Manual book

Dry chemical urine analyzer

Model： HSY-H-III

Beijing Huashengyuan Medical Technology Co.,Ltd

 Content
Notice！.................................................................................................................................................................. 2
I. Overview ............................................................................................................................................................. 2
1.1 Introduction............................................................................................................................................... 2
1.2 Technical index ......................................................................................................................................... 2
1.3 Test principle............................................................................................................................................. 3
1.4 Main product performance........................................................................................................................ 3
1.5 Product structure composition .................................................................................................................. 4
1.6 Mark.......................................................................................................................................................... 4
II. Functions and setting ...................................................................................................................................... 5
2.1 Overview................................................................................................................................................... 5
2.2 Installation Environment........................................................................................................................... 5
2.3 Installation steps ....................................................................................................................................... 6
2.4 Key Description ........................................................................................................................................ 8
III. Routine urine test ......................................................................................................................................... 12
3.1 Warning................................................................................................................................................... 12
3.2 Test operating procedures ....................................................................................................................... 12
IV. Cleaning and maintenance .............................................................................................................................. 12
4.1 Notes ....................................................................................................................................................... 13
4.2 Daily cleaning ......................................................................................................................................... 13
4.3 Regular cleaning ..................................................................................................................................... 13
4.4 Disinfection............................................................................................................................................. 13
4.5 Use period and production date .............................................................................................................. 13
4.6 Contraindications .................................................................................................................................... 13
V. Fault information table .................................................................................................................................. 13
VI. Fuse replacement ......................................................................................................................................... 15
VII. Transport and storage .................................................................................................................................... 16

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Notice！

1. Please read the manual carefully before using this instrument.

2. Please clean and disinfect the dry chemical urine analyzer according to the

requirements of this manual before repairing.

I. Overview

1.1 Introduction

The dry chemical urine analyzer is used in conjunction with Beijing Huashengyuan Medical
Technology Co., Ltd. Urine-H, T series urine analysis test strips (dry chemical method). Through the
color development of the test strip, the urine glucose, pH, ketone bodies, nitrite, bilirubin, protein,
occult blood, urobilinogen, specific gravity, white blood cells, ascorbic acid, creatinine, urine calcium,
microalbumin in urine Fourteen indicators are tested.
The dry chemical urine analyzer adopts ultra-high brightness cold light source testing technology,
which has the characteristics of anti-environmental interference and long service life. It can complete
the determination of 14 biochemical components in urine samples within one minute, can correct the
influence of ambient temperature and ambient light, pH, hematuria and abnormally colored samples
on the test results, and can be connected to the urine sediment analyzer.
The dry chemical urine analyzer is an in vitro diagnostic medical device for professionals.

1.2 Technical index

Test items: Urobilinogen (URO) Bilirubin (BIL) Urinary calcium (CA)

Ketone body (KET) Occult blood (BLD) Microalbumin (MA)
Protein (PRO) Nitrite (NIT) Leukocyte (LEU) Glucose (GLU)
Specific gravity (SG) pH
Ascorbic acid (Vc) Creatinine (CR)
Test speed: 540 tests/hour
Data storage capacity 2000 test records
Language Chinese, English
Use environment temperature 5～40℃, (optimum temperature 20～25℃)

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Relative humidity <80%
Communication interface RS-232 interface
Transmission rate 9600bps
Fuse F2AL 250V
Weight 6.5kg±0.2kg
Dimensions 340 ㎜×330 ㎜×290 ㎜
Printer Built-in thermal printer
Rated power supply AC220V, 50HZ
Power 60VA
Noise less than 70dB
Applicable test paper Urine-T/Urine-H urine analysis test strips

1.3 Test principle

The dry chemical urine analyzer uses the principle of photoelectric colorimetry to determine the
content of the biochemical components in the urine according to the color changes produced by the
reaction between the reagent area on the test strip and the biochemical components in the urine.

