Roche cobas e 402 User guide

cobas

®

pure integrated solutions

<e402 | SSU | c303>

User Guide

Publication version 1.0

Software version 01-01

2

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Publication information

Publication version Software version Revision date Change description

1.0 01-01 2020-11 First version

y Revision history

Edition notice

This publication is intended for operators of

cobas

®

pure 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.

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.

3

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

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

1, Roche Diagnostics GmbH.

License information

cobas

®

pure integrated solutions is protected by

contract law, copyright laws, and international treaties.

cobas

®

pure integrated solutions is licensed for use

between Roche Diagnostics GmbH and a licensee, and

only authorized users 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.

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.

4

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

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

stored on the control unit. 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. The path for the source code is C:\DriversAndTools

\UltraVNC

Open source and commercial software

cobas

®

pure 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

®

pure integrated

solutions please see the following license notifications

and licenses.

The product and cobas

®

pure 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

®

pure integrated solutions.

Trademarks

cobas

®

pure is a trademark and the cobas

®

pure logo

is a trademark of Roche.

Other product names and trademarks are the property of

their respective owners.

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

®

pure 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.

5

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

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 your

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.

Instrument approvals

Furthermore, the instrument is manufactured and tested

according to the following international safety standards:

• IEC 61010-1:2010

• IEC 61010-2-101:2015

• UL 61010-1

• UL 61010-2-101

The instrument complies with the emission and immunity

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

EN61326-2-6.

6

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Contact addresses

Inside the European Union and

EFTA member states

Manufacturer of the

instrument

Hitachi High-Tech Corporation

1-17-1 Toranomon

Minato-ku Tokyo 105-6409

Japan

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Japan

Outside the European Union and

EFTA member states

Manufactured by: Hitachi High-Tech Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Distributed in USA by: Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana, USA

7Table of contents

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Table of contents

Publication information 2

Contact addresses 6

Intended use 10

Symbols and abbreviations 10

Safety

1 Safety information

Safety classifications 19

Safety precautions 20

Warning messages 27

Caution messages 38

Notices 40

Product safety labels 43

Safety information for barcode readers 61

Safety interlock 64

Safety information for disposal 67

System overview

2 Overview of the system

About the system 73

Overview of laboratory IT setup 75

About racks and sample containers 80

Sample handling 87

Barcodes on samples 92

3 Overview of the instrument

About the control unit 99

About the sample supply unit 101

About the c303 analytical unit

107

About the e402 analytical unit

124

About rack flow 142

About rack priority 145

Optional components 148

4 Overview of the user interface

About the screen areas 153

About the user interface 162

About the status colors 163

Navigating in the user interface 164

About the Alarms dialog box 165

About reports 167

Taking a screenshot 170

System modes 171

Finding help 174

Searching for QC Value Sheets in the

e‑library 176

5 Overview of reagents and consumables

About reagents and consumables– ISE and

c303

181

About reagents and consumables– e402

187

About expiry of reagents and electrodes 199

Quick reference: Reagents and

consumables– ISE 203

Quick reference: Reagents and

consumables– c303

205

Quick reference: Reagents and

consumables– e402

209

Quick reference: cobaseflow HIV Duo

212

6 Specifications

Specifications– system 215

Specifications – control unit 220

Specifications – sample supply unit 222

Specifications – c303

223

Specifications – e402

228

Operation

7 Before operation

Starting up the system 235

Checking the system performance 239

Checking for system alarms 241

About pre-routine 242

Updating software components 244

Checking the liquid waste containers 245

Performing recommended maintenance 246

Replacing reagents and consumables 248

Downloading required parameters 272

Performing calibration and QC 274

Quick reference: Start up the system 281

Quick reference: Pre-routine workflow 282

Quick reference: Replacing reagents 285

8 During operation

Running patient samples 291

Prioritizing a sample 306

Checking test results 307

Unloading a sample ahead of schedule 313

Unloading racks from the sample supply unit 314

Replacing reagents and consumables during

operation 316

Checking the reagent status 319

Preventive sampling stop - e402

326

Manually masking and unmasking reagents,

tests, and analytical units 327

Performing calibration 333

Performing QC 339

Quick reference: Running patient samples 344

Quick reference: Checking test results 347

Quick reference: Performing calibration 348

Quick reference: Performing QC 350

9 After operation

About stopping the system 355

Stopping operation 356

Stopping operation after the current run 357

8 Table of contents

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Shutting down the system 358

