Roche cobas pro ISE analytical unit User guide

cobas

®

pro integrated solutions

User Guide

Publication version 2.1

Software version 01-04

2

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

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

2.0 01-03 2019-07 New software features added

Minor corrections

u What is new in publication version 2.0 (15)

2.1 01-04 2019-12 Minor corrections and additions

u What is new in publication version 2.1 (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.

3

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

The PC manufacturer’s manual contains all information

about the control unit hardware.

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.

The online User Assistance offers additional features

compared to the one on the system, such as printing,

downloading PDFs, and saving favorites.

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.

4

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Copyright

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.

5

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

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.

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

6

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

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

• 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

Distributed in USA by: Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana, USA

7Table of contents

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Table of contents

Publication information 2

Contact addresses 6

Intended use (intended purpose) 10

Symbols and abbreviations 10

What is new in publication version 2.1 14

What is new in publication version 2.0 15

Safety

1 Safety information

Safety classifications 23

Safety precautions 24

Warning messages 31

Caution messages 40

Notices 42

Product safety labels 43

Safety information for barcode readers 59

Safety interlock 62

Safety information for disposal 65

System overview

2 Overview of the system

About the system 71

Overview of laboratory IT setup 73

About racks and sample containers 78

Sample handling 87

Barcodes on samples 93

3 Overview of the instrument

About the control unit 101

About the sample supply unit 103

About the sample buffer 109

About the ISE analytical unit 111

About the c503 analytical unit

123

About the e801 analytical unit

138

About rack flow 158

About rack priority 163

Optional components 167

4 Overview of the user interface

About the screen areas 171

About the user interface 179

About the status colors 180

Navigating in the user interface 181

About the Alarm dialog box 182

Printing reports 184

List of symbols on reports 186

Taking a screenshot 187

List of system modes 188

About Rack Reception mode 190

Finding help 192

About the User Assistance 194

Searching for QC Value Sheets on the e-

library 205

5 Overview of reagents and consumables

About reagents and consumables– ISE and

c503

211

About reagents and consumables– e801

216

Quick reference: Reagents and consumables

- ISE 221

Quick reference: Reagents and consumables

– c503

224

Quick reference: Reagents and consumables

– e801

228

6 Specifications

Specifications – system 233

Specifications – control unit 238

Specifications – sample supply unit and

sample buffer 240

Specifications – ISE 242

Specifications – c503

244

Specifications – e801

247

Operation

7 Before operation

Logging on to the system 255

Checking for system alarms 256

About pre-routine 257

Updating software components 258

Replacing reagents and consumables 259

Downloading required parameters 283

Performing recommended maintenance 285

Performing calibration and QC 287

Quick reference: Pre-routine workflow 294

Quick reference: Replacing reagents 297

8 During operation

Running patient samples 303

Prioritizing a sample 317

Checking test results 318

Unloading a sample ahead of schedule 323

Unloading racks from the sample supply unit 324

Loading reagents during operation 326

Manually masking and unmasking reagents,

tests, and analytical units 329

Performing calibration 334

Performing QC 340

Quick reference: Running patient samples 344

Quick reference: Checking test results 346

Quick reference: Performing calibration 347

Quick reference: Performing QC 349

9 After operation

About stopping the system 353

8 Table of contents

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Stopping operation 354

Stopping operation after the current run 355

Logging off from the system 356

Quick reference: Post-routine workflow 357

10 Non-routine operation

Orders and results 365

Reagent management 389

Calibration 412

QC 440

Powering the system on or off 456

Saving and backing up data 473

Overview of masking functions 486

Working with a lab automation system 491

Guidance for blood donation screening–

e801

494

Maintenance

11 Overview of maintenance

Maintenance definitions 503

About self-operating maintenance 505

Moving internal sample data to storage

media 509

About system modes for maintenance 510

Canceling maintenance actions 515

About maintenance pipes and maintenance

pipe functions 516

Creating a maintenance type 522

Checking the maintenance due time 525

Checking the maintenance status 526

Creating a maintenance report 527

List of software maintenance actions 529

List of cleaning solutions 537

List of spare parts and replacement intervals 538

List of maintenance videos 539

Identifying the installed software version 541

12 Maintenance actions

List of maintenance intervals 547

Maintenance logs 549

Daily maintenance 554

Weekly maintenance 559

