Ver.

: A/0

Document No.: EU-TF-04-03

Operator’s Manual

Urine Analyzer
（Product Model Number：HT-115A）

◎ Please read this manual carefully before using this product

Qingdao Hightop Biotech Co., Ltd.

Urine Analyzer Version A/0

About this Instruction Manual

1. Instruction Manual

This manual describes the functions, safety and operation of the semi-automatic urine

analyzer, in order to ensure that you can use the semi-automatic urine analyzer correctly and safely.

Please read all sections of this manual carefully before using this product.

The manufacturer shall not be liable for any unauthorized part.

After reading this manual, please keep it properly and refer to it whenever necessary. Thank

you for purchasing a semi-automatic urine analyzer.

2. Version Information

Specification version: REV1.0

Revision date: May 2021

The version number of this manual may be upgraded due to changes in software or technical

specifications. We will try our best to modify it at that time. However, there may still be some

discrepancies in the description.

3. Copyright

The copyright of this manual belongs to Qingdao Hightop Biotech Co., Ltd. Without the

permission of Qingdao Hightop Biotech Co., Ltd., this manual shall not be photographed, copied,

copied or translated into other languages.

Copying or modifying the contents of this document without permission is considered illegal.

4.Applicable Objects

This manual is applicable to all users of this product.

5. Product Information

Product Name: Urine Analyzer

Product Model Number: HT-115A

Medical device registration Certificate No: Be sure to register with Lu machine 20202220107

Product technical requirement number: Be sure to register with Lu machine 20202220107

Production License No.: Shandong Food and Drug Administration mechanical production

license20120133

Person of registration/Enterprise of production: Qingdao Hightop Biotech Co., Ltd.

Registered address: No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao,
Urine Analyzer Version A/0

Shandong, China

Address of production: Add: No.369 Hedong Road, Hi-tech Industrial Development Zone,

Qingdao, Shandong, China

6. Patent

The patent of semi-automatic urine analyzer is owned by Qingdao Hightop Biotech Co., Ltd.

7.Liability of manufacturer

The manufacturer is liable for the impact on the safety, reliability and performance of the

equipment only in the following cases:

——Assembly, addition, commissioning, alteration or repair are carried out by personnel

approved by the manufacturer;

——The electrical facilities in the relevant rooms are in line with the relevant requirements;

——The equipment is used according to the instruction manual.

8.Return of the goods

If you really need to return the goods to Qingdao Hightop Biotech Co., Ltd., please contact

the after-sales Service department of Qingdao Hightop Biotech Co., Ltd., State the model number

and serial number of the product, and state the reason for return. Return requests will not be

accepted if the serial number of the product is indistinguishable.

9. After-sales service Information

After-sales service Unit: Qingdao Hightop Biotech Co., Ltd.

Address: No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao, Shandong,

China

Tel: 0532-58710705
Urine Analyzer Version A/0

Table of contents
Chapter 1 Safety and Precautions .......................................................................................................1

1.1 Safety Tips ............................................................................................................................ 1

1.2 Security Description ............................................................................................................. 1

1.3 General Notes ....................................................................................................................... 2

1.4 Warning .................................................................................................................................3

Chapter 2 Summarize ......................................................................................................................... 4

2.1 Principle of Operation .......................................................................................................... 4

2.2 Product main performance technical indicators ................................................................... 5

2.3 Product main structure composition .....................................................................................5

2.4 Scope of application/Intended use ........................................................................................5

2.5 Contraindications ..................................................................................................................6

2.6 Mark ......................................................................................................................................6

2.7 Instrument structure Introduction ......................................................................................... 7

Chapter 3 Installation ..........................................................................................................................9

3.1 Environmental conditions for instrument installation ..........................................................9

3.2 Unpacking .............................................................................................................................9

3.3 Installation .......................................................................................................................... 10

3.4 Initial startup check ............................................................................................................ 12

Chapter 4 Functions and Settings ..................................................................................................... 14

4.1 Summarize .......................................................................................................................... 14

4.2 Interface .............................................................................................................................. 14

Chapter 5 QC monitoring ................................................................................................................. 27

5.1 Run control ......................................................................................................................... 27

5.2 Check calibration ................................................................................................................ 28

Chapter 6 Operation Instruction ....................................................................................................... 30

6.1 Test operation program block diagram ...............................................................................30

6.2 Test operation procedure .....................................................................................................31

Chapter 7 Maintenance ..................................................................................................................... 34

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7.1 Daily cleaning .....................................................................................................................34

7.2 Clean regularly ....................................................................................................................34

7.3 Disinfection .........................................................................................................................35

Chapter 8 Packaging, Transportation and Storage ........................................................................... 36

8.1 Accessories in packing case ................................................................................................36

8.2 Requirements for Transportation ........................................................................................36

8.3 Storage requirements .......................................................................................................... 36

Appendix A ....................................................................................................................................... 37

Appendix B ....................................................................................................................................... 40

Appendix C ....................................................................................................................................... 42

Appendix D .......................................................................................................................................44

Appendix E ....................................................................................................................................... 46

Appendix F ....................................................................................................................................... 47

Manufacturer .....................................................................................................................................48
Urine Analyzer Version A/0

Chapter 1 Safety and Precautions

1.1 Safety Tips
This manual is intended to help users and operators operate the device safely and efficiently.

Before using the analyzer, the operator must be familiar with the safety instructions in the manual,

and follow the correct operation procedures. Users must pay attention to the information provided

in this manual. Only technicians specially trained by the manufacturer can carry out proper test

operation of this analyzer.

The instructions in this manual, there are three kinds of safety tips: danger, warning, attention,

before reading this manual, it is important to clearly understand these safety tips, the prompts are

defined as follows:

danger: If the situation described is unavoidable, it will cause personal injury to the operator,

patient or other people around.

warning:If the situation described is unavoidable, it may cause personal injury to the operator,

patient, or other nearby personnel.

attention: If the situation is unavoidable, it may cause device damage, data loss, or system

chaos.

1.2 Security Description

Users must take the security precautions and regulations in this section seriously.

Type of analyzer: The noise does not reach the level that may cause harm (within the safe

range), overpressure class II, pollution level 2.

During the use of the analyzer, the user shall ensure that the upper cover of the analyzer is

closed. The power supply of the grid must have a protective grounding terminal, and the

instrument must be reliably grounded through the power socket.

Replacement parts should be carried out by personnel designated by the manufacturer or

local distributor. Every component removed from the analyzer must be treated as a potential

infectious agent, with the manufacturer directing the parts, otherwise it may cause potential

hazards or lead to weakened protection. If the parts are not replaced according to this regulation,

the manufacturer shall not be responsible for the damage caused by the unauthorized operation.

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Tools and instruments used in the inspection must be disinfected after use.

The user must ensure that all technical activities related to installation, inspection and

maintenance are performed by professional technicians.

Operators have the obligation to comply with the local and national regulations on the

discharge and disposal of reagents, waste liquid, waste samples, consumables, etc.

