BKE Series Electrolyte

Analyzer
Models: BKE-A \BKE-B \BKE-C \BKE-D\BKE-E\BKE-F

User Manual

Biobase Biodustry (Shandong) Co., Ltd

Preamble
This manual introduces the use, function and usage of the instrument in detail. The
introduction is based on the instrument of full configuration, which ensures that the user
can carry out the daily testing work smoothly. It contains the relevant daily maintenance,
some of which may be not apply to every model. If have any questions, please contact our
company.
Before using this product, please read and understand the instructions of this manual
carefully to ensure the correct use.
The pictures in this user manual are only examples, not for any other purpose. Product
appearance depends on actual product.

User Manual 1
Product Introduction

Thank you for purchasing the BKE series electrolyte analyzer, which is used for analyzing
electrolyte levels in blood and body fluids, such as the test of K+, Na+, Cl+, Ca+ and pH.
The available models are BKE-A, BKE-B, BKE-C, BKE-D, BKE-E and BKE-F.
The structure of the product is composed of electrode module, testing module, pipeline
module, circuit module and data output module.
The product is used to analyze the electrolyte content in blood or body fluids. Do not use
for other purposes.
Product Name: Electrolyte Analyzer

BKE-A, BKE-B, BKE-C, BKE-D, BKE-E and

Model:
BKE-F

Service life: 8 year

Others: See the nameplate for detail

The company reserves the right to change the product design. If the product design
changes, the customer would not be notified.

Intellectual Property

This manual and its intellectual property belong to Biobase Biodustry (Shandong) Co.,
Ltd. (hereinafter referred to as “our company” or “us”).
No individual or organization can copy (including photographing, reprinting,
transcription, etc), modify or translate any part of this manual without the prior written
consent of our company.
is a registered trademark of Biobase Biodustry (Shandong) Co., Ltd.

User Manual 2
Manufacturer's Statement

Biobase Biodustry (Shandong) Co., Ltd has the final interpretation right of this manual.
Our company is responsible for the safety, reliability and performance of the product
when all of the following requirements are met:
 Assembly operations, expansion, re-adjustment, improvement, repair and
replacement of parts are performed by professionals approved by our company.
 All repairs involving replacement parts and supporting accessories and consumables
are original or approved by our company.
 The relevant electrical equipment complies with national standards and the
requirements of this manual.
 Product operation should be carried out in accordance with this manual.

Users

The users can be divided into the three parts below:

 Personnel who perform the daily operation of the instrument;
 Personnel who perform instrument maintenance and troubleshooting;
 A person who learns the operation of the instrument.
Before using, please read the manual carefully to operate the instrument in a right way.
Please keep this manual for reference at any time. Warranty is voided if the user doesn’t
follow the instructions and cautions mentioned in this manual.
In order to keep the instrument protection effective, the operator should consult and follow
the instructions in this manual.

Warning

This instrument can only used by inspection professionals,

physicians or laboratory technicians who trained by the company
or company agent.

User Manual 3
Instrument Size and Weight

Model BKE-A/BKE-C BKE-B/BKE-D BKE-E BKE-F

Size 405*214*471mm 682*287*471mm 405*214*471mm 682*287*471mm

Machine Weight 12.48kg 15.11kg 13.13kg 15.76kg

Packaged Size 500*390*530 mm 500*390*720 mm 500*390*530mm 500*390*720mm

Gross Weight 16.08kg 19.31kg 16.73kg 19.96kg

Product Category

The classification criteria are described as follows:

 Over voltage category: Class II
 Pollution level: Class II
 Noise level: 75dB（A） (place more than 1m away from the instrument)
 Fuse: F1AL250V
 Installation environment conditions:
a) Indoors only.
b) Power supply voltage:AC100-240V 50/60Hz.
c) The altitude does not exceed 2000m.
d) Ambient temperature: +10℃~+40℃.
e) Relative humidity: 30% ~ 80%.
f) The power supply voltage fluctuation is not more than ±10% of the nominal
voltage.
g) Typical transient over voltages present on grid power.
h) Applicable Rated Pollution Degree.
i) No abnormal noise.
j) The instrument complies with the emission and immunity requirements specified in
ICE 61326. Do not use this instrument near strong radiation sources (such as public
radio frequency sources), otherwise it may interfere with the normal operation.
k) Well grounded condition.
 Instrument category: clinical testing equipment. Code: 22-03-01
 Connection to the mains power supply: detachable power cord
 Operating Conditions: Continuous

User Manual 4
Transport and Storage

Transportation

When the instrument is packaged, pay attention to prevent rain and sun exposure during
transportation, and prevent it from being severely impacted, heavy pressure and dumping.
Note: If the instrument has been unpacked and needs to be moved for long-distance
transportation, please repackage the instrument before transportation.
Transport conditions: -20℃~+40℃ Humidity≤80%.

Storage

The packaged instrument should be stored in an environment where is -20℃~+55℃,

relative humidity ≤80%, no corrosive gas and good ventilation.

Warranty and Repair Services

The warranty period of the purchased instrument has been specified in the sales contract.
Consumables: Refers to disposable consumable materials that need to be replaced after
each use or fragile materials that need to be replaced regularly. Consumables have no
warranty service.
The warranty period starts from the "Purchase date" written on the "Warranty Card", which
is the only proof to calculate the warranty period. In order to protect your rights and
interests, please fill in the warranty card after the installation of the equipment, and give
the second copy (copy B) of the warranty card to the installation personnel or mail it back
to the customer service center of the company.
Please note that the following situations would not be covered under warranty:
 The serial number of the instrument provided by the customer is incorrect (our
company confirms the warranty with the serial number).
 The customer doesn’t fill the warranty card and return it after installation.
Our company is not responsible for equipment malfunctions or damages, directly or
indirectly, that occur in the following circumstances, or direct or indirect damage during
use:
 Malfunctions or damages caused by violation of the usage, precautions and purpose of
use described in this user manual.
 Malfunctions or damages caused by the operation of inspection professionals, doctors
or laboratory personnel not trained by the company or the agent designated by the
company.

User Manual 5
  Malfunctions or damages caused by maintenance or modification by companies other
than those designated by our company.
 Malfunctions or damages caused by using with instruments not specified by our
company.
 Malfunctions or damages caused by the operating environment (power supply
conditions, installation environment, etc.) not specified by our company.
 Malfunctions or damages caused by irresistible natural disaster.
 Malfunctions or damages caused by the company's unknowing movement or
transportation after installation.
 Malfunctions or damages caused by using reagents and consumables not approved by
the company.
 Other malfunctions not caused by the product itself.
During the warranty period, if the fault is caused by the defects of our company's design
and manufacture, our company would take corresponding countermeasures according to
the content of the fault.
After the warranty period expires, the company can continue to provide maintenance
services for fee.

Please order consumables or accessories from our company one month

in advance. Do not use any other company's consumables instead. Some of
the chemical components in them may cause damages to the instruments and
sensors, resulting in greater losses.

After-sales Service

After-sale service
Please contact our customer service center by calling the 24/7 service number which offer
you the professional technical help when encountering any unusual problems within or
beyond the warranty period.
Repair
 Confirm the fault and maintenance method: First contact the customer service center,
confirm the situation and the maintenance method including door-to-door maintenance
or back to factory repair.
 Maintenance cost: Negotiate with the company according to the specific situation.
 Freight: If the instrument is shipped to the company for maintenance, the user shall
bear the freight rate (including customs costs).

User Manual 6
Return
 Contact the customer service center of the company to get the right to return and
inform the product serial number (see in the instrument nameplate for details) to
explain the reason for the return. If the serial number of the product cannot be clearly
recognizable, the company would not receive the product.
 On the premise of obtaining the right to return, please go through the relevant
procedures according to the requirements of the company.
Contact information
Company name: Biobase Biodustry (Shandong) Co., Ltd
Manufacturing address: No.9 Gangxing Road, High-Tech Zone, Jinan City, Shandong
Province, China
Tel: +86-531-81307661
Post code: 25000

User Manual 7
Safety Signs
Various safety signs are used in this user manual and on the instrument to remind you of
matters needing attention during operation. As shown in the table below:
Signs Remark Indication
Used for sample injection probe and waste liquid drain.
Biological
Indicates that there are potential biological risks associated
risk
with the medical device.
Paper
Install the paper according to the instruction; otherwise
Installation
the printer fails to print.
Instructions
Marked on the peristaltic pump, indicate its rotation
Direction of
direction. Install the pipeline in the direction described in
rotation
the sign or the instrument may fail to work.
Drift Marked on the liquid distribution valve, indicating that
A correction the connecting line here is connected to the A correction
solution A solution.
Slope Marked on the liquid distribution valve, indicating that the
B correction connecting line here is connected to the B correction
solution B solution.
Marked on moving parts locations, indicate a potential
Prevent
danger to cause injury to personnel who is not trained or
dangers of
operates not according to the instruction.
moving parts

When seeing this sign, the user must consult the manual to
be aware of the potential danger and make preparations. If
Caution
not following the instructions, the protection function of
the instrument would fail.

Earthing For the inner and outer earthing parts, please ensure that
protection the instrument is well grounded.

Upward The package should be placed upwards.

Fragile
Contents of the distribution packages are fragile therefore
articles
it should be handled with care.

Non
The package should avoid rain during transportation.
water-proof

Do not roll The package shall not be rolled or turned over.

