This manual is applicable to the Urine Analyzer (Model: HC-300), hereinafter called “analyzer”.

Instructions

Dear users, thanks for purchasing Urine Analyzer (Model: HC-300).

Please read the manual carefully before operation as incorrect operation may affect the accuracy and precision of
test results and even cause the damages of the analyzer or personal injury.

After reading, please reserve the manual properly for reference at any time.

Name of Registered Person/Manufacturer: Dirui Industrial Co., Ltd.

Address of Registered Person/Manufacturer: 95 Yunhe Street, New & High Tech. Development Zone,
Changchun

Authorized Representative: SUNGO Europe B.V.

Address: Fascinatio Boulevard 522, Unit 1.7, 2909VA Capelle aan den IJssel, The Netherlands

Production Address: 3333 Yiju Road, New & High Tech. Development Zone, Changchun Post Code: 130103

Place of Production: Changchun, China

Tel.: 400 811 6695, 400 811 6605

Website: http://www.dirui.com.cn

E-mail: dirui@dirui.com.cn

Complaints Hotline: 0431-81935326, 85177245

Fax: 0431-85173354

Date of Production: See the label

Service Life: 7 years

Date of Publication/Revision: 08-2023

Version Number: 08-2023

Safety Precautions

(1) Biological hazard protection

For effective protection against biological hazards, please observe the following precautions.

● Improper use of samples may lead to infection. Do not touch samples, controls and waste strips with bare hands.
Be sure to wear gloves and work clothes to prevent infection, and protective glasses if necessary.

● If the sample accidentally comes into contact with the skin, please handle it according to the user's work
standard immediately and consult a doctor.

● Do not use single-use disposable articles again.

(2) Chemical hazard protection

For effective protection against chemical hazards, please observe the following precautions.

Certain cleansers and detergents can damage the skin. Be careful when handling cleansers and detergents to
prevent direct contact of hands and clothing with cleansers and detergents. In case of accidental contact with
hands or clothes, rinse them immediately with clean water. In case of accidental contact with eyes, rinse
immediately with plenty of water and consult an ophthalmologist.

(3) Environmental safety precautions — treatment of waste liquid and solid waste

In order to prevent waste liquid and solid waste from causing environmental pollution and personal injury, please
observe the following precautions when handling waste liquid and solid waste.

● Some substances in quality controls, cleansers, detergents and waste solutions are subject to pollution
regulations and discharge standards. Please comply with local discharge regulations and consult Dirui’s customer
service department.

● Used solid wastes such as waste strips, test tubes, etc. are subject to pollution regulations. Please follow local
waste disposal regulations to dispose of solid wastes.
● When handling waste liquid and solid waste, be sure to wear gloves and work clothes to prevent infection, and
protective glasses and masks if necessary.

(4) Environmental safety precautions — disposal of instrument

To prevent environmental pollution and personal injury from scrapped analyzers, observe the following
precautions when disposing of the instrument.

Some substances in the scrapped analyzer are regulated by contamination regulations. Dispose of the used
analyzer in accordance with local waste disposal regulations.

(5) Prevent fire and explosion

To prevent fire and explosion, please observe the following precautions.

Alcohol is flammable. Great care must be taken when using alcohol near the Analyzer to avoid fire and explosion.
Precautions for use

(1) User

● The Analyzer shall be used by professional medical examination personnel or trained doctors, nurses and testers.

● As the Analyzer has biological and chemical risks, the operator shall be trained and use personal protective
appliance to reduce the risk.

● Only trained operators are allowed to conduct dangerous operations, such as moving parts.

(2) Use environment

● If the transportation or storage humidity is greater than 70%, the Analyzer shall be turned on for testing only after
it is stored in a normal working environment for 24 hours (drying process at room temperature), because the
equipment may not meet the safety requirements soon after the drying process.

(3) Use and maintenance of instrument

● The protection measures provided for the Analyzer may become invalid if the Analyzer is not used according to
the manual.

