PR series

Electrolytes analyzer
User Manual
Rev. 4.01·12/21/11

MEIZHOU CORNLEY© HI-TECH CO. ,LTD.

Meizhou Cornley Hi-Tech Co.,Ltd Renault Petersen Limited
Nanshan Industrial Estate,Baigong Couching House
514765,Meixian, Guangdong Couching Street, Watlington
P.R.China Oxfordshire OX49 5PX
 Revised history

Version Date Description Author

Version 3.20 03/25/10 Software update Dong Lihai
Version 4.00 03/17/11 Software update Dong Lihai
Version 4.01 12/21/11 CE and Li Support Dong Lihai
 CONTENTS
1 General introduction..................................1 3.4.2 Whole blood test........................17
1.1 Application area...................................1 3.4.3 Urine test....................................17
1.2 System description..............................1 3.4.4 QC test.......................................18
1.3 Specifications......................................2 3.4.5 K test (For lithium only)..............18
1.4 Model differences................................3 3.5 Maintenance......................................19
1.4.1 For 4 parameters only..................3 3.5.1 Deproteinize...............................19
1.4.2 For 5 parameters only..................4 3.5.2 Conditioning...............................20
2 Installation...................................................5 3.5.3 Flush...........................................20
2.1 Operating environment........................5 3.5.4 Cleaning.....................................20
2.2 Unpacking............................................5 3.6 Setup.................................................21
2.3 Electrodes Installation.........................5 3.6.1 Time............................................21
2.3.1 Preparation...................................5 3.6.2 Reference range........................21
2.3.2 Installation....................................8 3.6.3 Maintenance interval..................21
2.4 Pump tube installation.........................9 3.6.4 Select channel............................22
2.5 Reagent pack installation....................9 3.6.5 Sample volume..........................22
2.6 Pinter paper installation.....................10 3.6.6 Coefficient factor........................22
2.7 Power on...........................................10 3.6.7 Printer option..............................23
2.8 Self test..............................................10 3.6.8 LCD contrast..............................23
2.9 Auto calibration..................................11 3.6.9 Calibration mode........................24
2.10 Shut down........................................12 3.6.10 Unit...........................................24
2.10.1 Within 24 hour..........................12 3.7 Service...............................................24
2.10.2 Beyond 24 hour........................12 3.7.1 Data retrieval..............................25
3 Operation..................................................13 3.7.2 Calibration data..........................25
3.1 Main menu.........................................13 3.7.3 Data transfer..............................25
3.2 Menu operation..................................13 3.7.4 Stop use.....................................26
3.3 Calibration.........................................14 3.7.5 Multiplexer check.......................26
3.3.1 1 Point Calibration......................14 3.7.6 Replace reagent.........................26
3.3.2 2 Point Calibration......................15 4 Maintenance.............................................27
3.4 Test....................................................16 4.1 Sterilization........................................27
3.4.1 Serum test..................................16 4.2 Daily maintenance.............................27
 4.3 Weekly maintenance.........................28 A.1 Sample collection and storage..........34
4.4 Monthly maintenance........................28 A.1.1 Whole blood ..............................34
4.5 Every 3 months..................................29 A.1.2 Serum.........................................34
4.6 Every 6 months..................................29 A.1.3 Plasma.......................................35
4.7 As necessary ....................................29 A.1.4 Urine...........................................35
5 Troubleshooting........................................30 A.2 mv range for electrodes....................36
5.1 Self test and liquid pathway problem 30 A.3 Interference factors...........................36
5.2 Electrodes problem...........................30 A.4 Reference Range for adult................37
5.2.1 Only one electrode.....................30 A.4.1 Electrolytes in serum and blood.37
5.2.2 More than two electrodes...........31 A.4.2 Electrolytes in urine ...................37
5.3 High or low test result........................31 A.4.3 Table of Critical values...............37
6 Packing list................................................33 A.5 Working principle...............................38
A Annex........................................................34
 Preface

Preface
1. Using this manual
This manual provides the information and procedures necessary to operate and
maintain the system. It is designed to meet the needs of medical personnel who use
the system on a daily basis and perform routine maintenance and troubleshooting.
2. Understanding the symbols
This section describes the symbols that may appear on the exterior of the system.
These symbols provide you with either important information or warning for proper
operations.
Complies with IVD directive 98/79/EC

In vitro diagnostic Medical devices

Biohazard Warning

Caution to alter the user to possible personnel injury or damage to the

instrument.

Note provides specific information in the form of recommendation, pre-

requirements etc.

Temperature limitation of storage

Batch code

Place upward

Consult instructions for uses

VI
 Preface

Serial NO

Expiration date

Manufactured date

Manufacturer

3. Cautions and hazards

3.1 Operator’s qualifications

This instrument should be operated by skilled or trained medical personnel.

It is crucial for the hospital or organization that employs this instrument to
carry out a reasonable service/maintenance plan. Ignorance of this
warning may result in function failure or shorten its life expectancy. Only
operate the instrument under the specified condition listed in this manual,
Otherwise, the system may not work normally or even damage is caused
to the instrument.
3.2 Safety precautions

Blood sample and blood products are potential source of infectious

diseases. Special care should be taken to avoid possible infections and
contamination when handling those sample and operating the system.
Gloves and protective clothing are always required.
3.3 Disposals of waste solution, waste bottle, used gloves

Waste solution and waste bottle which may contain or contact with bio
hazardous materials should be disposed in compliance with national or
local regulations . (Bio hazardous, dangerous solution)

VII
 Preface

3.4. Cleaning and sterilization maintenance

It is suggested that operators should strictly comply with national or local regulations
as well as the following:

clean the surface with blenching water of low concentration.

Sterile the surface with hydrogen peroxide solution of 2%.

Never use organic solution to clean or sterile the surface.

Always wear disposal gloves to avoid potential bio hazardous infections.

4. Technical assistance
Technical assistance is available over telephone and email. Please send email to
sales@.com/support@.com or contact us by +0086-755-86330866. If you are
interested in our products family, please go to our website: www..com for more
information.

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 User manual

1 General introduction
1.1 Application area
The instrument is intended for measuring ion concentration of potassium, sodium,
chloride, in the serum, plasma and whole blood, and potassium, sodium and chloride
in the urine.
The instrument is designed to be fast, efficient and easy use. You can easily operate
this system through keypad.

1.2 System description

This system mainly consists of probe, LCD display, keypad,measuring chamber,
multiplexer, pump, printer, etc.

