ISE9180 User Manual 7.1 Jul13 PDF

9180 Electrolyte Analyzer
Instructions for Use
2013 Roche
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
www.roche.com
Revision history
Manual Version
Software Version
Revision date
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 (not published)
February 2013
7.1
July 2013
Changes
Edition notice
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of publishing. 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 instrument will render the warranty or service
agreement null and void.
Software updates are done by Roche Service representatives.
Copyrights
2013, Roche Diagnostics GmbH. All rights reserved.
The contents of this document may not be reproduced in any form or communicated
to any third party without the prior written consent of Roche.
While every effort is made to ensure its correctness, Roche assumes no responsibility
for errors or omissions which may appear in this document.
Subject to change without notice.
Brands
ROCHE MICROSAMPLER, SNAPPAK, ISETROL are trademarks of Roche.
Roche
Instructions for Use Version 7.1
July 2013
3
Contact addresses
Manufacturer
Roche Diagnostics GmbH

Sandhofer Strasse 116
D-68305 Mannheim
Germany
Edition
Version 7.1, July 2013
First edition: April 1996
REF/No. 0 4381092001
Local Service Contact
Roche
4
July 2013
Table of contents
Revision history
Edition notice
Copyrights
Brands
Contact addresses
Edition
Local Service Contact
Table of contents
Preface
How to use this manual
Conventions used in this manual
Introduction and specifications
3
3
3
3
4
4
4
5
7
7
7
Part A
1 Safety information
Important information
Operating safety information
A-5
A-6
2 General description
Introduction
Measurement and calibration procedures
Measurement evaluation
Important safety instructions
Standby mode
Part B
5 System components
System description
Operation
B-5
Part C
6 Installation and Shutdown
Installation
Shutdown
C-5
C-18
7 Measurement
Preanalytics
Interference
Limitations of clinical analysis
Measuring procedure
Normal ranges (reference values)
Correlation factors
Additional settings
A-9
A-10
A-11
A-11
A-13
8 Quality control
A-17
A-21
A-23
A-23
Maintenance
3 Specification
Performance parameters
Linearity
Interferences
Limitations
Relationship of ionized calcium to total
calcium
Bibliography
Sample throughput
Sample volumes
Sample types
Calibrations
Environmental parameters
Product data
Printer
Display
System components
Quality control
Material setup
Performing a QC measurement
Printing a QC report
C-25
C-29
C-33
C-34
C-38
C-39
C-41
C-45
C-46
C-48
C-49
Part D
9 Maintenance
A-24
A-24
A-25
A-25
A-25
A-25
A-26
A-29
A-29
A-29
Maintenance
Disinfection
Daily maintenance
Weekly maintenance
Monthly maintenance
Semi annual maintenance
Annual maintenance
Unscheduled maintenance
Troubleshooting
D-5
D-5
D-6
D-8
D-10
D-13
D-14
D-15
Part E
4 Theoretical foundation
Reference and critical values

Principles of Operation
Electrode specifications
Calibration procedure
Roche
A-33
A-36
A-40
A-46
10 Troubleshooting
Troubleshooting
Service functions
Service codes
Deleting data
E-5
E-9
E-14
E-16
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5
Appendix
Part F
11 Appendix
Description of reports
Specifications of the solutions
Program flow chart
Maintenance schedule
Order information
Glossary
Index
F-5
F-7
F-8
F-9
F-10
F-13
Part G
Index
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July 2013
Preface
The 9180 Electrolyte Analyzer is a powerful tool designed to quickly, accurately and
efficiently conduct basic electrolyte testing in the convenience of the laboratory.
This manual has detailed descriptions of 9180 Electrolyte Analyzer features and
general operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling and maintenance procedures.
How to use this manual

o
Keep this Instructions for Use in a safe place to ensure that it is not damaged and
remains available for use.
This Instructions for Use should be easily accessible at all times.
To help you find information quickly, there is a table of contents at the beginning of
the book and each chapter. In addition, a complete index can be found at the end.
Conventions used in this manual

Visual cues are used to help locate and interpret information in this manual quickly.
This section explains formatting conventions used in this manual.
Symbols
The following symbols are used:

Symbol
Used for
Start of procedure
List item
Cross-reference
Call-up (software reference)

Tip
Attention
All sections / passages that are marked with this symbol describe
procedures and/or indicate conditions or dangers that could damage
or lead to a malfunction in the 9180 Electrolyte Analyzer.
Warning
Sections marked with this symbol contain information that must be

observed to avoid potential injuries (to patients, users and third
parties).
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Symbol
Used for
Risk of infection!
All sections and parts of texts that are marked with this symbol
describe procedures that may involve risk of infection.
ESD protective measures
All sections / text passages that are marked with this symbol refer to
components that require special care with respect to electrostatic
discharges. Packaging with this label may be opened by trained
personnel only.
IVD symbols
The symbols are used in accordance with DIN EN ISO 15223-1(a) and DIN EN ISO
780(b).
Symbol
Description
Conformit Europenne:
This product complies with the requirements in the guideline for
In Vitro Diagnostic 98/79/EC.
Batch code
Consumables: use by... (expiry date)
The product should not be used after expiry of the specified date.
If a day is not indicated, apply the last day of the respective month.
Temperature limitation
The conditions necessary to preserve the product's shelf life before
opening.
In Vitro Diagnostic Medical Device
Manufacturer
(according to In Vitro Diagnostic guidelines 98/79/EG)
Catalogue number
Caution, consult accompanying documents.
Consult Instructions for Use.
Serial number (model plate)
Do not use if package damaged.

Valid only for Roche MICROSAMPLER PROTECT:
Method of sterilization using ethylene oxide

(a) DIN EN ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
(b) DIN EN ISO 780: Packaging - Pictorial marking for the handling of goods
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July 2013
Symbol
Description
Valid only for BS2 Blood Sampler:
Method of sterilization using irradiation

Biological risk!
(according to the standard EN 61010-2-101(a)) (Instrument)
Biological risk!
(according to the standard DIN EN 980(b)) (Consumables)
(a) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and
laboratory use - (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment)
(b) DIN EN 980: Symbols for use in the labelling of medical devices
Other symbols
The following symbols are listed as additional information:

Symbol
Description
Danger symbol: Xi: Irritant.
Xi: R36/37/38, S26-37
Rating: Although not corrosive, momentary, longer-lasting, or

repeated contact with skin or mucous membrane may result in
inflammation. Danger of sensitization during contact with skin
(when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale vapors.
Danger symbol: T: Toxic (on the packaging of the reference
electrode).
T: R23/33/50-53
Rating: Inhalation, swallowing or skin contact with even small

quantities can lead to serious health risks, including fatal risks.
Characteristics of this type of item are severe, possibly irreversible
damage to health through repeated or prolonged contact,
particularly with carcinogenic, genetic or reproductive (danger to
reproductive capabilities) effects.
Caution: Avoid any contact with the human body. If you feel
unwell, contact a doctor immediately. Any substances with
carcinogenic, genetic or reproductive dangers are indicated
appropriately. Always observe the regulations when handling
such substances.
Danger symbol: N: Dangerous to the environment (on the
packaging of the reference electrode).
N: S45/60/61/7
Rating: If released into aquatic and non aquatic environments,

can cause immediate or delayed damage to ecosystems through a
change in environmental conditions.
These substances or their by-products can cause substantial
damage to sensitive environmental areas.
Caution: Depending on the potential for damage, do not allow
the substance to enter sewers, soils or the environment. Observe
the specific disposal regulations.
Store upright
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Symbol
Description
"Grner Punkt" (in Germany)
Protective gloves, protective goggles and suitable protective

clothing must be worn.
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Introduction and specifications
Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-15
Theoretical foundation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-31
July 2013
Table of contents
Safety information
The information provided in this chapter is essential for the safe, trouble-free
operation of the instrument and must be read and understood by the user.
In this chapter
Chapter
Important information .................................................................................................... A-5

Operating safety information ......................................................................................... A-6
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A-3
Table of contents
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These Instructions for Use contain vital warning and safety information.
This instrument is intended to be used only for the specialized purpose described in
the instructions. The most important prerequisites for use, operation, and safety are
explained to ensure smooth operation. No warranty or liability claims will be covered
if the instrument is used in ways other than those described or if the necessary
prerequisites and safety measures are not observed.
The instrument may be operated only by persons whose qualifications enable them to
comply with the safety measures that are necessary during operation of the
instrument.
Suitable protective equipment, like laboratory clothing, protective gloves, protective
goggles and if necessary mouth protectors, must be worn to prevent direct contact
with biological working materials. In addition, a face mask is required if there is a risk
of splashes. Suitable disinfection and sterilization procedures must be applied.
Adjustments and maintenance performed with removed covers and connected power
may be attempted only by a qualified technician who is aware of the associated
dangers.
Instrument repairs are to be performed only by the manufacturer or qualified service
personnel.
Only accessories and supplies either delivered by or approved by Roche are to be used
with the instrument. These items are manufactured especially for use with this
instrument and meet the highest quality requirements.
Operation of the instrument with solutions whose composition is not consistent with
that of the original solutions can negatively affect, above all, the long term
measurement accuracy. Deviations in the composition of the solutions can also
decrease the service life of the electrodes.
The quality control requirements must be completed at least once daily for safety
reasons. Since the measurements of the instrument depend not only on the correct
characteristic function, but also on a series of marginal conditions (e.g. pre-analysis),
results obtained from the instrument should be submitted for an expert opinion
before taking additional measures based on the supplied measurements.
Observe the documentation!
CAUTION
Roche
If the instrument is not used according to the Instructions for Use, existing safety
mechanisms may be impaired.
July 2013
A-5

The instrument has been constructed and tested according to the following European
Standards:
o
IEC/EN 61010-1(a)
IEC/EN 61010-2-101(b)
IEC/EN 61010-2-081 + A1(c)
It was delivered from the factory in flawless condition with regards to safety
features. In order to preserve this condition and ensure safe operation, the user
must observe the notices and warnings that are contained in these Instructions for
Use.
This instrument is classified under the protection class I according to

IEC/EN 61010-1.
The instrument meets the conditions for overvoltage category II.
The instrument meets the conditions for contamination level 2.
Do not operate the instrument in an explosive environment or in the vicinity of

explosive anesthetic mixtures containing oxygen or nitrous oxide.
Service must be carried out by authorized personnel only. The instrument does
not contain any user-serviceable parts.
Recurring inspections are to be carried out based on local regulations.

According to IEC/EN 62353(d) recurring inspections are to be carried out every
24 months.
If objects or liquids enter the internal areas of the instrument, remove the
instrument from its power supply and allow an expert to check it thoroughly
before using it again.
The instrument is suitable for long-term operation indoors.
Observe the regulations and safety instructions in the respective chapters of the
Instructions for Use.
WARNING
WARNING
The power cord must be plugged into a grounded power receptacle. When using an
extension cord, make sure it is properly grounded.
The power cable must conform to country-specific requirements.

Orders can be placed via the local Roche organization only.
Any rupture of the ground lead inside or outside the instrument or a loose ground
connection may result in hazardous operating conditions for the operating personnel.
Intentional disconnection of the grounding is not permitted.
The instrument is not suitable for operation with a direct current power supply.
Use only the original mains plug delivered with the instrument.
(a) IEC/EN 61010-1: Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 1: General requirements)
(b) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and
laboratory use (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment)
(c) IEC/EN 61010-2-081: Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes)
(d) IEC/EN 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical
equipment
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Table of contents
General description
This chapter contains a general description of the instrument, as well as

precautionary measures against special dangers and the proper handling of sensors,
and solutions.
In this chapter
Chapter
Introduction ...................................................................................................................... A-9

Measurement and calibration procedures .................................................................. A-10
Measurement procedure ......................................................................................... A-10
Calibration procedure ............................................................................................. A-10
Measurement evaluation ............................................................................................... A-11
Important safety instructions ....................................................................................... A-11
Sample collection and handling ............................................................................. A-11
Disposal of SnapPak, electrodes, and instrument ............................................... A-12
Disposal of the reference electrode ................................................................. A-12
Disinfection .............................................................................................................. A-12
Handling solutions .................................................................................................. A-12
Handling electrodes ................................................................................................. A-12
Standby mode ................................................................................................................. A-13
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A-7
Table of contents
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Introduction
Introduction
This manual will help guide through setting up the analyzer and analyzing samples.
As the user becomes familiar with the operation of the unit, the manual may be used
as a reference for day-to-day routines and as a guide for maintenance and
troubleshooting.
Figure A-1
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A-9

Measurement procedure
The 9180 Electrolyte Analyzer methodology is based on the ion selective electrode
(ISE) measurement to determine the measurement values
e see Chapter 4 Theoretical foundation, section Measurement principle on page A-36.
It is very important that the main door be closed during sampling to provide shielding from
sources of electromagnetic and electrostatic interference.
There are six different electrodes used in the 9180 Electrolyte Analyzer: sodium,
potassium, chloride, ionized calcium, lithium and a reference electrode. Each
electrode has an ion-selective membrane that undergoes a specific reaction with the
corresponding ions contained in the sample being analyzed. The membrane is an ion
exchanger, reacting to the electrical charge of the ion causing a change in the
membrane potential, or measuring voltage, which is built up in the film between the
sample and the membrane.
A galvanic measuring chain within the electrode determines the difference between
the two potential values on either side of the membrane. The galvanic chain is closed
through the sample on one side by the reference electrode, reference electrolyte and
the "open terminal".
The membrane, inner electrolyte and inner electrode close the other side.
A difference in ion concentrations between the inner electrolyte and the sample
causes an electro-chemical potential to form across the membrane of the active
electrode. The potential is conducted by a highly conductive, inner electrode to an
amplifier. The reference electrode is connected to ground as well as to the amplifier.
The ion concentration in the sample is then determined by using a calibration curve
determined by measured points of standard solutions with precisely known ion
concentrations.
A 2-point calibration is performed automatically every 4 hours in [READY] mode
and a 1-point calibration is automatically performed with every measurement.
An automatic calibration procedure is also performed shortly after power-on or reset.
A calibration cycle can also be initiated manually at times when no sample
measurements are performed.
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The validity of the test results from the 9180 Electrolyte Analyzer must be carefully
examined by a clinical-medical specialist who will take the patient's clinical condition
into consideration before any clinical decisions are reached based on the test results.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (1=low, 2=normal, 3=high) after each electrode exchange, after each
replacement of the SnapPak, after startup of the instrument as well as after monthly,
semi annual and annual maintenance steps.
Additionally, at least once daily one QC measurement has to be performed in
alternating levels (1=low, 2=normal, 3=high) (e.g., day 1 - level 1, day 2 - level 2, day 3
- level 3, day 4 - level 1, etc.). When required by local regulations, QC measurements
must be performed more often.
A quality control program for electrolytes includes the analysis of sample materials
with known ranges of expected values and the comparison of these values with
analyzer results.
e For further information, see Chapter 8 Quality control.

For your own safety and the proper operation of your equipment, always follow these
precautions when working with the 9180 Electrolyte Analyzer:
o
Keep the analyzer away from all sources of liquids such as sinks and wash basins.
Do not use ammonia-based or alcohol-based cleaners, which can chemically react with
plastic, on or around the analyzer.
CAUTION
Always handle blood samples and collection devices with appropriate care.
Use approved protective gloves to avoid direct contact with sample.
Aseptic procedures are required when cleaning the sampling probe to avoid
contamination.
Dispose of SnapPak according to local regulations.
Sample collection and handling

While handling samples, all necessary regulations concerning hygiene must be
observed.
Dangerous pathogenic agents could be present.
e For further information, see Chapter 7 Measurement.
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A-11
Disposal of SnapPak, electrodes, and instrument

Dispose of used SnapPak, electrodes and the instrument according to applicable
laboratory regulations (biologically contaminatedhazardous waste!).
Disposal of the reference electrode

This electrode contains mercury. Therefore dispose of it in accordance with applicable
regulations (hazardous waste!).
Disinfection
The purpose of this disinfection is to minimize risk when handling items that were in
contact with biological samples.
Roche recommends following a disinfection procedure in addition to regulations
specific to the laboratory.
These disinfection procedures should be performed periodically to minimize the risk
of infections.
Always wear gloves!
e For further information, see Chapter 9 Maintenance.
Handling solutions
Store the wash/calibrating solutions according to the specified packaging
requirements. The temperature of the solutions should be adapted to the ambient
temperature before use.
The shelf life of the solutions is limited.
Please read the label and the packaging for the correct storage temperature and the
maximum shelf life.
Do not freeze! If frozen, the solution's concentration may change and cause calibration
errors. Do not use damaged SnapPaks. Do not mix the individual components.
CAUTION
e For further information, see Chapter 3 Specification.
Handling electrodes
Store the electrodes according to the packaging specifications.
The shelf life of the electrodes is limited.
Please read the label and the packaging for the correct storage temperature and the
maximum shelf life.
e For further information, see Chapter 3 Specification.
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Standby mode
Standby mode
The 9180 Electrolyte Analyzer is designed to calibrate automatically every four hours
during normal operation. If sampling will be delayed for an extended period of time,
such as evenings and weekends, you may place the analyzer into Standby mode to
suspend automatic calibration.
The analyzer can be programmed to automatically enter Standby mode.
e For instructions see Chapter 10 Troubleshooting , section Service codes on page E-14.
To enter standby mode:

o
Press NO until [OPERATOR FUNCTIONS?] appears.
Press YES, then NO, until [Go to Standby Mode?] appears.
Press YES.
The analyzer shows a Standby mode status on the display.

To exit from Standby mode:
o
Press YES, [Leave Standby Mode?] will be displayed.
Press YES again.
Depending on the duration of the standby mode, an automatic calibration can be

performed. After that, the analyzer returns to [READY].
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A-13
Standby mode
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3 Specification
Table of contents
Specification
In this chapter, the performance data, as well as product and environmental data are
described.
In this chapter
Chapter
Performance parameters ............................................................................................... A-17

Measurement parameters ....................................................................................... A-17
Reproducibility ......................................................................................................... A-17
Material: ISETROL Protein Based Aqueous Control Material
(Level 1), n=80 ................................................................................................... A-18
(Level 2), n=80 ................................................................................................... A-18
(Level 3), n=80 ................................................................................................... A-18
Material: RNA EQUIL Reduced Bovine Hemoglobin Solution
(Level 2), n=80 ................................................................................................... A-18
Material: Aqueous Standard Solution (Level 1), n=80 ................................. A-19
Material: Aqueous Standard Solution (Level 2), n=80 ................................. A-19
Material: Pooled Human Serum, n=80 ........................................................... A-19
Material: Acetate Dialysate Solution, n=80 .................................................... A-19
Material: Bicarbonate Dialysate Solution, n=80 ............................................ A-20
Material: Urine, n=80 ........................................................................................ A-20
Linearity ........................................................................................................................... A-21
Linearity in aqueous standard solutions ............................................................... A-21
Linearity in serum .................................................................................................... A-21
Correlation to flame .......................................................................................... A-21
Correlation to direct ISE - not flame-correlated ........................................... A-22
Correlation to direct ISE - flame-correlated .................................................. A-22
Correlation to chloridometry ........................................................................... A-22
Interferences ................................................................................................................... A-23
Limitations ...................................................................................................................... A-23
Relationship of ionized calcium to total calcium ....................................................... A-24
Bibliography .................................................................................................................... A-24
Sample throughput ........................................................................................................ A-25
Sample volumes .............................................................................................................. A-25
Sample types ................................................................................................................... A-25
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3 Specification
Table of contents
Calibrations ..................................................................................................................... A-25

Environmental parameters ........................................................................................... A-26
Temperature / humidity / stability ........................................................................ A-26
Instrument .......................................................................................................... A-26
Electrodes ............................................................................................................ A-26
Solutions .................................................................................................................... A-27
SnapPak ............................................................................................................... A-27
Urine diluent ...................................................................................................... A-28
QC material .............................................................................................................. A-28
ISETROL Electrolyte Control .......................................................................... A-28
Product data .................................................................................................................... A-29
Electrical data ........................................................................................................... A-29
Classification (according IEC/ISO) ....................................................................... A-29
Dimensions ............................................................................................................... A-29
Printer .............................................................................................................................. A-29
Display ............................................................................................................................. A-29
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3 Specification
Measurement parameters
Na
K+
specified for:
specified range:
B/S/A/D/Q
40 205 mmol/L
1 300 mmol/L
B/S/Q
1.5 15 mmol/L
A/D
0.8 15 mmol/L
4.5 120 mmol/L
U*
60 120 mmol/L
B/S/A/D/Q
50 200 mmol/L
1 300 mmol/L
Ca
B/S/A/D/Q
0.2 5.0 mmol/L
Li+
B/S/Q
0.1 6.0 mmol/L
Cl-
2+
Table A-1
whole blood
serum or plasma
dialysis solutions containing acetate
dialysis solutions containing bicarbonate
aqueous QC material
urine samples (dilution required, see Chapter 7 Measurement, section Urine

samples on page C-37)
U*
urine samples (second dilution required, see Chapter 7 Measurement, section

