Roche cobas e 801 User guide

cobas

®

pro integrated solutions

User Guide

Publication version 1.1

Software version 01-02

2

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Publication information

Publication version Software version Revision date Change description

1 01-01 2018-09 First version

1.1 01-02 2019-03 Numerous minor additions and improvements

u What is new in publication version 1.1 (14)

y Revision history

Edition notice

This publication is intended for operators of cobaspro

integrated solutions.

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.

Where to find information

The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• Configuration information

• Background information, for example, about analytical

principles

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

system.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

The Quick Reference Guide gives a brief introduction

to important routine tasks and daily maintenance.

The cobas

®

e‑library provides access to important

updates, Method Sheets, Value Sheets, and other

important documents from Roche.

The PC manufacturer’s manual contains all information

about the control unit hardware.

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Privacy notice

User Assistance is also available online on the internet.

You can use it independently from the instrument on

computers or mobile devices with a current HTML5

browser. To obtain the appropriate links and usage

information, contact your Roche representative.

When you use User Assistance online, viewing events

(topics viewed and searches performed) and IP

addresses are logged.

The data collected is for Roche internal use only and is

never forwarded to third parties. It is anonymized, and

after one year it is automatically deleted.

Viewing events are analyzed to improve User Assistance

content and search functionality. IP addresses are used

to classify regional behavior.

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 system 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.

Screenshots

The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data, 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.

Copyright

4

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

License information

cobaspro integrated solutions is protected by contract

law, copyright laws, and international treaties.

cobaspro integrated solutions is licensed for use

between Roche Diagnostics GmbH and a licensee, and

only authorized users there under are permitted to

access and use the software. Unauthorized use and

distribution may result in civil and criminal penalties.

License agreement for UltraVNC software

UltraVNC is a piece of free software for all commercial

uses, which is installed on the control unit PC.

You can redistribute the software and/or modify it under

the terms of the GNU General Public License (version 2

or later), as published by the Free Software Foundation.

A copy of the GNU General Public License (version 2) is

stored on the control unit PC. The path for the license is

C:\Program Files\uvnc bvba\UltraVNC.

The software is distributed without warranty. There is no

implied warranty of merchantability or fitness for a

particular purpose. For more information, see the GNU

General Public License at http://www.gnu.org/licenses.

The source code for the software is stored on the control

unit PC. The path for the source code is C:

\DriversAndTools\UltraVNC

Open source and commercial software

cobaspro integrated solutions might contain

components or systems that are open source or

commercial software. For copyright and other notices

and licensing information regarding such software

programs included with cobaspro integrated solutions

please see the following license notifications and

licenses.

The product and cobaspro integrated solutions as a

whole may form a regulated device in accordance with

the applicable laws – please refer to the User Guide and

the labeling for details. Please note that the respective

authorization in accordance with the applicable laws

lapse in case of any unauthorized changes to cobaspro

integrated solutions.

Trademarks

cobas

®

pro is a trademark and the cobas

®

pro logo is a

trademark of Roche.

Other product names and trademarks are the property of

their respective owners.

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Feedback

Every effort has been made to ensure that this

publication fulfills the intended purpose. All feedback on

any aspect of this publication is welcome and is

considered during updates. Contact your Roche Service

representative, should you have any such feedback.

Approvals

cobaspro integrated solutions meets the requirements

laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

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.

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.

To view the full text of the 2014/53/EU declaration of

conformity, go to the Roche DiaLog Global Web Site

(https://dialog1.roche.com/) and choose the eLabDoc

link.

If you are unable to access Roche DiaLog, contact a

Roche Service representative.

Compliance is provided by means of the Declaration of

Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the IVD directive 98/79/EC on in vitro

diagnostic medical devices

Issued by Intertek for Canada and the US.

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Instrument approvals

Furthermore, the instrument is manufactured and tested

according to the following international safety standards:

• IEC 61010-1

• IEC 61010-2-101

The instrument complies with the emission and immunity

requirements described in standard IEC61326-2-6/

EN61326-2-6.

