Users Manual Elyte-1

High Technology, Inc.
Electrolyte Analyzer
Operator’s Manual
Document Number : OM-E-ELT-P-10

Revision Level : Rev. 13
Effective Date : 23Oct17
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Document Number OM-E-ELT-P-10
Revision Level Rev.13
Prepared By J.S. Bolio
Approved By S. Titov
Effective date 23Oct17
Operator’s Manual: E-Lyte Plus
Product Information
Product model: E-Lyte Plus
Product name: HTI E-Lyte Plus Electrolyte Analyzer
Manufacturer: High Technology, Inc.
Symbols
Symbols used in the Manual
Notes contain additional information or tips when using the instrument. All
recommendations must be followed carefully to ensure your instrument work correctly
and to avoid unnecessary personal injury.
Symbols on the Box
The symbol means the instrument packaged should not be upended at any time
This means that instrument should handle with care in the course of transportation,
so as not to damage it.
The symbol means that the environment of instruments must be damp-proof in the
course of transport, and instrument must be kept in a dry environment.
This symbol indicate that the analyzer should be protected from overexposure to
sunlight
Symbols on the Analyzer
This symbol indicated the location of the external ground connection
This symbol indicates the Power Switch. “O” is Power Off and “I” is Power On
This symbol indicates the power connection on the analyzer.
RS232 This symbol indicates the data connection for the analyzer
This symbol denotes the Catalog number

High Technology, Inc. Prepared By J.S. Bolio
The symbols for “SERIAL NUMBER”, The serial number shall be after or
below the symbol, adjacent to it
The symbol indicates the manufacturer and its address, after which are shown its
name and address
This symbol denotes to Consult instructions for use
This symbol denotes that this product conforms to the directive 98/79/EC (IVD-
directive)
The symbol indicates EU representatives of the manufacturer and their addresses,

after which are shown their names and addresses
The symbol means the product is in vitro diagnostic medical device.
Declaration
High Technology, Inc. reserves the right to change the product described in this Operating Manual. All information
contained in this Operating Manual is subject to change without prior notice.
Manufacturer’s Responsibility
High Technology, Inc. (HTI) is responsible for the safety, reliability and performance of the device, and will provide
warranty under the following conditions:
• Operation of this device conforms to the instructions in this Manual.

• Assembling, upgrading, installation, and repair will be performed by HTI authorized personnel.
• Product storage environment, operating environment, and electrical environment are as described in this
manual.
• Product serial number and labels are intact to verify the products identity as manufactured by HTI.
• Damages not due to by miss-use, physical impacts, or acts of God.
Free services apply to those products with applicable items within warranty period. For those beyond the
description of warranty conditions, HTI will charge for service. For all returned goods to HTI for service, customers
should pay for the transportation and any applicable customs fees.

Warranty
The Analyzer is covered by a one-year limited warranty from date of the purchase. The electrodes carry a one-year
limited warranty. Consumables are excluded from this warranty.
The following situations are not included in the warranty:
• The serial number of the analyzer or electrode is missing or unreadable

• The analyzer or electrode is damaged due to improper connection with other equipment
• The analyzer or electrode is accidentally damaged
• The analyzer or electrode has been modified without written authorization from the manufacturer.
Return Procedures
If a return is necessary, take the following steps:
• Obtain a return merchandise authorization from HTI’s Customer Service Department.

• Obtain the serial number and mark this serial number on the shipping box. If the serial number cannot be
recognized, the return cannot be accepted.
• Briefly describe the reasons for the return.
• Freight Charge: Customer is responsible for freight charges (including customs) for any returns.
• Software design may vary depending on modification of device

High Technology, Inc. Revision Level 13

109 Production Road, Prepared By J.S. Bolio
Walpole MA 02081 Approved By S. Titov
Operator’s Manual: HTI E-Lyte Plus
Table of Contents
1. INTRODUCTION ................................................................................................................................................ 1
1.1 OVERVIEW ................................................................................................................................................ 1
1.2 BRIEF INTRODUCTION ............................................................................................................................ 1
1.3 DESCRIPTION OF ELECTRODE.............................................................................................................. 1
1.3.1 Electrode Principles ........................................................................................................................... 2
1.3.2 Measuring Principles .......................................................................................................................... 2
1.4 DESCRIPTION OF REAGENT .................................................................................................................. 3
1.5 SAMPLE COLLECTION AND HANDLING ................................................................................................ 4
1.5.1 Safety ................................................................................................................................................. 4
1.5.2 Serum Samples .................................................................................................................................. 4
1.5.3 Urine Samples .................................................................................................................................... 4
1.6 SAFETY INFORMATION ........................................................................................................................... 5
1.6.1 Danger ................................................................................................................................................ 5
1.6.2 Warning .............................................................................................................................................. 5
1.6.3 Caution ............................................................................................................................................... 5
1.6.4 Attention ............................................................................................................................................. 5
2 DESCRIPTION OF ANALYZER ........................................................................................................................ 6
2.1 EXTERNAL AND INTERNAL FEATURES ................................................................................................ 6
2.1.1 Front Panel ......................................................................................................................................... 6
2.1.2 Rear Panel ......................................................................................................................................... 6
2.1.3 Internal Components .......................................................................................................................... 7
2.2 OPERATING ENVIRONMENT .................................................................................................................. 8
2.2.1 Placement .......................................................................................................................................... 8
2.2.2 Operating Conditions ......................................................................................................................... 8
2.2.3 Influence on other Equipment ............................................................................................................ 8
3 INSTALLATION ................................................................................................................................................. 9
3.1 EQUIPMENT UNPACKING ....................................................................................................................... 9
3.2 INSPECTION OF INSTRUMENT AND ACCESSORIES ........................................................................... 9
3.3 REAGENT PACK ..................................................................................................................................... 10
3.4 TUBING .................................................................................................................................................... 10
3.5 ELECTRODES ......................................................................................................................................... 11
3.5.1 Filling or Refilling Electrode Internal Solution .................................................................................. 11
3.5.2 Filling or Refilling the Reference Electrode ...................................................................................... 12
3.5.3 Electrode Installation ........................................................................................................................ 13
3.6 PRINTER PAPER .................................................................................................................................... 15
3.7 CONNECTING AC POWER .................................................................................................................... 15
3.8 TURNING ON THE UNIT ......................................................................................................................... 16
3.9 ACTIVATION ............................................................................................................................................ 16
3.9.1 Priming Reagent Pack ..................................................................................................................... 16
3.9.2 Activating Electrodes ........................................................................................................................ 18
3.9.3 Running QC for the First Time ......................................................................................................... 19
4 OPERATION .................................................................................................................................................... 20
4.1 MAIN MENU ............................................................................................................................................. 20
4.1.1 ISE Calibration ................................................................................................................................. 20
4.1.2 Quality Control.................................................................................................................................. 21
4.1.2.1 Test ................................................................................................................................................................... 22
4.1.2.2 Factor ................................................................................................................................................................ 23
4.1.2.3 QC Calibration................................................................................................................................................... 24
4.1.2.4 Manual QC Calibration ...................................................................................................................................... 25
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL I
4.1.2.5 Statistics ............................................................................................................................................................ 26

