Roche 9180 User manual

9180 Electrolyte Analyzer
Instructions for Use

9180 Electrolyte Analyzer
Roche Diagnostics
2Instructions for Use · Version 10.0
Publication information
Revision history
Edition notice This publication is intended for users 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, 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.
General attention
To avoid serious or fatal injury, ensure that you are familiar with the system and safety
information before you use the system.
rPay particular attention to all safety precautions.
rAlways follow the instructions in this publication.
rDo not use the instrument in a way that is not described in this publication.
rStore all publications in a safe and easily accessible place.
CAUTION
Incident reporting
rInform your Roche representative and your local competent authority about any serious
incidents which may occur when using this product.
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.
Images The images in this publication have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, such as tests, results, or path names
visible therein must not be used for laboratory purposes.
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
9.0 July 2020 Updated safety related
information
Updated urine diluent storage
specification
9.1 July 2021 uWhat is new in version 9.1
14
10.0 April 2022 uWhat is new in publication
version 10.0 (p. 13)
Table 1 Revision history

Roche Diagnostics
Instructions for Use · Version 10.0 3
9180 Electrolyte Analyzer
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.
Copyright © 1996-2022, F. Hoffmann-La Roche Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
SNAPPAK, ISETROL 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 such feedback.
Approvals Due to the transition phase of IVDD to IVDR, one of the following (Directive or
Regulation) applies to the products in scope of this manual. The applicable one is
mentioned in every product's EU Declaration of Conformity.
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices. (IVDD)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April
2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU. (IVDR)
The 9180 Electrolyte Analyzer meets the requirements laid down in:
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:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU directives and
regulations.
Issued by TÜV SÜD for Canada and the US.
Laboratory Equipment is the product identifier as shown on the
name plate.

9180 Electrolyte Analyzer
Roche Diagnostics
4Instructions for Use · Version 10.0
Contact addresses
Manufacturer
Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm
eLabDoc Electronic user documentation can be downloaded using the eLabDoc e-service on
Roche DiaLog:
www.dialog.roche.com
For more information, contact your local affiliate or Roche Service representative.
Edition
Version 10.0, April 2022
First edition: April 1996
Local Service Contact
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
www.roche.com

Roche Diagnostics
Instructions for Use · Version 10.0 5
9180 Electrolyte Analyzer
Table of contents
Publication information 2
Contact addresses 4
Edition 4
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 10.0 12
What is new in version 9.1 13
What is new in version 9.0 13
What is new in publication version 8.0 13
Introduction and specifications
1 Safety information
Safety classifications 18
Safety precautions 19
Safety labels on the instrument and
consumables 25
2 General description
Introduction 29
Measurement and calibration procedures 30
Measurement evaluation 31
Standby mode 32
3 Specifications
Performance parameters 35
Linearity 38
Interferences 40
Limitations 40
Relationship of ionized calcium to total
calcium 41
Bibliography 41
Sample throughput 43
Sample volumes 43
Sample types 43
Calibrations 43
Environmental parameters 44
Product data 47
Printer 47
Display 47
4 Theoretical foundation
Reference and critical values 51
Principles of operation 53
Electrode specifications 57
System components
5 System components
System description 69
Operation
6 Installation and shutdown
Installation 79
Shutdown 92
7 Measurement
Preanalytics 99
Interference 103
Limitations of clinical analysis 107
Measuring procedure 108
Normal ranges (reference values) 112
Correlation factors 113
Additional settings 115
8 Quality control
Quality control 119
Material setup 121
Performing a QC measurement 123
Printing a QC report 125
Maintenance
9 Maintenance
Maintenance 131
Disinfection 131
Daily maintenance 133
Weekly maintenance 135
Monthly maintenance 137
Semi-annual maintenance 140
Annual maintenance 141
Unscheduled maintenance 142
Troubleshooting
10 Troubleshooting
Troubleshooting 155
Service functions 159
Service codes 164
Deleting data 166

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6Instructions for Use · Version 10.0
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 10.0 7
9180 Electrolyte Analyzer
Preface
Intended use
The 9180 Electrolyte Analyzer is intended for in vitro testing of samples of whole
blood(1), serum or plasma, and urine for the quantitative measurement of electrolytes
(Na+, K+, Ca2+, and Cl-) and Lithium using electrochemical technologies
(potentiometry and amperometry) for aid in diagnosis and in monitoring.(2)
It is intended to be used for near-patient testing and not for self-testing.
Intended user
Users of the instrument are trained professionals in the laboratory and trained
technicians, nurses, physicians and therapists in a near patient testing environment.
Use environment
The 9180 Electrolyte Analyzer is intended to be used in critical professional near-
patient environments such as intensive care areas, emergency departments and
operating rooms as well as the hospital laboratories.
The 9180 Electrolyte Analyzer system is positioned as a near patient testing analyzer
with low to medium throughput for fast and convenient determination of electrolytes
to aid in diagnosis and in monitoring of patients.
Symbols and abbreviations
Symbols used in the publication
(1) In venous whole blood only.
(2) Not every parameter can be measured in each sample matrix. The details for the specificed sample
matrices per parameter are in the measurement table defined or for the respective electrodes.
Symbol Used for
oList item
rStart of a task
sEnd of a task
uRelated topics containing further information
qTip. Extra information on correct use or useful hints.
Table 2 Symbols used in the publication