Samples, quality control materials, and waste test strips are potentially biocontagious and

may irritate eyes, skin and mucous membranes. When handling relevant materials in the laboratory,

the operator should comply with the laboratory safety operation regulations and wear personal

protective equipment (such as gloves, masks, eye masks, protective clothing, etc.).

Don't reuse disposable items.

Samples or standard products should be washed and disinfected immediately if spilled on

clothing or skin.

1.3 General Notes

The configuration of the purchased device may differ from that described in this manual.

Please refer to the purchase contract.

Follow the work procedures in the operating manual at all times. Before performing the

examination, it is necessary to check whether the patient information is entered correctly. Incorrect

input of operating procedures or patient information may result in incorrect interpretation of the

examination results.

Users are forbidden to make any changes to the analyzer, including the application software

system. Any unapproved modifications and repairs that violate the rules are not covered by the

warranty agreement.

The software can only meet the needs of users for regular tests, and for some special tests,

users must edit and verify themselves.

Any changes made to existing testing procedures must be revalidated.

The user should prepare a maintenance plan and perform maintenance in strict accordance

with the maintenance plan. Otherwise, the device may fail.

For the use and storage of test strips and quality control products, please refer to the

operating instructions of the reagents and ensure that they are used within the validity period

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indicated in the instructions.

Do not use test strips that are past their expiration date.

Do not use cleaning agents containing rosin oil, benzene and other substances to clean the

stain outside the instrument, because it may cause the change of color and shape, with a soft cloth

or wet cloth scrub, for serious stains, with diluted cleaning agent or alcohol clean.

When the outdoor temperature is low in winter, the instrument is placed at room temperature

for 24 hours and then turned on for testing.

Improper operation of the device may cause biological hazards and operation hazards. Please

strictly follow the protection instructions and operation instructions of the manual when using the

device.

If the storage period exceeds 5 years, contact the customer or manufacturer before

installation.

1.4 Warning
Do not unplug the power supply with wet hands, you may get an electric shock.

Do not step on, twist or pull the wires and cables that have been damaged. If the wires and

cables are broken, it will cause a fire.

The analyzer must be used under good grounding conditions.

Verify that the input voltage meets the instrument requirements. Use fuses of specified

specifications.

Check the status of the analyzer switch in a before connecting the power cable.

Do not use in flammable and explosive environment.

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Chapter 2 Summarize
2.1 Principle of Operation
According to the photoelectric colorimetric principle, the urine analyzer can measure the

content of biochemical components in urine through the color changes generated by the reaction

between the reagent region on the test strip and the biochemical components in urine.

When the test strip soaked with urine sample is placed on the test strip rack, the transmission

device of the instrument will transmit the test strip to the right below the detector, the reagent

blocks that have produced chemical reactions on the test strip are irradiated by the light source, the

reflected light is received by the detector. Each reagent block in the test strip reacts independently

with the corresponding components in the urine, showing different colors, and the shade of the

color is proportional to a certain component in the urine. The darker the color of each reagent

block after reaction, the larger the value of the absorbed light and the smaller the value of the

reflected light, the smaller the reflectance; conversely, the lighter the color, the smaller the value

of the absorbed light and the larger the value of the reflected light, the larger the reflectance, that

is to say, the darker the color is proportional to the concentration of various components in the

urine sample.

The white datum on the test bench is used to compensate for the error caused by the change

of urine color and instrument. The value of light reflected by each reagent region was compared

with the value of light reflected by the blank block, and the reflectance was calculated. The

instrument determined the content of biochemical components in urine according to the

reflectance.

The reflection coefficient is calculated by the following formula:

T m  Cr
R
Tr  C m
In the formula:

R——Coefficient of reflection

Tr——The intensity of reflection of the test paper block against the reference light

Cr——The intensity of the blank block's reflection of the reference light

Tm——The strip is used to measure the intensity of light reflection

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Cm——The reflection intensity of the blank block to the measured light

2.2 Product main performance technical indicators

Monochromatic wavelength of light:525nm、572nm、610nm、660nm

Test Items: Urinogen, bilirubin, ketone bodies, blood, protein, glucose, white blood cells, nitrite,

pH, specific gravity, ascorbic acid, microalbumin, creatinine, urinary calcium

Test speed: 514times/hour

Data storage capacity: 2000 test records and 200 quality control records

Language used: Chinese and English

Working Environment:Temperature:5℃ ～ 40℃ ； Relative humidity:≤80% ； Range of air

pressure:75kPa～106kPa;

Transportation environment: Temperature:-40℃ ～ 55℃ ； Relative humidity:10%RH ～

95%RH(non-condensing)；Range of air pressure:70kPa～106kPa

Storage environment: Temperature: -40℃ ～ 55℃; Relative humidity: 10%RH ～

95%RH(non-condensing); Range of air pressure:70kPa～106kPa

External output: serial RS-232 interface、Parallel printing interface

Transmission rate:1200bps、9600bps

Power supply:～220V, 50Hz

Fuse break wire: 250V 2A

Power: 65VA

Weight: 6.5Kg

Overall dimensions: 380mm×380mm×275mm(L × W × H)

Printer: Built-in thermal printer

2.3 Product main structure composition

The instrument is composed of circuit system, optical system and mechanical system.

2.4 Scope of application/Intended use

It can be used together with urine analysis strips for semi-quantitative or qualitative detection

of biochemical components in human urine samples by medical institutions. Test items include

(Urochologen, bilirubin, ketone bodies, blood, protein, glucose, white blood cells, nitrite, pH,

specific gravity, ascorbic acid, microalbumin, creatinine, urinary calcium), provide reference for

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clinical examination and diagnosis.

2.5 Contraindications
Contraindications: No.

2.6 Mark
2.6.1 Host external marking

Mark Marking Instruction Mark Marking Instruction

Biological contamination

symbol to alert operators,

Alternating current symbol
otherwise there is a potential

risk of bioinfectivity.

Only for in vitro diagnostic use Serial number

Manufacturer Life of use

Pay attention! Refer to the

Date of manufacture
attached document

Power on, power on state Power off, Power off state

Authorized representative in the European

2.6.2 Package label

Graphic symbol Name Meaning

The correct position of the

Straight up
shipping box is straight up

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Keep the packing box out of

Afraid of the rain
the rain

The transport packing case is

Fragile item fragile. Please handle it with

care

The maximum number of

Level of stacking stacking layers of the same

packing box is 5

The packing boxes can be

Regeneration by circulation
recycled and reused

2.7 Instrument structure Introduction

Figure2-1

① Display unit

② Propeller of propeller

③ Work table

④ Built-in printer

⑤ External printer interface

⑥ Computer communication interface

⑦ Bar code reader interface

⑧ Air vent

⑨ Fuse breaker holder

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⑩ Power cable socket

⑪ Power supply switch

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Chapter 3 Installation
3.1 Environmental conditions for instrument installation
 Please place the instrument on a stable, flat surface, and do not place it with the centrifuge

and other vibration sources.

 Do not place the instrument in a place where it can be affected by chemicals, corrosive gases

or strong electromagnetic interference.