Contact addresses

Inside the European Union and

EFTA member states

Manufacturer of the

instrument

Hitachi High-Technologies

Corporation

1-24-14 Nishi-Shimbashi

Minato-ku Tokyo 105-8717

Japan

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

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

7Table of contents

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Table of contents

Publication information 2

Contact addresses 6

Intended use 10

Symbols and abbreviations 10

What is new in publication version 1.1 14

Safety

1 Safety

Safety classifications 21

Safety precautions 22

Warning messages 25

Caution messages 35

Notices 37

Product safety labels 39

Safety information for barcode readers 55

Safety interlock 58

Safety information for disposal 61

System overview

2 Overview of the system

About the system 67

Overview of laboratory IT setup 69

About racks and sample containers 74

Sample handling 82

Barcodes on samples 88

3 Overview of the instrument

About the control unit 95

About the sample supply unit 97

About the sample buffer 103

About the ISE analytical unit 105

About the c503 analytical unit

117

About the e801 analytical unit

132

About rack flow 152

About rack priority 157

Optional components 161

4 Overview of the user interface

About the screen areas 165

About the user interface 172

About the status colors 174

Navigating in the user interface 175

About the Alarm dialog box 176

Printing reports 178

List of symbols on reports 180

Taking a screenshot 181

List of system modes 182

About Rack Reception mode 184

Finding help 186

About the User Assistance 188

Searching for QC Value Sheets on the

cobas e‑library

200

5 Overview of reagents and consumables

About reagents and consumables– ISE and

c503

205

About reagents and consumables– e801

211

Quick reference: Reagents and consumables

- ISE 215

Quick reference: Reagents and consumables

– c503

218

Quick reference: Reagents and consumables

– e801

222

6 Specifications

Specifications – system 227

Specifications – control unit 232

Specifications – sample supply unit and

sample buffer 234

Specifications – ISE 236

Specifications – c503

237

Specifications – e801

240

Operation

7 Before operation

Logging on to the system 247

Checking for system alarms 248

About pre-routine 249

Updating software components 251

Replacing reagents and consumables 252

Downloading required parameters 275

Performing recommended maintenance 277

Performing calibration and QC 279

Quick reference: Pre-routine workflow 286

Quick reference: Replacing reagents 289

8 During operation

Running patient samples 295

Prioritizing a sample 308

Checking test results 309

Unloading a sample ahead of schedule 314

Unloading racks from the sample supply unit 315

Loading reagents during operation 317

Manually masking and unmasking reagents,

tests, and analytical units 320

Performing calibration 325

Performing QC 330

Quick reference: Running patient samples 334

Quick reference: Checking test results 336

Quick reference: Performing calibration 337

Quick reference: Performing QC 339

9 After operation

About stopping the system 343

Stopping operation 344

Stopping operation after the current run 345

Logging off from the system 346

8 Table of contents

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Quick reference: Post-routine workflow 347