● The Analyzer shall be used under a well-grounded condition, independent power supply shall be used and the
input voltage shall meet requirements. Use specified fuse.

● Confirm that the analyzer switch is on [o] before power on.

● The Analyzer shall be regularly maintained in strict accordance with the manual, or the Analyzer may have faults
or its test precision and accuracy of the Analyzer may be affected.

● Please use the Analyzer under conditions regulated in the manual. If not, the Analyzer may not operate normally,
the test results may not be reliable, the components of the Analyzer may be damaged and personal injuries may be
caused.

● Do not use turpentine, benzene or other organic solvent to clean the surface of the analyzer because they may
cause housing color or shape change. Wipe with soft cloth or moistened cloth. In case of severe dirt, diluted
alcohol can be used to clean it.

● As for the usage and storage of reagent strip and control, please refer to the relevant instructions. Confirm that
they are within shelf life.

● Don’t use expired strips.

● If any serious incident that has occurred in relation to the Analyzer, the user shall report it to the manufacturer and
the competent authority of the country.
Statement

Dirui Company has the final interpretation right of the manual.

Dirui Company declares that it will be responsible for the safety, reliability and performances of Urine Analyzer
(model: HC-300) only if all the following requirements are met:

(1) The installation, commissioning and servicing of the Analyzer are undertaken by professional personnel of
Dirui Company.

(2) Relevant electrical equipment complies with national standards.

(3) The Analyzer is operated according to the manual.

No further notice will be provided in case of any changes to the software interface.
 User Manual

Contents

Chapter 1 General Introduction ....................................................................................................1-1

1.1 Overview .......................................................................................................................................................... 1-1
1.1.1 Brief introduction .............................................................................................................................................................. 1-1
1.1.2 Intended purpose ............................................................................................................................................................... 1-1
1.2 Analyzer parameters ...................................................................................................................................... 1-1
1.3 Test principle................................................................................................................................................... 1-1
1.4 Analyzer structure .......................................................................................................................................... 1-2
1.5 Symbols ............................................................................................................................................................ 1-2
Chapter 2 Installation of Analyzer ................................................................................................2-1
2.1 Environment requirements ............................................................................................................................ 2-1
2.2 Unpack ............................................................................................................................................................. 2-1
2.3 Installation....................................................................................................................................................... 2-1
2.3.1 Install printer paper ........................................................................................................................................................... 2-1
2.3.2 Connect computer.............................................................................................................................................................. 2-2
2.3.3 Connect external power supply ......................................................................................................................................... 2-2
2.3.4 Connect barcode reader ..................................................................................................................................................... 2-2
2.4 Way of transport ............................................................................................................................................. 2-3
Chapter 3 Functions & Settings of Analyzer ................................................................................3-1
3.1 Block diagram of functions ............................................................................................................................ 3-1
3.2 Settings............................................................................................................................................................. 3-2
3.2.1 Sequence settings .............................................................................................................................................................. 3-2
3.2.2 Edit of ID, color and clarity ............................................................................................................................................... 3-2
3.2.3 Data query ......................................................................................................................................................................... 3-4
3.2.4 Standard strip test and control liquid test........................................................................................................................... 3-6
3.2.5 System settings .................................................................................................................................................................. 3-6
3.2.6 Registration of strips ....................................................................................................................................................... 3-11
3.2.7 Other instructions ............................................................................................................................................................ 3-12

Chapter 4 QC Monitoring ..............................................................................................................4-1

4.1 Standard strip test .......................................................................................................................................... 4-1
4.2 Control test ...................................................................................................................................................... 4-1
Chapter 5 Routine Urine Examination .........................................................................................5-1
5.1 Check strip table ............................................................................................................................................. 5-1
5.2 Start analyzer .................................................................................................................................................. 5-1
5.3 Operation method ........................................................................................................................................... 5-1
5.3.1 Fast mode .......................................................................................................................................................................... 5-1
5.3.2 Slow mode ......................................................................................................................................................................... 5-2

Chapter 6 Cleaning & Maintenance..............................................................................................6-1

