STARLYTE V

Electrolyte Analyzer
Instructions for use

STARLYTE V P/N 103507

 Manufactured for
Alfa Wassermann
Diagnostic Technologies, LLC
4 Henderson Drive,
West Caldwell, NJ 07006

Copyright © 2007 Alfa Wassermann, Diagnostic Technologies, LLC, all rights reserved
Copyright, 2007, Alfa Wassermann, Diagnostic Technologies, LLC. All rights reserved. Unless otherwise noted, no part of this
publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language in any
form without the written permission of Alfa Wassermann, Diagnostic Technologies, LLC.
ISETROL is a trademarks of Roche Diagnostics GmbH.
STARLYTE is a trademark of Alfa Wassermann.
Rev. 1.0, Oct 2007
– Important Information! – Follow Instructions Carefully! –

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.
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 Alfa Wassermann 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. Because accurate
measurement results depend not only on the proper functioning of the instrument, but also on a number of
other factors (such as preanalytics), the results produced by the instrument should be examined by a trained
expert before subsequent decisions are reached that are based on the measurement values.

Explanation:

"Caution, refer to accompanying documents".

– Important Information! – Follow Instructions Carefully! –

 – Operating Safety Information –

The instrument has been constructed and tested according to the following European Stan-
dards:
• IEC/EN 61010-1:2001
• IEC/EN 61010-2-101:2002
• IEC/EN 61010-2-081:2002 + A1:2003
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 1010-1 /
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.

• If an object or liquid enters 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.

CAUTION:

• The power cord may be plugged into a grounded socket only. When using an extension
cord, make sure it is properly grounded.

• Any rupture of the ground lead inside or outside the instrument or a loose ground connec-
tion may result in hazardous operating conditions. Intentional disconnection of the
grounding is not permitted.

– Operating Safety Information –

 Contents - Instructions for Use

Contents - Instructions for Use

1 Introduction
1.1 General notes ................................................................................................................... 1-2
1.2 Measurement and calibration procedures ................................................................ 1-5
1.3 Measurement evaluation .............................................................................................. 1-5
1.4 Important safety instructions ....................................................................................... 1-6
1.5 System description ......................................................................................................... 1-7
1.6 Installation ...................................................................................................................... 1-12
1.7 Shutdown ........................................................................................................................ 1-25
1.8 Standby mode ................................................................................................................ 1-29

2 Specifications
2.1 Performance parameters .............................................................................................. 2-1
2.2 Linearity ............................................................................................................................ 2-5
2.3 Interferences .................................................................................................................... 2-6
2.4 Limitations ........................................................................................................................ 2-7
2.5 Relationship of ionized calcium to total calcium ..................................................... 2-7
2.6 Bibliography ..................................................................................................................... 2-8
2.7 Sample throughput ......................................................................................................... 2-9
2.8 Sample volumes .............................................................................................................. 2-9
2.9 Sample types .................................................................................................................... 2-9
2.10 Calibrations ...................................................................................................................... 2-9
2.11 Environmental parameters .......................................................................................... 2-10
2.12 Product data ................................................................................................................... 2-13
2.13 Printer .............................................................................................................................. 2-14
2.14 Display ............................................................................................................................. 2-14

3 Measurement
3.1 Preanalytics ...................................................................................................................... 3-1
3.2 Limitations of clinical analysis ..................................................................................... 3-3
3.3 Measuring procedure .................................................................................................... 3-3
3.4 Normal ranges ................................................................................................................. 3-7
3.5 Correlation factors .......................................................................................................... 3-8
3.6 Additional settings .......................................................................................................... 3-9

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1

Contents - Instructions for Use

4 Quality control
4.1 General QC concept ........................................................................................................4-1
4.2 Material setup ..................................................................................................................4-2
4.3 Performing a QC measurement ....................................................................................4-3
4.4 Printing a QC report ........................................................................................................4-5

5 Maintenance
5.1 Decontamination .............................................................................................................5-1
5.2 Daily maintenance ...........................................................................................................5-3
5.3 Weekly maintenance .......................................................................................................5-5
5.4 Monthly maintenance .....................................................................................................5-6
5.5 Semi annual maintenance .............................................................................................5-9
5.6 Annual maintenance .................................................................................................... 5-10
5.7 Unscheduled maintenance ......................................................................................... 5-12

6 Troubleshooting
6.1 Error messages .................................................................................................................6-1
6.2 Service functions .............................................................................................................6-7
6.3 Service codes ................................................................................................................ 6-11
6.4 Deleting data ................................................................................................................. 6-13

7 Theoretical foundations
7.1 Clinical significance ........................................................................................................7-1
7.2 Principles of Operation ...................................................................................................7-7
7.3 Electrode specifications .............................................................................................. 7-10

8 Appendix
8.1 Description of reports .....................................................................................................8-1
8.2 Specifications of the solutions .....................................................................................8-3
8.3 Maintenance schedule ...................................................................................................8-4

9 Index

2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

1 Introduction
1.1 General notes ................................................................................................................... 1-2
1.1.1 Symbols.............................................................................................................................................................1-2
Used in the Instructions for Use ...............................................................................................................................1-4

1.2 Measurement and calibration procedures ................................................................ 1-5

1.2.1 Measurement procedure............................................................................................................................1-5

1.2.2 Calibration procedure..................................................................................................................................1-5

1.3 Measurement evaluation .............................................................................................. 1-5

1.4 Important safety instructions ....................................................................................... 1-6

1.4.1 Sample collection and handling ..............................................................................................................1-6
1.4.2 Disposal of Fluid pack, electrodes, and instrument .........................................................................1-6
Disposal of the reference electrode ........................................................................................................................1-6

1.4.3 Handling electrodes .....................................................................................................................................1-6

1.5 System description ......................................................................................................... 1-7

1.5.1 Analyzer components ..................................................................................................................................1-7
Display ................................................................................................................................................................................1-8
Keypad ...............................................................................................................................................................................1-8
Printer .................................................................................................................................................................................1-8
Measuring chamber ......................................................................................................................................................1-9
Peristaltic pump ..............................................................................................................................................................1-9
Sample probe mechanism ..........................................................................................................................................1-9
Valves .............................................................................................................................................................................. 1-10
Fluid pack ....................................................................................................................................................................... 1-10
Rear panel ...................................................................................................................................................................... 1-11
Serial port ....................................................................................................................................................................... 1-11

1.6 Installation ...................................................................................................................... 1-12

1.6.1 Location ......................................................................................................................................................... 1-12
Accessories ................................................................................................................................................................... 1-13

1.6.2 Setting up ...................................................................................................................................................... 1-13

1.6.3 Electrodes and measurement chamber............................................................................................. 1-14

1.6.4 Preparing the Analyzer for Operation................................................................................................. 1-18

1. Selecting language ................................................................................................................................................ 1-18
2. Start-up ...................................................................................................................................................................... 1-18
3. Setting date and time ........................................................................................................................................... 1-19
4. Installing the Fluid pack ....................................................................................................................................... 1-19
5. Installing the printer paper ................................................................................................................................. 1-20
6. Daily Maintenance (manual) ............................................................................................................................. 1-21

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-I

 7. Selecting parameter configuration .................................................................................................................. 1-23

1.7 Shutdown ........................................................................................................................ 1-25

1. Installing shutdown plug ..................................................................................................................................... 1-25
2. Installing the transport housing ........................................................................................................................ 1-26
3. Washing the lines ................................................................................................................................................... 1-26
4. Removing the electrodes and the shutdown plug ..................................................................................... 1-27
5. Installing the relief clamps and removing the pump windings ............................................................. 1-27
6. Turning the analyzer "off" ................................................................................................................................... 1-28

1.8 Standby mode ................................................................................................................ 1-29

1-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

1 Introduction
The STARLYTE V analyzer is a powerful tool designed to quickly, accurately and efficiently
conduct basic electrolyte testing in the convenience of the laboratory.

This manual will help guide through setting up the analyzer and analyzing samples. As the
user become 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.

Fig. 1-1

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-1

1 Introduction

1.1 General notes

1.1.1 Symbols

This product fulfills the requirements of the directive 98/79/EC on in vitro

diagnostic medical devices.

Lot number

Electrodes: This date indicates the limit of the maximum storage time of an
electrode. The electrode must be installed in the instrument no later than
the imprinted date.
If the installation takes place on the imprinted date, it still falls within the
specifications. The calculation of the “Install before” date is based on the
production date of the elctrode.

Consumables: use by... (expiry date)

The consumables must be completely consumed by the indicated date.
If a day is not indicated, apply the last day of the respective month.

Storage note
The conditions necessary to preserve the product's shelf life before opening.

For in vitro diagnostic use

„Grüner Punkt“ (Germany)

Manufacturer—according to In Vitro Diagnostic guidelines 98/79/EC

1-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

Danger symbol: T: Toxic (on the packaging of the reference electrode)

Rating: Inhalation, swallowing or skin contact with even small quantities
can lead to serious health risks, including fatal risks. Characteristics of this
T:R23/33/50-53 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, con-
tact a doctor immediately. Any substances with carcinogenic, genetic or
reproductive dangers are indicated appropriately. Always observe the reg-
ulations when handling such substances.

Danger symbol: N: Dangerous to the environment (on the packaging of the

reference electrode)
Rating: If released into aquatic and non aquatic environments, can cause
N:S45/60/61/7 immediate or delayed damage to ecosystems through a change in environ-
mental conditions.
These substances or their by-products can cause substantial damage to sen-
sitive environmental areas.
Caution: Depending on the potential for damage, do not allow the sub-
stance to enter sewers, soils or the environment. Observe the specific dis-
posal regulations.

Danger symbol: Xi: Irritant

Rating: Although not corrosive, momentary, longer-lasting, or repeated
contact with skin or mucous membrane may result in inflammation. Dan-
XI: R36/37/38, S 26-37 ger of sensitization during contact with skin (when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale vapors.

Store upright

Risk of infection! (according to the standard DIN EN 61010-2-101:2002)

(Instrument)

Risk of infection! (according to the standard DIN ISO 15223-1:2005)

(Consumables)

Reference and/or ordering number

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-3

1 Introduction

IMPORTANT: read and follow Instructions for Use!

Please read and follow the information on the packaging insert /

instructions for use.

Serial number (model plate)

Do not use content if the packaging is damaged

Protective gloves, protective goggles and suitable protective clothing must

be worn

Used in the Instructions for Use

Sections marked with this symbol (see Instructions for Use) contain information
that must be observed to avoid potential injuries (to patients, users and third par-
ties).

Risk of infection!

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
STARLYTE V analyzer, and therefore should never be attempted.

TIP: All sections / text locations marked with "TIP" describe safe procedures that are intend-
ed to provide the user with additional help.

1-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

1.2 Measurement and calibration procedures

1.2.1 Measurement procedure

The STARLYTE V methodology is based on the ion selective electrode (ISE) measurement
to determine the measurement values (see chapter 7, section "The measurement principle").
There are six different electrodes used in the STARLYTE V 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 con-
tained in the sample being analyzed. The membrane is an ion exchanger, reacting to the elec-
trical 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 poten-
tial is conducted by a highly conductive, inner electrode to an amplifier. The reference elec-
trode is connected to ground as well as to the amplifier.
The ion concentration in the sample is then determined by using a calibration curve deter-
mined by measured points of standard solutions with precisely known ion concentrations.

1.2.2 Calibration procedure

A 2-point or a 3-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.

1.3 Measurement evaluation

The validity of the test results from the STARLYTE V analyzer must be carefully examined
by a clinical-medical specialist who will take the patient's clinical condition into consider-
ation 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 (low, normal, high) after each electrode exchange, after each replacement of the
fluid pack, 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 (low, normal, 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.
For further information, see chapter 4: "Quality control".

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-5

1 Introduction

1.4 Important safety instructions

For your own safety and the proper operation of your equipment, always follow these pre-
cautions when working with the STARLYTE V analyzer:
• Keep the analyzer away from all sources of liquids such as sinks and wash basins.

Don’t use ammonia-based or alcohol-based cleaners, which can chemically react

with plastic, on or around the analyzer.

• 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 contamina-
tion.
• Dispose of Fluid pack according to local regulations.

1.4.1 Sample collection and handling

Universal precautions must be observed when collecting blood specimens. It is recommend-
ed that all blood specimens be handled as potentially infectious specimens capable of trans-
mitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or other blood-
borne pathogens. Proper blood collection technique must be followed in order to minimize
risk to the laboratory staff.
Suitable protective equipment, like laboratory clothing, protective gloves, protective gog-
gles and if necessary mouth protectors, must be worn to prevent direct contact with biolog-
ical working materials. In addition, a face mask is required if there is a risk of splashes. Suit-
able disinfection and sterilization procedures must be applied.
Please refer to NCCLS document M29-A2, "Protection of Laboratory Workers from Occupa-
tionally Acquired Infections", Approved Guidelines - Second Edition 2001, for further infor-
mation on safe handling of these specimens. For further information, see chapter 3: "Mea-
surement".

