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Shenzhen Kindle Medical Devices Co.

, Ltd

Operating Manual

KD720
KD Semi-auto Chemistry Analyzer
KD720 Semi auto Chemistry Analyzer Operating Manual Rev: A/0

Table of Contents
Table of Contents............................................................................................................................................................I

Chapter I: Brief Introduction.......................................................................................................................................1

1.1 Product Overview.............................................................................................................................................. 1


1.1.1 Brief introduction of this instrument............................................................................................................ 1
1.1.2 Basic performance and parameters........................................................................................................... 1
1.1.3 Product structure and composition............................................................................................................. 2
1.1.4 Scope of Application..................................................................................................................................... 2

1.2 Summary of the Operating Manual................................................................................................................ 2

1.3 Symbols, Stencils, Labels and Figures..........................................................................................................3


1.3.1 Symbols.......................................................................................................................................................... 3
1.3.2 Stencils and labels........................................................................................................................................ 3
1.3.3 Figures............................................................................................................................................................ 4

1.4 Warranty and Service....................................................................................................................................... 4

1.5 Training................................................................................................................................................................4

Chapter II: Safety and Precautions........................................................................................................................... 6

2.1 Safety...................................................................................................................................................................6

2.2 Precautions.........................................................................................................................................................7

Chapter III: Installation................................................................................................................................................. 9

3.1 Instrument Models.............................................................................................................................................9

3.2 Installation Operators........................................................................................................................................9

3.3 Damage Check.................................................................................................................................................. 9

3.4 Checklist........................................................................................................................................................... 10

3.5 Installation Requirements.............................................................................................................................. 10

3.6 Instrument Installation.................................................................................................................................... 10

Chapter IV: Structure..................................................................................................................................................12

4.1 Diagram of Main Components...................................................................................................................... 12

4.2 Diagram of Operation Panel..........................................................................................................................12

4.3 Diagram of Instrument Rear.......................................................................................................................... 13

4.4 Menu Interface.................................................................................................................................................13

Chapter V: Routine Operations................................................................................................................................14

5.1 Measurement Flowchart................................................................................................................................ 14

5.2 Routine Operations and Precautions...........................................................................................................15

5.3 Sample Measurement.................................................................................................................................... 15


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5.3.1 Aspirating the cleaning solution................................................................................................................ 18


5.3.2 Aspirating Distilled Water........................................................................................................................... 19
5.3.3 Aspirating Blank Solution........................................................................................................................... 20
5.3.4 Pipetting Standard Solution....................................................................................................................... 20
5.3.5 Aspirating Sample Solution........................................................................................................................21
5.3.6 Standby Status............................................................................................................................................ 22
5.3.7 Setup............................................................................................................................................................. 23
5.3.8 Search...........................................................................................................................................................25

5.4 Testing Examples............................................................................................................................................ 25

Chapter VI: Software Operation...............................................................................................................................28

6.1 QC Review....................................................................................................................................................... 28

6.2 Result Review.................................................................................................................................................. 29


6.2.1 To edit samples............................................................................................................................................30
6.2.2 To add results...............................................................................................................................................31
6.2.3 To search results......................................................................................................................................... 32

6.3 Editing Test Items(Program)..........................................................................................................................33


6.3.1 To add an item and edit its parameters................................................................................................... 34

6.4 System Setup...................................................................................................................................................39


6.4.1 Printing setup............................................................................................................................................... 39
6.4.2 Time setup....................................................................................................................................................40
6.4.3 COM setup................................................................................................................................................... 40
6.4.4 Contrast Setup.............................................................................................................................................41

6.5 System Maintenance...................................................................................................................................... 41


6.5.1 Temperature adjustment............................................................................................................................ 41
6.5.2 Setup of aspiration volume........................................................................................................................ 42
6.5.3 Aspiration adjustment................................................................................................................................. 43
6.5.4 Absorbance testing..................................................................................................................................... 43
6.5.5 ADC adjustment...........................................................................................................................................44
6.5.6 Restoration setup........................................................................................................................................ 45

Chapter VII: Daily Use and Maintenance...............................................................................................................47

7.1 Daily Maintenance and Care.........................................................................................................................47

7.2 Explanation about Elimination or Reduction of Instrument Downtime...................................................48

7.3 Preventive Maintenance and Inspection for Safety Purpose.................................................................. 49

7.4 List of Replacement Components................................................................................................................ 49

7.5 Common Faults and Troubleshooting..........................................................................................................49

Chapter VIII: Shipment and Storage.......................................................................................................................51

8.1.1 Shipment.......................................................................................................................................................51
8.1.2 Storage......................................................................................................................................................... 51
8.1.3 Graphic explanations on the outer package........................................................................................... 51
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Chapter IX: Commonly-Used Consumable Materials and Ordering Information.......................................52

Chapter X: Annex........................................................................................................................................................ 53

Annex 1: Replacement of Printing Paper........................................................................................................53


Annex 2: Replacement of Pump Tubes...........................................................................................................55
Annex 3: Washing Flow Cell............................................................................................................................. 56
Annex 4: COM Communication........................................................................................................................56
Annex 5: List of Test Items and Test Combinations...................................................................................... 57
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Chapter I: Brief Introduction

1.1 Product Overview

1.1.1 Brief introduction of this instrument

Product name: Semi-Automated Biochemistry Analyzer

Safety classification: Electric-Shock Safeguard Level I, Overvoltage Category II,


Pollution Degree II

Regulatory classification: A kind of biochemical analysis system in the category of


analyzing instruments for clinical tests (6840); Regulatory Class II

Operation mode: Continuous running

Manufacturer: Shenzhen Kindle Medical Device. Co.Ltd


Address:4F,Building 2, HongZhenGang industrial area, Gushu,Xixiang, Bao’an
District, Shenzhen, China

Tel.: 86-0755-27512545

E-mail: info@kindlemedcial.com

Website: www.kindlemedica.com

After-sales service provider: Shenzhen Kindle Medical Device. Co.Ltd

Customer service hotline: 86-0755-27512545

1.1.2 Basic performance and parameters


1.1.2.1 Basic performance
Deviation of filter Within ±3 nm
accuracy
Filter half-width No more than 12 nm
Stray light ≥ 2.5 of absorbance
Absorbance linearity For absorbance values in the range of 0.2 – 0.5, linear error is within ±
5%; for absorbance values in the range of 0.5 – 1.0, linear error is within
± 4%; for absorbance values in the range of 1.0 – 1.8, linear error is
within ± 2%
Absorbance stability At 340 nm, the absorbance variance in 20 minutes should be not more

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than 0.005
Absorbance It is expressed with coefficient of variation (CV) and the value should be
repeatability not more than 1.0%
Temperature accuracy Temperature deviation ≤ ± 0.3℃
℃, fluctuation ≤ ± 0.2℃

and fluctuation
Sample carryover rate No more than 1%

Intra-batch clinical ALT ≤ 5%, TP ≤ 2.5%, BUN ≤ 3.5%


precision (CV%)

1.1.2.2 Basic parameters

Wavelength Filtering
selector
Type of absorption Flow cells
cells
Analysis methods End-point, two-point, and kinetic methods.etc
Wavelength 340nm, 405 nm, 492 nm, 510 nm, 546 nm, 578nm , 630 nm and
800nm(optional)
Power ≤180 VA
Net weight About 6 kg

1.1.3 Product structure and composition


This instrument consists of a microprocessor, a main board, a power-supply system, a
pipetting system, a colorimetric system, a monitor, and a printer.