9180 Electrolyte Analyzer
Roche Diagnostics
8Instructions for Use · Version 10.0
Symbols used on the instrument
Symbol Description
Catalogue number
Serial number
Global Trade Item Number
Unique Device Identifier
Contents
Manufacturer
Date of manufacture
Alternating current
Temperature limitation
Humidity limitation
Air pressure limitation
Fragile handle with care
Keep dry
Store upright
Table 3 Symbols used on the instrument

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Instructions for Use · Version 10.0 9
9180 Electrolyte Analyzer
Symbols used on consumables
Stacking limit
Caution
Operator’s manual/operating instructions
Caution, consult accompanying documents
Device for near-patient testing
Device not for self-testing
Electrostatic-sensitive device (ESD)
Symbol Description
Table 3 Symbols used on the instrument
Symbol Description
Catalogue number
Batch code
Global Trade Item Number
Use by date
Temperature limitation
Do not use if package is damaged
Table 4 Symbols used on consumables

9180 Electrolyte Analyzer
Roche Diagnostics
10 Instructions for Use · Version 10.0
Abbreviations
Consumable contents
Control material
Fragile handle with care
Store upright
Do not reuse
Manufacturer
Sterilized using radiation
Sterilized using ethylene oxide
Install before
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
Table 5 Abbreviations

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Instructions for Use · Version 10.0 11
9180 Electrolyte Analyzer
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
IVDD In vitro diagnostic directive
IVDR In vitro diagnostic regulation
K
KCl Potassium chloride
L
LCD Liquid crystal display
LED Light-emitting diode
M
MV Mean value
N
NIST National Institute of Standards and Technology
Q
QC Quality control
R
RCon Reference contact
REF Reference solution
S
SD Standard deviation
Sdd Between-day precision
STTotal precision
Swr Within-run precision
V
VAC Volts alternating current
Abbreviation Definition
Table 5 Abbreviations

9180 Electrolyte Analyzer
Roche Diagnostics
12 Instructions for Use · Version 10.0
What is new in publication version 10.0
Li+measurements in whole blood Determination of Li+is usually done in serum or plasma and has therefore been
removed from the list of measurement parameters in whole blood.
uMeasurement parameters (p. 35)
Sample type dialysis solutions The sample type "dialysis solutions containing acetate and bicarbonate" has been
removed from the list of supported sample types and from the measurement
parameters because dialysis solutions are not defined as in vitro diagnostic sample
types.
uSample types (p. 43)
uMeasurement parameters (p. 35)
Specification The following specifications have been updated:
uSample throughput (p. 43)
uCalibrations (p. 43)
uInstrument (p. 44)
uElectrodes (p. 44)
uSolutions (p. 45)
uQC material (p. 47)
uPrinter (p. 48)
Incorrect handling of consumables A warning message about the incorrect handling of consumables has been added.
uConsumables (p. 22)
RS232 interface port Information about the RS232 interface port has been removed from the publication.
Verifying performance after
maintenance actions
For the following maintenance actions, a new step has been added to perform QC
measurements on 3 levels to verify the performance of the instrument:
uCleaning the reference electrode housing (p. 137)
uExchanging the pump tubing set (p. 140)
uExchanging main tubing harness (p. 141)
uChecking reagent fluid level and changing the SnapPak (p. 145)
uReplacing sample probe and fill port (p. 147)
uReplacing the mains fuse (p. 149)
Regulatory adaptations The following information was added as part of the adaptation to the EU regulation
2017/746 on in vitro diagnostic medical devices:
oInformation about incident reporting
oLink to the worldwide list of Roche affiliates
oDownload information about electronic user documentation
Minor changes Minor changes have been applied throughout the publication.

