Operating conditions (p. 44).
o Use the system indoors only and avoid heat and humidity.
o Make sure that the ventilation openings of the system always remain
unobstructed.
o To maintain the operating conditions of the system, perform maintenance
according to the specified intervals.
o To ensure that the Operator’s Manual is not damaged and remains available for
use, keep it in a safe place. 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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CLAS 2 for cobas® 8100 automated workflow series 1 General safety
Safety precautions
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage can damage the system or lead to data
loss. For preventative measures:
o Roche Diagnostics recommends that you only operate the system with an
uninterruptible power supply.
o Do not switch off power while the TSM PC accesses the hard disk or attached
storage media. 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 following devices 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
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. 30).
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Safety summary
Safety summary
This safety summary contains the most necessary general warning and caution
messages. Additionally, you will find specific safety information in other sections of
this manual.
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 covers specified in the
Operator’s Manual.
r Only authorized and qualified Roche personnel are to install, service, or repair the
system.
r Observe the safety labels on the instrument. See Location of safety labels on the
components (p. 20).
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 covers 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, during
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.
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CLAS 2 for cobas® 8100 automated workflow series 1 General safety
Safety summary
Reagents and working solutions
WARNING
Fire and burns
Alcohol is a flammable substance.
r Keep all sources of ignition (such as sparks, flames, or heat) away from the system
when you perform maintenance or checks that involve alcohol.
r When you use alcohol on or around the system, use no more than 20 mL at a time.
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 parts specified. Keep away from
moving parts during operation.
r Keep the covers closed and in place while the system is operating unless 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 Do not wear loose garments or jewelry that could catch in moving mechanisms.
r During operation and maintenance, proceed according to the instructions given in the
Operator’s Manual.
r Do not attempt to disassemble the CLAS 2 components.
Software updates
CAUTION
Data loss during software updates
TSM operates in a Windowsâ„¢ environment. Any attempts to modify the operating system
or the TSM installation may lead to a loss of data.
r Leave updates to the operating system or TSM to your Roche Service representative.
Evaporation of samples
CAUTION
Incorrect results due to evaporation of samples
Evaporation of samples can lead to incorrect results.
r Do not leave samples in open containers for an excessive period.
r Use general Good Laboratory Practices when determining how long a sample can be
open for.
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Safety summary
Fatigue due to long hours of operation
CAUTION
Fatigue due to long hours of operation
Looking at the monitor screen over an extended period can lead to eye strain or body
fatigue.
r Take a break to relax, in accordance with your local regulations.
r Avoid spending more than 6 hours per day looking at the monitor.
Transport belts
CAUTION
System malfunction due to dirty transport belts
Contamination on the transport belts may cause the instrument to malfunction.
r Ensure that you inspect the transport belts daily.
Malfunction due to interfering electromagnetic fields
CAUTION
Malfunction of system and incorrect processing due to interfering
electromagnetic fields
This system is designed and tested to CISPR 11 Class A standard. There might be items in
the local environment that can cause radio interference, in which case, you might need to
take measures to mitigate the interference.
r Evaluate the electromagnetic environment before operating the device.
r Do not operate this system close to sources of strong electromagnetic fields (for
example unshielded intentional RF sources), as they can interfere with proper
operations.
Notices
NOTICE
List of notices
Before operating, read the notices contained in this summary carefully. Failure to observe
them can result in damage to the system.
Circuit breakers and fuses
NOTICE
Damage to the system due to improper use
If one of the circuit breakers or fuses blows, do not attempt to operate the system before
contacting either your Roche Service representative or technical support.
Spillage
NOTICE
Malfunction due to spilled liquid
Any liquid spilled on the system can result in malfunction or damage.
r Do not place samples or any other liquid on the surface of the system.
r If liquid does spill on the system, wipe it up immediately and apply disinfectant. Be sure
to wear protective equipment.
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CLAS 2 for cobas® 8100 automated workflow series 1 General safety
Safety labels on the CLAS 2 components
Software
NOTICE
Corruption of software by viruses
The TSM PC does not have antivirus software installed and can be corrupted by malicious
programs.
r You must have a fire wall installed between TSM and your LIS. Contact your Roche
Service representative for appropriate fire wall software.
r Scan all removable storage devices for viruses and malware before mounting them on
the TSM PC.
r Do not install any third-party software on the TSM PC.
Safety labels on the CLAS 2 components
Warning labels are placed on the system to draw your attention to areas of potential
hazard. Listed below are labels and the definitions according to their locations.
The safety labels on the system comply with the following standards: ANSI Z535, IEC
61010-1, IEC 60417, or ISO 7000.
Q
Only Roche service personnel are to replace damaged labels. For replacement labels,
contact your local Roche representative.
Electrical warning
Contact with electrical components can cause an electric shock. This
label indicates that there is a danger of coming into contact with
electrical components when gaining access to parts of the system
marked with this label.
Refer to the Operator’s Manual for instructions on safe operations.
Pinch warning
This label indicates that there is a danger of pinching hands or fingers
within the vicinity of this label. Keep hands away from areas that can
pinch.
Avoid contact warning
This label indicates you must avoid touching the area in the vicinity
of this label or else slight or minor injuries or damage to equipment
may occur.
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Location of safety labels on the components
Location of safety labels on the components
The safety labels are attached to the connection line components in the positions
shown in the following figures.
Universal Connection Line (UCL)
Figure 1-1 Universal Connection Line (UCL) - front view
Figure 1-2 Universal Connection Line (UCL) - right side view
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Roche cobas 8100 AddOnBuffer User manual

Type
User manual

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