 Do not place the instrument in direct sunlight, humidity or high temperature.

 Do not use the device in a closed environment. Leave at least a 15cm distance between the

device and the wall or other surrounding devices to ensure proper ventilation and heat

dissipation.

 Leave a distance of at least 15cm between the back of the instrument and the wall or other

surrounding devices to ensure that the power switch can be easily operated.

 Ensure that the instrument is used in an environment with good heating and ventilation.

3.2 Unpacking
Take the semi-automatic urine analyzer and its accessories out of the packing box, the list is

as follows, check with the packing list, which shall prevail, and check whether the following parts

are damaged, if any, please contact the supplier.

Description: Electrical schematics and list of components shall only be provided to qualified

maintenance stations or personnel confirmed by the manufacturer.

The production date and service life of the products are listed on the outer packaging.

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1 Semi-automatic urine analyzer host

2 User Manual

3 Work bench

4 Scrap box

5 Propeller

6 Power cable

7 Communication cable

8 Test paper sample

9 Calibration bar box (with 1 calibration bar)

10 Fuse broken wire

11 Printing paper

3.3 Installation
3.3.1 Mounting workbench
Before installing the workbench, cut the nylon cable fastening the position of the propeller

support, remove the protective rubber pad, align the guide rail of the workbench with the guide

rail slot on the main engine, and push the workbench into the main engine in parallel, close to the

main engine. See Figure 3-1.

Figure 3-1

3.3.2 Mounting propeller

Hold the end of the propeller in hand, insert the propeller into the propeller mounting hole on the

sliding frame, and press the end of the propeller to the horizontal position, See Figure 3-2.

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Figure 3-2

3.3.3 Mounting the printer paper

(a)Choose the width of 57 mm, diameter less than 45 mm thermal printing paper roll;

(b)Press the hook at the back of the printer cover, lift the cover upward, and remove the cover, as

shown in Figure 3-3;

(c)Put the printer paper roll into the paper roll box, loosen the paper roll, let the paper end close to

the inside of the instrument;

(d)Remove the printer press roller, press the printing paper about 10cm under the roller, and

reinstall the press roller; (Note: Do not offset the printer paper)

(e)The printing paper through the printer cover paper outlet, cover the printer cover;

Figure 3-3

3.3.4 Connect bar code reader

A semi-automatic urine analyzer can be connected to a bar code reader to scan the bar code

on the sample tube. Take the bar code reader out of the packing box, connect the data cable of the

bar code reader, and connect the other end of the data cable (RS-232 interface) with the bar code

reader interface of the urine analyzer. Insert the bar code reader cable into the bar code reader

interface at the back of the instrument, as shown in Figure 3-4.

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Figure 3-4

3.3.5 Connect the computer

The semi-automatic urine analyzer can be connected to the computer and transmits data to

the computer.

3.3.6 Connecting to an external printer

Connect the end of the printer connection to the printer and plug the other end into the

external printer interface at the back of the instrument.

Semi-automatic urine analyzer can be connected to EPSONLQ1600K series,

EPSONLQ300K+ series needle printer.

3.3.7 Mounting Power Cables

Plug one end of the power cord into the power jack on the back of the urine analyzer and the

other end into the AC power supply.

3.4 Initial startup check

After the installation of the instrument, it should be checked for the first time.

1. After the power switch is turned on, the propeller moves, and the display screen shows "the

system is self-testing...", and the instrument is self-testing.

2. After the self-check passes, the main menu is displayed, as shown in Figure 3-5.

Figure 3-5

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3. Dip the strip completely into the urine sample, remove the strip and scrape the excess urine

from the strip along the wall of the tube.

4. Place the reagent area of the test strip upside down in the test strip area on the instrument

workbench (Figure 3-6).After the test, the built-in thermal printer prints the test report.

Do not touch any position on the touch screen during the instrument testing.

Figure 3-6

5. If the instrument does not display as expected, or the printed result is different from the

expected, please refer to the related item Settings.

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Chapter 4 Functions and Settings

4.1 Summarize
The semi-automatic urine analyzer realizes man-machine dialogue through the touch screen.

The user only needs to press the corresponding touch key to complete the setting operation.

Note: Do not touch the touch screen with hard or sharp objects.

4.2 Interface
4.2.1Test Main menu

After the self-test, the screen will display as follows:

Figure 4-1

In the picture:

 "#1" indicates the current test number;

 “2022-11-22 14:15:02” Represents the current date and time;

 “Ver:1.057”is the version number of the current host software;

 On the home screen (Figure 4-1), you can perform the following operations:

4.2.1.1 Serial number setting

Click to enter the serial number setting sub-screen (Figure 4-2):

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Figure 4-2
You can set the test number as shown in Figure 4-2.Click the number key to enter the serial

number; Click the button to confirm the modification and return to the upper-level menu.

Click the button to cancel the modification of the serial number.

The serial number displayed on the screen represents the test record number of the next paper

to be tested.

After each successful test of the strip, the serial number is automatically increased by 1.

4.2.1.2 ID Number

The ID number is encoded by the sample scanned by the bar code reader. The semi-automatic

urine analyzer can be connected to a bar code reader via an RS-232 port. The ID number will be

displayed on the output report. The ID number can be scanned by a bar code reader or manually

entered.

Input method: Click ID in Figure 4-1. The following information is displayed (Figure 4-3):

Figure 4-3

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The sequence number of the test corresponding to the first column, and the ID entered for that

column in the second column; If you continue to input the ID of No. 2, click "2", and the screen

will display the following picture (Figure 4-4):

Figure 4-4

Click the number key to enter the corresponding number, Click 、 move the cursor position,

Click to toggle the case of the input letter. After the input is complete, Click the button

to confirm; Click to cancel editing, Figure 4-3 is displayed.

4.2.1.3 Standard Strip test

Click the "Check calibration" in Figure 4-1 to enter the standard strip test interface, this

function will be introduced in "Chapter 5 QC Monitoring".

4.2.1.4 Quality control fluid testing

Click the "Run control" in Figure 4-1 to enter the QC solution test interface, this function will

be introduced in "Chapter 5 QC Monitoring".

4.2.1.5 Date and time Settings

Click the Figure 4-1“2020-09-11 13:01:05”, Enter the time setting screen (Figure 4-5).

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Figure 4-5

Users can modify the date and time by pressing the numeric keys to enter the corresponding

numbers, input is complete, press "ENTER" to confirm, such as giving up the modification, then

press the "ESC" key.

4.2.1.6 Test memory

4.2.1.6.1 Test memory

In Figure 4-1, Click “Test memory”. The following information is displayed (Figure 4-6):

Figure 4-6

As shown in the figure above, there are 2 samples recorded with serial number, test time and

corresponding ID.Click the 、 ,you can turn the page to see, click the displayed content of each

line, you can view the specific test results of the record. Figure 4-7 below (14A test paper is used

as an example):

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Figure 4-7

 If the print is set to "Internal" or "External", click the , Printable test results, If "Computer

Port" is set to "On", the test results will be output to the computer at the same time;

 Click the ,The instrument will delete all sample records;

 Click the ,The instrument returns to the record list, as shown in Figure 4-6;

 Click the ,The instrument directly returns to the main interface, as shown in Figure 4-1;

 Click the 、 ,You can flip the page to view the sample records.