4.1.3 Samples ........................................................................................................................................... 27
4.1.3.1 Manual............................................................................................................................................................... 27
4.1.4 Settings ............................................................................................................................................ 28
4.1.4.1 Date and Time ................................................................................................................................................... 29
4.1.4.2 Parameters ........................................................................................................................................................ 29
4.1.4.3 Print Setup......................................................................................................................................................... 30
4.1.4.4 Normal Ranges ................................................................................................................................................. 30
4.1.4.5 Test Speed ........................................................................................................................................................ 31
4.1.4.6 Cal Frequency ................................................................................................................................................... 31
4.1.5 Maintenance ..................................................................................................................................... 32
4.1.5.1 Deproteinize ...................................................................................................................................................... 32
4.1.5.2 Activate.............................................................................................................................................................. 34
4.1.5.3 Flushing ............................................................................................................................................................. 35
4.1.5.4 Replace Reagent Pack ...................................................................................................................................... 35
4.1.6 Other................................................................................................................................................. 36
4.1.6.1 Review Data ...................................................................................................................................................... 36
4.1.6.2 Send Data ......................................................................................................................................................... 39
4.1.6.3 Calibration Data................................................................................................................................................. 39
4.1.6.4 Advanced Setup ................................................................................................................................................ 40
5 MAINTENANCE ............................................................................................................................................... 43
5.1 INSPECTION ........................................................................................................................................... 43
5.2 DAILY MAINTENANCE ............................................................................................................................ 43
5.3 WEEKLY MAINTENANCE ....................................................................................................................... 43
5.4 MONTHLY MAINTENANCE .................................................................................................................... 43
5.5 MAINTENANCE OF KEY COMPONENTS .............................................................................................. 43
6 TROUBLESHOOTING ..................................................................................................................................... 44
7 AUTOMATIC SAMPLE LOADER (OPTIONAL) ............................................................................................. 45
7.1 INSTALLATION ........................................................................................................................................ 45
7.2 AUTOMATIC ACTIVATION ..................................................................................................................... 46
7.3 AUTOMATIC QC TEST ........................................................................................................................... 47
7.4 AUTOMATIC QC CALIBRATION............................................................................................................. 48
7.5 AUTOMATIC SAMPLE TEST .................................................................................................................. 49
7.6 EMERGENCY TESTING ......................................................................................................................... 51
7.7 AUTOMATIC DEPROTEINIZATION ........................................................................................................ 52
8 APPENDIX A: TECHNICAL SPECIFICATIONS ............................................................................................. 53
8.1 BASIC PARAMETERS ............................................................................................................................. 53
8.2 MEASURING RANGE AND MEASURING PRECISION ......................................................................... 53
8.3 CLINICAL ELECTROLYTE RANGE ........................................................................................................ 54
8.4 SLOPE RANGE........................................................................................................................................ 54
8.5 OPERATING PARAMETERS .................................................................................................................. 55
8.6 COMMUNICATION PROTOCOLS .......................................................................................................... 56
8.7 DIMENSIONS AND WEIGHT .................................................................................................................. 57
8.8 PACKAGING, TRANSPORTATION AND STORAGE ............................................................................. 57
9 APPENDIX B: CA AND PH INSTRUCTION ................................................................................................... 58
II HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

1. INTRODUCTION
1.1 Overview
The purpose of this manual is to provide operating, maintenance, and repair information to users. This manual
illustrates detailed performance indexes, routine installation, operation, maintenance procedures, and
important safety information. To ensure safety standards and performance functions carefully read this
manual prior to using the analyzer.
1.2 Brief Introduction

HTI E-Lyte Plus Electrolyte Analyzer is based on advanced Ion-Selective Electrode (ISE) technology and
sensor technology. With the advantages of easy operation and accurate measurement, it is a fast, accurate,
convenient and practical clinical instrument.
The instrument is intended for use in hospitals and labs to measure K+, Na+, Cl-, Ca2+, Li, Mg2+ ions, as well
as pH values, serum, and urine solution (diluted). This product has multi-parameter functions which can be
selected, combined and configured by the user according to the hospital or labs specific requirements. The
instrument has 7 combination types:
Type A : K+ Na+ Cl- - - - - - -

Type C : K+ Na+ Cl- iCa nCa TCa pH - -
Type E : K+ Na+ - - - - - Li+ -
Type F : K+ Na+ Cl- - - - - Li+ -
Type H : K+ Na+ Cl- iCa nCa TCa pH Li+ -
Type J : K+ Na+ Cl- - - - - - Mg2+
Type K : K+ Na+ Cl- iCa nCa TCa pH - Mg2+
1.3 Description of Electrode

The following diagram lists the description of the electrodes properties.
HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 1 of 58

1.3.1 Electrode Principles

Ion Selective Electrode is a kind of electrochemical sensor (also called an electrode). The activity changes
of a specific ion can be converted into the electrical potential changes of the electrode. The numerical values
of the concentration gradient relate to the electric gradient that balances it, according to the Nernst equation.
“Ion-Selective Electrode” means that each electrode is only sensitive to one type of ion. For example, the
Na electrode is only sensitive to Na+, but not sensitive to other ions. The key component of the electrode is
the ion-selective membrane. The two sides of the membrane get contact from a sample and the internal
Electrode Internal Solution respectively. The side touching the sample is responding to the ion
concentrations change. The other side touches the internal Electrode Internal Solution, the conversion from
ion conduction to electron conduction is carried out by Ag/AgCl inner electrode. The reference electrode
provides the reference potential to complete the measuring circuit. This electric potential does not change
along with ion concentration, therefore providing a standard reference for measuring potential difference.
1.3.2 Measuring Principles

The instrument applies ISE to measure the ion concentrations in the sample. Refer to the following figure
for the working principles of ISE.
1 Measured Solution
2 Conjunctive Point
3 Reference Electrode
4 Ion Selective Electrode
5 Internal Electrode Internal Solution
6 Ion Selective Membrane
ISE is sensitive to the ion activity in the sample. When the ion concentration in the sample is below 10-4M
and activity coefficient is close to 1, the difference between ion activity and concentration can be ignored
(when concentration goes over 10-4M, the activity coefficient decreases, and the difference increases.)
When the ISE contacts the measured solution, the measured ion in the sample goes to the ISE membrane
due to the diffusion effects of the concentration difference, which creates a potential between the measure
electrode and the reference electrode. The potential that an ideal ISE creates for the “X” ion can be described
by the Nernst formula:
E0 : Electrode Standard Potential

R : Gas Constant
2.3026RT T : Absolute Temperature

E=Eo + log10 a(x)
ZF F : Faraday Constant
Z : lon Valence
a(x) : Ion Activity
Page 2 of 58 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

When the activity coefficient is 1 and temperature is 25oC (298°K), the electrode potential is proportional to
the logarithm of ion concentration “C”, which can be described as the following formula:
59.12
E=E0 + log10 C(x)
Z
It is manifested that before applying ISE to perform the measurement, the values of potential (E0) and slope
(59.12/Z is the theoretical value) must be determined first through the two-point calibration by using two
standard solutions. Moreover, the ion activities in the standard solution and the testing sample must be kept
close enough to ensure the accuracy of measurement. The following figure shows the measurement
principle:
MV
Calibrating Curve
MV. B
MV. S
MV. A
STD. A Sample STD. B C
1.4 Description of Reagent
In Reagent Pack. For calibration of Sodium, Potassium,

Calibration Solution A Chloride, Ionized Calcium, pH, Magnesium and Lithium in the
electrolyte analyzer. Contents 430mL
In Reagent Pack. For calibration of Sodium, Potassium,

Calibration Solution B Chloride, Ionized Calcium, pH, Magnesium and Lithium in the
electrolyte analyzer. Contents 110mL
A salt bridge for calibration and measurement in the electrolyte

Reference Electrode Internal Solution
analyzer
Electrode Internal Solution A bridge for measurement in the electrolyte analyzer.
Cleaning Solution For cleaning the analyzer measuring system before shutdown.
For activation of Sodium, Potassium, Chloride, Ionized Calcium,

Activation Solution
pH, Magnesium and Lithium in the electrolyte analyzer
For correction of Sodium, Potassium, Chloride, Ionized

Linearity Control Material
Calcium, pH, Magnesium and Lithium in the electrolyte analyzer
For Deproteinization of Sodium, Potassium, Chloride, Ionized

Washing Solution (Deproteinizer) Calcium, pH, Magnesium and Lithium in the electrolyte
analyzer.

• Use of calibration solutions or electrodes not manufactured by HTI will void

warranty
• The storage temperature is 18oC - 25oC. The reagents can be refrigerated, but
must be brought back to room temperature before using.
• NEVER FREEZE ANY SOLUTION.
• The reagents are used for in-vitro diagnostics ONLY.
1.5 Sample Collection and Handling

1.5.1 Safety
Universal precautions must be observed when collecting blood specimens. It is recommended that all blood
specimens be handled as potentially infectious specimens capable of transmitting human immunodeficiency
virus (HIV), hepatitis B virus (HBV), or other blood borne pathogens. Proper blood collection technique must
be followed to minimize risk to the laboratory staff. Gloves should always be worn when handling blood
and other body fluids.
1.5.2 Serum Samples

Serum can be stored longer than whole blood, though preferably capped and placed in a refrigerator. Prior
to analysis, always allow sample to warm to room temperature.
• For serum samples, DO NOT use any surfactant, anticoagulants, etc., otherwise
it will cause incorrect results, or even destroy the sensor.
1.5.3 Urine Samples

• Dilute the urine sample as 1:9 with diluent prior to analysis. Diluent needs to be purchased separately
• Go to Advanced settings, enter the User password 123678, and then change sample type to Urine.
Press “OK” to save changes.
• Boracic acid is recommended as urine aseptic, other aseptic may affect the measurement.

