Roche cobas c 513 User manual

cobas c 513 analyzer

Operator's Manual

Version 5.0

Software Version 02-04

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

2

Publication information

Edition notice This publication is intended for operators of the

cobas c 513 analyzer.

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.

Where to find information The User Assistance contains all information about the

product.

The Safety Manual contains important safety

information. You must read the Safety Manual before

operating the system.

The Operator’s Manual focuses on operation and

maintenance. It contains the content below.

• System description

• Routine operation

• Maintenance

• Advanced operation

• Troubleshooting information

• Software description

Publication version Software version Revision date Change description

1.0 01-01 September 2015 Version 1.0

2.0 02-01 January 2016 Modified rinse station.

New air supply filter.

New tasks for cell detergent prime, downloading diluent

and detergent information, and masking of reagent

cassettes.

Minor revisions.

3.0 02-02 October 2016 New maintenance actions.

Added control for individual clot detection settings.

u What is new in publication version 3.0 (12)

4.0 02-03 July 2017 Added information about connecting to a CLAS.

Added task for programming calculated tests.

Added information about data alarm priority.

u What is new in publication version 4.0 (13)

5.0 02-04 January 2019 Updated task for cleaning the surfaces of the analyzer.

Minor revisions.

u What is new in publication version 5.0 (13)

y Revision history

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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!

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.

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.

reserved.

Trademarks The following trademarks are acknowledged:

COBAS and COBAS C 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.

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Approvals The cobas c 513 analyzer 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.

The following marks demonstrate compliance.

The cobas c 513 analyzer is manufactured and tested

according to the international safety standards below.

• IEC 61010-1

• IEC 61010-2-101

The RFID readers of the cobas c 513 analyzer meet the

requirements laid down in:

Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the

laws of the Member States relating to the making

available on the market of radio equipment and repealing

Directive 1999/5/EC.

The full text of the 2014/53/EU declaration of conformity

is available at the following internet address:

http://e-labdoc.roche.com

Complies with the IVD directive 98/79/EC and the

directive 2011/65/EU on RoHS.

Complies with the IVD directive 98/79/EC.

Complies with the directive 2011/65/EU on RoHS.

Issued by Intertek to prove compliance with safety

standards for Canada and the US.

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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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.

License agreement for UltraVNC software on

the control unit

UltraVNC is a piece of free software for all commercial

uses. It is installed on the control unit of the

cobas c 513 analyzer.

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 of the cobas c 513 analyzer.

The pathway 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 of the cobas c 513 analyzer. The pathway for the

source code is C:\DriversAndTools\UltraVNC.

Type

Charge weight

(kg)

CO

2

equivalent

(tonne)