1.4.2 Disposal of Fluid pack, electrodes, and instrument

Dispose of used Fluid pack, electrodes and the instrument according to applicable
laboratory regulations (biologically contaminated–hazardous waste!)

Disposal of the reference electrode

This electrode contains mercury. Therefore dispose of it in accordance

with applicable regulations (hazardous waste!).
T:R23/33/50-53 N:S45/60/61/7

1.4.3 Handling electrodes

• Store electrodes according to packaging instructions.
• The shelf life of the electrodes is limited.
• Please see electrode label and packaging for correct storage temperature and maximum
shelf life.

1-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

1.5 System description

1.5.1 Analyzer components

Display Keypad

Front cover

Sample door

Fluid pack

Fig. 1-2

Thermal printer Measuring chamber

Peristaltic pump Sample door

Valves

Fig. 1-3

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-7

1 Introduction

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

Fig. 1-4

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, pro-
gramming and quality control testing can be performed.

Fig. 1-5

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 Fluid pack 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.

Fig. 1-6

1-8 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

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.

Fig. 1-7

Peristaltic pump

A peristaltic pump transports all sample and operating fluids inside the instrument.

Fig. 1-8

Sample probe mechanism

The sample probe mechanism is located behind the sample door at the front of the unit.

Fig. 1-9

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1 Introduction

Valves

Valves control the movement of the liquid within the analyzer.

Fig. 1-10

Fluid pack

The self-contained Fluid pack is constructed to ensure that waste cannot spill out of the
package.

Fig. 1-11

1-10 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

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.

Fig. 1-12

Serial port

The analyzer is equipped with a serial RS232 interface and allows data to be exchanged with
commercially available computer systems. Measurement data is transferred after each mea-
surement and calibration data is transferred after each calibration. The interface is always
active, and data is sent independently of the printer setup.

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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-11

1 Introduction

1.6 Installation

1.6.1 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:
• Ambient temperature + 15°C to + 32°C
• 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, see Fig. 1-13.
• Avoid exposure to explosive gases or vapors.
• Check for correct voltage: 100 to 240 VAC, 50/60 Hz.

340 mm

350 mm
330 mm

Fig. 1-13

After setting up the STARLYTE V analyzer in a location that meets the above requirements,
perform the following steps to ensure the instrument is ready for operation:
• Refer to the packing slip to check for the completeness of the shipment.
• If the shipment is incomplete, please inform Alfa Wassermann 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 evi-
dence in the event of a damage claim.
Do not remove the analyzer from the shipping carton by pulling upward on the poly-
styrene (styrofoam) packing materials. These packaging materials do not provide
strength to support the analyzer.

1-12 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

Accessories

The following parts are delivered as standard equipment with the STARLYTE V analyzer:
• Printer paper
• Quad Ring, 1.78x1.02 mm
• Fuse set
• Sample probe stylet
• Syringe, 12 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.

1.6.2 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").

Fig. 1-14 Fig. 1-15

• Slip the two pump windings around the analyzer pump rollers, making sure not to over-
stretch the tubing.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-13

1 Introduction

1.6.3 Electrodes and measurement chamber

The next procedure involves preparing and installing the electrodes in the measurement
chamber.
• 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 o-ring on the
left side.

Fig. 1-16

• 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.

Fig. 1-17

• Carefully screw the reference electrode into the reference electrode housing and place it
with the other electrodes.

reference electrode
housing reference electrode

red transport housing

Fig. 1-18

1-14 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

• Slide the measurement chamber forward until it locks in the front position.
• Unclamp the left electrode holder by moving the clamp forward.

Fig. 1-19 Fig. 1-20

• 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

Fig. 1-21

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, lith-
ium 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-15

1 Introduction

• Check to make sure that the lettering on the electrode corresponds with the proper elec-
trode 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.

Fig. 1-22

• 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.

Fig. 1-23

• Slide the measurement chamber back until it snaps into position.

Fig. 1-24

1-16 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

• Plug the tubing connector of the reference housing assembly in the receptacle below the
left side of the measurement chamber.

Fig. 1-25

Possible parameter configurations are the following:

Electrode pos. Parameter configuration

Na + Na + Na + Na + Na + Na +
K+ K+ K+ Dummy K+ Dummy
Cl - / Ca ++ / Li + Dummy Cl - Cl - Ca 2+ Ca 2+

Electrode pos. Parameter configuration

Na + Na + Na + (Na + ) Na +
K+ K+ Dummy Dummy Ca 2+
Cl - / Ca ++ / Li + Li + Li + Li + Li +
Fig. 1-26 Parameter configurations

For details, see section "7. Selecting parameter configuration".

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-17

1 Introduction

1.6.4 Preparing the Analyzer for Operation

1. Selecting language

Before the analyzer is powered on, the language setting must be selected. The factory-set
language is English.
• 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

• 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).

Fig. 1-27

• Push the power switch to the ON (I) position. The unit will automatically begin to
operate.

Fig. 1-28

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 1 Introduction

Now that the STARLYTE V analyzer is functioning, begin using the keypad interface to com-
municate 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
Time: 00:00

To enter the correct date and time:

• 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 Fl.Pack] .

4. Installing the Fluid pack

• Record the installation date of the Fluid pack on the label on the Fluid pack.
• Remove the protective strip and slide the Fluid pack into position on the left side of the
analyzer. Save the protective strip for the case of a shutdown or disposal.

Fig. 1-29 Fig. 1-30

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-19

1 Introduction

Once the protective strip is removed, be sure to keep the Fluid pack upright to avoid
spillage. Save the protective strip to use to close the nipples on the Fluid pack prior
to disposing.

• At the prompt [New Fl.Pack 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.

• Place a the paper roll in the paper tray and thread it into the feeder slot.

Fig. 1-31

• Press the paper feed button to completely feed the paper through the printer.

Fig. 1-32

TIP: By pressing the paper advance button once, the paper will automatically advance 10
lines.

Do not pull the paper out of the printer to avoid damage to the printer.

Now perform the initial Daily Maintenance.

1-20 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

6. Daily Maintenance (manual)

Prior to performing the first calibration or running the first sample, the STARLYTE V ana-
lyzer 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 pre-
pares the STARLYTE V analyzer for calibration. The bottles containing Cleaning Solution
and Electrolyte Conditioning Solution should be ready, along with a package of lint-free tis-
sues 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 cur-
rent operation.

To start the daily maintenance:

• 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.

Fig. 1-33

• 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-21

1 Introduction

Fig. 1-34

• 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 .
• At the prompt [Open Sample Door Introduce Sample] , lift the sample door and
the pump will begin to aspirate.

Fig. 1-35

• 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.

1-22 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

Fig. 1-36

• 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 cal-
ibration will be started.

It is very important that the main door is closed during calibration, since it provides
shielding from sources of electromagnetic interference.

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.

After finishing the calibration, the analyzer returns to [READY] and is now ready for QC.

7. Selecting parameter configuration

After completion of the daily maintenance procedure, the analyzer starts an automatic cal-
ibration for sodium and potassium.
To select a different parameter configuration, interrupt the calibration by pressing NO .
• Continue pressing NO, until [OPERATOR FUNCTIONS?] is displayed. Press YES .
• Press NO until the prompt [Select Parameter Configuration?] is displayed, see
Fig. 1-26. Press YES and the current configuration will be displayed. The default config-
uration is the following:

Sel. Parameter:
[Na][K][ ] ok?

• Press NO until the desired configuration is displayed. Press YES to accept this selection.

TIP: If [(Na)][ ][Li] is selected, only lithium is reported. Install the sodium electrode
and calibrate for lithium.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-23

1 Introduction

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each replace-
ment of the Fluid pack, 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 alter-
nating levels (low, normal, 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 ana-
lyzer results. For further information, see chapter 4: "Quality control".

The STARLYTE V analyzer is now ready to operate.

1-24 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

1.7 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 perform-
ing a complete shutdown of the analyzer.
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:
• 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 water, the other one empty.
• Protective strip for Fluid pack (supplied with shutdown kit).

Starting at the [READY] display, do the following:

• 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?] .

• Remove the Fluid pack and push the protective strip firmly onto the Fluid pack connec-
tor.
• Fill one container of the shutdown kit about halfway with distilled water.
• Insert the shutdown plug carefully into the Fluid pack 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 .

Fig. 1-37

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1 Introduction

2. Installing the transport housing

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 hous-
ing.
• 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 back-
wards, making sure all electrodes are seated properly. The electrode holder remains in
the forward position.

Fig. 1-38 Fig. 1-39

• Press YES .

3. Washing the lines

The analyzer will take approximately one minute to flush all lines with water. Upon com-
pletion, you will receive the prompt [Remove Water and Press YES] .
• Remove the line with the blue mark from the distilled water and place it on a cloth.
• Press YES . During this cycle, all lines are purged of distilled water.
• Upon completion, [All Electrodes & Plug Removed?] will be displayed.

Fig. 1-40

1-26 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

4. Removing the electrodes and the shutdown plug

• Remove the shutdown plug from the Fluid pack 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 .

Fig. 1-41

5. Installing the relief clamps and removing the pump windings

The display will prompt [All 5 Relief Clamps Inserted?] .

• Install the red relief clamps making sure that they are snapped securely into position.

Fig. 1-42

• Press YES .

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1 Introduction

Never insert the solenoid relief clamps with the Fluid pack in place.

• 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.

Fig. 1-43

• 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 Fluid pack 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 labora-
tory later on.
• Press NO to retain all data.
See chapter 6.4.2: "Clearing all data".

6. Turning the analyzer "off"

• 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 (see chapter 5: "Maintenance", section "Clean sample probe
and fill port").
• Shutdown is complete.
• Use the original packaging when transporting the analyzer.

1-28 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 1 Introduction

1.8 Standby mode

The STARLYTE V 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 eve-
nings and weekends, you may place the analyzer into Standby mode to suspend automatic
calibration.
TIP: The analyzer can be programmed to automatically enter Standby mode. For instruc-
tions see chapter 6, section "Service codes".

To enter standby mode:

• 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:

• Press YES , [Leave Standby Mode?] will be displayed.
• Press YES again.

Depending on the duration of the standby mode, an automatic calibration can be per-
formed. After that, the analyzer returns to [READY] .

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 1-29

1 Introduction

1-30 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

2 Specifications
2.1 Performance parameters .............................................................................................. 2-1
2.1.1 Measurement parameters..........................................................................................................................2-1

2.1.2 Reproducibility................................................................................................................................................2-1
Material: ISETROL Protein Based Aqueous Control Material (Level 1), n=80 ........................................2-2
Material: ISETROL Protein Based Aqueous Control Material (Level 2), n=80 ........................................2-2
Material: ISETROL Protein Based Aqueous Control Material (Level 3), n=80 ........................................2-2
Material: RNA EQUIL Reduced Bovine Hemoglobin Solution (Level 2), n=80 .......................................2-2
Material: Aqueous Standard Solution (Level 1), n=80 ....................................................................................2-3
Material: Aqueous Standard Solution (Level 2), n=80 ....................................................................................2-3
Material: Pooled Human Serum, n=80 ..................................................................................................................2-3
Material: Acetate Dialysate Solution, n=80 ..........................................................................................................2-3
Material: Bicarbonate Dialysate Solution, n=80 .................................................................................................2-4
Material: Urine, n=80 ....................................................................................................................................................2-4

2.2 Linearity ............................................................................................................................ 2-5

2.2.1 Linearity in aqueous standard solutions...............................................................................................2-5

2.2.2 Linearity in serum..........................................................................................................................................2-5

Correlation to flame .......................................................................................................................................................2-5
Correlation to direct ISE - not flame-correlated .................................................................................................2-6
Correlation direct ISE - flame-correlated ..............................................................................................................2-6
Correlation to chloridometry ......................................................................................................................................2-6

2.3 Interferences .................................................................................................................... 2-6

2.4 Limitations ........................................................................................................................ 2-7

2.5 Relationship of ionized calcium to total calcium ..................................................... 2-7

2.6 Bibliography ..................................................................................................................... 2-8

2.7 Sample throughput ......................................................................................................... 2-9

2.8 Sample volumes .............................................................................................................. 2-9

2.9 Sample types .................................................................................................................... 2-9

2.10 Calibrations ...................................................................................................................... 2-9

2.11 Environmental parameters .......................................................................................... 2-10