1.6 Safety Information

This chapter lists all Warnings, Attentions, and basic safety information when using HTI E-Lyte Plus Electrolyte
Analyzer. Similar or related and other safety information can be found in appropriate chapters.
1.6.1 Danger
There is no safety information on levels of danger.
1.6.2 Warning
Improper and unsafe use of the analyzer can result in death, serious injury or material damage to the
operator.
• Only health professionals should use this analyzer for clinical diagnostics and under certain
conditions.
• Before using this analyzer, users must check the device and its accessories to ensure its proper
function and safety.
• Reagent should be disposed of per the regulations of the hospital / clinic.
• Do not use this analyzer in an environment where flammable substances are present to prevent
fire and explosion.
• Do not open the analyzer case as it may cause electric shock. Any services or upgrades should
be conducted by authorized personnel only.
• The packaging material should be disposed of per local regulations and should be kept in a place
where no children can reach.
• Connect this analyzer only to a power outlet with protective grounding. Do not use any power
outlets without grounding.
1.6.3 Caution
Failure to comply with the following and unsafe use of the analyzer can lead to injury, malfunction of the
instrument, damage, or other material damages.
• Use of calibration solutions or electrodes not manufactured by High Technology, Inc. could void
the warranty.
• The waste container holds human body fluids which may be potentially infectious; handle with
appropriate care to avoid skin contact or ingestion.
• Dispose the analyzer and consumables per local regulations. If there is any doubt, contact
manufacturer.
• Magnetic fields can affect the performance of the analyzer. Any equipment in use near the
analyzer must comply with EMC Standards. Cell phones, X-ray, or MRI devices are possible
interference sources, as they emit high electro-magnetic radiation.
• Before connecting the analyzer to power, make sure the voltage and frequency are in accordance
with the requirements on the label or in the manual.
• Install and transport the analyzer properly to prevent any damages by dropping, impact, shakes,
or other mechanical forces.
1.6.4 Attention
Some operations require extra attention. The following recommendations offer options to improve the
methods of operation of the instrument.
• Place this manual next to the analyzer for your convenience.

• Place the analyzer where easy observation, operation, and maintenance can be obtained.

2 DESCRIPTION OF ANALYZER
2.1 External and Internal Features
The following describes the external and internal components of the analyzer.
2.1.1 Front Panel
1 2 1 LCD Screen.
2 Internal Printer
3 Sample Probe
3
5 4 Wash Cup
4
5 Reagent Pack
6 5 Main Door
2.1.2 Rear Panel
1 Power Switch: “I” is on and “O” is off.
2 Grounding Connection
3 AC Power Connection
4 RS-232 Data Connection

1 2 3 4

2.1.3 Internal Components
1 2
1 Detector
2 Electrode Measuring Chamber

3
3 Peristaltic Pump
4 Distribution Valve
K Potassium Electrode
Na Sodium Electrode
Ca Calcium Electrode
pH pH Electrode
Cl Chloride Electrode
Ref Reference Electrode
• Electrode configuration will vary depending on model.

2.2 Operating Environment

2.2.1 Placement
The operating location should be suitable for the size of the analyzer.
The analyzer should be placed on a stable surface at an appropriate height for its use. Secure the
analyzer so it will not fall and/or cause injury.
There should be power with grounding within reach of the analyzers power cable.
• The instrument must have good grounding. Only connect power to an outlet that
has sufficient grounding.
2.2.2 Operating Conditions

Environment temperature: (10 ~ 30) oC
Relative humidity range: ≤ 70 %
Atmosphere pressure: (86 ~ 106) kPa
Power Voltage: AC 100-240V
Power Frequency: 50Hz±1Hz
2.2.3 Influence on other Equipment
If installed or not used per the instruction of this manual, it may cause or receive interference from nearby
equipment.
If the analyzer receives unstable readings, interruption of operation without obvious reasons, or if
malfunctions occur, it may be due to such interference. Keep the analyzer away from high efficiency
equipment such as an X-ray device to avoid interference.

3 INSTALLATION
3.1 Equipment Unpacking
Open the package per the marks on the box. Carefully remove the analyzer and its accessories (Please Note:
Sample Tray is optional and may not be included depending on model) per the pictures listed. Save all
original packaging for future storage and/or shipping needs.
• PLEASE NOTE: Sample tray is an optional component and may not be included
depending on model
3.2 Inspection of Instrument and Accessories
• Count and check the accessories per the packing list.

• Check the analyzer and accessories for any physical damage.
• Save the packaging material for future transportation and/or storage.
If there are any problems, contact your distributor immediately.
• Electrode serial number is the proof of warranty; please keep electrode and
packaging as well.

3.3 Reagent Pack

Follow the instructions below to install the Reagent Pack in the analyzer.
Put the reagent pack at the slot,

and push gently to secure it.
3.4 Tubing
Pump Tubing will need to be secured for the pump to operate. Follow the instructions below to secure the
tubing and the peristaltic pump.
Clip the pump tube to the bracket

and close the lock to secure it. The
“up” side of the tube should be
placed on the left side of the
bracket, otherwise the sample
cannot be aspirated.

3.5 Electrodes
3.5.1 Filling or Refilling Electrode Internal Solution
Rotate to open the head of electrode. Use clean syringe aspirate Electrode Internal Solution, then inject into
electrode chamber. The ISE Electrode Internal Solution should be filled up to about 2/3 - 3/4 of the electrode
chamber. Follow the steps listed below to properly fill or refill the solution in each electrode.
Unscrew the head of the inner

electrode and empty the solution.
Use a clean syringe aspirate

Electrode Internal Solution, then
inject into electrode chamber.
• The length of syringe probe should be 8-10mm. The probe should not enter the
electrode to avoid damaging the electrode membrane
• The Ag/AgCl inner electrode must always be immersed in reference solution.
• Add Electrode Internal Solution to reference electrode from the orifice on top
right corner of the electrode.
Replace the head of the inner

electrode to seal it. Screw down
(by hand) tightly to secure it.

• Flick the electrode bottom repeatedly. Make sure no air bubbles are present next
to the electrode membrane.
• Do not use expired, mildewed or damaged reagent.
• Immediately seal the reagent bottle after taking out the required reagent.
• Do not leave the reagent bottle opened for long periods of time.
• Check electrode regularly to make sure the Electrode Internal Solution is up to

2/3 - 3/4 of the electrode chamber and the Ag/AgCl inner electrode is immersed
in Electrode Internal Solution always.
• Keep the orifice on the top right corner of reference electrode clean, to avoid
clogging by salt crystallization.
3.5.2 Filling or Refilling the Reference Electrode

Rotate to open the head of the Reference electrode. Use clean syringe aspirate the Internal Reference
Solution, then inject into Reference electrode chamber. The Internal Reference Solution should be filled to
about 1/2 of the Reference electrode chamber. Follow the steps listed below to properly fill or refill the
solution in the Reference electrode.
Unscrew the head of the

Reference electrode and empty
the solution.
Use a clean syringe aspirate

Electrode Internal Solution, then
inject into the Reference electrode
chamber.

Check the head of the cover

there should be a small hole
in it. Replace the cover with
one that has a small hole.
Replace the head of the

Reference electrode to seal
it. Screw down (by hand)
tightly to secure it.
Solution should only be fill

about ½ of the chamber.
3.5.3 Electrode Installation

Install the electrodes into the electrode measuring chamber, beginning on the left and working to the right
(the reference electrode will be installed last). The sequence of electrodes for each machine type from left
to right is as follows:
Type A : K+ Na+ - - - Cl- Ref

Type C : K+ Na+ Ca2+ - pH Cl- Ref
Type E : K+ Na+ - Li+ - - Ref
Type F : K+ Na+ - Li+ - Cl- Ref
Type H : K+ Na+ Ca2+ Li+ pH Cl- Ref
Type J : K+ Na+ Ca2+ Mg2+ - - Ref
Type K : K+ Na+ Ca2+ Mg2+ pH Cl- Ref

Install the electrode in the

corresponding spot in the
measuring chamber
Once all electrodes are in place make sure that, they are all flush with each other.
Finally, rotate the knob by hand

(clockwise) on the right of
measuring chamber to secure the
electrodes.
• DO NOT use tools to tighten the electrodes. Tighten by hand.