Do not pile No piling on the package.

User Manual 8
 Contents
Preamble .............................................................................................................................................................. 1
Chapter 1 Overview ........................................................................................................................................ 11
Chapter 2 Measurement Principle .................................................................................................................. 12
2.1 Electrode Principle .............................................................................................................................. 12
2.2 Method Principle ................................................................................................................................. 12
Chapter 3 Instrument Introduction ................................................................................................................. 13
Chapter 4 Reagents ......................................................................................................................................... 15
Chapter 5 Installation ......................................................................................................................................17
5.1 Installation Requirements ....................................................................................................................17
5.2 Installation Steps ..................................................................................................................................20
Chapter 6 Software Operation ........................................................................................................................ 22
6.1 Power on .............................................................................................................................................. 22
6.2 System Flushing .................................................................................................................................. 22
6.3 Activation .............................................................................................................................................23
6.4 Self-check ............................................................................................................................................ 24
6.5 Main Menu ...........................................................................................................................................24
6.6 Service Menu ....................................................................................................................................... 28
Chapter 7 Instrument Maintenance ................................................................................................................ 38
7.1 Daily Maintenance ...............................................................................................................................38
7.2 Weekly Maintenance ........................................................................................................................... 39
7.3 Maintenance of Main Accessories .......................................................................................................39
Chapter 8 Precautions ..................................................................................................................................... 41
8.1 Operation ............................................................................................................................................. 41
8.2 QC ........................................................................................................................................................41
8.3 Environment ........................................................................................................................................ 42
8.4 Maintenance .........................................................................................................................................42
8.5 Sample Collection and Processing ...................................................................................................... 42
8.6 Others ...................................................................................................................................................42
Chapter 9 Normal Reference Ranges ............................................................................................................. 43
9.1 Normal Reference Ranges for Clinical Electrolytes ........................................................................... 43
9.2 Normal Range of Slope ....................................................................................................................... 43
9.3 Measuring Range and Accuracy ..........................................................................................................43
9.4 Display Resolution .............................................................................................................................. 43
Chapter 10 Failure Analysis ........................................................................................................................... 44
10.1 Treatment Methods for Self-check Failed .........................................................................................44
10.2 Treatment Methods for Unobstructed Sampling ............................................................................... 44
10.3 Treatment Methods for Electrode Drift .............................................................................................45
10.4 Treatment Methods for Electrode Slope Reduction .......................................................................... 46
10.5 Common Blockage Problems ............................................................................................................ 46
10.6 Treatment Methods for Abnormal Results ........................................................................................ 46
10.7 Function and assembly of reference electrode .................................................................................. 47
10.8 The Relationship Between nCa, TCa, iCa and pH ............................................................................47
10.9 Notes on Instrument Calibration ....................................................................................................... 48
User Manual 9
 10.10 Precautions for Fuse Replacement .................................................................................................. 48
10.11 Precautions of CO2 Model ...............................................................................................................49
10.12 Consumable List .............................................................................................................................. 50
Appendix A Inter-laboratory Quality Control ................................................................................................ 51
Appendix B Function Menu ........................................................................................................................... 53
Appendix C Operation Steps and Precautions ............................................................................................... 54
Appendix D Maintenance of Electrodes ........................................................................................................ 55

User Manual 10
 Chapter 1 Overview
BKE series electrolyte analyzer is an automatic analysis instrument that uses ion-selective
electrode measurement technology and sensor technology to realize analysis and control
through microcomputer. It is a quick-response, accurate, convenient and practical clinical
testing equipment.
K+, Na+, Cl-, Ca2+ are the main components of electrolytes in the human body. Quickly and
accurately measuring the content of electrolytes can provide considerable help for clinical
diagnosis.
The ion electrode method does not need to dilute the sample, which shortens the analysis time,
and the results can reflect the activity of the electrolyte and its changes, and also prevent the
pollution of the laboratory environment by the gas and the occurrence of accidents.
BKE series electrolyte analyzer is the latest product introduced by our company with foreign
advanced technology and production process. It is used in conjunction with special reagents to
measure the concentration of K+, Na+, Cl-, Ca2+ and other electrolytes in human blood, the
value of pH and carbon dioxide concentration.

Figure 1-1 Electrolyte analyzer

Model BKE-A BKE-B BKE-C BKE-D BKE-E BKE-F

K 、Na 、Cl 、 K 、Na+、Cl-、
+ + - +
K+, Na+, K+, Na+, K+, Na+, Cl-, K+, Na+, Cl-,
Electrode iCa2+、PH、 iCa2+、PH、
Cl- Cl- iCa 2+, pH iCa 2+, pH
CO2、AG CO2、AG
Sample tray No Yes No Yes No Yes

User Manual 11
Chapter 2 Measurement Principle

2.1 Electrode Principle

An ion-selective electrode is an electrochemical sensor (aka electrode) that converts changes in
the activity of specific ions in solution into changes in electrode potential according to the
Nernst equation.
The "select" in "ion-selective electrode" means that a certain sensor is only sensitive to a
certain ion.
For example: Na electrode is only sensitive to Na+ in solution. To conclude, various electrode
combinations can be used to simultaneously measure all ion concentrations of a sample.
The key part of the electrode is the sensitive membrane, which is close to the sample on one
side and responds to the change of electrolyte concentration in the sample, and the other side is
close to the filling liquid in the electrode, with the silver rod coated with silver chloride, the
transition from ion conduction to electron conduction is realized. It is called the inner
conductive electrode. In addition, there is a reference electrode, which provides a reference
potential to form a complete measurement loop. As the electrolyte concentration in the solution
changes, the potential of the reference electrode does not change, thus providing a reference
point from which to measure the potential difference.

2.2 Method Principle

The measurement principle of BKE series electrolyte analyzers is based on the Nernst response
of ion-selective electrodes. The connection between the measured ion activity (concentration)
and the electrode potential can be expressed by the Nernst formula:
E=E0+(RT/nF) lnAX
In the formula: E=The potential of the electrode in the measuring solution
E0=Standard potential of the electrode
R=Gas constant
T=Absolute temperature
F=Faraday constant
AX=The activity of the measured ion in solution
n=The charge number of the measured ion
It can be seen from the Nernst formula that, under specific experimental conditions, the
electrode potential has a linear relationship with the logarithm of the measured ion activity.
Therefore, the measured ion activity can be obtained only by measuring the electrode potential.

User Manual 12
 Chapter 3 Instrument Introduction
BKE series electrolyte analyzer consists of electrode module, measurement module, pipeline
module, circuit module and data output module, all operations are carried out by man-machine
dialogue.

Figure 3-1 External structure diagram

The technical parameters are shown in table 3-1.

Table 3-1
Product
Electrolyte Analyzer
name
Model BKE-A BKE-B BKE-C BKE-D BKE-E BKE-F
K+ Na+ Cl- K+ Na+ Cl-
Ion selective K+ Na+ Cl- K+ Na+ Cl-
K Na Cl
+ + -
K Na Cl
+ + -
iCa2+ pH CO2 iCa2+ pH CO2
electrode Ca2+ pH Ca2+ pH
AG AG
Sample tray / Yes / Yes / Yes
30 sample 30 sample 30 sample
position+5 position+5 position+5
Sample
/ emergency / emergency / emergency
location
position +2 QC position +2 position +2
position QC position QC position
The ion-selective electrode is used to convert the activity change of a specific ion in the solution into
Working
the electrode potential change, and then realize automatic control and analysis through sensor
principle
technology and microcomputer.
Structure It is mainly composed of electrode module, measurement module, pipeline module, circuit module and
composition data output module.
Sample
60-150
volume (μl)
Sample Serum and plasma
Screen 7 inch touch resistive screen
Data storage 50000
Measuring
≤25s
speed
Printing Built-in thermal printer
Control
32-bit main control chip
system
Data RS232 interface
User Manual 13
 interface
Calibration Automatic or manual
K+ 0.5-20.0mmol/L
Na +
15-200mmol/L
Measuring Cl -
15-200mmol/L
range Ca2+ 0.1-6.0mmol/L
pH 4-9
CO2 2.0-70.0mmol/L
K+ 0.01mmol/L
Na +
0.01mmol/L
Display Cl- 0.01mmol/L
resolution Ca2+ 0.01mmol/L
pH 0.01
CO2 0.1mmol/L
K+
≤1.5%
Na+ ≤1.5%
Measurement
Cl- ≤1.5%
accuracy
Ca2+ ≤1.5%
CO2 ≤3%
K+
40~70 mV/10 times concentration
Na +
40 ~70 mV/10 times concentration
Slope range Cl- 40 ~70 mV/10 times concentration
Ca 2+
20 ~40 mV/10 times concentration
pH 20 ~70 mV/10 times concentration
Fuse RF1-20 F1AL250V
Size 396*202*434mm 668*276*434mm 396*202*434mm 668*276*434mm 405*214*471mm 682*287*471mm
Machine
8.2kg 11.9kg 8.2kg 11.9kg 13.13kg 15.76kg
weight
Packaged 500*390*530 500*390*720 500*390*530 500*390*720
500*390*530mm 500*390*720mm
size mm mm mm mm
Gross weight 12.9kg 17.5kg 12.9kg 17.5kg 16.73kg 19.96kg

Input power 70VA

Power
AC100-240V 50/60Hz
supply
Temperature -20℃~+55℃.
Storage
Relative humidity ≤80%, no condensation.
environment
No corrosive gas, good ventilation.
Transport Temperature -20℃~+40℃.
environment Humidity ≤80%
Temperature +10℃~+40℃,volatility<±2℃/H.
Work Humidity 30%~80%, no condensation.
environment Atmospheric pressure 86.0kPa~106.0kPa.
The altitude is not higher than 2000 meters.

