Roche ISE 9180 User manual

9180 Electrolyte Analyzer

Instructions for Use

9180 Electrolyte Analyzer

Roche Diagnostics

2 Instructions for Use · Version 8.0

Publication information

Revision history

Edition notice This publication is intended for operators of the 9180 Electrolyte Analyzer.

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

publication is correct at the time of publishing. However, Roche may need to update

the publication information as output of product surveillance activities, leading to a

new version of this publication.

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.

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.

Warrant y 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:

ROCHE MICROSAMPLER, SNAPPAK, ISETROL are trademarks of Roche.

All other trademarks are the property of their respective owners.

Manual Version Software Version Revision date Changes

1.0 April 2004

2.0 April 2005

3.0 January 2007

4.0 April 2007

5.0 March 2008

6.0 March 2012

7.0 February 2013

7.1 July 2013

8.0 July 2016 Updated reference and critical

ranges

Updated compliance information

Table 1 Revision history

Roche Diagnostics

Instructions for Use · Version 8.0 3

9180 Electrolyte Analyzer

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 such feedback.

Approvals The 9180 Electrolyte 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.

This instrument complies with the emission and immunity requirements described

in this part of the IEC 61326 series.

Compliance is provided by means of the Declaration of Conformity.

The following marks demonstrate compliance:

Contact addresses

Manufacturer

Edition

Version 8.0, July 2016

First edition: April 1996

For in vitro diagnostic use.

Complies with the provisions of the applicable EU directives

Issued by TÜV SÜD for Canada and the US.

Laboratory Equipment is the product identifier as shown on the

name plate.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

www.roche.com

9180 Electrolyte Analyzer

Roche Diagnostics

4 Instructions for Use · Version 8.0

Local Service Contact

Roche Diagnostics

Instructions for Use · Version 8.0 5

9180 Electrolyte Analyzer

Table of contents

Publication information 2

Contact addresses 3

Edition 3

Local Service Contact 4

Table of contents 5

Preface 7

Intended use 7

Intended user 7

Use environment 7

Symbols and abbreviations 7

What is new in publication version 8.0 11

Introduction and specifications

1 Safety information

Safety classifications 16

Safety precautions 17

Safety labels on the instrument and

consumables 22

2 General description

Introduction 27

Measurement and calibration procedures 28

Measurement evaluation 29

Standby mode 30

3 Specifications

Performance parameters 33

Linearity 36

Interferences 38

Limitations 38

Relationship of ionized calcium to total

calcium 39

Bibliography 39

Sample throughput 40

Sample volumes 40

Sample types 40

Calibrations 40

Environmental parameters 41

Product data 44

Printer 44

Display 44

4 Theoretical foundation

Reference and critical values 47

Principles of operation 49

Electrode specifications 53

System components

5 System components

System description 65

Operation

6 Installation and shutdown

Installation 75

Shutdown 87

7 Measurement

Preanalytics 95

Interference 99

Limitations of clinical analysis 103

Measuring procedure 104

Normal ranges (reference values) 109

Correlation factors 110

Additional settings 112

8 Quality control

Quality control 117

Material setup 119

Performing a QC measurement 121

Printing a QC report 123

Maintenance

9 Maintenance

Maintenance 129

Disinfection 129

Daily maintenance 130

Weekly maintenance 133

Monthly maintenance 135

Semi-annual maintenance 138

Annual maintenance 140

Unscheduled maintenance 141

Troubleshooting

10 Troubleshooting

Troubleshooting 155

Service functions 159

Service codes 164

Deleting data 166

Roche Diagnostics

6 Instructions for Use · Version 8.0

9180 Electrolyte Analyzer

Appendix

11 Appendix

Description of reports 171

Specifications of the solutions 173

Program flow chart 174

Maintenance schedule 175

Available accessories and consumables 176

12 Glossary

Index

Index 183

Roche Diagnostics

Instructions for Use · Version 8.0 7

9180 Electrolyte Analyzer

Preface

Intended use

The 9180 Electrolyte Analyzer is intended to be used for measurements of sodium,

potassium, ionized calcium and lithium in whole blood, serum or plasma, urine,

dialysate solutions or QC materials as appropriate by minimally trained personal

qualified to perform and to report these values in a clinical laboratory setting. These

analytes are commonly used in the diagnosis and management of patients with a

broad range of renal, metabolic and cardiovascular disorders.

Intended user

The user is a trained staff member in critical care units, emergency departments,

intensive care units (ICUs) or laboratories.