1.1.4 Scope of Application


This instrument is applicable to quantitative analysis of clinical biochemistry items in
medical institutions.

1.2 Summary of the Operating Manual


This Manual mainly helps you learn about the safety, installation, structure, analysis
principles, operation procedures, maintenance and care, alarms and the handling actions
of the semi-automated biochemistry analyzer. Please operate the instrument as per this
Manual.
This Manual mainly includes:

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Chapter I Brief Introduction


Chapter II Safety and Precautions
Chapter III Installation
Chapter IV Structure
Chapter V Routine Operations
Chapter VI Software Operation
Chapter VII Daily Use and Maintenance

Chapter VIII Shipment and Storage


Chapter IX Commonly-Used Consumable
Materials and Ordering Information
Chapter X Annex

Note:
This Manual may be revised appropriately without notification.

1.3 Symbols, Stencils, Labels and Figures


1.3.1 Symbols

The following symbols listed in the table below are applicable to this Manual.

Symbol Meaning

Biological risk

May cause electric shock

High temperature, which may lead to personal injury

Strong light, which may lead to eye injury

1.3.2 Stencils and labels


The following stencils and labels listed in the table below are applicable to this Manual.

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Label Meaning
Serial number of the product

Isoelectric grounding rod

Production date

Device for in vitro diagnosis


~ Alternating current
Power ON

Power OFF
POWER Main power supply
WASTE Outlet of waste liquid
Communication port, which can connect
COM RS232 with the software system in the testing
department

1.3.3 Figures
All the figures in this Manual are only used for illustration or examples; they cannot be
used for other purposes. Specific operations should be based on the actual instrument;
changes may occur without notification.

1.4 Warranty and Service


The whole instrument will be warranted for one year since the date of installation.
However, this warranty does not cover the damage caused by the following situations:
(1) Used in an environment that cannot meet the requirements in this Manual;
(2) Damage caused by not using the specified power supply or having abnormality in
the power supply;
(3) Man-made damage;
(4) Damage due to reparation by personnel that do not acquire the authorization from
kindle ;
(5) Damage caused by other irresistible natural factors such as earthquake, fire and
war.
If you have any concern or question during use of this instrument, please do not hesitate
to contact us.

1.5 Training
We will hold free training periodically at different places for you, to facilitate the correct use

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of this analyzer and the maximization of its performance. For the training schedule, please
visit our website or consult our local office in your region.
Please read this Manual and the IFU of related reagents carefully before use; otherwise,
the protection provided by this instrument may be impaired.
This instrument can only be used by personnel who have received training by kindle or its
authorized representatives; otherwise, the protection provided by this instrument may be
impaired.

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Chapter II: Safety and Precautions


The following items are the warning symbols related to this analyzer. Please pay more
attention to them; otherwise, there may be the risks of death or serious injury. The
following warning symbols are not ordered as per its importance; all the symbols are
equally important.

2.1 Safety
Electric Shock
(1) When the power is ON, any person except authorized service
technicians is prohibited to open the analyzer panel.
(2) Avoid spilling any liquid onto the instrument tabletop. If some liquid
splashes into the analyzer, please cut off the power supply immediately
and contact kindle promptly.
High Temperature
(1) Before exchanging the bulb, please cut off the electricity and wait at
least 30 minutes until the bulb cools down.
(2) You may be scalded if touching the print head and the metal part around
it.
Strong Light
(1) Do not stare at the beams from the bulb, otherwise your eyes may be
injured.

Biological Pollution
(1) All the test samples, quality controls, and standards should be regarded
as infectious. Please wear gloves when contacting them.
(2) All the wastes should be regarded as infectious and thus you should
wear gloves when contacting them. The components touched with a test
sample, such as pipetting tips, cuvettes and measuring cups should be
regarded as infectious; so, you should wear gloves when contacting
them.
(3) All the wastes are potentially infectious, and should be regarded as
medical wastes and disposed of according to the current regulatory
requirements.
(4) When the service life of the instrument ends, it should be disposed of as
per local requirements for environmental protection, and it cannot be
disposed of and discarded as common wastes.

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2.2 Precautions

Scope of Application
(1) This instrument is applicable to quantitative analysis of clinical
biochemistry items in medical institutions.

Operators
(1) The analyzer can only be used by personnel who have been trained and
authorized by kindle or its representatives.

Actions in Case of Breakdown


(1) If the instrument has a hazardous breakdown, such as fire, strange smell,
smoke or other dangerous situations, anyone should directly cut off its
electricity or the main power supply, and then contact Genius.
Application Environment
(1) Please correctly install the instrument as per the environmental
conditions specified in this Manual. Otherwise, the test results obtained
may be inaccurate and the analyzer may be damaged.
(2) If it is necessary to change its work environment, please contact us or
our representative in your region.
Electromagnetic Interference
(1) The analyzer is susceptible to electromagnetic interference during
running, which may influence assay results and lead to wrong
operations. During its running, please do not use devices generating
electromagnetic waves, such as electric drill, mobile phone, and
intercom.
(2) The analyzer can emit electromagnetic waves during running. Please do
not install and use electromagnetic-sensitive equipment near the
analyzer.
Liquid Leakage
(1) Check all the pipe connections before testing to verify if there is leakage.
Liquid leakage can make the aspiration and dispensing volumes
inaccurate.
(2) Do not place reagents and samples on the analyzer tabletop, to avoid
liquid spillage and leakage.

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Water Quality
(1) The water quality should meet the following requirements; otherwise, the
valves and pumps may be easily damaged or cannot be cleaned:
• Particle diameter < 200 µm;
• Resistivity > 0.5 MΩ/cm;
• Colony count < 10 cfu/mL;
• Dissolved silicon < 0.1 mg/L.

Poor Grounding
(1) The power supply must be correctly grounded; otherwise, there is the
risk of electric shock.
(2) The grounding impedance must be lower than 0.1 Ω; poor grounding can
cause unstable test results and housing leakage, and thus there is the
risk of electric shock.
Device Connection
(1) For a device not permanently connected, please do not place it at a
location that is hard to disconnect.
(2) For all the external switches or breakers and external
overcurrent-protection systems, it is recommended to place them near
the analyzer.
(3) The devices connecting with the COM RS232 port of this analyzer should
satisfy the requirements in the National Standard GB 4793 of China.
Analysis Parameters
(1) Incorrect analysis parameters may lead to false results. For more
information, please consult kindle or the reagent supplier.

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Chapter III: Installation


3.1 Instrument Models
This kindle series can be divided into the following five models:

KD720A: Involving seven wavelengths, i.e. 340, 405, 492, 510, 546, 578, and 630 nm; a
type of semi-automated biochemistry analyzer with touch screen

KD720B: Involving seven wavelengths, i.e. 340, 405, 492, 510, 546, 578, and 630 nm; a
type of semi-automated biochemistry analyzer without touch screen

KD720C: Involving six wavelengths, i.e. 340, 405, 510, 546, 578, and 630 nm; a type of
semi-automated biochemistry analyzer with touch screen

KD720D: Involving six wavelengths, i.e. 340, 405, 510, 546, 578, and 630 nm; a type of
semi-automated biochemistry analyzer without touch screen

3.2 Installation Operators


This analyzer can only be installed by kindle or its authorized representatives, and the
user should provide the required environment and space. When you receive this analyzer,
please notify kindle or the local representative immediately.

