Roche cobas 8100 AliquoterModule User manual

cobas® 8100 automated workflow series

Operator’s Manual

Version 2.9.3

Software version 03-08

cobas® 8100 automated workflow series

Roche Diagnostics

2 Operator’s Manual · Version 2.9.3

Document information

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

2.5 02-09 February 2016 Added:

o New CLO and USU modules

o New alarm colors

o Alarm History dialog box

o Automatic shut down function

o New options to the Get Log function

2.6 02-12 September 2016 Added RSS module and software

Graphics updated

2.7 03–02 March 2017 Added:

o New IPB 2 module

o STAT port on the IPB module

o 25-position tray for the OBS module

o 100-position tray for the IPB, IPB 2, and OBS

modules

o Primary sample tubes on RSS module

Software update

Table 1 Revision history

Roche Diagnostics

Operator’s Manual · Version 2.9.3 3

cobas® 8100 automated workflow series

2.8 03–06 October 2017 Added:

o Section Results to the description of the Get

Log dialog box

o Function to check the settings of the Test -

Details and Processing Group - Details

dialog boxes

o Function Offline to the AOB module

o Function to recap incomplete samples

o Rack supply for a BRF module connected to a

post analytical system

o Icon for centrifugation error on the Sample

Monitor dialog box

o Properties for aliquot dialog box

o cobas® 6500 urine analyzer series

o Section Automatic masking and unmasking of

online systems

o Section Instrument Masking

o Statement of conformity to the directive

2014/53/EU

o Specifications of radio equipment

The destination for error sample tray for aliquot

errors was changed.

Software update

2.9 03-07 April 2018 Safety information on laser added.

The number of maximum reformatter per system

changed from 8 to 12.

A 2nd DSP module can be added to a 2nd output

station.

The function to exclude a reformatter module

after incomplete reset process.

Automatic masking and unmasking added to the

UCU module.

Software update

2.9.1 03-08 July 2018 Software update

2.9.2 03-08 October 2018 Added configurable connections: throughout the

document

o cobas® pro integrated solutions

o cobas t 711 coagulation analyzer

o Sysmex XN-9100 analyzer

2.9.3 03-08 January 2019 Added configurable connection throughout the

document

o Thermo Scientific™ TCAutomation™ CRA

Interface

Manual version Software version Revision date Changes

Table 1 Revision history

cobas® 8100 automated workflow series

Roche Diagnostics

4 Operator’s Manual · Version 2.9.3

Edition notice This publication is intended for operators 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

publication is correct at the time of publishing. However, the manufacturer of this

product may need to update the publication information as output of product

surveillance activities, leading to a new version of this publication.

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.

CAUTION

General attention

To avoid serious or fatal injury, ensure that you are familiar with the system and safety

information before you use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not described in this publication.

r Store all publications in a safe and easily retrievable place.

Training Do not carry out operation tasks or maintenance actions unless you have received

training from Roche Diagnostics. Leave tasks that are not described in the user

documentation to trained Roche Service representatives.

Images The screenshots and hardware images in this publication have been added exclusively

for illustration purposes. Configurable and variable data in screenshots, such as tests,

results, or path names visible therein must not be used for laboratory purposes.

War ranty Any customer modification to the system renders the warranty or service agreement

null and void.

For conditions of warranty, contact your local sales representative or refer to your

warranty contract partner.

Always leave software updates to a Roche Service representative, or perform such

updates with their assistance.

Trademarks The following trademarks are acknowledged.

Roche Diagnostics

Operator’s Manual · Version 2.9.3 5

cobas® 8100 automated workflow series

COBAS, COBAS C, COBAS INTEGRA, ELECSYS, and LIFE NEEDS ANSWERS are

trademarks of Roche.

All other trademarks are the property of their respective owners.

Feedback Every effort has been made to ensure that this publication fulfills the intended use. All

feedback on any aspect of this publication is welcome and is considered during

updates. Contact your Roche representative, should you have any such feedback.

System approvals The cobas® 8100 automated workflow series meets the requirements laid down in:

o Directive 98/79/EC of the European Parliament and of the Council of 27 October

1998 on in-vitro diagnostic medical devices.

o Directive 2011/65/EU of the European Parliament and of the Council of 8 June

2011 on the restriction of the use of certain hazardous substances in electrical and

electronic equipment.

o Directive 2014/30/EU of the European Parliament and Council of 26 February

2014 relating to electromagnetic compatibility (EMC).

o Directive 2014/53/EU of the European Parliament and of the Council of 16 April

2014 on the harmonization of the laws of the Member States relating to the

making available on the market of radio equipment and repealing Directive

1999/5/EC.

The full text of the 2014/53/EU declaration of conformity is available at the

following internet address: http://e-labdoc.roche.com.