1
4

5
2
6

3 7

1. LCD
2. Probe
3. Multiplexer
4. Keypad
5. Reagent pack connector
6. Measuring chamber
7. Peristaltic pump

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Fig. 1.1: Back view

1. RS232 port
2. Power switch
3. Power socket

1.3 Specifications
This section provides the requirements, specifications and typical performance of the
instrument.

Dimension

length(mm) Width(mm) Height(mm)

Main unit 300 260 360
Weight

Main unit 7.5kg

Power requirements and consumption

Power supply AC100~240V

Consumption 100VA
Fuse 2×F3.15L 250VAC
Operating environment

Ambient temperature 5~40ºC

Relative humidity Up to 85% non condensing
Storage and transportation conditions:

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Temperature -20ºC~+60ºC
Humidity Up to 95% non condensing
Sample volume

Typical 120µL(ISE)
Minimum 65µL(ISE)
Sample type

Type Whole blood, Serum, Plasma, Urine

Screen

Type LCD
Resolution 240×64 pixel
Printer

Type Thermal printer

Resolution 240×128 pixel
Full graphics 8 dots/mm
Printing speed 15mm/s
Paper width 57.5mm
Measured parameters

Parameters Measuring range Resolution

Potassium ion(K+) 0.30―10.00mmol/L 0.01mmol/L
Sodium ion(Na+) 20.0―200.0mmol/L 0.1mmol/L
Chloride ion(Cl-) 20.0―200.0mmol/L 0.1mmol/L
Calcium(Ca2+) 0.30―5.00mmol/L 0.01mmol/L
Lithium(Li+) 0.00―3.00mmol/L 0.01mmol/L
pH 6.0―9.0 0..01

1.4 Model differences

The model family consists of 3 models .
Model Configurations
3 Parameters K/Na/Cl
4 Parameters K/Na/Cl/Li
5 Parameters K/Na/Cl/Ca/pH
This manual is drafted on the base of 3 parameters. Most of its contents can be
applied to 4 parameters and 5 parameters except the following differences:

1.4.1 For 4 parameters only

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1. All menus concerned with K/Na/Cl will be replaced by K/Na/Cl/Li , such as calibration
test,report, etc.
2. Under QC>>K TEST, it is special for Lithium correction.

1.4.2 For 5 parameters only

1. All menus concerned with K/Na/Cl will be replaced by and K/Na/Cl/Ca/pH , such as
calibration, test,etc.
2. TCa, iCa, nCa and pH will be printed out on the report
3. Under Service>>Unit, Ca is displayed.
4. Under Setup>>Printer option, pH option is added.
5. Temperature correction is added.
Since pH is related to temperature and Ca is affected by pH (nCa≈iCa when
pH=7.40), it is necessary to compensate the temperature in order to get correct Ca
value. Please follow below procedures to setup temperature.
a) Power off the analyzer and open its rear cover.
b) Power up the analyzer for at least 30 minutes.
c) Enter SETUP, press key -, No, No, 1, 1, 9 to enable temperature compensation.
The system then prompts to enter the value of current room temperature with
message "T_Room=_____".
d) Test current room temperature with thermometer and enter the value with
numeric keys.
e) Press YES to save.
f) Close rear cover and power up for at least 30 minutes.
g) The measured temperature will display at the right bottom of main menu.
h) After temperature setup, the analyzer will compensate pH to 37ºC and get
correct nCa value ( inaccuracy <2ºC).

The temperature should be adjusted again if the variation of room

temperature exceeds 10ºC.

pH is use for Ca correction only. It can not be served as clinical

application.

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2 Installation
Always wear disposal gloves to avoid biohazardous infections when
handling or operating this instrument.

2.1 Operating environment

The environment which is going to install the instrument shall comply with the
following requirements:
6. Temperature : 5-40ºC.
7. Relative humidity :≤80% (without condensate).
8. Power supply :100-220V~50Hz/60Hz.
9. The earth of the socket shall be well grounded and keep way the instruments from
possible electromagnetic interference.
10. Working area: L*W (1.5*0.6) and at least 0.5m far from other instruments.
11. Others: Avoid sunlight irradiation, erosive gas, great temperature change and dust.

The instrument is intended for indoor use only.

2.2 Unpacking
Unpack and remove the instrument and the accessories from the cartoon. Place them
on a solid work table and check them with packing list. If any missing or damage is
found, please contact our distributors.
Please keep the carton and poly foam for future repacking in case of movement or
repairing.

2.3 Electrodes Installation

2.3.1 Preparation
a) Reference electrode
1. Take out the reference electrode. Left
cavity
2. Remove the tape on both sides the covers the
hole.
Right
3. Install O ring on both sides. cavity

Fig. 2.1: Reference electrode

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4. Use a syringe and aspirate refill solution for

reference(20ml).Then inject it into reference
electrode from the hole on the right cavity. The
solution surface should reach at least 1/3 of the
internal capsule.
5. Flip the bottom if there is any air bubbles
1/3
above membrane area on the left cavity.

Fig. 2.2: Refill reference electrode

1.Refill solution can be added directly. No need to replace.

2.It is normal if there is crystal formation in left cavity.
3.It is recommended to take out and shake the REF each week to prevent
crystal formation inside left cavity.
4.Reference is the common terminal for all electrodes.

Refill solution for ISE is totally different from refill solution for REF. Never
mix use those two solutions under any circumstances.

b) ISE electrodes
1. Take out electrodes from the box.
2. Replace refill solution if it is less than 1/2 height of internal cavity.
3. Follow the below procedure to replace refill solution of electrodes.
a) screw out the electrode head.Empty original refill solution.

2/3-3/4

Fig. 2.3: Screw out electrode head Fig. 2.4: Empty original solution

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b) Cut it open one vial of refill solution for ISE. Aspirate it with a syringe.
c) Insert syringe inside the electrode and lean the needle against the internal cavity.
Then inject slowly. Until the level reaches 2/3 height of internal cavity.

Fig. 2.5: Aspirate refill solution Fig. 2.6: Inject refill solution
d) Dry the screw hole of electrode with tissue.
e) Screw in the electrode head. Wipe dry the surface of electrode.
f) Flip the bottom to exclude air bubbles.

Fig. 2.7: Dry screw hole Fig. 2.8: Wipe dry surface

1.Empty the remaining refill solution before adding new.

2.The refill solution level should be around 2/3 to 3/4 height of internal
cavity. Otherwise the internal pressure can break the membrane.
3.Check the condition of the O ring. Missing or broken will cause sample
leakage.
4.There is a small slot on the electrode head to balance the pressure.Make
sure it is dry before screwing in.
5.Replace refill solution of ISE for every 3 months.

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Refill solution for Lithium is different from refill solution for ISE. Never mix
use those two solutions under any circumstances.

2.3.2 Installation
1. Open the cover of the instrument. Open the door of measuring chamber.
2. Pull out and twist the knob of measuring chamber to release it.
3. Wipe dry the internal surface of measuring chamber by tissue.
4. Install electrode one by one. First lift up then push forward until it is positioned.