3.3 Damage Check


All the analyzer packages have been strictly examined by kindle before shipment. When
you receive the instrument, please check carefully to verify whether there are any of the
following damages before opening the packaging box:
(1) Inversion or deformity of the outer package;
(2) Obvious moistened marks on the outer package;
(3) Obvious crash marks on the outer package;
(4) Indication of the opened outer package.
Once you find the issues above, please do not open the package and do not power on the
instrument. Otherwise, you may be injured. Please notify the local representative
immediately.
If the outer package is intact, please open the packaging box and check the articles in the
box with the presence of the representative or the personnel from Genius:

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(1) Verify if all the components are equipped according to the checklist;
(2) Check the appearance of all the components carefully to verify whether there
is breakage, impact, or deformity.

3.4 Checklist
Please refer to the Checklist in the packaging box of this instrument.

3.5 Installation Requirements


Content Requirements
Flat tabletop with a tilt of < 1/200 and sufficient intensity, which can bear the
weight of 50 kg;
Location Dust-free, without corrosive and inflammable gases, free from heat or wind
sources and mechanical vibration;
Avoidance of direct sunlight, and good ventilation
Space Enough space to place the analyzer with the area of at least 1 m2
Temperature 10℃
℃ - 30℃

Humidity Relative humidity ≤ 85%
Atmospheric 86.0 kPa - 106.0 kPa
pressure
Able to exchange air with the external environment, smooth air flow, not directly
Ventilation
blowing into the analyzer
Power supply ~100-240V, 50/60Hz, correct grounding, and grounding impedance < 0.1Ω
Electromagn Not close to the electric-brush engine and the electric devices frequently
etic waves switched on/off

3.6 Instrument Installation


1 Open the special packaging box of this analyzer and carefully verify if the
instrument and accessories in the box are consistent with the checklist. If there is any
loss or damage, please contact the supplier at once.
2 If the articles in the box are correct, take out the instrument carefully and put it on
the stable and flat workbench.
3 Ground the grounding rod at the rear panel of this analyzer via an earth wire
specially designed for medical instruments (grounding impedance < 0.1 Ω).
4 Take out the power cable, plug one end into the power jack at the rear panel and
insert the other end into the grounded three-wire socket.

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5 The fuse used in this instrument is indicated as “F3AL250V”, which is a type of


glass-tube rapid-fusing device with double-cap lead wires, and has 3 A of the rating
current and 250 V of the rating voltage.
6 If the analyzer should be connected with the analyzing system of the testing
department or the whole hospital, take out the serial cable, and connect one end with
COM RS232 at the instrument rear and the other end with the computer. The serial port
is set up as per the operating manual of the analyzing system used in the testing
department or the whole hospital.
7 For a device not permanently connected, please do not place it at a location that
is hard to disconnect.
8 If different devices need to cooperate together for achieving some functions, and
an identical reference potential is required, then it is necessary to connect all the
isoelectric terminals. Isoelectric connection can inhibit potential difference, thereby
eliminating electromagnetic interference. If it is necessary to make an isoelectric
connection, take out the attached isoelectric grounding wire and insert it into the
isoelectric port for connection with the isoelectric earth wire.

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Chapter IV: Structure


4.1 Diagram of Main Components

Display screen
Built-in thermal printer

Door at the housing


cover
Keyboard

Cuvettes
Figure 1

4.2 Diagram of Operation Panel

Number key

Power indicating lamp


Exit key, used for
returning to previous
menu

OK key, used for


Paper-Motion key, confirming an operation
used for manual
movement of paper

Figure 2

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4.3 Diagram of Instrument Rear

Housing fan RS-232 serial port Waste-liquid pipe

Isoelectric
Power
Power grounding rod Peristaltic pump
switch
jack

Figure 3

4.4 Menu Interface


Note: For the operations mentioned below, if you use an instrument with a touch screen,
you can click an appropriate icon or press the corresponding number key to perform the
specific operation; but if you use an instrument without touch screen, you can only use the
appropriate number keys.

As illustrated in the Figure above, the main interface displayed after instrument startup
has six submenus, which can be selected with the number keys by operators.

During routine work, operators mainly use Items 1 and 3; Item 1 can conduct the sample
testing, and Item 3 can help you view or print a report.

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Chapter V: Routine Operations


5.1 Measurement Flowchart
Turn on the power switch and preheat for more than 15 minutes

Press the number key “1” to open the “Measure Samples” window

Select the desired testing combination with number keys

Select the desired testing item with number keys

Preheat the light-source lamp

Press the number key “1” to start measurement

Aspirate the cleaning solution

This item is not measured at first time


Aspirate distilled water to measure its absorbance

This item is measured at first time after startup, and its blank
has been defined
Aspirate the blank solution and measure it
This item is measured at first time after startup, and its
standard has been defined
Aspirate the standard solution and measure it

Aspirate the sample solution

Press “Exit” to return to the main Press the number key “2” to Press the number key “3”
menu enter the “Setup” menu to enter the “Search”

Press the number key “3” to enter the Press the number key “1” to
“Result Review” interface perform the printing setup; Enter an appropriate ID to start
press ”2” to edit a test item; searching
Press the number key “1” to edit the press “3” to edit a sample;
sample; press “2” to add results; press press “4” to edit a QC; press
“3” to search and print results “5” to switch between the Print the result report
modes of sample testing and
QC testing

Press “Exit” or click the exit icon to return


to the main menu

Turn off the power switch

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5.2 Routine Operations and Precautions

Routine operations:
1. Startup: Turn on the instrument power supply and enter the main interface after the
system self-checking. Preheat the analyzer for above 15 minutes.
2. To measure samples: Prepare the samples and reagents as per the reagent IFU.
After reacting for the time period required by the IFU, press the number key “1” on
the main-menu interface to open the “Measure Samples” window, and then measure
the samples as per the wizard.
3. To print reports: After measurement, return to the main menu and directly press “3” to
open the “Result” window, then press “3” again and enter an appropriate No. to print
the desired report.
4. To edit samples: Press “3” to open the “Result Review” window, and then press “1” to
edit the patient’s information.
5. To wash pipes: After testing, please use the cleaning solution to wash the pipes.
6. Shutdown: After completion of all the operation procedures, please turn off the
electricity.

Precautions:
1. This analyzer should keep away from moisture and sunlight, and also should be
maintained periodically.
2. This instrument can only be used by trained medical professionals.
3. Please wash the flow cell to make them clean.
4. In North China and regions with a similar climate, after use at a low temperature in
the winter, please drain the liquid in flow cell before shutdown. Otherwise, the liquid
in flow cell may freeze at a low-temperature environment, thereby damaging the cell.
5. Calibration should be performed during analysis to ensure the result accuracy.
6. The wastes generated should be regarded as medical wastes for disposal.

5.3 Sample Measurement

Press the number key “1” on the main menu to open the “Item Choice” window, as
illustrated in Figure 5-1:

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Figure 5-1

Enter the desired item No. (e.g. “1 ALT”) to enter the measurement interface of this item,
as illustrated in Figure 5-2:

Figure 5-2

After the light-source lamp becomes stable, the system will open the measurement
interface, or you can press “Skip” to skip the preheating step and enter the measurement
interface, as illustrated in Figure 5-3:

Figure 5-3

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First, by pressing the number key “1”, the system will automatically switch to the
corresponding filter and test the original value of the measurement channel without
illumination (dark-current value), as illustrated in Figure 5-4:

Figure 5-4

If the filter wheel succeeds to switch, the screen is displayed as Figure 5-5:

Figure 5-5

If the filter wheel fails to switch, the screen is displayed as Figure 5-6:

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Figure 5-6

5.3.1 Aspirating the cleaning solution


After testing the dark current, the system will automatically enter the “Aspirate
Cleaning Solution” interface, as illustrated in Figure 5-7:

Figure 5-7

Operators can manipulate as follows:


a) Place the cleaning solution (distilled water or sodium hypochlorite) onto the analyzer
and press the number key “1” to confirm. Then, the instrument will begin to aspirate
the cleaning solution.
b) If washing once is not enough, press the number key “2” to return to previous step
for washing again.
c) If it is not necessary to wash, press the number key “3” to skip the “Aspirate
Cleaning Solution” procedure and directly enter the next step.
d) Press “Exit” to return to the main menu.