User Manual 14
Chapter 4 Reagents
BKE series electrolyte analyzers need electrolyte analyzer supporting reagents (ISE) in the
process of use and maintenance to analyze the electrolyte content in blood and body fluids. The
reagents required in the use and maintenance are shown in Table 4-1.
Table 4-1

Name Size Function Storage conditions & expiration date

Drift correction
350mL Reagents should be stored at 0℃~40℃
solution A
Reagent in a non-corrosive gas environment
Slope correction To assist the quantitative
for 350mL away from light. Unopened reagents
solution B detection of Na+, K+, Cl-,
Electrol are valid for 24 months, and drift Drift
Reference solution 10mL Ca2+ concentration and
yte correction solution A, Slope correction
Filling solution in pH value in human serum
Analyze 3mL solution B, and Internal correction
electrode and plasma samples.
r (ISE) solution valid for 30 days. Do not
Internal correction freeze reagents.
100mL
solution
to maintain the electrode
Stored at 0-40℃, the validity period is
to wake it up quickly and
Electrode Activation Fluid 100mL 24 months, and it should not be mixed
let the electrode reach the
with toxic, harmful and corrosive
working state.
substances, and it is forbidden to
For electrolyte analyzer
Cleaning Fluid E 100mL freeze.
line cleaning.
Stored at room temperature, the
Decomposition of
validity period is 12 months, and it
Electrode cleaning Fluid 25mg× proteins for cleaning and
should not be mixed with toxic,
(protease) 5 flushing of electrodes
harmful and corrosive substances, and
and pipelines.
it is forbidden to freeze.
Drift correction solution (CO2 This product is stored at 0-40℃, valid
100mL
marked with 1) for 24 months, shall not be mixed with
It is used to
Slope correction solution (CO2 toxic, harmful and corrosive
100mL quantitatively detect the
marked with 2) substances, and shall not be frozen.
concentration of CO2 in
This product is stored at 0-40℃, valid
human serum and plasma
Carbon dioxide acid cleaning for 12 months, shall not be mixed with
100mL samples.
solution toxic, harmful and corrosive
substances, and shall not be frozen.

User Manual 15
 Notes:
 Electrolyte analyzer reagents are for in vitro diagnostic use only.
 Reagents can be refrigerated, but freezing is strictly prohibited. If it is taken out of the
refrigerator, it should be placed for more than 30 minutes to turn it to the indoors
temperature before it can be measured on the machine.
 All reagents should be used within the validity period.
 Some agents may hurt the skin. Please use it with care to prevent direct contact of the
reagent with hands or clothes. In case of accidental contact, please rinse immediately
with soap and water. In case of accidental contact with eyes, rinse immediately with
plenty of water and see a doctor.

User Manual 16
Chapter 5 Installation

5.1 Installation Requirements

The instrument should be kept away from equipment that may cause electromagnetic
interference, otherwise, the electrode would drift during the calibration.
The platform on which the instrument is installed should be stable and even. Avoid direct
sunlight and do not install it on the vent. The ambient temperature is +10℃~+40℃, the
relative humidity is 30%~80%, and the atmospheric pressure is 86kPa~106kPa. The lab had
better equip with air conditioners and dehumidifiers. The power supply is AC100-240V,
50/60Hz. The lab had better equip with regulated power supply or UPS. Do not place the
instrument in a location where it is difficult to disconnect device.
Power requirements
Power supply: AC100-240V, 50/60Hz.
Instrument power: 70VA.
The power socket needs to be well grounded (at least three available 5A sockets). Heavy-duty
electrical equipment such as air conditioners, refrigerators, and ovens should be connected in
the same socket.
Electromagnetic compatibility requirements
The radiated and conducted emission of the electrolyte analyzer shall meet the requirements of
CISPR11 group I class A. Its immunity shall meet the requirements.
The user should ensure the electromagnetic compatibility environment of the instrument so that
can work properly. It is recommended to evaluate the electromagnetic environment before use.
 In accordance of the design and test according to Group Ⅰ Class A equipment in GB4824.
In a domestic environment, this equipment may cause radio interference, requiring
precautions.
 Do not use this instrument near strong radiation sources (such as unshielded radio
frequency sources), otherwise it may interfere the equipment working.
Table5-1 Immunity requirements

Port Test item EMC standards Testing valve Class

Air discharge: ±2/4/8kV
Electrostatic
IEC 61000-4-2 Contact discharge: ±2/4kV A
discharge（ESD）
Indirect discharge: ±2/4kV
Frequency: 80MHz~2.0GHz
Enclosure Radiated
IEC 61000-4-3 Level: 3V/m A
port electromagnetic fields
Modulation: 80%AM@1kHz
Rated power
frequency magnetic IEC 61000-4-8 Level: 3A/m ,50Hz A
field
0%,1 cycle A
AC power Voltage sag IEC 61000-4-11
40%,5 cycle A

User Manual 17
 Port Test item EMC standards Testing valve Class
70%,25 cycle A

Voltage interruption IEC 61000-4-11 5%,5s C

Burst IEC 61000-4-4 1kV：(5/50ns ,5KHz) A

wire to ground: ±2kV
Surge IEC 61000-4-5 A
wire to wire: ±1kV
Frequency: 15kHz~80MHz
RF conduction IEC 61000-4-6 Level: 3V A
Modulation: 80%AM@1kHz
Work environment requirements
a) Indoor use only.
b) Power supply voltage: AC100-240V, 50/60Hz.
c) The altitude does not exceed 2000m.
d) Ambient temperature: +10℃~+40℃.
e) Relative humidity: 30％~80％.
f) The fluctuation of the power supply voltage is not more than ±10% of the nominal voltage.
g) Typical transient over voltages that appear on grid power.
h) Applicable rated pollution degree.
i) No abnormal noise equipment nearby.
j) The instrument complies with the emission and immunity requirements specified in GB/T
18268. It is forbidden to use this equipment near strong radiation sources (such as
unshielded radio frequency sources), otherwise it may interfere with the normal operation of
the equipment.
k) Work with a well grounded environment.

Warning:

The instrument cannot guarantee normal operation and accurate results in

environments other than those described above. If the temperature or humidity
cannot meet the above requirements, please use air conditioner and humidifier.

The heat generated by the instrument would dissipate through the rear of the
instrument. The working environment should be well ventilated, and
ventilation equipment can be used if necessary. However, the airflow should be
avoided to blow directly to the instrument, otherwise it may affect the accuracy
of the instrument test.

Software operating environment requirements

The software components of the electrolyte analyzer do not need to be connected to the internet,
and the embedded software is programmed on the control board chip. The operating
environment requirements are as follows:
Compile and control program software: Keil uVision
User Manual 18
Version number: V4.02
Company: Keil Sofeware
Motherboard hardware configuration:
Control board main control chip: STM32F207ZET6
Memory: 25Q64FVF
Discharge of waste
Keep the instrument drain hole and pipeline installation unobstructed, and the instrument drain
should be higher than the waste bottle mouth (or the waste liquid special discharge port), and
the length of the waste pipe should not exceed 0.5m.
Biological Infection Hazard:
Dispose of the waste liquid in accordance with local discharge standards. When
installing the drain pipeline, be sure to wear gloves, work clothes and goggles, if
necessary, to prevent infection.

Instrument Installation

Warning:

In order to ensure the normal operation after installation, the first installation
and initial setting should be performed by authorized personnel of the
company.

Unpacking
After the instrument arrives, please check the packaging carefully to see if there is any damage.
If the package is damaged, please contact our company or local agent. After confirming that the
package is perfect, unpack as follows:
 Make sure the arrow on the box is upright.
 Check whether the accessories are complete against the packing list. If there is any
missing, please contact the company or local agent in time.
 Check the appearance of the instrument carefully to see if there is any damage to the
parts caused by improper transportation. If the package is broken, please contact the
company or local agent immediately.
Move method
 Confirm that the appearance of the instrument is intact and all parts are in good
condition before carrying.
 During all moving and transportation, the instrument must be kept upright, not inclined
or sideways.
 When carrying, try to avoid vibration. After carrying, you should check and debug it
first, and then use the instrument after it is normal.

User Manual 19
5.2 Installation Steps
1) After unpacking and checking, place the instrument on a stable and even workbench.
2) Installation of solution and pipeline
Take out the drift correction solution A and slope correction solution B. Push the front door of
the instrument to open, insert the pipes marked A and B on the distribution valve into each
bottle. The sample pump tube of the carbon dioxide model should be put into carbon dioxide
acid cleaning solution. Place solution A and B bottles in the position shown in the picture. The
waste bottle is placed on the right side outside the instrument, and insert the waste tube shown
in the figure into the waste bottle.

Figure 5-1

3) Installation of the electrodes：

Take out the electrodes, install them to the electrode holder in the order shown in the figure.
After installing the electrodes, tighten the nuts shown in the figure to ensure that the electrodes
are installed in the center properly, and the electrode pipes are well sealed.