Fig. 2.9: Install electrode Fig. 2.10: Release lock knob

5. Level them with thumb by pressing hard.

6. Return lock knob.

7. Close the door of measuring chamber.

Fig. 2.11: Level electrode

1.Clean the surface of measuring chamber and the electrodes first.
2.Missed or broken O ring can cause blockage or leakage.
3.Before taking out electrode, first lift up probe ,then manually rotate pump
to empty the pathway. Otherwise the remaining liquid can leak to the
measuring chamber.
4.The tension of knob can be adjusted by screwing in and out the knob

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2.4 Pump tube installation

1. Connect tubes on both ends.
2. Insert one end into the slot.
3. Stretch the pump tube ,then roll it around the wheel and insert another end into the
slot .

Fig. 2.12: Connect pump tube Fig. 2.13: Insert both ends

2.5 Reagent pack installation

1. Open the front door and disassemble the
connector from old reagent pack if there is one.
2. Tear off the tape on the new reagent pack,
Remove the protective tie-in.
3. Insert the reagent pack into the analyzer as
right figure shown.
4. Insert silicon connector into reagent pack.
5. Close the front door.
6. Cover old reagent back with protective tie-in.
Fig. 2.14: install reagent pack

Used reagent pack which may contain or contact with biohazardous

materials should be disposed in accordance with local regulations of
government or Lab.

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2.6 Pinter paper installation

1. Press open button on the printer to open the
cover.
2. Remove old paper roll.
3. Insert the paper into the slot. keep printable
side downwards.( This side can be easily
marked by nail).
4. Close the cover.
5. Press LF to feed paper.
Fig. 2.15: Install paper
2.7 Power on
1. Before powering on the instrument, make sure the voltage of power supply matches
the requirement listed on rear label.
2. Insert the power cord into the socket of the instrument.
3. Plug another end of power cord into a grounded outlet.
4. Turn the switch on the back.

1.An ungrounded power supply can lead to drift problem of all electrodes.
2.High power instrument with the same outlet can interfere with the
instrument.

2.8 Self test

After power on, self test will be performed first
to check its essential functions. A series of test
will be performed. If one of tests is failed, error Checking Cal A

message will be prompted and the system is

stopped.
Fig. 2.16: Self test

Battery and sample sensor is checked first. Then Cal A and B is aspirated
respectively to measuring chamber to check. Clock is tested finally.

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If self test is failed for a second time, power off the instrument and start
trouble shooting. Please refer to the section of trouble shooting.

Hold any key to skip self test after power on.

2.9 Auto calibration

Auto calibration starts automatically after self test is passed successfully.
The first time after power up, two successful cycles of calibration are required. The
first calibration establishes a history data and the second calibration compares with
the previous one to decide the status of electrodes.

The first passed Cal A shows in the right figure. ==============Cal A================28

The first pass shows no concentration.

K = 70.49 mv
The number in upper right corner is a 30 Na = 73.23 mv
Cl = 67.80 mv
second down-counter. It stops counting when
===============DONE!================
the response of electrodes is stable.
Fig. 2.17: First pass of Cal A

When Cal A is passed, then Cal B starts ==============Cal B================28

automatically. 28
K = 8.00 mmol/L 83.45 mv
The second passed Cal B shows the Na = 110.00 mmol/L 68.00 mv
Cl = 70.00 mmol/L 77.30 mv
concentration of Cal B solution.
===============DONE!================

Fig. 2.18: Second pass of Cal B

For new electrodes, if the problem of drift is happened, feed fresh serum to
activate electrode for 30 minutes, then check again.

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2.10 Shut down

2.10.1 Within 24 hour
If the instrument will be needed within 24 hours, switch the instrument off directly.

2.10.2 Beyond 24 hour

If the instrument will be needed longer than 24 hours, perform the following
procedures:
1. Perform Stop Use under Service>>Stop use.
2. Remove reagent pack from its housing and cover the protective insert.
3. Remove Electrodes from measuring chamber and place it into box.
4. Release pump tube.
5. Place reagent pack in a safety place.
6. Clean the surface of instrument and place it into carton box.

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3 Operation
3.1 Main menu
There are 5 sub menus under main menu.
2011-03-09 10:30
1. Test
2. Calibration Test
1---5
3. Setup
4. Maintenance
5. Service Fig. 3.1: Main menu
The first line shows system date and time. The second line shows the name of current
menu. The number in the third line indicates the No. of menu. Current No. is
highlighted. Press this number can direct enter this menu.

3.2 Menu operation

There are 3 command keys,10 digital keys, 1 dot and 1 minus key to operate this
system.
← Exit current menu or return upper menu.
YES Confirm selection or move to next item.
NO Exit or skip current items or menu.
1-9 Digital input/option command/shortcut of menu.
The menu operation is quite easy by using above keys. Normal operations are listed
below:
1. Use NO key to skip to next menu, use ← to return upper menu , press YES to
confirm.
2. Use shortcut to enter a menu. For example, press 1 1 to directly enter serum test
under main menu.
3. Use digital key to select option or toggle option.
4. Use YES to move to next items under certain menu,use → to clear, use← to move
previous( for example, under Reference range).
5. Use keys prompted displayed at the bottom.

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3.3 Calibration
Electrodes need calibration to associate the
2011-03-09 10:30
response of electrode (in mV) with the
known concentration of ion in the calibration Calibration
12--5
solution. The Nernst equation shows that mv
is proportional to the logarithm of
concentration. If two mvs from two different Fig. 3.2: Calibration
known concentrations are measured, then an unknown concentration of ion in the
sample can be calculated once its mv is measured.
In this system,each calibration will try 3 times if it is failed. If the third trial is
failed, the system will stop and ask for recalibration. Press YES to
continue, or press NO to exit.
Electrodes as well as the problem will be displayed on LCD if the
calibration is failed. Please refer to trouble shooting or contact the service
engineer for more help.
3.3.1 1 Point Calibration
1 PT calibration can associate mv values with mV
ion concentration of Cal A. It defines the first
point of two point calibration. 1 PT calibration is
Va
also used to check the status of electrodes
after two point calibrations is passed. In this CA mmol/L
case Cal B is presumed to be fixed and only
Fig. 3.3: 1 PT calibration
Cal A is required.
1. Select 1 Point Calibration, then press YES to ==============Cal A================28

start 1 PT calibration. 28
K = 4.00 mmol/L 82.21 mv
2. Then Cal A solution is aspirated and moved to Na = 140.00 mmol/L 65.98 mv
Cl = 100.00 mmol/L 99.26 mv
measuring chamber for test.
===============DONE!================
3. Once it is finished, the concentration of Cal A
solution will be displayed on the LCD. Fig. 3.4: 1 PT calibration is passed

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1. The number showed on the upper right corner is a down counter(30s).

2.The second column shows equal mark(=) when mv reading is stable.
3.The third column indicates respective concentrations of Cal A.
4.The fifth column shows the measured mV values from Cal A.

