Roche cobas t 511 User guide

cobas t 511 coagulation analyzer

User Guide version 4.0

Software version 2.1.1

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

2

Publication information

Edition notice This publication is intended for operators of the

cobas t 511 coagulation 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 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

• A software reference

• Configuration information

• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

Publication version Software version Revision date Change description

1.0 1.0 March 2017 Initial version

1.1 1.0 July 2017 Updated safety messages

2.0 2.0 August 2018 Revised for software 2.0

Update safety labels on the sample area and

on the fluid tray

2.1 2.0.2 March 2019 Update for maintenance action "Cleaning

probe assembly"

3.0 2.1 August 2019 New work area implemented - Sample and

results

New QC initial run type settings

New illustration concept

4.0 2.1.1 September 2020 IVDR Compliance to the Regulation (EU)

2017/746

Backup system procedure

New safety messages

Handling tubes

Maintenance videos

y Revision history

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

The Quick Reference Guide focuses on routine

operation. The Quick Reference Guide is organized

according to the normal operation workflow. It provides

information in a concentrated version. For more detailed

information, refer to the User Guide or the User

Assistance.

!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the system and safety information before you

use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

r Store all publications in a safe and easily retrievable

place.

!

Incident reporting

r Inform your Roche representative and your local

competent authority about any serious incidents

which may occur when using this product.

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.

Always leave software updates to a Roche Service

representative, or perform such updates with their

assistance.

reserved.

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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License information The software of the cobas t 511 coagulation analyzer is

protected by contract law, copyright law, and

international treaties. The cobas t 511 coagulation

analyzer contains a user license between F. Hoffmann-

La Roche Ltd. and a license holder, and only authorized

users may access the software and use it. Unauthorized

use and distribution may result in civil and criminal

penalties.

Open Source and Commercial Software The cobas t 511 coagulation analyzer may include

components or modules of commercial or open-source

software. For further information on the intellectual

property and other warnings, as well as licenses

pertaining to the software programs included in

cobas t 511 coagulation analyzer refer to the electronic

distribution included with this product.

This open source and commercial software and

cobas t 511 coagulation analyzer as a whole can

constitute a device regulated in accordance with

applicable law.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to cobas t 511

coagulation analyzer.

Trademarks The following trademarks are acknowledged:

COBAS and COBAS T 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 feedback.

Approvals The cobas t 511 coagulation analyzer meets the

requirements laid down in:

Regulation (EU) 2017/746 of the European Parliament and

of the Council of 5 April 2017 on in vitro diagnostic

medical devices and repealing Directive 98/79/EC and

Commission Decision 2010/227/EU.

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.

Compliance is provided by means of the Declaration of

Conformity.

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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The following marks demonstrate compliance:

Contact addresses

Roche affiliates A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

eLabDoc Electronic user documentation can be downloaded using

the eLabDoc e-service on Roche DiaLog:

www.dialog.roche.com

For more information, contact your local affiliate or Roche

Service representative.

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

regulations.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Issued by CSA Group for Canada and the US.

CUS

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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Table of contents 7

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

Table of contents

Publication information 2

Contact addresses 5

Table of contents 7

Intended use 9

Intended use for IVD accessories and

software 9

Intended users 10

Symbols and abbreviations 10

What is new in publication version 4.0 12

What is new in publication version 3.0 13

What is new in publication version 2.1 13

What is new in publication version 2.0 13

System description

5 Overview of the system

About the system 19

About the measuring principle 20

About the measurement technology 21

6 Overview of the hardware

Hardware description 25

System operation

7 Before operation

Checklist: Before operation 43

Starting up the system 44

Checking supplies and waste 47

System alarm concept 53

About tube handling 60

8 Overview of operation

Overview of the main workflow 65

About test order prioritization 67

Overview of the software 68

9 Reagents and consumables

Reagents 83

Reagent handling 88

Other resources 114

10 Calibration

About calibration 133

Calibration panels 145

Calibration on the system 158

11 Quality control

About QCs 195

Loading and unloading QCs 199

List of actions 202

About general QC order behavior 203

QC panels 204

Managing a QC lot 211

Ordering a routine QC 212

Ordering a preparation QC 213

Ordering a study QC 215

Canceling a QC order 216

Reviewing a QC 217

Setting QC target ranges 219

Printing a cumulative QC report 221

12 Test orders and rack handling

Test orders 225

Rack handling 236

13 Samples and results

List of actions 245

Samples and results tab 246

Handling results 264

Creating and printing a report 267

Factor parallelism result handling 269

Quick reference: Factor parallelism result

handling 276

14 After operation

Checklist: After operation 279

Stopping the system 280

Performing a system restart/reinitialization 284

Shutting down the system 285

Shutting down the analyzer for an extended

period 286

15 Maintenance

About maintenance 291

Maintenance actions 292

Additional maintenance 300

Cleaning and decontamination 304

Appendix

16 Specification

List of system specifications 311

Supported material 314

17 Glossary

Index 323

8 Table of contents

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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Intended use