2.11.1 Temperature / humidity / stability........................................................................................................ 2-10
Instrument ...................................................................................................................................................................... 2-10
Electrodes ...................................................................................................................................................................... 2-10
Solutions ......................................................................................................................................................................... 2-11
Fluid pack ....................................................................................................................................................................... 2-11
Urine diluent ................................................................................................................................................................. 2-13
QC material .................................................................................................................................................................... 2-13

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-I

 2.12 Product data .................................................................................................................. 2-13
2.12.1 Electrical data............................................................................................................................................... 2-13

2.12.2 Classification ................................................................................................................................................ 2-13

2.12.3 Dimensions ................................................................................................................................................... 2-14

2.13 Printer .............................................................................................................................. 2-14

2.14 Display ............................................................................................................................ 2-14

2-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

2 Specifications
2.1 Performance parameters

2.1.1 Measurement parameters

specified for: specified range:

Na + B/S/A/D/Q 40 − 205 mmol/L

U 1 − 300 mmol/L

K+ B/S/Q 1.5 − 15 mmol/L

A/D 0.8 − 15 mmol/L
U 4.5 − 60 mmol/L
U* 60 − 120 mmol/L

Cl - B/S/A/D/Q 50 − 200 mmol/L

U 1 − 300 mmol/L

Ca 2+ B/S/A/D/Q 0.2 − 5.0 mmol/L

Li + B/S/Q 0.1 − 6.0 mmol/L

B ...... whole blood

S ....... serum or plasma
A ...... dialysis solutions containing acetate
D ...... dialysis solutions containing bicarbonate
Q ...... aqueous QC material
U ...... urine samples (dilution required, see chapter 3.3.4: "Urine samples")
U* .... urine samples (second dilution required, see chapter 3.3.4: "Urine samples")

2.1.2 Reproducibility
Typical Within-Run (S wr ), Between-Day (S dd ) and Total (S T ) Precision is determined from
2 runs per day with 2 replicates per run for 20 days on two STARLYTE V analyzers. Values
for sodium and potassium are 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-1

2 Specifications

Material: I S ETROL Protein Based Aqueous Control Material (Level 1), n=80

Parameter Mean S wr (CV %) S dd (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

Material: I S ETROL Protein Based Aqueous Control Material (Level 2), n=80

Parameter Mean S wr (CV %) S dd (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

Material: I S ETROL Protein Based Aqueous Control Material (Level 3), n=80

Parameter Mean S wr (CV %) S dd (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

Material: R NA EQU I L Reduced Bovine Hemoglobin Solution (Level 2), n=80

Parameter Mean S wr (CV %) S dd (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

2-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

Material: Aqueous Standard Solution (Level 1), n=80

Parameter Mean S wr (CV %) S dd (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

Material: Aqueous Standard Solution (Level 2), n=80

Parameter Mean S wr (CV %) S dd (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

Material: Pooled Human Serum, n=80

Parameter Mean S wr (CV %) S dd (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

Material: Acetate Dialysate Solution, n=80

Parameter Mean S wr (CV %) S dd (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

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-3

2 Specifications

Material: Bicarbonate Dialysate Solution, n=80

Parameter Mean S wr (CV %) S dd (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

Material: Urine, n=80

Parameter Mean S wr (CV %) S dd (CV %) ST (CV %)

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

2-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

2.2 Linearity

2.2.1 Linearity in aqueous standard solutions

Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and
measured on each of six STARLYTE V analyzers, two of each configuration: Na/K/Cl,
Na/K/Ca and Na/K/Li.

Correlation
Parameter Slope Intercept Coefficient Sy·x Range [mmol/L] n
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

2.2.2 Linearity in serum

Linearity in serum was established with the analysis of two specimen sets in non-clinical
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 STARLYTE V 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 com-
parison to various methods:

Direct ISE, not flame correlated 983 Na/K/Cl Analyzer

(listed as 98X) 984 Na/K/Ca Analyzer
985 Na/K/Li Analyzer

Direct ISE, flame correlated 9130 Na/K/Cl Analyzer

(listed as 91XX) 9140 Na/K/Ca Analyzer

Flame Absorbance Emission Spectroscopy IL 943 Flame Photometer

Chloridometry Labconco Digital Chloridometer

Correlation to flame

IL 943 Flame Photometer

Correlation
Parameter Slope Intercept Coefficient Sy·x Range [mmol/L] n
Sodium 0.9617 5.83 0.9908 2.04 104 − 178 50
Potassium 1.0249 0.015 0.9991 0.075 1.8 − 11.5 50
Lithium 0.9803 0.0011 0.9822 0.028 0.11 − 0.71 15

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-5

2 Specifications

Correlation to direct I S E - not flame-correlated

98X Electrolyte Analyzers

Correlation
Parameter Slope Intercept Coefficient Sy·x Range [mmol/L] n
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

Correlation direct I S E - flame-correlated

91XX Electrolyte Analyzers

Correlation
Parameter Slope Intercept Coefficient Sy·x Range [mmol/L] n
Sodium 0.9856 -2.02 0.9856 1.21 104 − 179 50
Potassium 0.9992 0.02 0.9994 0.05 1.9 − 11.8 50
Chloride 1.0026 -5.31 0.9989 0.73 70 − 152 50
ionized Calcium 1.0023 0.040 0.9954 0.022 0.62 − 1.54 50

Correlation to chloridometry

Labconco Digital Chloridometer

Correlation
Parameter Slope Intercept Coefficient Sy·x Range [mmol/L] n
Chloride 1.0222 2.75 0.9923 2.03 66 − 145 50

2.3 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 concentra-
tion, 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 mea-
surement values! If sample containers are used which contain lithium as an antico-
agulant, this may lead to incorrect patient measurements, which may result in
incorrect clinical decisions, possibly endangering the patient's health.

2-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

2.4 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 with-
out 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 sam-
ple.
The STARLYTE V analyzer reports lithium in the range of 95 - 180 mmol/L
(89.6 - 169.5 mmol/L for blood/serum) Na + .

2.5 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 % 1 . These relationships may be altered when using citrate in blood, or when the acid-
base metabolism is disturbed.

1. Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1990) p.98-99, 118-119,
456-459, 510-511, 720-721.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-7

2 Specifications

2.6 Bibliography

Bishop ML, Duben-Engelkirk JL, Fody EP. Clinical Chemistry Principles Procedures Corre-
lations, 2nd Ed., (Philadelphia: J.B.Lippincott Co.),1992,p.281.
Burritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calci-
um values 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
National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers
from Occupationally Acquired Infections, Second Edition; Approved Guidelines; NCCLS
Document M29-A2, (2001).
National Committee for Clinical Laboratory Standards. Additives for Blood Collection
Devices: Heparin; Tentative Standard; NCCLS Document H24-T, (1988).
National Committee for Clinical Laboratory Standards. Evaluation of Precision Perfor-
mance of Clinical Chemistry Devices, Second Edition; Tentative Guideline. NCCLS Docu-
ment EP5-T2, (1992).
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. Saun-
ders, 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.

2-8 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

2.7 Sample throughput

45 per hour with printout
60 per hour without printout

2.8 Sample volumes

95 μL typical

2.9 Sample types

Whole blood, serum, plasma, dialysis solutions containing acetate and bicarbonate, urine,
QC material

2.10 Calibrations
1-point calibration after each sample
2-point or 3-point calibration every 4 hours

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-9

2 Specifications

2.11 Environmental parameters

2.11.1 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 conditions in original package:

Temperature ..................................................................... 15 to 30 °C (dry)
Humidity ........................................................................... 15 - 85 % (not condensing)

Transportation conditions in original packaging:

Temperature ..................................................................... -5 to 40 °C
Humidity ............................................................. 15 - 85 % (not condensing)

2-10 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

Solutions

Fluid pack

Contains the following reagents:

Standard A
For calibration of sodium, potassium, ionized calcium and lithium in the STARLYTE V ana-
lyzer.

Contents: 350 mL
Active ingredients: Na + 150 mmol/L
K+ 5.0 mmol/L
Cl - 115 mmol/L
Ca 2+ 0.9 mmol/L
Li + 0.3 mmol/L
Additives: Germicides
Storage temperature: 15 - 30 °C
Stability: Expiration date and lot number are printed on each container label
On-board stability: 14 weeks

Standard B
For calibration of sodium, potassium, ionized calcium and lithium in the STARLYTE V ana-
lyzer.

Contents: 85 mL
Active ingredients: Na + 100 mmol/L
K+ 1.8 mmol/L
Cl - 72 mmol/L
Ca 2+ 1.5 mmol/L
Li + 0.3 mmol/L
Additives: Germicides
Storage temperature: 15 - 30 °C
Stability: Expiration date and lot number are printed on each container label
On-board stability: 14 weeks

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-11

2 Specifications

Standard C
For calibration of sodium, potassium, ionized calcium and lithium in the STARLYTE V ana-
lyzer.

Contents: 85 mL
Active ingredients: Na + 150 mmol/L
K+ 5.0 mmol/L
Cl - 115 mmol/L
Ca 2+ 0.9 mmol/L
Li + 1.4 mmol/L
Additives: Germicides
Storage temperature: 15 - 30 °C
Stability: Expiration date and lot number are printed on each container label
On-board stability: 14 weeks

Reference Solution
A salt bridge for calibration and measurement in the STARLYTE V analyzer.

Contents: 85 mL
Active ingredients: Potassium chloride 1.2 mmol/L
Additives: Germicides
Storage temperature: 15 - 30 °C
Stability: Expiration date and lot number are printed on each container label
On-board stability: 14 weeks

On-board stability refers to the Fluid pack installed in the analyzer.

The Fluid pack has to be exchanged at the latest after 14 weeks.

Dispose of the Fluid pack according to local regulations (hazardous waste!).

A waste container is provided with the Fluid pack which, when used, holds human
body fluids which may be potentially infectious; handle with appropriate care to
avoid skin contact or ingestion.

2-12 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 2 Specifications

Urine diluent

For use as a diluent for the measurement of urine samples in the STARLYTE V analyzer.

Contents: Each dispensing bottle contains 500 mL of solution

Active ingredients: Sodium chloride 120 mmol/L
Additives: Germicides
Storage temperature: 5 - 30 °C
Stability: Expiration date and lot number are printed on each container label

QC material

ISETROL Electrolyte Control

Storage conditions in original packaging

Temperature ............................ 15 to 30 °C

Transportation conditions in original packaging

Temperature ............................ 2 to 30 °C
2 to 45 °C < 5 days

2.12 Product data

2.12.1 Electrical data

Mains voltage range ..................... 100 to 240 VAC
Frequency ................................... 50/60 Hz
Required power ........................... 50 W
Main fuse .................................... 1.6 A (slow blow) (2 pcs.)

2.12.2 Classification
Safety Category ........................... I
Overvoltage category ................... II
Contamination level .................... 2

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 2-13

2 Specifications

2.12.3 Dimensions
Height ......................................... 33.5 cm
Width .......................................... 31.5 cm
Depth .......................................... 29.5 cm
Weight ........................................ < 6 kg

2.13 Printer
Type thermal printer
Resolution 16 characters / line
Printing speed 4 mm / sec.
Paper width 38 mm
Paper length about 30 m

2.14 Display
Type monochrome LCD
Resolution 2 lines, 16 characters per line

2-14 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

3 Measurement
3.1 Preanalytics ...................................................................................................................... 3-1
3.1.1 Sample collection ..........................................................................................................................................3-1
Safety ..................................................................................................................................................................................3-1
Sample requirements ....................................................................................................................................................3-1
Acceptable anticoagulants .........................................................................................................................................3-1
Sample collection containers ....................................................................................................................................3-2

3.1.2 Sample handling............................................................................................................................................3-2

Whole blood .....................................................................................................................................................................3-2
Serum .................................................................................................................................................................................3-2
Plasma ................................................................................................................................................................................3-2
Aqueous solutions .........................................................................................................................................................3-3
Dialysate ............................................................................................................................................................................3-3

3.2 Limitations of clinical analysis ..................................................................................... 3-3

3.2.1 General ..............................................................................................................................................................3-3

3.2.2 Electrolytes.......................................................................................................................................................3-3

3.3 Measuring procedure .................................................................................................... 3-4

3.3.1 Sample measurement..................................................................................................................................3-4
3.3.2 Direct ISE ..........................................................................................................................................................3-6

3.3.3 Dialysate samples..........................................................................................................................................3-6

3.3.4 Urine samples.................................................................................................................................................3-7

3.4 Normal ranges ................................................................................................................. 3-8

3.5 Correlation factors .......................................................................................................... 3-8

3.6 Additional settings ........................................................................................................ 3-10

3.6.1 Printer settings ............................................................................................................................................ 3-10

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 3-I

3-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007
 3 Measurement

3 Measurement
3.1 Preanalytics

3.1.1 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, hep-
atitis B and C viruses or other pathogens transmissible by blood. Employ suitable
blood sampling techniques in order to reduce risk to personnel.
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.
Please refer to NCCLS document M29-A2, "Protection of Laboratory Workers from Occupa-
tionally Acquired Infections", Approved Guidelines - Second Edition 2001, for further infor-
mation on safe handling of specimens.