Urine samples on page C-37)
Reproducibility
Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) Precision is
determined from 2 runs per day with 2 replicates per run for 20 days on two 9180
Electrolyte Analyzers. Values for sodium and potassium are the average of all
instruments, while values of chloride, ionized calcium and lithium are determined
from the measurement of two of each respective unit configuration. All values are
reported in mmol/L.
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A-17
3 Specification
Material: ISETROL Protein Based Aqueous Control Material (Level 1), n=80
Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
114.6
0.48
0.42
0.76
0.66
0.89
0.78
Potassium
2.82
0.025
0.87
0.035
1.24
0.041
1.44
Chloride
76.7
0.29
0.38
0.52
0.67
0.72
0.94
ionized Calcium
2.07
0.015
0.72
0.024
1.18
0.034
1.66
Lithium
0.40
0.010
2.40
0.018
4.57
0.026
6.41
Table A-2
Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
141.2
0.40
0.28
0.30
0.21
0.46
0.33
Potassium
4.35
0.024
0.55
0.023
0.53
0.036
0.82
Chloride
102.4
0.18
0.18
0.20
0.20
0.32
0.31
ionized Calcium
1.35
0.016
1.21
0.021
1.55
0.042
3.10
Lithium
1.04
0.012
1.19
0.035
3.36
0.045
4.31
Table A-3
Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
158.8
0.51
0.32
0.76
0.48
0.90
0.56
Potassium
5.74
0.027
0.48
0.026
0.45
0.036
0.62
Chloride
123.2
0.36
0.29
0.89
0.72
1.17
0.95
ionized Calcium
0.63
0.010
1.52
0.007
1.07
0.014
2.29
Lithium
2.59
0.025
0.97
0.063
2.44
0.082
3.18
Table A-4
Material: RNA EQUIL Reduced Bovine Hemoglobin Solution (Level 2), n=80
Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
134.8
0.53
0.40
0.45
0.33
0.63
0.47
Potassium
4.89
0.039
0.79
0.021
0.42
0.043
0.88
Chloride
100.4
0.43
0.43
0.42
0.41
0.58
0.57
ionized Calcium
1.10
0.008
0.75
0.004
0.40
0.011
0.95
Lithium
N/A
Table A-5
Roche
A-18
July 2013
3 Specification
Material: Aqueous Standard Solution (Level 1), n=80

Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
150.0
0.55
0.37
0.34
0.23
0.57
0.38
Potassium
4.97
0.022
0.44
0.018
0.36
0.029
0.57
Chloride
115.0
0.11
0.09
0.08
0.07
0.16
0.14
ionized Calcium
0.96
0.004
0.41
0.004
0.39
0.007
0.76
Lithium
0.30
0.004
1.27
0.005
1.60
0.008
2.48
Table A-6
Material: Aqueous Standard Solution (Level 2), n=80

Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
113.2
0.51
0.45
0.96
0.85
1.07
0.95
Potassium
1.82
0.033
1.88
0.043
2.36
0.053
2.92
Chloride
82.9
0.27
0.33
0.67
0.80
0.87
1.05
ionized Calcium
2.43
0.014
0.56
0.032
1.33
0.043
1.76
Lithium
5.42
0.043
0.78
0.155
2.86
0.196
3.62
Table A-7
Material: Pooled Human Serum, n=80

Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
138.8
0.30
0.22
0.36
0.28
0.47
0.34
Potassium
4.49
0.034
0.75
0.041
0.92
0.051
1.13
Chloride
106.8
0.18
0.17
1.00
0.93
1.24
1.16
ionized Calcium
1.19
0.007
0.55
0.031
2.64
0.039
3.29
Lithium
0.17
0.011
6.19
0.015
8.40
0.023
13.28
Table A-8
Material: Acetate Dialysate Solution, n=80

Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
86.1
0.85
0.98
1.81
2.10
1.78
2.07
Potassium
2.09
0.029
1.41
0.041
1.94
0.049
2.32
Chloride
107.8
0.25
0.24
0.23
0.21
0.40
0.37
ionized Calcium
1.77
0.020
1.13
0.092
5.20
0.115
6.50
Lithium
N/A
Table A-9
Roche
July 2013
A-19
3 Specification
Material: Bicarbonate Dialysate Solution, n=80

Parameter
Mean
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Sodium
135.2
0.45
0.33
0.59
0.44
0.72
0.54
Potassium
1.58
0.023
1.46
0.031
1.95
0.037
2.37
Chloride
107.3
0.37
0.35
0.63
0.59
0.86
0.80
ionized Calcium
1.68
0.012
0.72
0.016
0.96
0.027
1.63
Lithium
N/A
Swr
(CV %)
Sdd
(CV %)
ST
(CV %)
Table A-10
Material: Urine, n=80

Parameter
Mean
Sodium
51.5
1.98
3.84
3.06
5.94
3.65
7.08
Potassium
48.4
0.65
1.34
0.97
2.00
1.11
2.29
Chloride
85.9
0.53
0.62
0.66
0.76
0.99
1.16
ionized Calcium
N/A
Lithium
N/A
Table A-11
Roche
A-20
July 2013
3 Specification
Linearity
Linearity
Linearity in aqueous standard solutions
Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable
salts and measured on each of six 9180 Electrolyte Analyzers, two of each
configuration: Na/K/Cl, Na/K/Ca and Na/K/Li.
Parameter
Slope
Intercept
Correlation coefficient
Syx
Range [mmol/L]
Sodium
0.99993
0.0128
0.99995
0.666
51 196
300
Potassium
0.99838
0.0119
0.99919
0.194
2.0 12.6
300
Chloride
0.97556
-0.1775
0.99994
0.674
56 194
100
ionized Calcium
1.01552
-0.0078
0.99980
0.037
0.4 3.3
100
Lithium
0.99850
0.0087
0.99985
0.038
0.3 5.3
100
Table A-12
Linearity in serum
Linearity in serum was established with the analysis of two specimen sets in nonclinical tests: commercially prepared serum linearity standards for sodium, chloride
and potassium with normal protein content, and a group of random patient serum
samples. All samples were analyzed in pairs on each of two of 9180 Electrolyte
Analyzers in each configuration:
Na/K/Cl, Na/K/Ca and Na/K/Li, and in pairs on each of the following instrument
types for comparison to various methods:
Direct ISE, not flame correlated (listed as 98X)
983 Na/K/Cl-Analyzer
984 Na/K/Ca-Analyzer
985 Na/K/Li-Analyzer
Direct ISE, flame correlated (listed as 91XX)
9130 Na/K/Cl-Analyzer
9140 Na/K/Ca-Analyzer
Flame Absorbance Emission Spectroscopy
IL 943 Flame Photometer
Chloridometry
Labconco Digital Chloridometer
Correlation to flame
IL 943 Flame Photometer
Parameter
Slope
Intercept
Correlation Coefficient
Syx
Range [mmol/L]
Sodium
0.9617
5.83
0.9908
Potassium
1.0249
0.015
0.9991
2.04
104 178
50
0.075
1.8 11.5
50
Lithium
0.9803
0.0011
0.9822
0.028
0.11 0.71
15
Table A-13
Roche
July 2013
A-21
3 Specification
Linearity
Correlation to direct ISE - not flame-correlated

98X Electrolyte Analyzers
Parameter
Slope
Intercept
Syx
Range [mmol/L]
Sodium
0.9895
-6.35
0.9992
0.61
110 186
50
Potassium
1.0223
-0.25
0.9996
0.05
2.0 11.6
50
Chloride
0.9631
-1.01
0.9995
0.51
70 152
50
ionized Calcium
0.8898
0.107
0.9960
0.021
0.67 1.66
50
Lithium
0.9923
0.008
0.9985
0.010
0.11 0.71
15
Table A-14
Correlation to direct ISE - flame-correlated

91XX Electrolyte Analyzers
Parameter
Slope
Intercept
Sodium
0.9856
-2.02
0.9856
Potassium
0.9992
0.02
0.9994
Chloride
1.0026
-5.31
0.9989
ionized Calcium
1.0023
0.040
0.9954
Syx
Range [mmol/L]
1.21
104 179
50
0.05
1.9 11.8
50
0.73
70 152
50
0.022
0.62 1.54
50
Table A-15
Correlation to chloridometry
Labconco Digital Chloridometer
Parameter
Slope
Intercept
Syx
Range [mmol/L]
Chloride
1.0222
2.75
0.9923
2.03
66 145
50
Table A-16
Roche
A-22
July 2013
3 Specification
Interferences
Interferences
Salicylate, in extremely high levels, is known to interfere with the chloride electrode
and results in a positive bias of the chloride result. At therapeutic levels of salicylate
concentration, the influence on chloride is clinically insignificant.
The lithium electrode shows a slight sensitivity to the ionized calcium present in the
sample and results in a negative bias of the lithium result. At normal physiological
ionized calcium concentrations, the influence of ionized calcium is clinically
insignificant.
Use only lithium-free sampling containers for the determination of lithium measurement
values! If sample containers are used which contain lithium as an anticoagulant, this may
lead to incorrect patient measurements, which may result in incorrect clinical decisions,
possibly endangering the patient's health.
e For further information, see Interference on page C-29.
Limitations
A number of substances have been reported to cause physiological changes in blood,
serum and plasma analyte concentrations. A comprehensive discussion concerning
these and other interfering substances, their blood, serum or plasma concentrations,
and their possible physiological involvement is beyond the scope of this Instructions
for Use. No significant effect on serum has been demonstrated from bromide,
ammonium and iodide.
As with any clinical reaction, users must be alert to the possible effect on results due
to unknown interference from medications or endogenous substances. All patient
results must be evaluated by the laboratory and the physician in light of the total
clinical status of the patient.
Opening and closing the fist with a tourniquet in place results in an increase in
potassium levels by as much as 10 to 20 %. It is recommended that the blood sample
is obtained without a tourniquet, or that the tourniquet be released after the needle
has entered the vein and 2 minutes elapsed before the sample is withdrawn.
Since the concentration of potassium inside erythrocytes is much greater than that in
extra cellular fluid, hemolysis should be avoided, and the serum should be separated
from the cells as soon as possible after collection.
The lithium electrode response is dependent on the actual sodium concentration of
the sample.
The 9180 Electrolyte Analyzer reports lithium in the range of 95 - 180 mmol/L
(89.6 - 169.5 mmol/L for blood/serum) Na+.
Roche
July 2013
A-23
3 Specification
Relationship of ionized calcium to total calcium
Relationship of ionized calcium to total calcium

The ratio of ionized calcium to total calcium in a healthy population is around 0.50 or
50%(a). These relationships may be altered when using citrate in blood, or when the
acid-base metabolism is disturbed.
Bibliography
o
Bishop ML, Duben-Engelkirk JL, Fody EP. Clinical Chemistry Principles

Procedures Correlations, 2nd Ed., (Philadelphia: J.B. Lippincott Co.),1992, p.281.
Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized
serum calciumvalues in normal subjects and in patients with renal disorders.
Mayo Clinic Proc. 55:606,1980.
Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed.,

(Philadelphia: W.B. Saunders, Co.,1994) pp.1354-1360,2180-2206.
Calbreath, Donald F., Clinical Chemistry A Fundamental Textbook,

(Philadelphia: W.B. Saunders Co., 1992) pp.371, 376, 390-395.
Henry, R.J., Clinical Chemistry - Principles and Technics, (New York, Harper and
Row, 1974)
Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p.890-95
Clinical and Laboratory Standards Institute. Protection of Laboratory Workers

fromOccupationally Acquired Infections; Approved GuidelineThird Edition;
CLSI Document M29-A3, (2005).
National Committee for Clinical Laboratory Standards. Additives for Blood

Collection Devices: Heparin; Tentative Standard; NCCLS Document H24-T,
(1988).
Clinical and Laboratory Standards Institute. Evaluation of Precision Performance

ofQuantitative Measurement Methods; Approved GuidelineSecond Edition;
CLSI DocumentEP5-A2, (2004).
Rose, Burton David, Clinical Physiology of Acid-Base and Electrolyte Disorders,

4th Ed.,(New York: McGraw-Hill, Inc., 1993) pp. 346-348, 432, 797-798.
Schoeff, Larry E & Williams, Robert H. (Eds.) Principles of Laboratory

Instruments, (St. Louis: Mosby Year Book Inc., 1993) pp. 150-157, 161-164.
Snyder John R., Senhauser Donald A, (Eds.), Administration and Supervision in

Laboratory Medicine, 2nd Ed, (Philadelphia: J.B.Lippincott Co., 1989)
pp. 262-284.
Tietz, Norbert W.,Ed.,Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia:

W.B. Saunders Co., 1990), pp.98-99, 118-119, 456-459, 510-511, 720-721
Tietz, Norbert W.,Ed., Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia:

W.B. Saunders, Co.,1986), pp.1816, 1837, 1840-1842, 1845.
Toffaletti J, Gitelman JH, Savory J: Separation and quantification of serum

constituents associated with calcium by gel filtration. Clin Chem 22: 1968-72,
1976.
(a) Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co.,
1990) S. 98-99, 118-119, 456-459, 510-511, 720-721.
Roche
A-24
July 2013
3 Specification
Sample throughput
Sample throughput
45 samples per hour with printout
60 samples per hour without printout
Sample volumes
95 L typical
Sample types
Whole blood, serum, plasma, dialysis solutions containing acetate and bicarbonate,
urine, QC material
Calibrations
1-point calibration after each sample
2-point calibration every 4 hours
Roche
July 2013
A-25
3 Specification
Temperature / humidity / stability
Instrument
Operating conditions:
Ambient temperature
15 to 32 C
Relative humidity
< 85 % (not condensing)
Storage and transportation conditions:
Temperature
-20 to 40 C
Humidity
< 85 % (not condensing)
Electrodes
Operating conditions:
Operating temperature
15 to 33 C
Relative humidity
20 - 95 %, if T 15 to 31 C
20 - 90 %, if T > 31 to 33 C
Storage and transportation conditions:
Roche
A-26
Temperature
15 to 30 C (dry)
Humidity
15 - 85 % (not condensing)
July 2013
3 Specification
Solutions
SnapPak
Contains the following reagents:
Standard A
For calibration of sodium, potassium, chloride, ionized calcium and lithium in the
9180 Electrolyte Analyzer.
Contents:
350 mL
Active ingredients:
Na+
150 mmol/L
K+
5.0 mmol/L
115 mmol/L
2+
0.9 mmol/L
Cl
Ca
Li
0.3 mmol/L
Storage temperature:
15 - 30 C
Stability:
Expiration date and lot number are printed on each container

label
On-board stability:
14 weeks
Table A-17
Standard B
Contents:
85 mL
Active ingredients:
Na+
100 mmol/L
1.8 mmol/L
Cl-
72 mmol/L
Ca
2+
Li
1.5 mmol/L
0.3 mmol/L
15 - 30 C
Stability:

label
On-board stability:
14 weeks
Table A-18
Standard C
Contents:
85 mL
Active ingredients:
Na+
150 mmol/L
5.0 mmol/L
115 mmol/L
Ca2+
0.9 mmol/L
1.4 mmol/L
Cl
Li
15 - 30 C
Stability:

label
On-board stability:
14 weeks
Table A-19
Roche
July 2013
A-27
3 Specification
Reference Solution
A salt bridge for calibration and measurement in the 9180 Electrolyte Analyzer.
Contents:
85 mL
Active ingredients:
Potassium chloride
15 - 30 C
Stability:

label
On-board stability:
14 weeks
1.2 mol/L
Table A-20
On-board stability refers to the SnapPak installed in the analyzer. The SnapPak has to be
exchanged at the latest after 14 weeks.
WARNING
Dispose of the SnapPak according to local regulations (hazardous waste!).
Use of calibration solutions, electrodes or QC-material that were not produced by Roche
leads to an invalidation of the instruments guarantee.
WARNING
A waste container is provided with the SnapPak which, when used, holds human body
fluids which may be potentially infectious; handle with appropriate care to avoid skin
contact or ingestion.
Urine diluent
For use as a diluent for the measurement of urine samples in the 9180 Electrolyte
Analyzer.
Contents:
Each dispensing bottle contains 500 mL of solution
Active ingredients:
Sodium chloride 120 mmol/L
5 - 30 C
Stability:

label.
Table A-21
QC material
ISETROL Electrolyte Control
Storage conditions in original packaging
Temperature
Roche
A-28
15 to 30 C < 24 months
July 2013
3 Specification
Product data
Product data
Electrical data
Mains voltage range
100 to 240 VAC
Frequency
50/60 Hz
Required power
50 W
Main fuse
250 VAC / 1.6 AT (2 pcs.)
Classification (according IEC/ISO)

Safety category
Overvoltage category
II
Contamination level
Height
33.5 cm
Width
31.5 cm
Dimensions
Depth
29.5 cm
Weight
< 6 kg
Type
thermal printer
Resolution
16 characters / line
Printer
Printing speed
4 mm / sec
Paper width
38 mm
Paper length
about 30 m
Type
monochrome-LCD
Resolution
2 lines, 16 characters per line
Display
Roche
July 2013
A-29
3 Specification
Display
Roche
A-30
July 2013
Table of contents
Theoretical foundation
In this chapter
Chapter
Reference and critical values ......................................................................................... A-33

Sodium ...................................................................................................................... A-33
Potassium .................................................................................................................. A-34
Chloride ..................................................................................................................... A-34
Ionized calcium ........................................................................................................ A-35
Lithium ...................................................................................................................... A-35
Principles of Operation ................................................................................................. A-36
Measurement principle ........................................................................................... A-36
Physical principle ..................................................................................................... A-37
Electrode specifications ................................................................................................. A-40
Sodium electrode ..................................................................................................... A-40
Construction ....................................................................................................... A-40
Use and care ....................................................................................................... A-40
Potassium electrode ................................................................................................. A-41
Construction ....................................................................................................... A-41
Use and care ....................................................................................................... A-41
Chloride electrode .................................................................................................... A-42
Construction ....................................................................................................... A-42
Use and care ....................................................................................................... A-42
Calcium electrode .................................................................................................... A-43
Construction ....................................................................................................... A-43
Use and care ....................................................................................................... A-43
Lithium electrode ..................................................................................................... A-44
Construction ....................................................................................................... A-44
Use and care ....................................................................................................... A-44
Reference electrode assembly ................................................................................. A-45
Construction ....................................................................................................... A-45
Reference electrode housing ............................................................................ A-45
Use and care ....................................................................................................... A-45
Reference electrode ............................................................................................ A-46
Use and care ....................................................................................................... A-46
Roche
July 2013
A-31
Table of contents
Calibration procedure ................................................................................................... A-46

ISE calibration .......................................................................................................... A-46
Roche
A-32
July 2013