6.1 Daily cleaning .................................................................................................................................................. 6-1
6.2 Regular cleaning ............................................................................................................................................. 6-1

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6.3 Sterilization ..................................................................................................................................................... 6-2

6.4 Maintenance before stopping using analyzer ............................................................................................... 6-2
6.5 Handling of wastes .......................................................................................................................................... 6-2
Chapter 7 Transportation of Storage ............................................................................................7-1
7.1 Transportation ................................................................................................................................................ 7-1
7.2 Storage ............................................................................................................................................................. 7-1
Appendix A Letter of Guarantee .................................................................................................. A-1
Appendix B Connection of Analyzer & Computer ..................................................................... B-1
Appendix C Analyzer Output ....................................................................................................... C-1
Appendix D Fault Information List ............................................................................................. D-1
Appendix E Performance Indicators ........................................................................................... E-1
Appendix F List of Spare Parts .................................................................................................... F-1
Appendix G Statement on Electromagnetic Compatibility....................................................... G-1
Appendix H Name and content of hazardous substances in the product ................................ H-1
Appendix I Software Information ................................................................................................. I-1

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Chapter 1 General Introduction

1.1 Overview
1.1.1 Brief introduction
Urine Analyzer (Model: HC-300) is an in vitro diagnostic (IVD) device.
Urine Analyzer (Model: HC-300) should be used together with Dirui urinalysis strips.
Adopting the advanced “high luminosity cold light source reflection determination” technology, the analyzer has a
long lifespan. It can finish the testes of biochemical components in urine within 30 seconds, and it also can revise
the effects on the test result which is caused by pH, hematuria, and abnormally colored sample. It can also be
connected with FUS series urine sediment analyzer.
Contraindication: None.
1.1.2 Intended purpose
The product is a semi-automated instrument for the semi-quantitative analysis of chemical components in human
urine. It can screen normal people and patients with urine-related diseases.
The product has no independent measuring function and uses the supporting reagent strips for urinalysis
manufactured by DIRUI to finish testing. Detectable chemical indicators include (vitamin C (VC), microalbumin
(MALB), creatinine (Cr) and urinary calcium (Ca) are optional): urobilinogen, bilirubin, ketone body, creatinine,
blood, protein, microalbumin, nitrite, leukocyte, glucose, specific gravity (colorimetry), pH, vitamin C, and
urinary calcium.

1.2 Analyzer parameters

Model
Indicators
HC-300
Urobilinogen (UBG), Bilirubin (BIL), Ketone Body (KET), Creatinine (CRE), Blood (BLD), Protein
(PRO), Micro-albumin (MALB), Nitrite (NIT), Leucocytes (LEU), Glucose (GLU), Specific gravity
Test items
(SG), pH, Vitamin C (VC), and urinary calcium (Ca) (among which, Creatinine, Micro-albumin,
Vitamin C (VC) and urinary calcium are optional)
Throughput 60 t/h or 120t/h
Storage
5000 records
capacity
Calibration, Database Query, Speed Switch, Sequence Setting, Language Setting, Time Setting, Status
Function
Setting, Date Format, Selection of Units, Critical Value Settings
Dimensions 140mm×265mm×125mm
Power 60VA
Net weight 1.6kg

Normal Working Conditions:

(1)Ambient Temperature: 10℃~30℃
(2)Relative Humidity: no more than 70%
(3)Atmospheric pressure: 75kPa~106kPa
(4)Power Supply: 12VDC 5A
(5)Light: avoid direct sunlight.