1.4 Main product performance

1.4.1 Accuracy: The difference between the test result and the label value of the corresponding
reference solution is not more than one order of magnitude in the same direction, and there must be no
reverse difference. A positive reference result must not have a negative result, and a negative reference
result must not have a positive result.
1.4.2 Repeatability: The coefficient of variation (CV, %) of the reflectance test result of the analyzer is
≤1.0.
1.4.3 Stability: Within 8 hours of starting the analyzer, the coefficient of variation (CV, %) of the
reflectance test results is ≤1.0.
1.4.4 Main functions:
(1) After starting up, the system software can perform self-check on each part of the system, and enter
the system standby screen after the self-check is completed.
(2) When each test record needs to be displayed on one screen (without turning the screen), the screen
displays the plus sign system, and the printed results are "plus sign system + conventional unit
system" and "plus sign system + international unit system". .
(3) The system can display and print the results in Chinese and English, and the result unit should
have at least the international system of units.
(4) It has an output device to output data and information.
(5) The instrument can transmit data through the serial port connection with the computer;
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(6) The instrument can store 2000 test results.
(7) Test data can be stored and memorized after power off.
(8) There is a fault prompt function:
a) It can prompt that the position of the test strip is incorrect;
b) For hardware failure, please contact the product seller or manufacturer;
c) The built-in printer is faulty.
(9) The stored inspection records can be browsed and printed by serial number.
(10) Can choose the type of test paper, Urine-H, T series urine analysis test strips.
(11) The system has a real-time clock, which can modify the date.
(12) The instrument has batch printing function.
(13) The instrument has a unit conversion function.
(14) The instrument has a Chinese-English conversion function.
(15) The instrument has a calibration function.

1.5 Product structure composition

Upper and lower case, main support, transmission box, switching power supply, LCD screen,
workbench, built-in thermal printer, fan, main control board, test head control board, printing control
board, infrared scanning control board, LCD control board.

1.6 Mark

Biological hazard Warning Ground protection

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II. Functions and setting

2.1 Overview

20 12 - 01 - 01 08 : 08

（Manu） →
International unit

Conventional unit
(ID setting)

（Transport）

（No transporting）

（Print）

（No printing）

（Scan）

（No scanning）
Strip setting T11
T11
T14
（Advanced setting）

(Return)

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2.2 Installation Environment

2.2.1 Please place the instrument on a stable and level table, and do not put it together with a vibration
source such as a centrifuge.
2.2.2 Do not place the instrument where it can be affected by chemicals, corrosive gases or strong
electromagnetic interference.
2.2.3 Please do not put the instrument in direct sunlight, humid or high temperature places.
2.2.4 The power connection should be well grounded, and the power supply should be completely
disconnected when the instrument is not in use or stored.

2.3 Installation steps

2.3.1 Install the stepper board

Hold the stepping board with the saw teeth upwards, and the rectangular protruding side toward the
instrument connection board, push the guide grooves at both ends of the stepping board along the left
and right sides of the connection board to the locked position in parallel. (As shown in Figure 1)

Figure 1 Figure 2

2.3.2 Installing the workbench

Align the guide rails of the workbench with the guide grooves on the host, and push the workbench
parallel into the host, just close to the host. (as shown in picture 2)
Note: The instrument must be turned off when the screen display is in the standby interface
before the workbench can be removed.

2.3.3 Install push rod

Hold the end of the push rod, insert the pusher into the pusher mounting hole on the carriage, and
press the end of the push rod to a horizontal position. (As shown in Figure 3)

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 Figure 3
2.3.4 Install printing paper
⑴Choose a thermal printing paper roll with a width of 57 mm and a diameter of less than 45 mm.
(2) Put the printing paper roll into the paper roll box, insert one end of the printing paper under the
printer roll, the printer will automatically load the paper.(As shown in Figure 4)
⑶Put the printing paper through the paper outlet of the printer cover and close the printer cover. (As
shown in Figure 5)