Sample requirements

Only qualified personnel may perform the collection of blood needed for analytical purpos-
es.
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 measure-
ment values.
See, for example, NCCLS document H11-A3, "Procedures for the collection of arte-
rial blood specimens – Third Edition", Approved Standard, 1999, for detailed infor-
mation about blood sampling, storage, and handling.

Acceptable anticoagulants

The only clot inhibitors that may be used for analyses in the STARLYTE V analyzer are hep-
arin salts. 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 rea-
son.

Use only lithium-free sampling containers for the determination of lithium mea-
surement values! If sample containers are used which contain lithium as an antico-
agulant, this may lead to incorrect patient measurements, which may result in
incorrect clinical decisions, possibly endangering the patient's health.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 3-1

3 Measurement

Sample collection containers

Use only lithium-free sampling containers for the determination of lithium mea-
surement values! If sample containers are used which contain lithium as an antico-
agulant, this may lead to incorrect patient measurements, which may result in
incorrect clinical decisions, possibly endangering the patient's health.

Do not use sampling containers containing silicone!

3.1.2 Sample handling

For ionized calcium values, anaerobic conditions must be followed for all sample types.
Contact with ambient air will cause a loss of CO 2 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 or capillaries. Analyze the sam-
ples as soon as possible after sampling. Remove air bubbles from the sample collection con-
tainer immediately after the sampling procedure. Samples analyzed within 15 minutes of
collection can be stored at room temperature. If analysis cannot be performed within
15 minutes, store the sample in an ice bath (Do not freeze!) immediately after collection.
Samples must be analyzed within 60 minutes of collection. Please consult the relevant liter-
ature.

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 anal-
ysis.

Plasma

Plasma samples are obtained by centrifuging heparinized whole blood, during which the cel-
lular 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 acceptability of its own blood collection syringes,
capillaries and tubes and the serum or plasma separation products. Variations in these prod-
ucts exist between manufacturers, and at times, from lot to lot.

3-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 3 Measurement

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 corre-
lation factors or the setting of QCC (see chapter 6.3: "Service codes").

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.

3.2 Limitations of clinical analysis

The determined performance data can be influenced by known and unknown factors as
described below.

3.2.1 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 phe-
nomena can be found at different places in the technical literature. With respect to the
STARLYTE V analyzer, an attempt was made to identify or evaluate these possible influenc-
es. But since it is not possible to check all medication or substances, the user should be
immediately informed with abnormal deviations of the measurement results—as with every
clinical analysis—and evaluate the complete picture of the patient or perform expanded
measurements in his own laboratory, if necessary.

3.2.2 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.

3.3 Measuring procedure

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 deci-
sions, possibly endangering the patient's health.
In order to ensure the quality of the measurement results, complete a quality control test on
3 levels (low, normal, high) after each electrode exchange, after each replacement of the

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 3-3

3 Measurement

fluid pack, 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 (low, normal, 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.

3.3.1 Sample measurement

The STARLYTE V 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 shield-
ing from sources of electromagnetic interference.

Urine samples require dilution, and must be analyzed in the urine mode. Instruc-
tions for analyzing urine samples: see chapter 3.3.4: "Urine samples".

• Open the sample door. The prompt [Introduce Sample] will be displayed and the
pump will start to aspirate.

Fig. 3-1

It is very important that the main door be closed during sampling to provide shield-
ing from sources of electromagnetic interference.

3-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 3 Measurement

• Hold the ampoule under the probe until [Wipe Probe Close Sample Door] is dis-
played.
• Use a lint-free tissue to clean the probe, then close the sample door when prompted.

Fig. 3-2

It is very important that the sample probe is carefully cleaned each time following a
sample introduction.

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 - STARLYTE V -
143.9 4.93 103.5 ELECTROLYTE ISE
- NA-K-CL -
HOSPITAL WEST

Name: ..........
..........
Sample: STANDARD

Sample No.28

Na=143.9 mmol/L
K = 4.93 mmol/L
Cl=103.1 mmol/L

Fig. 3-3 Fig. 3-4

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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 3-5

3 Measurement

If an additional sample report is desired or the automatic sample report is turned off, the
results may be printed by following these steps:
• 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 be printed.
• The analyzer returns to [READY] .

3.3.2 Direct ISE

• Press NO until [QC/STD/DIALYSATE URINE SAMPLE?] appears; press YES and then
NO, until [Standard Sample?] is displayed. Press YES to confirm.

The Standard Mode ALWAYS reports direct ISE values and is not affected by corre-
lation factors or the setting of QCC (see chapter 6.3: "Service codes").

3.3.3 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
(see chapter 3: "Correlation factors").
To enter the dialysate mode:
• 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.

3.3.4 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 sam-
ples, diluted with urine diluent, are analyzed in the urine mode. To enter this mode:
• 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.

3-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 3 Measurement

Na K Cl - STARLYTE V - - STARLYTE V -
263 18.3 118 ELECTROLYTE ISE ELECTROLYTE ISE
- NA-K-CL - - NA-K-CL -
HOSPITAL WEST HOSPITAL WEST

Name: .......... Name: ..........

.......... ..........
Sample: URINE Sample: URINE

Sample No.29 Sample No.30

Na=263 mmol/L Na=142 mmol/L

K = 18.3 mmol/L K = ↑↑↑ mmol/L
Cl=118 mmol/L Cl=156 mmol/L
Fig. 3-5 Fig. 3-6 Fig. 3-7

Ca 2+ and Li + are not measured in urine.

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.

3.4 Normal ranges

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.
The correlation factors can be changed through the programming menu. Follow the instruc-
tions for [PROGRAM INSTRUMENT?] in chapter 4.2 and enter the password.
• 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 :
• 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.
• After entering the normal ranges, the new values will be displayed. Verify correctness of
the ranges:
Na low =xxx
Na high=xxx ok?

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 3-7

3 Measurement

TIP: 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 pro-
grammed, the display prompts [Program Corr Factors?] . This allows programming the
correlation factors.

3.5 Correlation factors

The correlation factors allow to correlate the measurement results of the STARLYTE V ana-
lyzer to other electrolyte analyzers. Activated correlation values are taken into consider-
ation 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
'Service Codes'), 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 nor-
mal ranges to your correlation factors.

The correlation factors can be changed through the programming menu. Follow the instruc-
tions for [PROGRAM INSTRUMENT?] in chapter 4.2 and enter the password.

3-8 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 3 Measurement

• 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 opera-
tor to change the correlation factors or to verify correlation factors already pro-
grammed.

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 - , Ca 2+ and Li + .

Only activated parameters can be programmed.

If Na + /K + , Na + /K + /Cl - , or Na + /K + /Ca 2+ are activated, a separate set of bicarbonate and

acetate correlation factors can be programmed:
• 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 measure-
ments.
A separate set of correlation factors is available for urine samples.
• 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 Ca 2+ and Li + , since these
parameters are not measured in urine mode.

3.6 Additional settings

3.6.1 Printer settings

The STARLYTE V analyzer allows easy programming of printer settings by the operator for
printing automatic measurement and calibration reports.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 3-9

3 Measurement

With factory settings, a measurement report is printed automatically after each measure-
ment, a calibration report is not printed automatically. These settings can be changed in the
programming menu.
• Press NO, until [Program Instrument?] is displayed. Press YES .

For safety and security, the analyzer can only be programmed or have existing
parameters changed by entering the correct password.

The analyzer prompts [Enter Code: AAA] . The code " KEY " has to be entered as follows:
• 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 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 advan-
ces to the settings for the calibration report.
- Press NO to automatically print a measurement report after each measurement.
• [Print two Patient Reports?] is displayed.
- 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.
- 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?] .

• 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.
• 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.

3-10 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

4 Quality control
4.1 General QC concept ....................................................................................................... 4-1

4.2 Material setup .................................................................................................................. 4-2

4.3 Performing a QC measurement ................................................................................... 4-3

4.4 Printing a QC report ........................................................................................................ 4-5

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 4-I

4-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007
 4 Quality control

4 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 deci-
sions, possibly endangering the patient's health.

4.1 General QC concept

Alfa Wassermann 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. Alfa Wassermann offers an aqueous
QC material called ISETROL that should be used to ensure that the STARLYTE V analyzer
provides measurements of high quality in order to protect patients.
In order to ensure the quality of the measurement results, complete a quality control test on
three levels (low, normal, high) after each electrode exchange, after each replacement of the
Fluid pack, 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 (low, normal, 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 following control material is recommended:

• 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 4-1

4 Quality control

4.2 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 [PROGRAM INSTRU-
MENT?] 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.

The analyzer prompts [Enter Code: AAA] . The code " KEY " has to be entered as follows:
• 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 . The analyzer is ready for program-
ming 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 STARLYTE V
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 .

• 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.

4-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 4 Quality control

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 cur-
sor 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 .

TIP: 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 deacti-
vated 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 indi-
vidually. The analyzer uses these normal ranges to mark abnormal patient data, both on the
display and on the printed log (see chapter 8.1.2: "QC report").

4.3 Performing a QC measurement

In order to ensure the quality of the measurement results, complete a quality control test on
3 levels (low, normal, high) after each electrode exchange, after each replacement of the
fluid pack, 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 (low, normal, 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.

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
shielding from sources of electromagnetic interference.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 4-3

4 Quality control

• Starting from the [READY] screen, press NO until [QC/STD/DIALYSATE/URINE SAM-

PLE?] appears.
• Press YES , [QC Level 1 Sample?] will be displayed. Press YES .

The prompt [Open Sample Door Introduce Sample] will be displayed.

• 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.

• 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 K ↓Cl
125.1 3.05 77.8

The STARLYTE V 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?] dis-
play, 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.

TIP: To discontinue QC measurement, press the NO key, until [READY] is displayed.

4-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 4 Quality control

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.

TIP: Responding YES to the [Remain in QC/Std./Urine Sample?] prompt, the ana-
lyzer returns to [QC Level 1 Sample?] .

4.4 Printing a QC report

The STARLYTE V analyzer will store in memory the last 35 QC measurement values for each
of the three QC levels.
• 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 4-5

4 Quality control

4-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

5 Maintenance
5.1 Decontamination ............................................................................................................. 5-1
5.1.1 Decontamination ...........................................................................................................................................5-1
Sample probe mechanism ..........................................................................................................................................5-1
Surfaces of the instrument .........................................................................................................................................5-1
Recommended disinfectants .....................................................................................................................................5-2

5.2 Daily maintenance .......................................................................................................... 5-3

5.3 Weekly maintenance ...................................................................................................... 5-5

5.3.1 Clean sample probe and fill port .............................................................................................................5-5

5.3.2 Cleaning analyzer surfaces........................................................................................................................5-5

5.4 Monthly maintenance .................................................................................................... 5-6

5.4.1 Cleaning the reference electrode housing ..........................................................................................5-6

5.5 Semi annual maintenance ............................................................................................ 5-9

5.5.1 Exchanging the pump tubing set ............................................................................................................5-9

5.6 Annual maintenance .................................................................................................... 5-10

5.6.1 Exchanging main tubing harness......................................................................................................... 5-10

5.7 Unscheduled maintenance ......................................................................................... 5-12

5.7.1 Replacing electrodes................................................................................................................................. 5-12
5.7.2 Checking reagent fluid level and changing the Fluid pack........................................................ 5-13

5.7.3 Replacing sample probe and fill port.................................................................................................. 5-15

5.7.4 Replacing printer paper ........................................................................................................................... 5-16

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-I

5-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007
 5 Maintenance

5 Maintenance
After use, components of the STARLYTE V analyzer, including tubing, fill port,
fluid pack etc., contain biological fluids and therefore represents a possible infec-
tious risk.
Handle these components with care and according to regulations surrounding
potentially infectious materials.
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.

5.1 Decontamination

5.1.1 Decontamination
The purpose of this procedure is to minimize the risk of infections when replacing items that
were in contact with blood.
Perform these decontamination procedures regularly.

Never use alcohol based disinfectants!

Never use disinfectant sprays.
IMPORTANT: Do not attempt to decontaminate 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 decontaminate the following parts of the instrument:

• 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

See “Clean sample probe and fill port” on page 5-5.