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5.3.2 Aspirating Distilled Water


After Aspirating the cleaning solution, the system will automatically enter the “Aspirate
Distilled Water” interface, as illustrated in Figure 5-8:

Figure 5-8

Operators can perform the following operations:


a) Place distilled water onto the analyzer and press the number key “1” to confirm.
Then, the instrument will begin to pipette distilled water and measure its ADC value;
the screen is displayed as Figure 5-9:

Figure 5-9

Every time after the filter wheel rotates, the system will prompt you to aspirate distilled
water for calibration of absorbance zero-value. If the difference between the original value
and zero value of distilled water is less than 1000, the system will display “Abnormal Light
Path”. At this time, please check the light path. If the difference between the original value
and zero value of distilled water is more than 1000 but less than 30,000, the system will
display “Abnormal ADC”. At this time, please check the ADC amplification factor and
whether there are air bubbles in the liquid lines.

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5.3.3 Aspirating Blank Solution


When a test item is measured at first time and its blank measurement has been defined,
the system will automatically enter the blank measurement interface after completion of
absorbance testing, and the words “Aspirating Blank Solution” continuously flashes. The
screen is displayed as Figure 5-10:

Figure 5-10

After placing the blank solution onto the analyzer, press the number key “1”. Then, the
instrument will begin to aspirate the blank solution; after measurement, the absorbance
value of the blank solution will display on the screen and tell you to remove the blank
solution. The screen is displayed as Figure 5-11.

Figure 5-11

5.3.4 Pipetting Standard Solution


When the system enters the “Aspirate Standard Solution” interface, if there is only one
calibrator value, the screen is displayed as Figure 5-12:

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Figure 5-12

After placing the standard solution onto the analyzer, press the number key “1”. Then, the
instrument will begin to aspirate the standard solution; after measurement, the
absorbance value of the standard solution will display on the screen and tell you to
remove the standard solution. The screen is displayed as Figure 5-13.

Figure 5-13

5.3.5 Aspirating Sample Solution


If the analyzer has tested the blank and standard solutions for this item, then after
measurement of the sample solution, the system will directly enter into the testing
interface for next sample, as illustrated in Figure 5-14. If this item is tested for the first time,
and its blank and standard have been defined, then the blank and standard testing should
be performed before sample measurement.

Figure 5-14

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After placing the sample solution onto the analyzer, press the number key “1”. Then, the
instrument will begin to aspirate the sample solution; after measurement, the absorbance
value of the sample solution will display on the screen and tell you to remove the sample
solution. The measurement results are displayed as in Figure 5-15; meanwhile, the
system will automatically measure the next patient sample under the same test item.

Figure 5-15

If the item is tested by the kinetic method, the screen will dynamically display the reaction
curve during measurement of the standard and sample, as illustrated in Figure 5-16:

Figure 5-16

The results are displayed with the same way as other measurement methods.

5.3.6 Standby Status


If there are no operations within 30 minutes, the instrument will be in standby status and
the light-source lamp will turn off, and the screen is displayed as Figure 5-17; ten minutes
later, the monitor backlight will shut down.

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Figure 5-17

Press any key on the standby interface to return the last interface before standby.

5.3.7 Setup
In the ‘measure’ menu ,choose an item,after heating,you can set this prarameter.Press
‘set’ or the keypad“2”and display like Figure 5-18:

Figure 5-18

In this interface, you can perform the printing setup, edit a test item, sample or QC, and
switch between different modes.

5.3.7.1 Printing setup


See details in 6.4.1.

5.3.7.2 Item Editing


See details in 6.3.1.2.

5.3.7.3 Sample Editing


See details in 6.2.1.

5.3.7.4 QC Editing
Press the number key “4” on the “Setup” interface to display a screen like Figure
5-19:

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Figure 5-19

In the “Edit QC” interface, you can make the following operations:
a) No.
Operation: If you need to repeatedly measure a single test item for the same blood QC,
change the current “No.” to the original number of this QC. Press the number key “1” to set
the number.
b) LN
Operation: Press the number key “1” to set the number. The LN number can be freely
revised in the range of 1 – 99999999999999, but repetition is not allowable. If you do not
change it, the default value is 0, which means no increase will occur.
c) Item
Operation: Select an item by using the left and right cursor keys or pressing the number
key “1”.
d) Target value
Operation: Press the number key “1” to set the value.

5.3.7.5 Mode Switching


Press the number key “5” and display a screen like Figure 5-20:

Figure 5-20

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Setup of normal mode: The mode for measurement of patient samples:


Setup of QC mode: The mode for measurement of QCs;
Press “Exit” key to return to the measurement interface.

5.3.8 Search
Press the number key “3” to search using the “QC Review” or “Result Review” menus.
See details in 6.1 or 6.2.3.

5.4 Testing Examples


I. GPT/ALT determination by kinetic method

1. Set up the following parameters of this item in the “Program” menu as per the reagent
IFU:

Assay code: 1 Name: GPT/ALT Reagent Biosino


manufactur
er:
Factor: 1746.0 Unit: µ/L Method: Kinetic
Temperature 37℃
℃ Decimal 0 Wavelengt 340
: digits: h:
Reagent N Sample N Normal 40
blank: blank: value
(high):
Normal 0 Calibratio Not calibration Linear < 500
value (low): n: range:
Delay time: 30 s Interval 40 s Aspiration 500 µL
time: volume:
Sampling 2
points:

2. Press the number key “1” on the “Item Choice” window to choose the “ALT” item.
Then, the system begins to preheat and will enter the measurement interface after
the temperature is stable. Enter the number key “1” to select “Measure”. When the
system is ready, the screen will display “ASP Rinse”. Place the cleaning solution onto
the analyzer and press “1 Sample” to start the washing operation. After completion,
the screen displays “ASP Distilled Water”. Place distilled water onto the instrument
and press “1 Sample” to measure the absorbance.
3. The screen displays “ASP Sample”. Place the numbered patient samples onto the

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instrument in order and press “1” to start measurement of sample.