4.2.1.6.2 Query by serial number

Click the “seq No.” in Figure 4-6. The following information is displayed (Figure 4-8):

Figure 4-8

The user can enter the seq No. through the number key, and the seq No. ranges from 0001 to

9999. After the input is complete, Click “ENTER’. If the machine stores this record, the record list

displayed on the screen is all the records under the same seq No. entered; Click the corresponding

line to view the detailed test results of this record; If the machine has no such record, "No record"

is displayed.

4.2.1.6.3 Query by date

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Click the "Time" area in Figure 4-6, as shown in Figure 4-9:

Figure 4-9

After the date is entered, As input”2020-04-08”,Click the Figure 4-9 ,The screen is

displayed, as shown in Figure 4-6,All the records on the screen are for April 8, 2020;Click the

corresponding line to view the detailed test results of this record; Click the unedit it, Return

to Figure 4-6.

4.2.1.6.4 Query by ID

In Figure 4-6, Click the ”ID” area, The screen display is as shown in Figure 4-4.After entering the

corresponding ID, Click the ,The record list displayed on the screen is all the records
under the same ID. Click the corresponding line to view the detailed test results of this record;

Click the

Click “Strip Type” to enter the test strip selection interface, as shown in Figure 4.2 Unedit it,

Figure 4-6 is displayed.

4.2.1.6.5 Query QC records

The instrument can hold 1000 QC records.Click the "Sample Record" area in the lower left

corner of Figure 4-6, The screen will switch to the query list of QC records.Click the "QC Record"

area in the lower left corner of the figure, the screen will switch back to the “sample record” query

list.

4.2.2 Setting Menu

The user can set the language, unit, strip, printer, symbol, bar code (ID), PC interface, baud

rate, date format, abnormal flag,set abnormal value,.manufacture set up.

4.2.2.1 Setting Menu 1

Click Figure 4-1” ”, the menu list screen is displayed (Figure 4-10).The user can set the

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options.

Figure 4-10

This interface consists of a total of 4 operations: language, unit, strip, printer.

4.2.2.1.1 Language

Click “Language”, The following information is displayed (Figure 4-11):

Figure 4-11

The content after "Language" will be toggled with the options listed in the following table.

1 Chinese
2 English
Table 4-12
4.2.2.1.2 Unit
Click the "Unit" key and the content after "unit" will be toggled according to the options
listed in the following table.
1 Symbol
2 Conventional
3 SI
Table 4-13
4.2.2.1.3 Strip selection
Click the content after "Strip" to switch between the options listed in the following table.
1 11A
2 14A

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Table 4-14
The content after " Strip " refers to the type of strip currently used. (See Appendix F for test
items of each strip)

Semi-automatic urine analyzer for test paperHT-N11、HT-N14Urine analysis strip.

4.2.2.1.4 Printer
Click "Printer" and the content after "Printer" on the screen will switch between the options
listed in the following table.
1 Internal
2 External
3 All ON
4 All OFF
Table 4-15
"Internal" means the test results are output through the thermal printer built in the instrument;

"External" means that test results are output by an external printer connected to the instrument;

"Full on" means that test results can be output through both the built-in thermal printer and the

external printer connected with the instrument; "All Off" indicates that test results are not output

by either the thermal printer built into the instrument or the external printer connected to the

instrument.

4.2.2.2 Setting Menu 2

In Figure 4-10, Click to turn the page, That is, enter the Settings menu 2 (Figure 4-16):

This interface contains the Settings of "symbol", "ID", "PC interface", "Abnormal flag" and so on.

Click the corresponding selection key, the content after the corresponding item will switch

between "on" and "off";

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Figure 4-16

4.2.2.2.1 System of Symbols

Click the "Symbol" key and the "symbol" option toggles between "On" and "off"

 When "Symbol" is "on" and "Unit" is "Conventional" :

(1) 11A strip print test results are shown in Figure 4-17; "unit" for "SI", print test results see
Figure 4-18
Date：2016-06-09 12：10 Date：2016-06-09 12：12
Doctor No.：0017 Doctor No.：0018
ID：-------------------------- ID：--------------------------
URO Normal 0.2mg/dL URO Normal 3.4µmol/L
BIL Neg BIL Neg
KET Neg KET Neg
* BLD +- Ca10Ery/µL * BLD +- Ca10Ery/µL
PRO Neg PRO Neg
NIT Neg NIT Neg
* LEU 3+ >=Ca500Leu/µL * LEU 3+ >=Ca500Leu/µL
GLU Neg GLU Neg
SG >=1.030 SG >=1.030
PH <=5.0 PH <=5.0
VC 50mg/dL VC >=0.6mg/dL

Figure 4-17 Figure 4-18

(2) 14A strip print test results are shown in Figure 4-19; "unit" for "SI", print test results see
Figure 4-20.

Date：2016-06-09 12：10 Date：2016-06-09 12：12

Doctor No.：0017 Doctor No.：0018
ID：-------------------------- ID：--------------------------
URO Normal 0.2mg/dL URO Normal 3.4µmol/L
BIL Neg BIL Neg
KET Neg KET Neg
* BLD +- Ca10Ery/µL * BLD +- Ca10Ery/µL
PRO Neg PRO Neg
NIT Neg NIT Neg
* LEU 3+ >=Ca500Leu/µL * LEU 3+ >=Ca500Leu/µL
GLU Neg GLU Neg
SG >=1.030 SG >=1.030
PH <=5.0 PH <=5.0
VC 50mg/dL VC >=0.6mg/dL
Cr 50 mg/dL Cr 4.4mmol/L
Ca >=40 mg/dL Ca 1.0 mmol/L
A:C <30 mg/g A:C <3.4 mg/mmol
Normal Normal

Figure 4-19 Figure 4-20

 When "Symbol" is "off" and "Unit" is "Conventional" :
(1) 11A strip print test results are shown in Figure 4-21; "unit" for "SI", print test results see
Figure 4-22.

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Urine Analyzer Version A/0

Date：2016-06-09 12：10 Date：2016-06-09 12：12

Doctor No.：0017 Doctor No.：0018
ID：-------------------------- ID：--------------------------
URO Normal 0.2mg/dL URO Normal 3.4µmol/L
BIL Neg BIL Neg
KET Neg KET Neg
* BLD Ca10Ery/µL * BLD Ca10Ery/µL
PRO Neg PRO Neg
NIT Neg NIT Neg
* LEU >=Ca500Leu/µL * LEU >=Ca500Leu/µL
GLU Neg GLU Neg
SG >=1.030 SG >=1.030
PH <=5.0 PH <=5.0
VC 50mg/dL VC >=0.6mg/dL

Figure 4-21 Figure 4-22

(2)14A strip print test results are shown in Figure 4-23; "unit" for "SI", print test results see Figure

4-24.

