Roche cobas 8100 AliquoterModule User manual

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.

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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Operator’s Manual · Version 1.0 3

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

Roche Diagnostics

4 Operator’s Manual · Version 1.0

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Operator’s Manual · Version 1.0 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 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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Operator’s Manual · Version 1.0 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 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

Roche Diagnostics

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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Operator’s Manual · Version 1.0 9

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

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

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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1 General safety information cobas® 8100 automated workflow series

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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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. 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.

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Roche cobas 8100 AliquoterModule User manual

Roche cobas 8100 AliquoterModule User manual

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