The result of laboratory tests have little practical utility until clinical studies have
ascribed various states of health and disease to intervals of values.(a)
Reference intervals are useful because they attempt to describe the typical results
found in a defined population of apparently healthy people. Different methods may
yield different values, depending on calibration and other technical considerations.
Hence, different reference intervals and results may be obtained in different
laboratories.
Reference intervals, although useful as guideline for clinicians, should not be used as
absolute indicators of health and disease.(b)
The reference intervals presented in this chapter are for general information purposes only.
Individual laboratories should generate their own set of reference intervals.
WARNING
Sodium
Reference values:(a)
Premature, cord
116 - 140 mmol/L
116 - 140 mEq/L
Premature, 48 h.
128 - 148 mmol/L
128 - 148 mEq/L
Newborn, cord
126 - 166 mmol/L
126 - 166 mEq/L
Newborn
133 - 146 mmol/L
133 - 146 mEq/L
Infant
139 - 146 mmol/L
139 - 146 mEq/L
Child
138 - 145 mmol/L
138 - 145 mEq/L
Adult
136 - 145 mmol/L
136 - 145 mEq/L
Adult > 90 years
132 - 146 mmol/L
132 - 146 mEq/L
(a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2294 f.
Critical values:
Serum or plasma:(a)
(a) Tietz Textbook of Clinical Chemistry and
Lower Limit
Upper Limit
120 mmol/L
160 mmol/L
Molecular Diagnostics: 4th Edition 2006,
p. 2317
(a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th Edition 2006, p. 2252
(b) see Chapter 16 of "Tietz' Textbook of Clinical Chemistry and Molecular Diagnostics", 4th Edition 2006
Roche
July 2013
A-33
Potassium
Reference values:
Serum(a)
Plasma (heparin)(a)
Premature, cord
5.0 - 10.2 mmol/L
5.0 - 10.2 mEq/L
Premature, 48 h.
3.0 - 6.0 mmol/L
3.0 - 6.0 mEq/L
Newborn, cord
5.6 - 12.0 mmol/L
5.6 - 12.0 mEq/L
Newborn
3.7 - 5.9 mmol/L
3.7 - 5.9 mEq/L
Infant
4.1 - 5.3 mmol/L
4.1 - 5.3 mEq/L
Child
3.4 - 4.7 mmol/L
3.4 - 4.7 mEq/L
Adult
3.5 - 5.1 mmol/L
3.5 - 5.1 mEq/L
Adult, male
3.5 - 4.5 mmol/L
3.5 - 4.5 mEq/L
Adult, female
3.4 - 4.4 mmol/L
3.4 - 4.4 mEq/L
Critical values:
Serum or plasma:(a)
p. 2291
Lower Limit
Upper Limit
Adult
2.8 mmol/L
6.2 mmol/L
Newborn
2.8 mmol/L
7.8 mmol/L
th
(a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4 Edition 2006, p. 2317
Chloride
Reference values:
Serum, plasma:(a)
Cord
96 - 104 mmol/L
96 - 104 mEq/L
Premature
95 - 110 mmol/L
95 - 110 mEq/L
0 - 30 days
98 - 113 mmol/L
98 - 113 mEq/L
Adults
98 - 107 mmol/L
98 - 107 mEq/L
Adults, > 90 years
98 - 111 mmol/L
98 - 111 mEq/L
Critical values:
Serum or plasma:(a)
p. 2260
Lower Limit
Upper Limit
80 mmol/L
120 mmol/L
th
(a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4 Edition 2006, p. 2317
Roche
A-34
July 2013
Ionized calcium
Reference values:
Whole blood, serum, plasma:(a)(b)
Adult
female & male
Cord blood
1.15 - 1.35 mmol/L
4.6 - 5.4 mg/dL
1.30 +/- 0.061 mmol/L
5.20 +/- 0.24 mg/dL
Newborn
1 day
1.10 +/- 0.059 mmol/L
4.40 +/- 0.24 mg/dL
Newborn
3 days
1.13 +/- 0.051 mmol/L
4.52 +/- 0.20 mg/dL
Newborn
5 days
1.22 +/- 0.053 mmol/L
4.86 +/- 0.21 mg/dL
Children
1 - 20 years
1.18 +/- 0.069 mmol/L
4.70 +/- 0.28 mg/dL
(a) Labor und Diagnose: Indikation und Bewertung von Laborbefunden fr die medizinische Diagnostik, Thomas Lothar, 7th Edition, p. 332
Critical values:
Plasma:(a)
Adult
Lower Limit
Upper Limit
0.75 mmol/L or 3.01 mg/dL
1.6 mmol/L or 6.41 mg/dL
p. 2317
Lithium
Therapeutic range:
Serum, Plasma:(a)
0.6- 1.2 mmol/L
(a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2309
Toxic range:
Serum, Plasma:(a)
> 2.0 mmol/L
(a) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics: 4th Edition 2006, p. 2309
Roche
July 2013
A-35
Measurement principle
The 9180 Electrolyte Analyzer is a sophisticated medical instrument that uses the Ion
Selective Electrode (ISE) measurement principle to precisely determine electrolyte
values.
Although the technology itself is quite complicated, understanding how the
instrument performs sampling analysis is relatively simple. Basically, the analyzer
compares an unknown value against a known value to compute the samples
electrolyte level.
An ion-selective membrane undergoes a specific reaction with the type of electrolyte
contained in the sample. The membrane is an ion exchanger, reacting to the electrical
change of the ion causing a change in the membrane potential, or measuring voltage,
which is built up in the film between the sample and the membrane.
A galvanic measuring chain within the electrode determines the difference between
the two potential values on either side of the membrane.
The galvanic chain is closed through the sample on one side by the reference
electrode, the reference electrolyte and the open terminal. The membrane, inner
electrolyte and inner electrode close the other side (see Figure A-2).
The different ion concentrations between the inner electrolyte and the sample cause
an electro- chemical potential to form on the membrane of the active electrode. The
potential is conducted by the inner electrode to the input of an amplifier. The
reference electrode is connected to ground as well as the second input of the
amplifier.
Since the reference electrode is on ground, amplification of the electrode potential
allows further signal processing.
The ion concentration in the sample is then determined and displayed by using a
calibration curve determined by two measured points of standard solutions with
precisely known ion concentrations (two-point calibration), and by using the
measured voltage of the sample and the Standard-A (one-point calibration).
C
B
D
E
A
G
A
Glass capillary
Voltmeter
Ion-selective electrode
Reference electrode
Inner solution
Ion-selective membrane
Measured solution
Figure A-2
Roche
A-36
Measurement principle
July 2013
Physical principle
An ion-selective electrode is connected with a reference electrode to form a
measuring system (see Figure A-3). When immersed in a solution that contains the
relative ion, the Nernst equation applies:
1.
T- ln a
E = E R
---------i
nF
or
2.
T- ln f c
E = E R
---------i
i
nF
(+) for cations
() for anions
The equation can also be written:
3.
Roche
E = E S log fi c i
measured electrical potential
e.m.f. of the system in standard solution
ai
activity of ion measured
general gas constant (8.31 J/Kmol)
temperature
valence of measured ion
Faraday constant (96.496 As/g)
fi
ci
activity coefficient
slope of the electrode
concentration of measured ion
July 2013
A-37
C
B
J
K
L
Glass capillary
K+ electrode
M Chloride-selective membrane
Reference electrode
Amplifier
Sample
Reference solution (KCl)
Display
Potassium-selective membrane
Reference electrode housing
Cl- electrode
Sodium-selective glass capillary
Ground
Inner electrode
Na+ electrode
Inner electrolyte
Figure A-3
Physical principle
If the ion concentration of one measuring solution is known, the ion concentration of
the sample can be determined on the basis of the difference of two measured
potentials.
4.
E sample = E + S log f i c i sample
5.
E s tan dard = E + S log f i c i standard
6.
c i sample
E = E sample E s tan dard = S log ----------------------c i standard
Roche
A-38
the difference between the measured potentials of the sample and the
standard
the potential difference of the electrode, determined from the potential

difference of two measured standard solutions
ci,sample
ci,standard
concentration of the measured ions in the sample

concentration of the measured ions in the standard solutions
July 2013
The unknown ion concentration in the sample can now be determined by:
7.
c i sample = c i s tan dard 10
E S
As demonstrated by these equations, the ion selective electrodes do not measure the
ion concentration but the activity of the ions concerned. This activity is a criterion of
the ions ability to interact with other ions, in which each ion binds a proportion of its
energy.
The ion concentration is calculated on the basis of the ion activity. The correlation is
affected by the total number of ions in the solution. Since sodium is the predominant
ion in whole blood and serum, the known value of the sodium concentration makes it
possible to ascertain and adjust for total ion effect and strength.
Roche
July 2013
A-39
e For technical safety information see Chapter 2 General description, section Important
safety instructions on page A-11.
Sodium electrode
The sodium electrode is a glass capillary electrode used for in-vitro diagnostic
measurement of sodium ions present in fluid samples. It is designated with a
Na+ marking on the top surface of the housing.
Construction
Electrode housing:
transparent acrylic plastic
Measuring capillary:
sodium selective glass
Electrolyte chamber:
airtight, filled with electrolyte solution for Na+ electrodes
Pin connector:
silver, silver chloride (Ag / AgCl)

B
C
D
E
Glass capillary
Inner electrode
Marking
Connecting pin
O-ring seal
Marking - serial number - 5 digits of lot
Electrolyte chamber
Figure A-4
number
Sodium electrode
Use and care

Sodium electrodes are manufactured for use in 9180 Electrolyte Analyzers.
Proper care should be used in handling and storage of the electrode. Never use strong
or abrasive cleaners such as alcohol or amphyl on the electrode since these will
damage the plastic housing.
Store the electrode in a clean, dry place only after the electrode has been cleaned and
rinsed with distilled water and dried with a lint-free cloth.
The o-ring seal should be installed in the electrode during storage.
Roche
A-40
July 2013
Potassium electrode
The potassium electrode is a membrane electrode used for in-vitro diagnostic
measurement of potassium ions present in fluid samples. It is designated with a
K+ marking on the top surface of the housing.
Construction
Electrode housing:
Measuring membrane:
potassium ion selective
airtight, filled with electrolyte solution for K+ electrodes
Pin connector:

C
D
E
F
B
A
Inner electrode
Electrolyte chamber
Sample path
Connecting pin
Marking
O-ring seal
Figure A-5
number
Potassium electrode
Use and care

Potassium electrodes are manufactured for use in 9180 Electrolyte Analyzer.
Roche
July 2013
A-41
Chloride electrode
The chloride electrode is a membrane electrode used for in-vitro diagnostic
measurement of chloride ions present in fluid samples. It is designated with
Cl- marking on the top surface of the housing.
Construction
Electrode housing:
Measuring membrane:
chloride ion selective
airtight, filled with electrolyte solution for Cl- electrodes
Pin connector:

C
D
E
F
B
A
Inner electrode
Electrolyte chamber
Sample path
Connecting pin
Marking
O-ring seal
Figure A-6
number
Chloride electrode
Use and care

Chloride electrodes are manufactured for use in 9180 Electrolyte Analyzer.
Roche
A-42
July 2013
Calcium electrode
The calcium electrode is a membrane electrode used for in-vitro diagnostic
measurement of calcium ions present in fluid samples. It is designated with a
Ca2+ marking on the top surface of the housing.
Construction
Electrode housing:
Measuring membrane:
calcium ion selective
airtight, filled with electrolyte solution for Ca2+ electrodes
Pin connector:

C
D
E
F
B
A
Inner electrode
Electrolyte chamber
Sample path
Connecting pin
Marking
O-ring seal
Figure A-7
number
Calcium electrode
Use and care

Calcium electrodes are manufactured for use in 9180 Electrolyte Analyzer.
Roche
July 2013
A-43
Lithium electrode
The lithium electrode is a membrane electrode used for in-vitro diagnostic
measurement of lithium ions present in fluid samples. It is designated with a
Li+ marking on the top surface of the housing.
Construction
Electrode housing:
Measuring membrane:
lithium ion selective
airtight, filled with electrolyte solution for Li+ electrodes
Pin connector:

C
D
E
F
B
A
Inner electrode
Electrolyte chamber
Sample path
Connecting pin
Marking
O-ring seal
Figure A-8
number
Lithium electrode
Use and care

Lithium electrodes are manufactured for use in 9180 Electrolyte Analyzer.
Roche
A-44
July 2013
Reference electrode assembly

The reference electrode assembly is a device used as an electrical junction between
the sample and electrical ground.
Construction
The reference electrode assembly consists of two parts: the reference electrode
housing and the reference electrode.
In the reference electrode housing, reference electrolyte solution establishes the
electrical contact between the reference electrode and the sample. At the beginning of
each measurement, reference electrolyte is pumped into the housing. At the same
time a glass capillary allows a small amount of reference electrolyte to pass into the
measuring capillary, thus establishing electrical contact between the sample and the
reference electrode (see Figure A-9).
C
O-ring seal (a)
Exit - reference solution
Marking
O-ring seal (c)
Glass capillary
O-ring seal (b)
Entrance - reference solution

number
Figure A-9
Reference elctrode assembly
Use and care

Reference electrode housings are manufactured for use in 9180 Electrolyte Analyzer.
Proper care should be used in handling and storage of the electrode housing. Never
use strong or abrasive cleaners such as alcohol or amphyl on the housing.
Store the Reference Electrode Housing in a clean, dry place only after the Reference
Electrode has been removed and the housing cleaned and rinsed with distilled water
and dried with a lint-free cloth.
The o-ring seals should be installed in the housing during storage.
Roche
July 2013
A-45
Reference electrode
The reference electrode completes the electrical circuit between the reference
electrolyte and electrical ground. This is accomplished by a cotton wool (saturated
with reference electrolyte)- calomel (Hg2 Cl2)- mercury (Hg)-platinum wireconnecting pin junction (see Figure A-10).
A
Platinum wire
Calomel (Hg2 Cl2)
Cable housing
Mercury (Hg)
Glass tube
Serial number
Cotton wool
Figure A-10
Reference electrode
Use and care

Reference electrodes are manufactured for use in 9180 Electrolyte Analyzer.
Proper care should be used in handling and storage of the reference electrode. Never
use strong or abrasive cleaners such as alcohol or amphyl on the electrode.
Store the reference electrode in the transport housing provided with the electrode at
the time of purchase. Make sure that the transport housing is filled with reference
electrolyte solution (you may use the reference electrolyte solution remaining in the
reference electrode housing at the time of disassembly).
Never rinse the reference electrode with distilled water!
Never allow the reference electrode to become dry!
CAUTION
ISE calibration
The 9180 Electrolyte Analyzer uses a patented, novel approach for the simultaneous
calibration of Na+, K+, Ca2+ and Cl- sensors, using only two aqueous base solutions.
Roche
A-46
July 2013
System components
System components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
July 2013
5 System components
Table of contents
System components
In this chapter
Chapter
System description ............................................................................................................B-5

Analyzer components .................................................................................................B-5
Display ....................................................................................................................B-6
Keypad ....................................................................................................................B-6
Printer ....................................................................................................................B-7
Measuring chamber ..............................................................................................B-7
Peristaltic pump ....................................................................................................B-7
Sample probe mechanism ....................................................................................B-8
Valves .....................................................................................................................B-8
SnapPak ..................................................................................................................B-9
Rear panel ..............................................................................................................B-9
Serial port ............................................................................................................ B-10
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July 2013
B-3
5 System components
Table of contents
Roche
B-4
July 2013
5 System components
System description
System description
Analyzer components
B
ISE SnapPakTM
Front cover
Display
Sample door
Keypad
Figure B-1
Roche
July 2013
B-5
5 System components
System description
B
C
Peristaltic pump
Sample door
Thermal printer
Valves
Measuring chamber
Discharge point
Figure B-2
Display
The analyzer communicates to the user through a dot matrix display. This two line,
alpha-numeric read-out allows up to 16 characters per line, displaying the activities
of the analyzer, sample results and other programmed information.
Na K Cl
READY
Figure B-3
Keypad
The communication with the analyzer is performed through a keypad with YES and
NO keys.
With these keys, all analyzer functions, including: sample measurement, data input,
programming and quality control testing can be performed.
Figure B-4
Roche
B-6
July 2013
5 System components
System description
Printer
The thermal printer uses heat-sensitive paper to output information in 16 columns.
The analyzer will print measured values, calibration values, electrode voltages, and
amount of liquid remaining in the SnapPak as well as cleaning and maintenance
information. The unit is configured to allow convenient storage of a second roll of
paper in the paper tray.
Figure B-5
Measuring chamber
The measuring chamber consists of the movable left locking device that holds the
electrodes in place, the electrodes, the right electrode holder with sample sensor
connector, and the measuring chamber base.
Figure B-6
Peristaltic pump
A peristaltic pump transports all sample and operating fluids inside the instrument.
Figure B-7
Roche
July 2013
B-7
5 System components
System description
Sample probe mechanism

The sample probe mechanism is located behind the sample door at the front of the
unit.
Figure B-8
Valves
Valves control the movement of the liquid within the analyzer.
Figure B-9
Roche
B-8
July 2013
5 System components
System description
SnapPak
The self-contained SnapPak is constructed to ensure that waste cannot spill out of the
package.
Attention
Do not touch the contact surface of the smart memory chip!
Figure B-10
Rear panel
The rear panel of the unit contains a serial number plate, as well as the power switch/
power receptacle module and an RS232 interface port.
Figure B-11
Roche
July 2013
B-9
5 System components
System description
Serial port
The analyzer is equipped with a serial RS232 interface and allows data to be
exchanged with commercially available computer systems. The analyzer can be
connected to COMPACT 2/ 3 systems via the 9-pin DB-9 connector to output a
common measurement report.
Measurement data is transferred after each measurement and calibration data is
transferred after each calibration. The interface is always active, and data is sent
independently of the printer setup.
e Refer to COMPACT 2/3 Instructions for Use for details.
A higher leakage current can be expected when using the serial interface. This must be
checked by suitably qualified personnel, depending on the local regulations.
Roche
B-10
July 2013
Operation
Installation and Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-23
Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-43
July 2013

Table of contents
Installation and Shutdown
In this chapter
Chapter
Installation ........................................................................................................................ C-5

Location ....................................................................................................................... C-5
Accessories ............................................................................................................ C-5
Setting up .............................................................................................................. C-6
Electrodes and measurement chamber ............................................................. C-6
Preparing the Analyzer for Operation .................................................................. C-11
1. Selecting language ......................................................................................... C-11
2. Start-up ........................................................................................................... C-11
3. Setting date and time ..................................................................................... C-12
4. Installing the SnapPak .................................................................................. C-12
5. Installing the printer paper .......................................................................... C-13
6. Daily Maintenance (manual) ....................................................................... C-14
7. Selecting parameter configuration .............................................................. C-17
Shutdown ........................................................................................................................ C-18
1. Installing shutdown plug .............................................................................. C-18
2. Installing the transport housing .................................................................. C-19
3. Washing the lines .......................................................................................... C-19
4. Removing the electrodes and the shutdown plug ..................................... C-20
5. Installing the relief clamps and removing the pump windings ............... C-20
6. Turning the analyzer "off" ............................................................................ C-22
Roche
July 2013
C-3
Table of contents
Roche
C-4
July 2013

Installation
Installation
Location
Location is important for optimal operation of your analyzer. Before you begin setup,
choose a site that is convenient for your sampling needs and meets the following
physical requirements of the unit:
o
Ambient temperature + 15C to + 32C.
Avoid exposure to direct sunlight, vibration and strong electromagnetic fields

(electric motors, transformers, X-ray equipment, cellular phones, etc.).
Use a stable and level work surface.
Maximum relative humidity of 85 % (15 % - 85 %).
Ample room to allow air to circulate freely around the unit.
Avoid exposure to explosive gases or vapors.
Check for correct voltage: 100 to 240 VAC, 50/60 Hz.
After setting up the 9180 Electrolyte Analyzer in a location that meets the above
requirements, perform the following steps to ensure the instrument is ready for
operation:
o
Refer to the packing slip to check for the completeness of the shipment.
If the shipment is incomplete, please inform your Roche representative

immediately.
If the instrument was damaged during shipment, immediately inform the company
that made the delivery. Retain all packaging materials and products as this may be
needed as evidence in the event of a damage claim.
WARNING
Do not remove the analyzer from the shipping carton by pulling upward on the polystyrene
(styrofoam) packing materials. These packaging materials do not provide strength to
support the analyzer.
Accessories
The following parts are delivered as standard equipment with the 9180 Electrolyte
Analyzer:
o
Printer paper
Electrode Dummy
Quad Ring, 1.78x1.02 mm
Fuse set
Sample probe stylet
Syringe, 10 mL, with tapered tip
Quick Reference Guide
You also need a supply of lint-free tissues and disposable sample cups, which should
be kept in a location convenient to the analyzer.
Roche
July 2013
C-5
Installation
Setting up
Prior to beginning the actual installation, it is recommended to completely read
through this chapter to develop an understanding of the procedures that are required.
Begin by placing the analyzer on a secure table top that allows plenty of working
space and is convenient to a power connection.
Open the analyzer main door. Locate and carefully remove the five red relief clamps.
Save the clamps for reuse to prevent damaging the tubes, if the analyzer is later shut
down for any reason.
TIP:
Save the relief clamps for reuse to prevent damaging the tubes, if the analyzer is later shut
down (see section Shutdown on page C-18).
(A)
(B)
Figure C-1
Slip the two pump windings around the analyzer pump rollers, making sure not to
overstretch the tubing.
Electrodes and measurement chamber
The next procedure involves preparing and installing the electrodes in the
measurement chamber.
o
Remove the reference housing and electrodes from their protective boxes and
place them on a soft, clean surface. Check to make sure each electrode has an oring on the left side.
Figure C-2
Roche
C-6
July 2013

Installation
Unscrew the red transport housing from the reference electrode and check that
the o-ring on the electrode is properly seated. Rinse, dry and save the transport
housing for storage of the reference electrode in the event the analyzer is turned
off or taken out of service for any reason.
Figure C-3
Carefully screw the reference electrode into the reference electrode housing and
place it with the other electrodes.
A
C
A
Reference electrode
Red transport housing
Figure C-4
Slide the measurement chamber forward until it locks in the front position.
Unclamp the left electrode holder by moving the clamp forward.
Figure C-5
Roche
July 2013
C-7
Installation
Locate the sample sensor cable and ensure that it is securely inserted in the
receptacle above the measurement chamber. Check that an o-ring is present in the
right electrode holder.
Figure C-6
Now install the electrodes in the measurement chamber, beginning on the right and
working to the left (the reference electrode will be installed last).
TIP:
The electrode on the right may be one of the following: chloride, ionized calcium, lithium or
a dummy electrode, if no third test is needed. If sodium and lithium are selected, the
potassium electrode is replaced by a dummy electrode.
Check to make sure that the lettering on the electrode corresponds with the
proper electrode station number on the tray. Also, note that all electrodes have a
lip on the bottom that rests on the flat edge of the measurement chamber to aid in
proper positioning.
Figure C-7
Roche
C-8
July 2013

Installation
After all electrodes have been installed, close the clamp on the left electrode
holder by lifting it upward until it locks in the back position, and ensure that the
electrodes are properly seated.
Figure C-8
Slide the measurement chamber back until it snaps into position.
Figure C-9
Roche
July 2013
C-9
Installation
Plug the tubing connector of the reference housing assembly in the receptacle
below the left side of the measurement chamber.
Figure C-10
Possible parameter configuration are the following:

Electrode pos.
+
Na
K
+
-
Cl / Ca
2+
/ Li
Parameter configurations
Na+
Na+
Na+
Na+
Na+
K+
K+
Dummy
K+
Dummy
Dummy
Cl-
Cl-
Ca2+
Ca2+
Electrode pos.
Na+
K
Cl- / Ca2+ / Li+

Table C-1
Na+
Na+
(Na+)
Na+
K+
Dummy
Dummy
Ca2+
Li+
Li+
Li+
Li+
e For details, see section 7. Selecting parameter configuration on page C-17.
Roche
C-10
July 2013

Installation
Preparing the Analyzer for Operation

1. Selecting language
Before the analyzer is powered on, the language setting must be selected. The factoryset language is English.
o
Remove the paper tray and use a pen to set the switch to the desired language
position as indicated on the label.
TIP:
If you decide to change the language after the unit is powered on, you must cycle the
power to activate the new language.
2. Start-up
o
Locate the power switch on the back of the unit and make sure that it is in the
OFF (O) position.
Plug the power cord into the power receptacle module on the back of the unit,
then plug the cord into a grounded electrical outlet (100 - 240 V, 50/60 Hz).
Figure C-11
Push the power switch to the ON (I) position. The unit will automatically begin to
operate.
Figure C-12
Roche
July 2013
C-11
Installation
Now that the 9180 Electrolyte Analyzer is functioning, begin using the keypad
interface to communicate with the instrument. Use the NO key to make changes, the
YES key to accept the displayed values or information.
TIP:
After start-up, date and time should be set and the printer paper inserted.
3. Setting date and time

The analyzer will display a default date and time and will allow the operator to input
the correct date and time:
Date:
01-JAN-02
dd-mmm-yy
Time:
00:00
hh:mm
To enter the correct date and time:

o
Press NO, until the actual day is displayed. To accept this value, press YES and the
cursor will move to the month.
By keeping the NO key depressed, the analyzer will automatically scroll through
the numbers, first slowly, then faster.
Press NO, until the actual month is displayed. To accept this value, press YES.
Press NO, until the actual year is displayed. To accept this value, press YES. Now,
the actual date will be displayed.
Follow the same procedure to enter the current time.
After entering the time, the analyzer will prompt [ok?]. Press YES if the date and
time entered are correct, or press NO to make a change.
After pressing YES at the last prompt, the analyzer will prompt:
[STATUS: NO SnapPak].
4. Installing the SnapPak

Record the installation date of the SnapPak on the label on the SnapPak.
Remove the protective strip and slide the SnapPak into position on the left side of
the analyzer. Save the protective strip for the case of a shutdown or disposal.
Figure C-13
Roche
C-12
July 2013

Installation
Once the protective strip is removed, be sure to keep the SnapPak upright to avoid spillage.
Save the protective strip to use to close the nipples on the SnapPak prior to disposing.
At the prompt [New SnapPak Installed?], press YES.
Again, at the prompt [Are you sure?], press YES.
5. Installing the printer paper

TIP:
The printer paper is heat sensitive on one side only. Please make sure that you insert the
paper roll correctly.
The thermal printer paper supplied by Roche Diagnostics contains an indicator strip
to alert you when the paper roll should be changed. To change the roll:
o
Place a new paper roll in the paper tray and thread it into the feeder slot.
Figure C-14
Press the paper feed button to completely feed the paper throught the printer.
Figure C-15
TIP:
By pressing the paper advance button once, the paper will automatically advance 10 lines.
Roche
July 2013
C-13
Installation
Do not pull the paper out of the printer to avoid damage to the printer.
Now perform the initial Daily Maintenance.