Figure 5-2

User Manual 20
4）Power connection
Check whether the power supply is AC100-240V, 50/60Hz and stable, if unstable, it should be
connected to UPS or a good quality regulated power supply.
Turn the instrument power switch to the off.
Use the power cord to connect the instrument and the power socket, and do not loosen it.
The power socket must be well grounded.
5）Installation of automatic sample tray (applicable to models with sample tray):
Confirm that the instrument and the sample tray are placed on the same level, align the two
blue interfaces shown in the figure, and then insert them smoothly.

Figure 5-3

User Manual 21
Chapter 6 Software Operation
The software operation steps described in this chapter based on the BKE-F model.

6.1 Power on
Switch the power button to "I". The screen would display the and start the enter login page.

Figure 6-1

Input the username and password to login (Default username: 111111, password: 1), the system
automatically checks the communication connection of power supply, memory, and printer, and
makes the internal circuit reach a thermally stable state, and then the peristaltic pump rotates to
flush the system.

Figure 6-2

6.2 System Flushing

The figure below indicates that the instrument is under system flushing. It inhales slope
correction solution B, drift correction solution A and air to clean their respective flow paths.
During system flushing, the user can check whether the A and B correction solutions flow
smoothly and the pipes are blocked or leaked.

User Manual 22
 Figure 6-3

The operator should pay attention: when the system is flushed, please observe whether the
solution flow in the pipe and electrode is normal. If the solution cannot be sucked up, or there
are many air bubbles, please refer to the first item of troubleshooting. After the system flushing,
the instrument switches to the activation procedure.

6.3 Activation
After the system flushing, the instrument would automatically sucks the drift correction
solution A to activate the electrode. The screen shows default activation time 30 minutes, and
after 30 minutes, it would automatically conduct the system calibration.
The purposes of activation are as follows:
1）Stabilize the electrode as soon as possible.
2）Prolong the electrode life.
Based on the above purposes, the operator should notice that the activation time should be
controlled within 15 minutes. During the activation, the interface is displayed as follows. If you
need to exit to analyze the sample, please press "Cancel" on the screen.

Figure 6-4

User Manual 23
6.4 Self-check

6.4.1 System correcting

After the activation, the instrument sucks drift correction solution A and slope correction
solution B in turn for system calibration. After the calibration, the instrument of carbon dioxide
model would remind to calibrate carbon dioxide. If necessary, please press "Yes" to start; if not,
press "No" to exit. The operator should use "CO2 correction" to calibrate the CO2 sensor before
analyzing the blood sample. CO2 calibration should be done once every 2-3 days in normal use.
6.4.2 Self-check
After calibration, the instrument would automatically suck the drift correction solution A for
self-checking. The concentration of drift correction solution A is displayed as QC value. When
the sample test accumulates 15 times, the system would automatically perform system
calibration and self-check to ensure the accuracy of the test results.

6.5 Main Menu

After the self-check, the screen would automatically display the main menu, as shown below:

Figure 6-5

6.5.1 Sample Analysis

After clicking “Sample Analysis”, the user can set the sample parameters. As shown in the
figure below, the start position refers to the position of the No. 1 sample to be tested on the
sample tray. If “Retest” is turned on, the sample quantity is the test times of the samples at the
start position. If “Retest” is off, the sample quantity is the number of samples be would tested
from the starting position.

User Manual 24
 Figure 6-6

6.5.1.1 Auto mode

After setting the sample analysis parameters, place the sample in the sample tray and click [OK]
(Note: the sample temperature should range from 10℃ to 30℃), the instrument would
automatically clean and draw the sample.
If you need to test an emergent sample, click [Emergency]. After measuring the current sample,
enter the emergency measurement interface automatically. After measuring the emergency
sample, continue to test the ordinary sample and output the test result of the previous ordinary
sample.
After the test, the instrument displays and prints the test result.
Notice:
(1) Ordinary samples cannot be placed in the four functional cup positions of
Deproteinize, Activated Liquid, QC1, QC2" or the 5 emergency positions in
the sample tray, otherwise the sample cup would not be found correctly.
(2) The sample ID is reset to 0 every day. If you need to set the sample start
number, or encounter an unexpected power failure, you can manually set the
sample start number. For details, see chapter 6.6.2.1.

6.5.1.2 Manual mode

For instruments that need to manually add samples, click "Sample Analysis" and wait for the
prompt as shown in the following figure, then manually lift the blue baffle in front of the
instrument, lift the syringe, and insert the needle into the sample.

User Manual 25
 Figure 6-7

If the sample is blood, do not insert the needle into the clot. Click "YES", the syringe would
suck the sample, after the sampling is completed, the instrument would beep and the screen
display as follows:

Figure 6-8

The instrument transfers the sample to each electrode for measurement automatically.
After about 30 seconds, the instrument displays the concentration of K+, Na+, Cl-, iCa2+ and
pH.

User Manual 26
 Figure 6-9

After the test, the system would conduct system flushing automatically and the printer print out
the results automatically .
6.5.2 Analyze QC
This program is set for the user to do QC with a certain target range. The user can perform QC
two or three times before observing whether the QC results are within the target range.
6.5.3 System Calibration
Electrode system correction:
The system calibration of this program is to analyze the A and B correction solutions twice, to
reflect the deviation range of the data measurement by calculating the difference between the
two groups data, and to calculate the slope through the analysis results of the first set of A and
B correction solutions. After the calibration, the instrument self-check displays the QC analysis
results but not print.
CO2 system calibration:
This procedure is to measure two groups of CO2 standard liquid, and put CO2 standard liquid
into the "QC 1". The reference value in the test result refers to the pressure value in the reaction
pool before reacting. Value 1 and 2 are the pressure value in the reaction pool after the reaction
of CO2 standard liquid twice. When the difference between the value 1 and 2 is less than or
equal to 10, the instrument works normally.

User Manual 27
 Figure 6-10

6.6 Service Menu

The service menus are designed to facilitate the user to better maintain and use the instrument.
After entering the service menu, the upper part of the screen would display: “Maintenance”,
User Manual 28
“Settings”, “Query”, and “Other”.
6.6.1 Maintenance
There are four main functions in the maintenance program: "Deproteinization", "Washing
Tube", "Activate Electrode" and "Electrode Correction", mainly for daily maintenance to
prolong the service life and accuracy of the instrument.

Figure 6-11

6.6.1.1 Deproteinization
During testing some protein would remain in the electrode pipeline, which would affect its
normal working. Click “Deproteinization” to see the figure below to suck the protein removal
solution to perform automatic protein removal procedure:

Figure 6-12

Click "YES" to deproteinize. The interface would start to countdown, which lasts for 60
minutes, and would automatically continue flushing after deproteinization. The purpose of this
program is to wash the pipeline thoroughly to avoid the existing of protein, coagulation and salt
in the pipeline and electrodes. Deproteinization should be conducted after the measurement or
before the shutdown. (Deproteinization should be done at least once a week, and hospitals with
User Manual 29
a large amount of specimens should conduct the deproteinzation once every 2-3 days).
Notice
After cleaning with deproteinizing reagent, if the sample needs to be
measured, the electrodes must be activated for 60-120 minutes, and
then re-calibrated before measuring.

6.6.1.2 Washing Tubes

After measuring, select the Washing Tube function to thoroughly clean the channel. Distilled
water or slope correction solution B can be sucked to clean.
6.6.1.3 Activate Electrode
The stability of the electrode would decrease after deproteinization. The user can click
“Activate Electrode” to suck the activation solution. The instrument would automatically count
down for 30 minutes to activate the electrode. Press "Cancel" in the middle to exit.
6.6.1.4 Electrode correction
The user can choose one-point or two-point correction. The premise of calibration is that the
electrode is stable, so the user should repeat the calibration several times. The calibration is for
quality control, and the user can perform two-point (slope and intercept) calibration or
single-point calibration (slope calibration) as needed. , (see the appendix A "Inter-laboratory
quality control").

Figure 6-13

Click "one-point correction” and place the QC solution in the QC1 position of the sample tray,
click the screen to input the target value and start the calibration. The system would prompt the
user when the correction completes.

User Manual 30
 Figure 6-14

6.6.2 System Setting

This menu mainly controls some basic settings of the instrument, including setting the sample
number, test items, time and date and print function.

Figure 6-15

6.6.2.1 Sample Start ID

This function can set the original number of the sample. The current sample number shows in
the interface. Input the starting number and click “OK” to save. The sample number would be
used from the set starting number during sample analysis.
Attention: The sample number set by the user must not be less than the current sample number.
6.6.2.2 Test Parameter
This function is the switch setting for the test procedure of the instrument. If you do not need a
certain item of the test sample, you can set the corresponding item to OFF under this function,
and the test result of this item would not be displayed and printed after the test is completed. .
6.6.2.3 Data and Time
This function can change the time setting of the instrument. The time format is
User Manual 31
“year-month-day hour-minute-second”. Click “Date and Time” to set and “OK” to save.
6.6.2.4 Prt & Lang
The user can choose to print in this interface. The result would not be printed when the printing
is canceled. The user can choose switch languages between Chinese and English.
6.6.3 Query
In the Query interface, the user can find the sample test results, QC parameter, instrument
correction factors, and electrode slopes display.

Figure 6-16

6.6.3.1 Query Result

The user can check test results according to the date through the Query Result interface.
The user enters the specific date of the sample inquired, and the sample number to check the
test result. The instrument automatically stores at least 10,000 patient samples.

