Roche cobas c 311 User manual

Brand: Roche

Model: cobas c 311

Type: User manual

Roche cobas c 311 is an automated clinical chemistry analyzer designed for quantitative and qualitative in vitro determinations, using a variety of tests for analysis. It performs photometric assays and ion-selective electrode measurements, using serum/plasma, urine, CSF, and supernatant sample types.

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0.1 Replacement pages

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.

3.0.1 01-09 2016-07 Replacement pages with minor additions:

o UltraVNC licence agreement

o RoHS and Content symbol explanation

y Revision history

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0.1 Replacement pages

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 agreement for UltraVNC software and

Linux Kernel

UltraVNC and Linux Kernel are pieces of free software for

all commercial uses, which are 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.

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.

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0.1 Replacement pages

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.

Approvals The cobas c 311 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.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

The cobas c 311 analyzer complies with the emission

and immunity requirements described in the standard

IEC 61326-2-6 / EN 61326-2-6.

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.

CUS

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0.1 Replacement pages

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

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0.1 Replacement pages

Table of contents 5

Roche Diagnostics

cobas c 311 analyzer · Software version 01-09 · Operator's Manual · Version 3.0.1 Replacement pages

Table of contents

Publication information 2

Contact addresses 5

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 47

Overview of the main workflow 54

Quick start guide 55

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 177

Processing reruns 186

Processing open test requests 191

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 3.0.1 Replacement pages

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 3.0.1 Replacement pages

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

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 3.0.1 Replacement pages

Symbols used on products

Abbreviations The following abbreviations are used.

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

y Symbols used on products

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 cobas c 311 User manual

Roche cobas c 311 User manual

Roche cobas c 311 User manual

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