3.6 Printer Paper

Place a new thermal roll into the chamber and thread it into the feeder (make sure the thermal side faces
down), then close the cover.
Open printer cover. Place thermal

roll and thread paper into feeder.
Then close printer cover.
• DO NOT pull paper backwards.
3.7 Connecting AC Power

Confirm that the AC power source conforms to the requirements of this equipment: AC 100-240V, 50Hz±1Hz.
Connect the analyzer to the AC

power adapter and connect to a
grounded power outlet
• The analyzer power cable must be connected to a suitable power outlet

designated for hospital use.
• If the power voltage is unstable, a UPS or high quality stabilizer is strongly
recommended.
• Connections to external equipment should conform to the requirements
specified in this manual.
• Electric balancing terminal should be connected to the grounding end of the
public power grid or properly connected to the other protective grounding ends
if necessary.

3.8 Turning on the Unit

Turn on the instrument by using the power switch on the rear panel. The distribution valve will start running
and a system check will begin.
The instrument begins initialization. The

microcomputer checks power, memorizer
and the printer, preheats the inner
hardware circuitry until stable. Then, the
peristaltic pump begins to run. The system
will display the initialization results.
3.9 Activation
3.9.1 Priming Reagent Pack
After checking the analyzers fluid lines, the screen will display:
Select “NO”. You will first need to prime

the Reagent Pack before activating the
Electrodes.

After you select “NO”, press “CANCEL”

on this screen to return to the Main Menu
From the Main Menu select the

“MAINTENANCE” menu and choose
“REPLACE REAGENT PACK”.
Press “OK” to continue, or press

“CANCEL” to return to the previous
menu

Once the Reagent Pack has been

verified the analyzer will countdown and
then prime the reagents from the pack..
3.9.2 Activating Electrodes

Once Reagent Pack has been primed, you can now activate the electrodes.
From the Main Menu select

“MAINTENANCE”, then press
“ACTIVATE” to start activation.
Activation time is automatically setup for

30 minutes.
New electrode installation is 30 minutes.
It is recommended to run daily at end of

day for 30 minutes
• The default activation time is 30 minutes.

• For new electrodes, unstable electrodes, or if an electrode is not used for some
time (e.g. one week), the operator must run activation on the instrument with QC
serum or fresh serum for at least 2 hours. Method: Aspirate QC serum or fresh
serum, turn off machine for 2 hours for activation.
• Activation can make the electrodes stable and prolong the electrodes life.

When prompted, add Activation solution

into probe as pictured below, and then
press “OK” to start activation.
3.9.3 Running QC for the First Time

Before running samples, you will need to run Quality Control.
• Follow the instructions in Chapter 4.1.2.1 to run a Quality Control test.
If QC ranges are unacceptable or if Quality Control fails, you will need to run QC Calibration.
• Follow the instructions in Chapter 4.1.2.3 to run QC Calibration.

4 OPERATION
This chapter will cover all the functionality of the analyzers software. All software menus and sub-menus will
be explained.
4.1 Main Menu

The instrument contains six Main menu items: ISE Calibration, QC (Quality Control), Samples, Settings,
Maintenance, and Other. This section will describe the functions of each of the corresponding menus. After
initialization is complete, the screen will display:
4.1.1 ISE Calibration

The instrument can obtain and store the electrodes slope data by running ISE calibration, also it can evaluate
the electrode stability by comparing the electrodes’ mv values during calibration. To perform ISE Calibration,
from the Main Menu select “CALIBRATION”, the screen will display:
When performing calibration, the

instrument automatically aspirates the
standard solution A & B to perform ISE
calibration.
AA.A and BB.B denote the electrodes’

mv values after calibration.
SS.S denotes the slope of the ISE

calibration.
XX.X denotes the calculated

concentration values for each measured
electrode

Below are their effective value ranges:
CAL A/B Slope Range

K mV 20 – 100 20 – 70
Na mV 20 – 100 20 – 70
Cl mV 20 – 100 20 – 70 Difference between A1 and A2/B1 and B2: less
Ca mV 20 – 100 5 – 50 than .5mV
Li mV 20 – 100 20 - 70
Mg mV 20 – 100 5 – 50
pH mV 40 -140 20 - 70
• Calibrate the instrument after every 10-15 sample tests.

• Calibrate the instrument before measuring, especially if the instrument has not
been used for a long time.
• It's very important that the main door is closed during calibration, since it
provides shielding from sources of electromagnetic interference.
4.1.2 Quality Control

This menu will allow the user to run Quality Control Tests, view Quality Control Factors, run Quality
Control Calibration and view Quality Control Statistics for Quality Control Analysis. The instrument can
store up to 900 QC results for the previous 31 days. From the Main Menu select “QC”, and the screen will
display:

4.1.2.1 Test
Users should perform a “Quality Control Test” every day. From the QC Analysis Menu select “TEST”, the
screen will display:
This menu is used when operator needs

to run QC Testing. Select desired
Quality Control level for testing
•
Enter Lot Number and the High and Low

values for each parameter on the Insert
Sheet from your Quality Control material
for the level that you are testing then
press “SAVE TARGET”.
To run the Quality Control test, after the

Lot Number, High and Low values have
been entered press “START TEST”.
When prompted follow the on-screen

instructions for Quality Control testing.
Repeat testing for each Quality Control

Level.
• Each QC test needs to be run individually. Run QC1, once complete repeat for
both QC2 and QC3

Test result will be printed out and shown

on the screen. Check and verify the
results against the Quality Control insert
sheet.
Press “SAVE” to save the result in the

QC log. Otherwise press “REJECT”.
•
4.1.2.2 Factor
The Factor screen will display the Slope and Intercept factors from the last QC Calibration that was
performed. Users can manually enter these factors by entering the Slope and Intercept values calculated
by using the formula and instructions from section 4.1.2.4. From the QC Analysis Menu select FACTOR”,
the screen will display the current factors:
Factors are automatically calculated for

all parameters except for Li and Mg.
These parameters will need to be
manually calculated and entered.
Once new factors are calculated and

entered, press “OK” to save and return
to previous menu

4.1.2.3 QC Calibration
The QC Calibration screen is used to calculate new factors for Slope and Intercept for each parameter. The
user will enter the target (or mean) values for the Low and High controls on the Insert Sheet from the Quality
Control material. Select “QC CALIBRATION”, the screen will display:
The QC Calibration will allow the user to

automatically calculate new factors for
K, Na, Cl, Ca, and pH
Press “START” to test. Follow the on-

screen instructions. Run control level 3
first (High QC), then level 1 (Low QC).
Slide the QC control into the probe.
• The analyzer will not automatically calibrate and calculate factors for Li or Mg.
New factors will be calculated automatically:
Press “OK” to save new factors or press

menu. Run a QC test as described in
4.1.2.1 to confirm new factors.

4.1.2.4 Manual QC Calibration

If needed the user can perform the steps in this section to perform a manual calculation to get new factors
for the Slope and Intercept values for all parameters. If performing a manual calibration factors for all
parameters must be set to 1.00 for slope, and 0.00 for intercept prior to performing these steps.
Calibration for Li and Mg need to be run manually. Use the following steps to run calibration to get the Slope
and Intercept values for.
• From the Main Menu, select “SAMPLES”

• Use any Sample ID value (e.g. 0001) and press “START”
• Run your High QC control first. Take note of the Li or Mg value, this will be your Calculated High.
• Run your Low QC control second. Take note of the Li or Mg value, this will be your Calculated Low.
Using the control insert sheet, your calculated values and the formulas below to calculate the Slope and
Intercept values for Li and Mg. The following formulas describe how the Slope ( m) and the Intercept (b)
are calculated:
𝒉𝒚𝒑. 𝑯 − 𝒉𝒚𝒑. 𝑳 hyp.H Hypothetical High

𝒎=
𝒄𝒂𝒍. 𝑯 − 𝒄𝒂𝒍. 𝑳 hyp.L Hypothetical Low
cal.H Calculated High
𝒃 = 𝒉𝒚𝒑. 𝑯 − (𝒎)𝒄𝒂𝒍. 𝑯
cal.L Calculated Low
• From the Main Menu select “QC”, and then select “FACTOR”.
• Enter the calculated values for Slope and Intercept into the corresponding boxes and press “OK”.