Figure 6-17

Click "Return" to return to the previous menu.

6.6.3.2 Correction Factor
Correction Factor is a factor automatically calculated by the instrument after QC correction.
User Manual 32
The user can view, clear, and edit the factor in Correction Factor. If the result is unsatisfactory,
the user can turn up the factor in this interface and then to conduct QC test. It is recommended
to choose one-point calibration. Select Clear Correction Factor to restore the original factor to
the factory default settings.
6.6.3.3 QC Parameter
The user can view the average, standard deviation and coefficient of variation of the last five
QC tests, namely AVG, SD, CV values, in the "Quality Control Parameters" interface, which
can clear and print the QC results. If the user replaces the QC product with a new target value,
please clear the previous QC data, and then make a new QC product.
6.6.3.4 Slope
The slope is an important parameter showing the quality of the electrode. Each electrode has a
normal range. The purpose of checking the slope is to check the state of the electrode. If the
slope is too low, it means that the electrode is in poor condition and needs to be dealt with in
time.
The display slope interface is shown in the following figure:

Figure 6-18

6.6.4 Other
Entering this interface, the screen displays as follows:

User Manual 33
 Figure 6-19

6.6.4.1 CO2 hermetic test

This interface to conduct the CO2 hermetic test of the pipeline. The interface shows as below:

Figure 6-20

6.6.4.2 Suction step adjustment

This function is used to adjust the number of liquid suction steps. Observe the position of the
sample liquid column in the electrode. The left end of the liquid column should be on the left
side of K+ ion electrode, and the right end of the liquid column should be on the right side of
the Ref electrode. "-" makes the liquid column move to the left, and "+" the right, finally
ensuring that the liquid column is inside the ion electrode.
6.6.4.3 Setting
After entering this interface, the screen displays as follows:

User Manual 34
 Figure 6-21
1. Screen brightness: Adjust the screen brightness.
2. Sample Volume: This function can set the drawing volume of the sample.
3. Sample setting: This function can select the object of the test sample of this instrument. The
default sample type is serum
4. Reference value setting: This function can adjust the reference range of samples and QC.
Before sample analysis or QC analysis, users can edit it by themselves.
5. Standby time: This function is used to adjust the standby time of the instrument when it is
not in operation for a long time. The default standby time is 30 minutes. If the instrument
does not perform any operation within 30 minutes, the screen would automatically turn off.
After the screen is re-lit, the instrument would automatically absorb the Slope correction
solution B to flush the pipeline. After the pipeline is flushed, it would automatically absorb
the A correction solution. The self-test is carried out with the correction solution A and the B.
The user can adjust it according to actual needs. The standby time can be adjusted from 30
minutes to 270 minutes, and the time adjustment interval is 30 minutes. Standby state: When
the instrument does not operate within the standby time, it would automatically turn the
standby state. The instrument would automatically flush and calibrate every 30 minutes to
moisten and stabilize the electrode.
6.6.4.4 Inspection & Maintenance
The interface is shown below:

User Manual 35
 Figure 6-22
1. Calibration value: This function can used to print the value of the scaling slope, and the
factory default setting is "On".
2. User management: One administrator and two ordinary users can be set. Users have no right
to conduct the following operations, electrode correction, factor correction, mechanical
adjustment, user management, factory maintenance and other functions.
3. Test simple size: This function can check whether the "Simple size setting" function is
normal, after clicking "Start". The instrument sucks air and 150ml of drift correction
solution A to correct the amount of sample suction.
4. Factory Maintenance: It is used by our company's customer service center engineers to
maintain and repair the instrument, seldom used by users. When the instrument is not
operated for 30 minutes, it would automatically enter the standby state. The instrument is
automatically flushed at intervals to achieve the purpose of moistening and stabilizing the
electrode.
6.6.4.5 About
In this interface, you can check the factory number and version number information of the
instrument.
The interface is shown below:

Figure 6-23
User Manual 36
6.6.4.6 Position Adjustment

Figure 6-24
The user can adjust the lowest position of the syringe during cleaning in "Suction fluid
position" through clicking “+” and “-”.
"The Sample location" can be used to adjust the lowest position of the syringe during
aspiration through clicking “+” and “-”.
"The distance from No.1" can be used to adjust the position of the No. 1 position of the sample
adding disk relative to the sample adding needle through clicking “+” to rotate the disk
counterclockwise, and “-” to rotate the disk clockwise.

User Manual 37
Chapter 7 Instrument Maintenance
To ensure that the instrument is always in good working condition, it is necessary to maintain
the instrument regularly.
We should pay attention to the following issues in the maintenance process:
1）Maintainers are required to maintain the machine.
2）Maintainers should emphasize the importance of maintenance to the user of the instrument.
3）The specific responsibilities of the maintainer are:
a, Storage of commonly used consumables and accessories.
b, Record instrument status which help the company to provide after-sales service to
customers in the future.
c, Contact with the manufacturer when necessary.
The analyzer shell or frequently touched parts are easy to get dirty. In addition, the parts that
come into contact with samples and reagents, such as the sample tray, syringes, and pipette
holders, also need to be cleaned and disinfected regularly to improve the accuracy of detection,
and reduce biological risks. Use a clean soft cloth soaked in water and wring it out, gently wipe
the surface, if necessary, soak a small amount of soap or 75% medical alcohol. After cleaning,
dry the surface with a dry cloth.
Precautions

Warning：

Never spill liquids on the analyzer, as liquid immersion would damage the
instrument.

Biological risk:

 Wear gloves and work clothes during maintenance to prevent infection,

and goggles if necessary.
 Do not throw away the cotton cloth used for wiping, please dispose of it
properly in accordance with the relevant regulations.

7.1 Daily Maintenance

1）Daily check whether the printing paper of the printer is enough.

2）Daily check the volume of Drift correction solution A and B correction solution.
3）Check the pipeline daily to ensure that it is unobstructed. If there is any blockage, please
refer to the second item of User Troubleshooting.
4）Disinfect the syringe and waste host every day. When sampling and pouring waste, the
infectious solution may come into contact with the skin of fingers. Please wear effective
protective gloves for protection.

User Manual 38
5）Empty the waste bottle every day, dispose of the waste according to the "Medical Waste
Management Measures", and clean and disinfect the emptied waste bottle.
6）Activate it according to the normal startup process before everyday use (the machine
conduct it automatically).
7）The pipe should be cleaned before shutdown every day.
First clean: Rinse the pipe once with cleaning solution E, lift the sampling needle in manual
mode and place it in cleaning solution E/Replace liquid B reagent with cleaning solution E in
automatic mode, and then click "Washing tube" to rinse the pipe once.
Second clean: In manual mode, keep the sampling needle lifted and wipe the surface of the
sampling needle; in automatic mode, remove the liquid B pipet from the cleaning liquid E and
wipe the surface of the liquid B pipet, and then click "Washing tube" to empty the pipe.
Third clean: Push the manual sampling needle back/liquid B pipette back into liquid B reagent,
click "Washing tube" and rinse the pipe with liquid B.
8）Users with a large sample (about 70 samples) should use electrode cleaning solution
(protease) to remove protein once a day after test. After treatment with "Electrode cleaning
solution (protease)", the sample must be reactivated with serum for 30 minutes - 2 hours and
re-calibrated before test.

7.2 Weekly Maintenance

1）Check the pipette holder and sample pan once a week, and clean the dried solution and
sample to keep the measurement area clean.
2）Clean the screen and shell of the analyzer, then open the front door to clean the solution
storage area.
3）Check the volume of the reference solution of the reference electrode, it must be ensured
that the internal electrode is always immersed in the reference solution. If the reference
solution is not sufficient, use a syringe to add it from the small hole on the upper right of the
reference electrode, and ensure that the small hole is unblocked.
4）Use the electrode deproteinization procedure every week, and use the electrode washing
solution(enzyme) to do deproteinization once a week.

7.3 Maintenance of Main Accessories

1）The pipes on the instrument should be removed at least every two months, soaked in
distilled water, and rinsed.
2）When the surface of the reference solution is cloudy and lower than the reference electrode,
it should be replaced.
3）Check the reference solution of the common electrode regularly. If the liquid level of the
internal is lower than the internal electrode or is cloudy, the internal solution should be
added in time or the corresponding electrode should be replaced.
Note:
① When the instrument is not in use, it should be powered on once every 3 days to conduct a
self-test.
User Manual 39
② If the instrument is not used for a long time, use pure water to flush the pipe 2 to 3 times.
③ If the instrument is not used for more than one month, empty the ion electrode and
reference electrode of the internal liquid and reference liquid, and store it away from light.

User Manual 40
Chapter 8 Precautions

8.1 Operation

1）During the sampling process, be careful not to suck up the blood clot to avoid clogging the
tubing.
2）Do not draw air bubbles during the sampling process, otherwise the measurement results
would be unreliable.
3）Do not use mildewed or cloudy solutions with precipitation.
4）Every time the numbers of samples reaches 15, or if there is no measurement for a long
time after calibration, it needs to be re-calibrated.
5）After taking the solution, the bottle should be sealed immediately to avoid exposing to the
air for a long time.
6）This instrument must be operated by professional or trained personnel.
7）This instrument has no user-repairable components, so please do not disassemble it.
8）Ensure that the power supply environment and grounding environment of the instrument
are good and stable.
9）Before performing QC, the instrument must be calibrated.
10）If the electrode membrane tube is blocked, use a needleless syringe to absorb distilled
water and clean it from the opposite direction.
11）When the electrode is not used for a long time, it must be cleaned and sealed according to
the requirements in Appendix D.
12）Do not use this instrument in places with high temperature, high humidity, imbalance,
direct sunlight or heavy dust.
13）In order to reduce effecting from the external environment on the data results, please keep
the electrode cover and the front door closed during the data test.

