Roche cobas 8100 AddOnBuffer User manual

cobas® 8100 automated workflow series

Operator’s Manual

Version 2.9.5

Software version 04-01

cobas® 8100 automated workflow series

Roche Diagnostics

2 Operator’s Manual · Version 2.9.5

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 2.9.5 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

Manual version Software version Revision date Changes

Table 1 Revision history

cobas® 8100 automated workflow series

Roche Diagnostics

4 Operator’s Manual · Version 2.9.5

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.

2.9.3 03-08 January 2019 Added configurable connection throughout the

document

o Thermo Scientific™ TCAutomation™ CRA Interface

2.9.4 03-09 March 2019 Updated images:

o The Sample Type dialog box

o The Draw Volume Settings dialog box

o The Function Offline Settings dialog box

Added:

o Bulk loader systems to the configurable connections

o Section Radius of the rotor room Specifications -

ACU module

o Section Performance guarantee of barcode label in

Specifications - BCL module

o Information about barricor tubes

o Information about Function Offline Settings of the

SCM module

o Sections Tube Type Settings and Cap Color Settings

to the description of the Draw Volume Settings

dialog box

Revised:

o The procedure: Assigning samples to color classes

on the SCM module

New user interface of the software of the SCM module

2.9.5 04-01 March 2020 Update to Windows 10 (SW 04-01).

Information from the Addenda 1.0 and 2.0 to

Operator’s Manual version 2.9.4 have been integrated.

u What is new in publication version 2.9.5 (p. 11)

Manual version Software version Revision date Changes

Table 1 Revision history

Roche Diagnostics

Operator’s Manual · Version 2.9.5 5

cobas® 8100 automated workflow series

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.

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.

cobas® 8100 automated workflow series

Roche Diagnostics

6 Operator’s Manual · Version 2.9.5

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 distinction between the 2 fluorinated greenhouse gas types is made with a name

label on the front of the ACU module.

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

R-448A 0.260 0.36 1387

Table 2 Fluorinated greenhouse gas detail.

Roche Diagnostics

Operator’s Manual · Version 2.9.5 7

cobas® 8100 automated workflow series

Figure 1 Fluorinated greenhouse gas label on the centrifuge unit inside the ACU module.

A Name label

Type: R-404A Type: R-448A

Name label

Table 3 Name labels of different types of fluorinated greenhouse gas.

A

TYPE

ME30C

CENTRIFUGE UNIT

200V~60Hz

208V~60Hz

S311617

Refrigerant R-404A

260g (0.573 lb)

Design Pressure

High-side 3.45 MPa (500 psi)

1.2 MPA (174 psi)

Koki Holdings Co., Ltd.

Low-side

200V~50Hz

230V~50Hz

2kVA

S102366

VOLT.

POWER

CAT.NO.

MFG.NO.

TYPE

ME30C

CENTRIFUGE UNIT

200V~60Hz

208V~60Hz

S311801

Refrigerant R-448A

260g (0.573 lb)

Design Pressure

High-side 2.8 MPa (406 psi)

0.33 MPA (48 psi)

Koki Holdings Co., Ltd.

Low-side

200V~50Hz

230V~50Hz

2kVA

S102366

VOLT.

POWER

CAT.NO.

MFG.NO.