4.1.2.5 Statistics
The QC Statistics screen will allow the user to review saved QC data for the previous 30 days. QC Statistics
data consists of the Mean, Standard Deviation (SD), and Coefficient Variation (CV) from the last saved test
of the day, for the previous 31 days for all tested parameters. Users can review and print the selected data
for all 3 levels of QC. To review or print results select “STATISTICS”, the screen will display:
Select any one of the corresponding QC

levels to review the statistics for Quality
Control results.
QC Statistic Results will be displayed on

this screen. Users will have the option to
Delete or Print the displayed QC
Statistics

4.1.3 Samples
This section will describe how to process samples, the analyzer will test the following sample types, Serum
and Pre-diluted urine. Sample ID’s will consist of 4 digits (e.g. 0001). Sample ID’s will count in succession if
continuous samples are run. Conversely a unique ID can be entered for each sample. The analyzer can
store data for up to 7100 samples and if connected to and LIS or computer will automatically send data after
sample analysis is complete. From the Main Menu select “SAMPLES” to start sample analysis.
4.1.3.1 Manual
Follow the instructions below to perform sample analysis.
Enter the sample ID number to test a

specific sample.
Press “START” to begin testing.
When prompted remove the sample

from the probe to allow the analyzer to
analyzer the sample

When prompted scan the barcode for

the sample.
Please Note: The Barcode Scanner is

an optional component.
Sample results will be displayed on

screen and printed after analysis is
complete
4.1.4 Settings
The settings menu will allow the user to adjust the analyzers settings for Date & Time, Parameters, Print
Setup, Normal Ranges, Test Speed and Calibration Frequency. From the Main Menu select “SETTINGS” to
set make adjustment to the system settings

4.1.4.1 Date and Time

User can adjust the Date and Time from this menu. From the System Settings Menu select “DATE & TIME”,
the screen will display:
Press “START” to adjust the both date

and time. Date will be adjusted first,
use the number keys to enter the current
date using the format Month-Day-Year.
Then adjust the time to current time.
Press “YES” to save, then press

“RETURN” to return to the previous
screen.
4.1.4.2 Parameters
Parameters will allow the user to turn on and off selected parameters for testing. Turning off a parameter
means that it will not be tested or calibrated. For system models that do not support a specific parameter
these will be off by default. From the System Settings Menu select “PARAMETERS”, the screen will display:
Here the user will choose the testing

parameters of the analyzer, place a
green check next to the desired testing
parameters.
Press “OK” to save or “CANCEL” to

return to the previous screen
• Certain parameters are model specific and may not be selected.

4.1.4.3 Print Setup

The Print Setup menu will allow the user to turn on and off real time sample printing. From the System
Settings Menu select “PRINT SETUP”, the screen will display:
This screen will allow you to change the

internal printer’s settings. Press the
green check mark to turn off real-time
printing.
Printer type default is ESR
Print title will print a string at the top of

the sample printout.
Press “OK” to save, press “CANCEL” to

return to the previous screen
4.1.4.4 Normal Ranges

In the Normal Ranges setting the user can adjust the Low and High limits for all parameters. These limits
will print on the tested sample printouts. It is recommended to that each laboratory establishes its own
ranges for normal patient ranges. From the System Settings Menu select “NORMAL RANGES”, the screen
will display:
Enter the Labs default values for Low

and High limits for each parameter.
Press “OK” to save, press “CANCEL” to

return to the previous screen.

4.1.4.5 Test Speed

The Test Speed setting is used for changing the time the instrument take to calculate tested samples.
Normal is the analyzer default calculations will take around 40 seconds to complete after analysis when set
at this speed. Faster setting will take around 35 seconds, and Fastest setting will take around 30 seconds
to calculate. Changing this setting will not change the speed of the instrument or consumption of reagent.
Changing the setting from Normal can produce unreliable results for reproducibility. From the System
Settings Menu select “TEST SPEED”, the screen will display:
Users can change the testing speeds in

this menu.
Select desired testing speed and press

“OK” to save or press “CANCEL” to
return to the previous menu.
4.1.4.6 Cal Frequency

The Calibration Frequency settings will allow the user to adjust the One and Two Point Calibration
Frequencies. These settings should be adjusted by the user depending on the volume of samples tested
in each laboratory. From the System Settings Menu select “CAL FREQUENCY”, the screen will display:
The instruments default is to perform a

One-Point calibration every 10 samples,
and a Two-Point Calibration every 30
samples. Users can change the One-
Point Calibration frequency to calibrate
for each sample or for every 10 or 20
samples.
Select the desired frequency and press

“OK” to save or press “CANCEL” to
return to the previous menu

4.1.5 Maintenance
The instrument has four system maintenance programs, Deproteinize, Activate Electrode, Flushing and
Replace Reagent Pack. This section will describe the functionality of each menu. From the Main Menu select
“MAINTENANCE”, the screen will display:
4.1.5.1 Deproteinize
Deproteinizing is used to help keep the tubing in the analyzer clean and free of debris. The software is
preprogramed to request deproteinization every 100 samples. It is recommended to run deproteinization
2 times per week. Before running Deproteinize you must prepare the solution:
Prepare the solution by adding

diluent to enzyme. Mix well until
the powder is completely
dissolved. Let stand for 5 minutes
before use.
• Take caution not to have the probe touch the bottom of the mixed solution. The
probe touching the bottom of the cup can cause an aspiration error.

Select “DEPROTIENIZE” and place the

Deproteinizer under the sample probe.
Press “OK” to aspirate. Wait until
complete.
2:47
Wait for the process to complete, or

press “CANCEL” if necessary to stop the
process
• Deproteinizer storage and stability: Unmixed: 0-40 °C (2 year) Mixed: 2-8 °C (2

weeks)

4.1.5.2 Activate
Activation of electrode is required for when new electrodes have been installed, or for when there is a need
if ISE calibration fails. From the Maintenance Menu select “ACTIVATE”, the screen will display:
Default activation time is 30 minutes, for

new electrodes activation time is 30
minutes, it is also recommended to run
activation at end of day, activation time
is 30 minutes.
The timer will start, if the user chooses

Activation can be canceled at any time
during the procedure by selecting
“CANCEL”
• The default activation time is 30 minutes.

• For new electrodes, unstable electrodes, after deproteinization, or if
electrodes are unused for long time (e.g. one week), operator must run
activation on the instrument with QC serum or fresh serum for at least 2
hours. Method: Aspirate QC serum or fresh serum, turn off machine for
2 hours for activation.
• Activation can make the electrodes stable and prolong the electrode life.

4.1.5.3 Flushing
The Flushing function is used for flushing the tubing in the analyzer of liquid. The analyzer will use
Calibration Solution A from the pack to perform flushing. From the Maintenance Menu select “FLUSHING”,
the screen will display:
Use “Flushing” after testing has

completed several samples. The
instrument aspirates Calibration
Solution A to perform flushing
automatically
4.1.5.4 Replace Reagent Pack

This function is used when a new reagent pack need to be installed. From the Maintenance Menu select
“REPLACE REAGENT PACK”, the screen will display:
When the instrument prompts “Reagent

Pack is empty” use this function. The
procedure is the same as installation of
the reagent pack.
Once the new Reagent Pack has been

installed press “OK” to accept, or press
menu
Once the Reagent Pack has been

verified the analyzer will prime the
reagents, after completion, you will be
returned to the previous menu.

4.1.6 Other
This menu will allow users to Review and Upload Data, check Calibration Data used Advanced Setup
features on the instrument. From the Maintenance Menu select “OTHERS” the screen will display:
4.1.6.1 Review Data

The Review Data function will allow you to review both Sample and QC data stored from testing. The
instrument can store a total of 8000 results. From the Other Services Menu select. “REVIEW DATA”, the
screen will display:
Choose either Sample Data or QC Data

to review previously stored results
Sample Data storage is 7100 total

samples.
QC Data storage is 10 results per level

of QC per day or 900 total stored results.

