Roche Cedex Bio User manual

Cedex Bio Analyzer Operator’s Manual

Software Version 2.2 December 2017

For use in quality control/manufacturing process only.

How to Use the Cedex Bio Analyzer Manual

Before reading, please review the section "Revisions" at the end

of the Operator’s Manual for important information.

Revisions

Provides updates to the Cedex Bio Analyzer Manual, including new supplementary information

and corrections to previous editions.

Operator´s Manual

Provides a detailed description of the Cedex Bio Analyzer, system components and all relevant

software information. For installation requirements, always refer to the Operator´s Manual.

For use in quality control/manufacturing process only.

Cedex Bio Analyzer

Operator’s Manual

Software Version 2.2

Cedex Bio analyzer

Roche Diagnostics

2 Operator’s Manual · Version 3.2

Document information

Revision history

Edition notice The Cedex Bio analyzer is a continuous random-access analyzer intended for the

determination of chemical and biochemical parameters in aqueous solutions. It is

optimized for small throughput workloads of up to 50 samples per day, utilizing

photometric analysis and a unit for ion selective electrodes (ISE).

This manual is for users of the Cedex Bio analyzer running software version 2.2.

Every effort has been made to ensure that all the information contained in this

manual is correct at the time of printing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary without notice as part of ongoing

product development.

Any customer modification to the analyzer will render the warranty or service

agreement null and void.

Software updates are done by service representatives.

Intended use The Cedex Bio analyzer is a continuous random-access analyzer intended for the

determination of chemical and biochemical parameters in aqueous solutions

For use in quality control/manufacturing process only.

It is important that the operators read this manual thoroughly before using the

system.

Trademarks The following trademarks are acknowledged:

CEDEX and ISE are trademarks of Roche.

All other product names and trademarks are the property of their respective owners.

Instrument approvals The Cedex Bio analyzer meets the protection requirements laid down in the

following directives:

Directive 2014/30/EU of the European Parliament and Council of 26. February 2014

relating to electromagnetic compatibility (EMC).

Manual version Software version Revision date Changes

1.0 1.0 June 2011 First publication.

2.0 1.0 September 2011 Editorial corrections

3.0 2.0 July 2012 Hardware improvements.

Adjustments to reflect latest

software version (time indication

for running tests and disk space

indication).

3.1 2.1 November 2013 The TRL Check feature was

introduced. Minor textual

adjustments were made.

3.2 2.2 April 2016 Product IT Security Risk update.

Upgraded analyzer display, and

updates to user interface design.

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Operator’s Manual · Version 3.2 3

Cedex Bio analyzer

Directive 2014/35/EU of the European Parliament and Council of 26. February 2014

relating to electrical equipment designed for use within certain voltage limits.

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 with the applicable directive(s) is provided by means of the Declaration

of Conformity.

The following marks demonstrate compliance:

Laboratory equipment Product identifier as shown on the type plate.

Contact address

Complies with the provisions of the applicable EU Directive(s).