Compliance is demonstrated by the marks below.

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

immunity requirements described in standard IEC 61326-2-6 / EN 61326-2-6.

Furthermore, the cobas® 8100 automated workflow series instrument is

manufactured and tested according to the international safety standards

IEC 61010-2-101, IEC 61010-2-020, IEC 60825-1:2007, and IEC 60825-1:2014.

Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the hermetically sealed

refrigeration.

The insulation of the chamber includes foam blown with fluorinated greenhouse gas.

The cobas® 8100 automated workflow series instrument

complies with IVD Directive 98/79/EC.

The cobas® 8100 automated workflow series instrument

complies with RoHS Directive 2011/65/EU.

Issued by TÜV Rheinland for Canada and the US.

Type Charge weight (kg) CO

2

equivalent (tonne) Global warming potential

R-404A 0.260 1.02 3920

Table 2 Fluorinated greenhouse gas detail.

cobas® 8100 automated workflow series

Roche Diagnostics

6 Operator’s Manual · Version 2.9.3

Contact addresses

Inside the European Union and EFTA member states

Manufacturer of cobas® 8100

automated workflow series

instrument

Authorized representative

Outside the European Union and EFTA member states

Hitachi High-Technologies Corporation

1-24-14 Nishi-Shimbashi Minato-ku, Tokyo 105–8717

Japan

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

Manufactured by

Hitachi High-Technologies Corporation

Manufactured for

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

Roche Diagnostics

Operator’s Manual · Version 2.9.3 7

cobas® 8100 automated workflow series

Table of contents

Document information 2

Contact addresses 6

Table of contents 7

About the cobas® 8100 automated workflow

series 9

Where to find information 9

User information 9

Conventions used in this document 10

Symbols used on packaging materials 12

System Description

1 General safety information

Safety classifications 17

Safety precautions 18

Safety summary 20

Safety labels on the system 30

Disposal 37

2 Overview of the system

Overview 41

System configuration 52

General specifications 54

Hardware components of the system 55

Sample and holder workflow 71

Sample tubes 74

Sample and holder identification 76

Operating modes 82

Overview of alarms 83

3 About the modules of the instrument

Overview of sample stations 87

Input station 88

Aliquot station 110

Output station 118

RFM module 134

4 About the connection components

About the connection components 141

BRF module 142

RFX module 147

URF module 152

CLO module 156

CLW module 158

CRO module 161

CRW module 164

PXT module 167

UCU module 169

SLL line 172

SLR line 174

TLJ line 176

5 Overview of the control unit PC and software

The control unit PC 181

Overview of the control unit software 182

Overview of key software areas 186

Online Help 194

Operation

6 Safety information for operation

General information 205

Safety messages of the overall system 206

Safety messages for specific modules 209

7 Daily operation

Daily workflow 213

Prepare for system startup 214

System startup 217

Handling samples, sample trays, and tip trays 226

Loading samples 227

Monitoring the processing of samples 235

Monitoring and controlling the system 238

Searching for samples 240

Retrieving samples 242

Error samples 244

Unloading samples 249

Post-operation checks and inspections 256

Full system shutdown 257

System restart 260

Logging off, shutting down, and closing the

control unit software 268

8 Extended operation

Overview of extended operation 271

Backing up and restoring parameters 272

Adding new users and modifying existing

users 274

Adding new tests and modifying existing tests 275

Adding new processing groups and modifying

existing processing groups 276

Adding new sample types and modifying existing

sample types 277

Saving and restoring system profiles 278

Switching between ACU profiles 279

Setting ACU profiles 280

Naming online systems 281

Setting alarm sounds and lights 282

Assigning samples to color classes on the SCM

module 283

Backing up sample images on the SCM

module 286

Roche Diagnostics

8 Operator’s Manual · Version 2.9.3

cobas® 8100 automated workflow series

9 Reports

Reports overview 289

Generating result reports 290

Generating sample summary reports 291

Generating process result reports 292

Generating sample count reports 293

Generating data log reports 294

Maintenance

10 Safety information for maintenance

General information 299

Safety messages of the overall system 300

11 Maintenance actions

Overview 307

Maintenance schedule 310

Maintenance checklist 314

Maintenance of the input station 322

Maintenance of the aliquot station 361

Maintenance of the output station 391

Maintaining the RFM module 406

Maintenance of the connection components 413

General maintenance actions 436

Troubleshooting

12 Troubleshooting

General information about troubleshooting 443

Troubleshooting alarms 444

Troubleshooting problems with the system 447

Troubleshooting problems with modules 457

Troubleshooting problems with connection

components 498

Troubleshooting problems with online

systems 512

13 Limited Operation

Overview of limited operation 515

Masking modules 515

Masking online systems 523

Masking processing groups and tests 525

Appendices

Glossary

14 Glossary

Index

Index 537

Revisions

Roche Diagnostics

Operator’s Manual · Version 2.9.3 9

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 cobas® pro integrated solutions, the

cobas® 6500 urine analyzer series, the STAGO STA-R Evolution®, the STAGO STA-

R Max®, the DiaSorin LIAISON® XL, the Sysmex XN-9000 / Sysmex XN-9100

analyzer, the Thermo Scientific™ TCAutomation™ CRA Interface, and post-

analytical units including the cobas p 501, cobas p 701, and cobas t 711 coagulation

analyzer.