8.2 QC

1）Before QC, make sure the calibration of the instrument is stable.

2）It is strictly forbidden to use the standard solution of the flame photometer as the sample to
measure. Since it contains relatively concentrated acid and other additives, it cannot be
measured by the ion electrode method, otherwise it would cause electrode poisoning.
3）Not all QC serums on the market are suitable for the measurement of ion electrode method,
some manufacturers' QC serum contains more additives, which would interfere with the ion
electrode (especially the determination of Cl-).
4）If the fluctuation of the ambient temperature is more than 10 °C, it needs to be
re-calibrated.

User Manual 41
8.3 Environment

1）The socket is well grounded.

2）Stable voltage, preferably connected to UPS or regulated power supply.
3）The instrument must be kept away from high-power equipment to avoid electromagnetic
interference.
4）Avoid direct sunlight.

8.4 Maintenance

1）If the pipe or electrode is blocked, remove the pump tube and use a needleless syringe to
suck distilled water for cleaning in an opposite direction, so that the water flows out of the
syringe. It is strictly forbidden to use an injection needle to avoid puncturing the electrode
membrane and damaging the electrode.
2）If the electrode is not used for a long time, the residual liquid in the electrode membrane
should be rinsed with distilled water and the electrode should be sealed and stored.
3）Electrodes should preferably be activated daily.
Note: Please use the materials recommended by our company for cleaning and disinfection.

8.5 Sample Collection and Processing

The collection and processing of samples must be completed by professionals to avoid
hemolysis affecting the measurement results. Also note the following:
Serum and plasma samples:
1） Serum and plasma stored in the refrigerator can be used for analysis, but they must be
returned to room temperature before analysis.
2） When preparing serum samples, do not add substances that will cause errors in the
measurement, such as surfactants, anticoagulants, etc. These substances can interfere with
the measurement and even cause damage to the sensor. See Appendix III for details.
Urine sample:
1) Before measurement, it must be diluted ten times with urine diluter (1:9).
Boric acid is recommended as a preservative for urine samples to avoid interference with other
preservatives.

8.6 Others
Standby state: If the instrument does not work for a long time in the measurement state, it
would automatically switch to the standby state.

User Manual 42
Chapter 9 Normal Reference Ranges

9.1 Normal Reference Ranges for Clinical Electrolytes

Reference range Urine

Electrolyte
(mmol/L) (mmol/L)
K 3.5-5.5 50-100

Na 135-145 130-217

Cl 98-106 170-250
Ca 1.09-1.35
CO2 22~30

9.2 Normal Range of Slope

Electrode Normal range of slope

K 40-70 mv/10 times concentration
Na 40-70 mv/10 times concentration
Cl 40-70 mv/10 times concentration
Ca 20-40 mv/10 times concentration
pH 20-70 mv/10 times concentration

9.3 Measuring Range and Accuracy

Measuring range and accuracy

K+ 0.5-20.0 mmol/L 1.0(cv%)
Na+ 30-200 mmol/L 1.0(cv%)
Cl
-
20-200 mmol/L 1.0(cv%)
Ca 2+
0.1-6.0 mmol/L 1.5(cv%)
pH 4-9 0.5(cv%)
CO2 2~70 mmol/L 3.5（cv%）

9.4 Display Resolution

Display resolution
K+ 0.01mmol/L
Na +
0.01mmol/L
Cl
-
0.01mmol/L
Ca+ 0.01mmol/L
pH 0.01
CO2 0.1 mmol/L

User Manual 43
Chapter 10 Failure Analysis

10.1 Treatment Methods for Self-check Failed

The main reasons for the failure of self-test:
1) The detector: A, the plug of the detector is loose B, the detector is faulty
2) The valve: C, the fixing screw on the spool and the rotating shaft of the motor are loose D,
the spool itself is too tight and cannot be rotated
Solution:
The inspection order is:

3) The tray (models including the injection tray)

A The fixing screw in the middle of the tray is loose, just tighten it.
B The tray was fixed too tightly. Check if something stuck and prevent dirt from getting
into the bottom of the tray.
C The detector inside the tray fails to work.
D The setting screw on the tray is loose from the motor rotation shaft, re-tighten it.
4) The needle:
The travel switch is not pressed, adjust it.
After understanding the reason, please find the reason step by step and solve it, or call our
company to deal with it.

10.2 Treatment Methods for Unobstructed Sampling

If it is found that the syringe does not suck the sample, please check the sections from the pump
forward and check which of the following parts is blocked:
1) Check whether the tube of the peristaltic pump is stuck, whether it is leaking or overworking.
The adhesion of the pump tube would cause noises. The pump tube should be removed and
knead with hands, or replacing a new one if it overworks
2) Check whether the tubes at each interface (including between the electrode and the valve,
between the electrode and the pump tube) are inserted properly.
Notes: If the pipe, syringe or electrode is blocked, remove the pump pipe and use a syringe
whose needle is replaced by rubber tube to suck distilled water from the opposite direction to
clean, and let the water flow out from the injection needle (it is strictly forbidden for the
injection needle to penetrate the electrode membrane or pipeline).
3) Even if the pump tube is replaced with a new one, the obstructed sample suction still exists.
Maybe there is protein precipitation in each pipeline, especially at each joint. In this case, the
user need to remove each joint and clean it with water.
User Manual 44
4) Distribution valve: When the number of samples is small and the solution is used for a long
time after opening (stored 2-3 months out of the refrigerator), floccules may be generated in
the solution and cause the distribution valve to be blocked.
Treatment method: Put the sample suction tubes of A and B correction solutions in an empty
bottle. Remove the needle of a syringe, filling with water, with which a rubber tube connects
to the middle of the front of the dispensing valve. Then start the machine, inject distilled water
while the system is flushing the distribution valve, and the distilled water would flow into the
waste liquid bottle from the A and B pipes respectively. Repeat the above operation for
cleaning, and finally replace the solution. On the electrode base, there is a stainless steel tube
in front of the K electrode, and the hole on it can be directly stabbed with a needle.
Check whether the distributing valve will operate when the liquid is not aspirated. Observe
whether the circular black plate (with notch) in the distributing valve will rotate when the
liquid is aspirated from the front.If rotate normally means the liquid circuit system is blocked ,
if not, it means the fixing screw on the valve core and the motor rotation shaft is loose,
re-tighten the screw.
5) Blockage of electrodes: Mainly due to accumulation of hemoglobin.
Treatment method: Remove the electrodes and check them one by one. After finding the
blocked electrodes, first use a needleless syringe to suck the Electrode cleaning Fluid
(protease)(enzyme) and inject it into the blocked electrodes for soaking, and then rinse with
distilled water for about 3 minutes.

10.3 Treatment Methods for Electrode Drift

1) The small hole on the upper right side of the reference electrode is blocked by salt, and the
small hole should be opened with the a needle.
2) There are air bubbles in the electrode cavity, which can be shaken off with force.
3) If the internal solution of the electrode not sufficient, the internal electrode cannot be sensed,
and the internal solution of the electrode should be added.
4) The Filling solution, which cannot exceed 2/3-3/4 of the cavity, in electrode is too much.
5) If the inner electrode coating of the reference electrode falls off or turns white, the inner
electrode or reference electrode needs to be replaced.
6) Check the drifting electrode surface for dirt or oxide film.
7) Check the drifting gold-plated electrode head or electrode terminal for dirt or oxide film, and
lightly polish the contact area.
8) If the voltage is unstable, connect UPS uninterruptible power supply or good regulated power
supply (poor quality regulated power supply would cause electrode drift).
9) To avoid electromagnetic interference, equipment with high power should be kept away from
the instrument, and the power supply should be set independently.
10) Check if the correction solution has been used up.
11) If all electrodes drift, check whether the reference electrode has expired, or if there are air
bubbles at the reference membrane, which should be cleared.
12) If all the calibration values are 240, generally there are bubbles in the contact part between the
reference electrode and the test solution (some bubbles are so small that it is difficult to see),
User Manual 45
 at this time, please take out the reference electrode and repeatedly flick the bottom end of the
reference electrode with your finger (Below the silver rod). The bubbles can be shaken several
times.
13) If the solution is expired or contaminated, please check whether the A and B correction
solutions have flocculent precipitates.
14) After the electrode is deproteinized or the instrument has not been calibrated for a long time,
the first self-test is easy to get out of control. The machine should be activated for 1-2 hours
and then calibrated.

10.4 Treatment Methods for Electrode Slope Reduction

Low electrode slope would result in poor linearity of test results and sometimes affect the
repeatability of the electrode. The main reasons are:
1) Too much protein adhere on the electrode membrane tube, please use electrode cleaning
solution (enzyme) to remove.
2) The temperature is too low or the humidity is too high. When the air humidity is too high, use
the dehumidifier to lower the humidity. When the temperature is too low, use the air
conditioner to heat up the room.
3) The electrode is near expiration. (replace electrodes)
Notice:
A, B correction solution have been used up, reference internal
solution leakage, reference electrode aging and other reasons also
would cause all or part of the electrode slope to decline, if it is caused
by such a fault, it has nothing to do with the electrode.