4. After pipetting the sample solution, the analyzer will display the reaction curve on its
screen during testing, as illustrated in Figure 5-21:

Figure 5-21

II. Determination of total protein by end-point method

1. Set up the following parameters of this item in the “Program” menu as per the reagent
IFU:

Assay code: 5 Name: Total protein Reagent Huili


[TP] manufacture
r:
Factor: 0 Unit: g/L Method: End-point
Temperature 37℃
℃ Decimal 1 Wavelength: 546
: digits:
Reagent Y Sample N Normal 82.0
blank: blank: value (high):
Normal 62.0 Linear < 100.0 Delay time: 3s
value (low): range:
Interval 2s Aspiration 800 µL Standard: 70.0
time: volume:

2. Choose the “Liver Function Tests” item on the “Measure Samples” interface, then
press the downward cursor key to jump to the desired page and press the number
key “1” to select “TP”. Then, the system begins to preheat and will enter the
measurement interface after the temperature is stable. Enter the number key “1” to
select “Measure”. When the system is ready, the screen will display “ASP Rinse”.
Place the cleaning solution onto the analyzer and press the key “1” to start the

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washing operation.
3. After completion, the screen displays “ASP DI Water”. Place distilled water onto the
instrument and press “1” to measure the absorbance. After testing, the screening
display “ASP Blank Solution”. Place the blank solution onto the analyzer and press
“1” to confirm the operation.
4. At this time, the screen displays “ASP Standard Solution” (if the screen displays “ASP
Sample”, please press the number key “2” to open the “ASP Standard Solution”
window). Place the standard solution onto the instrument and press “1” to perform
measurement. Calculate the factor after the testing is completed.
5. After measurement of the standard solution, the screen displays “ASP Sample
Solution”. Place the numbered patient samples onto the instrument in order and
press “OK” to start measurement of sample solutions.

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Chapter VI: Software Operation


6.1 QC Review
Quality controls are used to examine and control the instrument precision during assay,
monitor the changes of stability, improve the result consistency for inter- and intra-batch
samples during routine assay, and thus finally ensure the reliability of test results for every
patient sample.

To complete a QC, a kind of QC material should be measured in the “Measure Samples”


interface. After obtaining more than five groups of results for a single QC number under
the same test item, a QC statistical report for this QC number under the test item can be
made.

Press the number key “2” on the main menu and display a screen like Figure 6-1:

Figure 6-1

a) To enter a QC number
Set a QC number by searching with left and right cursor keys or pressing the number
key “1”
b) To search results
Press the number key “2” to view the QC results. The screen is displayed as Figure
6-2:

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Browse
This item has the
ten QC results, results
of which the
third is currently
displayed

Figure 6-2

Press to browse the results;


Press the number key “1” to print the results;
Press the number key “2” to delete currently displayed results;
Press “Exit” to return to previous interface.
c) Statistics
Press the number key “3” on the “QC Review” interface to display a screen like Figure
6-3:

Figure 6-3

a) Press the number key “1” to change the target value;


b) Press the number key “2” to print the statistical results;
c) Press “Exit” to return to previous interface.

6.2 Result Review


Press the number key “3” on the main menu and display a screen like Figure 6-4:

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Figure 6-4

6.2.1 To edit samples


Press the number key “1” on the “Result Review” interface to display a screen like Figure
6-5:

Figure 6-5

You can edit the information about patient samples on the sample editing interface, and
the specific operations are described as follows:

6.2.1.1 No.
If you need to measure another test item for the same patient, change the current “No.” to
the original “No.” of this patient.

6.2.1.2 ID
The ID number can be freely revised in the range of 1 – 99999999999999, but
repetition is not allowable. If you do not change it, the default value is 0, which means
no increase will occur.

6.2.1.3 Sex
Operation: Use left and right cursor keys to choose
Options: (None), Male, Female, Child, Infant, Newborn

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6.2.1.4 Age
Operation: Press the number key “1” to set the value.

6.2.1.5 Blood group


Operation: Use left and right cursor keys to choose
Options: (None), A, B, AB, O, RH+, RH-

6.2.2 To add results


Some test items must be completed by other instruments, but the results should be stored
or printed with those obtained in this analyzer. At this time, you can use this function.
However, you must define the item first.
Press the number key “2” on the “Result Review” interface to add results. The screens are
displayed as Figures 6-6.1 and 6-6.2:

Figure 6-6.1

Figure 6-6.2

a) No.
If you need to measure another test item for the same patient, change the current
“No.” to the original “No.” of this patient.
b) ID

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The ID number can be freely revised in the range of 1 – 99999999999999, but


repetition is not allowable. If you do not change it, the default value is 0, which means
no increase will occur.
c) Sex
Operation: Use left and right cursor keys to choose
Options: (None), Male, Female, Child, Infant, Newborn
d) Age
Operation: Press “Set” or the number key “1” to set the value.
e) Blood group
Operation: Use left and right cursor keys to choose
Options: (None), A, B, AB, O, RH+, RH-
f) Decimal digits
Operation: Use left and right cursor keys to choose
Options: 0, 1, 2, 3, 4, 5
g) Results
Operation: Press the number key “1” to set the value.
h) Unit
Operation: Use left and right cursor keys to choose
Options: µ/L, µ/mL, µmol/L, mmol/L, g/L, mg/L, g/dL, g/mL, X10 12/dL, ABS

If you enter a patient number that dose not exist, the system will display “This No. is not
present”. Then, the system will automatically return to the “Add Results” interface.

After adding, press “Exit” key to save and exit.

6.2.3 To search results


Press “3” on the “Result Review” interface to display a screen like Figure 6-7:

Figure 6-7

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a) Entering the “No.”

Operation: Press the number key “3” to open the keyboard interface. And then enter

the “No.” directly.

b) Entering the ID

Operation: Press the number key “4” to open the keyboard interface. And then enter

the “ID” directly.

c) Printing

Operation: Press the number key “1” to print all the results of the currently displayed

“No.”.

d) Searching

Operation: Press the number key “2” to view all the results of the currently displayed

sample number. The screen is displayed as Figure 6-8:

Figure 6-8

Press the number key “1” to print all the current results; press “Up” or “Down” to view
the last or next result.
e) Exit
Return to previous interface.

6.3 Editing Test Items(Program)


Press the number key “4” on the main interface to display a screen like Figure 6-9:

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Figure 6-9

6.3.1 To add an item and edit its parameters


6.3.1.1 To add an item
Press the up and down cursor keys to jump to the desired page.
Press the number key “1” and display a screen like Figure 6-10:

Figure 6-10

You can set up the name of a new item and its parameters.

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6.3.1.2 To set up the item parameters


In an interface as illustrated in Figure 6-9, press the number key of the corresponding item
to open the “Program” window like Figure 6-11:

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Figure 6-11

You can set up the following parameters in the “Program” window:


Method
Operation: Use left and right cursor keys to choose
Options: End-point [E], two-point, kinetics [K], cutoff [C], division [D]
Wavelength
Operation: Use left and right cursor keys to choose
Options: 1 or 2
Temperature
Operation: Use left and right cursor keys to choose
Options: 37℃, 30℃, room temperature

Aspiration volume
Operation: Press the number key “1” to set the value.

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Setting range: 0 - 9999µL


Decimal digits
Operation: Use left and right cursor keys to choose
Options: 0, 1, 2, 3, 4,
Reagent blank
Operation: Use left and right cursor keys to choose
Options: Yes, No
Wavelength
Operation: Use left and right cursor keys to choose
Options: 340nm, 405 nm, 492 nm, 510 nm, 546 nm, 578nm,and 630 nm

Sampling points
Operation: Use left and right cursor keys to choose
Note: The setting range of the kinetic [K] method is 3 – 9.
Unit
Operation: Use left and right cursor keys to choose
Options: (None), µ/L, µ/mL, µmol/L, mmol/L, g/L, mg/L, g/dL, g/mL, X10 12/dL, ABS
Normal values
Operation: After selecting this parameter, press the number key “1” to set the
value.
Calibration
Operation: Use left and right cursor keys to choose
Options: Single-point linear, two-point linear, multiple-point non-linear, not
calibration
Linear range
Operation: Choose “>” or “<” using left and right cursor keys and press the number
key “1” to set the value.
Delay time
Operation: Press the number key “1” to set the value.