Use environment

The 9180 Electrolyte Analyzer is intended to be operated in laboratories of hospitals

as well as in the point of care setting, such as intensive care areas (ICU, NICU, PICU),

emergency departments (A&E) and operating rooms (OR).

Symbols and abbreviations

Symbols used in the publication

Symbol Used for

o List item

r Start of a task

s End of a task

u Related topics containing further information

q Tip. Extra information on correct use or useful hints.

Table 2 Symbols used in the publication

9180 Electrolyte Analyzer

Roche Diagnostics

8 Instructions for Use · Version 8.0

Symbols used on the instrument

Symbol Description

Catalogue number

Serial number

Global Trade Item Number

Manufacturer

Date of manufacture

Alternating current

Caution

Operator’s manual/operating instructions

Caution, consult accompanying documents

Table 3 Symbols used on the instrument

Roche Diagnostics

Instructions for Use · Version 8.0 9

9180 Electrolyte Analyzer

Symbols used on consumables

Symbol Description

Catalogue number

Batch code

Global Trade Item Number

Use by date

Temperature limitation

Do not use if package is damaged

Consumable contents

Control material

Fragile handle with care

Store upright

Do not reuse

Table 4 Symbols used on consumables

9180 Electrolyte Analyzer

Roche Diagnostics

10 Instructions for Use · Version 8.0

Abbreviations

Manufacturer

Sterilized using radiation

Sterilized using ethylene oxide

Sufficient for <n> tests

Operator’s manual/operating instructions

Caution, consult accompanying documents

Symbol Description

Table 4 Symbols used on consumables

Abbreviation Definition

A

ANSI American National Standards Institute

C

CLSI Clinical and Laboratory Standards Institute

CV Coefficient of variation

D

DIN German Institute of Standardization

E

EC European community

I

IEC International Electrotechnical Commission

ISE Ion selective electrode

ISO International Organization of Standardization

IVD In vitro diagnostic

K

KCl Potassium chloride

L

LCD Liquid crystal display

LED Light-emitting diode

M

MV Mean value

N

Table 5 Abbreviations

Roche Diagnostics

Instructions for Use · Version 8.0 11

9180 Electrolyte Analyzer

What is new in publication version 8.0

"What is new in publication

version" section

This section describes new content that is found in this version of the Instructions for

Use.

Harmonization of reference ranges

and removal of critical values

Reference ranges are harmonized to age- and gender-independent values, where

applicable, from well-accepted clinical chemistry and molecular diagnostics

textbooks. Critical ranges have been removed because they depend on numerous

patient-specific factors.

u Reference and critical values (p. 47)

New consumable information Plastic capillary tubes (material 05174791001) have been discontinued.

u Available accessories and consumables (p. 176).

Revised name plate New information, such as the reference number, Global Trade Item Number and

production date of each 9180 Electrolyte Analyzer, and compliance information can

now be found on the name plate. In addition, production information for each

system is stored on a QR code on the top right-hand corner of the name plate.

New approvals section Compliance of all applicable directives and guidelines for the

9180 Electrolyte Analyzer can now be found in the approvals section at the front of

the Instructions for Use.

u Approvals (p. 3)

Cleaning instructions for

connector pins after each SnapPak

exchange

Connector pins, which detect the SnapPak for all 9180 Electrolyte Analyzers with a

serial number greater than 21000, should be visually inspected for moisture, dirt and

damage after each SnapPak exchange.

u Checking reagent fluid level and changing the SnapPak (p. 144).

New mains fuse replacement

procedure

u Replacing the mains fuse (p. 148)

NIST National Institute of Standards and Technology

Q

QC Quality control

R

RCon Reference contact

REF Reference solution

S

SD Standard deviation

S

dd

Between-day precision

S

T

Total precision

S

wr

Within-run precision

V

VAC Volts alternating current

Abbreviation Definition

Table 5 Abbreviations

9180 Electrolyte Analyzer

Roche Diagnostics

12 Instructions for Use · Version 8.0

Introduction and specifications

1 Safety information ........................................................................................................................... 15

2 General description.......................................................................................................................... 25

3 Specifications.................................................................................................................................... 31

4 Theoretical foundation..................................................................................................................... 45

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Instructions for Use · Version 8.0 15

9180 Electrolyte Analyzer 1 Safety information

Table of contents

Safety information 1

This chapter provides information about the safe operation of the

9180 Electrolyte Analyzer.

In this chapter

Chapter

1

Safety classifications.............................................................................................................16

