Roche cobas 8100 AliquoterModule User manual

cobas® 8100 automated workflow series

Operator’s Manual

Software Version 02-06

cobas® 8100 automated workflow series

Roche Diagnostics

2 Operator’s Manual · Version 2.4

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.

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

2.1 02–03 March 2015 Added RFX and PXT modules

Graphics updated

Software updated

2.2 02–03 April 2015 Updated RFX module

troubleshooting section

Added power supply

specifications

2.3 02-04 and above June 2015 Added CLW and CRO

modules, and SLL and SLR

lines

Minor revisions

2.4 02-06 October 2015 Added SCM module and

software

Graphics updated

Table 1 Revision history

Roche Diagnostics

Operator’s Manual · Version 2.4 3

cobas® 8100 automated workflow series

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.

Instrument approvals The cobas® 8100 automated workflow series instrument complies with the emission

and immunity requirements described in standard IEC 61326-2-6:2005.

Furthermore, the cobas® 8100 automated workflow series instrument is

manufactured and tested according to the international safety standards

IEC 61010-2-101:2002, IEC 61010-2-020:2006, and IEC 60825-1:2007.

Contact addresses

Inside the European Union and EFTA member states

Manufacturer of cobas® 8100

automated workflow series

instrument

Authorized representative

The cobas® 8100 automated workflow series instrument

complies with IVD Directive 98/79/EC.

Issued by TÜV Rheinland 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

68305 Mannheim, Germany

cobas® 8100 automated workflow series

Roche Diagnostics

4 Operator’s Manual · Version 2.4

Outside the European Union and EFTA member states

Manufactured by

Hitachi High-Technologies Corporation

Manufactured for

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

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cobas® 8100 automated workflow series

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Operator’s Manual · Version 2.4 7

cobas® 8100 automated workflow series

Table of contents

Document information 2

Contact addresses 3

Table of contents 7

About the cobas 8100 automated workflow

series 11

Where to find information 11

User information 11

Conventions used in this document 12

System Description

1 General safety information

Safety classifications 19

Safety precautions 20

Safety summary 22

Safety labels on the system 32

Disposal 39

2 Overview of the system

Overview 43

System configuration 51

General specifications 52

Hardware components of the system 53

Sample and holder workflow 67

Sample tubes 70

Sample and holder identification 71

Operating modes 75

Overview of alarms 76

3 About the modules of the instrument

Overview of sample stations 79

Input station 80

Aliquot station 99

Output station 108

RFM module 119

4 About the connection components

About the connection components 125

BRF module 126

RFX module 131

URF module 136

CLW module 140

CRO module 143

CRW module 146

PXT module 149

SLL line 151

SLR line 153

TLJ line 155

5 Overview of the control unit PC and software

The control unit PC 161

Overview of the control unit software 163

Overview of key software areas 167

Online help 175

Operation

6 Safety information for operation

General information 185

Safety messages of the overall system 186

Safety messages for specific modules 189

7 Daily operation

Daily workflow 193

Prepare for system start-up 194

System start-up 197

Handling samples, sample trays, and tip trays 206

Loading samples 207

Monitoring the processing of samples 212

Monitoring and controlling the system 215

Searching for samples 217

Retrieving samples 219

Error samples 221

Unloading samples 226

Post-operation checks and inspections 230

Full system shutdown 231

System restart 234

Logging off, shutting down, and closing the

control unit software 242

8 Extended operation

Overview of extended operation 245

Backing up and restoring parameters 246

Adding new users and modifying existing

users 248

Adding new tests and modifying existing

tests 249

Adding new processing groups and modifying

existing processing groups 250

Adding new sample types and modifying

existing sample types 251

Saving and restoring system profiles 252

Switching between ACU profiles 253

Setting ACU profiles 254

Naming online systems 255

Setting alarm sounds and lights 256

Assigning samples to color classes on the

SCM module 257

Backing up sample images on the SCM

module 260

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cobas® 8100 automated workflow series