Quick reference: Post-routine workflow 364

10 Non-routine operation

Orders and results 371

Calibration 392

QC 422

Switching off and starting up the system 438

Saving and backing up data 452

Overview of masking functions 466

Maintenance

11 Overview of maintenance

Maintenance definitions 475

About self-operating maintenance 477

About system modes for maintenance 481

Canceling maintenance actions 488

About maintenance pipes and maintenance

pipe functions 489

Creating a maintenance type 495

Checking the maintenance due time 498

Checking the maintenance status 499

Creating a maintenance report 500

List of software maintenance actions 502

List of cleaning solutions 508

List of spare parts and replacement intervals 509

List of maintenance videos 510

Identifying the installed software version 512

12 Maintenance

List of maintenance intervals 515

Daily maintenance 517

Weekly maintenance 523

Every 2 weeks maintenance 525

Monthly maintenance 548

Every 2 months maintenance 565

Every 3 months maintenance 570

Every 6 months maintenance 575

Maintenance as required 580

Troubleshooting

13 System troubleshooting

General troubleshooting information 615

About data alarms and system alarms 617

Data problems without alarm 619

14 Data alarms

List of data alarms 629

Data alarms for tests 633

Calibration data alarms 680

QC data alarms 691

List of data alarms that generate an

automatic rerun test 695

Configuration

15 System settings

Creating a user 703

List of access rights 705

Rack ranges 711

Test keys and test profiles 719

Reagent warning levels 723

Configuring filters for results 725

About non-24/7 operation 726

About the diluted liquid waste container 728

Setting up a host 729

16 Application-related settings

Setting up a test 733

Setting up special reagents, diluents, and

wash solutions 753

Updating an application 755

Deleting an application 759

Analytical principles

17 Measurement technology

About ISE technology 765

About photometric technology 770

About the ECL technology 775

18 Test principles

About test principles - ISE 785

About photometric test principles - c303

787

About sample index principles 803

Overview of immunology principles - e402

807

About limit of detection and limit of

quantitation 814

19 Calibration principles

About calibration of ISE tests 817

About calibration of photometric tests 821

Calibration of immunology tests 846

20 Rules for attaching data alarms

About data alarm rules for photometric tests 857

Index

Glossary

9

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

10

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Intended use

cobaspure 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 not intended to be used for the

screening of blood donations.

Intended users

cobaspure 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pure integrated solutions

system

cobasc303 analytical unit c303 analytical unit

cobase402 analytical unit e402 analytical unit

cobaseflow cobaseflow test

cobas

®

e‑library

cobas

®

e‑services

electronic services

cobas

®

link cobaslink

Sample Cup standard cup

Micro-Sample Cup micro cup

Sarstedt Micro Tube cryo cup

Sarstedt False Bottom Tube Sarstedt FBT

AssayTip tip

AssayCup cup

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

y Symbols used in the publication

11

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Symbol Explanation

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 button — the blue LED is flashing, the

green LED is lit

Status button — the blue LED is flashing, the

green LED is off

Status button — the blue LED is lit, the green

LED is flashing

Status button — the blue LED is lit, the green

LED is off

Status button — both LEDs are off

y Symbols used in the publication

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

Maintenance tab: Perform maintenance

actions

History tab: Show previously viewed topics

again

Favorites tab: Select topics that have been

added to the favorites list

12

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Zoom in button: Enlarge images and videos in

the User Assistance

Play button: Play videos in the User Assistance

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 and

2015/863/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

CDC Closed Development Channel

CFAS Calibrator for automated systems (also

C.f.a.s.)