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 always.

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. 194).

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 catalog number and

reference name for each item. Contact Roche technical support for the detailed

ordering list.

cobas® 8100 automated workflow series

Roche Diagnostics

10 Operator’s Manual · Version 2.9.3

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 3 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 dialog box

Table 4 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 5 Abbreviations used in this document

Roche Diagnostics

Operator’s Manual · Version 2.9.3 11

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

CLO Connection line type L without power unit

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 / Sysmex XN-9100

analyzers

RSF Restopper module flexible

RSS Restopper (screw) module

S

SCM Sample check module

SLL Simple line type L

SLR Simple line type R

Abbreviation Definition

Table 5 Abbreviations used in this document

cobas® 8100 automated workflow series

Roche Diagnostics

12 Operator’s Manual · Version 2.9.3

Symbols used on packaging materials

STAT Short turnaround time

Originally an abbreviation of Statim, meaning immediately or urgent.

T

TLJ Transport line with junction

U

UCL Universal connection line

UCU Universal connection unit

UL Underwriters Laboratories Inc.

URF Uni-directional reformatter module

W

WEEE European Waste Electrical and Electronic Equipment directive

Abbreviation Definition

Table 5 Abbreviations used in this document

Symbol Definition

Quantity in the package

Table 6 Symbols used on packaging materials

System Description

1 General safety information.............................................................................................................. 15

2 Overview of the system .................................................................................................................... 39

3 About the modules of the instrument.............................................................................................. 85

4 About the connection components................................................................................................. 139

5 Overview of the control unit PC and software.............................................................................. 179

Roche Diagnostics

Operator’s Manual · Version 2.9.3 15

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.............................................................................................................17

Safety precautions.................................................................................................................18

Operator qualification...................................................................................................18

Safe and proper use of the system................................................................................18

Miscellaneous safety precautions.................................................................................19

Safety summary ....................................................................................................................20

Warning messages..........................................................................................................20

Electrical safety.........................................................................................................20

Biohazardous materials...........................................................................................21

Flammable materials ...............................................................................................22

Waste..........................................................................................................................22

False or wrongly reported results...........................................................................22

Lasers.........................................................................................................................23

Caution messages...........................................................................................................24

Mechanical safety.....................................................................................................24

Working solutions....................................................................................................25

Exposure to lasers ....................................................................................................25

Insoluble contaminants in samples........................................................................25

Evaporation of samples ...........................................................................................25

Fatigue due to long hours of operation.................................................................26

Malfunction due to interfering electromagnetic fields.......................................26

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

Instrument ................................................................................................................26

Sample identification...............................................................................................27

Delayed results .........................................................................................................27

Notices.............................................................................................................................28

Moving parts.............................................................................................................28

Circuit breakers and fuses.......................................................................................28

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

Roche Diagnostics

16 Operator’s Manual · Version 2.9.3

1 General safety information cobas® 8100 automated workflow series

Table of contents

Fixed size trays .........................................................................................................28

Software.....................................................................................................................29

Safety labels on the system..................................................................................................30

Location of safety labels on the instrument................................................................31

Locations of safety labels on the connection components .......................................34

Disposal .................................................................................................................................37

Roche Diagnostics

Operator’s Manual · Version 2.9.3 17

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. 30).

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.

Roche Diagnostics

18 Operator’s Manual · Version 2.9.3

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. 54).

o Use the system indoors only and avoid heat and humidity.

o Make sure that the ventilation openings of the system remain unobstructed

always.

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.

Roche Diagnostics

Operator’s Manual · Version 2.9.3 19

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

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 devices below in close proximity to where the system is installed.

o Mobile phone

o Transceiver

o Cordless phone

o Other electrical devices that generate strong 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. 37).

Aliquot tip containers To prevent injury to your hands, carefully open aliquot tip containers.

Roche Diagnostics

20 Operator’s Manual · Version 2.9.3

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. 30), particularly Electrical safety (p. 31).

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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Roche cobas 8100 AliquoterModule User manual

Roche cobas 8100 AliquoterModule User manual

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