There are 4 possible results from 1 point calibration.

When it is passed, concentration of Cal A will be displayed and system

Pass
returns to main menu.
Unstable Electrodes can not reach stable when down-counter is finished.
The mV difference from two consecutive tests exceeds the limit. It
Drift
means electrode is unstable.
MV exceeds the limit of electrodes. It also means a failed electrode or
Over Range
channel.

1 PT Calibration will be auto started after every 10 tests .

3.3.2 2 Point Calibration

2 PT calibration defines both points of Cal A mV

and Cal B. When 2 point calibration is passed,

VB
the concentration in an unknown sample can
VA
be calculated from the two points via Nernst
equation. The mv difference between Cal B CA CB mmol/L

and Cal A should fall within the requirement to Fig. 3.5: 2 PT calibration
ensure linearity range of electrodes.
2 PT calibration includes two steps: Cal A (1 PT calibration) and Cal B. When both
calibrations are passed, the 2 PT calibrations are passed.
1. Select 2 Point calibration, press YES to start. ==============Cal B================28

2. Cal A will start first. That is 1 PT calibration. 28

K = 8.00 mmol/L 83.45 mv
After Cal A is passed, the instrument will start Na = 110.00 mmol/L 68.00 mv
Cl = 70.00 mmol/L 77.30 mv
Cal B automatically. Then Cal B solution is
===============DONE!================
aspirated and sent to measuring chamber for
test. Fig. 3.6: 2 PT calibration
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3. After Cal B is passed, concentration of Cal B solution will be displayed on the LCD.
There are five possible results from this calibration.
When it is passed, concentration of Cal B will be displayed and
Pass
system returns to main menu.
Unstable Electrodes can not reach stable when down-counter is finished.
The mv difference from two consecutive tests exceeds the limit of 0.5
Drift mv. It means electrode is unstable. The failed electrode is displayed
at the bottom of screen.
Mv exceeds the limit of electrodes. It also means a failed electrode
Over Range
or channel.
The Value of Cal B-Cal A is out of limited range. It means that
Abnormal
linearity range of electrode can not assure its performance.

2 PT Calibration will be auto started after every 2 times of 1 PT calibration .

3.4 Test
There are 4 menus to test sample.
2011-03-09 10:30
1. Serum
2. Whole blood Test
1---5
3. Urine
4. QC test
Fig. 3.7: Test

Always wear gloves to avoid bio-hazardous infections while performing all

the tests concerned.

3.4.1 Serum test

Serum sample can be tested under Serum
TEST
menu.
1. Enter Serum menu under Test menu. Serum
1--4

Fig. 3.8: Serum test

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2. Input a serial number by press 1. ============SERUM============

0018:0000
3. Lift up probe and feed serum sample. Then
Lift up probe to aspirate
press YES to aspirate.

===============================
Y=ASPIRATE N=EXIT 1=SERIAL

Fig. 3.9: Serum test

4. When the test finished, the result shows on the ============SERUM============
LCD and the report will be printed out. K = 6.58 mmol/L 70.74mv
Na = 113.78 mmol/L 75.20mv
Cl = 101.35 mmol/L 92.50mv

5. After all test are finished, Cal A is aspirated to =============Washing===========

flush the pathway. Y=ASPIRATE N=EXIT 1=SERIAL

Fig. 3.10: Serum test result

↑ or ↓ will be printed after the result if normal range of one item is

exceeded

3.4.2 Whole blood test

Whole blood sample can be tested under this =========WHOLE BLOOD=========
0018:0000
menu.
Lift up probe to aspirate
1. Enter Whole blood test.
2. The test procedures for whole blood test are ==============================
the same as serum test. Please refer to serum Y=ASPIRATE N=EXIT 1=SERIAL

test. Fig. 3.11: Whole blood test

Extra flushing is required after whole blood test to avoid blockage.

3.4.3 Urine test

Urine sample can be tested under this menu. ============URINE=============
0018:0000
1. Select Urine test.
2. Dilute the urine sample with Cal A in 1:9 first. Lift up probe to aspirate
Mix urine with Cal A in 1:9
3. The following procedures are the same as ==============================
Serum Test Y=ASPIRATE N=EXIT 1=SERIAL

Fig. 3.12: Urine test

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1.Only K, Na, Cl are tested for urine sample.

2.Urine shall be collected from 24 hours and the test is an average value
against 24 hours.
3.Urine sample must be diluted with Cal A first. The ratio for dilution is 1:9.
One part of urine adds into 9 part of Cal A. The instrument will calculate
and give the result automatically.
3.4.4 QC test
This menu is applicable to perform quality control test.
1. Enter QC test. ============QC test===========
2. There are six options under this menu.
1 QC Level 1 4 Level 1 range
1-3: Start to test QC level 1/2/3. 2 QC Level 2 5 Level 2 range
3 QC Level 3 6 Level 3 range
4-6: Setup Level 1/2/3 range. =============================
1-6=SELECT NO=EXIT

Fig. 3.13: QC text

3. Setup level range and test QC level ===========QC Level 1===========
accordingly. NO. 0004
There are two commands to show data.
Lift up probe to aspirate
1: Show statics data (mean, SD) ===============================
2: Show single record. Y=ASPIRATE N=EXIT 1=STAT 2=READ

Fig. 3.14: QC test level 1

When QC test is used to calculate Coefficient factor, history data must be

cleared first. That means QC test starts from 0001.

3.4.5 K test (For lithium only)

This menu is applicable to perform Lithium calibration.
1. Perform QC test as 3.4.4 for 3 levels, continue ==============K TEST================

next step only after Na is passed. 0001 28

K = 8.00 mmol/L 83.45 mv
2. Enter QC test and select K test. Na = 110.00 mmol/L 68.00 mv
Cl = 70.00 mmol/L 77.30 mv
3. Feed elective coefficient calibrator (for Li ＋ ) to Li = 2.00 mmol/L 86.20 mv
===============DONE!================
the probe as required. When finished test, the
result will be shown as right. Fig. 3.15: K TEST

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4. After 3 times of repeated K test, the result of K is automatically printed out and the
analyzer returns to main menu.

Li is affected by the status of Na electrode. Make sure Na is stable when

Li has problem.

3.5 Maintenance
The performance of electrodes will decrease with the increasing tests of samples.
Routine maintenance is essential to maintain electrodes and prolong their lifetime.
There are 4 menus under Maintenance menu.
2011-03-09 10:30
1. Deproteinize
2. Conditioning Maintenance
1--45
3. Cleaning
4. Flush

3.5.1 Deproteinize Fig. 3.16: Maintenance

This is a routine maintenance procedure required for electrodes.