6. Daily Maintenance (manual)
Prior to performing the first calibration or running the first sample, the 9180
Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure
that helps ensure that the analyzer will perform properly. This procedure is called
daily maintenance, because it must be performed each day the analyzer is used to
conduct sampling.
The process involves cleaning and conditioning the sample path and electrodes,
which prepares the 9180 Electrolyte Analyzer for calibration. The bottles containing
Cleaning Solution and Electrolyte Conditioning Solution should be ready, along with
a package of lint-free tissues that will be used to dry the probe.
Check expiration date on the bottles of the Cleaning Solution and the Electrolyte
Conditioning Solution.
In some cases, when the analyzer prompts you for an action and you do not respond within
a set period of time, an alarm will sound and the unit will discontinue its current operation.
To start the daily maintenance:

o
Press the NO key, until [DAILY MAINTENANCE?] is displayed, and YES to

select. Select [Perform Daily Cleaning?] by pressing YES.
Pour a small amount of Cleaning Solution into a clean container.
At the prompt [Open Sample Door Introduce Sample], lift the sample door and
the pump will begin to aspirate.
Figure C-16
Roche
C-14
July 2013

Installation
Hold the Cleaning Solution under the probe, until

[Wipe Probe/Close Sample Door] is displayed, and use a lint-free tissue to
remove the cleaning solution from the probe. Close the sample door.
Figure C-17
While the analyzer displays [Thank You!] and a brief countdown, pour a small
amount of conditioning solution into a clean container.
Answer the prompt [Perform Daily Conditioning?] by pressing YES.
Figure C-18
Roche
July 2013
C-15
Installation
Hold the Electrolyte Conditioning Solution under the probe, until

[Wipe Probe/Close Sample Door], use a lint-free tissue to remove the
conditioning solution from the probe. Close the sample door.
Figure C-19
After the analyzer has displayed [Thank You!] and a brief countdown, the
prompt [Remain in Daily Maintenance?] can be answered with NO, and an
automatic calibration will be started.
It is very important that the main door is closed during calibration, since it provides
shielding from sources of electromagnetic and electrostatic interference.
Before working on ESD critical parts discharge yourself by touching the discharge point
(see Figure B-2 on page B-6).
Calibration is an automatic process. During this time, the analyzer is conducting
measurement operations to ensure the accuracy of the instrument. Occasionally, additional
time is required, and the analyzer displays an asterisk.
Roche
C-16
After finishing the calibration, the analyzer returns to [READY] and is now ready
for QC.
July 2013

Installation
7. Selecting parameter configuration

After completion of the daily maintenance procedure, the analyzer starts an
automatic calibration for sodium and potassium.
To select a different parameter configuration, interrupt the calibration by pressing
NO.
o
Continue pressing NO, until [OPERATOR FUNCTIONS?] is displayed. Press

YES.
Press NO until the prompt [Select Parameter Configuration?] is displayed, see

Table C-1. Press YES and the current configuration will be displayed. The default
configuration is the following:
Sel. Parameter:
[Na] [K] [ ] ok?
Press NO until the desired configuration is displayed. Press YES to accept this
selection.
If [(Na)][ ][Li] is selected, only lithium is reported. Install the sodium electrode and
calibrate for lithium.
In order to ensure the quality of the measurement results, complete a quality control test
on 3 levels (1=low, 2=normal, 3=high) after each electrode exchange, after each
replacement of the SnapPak, after startup of the instrument as well as after monthly, semi
annual and annual maintenance steps.
Additionally, at least once daily one QC measurement has to be performed in alternating
levels (1=low, 2=normal, 3=high) (e.g., day 1 - level 1, day 2 - level 2, day 3 - level 3, day 4
- level 1, etc.). When required by local regulations, QC measurements must be performed
more often.
A quality control program for electrolytes includes the analysis of sample materials with
known ranges of expected values and the comparison of these values with analyzer
results.
The 9180 Electrolyte Analyzer is now ready to operate.
Roche
July 2013
C-17
Shutdown
Shutdown
A complete shutdown of the analyzer may be indicated to prepare the analyzer for
shipping or in case the analyzer is not being used for an extended period of time. For
this procedure, you will need a special shutdown kit (not supplied with the analyzer).
Never attempt to turn the power off for an extended period of time without performing a
complete shutdown of the analyzer.
WARNING
In case the analyzer is not being used for several days only, it is not recommended to
perform a complete shutdown, but to put the analyzer in Standby Mode.
To perform the shutdown, you will need the following items:

o
One shutdown plug (supplied with shutdown kit).
Five solenoid relief clamps (supplied with analyzer and shutdown kit).
Two reference electrode transport housings (supplied with shutdown kit).
Two containers, one filled with at least 100 mL of distilled water, the other one
empty.
Protective strip for SnapPak (supplied with shutdown kit).
Starting at the [READY] display, do the following:

o
Press NO until [OPERATOR FUNCTIONS?] is displayed. Press YES.
Select [Take out of Operation?] and press YES.
Confirm [Are you sure?] by pressing YES.
1. Installing shutdown plug

The analyzer prompts [Shut Down Plug & Water Installed?].
o
Remove the SnapPak and push the protective strip firmly onto the SnapPak
connector.
Fill one container of the shutdown kit about halfway with distilled water.
Insert the shutdown plug carefully into the SnapPak receptacle.
Place the blue marked line into the disposable container filled with distilled water.
Place the red marked line into the empty container.
Begin the tubing wash procedure by pressing YES.
Figure C-20
Roche
C-18
July 2013

Shutdown
2. Installing the transport housing

o
The analyzer will prompt [Transport Ref Housing Installed?].
Pull the electrode holder forward and remove the reference electrode assembly.
Carefully unscrew the reference electrode from the reference electrode housing.
Temporarily place the reference electrode on a clean, soft cloth.
Pour the remaining reference solution in the reference housing into a transport
housing.
Carefully screw the reference electrode into the filled transport housing.
The second transport housing is screwed into the reference housing.
Place the reference housing back into the electrode holder and move the lever
backwards, making sure all electrodes are seated properly. The electrode holder
remains in the forward position.
Press YES.
Figure C-21
3. Washing the lines

The analyzer will take approximately one minute to flush all lines with water. Upon
completion,you will receive the prompt [Remove Water and Press YES].
o
Remove the line with the blue mark from the distilled water and place it on a
cloth.
e See Figure C-22.
Press YES. During this cycle, all lines are purged of distilled water.
Upon completion, [All Electrodes & Plug Removed?] will be displayed.
Line with the blue mark
Figure C-22
Roche
July 2013
C-19
Shutdown
4. Removing the electrodes and the shutdown plug

o
Remove the shutdown plug from the SnapPak receptacle.
Unplug the reference connector below the left side of the electrode holder.
Move the lever on the left side forward and remove all electrodes, placing them on
a soft cloth.
Move the lever back and push the empty electrode holder into its back position.
Unscrew the transport housing from the reference housing.
Empty the reference housing and place all electrodes into their protective boxes.
Press YES.
Figure C-23
5. Installing the relief clamps and removing the pump windings

The display will prompt [All 5 Relief Clamps Inserted?].
o
Install the red relief clamps making sure that they are snapped securely into
position.
The relief clamps can be installed at the
following positions:
o
o
o
o
o
A
B
C
V
R
Figure C-24
Press YES.
Never insert the solenoid relief clamps with the SnapPak in place.
WARNING
Roche
C-20
July 2013

Shutdown
The prompt [Pump Windings Relieved?] appears.
Grasp the front winding close to the pump roller and gently pull it off the roller.
Repeat the same procedure for the rear pump winding.
Figure C-25
Press YES. The prompt [Do You Wish to DELETE All Data?] will appear.
By pressing YES, all QC values and statistics will be deleted and the sample
number is reset to 0. QC and normal ranges as well as correlation factors, printer
settings, date/ time and SnapPak volume are reset to default. Also, all service
codes are deactivated.
A deletion of all data is recommended in case the analyzer is used by different
laboratory later on.
Press NO to retain all data.

e See Chapter 10 Troubleshooting, section Clearing all data on page E-16.
Roche
July 2013
C-21
Shutdown
6. Turning the analyzer "off"

o
The prompt [Shutdown Complete Turn Power Off] will appear.
Turn the analyzer off.
Unplug the power cord from the receptacle.
Close the front door.
Clean all external surfaces of the analyzer as well as the areas accessible through
the main door and sample door.
e see Chapter 9 Maintenance, section Clean sample probe and fill port on page D-8.
Electrical contacts may only be cleaned with a clean, dry or with water moistened cloth.
Never use disinfectants or Roche Deproteinizer!
Roche
C-22
Shutdown is complete.
Use the original packaging when transporting the analyzer.
July 2013
7 Measurement
Table of contents
Measurement
In this chapter
Chapter
Preanalytics ..................................................................................................................... C-25

Sample collection ..................................................................................................... C-25
Safety ................................................................................................................... C-25
Sample requirements ......................................................................................... C-25
Acceptable anticoagulants ................................................................................ C-25
Sample collection containers .................................................................................. C-26
Syringes ............................................................................................................... C-26
Capillary tubes .................................................................................................... C-26
Roche MICROSAMPLER PROTECT ............................................................ C-26
Sample handling ....................................................................................................... C-27
Whole blood ....................................................................................................... C-27
Serum .................................................................................................................. C-27
Plasma ................................................................................................................. C-27
Aqueous solutions ............................................................................................. C-28
Dialysate .............................................................................................................. C-28
Interference ..................................................................................................................... C-29
Substances without effect ........................................................................................ C-29
Plasma samples .................................................................................................. C-29
Whole blood samples ........................................................................................ C-30
Substances with effect .............................................................................................. C-31
Effect of the substances (plasma samples) ...................................................... C-31
Effect of the substances (whole blood samples) ............................................ C-31
Limitations of clinical analysis ..................................................................................... C-33
General ...................................................................................................................... C-33
Electrolytes ................................................................................................................ C-33
Measuring procedure ..................................................................................................... C-34
Sample measurement .............................................................................................. C-34
Direct ISE ............................................................................................................ C-36
Dialysate samples ............................................................................................... C-37
Roche
July 2013
C-23
7 Measurement
Table of contents
Urine samples ..................................................................................................... C-37

Normal ranges (reference values) ................................................................................ C-38
Correlation factors ......................................................................................................... C-39
Additional settings ......................................................................................................... C-41
Printer settings ......................................................................................................... C-41
Interface settings ...................................................................................................... C-42
Roche
C-24
July 2013
7 Measurement
Preanalytics
Preanalytics
Sample collection
Safety
Follow the usual applicable safety precautions when drawing blood samples. When
handling blood samples, there always exists the danger of transmission of HIV, hepatitis B
and C viruses or other pathogens transmissible by blood. Employ suitable blood sampling
techniques in order to reduce risk to personnel.
Suitable safety equipment such as laboratory clothing, protective gloves, safety glasses
and, if necessary, masks must be worn in order to prevent direct contact with biological
substances. If there is a danger of splashes, a safety visor is also required. Suitable
disinfection procedures must be used.
e Please refer to CLSI document M29-A3, Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved GuidelineThird Edition, (2005), for

further information on safe handling of specimens.
Sample requirements
Blood for analysis must be drawn by qualified personnel.
The puncture site may never be squeezed! Mixing the blood sample with tissue fluid may
lead to the premature onset of clotting despite sufficient heparinization of the sample
collection containers! Incorrect sample collection or the use of an unsuitable sample
collection container may lead to errors and discrepancies in the measurement values.
e See, for example, CLSI document H11-A4, Procedures for the Collection of Arterial
Blood Specimens; Approved StandardFourth Edition, (2004), for detailed information

about blood sampling, storage, and handling.
Acceptable anticoagulants
For whole blood and plasma samples, electrolyte-balanced heparin anticoagulation
salts, which have no influence on the electrolyte levels, are recommended.
Electrolyte-balanced sodium heparin can also be used as anticoagulant in the
electrolyte analysis. It should be noted that non-electrolyte-balanced heparin binds
ionized calcium, which can lead to a distortion of the measured values.
Other clot inhibitors, such as EDTA, citrate, oxalate, fluoride, and ammonium- based
materials have significant influence on parameters and may not be used for this
reason.
Roche
July 2013
C-25
7 Measurement
Preanalytics
Sample collection containers

TIP:
When possible, use the sample collection systems manufactured by Roche.
The 9180 Electrolyte Analyzer will accept samples directly from syringes, collection
tubes, sample cups and, with the use of an adapter, from capillary tubes or the
Roche MICROSAMPLER PROTECT.
Do not use sampling containers containing silicone!
Syringes
If using another manufacturer's product with liquid heparin as a clot inhibitor, the
collection container should not be larger than required for the blood volume. This
will minimize the effects of the clot inhibitor on the thinning of the blood.
Use only heparinized syringes. Improper use of syringes with liquid heparin will affect the
parameters, especially the ISE parameters!
Capillary tubes
Capillary tubes must have a minimum volume of 100 L.
When using stirring rods like those offered by a few manufacturers, remove these
rods before inserting the sample in order to avoid clogging the sample path of the
instrument.
Roche MICROSAMPLER PROTECT
To make arterial sample collection technically easier, the Roche MICROSAMPLER
PROTECT was developed.
The Roche MICROSAMPLER PROTECT consists of one curved plastic capillary
tube (~220 L) in a plastic container and is ideally suited to atraumatic arterial blood
collection.
Each laboratory should determine the permissibility of sample containers that are
used. These products vary from manufacturer to manufacturer and sometimes from
lot to lot.
The use of sample containers or clot inhibitors other than those manufactured by Roche
may lead to adulteration of the samples and errors and differences in the measurement
values.
Roche developed a specialized sample collection container for this purpose and
recommends its use for this reason.
Roche
C-26
July 2013
7 Measurement
Preanalytics
Sample handling
For ionized calcium values, anaerobic conditions must be followed for all sample
types. Contact with ambient air will cause a loss of CO2 in the sample and the
subsequent rise in pH will cause a reduction in ionized calcium.
Whole blood
Withdraw whole blood samples using heparinized syringes, capillaries, or the
Roche MICROSAMPLER PROTECT and analyze the samples as soon as possible
after sampling. Remove air bubbles from the sample collection container
immediately after the sampling procedure.
Immediately after withdrawing the sample with syringes, thoroughly mix the sample
with anticoagulant. This can be done by rolling the sample between both hands or
shaking. Properly label the samples, following the standard documentation
procedure.
o
Samples that are measured within 15 minutes may be retained at room

temperature.
If unable to measure samples within 15 minutes, place them temporarily in ice

water. Complete the measurement within 30 minutes (but not after more than 60
minutes).
Despite proper sampling procedures, errors can arise in the analysis:

o
due to insufficient mixing of the sample after sampling and before the
measurement
due to ambient air contamination caused by air bubbles that are not removed
after sampling
due to changes in metabolism in the sample
Serum
After the appearance of spontaneous clotting, process the sample in a centrifuge to
separate the cellular, solid components and the fibrin from the watery serum.
Transfer the serum to a suitable sample container and seal.
If it is necessary to store the sample, close the sample container tightly and cool it to
4 - 8 C. If a sample has been cooled, warm it to room temperature (15 - 33 C) before
analysis.
Plasma
Plasma samples are obtained by centrifuging heparinized whole blood, during which
the cellular components of the blood are removed from plasma.
Complete the analysis as quickly as possible.
If it is necessary to store the sample, close the sample container tightly and cool it to
4 - 8 C. If a sample has been cooled, warm it to room temperature (15 - 33 C) before
analysis.
Plasma samples older than 1 hour must be re-centrifuged in order to remove fibrin
clumps that may have formed.
Each laboratory should determine the permissibility of sample containers that are
used. Variations in these products exist between manufacturers, and at times, from
lot to lot.
Roche
July 2013
C-27
7 Measurement
Preanalytics
Aqueous solutions
Aqueous samples, such as Standard A, have to be measured in the Standard Mode.
The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation
factors or the setting of QCC.
e see Chapter 10 Troubleshooting, section Service codes on page E-14.
Dialysate
Either acetate or bicarbonate dialysate fluids may be analyzed. Dialysate samples can
be stored longer than whole blood, though preferably capped and placed in the
refrigerator. Prior to measurement, always bring the sample to room temperature.
If lithium is activated, the dialysate mode is not available.
Roche
C-28
July 2013
7 Measurement
Interference
Interference
The measuring module and measuring sensors were tested with respect to their
interference stability with the given chemical substances and pharmaceuticals.
Interferents can be a significant source of error in clinical analyses. While the
precision can be determined by internal QC and the correctness can be determined
by verifying reference samples, possible sources of interference cannot be identified
during ongoing operation. For this reason, the effect of potentially interfering
substances was determined.
e For additional information, refer to Interference Testing in Clinical Chemistry; Approved
Guideline EP-7 Vol. 25; No. 27 of the Clinical and Laboratory Standard Institutes (CLSI).
The results of the interference measurements have been divided into 3 categories:
1. Substances that do not impair precision and thus show no effect of interference
(refer to Table C-2 and Table C-3).
2. Substances that impair precision, but for which the deviation is within the limits
of correctness (see Table C-4 and Table C-5) and
3. Substances that violate the specified limits of correctness and cause a significant
deviation of the measured value. The deviations as a function of the
concentrations are specified in Table C-4 and Table C-5.
Substances without effect

The following substances were tested, but show no effect on the measurement
parameters and thus do not violate the specifications.
Plasma samples
Substance
Concentration
Tested analyte
Acetoacetic acid (3-Oxobutyric acid)
2.000 mmol/L
K, Na, Cl
Acetylcysteine
10.200 mmol/L
Cl, Li
Ampicillin
0.152 mmol/L
Cl, Li
Aspirin (Acetylsalicylic acid)
3.620 mmol/L
Cl, Li
Calcium chloride
5.000 mmol/L
Li
Cefoxitin
1.546 mmol/L
Cl, Li
Chlorpromazine
0.0063 mmol/L
Cl, Li
Doxycycline
0.0675 mmol/L
Cl, Li
EDTA
(Ethylenediaminetetraacetic acid)
0.0034 mmol/L
Cl, Li
Hemoglobin
2.000 g/L
Cl, Li
Ibuprofen
2.425 mmol/L
Cl, Li
Isoniazid
0.292 mmol/L
K, Ca, Na, Cl, Li
Lithium acetate
3.200 mmol/L
K, Na, Cl
Magnesium acetate
15.000 mmol/L
K, Cl, Li
Metronidazole
0.701 mmol/L
K, Ca, Na, Cl, Li
Paracetamol
1.324 mmol/L
Cl, Li
Table C-2
Roche
Substances without effect (plasma samples)