Surfaces of the instrument

See “Cleaning analyzer surfaces” on page 5-5.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-1

5 Maintenance

Recommended disinfectants

Surfaces
Protein remover (Roche deproteinizer)
• 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: breath fresh air, drink large amounts of water
After skin contact: wash with generous amounts of water, remove contaminated cloth-
ing.
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.

5-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

5.2 Daily maintenance

Prior to running the first sample of the day, the STARLYTE V analyzer needs to undergo a
simple cleaning and conditioning procedure that helps ensure the unit will perform prop-
erly. 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 Dai-
ly Maintenance!] .

TIP: If fewer than 5 samples are analyzed each day, cleaning should be performed once a
week instead of daily (see "Weekly maintenance").

• 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.
• 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.

Fig. 5-1 Fig. 5-2

• 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 .
• At the prompt [Open Sample Door Introduce Sample] , lift the sample door and
the pump will begin to aspirate.
• 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-3

5 Maintenance

It is very important that the main door be closed during calibration, since it provides
shielding from sources of electromagnetic interference.

Wipe the sample probe from top to bottom in order to avoid injury.

5-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

5.3 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.

5.3.1 Clean sample probe and fill port

Starting from the [READY] screen, perform the following actions:
• 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 dis-
played, 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
STARLYTE V analyzer. Use a slightly damp cloth to avoid getting fluid inside the
analyzer.

Fig. 5-3

5.3.2 Cleaning analyzer surfaces

Never use alcohol based disinfectants!

Never use disinfectant sprays.
IMPORTANT: Do not attempt to decontaminate 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, 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 deprotein-
izing 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!).

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-5

5 Maintenance

5.4 Monthly maintenance

5.4.1 Cleaning the reference electrode housing

Monthly maintenance involves cleaning the reference electrode housing, and should be per-
formed prior to daily maintenance. To complete this procedure, a small amount of depro-
teinizer is needed.
• 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.

Fig. 5-4

• Slide the measuring chamber forward until it locks in the front position.
• Unclamp the left electrode holder by moving the clamp forward.

Fig. 5-5 Fig. 5-6

5-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

• Remove the reference electrode assembly from the analyzer

• Unscrew the reference electrode from the reference housing. Store the reference elec-
trode in the red transport housing filled with reference solution.

Fig. 5-7

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.

• 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.

• 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 posi-
tion. Ensure the electrodes are seated properly.

Fig. 5-8

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-7

5 Maintenance

• Plug the tubing of the reference electrode into the receptacle below the left side of the
measuring chamber.
• Slide the measuring chamber back until it snaps into position, and close the front cover
of the analyzer.

Fig. 5-9 Fig. 5-10

• 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.

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each replace-
ment of the Fluid pack, 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 alter-
nating levels (low, normal, 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.

5-8 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

5.5 Semi annual maintenance

5.5.1 Exchanging the pump tubing set

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 Clean-
ing?] will appear. Then, do not press any keys.

When changing the pump tubing set, proceed as follows:

• 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.

Fig. 5-11 Fig. 5-12

• 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!).

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each replace-
ment of the Fluid pack, 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 alter-
nating levels (low, normal, 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-9

5 Maintenance

5.6 Annual maintenance

5.6.1 Exchanging main tubing harness

Once a year or as needed, the main tubing harness should be replaced.
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.

• 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 Fluid pack and slide out the white Fluid pack 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 5.7.3: Replacing sample probe and fill
port).

• Press NO until [CALIBRATION?] is displayed.

• Press YES to start a calibration.

5-10 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each replace-
ment of the Fluid pack, 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 alter-
nating levels (low, normal, 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-11

5 Maintenance

5.7 Unscheduled maintenance

5.7.1 Replacing electrodes

• Slide the measuring chamber forward until it locks in the front position.
• Unclamp the left electrode holder by moving the clamp forward.

Fig. 5-13 Fig. 5-14

• Remove the used electrode from the measuring chamber.

Fig. 5-15

• 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 elec-
trode has a lip on the bottom that rests on the flat edge of the measuring chamber to aid
in proper positioning.

Fig. 5-16 Fig. 5-17

5-12 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

• Close the clamp on the left electrode holder by lifting it until it locks in the back posi-
tion. Ensure that the electrodes are seated properly.
• Slide the measuring chamber back until it snaps into position.

Fig. 5-18 Fig. 5-19

After installing a new electrode, the STARLYTE V analyzer needs to undergo Daily Mainte-
nance, Calibration and QC Measurement to verify the performance of the electrode.

Dispose of the electrodes according to applicable regulations (hazardous waste!).

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each replace-
ment of the Fluid pack, 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 alter-
nating levels (low, normal, 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 ana-
lyzer results. For further information, see chapter 4: "Quality control".

5.7.2 Checking reagent fluid level and changing the Fluid pack
The STARLYTE V analyzer monitors the level of solutions in the Fluid pack and displays the
amount remaining. To check the status of fluid remaining in the Fluid pack:
• In the [READY] screen, press the NO key, until [OPERATOR FUNCTIONS?] is displayed.
Press YES .
• The prompt [Check/Change Fl.Pack?] will be displayed. Press YES .
• The analyzer will display the amount of fluid remaining.

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.

• To change the Fluid pack, just grasp the extended portion and slide it out.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-13

5 Maintenance

Fig. 5-20

As soon as the analyzer detects that the Fluid pack has been removed, the display prompts
[STATUS: NO Fl.Pack] . In addition, the printer will print the current status of the Fluid
pack.

Do not remove the Fluid pack during a calibration or measurement procedure.

Dispose of the Fluid pack according to applicable regulations (hazardous waste!).

• Prepare the new Fluid pack by carefully removing the protective strip. Save this cover to
close the connectors prior to disposal of the used Fluid pack.
• Write the installation date on the label of the new Fluid pack.

Once the protective strip is removed, be sure to keep the Fluid pack upright to avoid
spillage.

• Slide the new Fluid pack into position on the left side of the analyzer.
The analyzer will prompt [New Fl.Pack Installed?] .

Fig. 5-21 Fig. 5-22

• Press YES to indicate that a new Fluid pack is installed. Again, at the prompt [Are you
sure?] , press YES . The STARLYTE V analyzer will automatically reset the Fluid pack

5-14 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 5 Maintenance

counter to 100 % and commence system calibration.

• Press NO if you reinstall the Fluid pack that was removed.

In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (low, normal, high) after each electrode exchange, after each replace-
ment of the Fluid pack, 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 alter-
nating levels (low, normal, 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.

5.7.3 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 5.6.1: Exchanging main tubing harness).

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.
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 Clean-
ing?] will appear. Then, do not press any keys.

• Open the front door.

• Open the sample door.
• Remove the needle carefully (to prevent injury) from the holder. Unplug the tubing.
• Attach the new needle to the tubing and snap the needle back into the holder.

Fig. 5-23

Then replace the fill port as follows:

• 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

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 5-15

5 Maintenance

tubing.
• Mount the fill port holder at it’s 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!).

5.7.4 Replacing 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 Alfa Wassermann contains an indicator strip to alert
you when the paper roll should be changed. To change the roll:
• 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.

Fig. 5-24 Fig. 5-25

TIP: 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.

5-16 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

6 Troubleshooting
6.1 Error messages ................................................................................................................ 6-1

6.2 Service functions ............................................................................................................ 6-7

6.2.1 Testing the electrodes .................................................................................................................................6-7
Not calibrated potassium electrode ........................................................................................................................6-8

6.2.2 Testing the sample sensor .........................................................................................................................6-8

6.2.3 Testing the Fluid pack sensor...................................................................................................................6-8

6.2.4 Testing the language switch .....................................................................................................................6-9

6.2.5 Testing the sample door .............................................................................................................................6-9

6.2.6 Testing the pump ..........................................................................................................................................6-9

6.2.7 Testing the valves....................................................................................................................................... 6-10

6.2.8 Testing the interface ................................................................................................................................. 6-10

6.2.9 Testing the amplifier.................................................................................................................................. 6-10

6.2.10 Status-LEDs.................................................................................................................................................. 6-10

6.3 Service codes ................................................................................................................. 6-11

6.3.1 Entering service codes ............................................................................................................................. 6-11

6.3.2 Removing service codes .......................................................................................................................... 6-11

6.3.3 List of service codes.................................................................................................................................. 6-12

6.4 Deleting data .................................................................................................................. 6-13

6.4.1 Clearing sample count ............................................................................................................................. 6-13

6.4.2 Clearing all data.......................................................................................................................................... 6-13

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-I

6-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007
 6 Troubleshooting

6 Troubleshooting
Your STARLYTE V 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 STARLYTE V analyzer to operation. If your STARLYTE V analyzer does not
perform correctly after conducting the basic steps outlined in this chapter, you should con-
tact Alfa Wassermann for technical assistance.

6.1 Error messages

Message Cause Action

Status: Calibration has been interrup- Perform system calibration to return
Not calibrated ted the instrument to the [READY]
mode
Na/K/Cl/Ca/Li A specific electrode could not • Perform daily maintenance.
not calibrated be calibrated. • Check if the electrode holder is
Possible causes: locked in the back position.
• No stable value for • Check for leaks, blockages and air
Standard A bubbles.
• The slope A-B or A-C is out- • Clean or replace the electrode.
side the range (see • Check the fluid remaining in the
chapter 6.2.1: "Testing the Fluid pack. If less than 5 %
electrodes") remains, replace the Fluid pack.
• Is K still not calibrated, perform
external electrode test using serum
or plasma (see chapter 6.2.1.1:
"Not calibrated potassium elec-
trode").
Standard A not As the analyzer aspirates a sam- • Check the fluid remaining in the
detected ple of Standard A, the solution Fluid pack. If less than 5 %
is detected by the sample sen- remains, replace the Fluid pack.
sor, which must detect its • Check for clots or crystals that
presence without encountering may have formed in the Standard
any air bubbles. If the sample A tubing or the electrode chamber.
sensor is unable to properly • Replace the Fluid pack.
detect the presence of Standard • Ensure the sample sensor is
A solution in a programmed securely plugged in and perform
time period, above error mes- the sample sensor test to ensure
sage will be displayed. that the sensor is operating cor-
rectly. If necessary, clean the sam-
ple sensor.
• Replace the peristaltic pump tube
set to ensure correct aspiration of
Standard A.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-1

6 Troubleshooting

Message Cause Action

Standard B not Detection of Standard B aspira- • Replace the Fluid pack.
detected tion 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.
Standard C not Detection of Standard C aspira- • See remedy for Standard B.
detected tion is the same as for Standard
(Li activated) B.
Check Sample The sample sensor is calibrated • Clean sample sensor by using the
Sensor with air during each calibra- Electrode Maintenance procedure.
tion. For proper functioning, • Check for correct drying of the
the sensor must provide a rea- measuring chamber during the
ding of 80 - 120 units when air wash cycle.
is detected. To check sample • Replace the peristaltic pump tube
sensor response, perform the set.
Sample Sensor Test • Perform a calibration to remove
Open the sample door and press the error message.
the YES button to aspirate
various fluids through the sen-
sor. For transparent fluids (e.g.
water), the reading should
increase by at least 40 units. For
blood samples (not transpa-
rent), the reading should
decrease by at least 40 units.
The pump can be stopped at
any time by pressing NO.
Check Refe- When the analyzer fails to • Check for proper filling of the ref-
rence Housing detect a flow of Reference Solu- erence housing.
tion into the measuring cham- • Ensure that the reference tubing is
ber, this message will be securely connected to the recepta-
displayed. This test is perfor- cle.
med at the beginning of each • Since this test utilizes Standard A,
calibration cycle. make sure that it is aspirated
properly into the measuring cham-
ber.
If not, replace the Fluid pack.
• Clean the reference housing. (See
chapter 5.4: "Monthly mainte-
nance").