Safety precautions.................................................................................................................17

Operator qualification...................................................................................................17

Installation and deinstallation......................................................................................17

Operating conditions.....................................................................................................17

Safe and proper use of the system................................................................................18

Electrical safety...............................................................................................................18

Biohazardous materials .................................................................................................19

Mechanical safety...........................................................................................................19

Reagents and working solutions...................................................................................20

Incorrect results..............................................................................................................20

Software and data security............................................................................................21

Instrument damage........................................................................................................21

Safety labels on the instrument and consumables ...........................................................22

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16 Instructions for Use · Version 8.0

1 Safety information 9180 Electrolyte Analyzer

Safety classifications

This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the ANSI

Z535.6 Standard. Familiarize yourself with the following meanings and icons:

Safety alert

The safety alert symbol is used to alert you to potential physical injury hazards. Obey all

safety messages that follow this symbol to avoid possible damage to the system, injury, or

death.

These symbols and signal words are used for specific hazards:

WARNING

r ... indicates a hazardous situation that, if not avoided, could result in death or serious

injury.

CAUTION

r ... indicates a hazardous situation that, if not avoided, could result in minor or moderate

injury.

NOTICE

r ... indicates a hazardous situation that, if not avoided, may result in damage to the

instrument.

Protective gloves and goggles, suitable protective clothing, and if necessary, mouth

protection have to be worn.

Important information that is not safety relevant is indicated with the following

symbol:

q

Tip

... indicates additional information on correct use or useful tips.

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Instructions for Use · Version 8.0 17

9180 Electrolyte Analyzer 1 Safety information

Safety precautions

To avoid serious or fatal injury, read and comply with the following safety

precautions.

Operator qualification

Insufficient knowledge and skills As an operator, ensure that you know the relevant safety precaution guidelines and

standards and the information and procedures contained in these instructions.

o Do not carry out operation and maintenance unless Roche Diagnostics has

trained you to do so.

o Leave maintenance, installation, or service that is not described to trained Roche

Service representatives.

o Carefully follow the procedures specified in the instructions for operation and

maintenance.

o Follow standard laboratory practices, especially when you work with

biohazardous material.

Installation and deinstallation

Disposal A biohazardous system may lead to infection.

o Treat the system as biohazardous waste. Decontamination (the combination of

processes including cleaning, disinfection, and/or sterilization) is required before

reuse, recycling, or disposal of the system.

o Dispose of the system according to the local regulations. For more information,

contact your Roche service representative.

Operating conditions

Unsuitable operating conditions Operation outside of the specified ranges may lead to incorrect results or malfunction

of the system.

o Use the system indoors only, and avoid heat and humidity outside of the specified

range.

o Make sure that the system’s ventilation openings remain unobstructed always.

o Keep the analyzer away from all sources of liquids, such as sinks and wash basins.

o To maintain the operating conditions of the system, perform maintenance in

accordance with the specified intervals.

o Keep the operating instructions undamaged and available for use. Operating

instructions must be easily accessible for all users.

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18 Instructions for Use · Version 8.0

1 Safety information 9180 Electrolyte Analyzer

Safety precautions

Electromagnetic interference Strong electromagnetic fields (originating from unshielded radio-frequency sources)

can interfere with proper operation and may lead to malfunction of the system and

incorrect results.

o Do not use this system near sources of strong electromagnetic fields because these

fields can interfere with the proper operation.

o Evaluate the electromagnetic environment before you operate the system.

o Take measures to mitigate the interference.

Safe and proper use of the system

Missing personal protective

equipment

Working without personal protective equipment means danger to life or health.

o Wear appropriate personal protective equipment, including, but not limited to,

the following items: eye protection with side shields, fluid-resistant laboratory

coat, approved lab gloves, and face shield if there is a change of splashing or

splattering.

System not used for an extended

period

o Place the analyzer into Standby mode if you do not use the analyzer for an

extended period.

o Remove and refrigerate any remaining reagents.

o For further information, call your Roche Service representative.

Non-approved parts Use of non-approved parts or devices may result in malfunction of the system and

may render the warranty null and void.

o Use only parts and devices approved by Roche Diagnostics.

Electrical safety

Electrical shock Removing the covers of electronic equipment can cause electric shock because there

are high-voltage parts inside.

o Do not attempt to work in any electronic equipment.

o Do not remove any cover of the system except those covers specified in the

instructions.

o Only Roche Service representatives may install, service, and repair the system.

