Roche cobas t 511 User guide

cobas t 511 coagulation analyzer

User Guide Version 1.1

Software version 1.0

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

!

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.

Publication

version

Software version Revision date Change description

Version 1.0 1.0 March 2017 Initial version

Version 1.1 1.0 July 2017 Updated safety messages

y Revision history

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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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.

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. For more detailed information, refer to the

user manual and labeling.

Please 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:

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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COBAS, COBAS T, and LIFE NEEDS ANSWERS 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:

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.

Compliance is provided by means of the Declaration of

Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Issued by CSA Group for Canada and the US.

CUS

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Table of contents 7

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

Table of contents

Publication information 2

Contact addresses 5

Table of contents 7

Intended use 9

Intended users 9

Symbols and abbreviations 9

System description

1 Overview of the system

About the system 17

Measurement principle 18

2 Overview of the hardware

Hardware description 23

System operation

3 Overview of operation

Overview of the main workflow 41

Overview of the software 43

4 Before operation

Checklist: Before operation 57

Starting up the system 58

System alarm concept 61

5 Reagents and consumables

Reagents 67

Reagent handling 72

Other resources 100

6Calibration

About calibration 117

Loading and unloading calibrators 119

List of actions 122

Calibration panels 123

Ordering a calibration 127

Releasing and activating a calibration 129

Performing a standby calibration 132

7 Quality control

About QCs 139

Loading and unloading QCs 142

List of actions 144

QC panels 145

Managing a QC lot 149

Ordering a routine QC 150

Ordering a study QC 151

Reviewing a QC 152

Setting QC target ranges 154

8 Test orders and rack handling

Test orders 159

Rack handling 163

9 Samples and results

List of actions 171

Samples and results panels 172

Handling results 177

Creating and printing a report 179

10 After operation

Checklist: After operation 185

Stopping the system 186

Performing a system restart/reinitialization 191

Shutting down the analyzer for an extended

period 193

11 Maintenance

About maintenance 199

Maintenance actions 200

Additional maintenance 207

Cleaning and decontamination 211

Appendix

12 Specification

List of system specifications 219

Supported material 221

13 Glossary

Index 229

8 Table of contents

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Intended use

The cobas t 511 coagulation analyzer is a fully

automated, random continuous-access, software

controlled system for clotting, chromogenic and immuno-

turbidimetric analysis intended for qualitative and

quantitative in vitro coagulation determinations using a

wide variety of coagulation tests, the results of which aid

in the diagnosis of coagulation abnormalities and in

monitoring anticoagulant therapy.

The cobas t 511 coagulation analyzer is a system that

uses human citrated plasma for the determination of

coagulation analytes.

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 & QC (Quality Control)

• Maintenance of instrument and related inventories

Supervisor Responsibilities:

• Reviewing & 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:

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Symbols used in the publication

Symbols used on product

Product name Abbreviation

Instrument Software for

cobas t 511 coagulation

analyzer

software

cobas t 511 coagulation

analyzer

System Cleaner cobas t System Cleaner

cobas Waste Bag solid waste bag

Cuvette COBAS INTEGRA

®

cuvette

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 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.

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Quantity contained in the package.

Indicates that the equipment is suitable for

alternating current only; to identify relevant

terminals.

Serial number

y Symbols used on the instrument

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Catalog number

Manufacturer

Date of manufacture

Caution

Humidity range

Temperature limits

This side up

Fragile, handle with care

Keep dry

Symbol Explanation

y Symbols used on the instrument

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Abbreviations The following abbreviations are used.

Keep away from sunlight

Do not stack

Do not use blades to open.

Symbol Explanation

y Symbols used on the instrument

Abbreviation Definition

ANSI American National Standards

Institute

CISPR Comité International Spécial des

Perturbations Radioélectriques

(International Special Committee

on Radio Interference)

CSA Canadian Standards Association

EC European Community

EN European standard

EU European Union

ID Identification

IEC International Electrical

Commission

IfU Instructions for Use

IVD In vitro diagnostic

n/a Not applicable

RVC Reagent volume check

STAT Short turn around time

UI User interface

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

y Abbreviations

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

System description

1 Overview of the system........................................................................................ 15

2 Overview of the hardware................................................................................... 21

1 Overview of the system

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cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Table of contents

Overview of the system 1

In this chapter

1

About the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . 18

About the measuring principle . . . . . . . . . . . . . . . . 18

About the measurement technology . . . . . . . . . . . 19

1 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

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Table of contents

1 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

Overview of the system 17

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

1 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

18 Measurement principle

Measurement principle

In this section

About the measuring principle (18)

About the measurement technology (19)

About the measuring principle

The analyzer performs optical measurements for clotting

tests, chromogenic tests, and immuno-turbidimetric 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 chromogenic

substrate for a specific enzyme. The activation of the

enzyme results in the chromogenic substrate cleaving

and a product changing the color of the reaction mixture

is formed. This change of absorbance is measured and

calculated per unit of time.

Immuno-turbidimetric 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

Seconds after reaction

1.089

1.076

1.064

1.051

1.039

1.027

1.014

1.002

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

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

Seconds after reaction

Absorbance

Time

abs.

323.025

1 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

Overview of the system 19

About the measurement technology

The analyzer takes measurements using photometric

technology.

General photometric characteristics

w Photometer concept, featuring LED source, fiber bundle and cuvette optics

The photometer consists of an integrated light source

featuring the necessary wavelengths, each covered by a

dedicated LED dye. The light is mixed in a quartz rod to

distribute it uniformly over the fibers that transport it to

the measurement cuvettes. Light is then guided by

polymer fibers to the measurement positions in the

coagulation analyzer. The light that passes through the

cuvettes is measured using a photodiode – one for each

cuvette. A reference fiber and diode are included to

monitor light source intensity deviations.

A Light source (LED) C Collimation optics E Photodiode array

B Optical fiber bundle D Cuvette F Reference

A

B

C

D

E

F

1 Overview of the system

Roche Diagnostics

cobas t 511 coagulation analyzer · Software version 1.0 · User Guide · Version 1.1

20 Measurement principle

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