10.5 Common Blockage Problems

1) Dispense valve: Please refer to chapter 10.2-4) of this manual for the causes and treatment
methods of blockage.
2) Electrodes: Please refer to chapter 10.2-5) of this manual for the causes and treatment methods
of blockage.
3) Blockage of pipe or syringe: Please refer to chapter 10.2-2) of this manual for the causes and
treatment methods of blockage.

10.6 Treatment Methods for Abnormal Results

When testing blood samples, if there are abnormal values in the test records, please follow the
steps below to check:
1) Whether there are high-power electrical appliances running or electric leakage (such as
centrifuges, refrigerators), leading to unstable voltage.
2) Check to see if blood clots were sucked during the test.
3) Check whether the sample cup is contaminated and whether there are residual substances such
User Manual 46
 as disinfectant.
4) Check whether the correction factor is correct, and clear the correction factor if there is any
abnormality.
5) If it has not been calibrated for a long time, do calibration before test.

10.7 Function and assembly of reference electrode

The reference electrode plays a role in providing standard potential for other electrodes in the
instrument. If the reference electrode is unstable, all electrodes will be unstable. After a period of
use, the saturated potassium chloride in the reference electrode will gradually permeate out, and
the reference liquid will gradually decrease.
Filling of reference solution:
1) Absorb a certain amount of reference liquid with a syringe and add it from the small hole in the
upper right corner of the reference electrode (Not full, just fill the left cavity).
2) Check regularly to prevent small hole from being blocked by salt crystals.
3) If all the calibration values appear to be 240, it is generally the contact part between the
reference electrode and the test liquid - there are bubbles at the reference film. Some bubbles
are very small and difficult to see. At this time, please take out the reference electrode and flick
the bottom end of the reference electrode with your finger (below the silver rod), repeated many
times.
4) Check the reference electrode regularly, if find that there is salt crystals on the shell please wipe
it clean, otherwise it will lead to unstable measurement.

10.8 The Relationship Between nCa, TCa, iCa and pH

The composition of serum is very complex, containing a large amount of protein and citrate, etc.,
which can combine with iCa to form calcium complex. Since calcium complex does not have
physiological activity, the standard for regulating calcium balance in human body is iCa rather
than TCa. This instrument measures iCa in serum by an ion-selective electrode. The relationship
between TCa, iCa and Calcium complex is as follows:
TCa =iCa+ Calcium complex
The ionized calcium value of human serum pH=7.40 is nCa (standard iCa)
The iCa value in human serum pH=7.40 is nCa.

After the serum is separated, with passing time and the effect of centrifugation, CO2 in the blood
escapes, and the pH value increases, and the iCa concentration decreases, so the iCa value
measured at this time is inaccurate. Therefore, the measured iCa has no clinical significance, and
the main basis for clinical diagnosis is nCa. The pH displayed on the screen is the measured pH
value, and nCa (which can be considered as the concentration of iCa in the human body) can be
calculated using the formula. In the sample analysis results, the screen shows that Ca2+ is the
standard calcium, and there are three items covering iCa, nCa and TCa in the printed results, of
which nCa can be used for clinical diagnosis, and iCa and TCa are only for user reference during
the sample analysis.

User Manual 47
10.9 Notes on Instrument Calibration
The instrument can perform one point correction and two point correction, and can be calibrated
individually or with multiple electrodes at the same time.
One point correction: When calibrating one or several electrodes, please keep the default value of
000.00 for the electrodes that do not need to be calibrated, prepare the QC solution and put it on
the sample plate, enter the QC target value, and then click “OK”.
Two point correction: In the two-point calibration, it is recommended to measure the low target
value QC at the first point and the high target value QC at the second point. Same as one point
calibration, please keep the default 000.00 for electrodes that do not need calibration. Do not use a
QC solution with a target value for two-point calibration, otherwise the calibration result would be
invalid, and the calibration factor needs to be confirmed and then calibrated again.
Notice:
No matter what kind of electrode calibration method, please do not
change the initial value of 000.00 for electrodes that do not need
calibration. Press “YES” to let it pass. After calibration, be sure to
check the calibration factor to check whether the calibration factor is
correct.
When the data is cluttered, clear the correction factor and calibrate
again.

10.10 Precautions for Fuse Replacement

A burnt fuse would lead to a start failure of the machine.
Purpose
Replace the fuse.
Maintenance timing
The maintenance should be performed when the power plug is well connected, but the the machien
cannot be activated.
Maintenance tools
Flat-blade screwdriver
Instrument status
Make sure the instrument is turned off when maintaining.
Precautions

Warning
Do not replace with other specifications of the fuse.

Steps

User Manual 48
1. Make sure the instrument is turned off and unplug the power cord.
2. Prepare a new fuse (F1AL250V).
3. Use a flat-blade screwdriver to lift out the fuse holder at the power socket on the right side of
the instrument, and take out the fuse.
4. Observe whether the fuse is blown, burnt black and other problems.
5. If blown or burnt, replace with a new fuse in the current position.
6. Install and tighten in the reverse order of removal.
Notice:
This analyzer is valid for 8 years. Please read this manual carefully, and
must operate according to the operation method specified by the
manufacturer and use the original electrodes and reagents, otherwise
the adverse consequences would be borne by the user!

10.11 Precautions of CO2 Model

1. If the CO2 test is abnormal, please check according to the following steps:
a. Re-calibrate CO2. If the test results are still wrong after the calibration, the following checks
shall be carried out;
b. The tubes on the CO2 reaction tank is not inserted properly, and there is gas leakage;
c. Whether the reaction liquid pump pipe is installed reversely.
d. Whether the reaction liquid has been used up. When changing the reaction liquid each time,
do not wait for all the absorption before changing. All sucked dry, please rotate the pump head
sucking reaction liquid by hand, so that the pump tube is full of reaction liquid. If not, the
pump tube would be empty. Thus the reaction liquid cannot be added in, resulting in a wrong
test CO2 value.
2. Pay attention to avoid blood clots during sampling, otherwise it would change the CO2 value
and affect the measurement. If the CO2 test is abnormal and the repeatability is not good, clean
the whole tube and reaction pool with the protein removal solution.
Common Problems in CO2 model:
1) If the sample size is small and there is not emergent, it is best to remove the upper and lower
two pump tubes, at least the lower one, after shutting down every day. The upper and lower
pump pipes are severely tightened since they are used for sealing. If the pump pipes are not
used for a long time, it would accelerate the aging of the pump pipes and the adhesion of the
pump pipes (especially the pump pipes with reaction liquid). The result is that the CO2 reaction
liquid is not enough and leads to the low CO2 result. But if it works all day, the user do not
need to take off the pump tube. (Install the pump tube correctly, otherwise the sample cannot
be sucked.)
2) CO2 should be re-calibrated every 1-3 days, so as to maintain the true and accurate CO2
results.
Low CO2 value: The reaction liquid was not added to the pump tube due to adhesion.
Treatment method: First take off the pump tube, then pinch to disconnect the adhered part of
the pump tube, and then install the pump tube. Manually rotate the reaction liquid pump head
User Manual 49
to suck the "reaction liquid" until it flows to the reaction pool.
High CO2 value: Without re-calibration for a long time.
Treatment method: re-calibrate CO2.

10.12 Consumable List

No. Part name Note Replace cycle

1 Sample cup WB2 Φ12×37mm Disposable
2 Drift correction solution A 350mL/Bottle Replace when using up
3 Slope correction solution B 350mL/Bottle Replace when using up
4 Reference solution 10mL/Bottle Replace when using up
Filling solution in
5 3mL/Bottle Replace when using up
electrode
5 Internal correction solution 100mL/Bottle Replace when using up
Electrode activation
7 100mL/Bottle Replace when using up
solution
8 Cleaning solution E 100mL/Bottle Replace when using up
Protease reagent:
25mg×5.
Electrode cleaning solution
9 Diluent: 5mL×1. Replace when using up
(protease)
Plastic dropper: 1
branch.
10 Printing paper 56*28 Replace when using up
K+, Na+, Cl-, iCa 2+,
11 Electrode 1 year
pH, Li+, Mg2+
12 Reference electrode Ref 1 year