Figure 4 Figure 5
2.3.5 Install the power cord
Plug one end of the power cord into the power jack on the back of the urine analyzer, and plug the
other end into the AC power source. (As shown in Figure 6)
2.3.6 Connect to computer
The urine analyzer can be connected to the RS232 interface of the computer through a communication
cable. Insert one end of the communication cable into the communication interface on the back of the
instrument, and insert the other end into the RS232 communication interface of the host computer. (As
shown in Figure 6)

Figure 6

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2.3.7 Connect Printer
The urine analyzer can be connected to the interface of the printer through a communication cable.
Insert one end of the communication cable into the parallel communication interface on the back of
the instrument, and insert the other end into the communication interface of the printer.
2.3.8 External scanner
The urine analyzer can be connected to an ID scanning gun. Insert one end of the communication
cable of the scanning gun into the serial communication interface on the back of the urine analyzer.

2.4 Key Description

2.4.1 Main interface

2012-01-01 08:08

（Search）

（ID searching） Please put the test strip

（Manu）

0001 (Consultation number)

2.4.1.1 Consultation number setting：

Click 0001 ，the keyboard will to be

Input the NO. of 4 numbers, click ，The instrument automatically stores the modified content.

Return, Delete

2.4.1.2 To search records

(1) Click , the screen will to be

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 Exactly search Search in batch

Total record：XXX

(2) Click Exactly search , the screen will be

20 12 - 01 - 01 ------

At this point of time, the date is the date of the final result. Input the date: 20 12 - 01 01

and enter the sequence number in ------- After that, click on the button on the right
bottom corner, the corresponding sequence number will be shown. By clicking on the number, the

detail will be given and the information can be transmitted and printed by clicking . If the
sequence number is not entered, all the sequence number on the selected date will be given. After
selecting one of them, all the result will be shown, transmitted and printed by clicking

（3）Click Search in batch the screen will be

20 12 - 01 - 01 000000

<------->

20 12 - 01 - 01 009999

Input the date period in: 20 12 - 01 - 01 , input number range in ________ , to click

，it will show ‘XX records matched’, could be transmitted and printed by clicking . If not

enter the range of consultation numbers to be queried, all records within the entered date range can be

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searched.

2.4.1.3 ID search:

The instrument has a buffer that can store 200 ID numbers. When the ID number is entered in the

cache, during the test, the ID number is assigned to the test result according to the principle of input

first, use first. After the ID number in the cache is used up, if you continue to test, the ID number

assigned by the new test result is the new ID number generated after the last ID number is increased

by 1.

（1）Directly input

In the main interface, press to enter the ID query interface. The screen will display a list of IDs

that already exist but have not been used (if no such ID exists, shows "empty"). Press to see all

the IDs, press to clear all the ID cache, press to enter ID number. After pressing

and enter the ID through keyboard, two options will appear: "Add ID" and "Overwrite the current
ID". If "Add ID" is selected, the newly inputed ID will be stored as a new ID; if "Overwrite the
current ID" is selected, the last ID will be replaced by new ID, and store in cache.
(2) ID Scanning Input:

First, make sure that the ID scanning function is enabled. Touch to enter the setting interface.

shows that the ID scanning function is enabled, and shows the otherwise. Touch it to

change the status of ID scanning function. After that, go back to the main interface, touch to
enter the ID number view interface, the scanner connected with the instrument, ID bar code will be
scaned and the ID number will be input ID cache.

2.4.2 Pressing (Menu) on the main screen displays as follows:

20 12 - 01 - 01 08 : 08

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 H11

2.4.2.1 Date and time setting

20 12 - 01 - 01 08 : 08

Click on the content to be modified, it will display as follows:

To input the content, click , the instrument automatically stores the modified content.

is Return， is Backspace

2.4.2.2 Language setting

Click , it will show ，the language will be changed into English

2.4.2.3 Unit Settings:

Click on , the screen will become . By doing so, the unit of the device is
set to conventional unit.

2.4.2.4 ID setting：

Click ，the screen will show

ID setting

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Input the required number of ID digits on the keyboard, the input range is 6-20 digits. Click on ，

the instrument automatically stores the modified content. is Return， is backspace.