1.3 Test principle

The analyzer applies the principle of photoelectric colorimetry. The content of chemical components in urine will
be determined according to the color change caused by the reaction between the strip blocks on the strip and the
chemical components in urine.
The analyzer uses four kinds of monochromatic light to scan the modules on the reagent strip one by one and the
optical signal got from the scanning will be converted to an electrical signal. After the electrical signal has A/D

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conversion, the reflectivity of a module can be calculated based on these conversion data. The analyzer will
determine the content of relevant components in the urine according to the reflectivity.
Dual-wavelength testing method is used in application, that is, final test data is obtained according to the ratio of
the reflectivity of the strip block when two kinds of light are used. The formula used for calculation is shown
below.
Tm  C r
R
Tr  C m

Where:
R Test data of strip block
Tr Reflected intensity of strip block to reference light
Cr Reflected intensity of white benchmark to reference light
Tm Reflected intensity of strip block to test light
Cm Reflected intensity of white benchmark to test light

1.4 Analyzer structure

This analyzer is composed of: control system, optical system, mechanical system and input & output system.
Control System: includes main control board, monitoring modules and built-in software.
Optical System: includes LED lighting part and data collection part to collect all data of strips.
Mechanical System: includes housing, frame, drive motor, transmission gear, strip table, strip holder,
white-benchmark, etc. to fulfill the strips feeding.
Input & Output System: includes LCD, thermal printer and output serial ports and external printer interface to
control the commands input and output and test result output.
See the figure below for the analyzer structure:

1 housing 2 strip holder 3 LCD 4 SD card slot 5 thermal printer 6 power switch
7 12V DC power socket 8 RS-232 interface 9 barcode reader interface
Fig. 1-4-1

1.5 Symbols
Table 1-5-1

Symbol Meaning

Biohazard, reminding the user to pay attention; otherwise there is risk of potential bio-infectivity

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Symbol Meaning

LASER, DANGER SYMBOL

ALTERNATING CURRENT

IN VITRO DIAGNOSTIC MEDICAL DEVICE

BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

PROTECTIVE GROUND

MANUFACTURER

CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED WARNING OR

MATTERS NEEDING ATTENTION

THE DEVICE MEETS THE REQUIREMENTS OF REGULATIONS ON IN VITRO

DIAGNOSTIC MEDICAL DEVICES

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

The symbol of the crossed out wheeled bin indicates that the product (electrical and electronic
equipment) should not be placed in municipal waste. Please check local regulations for disposal of
electronic products.

CATALOGUE NUMBER

“ON”(POWER)

“OFF”(POWER)

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Chapter 2 Installation of Analyzer

2.1 Environment requirements

(1)The analyzer should be located on a stable, flat, and vibration-free surface which can bear at least 3kg.
(2)Keep away from chemicals and avoid the effect from corrosive gas and strong electromagnetic waves.
(3)Keep out of direct sunshine, dampness and high temperature.
(4)The ambient temperature range for operation is 10℃~30℃. (20℃~25℃ would be the best); relative humidity
≤70%.
(5)Keep a good ventilation status. If need be, a ventilation device can be used. However, the analyzer should
avoid direct airflow. Otherwise, the test accuracy would be affected.

2.2 Unpack
Please take out the analyzer and its accessories, and check them with the packing list. If there is damage to the
following parts, please contact the supplier immediately.

1 2 3 4 5

6 7 8 9
1 analyzer 2 power adapter 3 serial port cable 4 barcode reader (optional)
5 User Manual/certificate, etc. 6 sample of strip 7 printing paper
8 standard strip box (with strips inside) 9 CD
Fig. 2-2-1

2.3 Installation
2.3.1 Install printer paper
(1)Obtain a roll of thermal printer paper (Figure 2-3-1) with width of 57mm and diameter less than 45mm.
(2)Press to open the cover of the printer.
(3)Put the new roll of paper into the paper groove, with paper output upwards and near the printer.
(4)Put the printing paper in the printer. Pull the paper up and down to facilitate paper output.
(5)Pull the paper through the hole on the cover the printer and close the printer cover.

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Fig. 2-3-1

2.3.2 Connect computer

The analyzer can be connected to a computer through a serial port cable, so as to transmit data to the computer.
Insert one end of the serial port cable into the communication interface (Figure 2-3-2) on the back of the analyzer,
and the other end into the serial port of the computer’s main case.