Sample Data Review

Sample Data review is for the user to review sample data from previous stored results. Users can
review date from a specific date or date and sample ID for review on screen and print selected data.
To review all samples from a specific date, enter the date and then enter the sample ID as 0000. Use
the “PREV” and “NEXT” buttons to switch between sample ID’s for the specified day.
Input date to access the records

from the specified date. Input
Sample No. to query the specified
sample.
Press “REVIEW” to review data,

press “RETURN” to return to the
previous menu
On this screen, you can view and

print the selected results.
Use the “PREV” and “NEXT”

buttons to move between samples
on the selected date.

QC Data Review
QC Data review is for the use to review QC data from previous saved QC results. Users can review
date from a specific date, review on screen and print selected data.
Select the desired QC level to

review saved QC data for that level
of Quality Control tests
Enter the day number of the QC

data you wish to review and press
“REVIEW”
On this screen, you can print the

selected results. Use the “PREV”
and “NEXT” buttons to move
between samples on the selected
day.

4.1.6.2 Send Data

Use the send data button to send Sample and QC data from the day to an external computer or to an LIS
system. From the Other Services Menu select “SEND DATA”, the screen will display:
Connect the analyzer to a computer or

LIS system using an RS-232 cable.
Then click “SEND DATA” to copy the

measuring records to the computer or
LIS.
After data transmission is complete press

anywhere on the screen to continue.
4.1.6.3 Calibration Data

ISE Calibration data is stored for the previous month, the values displayed are the averages of the ISE
calibrations for all parameters. From the Other Services Menu select “CALIBRATION DATA”, the screen
will display:
Once the ISE calibration data has

calculated it will display on screen for
review. You can select “PRINT” to
obtain a print out of the results or press
“RETURN” to return to the previous
menu.

4.1.6.4 Advanced Setup

This function is for administrator and service technician use only. From the Other Services Menu select
“ADVANCED SETUP” to enter the advanced setup maintenance menu.
Select User Password and enter 123678

and press “OK”, select “QUIT” to return
to the previous menu.
Once logged in, the Administrator can

adjust values for Activation times,
Deprotein Counter, Objective (sample
type), Sample Volume, Auto Flush Time,
Deprotein Time, and Auto Cal Time.
Also, can check to how the Reagent
Pack solution flows by pumping solution.
• Adjustments can be made by using the

green arrows next to each parameter.
Press “OK” to save, or “CANCEL” to
return to the previous menu.
• Function • Values (Description) • Default Values
• Detector Enabled • Service Technician use only • Yes

• Activation (minutes) • 30 - 120 • 30
• Deprotein Counter • 50 - 300 • 100
• Sample Type • Serum, Urine • Serum
• Sample Volume • Service Technician use only • 140u
• Auto Flush Time (hours) • 0 (off) 1 – 5 • 1
• Deprotein Time (minutes) • 3 – 60 • 3
• Auto Cal Time (minutes) • 30 - 240 • 60

• Detector Enabled
The Detectors functionality is used for detecting liquid in the tubing it serves as the key component for
sensing samples and calibration solution from the reagent pack. The default setting is on. If turned off
the analyzer can still function when the fluidic line adjustment is performed to account for enough liquid
reaching though the electrode housing
• Activation (minutes)
Activation time setting is for the number of minutes that the Activate function runs when new electrodes
are installed or for when the Activate function is performed. The default setting is 30 minutes, but users
can adjust the time from 30 to 120 minutes.
• Deprotein Counter
The Deprotein counter setting is used for alerting the user when deproteinization needs to be
performed. Deproteinization should be performed weekly and when requested. The default setting is
every 100 samples and can be adjusted by the user from 50 to 300 samples
• Sample Type
The objective or sample type setting is used for changing the type of sample that can be tested by the
analyzer. Currently the supported sample types are Serum and Urine (diluted). The default objective is
Serum and users can change this setting by using this function
• Sample Volume
The Sample volume setting is used to change the volume amount that is aspirated when samples are
requested. Users can change this setting to the following volumes, 65μ, 100 μ, and 140μ. The default
setting is 140μ
• Auto Flush Time

The Auto Flush Time setting is used for setting the time that the instrument takes before performing the
auto flush function after the analyzer is in standby. Users can adjust the Auto Flush Time setting from
0 (off) to 5. Increments are in hours; the default setting is 1
• Deprotein Time (minutes)

The Deprotein Time setting is used for setting the time duration of the deproteinize function. Users can
adjust the time settings for this function from 3 to 60 minutes. The default setting is 3 minutes.
• Auto Cal Time

The Auto Cal Time setting is used for setting the time duration for the auto calibration after the analyzer
is in standby. The user can adjust the auto cal time from 30 to 240 minutes, the default setting is 60
minutes. For example, if the analyzer is set to 60 minutes for Auto Cal Time, after the analyzer has
been in standby mode for more than 60 minutes, upon wakeup the instrument will perform and ISE
calibration.

• Detector Adjust • Service Technician use only
• Fluid Adjust • Service Technician use only
• Pumping A 10ts • Use to pump (10 times per) Solution A from Reagent Pack into analyzer tubing
• Pumping B 10ts • Use to pump (10 times per) Solution B from Reagent Pack into analyzer tubing
• Scanner Adjust • Service Technician use only
• Electrode Test • Service Technician use only
• Auto Tray Test • Service Technician use only
• Detector Adjust
The Detector Adjust function is used to calibrate the detector. Performing this test will test the mV
values of the detector with and without liquid. The detector will be calibrated based on the values of the
mV readings. This function should be performed by trained Service Technicians only.
• Fluid Adjust
The Fluid Adjust function is for adjusting the liquid position in the analyzer tubing. Performing this test
will adjust the position of the liquid while sample analysis is being performed. This function should be
performed by trained Service Technicians only
• Pumping A 10ts
The Pumping A 10ts function is for pumping Solution A from the reagent pack. Performing this function
will allow the user to manually prime reagents for troubleshooting purposes.
• Pumping B 10ts
The Pumping B 10ts function is for pumping Solution B from the reagent pack. Performing this function
will allow the user to manually prime reagents for troubleshooting purposes
• Scanner Adjust (requires optional equipment)

The Scanner Adjust function is for checking and adjusting the barcode scanner. Performing this function
will test and adjust the barcode scanner. This function should be performed by trained Service
Technicians only
• Electrode Test
The Electrode Test function is for testing the stability of the electrodes. Performing this function will test
the mV values for all electrode over time. This function should be performed by trained Service
Technicians only
• Auto Tray Test (requires optional equipment)

The Auto Tray Test function is for testing the functionality of the sample tray. Performing this function
will test the speed and precision of the tray and to make mechanical adjustments. This function should
be performed by trained Service Technicians only

5 MAINTENANCE
5.1 Inspection
Before using the system, perform the following inspection:
• Check for any mechanical damage.

• Thoroughly inspect components, cables, and accessories.
• Inspect all the functions to be used on patients. Make sure the analyzer is in good working condition.
If any signs of damage is found and evidenced, the analyzer should not be used for any measurements.
Contact the service department or a local representative. Inspect the analyzer’s functions and safety every 6-
12 months or after service by authorized personnel. All safety and maintenance inspections should be done
by qualified maintenance personnel. Contact High Technology, Inc. for information on local
maintenance/service centers.
• If any inspection finds the equipment with an abnormality or its performance

changed due to environmental changes, replace related parts immediately. Any
changes in performance will result in incorrectly measured data or system being
down.
• If the hospital / clinic does not implement a satisfactory maintenance plan, it will
result in equipment malfunction.
• When the equipment is dampened or gets wet, do not turn it on. Ask qualified
service personnel to open the equipment and let it air dry immediately.
• Dispose of spare parts (including batteries) in accordance with local
government’s regulations.
5.2 Daily Maintenance