2.4.2.5 Transmission Settings:

Click on , the screen will become . By doing so, the device is switched for allow
transmission to prohibit transmission.
2.4.2.6 Printing Settings:

Click on , the screen will become . By doing so, the device is switched for allow
printing to prohibit printing.
2.4.2.7 Scanning Gun Settings:

Click on , the screen will become . By doing so, the device is switched for allow scanning
to prohibit scanning.
2.4.2.8 Test Strip Settings:
Click on H11, to choose from Type H10 and H11 test strips.

2.4.2.10 Advance Settings:

Note: This operation is only for the manufacturer's professional operation.

III. Routine urine test

3.1 Warning
3.1.1 As urine may be potentially contagious, when testing or cleaning and maintaining the instrument,
professionals with clinical operation experience or professionally trained personnel must take
protective measures and wear medical protective gloves.
3.1.2 In order to protect the environment, please handle urine samples and used waste test strips in
accordance with local laboratory regulations or relevant hygiene requirements. Operators should take
protective measures and wear medical protective gloves.
3.1.3 When the instrument is out of service or needs to be scrapped, it should be handled in
accordance with the regulations of the medical institution or returned to the original packaging box for
centralized processing.
3.1.4 The dry chemical urine analyzer is a precision instrument. In order to avoid damage to the
instrument, it should be operated in strict accordance with this manual or the manufacturer's
requirements, otherwise the protection provided by the equipment may be damaged.
3.2 Test operating procedures
3.2.1 After the instrument is installed, turn on the power switch and the system will perform

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self-check. The screen displays "systems self-test". After the self-test is over, the screen displays the
main screen:
2012-01-01 08:08

（Search）

（ID Search）

（Menu）

0001 (Consultation number)

3.2.2 After passing the self-test, it will directly enter the automatic test mode, and then the test can be
performed continuously in this mode.
3.2.3 The operation method is as follows:
a., after passing the self-check, the thruster is in the initial position.
b. to completely invade the reagent area of the test strip into the fresh, well-mixed, uncentrifuged urine
sample and take it out immediately, and scrape the side edge of the test strip along the tube wall of the
urine sample container to remove excess urine.
c. to place the test paper flat on the workbench, and ensure that the front end of the test paper is in
contact with the front wall of the workbench. The instrument automatically detects the test strip, the
pusher pushes the test strip into the test area, and the instrument starts testing.
d. when the thruster returns to the initial position, put down a piece of test paper to achieve continuous
testing.
Note: Do not place test strips when the thruster is moving.
e: The discarded test strips after use will automatically fall into the discard box for disposal.

IV. Cleaning and maintenance

4.1 Notes
4.1.1 Do not clean the instrument when the instrument is powered on.
4.1.2 Do not wipe the instrument with corrosive organic solvents such as gasoline, paint thinner, and
benzene compounds.
4.1.3 Do not clean the LCD screen with water.
4.2 Daily cleaning
4.2.1 Wipe the surface of the instrument with a soft dry cloth or a soft cloth with a small amount of
mild detergent to keep the surface of the instrument clean.
4.2.2 Wipe the LCD screen with a soft, non-abrasive cloth.
4.2.3 In order for the instrument to operate normally and provide accurate test results, the workbench