Global

warming

potential

R-134a 0.160 0.23 1430

y Fluorinated greenhouse gas detail

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Contact addresses

Inside the European Union and

EFTA member states

Outside the European Union and

EFTA member states

Manufacturer of

cobas c 513 analyzer

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

Manufactured by: Hitachi High-Technologies

Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Table of contents 7

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

Table of contents

Publication information 2

Contact addresses 6

Table of contents 7

Intended use 11

Symbols and abbreviations 11

What is new in publication version 3.0 12

What is new in publication version 4.0 13

What is new in publication version 5.0 13

System description

1 Description of the cobas c 513 analyzer

Overview of the cobas c 513 analyzer 19

About the control unit 21

About the analyzer 23

Sample types, containers, and racks 43

2 Specifications

List of system specifications 51

List of sampler unit specifications 54

List of analytical unit specifications 55

List of external media specifications 57

List of sample container specifications 58

List of barcode specifications 59

List of specifications for radio equipment 61

Operation and maintenance

3 Overview of operation

System modes 67

Overview of the software 71

Using the User Assistance 78

Using cobas

®

link 80

Overview of the daily workflow 86

Quick start guide 87

4 Before operation

Starting the system 95

Logging on to the software 97

Changing your password 98

Defining a new password when your password

expires 99

Preparing the system for operation 100

5 Reagents

About reagents 121

About reagent cassettes 123

Monitoring reagents 124

Viewing the reagent load/unload list 127

Loading reagent cassettes 129

Unloading reagent cassettes 131

Masking reagent cassettes 133

Unmasking reagent cassettes 134

Replacing system reagents 135

6 Calibration

About calibration 143

About recommended and manual

calibration 145

About lot calibration and cassette

calibration 147

About calibration methods 148

Configuring calibration 149

Performing calibration 161

Calibration results 168

7 Quality Control

About QC 179

About QC requests 180

About QC accumulation methods 182

Configuring QC 183

Performing QC 197

QC results 207

8 Orders and results

About orders and results 227

Ordering tests manually 228

Repeating test selections in non-barcode

mode 230

Loading samples on the analyzer 231

Testing samples 236

Test results 242

Rerunning samples 263

Unloading racks 266

9 After operation

After operation tasks 269

Logging off from the software 277

Shutting down the system 278

Extended shutdown 286

8 Table of contents

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

10 Maintenance

Overview of maintenance 291

Interlock override mode 294

Maintenance pipes and maintenance pipe

functions 298

Maintenance types 305

Maintenance status 310

Automatic maintenance actions and

checks 312

Periodic maintenance actions 317

As-needed maintenance actions 364

Advanced operation

11 Advanced operation

Operator IDs 397

Rack ranges and sample containers 403

Rack reception mode 412

Operating the system with a CLAS 416

Downloading application parameters 423

Programming calculated tests 425

Downloading diluent and detergent

information 427

Configuring mandatory reagents 429

Masks 431

Viewing system information 434

Saving and loading system parameters 436

Formatting external media 441

Saving reports to external media 443

Test profiles 445

Upload settings 450

Configuring barcode settings 454

Configuring print settings 456

Configuring the workflow 458

Configuring comment titles 460

Configuring display settings 462

Configuring the display order for results 464

Editing analyzer factors 466

Configuring the initial reaction cell 468

Configuring the number of wash cycles for the

wash rack 470

Troubleshooting

12 Alarms

About alarms 477

About system alarms 478

About data alarms 479

Configuring alarm settings 480

Configuring alarm sounds 482

Stopping the system 483

Resetting the mechanical parts of the

analyzer 484

13 Troubleshooting general problems

About troubleshooting 487

Checklists for handling materials 488

Troubleshooting problems with test results 490

Troubleshooting problems with calibration 494

Troubleshooting problems with QC 495

Handling unresolved problems 496

14 Troubleshooting data alarms

List of data alarms 501

About data alarm priority 503

Resolving data alarms for sample results 504

Resolving data alarms for calibrations 517

Resolving data alarms for QC results 521

Rerun list 526

15 Troubleshooting hardware

problems

Troubleshooting problems with the

analyzer 531

Table of contents 9

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

Software description

16 Global buttons and windows

Overview of the user interface 541

Rack Monitor window 550

Search Sample dialog box (extended) 554

Data Monitor window 556

Backup dialog box (Data Monitor window) 558

Shutdown dialog box 559

Logon dialog box 560

Sleep Conditions window 561

Shutdown Conditions dialog box 563

Change Password dialog box 564

Menu window 565

Workflow window 566

Maintenance window 572

Maintenance action windows 574

Maintenance check windows 583

Alarm window 589

Sound Setting window 592

Print window 593

History window 595

Backup dialog box (History window) 597

Print dialog box 598

Reports 599

Workplace tab (Print window) 600

Reagent tab (Print window) 610

Calibration tab (Print window) 614

QC tab (Print window) 625