6-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 6 Troubleshooting

Message Cause Action

Please close This message occurs when the • Close the sample door within time
sample door sample door is not closed allowed.
within 20 seconds after the
sample is in place, or when the
door has been opened and no
sample is detected.
No sample Under certain conditions, the • Repeat the sample to see if it is
analyzer may not detect the detected properly on a second
presence of a sample and an trial.
error message will occur: • Close the sample door within time
• sample door remaining open allowed.
more than 20 seconds after • Check sample aspiration and look
samples are in place for the presence of clots in the
• air bubbles in the sample sampling system.
• a sample volume too small to • Check for the presence of o-rings
analyze and for proper sealing of the elec-
• no sample being aspirated trodes.
through the sampling mecha- • Ensure that the sample sensor is
nism. plugged in and perform the Sam-
If you wish to abort a sample, ple Sensor Test to verify that it is
you can do so by closing the operating correctly.
sample door during sample • Replace pump tubing.
aspiration.
Cleaning fluid Under certain conditions, the • Check for the presence of o-rings
not detected analyzer may not detect the and for proper sealing of the elec-
presence of cleaning solution: trodes.
• air bubbles in the cleaning • Check for aspiration of cleaning
solution solution and look for presence of
• too small volume of cleaning clots in the sampling system.
solution • Check for the proper sealing of the
• the cleaning solution not pump windings.
being aspirated properly • Ensure that the sample sensor is
through the sampling mecha- plugged in and perform the Sam-
nism ple Sensor Test to verify that it is
operating correctly
Conditioning Under certain conditions, the • Check for the presence of o-rings
fluid not detec- analyzer may not detect the and for proper sealing of the elec-
ted presence of conditioning solu- trodes.
tion • Check for aspiration of
• air bubbles in the condition- conditioning solution and look for
ing solution presence of clots in the sampling
• too small a volume of condi- system.
tioning solution • Check for the proper sealing of the
• the conditioning solution not pump windings.
being aspirated properly • Ensure that the sample sensor is
through the sampling mecha- plugged in and perform the Sam-
nism. ple Sensor Test to verify that it is
operating correctly.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-3

6 Troubleshooting

Message Cause Action

Paper jam or If the printer attempts to print • First turn analyzer off, then
printer defect to the paper and the paper jams remove the printer by placing your
in the feeder, this message will index finger behind the back edge
be displayed briefly, then the of the printer module and pull it
sample results will appear on forward. Remove the jammed
the display. paper and re-insert the printer
into the analyzer. Turn analyzer
back on.
TIP: 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.
Check electro- If none of the electrodes passes • Ensure that electrodes are properly
des the calibration: plugged in.
• a stable reading of Standard A • Check for proper operation of the
could not be obtained within reference electrode assembly. If
6 aspirations of Standard A necessary, clean the reference elec-
• the slope A-B or A-C is out- trode housing or replace the refer-
side of the limits ence electrode.
• Perform daily maintenance.
• Replace the Fluid pack.
Clog check If the unit is unable to clear the • Make sure that the electrode O-
fluid path sample path or to aspirate any rings are present and seated prop-
of the 3 Standards at the begin- erly.
ning of a calibration: • Make sure there are no leaks in the
• the cause: fluid path.
a defective reference housing • Check for a clog or crystallization
(increased discharge of KCl). 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.

6-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 6 Troubleshooting

Message Cause Action

↑↑↑↑ ↓↓↓↓ In case the unit displays arrows • In the case of a urine sample,
up or arrows down instead of arrows up instead of the K + -result
the sample results, the concen- indicate that further dilution of
tration of the sample is outside the sample is necessary (see
of the measurement range (see chapter 3.3.4: "Urine samples").
chapter 2: "Specifications"). • Check for proper sample prepara-
tion (see chapter 3).
• Check for small air bubbles in the
sample after aspiration into the
sample chamber.
• Check for proper aspiration of
Standard A.
↑↓ With Ca 2+ activated, the cali- • Ensure the sample sensor cable is
bration report will print an securely plugged in.
arrow up or down instead of the • Make sure room temperature is
actual temperature, if the tem- within specified limits (15°C to
perature measured is out of 32°C / 60°F to 90°F).
range (Range 10.0°C - 40°C). • Perform the Amplifier Test to
The temperature sensor is loca- measure the actual temperature.
ted in the right side electrode • With the front door opened, the
holder. temperature displayed should be
approx. 5°C above the actual room
temperature.
Err. If this message is displayed • Check for proper sample prepara-
instead of the sample results, no tion (see chapter 3).
valid voltage reading could be • Check if the electrode holder is
obtained from the electrode. locked in the back position.
• Check for proper filling of the ref-
erence housing.
• Check for air bubbles in the sam-
ple.
Change When the monitored fluid level • Replace the Fluid pack (see
Fl.Pack in the ISE Fluid pack reaches chapter 5.7.2: "Checking reagent
5 % remaining, the analyzer fluid level and changing the Fluid
will automatically print pack").
[Change Fl.Pack] at the end
of each sample report.
This message is present only in
printed form.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-5

6 Troubleshooting

Message Cause Action

*** Li The lithium result can only be
Calculation calculated for a
not possible 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 mes-
sage will be displayed and prin-
ted instead of the Li + value.
Interface The interface test (see • Check if pins 2 and 3 of the serial
error chapter 6.2.8: "Testing the port were connected properly.
interface") was not successful. • If the error persists, contact
Technical Support.
**Check This message is printed at the • Check for proper sample prepara-
Temp** end of the sample report and tion (see chapter 3).
(Ca 2+ activated) displayed while the measure- • Ensure the sample sensor cable is
ment is in process in case the securely plugged in.
temperature of the sample is • Make sure room temperature is
outside the range (Range: 10°C within specified limits (15°C to
- 40°C). 32°C / 60°F to 90°F).
• Perform the Amplifier Test to
measure the actual temperature.
• With the front door opened, the
temperature displayed should be
approx. 5°C above the actual room
temperature.

6-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 6 Troubleshooting

6.2 Service functions

The STARLYTE V 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 .

6.2.1 Testing the electrodes

The voltage levels of the electrodes can be tested by using standard solutions or an external
sample.
• 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.
• Record these values.
• Press YES and the electrode voltages will be displayed.

• To exit this function, press NO.

• The prompt [Test Standard C?] will be displayed.
• Record these values.
• Press YES and the electrode voltages will be displayed.
• Compare the measured values to the following table:

Electrode 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

K+ -700 to +1000 -2500 to +500 -700 to +100 +470 to +1200 -40 to +40

Cl - -3100 to -100 -1000 to +3000 -3100 to -100 -860 to -370 unused

Ca 2+ -3100 to +1000 -2300 to +2500 -3100 to +1000 -660 to -350 -150 to +150

Li + -3100 to +1900 -3600 to +1400 -2600 to +3400 +1 to +760 -1730 to -285

TIP: If the voltage difference A-B or A-C is outside the allowable difference, perform daily
maintenance or replace the electrode.

• After testing the electrodes against the standard solutions, the STARLYTE V 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-7

6 Troubleshooting

6.2.1.1 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.
• Call up the procedures for testing electrodes (see "Testing the electrodes" on page 6-7).
• Press NO, until [Test External Sample?] is displayed. Press YES .

Prepare a serum or plasma sample and introduce the sample:

• The prompt [Open Sample Door Introduce Sample] appears. Introduce the sam-
ple.
• 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.

6.2.2 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.
• 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

• Press NO to exit and after a short [Please Wait] message, the prompt [Test
Fl.Pack Sensor?] will appear.

6.2.3 Testing the Fluid pack sensor

• Press NO, until [Test Fl.Pack Sensor?] is displayed.
• Press YES and the current Fluid pack sensor status will be displayed:
Fl.Pack: I
I=In O=Out

• Remove the Fluid pack to test the Fluid pack sensor.

If the Fluid pack has been removed during this test, a calibration should be per-
formed to prime all fluid lines.

• Press NO to exit or to perform other service functions.

6-8 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 6 Troubleshooting

6.2.4 Testing the language switch

• 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.

• Press NO to exit or to perform other service functions.

English ᣣᧄ⺆

Deutsch Polski
Français Português
Español Spare 3
Italiano Spare 4
Fig. 6-1

6.2.5 Testing the sample door

• Press NO, until [Test Sample Door?] is displayed.
• Press YES and the current status will be displayed:
Sample Door: C
C=closed O=open

• Open the sample door to see the changes of the status.

• Press NO to exit or to perform other service functions.

6.2.6 Testing the pump

• 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:

• Very low speed
• Low speed
• Medium speed
• Fast speed
An audible change should be heard at the pump’s speed change.

• Close the front cover and press NO to exit or to perform other service functions.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-9

6 Troubleshooting

6.2.7 Testing the valves

• Press NO, until [Test Pinch Valves?] is displayed.
• Press YES and the following will be displayed:
Test Valve A:
YES/NO = ON/OFF

• 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 func-
tions.

6.2.8 Testing the interface

• 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 .

Be sure not to short pin 2 or pin 3 to ground, otherwise the interface may get dam-
aged.

• 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.
• Press NO to exit or to perform other service functions.

6.2.9 Testing the amplifier

• 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) = ##.#

• Press NO to exit or to perform other service functions.

6.2.10 Status-LEDs
The 5 status LEDs at the bottom of the chassis back panel are lit simultaneously during nor-
mal operation. If this is not the case, contact technical support.

6-10 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 6 Troubleshooting

Fig. 6-2 Status LEDs (back panel, bottom)

6.3 Service codes

The [Enter Service Code?] menu allows the programming of various functions into the
STARLYTE V analyzer.

6.3.1 Entering service codes

• 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:

• Press NO, until the first character appears.
• Press YES and the cursor will advance to the second position.
• Repeat this procedure for the other characters.
• Pressing YES after the third character will activate the service code.

TIP: If the desired character was missed, keep pressing the NO key until the correct character
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.

6.3.2 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-11

6 Troubleshooting

6.3.3 List of service codes

Code Action
DEC This service code will increase the resolution by one digit for all para-
meters 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 fea-
ture 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 elec-
trodes 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 Ca 2+ values in mg/dL instead of
Ca 2+ activated mmol/L. When this code is set, the unit automatically converts the cur-
rent 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 Ca 2+ values to the
ISETROL assay ranges.
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 Fluid pack counter.
When this code is activated, the analyzer displays:

Fl.Pack Counter:
xxx% ok?

If this percentage is not correct, press NO and enter the correct percen-
tage 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 repor-
ted 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 equi-
valent values with correlation factors applied.
NOTE: The default condition is that this code is disabled.

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 cali-
bration report.

6-12 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 6 Troubleshooting

6.4 Deleting data

6.4.1 Clearing sample count

To reset the sample count to 0, carry out the following procedure:
• 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.

6.4.2 Clearing all data

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

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
fluid pack will be reset to default values. All service codes will be deactivated. It is recom-
mended that all data be deleted if the analyzer is to be used by other persons at a later date.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 6-13

6 Troubleshooting

6-14 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

7 Theoretical foundations
7.1 Clinical significance ....................................................................................................... 7-1
7.1.1 Sodium ..............................................................................................................................................................7-1

7.1.2 Potassium .........................................................................................................................................................7-2

7.1.3 Chloride.............................................................................................................................................................7-3

7.1.4 Ionized calcium ..............................................................................................................................................7-4

7.1.5 Lithium...............................................................................................................................................................7-6

7.2 Principles of Operation .................................................................................................. 7-7

7.2.1 The measurement principle.......................................................................................................................7-7
7.2.2 Physical principle...........................................................................................................................................7-8

7.3 Electrode specifications .............................................................................................. 7-10

7.3.1 Sodium electrode ....................................................................................................................................... 7-10
Construction .................................................................................................................................................................. 7-10
Use and care ................................................................................................................................................................. 7-10

7.3.2 Potassium electrode .................................................................................................................................. 7-11

Construction .................................................................................................................................................................. 7-11
Use and care ................................................................................................................................................................. 7-11

7.3.3 Chloride electrode...................................................................................................................................... 7-12

Construction .................................................................................................................................................................. 7-12
Use and care ................................................................................................................................................................. 7-12

7.3.4 Calcium electrode ...................................................................................................................................... 7-13

Construction .................................................................................................................................................................. 7-13
Use and care ................................................................................................................................................................. 7-13

7.3.5 Lithium electrode........................................................................................................................................ 7-14

Construction .................................................................................................................................................................. 7-14
Use and care ................................................................................................................................................................. 7-14

7.3.6 Reference electrode assembly .............................................................................................................. 7-15

Construction .................................................................................................................................................................. 7-15
Reference electrode housing ................................................................................................................................. 7-15
Use and care ................................................................................................................................................................. 7-15
Reference electrode ................................................................................................................................................... 7-16
Use and care ................................................................................................................................................................. 7-16

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-I

7-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007
 7 Theoretical foundations

7 Theoretical foundations
7.1 Clinical significance

7.1.1 Sodium
The vast majority of sodium in organisms is located in the extracellular area (about 97 %).
Even with greatly varying supply with nourishment, the sodium concentration in serum is
subject to strong regula tion. In the kidneys, sodium is glomerularly filtered and most of this
(about 60 - 70 %) is reabsorbed in the proximal tubule.
The most important function of the sodium is to maintain constant osmolarity in the extra-
cellular fluid. For that reason, the levels of sodium and water are always closely interrelated.
However, in pathological conditions, there may be marked tissue hypo or hyperhydration
with values in the standard range. Conversely, an increased, respec tively a decreased sodium
concentration is found in serum due to a loss or gain of water when there is a normal level
of sodium.
An increased sodium level in serum occurs when there is:
• a decreased supply of liquid
• increased loss of water
• through the kidneys
- central diabetes insipidus
- renal diabetes insipidus
- osmotic diuresis (e.g. mannitin fusions)
• through the intestine
- infection deseases (especially dysentery and cholera)
• excessive supply of hypertonic saline solution (infusion therapy dosed too high)
• increase of aldosterone-induced sodium reabsorption
- primary hyperaldosteronism (CONN syndrome)
- secondary hyperaldosteronism