9 Reports

Reports overview 263

Generating result reports 264

Generating sample summary reports 265

Generating process result reports 266

Generating sample count reports 267

Generating data log reports 268

Maintenance

10 Safety information for maintenance

General information 273

Safety messages of the overall system 274

11 Maintenance actions

Overview 281

Maintenance schedule 284

Maintenance checklist 288

Maintenance of the input station 296

Maintenance of the aliquot station 335

Maintenance of the output station 368

Maintaining the RFM module 381

Maintenance of the connection components 388

General maintenance actions 411

Troubleshooting

12 Troubleshooting

General information about troubleshooting 419

Troubleshooting alarms 420

Troubleshooting problems with the system 423

Troubleshooting problems with modules 433

Troubleshooting problems with connection

components 474

Troubleshooting problems with online

systems 487

13 Limited Operation

Overview of limited operation 491

Masking modules 491

Masking online systems 498

Masking processing groups and tests 499

Glossary

14 Glossary

Index

Index 509

Revisions

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cobas® 8100 automated workflow series

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Operator’s Manual · Version 2.4 11

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®, the

Sysmex XN-9000 analyzer, 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. Online help contains extra information about the software, for example, the

purpose of software buttons.

u For more information, see Online help (p. 175).

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

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12 Operator’s Manual · Version 2.4

Conventions used in this document

Visual cues and shortened names 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

Table 4 Abbreviations used in this document

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cobas® 8100 automated workflow series

BRF Bi-directional reformatter module

C

CE European Conformity marking

CL8 CLAS 2 connection line between the instrument and the UCL

CLAS 2 Clinical laboratory automation system 2

CLW Connection line type L with power unit

CRO Connection line type R without power unit

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

LLD Liquid level detection

N

n/a not applicable

O

OBS Output buffer/sorter module

P

PC Personal computer

PXT Power extension module

R

RCL Reformatter connection line

RFID Radio frequency identification

RFM Reformatter module

RFX Reformatter module for Sysmex XN-9000 analyzers

RSF Restopper module flexible

S

SCM Sample check module

SLL Simple line type L

SLR Simple line type R

STAT Short turnaround time

Originally an abbreviation of Statim, meaning immediately or urgent.

T

Abbreviation Definition

Table 4 Abbreviations used in this document

cobas® 8100 automated workflow series

Roche Diagnostics

14 Operator’s Manual · Version 2.4

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

System Description

1 General safety information.............................................................................................................. 17

2 Overview of the system .................................................................................................................... 41

3 About the modules of the instrument.............................................................................................. 77

4 About the connection components................................................................................................. 123

5 Overview of the control unit PC and software.............................................................................. 159

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Operator’s Manual · Version 2.4 17

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.............................................................................................................19

Safety precautions.................................................................................................................20

Operator qualification...................................................................................................20

Safe and proper use of the system................................................................................20

Miscellaneous safety precautions.................................................................................21

Safety summary ....................................................................................................................22

Warning messages..........................................................................................................22

Electrical safety.........................................................................................................22

Biohazardous materials ...........................................................................................23

Flammable materials ...............................................................................................24

Waste..........................................................................................................................24

False or wrongly reported results...........................................................................24

Lasers.........................................................................................................................25

Caution messages...........................................................................................................25

Mechanical safety.....................................................................................................26

Working solutions....................................................................................................27

Exposure to lasers ....................................................................................................27

Insoluble contaminants in samples........................................................................27

Evaporation of samples ...........................................................................................27

Fatigue due to long hours of operation.................................................................28

Malfunction due to interfering electromagnetic fields .......................................28

Spillage.......................................................................................................................28

Instrument ................................................................................................................28

Sample identification...............................................................................................29

Delayed results .........................................................................................................29

Notices .............................................................................................................................30

Moving parts.............................................................................................................30

Circuit breakers and fuses.......................................................................................30

Spillage.......................................................................................................................30

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1 General safety information cobas® 8100 automated workflow series

Table of contents

Fixed size trays .........................................................................................................30

Software.....................................................................................................................31

Safety labels on the system ..................................................................................................32

Locations of safety labels on the instrument ..............................................................33

Locations of safety labels on the connection components........................................36

Disposal .................................................................................................................................39

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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. 32).

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.

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

malfunction of the system.

u See Environmental conditions (p. 52).

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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Roche cobas 8100 AliquoterModule User manual

Roche cobas 8100 AliquoterModule User manual

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