Interval time
Operation: Press the number key “1” to set the value.
Standard values
Operation: Press the number key “1” to set the value.
Attached explanation:
If the measurement method is set as “division [D]”, the screen will be displayed as
Figure 6-12 below:

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Figure 6-12

Note: “Y=A/B” is a formula, in which A and B represent two related items that have been
tested

If the measurement method is set as “cutoff [C]”, the screen will be displayed as Figure
6-13 below:

Figure 6-13

Note: “Y=A+B+C-D-E-F” is a formula, in which A, B, C, D, E and F represent two related


items that have been tested

After completion of editing or pressing “Exit”, display a screen like Figure 6-14:

Figure 6-14

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Press “1” to save the changes.


Press “2” to cancel the changes and return to the “Program” interface.
Directly press “Menu” to exit the “Program” interface. At this time, the changes you made
will not be saved.

6.4 System Setup


Press the number key “5” on the main interface to enter the system setup interface. The
screen is displayed as Figure 6-15:

Figure 6-15

6.4.1 Printing setup


Press the number key “1” on the “Setup” interface to display a screen like Figure 6-16:

Figure 6-16

Press “1” to select or cancel this option. When the option is checked, the instrument will
automatically print the result report after measuring a patient’s sample.
Press “2” to select or cancel this option. When the option is checked, if you use the
kinetics method to measure samples, the instrument will automatically print the reaction
curve after measuring a patient’s sample.
Press “3” to select or cancel this option. When the option is checked, absorbance values
will be added into the result report after measuring a patient’s sample.

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6.4.2 Time setup


In the system setup interface, press “2” to open the “Set Time” window. The screen is
displayed as Figure 6-17:

Figure 6-17

Press left and right direction keys or directly click the left and right keys on the screen to
select the date and time needing to be changed. After entering the desired values, press
“OK” to save the changes or press “Menu” to cancel the changes.

6.4.3 COM setup


In the system setup interface, press “3” to open the “COM” window. The screen is
displayed as Figure 6-18:

Figure 6-18

You can set up the parameters for COM communication. Press left and right keys to select
the desired parameters.

You can select “On” or “Off” for COM status. If you select “On”, the parameters will be
displayed in the COM parameter-setup interface.

There are five options for baud rate, i.e. 9600, 19200, 38400, 57600 and 115200.

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After determining the baud rate, you can select the check parameters; for parity check,
there are three options, including “Odd”, “Even” or “None”.

6.4.4 Contrast Setup


Due to fluctuation of environmental temperature, personal habits or other external factors,
the screen contrast may be not very satisfying. You can adjust the contrast as per the
following procedure.
In the system setup interface, press “4” to open the “Contrast” window. The screen is
displayed as Figure 6-19:

Figure 6-19

Adjust the backlight as needed by pressing the up, down, left and right keys on the
keyboard.

6.5 System Maintenance


Press the number key “6” on the main interface to open the “Maintain” window. The screen
is displayed as Figure 6-20:

Figure 6-20

6.5.1 Temperature adjustment


In the “Maintain” interface, press “1” to open the “TEMP ADJ” window. The screen is

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displayed as Figure 6-21:

Figure 6-21

Press the up, down, left and right keys on the keyboard to set the parameters.

“TEMP” is used to observe the real-time temperature changes of colorimetric cells during
running.
For “Set TEMP”, you have two options: 30℃ and 37℃.

“ADJ” is used to perform fine tuning for the working temperature of colorimetric cells.

“Parameter” indicates the default base value.

A thermometer is required for comparative adjustment.

6.5.2 Setup of aspiration volume


In the “Maintain” interface, press “2” to open the “Set ASP” window. The screen is
displayed as Figure 6-22:

Figure 6-22

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By using this function, you can arbitrarily set the “Clean VOL” and “Sample VOL” in the
range of 0 – 9999 µL. The set cleaning volume must ensure that the lines are clean after
washing. The default value of “Clean VOL” is 1200 µL and that of “Sample VOL” is 1000
µL, which can be adjusted as per actual situation.

6.5.3 Aspiration adjustment


In the “Maintain” interface, press “3” to open the “ASP ADJ” window. The screen is
displayed as Figure 6-23:

Figure 6-23

Enter the desired values in the fields of “Set VOL” and “Real VOL” and get the aspiration
volume determined in the “Set VOL” field. Press “1” to start pipetting and observe whether
the aspirated volume is accurate. If the sample after aspiration is exhausted, increase the
value in “Real VOL”; if the sample after aspiration remains a large amount, decrease the
value in “Real VOL”.

6.5.4 Absorbance testing


In the “Maintain” interface, press “4” to open the “ABS” window. The screen is displayed
as Figure 6-24:

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Figure 6-24

Please operate as per the displayed words on the screen. Absorbance testing is to allow
the system to determine the absorbance changes in different periods and correct
accordingly, thereby making the results more reliable.

6.5.5 ADC adjustment


In the “Maintain” interface, press “5” to open the “ADC ADJ” window. The screen is
displayed as Figure 6-25:

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Figure 6-25

Press or to set up the parameters; press or to switch among the set


parameters.
Place distilled water onto the instrument and click “Sample” or press “1” to start aspiration.
a) By using and , the wavelength can be set as 340, 405, 492, 510, 546, 578, and
630 nm.
b) Generally, 50000 – 55000 of the ADC value is the most suitable. If the ADC value for a
wavelength is not within this range, the parameter can be adjusted. Using or ,
the parameter can be set up in the range of 0 – 255.
c) Using and , the working status of light-source lamp can be switched between
“On” and “Off”.
During ADC adjustment, the light-source lamp should be set as “On”.

6.5.6 Restoration setup


In the “Maintain” interface, press “6” to open the “Restore” window. The screen is
displayed as Figure 6-26:

Figure 6-26

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6.5.6.1 To delete results

Press “1” to delete all the patient results stored in the instrument.

6.5.6.2 To delete QC

Press “2” to delete all the QC results stored in the instrument.

6.5.6.3 To initialize items

Press “3” to initialize the parameter settings of all the built-in items in the
instrument.

6.5.6.4 To initialize system settings

Press “4” to initialize the built-in parameter settings in the instrument, such as print
settings, COM, contrast and aspiration volume.

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Chapter VII: Daily Use and Maintenance


In order to maximize the analyzer performance, ensure its reliability, and extend its service
life, please perform maintenance and care strictly as per the requirements in this Chapter.

7.1 Daily Maintenance and Care


To ensure the normal functionality of the instrument, this Chapter will describe the
maintenance and care methods. Please implement accordingly.

1. Use method of keyboard

The instrument keyboard is a type of slight-touch product; a key has no response when
pressed and can only respond during releasing. Therefore, operators should pay careful
attention not to press the keys strongly, thereby avoiding keyboard damage.

2. Daily maintenance
After sample measurement, immediately wash the lines with distilled water several times,
to minimize the residual reagents or serum albumin on the inner wall of the lines,
especially the residual materials on the inner wall of flowing colorimetric cells. Fill distilled
water into the lines after washing.

3. Weekly maintenance
Wash the lines with distilled water several times and then aspirate the cleaning solution
once (main ingredient: sodium hypochlorite, diluted to 5%); after that, maintain the
cleaning solution in the lines for ten minutes and finally wash the lines with distilled water
for three times. Fill distilled water into the lines after washing. Neutral or alkaline cleaning
solutions are applicable to this instrument, but acidic cleaning solution is prohibited.