Fig. 2-3-2

2.3.3 Connect external power supply

Use the power adapter among the instrument’s accessories, and the power parameters are:
(1)Power adapter input power voltage: 100-240V~ 50/60Hz.
(2)Power adapter output power voltage: 12VDC 5.0A.

● The socket connected to the power adapter must be reliably grounded.

● The power strip of the power adapter should be placed near the analyzer where it’s easy to disconnect it.
● Please use a power adapter that the instrument recommends; to change the type of the power adapter,
please contact Dirui customer service.
Insert the output (round) of the power adapter into the power socket (Fig. 2-3-3) on the back of the analyzer,
check and make sure that the power switch of the analyzer is in the status of [O], and connect the input plug to an
AC power supply.

Fig. 2-3-3

2.3.4 Connect barcode reader

The analyzer can be connected to a barcode reader to scan the barcode on a test tube. Take out the barcode reader
(optional) from the package box, and connect the serial port connector of the barcode reader to the analyzer

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according to Fig. 2-3-4.

Fig. 2-3-4

The barcode reader (optional) that the analyzer uses is a laser one. Do not look directly at the reading
window of the barcode reader when it is power on.

2.4 Way of transport

(1) Keep the analyzer upright during transport.
(2) Avoid vibration during transport. After transport, check and adjust it before use.

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 Clear QC records
Calibration
Strip type
Clear records
Chapter 3 Functions & Settings of Analyzer

LIS standard
QC record query
QC

Sequence number query Transmission speed

ID query Test mode
Record query
Cuurent record
Menu settings
User Manual

Main interface

Fig. 3-1-1
More settings

3-1
LIS switch
Settings of standards
Strip registration
Clarity switch
Unit system stettings
Color switch
3.1 Block diagram of functions

Sample number settings Cutoff settings

Printer switch
Language settings
+ system switch
Sample edit Status settings
Cutoff switch
Strip selection
ID switch
Start test
Clock settings
 User Manual

3.2 Settings

Fig. 3-2-1

3.2.1 Sequence settings

On the main screen (Fig. 3-2-1), press to enter the main menu, and the following is displayed on the
screen:

Fig. 3-2-2

Press to return to the main screen (Fig. 3-2-1).

After entering a sequence number, press to save it.

The sequence number can be any number within the range of 1-9999. Every time the analyzer executes one test,
the number is increased by 1.

To give up the setting, click to return to the main menu (Fig. 3-2-2). The original number does
not change.
3.2.2 Edit of ID, color and clarity

Press to enter the edit interface of ID, color and clarity, and the screen display is shown in the figure
below:

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Fig. 3-2-3

After edit, press to return to the main screen.

Press to finish editing the sample and to enter the page of editing the next sample.

At most 30 pieces of information can be entered each time; the sample beyond the range is invalid.
(1) Manual input
a) ID edit
Numbers, upper-case letters and lower-case letters can be entered in ID, 20 digits at most.
b) Color edit

Press to switch. The switching result is as shown in the list.

When editing color, “On” should be selected for the color status switch; otherwise, no color valve will be
displayed.
c) Clarity edit

Press to switch. The switching result is as shown in the list.

When editing clarity, “On” should be selected for the clarity status switch; otherwise, no color valve will be
displayed.
As the next test is under execution, the set ID number, color and clarity will be displayed on the next result.
Table 3-2-1

Color Clarity

YELLOW CLEAR
ORANGE SL CLOUDY
RED CLOUDY
GREEN TURBID
BLUE OTHER

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Color Clarity
BROWN /
OTHER /

(2) Barcode scanning input

When using the external barcode reader to scan an “ID barcode”, “Color barcode” and “Clarity barcode”, the
interface displays the corresponding information, and at last “Confirm barcode” is scanned. Every time “Confirm
barcode” is scanned, the sample test end number is increased by 1 automatically.
Every time barcode scanning succeeds, the buzzer will make a sound to prompt you.
3.2.3 Data query
The analyzer can store 5,000 test records, each record containing test time, sequence number and test result. Every
time testing ends, the analyzer automatically saves the test record. If storage exceeds 5,000 pieces, the analyzer
will prompt “The memory is full; please clear records!” If no records are cleared, the analyzer will not continue
testing.