The protein or fat in the samples can clot on the surface of membrane and reduce the
performance of electrodes. The deproteinize procedure can remove those protein or
fat and maintain the electrodes. The requirement for such maintenance is based on
sample load. For example, every 60 samples or every 10 days to perform one
deproteinize when the instrument gives message to maintain electrodes. The interval
between maintenance can be set under SERVICE>> Maintenance interval.
1. Enter Deproteinize.
2. Prepare the deproteinizer. Take out one pair of
Dissolve enzyme completely
enzyme and dilutor. Add the dilutor into the Then lift up probe to aspirate

enzyme. Shake the vial for several times then ===============================

wait for 2 minutes until the enzyme power is Y=ASPIRATE N=EXIT

completely dissolved (clear solution). Fig. 3.17: Deproteinize

3. Lift up probe and press YES to aspirate.

29.30
4. The whole procedure will last 30 minutes.
Press NO to stop if an early exit is desired. Deproteinizing

5. 2 PT calibration is performed automatically ===============================

NO=EXIT
after exiting Deproteinize.
Fig. 3.18: Deproteinizing
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Feed fresh serum instead of deproteinizer under Deproteinize when

activating new electrodes.

3.5.2 Conditioning
Conditioning is only effective to Na and pH electrodes. Perform it only when Na and
pH have problem.
1. Enter Conditioning.
4.30
2. Take out one piece of conditioner and feed it to
the probe.Then press YES to aspirate. Conditioning

3. The conditioning procedure takes 5 minutes. ===============================

NO=EXIT
Press NO to stop and if an early exit is desired.
4. 2 PT calibration is performed automatically Fig. 3.19: Conditioning
after exiting Conditioning.

3.5.3 Flush
When whole blood or urine is tested, extra
flush is required.
1. Enter Flush.
2. Cal A is aspirated to flush the pathway. ============Flushing=============
NO=EXIT

Fig. 3.20: Flush

3.5.4 Cleaning
Perform cleaning when electrode has abnormal problem or membrane is dyed. It can
also help to clean electrodes and liquid pathway to prevent them from blockage or
clot.
1. Enter Cleaning. 04:32
2. Cleaning solution is aspirated to clean
electrodes. Cleaning
3. Cleaning lasts 2 minutes. Press NO to exit if an ===============================
early stop is wanted. NO=EXIT

4. After exiting, 2 PT calibrations will start Fig. 3.21: Cleaning

automatically.

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3.6 Setup
There are ten menus under Setup menu.
1. Time
2011-03-09 10:30
2. Reference range
3. Maintenance interval Setup
1-3-5
4. Select channel
5. Sample Volume
6. Coefficient factor Fig. 3.22: Setup
7. Printer option
8. LCD contrast
9. Calibration mode
10. Unit

3.6.1 Time
1. Enter Time setup.
2. Input date and time accordingly.
2011-09-13
3. The system can maintain the date 10:30

automatically by its on board battery. Stay ===============================

power on to recharge the battery or replace a YES=SAVE NO=EXIT ←=BACK

new one. Fig. 3.23: Time setup

3.6.2 Reference range

This sets up the reference range of electrolytes
1. Enter Reference range setup. K 3.48 - 5.50
Na 135.00 - 145.00
2. Input low limit and high limit of each electrode. Cl 96.00 - 106.00

3. Press YES to save. ===============================

YES=SAVE NO=EXIT ←=BACK

Fig. 3.24: Reference range

3.6.3 Maintenance interval
The performance of electrodes can decrease with increasing tests of samples. The
electrodes requies routine deproteinize or cleaning to assure its performance. The
menu can setup up the interval between mainteance.

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1. Enter Maintenance interval setup.

Deproteinize after : 060 tests
2. Input days and tests for Deproteinize. When Deproteinize after : 007 days
Cleaning after : 005 days
either condition is met, Need de-proteinize is
prompted. ===============================
3. Input number of days for Cleaning. When this YES=SAVE NO=EXIT ←=BACK

condition is met, Need cleaning is prompted. Fig. 3.25: Maintenance interval

4. Press YES to save.

3.6.4 Select channel

A channel can be turned off when it is failed.
1 K ON
The test can be continued with other channels. 2 Na ON
3 Cl ON
1. Enter Select channel .
2. Setup each channel by using 1-3. Press YES ===============================
to save. 1-3=ALT YES=SAVE NO=EXIT

Fig. 3.26: Select channnel

Calibration will be performed if one channel is re turned on.

3.6.5 Sample volume

This can adjust the aspiration volume when pump tube is aging. It proves 5 levels of
adjustment.
1. Select Sample volume.
2. Press 1 to increase. Press 2 to decrease. Volume
3
3. Press YES to save.
3 is roughly correspoding to 130-150 µl and ===============================
each step has 20µl difference. YES=SAVE NO=EXIT 1=INC 2=DEC

Fig. 3.27: Sample volume

Adjust the volume for every 3 months to compensate the aged pump tube.

3.6.6 Coefficient factor

The instrument supports to correct the electrodes when the result is different from
standard values

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1. Select Coefficient factor.

SLOPE INTERCEPT
2. The first column is slope, and the second one K 1.00 0.00
Na 1.00 0.00
is intercept. The password for editing is 55. Cl 1.00 0.00

←: Reset slope and intercept to 1.00 and 0.00 ===============================

1: Input slope and intercept directly. ←=RESUME 1=INPUT 2=CAL YES=SAVE

Fig. 3.28: Coefficient factor

2: Calculate intercept and slope according to
QC level 1 2 3
QC data in QC test. The next menu is shown K 0.00 0.00 0.00
Na 0.00 0.00 0.00
as right figure to input target value when cal is Cl 0.00 0.00 0.00

selcted.
==============================
YES=CONFIRM/CAL NO=EXIT ←=BACK

Fig. 3.29: Input target value

1.Only K, Na, Cl, Ca can be calculated.

2.The calculation adopts results from QC level 1/2/3. The history data
must be cleared first before starting QC test (No. starts from 0001).
3.6.7 Printer option
This menu controls the setup of printer.
1. Select Printer option. ---------------------SETUP---------------------
11 Printer
Printer ON
ON
2. There are two options to control the printer and
22 Reference
Referencerange
range ON
ON
test report. 33 Cal
Calstatus
status ON
ON
4 QC range ON
Printer : Turn printer on or off.
-----------------Printer
==============================
option-----------------
Reference range: Select to print reference 1-4=ALT 1-3=ALT
YES=SAVE YES=SAVE
NO=EXITNO=EXIT

range on the report or not. Fig. 3.30: Printer option

Cal status: Enable or disable auto Cal status print.
QC range: Enable or disable QC range print when QC test.

