Roche cobas 8100 AddOnBuffer User manual

cobas® 8100 automated workflow series

Operator’s Manual

Version 2.7

Software version 03-02

cobas® 8100 automated workflow series

Roche Diagnostics

2 Operator’s Manual · Version 2.7

Document information

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.

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

u What is new in publication version 2.5

(p. 10)

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 2.7 3

cobas® 8100 automated workflow series

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.

Warranty 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

4 Operator’s Manual · Version 2.7

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).

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

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.

Roche Diagnostics

Operator’s Manual · Version 2.7 5

cobas® 8100 automated workflow series

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-Shinbashi 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

cobas® 8100 automated workflow series

Roche Diagnostics

6 Operator’s Manual · Version 2.7

Roche Diagnostics

Operator’s Manual · Version 2.7 7

cobas® 8100 automated workflow series

Table of contents

Document information 2

Contact addresses 5

Table of contents 7

What is new in publication version 2.7 9

What is new in publication version 2.6 9

What is new in publication version 2.5 10

About the cobas 8100 automated workflow

series 10

Where to find information 11

User information 11

Conventions used in this document 12

Symbols used on packaging materials 14

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 54

General specifications 55

Hardware components of the system 56

Sample and holder workflow 79

Sample tubes 82

Sample and holder identification 83

Operating modes 88

Overview of alarms 89

3 About the modules of the instrument

Overview of sample stations 93

Input station 94

Aliquot station 117

Output station 125

RFM module 141

4 About the connection components

About the connection components 147

BRF module 148

RFX module 153

URF module 158

CLO module 162

CLW module 164

CRO module 166

CRW module 169

PXT module 172

UCU module 174

SLL line 177

SLR line 179

TLJ line 181

5 Overview of the control unit PC and software

The control unit PC 187

Overview of the control unit software 188

Overview of key software areas 192

Online help 200

Operation

6 Safety information for operation

General information 211

Safety messages of the overall system 212

Safety messages for specific modules 215

7 Daily operation

Daily workflow 219

Prepare for system startup 220

System startup 223

Handling samples, sample trays, and tip trays 232

Loading samples 233

Monitoring the processing of samples 241

Monitoring and controlling the system 244

Searching for samples 246

Retrieving samples 248

Error samples 250

Unloading samples 255

Post-operation checks and inspections 262

Full system shutdown 263

System restart 266

Logging off, shutting down, and closing the

control unit software 274

Roche Diagnostics

8 Operator’s Manual · Version 2.7

cobas® 8100 automated workflow series

8 Extended operation

Overview of extended operation 277

Backing up and restoring parameters 278

Adding new users and modifying existing

users 280

Adding new tests and modifying existing

tests 281

Adding new processing groups and modifying

existing processing groups 282

Adding new sample types and modifying

existing sample types 283

Saving and restoring system profiles 284

Switching between ACU profiles 285

Setting ACU profiles 286

Naming online systems 287

Setting alarm sounds and lights 288

Assigning samples to color classes on the

SCM module 289

Backing up sample images on the SCM

module 292

9 Reports

Reports overview 295

Generating result reports 296

Generating sample summary reports 297

Generating process result reports 298

Generating sample count reports 299

Generating data log reports 300

Maintenance

10 Safety information for maintenance

General information 305

Safety messages of the overall system 306

11 Maintenance actions

Overview 313

Maintenance schedule 316

Maintenance checklist 320

Maintenance of the input station 328

Maintenance of the aliquot station 367

Maintenance of the output station 397

Maintaining the RFM module 412

Maintenance of the connection components 419

General maintenance actions 442

Troubleshooting

12 Troubleshooting

General information about troubleshooting 449

Troubleshooting alarms 450

Troubleshooting problems with the system 453

Troubleshooting problems with modules 463

Troubleshooting problems with connection

components 504

Troubleshooting problems with online

systems 517

13 Limited Operation

Overview of limited operation 521

Masking modules 521

Masking online systems 528

Masking processing groups and tests 529

Appendices

14 Appendix 1

License agreement for control unit PC or

SCM module software 535

Glossary

15 Glossary

Index

Index 545

Revisions

Roche Diagnostics

Operator’s Manual · Version 2.7 9

cobas® 8100 automated workflow series

What is new in publication version 2.7

New IPB 2 module Descriptions and graphics have been added for the new IPB 2 module.

u

IPB module and IPB 2 module (p. 94)

STAT port on the IPB module On the IPB module and the IPB 2 module, the priority of samples loaded into the

STAT port lane can be chosen by pressing the STAT loading button or the

ROUTINE loading button, respectively.

u

IPB module and IPB 2 module (p. 94)

25-position tray The OBS module can be modified to work with 25-position racks.

u

Other rack types and tray types - OBS module (p. 138)

100-position tray The IPB module and the IPB 2 module can be modified to work with 100-position

racks.

