Roche cobas 8100 AliquoterModule User manual

cobas® 8100 automated

workflow series

Operator’s Manual

Software Version 02-01

cobas® 8100 automated workflow series

Roche Diagnostics

2 Operator’s Manual · Version 2.0

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 processing modules,

connection components, and a control unit PC, 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 an automated, software controlled

system for processing patient samples before they go for analysis.

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 to

connected analyzers.

The cobas® 8100 automated workflow series is intended for use with analyzers that

perform tests in the areas of immunology, clinical chemistry, coagulation, urinalysis,

and hematology.

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 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.

Manual version Software version Revision date Changes

1.0 01–02 August 2013

1.1 01–02 September 2013 Graphics updated

Minor revisions

1.2 01–03 July 2014 Software updated

2.0 02–01 January 2015 New connection components

and updated DSP module

Software updated

Table 1 Revision history

Roche Diagnostics

Operator’s Manual · Version 2.0 3

cobas® 8100 automated workflow series

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.

Contact addresses

Manufacturer of cobas®8100

automated workflow series

instrument

Authorized representative

The cobas® 8100 automated workflow series instrument

complies with IVD Directive 98/79/EC.

Hitachi High-Technologies Corporation

1-24-14 Nishi-Shinbashi Minato-ku, Tokyo 105-8717

Japan

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

cobas® 8100 automated workflow series

Roche Diagnostics

4 Operator’s Manual · Version 2.0

Roche Diagnostics

Operator’s Manual · Version 2.0 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 system 28

Disposal 33

2 Overview of the system

Overview 37

System configuration 44

General specifications 45

Hardware components of the system 46

Sample and holder workflow 56

Sample tubes 59

Sample and holder identification 60

Operating modes 64

Overview of alarms 65

3 About the modules of the instrument

Overview of sample stations 69

Input station 70

Aliquot station 86

Output station 95

RFM module 106

4 About the connection components

About the connection components 113

BRF module 114

URF module 119

CRW module 123

TLJ line 126

5 Overview of the control unit PC and software

The control unit PC 131

Overview of the control unit software 133

Overview of key software areas 137

Online help 145

Operation

6 Safety information for operation

General information 157

Safety messages of the overall system 158

Safety messages for specific modules 161

7 Daily operation

Daily workflow 165

Prepare for system start-up 166

System start-up 168

Handling samples, sample trays, and tip trays 174

Loading samples 175

Monitoring the processing of samples 180

Monitoring and controlling the system 183

Searching for samples 185

Retrieving samples 187

Error samples 189

Unloading samples 194

Post-operation checks and inspections 198

Full system shutdown 199

System restart 202

Logging off, shutting down, and closing the

control unit software 209

8 Extended operation

Overview of extended operation 213

Backing up and restoring parameters 214

Adding new users and modifying existing

users 216

Adding new tests and modifying existing

tests 217

Adding new processing groups and modifying

existing processing groups 218

Adding new sample types and modifying

existing sample types 219

Saving and restoring system profiles 220

Switching between ACU profiles 221

Setting ACU profiles 222

Naming online systems 223

Setting alarm sounds and lights 224

9 Reports

Reports overview 227

Generating result reports 228

Generating sample summary reports 229

Generating process result reports 230

Generating sample count reports 231

Generating data log reports 232

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6 Operator’s Manual · Version 2.0

cobas® 8100 automated workflow series

Maintenance

10 Safety information for maintenance

General information 237

Safety messages of the overall system 238

11 Maintenance actions

Overview 245

Maintenance schedule 248

Maintenance of the input station 252

Maintenance of the aliquot station 282

Maintenance of the output station 315

Maintaining the RFM module 328

Maintenance of the connection components 335

General maintenance actions 351

Troubleshooting

12 Troubleshooting

General information about troubleshooting 359

Troubleshooting alarms 360

Troubleshooting problems with the system 363

Troubleshooting problems with modules 373

Troubleshooting problems with connection

components 412

Troubleshooting problems with online

systems 417

13 Limited Operation

Overview of limited operation 421

Masking modules 421

Masking online systems 427

Masking processing groups and tests 428

Glossary

14 Glossary

Index

Index 439

Revisions

Roche Diagnostics

Operator’s Manual · Version 2.0 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 systems, 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.