3.6.8 LCD contrast

This can adjust the contrast of LCD.
1. Enter LCD contrast. Contrast
3
2. Adjust the contrast accordingly
3. Press YES to save. ==============================
YES=SAVE NO=EXIT 1=INC 2=DEC

Fig. 3.31: LCD contrast

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3.6.9 Calibration mode

This can setup the interval of auto calibration and sleep mode.
1. Select Calibration mode.
Current :60 min interval
2. There are two setup options: Cal Interval: 1 60 2 120 3 180
4 240
Cal interval: there are four options for this
Sleep Period: 5 From 07:30
items, 60 minutes, 120 minutes, 180 minutes To 19:30
===============================
and 240 minutes. YES=SAVE NO=EXIT 1-5=SEL MODE

Sleep mode: Setup sleep interval. There is no Fig. 3.32: Calibration mode
calibration under sleep mode.
3. Press YES to save changes.
The cycle of auto calibration is pre-defined as following:
Every 2 times of 1 PT calibration follows one time of 2 PT calibrations.

Interval of 1 point calibration

  1 point calibration  1 point calibration 2 point calibration

3.6.10 Unit
This controls unit of test result.
1. Enter Unit. 1 K mmol/L
2 Na meq/L
2. Press corresponding digit to toggle between 3 Cl mmol/L
4 Ca mg/dL
option. ===============================
YES=SAVE NO=EXIT 1-4=ALT

Fig. 3.33: Unit

mmol/L is available for K Na Cl Ca. meq/l is available for K Na Cl. mg/dL is
only available for Ca.

3.7 Service
There are 6 menus under service menu.
1. Data retrieval
2011-03-09 10:30
2. Calibration data
3. Data transfer Service
1---5
4. Stop use
5. Multiplexer check
Fig. 3.34: Service
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6. Replace reagent

3.7.1 Data retrieval

1. Select Data retrieval.
2. Next input the searching rules either by date or Date: 2011/03/21
Serial: 0000
by serial then press YES to search.
3. The result shows after searching. ===============================
4. Press -,No, No,2,2 can delete all history data. -,No,No,2,2=Delete all data!

Fig. 3.35: Data retrieval

3.7.2 Calibration data
This menu provides information for trouble shooting. Calibration data can be used to
judge the status of electrodes.
1. Select Calibration data. CAL B 2
2. Press 1 or 2 to skip between data. K 81.04
10.38 Na 77.25
3. The last 32 records can be reviewed. "B2" Cl 99.92

means the second trial of Cal B. "10:38" is the ===============================

time when Cal B2 is carried out. The number 1=PRV 2=NEXT 3=PRINT NO=EXIT

after each electrode is mv value. Fig. 3.36: Calibration data

3.7.3 Data transfer

The instrument can transfer data to computer via RS232 serial cable.
1. Connect the instrument and the computer via
serial cable using the port of RS232 on the
back cover.
2. On the computer, select Start >> All
program>>Accessories>>Communication
>>HyperTerminal, setup the HyperTerminal as
Fig. 3.37: Protocol
right shown.
3. Enter Data transfer to start transmitting. This will dump all the history record into
computer.
Transmitting data!

===============================
NO=EXIT

Fig. 3.38: Data transfer

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3.7.4 Stop use

This function guides the operator to prepare for long time shut down or before
transportation.
1. Enter Stop use.
2. Follow the instructions to flushing the pathway.
3. Remove the reagent pack and cover its protective insert.
4. Remove the electrodes from measuring chamber.
5. Screw out the head of reference electrode and empty its refilling solution

3.7.5 Multiplexer check

This function is used to troubleshoot multiplexer.
1. Enter Multiplexer check.
2. There are four options at the bottom.
Press 1/2/3/4 to switch multiplexer to
1: Switch multiplexer to Cal A. different position
2: Switch multiplexer to Cal B.
===============================
3: Switch multiplexer to cleaning. 1=A 2=B 3=Clean 4=AIR
4: Switch multiplexer to null. Fig. 3.39: Multiplexer check
3. Lift up probe. Select one option and inject DI water from connector to check
corresponding flow path. Normally, DI water will come out from probe tie-in if there is
no blockage.

3.7.6 Replace reagent

This function guides the operator to replace new reagent pack.
1. Enter Replace reagent.
2. Follow the instructions to replace the reagent pack.

This operation is only necessary when reagent counter is activated

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4 Maintenance
This section includes the recommended maintenance procedures for the instrument.
The frequency of preventive maintenance operations is based on average workload of
20 to 30 samples per day with a normal instrument use. Facilities with heavier
workloads should schedule maintenance operations more frequently.

Wear disposable gloves to avoid contact with potentially infectious

materials while maintaining the instrument.

4.1 Sterilization
The purpose of sterilization is to minimize the danger` of infection when contacting
with blood-contaminated parts.
The sterilization should be performed routinely.
It is recommended the operator comply with sterilization procedures and special
requirement of lab.

Only use liquid disinfector such as 2% hydrogen peroxide. Never use

organic solution or alcohol to clean or sterilize the surface.

Do not pour any liquid such as the disinfector directly on the surface, or it
will cause electrical short circuit.

The following parts need to be sterilized periodically.

1. Probe
2. Liquid flow path
3. Display and keys

4.2 Daily maintenance

The maintenance operations described here are recommended to be performed

everyday just before or after routine measurements.

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1. Clean the probe

2. Clean surface of the instrument.
3. Do 2 PT calibration first to check the instrument first. After calibration is passed, test a
sample to check.
4. Near day off, do Deproteinize or cleaning to maintain electrodes if necessary.

4.3 Weekly maintenance

The maintenance operations described here are recommended to be performed every
week at the end of the routine measurements.
1. Sterilize exterior and interior surface and aspiration probe tie-in
2. Take out reference electrode and shake it for several times to avoid crystal formation.
3. Cleaning the pathway to prevent blockage.
4. Check the multiplexer if there is any leakage.
5. Test middle level QC, adjust intercept and slope accordingly.
6. Perform Deproteinize and cleaning to maintain electrodes.
7. Clean liquid pathway by injecting DI water with a syringe. Avoid hard pushing from
breaking the membrane.

Careful cautions should be taken when sterilizing probe to avoid injury

and potential infections.

4.4 Monthly maintenance

1. Check the solution level of K +, Na+, Cl- ,Li+ electrodes. Replace the refill solution if it is
less than 2/3.

For K+, Na+, Cl-, Ca2+, Li+ and pH electrodes, empty the remaining refill
solution before filling new.

2. Correct coefficient factors (slope and intercept) with high/middle/low level QC.
3. Take out reference electrode, remove crystal if there is too much. Refill if the solution
is not enough.

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4. Clean all the pathway to avoid blockage

4.5 Every 3 months

Replace refill solution for K+, Na+, Cl-, Ca2+, Li+ and pH electrodes
Adjust sample volume of aspiration if it is not enough.