Reduced sodium level in serum occurs following:

• excessive supply of liquid without sufficient absorption of sodium
• excessive water supply with normal level of sodium in the organism
(for example: congestive heart failure)
• disturbance of sodium reabsorption caused by aldosterone deficiency
- suprarenal gland insufficiency (M. ADDISON)
- adrenogenital syndrome with saline loss (aldosterone insufficiency with high grade
enzyme defect)

Normal values:
Adult: 135 - 148 mmol/L
Newborn: 134 - 144 mmol/L
Child: 138 - 144 mmol/L

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-1

7 Theoretical foundations

Critical values a :

Na + < 120 mmol/L

Na + > 160 mmol/L
a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

7.1.2 Potassium
About 97% of potassium within the organism is intracellular. Transport into the cells is reg-
ulated by the Na/K ATPase localized in the cell membrane. Only about 3% of the potassium
is contained in the extracellular fluid. Potassium is glomerularly filtered and most of it
(about 90%) is reabsorbed in the proximal tubule and in Henle's loop. Reabsorption or
excretion in the distal tubules is influenced especially by aldosterone and the blood pH val-
ue.
Due to the high intracellular concentration of potassium, the serum potassium values do not
always reflect the potassium level of the organism. Therefore, the data obtained from the
serum may be interpreted only with careful consideration of the patient's clinical situation
and acid-base status. Consider the following examples: diabetic coma, during which the flow
of potassium into the cell is reduced due to the lack of insulin, and acute intoxication with
heart glycosides with accompanying inhibition of the Na/K ATPase membrane. In both cases
exists, despite a more or less greatly increased serum potassium level, intracellular potassi-
um deficiency.
Increased potassium concentration in serum occurs during:
• decreased excretion through the kidneys
- acute and chronic kidney insufficiency (especially pronounced with oliguria and
anuria)
- Aldosterone deficiency with suprarenal gland insufficiency (M. ADDISON)
- dosage of potassium-saving diuretic
- oral potassium substitution with (possibly unknown) mild limitation of kidney func-
tions
• displacement between intracellular and extracellular potassium
- severe insulin deficiency
- intoxication with heart glycosides
- severe acidosis
- (each 0.1 reduction of the blood pH results in a rise in potassium of 0.4 to 1.2 mmol/
L serum)
- malignant hyperthermia
• release of potassium on massive cell destruction
- hemolytic crisis
- transfusions with cold or very cold blood
- cytostatic therapy for leukemia and others
- burns
- severe soft tissue injuries

Hypokalemia is observed during:

• gastrointestinal potassium losses
- laxative abuse

7-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

- massive diarrhea
- fistulas in the area of the gastrointestinal tract
- villous papillary adenoma
- VERNER-MORRISON syndrome (pancreatic cholera)
• increased renal excretion
- primary hyperaldosteronism (CONN syndrome)
- secondary hyperaldosteronism
- cirrhosis of the liver (caused by decreased aldosterone breakdown)
- therapy with loop diuretics and thiazides
- CUSHING syndrome
- Aldosterone producing suprarenal gland carcinoma
- overdose of mineral corticoids
- renal tubular acidosis
• displacement between intracellular and extracellular potassium
- severe alkalosis
- insulin therapy for diabetic coma (potassium substitution required!)

Normal values:
Adult: 3.5 – 4.5 mmol/L
Newborn: 3.7 – 5.9 mmol/L
Child: 3.4 – 4.7 mmol/L

Critical values a :

K + < 2.8 mmol/L

K + > 6.2 mmol/L
a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

7.1.3 Chloride
Chloride is the most important anion in bodily fluids. Chloride is located – like sodium –
mostly in the extracellular area. Erythrocytes represent the highest intracellular content.
The concentration of chloride in serum, like the level of sodium, is held constant within
tight limits in healthy people. Chloride is glomerulary filtered in the kidneys and is tubu-
larly reabsorbed by passively following the sodium.
Chloride may be exchanged for bicarbonates during disturbances to the acid/base status,
causing chloride to adopt the additional task (in addition to maintaining the isotones in the
extracellular area) of working with sodium to regulate the acid/base status.
Changes to the chloride and sodium concentrations in serum usually occur in parallel.
Exceptions to this occur during disturbances to the acid/base status caused by the previously
mentioned exchange of chloride for bicarbonates as well as during massive chloride loss
with gastric juices during extended periods of vomiting (hypochloremic alkalosis).

Normal values a :
Adult: 98 - 107 mmol/L

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-3

7 Theoretical foundations

Normal values a :
Newborn: 98 - 113 mmol/L
a. Tietz Textbook of Clinical Chemistry, 3rd Edition 1999

Critical values a :

Cl - < 75 mmol/L
Cl - > 126 mmol/L
a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

7.1.4 Ionized calcium

Approximately 99% of calcium in the human body is localized in bone substance – mostly
in the form of hydroxylapatite.
About 1% of the cations are located in the extracellular area. Only very small amounts exist
intracellularly; the calcium ions here act especially as activators for numerous enzymes and
play a role in the effect mechanism of hormones.
It is possible to exchange calcium in the extracellular fluid for that in bones.
In addition, hydroxylapatite serves as a reserve holder from which calcium can be rapidly
mobilized when needed.
Calcium is present in plasma in 3 forms:
• About 50% are ionized and biologically active,
• about 40% are bound to proteins (especially albumin) and
• about 10% are present in complex bonds with citrate, phosphate, bicarbonate, lactate,
and others.
Protein bonding is dependent on the concentration of albumin in plasma and on the pH lev-
el of the blood:
With lower total albumin and an acidic pH level, fewer calcium ions are bound, causing the
ionized proportion to increase. This also explains why, despite a low level of calcium in
serum during severe acidosis (due to chronic kidney insufficiency), tetanic reactions do not
occur.
The portion of calcium suitable for ultrafiltration (ionized and complex bound) is glomer-
ularly filtered in the kidneys and up to 95 - 99% reabsorbed in the proximal and distal
tubule.
A small portion of the calcium can also be excreted via the intestine.
The regulation of calcium exchange is closely related to the regulation of the phosphate lev-
el. Therefore, the concentrations of both substances in serum and the excretion with urine
should always be seen and judged in relationship to each other.
The level of calcium in plasma is decisive for calcium-phosphate exchange. Three hormones
play roles in the regulation. They affect the maintenance of the extracellular calcium con-
centration via the reabsorption of calcium ions from the intestine, the release or storage
processes in bones and the extent of the renal excretion.
Parathormone and 1.25-dihydroxycholecalciferol:
• lead to an increase of the calcium concentration in plasma

7-4 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

Calcitonin:
• reduces the level of calcium
Increased concentrations of calcium in serum occur during:
• disturbances to the hormonal regulation of primary and tertiary hyperparathyreoidism
• increased release from the bones
- osteolysis through bone metastasis
- plasmocytome
- paraneoplastic symptom (through ectopic production of parathormone or similar
substances or prostaglandin E2)
- long-lasting immobilization
• vitamin D intoxication within the scope of therapeutic measures
• sarcoidosis
Reduced calcium levels in serum will be noticed as a result of:
• insufficient calcium reabsorption
- undernourishment
- malabsorption syndrome
- vitamin D3 deficiency
- deficiency of 1.25-dihydroxycholecalciferol
- chronic kidney insufficiency
- hypoparathyreoidism
- hypomagnesium
• greatly decreased concentration of albumin in the serum
(Note: ionized calcium is in the normal range!)
- nephrotic syndrome
- cirrhosis of the liver
• acute pancreatitis

Normal values:
Adult: 1.12 – 1.32 mmol/L
Child: 1.10 – 1.50 mmol/L

Critical values a :

Ca 2+ < 0.82 mmol/L or 3.28 mg/dL

Ca 2+ > 1.55 mmol/L or 6.20 mg/dL
a. Critical Care Testing: A Quick Reference Guide by Andrew St John, First Edition 2001

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-5

7 Theoretical foundations

7.1.5 Lithium 1
In clinical practice, lithium is given orally in a carbonate or citrate form in the treatment of
recurrent bipolar affective disorders. Bipolar disorders are psychotic illnesses characterized
by alternating mania and depression (typical manic-depressive symptoms).
The mechanism of action of lithium is thought to be based on its effect on the synthesis,
storage, release and reuptake of monoamine neurotransmitters. Onset of the acute antiman-
ic effect of lithium usually occurs within five to seven days; full therapeutic effect requires
10 - 21 days.
Lithium is absorbed quickly by the gastrointestinal tract; approximately 90 - 95 % of the
lithium dosage is excreted through the kidneys. GFR disorders reduce lithium elimination.
Excretion through perspiration, saliva and feces is negligible in normal circumstances.
The therapeutic range of lithium is very narrow. To avoid intoxication (dizziness, nausea,
trembling, and, ultimately, coma and shock), the lithium level must be determined every
4 - 5 days at the start of therapy. A blood sample is taken 8 - 12 hours after the last lithium
dose is administered. If the patient is clinically stable and the lithium level constant, the
monitoring interval can be extended to 1 - 3 months.

Therapeutic range a :
0.6 - 1.2 mmol/L
Toxic range:

Li + > 2 mmol/L
a. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Eds: Burtis C & Ashwood E & Bruns
D. Elsevier Saunders 4th Ed., USA 2006

1
Gelenberg AJ, Kane JM, Kekller MB et al. Comparison of standard and low serum levels of lithium for maintenance
treatment of bipolar disorder. N Engl J Med 1989; 321:1489-93.

7-6 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

7.2 Principles of Operation

7.2.1 The measurement principle

The STARLYTE V 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 sam-
pling analysis is relatively simple. Basically, the analyzer compares an unknown value
against a known value to compute the sample’s electrolyte level.
An ion-selective membrane undergoes a specific reaction with the type of electrolyte con-
tained 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 Fig. 7-1).
The different ion concentrations between the inner electrolyte and the sample cause an elec-
tro-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).

voltmeter
reference
electrode
inner solution

ion-selective
electrode
glass capillary
ion-selective
membrane

measured
solution

Fig. 7-1

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-7

7 Theoretical foundations

7.2.2 Physical principle

An ion-selective electrode is connected with a reference electrode to form a measuring sys-
tem (see Fig. 7-2). When immersed in a solution that contains the relative ion, the Nernst
equation applies:

R⋅T
1. E = E′ ± ----------- ⋅ ln a i
n⋅F
or

R⋅T
2. E = E′ ± ----------- ⋅ ln ( f i ⋅ c i ) (+) for cations
n⋅F (–) for anions

The equation can also be written:

3. E = E′ ± S ⋅ log ( f i ⋅ c i )

E the measured electrical potential

E’ the e.m.f. of the system in a standard solution
a i activity of the ion measured
R the general gas constant (8.31 J/Kmol)
T temperature
n valence of the measured ion
F Faraday constant (96.496 A·s/g)
f
i the activity coefficient
c i the concentration of the measured ion
S the slope of the electrode

Na + electrode K + electrode
ground amplifier display
reference
electrode
housing

reference
solution (KCl)

reference
electrode Cl - electrode
glass
capillary inner electrode
inner electrolyte
sample

chloride-selective
sodium-selective potassium-selective membrane
membrane membrane

Fig. 7-2

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.

7-8 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

4. E sample = E′ + S ⋅ log ( f i ⋅ c i, sample )

5. E s tan dard = E′ + S ⋅ log ( f i ⋅ c i, standard )

c
i, sample
6. ΔE = E sample – E s tan dard = S ⋅ log -----------------------
-
c i, standard

ΔE the difference between the measured potentials of the sample and the
standard
S the potential difference of the electrode, determined from the potential
difference of two measured standard solutions
c i,sample concentration of the measured ions in the sample
c i,standard concentration of the measured ions in the standard solutions

The unknown ion concentration in the sample can now be determined by:
ΔE ⁄ S
7. c i, sample = c i, s tan dard ⋅ 10

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 ion’s
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 affect-
ed 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 ascer-
tain and adjust for total ion effect and strength.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-9

7 Theoretical foundations

7.3 Electrode specifications

7.3.1 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 sur-
face 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)

O-ring seal

electrolyte chamber

inner electrode

glass capillary

serial number connecting pin

Fig. 7-3

Use and care

Sodium electrodes are manufactured for use in STARLYTE V 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 attack the plas-
tic 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.