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must be kept clean.
4.2.4 Remove the propeller, workbench, and stepping board from the instrument in sequence, rinse
with clean water, and wipe with a soft cloth to dry.
4.3 Regular cleaning
If there is dirt on the propeller, workbench, and stepping board, you can clean it according to the
following steps
4.3.1 Prepare a small amount of 0.1mol/L NaOH solution
4.3.2 Remove the thruster, workbench, and stepping board in sequence from the instrument.
4.3.3 Dip a cotton swab with 0.1mol/L NaOH solution, scrub thoroughly and rinse off the remaining
NaOH solution with clean water.
4.3.4 Dry the propeller, workbench, and stepping board with a soft cloth and install according to the
content of Chapter 2.
4.3.5 Restart self-test.
4.4 Disinfection
Since the pusher, workbench, and step board are in contact with urine samples, they should be
disinfected regularly.
4.4.1 One of the following solutions can be used for disinfection:
-----2% glutaraldehyde solution.
-----5% sodium hypochlorite solution.
4.4.2 Choose an appropriate container to inject the disinfectant.
4.4.3 Invade the workbench, pusher, and step board into the disinfectant, and ensure that the white
reference does not touch the disinfectant.
4.4.4 Soak for 10 minutes.
4.4.5 After taking it out, rinse the disinfectant on the above items with water.
4.4.6 Use a soft cloth to dry the workbench, propeller and stepping board.
4.4.7 Restart self-test.
4.5 Use period and production date
The design life of the dry chemical urine analyzer is 10 years. If it is used for more than 10 years, it
may affect the correct judgment of the instrument. When the instrument is used for more than 10 years,
it is recommended to scrap it or notify the manufacturer for disposal according to the relevant
regulations of the medical institution.
See product label for production date.
4.6 Contraindications
No contraindications for dry chemical urine analyzers have been found.

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V. Fault information table

Item Fault Cause Solution

1. After the instrument is powered on, the main
board controls each moving part to perform
initializing movement. If the initializing
movement is not observed, the main board is not
working, and the main board voltage and the main
control chip reset circuit need to be checked;
2. If the motherboard is working and a blue screen
appears, touch the lower left corner of the display,
1. The main board is and enter the administrator password after the
not working; keyboard interface appears to enter the
2. The main board administrator interface. Touch the "Instrument
and the display debugging" icon to enter the instrument
Blue screen and board cannot debugging interface. Observe the 1, 2, and 3
1 prompting hardware communicate; lights and the measurement value of the scanning
failure 3. The main board board. If there is no measurement display (display
motor limit "----"), it indicates that the communication
photocoupler is between the display board and the main board is
faulty, and you need to check the connection
invalid.
between the display board and the main board;
3. If the above conditions are all normal, in the
instrument debugging interface, touch the two
"test" icons, "tooth plate go one bit" icon and
"raw data input" icon respectively to observe the
tooth plate, test strip lever and bald head For the
movement of the sensor, find the failed
optocoupler and handle it accordingly.
When the self-checking of the instrument during
the test finds that the light quantity of the optical
head is too low, it will prompt ERROR_1. After
2 ERROR_1 Wrong light value
this error occurs, enter the instrument debugging
interface, check the value of the 1, 2, and 3 lights
and re-adjust.
During the test, when the tooth plate pushes the
Test strip
3 ERROR_2 test strip, if the test strip is misaligned, the
misalignment error
instrument will prompt ERROR_2
When the printer is in use, the screen displays an
4 Printer failure icon, indicating that the printer is out of paper or
the print head is raised.
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VI. Fuse replacement

This instrument is equipped with a replaceable fuse. When replacing the fuse, be sure to turn off the
power switch and unplug the power cord plugged into the power socket. Use a screwdriver to buckle
off the small tongue on the power socket to remove the damaged fuse. Take out and install the fuse of
the same specification (do not use fuses of other specifications)

VII. Transport and storage

The dry chemical urine analyzer has rainproof and soft liners in the outer packaging box to ensure that
the product is not damaged by nature. The product should be protected from strong mechanical
collisions during transportation, or choose a reasonable transportation method according to customer
requirements.
Dry chemical urine analyzer should be stored in a clean, ventilated and dry environment, away from
direct sunlight and away from chemical reagents and corrosive gases.

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Manual revision date: August 10, 2020
Registration Certificate Number: 京械注准 20152400387
Production license number: 京食药监械生产许 20060039

Manufacturer：Beijing Huashengyuan Medical Technology Co., Ltd

Add ： 2nd Floor, Building 4, Sanli Industrial zone, NO.1 Shengfang Road,Daxing
District, Beijing, China,102600
Tel：010-87589645 Fax：010-87586646
Web: www.hsyhealth.com