4.6 Every 6 months

1. Replace pump tube
2. Check O ring of electrode
3. Check connection of tube
4. Check the movement of multiplexer

4.7 As necessary
1. Replace printer paper
2. Replace O rings
3. Perform Conditioning if Na+ and pH electrode has problem.
4. Perform Deproteinize if K+, Cl+ ,Ca++, Li+ and pH has problem.
5. Perform Cleaning if Deproteinize is invalid.

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5 Troubleshooting
This section covers the trouble shooting procedures of the instrument.
The instrument can perform self test when power up. It will detect most of the problem
except electrodes.

5.1 Self test and liquid pathway problem

Problem Possible causes Measures
Multiplexer error Sensor is broken Need replacement
Need adjustment Adjust R39 or R65
Lens inside lock knob is Take out the lens and
Sample sensor error
polluted clean
Sensor is broken Need replacement
Reagent pack is run out Replace new one
Reagent connector is loose Re insert the connector
Electrodes is not installed
Level the electrode
correctly
No Cal A Knob of measuring chamber is
Pull out and twist to lock
No Cal B open
O ring of electrodes is broken Replace O ring
No Cleaning solution Pull out by two handles
Blockage in the multiplexer
&clean
Leakage in the liquid pathway. Check by injecting water
Blockage in the probe Clean
Blockage in the waste tube Clean by injecting water

5.2 Electrodes problem

If the problem happens with

5.2.1 Only one electrode

Problem Possible causes Measures
Refill solution is less than 3/4 Empty and replace new
Coat of internal core is broken Replace new electrode
OR
Incomplete installation Press and level with thumb
Air bubble above membrane Fillip and exclude
Membrane is polluted Deproteinize or cleaning
Electrode case is cracked Replace new electrode
Abnormal
Internal core is broken Replace new electrode
Lifetime is exhausted Replace new electrode
Drift Activate with fresh serum for
Need activation (only for new)
30 mins

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Problem Possible causes Measures

Liquid on the surface Take out and clean
Incomplete installation Press and level with thumb
Drift Insufficient refill solution Replace new refill solution
Rusty electrode head Replace new electrode
Air bubbles above membrane Fillip and exclude
Na electrode problem Maintain Na
Li problem Li electrode problem Maintain Li
Inaccurate K value Perform K Test
5.2.2 More than two electrodes
Problem Possible causes Measures
Poor grounded power supply Connect earth
Air bubble in REF electrode Exclude air bubble
Crystal formation in REF Clean
REF is unstable Replace
Liquid in the measuring Take out electrodes and clean
Drift or Abnormal or
chamber all surface
OR
O ring is missing or broken Replace new
Membrane is polluted Deproteinize or cleaning
Blockage in the liquid flowpath Check with syringe
Leakage in the liquid flowpath Check with syringe
Air bubble in the liquid pathway Check leakage or blockage

5.3 High or low test result

The high or low test result may caused by coefficient factors. The electrode requires
correction to match standard value through coefficient factor. The performance of
electrode is affected by the protein or fat clot of samples. It is recommended to do
routine QC test to monitor this affection. Once the result is higher or lower than
normal level, it is required to correct the electrode by adjusting coefficient factor.
YH − YL
SLOPE =
XH − X L
INTERCEPT=YH-SLOPE*XH Or YL-SLOPE*XL
Where: YH, YL is the target value of the High level, Low level QC
XH, XL is the average test value excluding the highest and lowest test value.

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Target value Y = ax + b
Y = ax + b’

High level QC Adjust the intercept

Intercept M iddle level QC

Low level QC

Slope Test value

The program in the Setup>>Coefficient factor is used to change slope and intercept
values to provide best correlation with Linearity Quality Control materials
The following procedure should be utilized to determine slope and intercept values:
Prepare the Linearity Control Materials as recommended.(High, Middle, Low level
provided by the same manufacturer).
1. Select Setup>>Coefficient factor to enter. Select ← to reset the values. (slope =1.0,
intercept = 0.0 , Password: 55). Press YES to save.
2. Enter QC test and select level 1,clear the history data, the serial No should be
started from 0001.
3. Enter QC test and select level 2,clear the history data, the serial No should be
started from 0001.
4. Test QC level 2 at least 5 times.
5. Enter QC test and select level 3,clear the history data, the serial No should be
started from 0001.
6. Test QC level 3 at least 5 times.
7. Select Setup>>Coefficient factor. Press 2 to select calculation.
8. Input expected value of QC level1/2/3, Press YES to continue.
9. The calculated coefficient factor will display on the LCD. Press YES to save.
10. Enter QC test and select level 2, test QC level 2 to check.
11. If the result is still a little lower or elevated, just fine adjust intercept accordingly. After
adjustment, recheck with QC level 2.

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6 Packing list

Standard Packing List Quantity

Electrolytes analyzer 1 unit
K/Na/Cl Electrodes 1set
Ca/pH Electrodes(optional) 1 set
Li Electrode(optional) 1 set
Ref Electrode 1piece
Refill solution for ISE electrodes 5×0.8ml pieces/set
Refill solution for Ref electrode 20ml/bottle
Refill solution for Lithium(optional) 20ml/bottle
Selective coefficient calibrator(optional) 20ml/bottle
Reagent pack 1 pack
Electrodes conditioner 5×0.8ml pieces/set
Deproteinizer 5 pieces / set
Quality control materials(H/M/L) H(1ml×3) M(1ml×4)L(1ml×3)
Cal A for urine dilution 20ml/bottle
Pump tube 3 pieces
Reagent pack connector 1 piece
Probe tie in 2 pieces
Test kit with tubing 1 piece
Power cord 1 piece
Fuse 3.15A 2 piece
Printer paper 3 rolls
User manual 1 set
Syringe 1 piece
Long needle for blockage elimination 1 piece
Allen key 1 piece
Electrode O’ ring 5 pieces

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A Annex
A.1 Sample collection and storage
There is complete sample handling and storage information in the standard Clinical
Chemistry procedures published by NCCLS. This section only lists a few of them.
Please refer to them for more details.

Wear disposal gloves to avoid potential infections during these operations

A.1.1 Whole blood

Blood from artery vessels, vein and capillary vessel can all be used for test with this
analyzer. Whole blood samples should be drawn carefully to avoid hemolysis.
Elevated potassium values may indicate a hemolyzed sample; if hemolysis is
suspected, a new sample should be drawn and analyzed. Finger stick methods
should be avoided since they can result in elevated potassium values.
1. Collect the samples by venipuncture into a lithium-Heparin evacuated blood collection
tube. Do not use AMMONIUM HEPARIN, EDTA or NaF tubes. Note the time of
collection.
2. Mix the sample by inverting and rotating the tube. Do not shake.
3. Analyze the sample within one hour of collection. Beyond this time elevated
potassium may be obtained.
For the same sample, there is a difference of about 3mmol/L Cl - ion
between blood (serum) and whole blood.
Salicylate (and its derivatives) and bromide inside the sample can increase
the Cl reading. The sample may be polluted by perchlorate, cyanide
sulfate, iodide or nitrate.