CUS

®

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

US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Cedex Bio analyzer

Roche Diagnostics

4 Operator’s Manual · Version 3.2

Roche Diagnostics

Operator’s Manual · Version 3.2 5

Cedex Bio analyzer

Table of contents

Document information 2

Contact address 3

Table of contents 5

Preface 7

How to use this manual 7

Online Help system 7

Conventions used in this manual 8

System Description Part A

1Safety

Safety classification A–5

Safety information A–5

Data security A–10

Disposal recommendation A–11

Legal liability A–11

Safety labels A–12

2 Introduction to the analyzer

Overview A–15

User interface A–18

Wizards A–19

Daily operation A–20

Maintenance A–33

System status A–34

3 Hardware

Covers and panels A–37

LEDs and color indicators A–39

Main components A–41

Hardware overview A–42

Technical specifications A–63

4 Software

Introduction A–67

Screen layout A–68

Display items A–69

Workflows and wizards A–70

Working with the user interface A–71

Key screens A–84

Color interpretation for LEDs and global

action buttons A–124

Buttons A–126

Operation Part B

5 Daily operation

Introduction B–5

Starting the shift B–11

Preparing the system B–13

Analyzing samples B–37

Validating sample results B–56

Performing calibrations B–64

Performing QC B–73

Finishing the shift B–83

Logging off B–95

Shutting down the system and switching off

the analyzer B–95

Using the barcode scanner B–96

6 Special operations

Deleting sample orders B–101

Deleting sample results B–102

Calibration B–103

Deleting QC results B–104

Lot handling B–106

Exporting data B–112

Importing data B–120

Preparing a new disk B–125

Assigning tests to test tabs B–128

Deleting bottle sets from the Inventory list B–129

Refilling printer paper B–131

Removing condensation water from the

reagent cooler B–133

Replacing the probe B–134

Connecting and disconnecting the external

fluid containers B–136

Adjusting the touchscreen B–140

Cleaning the touchscreen B–141

7 Configuration

Introduction B–145

Applications B–147

Configuration B–167

Analysis methods Part C

8 Data analysis methods

Photometric measurements C–5

Quality control C–29

ISE measurements C–31

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Cedex Bio analyzer

Maintenance Part D

9 General maintenance

Overview D–5

Maintenance actions D–8

Troubleshooting Part E

10 Messages and alarms

About messages E–5

Message screen E–5

Acoustic signals E–6

Alarm monitor E–6

List of alarm messages E–10

11 Result flags

About flags E–25

Safety E–27

List of flags E–28

12 Troubleshooting

Introduction E–41

Dealing with exceptional situations E–42

Reacting to messages E–44

Detailed procedures E–46

ISE Part F

13 ISE description

Overview F–5

Hardware F–9

Basic operation F–12

Technical specifications F–13

14 ISE operation

Daily operation F–17

Replacing ISE fluid bottles F–33

Replacing electrodes F–36

Cleaning the ISE tower off the analyzer F–40

15 ISE maintenance

Introduction F–45

ISE maintenance actions F–46

16 ISE troubleshooting

Introduction F–73

Safety F–74

List of ISE flags F–75

Reacting to error messages F–84

Glossary and Index Part G

Glossary G–3

Index G–11

Revisions Part H

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Operator’s Manual · Version 3.2 7

Cedex Bio analyzer

Preface

The Cedex Bio analyzer is a continuous random-access analyzer intended for the

determination of chemical and biochemical parameters in aqueous solutions. It is

optimized for small throughput workloads of up to 50 samples per day, utilizing

photometric analysis and a unit for ion selective electrodes (ISE).

This manual describes the Cedex Bio features and general operational concepts, and

it provides operating, maintenance, and emergency procedures.

How to use this manual

To help you find information quickly, there is a table of contents at the beginning of

the manual and each chapter. In addition, a complete index can be found at the end.

Online Help system

The Cedex Bio analyzer has a context-sensitive online Help feature to aid in its

operating. “Context-sensitive” means that wherever you are located within the

Cedex Bio software, choosing Help ( ) displays Help text relating to that area of

the software. The online Help offers a quick and convenient way of finding

information, such as explanations of screens and dialog boxes and on how to perform

particular tasks.

Parts B through E describe the analyzer without using an ISE unit, ISE specific information

is given in part F.

o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use.

o This Operator’s Manual should be easily accessible at all times.

Cedex Bio analyzer

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8 Operator’s Manual · Version 3.2

Conventions used in this manual

Visual cues are used to help locate and interpret information in this manual quickly.

This section explains the formatting conventions used in this manual.

Symbols The following symbols are used:

Buttons When used for identification purposes, a generic form of the buttons is used, without

color or navigation indicators.

Screenshots The screen representations shown in this publication are for illustrative purposes

only. The screens do not necessarily show valid data.