cobas® 8100 automated workflow series

Roche Diagnostics

8 Operator’s Manual · Version 2.9.5

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

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

Manufactured by

Manufactured for

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany

Hitachi High-Technologies Corporation

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

Japan

Hitachi High-Technologies Corporation

Roche Diagnostics

Operator’s Manual · Version 2.9.5 9

cobas® 8100 automated workflow series

Table of contents

Document information 2

Contact addresses 8

Table of contents 9

What is new in publication version 2.9.5 11

What is new in publication version 2.9.4 11

About the cobas® 8100 automated workflow

series 12

Where to find information 12

User information 13

Conventions used in this document 13

Symbols used on packaging materials 15

System Description

1 General safety information

Safety classifications 21

Safety precautions 22

Safety summary 24

Safety labels on the system 34

Disposal 41

2 Overview of the system

Overview 45

System configuration 56

General specifications 58

Hardware components of the system 59

Sample and holder workflow 76

Sample tubes 79

Sample and holder identification 81

Operating modes 87

Overview of alarms 88

3 About the modules of the instrument

Overview of sample stations 91

Input station 92

Aliquot station 114

Output station 123

RFM module 139

4 About the connection components

About the connection components 145

BRF module 146

RFX module 151

URF module 156

CLO module 160

CLW module 162

CRO module 165

CRW module 168

PXT module 171

UCU module 173

SLL line 176

SLR line 178

TLJ line 180

5 Overview of the control unit PC and software

The control unit PC 185

Overview of the control unit software 186

Overview of key software areas 190

Online Help 198

Operation

6 Safety information for operation

General information 209

Safety messages of the overall system 210

Safety messages for specific modules 213

7 Daily operation

Daily workflow 217

Prepare for system startup 218

System startup 221

Handling samples, sample trays, and tip trays 230

Loading samples 231

Monitoring the processing of samples 239

Monitoring and controlling the system 242

Searching for samples 244

Retrieving samples 246

Error samples 248

Unloading samples 253

Post-operation checks and inspections 260

Full system shutdown 261

System restart 264

Logging off, shutting down, and closing the

control unit software 272

Roche Diagnostics

10 Operator’s Manual · Version 2.9.5

cobas® 8100 automated workflow series

8 Extended operation

Overview of extended operation 275

Backing up and restoring parameters 276

Adding new users and modifying existing

users 278

Adding new tests and modifying existing tests 279

Adding new processing groups and modifying

existing processing groups 280

Adding new sample types and modifying existing

sample types 281

Saving and restoring system profiles 282

Switching between ACU profiles 283

Setting ACU profiles 284

Naming online systems 285

Setting alarm sounds and lights 286

Assigning samples to color classes on the SCM

module 287

Backing up sample images on the SCM

module 290

9 Reports

Reports overview 293

Generating result reports 294

Generating sample summary reports 295

Generating process result reports 296

Generating sample count reports 297

Generating data log reports 298

Maintenance

10 Safety information for maintenance

General information 303

Safety messages of the overall system 304

11 Maintenance actions

Overview 311

Maintenance schedule 314

Maintenance checklist 318

Maintenance of the input station 326

Maintenance of the aliquot station 365

Maintenance of the output station 395

Maintaining the RFM module 410

Maintenance of the connection components 417

General maintenance actions 440

Troubleshooting

12 Troubleshooting

General information about troubleshooting 447

Troubleshooting alarms 448

Troubleshooting problems with the system 451

Troubleshooting problems with modules 461

Troubleshooting problems with connection

components 502

Troubleshooting problems with online

systems 516

13 Limited Operation

Overview of limited operation 519

Masking modules 519

Masking online systems 527

Masking processing groups and tests 529

Glossary

14 Glossary

Index

Index 539

Revisions

Roche Diagnostics

Operator’s Manual · Version 2.9.5 11

cobas® 8100 automated workflow series

What is new in publication version 2.9.5

Update to Windows 10 The software version 04-01 is functional identical to version 03-09 but has been

designed for Windows 10 computers.

Information from Addendum 1

integrated

The ACU module uses a fluorinated greenhouse gas, either R-404A or R-448A (new).

Check the name label to identify the refrigerant used.

u Fluorinated greenhouse gas (p. 6)

Two graphics showing the centrifuge unit inside the ACU module have been

updated.

u ACU module (p. 103)

Information from Addendum 2

integrated

A warning message about sharp, rough edges has been added.

u Sharps, rough edges, and/or moving parts (p. 24)

What is new in publication version 2.9.4

Bulk loader systems Bulk loader systems added to the configurable connections.

u About the cobas® 8100 automated workflow series (p. 12)

Radius of the rotor room in the

ACU module

Information about the radius of the rotor room added.

u Specifications - ACU module (p. 105)

Performance guarantee of barcode

label

Information about the performance guarantee of barcode labels o f the BCL module

added.

u Specifications - BCL module (p. 116)

Barricor tubes A new caution message added and information about loading barricor tubes.

u Loading routine samples (p. 231)

Changed user interfacer of the

software of the SCM module

The user interface of the software of the SCM module is updated. The update leads to

changes in some procedures.

u Assigning samples to color classes on the SCM module (p. 287)