On the main menu (Fig. 3-2-1) select , and the screen display is shown in the figure below:

Fig. 3-2-4
The user can query records by “Current Results”, “Query by sample NO.” and “Query by ID”.
3.2.3.1 Current Results

From Fig. 3-2-4 select , the screen displays the current record, press to query

records forwards and backwards, press to print the record shown on the screen, and click to
return to Fig. 3-2-4.
3.2.3.2 Query by sample NO.

From Fig. 3-2-4 select , and the screen display is shown in the figure below:

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Fig. 3-2-5

Enter the initial sequence number, press to search for sequence records of finished tests. If the
analyzer has the record, the screen displays the test record of the sequence number; if the analyzer does not have
the record, the screen displays “Blank record” (as shown in Fig. 3-2-6); press to return to Fig.
3-2-4.

Fig. 3-2-6
3.2.3.3 Query by ID

From Fig. 3-2-4 select , and the screen display is shown in the figure below:

Fig. 3-2-7

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After entering the ID number, press . If the analyzer has the record corresponding to the ID
number, the screen will display the record. If the analyzer does not have the record corresponding to the number,
the screen will display “Blank record” as shown in Fig. 3-2-6.
3.2.3.4 QC query

The analyzer can save 50 QC records. From Fig. 3-2-4 select , press to query

records forwards and backwards, press to print the record displayed on the screen, and press
to return; if the analyzer does not have the record corresponding to the number, the screen displays “Blank
record”.
3.2.3.5 Record clearing

From Fig. 3-2-4 select or and the screen display is shown in the figure
below:

Fig. 3-2-8

Select to keep the saved records in the analyzer; select to clear the saved
records.
3.2.4 Standard strip test and control liquid test
“Standard strip test” and “Control test” will be introduced in “Chapter 4 QC Monitoring”.
3.2.5 System settings

On the main menu (Fig. 3-2-1) select , and the screen display is shown in the figure below:

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Fig. 3-2-9

3.2.5.1 Clock settings

From Fig. 3-2-9 select , and the screen display is shown in the figure below:

Fig. 3-2-10

3.2.5.2 Selection of strip

From Fig. 3-2-9 select , and the screen display is shown in the figure below:

Fig. 3-2-11

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Press to save the strip type.

● The matching strips of the analyzer are Dirui reagent strips for urinalysis. To guarantee accurate test
results, please don’t use strips of other models.
● The strip selecting function needs the supplier’s authorization.
3.2.5.3 Status settings

From Fig. 3-2-9 select , and the screen display is shown in the figure below:

Fig. 3-2-12
In status settings, the user can set the switches of ID, cutoff, plus system, internal printing, color, turbidity, and
LIS port.

(1) : When “ID” is set on “On”, if the barcode reader is connected, the barcode on a test tube
can be scanned; the output result shows the report ID number (Fig. 3-2-13). When “ID” is set on “Off”, the output
result does not show the ID number (Fig. 3-2-14). As to all the following reports, H11 is taken as an example for
explanation.

The quantity of barcodes scanned each time cannot exceed 30. After sample testing, you can continue
scanning a barcode, but the total number of barcodes for testing cannot exceed 30. Once exceeding 30, the
barcode scanned is invalid; the length of a barcode should be less than 20 characters. It indicates scanning
failure if no response sound is sent out by the analyzer when scanning a barcode.

Date: 2005-03-01 11：40 Date: 2005-03-01 11：40

No. 0584 No. 0584
ID：000015214810234 UBG Normal 3.4µmol/L
UBG Normal 3.4µmol/L BIL Neg
BIL Neg KET Neg
KET Neg BLD Ca80 Ery/µL
* BLD 1+ Ca25 Ery/µL PRO Neg
PRO Neg NIT Pos
NIT Pos LEU >=Ca500 Leu/µL
* LEU 3+ >=Ca500 Leu/µL GLU 14 mmol/L
* GLU 2+ 14 mmol/L SG >=1.030
SG >=1.030 pH <=5.0
pH <=5.0 VC 2.8 mmol/L
VC 2.8 mmol/L

Fig. 3-2-13 Fig. 3-2-14

(2)

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When “Abnormal” is set on “On”, if the test value is equal to or more than the cutoff set by the user, “*” is printed
before the test item (Fig. 3-2-13); When “Abnormal” is set on “Off”, “*” is not printed in the test result (Fig.
3-2-14).