Symbol Used for

a Start of procedure

o List item

e

Cross-reference

h Call-up (software navigation path)

Color of display item on the screen

Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

Global Trade Item Number

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Operator’s Manual · Version 3.2 9

Cedex Bio analyzer

Abbreviations The following abbreviations are used:

Abbreviation Definition

DIL Diluent

DM Data management

DRAM Dynamic random access memory

e.g. Exempli gratia – for example

EMC Electromagnetic compatibility

EN European standard

i.e. Id est – that is to say

IEC International Electrical Commission

ISE Ion-Selective Electrode

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

n/a Not applicable

QC Quality control

REF Reference solution for ISE unit

ROM Read only memory

SD Standard deviation

SRAM Static random access memory

TRL Test range low (lower limit of measuring range)

Cedex Bio analyzer

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10 Operator’s Manual · Version 3.2

Units

Abbreviation Description

°C degree centigrade

μLmicroliter

μm micrometer

A ampère

cm centimeter

hhour

Hz hertz

LB pound (weight)

in inch

kg kilogram

kVA kilo volt-ampere

L liter

m meter

MB megabytes

min minute

mL milliliter

mm millimeter

nm nanometer

ssecond

Vvolt

VA volt-ampère

V AC volt alternating current

V DC volt direct current

Wwatt

1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Introduction to the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

3 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-35

4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-65

System Description

A

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Operator’s Manual · Version 3.2 A-3

Cedex Bio analyzer 1Safety

Table of contents

Safety

Protecting yourself and the environment

In this chapter, you will find information on the safe operation of the Cedex Bio

analyzer.

Safety classification ......................................................................................................... A–5

Safety information ........................................................................................................... A–5

Transport ................................................................................................................... A–5

Electrical safety .......................................................................................................... A–5

Optical safety ............................................................................................................. A–6

Mechanical safety ...................................................................................................... A–6

Analyzer covers ......................................................................................................... A–6

Operation and maintenance .................................................................................... A–6

Biohazardous materials ............................................................................................ A–6

Waste ..........................................................................................................................A–7

Reagents and other working solutions ................................................................... A–7

Installation ................................................................................................................. A–7

Environmental conditions ....................................................................................... A–7

Power interruption ................................................................................................... A–8

Electromagnetic devices ........................................................................................... A–8

Approved parts .......................................................................................................... A–8

Third-party software ................................................................................................ A–8

Operator qualification .............................................................................................. A–9

Operation over an extended period of time .......................................................... A–9

Cross contamination of sample .............................................................................. A–9

Insoluble contaminants in sample .......................................................................... A–9

Spillage ........................................................................................................................ A–9

Data security ..................................................................................................................A–10

Disposal recommendation ........................................................................................... A–11

Disposal label ........................................................................................................... A–11

Disposal of external components ......................................................................... A–11

Disposal of the analyzer ......................................................................................... A–11

Constraint ................................................................................................................ A–11

In this chapter

Chapter

1

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1Safety Cedex Bio analyzer

Table of contents

Legal liability .................................................................................................................. A–11

Safety labels .................................................................................................................... A–12

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Operator’s Manual · Version 3.2 A-5

Cedex Bio analyzer 1Safety

Safety classification

Before you attempt to use the Cedex Bio analyzer, you must be fully familiar with the

following symbols and their meanings:

Safety information

Before operating the Cedex Bio analyzer, it is essential that you both read and

understand the safety information listed below.

Read all Roche safety notices carefully and make sure you understand them.

Transport

Electrical safety

WARNING

Warning

Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

CAUTION

Caution

Indicates a hazardous situation which, if not avoided, may result in minor or moderate

injury.

NOTICE

Notice

Indicates a hazardous situation which, if not avoided, may result in property damage.

WARNING

Injury from heavy loads

You may injure your hands, fingers, or back when putting the analyzer in place. Carry the

analyzer according to the transport instructions.

WARNING

Electrical shock by electronic equipment

Do not attempt to work in any electronic compartment. Installation, service, and repair

must only be performed by authorized and qualified personnel.

Electrical safety

Connect the analyzer to grounded power outlets only (IEC protection class 1). All periph-

eral devices that are connected to the Cedex Bio analyzer must comply with safety stan-

dard IEC 60950 for information technology equipment, or with IEC/UL 61010-1 for

laboratory use instruments.

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1Safety Cedex Bio analyzer

Safety information

Optical safety

Mechanical safety

Analyzer covers

Operation and maintenance

Biohazardous materials

WARNING

Loss of sight

The intense light of the LEDs may severely damage you eyes. Do not stare into the LEDs.