July 2013
C-29
7 Measurement
Interference
Substance
Concentration
Tested analyte
Phenobarbital
0.431 mmol/L
K, Ca, Na, Cl, Li
pH (high)
~8.0
Cl, Li
Potassium chloride
7.000 mmol/L
Li
Potassium thiocyanate
6.880 mmol/L
Li
Protein human (high)
>9.0%
K, Na, Cl, Li
Rifampicin
0.0781 mmol/L
Cl, Li
Sodium fluoride
0.105 mmol/L
K, Ca, Cl
Sodium Bicarbonate (Sodium

Hydrogen Carbonate)
35.000 mmol/L
Cl, Li
Sodium heparin
3000.000 U/L
K, Ca, Cl
Sodium iodide
2.990 mmol/L
K, Ca, Cl
Triglyceride
37.000 mmol/L
K, Ca, Cl
Vancomycin
0.069 mmol/L
K, Ca, Cl
(a)[1]
Table C-2
Substances without effect (plasma samples)
(a) Lipidem was used to represent the Triglycerides, c=1%
Whole blood samples

Substance
Concentration
Tested analyte
Acetone
12.0 mmol/L
K, Ca, Na, Cl, Li
Aspirin (Acetylsalicylic acid)
3.620 mmol/L
K, Na, Cl, Li
Benzalkonium chloride
0.0285 mmol/L
Ca, Na
Bilirubin, total
0.342 mmol/L
K, Ca, Na, Cl, Li
Creatinine
0.442 mmol/L
K, Ca, Na, Cl, Li
Ethanol
86.8 mmol/L
Ca, Na, Cl, Li
Sodium bromide
37.5 mmol/L
Ca
Sodium iodide
2.99 mmol/L
Ca, Cl, Li
Propofol
1.0 %
K, Ca, Na, Cl, Li
Salicylic acid
4.34 mmol/L
Cl, Li
Table C-3
Roche
C-30
Substances without effect (whole blood samples)
July 2013
7 Measurement
Interference
Substances with effect

Effect of the substances (plasma samples)
Substance
Concentration of
Parameter
the substance
Parameter
Effect of the substance
Trueness
concentration (MV)
[mmol/L]
[mmol/L]
2.59 0.32
2.50
[mmol/L]
Magnesium acetate
15.000 mmol/L
1.04
0.26 0.01
0.08
Na
137.90
2.02 0.23
2.50
Ca
1.05
0.23 0.01
0.08
7.500 mmol/L
Ca
1.08
0.14 0.07
0.08
4.500 mmol/L
Ca
1.07
0.13 0.02
0.08
3.750 mmol/L
Ca
1.06
0.11 0.01
0.08
3.375 mmol/L
Ca
1.03
0.10 0.01
0.08
2.250 mmol/L
Ca
1.07
0.06 0.01
0.08
6.880 mmol/L
Cl
104.7
-7.63 4.68
4.00
5.160 mmol/L
Cl
104.7
-5.95 2.58
4.00
3.440 mmol/L
Cl
104.9
-4.18 1.54
4.00
1.720 mmol/L
Cl
104.8
-2.04 0.72
4.00
37.5 mmol/L
Sodium bromide
28.1 mmol/L
18.8 mmol/L
Sodium chloride
Table C-4
138.1
Ca
11.250 mmol/L
Na
Cl
104.5
56.56 8.87
Li
0.35
4.00
0.13
Cl
103.8
51.47 20.46
4.00
Li
0.34
0.13
Cl
103.5
31.71 12.12
4.00
Li
0.36
0.02 0.01
0.12
9.4 mmol/L
Cl
99.3
12.17 1.88
4.00
7.0 mmol/L
Cl
99.2
8.73 1.02
4.00
4.7 mmol/L
Cl
99.2
5.53 0.54
4.00
2.3 mmol/L
Cl
99.2
2.70 0.28
4.00
180.0 mmol/L
Li
0.35
0.13
170.0 mmol/L
Li
0.35
-0.05 0.01
0.12
Effect of the substances (plasma samples)
Sodium value is over 169.5 mmol/L and therefore no Lithium value can be evaluated.
Effect of the substances (whole blood samples)

Substance
Concentration of
Parameter
the substance
Parameter
Trueness
concentration (MV)
[mmol/L]
[mmol/L]
[mmol/L]
Benzalkonium chloride
Table C-5
0.0285 mmol/L
Li
0.79
0.46 0.08
0.10
0.0214 mmol/L
Li
0.81
0.21 0.08
0.10
0.0143 mmol/L
Li
0.32
0.47 0.03
0.13
0.0107 mmol/L
Li
0.32
0.33 0.02
0.13
0.0071 mmol/L
Li
0.31
0.23 0.02
0.13
Roche
July 2013
C-31
7 Measurement
Interference
Substance
Concentration of
Parameter
the substance
Parameter
Trueness
concentration (MV)
[mmol/L]
[mmol/L]
[mmol/L]
0.0036 mmol/L
Li
0.31
0.12 0.02
0.13
6.8800 mmol/L
Na
138.7
-3.21 0.26
2.50
Cl
104.8
7.96 0.46
4.00
Ca
1.21
-0.05 0.02
0.08
Li
0.43
0.24 0.01
0.12
Na
139.2
-3.82 0.46
2.50
Cl
105.1
5.99 0.37
4.00
Ca
1.22
-0.07 0.02
0.08
Li
0.43
0.19 0.01
0.12
Na
138.9
-1.24 0.19
2.50
Cl
105.0
4.43 0.23
4.00
Ca
1.21
-0.02 0.01
0.08
Li
0.44
0.13 0.01
0.12
Cl
105.34
2.23 0.13
4.00
Li
0.44
0.07 0.01
0.12
4.34 mmol/L
3.64
0.40 0.05
0.20
3.26 mmol/L
3.63
0.29 0.06
0.20
2.17 mmol/L
3.64
0.19 0.06
0.20
1.09 mmol/L
3.66
0.07 0.06
0.20
5.1600 mmol/L
3.4400 mmol/L
1.7200 mmol/L
Salicylic acid
Sodium bromide
37.5 mmol/L
28.1 mmol/L
18.8 mmol/L
9.4 mmol/L
7.0 mmol/L
Table C-5
C-32
4.06
0.76 0.03
0.20
107.8
66.46 8.64
4.00
Li
0.56
0.10
4.07
2.31 0.11
0.20
Cl
107.8
47.91 4.77
4.00
Li
0.56
0.10
4.12
1.19 0.06
0.20
Cl
107.1
30.75 1.73
4.00
Li
0.57
-0.08 0.01
0.10
3.51
0.44 0.45
0.20
Cl
103.2
13.11 1.51
4.00
3.38
0.11 0.07
0.20
Cl
102.2
9.52 1.30
4.00
4.7 mmol/L
Cl
102.1
6.29 0.58
4.00
2.3 mmol/L
Cl
102.2
3.04 0.31
4.00
Roche
K
Cl
Sodium value is over 169.5 mmol/L and therefore no Lithium value can be evaluated.
July 2013
7 Measurement

The determined performance data can be influenced by known and unknown factors
as described below.
e For details, see section Interferences on page A-23.
General
The literature lists various substances which may negatively impact upon the
measurement result of the blood and plasma/serum sample material. A detailed
discussion of these phenomena can be found at different places in the technical
literature. With respect to the 9180 Electrolyte Analyzer, an attempt was made to
identify or evaluate these possible influences.
But since it is not possible to check all medication or substances, the user should be
immediately informed with abnormal deviations of the measurement resultsas
with every clinical analysisand evaluate the complete picture of the patient or
perform expanded measurements in his own laboratory, if necessary.
Electrolytes
It is well-known, for example, that the potassium value of a patient can vary by up to
20 % from the normal state, simply because of the presence of a pressure bandage.
Hence, taking a blood sample while a pressure bandage is present should be avoided.
In general, a local hemolysis caused by pressure should be avoided prior to taking a
blood sample.
Roche
July 2013
C-33
7 Measurement
Measuring procedure
Measuring procedure
SAFETY INSTRUCTIONS
When drawing blood samples, the generally valid safety precautions must be followed.
When handing blood samples, a danger of transmission of HIV, Hepatitis B and C viruses
or other bloodborne pathogens exists. Suitable blood drawing techniques must be used to
minimize risk for operating personnel.
Suitable safety equipment such as laboratory clothing, protective gloves, safety glasses
and, if necessary, masks must be worn in order to prevent direct contact with biological
substances. If there is a danger of splashes, a safety visor is also required. Suitable
disinfection and sterilization procedures must be used.
QC measurements must be performed in their entirety (i.e., all three QC levels must be
measured). Omitting QC measurements or ignoring QC measurement results may lead to
incorrect patient measurements, which may result in incorrect clinical decisions, possibly
endangering the patient's health.
analyzer results.
Sample measurement
The 9180 Electrolyte Analyzer provides fast and easy operation. Whenever [READY]
appears, the analyzer is ready to perform sample measurements.
It is very important that the main door is closed during sampling to provide shielding from
Urine samples require dilution, and must be analyzed in the urine mode. Instructions for
analyzing urine samples: see section Urine samples on page C-37.
Roche
C-34
July 2013
7 Measurement
Measuring procedure
Open the sample door. The prompt [Introduce Sample] will be displayed and the
pump will start to aspirate.
Figure C-26
It is very important that the main door be closed during sampling to provide shielding from
Hold the ampoule under the probe until [Wipe Probe Close Sample Door] is
displayed.
Use a lint-free tissue to clean the probe, then close the sample door when
prompted.
Figure C-27
It is very important that the sample probe is carefully cleaned each time following a sample
introduction.
Roche
July 2013
C-35
7 Measurement
Measuring procedure
The analyzer will display [Thank You!] and a brief countdown will begin. At
completion of analysis, the test results will be displayed and printed.
Na
K
Cl
143.9 4.93 103.1
ROCHE 9180 ELEKTROLYT ISE

NA-K-CL
HOSPITAL WEST
Name: ..........
..........
Sample: STANDARD
Sample No.:28
Na=143.9
K = 4.93
Cl=103.1
mmol/L
mmol/L
mmol/L
Figure C-28
Values that are higher or lower than the programmed normal range will be indicated by an
arrow pointing up or down.
If the Na+ result is above 180 mmol/L (above 169.5 mmol/L for blood/serum) or below
95 mmol/L (below 89.6 mmol/L for blood/serum), the Li+ value cannot be derived.
WARNING
If an additional sample report is desired or the automatic sample report is turned off,
the results may be printed by following these steps:
o
Press NO.
The prompt [PRINT FUNCTIONS?] appears.
Press YES.
The prompt [Print last Sample Report?] is displayed.
Press YES.
The measurement results will be displayed, and the report will print.
The analyzer returns to [READY].
Press NO until [QC/STD/DIALYSATE URINE SAMPLE?] appears; press YES

and then NO, until [Standard Sample?] is displayed. Press YES to confirm.
Direct ISE
The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation
factors or the setting of QCC (see Chapter 10 Troubleshooting, section Service codes on
page E-14).
Roche
C-36
July 2013
7 Measurement
Measuring procedure
Dialysate samples
Dialysate samples are measured in the dialysate mode. In the default analyzer setting,
the dialysate mode provides measurements identical to those performed in the
standard mode. Separate correlation factors for bicarbonate and acetate permit
optimization of absolute measurement, which may be necessary for certain dialysate
compositions.
e see section Correlation factors on page C-39.
To enter the dialysate mode:

o
Press NO, until [QC/STD/DIALYSATE/URINE SAMPLE?] appears. Press YES.
Press NO, until [Bicarbonate Sample?] or [Acetate Sample?] appears.
If lithium is selected, the dialysate mode is not available.
Due to interfering substances inherent in some dialysate solutions, it may be

necessary to establish correlation factors to obtain correct results.
Urine samples
Before measuring urine, accurately dilute the sample with Urine Diluent in the ratio
of 1 part urine to 2 parts diluent (e.g., 1 mL urine and 2 mL urine diluent).
Thoroughly mix the sample and analyze in the urine mode.
As soon as [READY] will be displayed, the analyzer is ready for measurements. Urine
samples, diluted with urine diluent, are analyzed in the urine mode. To enter this
mode:
Na
263
K
18.3
Cl
118
Press NO, until [QC/STD/DIALYSATE/URINE SAMPLE?] is displayed. Press

YES.
Press NO, until [Urine Sample?] is displayed. Press YES and follow the
instructions.
Upon completion of measurement, the analyzer will display and print the results.
-

NA-K-CL
HOSPITAL WEST
Name: ..........
..........
Sample: URINE
Name: ..........
..........
Sample: URINE
Sample No.:29
Sample No.:30
Na=263
K = 18.3
Cl=118
Na=142
K =
Cl=156
mmol/L
mmol/L
mmol/L

NA-K-CL
HOSPITAL WEST
mmol/L
mmol/L
mmol/L
Figure C-29
Ca2+ and Li+ are not measured in urine.
Roche
July 2013
C-37
7 Measurement
WARNING
If the result of the urine sample is given with the K+ value of the sample is higher
than 60 mmol/L, and outside the measurement range of the analyzer. The measurement
must be repeated using the following procedure:
Record the Na+ value (as well as Cl-, if activated) of the first urine measurement.
Dilute the diluted urine (already diluted 1:2 with urine diluent) with distilled
water in the ratio of 1:1 (e.g., 1 mL of diluted urine and 1 mL distilled water).
Thoroughly mix the sample.
Run a second urine measurement with the twice-diluted urine sample.
Ignore the Na+ value (and Cl-, if activated).
Multiply the K+ value by 2 and record.

The normal ranges can be adapted to the respective laboratory-specific requirements.
Values that are higher or lower than the programmed normal range will be indicated
by an arrow pointing up or down.
o
The correlation factors can be changed through the programming menu. Starting
from the [READY] screen, press NO, until the prompt
[PROGRAM INSTRUMENT?] appears, and select with YES.
For safety and security, the analyzer can only be programmed or have existing parameters
changed by entering the correct password.
WARNING
The analyzer prompts [Enter Code: AAA].

In order to proceed with the programming, the code "KEY" has to be entered as
follows:
o
Press NO, until the character K appears.
Press YES and the cursor will advance to the second position.
Press NO, until the character E appears.
Press YES and the cursor will advance to the last position.
Press NO, until Y appears.
TIP:
If the desired character was missed, keep pressing the NO key until the correct character
appears.
If the code has been entered correctly, press YES.
Press NO until [Program Normal Ranges?] is displayed. Press YES.
The analyzer will display the normal ranges of the current parameter
configuration:
Na low =xxx
Na high=xxx ok?
Normal ranges can be entered by pressing NO:
o
Roche
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Press NO until the desired number is displayed, and press YES to advance to the
next position. Repeat this for all numbers of the normal range.
July 2013
7 Measurement
Correlation factors
After entering the normal ranges, the new values will be displayed. Verify
correctness of the ranges:
Na low =xxx
Na high=xxx ok?
If an incorrect number was entered inadvertently, press NO, and the analyzer allows the
operator to retype the normal range.
Press YES and the display will advance to the next parameter.
Repeat the above procedure for all parameters. After all activated parameters have
been programmed, the display prompts [Program Corr Factors?]. This allows
programming the correlation factors.
Correlation factors
The correlation factors allow correlation of the measurement results of the 9180
Electrolyte Analyzer to other electrolyte analyzers. Activated correlation values are
taken into consideration when sampling whole blood, serum, plasma and QC
samples. They are not used for standard samples analyzed in the
[QC/STD/DIALYSATE/URINE SAMPLE] mode. A separate set of correlation
factors is available for dialysate and urine samples.
In case the QC samples were switched to report direct ISE values (Code QCC, see Chapter
10 Troubleshooting, section Service codes on page E-14), the values are NOT affected by
correlation factors.
The measurement range as well as normal and QC ranges are ALWAYS checked against
the DISPLAYED values. Therefore, you may have to adjust the QC and normal ranges to
your correlation factors.
The correlation factors can be changed through the programming menu. Starting
from the [READY] screen, press NO, until the prompt
WARNING
The analyzer prompts [Enter Code: AAA]. The code "KEY" has to be entered as
follows:
o
TIP:
appears.
o
Roche
If the code has been entered correctly, press YES.

July 2013
C-39
7 Measurement
Correlation factors
Press NO, until [Program Corr. Factors?] is displayed.
Press YES, the analyzer prompts [Reset Correlat. Factor(Default)?].
Pressing YES deletes all current correlation factors. The analyzer will then
advance to the other correlation programming functions.
Pressing NO shows the prompt [Input/Verify Corr Factors?] and allows the
operator to input or to verify correlation factors for each parameter.
Pressing YES to the prompt [Input/Verify Corr Factors?] will allow the operator
to change the correlation factors or to verify correlation factors already
programmed.
The current values will be displayed, such as:
Na(b) = +00.0
Na(m) = 1.000ok?
If the Na+ intercept (b) and the slope (m) are correct, press YES.
To change these values, press NO.

The intercept and slope values may be adjusted by pressing NO to change the
number, and by pressing YES to accept the number.
The programmed factors are automatically applied to blood/serum and QC
samples.
Follow the same procedure for the intercept (b) and slope (m) for K+, Cl-, Ca2+ and
Li+.
Only activated parameters can be programmed.
If Na+/K+, Na+/K+/Cl-, or Na+/K+/Ca2+ are activated, a separate set of bicarbonate

and acetate correlation factors can be programmed:
o
At the prompt [Program Bicarb. Corr Factors?] and/or

[Program Acetate Corr Factors?], press YES.
Program these factors as described above.
The programmed factors are automatically applied to acetate and bicarbonate

measurements.
A separate set of correlation factors is available for urine samples.
o
At the prompt [Program Urine Corr Factors?], press YES.
Program the factors as described above.
Note that there are no urine correlation factors available for Ca2+ and Li+, since these
parameters are not measured in urine mode.
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July 2013
7 Measurement
Additional settings
Additional settings
Printer settings
The 9180 Electrolyte Analyzer allows easy programming of printer settings by the
operator for printing automatic measurement and calibration reports.
With factory settings, a measurement report is printed automatically after each
measurement, a calibration report is not printed automatically. These settings can be
changed in the programming menu.
o
Press NO, until [Program Instrument?] is displayed. Press YES.
WARNING
follows:
o
TIP:
appears.
If the code was entered correctly, press the YES key.
Press NO, until [Program Printer Setup?] is displayed.
Press YES, until [Patient Report off?] is displayed.
Press YES to deactivate the automatic measurement report. The programming

advances to the settings for the calibration report.
Press NO to automatically print a measurement report after each

measurement.
[Print two Patient Reports?] is displayed.

O
Press YES to print two measurement reports after each measurement.
Press NO to print one measurement report after each measurement.
[Automatic Cal Report?] is displayed.

O
Press YES to automatically print a calibration report after each calibration.
Press NO to deactivate the automatic calibration report.
TIP:
A copy of the last measurement report and the last calibration report as well as the QC
report can be printed in the menu [PRINT FUNCTIONS?].
Roche
The analyzer displays [Enter Comment Line?]. This setting allows the operator to
enter a comment (one line up to 16 characters) which will be printed on each
report.
Press YES, [Enter Comment:] is displayed.

July 2013
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7 Measurement
Additional settings
Roche
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Press NO to select the desired letters A-Z or numbers 0-9 above the cursor.
Press YES to advance the cursor to the next character.
Repeat this procedure for all characters.
July 2013
8 Quality control
Table of contents
Quality control
In this chapter
Chapter
Quality control ............................................................................................................... C-45

General QC concept ................................................................................................ C-45
Material setup ................................................................................................................. C-46
Performing a QC measurement ................................................................................... C-48
Printing a QC report ...................................................................................................... C-49
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July 2013
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8 Quality control
Table of contents
Roche
C-44
July 2013
8 Quality control
Quality control
Quality control
QC measurements must be performed in their entirety (i.e., all three QC levels must be
measured). Omitting QC measurements or ignoring QC measurement results may lead to
incorrect patient measurements, which may result in incorrect clinical decisions, possibly
endangering the patient's health.
General QC concept
Roche always strives to ensure the highest quality standards for its products. This
quality awareness is the result of a sense of responsibility toward the customer and
the well-being of the patient.
Quality control is an important element of this claim. Roche offers an aqueous QC
material called ISETROL that should be used to ensure that the 9180 Electrolyte
Analyzer provides measurements of high quality in order to protect patients.
test on three levels (1=low, 2=normal, 3=high) after each electrode exchange, after
each replacement of the SnapPak, after startup of the instrument as well as after
monthly, semi annual and annual maintenance steps.
analyzer results.
The following control material is recommended:
o
ISETROL
The target values listed in the package insert sheet should be taken as 2 SD values
(SD = standard deviation).
The QC measurement results within the target value range 2SD are acceptable.
If QC measurement results fall outside the target value range 3SD, the parameter
must not be used for further measurements!
QC measurement results that are greater than the target value 2SD, but less than
the target value 3SD, must be treated accordingly.
Roche
July 2013
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8 Quality control
Material setup
Material setup
TIP:
Lot number, date of expiration, sample type and normal ranges from the text included in
the recommended QC material.
The QC material must be defined prior to the QC measurement.