Date：2016-06-09 12：10 Date：2016-06-09 12：12

Doctor No.：0017 Doctor No.：0018
ID：-------------------------- ID：--------------------------
URO Normal 0.2mg/dL URO Normal 3.4µmol/L
BIL Neg BIL Neg
KET Neg KET Neg
* BLD Ca10Ery/µL * BLD Ca10Ery/µL
PRO Neg PRO Neg
NIT Neg NIT Neg
* LEU >=Ca500Leu/µL * LEU >=Ca500Leu/µL
GLU Neg GLU Neg
SG >=1.030 SG >=1.030
PH <=5.0 PH <=5.0
VC 50mg/dL VC >=0.6mg/dL
Cr 50 mg/dL Cr 4.4mmol/L
A:C <30 mg/g A:C <3.4 mg/mmol
Normal Normal

Figure 4-23 Figure 4-24

 "ID - on", the ID number is displayed in the output result;ID - Off: The ID number is not

displayed in the output result.

 "PC interface- open", after testing each sample, the test results will be uploaded to the

computer data receiving software, otherwise no data will be sent to the computer;

 "Abnormal flag-on" In the output test result, when the test value of a certain item is higher

than its abnormal value, the test result is marked with "*";"Abnormal flag - off", there is no

"*" mark in the output test result.

4.2.2.3 Setting Menu 3

In the Figure 4-16, Click " " to turn the page,That is, enter the Settings menu 3( Figure

4-25):

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Urine Analyzer Version A/0

This screen contains Settings such as “Baud rate”, “Date formate”, Set abnormal value”, and

Manufacture set up”;

Figure 4-25

4.2.2.3.1 Baud Rate

“Baud rate” is used to set the instrument to be connected to the computer, Click “Baud rate”,

the content displayed thereafter will be switched in sequence according to the options listed in the

following table.

1 115200

2 9600

3 1200

Table 4- 26

4.2.2.3.2 Date format

Click “Date format”, What follows "Date format" toggles between the options in the

following table, The screen of the instrument and the date of the test result are set according to the

corresponding format.

1 YY/MM/DD

2 MM/DD/YY

3 DD/MM/YY

Table 4- 27

4.2.2.3.3 Set abnormal value

Click “Set abnormal value”, The following information is displayed (Figure 4-28):

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 Urine Analyzer Version A/0

Figure 4-28

In the Figure4-28, Users can set leukocyte, nitrite, urochologen, protein, blood, ketone body,

bilirubin, glucose. According to the corresponding setting gradient of each item, the following

contents will be switched according to the options listed in the following table.

Name
LEU NIT URO PRO BLD KET BIL GLU
Number
1 +-15cell/μL Pos 17μmol/L +-Trace Ca10Ery/μL 0.5mmol/L 17μmol/L 5.6mmol/L

2 1+70cell/μL 34μmol/L 0.3g/L Ca25Ery/μL 1.5mmol/L 51μmol/L 14mmol/L

3 2+125cell/μL 68μmol/L 1.0g/L Ca80Ery/μL 3.9mmol/L ≥103μmol/L 28mmol/L

4 3+≥500cell/μL ≥135μmol/L ≥3.0g/L ≥Ca200Ery/μL ≥7.8mmol/L ≥56mmol/L

Table 4-29

When one of the test results is higher than the set value in Figure 4-28, In the output, an "*"

is displayed before the item. Figure 4-30 shows the printed result.

Date：2020-06-09 15：47
Doctor No：0001
ID：– – – – – – – – – – – – –
URO Normal 3.4µmol/L
BIL Neg
KET Neg
* BLD 1+ Ca25 Ery/µL
PRO Neg
MCA 10mg/L
NIT Neg
* LEU 3+ >=Ca500Leu/µL
GLU Neg
SG >=1.030
PH <=5.0
VC >=0.6 mmol/L
Cr 4.4 mmol/L
A:C <3.4 mg/mmol
Normal

Figure 4-30

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Urine Analyzer Version A/0

4.2.2.3.4 Manufacture set up

Click ‘‘Manufacture set up’’, The following information is displayed (Figure 4-31):

Figure 4-31

Only the correct password can be entered to set the internal parameters of the instrument.

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Urine Analyzer Version A/0

Chapter 5 QC monitoring
5.1 Run control
In order to ensure the accuracy of test results, positive and negative urinalysis quality control

solution can be used for quality control monitoring under the following circumstances.

(a)At the beginning of each day

(b)When replacing a new tube of strips

(c)When changing the operator

(d)When test results are in doubt

Test Method:

On the home screen (Figure 5-1), Click "Run control" to enter the Run control screen (Figure 5-2).

Figure 5-1

Figure 5-2

Place the test strip stained with urinalanalysis QC solution in the strip area of the workbench

(Figure5-3). After the instrument detects the presence of the test paper, the thruster pushes the test

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Urine Analyzer Version A/0

paper to the test area (Figure 5-4).After the test is finished, output the test result and Click "Back"

to return to the main screen of the test (Figure 5-1). QC results refer to the reference value in the

QC fluid manual.

Figure5-3 Figure5-4

5.2 Check calibration

1. Do not test the calibration strip with water or other liquids;

2. The instrument is equipped with a calibration strip;

3. If the calibration strip is stained or damaged, please contact the supplier and do not

continue to use the calibration strip for testing;

4. To ensure correct test results, it is recommended to test the instrument with a calibration

strip every 1 to 2 weeks.

Test Method:

Click “Check calibration” on the home screen (Figure 5-1) to enter the Check calibration

interface (Figure 5-5).

Figure 5-5

Place the calibration strip in the check bar area on the instrument workbench (Figure 5-6),

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Urine Analyzer Version A/0

Figure 5-6

The instrument is tested with calibration strip, and the results are printed after the test.

After the test, if the calibration passes, the measurement result will be "Calibration passed";

if the calibration fails, the measurement result will be "Calibration failed".

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Urine Analyzer Version A/0

Chapter 6 Operation Instruction

Note:

 Since urine can be potentially infectious, please take protective measures during testing

or when cleaning or repairing the instrument.

 Please dispose of urine samples and used discarded test strips in accordance with local

laboratory regulations.

This chapter describes the method of semi-automatic urine analyzer for routine urine test.

Please read Chapter 4, "Functions and Settings," in detail before you begin testing.

6.1 Test operation program block diagram

Figure 6-1

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Urine Analyzer Version A/0

Note:

 For specific operations, please read the test operation procedures in detail.

 If the self-check fails, refer to the fault information table in Appendix D to rectify the

fault.

6.2 Test operation procedure

Note:

 Do not place the instrument in direct sunlight during the test, so as not to affect the test

accuracy.

 Please check the urine test paper type before the test to avoid incorrect test results due

to incorrect urine test paper type.

 Do not use expired or deteriorated urine analysis strips.

6.2.1 Check the loading platform

Before starting the instrument, ensure that the workbench and the white datum are clean and

free of foreign bodies.Follow the instructions in Chapter 7, " Maintenance".