4. Washing and disinfection of instrument surface


Washing: Dip a piece of wet towel with cleaning solution to wipe the analyzer tabletop,
until all the stains are removed. It is recommended to perform this operation once a day.
Disinfection: Dip a piece of wet cloth with 75% alcohol or pasteurization solution to wipe
and disinfect the analyzer surface. It is recommended to perform this operation once a
week.
Note: Make sure to turn off the power switch and pull out the plug before cleaning the
analyzer housing. Please use clean water, neutral cleansers or corrosion-free detergents
for washing; do not use organic solvents or hot water to avoid instrument damage due to
deformity.

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5. Waste disposal
The daily-generated wastes, including waste water, test tubes and gloves, should be
removed. All the wastes should be regarded as medical wastes and they should be
disposed of as per the regulations of the hospital and local environmental protection
agency.

Note: Make sure to turn off the power switch and pull out the plug before cleaning
the analyzer housing. Please use clean water, neutral cleansers or corrosion-free
detergents for washing; do not use organic solvents or hot water to avoid
instrument damage due to deformity.

7.2 Explanation about Elimination or Reduction of


Instrument Downtime
We provide the responsible personnel with specific explanations to eliminate or reduce
instrument downtime, and the risks in product shipment or disposal. These explanations
should include the requirements about minimizing biological harm:
1) Serum, reagents, and all the other liquid should be regarded as contaminating. If
a small amount of these materials spills on the instrument surface, please wipe it off using
a cotton ball dipped with 75% alcohol; otherwise, touching the instrument surface may
cause biological risks such as infection. If a large amount of liquid splashes and
penetrates into the analyzer, please stop using the instrument and pull out the power plug,
and then contact kindle or local representative.
2) If the instrument needs to be moved, relocated, presented, lent or repaired,
thoroughly disinfect its surface to minimize the biological harm. If the instrument is
crashed or dropped, whether there is obvious damage on its surface or inside, stop using
it and contact kindle or local representative.
3) If there is an instrument breakdown after the warranty period, ask Genius’s
service engineer, reparation engineer in the device department of the hospital or other
qualified engineers to repair it; otherwise, there is the risk of electric shock. Please
contact kindle before reparation.
4) When the expected service life of this instrument ends (about eight years), it is
recommended to stop using it or resume using after overall troubleshooting, maintenance
and care by Genius.
5) This analyzer can only be used by personnel who are trained and authorized by
kindle or its representative; otherwise, the protection provided by the instrument may be
impaired or the test results may be negatively and significantly affected.

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7.3 Preventive Maintenance and Inspection for Safety


Purpose
(1) Check if the power cable is connected and well grounded before startup.
(2) Check if the isoelectric grounding rod is well connected before startup.
(3) Strictly comply with the maintenance requirements in the “Daily Maintenance
and Use” section to perform the instrument maintenance and care.

7.4 List of Replacement Components


(1) List of replaceable parts and consumable materials
Consumable materials: Printing paper, see Annex 1
Parts: None
(2) List of parts that should be replaced by authorized service engineers
Fuse, with specifications of F3A250V
Power supply and the switch
PCB hardware system

7.5 Common Faults and Troubleshooting


Fault Description Cause Analysis Troubleshooting

1. The tightening screw at the pump


1. The aspiration pump does head is loose. Tighten the screw.
not rotate 2. Cut out a small part at the
2. The pump tube is loose connection of the pump tube
No aspiration
3. The aspiration volume is 3. Reset the correct aspiration
zero volume
4. The pump tube is broken 4. Replace with a new pump tube
(see Annex)
1. The power switch is off
2. The power supply is 1. Turn on the power switch
No display on the
unavailable 2. Reinsert the power plug
screen
3. The display signal cable is 3. Reinsert the display cable
loose

The display contrast of the


The screen is Adjust the contrast regulator inside
LCD changes with the
blurred or too dark the instrument
environment

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Fault Description Cause Analysis Troubleshooting

1. The printing paper is


unavailable
1. Replace with new printing paper
2. The printing paper is
2. Adjust the location of printing
seized up after paper
The printer does paper
tearing
not print 3. Reinsert the printing paper
3. The heat-sensitive printing
4. Print again after the printer cools
paper is inserted reversely
down
4. The printer temperature is
too high
1. The absorbance testing at
a specific wavelength fails,
but the testing at other 1. Test again with clean and fresh
wavelengths are normal: distilled water
Distilled water is not used 2.
2. The absorbance testing at A Remove the air bubbles in the
Failure of
all the wavelengths fails colorimetric cell
absorbance testing
A There are air bubbles in B Wash the colorimetric cell with
the colorimetric cell; cleaning solution
B The colorimetric cell is C Exchange for a new
unclean; light-source lamp
C C. The light-source lamp
is ageing
1. Perform absorbance testing
1. Absorbance testing is not
during system maintenance
performed during startup
2. Exchange for effective reagents
2. A reagent is ineffective
3. Adjust the aspiration volume to
3. The aspiration volume is
make it ≥ 600 µL
Unstable assay insufficient
4. Measure the blank and standard
results 4. The standard is not tested
again
5. The wavelength is
5. Use another wavelength to
unavailable
measure again
6. Air is aspirated carelessly
6. Careful operation as per related
during operation
requirements

If the instrument fault is still present, or there are other faults, please contact our customer
service division.

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Chapter VIII: Shipment and Storage

8.1.1 Shipment
This analyzer can be delivered by general transportation; however, fierce impact, vibration,
or exposure in rain or snow should be avoided during shipment. Please make sure to
place and transport the instrument as per the related graphics on its outer packaging box.
The shipment requirements are determined according to the ordering contract.

8.1.2 Storage
The packaged analyzer should be stored a well-ventilated room that has the
environmental temperature of -10℃ to +55℃ and relative humidity of 93% and is free
from corrosive gases.

8.1.3 Graphic explanations on the outer package

——“Fragile Article”: Please place it careful when moving the packaging.

——“Upright”: The shipment package should be upright.

——“Rain Avoidance”: The package shall not be exposed in rain.

——“Maximal stacked layers”: The same packages should be stacked for four layers
at most.
Note: These graphics can only be used for reference; you should operate as per the
actual figures on the product outer package.

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Chapter IX: Commonly-Used Consumable


Materials and Ordering Information
During normal use and maintenance of this KD720 Semi-Automated Biochemistry
Analyzer, the required consumable materials are listed as follows:

No. Name Specifications

1 Thermal printing paper 80 mm × 35 mm

2 Light-source lamp 6V/10W, PHILIP, 6605, G4

3 Pump tube φ4 mm × φ2 mm × 100 mm

4 Cuvette φ1.5 mm × φ0.8 mm

5 Connection tube φ3 mm × φ1.0 mm

6 Flow cell 8.5 mm quartz flow cell

7 Filter 340 nm

8 Filter 405 nm

9 Filter 492 nm

10 Filter 510 nm

11 Filter 546 nm

12 Filter 578 nm

13 Filter 630 nm

1.8m, three-core power cable compliant with


14 Power cable
the national standard in China

15 Fuse 3A, φ5 mm × 20mm

Ordering method
1. Order via the local distributors of the consumable materials.
2. Order from the manufacturer by phone.

Ordering hotline: 86-0755-29980143/27512545


Fax: 86-0755-27512545

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KD720 Semi auto Chemistry Analyzer Operating Manual
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Chapter X: Annex

Annex 1: Replacement of Printing Paper


1. Open the printer cover and remove the roller (first take out the terminal without gears
and then the other terminal with gears; please handle them gently), and take out the
residual printing paper.
2. Put the paper roll into the paper trough. Please note that there are differences
between the sides of thermal printing paper. Please make sure the thermal side faces
downward. Place the printing paper below the roller, as illustrated in the figure below.
Please ensure that the movement direction of the printing paper should be vertical
with the roller orientation, thereby avoiding inability of normal printing due to paper
seizure.