Every 2weeks maintenance 561

Monthly maintenance 586

Every 3months maintenance 605

Maintenance as required 611

Troubleshooting

13 Introduction to troubleshooting

General troubleshooting information 679

About data alarms and system alarms 681

Data problems without alarm 682

Problems loading reagent packs 686

Troubleshooting liquid level sensor alarms 692

14 Data alarms

List of data alarms 697

Data alarms for tests 701

Calibration data alarms 739

QC data alarms 751

List of data alarms that generate an

automatic rerun test 755

Configuration

15 System settings

Adding a user 763

List of access rights 765

Rack ranges 771

Test keys and test profiles 780

Reagent warning levels 784

Configuring filters for results 787

About non-24/7 operation 788

Setting up a host 789

16 Application-related settings

Setting up a test 793

Setting up special washes 814

Downloading special reagents, diluents, and

wash solutions 818

Updating an application 820

Deleting an application 824

Analytical principles

17 Measurement technology

About ISE technology 829

About photometric technology 834

About the ECL technology 839

18 Test principles

About test principles - ISE 849

About photometric test principles - c503

851

About sample index principles 867

Overview of immunology principles - e801

871

About limit of detection and limit of

quantitation 878

19 Calibration principles

About calibration of ISE tests 881

About calibration of photometric tests 885

Calibration of immunology tests 912

20 Rules for attaching data alarms

About data alarm rules for photometric tests 923

Index

Glossary

9

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

10

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Intended use (intended purpose)

cobaspro integrated solutions is an in-vitro diagnostic

(IVD) device used for the quantitation of clinical

chemistry, immunochemistry and ion-selective electrolyte

parameters from various biological fluids.

Intended users

The cobaspro integrated solutions is intended to be

used by trained laboratory technicians.

Target customers

Target customers of cobaspro integrated solutions are

commercial and public clinical laboratories.

The use of the e801 analytical unit in blood donation

screening was confirmed according to the IVD Directive

98/79/EC. Outside the EU and EFTA countries, consider

the respective local registration.

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 sample supply unit

sample supply unit

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

SBL-TL-c503 transport line

SBL-DL-e801 drive line

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

e-library

cobas

®

e‑services

electronic services

cobas

®

link cobaslink

Sample Cup standard cup

Micro-Sample Cup micro cup

Roche Standard False Bottom

Tube

false bottom tube

y Product names

11

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Product name Descriptor

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

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

y Symbols used in the publication

12

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Symbol Explanation

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

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

Serial number

Date of manufacture

y Symbols used on products

13

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Abbreviations

The following abbreviations are used:

Abbreviation Definition

Abs. Absorbance units

ACN Application code number

ANSI American National Standards Institute

AU Analytical unit

AUX Auxiliary (system reagents and

consumables)

CDC Closed Development Channel

CFAS Calibrator for automated systems (also

C.f.a.s.)

CSV Comma-separated values

CV Coefficient of variation

DIL ISE Diluent

DL Drive line

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

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

MC Measuring cell

NACL NaCl solution, used as diluent

NaOHD Wash solution for reagent probes and

reaction cells (D1)

OBS Onboard stability

PC Personal computer

QC Quality control

y Abbreviations

14

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Abbreviation Definition

RCM Reaction calculation mode

RE Reference electrode

REF ISE Reference Electrolyte solution

RFID Radio-frequency identification

RP Reagent pack

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)

SOM Self-operating maintenance

SSU Sample supply unit

STAT Short turnaround time

SW Software

SysClean ISE Cleaning Solution/SysClean

TL Transport line

WEEE Waste Electrical and Electronic

Equipment

y Abbreviations

u Related topics

• Overview of the User Assistance (194)

What is new in publication version 2.1

The software version 01-04 provides a bugfix regarding

2data alarms.

Data alarms

In software 01-04, the implementation of the following

data alarms has been revised:

• Calc.? (Calculation of result not possible)

• Samp.? (ABS maximum over (non-linear curve))

u Calc.? (705)

u Samp.? (730)

New topic in this publication

The following topic has been added:

u About the protection of personal data and software

security (27)

15

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Changes in this publication

In addition to numerous minor corrections and

improvements, mainly the following topics have been

revised since the last publication:

u Setting up the Calib. Now settings (433)

u Viewing QC target values and QC ranges (445)

u List of data alarms that generate an automatic rerun

test (755)

u Adding a user (763)

What is new in publication version 2.0

The software version 01-03 comprises many new

software features and improvements.