(3)
When “Plus Used” is set on “On”, the analyzer display and print the test value and “+” corresponding to the test
value under the current unit system (Fig. 3-2-13); When “Plus Used” is set on “Off”, the analyzer only displays
and prints the test value under the current unit system (Fig. 3-2-14).

(4)
When “Printer” is “On”, the built-in printer of the analyzer prints test data; when “Printer” is “Off”, the built-in
printer of the analyzer does not print test data.

(5)
When “LIS Port” is “On”, the analyzer can transmit data to the computer; when “LIS Port” is “Off”, the analyzer
cannot transmit data to the computer.

(6) ,
When “Color” is set on “On”, the “Color” item is printed simultaneously in the test result; when “Clarity” is set
on “On”, the “Clarity” item is printed simultaneously in the test result. The inspector can write the test results by
hand according to the “Color” and “Clarity” of the sample tested. When “Color” or “Clarity” is set on “Off”,
“Color” or “Clarity” will not be printed in the test result.
3.2.5.4 Selection of language

From Fig. 3-2-9 select , the screen displays the following figure:

Fig. 3-2-15
The analyzer offers eight languages. The default is English. Other languages need upgrade of language packs.
In Chinese mode, the screen of the analyzer displays Chinese prompts and Chinese reports are output.
In mode of other languages, the screen of the analyzer displays English prompts and English reports are output.
3.2.5.5 Cutoff settings

From Fig. 3-2-9 select , and the screen display is shown in the figure below:

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Fig. 3-2-16

Press “ ” to select a level, and press . Press and the setting is not saved.
3.2.5.6 Unit settings

From Fig. 3-2-9 select , and the screen display is shown in the figure below:

Fig. 3-2-17

3.2.5.7 Settings of standards

From Fig. 3-2-9 select .

The values are all related to the test accuracy of the analyzer; the user cannot change them arbitrarily.
3.2.5.8 More settings

From Fig. 3-2-9 select , and the screen display is shown in the figure below:

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Fig. 3-2-18
(1) Test mode: The analyzer offers two kinds of test mode. You can switch between “Fast mode” and “Slow
mode”.
a) In fast mode, after testing one strip, the analyzer can continuously test next ones with no need of pressing any
button; the fast mode is suitable for continuous tests of a large amount of urine samples; the test time of each
strip is 30 seconds.

b) In slow mode, the analyzer stops after each test. You need to press for the next test; the slow
mode is applicable to inconsecutive tests and the test time of each strip is 60 seconds.
(2) Baud rate: used to set analyzer’s transmission speed; the baud rate is switched between “9600” and “1200”.
(3) LIS: Standard or Simple can be selected.
3.2.6 Registration of strips

Fig. 3-2-19

On the main screen (Fig. 3-2-19), press and the screen displays the following:

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Fig. 3-2-20
Recharge steps:

(1) Press , put the recharge card near the card reading area of the analyzer, and the card
information will be displayed on Fig. 3-2-20 after successive reading.

(2) Set the quantity for recharge by ; unit: bottle.

(3) Press , put the recharge card near the card reading area of the analyzer, and you can take away
the card after successive recharge.

(4) The recharge quantity will be display in the area of .

3.2.7 Other instructions

: Printer paper feeding

: Strip table moved out; remove the strip table and clean it

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Chapter 4 QC Monitoring

4.1 Standard strip test

● Do not dip standard strips in water or other liquid for tests.