White datum

Figure 6-2

6.2.2 Start up instrument

After the installation of the instrument, turn on the power switch and self-check the

system.After the self-test, the screen will display as follows:

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Urine Analyzer Version A/0

Figure 6-3

6.2.3 Routine test

The instrument tests 514 strips per hour, with a single strip measuring for 7 seconds. The

operation method is as follows:

Step 1: After the self-test is passed, the propeller are in the initial position.

Step 2: The reagent area of the test strip is completely immersed in the fresh, fully mixed,

uncentrifuged urine sample book and removed. Scrape the side of the test strip along the wall of

the urine sample container to remove excess urine.

Step 3: Lay the test paper flat on the workbench, making sure that the front end of the test

paper is in contact with the front wall of the workbench (Figure 6-4).After the instrument detects

the presence of the test paper, the propeller pushes the test paper to the test area (Figure 6-5).

Step 4: When the propeller returns to the original position (Figure 6-6), place another strip of

test paper......This enables continuous testing.

Workbench front wall Initial position of propeller

Figure 6-4 Figure 6-5 Figure 6-6

Do not place the strip while the propeller is in motion.

The operator must be trained by the manufacturer to operate correctly and

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Urine Analyzer Version A/0

avoid touching the propeller during operation. The area above the propeller

movement is marked to indicate that there is some danger in this area,

Please place the test strip and standard strip when the propeller is in the initial

position. Do not operate during the movement of the thruster to avoid touching

your hand during the movement of the propeller.

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Urine Analyzer Version A/0

Chapter 7 Maintenance

 Do not clean the instrument while it is powered on.

 Do not spill liquid on the equipment or electronic parts to prevent damage to the

equipment.

 Do not wipe the instrument with gasoline, paint thinner, benzene compounds and other

organic solvents that may corrode the instrument.

 Do not clean the LCD with water.

 Do not wipe the bench with any material that will bruise the bench and the white base.

 Do not use any solvent to clean the white reference.

 If the white datum is visibly scratched or damaged, contact the supplier

7.1 Daily cleaning

Clean the instrument after it stops running and before it is repaired or disposed of:

(1) Keep the instrument clean by wiping it with a soft dry cloth or a soft cloth dipped with a mild

stain remover.

(2) Wipe the LCD screen with a soft, non-frayed cloth.

(3) In order for the instrument to operate properly and provide accurate test results, the workbench

must be kept clean.

(4) Remove the propeller, workbench and stepper plate from the instrument, rinse with clean water,

and dry with a soft cloth.

(5) Wipe the white datum clean with a soft dry cloth.

(6) Discard discard test strips, sample tubes.

(7) Install as described in Chapter 3.

(8) Reboot self-test.

7.2 Clean regularly

If there is scale on the propeller, workbench or stepper plate, clean it by following steps:

(1)Prepare a small amount of solution about 0.1mol/L NaOH.

(2)Remove propeller, bench and stepper from instrument.

34
Urine Analyzer Version A/0

(3)Use a cotton swab 0.1mol/L NaOH solution, crub thoroughly and rinse the remaining NaOH

solution with clean water.

(4)Dry with a soft cloth and install as described in Chapter 3.

(5)Reboot self-test.

 Do not expose the NaOH solution to the white datum.

 Users are advised to clean the instrument in this way once a week.

7.3 Disinfection
(a)As datum, workbenches and stepper plate come into contact with urine samples, they should be

disinfected.

(b)One of the following solutions can be used for disinfection:

——2% Glutaraldehyde solution

——5% Sodium hypochlorite solution

(c)Use appropriate containers to inject disinfectant.

(d)Dip the workbench, propeller, stepper plate into the disinfectant and make sure the white datum

does not touch the disinfectant.

(e)Let soak for 10 minutes.

(f)After removal, rinse the disinfectant on the above items with water.

(g)Dry with a soft cloth and install as described in Chapter 3.

(h)Reboot self-test.

 Repeated use of glutaraldehyde solution for a long time may result in slight

discoloration of the table, which does not affect the instrument test results.

 Do not allow the disinfectant to come into contact with the white datum.

The service life of the product is 8 years, and the treatment of the product at the end of the

service life shall comply with the requirements of local laws and regulations.

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Urine Analyzer Version A/0

Chapter 8 Packaging, Transportation and

Storage
8.1 Accessories in packing case
The attachments in the packing box are as follows:
No. Item Quantity Verify Note

1 Mainframe（HT-115A） 1 □

2 Thermal printing paper 1 □

Put in instrument

3 Power line 1 □

4 Fuse 2 □ Put in instrument

5 Conformity certificate 1 □

6 Instruction book 1 □

7 Serial port line 1 □

8 Scrap box 1 □

8.2 Requirements for Transportation

1、The instrument should be moisture-proof and waterproof in transportation to prevent violent

vibration and extrusion. Handle with care when handling, loading and unloading.

2、The instrument shall be kept upright during transportation.

8.3 Storage requirements

The instrument should be stored in free of chemicals and corrosive gases, well ventilated and
clean.

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Appendix A
Semi-automatic urine analyzer and computer interface
The semi-automatic urine analyzer is connected to the computer through an RS-232 interface, The

communication protocol is as follows:

Baud rate 9600bps，1200bps ,115200bps is

optional

Bit of data 8 bits, 7 bits optional

Stop bit 1 bit, 2 bits optional

Check none

Hardware handshake none

Start character 02H

Single byte space 20H

Double byte space 40H

Line break character 0DH0AH

End of character 03H

Connection between semi-automatic urine analyzer and computer:

SI units, conventional units, symbol system communication format (bar code scanning off state):

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

STX CR LF

SP D a t e : × × × × - × × - × × SP × × : × × CR LF

SP N o . SP × × × × CR LF

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 Urine Analyzer Version A/0

SP(﹡) U B G SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) B I L SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) K E T SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) B L D SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) P R O SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) M C A SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) N I T SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) L E U SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) G L U SP × × × × × × × × × × × × × × × × CR LF

SP S G SP SP × × × × × × × × × × × × × × × × CR LF

SP p H SP SP × × × × × × × × × × × × × × × × CR LF

SP V C SP SP × × × × × × × × × × × × × × × × CR LF

SP C R E SP × × × × × × × × × × × × × × × × CR LF

SP A : C SP × × × × × × × × × × × × × × × × CR LF

SP × × × × × × × × × × × × × × × × CR LF

ETX

SI units, conventional units, symbol system communication format (bar code scanning open state):

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

STX CR LF

SP D a t e : × × × × - × × - × × SP × × : × × CR LF

SP N o . SP × × × × CR LF

SP I D : × × × × × × × × × × × × × × × CR LF

SP(﹡) U B G SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) B I L SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) K E T SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) B L D SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) P R O SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) M C A SP × × × × × × × × × × × × × × × × CR LF

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 Urine Analyzer Version A/0

SP(﹡) N I T SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) L E U SP × × × × × × × × × × × × × × × × CR LF

SP(﹡) G L U SP × × × × × × × × × × × × × × × × CR LF

SP S G SP SP × × × × × × × × × × × × × × × × CR LF

SP p H SP SP × × × × × × × × × × × × × × × × CR LF

SP V C SP SP × × × × × × × × × × × × × × × × CR LF

SP C R E SP × × × × × × × × × × × × × × × × CR LF

SP A : C SP × × × × × × × × × × × × × × × × CR LF

SP × × × × × × × × × × × × × × × × CR LF

ETX

Note:SP(*)---SPor*STX=0X02CR=0X0DLF＝0X0A

SP＝0X20ETX＝0X03X＝Any ASCII character

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Urine Analyzer Version A/0

Appendix B
Electromagnetic compatibility
Definition: EMC (Electromagnetic Compatibility) is the ability of a device to suppress

electromagnetic interference from other devices without causing similar electromagnetic radiation

interference from other devices.