10 Non-routine operation

Orders and results 353

Reagent management 374

Calibration 396

QC 422

Powering the system on or off 438

Saving and backing up data 454

Overview of masking functions 468

Working with a lab automation system 472

Maintenance

11 Overview of maintenance

Maintenance definitions 479

About self-operating maintenance 481

Moving internal sample data to storage

media 484

About system modes for maintenance 485

Canceling maintenance actions 490

About maintenance pipes and maintenance

pipe functions 491

Creating a maintenance type 497

Checking the maintenance due time 500

Checking the maintenance status 501

Creating a maintenance report 502

List of software maintenance actions 504

List of cleaning solutions 511

List of spare parts and replacement intervals 512

List of maintenance videos 514

12 Maintenance

List of maintenance intervals 521

Maintenance logs 523

Daily maintenance 528

Weekly maintenance 533

Every 2weeks maintenance 535

Monthly maintenance 560

Every 3months maintenance 578

Maintenance as required 584

Troubleshooting

13 Introduction to troubleshooting

General troubleshooting information 649

About data alarms and system alarms 651

Data problems without alarm 653

Problems loading reagent packs 657

Problem with a liquid level sensor fixed to

low voltage 663

14 Data alarms

List of data alarms 669

Data alarms for tests 673

Calibration data alarms 710

QC data alarms 722

List of data alarms that generate an

automatic rerun test 726

Configuration

15 System settings

Adding a user 733

List of access rights 735

Rack ranges 741

Test keys and test profiles 750

Reagent warning levels 754

Configuring filters for results 756

About non-24/7 operation 757

16 Application-related settings

Setting up a test 761

Setting up special reagents, diluents, and

wash solutions 782

Updating an application 784

Deleting an application 788

Analytical principles

17 Measurement technology

About ISE technology 793

About photometric technology 798

About the ECL technology 803

18 Test principles

About test principles - ISE 813

About photometric test principles - c503

815

About sample index principles 831

Overview of immunology principles - e801

835

About limit of detection and limit of

quantitation 842

19 Calibration principles

About calibration of ISE tests 845

About calibration of photometric tests 849

Calibration of immunology tests 876

20 Rules for attaching data alarms

About data alarm rules for photometric tests 887

Index

Glossary

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Intended use

The cobaspro integrated solutions is an in-vitro IVD

device used for the quantitation of clinical chemistry,

immunochemistry and Ion Selective Electrolyte

parameters from various biological fluids.

• The system is an in-vitro diagnostic (IVD) medical

equipment.

• The system is not intended to be used for screening

of blood donations.

Intended users

The cobaspro integrated solutions is intended to be

used by trained laboratory technicians.

Symbols and abbreviations

Product names

Except where the context clearly indicates otherwise, the

following product names and descriptors are used.

Product name Descriptor

cobaspro integrated solutions

system

cobaspro ISE analytical unit

ISE analytical unit

cobasc503 analytical unit c503 analytical unit

cobase801 analytical unit e801 analytical unit

cobascpack green

reagent pack

cobasepack green

reagent pack

cobaseflow cobaseflow test

SonicWash sonic wash station

cobas

®

e‑library cobas e‑library

cobas

®

e‑services cobas e‑services

cobas

®

link cobaslink

Sample Cup standard cup

Micro-Sample Cup micro cup

Sample Cup Micro 13/16 micro cup

Roche Standard False Bottom

Tube

false bottom tube

Sarstedt False Bottom Tube Sarstedt false bottom tube

Sarstedt S-Monovette K2 EDTA Sarstedt S-Monovette tube

Sarstedt Micro Tube micro tube

AssayTip tip

AssayCup cup

y Product names

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Product name Descriptor

AssayTip/AssayCup tray tip and cup tray

WasteLiner solid waste box

y Product names

Symbols used in the publication

Symbol Explanation

o

List item

u

Related topics containing further information

q

Tip: extra information on correct use or useful

hints

r

Start of a task

I

Extra information within a task

f

Result of an action within a task

c

Frequency of a task

n

Duration of a task

d

Materials that are required for a task

j

Prerequisites of a task

u

Topic (used in cross-references to topics)

p

Task (used in cross-references to tasks)

w

Figure (used in figure titles and cross-

references to figures)

y

Table (used in table titles and cross-references

to tables)

z

Equation (used in cross-references to

equations)

Status indicator is on

Status indicator is flashing

Status indicator is off

Home tab: View the home screen of the User

Assistance

Search tab: Find matching topics in the User

Assistance

System explorer tab: Navigate visually through

the system

Interactive help tab: Use the guided, interactive

help to resolve specific problems

y Symbols used in the publication

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Symbol Explanation

Maintenance tab: Perform maintenance

actions

History tab: Show previously viewed topics

again

Favorites tab: Select topics that have been

added to the favorites list

Zoom button: Enlarge images and videos in the

User Assistance

Play button: Play videos in the User Assistance

y Symbols used in the publication

Symbols used on products

Symbol Explanation

Global Trade Item Number

Quantity contained in the package

Orientation of the package during

transportation

Complies with the directive 2011/65/EU on

RoHS

y Symbols used on products

Abbreviations

The following abbreviations are used:

Abbreviation Definition

Abs. Absorbance units

ACN Application Code Number

ANSI American National Standards Institute

AU Analytical unit

CC CleanCellM, wash solution for

measuring cells after measurement

CDC Closed Development Channel

y Abbreviations

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Abbreviation Definition

CFAS Calibrator for automated systems (also

C.f.a.s.)