A.1.2 Serum

1. Collect the sample by venipuncture into an untreated tube. Fill the tube to at least 2/3
of the total volume. Note the time of collection.
2. Let the sample stand for 20-30 minutes to wait for clot formation.
3. Rim the clot with an applicator stick, then centrifuge the tube for 10-15 minutes and

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remove the serum to a clean sample tube.

4. Serum may be analyzed immediately. If immediate analysis is inapplicable, then the
sample should be stored at 4ºC for 24 hours or frozen at -20ºC for up to one week.
Samples must be brought to room temperature and mixed well prior to analysis.
5. In order to obtain accurate results, samples should be free of any clots, fibrin, etc.,
which would obstruct sample flow and affect results. The use of a serum clearing
agent is strongly recommended.
If a serum separator tube is utilized, care must be taken to avoid inserting
the Probe into the gel layer. This can create obstructions in the Probe and
electrodes.
Plasma samples offer no advantage over whole blood samples for stat
analysis. If the sample is to be stored, serum specimens are preferable.

A.1.3 Plasma

1. Collect the specimen by venipuncture into a Lithium-Heparin evacuated blood

collection tube. The heparin level should not exceed 15 U per ml of tube volume.
Normally total 1000 unit is recommended
2. Do not use AMMONIUM HEPARIN, EDTA or NaF tubes. Note the time of collection.
3. Centrifuge the sample within one hour of collection. Carefully remove the top plasma
layer fro analysis. Use a syringe fitted with a blunt-tipped needle for this procedure.
4. Analyze plasma sample within 4 hours of collection. Refrigerated samples must be
brought to room temperature and centrifuged prior to analysis.

A.1.4 Urine

1. Follow standard clinical procedures for collection of random and 24-hour urine
sample.
2. Refrigerate urine sample until time of analysis.
3. Centrifuge urine samples to remove cellular matter, crystals, etc.
4. Dilute the urine sample with one part of the urine to 4 parts of Cal A. Urine must be
diluted. Do not attempt to analyze undiluted urine.

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A.2 mv range for electrodes

Normal range (mV) mV(CAL B) – mV(CAL A)
K 45 ~ 140 12~ 21.0
Na 45 ~ 120 -4.2 ~ -7.3
Cl 50 ~ 120 5.4 ~ 10.8
Ca 35 ~ 100 6.6 ~ 10.5
pH 70 ~ 170 16 ~ 28
Li 50 ~ 150 5.0 ~ 9.0
When response potential of the electrode is outside the normal range, the system
prompts OR error.
When potential difference of Cal B-Cal A falls beyond above limit, the system prompts
abnormal error.

A.3 Interference factors

There are some medicines or factors that can affect the value of electrodes. The
following are some examples and their effect.

Medicine Effect
Heparinate anticoagulant K↑, Na↑, Ca↓
Hemolysis K↑, Ca↓
Contaminated container K↑, Na↑, Cl↑, Ca↑
Salvolatile K↑, Na↑, Ca↓
Nystatin K↑, Ca↓
Amphoterisin K↑, Ca↓
Procaine K↓, Ca↓
Lidocaine K↓, Ca↓
Bromide Cl↑
Iodide Cl↑
Nitrate Cl↑
Thiocyanate Cl↑, Ca↓
Salicylate Cl↑, Ca↓

Other than above factors, electromagnetic interference, irradiation of strong light,

degraded calibrate, additives and preservatives in the QC materials, imperfection of
the grounding, unstable power supply, dry out of electrode refill solution, chloride layer
falling off the silver stick of the electrode or corrosion and moist of grounding points
are all the inducements to imperfection in calibration and testing.

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A.4 Reference Range for adult

A.4.1 Electrolytes in serum and blood
Reference Range Unit
pH(37ºC) 7.35 ~7.45
Sodium(Na+) 136~146 mmol/L
Potassium(K+) 3.5~5.1 mmol/L
Chloride(Cl-) 98~106 mmol/L
Calcium Ionized(Ca++) 1.12~1.23 mmol/L
TCO2 23~29 mmol/L
A.4.2 Electrolytes in urine
The normal range of electrolytes in urine is shown in below.
Range Unit
K +
25 ~ 100 mmol/24hour
Na +
130 ~ 145 mmol/24hour
Cl -
110 ~ 250 mmol/24hour
Note: The unit is mmol/24 hour. Since electrolytes in urine vary greatly in one day, the
range is an average concentration of all urine collected from one patient in 24 hours.

A.4.3 Table of Critical values

A critical value is a value at such variance with normal as to represent a path
physiological state which is life threatening unless some action is taken immediately
and for which an appropriate action is possible. It is the laboratory’s responsibility to
communicate these values immediately and flawlessly to the responsible clinicians.
Each laboratory should determine its own critical values. The above values are stated
for reference purposes only.
Analyte Value Possible Effect
<7.2 Complex interwoven patterns of acidosis,
alkalosis and anoxemia
pH
>7.6 Complex interwoven patterns of acidosis,
alkalosis and anoxemia
Extremes of dehydration, vascular collapse, or
<120 mmol/L
edema, hypervolemia, heart failure
Sodium(Na+)
Extremes of dehydration, vascular collapse, or
>160 mmol/L
edema, hypervolemia, heart failure
Potassium(K )
+
<2.5 mmol/L Muscle weakness, paralysis, cardiac

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Analyte Value Possible Effect

arrhythmias
Over hydration, congestive failure, chronic
<80 mmol/L respiratory acidosis, metabolic alkalosis
Chloride(Cl-)
>115mmol/L Dehydration, excessive infusion of normal
saline
Calcium(Ca++) None established

A.5 Working principle

Ion-selective electrode is a kind of chemical sensor that converts the activity of a
certain ion into an electric potential. It is only sensitive to one kind of ion in the
solution. When the ion is selective by the sensor and an electric potential is
established against the sensor. The relationship between activity and potential is
expressed by Nernst equation

Where:
E= electric potential of ion-selective electrode in the solution being measured
EO= standard electrode potential of ion-selective electrode
n =electrovalence of the ion being measured
R=gas constant (8.314 J/K.mol)
T=absolute temperature (273+tºC)
F=Faraday constant (96487 c/mol)
Cx=concentration of the ion being measured
fx=activity coefficient of the ion being measured
In given conditions such as room temperature, Nernst equation shows that electrode
potential of ion-selective electrode is linear to the logarithm of the activity (or
concentration) of the ion being measured.
There is one exception of lithium electrode. The sodium ion will also affect lithium
electrode. A selective coefficient calibrator is used to minimize the interference of
sodium.

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