Function Offline Settings On the SCM module, you can set specific module functions to Offline mode.

u Setting specific module functions to Offline mode (p. 525)

Draw Volume Settings Sections Tube Type Settings and Cap Color Settings added to the description of the

Draw Volume Settings dialog box.

cobas® 8100 automated workflow series

Roche Diagnostics

12 Operator’s Manual · Version 2.9.5

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:

o Online systems including

O cobas® 6000 analyzer series

O cobas® 8000 modular analyzer series

O cobas® pro integrated solutions

O cobas® 6500 urine analyzer series

O cobas t 711 coagulation analyzer

O STAGO STA-R Evolution®

O STAGO STA-R Max®

O DiaSorin LIAISON® XL

O Sysmex XN-9000 / Sysmex XN-9100 analyzer

O Thermo Scientific™ TCAutomation™ CRA Interface

O Phadia™ 250 analyzer

o Post-analytical units including

O cobas p 501

O cobas p 701

o Bulk Loader system

O Bulk Loader Module (BLM) for centrifuge unit cobas p 671 (67x)

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. 198).

Roche Diagnostics

Operator’s Manual · Version 2.9.5 13

cobas® 8100 automated workflow series

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.

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.

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

BD Vacutainer® Barricor Plasma Blood

Collection Tubes

Barricor tube

Table 4 Product names used in this document

Symbol Used for

Safety caution symbol

Q Tip

P Start of procedure

S End of procedure

Table 5 Symbols used in this document

cobas® 8100 automated workflow series

Roche Diagnostics

14 Operator’s Manual · Version 2.9.5

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

o List item

U Cross-reference

f Path to the active menu or dialog box

Symbol Used for

Table 5 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

BLM Bulk Loader Module

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

Table 6 Abbreviations used in this document

Roche Diagnostics

Operator’s Manual · Version 2.9.5 15

cobas® 8100 automated workflow series

Symbols used on packaging materials

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

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 6 Abbreviations used in this document

Symbol Definition

Quantity in the package

Table 7 Symbols used on packaging materials

cobas® 8100 automated workflow series

Roche Diagnostics

16 Operator’s Manual · Version 2.9.5

System Description

1 General safety information.............................................................................................................. 19

2 Overview of the system .................................................................................................................... 43

3 About the modules of the instrument.............................................................................................. 89

4 About the connection components................................................................................................. 143

5 Overview of the control unit PC and software.............................................................................. 183

Roche Diagnostics

Operator’s Manual · Version 2.9.5 19

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.............................................................................................................21

Safety precautions.................................................................................................................22

Operator qualification...................................................................................................22

Safe and proper use of the system................................................................................22

Miscellaneous safety precautions.................................................................................23

Safety summary ....................................................................................................................24

Warning messages..........................................................................................................24

Sharps, rough edges, and/or moving parts...........................................................24

Electrical safety.........................................................................................................24

Biohazardous materials...........................................................................................25

Flammable materials ...............................................................................................26

Waste..........................................................................................................................26

False or wrongly reported results...........................................................................26

Lasers.........................................................................................................................27

Caution messages...........................................................................................................28

Mechanical safety.....................................................................................................28

Working solutions....................................................................................................29

Exposure to lasers ....................................................................................................29

Insoluble contaminants in samples........................................................................29

Evaporation of samples ...........................................................................................29

Fatigue due to long hours of operation.................................................................30

Malfunction due to interfering electromagnetic fields.......................................30

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

Instrument ................................................................................................................30

Sample identification...............................................................................................31

Delayed results .........................................................................................................31

Notices.............................................................................................................................32

Moving parts.............................................................................................................32

Circuit breakers and fuses.......................................................................................32

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20 Operator’s Manual · Version 2.9.5

1 General safety information cobas® 8100 automated workflow series

Table of contents

Spillage.......................................................................................................................32

Fixed size trays .........................................................................................................32

Software.....................................................................................................................33

Safety labels on the system..................................................................................................34

Location of safety labels on the instrument................................................................35

Locations of safety labels on the connection components .......................................38

Disposal .................................................................................................................................41

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Roche cobas 8100 AddOnBuffer User manual

Roche cobas 8100 AddOnBuffer User manual

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