Roche Diagnostics
Instructions for Use · Version 10.0 13
9180 Electrolyte Analyzer
What is new in version 9.1
Ca2+ unit set to mg/dL A caution statement has been added to indicate that the guiding arrow on the display
can be wrong if the unit for Ca2+ is set to mg/dL (Service Code MGL configured) and
if a measured Ca2+ value is lower than the normal range.
uCalcium electrode (p. 60)
What is new in version 9.0
Name plate Section update due to change in name plate.
uName plate (p. 73)
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.
uReference and critical values (p. 51)
New consumable information Plastic capillary tubes (material 05174791001) have been discontinued.
uAvailable 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.
uApprovals (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.
uChecking reagent fluid level and changing the SnapPak (p. 145).
New mains fuse replacement
procedure
uReplacing the mains fuse (p. 149)

9180 Electrolyte Analyzer
Roche Diagnostics
14 Instructions for Use · Version 10.0

Introduction and specifications
1 Safety information ........................................................................................................................... 17
2 General description.......................................................................................................................... 27
3 Specifications.................................................................................................................................... 33
4 Theoretical foundation .................................................................................................................... 49

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Instructions for Use · Version 10.0 17
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.............................................................................................................18
Safety precautions.................................................................................................................19
Operator qualification...................................................................................................19
Safe and proper use of the system................................................................................19
Installation and deinstallation......................................................................................20
Operating conditions.....................................................................................................20
Electrical safety...............................................................................................................20
Biohazardous materials .................................................................................................21
Mechanical safety...........................................................................................................22
Consumables...................................................................................................................22
Reagents and working solutions...................................................................................22
Incorrect results..............................................................................................................23
Software and data security............................................................................................23
Instrument damage........................................................................................................24
Safety labels on the instrument and consumables ...........................................................25

Roche Diagnostics
18 Instructions for Use · Version 10.0
1 Safety information 9180 Electrolyte Analyzer
Safety classifications
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
WARNING
r... indicates a hazardous situation that, if not avoided, could result in death or serious
injury.
CAUTION
CAUTION
r... indicates a hazardous situation that, if not avoided, could result in minor or moderate
injury.
NOTICE NOTICE
r... indicates a hazardous situation that, if not avoided, may result in damage to the
instrument.
Wear appropriate personal protective equipment, such as, but not limited to, the
following items:
oEye protection
oLab coat
oLab gloves
Important information that is not safety relevant is indicated with the following
symbol:
qTip
... indicates additional information on correct use or useful tips.

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9180 Electrolyte Analyzer 1 Safety information
Safety precautions
Safety precautions
To avoid serious or fatal injury, read and comply with the following safety
precautions.
Operator qualification
CAUTION
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.
rDo not carry out operation and maintenance unless Roche Diagnostics has trained you
to do so.
rLeave maintenance, installation, or service that is not described to trained Roche
Service representatives.
rCarefully follow the procedures specified in the instructions for operation and
maintenance.
rFollow standard laboratory practices, especially when you work with biohazardous
material.
Safe and proper use of the system
WARNING
Personal injury and infection due to sharps, rough edges, and/or moving parts
rGood Laboratory Practice can reduce the risk of injury. Be aware of your laboratory
environment, well-prepared, and follow the instructions for use. Some areas of the
instrument may have sharps, rough edges, and/or moving parts. Wear personal
protective equipment to minimize the risk of injury from bodily contact with such parts,
especially in less accessible areas, or while cleaning the instrument. Your personal
protective equipment should be appropriate to the degree and type of potential hazard,
e.g. suitable lab gloves, eye protection, lab coat, and footwear.
WARNING
Missing personal protective equipment
Working without personal protective equipment means danger to life or health.
rWear appropriate personal protective equipment, such as, but not limited to, the
following items:
oEye protection
oLab coat
oLab gloves
System not used for an extended
period
oPlace the analyzer into Standby mode if you do not use the analyzer for an
extended period.
oRemove and refrigerate any remaining reagents.
oFor 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.
oUse only parts and devices approved by Roche Diagnostics.

Roche Diagnostics
20 Instructions for Use · Version 10.0
1 Safety information 9180 Electrolyte Analyzer
Safety precautions
Installation and deinstallation
Disposal A biohazardous system may lead to infection.
oTreat 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.
oDispose of the system according to the local regulations. For more information,
contact your Roche service representative.
Operating conditions
WARNING
Unsuitable operating conditions
Operation outside of the specified ranges may lead to incorrect results or malfunction of
the system.
rUse the system indoors only, and avoid heat and humidity outside of the specified
range.
rMake sure that the system’s ventilation openings remain unobstructed always.
rKeep the analyzer away from all sources of liquids, such as sinks and wash basins.
rTo maintain the operating conditions of the system, perform maintenance in
accordance with the specified intervals.
rKeep the operating instructions undamaged and available for use. Operating
instructions must be easily accessible for all users.
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.
oDo not use this system near sources of strong electromagnetic fields because these
fields can interfere with the proper operation.
oEvaluate the electromagnetic environment before you operate the system.
oTake measures to mitigate the interference.
Electrical safety
WARNING
Electrical shock
Removing the covers of electronic equipment can cause electric shock because there are
high-voltage parts inside.
rDo not attempt to work in any electronic equipment.
rDo not remove any cover of the system except those covers specified in the
instructions.
rOnly Roche Service representatives may install, service, and repair the system.