Declaration: The equipment meets the emission and anti-interference requirements stipulated

in GB/T 18268.1-2010 and GB/T 18268.26-2010.

Note:

This equipment is designed and tested according to the Class A equipment in GB4824.In the

home environment, the device may be subjected to radio interference, and protective measures

should be taken.

It is recommended to evaluate the electromagnetic environment before using this analyzer.

The use of devices that emit radio waves in the vicinity of the analyzer, such as cellular

phones, transceivers, mobile radio-controlled toys, etc., may cause instability in the analyzer's

function. The power to these devices should be cut off near the analyzer.

During installation, keep the analyzer away from other electronic equipment as far as

possible.

Cables provided or designed by the company must be used and connected according to

installation procedures.

Specified peripherals that can be connected to the analyzer should be used. Avoid using other

devices that are not specified. Otherwise, the EMC performance of the analyzer may be reduced.

Do not make any changes to this analyzer. The EMC performance of the analyzer will be

degraded if the user changes unilaterally. The changes of this analyzer include cable changes,

system installation/layout changes, system configuration/components changes, fixed system/parts

method changes, etc.

Make sure to tighten all screws after the repair. Loose screws may degrade EMC

performance.

①Manufacturers are responsible for providing EMC information to customers or users.

②It is the responsibility of the user to ensure that the EMC environment of the equipment is in

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Urine Analyzer Version A/0

order for the equipment to work properly.

Solutions to EMC problems:

①Electromagnetic interference can be mitigated by keeping other devices away from the analyzer.

②Electromagnetic interference can be reduced by adjusting the relative position/installation Angle

between the analyzer and other equipment.

③Electromagnetic interference can be reduced by changing the wiring position of the

power/signal cables of other devices.

④Electromagnetic interference can be reduced by changing the power channels of other devices.

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Urine Analyzer Version A/0

Appendix C
Semi-automatic urine analyzer output value
Regular system of units SI of Units
Projec symbol symbol
Conventional The plus symbol
t system is system
system is on system is on system is off
off
Norma Norma
l 0.2mg/dL 0.2mg/dL l 3.4μmol/L 3.4μmol/L Normal
Norma 1mg/dL 1mg/dL Norma 17μmol/L 17μmol/L Normal
URO l 2mg/dL 2mg/dL l 34μmol/L 34μmol/L 1+
1+ 4mg/dL 4mg/dL 1+ 68μmol/L 68μmol/L 2+
2+ ≥8mg/dL ≥8mg/dL 2+ ≥135μmol/L ≥135μmol/L 3+
3+ 3+
Neg Neg Neg Neg Neg
1+ 1mg/dL 1mg/dL 1+ 17μmol/L 17μmol/L 1+
BIL
2+ 3mg/dL 3mg/dL 2+ 51μmol/L 51μmol/L 2+
3+ ≥6mg/dL ≥6mg/dL 3+ ≥103μmol/L ≥103μmol/L 3+
Neg Neg Neg Neg Neg
+- 5mg/dL 5mg/dL +- 0.5mmol/L 0.5mmol/L +-
KET 1+ 15mg/dL 15mg/dL 1+ 1.5mmol/L 1.5mmol/L 1+
2+ 40mg/dL 40mg/dL 2+ 3.9mmol/L 3.9mmol/L 2+
3+ ≥80mg/dL ≥80mg/dL 3+ ≥7.8mmol/L ≥7.8mmol/L 3+
Neg
Neg Neg Neg Neg
Ca10Ery/μL Ca10Ery/μL
+- +- Ca10Ery/μL Ca10Ery/μL +-
Ca25Ery/μL Ca25Ery/μL
BLD 1+ 1+ Ca25Ery/μL Ca25Ery/μL 1+
Ca80Ery/μL Ca80Ery/μL
2+ 2+ Ca80Ery/μL Ca80Ery/μL 2+
≥Ca200Ery/μ ≥Ca200Ery/μ
3+ 3+ ≥Ca200Ery/μL ≥Ca200Ery/μL 3+
L L
Neg Neg Neg Neg Neg
Trace Trace Trace Trace Trace
PRO 1+ 30mg/dL 30mg/dL 1+ 0.3g/L 0.3g/L 1+
2+ 100mg/dL 100mg/dL 2+ 1.0g/L 1.0g/L 2+
3+ ≥300mg/dL ≥300mg/dL 3+ ≥3.0g/L ≥3.0g/L 3+
10mg/L 10mg/L 10mg/L 10mg/L 10mg/L
30mg/L 30mg/L 30mg/L 30mg/L 30mg/L
MCA
80mg/L 80mg/L 80mg/L 80mg/L 80mg/L
150mg/L 150mg/L 150mg/L 150mg/L 150mg/L
Neg Neg Neg Neg Neg
NIT
Pos Pos Pos Pos Pos
Neg Neg Neg Neg Neg
LEU +- Ca15Leu/μL Ca15Leu/μL +- Ca15Leu/μL Ca15Leu/μL +-
1+ Ca70Leu/μL Ca70Leu/μL 1+ Ca70Leu/μL Ca70Leu/μL 1+

