Roche cobas 8100 AliquoterModule 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.

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

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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

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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

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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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1 General safety CLAS 2 for cobas® 8100 automated workflow series

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

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

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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1 General safety CLAS 2 for cobas® 8100 automated workflow series

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 Windows™ 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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1 General safety CLAS 2 for cobas® 8100 automated workflow series

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 AliquoterModule User manual

Roche cobas 8100 AliquoterModule User manual

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