7-10 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

7.3.2 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: transparent acrylic plastic

Measuring membrane: potassium ion selective
Electrolyte chamber: airtight, filled with electrolyte solution for K + electrodes
Pin connector: silver, silver chloride (Ag / AgCl)

ion-selective membrane

O-ring seal

electrolyte chamber

measuring capillary

serial number
connecting pin
inner electrode

Fig. 7-4

Use and care

Potassium electrodes are manufactured for use in STARLYTE V 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 attack the plas-
tic 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-11

7 Theoretical foundations

7.3.3 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 a Cl - marking on the top sur-
face of the housing.

Construction

Electrode housing: transparent acrylic plastic

Measuring membrane: chloride ion selective
Electrolyte chamber: airtight, filled with electrolyte solution for Cl - electrodes
Pin connector: silver, silver chloride (Ag / AgCl)

ion-selective membrane

O-ring seal

electrolyte chamber

measuring capillary

serial number
connecting pin
inner electrode

Fig. 7-5

Use and care

Chloride electrodes are manufactured for use in STARLYTE V 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 attack the plas-
tic 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.

7-12 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

7.3.4 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 Ca 2+ marking on the top sur-
face of the housing.

Construction

Electrode housing: transparent acrylic plastic

Measuring membrane: calcium ion selective
Electrolyte chamber: airtight, filled with electrolyte solution for Ca 2+ electrodes
Pin connector: silver, silver chloride (Ag / AgCl)

ion-selective membrane

O-ring seal

electrolyte chamber

measuring capillary

serial number
connecting pin
inner electrode

Fig. 7-6

Use and care

Calcium electrodes are manufactured for use in STARLYTE V 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 attack the plas-
tic 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-13

7 Theoretical foundations

7.3.5 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: transparent acrylic plastic

Measuring membrane: lithium ion selective
Electrolyte chamber: airtight, filled with electrolyte solution for Li + electrodes
Pin connector: silver, silver chloride (Ag / AgCl)

ion-selective membrane

O-ring seal

electrolyte chamber

measuring capillary

serial number
connecting pin
inner electrode

Fig. 7-7

Use and care

Lithium electrodes are manufactured for use in STARLYTE V 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 attack the plas-
tic 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.

7-14 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 7 Theoretical foundations

7.3.6 Reference electrode assembly

The reference electrode assembly is a device used as an electrical junction between the sam-
ple and electrical ground.

Construction

The reference electrode assembly consists of two parts: the reference electrode housing and
the reference electrode.

Reference electrode housing

In the reference electrode housing, reference electrolyte solution establishes the electrical
contact between the reference electrode and the sample. At the beginning of each measure-
ment, 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 Fig. 7-8).

entrance of exit of
ref. solution ref. solution
glass capillary

O-ring seal (c)

O-ring seal (b)

O-Ring seal (a) serial number

Fig. 7-8

Use and care

Reference electrode housings are manufactured for use in STARLYTE V analyzers.

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 Elec-
trode 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.

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 7-15

7 Theoretical foundations

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 elec-
trolyte)-calomel (Hg 2 Cl 2 )- mercury (Hg)-platinum wire-connecting pin junction
(see Fig. 7-9).

cable housing
platinum wire
glass tube

cotton wool
calomel (Hg 2 Cl 2 )
mercury (Hg)

Fig. 7-9

Use and care

Reference electrodes are manufactured for use in STARLYTE V analyzers.

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 elec-
trode housing at the time of disassembly).

Never rinse the reference electrode with distilled water!

Never allow the reference electrode to become dry!

7-16 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

8 Appendix
8.1 Description of reports .................................................................................................... 8-1
8.1.1 Measurement report ....................................................................................................................................8-1

8.1.2 QC report ..........................................................................................................................................................8-1

8.1.3 Calibration report ..........................................................................................................................................8-2

8.2 Specifications of the solutions ..................................................................................... 8-3

8.3 Maintenance schedule .................................................................................................. 8-4

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 8-I

8-II Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007
 8 Appendix

8 Appendix
8.1 Description of reports

8.1.1 Measurement report

- STARLYTE V -
ELECTROLYTE ISE
- NA-K-CL -
26SEP03 08:16 - STARLYTE V - - STARLYTE V -
HOSPITAL WEST ELECTROLYTE ISE ELECTROLYTE ISE
- NA-K-CL - - NA-K-CL -
Name: .......... 26SEP03 08:27 26SEP03 08:31
.......... HOSPITAL WEST HOSPITAL WEST
Sample: STANDARD
Name: .......... Name: ..........
Sample No.35 .......... ..........
Sample: SERUM Sample: URINE
Na=151.7 mmol/L
K = 5.56 mmol/L Sample No.36 Sample No.37
Cl=114.5 mmol/L
Na= 263 mmol/L Na=143.9 mmol/L
*PERFORM DAILY * K = 18.3 mmol/L K = 4.93 ↓ mmol/L
* MAINTENANCE! * Cl= 118 mmol/L Cl=103.1 mmol/L
Fig. 8-1 Fig. 8-2 Fig. 8-3

8.1.2 QC report

- STARLYTE V -
ELECTROLYTE ISE
- NA-K-CL -
26SEP03 09:21
HOSPITAL WEST
QUALITY CONTROL

*** Level 1 *** *** Level 2 *** *** Level 3 ***

Lot Number:1150 Lot Number:1261 Lot Number:1373

Na/K/Cl Na/K/Cl Na/K/Cl

1 Na-values 1 Na-values 1 Na-values
118.0 145.4 160.5
1 K-values 1 K-values 1 K-values
2.71 4.51 6.46
1 Cl-values 1 Cl-values 1 Cl-values
69.6 103.6 120.0

Fig. 8-4

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 8-1

8 Appendix

8.1.3 Calibration report

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

Fig. 8-5

8-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 8 Appendix

8.2 Specifications of the solutions

Reagents are to be used for in-vitro diagnostic use only.

The Fluid pack contains the following solutions:

Standard A
Standard B
Standard C
Reference solution

Caution: A waste container is provided inside the Fluid pack which, when used,
holds human body fluids which may be potentially infectious; handle with appropri-
ate care to avoid skin contact or ingestion!

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 8-3

8-4
8.3
8 Appendix

STARLYTE V analyzer
Maintenance schedule

Month:...........................

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
DAILY
Perform cleaning
Maintenance schedule

Perform conditioning

WEEKLY
Clean sample probe/fill port
Clean analyzer surfaces

MONTHLY
Clean reference electrode housing
TIP: This page can be used as template for duplication.

SEMI-ANNUALLY
Change pump tubing

ANNUALLY
Change main tubing harness

UNSCHEDULED MAINTENANCE

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007

 9 Index

9 Index Reference electrode assembly ............................ 7-15

Sodium electrode ................................................... 7-10
Environmental parameters ......................................... 2-10
A Solutions .................................................................... 2-11
Fluid pack ......................................................... 2-11
Additional settings
Error messages ................................................................... 6-1
Printer settings .......................................................... 3-9
Exchanging
Analyzer components .................................................... 1-7
Main tubing harness ............................................. 5-10
Appendix ............................................................................. 8-1
Pump tubing set ....................................................... 5-9
B F
Bibliography ...................................................................... 2-8
Fluid pack .......................................................................... 1-10
C G
Calibrations ........................................................................ 2-9
General notes ..................................................................... 1-2
Classification ................................................................... 2-13
Cleaning I
Analyzer surfaces ..................................................... 5-5
Reference electrode housing ............................... 5-6 Installation ........................................................................ 1-12
Sample probe mechanism .................................... 5-5 Preparing the Analyzer for Operation ........... 1-18
Clear Selecting language .................................................. 1-18
all data ........................................................................ 6-13 Interferences ....................................................................... 2-6
Sample count .......................................................... 6-13 K
Clinical significance
Chloride ...................................................................... 7-3 Keypad .................................................................................. 1-8
Ionized calcium ........................................................ 7-4
Lithium ........................................................................ 7-6 L
Potassium ................................................................... 7-2 Limitations .......................................................................... 2-7
Sodium ........................................................................ 7-1 Limitations of clinical analysis .................................... 3-3
Correlation factors .......................................................... 3-8 Electrolytes ................................................................. 3-3
General ......................................................................... 3-3
D Linearity ............................................................................... 2-5
Decontamination ............................................................. 5-1 Correlation to direct ISE - flame-correlated . 2-6
Description of reports .................................................... 8-1 Correlation to direct ISE - not flame-correlated
Dimensions ...................................................................... 2-14 2-6
Display ....................................................................... 1-8, 2-14 Electrolytes in serum ......................................2-5, 2-6
Disposal of... in aqueous standard solutions ............................ 2-5
Electrodes ................................................................... 1-6 in serum ....................................................................... 2-5
Fluid pack ................................................................... 1-6 Location ............................................................................. 1-12
Instrument ................................................................. 1-6
Reference electrode ................................................. 1-6 M
Maintenance
E Annual ........................................................................ 5-10
Electrical data .................................................................. 2-13 Exchanging main tubing harness ............ 5-10
Electrode specifications ............................................... 7-10 Cleaning reference electrode housing .............. 5-6
Electrodes Daily .............................................................................. 5-3
Calcium electrode ................................................. 7-13 Monthly ....................................................................... 5-6
Chloride electrode ................................................. 7-12 Semi annual ................................................................ 5-9
Lithium electrode .................................................. 7-14 Exchanging the peristaltic pump tubes .. 5-9
Potassium electrode .............................................. 7-11 Unscheduled maintenance ................................. 5-12
Reference electrode ............................................... 7-16 Material setup .................................................................... 4-2

Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007 9-1

9 Index

Measurement and calibration procedures .............1-5 Plasma .......................................................................... 3-2

Measuring chamber .........................................................1-9 Serum ........................................................................... 3-2
Measuring procedure ......................................................3-3 Whole blood .............................................................. 3-2
Sample measurement ..................................................... 3-4
N Dialysate samples ..................................................... 3-6
Normal ranges ...................................................................3-7 Direct ISE .................................................................... 3-6
Urine samples ........................................................... 3-6
P Sample probe mechanism ............................................ 1-9
Sample throughput ......................................................... 2-9
Performance parameters ...............................................2-1
Sample types ...................................................................... 2-9
Peristaltic pump ................................................................1-9
Sample volumes ................................................................ 2-9
Preanalytics .........................................................................3-1
Serial port .......................................................................... 1-11
Acceptable anticoagulants ....................................3-1
Service codes .................................................................... 6-11
Sample collection .....................................................3-1
Service functions .............................................................. 6-7
Sample collection containers ...............................3-2
Testing the amplifier ............................................ 6-10
Sample handling .......................................................3-2
Testing the electrodes ............................................ 6-7
Sample requirements ..............................................3-1
Not calibrated potassium electrode ......... 6-8
Printer .........................................................................1-8, 2-14
Testing the fluid pack sensor .............................. 6-8
Printing
Testing the interface ............................................. 6-10
QC report ....................................................................4-5
Testing the language switch ................................ 6-9
Product data .....................................................................2-13
Testing the pump .................................................... 6-9
Q Testing the sample door ....................................... 6-9
Testing the sample sensor .................................... 6-8
QC Testing the valves ................................................... 6-10
Material setup ............................................................4-2 Shutdown .......................................................................... 1-25
R Specifications ..................................................................... 2-1
Measurement parameters .................................... 2-1
Rear panel ..........................................................................1-11 Reproducibility ......................................................... 2-1
Recommended decontaminants ................................5-2 Standby mode ................................................................. 1-29
Replacing Symbols ................................................................................ 1-2
Electrodes ..................................................................5-12 System description .......................................................... 1-7
Fluid pack ..................................................................5-13
Printer paper ............................................................5-16 T
Sample probe ...........................................................5-15 Temperature / humidity / stability ......................... 2-10
Reports Electrodes ................................................................. 2-10
Calibration report ....................................................8-2 Instrument ............................................................... 2-10
Measurement report ...............................................8-1 QC material ............................................................. 2-13
QC report ....................................................................8-1 Urine diluent ........................................................... 2-13
S Theoretical foundations ................................................ 7-1
Troubleshooting ............................................................... 6-1
Sample collection .............................................................3-1
Sample handling ...............................................................3-2 V
Aqueous solutions ...................................................3-3 Valves .................................................................................. 1-10
Dialysate ......................................................................3-3

9-2 Instructions for Use, STARLYTE V, Rev. 1.0, Oct. 2007