• Clean probe and injection port manually every day.
• Perform activation every day for 30 minutes.
5.3 Weekly Maintenance
• Check the Electrode Internal Solution in each electrode
• Check the reference solution volume, make sure inner electrode is submerged into reference solution.
When necessary, add Electrode Internal Solution from orifice by syringe. Make sure the orifice is
unobstructed
• Use deproteinizer solution (with enzyme) to perform electrode deproteinization.
5.4 Monthly Maintenance
• Check tubes and liquid flow system to makes sure the liquid path is unobstructed.
• Check peristaltic pump tubing, inspect for blockage, cracks in tubing, to make sure that the liquid path is
unobstructed.
5.5 Maintenance of Key Components
• Take out all tubes and immerse into distilled water for cleaning at least every 2 months.
• Replace Electrode Internal Solution when it’s turbid or mildewed, replace electrode if necessary.
• If electrode is dirty, use protein-removing solution to clean substances on electrode membrane. If severely
dirty, use a cotton thread to pull, come-and-go through electrode orifice to clean it. (DO NOT poke
electrode with needle or any other foreign objects).
• If tube or electrode clogs, lift the lower part of the tube, apply distilled water with injector and clean it out.
Allow distilled water effuse from sample probe. DO NOT punch through the electrode membrane with
injector head.
• If the electrodes are not used for a long time, clean residue in the electrode membrane tube with distilled
water, airproof it for storage.
6 TROUBLESHOOTING
Please refer to the following troubleshooting techniques if you come across any problems while operating the
analyzer. This topic covers the most common problems that can occur. Please refer to the service manual if
the topics are not covered.
Problem Suggested Resolution
• Remove air bubbles in electrode by flicking bottom of electrode repeatedly

• Check to make sure all electrode connectors are clean
• ISE Calibration • Check the Ag/AgCl inner electrode is immersed in Electrode Internal Solution
Fail • Make sure electrodes a securely connected
• Make sure electrodes sit flush in the Measuring Chamber
• Insufficient grounding, connect to a well-grounded outlet, UPS, etc.
• Make sure power cable is securely connected to analyzer and outlet
• Analyzer has no • Instrument must be connected to an outlet that has sufficient grounding
Power • If the power voltage is unstable, a UPS or high quality stabilizer is strongly
recommended
• Printer will not • Check that paper is loaded
Print • Check that paper is fed properly (thermal side up)
• Data Transmission • Check RS-232 connector on the analyzer and receiving computer is secure
Fails • Ensure that a Straight RS-232 cable is being used
• Run ISE calibration
• Unstable Testing • Check reagent pack, replace if empty or expired
Results • Possible interference from nearby equipment, move away from any high
efficiency equipment
• The pump will run one more cycle automatically if it continues to fail, please
• Detector Fails
refer to the Service Manual
• Sample Probe • Turn off the analyzer, grab the sample probe (line up the probe with the sample
Fails tray) and gently slide it up to down.
• Turn off the analyzer, check the connection to make sure it is secure. Re-
connect the sample tray if necessary.
• Sample Tray Fails
• Use extreme caution when connecting sample tray, the probe sample tube is
extremely close to the connector and could be damaged if care is not taken.
• Test Results drift • Use Pipe Adjust in the Advanced Settings menu (PW 123678) to adjust the
out of Range liquid to the correct position (about 1 inch past the electrode housing)
• Check for blockage from salt crystallization in the tubing, most commonly
around distribution valve. Clean/flush with syringe using DI water.
• Liquid Path Error
• Check electrodes for missing/damaged O-Rings, replace if necessary
(A) or (B)
• Use pumping A/B 10ts in the advanced settings menu (PW 123678) to check is
fluid is flowing properly from Reagent Pack

7 Automatic Sample Loader (Optional)

This section will cover the optional automatic sample loader and its functionality, installation instructions an
usage
7.1 Installation
Push the plug on the side of sample tray into the socket on the left of analyzer
1 2
• •1 Sample Tray Connector (male)
• 2• Analyzer Connector (female)
• •
• Use extreme caution when connecting sample tray, the probe sample tube is
extremely close to the connector and could be damaged if care is not taken.
• Gently push sample tray into

analyzer
• •

7.2 Automatic Activation

To perform automatic activation, select “Maintenance” from the Main Menu, and the select “Activate”
• When prompted to Activate Electrode

press “YES”
• The instrument with the sample tray

(optional) automatically detects the
activated cup and aspirates solution to
activate.
•
Activation solution should be placed in the
Activation position of the sample tray
•
• Press “OK” to start activation or wait 30
seconds, activation will start automatically.
Press, “CANCEL” to return to the previous
menu
•
• The Activation process with start, users

can cancel the Activation at any time
during the procedure by pressing
“CANCEL”

7.3 Automatic QC Test

To perform automatic QC Testing, from the QC Menu select “TEST”
This menu is used when operator needs

to run QC Testing. Select desired Quality
Control level for testing.
Enter Lot Number, then the High and Low

values for each parameter from the Insert
Sheet from your Quality Control material
for the level that you are testing then
press “SAVE TARGET”.
To run the Quality Control test, after the

Lot Number, High and Low values have
been entered press “START TEST”.
Place the QC sample in the QC1 position

on the sample tray. and press “OK” to
start the QC test.
Repeat these steps for each QC Level.

7.4 Automatic QC Calibration

To perform automatic QC Calibration, from the Main Menu select QC, then press QC Calibration.
To perform automatic QC calibration

press the QC Calibration button.
On the QC Calibration screen enter the

target (mean) values for both the Low and
High control. After verification press the
“START” button to begin the QC
Calibration.
Once prompted, place the low and high

control on the sample tray.
Low control – place in the QC1 position

High control – place in the QC 2 position

Once the QC Calibration is complete new

Calibration factors will be automatically
calculated. Press “OK” to save the new
factors.
7.5 Automatic Sample Test

To perform automatic sampling, from the Main Menu select Samples. There are two cup detection
methods for systems equipped with the sample tray.
7.5.1 Automatic Cup Detection Method

The automatic cup detection method will automatically detect any cups on the sample tray and assign a
unique sample ID to the detected cup number, these ID numbers will count sequentially.
Select the Cup Type, and set the Cup

detection method to Automatic. Press
“START” and the analyzer will detect the
cups and start sampling procedure.
As testing completes results will show

on screen and print automatically.
Sample ID’s will be automatic and will
count sequentially.

7.5.2 Manual Cup Detection Method

The Manual cup detection method will allow the user to enter a unique ID for each position entered.
If manual cup detection is selected,

enter a number (1-200) in the position
dialog box, and then press the “ENTER
POSITION” button to enter each ID
based on the position of the sample on
the tray
For each desired position enter the

sample ID number, press “NEXT” to
enter or change the next position
sample ID, press “PREVIOUS” to review
or change the sample ID.
Once Complete press start to begin

testing
Sample results will be displayed on

screen and printed after analysis is
complete

7.6 Emergency Testing

Emergency Testing can be performed at any time during the automatic sampling process. The user can
select up to 5 emergency samples to be run, place the emergency samples in the desired “Emergency”
position on the sample tray. To run emergency samples at any time during the process press the “STAT”
button
Press the “STAT” button at any time

during the automatic sampling process to
order emergency samples
Select the desired emergency position,

and place the emergency sample in that
position on the sample tray
Once emergency positions have been

selected press “OK”

Enter the desired ID for each sample

position, and then press “OK”
7.7 Automatic Deproteinization

From the Maintenance Menu select “DEPROTEINIZE”, the screen will display:
• Place the Deprotein Solution in position

“Deproteinize” on the sample tray.
•
• From the “MAINTENANCE” menu select
“DEPROTEINIZE” and follow the on-
screen instructions.
2:47
Wait for the process to complete, or if

necessary press “CANCEL” to stop the
process.