Starting from the [READY] screen, press NO, until the prompt
WARNING
follows:
o
TIP:
appears.
If the code has been entered correctly, press YES. The analyzer is ready for
programming and the display reads [Program QC Level 1 Ranges?].
TIP:
If a wrong code is entered accidentally, the following display appears:
[CODE ERROR! RETRY?].
Press YES, and the system returns to the prompt [Enter Code:]. To exit this menu, press
NO.
If the pack of ISETROL electrolyte control is new, enter the lot number and the target
ranges into the analyzer. Each level has its own lot number which can be found on the
information sheet enclosed with the ISETROL pack.
The ISETROL electrolyte control is made specifically for use in the 9180 electrolyte
analyzer. To ensure the accuracy of the analyzer, only ISETROL should be used for quality
control.
To enter the lot number, go to the display [Program QC Level 1 Ranges?] and
press YES.
The analyzer display reads [Current Lot:xxxx Change Lot #?]
TIP:
When a lot number is entered for the first time, the analyzer shows a preset lot number
which still has to be changed. If the current lot information does not have to be changed
and only the programmed QC ranges need to be verified, press NO.
Roche
C-46
July 2013
8 Quality control
Material setup
Press YES, and the analyzer display reads [Print old Values and Statistics?].
After you press YES, a log containing the following information is printed: mean
value, standard deviation (SD) and coefficient of variation (CV) of the saved data.
Press NO. The display [NEW LOT! Delete old Data?] appears.
If this function is selected, all statistical data saved for this QC lot will be deleted
automatically.
Press YES to display [Enter last 4 Dig of Lot: xxxx].
Enter the new lot number. Press NO until the desired number is displayed above
the cursor and move to the next digit with YES. Repeat this process for all 4 digits.
After entering the lot number, check the correctness of the entry and confirm
with YES.
If an incorrect lot number is entered, press NO to return to the prompt [Enter last 4 Dig of
Lot: xxxx].
The analyzer now shows the upper and lower ranges of the QC level parameters, e.g.:
Na low
040
Na high =
205
Press YES to display the next parameter range.
After all activated parameters have been programmed, the following display
appears: [Additional Parameters?]. This option can also be used to program the
deactivated parameters.
Programming of QC Level 1 is complete after all ranges have been displayed.
Repeat this process for QC Level 2 and QC Level 3.

After programming of QC Level 3 has been completed, the prompt
[Program Normal Ranges?] is displayed. This programming function allows the
normal ranges to be set individually. The analyzer uses these normal ranges to mark
abnormal patient data, both on the display and on the printed log.
e see Chapter 11 Appendix, section QC report on page F-5.
Roche
July 2013
C-47
8 Quality control
TIP:
Up to 35 QC measurements can be stored per level. The values can be stored and the
statistics be printed at any time.
ISETROL should be stored at 15 - 30 C and brought to room temperature before use.
It is very important that the main door be closed during sampling, since it provides
Starting from the [READY] screen, press NO until [QC/STD/DIALYSATE/

URINE SAMPLE?] appears.
Press YES, [QC Level 1 Sample?] will be displayed. Press YES.
The prompt [Open Sample Door Introduce Sample] will be displayed.

o
Take a Level 1 ampoule from the ISETROL box and mix it carefully.
Gently tap the head of the ampoule with the fingernail to remove any liquid.
Carefully open the ampoule by breaking off the top.
Protect fingers by using gloves and tissue while breaking ampoule.
Open the sample door: The prompt [Introduce Sample] appears.
TIP:
Introduce the QC material directly from the ampoule!
Hold the ampoule under the probe until [Wipe Probe/Close Sample Door]
is displayed.
Use a lint-free tissue to clean the probe, then close the sample door.
It is very important that the sample probe be carefully cleaned each time following a
sample introduction.
Roche
C-48
The instrument will display [QC Level 1 in progress] and a countdown will
begin, during which the QC will be analyzed. Upon completion, the results will be
briefly displayed, such as:
Na
Cl
125.1
3.05
77.8
July 2013
8 Quality control
The 9180 Electrolyte Analyzer flags values that are above or below the programmed
target ranges by using an up or down arrow.
The prompt [Store values in memory?] appears.
To save the values in memory, press YES. To reject the values, press NO.
If the values are rejected, the analyzer will return to the [QC Level 1 Sample?]
display, allowing to repeat the QC Level 1 measurement by pressing YES, or to
skip to QC Level 2
.In case the value is outside the measurement range , or ERR), it will
automatically be rejected.
If the values have been saved, [Values Accepted!] will be displayed shortly, followed
by the prompt [QC Level 2 Sample?].
For further QC measurements (Level 2 and Level 3), follow the outlined instructions
for Level 1, being sure to use a Level 2 or Level 3 ISETROL.
To discontinue QC measurement, press the NO key, until [READY] is displayed.
At completion of QC Level 3 measurement, the analyzer prompts
[Remain in QC/Std./Urine Sample?]. If measurements for all levels have been
completed, press NO and the analyzer returns to the [READY] display.
Responding YES to the [Remain in QC/Std./Urine Sample?] prompt, the analyzer
returns to [QC Level 1 Sample?].
The 9180 Electrolyte Analyzer will store in memory the last 35 QC measurement
values for each of the three QC levels.
o
To print a report of these values along with their mean, standard deviation (1 SD)
and coefficient of variation (CV), press NO, until [PRINT FUNCTIONS?]
appears, and press YES.
Press NO twice, [Print QC Values and Statistics?] appears.
Press YES, the analyzer will print all QC values grouped by level.
After printing, the analyzer will return to [READY].

If correlation factors are changed or QC values switched to direct ISE, ALL values in
memory are recalculated and printed per the new setting.
Roche
July 2013
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8 Quality control
Roche
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July 2013
Maintenance
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
July 2013
9 Maintenance
Table of contents
Maintenance
In this chapter
Chapter
Maintenance .....................................................................................................................D-5
Disinfection .......................................................................................................................D-5
Sample probe mechanism .........................................................................................D-5
Surfaces of the instrument ........................................................................................D-5
Recommended disinfectants ....................................................................................D-6
Daily maintenance ........................................................................................................... D-6
Weekly maintenance ....................................................................................................... D-8
Clean sample probe and fill port ..............................................................................D-8
Cleaning analyzer surfaces ........................................................................................D-9
Monthly maintenance ...................................................................................................D-10
Cleaning the reference electrode housing ............................................................D-10
Semi annual maintenance .............................................................................................D-13
Exchanging the pump tubing set ...........................................................................D-13
Annual maintenance ......................................................................................................D-14
Exchanging main tubing harness ..........................................................................D-14
Unscheduled maintenance ...........................................................................................D-15
Replacing electrodes ................................................................................................D-15
Checking reagent fluid level and changing the SnapPak ....................................D-17
Replacing sample probe and fill port ....................................................................D-18
Replacing printer paper ..........................................................................................D-20
Yearly maintenance .................................................................................................D-20
Roche
July 2013
D-3
9 Maintenance
Table of contents
Roche
D-4
July 2013
9 Maintenance
Maintenance
Maintenance
After use, components of the 9180 Electrolyte Analyzer, including tubing, fill port, SnapPak
etc., contain biological fluids and therefore represents a possible infectious risk.
Handle these components with care and according to regulations surrounding potentially
infectious materials.
goggles and if necessary mouth protectors, must be worn to prevent direct contact with
biological working materials. In addition, a face mask is required if there is a risk of
splashes. Suitable disinfection procedures must be applied.
Disinfection
The purpose of this procedure is to minimize the risk of infections when replacing
items that were in contact with blood.
Perform these disinfections procedures regularly.
Never use alcohol based disinfectants!
Do not use any type of bleaching agent. Exception: Roche Deproteinizer.
Never use disinfectant sprays.
IMPORTANT:
Do not attempt to disinfect any part of the instrument before shutting it down and
unplugging it from the power source.
Before plugging the instrument back in and turning it on, always wait 15 minutes to allow
the disinfectant to evaporate.
Regularly disinfect the following parts of the instrument:

o
Sample probe mechanism consisting of sample probe and fill port
Surfaces of the instrument
All areas which can become contaminated with biological liquids and therefore
pose a potential infection hazard
Sample probe mechanism

e See section Clean sample probe and fill port on page D-8.
Surfaces of the instrument

e See section Cleaning analyzer surfaces on page D-9.
Roche
July 2013
D-5
9 Maintenance
Daily maintenance
Recommended disinfectants
Surfaces
Protein remover (Roche Deproteinizer)
o
Potential dangers
Due to the alkaline and oxidizing character of this preparation, local irritation to
the skin, eyes, and mucous membranes is possible.
First Aid measures

After inhalation: breathe fresh air, drink large amounts of water.
After skin contact: wash with generous amounts of water, remove contaminated
clothing.
After eye contact: rinse eyes with generous amounts of water, contact an eye
doctor.
After drinking: drink large amounts of water, avoid vomiting, contact a doctor.
Do not use any type of bleaching agent. Exception: Roche Deproteinizer.

WARNING
Daily maintenance
Prior to running the first sample of the day, the 9180 Electrolyte Analyzer needs to
undergo a simple cleaning and conditioning procedure that helps ensure the unit will
perform properly. This procedure is called "daily maintenance" because it must be
performed once each day the analyzer is used to conduct testing.
In case cleaning and/or conditioning has not been performed within the last 24 hours, the
analyzer will automatically print on each sample report [Perform Daily Maintenance!].
TIP:
If fewer than 5 samples are analyzed each day, cleaning should be performed once a
week instead of daily (see section Weekly maintenance on page D-8).
Roche
D-6
Press the NO key, until [DAILY MAINTENANCE?] is displayed, and YES to

select. Select [Perform Daily Cleaning?] by pressing YES.
At the prompt [Open Sample Door Introduce Sample], pour a small amount of
Cleaning Solution into a clean container. Lift the sample door and the pump will
begin to aspirate.
July 2013
9 Maintenance
Daily maintenance
Hold the Cleaning Solution under the probe until [Wipe Probe/Close Sample
Door] is displayed, and use a lint-free tissue to remove the cleaning solution from
the probe. Close the sample door.
Figure D-1
While the analyzer displays [Thank You!] and a brief countdown, pour a small
amount of conditioning solution into a clean container.
At the prompt [Perform Daily Conditioning?], press YES.
Hold the conditioning solution under the probe until [Wipe Probe/Close Sample
Door] is displayed, use a lint-free tissue to remove the conditioning solution from
the probe. Close the sample door.
After the analyzer displays [Thank You!] and a brief countdown, press NO at the
prompt [Remain in Daily Maintenance?]. An automatic calibration will be
started.
It is very important that the main door is closed during calibration, since it provides
Before working on ESD critical parts discharge yourself by touching the discharge point
(see Figure B-2 on page B-6).
Wipe the sample probe from top to bottom in order to avoid injury.
Roche
July 2013
D-7
9 Maintenance
Weekly maintenance
Weekly maintenance
At least on a weekly basis, and additionally as needed, you should clean the sample fill
port and sample probe as well as the exterior analyzer surfaces.
Clean sample probe and fill port
Figure D-2
Starting from the [READY] screen, perform the following actions:

o
Open the sample door.
Clean the fill port, probe and surrounding area with a damp cotton swab.
If the analyzer attempts to perform sample analysis, [NO SAMPLE] will be briefly
displayed, and it will return to the [READY] screen.
The exterior surfaces should be wiped clean with a soft, damp cloth.
Never use strong or abrasive cleaners and no cleaners containing alcohol on the 9180
Electrolyte Analyzer. Use a slightly damp cloth to avoid getting fluid inside the analyzer.
WARNING
Roche
D-8
July 2013
9 Maintenance
Weekly maintenance
Cleaning analyzer surfaces

Never use alcohol based disinfectants!
Never use disinfectant sprays.
WARNING
IMPORTANT:
Do not attempt to disinfect the entire instrument before shutting it down and unplugging it
from the power source.
Before plugging the instrument back in and turning it on, always wait 15 minutes to allow
the disinfectant to evaporate.
Regularly, according to the lab-specific regulations, decontaminate the surfaces of

the analyzer including the front door with an undiluted disinfectant
(Deproteinizer). Use swabs or cellulose that have been soaked with Deproteinizer.
The minimum deproteinizing disinfection contact time of 15 minutes is to be
strictly followed.
Very dirty surfaces (e.g., contaminated with blood) should first be cleaned with
swabs or cellulose that have been soaked with Deproteinizer disinfectant. If the
grooves in the front door or the areas around the measuring chamber window are
concerned, use a small commercial plastic brush to clean them. All visible
impurities are to be removed.
Subsequently, the deproteinizing disinfection procedure takes place as described
above.
Dispose of used disinfectants according to applicable regulations (hazardous waste!).
Roche
July 2013
D-9
9 Maintenance
Monthly maintenance
Monthly maintenance
Cleaning the reference electrode housing
Monthly maintenance involves cleaning the reference electrode housing, and should
be performed prior to daily maintenance. To complete this procedure, a small
amount of deproteinizer is needed.
o
From the [READY] screen, press NO to access [DAILY MAINTENANCE?].
Press YES, the prompt [Perform Daily Cleaning?] appears.
Do not press any keys.
Open the front cover of the analyzer.
Release the tubing of the reference electrode from the receptacle below the left
side of the measuring chamber.
Figure D-3
Slide the measuring chamber forward until it locks in the front position.
Remove the reference electrode assembly from the analyzer
Figure D-4
Roche
D-10
July 2013
9 Maintenance
Monthly maintenance
Unscrew the reference electrode from the reference housing. Store the reference
electrode in the red transport housing filled with reference solution.
Figure D-5
TIP:
The reference solution can be taken from the reference electrode housing.
It is important that reference electrode always be stored in reference solution and never
allowed to dry.
WARNING
Pour deproteinizer solution into a small container and submerge the reference
housing into it, ensuring that no air bubbles remain in the housing.
The reference connector and tubing do not need to be submerged.

WARNING
After 15 minutes, remove the reference housing from the deproteinizer.

Thoroughly rinse the housing with tap water and dry.
Unscrew the red transport housing from the reference electrode and check that
the o-ring on the electrode is properly seated. Save the transport housing.
Carefully screw the reference electrode into the reference electrode housing and
place the assembly into the left side of the measuring chamber.
Close the clamp on the left electrode holder by lifting it until it locks in the back
position. Ensure the electrodes are seated properly.
Figure D-6
Roche
Plug the tubing of the reference electrode into the receptacle below the left side of
the measuring chamber.
July 2013
D-11
9 Maintenance
Monthly maintenance
Slide the measuring chamber back until it snaps into position, and close the front
cover of the analyzer.
Figure D-7
WARNING
At this time, you may perform daily maintenance by pressing YES.
If daily maintenance is not needed, press NO until [CALIBRATION?] is

displayed. Press YES and a complete calibration cycle will be performed.
If Roche Deproteinizer is not used for cleaning or if the reference electrode housing is not
cleaned correctly (cleaned for too long, not rinsed long enough, not completely dried), QC
results may be falsified or electrodes may not be calibrated.
more often.
Roche
D-12
July 2013
9 Maintenance

Exchanging the pump tubing set
Every six months the peristaltic pump tubing has to be replaced.
To make sure that the pump does not turn on during this procedure, press NO until
[DAILY MAINTENANCE?] is displayed. Press YES and [Perform Daily Cleaning?] will
appear. Then, do not press any keys.
When changing the pump tubing set, proceed as follows:

o
Remove the front cover and slip the two pump windings from the pump rollers.
Next, disconnect one tube at a time from the old pump winding plate and
reconnect to the same place on the new pump winding plate.
Figure D-8
Install the new pump winding plate and slip the new pump windings over the
pump rollers, being careful not to cross the tubes.
Press NO until [CALIBRATION?] is displayed. Press YES to initiate a calibration

cycle.
Dispose of the pump tubing set according to applicable regulations (hazardous waste!).
more often.
Roche
July 2013
D-13
9 Maintenance
Annual maintenance
Annual maintenance
Exchanging main tubing harness
Once a year or as needed, the main tubing harness should be replaced.
splashes. Suitable disinfection and sterilization procedures must be applied.
At the [READY] screen press NO, until [SERVICE FUNCTIONS?] appears, and
press YES.
Press NO, until [Test Pinch Valves?] appears. Press YES.
Remove the valve caps, sliding them in the direction of the arrow.
Then remove the pinch bars.
TIP:
Each valve consists of the solenoid coil inside the analyzer, the pinch bar and the valve cap.
For further details concerning the position of the valves, see tubing diagram inside the
front door.
Disconnect the reference electrode and pull out the white reference electrode
receptacle.
Disconnect the tubing with the green band from the left side electrode holder.
Open the sample flap and pull out the fill port.
Remove the SnapPak and slide out the white SnapPak receptacle. Disconnect the
tubes from the pump winding plate and pull out the tubing harness.
Re-install the new main harness in reverse order, use the tubing diagram in the
front door as a guide for installation. Take special care to reconnect the tubes to
the correct nipples of the pump winding.
Activate each valve by pressing YES, then slide the pinch bar on and snap on the
valve cap in the direction of the arrow.
Press NO to activate the next valve. Notice the text on the display.
TIP:
It may be necessary to pull on the metal tip of the valve in order to put the valve cap into
position.
Dispose of the main tubing harness according to applicable regulations (hazardous
waste!).
TIP:
It is recommended to replace the sample probe and the fill port at the same time as the
main tubing harness is replaced (see section Replacing sample probe and fill port on
page D-18).
Roche
D-14
Press NO until [CALIBRATION?] is displayed.
Press YES to start a calibration.

July 2013
9 Maintenance
levels (1=low, 2=normal, 3=high) (i.e,. day 1 - level 1, day 2 - level 2, day 3 - level 3, day 4 level 1, etc.). When required by local regulations, QC measurements must be performed
more often.
Replacing electrodes
o
Slide the measuring chamber forward until it locks in the front position.
Remove the used electrode from the measuring chamber.
Figure D-9
Figure D-10
Roche
Remove the new electrode from its protective box and check for the presence of
an o-ring in the left side of the electrode.
Install electrode in its labeled position in the measuring chamber. Note that the
electrode has a lip on the bottom that rests on the flat edge of the measuring
chamber to aid in proper positioning.
July 2013
D-15
9 Maintenance
Figure D-11
Close the clamp on the left electrode holder by lifting it until it locks in the back
position. Ensure that the electrodes are seated properly.
Slide the measuring chamber back until it snaps into position.
Figure D-12
After installing a new electrode, the 9180 Electrolyte Analyzer needs to undergo Daily
Maintenance, Calibration and QC Measurement to verify the performance of the
electrode
.Use of calibration solutions, electrodes or QC-material that were not produced by Roche
Dispose of the electrodes according to applicable regulations (hazardous waste!).
more often.
A quality control program for electrolytes includes the analysis of sample materials with
known ranges of expected values and the comparison of these values with analyzer
results.
Roche
D-16
July 2013
9 Maintenance
Checking reagent fluid level and changing the SnapPak

The 9180 Electrolyte Analyzer monitors the level of solutions in the SnapPak and
displays the amount remaining. To check the status of fluid remaining in the
SnapPak:
o
In the [READY] screen, press the NO key, until [OPERATOR FUNCTIONS?] is

displayed. Press YES.
The prompt [Check/Change SnapPak?] will be displayed. Press YES.
The analyzer will display the amount of fluid remaining.

To change the SnapPak, just grasp the extended portion and slide it out.
Figure D-13
As soon as the analyzer detects that the SnapPak has been removed, the display
prompts [STATUS: NO SnapPak]. In addition, the printer will print the current
status of the SnapPak.
Do not remove the SnapPak during a calibration or measurement procedure.

WARNING
Dispose of the SnapPak according to applicable regulations (hazardous waste!).
Prepare the new SnapPak by carefully removing the protective strip. Save this
cover to close the connectors prior to disposal of the used SnapPak.
Write the installation date on the label of the new SnapPak.
WARNING
Once the protective strip is removed, be sure to keep the SnapPak upright to avoid spillage.
Roche
Slide the new SnapPak into position on the left side of the analyzer.
July 2013
D-17
9 Maintenance
The analyzer will prompt [New SnapPak Installed?].
Figure D-14
Press YES to indicate that a new SnapPak is installed. Again, at the prompt [Are
you sure?], press YES. The 9180 Electrolyte Analyzer will automatically reset the
SnapPak counter to 100% and commence system calibration.
Press NO if you reinstall the SnapPak that was removed.
more often.
Replacing sample probe and fill port

TIP:
It is recommended to replace the sample probe and the fill port at the same time as the
main tubing harness is replaced (see section Exchanging main tubing harness on
page D-14).