U

For more information, see Online help (p. 145).

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 2.0

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.

Product names Except where the context clearly indicates otherwise, the product names and

abbreviations below are used in this Operator's Manual.

Symbols The symbols below are used in this Operator's Manual.

Abbreviations The abbreviations below are used in this Operator's Manual.

Product name Abbreviation

cobas® 8100 automated workflow series,

including processing modules, control unit

software, and connection components.

System

cobas® 8100 automated workflow series,

processing modules only.

Instrument

cobas® 8100 automated workflow series,

including the RFM module and CLAS 2

system.

Version 1

cobas® 8100 automated workflow series,

including new bi-directional connection

components.

Version 2

Table 2 Product names used in this document

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 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

BRF Bi-directional Reformatter module

Table 4 Abbreviations used in this document

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cobas® 8100 automated workflow series

C

CE European Conformity marking

CL8 CLAS 2 Connection Line between the instrument and the UCL

CLAS 2 Clinical Laboratory Automation System 2

CRW Connection line type R With power unit

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

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 Flexible

S

STAT Short Turnaround Time

Originally an abbreviation of Statim, meaning immediately or urgent.

T

TLJ Transport Line with Junction

U

UCL Universal Connection Line

UL Underwriters Laboratories Inc.

URF Uni-directional Reformatter module

W

WEEE European Waste Electrical and Electronic Equipment directive

Abbreviation Definition

Table 4 Abbreviations used in this document

cobas® 8100 automated workflow series

Roche Diagnostics

10 Operator’s Manual · Version 2.0

System Description

1 General safety information ..............................................................................................................13

2 Overview of the system .....................................................................................................................35

3 About the modules of the instrument..............................................................................................67

4 About the connection components................................................................................................111

5 Overview of the control unit PC and software............................................................................. 129

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Operator’s Manual · Version 2.0 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

False or wrongly reported results ..........................................................................20

Caution messages...........................................................................................................21

Mechanical safety.....................................................................................................22

Working solutions...................................................................................................23

Insoluble contaminants in samples.......................................................................23

Evaporation of samples...........................................................................................23

Fatigue due to long hours of operation ................................................................23

Malfunction due to interfering electromagnetic fields.......................................24

Spillage ......................................................................................................................24

Instrument................................................................................................................24

Sample identification ..............................................................................................25

Delayed results .........................................................................................................25

Notices.............................................................................................................................25

Moving parts ............................................................................................................26

Circuit breakers and fuses ......................................................................................26

Spillage ......................................................................................................................26

Fixed size trays .........................................................................................................26

Software.....................................................................................................................26

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14 Operator’s Manual · Version 2.0

1 General safety information cobas® 8100 automated workflow series

Table of contents

Safety labels on the system..................................................................................................28

Locations of safety labels on the instrument..............................................................29

Locations of safety labels on the connection components.......................................31

Disposal .................................................................................................................................33

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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 system

(p. 28).

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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16 Operator’s Manual · Version 2.0

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.

Environmental conditions o Operation outside of the specified ranges can lead to incorrect processing or

malfunction of the system.

U

See Environmental conditions (p. 45).

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 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

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. 33).

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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 system (p. 28), particularly Electrical safety (p. 29).

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 If you must remove an open sample from the system, hold the sample tube firmly and

upright. Do not drop the sample tube.

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.

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1 General safety information cobas® 8100 automated workflow series

Safety summary

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.

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. 33).

False or wrongly reported results

WARNING

Multiple barcode labels

Multiple barcode labels on sample tubes can cause the system to misidentify samples.

Misidentification can cause wrongly reported results.

r Check each sample tube for multiple barcode labels.

r Check each barcode label against information from the LIS.

r Remove extra and incorrect barcode labels.

r If necessary, print a new barcode label.

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Roche cobas 8100 AliquoterModule User manual

Roche cobas 8100 AliquoterModule User manual

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