Utility tab (Print window) 639

Automatic Data Monitor report 661

Automatic maintenance reports 667

Stop dialog box 673

S. Stop dialog box 674

Start Conditions window 675

Start Up Pipe Settings dialog box 679

Automatic Rerun dialog box 680

Host Settings dialog box 681

Rack Reception Settings dialog box 682

CLAS Settings dialog box 683

Default Profile dialog box 684

17 Workplace menu

Test Selection window 687

Sample Information dialog box 692

Barcode Read Error dialog box (barcode

mode) 694

Repeat Test Selection dialog box (non-barcode

mode) 696

Data Review window 697

Read Backup dialog box 702

Filter Setting window 703

Search Sample dialog box 705

Test Display Setting window 707

Send To Host dialog box 708

Backup Data dialog box 710

Reaction Monitor window 712

Scale Setting dialog box - Reaction

Monitor 715

Overlay window 716

Reagent Detail dialog box 718

Test Review window 719

Edit Result dialog box 723

18 Reagent menu

Reagent window 727

Reagent Registration dialog box 735

Bottle Set Information dialog box 736

19 Calibration menu

Calibration window 741

Start Up Setting window 744

Result window 746

Working Information window 750

Scale Setting dialog box - Working

Information 753

Reaction Monitor window 754

Scale Setting dialog box - Reaction

Monitor 756

Calibration Trace window 757

Scale Setting dialog box - Calibration Trace 760

Comment dialog box 761

Calibration Factor dialog box 762

Instrument Factor dialog box 764

Calibrators window 766

Rack Assignment window 768

Install window 770

Download Calibrator window 772

Registration dialog box 775

Rename Calibrator dialog box 777

Calibrator Detail window 778

10 Table of contents

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

20 QC menu

QC window 783

Standby Cassette QC window 785

Result window 787

Individual window 790

Individual QC Chart window 792

Comment dialog box 795

Select Chart window 796

Realtime QC window 797

Select Control window 800

Select Rules dialog box 802

Reject Data dialog box 803

Accumulate Data dialog box 804

Cumulative window 805

Cumulative QC Chart window 807

Controls window 810

Rack Assignment window 812

Install window 814

Add Control dialog box 816

Download Control window 817

Registration dialog box 819

Edit Control window 820

21 Utility menu

Utility window 825

Operator ID dialog box 829

Input ID dialog box 831

Access levels 832

Add Operator ID dialog box 838

Password Policy dialog box 839

Rack Assignment window 840

Tube Settings window 844

Barcode Settings dialog box 845

Communication Settings window 847

Review By Exception dialog box 848

Key Settings window 849

Test Key Setting dialog box 850

Profile Setting window 851

Print Settings dialog box 853

Comment Titles dialog box 855

Display Settings dialog box 856

Rack Reception dialog box 858

Analyzer Settings dialog box 859

Wash Racks dialog box 860

Maintenance Settings window 861

Edit Maintenance Type window 863

Pipe Settings window 866

Edit Pipe Setting window 868

Wake Up Settings window 870

Add Wake Up dialog box 872

Rack Delivery dialog box 874

Workflow Settings window 875

Alarm Settings dialog box 876

Result Upload Settings dialog box 878

QC Settings dialog box 880

Reagent Level window 882

Diluent and Cleaner window 884

Download Diluent and Cleaner window 888

Application window 890

Download Application window 906

Registration dialog box 908

System Configuration window 910

Test Assignment window 911

Appendix

22 Glossary

Index 923

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Intended use

The cobas c 513 analyzer is a fully automated,

standalone clinical chemistry analyzer intended for the

in-vitro quantitative determination of analytes in body

fluids.

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the

product names below are used.

Symbols used in the publication

GTIN icon used on the analyzer

Product name Term

cobas c 513 analyzer system system

cobas c 513 analyzer analyzer

cobas c 513 analyzer

software

cobas c pack reagent cassette

cobas

®

user assistance

User Assistance

y Product names

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 a user 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

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.

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number

y GTIN icon used on the analyzer

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Content icon

Abbreviations The following abbreviations are used.

What is new in publication version 3.0

New maintenance actions There are new maintenance actions for cleaning racks

and rack trays.

u Cleaning the rack trays (387)

Cleaning the sample racks (390)

Individual clot detection settings The clot detection settings can now be individually

configured for the S1 probe and the S2 CTS probe by

your Roche Service representative.

u Configuring alarm settings (480)

Alarm Settings dialog box (876)

Symbol Explanation

Quantity in the package

y Content icon

Abbreviation Definition

ANSI American National Standards Institute

CLAS Clinical laboratory automation system

CSA Canadian Standards Association

CTS Closed tube sampling

EC European Community

EN European Standard

IEC International Electrical Commission

IVD In vitro diagnostic

LIS Laboratory information system

QC Quality control

RFID Radio frequency identification

RoHS Restriction of Hazardous Substances

SD Standard deviation

UL Underwriters Laboratories

WEEE Waste Electrical and Electronic Equipment

y Abbreviations

Roche Diagnostics

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What is new in publication version 4.0