To make sure that the pump does not turn on during this procedure, press NO until
[DAILY MAINTENANCE?] is displayed. Press YES and [Perform Daily Cleaning?] will
appear. Then, do not press any keys.
Roche
D-18
Open the front door.
Open the sample door.
Remove the needle carefully (to prevent injury) from the holder. Unplug the
tubing.
July 2013
9 Maintenance
Attach the new needle to the tubing and snap the needle back into the holder.
A
B
Sample probe needle
Fill port
Figure D-15
Then replace the fill port as follows:

o
Remove the fill port holder from the sample probe mechanism.
Carefully remove the fill port from the fill port holder. Unplug the tubing.
Mount the new fill port into the fill port holder in the reverse order and attach the
tubing.
Mount the fill port holder at its default position.
Close the sample door and the front cover.
Press NO until [CALIBRATION?] will be displayed.
Press YES to start the calibration.
Dispose of the sample probe and the fill port according to applicable regulations
(hazardous waste!).
Roche
July 2013
D-19
9 Maintenance
Replacing printer paper

The printer paper is heat sensitive on one side only. Please make sure that you insert the
paper roll correctly.
The thermal printer paper supplied by Roche contains an indicator strip to alert you
when the paper roll should be changed. To change the roll:
o
Open the front cover of the analyzer.
Remove the remaining paper by pressing the paper feed button.
Place a new paper roll in the paper tray and thread it into the feeder slot.
Press the paper feed button to completely feed the paper through the printer.
Figure D-16
By pressing the paper advance button once, the paper will automatically advance 10 lines.
Close the front cover and tear off any excess paper.
Cut the end of the roll to make a square edge.
Do not pull the paper out of the printer to avoid damage to the printer.
Yearly maintenance
The yearly maintenance work must be conducted by customer service or fully qualified
technicians only.
CAUTION
The components have been tested during development of the device to identify worn parts.
They must be replaced at the annual service to prevent potential malfunctions.
e Please refer to the Service Manual for details.
Roche
D-20
July 2013
Troubleshooting
10
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
July 2013
10 Troubleshooting
Table of contents
Troubleshooting
In this chapter
Chapter
10
Troubleshooting ................................................................................................................E-5
Error messages ............................................................................................................E-5
Service functions ...............................................................................................................E-9
Testing the electrodes .................................................................................................E-9
Not calibrated potassium electrode ..................................................................E-10
Testing the sample sensor ........................................................................................E-10
Testing the SnapPak sensor .....................................................................................E-11
Testing the language switch .....................................................................................E-11
Testing the sample door ...........................................................................................E-11
Testing the pump ......................................................................................................E-12
Testing the valves ......................................................................................................E-12
Testing the interface .................................................................................................E-12
Testing the amplifier ................................................................................................E-13
Status-LEDs ...............................................................................................................E-13
Service codes ....................................................................................................................E-14
Entering service codes ..............................................................................................E-14
Removing service codes ...........................................................................................E-14
List of service codes ..................................................................................................E-15
Deleting data ....................................................................................................................E-16
Clearing sample count ..............................................................................................E-16
Clearing all data ........................................................................................................E-16
Roche
July 2013
E-3
10 Troubleshooting
Table of contents
Roche
E-4
July 2013
10 Troubleshooting
Troubleshooting
Troubleshooting
Your 9180 Electrolyte Analyzer is designed to provide long, trouble-free service.
However, any scientific measuring device may occasionally malfunction, requiring
the operator to identify the cause of the problem.
The following information lists displayed messages and recommends steps that
should help you return your 9180 Electrolyte Analyzer to operation. If your 9180
Electrolyte Analyzer does not perform correctly after conducting the basic steps
outlined in this chapter, you should contact Roche for technical assistance.
Error messages
Message
Cause
Action
Calibration has been interrupted
Perform calibration to return the instrument to the

[READY] mode
Na/K/Cl/Ca/Li
A specific electrode could not be calibrated.
not calibrated
Possible causes:
o
o
Status:
Not calibrated
o
o
No stable value for Standard A

The slope A-B or A-C is outside the
range (see Testing the electrodes on
page E-9)
o
o
o
o
o
Standard A not
detected
As the analyzer aspirates a sample of

Standard A, the solution is detected by the
sample sensor, which must detect its
presence without encountering any air
bubbles. If the sample sensor is unable to
properly detect the presence of Standard A
solution in a programmed time period,
above error message will be displayed.
o
o
o
o
o
Standard B not
detected
Standard C not
detected
Perform daily maintenance.

Check if the electrode holder is locked in the back
position.
Check for leaks, blockages and air bubbles.
Clean or replace the electrode.
Check the fluid remaining in the SnapPak. If less than
5 % remains, replace the SnapPak.
Is K+ still not calibrated, perform external electrode test
using serum or plasma (see section Not calibrated
potassium electrode on page E-10).
Ensure that electrodes are properly plugged in.
Check the fluid remaining in the SnapPak. If less than
5 % remains, replace the SnapPak.
Check for clots or crystals that may have formed in the
Standard A tubing or the electrode chamber.
Replace the SnapPak.
Ensure the sample sensor is securely plugged in and
perform the sample sensor test to ensure that the sensor
is operating correctly. If necessary, clean the sample
sensor.
Replace the peristaltic pump tube set to ensure correct
aspiration of Standard A.
Detection of Standard B aspiration is the

same as for Standard A. If Standard A is
aspirated properly, but Standard B is not
detected, check Standard B tubing for
crystallization. If no crystallization or leaks
are found, see Action.
Detection of Standard C aspiration is the

same as for Standard B.
See remedy for Standard B.
(Li+ activated)
Table E-1
Roche
July 2013
E-5
10 Troubleshooting
Troubleshooting
Message
Check Sample
Sensor
Check Reference
Housing
Cause
Action
The sample sensor is calibrated with air

during each calibration. For proper
functioning, the sensor must provide a
reading of 80 - 120 units when air is detected.
To check sample sensor response, perform
the Sample Sensor Test
Open the sample door and press the YES
button to aspirate various fluids through the
sensor. For transparent fluids (e.g. water),
the reading should increase by at least 40
units. For blood samples (not transparent),
the reading should decrease by at least 40
units. The pump can be stopped at any time
by pressing NO.
When the analyzer fails to detect a flow of

Reference Solution into the measuring
chamber, this message will be displayed. This
test is performed at the beginning of each
calibration cycle.
o
o
o
o
o
o
o
Check for proper filling of the reference housing.

Ensure that the reference tubing is securely connected to
the receptacle.
Since this test utilizes Standard A, make sure that it is
aspirated properly into the measuring chamber.
If not, replace the SnapPak.
Clean the reference housing (see Chapter
9 Maintenance, section Monthly maintenance on
page D-10).
Check the peristaltic pump tube set.
Perform a calibration to remove the error message.
This message occurs when the sample door

is not closed within 20 seconds after the
sample is in place, or when the door has been
opened and no sample is detected.
Close the sample door within time allowed.
Under certain conditions, the analyzer may

not detect the presence of a sample and an
error message will occur:
Repeat the sample to see if it is detected properly on a

second trial.
Close the sample door within time allowed.
Check sample aspiration and look for the presence of
clots in the sampling system.
Check for the presence of o-rings and for proper sealing
of the electrodes.
Ensure that the sample sensor is plugged in and perform
the Sample Sensor Test to verify that it is operating
correctly.
Replace pump tubing.
Please close sample

door
No sample
o
o
o
o
Cleaning fluid not

detected
Clean sample sensor by using the Electrode Maintenance

procedure.
Check for correct drying of the measuring chamber
during the wash cycle.
Replace the peristaltic pump tube set.
sample door remaining open more than

20 seconds after samples are in place
air bubbles in the sample
a sample volume too small to analyze
no sample being aspirated through the
sampling mechanism.
o
o
o
o
If you wish to abort a sample, you can do so

by closing the sample door during sample
aspiration.

not detect the presence of cleaning solution:
o
o
o
air bubbles in the cleaning solution

too small volume of cleaning solution
the cleaning solution not being aspirated
properly through the sampling
mechanism
o
o

of the electrodes.
Check for aspiration of cleaning solution and look for
presence of clots in the sampling system.
Check for the proper sealing of the pump windings.
correctly
Table E-1
Roche
E-6
July 2013
10 Troubleshooting
Troubleshooting
Message
Conditioning fluid
not detected
Cause

not detect the presence of conditioning
solution
o
o
o
Check electrodes
air bubbles in the conditioning solution

too small a volume of conditioning
solution
the conditioning solution not being
aspirated properly through the sampling
mechanism.
If none of the electrodes passes the

calibration:
a stable reading of Standard A could not be
obtained within 6 aspirations of Standard A
the slope A-B or A-C is outside of the limits
Clog check fluid path
If the unit is unable to clear the sample path

or to aspirate any of the 3 Standards at the
beginning of a calibration:
the cause:
a defective reference housing (increased
discharge of KCl).
Action
o
o
o
o
o
o
o
o
o
o
o
o
o
o
In case the unit displays arrows up or arrows
down instead of the sample results, the
concentration of the sample is outside of the
measurement range (see Chapter
3 Specification).
o
o
o
With Ca2+
Err.
activated, the calibration report

will print an arrow up or down instead of the
actual temperature, if the temperature
measured is out of range (Range 10.0C 40C).
The temperature sensor is located in the
right side electrode holder.
o
o
If this message is displayed instead of the

sample results, no valid voltage reading
could be obtained from the electrode.
o
o
o
o
o

of the electrodes.
Check for aspiration of conditioning solution and look
for presence of clots in the sampling system.
Check for the proper sealing of the pump windings.
correctly.
Ensure that electrodes are properly plugged in.
Check for proper operation of the reference electrode
assembly. If necessary, clean the reference electrode
housing or replace the reference electrode.
Perform daily maintenance.
Make sure that the electrode O-rings are present and
seated properly.
Make sure there are no leaks in the fluid path.
Check for a clog or crystallization in the fluid path:
especially in the sample probe, the tubing to the sample
sensor and in the sample sensor.
Ensure that the sample sensor is securely plugged in and
perform a sample sensor test to ensure the sensor is
operating correctly. If necessary, clean the sample
sensor.
Replace reference electrode housing.
Check the peristaltic pump tube set.
In the case of a urine sample, arrows up instead of the
K+-result indicate that further dilution of the sample is
necessary (see Chapter 7 Measurement, section Urine
samples on page C-37).
Check for proper sample preparation (see Chapter
7 Measurement).
Check for small air bubbles in the sample after aspiration
into the sample chamber.
Check for proper aspiration of Standard A.
Ensure the sample sensor cable is securely plugged in.
Make sure room temperature is within specified limits
(15C to 32C / 60F to 90F).
Perform the Amplifier Test to measure the actual
temperature.
With the front door opened, the temperature displayed
should be approx. 5C above the actual room
temperature.
7 Measurement).
Check if the electrode holder is locked in the back
position.
Check for proper filling of the reference housing.
Check for air bubbles in the sample.
Table E-1
Roche
July 2013
E-7
10 Troubleshooting
Troubleshooting
Message
Change SnapPak
Cause
Action
When the monitored fluid level in the ISE

SnapPak reaches 5 % remaining, the analyzer
will automatically print [Change SnapPak]
at the end of each sample report.
Replace the SnapPak (seeChapter 9 Maintenance,

section Checking reagent fluid level and changing the
SnapPak on page D-17).
Check if pins 2 and 3 of the serial port were connected

properly.
If the error persists, contact
Technical Support.
This message is present only in printed form.

*** Li
Calculation not
possible
The lithium result can only be calculated for

a Na+ range: 95 - 180 mmol/L
(89.6 - 169.5 mmol/L for blood/serum).
If the Na+ value of the sample is outside of
this range, this message will be displayed and
printed instead of the Li+ value.
Interface error
The interface test (see section Testing the

interface on page E-12) was not successful.
o
**Check Temp**
(Ca2+ activated)
This message is printed at the end of the

sample report and displayed while the
measurement is in process in case the
temperature of the sample is outside the
range (Range: 10C - 40C).
o
o
o
o
o

7 Measurement).
Ensure the sample sensor cable is securely plugged in.
Make sure room temperature is within specified limits
(15C to 32C / 60F to 90F).
Perform the Amplifier Test to measure the actual
temperature.
With the front door opened, the temperature displayed
should be approx. 5C above the actual room
temperature.
This message appears at the end of a

measuring report if daily maintenance is not
performed.
STATUS: NO SnapPak
o
o
o
o
Insert a SnapPak if none is inserted.

Check if the SnapPak is expired. The onboard stability is
14 weeks.
Paper jam or printer
If the printer attempts to print to the paper

and the paper jams in the feeder, this
message will be displayed briefly, then the
sample results will appear on the display.
First turn analyzer off, then remove the printer by

placing your index finger behind the back edge of the
printer module and pull it forward. Remove the jammed
paper and re-insert the printer into the analyzer. Turn
analyzer back on.
Perform Daily
Maintenance
defect
No SnapPak inserted
SnapPak expired
Perform daily maintenance

e For details, see Daily maintenance on page D-6.
Table E-1
To ease removal of jammed paper, the printer head can be moved by turning the spindle
gear on the left side.
Paper jams should be cleared as soon as possible to avoid damaging the printer.
Roche
E-8
July 2013
10 Troubleshooting
Service functions
Service functions
The 9180 Electrolyte Analyzer has various built-in functions that you can access to
evaluate the performance of the instrument. Starting at the [READY] display, press
NO until [SERVICE FUNCTIONS?] is displayed, and enter YES.
Testing the electrodes

The voltage levels of the electrodes can be tested by using standard solutions or an
external sample.
Electrode
Press NO, until [Test Electrodes?] is displayed.
Press YES and the prompt [Test Standard A?] will be displayed.
Record these values.
Press YES and the electrode voltages will be displayed.
To exit this function, press NO.
The prompt [Test Standard B?] will be displayed.
To exit this function, press NO.
The prompt [Test Standard C?] will be displayed.
Compare the measured values to the following table:
Standard A
Standard B
Standard C
Allowed difference
A-B
+
A-C
Na
-600
to +2400
-1600
to +2000
-600
to +2400
+250
to +680
-50
to +50
-700
to +1000
-2500
to +500
-700
to +100
+470
to +1200
-40
to +40
-3100
to -100
-1000
to +3000
-3100
to -100
-370
to -860
-3100
to +1000
-2300
to +2500
-3100
to +1000
-350
to -660
-150
to +150
-3100
to +1900
-3600
to +1400
-2600
to +3400
+1
to +760
-1730
to -285
Cl
Ca2+
+
Li
unused
If the voltage difference A-B or A-C is outside the allowable difference, perform daily
maintenance or replace the electrode.
Roche
After testing the electrodes against the standard solutions, the 9180 Electrolyte
Analyzer will prompt [Test External Sample?]. Press YES.
The instrument will prompt [Open Sample Door Introduce Sample].
After introducing the sample, the analyzer will display [Thank you!] shortly,
followed by the electrode voltages.
Check for stable readings.
Press NO to exit and after a short [Please Wait] message, the prompt [Remain in
Test Electrodes?] will appear.
Press NO to exit or to perform other service functions.
July 2013
E-9
10 Troubleshooting
Service functions
Not calibrated potassium electrode

If the potassium electrode cannot be calibrated after an electrode exchange, then a
serum or plasma sample should be introduced as an external sample.
o
Call up the procedures for testing electrodes

e see Testing the electrodes on page E-9.
Press NO, until [Test External Sample?] is displayed. Press YES.
Prepare a serum or plasma sample and introduce the sample:

o
The prompt [Open Sample Door Introduce Sample] appears. Introduce the
sample.
The sample is aspirated, until the prompt [Wipe Probe/Close Sample Door] is
displayed.
Test the sample for 15 minutes.
Repeat the procedure a second time.
Testing the sample sensor

The dry sample sensor should indicate a value of 80-120, aspiration of a clear fluid
should increase this value by at least 40 Units.
o
Press NO, until [Test Sample Sensor?] is displayed.
Press YES and the analyzer will display the current sample sensor reading:
Dry: 80-120: 99
YES=Pump/NO=Exit
Press YES introduce an external sample through the probe. The display will be
like:
External: 236
Pump: NO=OFF
Roche
E-10
Press NO to exit and after a short [Please Wait] message, the prompt
[Test SnapPak Sensor?] will appear.
July 2013
10 Troubleshooting
Service functions
Testing the SnapPak sensor

o
Press NO, until [Test SnapPak Sensor?] is displayed.
Press YES and the current SnapPak sensor status will be displayed:
SnapPak: I
I=In O=Out
"I" on the display indicates that the SnapPak is inserted properly, "O" means that
the SnapPak either is not installed or is not inserted correctly.
During insertion the detection of the SnapPak can be a delayed up to 10 seconds.
If the SnapPak has been removed during this test, a calibration should be performed to
prime all fluid lines.
Testing the language switch

o
Press NO, until [Test Language Switch?] is displayed.
Press YES and the current language switch status will be displayed:
Open the front door and remove the printer paper tray.
Change the language settings with a pen.
To activate a new language setting, turn the analyzer off and back on.

English
Deutsch
Polski
Franais
Portugus
Espaol
Spare 3
Italiano
Spare 4
Figure E-1
Testing the sample door

o
Press NO, until [Test Sample Door?] is displayed.
Press YES and the current status will be displayed:

Sample Door: C
C=closed O=open
Roche
Open the sample door to see the changes of the status.

July 2013
E-11
10 Troubleshooting
Service functions
Testing the pump

o
Press NO, until [Test Pump?] is displayed.
Open the front cover and press YES to begin the pump test. The analyzer will
display:
---Test Pump!---
The following tests will be performed and displayed:

o
Very low speed
Low speed
Medium speed
Fast speed
An audible change should be heard at the pumps speed change.

o
Close the front cover and press NO to exit or to perform other service functions.
Press NO, until [Test Pinch Valves?] is displayed.
Press and the following will be displayed:
Testing the valves
Test Valve A:
YES/NO = ON/OFF
o
Press YES to move the valve to the open position.
Press NO to move the valve back to the closed position.
Press NO once more to test the next valve.
After [Test Valve R] is finished, press NO to exit or to perform other service

functions.
Press NO, until [Test Interface? Jump Pins 2 & 3] is displayed.
Jump pins 2 and 3 of the serial interface making sure not to short the jumper to
ground. Press YES.
Testing the interface
Be sure not to short pin 2 or pin 3 to ground, otherwise the interface may get damaged.
WARNING
Roche
E-12
The analyzer will display [Interface Test] and tries to send some characters and
checks if they are received within a set time period.
Check that there was no interface error.
July 2013
10 Troubleshooting
Service functions
Testing the amplifier

o
Press NO, until [Test Amplifier?] is displayed.
Press YES and the analyzer will display the current amplifier values:
Na=#### K=####
Cl/Ca/Li=####
Press NO and the ground voltage will be displayed:

GND =0
-2500mV=-2499
Press NO and the temperature will be displayed:

Temp(mV) =-####
Temp(C) = ##.#
Status-LEDs
The 5 status LEDs at the bottom of the chassis back panel are lit simultaneously
during normal operation. If this is not the case, contact technical support.
Figure E-2
Roche
Status LEDs (back panel, bottom)
July 2013
E-13
10 Troubleshooting
Service codes
Service codes
The [Enter Service Code?] menu allows the programming of various functions into
the 9180 Electrolyte Analyzer.
Entering service codes

o
Starting at the [READY] display, press NO until [SERVICE FUNCTIONS?] is

displayed, and enter YES.
Press NO until [Enter Service Code?] is displayed.
The prompt [Enter Code: AAA] will appear.
Enter the service code as follows:

o
Press NO, until the first character appears.
Repeat this procedure for the other characters.
Pressing YES after the third character will activate the service code.
TIP:
appears.
If an incorrect code is entered during the process, the analyzer will prompt [Code Error!
Retry?]. Press YES to correct the code or NO to exit.
Removing service codes

To remove a service code, enter the reversed sequence of the code letters (example:
DEC becomes CED, ECO becomes OCE, MGL becomes LGM, etc.). To clear all
service codes at one time, enter CDC.
Roche
E-14
July 2013
10 Troubleshooting
Service codes
List of service codes

Code
Action
DEC
This service code will increase the resolution by one digit for all
parameters in blood and serum samples. QC and standard samples
are always shown in high resolution, urine samples in low resolution.
ECO
This service code will automatically put the instrument into Standby
Mode, if no samples are run between two calibrations (4 hrs.). This
feature mainly helps to conserve reagents. When the unit
automatically enters the Standby Mode, it is always necessary to
perform a calibration to get back to the [READY] prompt.
FIF
This service code will automatically print the voltage levels of the
electrodes on sample and calibration reports.
This code should only be used by trained service technicians. To
disable this code, either enter IFI or turn the power off and back on.
LEM
This service code will print the last 20 error messages with the date
and time of occurrence. MEL will erase all error messages stored.
MGL
This service code allows you to report Ca2+ values in mg/dL instead
of mmol/L. When this code is set, the unit automatically converts the
current high and low values of the normal ranges to mg/dL. Note
that QC and standard measurements are always reported in mmol/L
independent of the MGL setting. This allows you to compare the
Ca2+ values to the ISETROL assay ranges.
Ca2+ activated
NOB
This service code disables the beep.
SLC
When this code is set, the current setting of the leasing counter,
which cannot be reset by the operator, is printed on the calibration
report.
SFC
This code allows the input of a percentage for the SnapPak counter.
When this code is activated, the analyzer displays:
SnapPak Counter:
xxx% ok?
If this percentage is not correct, press NO and enter the correct
percentage between 0 and 100 % using the NO and YES keys.
Pressing YES to [ok?] will return the analyzer to the ready screen.
QCC
When this code is enabled (using QCC) QC measurements will be

reported in direct ISE values without correlation factors.
In order to disable this code enter the code CCQ. When the code is
disabled (using CCQ) QC measurements will be reported as flame
equivalent values with correlation factors applied.
NOTE: The default condition is that this code is disabled.
Table E-2
With the exception of FIF, all service codes are permanently stored in memory and
will be retained during power failures. The service codes currently set can be printed
on the calibration report.
Roche
July 2013
E-15
10 Troubleshooting
Deleting data
Deleting data
Clearing sample count
To reset the sample count to 0, carry out the following procedure:
o
Open the [READY] display and press NO until the display [OPERATOR
FUNCTIONS?] appears. Confirm with YES.
Press NO until [Reset Sample Number?] appears. Press YES.
When the prompt [Are you sure?] appears, press YES again.
Clearing all data

To reset the analyzer software to the default values, press the YES and NO keys
simultaneously and switch the analyzer off and on again. This function can be
performed optionally upon completion of decommissioning.
All QC data and analyzer settings will be lost!