CSV Comma-separated values

CV Coefficient of variation

DIL ISE Diluent

EC European Community

ECL Electrochemiluminescence

Eco-D EcoTergent, additive to the incubation

bath water

EFTA European Free Trade Association

EN European standard

EU European Union

FBT False bottom tube

ICVC Initial cassette volume check

IEC International Electrical Commission

IS ISE Internal Standard solution

ISE Ion-selective electrode

ISEhigh ISEStandardHigh, used as calibrator2

ISElow ISEStandardLow, used as calibrator1

ISES3 ISE standard, used as calibrator3

according to ISE package insert

IVD In-vitro diagnostic

LAS Laboratory automation system

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

n/a Not applicable

NACL NaCl solution, used as diluent

NaOHD Wash solution for reagent probes and

reaction cells (D1)

PC ProCellIIM, signal generating buffer

solution for the ECL detection

QC Quality control

RCM Reaction calculation mode

REF ISE Reference Electrolyte solution or

reference electrode

RFID Radio-frequency identification

SB Sample buffer

SCCS Special Cell Cleaning Solution

SD Standard deviation

SMS Selective Mode Solution, a wash

solution for reagent probes and reaction

cells (D2)

SSU Sample supply unit

STAT Short turn-around time

y Abbreviations

14

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Abbreviation Definition

SW Software

SysClean ISE Cleaning Solution/SysClean

WEEE Waste Electrical and Electronic

Equipment

y Abbreviations

u Related topics

• Overview of the User Assistance (188)

What is new in publication version 1.1

New topics

The following topics have been added since the last

publication:

u About rack stickers for rack ID ranges (76)

u About transport lines (152)

u List of symbols on reports (180)

u Taking a screenshot (181)

u Moving internal sample data to storage media (484)

u Problem with a liquid level sensor fixed to low

voltage (663)

u About sample containers for whole blood samples

(773)

u Using Sarstedt S-Monovette tubes for the HbA1c test

(773)

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Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Corrections and improvements

Feedback from different sources has been implemented,

including text corrections, terminology changes, and

graphic corrections.

• Table footnotes have been replaced by text within

table cells where possible.

• Part Troubleshooting has been slightly restructured

for alignment between User Guide and User

Assistance.

• Additional utility films and interactive help procedures

have been integrated in the User Assistance

• The glossary has been included. Blue links to the

corresponding glossary definition have been inserted

at the most important places in the text.

Hardware changes

Several illustrations have been revised to reflect

hardware changes, for example:

• Tubings at the water container

• ISE top cover

• c503 reagent manager

• c503 solenoid valve (below reaction disk)

• Instrument labels (rear and side views)

Software features

Descriptions of software features have been revised:

• Update of software components

• Auto calibration

• Support for Sarstedt S-Monovette tubes

• Preventive maintenance and interactive maintenance

• Reinstalling applications after deletion

u Updating software components (251)

u Ordering a calibration for an AutoCal reagent (404)

u Using Sarstedt S-Monovette tubes for the HbA1c test

(773)

u Maintenance definitions (479)

u Deleting an application (788)

16

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Safety

1 Safety .................................................................................................................19

19

Table of contents

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

Safety

In this chapter

1

Safety classifications............................................................. 21

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

About operator qualification................................... 22

About safe and proper use of the system ......... 22

About environmental conditions........................... 23

About installation and deinstallation................... 24

Warning messages................................................................ 25

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

Waste............................................................................... 27

Results............................................................................. 28

Electrical safety............................................................ 32

Software and data security...................................... 33

Caution messages ................................................................. 35

Mechanical safety....................................................... 35

Reagents and working solutions........................... 36

Notices ....................................................................................... 37

Spillage ........................................................................... 37

Mechanical overload ................................................. 37

Third-party software .................................................. 38

Product safety labels............................................................. 39

List of product safety labels.................................... 39

Product safety labels – sample supply unit....... 41

Product safety labels – sample buffer................. 42

Product safety labels – ISE ...................................... 43

Product safety labels – c503 .................................

45

Product safety labels – e801 .................................

48

Safety information for barcode readers......................... 55

About the laser barcode reader ............................ 55

About the LED barcode readers ........................... 56

Safety interlock ....................................................................... 58

1 Safety

20

Table of contents

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-02 · User Guide · Publication version 1.1

About safety interlock of covers............................ 58

Using maintenance mode – c503 .......................

59

Safety information for disposal......................................... 61

Disposal information.................................................. 61

1 Safety

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