The cobas t 511 coagulation analyzer is a fully

automated, discrete coagulation analyzer intended for the

in-vitro qualitative and quantitative determination of

coagulation analytes in human citrated plasma, the

results of which aid in the diagnosis of coagulation

abnormalities and in monitoring anticoagulant therapy.

The cobas t 511 coagulation analyzer is a standalone

instrument.

Intended use for IVD accessories and software

The Intended use of accessories and software might be

not always limited to the cobas t 511 coagulation

analyzer.

Conductive sample racks Conductive sample racks are intended to be used to

handle different sample types on the cobas t 711

coagulation analyzer and cobas t 511 coagulation

analyzer.

Dependent on the sample types, different racks are

available indicated by a specific color:

• Gray for routine runs (Sample Rack COAG)

• Black for calibrator runs (Calibrator Rack COAG)

• White for Quality Control runs (QC Rack COAG)

• Green for routine runs with cup on tubes (Cup on tube

rack COAG)

Insert Sarstedt 8 mm Tube Rack insert to handle small volume sample tubes on the

cobas t 711 coagulation analyzer and cobas t 511

coagulation analyzer.

Instrument SW Instrument software for the cobas t 711 coagulation

analyzer and cobas t 511 coagulation analyzer.

Control unit Image Image software for the control unit of the cobas t 711

coagulation analyzer and cobas t 511 coagulation

analyzer.

Language Pack Installer Software language packages for the cobas t 711

coagulation analyzer and cobas t 511 coagulation

analyzer.

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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Intended users

The intended users of the cobas t 511 coagulation

analyzer are appropriately trained coagulation

professionals operating the system in a laboratory setting.

Routine operator Primary tasks:

• Running system(s) on a daily basis

• Processing routine and emergency patient samples

• Running calibration and QC (Quality Control)

• Maintenance of instrument and related inventories

Supervisor Responsibilities:

• Validating results on system or via LIS

• Reviewing and validating QC results

• Ensuring accreditation compliance

• Interface with clinicians in case of result query

• Monitor performance efficiency of systems

• Configuration of system

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the

following product names and abbreviations are used:

Abbreviations The following abbreviations are used.

Product name Descriptor

Instrument Software for

cobas t 511 coagulation

analyzer

software

cobas t 511 coagulation

analyzer

System Cleaner cobas t System Cleaner

y Product names

Abbreviation Definition

ANSI American National Standards

Institute

CFR Code of Federal Regulations

CISPR Comité International Spécial des

Perturbations Radioélectriques

(International Special Committee

on Radio Interference)

FCC Federal Communications

Commission

IEC International Electrotechnical

Commission

y Abbreviations

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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ISO International Organization for

Standardization

IVD In vitro diagnostic

IVDR In vitro diagnostics regulation

SOP Standard Operating Procedure

Abbreviation Definition

y Abbreviations

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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What is new in publication version 4.0

IVDR Compliance to the new European IVD Regulation (EU)

2017/746

Backup system The backup system procedure is updated.

New safety message Safety message about forwarding results implemented.

u Handling results (264)

Safety message about extended measuring time

implemented.

u About extended measuring time (229)

Delayed results due to computational resources

depletion.

u Overview of the main workflow (65)

Tube handling How to attach barcode labels on tubes and how to place

tubes on 5-position racks.

u About tube handling (60)

Maintenance videos New maintenance videos implemented to support the

following actions:

• How to prepare a maintenance cassette

• How to fill the water container

• How to empty the liquid waste container

• How to empty the solid waste container

• How to replace the System Cleaner bottle

• How to recover from a cuvette jam

u See:

Preparing a maintenance cassette (86)

Filling water (116)

Emptying liquid waste (120)

Emptying solid waste (123)

Replacing the System Cleaner bottle (126)

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What is new in publication version 3.0

New safety message Safety message about sharp edges implemented.