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Instructions for Use · Version 8.0 19

9180 Electrolyte Analyzer 1 Safety information

Safety precautions

Biohazardous materials

Infectious samples Contact with samples containing material of human origin may result in infection.

All materials and mechanical components associated with samples containing

material of human origin are potentially biohazardous.

o Follow standard laboratory practices, especially when working with biohazardous

material.

o Keep all covers closed while the system is operating.

o Always switch off the system or go to Standby mode, if possible, before you work

with an opened cover (for example, for cleaning or maintenance).

o Wear appropriate personal protective equipment.

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

disinfectant.

o If sample or waste comes into contact with your skin, wash the affected area

immediately with soap and water and apply a disinfectant. Consult a physician.

Sharp objects Contact with probes or needles may result in infection.

o When you wipe probes or needles, use several layers of gauze and wipe from the

top down.

o Take care not to puncture yourself.

o Wear appropriate personal protective equipment. Take extra care when working

with lab gloves, which can easily be pierced or cut, leading to infection.

Infectious waste Contact with waste (liquid and/or solid) may result in infection. All materials and

mechanical components associated with the waste systems are potentially

biohazardous.

o Wear appropriate personal protective equipment. Take extra care when working

with lab gloves. They can be easily pierced or cut, leading to infection.

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

disinfectant.

o If waste comes into contact with your skin, wash the affected area immediately

with soap and water and apply a disinfectant. Consult a physician.

Environmental harm The system generates liquid and/or solid waste. This waste contains concentrated

reaction solutions and is potentially biohazardous. Improper disposal may

contaminate the environment.

o Treat this waste as infectious waste.

o Dispose of waste in accordance with the local regulations.

Mechanical safety

Moving parts Contact with moving parts may result in personal injury.

o Keep all covers closed and in place while the system is operating.

o Always switch off the system or go to Standby mode before you work with an

opened cover (for example for cleaning or maintenance).

o Do not touch any parts of the system except those parts specified. Keep away from

moving parts during operation.

o During operation and maintenance, carefully follow the instructions.

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20 Instructions for Use · Version 8.0

1 Safety information 9180 Electrolyte Analyzer

Safety precautions

Reagents and working solutions

Skin inflammation or injury Direct contact with reagents, detergents, cleaning solutions, or other working

solutions may cause skin irritation, inflammation, or burns.

o When you handle reagents, exercise the precautions required for handling

laboratory reagents.

o Wear appropriate personal protective equipment.

o Observe the instructions given in the Instructions for Use.

o Observe the information given in Material Safety Data Sheets (available for Roche

Diagnostics reagents and cleaning solutions).

o If reagents, detergents, or other cleaning solutions come into contact with your

skin, wash the affected area immediately with soap and water and apply a

disinfectant. Consult a physician.

Fire and burns Alcohol is a flammable substance.

o Keep all sources of ignition (such as sparks, flames, or heat) away from the system

when you perform maintenance or checks that involve alcohol.

o When you use alcohol on or around the system, use no more than 20 mL at a

time.

Incorrect results

Poor accuracy and precision Incorrect results may lead to errors in diagnosis, posing danger to the patient.

o For the proper use of the system, run QC tests and monitor the system during

operation.

o Do not use reagents or consumables that have exceeded their expiry date,

otherwise you may obtain inaccurate data.

o For diagnostic purposes, always assess the results with the patient’s medical

history, clinical examination, and results from other consultations.

Incorrect reagent volume Incorrect reagent handling may cause an undetectable loss of reagent.

o Always store reagents according to the specified storage conditions as stated in

the Instructions for Use for the test.

Foam, clots, films, or bubbles Incorrect results may occur due to foam, fibrin clots, films, or bubbles in reagents or

samples.

o Avoid the formation of foam, clots, and bubbles in all reagents, samples,

calibrators, and controls.

Evaporation of samples or

reagents

Evaporation of samples or reagents may lead to incorrect or invalid results.

o Sample material may evaporate if left open. Do not leave samples open for any

length of time.

o Do not use improperly stored reagents. Ensure that reagents are stored according

to the Instructions for Use.

Carryover Traces of analytes or reagents may be carried over from one test to the next.

o Take adequate measures (for example, extra wash cycles) to avoid extra testing

and potentially incorrect results.

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Roche ISE 9180 User manual

Roche ISE 9180 User manual

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