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Urine Analyzer Version A/0

2+ Ca125Leu/μL Ca125Leu/μL 2+ Ca125Leu/μL Ca125Leu/μL 2+

3+ ≥Ca500Leu/μ ≥Ca500Leu/μ 3+ ≥Ca500Leu/μL ≥Ca500Leu/μL 3+
L L
Neg Neg Neg Neg Neg
1+ 100mg/dL 100mg/dL 1+ 5.6mmol/L 5.6mmol/L 1+
GLU 2+ 250mg/dL 250mg/dL 2+ 14mmol/L 14mmol/L 2+
3+ 500mg/dL 500mg/dL 3+ 28mmol/L 28mmol/L 3+
4+ ≥1000mg/dL ≥1000mg/dL 4+ ≥56mmol/L ≥56mmol/L 4+
<=1.005 <=1.005 <=1.005 <=1.005 <=1.005
1.010 1.010 1.010 1.010 1.010
1.015 1.015 1.015 1.015 1.015
SG
1.020 1.020 1.020 1.020 1.020
1.025 1.025 1.025 1.025 1.025
≥1.030 ≥1.030 ≥1.030 ≥1.030 ≥1.030
<=5.0 <=5.0 <=5.0 <=5.0 <=5.0
6.0 6.0 6.0 6.0 6.0
6.5 6.5 6.5 6.5 6.5
pH 7.0 7.0 7.0 7.0 7.0
7.5 7.5 7.5 7.5 7.5
8.0 8.0 8.0 8.0 8.0
8.5 8.5 8.5 8.5 8.5
0mg/dL 0mg/dL 0mmol/L 0mmol/L 0
10mg/dL 10mg/dL 0.6mmol/L 0.6mmol/L 0.6
VC 25mg/dL 25mg/dL 1.4mmol/L 1.4mmol/L 1.4
50mg/dL 50mg/dL 2.8mmol/L 2.8mmol/L 2.8
≥100mg/dL ≥100mg/dL ≥5.7mmol/L ≥5.7mmol/L ≥5.7
<30mg/g <30mg/g <3.4mg/mmol <3.4mg/mmol <3.4mg/mmol
Normal Normal Normal Normal Normal
30-300mg/g 30-300mg/g 3.4-33.9mg/mm 3.4-33.9mg/mm 3.4-33.9mg/mm
A:C Abnormal Abnormal ol ol ol
>300mg/g >300mg/g Abnormal Abnormal Abnormal
High High >33.9mg/mmol >33.9mg/mmol >33.9mg/mmol
abnormal abnormal High abnormal High abnormal High abnormal
10.2mg/dL 10.2mg/dL 0.9mmol/L 0.9mmol/L 0.9mmol/L
49.8mg/dL 49.8mg/dL 4.4mmol/L 4.4mmol/L 4.4mmol/L
Cr 99.5mg/dL 99.5mg/dL 8.8mmol/L 8.8mmol/L 8.8mmol/L
200.2mg/dL 200.2mg/dL 17.7mmol/L 17.7mmol/L 17.7mmol/L
299.8mg/dL 299.8mg/dL 26.5mmol/L 26.5mmol/L 26.5mmol/L
4mg/dL 4mg/dL 1.0mmol/L 1.0mmol/L 1.0mmol/L
10mg/dL 10mg/dL 2.5mmol/L 2.5mmol/L 2.5mmol/L
Ca 20mg/dL 20mg/dL 5mmol/L 5mmol/L 5mmol/L
30mg/dL 30mg/dL 7.5mmol/L 7.5mmol/L 7.5mmol/L
40mg/dL 40mg/dL 10mmol/L 10mmol/L 10mmol/L.

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Appendix D
Fault Information Table

No. Fault Symptoms Cause of failure Method of elimination

NO.
The power supply 1. Check whether the power cable is securely installed.
Nothing is
cannot be connected 2. Check the tubular fuse for damage.
1 displayed on the
properly dealer for 3. If it still cannot be ruled out, please contact the
LCD
maintenance. supplier.

1. Check whether “Internal” is set to “On”.

2. Check whether the printer is equipped with printer
The print setting is paper.
The printer does incorrect or the 3. Check whether the paper guide wheel cannot rotate due
2
not print printer does not work to the deflection of the printer paper. If so, reinstall the
properly printer paper.
4. If it still cannot be ruled out, please contact the
supplier.

Printer out of No printer paper

3 paper installed Install the printer paper.

1. The white datum is damaged or missing, replace the

The white datum white datum.
Screen
is damaged, lost 2. Replace the optical coupling stopper.
display“Calibratio
4 Contaminated or 3. Wipe the white datum.
n not found”
optical coupling 4. Re-open self-test.
stopper Damaged 5. If you still can't solve the problem, please contact the
supplier.

1. Reboot self-test.
The strip does not
2. Clean the workbench.
Screen display move to the test
5 3. Check that the test strip is selected correctly.
“Strip missing” position
4. Check the workbench and cover plate for foreign bodies.
5. If it still cannot be ruled out, please contact the supplier.

1. Shut down and clean the workbench. Retest.

Screen display White reference dirt
2. Erase the white datum.
“Calibration Not Aging of light tube
6 3. Replace the calibration bar.
ok” Calibration strip dirty
4. If it still cannot be ruled out, please contact the
supplier.

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Ambient light is
abnormal. The
Screen display 1. Place the instrument away from strong light sources.
instrument is exposed
7 “Stray Light 2. Turn off flashing light sources.
to strong sunlight or
Warning” 3. Restart the machine.
near a flashing light
source
1. Check whether the type of strip used is consistent with
The type of strip is that set in the instrument.
Screen display
8 wrong 2. Check that the strip is fully dipped into the sample.
“Strip Error”
3. If it still cannot be ruled out, please contact the
supplier.
The strip optical
The thruster does 1. Check for direct sunlight on the work surface. If so,
detector can not
not perform the move the instrument away from direct sunlight.
9 determine the
normal push bar 2. If it still cannot be ruled out, please contact the
presence or absence
action supplier.
of test strips
Screen display
1. Reboot self-test.
10 “Test system Test system failure
2. Please contact the supplier.
error”
Screen display
The push bar system 1. Reboot self-test.
11 “Strip push system
is faulty 2. Please contact the supplier.
error”
or”
Screen display
The conveyor system 1. Reboot self-test.
12 “Strip moving
is faulty 2. Please contact the supplier.
error”

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Appendix E
Test strip test items
HT-N11 Test Items:Vc,LEU,GLU,BIL,pH,BLD,SG,KET,PRO,NIT,URO

HT-N14 Test Items:Vc,LEU,GLU,MCA,BIL,pH,BLD,SG,KET,PRO,NIT,URO,Cr,Ca

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Appendix F
Product pollution control label
Table of contents of toxic or hazardous substances or elements

Toxic or hazardous substance or element content

Name of part
（Pb） （Hg） （Cd） （Cr(VI)） （PBB） （PBDE）

Plastic/polymer
○ ○ ○ ○ ○ ○
parts

Part of metal × ○ ○ ○ ○ ○

Circuit board
× ○ ○ ○ ○ ○
assembly*

Cables and cable

× ○ ○ ○ ○ ○
assemblies

The battery ○ ○ ○ ○ ○ ○

Solder × ○ ○ ○ ○ ○

*: Circuit board components include printed circuit boards and their components, such as resistors,

capacitors, inductors, semiconductor devices, connectors, etc.;

○: It means that the content of the toxic and harmful substances in all homogeneous materials of

the component is below the limit requirements stipulated in the SJ/T11363-2006 standard;

×: Indicates that the content of the toxic or hazardous substance in at least one homogeneous

material of the component exceeds the limit required by the SJ/T11363-2006 standard.

Note: This table indicates that the recorder may contain such substances.

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Manufacturer
Qingdao Hightop Biotech Co., Ltd.
Add: No. 369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao,
Shandong, China
Tel: 0086-532-58710705 Fax: 0086-532-58710706
Web: www.hightopbio.com E-mail: [email protected]
European representative
MedNet EC-REP GmbH
Borkstrasse 10, 48163 Muenster, Germany

All rights reserved.

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