8 APPENDIX A: TECHNICAL SPECIFICATIONS

8.1 Basic Parameters
• K+ • Na+ • Cl- • iCa • nCa • TCa • pH • Li+ • Mg2+
8.2 Measuring Range and Measuring Precision
Parameter Measuring Range Resolution Precision (CV%)
K+ 0.5-15.0 mmol/L 0.01 mmol/L ≤1.5%
Na+ 30.0-200.0 mmol/L 0.1 mmol/L ≤1.5%
Cl- 20.0-200.0 mmol/L 0.1 mmol/L ≤1.5%
Ca2+ 0.10-6.00 mmol/L 0.01 mmol/L ≤2.0%
Li+ 0.10-6.00 mmol/L 0.01 mmol/L ≤3.0%
Mg2+ 0.10-6.00 mmol/L 0.01 mmol/L ≤3.5%
pH 4.00-9．00 0.01 pH ≤2.0%

8.3 Clinical Electrolyte Range
Parameter Serum Urine
K+ 3.5-5.2 mmol/L 50-100 mmol/L
Na+ 136-145 mmol/L 130-217 mmol/L
Cl- 96-106 mmol/L 170-250 mmol/L
Ca2+ 1.09-1.35 mmol/L
Li+ 0.5-1.40 mmol/L
Mg2+ 0.8-1.2 mmol/L
8.4 Slope Range
Items Slope range
K+ 40-70 mv/10 times concentration
Na+ 40-70 mv/10 times concentration
Cl- 40-70 mv/10 times concentration
Ca2+ 20-35 mv/10 times concentration
Li+ 40-70 mv/10 times concentration
pH 40-70 mv/10 times concentration

8.5 Operating Parameters
Sample Volume Size 65u, 100u, 140u,
Sample Type Serum, Urine (diluted)
Sample Application Sample cup, collection tube
Normal (40 Seconds)

Analysis time Faster (35 Seconds)
Fastest (30 Seconds)
Sample Rate 60 per hour
Calibration ISE Automatic, QC Automatic (except for Li and Mg)
Data Management 8000 Total Stored Results, 7100 Sample, 900 QC
Electronics Microprocessor Controlled
Display LCD, Screen Size 7” (178mm), Resolution 800x480
Printout ESR Built-in, thermal printer roll
Computer Interface RS-232 serial port (straight cable)
Power Voltage: AC 100-240V

Power Requirements
Power Frequency: 50Hz±1Hz
Atmosphere pressure (86 ~ 106) kPa
Environment temperature (10 ~ 30) °C
Relative humidity range ≤ 70 %

8.6 Communication Protocols

The E-Lyte Plus analyzer can send both Sample and QC results to an external computer or LIS system. The
analyzer will automatically transmit data after each sample is analyzed, conversely all sample data for the day
can be transmit by using the “SEND DATA” function from the “OTHER” menu. The analyzer does not
support orders from an LIS system, data communication is one way only. Below are the communication
protocols for both the connection and how the data is transmitted.
Connection Type: Serial RS232 (straight cable)

Baud Rate: 9600
Data Bit: 8
Stop Bit: 1
Parity: None
There are three kinds of protocol formats for the E-Lyte Plus analyzer, Real-Time Testing Data, Batch Testing
Data, and QC Testing Data.
* : stands for a space, which is not needed for a new line

? : stands for Barcode, which includes 20 digits
12 digits should be kept between items no matter if there are one, two or three numbers in each item’s value
Real-Time Testing Data Batch Testing Data
Sample*Report** Sample*Report**
Date**00-00-00** Date**00-00-00**
Time**00:00:00** Time**00:00:00**
PAT*******000** PAT*******000**
Reel*******000** Reel*******000**
Cup*******000** Cup*******000**
Barcode***????????????????????** Barcode***????????????????????**
K******0.00** K******0.00**
Na******0.00** Na******0.00**
Cl******0.00** Cl******0.00**
iCa******0.00** iCa******0.00**
TCa******0.00** TCa******0.00**
nCa******0.00** nCa******0.00**
pH******0.00** pH******0.00**
Mg******0.00** Mg******0.00**
Li******0.00** Li******0.00**
End End

* : stands for a space, which is not needed for a new line
QC Data
QC*Report*
Date:YY-MM-DD*
QC?*
Lot*No:??????* ? stands for 6-digit number
K*:????* ? stands for numbers or decimal point without limited digits
Na:????*
Cl:????*
iCa:????*
Li:????* Or Mg:????* Only one choice between them
End
8.7 Dimensions and Weight
Model Dimensions (mm) W*D*H Net Weight (kg)
HTI E-Lyte Plus w/Sample Tray 673 x 280 x 438 6.34
HTI E-Lyte Plus 368 x 280 x 438 5.20
8.8 Packaging, Transportation and Storage

Place the analyzer in a plastic bag. Place it in its original packaging material. If original packing material was
not saved, use a corrugated carton filled with foam or other fillers. Seal the carton.

9 APPENDIX B: CA AND PH INSTRUCTION

The serum composition is very complex. Protein and Citrate in serum samples can combine with calcium ions
which can become complexed calcium, which does not have physiological activity. The standard of calcium
balance in the human body is ionized calcium, not total calcium. Due to the limit of measuring methods, the
traditional methods (titration and colorimetric) are used to measure total calcium. After ion-selective electrode
technology emerged, the ion-selective electrode can measure ionized calcium more conveniently and
accurately.
The relationship between nCa, TCa and complexed calcium is described below:
TCa = nCa + Complexed calcium
(When pH = 7.40, TCa ≈ 2·nCa)
The electrolyte analyzer measures ion concentration by analyzing a serum sample. After serum is separated,
due to centrifugal role and time extend, contact with ambient air will cause a loss of CO2 in the serum sample
and the subsequent rise in pH will cause a reduction in ionized calcium. In this case, the iCa value in the
measuring result is not clinically significant.
The pH value displayed on screen is on the high side because of CO2 emission. Based on this actual pH
value, the instrument calculates the nCa value (equal to ionized calcium in human body) according to a specific
formula (nCa = iCa + (pH-7.4)/1.89). The nCa value is the main basis for clinical diagnosis when testing serum.
During sample analyzing, the system displays only nCa on screen, but it will print out iCa, nCa and TCa in the
measuring results, therein nCa is used for clinic diagnosis, iCa and TCa are only for reference.
Because CO2 emission is irregular, the pH value is only for reference in serum analyzing, it mainly works to
correct calcium ion.
When testing using a QC solution or other samples (with the exception of serum) which have no CO2 emission,
the iCa and displayed pH value on screen should be the basis for clinical diagnostics

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High Technology, Inc.

Document Number : OM-E-ELT-P-10

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Operator’s Manual: E-Lyte Plus

Symbols on the Box

Symbols on the Analyzer

This symbol indicated the location of the external ground connection

This symbol indicates the power connection on the analyzer.

This symbol denotes the Catalog number

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Operator’s Manual: E-Lyte Plus

This symbol denotes to Consult instructions for use

The symbol indicates EU representatives of the manufacturer and their addresses,

The symbol means the product is in vitro diagnostic medical device.

• Operation of this device conforms to the instructions in this Manual.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Operator’s Manual: E-Lyte Plus

The following situations are not included in the warranty:

• The serial number of the analyzer or electrode is missing or unreadable

• Obtain a return merchandise authorization from HTI’s Customer Service Department.

• Software design may vary depending on modification of device

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

High Technology, Inc. Revision Level 13

Operator’s Manual: HTI E-Lyte Plus

Operator’s Manual: HTI E-Lyte Plus

4.1.2.5 Statistics ............................................................................................................................................................ 26

II HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Operator’s Manual: HTI E-Lyte Plus

1.2 Brief Introduction

Type A : K+ Na+ Cl- - - - - - -

1.3 Description of Electrode

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 1 of 58

Operator’s Manual: HTI E-Lyte Plus

1.3.1 Electrode Principles

1.3.2 Measuring Principles

4 Ion Selective Electrode

5 Internal Electrode Internal Solution

6 Ion Selective Membrane

E0 : Electrode Standard Potential

2.3026RT T : Absolute Temperature

Page 2 of 58 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Operator’s Manual: HTI E-Lyte Plus

STD. A Sample STD. B C

1.4 Description of Reagent

In Reagent Pack. For calibration of Sodium, Potassium,

In Reagent Pack. For calibration of Sodium, Potassium,

A salt bridge for calibration and measurement in the electrolyte

Electrode Internal Solution A bridge for measurement in the electrolyte analyzer.

For activation of Sodium, Potassium, Chloride, Ionized Calcium,

For correction of Sodium, Potassium, Chloride, Ionized

For Deproteinization of Sodium, Potassium, Chloride, Ionized

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 3 of 58

Operator’s Manual: HTI E-Lyte Plus

• Use of calibration solutions or electrodes not manufactured by HTI will void

1.5 Sample Collection and Handling

1.5.2 Serum Samples

1.5.3 Urine Samples

Page 4 of 58 HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL

Operator’s Manual: HTI E-Lyte Plus

1.6 Safety Information

• Place this manual next to the analyzer for your convenience.

HIGH TECHNOLOGY, INC. PROPRIETARY AND CONFIDENTIAL Page 5 of 58

Operator’s Manual: HTI E-Lyte Plus