The following sections list the main improvements per

software area:

Routine work area

• The masking symbols on the Order Tests tab are

consolidated.

• When you select a sample, the software displays the

estimated sample processing time.

• The Test Result Details dialog box displays the date

and time when the sipper flow paths have been

washed the last time.

• The Test Result Details dialog box displays when a

copy QC is used for a test.

• The Test Result Details dialog box is available for

results backed up on a storage medium.

Sample Status work area

• The estimated sample processing time is displayed on

the Sample Tracking and Rack Monitor tabs.

Reagents work area

• If you selected a reagent pack for unloading, it is

displayed in blue on Reagents > Overview until it is

unloaded from the system.

• The onboard stability of the ISE Reference Electrolyte

bottle is displayed on the Overview and Status tabs.

• The diluent used for an e801 test is displayed on

Reagents > Overview > Details.

• If wash rack maintenance is overdue, ISE electrodes

are masked and indicated in gray on Reagents

indicator.

• The Prime Flow Paths button was removed because

the system primes the flow paths automatically.

16

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

• For e801 system reagents, you can set up a purple

and a yellow alarm. In addition to the user-defined

settings, the system issues a yellow alarm when the

first bottle is half empty and a red alarm when the

second bottle is empty.

Calibration work area

• On Calibration > Results, absorbance values and

additional dates and times are displayed to provide

more details.

QC work area

• The QC Chart dialog box has been improved.

• The software guides you through the installation of

QC material by the Edit QC dialog box. The QC

ranges are editable from 3 SD to 2.5, 2, 1.5 or 1SD.

• You can select standard containers or one of the 3

false bottom tube types for each QC material on QC

> Installation > Edit QC.

• If you use lab-specific QC target values or QC ranges,

the values are highlighted on QC > Installation.

Menu > System

• Administrators can register USB flash drives for use

at the system.

• Host connection: You can either select a predefined

IP address and port or enter them manually.

The system periodically sends information about the

instrument status and reagent status to the host. The

host takes this information into account when

sending test orders to connected instruments.

Overview button

The Overview button at the right side turns blue when

user interaction is required (identical to interactive

maintenance), i.e. to unmask an analytical unit.

Maintenance dialog box

• After replacing an ISE electrode, the system performs

the required ISE check automatically.

• After replacing a sample probe, the software guides

you through 2 necessary maintenance checks.

• The maintenance action SW Files Check displays

the installed software version directly, i.e. without

having to start the maintenance action.

• The Alarm Log report logs the date and time when

the ISE wash rack was performed the last time.

• The Alarm Log report also logs maintenance actions

performed by self-operating maintenance.

• The system issues a pre-warning (yellow alarm)

700tests before the e801 sipper flow paths must be

washed so that you can schedule this maintenance.

• To protect personal data, the maintenance action 27

Generate Log-Files does not store any personal

data in the log file for the technical support.

17

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Start Conditions dialog box

Operator level access is sufficient to view the rack ranges

assigned for sample types and container types.

Further improvements

• False bottom tubes can now be used for QC material.

• The dead volume for whole blood samples in Sarstedt

FBTs was reduced to 300µL.

• The Parameter Download dialog box displays only

parameters for download that are relevant for the

respective system.

• Operation at altitudes 2000-3000m above sea level is

possible on request.

New topics in this publication

The following topics have been added since the last

publication:

u Finding a suitable rack ID for a container type and

sample type (370)

u Identifying the diluent used for certain tests – e801

(410)

u Identifying the installed software version (541)

u Registering USB flash drives (483)

u Guidance for blood donation screening– e801 (494)

u Setting up a host (789)

u Setting up special washes (814)

18

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Roche Diagnostics

cobas

®

pro integrated solutions · Software version 01-04 · User Guide · Publication version 2.1

Safety

1 Safety information.........................................................................................21

Page is loading ...

Roche cobas pro ISE analytical unit User guide

This manual is also suitable for

Roche cobas pro ISE analytical unit User guide

Related papers

Other documents