Roche cobas c 311 User manual

cobas c 311 analyzer

Operator’s Manual

Software version 01-09

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

2

Publication information

Edition notice This publication is intended for operators of the

cobas c 311 analyzer.

Every effort has been made to ensure that all the

information is correct at the time of publishing. However,

Roche Diagnostics reserves the right to change this

publication as necessary and without notice as part of

ongoing product development.

Where to find information The Safety Manual contains important safety

information. You must the read the Safety manual before

operating the instrument.

The Operator’s Manual focuses on routine operation

and maintenance. The chapters are organized according

to the normal operation workflow.

The Online Help contains the content of the Operator’s

Manual and additionally:

• Troubleshooting information

• A software reference

• Configuration information

• Background information

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the instructions and safety information

before you use the instrument.

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

1.0 01-01 2007-11 First version

1.1 01-04 2009-11 Addendum 3.0 implemented in Online help

2.0 01-06 2010-12 General update

3.0 01-09 2014-10 Documentation redesigned according to the new Roche

documentation concept.

Description of new software features added.

y Revision history

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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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.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS INTEGRA, 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 purpose as mentioned above. 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.

Instrument approvals Compliance is demonstrated by the following marks:

The cobas c 311 analyzer meets the requirements of the

Directive 98/79/EC.

Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and

the US.

CUS

®

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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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 311 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

Manufactured by: Hitachi High-Technologies

Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Table of contents 5

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

Table of contents

Publication information 2

Contact addresses 4

Table of contents 5

Intended use 7

Symbols and abbreviations 7

What is new in software version 01-09? 9

Operation

1 Overview of the instrument

About the c 311 analyzer 15

Overview of the hardware 16

Overview of the power switches 24

2 Overview of operation

Overview of the user interface 29

Using the online help 42

Overview of cobas link 48

Overview of the main workflow 55

Quick start guide 56

3 Before operation

Starting from Sleep mode 63

Starting from power-off 70

Troubleshooting system alarms 74

Preparing the analyzer for operation 75

Measuring patient samples 86

4 Reagents

About positions of reagents 91

About statuses of reagents 94

Loading reagent packs 97

Unloading reagent packs 100

Changing ISE reagents 102

Changing sample probe detergents 107

Changing cell detergents 108

Performing a cell detergent prime 110

Defining reagent level alarms 111

5 Calibration

About calibration 117

About calibration methods 118

About recommended calibration 120

About manual calibration 122

Performing recommended calibration 123

Performing manual calibration 125

Checking calibration results 128

Assigning non-barcoded calibrators to

sample disk positions 129

6 Quality control

About quality control (QC) 133

Performing QC for individual tests 137

Performing QC after calibration 140

Performing QC for individual standby

reagents 142

Checking QC results 145

About the handling of QC results 146

Workflows for handling and deleting QC

results 148

Assigning non-barcoded controls to disk

positions 154

7 Orders and results

Workflow for sample processing 159

Ordering tests 161

Loading samples 166

Processing samples 170

Working with sample results 178

Processing reruns 187

Processing open test requests 192

Unloading samples 202

About barcodes 204

8 After operation

Preparing the analyzer for switching off 211

Switching off the analyzer 213

9 Overview of maintenance

Maintenance definitions 221

About Maintenance mode 222

About maintenance pipes and

maintenance pipe functions 225

Checking maintenance due time 233

Checking maintenance status 234

Requesting the Maintenance Report 235

List of maintenance items 237

List of maintenance checks 239

List of spare parts and replacement

intervals 240

10 Periodic maintenance

List of maintenance tasks 245

Daily maintenance 247

Weekly maintenance 256

Monthly maintenance 262

Every two months maintenance 279

Every three months maintenance 284

Every six months maintenance 292

6 Table of contents

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

11 Maintenance as required

Checking and draining the vacuum tank 311

Replacing the sample probe 313

Eliminating clogging of the sample probe 319

Replacing the reagent probe 321

Eliminating clogging of the reagent probe 327

Replacing nozzle tips on cell rinse nozzles 329

Eliminating clogging of the cell rinse

nozzles 332

Appendix

12 Specifications

System specifications 339

Analytical specifications 342

List of sample containers 346

List of barcode specifications 347

13 Glossary

Index 351

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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Intended use

The cobas c 311 analyzer is an automated, software-

controlled system for clinical chemistry analysis. It is

designed for both quantitative and qualitative in vitro

determinations using a large variety of tests for analysis.

The cobas c 311 analyzer performs photometric assays

and ion-selective electrode measurements and uses

serum/plasma, urine, CSF and supernatant sample types.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and abbreviations are used.

Symbols used in the publication

Abbreviations The following abbreviations are used.

Product name Abbreviation

cobas c 311 analyzer analyzer

cobas c pack reagent pack

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

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.

y Symbols used in the publication

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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Abbreviation Definition

ANSI American National Standards

Institute

COBI Compendium of Background

Information

CSV comma separated values

EC European Community

EFTA European Free Trade Association

EN European standard

IEC International Electrical

Commission

IVD In vitro diagnostic

LIS Laboratory information system

n/a not applicable

QC Quality control

SBS scan before sample stop

SD Standard deviation

WEEE Waste Electrical and Electronic

Equipment

y Abbreviations

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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What is new in software version 01-09?

Short description of all major changes in this version.

Detergent for the incubator bath Hitergent is replaced by Ecotergent. This detergent is

indicated as BathDet (water bath detergent) in the

instrument software.

New ISE calibration scheme ISE compensator is replaced by the use of a second

aliquot of ISE Standard High for the purpose of ISE

compensation at full calibration.