User Manual 50
Appendix A Inter-laboratory Quality Control
The instruments, electrodes, and reagents have been adjusted before the instrument leaves the
factory, but when the results are high or low during the using, which may be caused by
changes in ambient temperature, humidity, voltage, quality control standards, and the use of
electrodes, it is necessary to conduct the quality control calibration procedure when doing
inter-laboratory quality control.
First, take the constant quality control of two high and low target values, which requires the
same manufacturer as the inter-laboratory quality control. Calibration should be performed
before use, and the electrode test should be stabilized, and then enter the calibration program.
Then the user can input the target values of two different batches into the instrument to test
the two QCs, and then the program would automatically exit, and the correction factor would
be introduced in the blood sample measurement in the future.
With good calibration procedures, users can achieve good results in provincial and municipal
quality control tests. The specific method is: Take the constant QC, which is consistent with
the manufacturer and type of the unknown QC provided by the superior competent
department, perform QC correction, and then measure the unknown QC to be checked.
(Because the constant QCs produced by various manufacturers are incompatible with each
other, and there is large deviation sometimes, the same type of QC should be used for
correction.)
Note: QC serum is lyophilized from porcine or human serum after treatment, and is often
added with iCa2+ and preservatives, which is quite different from normal human serum.
Therefore, the nCa measured by the instrument does not conform to the ratio of TCa≈2nCa,
and the ratio of QC serum of different batches is different, so the quality control serum
cannot use iCa2+ to convert nCa.
The specific operations of calibration are as follows:
1. The instrument is adjusted to the best condition
Step 1: Clean and activate the electrode for one hour after starting the machine.
Step 2: Re-calibrate three or four times, record the mv value, and observe the change of the
mv value. If the mv value is less than 0.5 (except pH) between the two consecutive A and
B correction solutions, it means that the electrode is stable and can go to the next step. If
the mv value is greater than 0.5 (except pH), it means that the electrode is unstable, and the
protein removal, activation and calibration should be performed again.
Step 3: After the calibration is stable, perform random QC 1-2 times to observe the
repeatability. If the repeatability is good, go to the next step, if not, the user should
re-calibrate and check the instrument.
2. Enter the "two point calibration" procedure: after each QC, use the constant QC with the
known target value (should be the same as the origin of the inter-laboratory QC) to do a
QC, had better do the constant QC with the lower target value first.
3. Do a QC with another constant QC (high value) with a known target value.

User Manual 51
 4. In "Analyze Serum", do a random QC first, then do an inter-chamber QC with unknown
target value, and finally do a low-value constant QC and a high-value constant QC once
each. Then to analyze the QC results. If the last two low-value and high-value constant
QCs are very close to the target value, the unknown QC results are considered to be
reliable. If the QC results of these two constants are not accurate, the user need to
reactivate the electrode, do two-point calibration after the calibration is stable, and then do
a QC according to the above steps, until the constant QC hits the target can be considered
reliable .
5. If there are multiple unknown QCs, re-calibrate twice, and then follow steps 2, 3, and 4
one by one. The user cannot conduct all unknown quality controls after one calibration.
Before each new QC, two-point calibrations need to be completed, which ensure the
reliability of the results of each QC.

Notice:
1. The constant value QC and inter-laboratory QC as the known target
value used for calibration should be produced by the same
manufacture. (it is best to use RANDOX quality control calibration).
2. If constant QC is TCa, the user must divide TCa by 2 when entering
the target value. After the TCa value is completed, it is better to
check it by other methods, because the value measured by the
instrument is iCa2+. If the pH difference between the two QCs
(constant QC and inter-laboratory quality control) is too large or the
ratio of added Ca2+ is different, TCa may be inaccurate.
3. When the instrument is stabilized, do constant QC and
inter-laboratory quality control measurements immediately.
4. When testing only for patient serum samples, one point calibration
can be adopted, and only one constant QC can be used.
5. When the QC result is not stable (usually Cl), it is because this QC
product has added a preservative (such as gentamicin, etc.) that has a
great influence on the Cl electrode, please use other methods (such
as biochemical methods) for measurement and contrast.

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Appendix B Function Menu

User Manual 53
Appendix C Operation Steps and Precautions
1. Power on: Turn on the power switch.
2. When the instrument performs "system flushing", the Slope correction solution B and the
Drift correction solution A are sucked in sequence.
3. Activation: The activation time is generally controlled at about 15 minutes. If the instrument
is not used for a long time or the electrode is aging, the activation time should be controlled
within 30 minutes.
4. System Calibration: First, correcting the difference of mv value to be less than 0.5 (except
pH). If it exceeds the range, use electrode cleaning solution (protease) to clean, and then
calibrate after reactivation. Second, the electrode slope must be within the normal range.
5. Sample Analysis: During the operation, be careful not to suck the blood clot to avoid
blocking the tube and electrode. If it is accidentally blocked, use a balloon or a syringe to
blow it through in sequence (pump tube, each electrode, syringe) , and a section that cannot
be blown through should be replaced. When sucking the sample, bubbles should exist,
otherwise the measurement results would be inaccurate and need to be re-measured.
6. "service Menu" There are several subroutines in this program:
 Deprotein: The instrument does protein removal at least once a week. When the sample
volume is large, the user can also use this procedure for daily electrode cleaning. Note that
after treatment with "electrode cleaning solution (enzyme)", it must be reactivated for 30
minutes to 2 hours, and the sample can be tested after re-calibration.
 Electrode Calibration: In order to prolong the service life of the electrode and meet the
requirements of different inter-chamber quality control. Only the electrode calibration is
stable can the user operates. When two-point calibration is adopted, two QC serums with
high and low target values from the same manufacturer must be used. When one point
calibration is adopted, any manufacturer's QC approved by the user can be used (but
products with added preservatives that affect the ion electrode method cannot be used).
 Data and Time: adjust date and time.
 Display Slope: check whether the electrode slope is within the normal range.
 Result query: view and print results.
 Correction Factor: view and clear correction factors.
 Starting number: change the patient sample ID.
7. Transport requirements for return for maintenance: the instrument must be sterilized and
disinfected before packaging, the host machine should be padded with shock-absorbing
foam and packaged (no reagents are placed in it), the transportation environment is -20℃～
+40℃, relative humidity ≤80%, and handle with care, not upside down.

User Manual 54
Appendix D Maintenance of Electrodes
D.1 Composition of Electrodes
The ion-selective electrode consists of an ion-selective membrane, an electrode shell, an
Ag/AgCl inner conducting electrode, an electrode filling liquid and a sealing ring (see Figure
1).

D.2 Add reference solution in electrode

The electrode must be filled with the reference solution in electrode before use. When adding
the reference solution in electrode, the included syringe needle should be used (avoid
puncturing the electrode membrane during operation). The filling amount is 2/3 to 3/4 of the
electrode cavity. (see Figure 2). Tighten the inner conductive electrode, no air bubbles are
allowed between the reference solution in electrode and the electrode film, wipe the electrode
surface dry, and install the electrodes into the electrode holder in sequence.

Notice:
 During the process of adding liquid, the needle should not be
inserted into the cavity of the electrode chamber to avoid puncturing
the electrode membrane.
 The filling amount of the reference solution in electrode is 2/3~3/4
of the electrode chamber cavity.
The reference electrode provides the standard potential of other electrodes in the instrument. If
the reference electrode is unstable, all electrodes would be unstable. After a period of use, the
saturated KCL in the reference electrode would gradually penetrate out, and the reference
solution would gradually decrease. Once the solution decreases, it should be refilled

User Manual 55
immediately.
How to add the reference solution: Unscrew the filling cap on the upper right corner of the
reference electrode by turning counterclockwise, and then use a syringe to add the reference
solution into the electrode cavity until it is full. Tighten the liquid filling cap of the reference
electrode, swing the reference electrode downwards, let the reference solution flow into the
electrode cavity, clear the bubbles in the reference electrode, and make the solution fully
contact with the reference electrode.

Notice
 When installing the reference electrode, please suck out the
reference solution with a clean syringe and inject it into the
reference electrode. Make sure that there are no bubbles on the
electrode membrane under the reference electrode cavity.
 If all the calibration values are 240, there are usually bubbles in the
reference film, and some of the bubbles are so small that it is
difficult to see. Please take out the reference electrode, flick the
bottom end of the reference electrode (under the silver rod) with
your finger, and repeat several times.
 During use, the Reference solution should be replaced regularly,
and there should be no turbidity. Note that the reference solution is
added in time (2/3-3/4 of the cavity), and the filling hole in the
upper right corner of the reference electrode must be kept
unobstructed to prevent it from being blocked by crystalline salt.
D.3 Maintenance of electrodes
New electrodes must be activated with fresh QC serum or fresh serum for more than 2 hours
after the first installation. During the use of the electrode, problems such as contamination,
poisoning and reduction of internal filling liquid would occur, and the specific manifestations
are electrode drift and abnormal electrode response (including abnormal electrode mV and
abnormal electrode mV difference). The contamination of the electrode can be removed by
inhaling the protein-removing cleaning solution to remove the contaminants attached to the
electrode membrane. When the contamination is severe, a cotton thread can be used to pull
back and forth through the electrode hole to remove the adhesion in the electrode hole (all
electrodes are strictly prohibited to use hard objects to clean up). If the reference solution in
electrode in the electrode is insufficient, the user can clear the original solution and refill it.
If the electrode mV count is abnormal (including electrode protein removal and electrode
regeneration, because the use of acidic substances may also cause abnormal electrode mV
count), fresh QC serum or fresh serum can be used for activation for more than 2 hours until
the electrode is stable.
D.4 Storage of electrodes
User Manual 56
Electrodes can be stored for a long time at room temperature, but should avoid direct sunlight
and freezing.

Notice:
 The electrode number is one of the warranty certificates of the electrode.
Please keep the electrode and the outer packaging in a safe place for
inquiries.
 The optimal use period of the electrodes is 1 year.

User Manual 57
 Biobase Biodustry (Shandong) Co., Ltd.
Add: No.9 Gangxing Road, High-Tech Zone,Jinan City, Shandong Province, China
Tel: +86-531-81307661
E-mail: service_ivd@biobase.cc
Web:www.biobase.cc/www.meihuatrade.com/www.biobase.com

User Manual 58