CSV Comma-separated values

CV Coefficient of variation

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

y Abbreviations

13

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Abbreviation Definition

IEC International Electrical Commission

IS ISE Internal Standard

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High, used as calibrator3

according to ISE package insert

ISE-DIL ISE Diluent

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 (D1) Wash solution for reagent probes and

reaction cells

OBS Onboard stability

QC Quality control

RCM Reaction calculation mode

REF ISE Reference Electrolyte solution

RFID Radio-frequency identification

SCCS (D3) Additive to prevent reaction cell

carryover in long HbA1c batches

SD Standard deviation

SMS (D2) Selective Mode Solution, a wash

solution for reagent probes and reaction

cells

SSU Sample supply unit

STAT Short turnaround time

SysClean ISE Cleaning Solution/SysClean

WEEE Waste Electrical and Electronic

Equipment

y Abbreviations

14

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Safety

1 Safety information.........................................................................................17

17

Table of contents

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Safety information

In this chapter

1

Safety classifications............................................................. 19

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

About operator qualification................................... 20

About safe and proper use of the system ......... 21

About environmental conditions........................... 22

About installation and deinstallation................... 22

About the protection of personal data and

software security......................................................... 23

Warning messages................................................................ 27

Biohazardous materials ............................................ 27

Electrical safety............................................................ 29

Flammable materials.................................................. 30

Waste............................................................................... 30

Results............................................................................. 31

Caution messages ................................................................. 38

Mechanical safety....................................................... 38

About reagents and working solutions .............. 39

Notices ....................................................................................... 40

Spillage ........................................................................... 40

Tip and cup tray drawer – e402...........................

40

Solid waste drawer – e402.....................................

41

Emergency stop........................................................... 41

Reagents and wash solutions loading

position ........................................................................... 41

Microbeads mixer....................................................... 42

Water container........................................................... 42

Product safety labels............................................................. 43

List of product safety labels.................................... 43

Product safety labels on the sample supply

unit.................................................................................... 45

1 Safety information

18

Table of contents

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Product safety labels on the c303 analytical

unit.................................................................................... 47

Product safety labels on the e402 analytical

unit.................................................................................... 51

Safety information for barcode readers......................... 61

About the laser barcode reader ............................ 61

About the LED barcode readers ........................... 62

Safety interlock ....................................................................... 64

About safety interlock of covers............................ 64

Using maintenance mode - c303........................

65

Safety information for disposal......................................... 67

Disposal information.................................................. 67

1 Safety information

19Safety information

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Safety classifications

The safety precautions and important user notes are

classified according to the ANSIZ535.6-2011 standard.

Familiarize yourself with the following meanings and

icons:

Safety alert

r The safety alert symbol is used to alert you to

potential physical injury hazards. Obey all safety

messages that follow this symbol to avoid possible

damage to the system, injury, or death.

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,

may result in damage to the system.

Important information that is not safety relevant is

indicated with the following icon:

i

Tip...

...indicates additional information on correct use

or useful tips.

1 Safety information

20 Safety precautions

Roche Diagnostics

cobas

®

pure integrated solutions · Software version 01-01 · User Guide · Publication version 1.0

Safety precautions

Non-observance of safety precautions

r To avoid serious or fatal injury, read and comply with

the following safety precautions.

The hazard warnings in the user documentation and on

the system cannot cover every possible case, as it is

impossible to predict and evaluate all circumstances

beforehand.

Just following the given directions may, therefore, be

inadequate for operation. Always be alert and use your

common sense.

In this section

About operator qualification(20)

About safe and proper use of the system(21)

About environmental conditions(22)

About installation and deinstallation(22)

About the protection of personal data and software

security(23)

About operator qualification

Insufficient knowledge and skills

As an operator, ensure that you know the relevant safety

precaution guidelines and standards, and the

information and procedures contained in these

instructions.

r Do not carry out operation and maintenance unless a

trainer certified by Roche Diagnostics has trained you

to do so.

r Leave maintenance, installation, or service that is not

described in this document to the trained Roche

Service representatives.

r Carefully follow the procedures specified in the

instructions for operation and maintenance.

r Follow laboratory best practices, especially when

working with biohazardous material.

1 Safety information

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