Sample and results tab New sample and results tab implemented. Better

playback of routine-relevant data and procedures.

u See:

Samples and results tab (246)

About the Samples and results - split screen with

Sample details: panel (255)

You can customize the sample and results tab according

to your laboratory needs.

QC initial run type Provide initial run type options for each application/QC

material combination.

KABE sample tube The system supports the following KABE sample tubes:

• Primavette S (2.9 mL)

• Kabevette G (3.5 mL)

u List of supported tube types (314)

Data alarm New data alarm for test results using the extended

measuring time.

Time to standby The system provides a time to standby estimation which

reflects the latest time to result completion.

u About the global information area (69)

Illustration concept For a better readability and guidance screenshots are

replaced by illustrations.

What is new in publication version 2.1

Maintenance action update The maintenance action "Cleaning probe assembly" was

simplified.

What is new in publication version 2.0

Calibration Complete rework of the chapter for version 2.0:

u About calibration (133)

QC Update of the chapter for version 2.0:

u About QCs (195)

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

System description

5 Overview of the system ........................................................................................ 17

6 Overview of the hardware................................................................................... 23

5 Overview of the system

Roche Diagnostics

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Table of contents

Overview of the system 5

In this chapter

5

About the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

About the measuring principle . . . . . . . . . . . . . . . . . . . 20

About the measurement technology . . . . . . . . . . . . . . 21

5 Overview of the system

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cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

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Table of contents

5 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

About the system 19

About the system

The cobas t 511 coagulation analyzer is a fully

automated, medium throughput system for coagulation

tests. The analyzer is designed for a large array of

qualitative and quantitative in vitro tests and can be

operated 24 hours a day, 7 days a week.

The analyzer consists of the following components:

Component Function

Analyzer unit Contains the incubators and photometers, used for making

measurements; also contains the cuvette handlers, which

move the cuvettes for pipetting, mixing, and measuring.

Control unit Controls the analyzer functions

Cuvette transport unit Transports the cuvettes from the cuvette reservoir to the

analyzer unit.

Fluid unit Manages the system fluids: Water, liquid waste, System

Cleaner, samples, and reagents.

Reagent storage Refrigerates and stores the reagent cassettes.

Sampling unit Includes the rack area slots for placing different types of racks.

From the slots, racks are moved to the barcode reader for

scanning and are then moved to the rack area.

Transfer unit Pipettes samples, reagents, and other fluids from their

containers into cuvettes for mixing so that measurements can

be performed.

y Components of the analyzer

5 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · 2.1.1 · User Guide · 4.0

20 About the measuring principle

About the measuring principle

The analyzer performs optical measurements for clotting

tests, chromogenic tests, and immunoturbidimetric tests.

The analyzer performs the following tasks:

• Sample and reagents are pipetted into a cuvette and

incubated to ensure that all reaction components are

at the correct temperature.

• The reaction is started by adding a start reagent.

• The photometer measures turbidity or color change

for the respective test.

Clotting test

Plasma is mixed with a reagent or reagents, resulting in

the formation of a fibrin clot that increases the turbidity of

the mixture. The clotting time is calculated based on the

change in turbidity.

Chromogenic test

Plasma is mixed with reagent containing a chromogenic

substrate for a specific enzyme. The activation of the

enzyme results in cleavage of the chromogenic substrate

and a product changing the color of the reaction mixture

is formed. This change of absorbance is measured and

calculated per unit of time.

Immunoturbidimetric test

Plasma is mixed with reagent containing latex particles

coated with antibodies for a specific analyte. The latex

particles form complexes with the analyte, resulting in a

change of turbidity of the reaction mixture. This change is

then measured.

-9.548 30.453 70.45350.453

1.089

1.076

1.064

1.051

1.039

1.027

1.014

1.002

Clotting time

Seconds after reaction

Absorbance

Clotting time

-7.657 12.343 32.343 52.343 92.343 112.34372.343

0.030

0.078

0.126

0.173

0.221

0.268

0.316

0.363

Time

abs.

Seconds after reaction

Absorbance

Time

abs.

-26.975 23.025 73.025 123.025 223.025 273.025173.025

1.335

1.342

1.350

1.358

1.365

1.373

1.381

1.388

Time

abs.

323.025

Seconds after reaction

Absorbance

Time

abs.

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Roche cobas t 511 User guide

Roche cobas t 511 User guide

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