Scanning equipment using LED technology is covered by the international standard

EN/IEC 60825-1 LED Safety: Class 1.

WARNING

Personal injury or damage to the analyzer due to contact with analyzer

mechanism

Do not touch moving parts during analyzer operation.

WARNING

Personal injury or damage to the analyzer due to contact with analyzer

mechanism

Keep all covers closed, operate them as instructed on the screen.

WARNING

Personal injury or damage to the analyzer due to contact with analyzer

mechanism

Do not touch any parts of the analyzer other than those specified. During operation and

maintenance of the analyzer, proceed according to the instructions.

WARNING

Infection by biohazardous materials

Contact with samples containing material of human origin may result in infection. All mate-

rials and mechanical components associated with samples of human origin are potentially

biohazardous.

o Be sure to wear protective equipment. Take extra care when working with protective

gloves; these can easily be pierced or cut, which can lead to infection.

o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

o If waste solution contacts your skin, wash it off immediately with water and apply a dis-

infectant. Consult a physician.

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Cedex Bio analyzer 1Safety

Safety information

Waste

Reagents and other working solutions

Installation

Environmental conditions

e

For details on the required environmental conditions, see Environmental conditions on

page A-63.

WARNING

Infection by waste solution

Contact with waste solution may result in infection. All materials and mechanical compo-

nents associated with the waste systems are potentially biohazardous.

o Be sure to wear protective equipment. Take extra care when working with protective

gloves; these can easily be pierced or cut, which can lead to infection.

o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

o If waste solution contacts your skin, wash it off immediately with water and apply a dis-

infectant. Consult a physician.

WARNING

Injury through reagents and other working solutions

Direct contact with reagents, cleaning solutions, or other working solutions may cause

personal injury.

When handling reagents, exercise the precautions required for handling laboratory

reagents, observe the cautions given in the Instructions for Use, and observe the informa-

tion given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning

solutions.

Skin inflammation caused by reagents

Direct contact with reagents may cause skin irritation, inflammation, or burns.

When handling reagents, be sure to wear protective equipment and observe the cautions

given in the Instructions for Use.

WARNING

Incorrect results or damage to the analyzer due to wrong installation

Follow the specified installation instructions carefully.

WARNING

Incorrect results or damage to the analyzer due to heat and humidity

Use the analyzer indoor only.

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1Safety Cedex Bio analyzer

Safety information

Power interruption

Electromagnetic devices

Approved parts

Third-party software

NOTICE

Data loss or damage to the system due to voltage drop

By a power failure or momentary voltage drop the operation unit or software of this system

may get damaged or data loss may occur. Use only uninterruptible power supply.

WARNING

Malfunction of analyzer and incorrect results due to interfering electromagnetic

fields

Devices that emit electromagnetic waves may cause the instrument analyzer to malfunc-

tion. Do not use this device in close proximity to sources of strong electromagnetic radia-

tion (for example, mobile phone, transceiver, cordless phone) as these can interfere with

the proper operation.

Class B FCC rule compliance

This equipment has been tested and found to comply with the limits for Class B digital

device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reason-

able protection against harmful interferences when the equipment is operated in a resi-

dential area. However, this equipment generates, uses, and can radiate radio frequency

energy and, if not installed and used in accordance with the present manual, may cause

harmful interference to radio communications.

The electromagnetic environment should be evaluated prior to operation of the device.

Class B International rules

Class B equipment is suitable for use in domestic establishments and in establishments

directly connected to a low voltage power supply network which supplies buildings used

for domestic purposes (CISPR 11, 4.2).

WARNING

Malfunction of analyzer and incorrect results due to nonapproved parts

Use of nonapproved parts or devices may result in malfunction of the analyzer and may

render the warranty null and void. Only use parts and devices approved by Roche Diagnos-

tics.

WARNING

Malfunction of analyzer and incorrect results due to third-party software

Installation of any third-party software that is not approved by Roche Diagnostics may

result in incorrect behavior of the system. Do not install any nonapproved software.

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