The OBS module can be modified to work with 100-position racks.

u

Other rack types and tray types - IPB module and IPB 2 module (p. 103)

u Other rack types and tray types - OBS module (p. 138)

Primary sample tubes on RSS

module

The RSS module is able to work with primary sample tubes. The RSS module receives

primary sample tubes scheduled for capping.

u

RSS module (p. 127)

What is new in publication version 2.6

New RSS module Descriptions and graphics have been added for the new RSS module.

u

RSS module (p. 127)

Rack tray modifications The IPB module can be modified to work with 5-position racks.

The OBS module can be modified to work with 5-position racks and with 10-position

racks.

u

Other rack types and tray types - IPB module and IPB 2 module (p. 103)

u Other rack types and tray types - OBS module (p. 138)

PAUSE button status For the BRF module, the URF module, the RFX module, and the UCU module, the

PAUSE button status is displayed in the System Monitor window.

u

System Monitor window (p. 195)

cobas® 8100 automated workflow series

Roche Diagnostics

10 Operator’s Manual · Version 2.7

What is new in publication version 2.5

New CLO and UCU modules Descriptions and graphics have been added for the new CLO and UCU modules.

u

CLO module (p. 162)

u UCU module (p. 174)

New alarm colors To indicate the level of an alarm, the background color for the alarm is now yellow or

red. Yellow indicates a Caution level alarm. Red indicates a S.Stop or Stop level alarm.

u

Overview of alarms (p. 89)

u The Alarm List window (p. 597)

New Alarm History - Detail dialog

box

A new dialog box has been added that displays details of alarms in the alarm history.

u

The Alarm History - Detail dialog box (p. 589)

New automatic shut down

function

The system now shuts down automatically after you perform the tasks below.

o Restore system parameters

o Restore system profiles

o Set modules from Offline mode to Online mode

u

Backing up and restoring parameters (p. 278)

u Saving and restoring system profiles (p. 284)

u Setting modules to Offline mode (p. 525)

New Get Log functions New options have been added to the Get Log dialog box.

u

The Get Log dialog box (p. 591)

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

STAGO STA-R Max®, the DiaSorin LIAISON® XL, the Sysmex XN-9000 analyzer,

and post-analytical units including the cobas® p 501 and cobas® p 701.

Roche Diagnostics

Operator’s Manual · Version 2.7 11

cobas® 8100 automated workflow series

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. 200).

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

12 Operator’s Manual · Version 2.7

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

Start of procedure. To open the procedure, choose the symbol.

S End of procedure

o List item

U Cross-reference

f

p

Path to the active menu or window

W Figure

Y Table

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

Table 5 Abbreviations used in this document

Roche Diagnostics

Operator’s Manual · Version 2.7 13

cobas® 8100 automated workflow series

B

BC Barcode

BCL Barcode labeler/tube feeder 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

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

RSS Restopper (screw) module

S

SCM Sample check module

Abbreviation Definition

Table 5 Abbreviations used in this document

cobas® 8100 automated workflow series

Roche Diagnostics

14 Operator’s Manual · Version 2.7

Symbols used on packaging materials

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

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

3 About the modules of the instrument..............................................................................................91

4 About the connection components................................................................................................145

5 Overview of the control unit PC and software............................................................................. 185

Roche Diagnostics

Operator’s Manual · Version 2.7 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

Roche Diagnostics

18 Operator’s Manual · Version 2.7

1 General safety information cobas® 8100 automated workflow series

Table of contents

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

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

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

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

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

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

Roche Diagnostics

Operator’s Manual · Version 2.7 19

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.

Roche Diagnostics

20 Operator’s Manual · Version 2.7

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. 55).

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 AddOnBuffer User manual

Roche cobas 8100 AddOnBuffer User manual

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