CAUTION
All QC values and statistics will be deleted and the sample number reset to 0. QC and
normal values as well as correlation factors, printer settings, date/time and liquid
content of the SnapPak will be reset to default values. All service codes will be
deactivated. It is recommended that all data be deleted if the analyzer is to be used by
other persons at a later date.
Roche
E-16
July 2013
Appendix
11
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
12
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-13
July 2013
11 Appendix
Table of contents
Appendix
In this chapter
Chapter
11
Description of reports ......................................................................................................F-5

Measurement report ...................................................................................................F-5
QC report .....................................................................................................................F-5
Calibration report .......................................................................................................F-6
Specifications of the solutions .........................................................................................F-7
Program flow chart ...........................................................................................................F-8
Maintenance schedule ......................................................................................................F-9
Order information ..........................................................................................................F-10
Electrodes ...................................................................................................................F-10
Solutions .....................................................................................................................F-11
QC material ...............................................................................................................F-11
Accessories .................................................................................................................F-12
Roche
July 2013
F-3
11 Appendix
Table of contents
Roche
F-4
July 2013
11 Appendix
Measurement report
ROCHE 9180 ELECTROLYTE ISE

NA-K-CL
26SEP03 08:16
HOSPITAL WEST
- ROCHE 9180 ELECTROLYTE ISE

NA-K-CL
26SEP03 08:27
HOSPITAL WEST

NA-K-CL
26SEP03 08:31
HOSPITAL WEST
Name: ..........
..........
Sample: STANDARD
Name: ..........
..........
Sample: SERUM
Name: ..........
..........
Sample: URINE
Sample No.35
Sample No.36
Sample No.37
Na=151.7
K = 5.56
Cl=114.5
Na= 263
K = 18.3
Cl= 118
mmol/L
mmol/L
mmol/L
Na=143.9 mmol/L
K = 4.93 mmol/L
Cl=103.1 mmol/L
*** Level 2 ***

Lot Number: 1261
*** Level 3 ***

Lot Number: 1373
Na/K/Cl
1 Na-values
145.4
1 K-values
4.51
1 Cl-values
103.6
Na/K/Cl
1 Na-values
160.5
1 K-values
6.46
1 Cl-values
120.0
mmol/L
mmol/L
mmol/L
*PEFORM DAILY *
MAINTENANCE! *
Table F-1
QC report

NA-K-CL
26SEP03 09:21
HOSPITAL WEST
QUALITY CONTROL
*** Level 1 ***
Lot Number: 1150
Na/K/Cl
1 Na-values
118.0
1 K-values
2.71
1 Cl-values
69.6
Table F-2
Roche
July 2013
F-5
11 Appendix
Calibration report

NA-K-CL
26SEP03 09:01
HOSPITAL WEST
*CALIBR. REPORT*
Daily Maintenance
Performed Last:
26SEP03 08:16
Standard A
Na = -369mV (4)
K = -1052mV (4)
Cl = -183mV (4)
Difference A-B:
Na =
584mV ( )
K = 1056mV ( )
Cl = -689mV ( )
Temp. = 26.2C
SnapPak:
83% Remaining
Corr. Factors:
Na Offs.=
0.0
Na Slope= 1.000
K Offs.=
0.0
K Slope= 1.000
Cl Offs.=
0.0
Cl Slope= 1.000
Bicarb. Factors:
Na Offs.=
0.0
Na Slope= 1.000
K Offs.=
0.0
K Slope= 1.000
Cl Offs.=
0.0
Cl Slope= 1.000
Acetate Factors:
Na Offs.=
0.0
Na Slope= 1.000
K Offs.=
0.0
K Slope= 1.000
Cl Offs.=
0.0
Cl Slope= 1.000
Urine Factors:
Na Offs.=
0.0
Na Slope= 1.000
K Offs.=
0.0
K Slope= 1.000
Cl Offs.=
0.0
Cl Slope= 1.000
Normal Ranges:
Units: [mmol/L]
Na: 136 145
K : 3.5 5.1
Cl:
97 111
QC Ranges:
Units: [mmol/L]
*** Level 1 ***
Lot number:1150
Na:
40 145
K : 1.5 - 15.0
Cl:
50 200
*** Level 2 ***
Lot number:1261
Na:
40 145
K : 1.5 - 15.0
Cl:
50 200
*** Level 3 ***
Lot number:1373
Na:
40 145
K : 1.5 - 15.0
Cl:
50 200
Service Codes:
,
,
,
,NOB,
,
,
,
,
Table F-3
Roche
F-6
July 2013
11 Appendix

Reagents are to be used for in-vitro diagnostic use only.
The SnapPak contains the following solutions:

o
Standard A
Standard B
Standard C
Reference solution
Caution:
A waste container is provided inside the SnapPak which, when used, holds human body
fluids which may be potentially infectious; handle with appropriate care to avoid skin
contact or ingestion!
Roche
July 2013
F-7
Na K Cl
READY
Roche
F-8
YES
NO
YES
NO
NO
NO
Remain in
Program Func?
NO
NO
Remain in
Service Func?
NO
Program
Interface?
NO
Enter
Service Code?
NO
Program Printer
Setup?
NO
Test
Amplifier?
NO
Program Urine
Corr Factors?
NO
NO
Test Interface?
Jump Pins 2 & 3
NO
Test
Pinch Valves?
NO
Test
Pump?
NO
Test
Sample Door?
NO
Test
Language Switch?
NO
Test SnapPak
Sensor?
NO
Test
Sample Sensor?
NO
Test
Electrodes?
YES
SERVICE
FUNCTIONS?
Program Acetate
Corr Factors?
NO
Program Bicarb.
Corr Factors?
NO
Remain in QC/Std
/Urine Sample?
NO
Remain in
Operator Func?
NO
Urine
Sample?
NO
NO
Program
Corr Factors?
NO
Take out of
Operation?
NO
Acetate
Sample?
NO
Program
Normal Ranges?
NO
Reset
Sample Number?
YES
NO
Program QC
Level 3 Ranges?
Bicarbonate
Sample?
YES
NO
Select Parameter
Configuration?
Program QC
Level 2 Ranges?
NO
Program QC
Level 1 Ranges?
NO
Enter Code:
AAA
YES
PROGRAM
INSTRUMENT?
NO
Calibration
NO
NO
NO
NO
Set
Time/Date?
NO
Go to
Standby Mode?
NO
Check/Change
SnapPak?
YES
OPERATOR
FUNCTIONS?
Standard
Sample?
NO
Remain in Daily
Maintenance?
NO
Remain in Print
Functions?
YES
NO
NO
QC Level 3
Sample?
NO
Print QC Values
and Statistics?
NO
Perform Daily
Conditioning?
NO
QC Level 2
Sample?
NO
Print
Cal Report?
YES
Perform Daily
Cleaning?
DAILY
MAINTENANCE?
YES
NO
QC Level 1
Sample?
QC/STD/DIALYSATE
URINE SAMPLE?
YES
NO
Print last
Sample Report?
PRINT FUNCTIONS?
NO
Calibration
YES
CALIBRATION?
NO
11 Appendix
Program flow chart
Program flow chart
Figure F-1
July 2013
Roche
UNSCHEDULED MAINTENANCE
Change main tubing harness
ANNUALLY
Change pump tubing
SEMI-ANNUALLY
Clean reference electrode housin
MONTHLY
Clean analyzer surfaces
Clean sample probe/fill port
WEEKLY
Perform conditioning
Perform cleaning
DAILY
Month: .
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31


11 Appendix
TIP:
This page can be used as template for duplication.
July 2013
F-9
11 Appendix
Order information
Order information
To measure the respective parameters, the following products are required.
Electrodes
Parameter
Cl
Na+
K+
Ca2+
Li+
Chloride Electrode
03110451180
Sodium Electrode
03110419180
Potassium Electrode
03110338180
Calcium Electrode
03110354180
Lithium Electrode
03110664180
Reference Electrode
03112306180
Reference Electrode Housing

03112284180
Dummy Electrode(a)
03110192035
Table F-4
(a) replaces an unused electrode
Roche
F-10
Has to be installed
Dummy or electrode has to be used for proper filling of the measuring chamber
July 2013
11 Appendix
Order information
Solutions
Parameter
Cl
Na+
K+
Ca2+
Li+
Deproteinizer
03110435180
Electrode Filling Solution

03110770035
Sodium Electrode Conditioner

03110362180
Urine Diluent
03110249180
Cleaning Solution
03111555180
SnapPak 918x
03112349180
SnapPak Dialysate 918x (a)

03112357182
Table F-5
(a) available in Japan only
Has to be installed
Dummy or electrode has to be used for proper filling of the measuring chamber
QC material
Parameter
Cl
ISETROL
03112888180
Na
K+
Ca2+
Li+
Table F-6
Roche
Can be used
July 2013
F-11
11 Appendix
Order information
Accessories
Parameter
Cl
Na+
K+
Ca2+
Li+
Adapter for Capillaries

03113817035
Caps for Roche MICROSAMPLER

03112152180(a)
Printer Paper
03112292018
Roche MICROSAMPLER PROTECT, non sterile

05772494001 (200 pcs.)(a)
Roche MICROSAMPLER PROTECT, sterile

05772583001 (50 pcs.)(a)
Roche MICROSAMPLER PROTECT, with accessories

05772591001(b)
Capillary Tubes, ~200 L

03113477180(a)
BS2 Blood Sampler

03113493035(a)
Capillary Tubes, ~115 L

03113507035(a)
Caps for Capillary Tubes

03113647035
Plastic Capillary Tubes, 140 L

05174791001(a)
Table F-7
(a) not available in USA.
(b) available in USA only.
Roche
F-12
Can be used.
July 2013
Glossary
Alkaline - Shutdown kit
Glossary
Alkaline Basic.
Peristaltic pump see "Pump"
Arterial blood Blood taken from an artery
Plasma Plasma samples are obtained by centrifuging

heparinized whole blood to separate the cellular
component of the blood.
D
Dummy electrode This is a flow-through electrode
with no measurement function used as a placeholder.
E
Electrodes Flow-through electrodes with visible
well counter.
PP Abbreviation for Peristaltic pump

Printer A quiet thermal printer.
Pump The sample and the aspirate fluids are
transported by a peristaltic pump.
Q
QC Abbreviation for Quality Control.
I
ISE measuring chamber The ISE measuring
chamber with its sensors is used to measure the Na+, K+,
Ca2+, Cl and Li+ electrolyte values.
QC materials See ISETROL.

Quality Control The known target ranges of QC
materials are compared with the QC results of the
instrument.
ISETROL QC material for checking ISE.
R
L
Locking lever Used to lock the sensors in the
measuring chamber.
Reference electrode The reference electrode is a

counter-electrode to the measuring electrodes. Its signal
remains constant because of the reference solution
regardless of the composition of the sample.
Reference housing The Reference housing and
Reference electrode form the reference electrode unit,
which establishes the contact to the sample.
MC Abbreviation for Measuring chamber.

Measuring chamber The ISE measuring chamber is
behind the front panel of the instrument.
N
Needle mechanism Used to input samples and
aspirate fluids from the SnapPak. It comprises the sample
needle and the filler funnel with funnel holder behind the
sample flap.
Relief clamps Used to protect the valves during

transport of the instrument. They must be removed
before operating the instrument.
S
Sample sensor The sample sensor positions the
sample (optically) while filling the measuring chamber
and is connected to the measuring chamber.
Sampling rate Number of samples per hour.
NIST standards Accurate sera with certified expected

values
Roche
Shutdown kit Used to rinse the tubing with distilled

water when the instrument is put out of operation.
July 2013
F-13
Glossary
SnapPak - Transport housing
SnapPak All aspirate fluids and a waste fluid container

are included in the SnapPak.
T
Transport housing The transport housing protects the
Reference electrode during transport.
Roche
F-14
July 2013
Index
13
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-3
July 2013
Index
Index
A
Accessories, C-5
Additional settings, C-41
Printer, C-41
Analyzer components, B-5
Display, B-6
Keypad, B-6
Measuring chamber, B-7
Peristaltic pump, B-7
Printer, B-7
Rear panel, B-9
Sample probe mechanism, B-8
Serial port, B-10
SnapPak, B-9
Valves, B-8
Annual maintenance
Exchanging main tubing harness, D-14
Aqueous solutions, C-28
Calibration, F-6
Measurement, F-5
QC, F-5
Dialysate, C-28
Dimensions, A-29
Disinfection, A-12, D-5
Display, A-29, B-6
Disposal
Reference electrode, A-12
SnapPak, electrodes, and instrument, A-12
Disposal of SnapPak, electrodes, and instrument, A-12
Disposal of the reference electrode, A-12
Document information, 3
E
Edition notice, 3
Electrical data, A-29
Entering service codes, E-14
Error messages, E-5
Exchanging main tubing harness, D-14
Exchanging the pump tubing set, D-13
Bibliography, A-24
G
C
Calcium electrode, A-43
Calibration procedure, A-10
ISE calibration, A-46
Calibrations, A-25
Callibration report, F-6
Capillary tubes, C-26
Checking reagent fluid level and changing the SnapPak,
D-17
Chloride electrode, A-42
Classification (according IEC/ISO), A-29
Cleaning analyzer surfaces, D-9
Cleaning the reference electrode housing, D-10
Clearing all data, E-16
Clearing sample count, E-16
Contact addresses, 4
Copyrights, 3
Correlation factors, C-39
D
Daily maintenance, D-6
Deleting data, E-16
Description of reports, F-5
Roche
General description
Introduction, A-9
General QC concept, C-45
H
Handling
Electrodes, A-12
Solutions, A-12
Handling electrodes, A-12
Handling solutions, A-12
How to Use This Manual, -7
I
Important information, A-5
Installation, C-5
Location, C-5
Interferences, A-23, C-29
Substances with effect, C-31
Substances without effect, C-29
Introduction, A-9
ISE calibration, A-46
July 2013
G-3
Index
K
Keypad, B-6
L
Limitations of clinical analysis, C-33
Electrolytes, C-33
General, C-33
Linearity
Aqueous standard solutions, A-21
Correlation to chloridometry, A-22
Correlation to direct ISE - flame-correlated, A-22
Correlation to direct ISE - not flame-correlated, A-22
Serum, A-21
Linearity in aqueous standard solutions, A-21
Linearity in serum, A-21
List of service codes, Service codes
List, E-15
Lithium electrode, A-44
Local Service Contact, 4
Location, C-5
M
Maintenance, D-5
Maintenance schedule, F-9
Material setup, C-46
Measurement
Interferences, C-29
Substances with effect, C-31
Substances without effect, C-29
Measurement evaluation, A-11
Measurement parameters, A-17
Measurement principle, A-36
Measurement procedure, A-10
Measurement report, F-5
Measuring chamber, B-7
Measuring procedure, C-34
Monthly maintenance
Cleaning the reference electrode housing, D-10
N
Normal ranges, C-38
IVD symbols, 8
version, -3
Order information, F-10
Accessories, F-12
Electrodes, F-10
QC material, F-11
Solutions, F-11
P
Performance parameters, A-17
Reproducibility, A-17
Performing a QC measurement, C-48
Peristaltic pump, B-7
Physical principle, A-37
Plasma, C-27
Potassium electrode, A-41
Preanalytics, C-25
Preparing the Analyzer for Operation, C-11
Principle
Measurement, A-36
Physical, A-37
Measurement principle, A-36
Physical principle, A-37
Printer, A-29, B-7
Printer settings, C-41
Printing a QC report, C-49
Procedure
Measurement, C-34
Procedures
Calibration, A-10
Measurement, A-10
Product data, A-29
Classification (according IEC/ISO), A-29
Dimensions, A-29
Electrical data, A-29
Program flow chart, F-8
Q
QC material, A-28
ISETROL Electrolyte Control, A-28
QC report, F-5
Quality contro
Performing a QC measurement, C-48
Quality control
General QC concept, C-45
Material setup, C-46
Printing a QC report, C-49
Operating safety information, A-6

Operators Manual
conventions used, -7
how to use, -7
Roche
G-4
July 2013
R
Rear panel, B-9
Reference and critical values, A-33
Chloride, A-34
Ionized calcium, A-35
Lithium, A-35
Potassium, A-34
Sodium, A-33
Relationship of ionized calcium to total calcium, A-24
Removing service codes, E-14
Replacing electrodes, D-15
Replacing sample probe and fill port, D-18
Reproducibility, A-17
Roche MICROSAMPLER PROTECT, C-26
S
Safety information
Important information, A-5
Operating safety information, A-6
Sample collection, C-25
Sample collection and handling, A-11
Sample collection containers
Capillary tube, C-26
Roche MICROSAMPLER, C-26
Syringes, C-26
Sample handling
Aqueous solutions, C-28
Dialysate, C-28
Plasma, C-27
Serum, C-27
Whole blood, C-27
Sample measurement, C-34
Dialysate samples, C-37
Direct ISE, C-36
Urine samples, C-37
Sample probe mechanism, B-8
Sample throughput, A-25
Sample types, A-25
Sample volumes, A-25
Exchanging the pump tubing set, D-13
Serial port, B-10
Serum, C-27
Service codes, E-14
Enter, E-14
Remove, E-14
Service functions, E-9
Testing
Amplifier, E-13
Electrodes, E-9
Interface, E-12
Language switch, E-11
Roche
Index
Pump, E-12
Sample door, E-11
Sample sensor, E-10
SnapPak sensor, E-11
Status-LEDs, E-13
Valves, E-12
SnapPak, A-27, B-9
Sodium electrode, A-40
Software
version, -3
Solutions, A-27
SnapPak, A-27
Urine diluent, A-28
Specification
Calcium electrode, A-43
Chloride electrode, A-42
Lithium electrode, A-44
Potassium electrode, A-41
Sodium electrode, A-40
Specifications of the solutions, F-7
Standby mode, A-13
Status-LEDs, E-13
Symbols, -7
Syringes, C-26
System description, B-5
T
Temperature / humidity / stability, A-26
Electrodes, A-26
Instrument, A-26
Testing the amplifier, E-13
Testing the electrodes, E-9
Testing the interface, E-12
Testing the language switch, E-11
Testing the pump, E-12
Testing the sample door, E-11
Testing the sample sensor, E-10
Testing the SnapPak sensor, E-11
Testing the valves, E-12
Theoretical foundation
Reference and critical values, A-33
Trademarks, 3
Troubleshooting, E-5
Error messages, E-5
Service functions, E-9
U
Unscheduled maintenance, D-15
Checking reagent fluid level and changing the SnapPak,
D-17
Replacing electrodes, D-15
July 2013
G-5
Index
Replacing printer paper, D-20

Replacing sample probe and fill port, D-18
Urine diluent, A-28
V
Valves, B-8
W
Weekly maintenance, D-8
Cleaning analyzer surfaces, D-9
Roche
G-6
July 2013

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9180 Electrolyte Analyzer

Instructions for Use

9180 Electrolyte Analyzer

7.0 (not published)

9180 Electrolyte Analyzer

Roche Diagnostics GmbH

Local Service Contact

9180 Electrolyte Analyzer

Introduction and specifications

6 Installation and Shutdown

Reference and critical values

9180 Electrolyte Analyzer

9180 Electrolyte Analyzer

How to use this manual

This Instructions for Use should be easily accessible at all times.

Conventions used in this manual

The following symbols are used:

Call-up (software reference)

Sections marked with this symbol contain information that must be

9180 Electrolyte Analyzer

Caution, consult accompanying documents.

Consult Instructions for Use.

Serial number (model plate)

Do not use if package damaged.

Method of sterilization using ethylene oxide

9180 Electrolyte Analyzer

Method of sterilization using irradiation

The following symbols are listed as additional information:

Danger symbol: Xi: Irritant.

Xi: R36/37/38, S26-37

Rating: Although not corrosive, momentary, longer-lasting, or

Rating: Inhalation, swallowing or skin contact with even small

Rating: If released into aquatic and non aquatic environments,

9180 Electrolyte Analyzer

"Grner Punkt" (in Germany)

Protective gloves, protective goggles and suitable protective

Introduction and specifications

Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

Theoretical foundation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-31

9180 Electrolyte Analyzer

Important information .................................................................................................... A-5

9180 Electrolyte Analyzer

9180 Electrolyte Analyzer

9180 Electrolyte Analyzer

Operating safety information

Operating safety information

IEC/EN 61010-2-081 + A1(c)

This instrument is classified under the protection class I according to

The instrument meets the conditions for overvoltage category II.

The instrument meets the conditions for contamination level 2.

Do not operate the instrument in an explosive environment or in the vicinity of

Recurring inspections are to be carried out based on local regulations.

The instrument is suitable for long-term operation indoors.

The power cable must conform to country-specific requirements.

9180 Electrolyte Analyzer

This chapter contains a general description of the instrument, as well as

Introduction ...................................................................................................................... A-9

9180 Electrolyte Analyzer

9180 Electrolyte Analyzer

9180 Electrolyte Analyzer

Measurement and calibration procedures

Measurement and calibration procedures