Connect to a CLAS The system can connect to a clinical laboratory

automation system (CLAS). A pre-analytical system can

perform time-consuming tasks before and after testing.

q Only Roche Service representatives are authorized

to install and configure the connection to a CLAS.

u Operating the system with a CLAS (416)

Program calculated tests Calculated tests are produced from applying a test

formula to the results of other tests performed on the

system.

u Programming calculated tests (425)

Data alarm priority When a data alarm occurs, the system attaches a flag to

the result. The system can only display one flag for a test

result in the software and on reports. If a test result has

multiple data alarms, the system prioritizes which flag to

display.

u About data alarm priority (503)

What is new in publication version 5.0

Updated maintenance actions There is an updated maintenance action for cleaning the

surfaces of theanalyzer.

u Cleaning the surfaces of the analyzer (273)

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

System description

1 Description of the cobas c 513 analyzer...................................................... 17

2 Specifications........................................................................................................... 49

1 Description of the cobas c 513 analyzer

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Table of contents

Description of the

cobas c 513 analyzer 1

In this chapter

1

Overview of the cobas c 513 analyzer . . . . . . . . . . . . 19

About the control unit . . . . . . . . . . . . . . . . . . . . . . . . . . 21

About the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

About the sampler unit . . . . . . . . . . . . . . . . . . . . . . 23

Components of the sampler unit . . . . . . . . . . . 24

Power switches on the sampler unit . . . . . . . . 26

Behind the front service doors of the sampler

unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

About the analytical unit . . . . . . . . . . . . . . . . . . . . . 28

Reagent area components of the analytical

unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Sample area components of the analytical

unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Reaction disk area components of the

analytical unit . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Photometric analysis workflow . . . . . . . . . . . . . 37

Behind the front service doors of the

analytical unit . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

At the front of the analytical unit . . . . . . . . . . . 40

Covers of the analytical unit . . . . . . . . . . . . . . . 40

At the rear of the analyzer. . . . . . . . . . . . . . . . . . . . 41

Sample types, containers, and racks . . . . . . . . . . . . . . 43

About sample types . . . . . . . . . . . . . . . . . . . . . . . . . 43

About sample containers. . . . . . . . . . . . . . . . . . . . . 43

About open sample tubes and closed sample

tubes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

About racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

1 Description of the cobas c 513 analyzer

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

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Table of contents

1 Description of the cobas c 513 analyzer

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

Overview of the cobas c 513 analyzer 19

Overview of the cobas c 513 analyzer

The cobas c 513 analyzer is a fully automated,

standalone clinical chemistry analyzer. It is intended for

the in-vitro quantitative determination of analytes in body

fluids.

The main features of the system are below.

• Measurement of HbA1c in whole blood or hemolysate

• A throughput of 400 tests or more per hour

• Functionality for closed-tube sampling

The system components are below.

• Control unit

• Analyzer

- Sampler unit

- Analytical unit

A Monitor of the control unit B Sampler unit C Analytical unit

C

B

A

1 Description of the cobas c 513 analyzer

Roche Diagnostics

cobas c 513 analyzer · Software Version 02-04 · Operator's Manual · Version 5.0

20 Overview of the cobas c 513 analyzer

u Related topics

• About the control unit (21)

• About the sampler unit (23)

• About the analytical unit (28)

Unit Main Components

Control unit PC, located in the sampler unit

Touchscreen monitor

Mouse

Printer

Sampler unit Rack loading area and rack unloading area

STAT port

Barcode reader to read barcodes on racks and sample tubes

Rack rotor

Conveyor lines to transport racks

Power panel

Main circuit breakers

Analytical unit Reagent area:

o Reagent probes

o Reagent disk

o Rinse stations

o RFID reader units for the reagent cassettes

Sample area:

o Sample probes

o S1 probe

o S2 CTS probe

o Rinse stations

Reaction disk area:

o Reaction disk

o Incubation bath

o Ultrasonic mixers

o Reaction cell rinse unit

o Photometer

y Main components of the system

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