Printer cover
Paper outlet

Paper trough Paper roll

Non-heat-sensitive
Printer roller
side upward

Figure 12-1: Diagram for installation of printing paper

3. Install the roller: First make the terminal with gears aligned and then gently press
down the other terminal.
4. Press the “Paper Motion” key, observe whether the paper moves smoothly and the
printer roller is vertical. Adjust it as needed. When a segment of the printing paper
moves out of the printer (passing the printer cover), press again the “Paper Motion”
key to stop it.

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5. Pull out the printing paper from the paper outlet at the printer cover and close the
cover.

Note: The “Paper Motion” key is available on the main interface, all the screens
waiting for keyboard entering, the “Print/Delete Result Reports” window in the
“Result Report” interface and the QC report interface. This function is disabled on
all the other interfaces to protect the printer.

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KD720 Semi auto Chemistry Analyzer Operating Manual
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Annex 2: Replacement of Pump Tubes


The peristalitic pump is located at the posterior cover of the bottom plate, as illustrated in
Figure 13-1.
1. Hold the connector of the pump tube with a hand, and then remove the liquid
charging tube and the waste-liquid pipe.
2. Take out the pump tube from the peristalitic pump.
3. Remove the tube connector outside the pump tube.
4. Get a new pump tube and fix the connector at the appropriate location of the new
tube.
5. Install the new tube as per the reverse steps of removing it. Let the tube slide along
the gap of the tube rack into the fixation trough.

Figure 13-1: Structure of the peristalitic pump

Housing

Peristalitic pump
tube

Waste-liquid pipe

Liquid charging tube

Peristalitic pump
Finger-like Connection of the pump tube
rack of the
liquid tube

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KD720 Semi auto Chemistry Analyzer Operating Manual
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Annex 3: Washing Flow Cell


1. Prepare a glass of distilled water or alcohol and place the sample tube into it.
2. Press “6” on the main interface to open the “Maintain” window and then press “4” to
enter the “ADC ADJ” interface.
3. Press “1” to start washing.
4. For alcohol washing, after completion, use distilled water to wash twice.
5. After washing, press “Exit” to return to the main menu.

Annex 4: COM Communication


Hardware conditions: Connect the RS-232C ports of the two instruments needing to be
communicated by RS-232C cable, or connect the instrument with the COM port of the
computer. This instrument provides the following options about COM status:
Connection: If you want to perform data exchanges with a computer, please connect a
standard RS-232 cable with the “COM RS232 1” port on the instrument rear, and connect
the other terminal with the COM at the computer rear.
Please set up as per the following steps:
Baud rate: 115200, 57600, 38400, 19200, 9600
Parity check: Odd, Even, None
Working status: On, Off

Item code (Items 001 – 200; at most 200 items):


No. Item Code No. Item Code
1 1 8 8
2 2 9 9
3 3 10 10
4 4 11 11
5 5 …… ……
6 6 …… ……
7 7 …… ……

Explanation about COM communication:


1 All the data sent is encoded with Code ASCII, e.g. using COM tools to switch to the
character format.
2 Each item name or number is followed at least one blank space

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Analysis of a typical frame:


After printing assay results or measuring a sample and QC, the instrument will send a
series of character data from the RS-232 serial port, as illustrated below:
Normal mode
1 3 0 20120214152114 No 00173 ID 00000000001752 1 ALT 1.08 u/mL 1.20 2.31
QC mode
1 3 0 20120214153928 No 00006 LN 00000000003699 1 ALT 2.21 u/mL 2.20 2.55
The analysis is as follows:
Frame head: 02H
Version number: 1
Instrument type: 3
Instrument No.: 0 (semi-automated biochemistry analyzer)
Measurement time: 20120214152114 (February 14, 2012 20:21:14)
No.: 00173
ID number: 00000000001752 (displaying LN during QC measurement)
Item number: 1
Item abbreviation: ALT
Measurement result: 1.08
Unit: µ/mL
Range: 1.20--2.31
Frame end: 03H

Annex 5: List of Test Items and Test


Combinations
The following 54 test items are built in this instrument:

Item No. Abbre Name Item Abbreviati Name


viation No. on
1 ALT Alanine 24 Mg Serum
transaminase magnesium
2 ALP Alkaline 25 Cu Serum copper
phosphatase
3 GOT Glutamic 26 Zn Serum zinc
oxaloacetic
transaminase
4 γ-
-GT γ-glutamyl 27 P Serum
transpeptidase phosphorus

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5 TP Total protein 28 K Serum


potassium
6 ALB Albumin 29 Na Serum sodium
7 TBIL Total bilirubin 30 TIBC Iron-binding
capacity
8 DBIL Direct bilirubin 31 Fe Serum iron
9 TTT Thymol enzyme 32 HGB Hematoglobin
10 BUN Blood urea 33 RBC Red-blood-cell
nitrogen count
11 CRE Creatinine 34 GRP Globulin
12 UA Uric acid 35 A/G Albumin/globulin
ratio
13 CO2 Carbon-dioxide 36 UDBIL Indirect bilirubin
combining power
14 NH3 Blood ammonia 37 IGG Immunoglobulin
G
15 GLU Blood glucose 38 IGM Immunoglobulin
M
16 TCHO Total cholesterol 39 C3 Complement C3
17 HDLC High density 40 CHE Cholinesterase
lipoprotein
18 LDLC Low density 41 CK Creatine kinase
lipoprotein
19 TG Triglyceride 42 BU Blood urea
20 LDH Lactic 43 CK-MB Creatine kinase
dehydrogenase isoenzyme
21 AMS Amylase 44 α-HBDH α-hydroxybutyric
dehydrogenase
22 CL Serum chloride 45 LQS Lipase
23 Ca Serum calcium 46 MAO Monoamine
oxidase

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Each test item should be tested with the corresponding reagent kit.
The test combinations built-in this instrument and their respective test items are as follows

Liver function tests


Alanine transaminase, alkaline phosphatase, glutamic oxaloacetic transaminase,
γ-glutamyl transpeptidase, total protein, albumin, total bilirubin, direct bilirubin, thymol
enzyme, globulin, albumin/globulin ratio, indirect bilirubin
Kidney function tests

Blood urea nitrogen, urea, uric acid, creatinine, carbon-dioxide binding capacity
Ion testing items
Serum potassium, serum sodium, serum chloride, serum calcium, serum iron, serum
magnesium, serum copper, serum zinc, serum phosphorus
Blood lipid items
High density lipoprotein, low density liproprotein, cholesterol, triglyceride
Heart function tests

Creatine kinase, cholinesterase, creatin kinase isoenzyme, lactic dehydrogenase,


α-hydroxybutyric dehydrogenase
Immunological items
Immunoglobulin G, immunoglobulin M, complement C3
Other items
Blood ammonia, blood glucose, amylase, iron-binding capacity, hematoglobin,
red-blood-cell count, lipase, monoamine oxidase

深圳市坤德生物电子有限公司
Shen Zhen Kindle Medical Devices Co., Ltd.

Address:4F,Buliding 2, The Hong Zhen Gang Industrial Area Gushu, Xixiang,


Bao'an District Shenzhen,China
Tel: 86-0755-27512545 Fax: 86-0755-27512545

59

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