The use of ISE Standard High (S3) improves the stability

of ISE results by eliminating the variation that comes with

the target value assignment of a serum based ISE

compensator. It further eliminates the necessity to enter

new compensator target values for new lots, since the

target values in ISE Standard High (S3) are fixed and lot-

independent.

ISE calibration curves It is possible to inactivate one of the two ISE calibration

curves, for example, ISE-B.

In the ISE Calibration Setting dialog box select the

same calibration curve type for all sample types to

inactivate the second ISE calibration curve.

The inactivated ISE calibration curve is deleted on the

following Calibration dialogs:

• Status submenu

• Calibration Trace dialog box

• Instrument Factor dialog box

• Start Up Setting dialog box

The inactivated ISE calibration curve cannot be applied

and the analyzer does not recommend a calibration for

this test.

u Setting up individual calibration curves for each ISE

sample type (618)

ISE volume reset The button for resetting the ISE reagent volume has been

moved from Reagent > Setting to Reagent > Status.

ISE.E and ISE.N alarms If the ISE.N or ISE.E data alarm is attached to one of the

ISE tests, the analyzer attaches this data alarm to all ISE

results for this sample.

Calibrator update New pop-up messages (Confirmation dialog boxes)

during calibrator update are implemented and previously

existing messages are modified.

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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Media Eject The Media Eject button is moved from the System

Overview menu to the global buttons.

Windows 7 support This software version can be installed on a control unit

running Windows 7 or Windows XP as operating system.

If the control unit uses Windows 7, cobas link must also

run under Windows 7.

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

Operation

1 Overview of the instrument ................................................................................ 13

2 Overview of operation........................................................................................... 27

3 Before operation ..................................................................................................... 61

4 Reagents.................................................................................................................... 89

5 Calibration...............................................................................................................115

6 Quality control .......................................................................................................131

7 Orders and results................................................................................................157

8 After operation ......................................................................................................209

9 Overview of maintenance..................................................................................219

10 Periodic maintenance.........................................................................................243

11 Maintenance as required ..................................................................................309

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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Table of contents

Overview of the instrument 1

Read this chapter to get familiar with the hardware of the

instrument.

In this chapter

1

About the c 311 analyzer. . . . . . . . . . . . . . . . . . . . . . . . 15

Overview of the hardware . . . . . . . . . . . . . . . . . . . . . . . 16

Top view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Front view with open front door . . . . . . . . . . . . . . . 20

Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Overview of the power switches. . . . . . . . . . . . . . . . . . 24

Main circuit breaker. . . . . . . . . . . . . . . . . . . . . . . . . 24

Power and maintenance switches . . . . . . . . . . . . . 25

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

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Table of contents

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

About the c 311 analyzer 15

About the c 311 analyzer

The cobas c 311 analyzer is an automated system for

qualitative and quantitative in vitro diagnostics. The

electrometric (ion-selective electrode/ISE) and the

photometric measurement provide a wide variety of tests.

The cobas c 311 analyzer consists of the following units:

• Analytical unit

• Control unit

A Analytical unit B Control unit

B

A

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

16 Overview of the hardware

Overview of the hardware

The cobas c 311 analyzer is a standalone device. For a

smooth operation, it is important to have access to all

parts of the analyzer.

u

• Top view (16)

• Front view (18)

• Front view with open front door (20)

• Rear view (22)

Top view

You can access most of the components of the analytical

unit from the top when opening the top cover.

Sampling area Samples are manually loaded to the sample disk. They are

scanned or placed to a manually assigned position. That

way, they are identifiable and easy to follow. From the

sampling area, samples are pipetted to the reaction or ISE

area.

A Sampling area C ISE area

B Reaction area D Reagent area

ACDB

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

Overview of the hardware 17

Reaction area A photometric measuring system measures the

absorbance of the reaction mixture in reaction cells on

the reaction disk.

ISE area An ion-selective electrode measuring system measures

the electromotive force (EMF) in millivolts between the

electrode in the diluted sample solution and the electrode

in the reference solution. The electrodes are selective for

CL

-

, K

+

, and Na

+

.

Reagent area Reagent packs are manually loaded to the reagent disk.

They are scanned and stored in a refrigerated

compartment. From the reagent area, reagents are

pipetted to the reaction area.

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

18 Overview of the hardware

Front view

You can access most of the components of the control

unit from the front.

Touchscreen monitor The touchscreen monitor displays information. You can

navigate through the software and start the analyzer

functions.

Keyboard/mouse With the keyboard or the mouse, you can navigate

through the software and select or enter information.

A Touchscreen monitor D Personal computer

B Keyboard/mouse E Cooling unit

C Height adjusting lever F Front door

A

B

C

D

E

F

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

Overview of the hardware 19

Height adjusting lever If you lift the height adjusting lever, you can adjust the

height of the touchscreen monitor.

Personal computer The personal computer monitors the functions and

operational modes of the analyzer. The installed software

has a graphical user interface (GUI) that allows you to

control all analyzer functions.

Printer (optional) If a printer is connected, you can print the results.

Cooling unit The cooling unit cools the reagent packs in the

refrigeration compartment.

Front door Some components of the analytical unit are located

behind the front door.

1 Overview of the instrument

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0

20 Overview of the hardware

Front view with open front door

You have to open the front door to access some

components of the analytical unit.

Reagent syringe The reagent syringe controls the pipetting of reagent to

the reaction cells.

Sample syringe The sample syringe controls the pipetting of sample to

the reaction cells.

ISE sipper syringe The ISE sipper syringe controls the pipetting of diluted

samples from the reaction cells and the pipetting of ISE

reagents to the ISE unit.

A Reagent syringe E Cell cleaner II

B Sample syringe F Alarm volume knob

C ISE sipper syringe G Water tank

D Cell cleaner I H Drain tube of the vacuum tank

A

B

C

D

E

F

G

H

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