● During testing, make sure that the standard strip does not depart from the testing position.
● The analyzer is accompanied by one piece of standard strip.
● If the standard strip is dirty or damaged, please contact the supplier and don’t use it.
In order to get correct test results, it’s recommended the analyzer be tested using the standard strip every 1 or 2
weeks.
Standard strip test method:

Place a standard strip flat in the center of the strip holder, push it to the top of the strip holder, select on
the main menu (Fig. 3-2-1), and the analyzer carries out testing.
After testing, if the calibration passed, the result would be “Calibration OK”; if it failed, the result is “Calibration
Not OK”.
In the case of calibration failure, please execute calibration testing again. If it still failed, please contact the Dirui
customer service department or the distributor.

4.2 Control test

To ensure accuracy of test results, use Dirui positive and negative control liquid to monitor QC in the following
cases:
(1) when starting tests every day;
(2) when replacing with a new bottle of strips;
(3) when changing the operator;
(4) when there is doubt about the test result.
Test method:

Put a strip with control liquid in the strip holder, select from the main menu (Fig. 3-2-1), and the result
will be output after testing. For QC results refer to the reference values in the instructions about the control liquid.
If QC failed, please use control liquid of another lot number to execute QC testing again. If it still failed, please
contact the Dirui customer service department or the distributor.

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Chapter 5 Routine Urine Examination

● Urine may be potentially infectious; please take protective measures during testing, cleaning or
maintenance.
● Please dispose of urine samples and used strips in accordance with local laboratory regulations.
This chapter introduces the routine urine test method of using the analyzer. Before using it for the first time,
please read “Chapter 3 Functions & Settings of Analyzer” in detail.

● When the self-test fails, the screen displays an error message code, please refer to “Appendix D Fault
Information Table” for processing.
● Do not place the analyzer in direct sunlight during the test, so as not to affect the test accuracy.
● Please check the urinalysis strip model before the test to avoid incorrect test results due to the incorrect
urinalysis strip model.
● Do not use urinalysis strips beyond the expiration date or that deteriorate.

5.1 Check strip table

Before starting the analyzer, make sure that the strip holder and the white benchmark are clean and free of foreign
objects. You can clean the strip holder, urine collector and white benchmark according to the relevant content in
“Chapter 6 Cleaning & Maintenance”.

5.2 Start analyzer

After the analyzer is installed, turn on the power switch and the system performs a self-test. “System Init” is
displayed on the screen (see Fig. 5-2-1 below), and the strip table is moved out.
After the self-test, the main screen is displayed, as shown in the following figure:

Fig. 5-2-1

5.3 Operation method

The test is divided into fast mode and slow mode.
5.3.1 Fast mode
The test can be carried out continuously. The test time of each strip is 30 seconds (the first one is 60 seconds). The
operation method is as follows:

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Step 1: Press for about two seconds. After hearing the prompt tone, completely immerse the reagent
area of the strip in a fresh, well-mixed and uncentrifuged sample, immediately take it out, place it in the center of
the strip holder, and push forward until it touches the top of the strip holder (this is the first strip).
Step 2: After hearing the prompt tone for the second time, immerse the second strip in the next sample,
immediately take it out and put it on the absorbent paper to wait for the test (this is the second strip).
Step 3: When hearing the prompt tone for the third time, immerse another strip and put it on the absorbent paper;
at this time, the first test is completed and the test result is printed; the strip table is removed, remove the first strip
from the strip holder, and put the second strip on the strip holder for testing.
Step 4: Repeat the operation of Step 3 every time you hear the prompt tone.

The analyzer stops testing: Remove the strip from the strip holder, the screen displays “No strip” or “Strip
not in place”, and the analyzer stops testing.
5.3.2 Slow mode
The test time for each strip is 60 seconds. The operation method is as follows:

On the main menu, press for about 2 seconds; after hearing the prompt sound, completely immerse the
reagent area of the strip in a fresh, well-mixed, uncentrifuged sample, take it out immediately, place it in the
center of the strip holder, and push it forward until it touches the top of the strip holder (this is the first strip).
After waiting for 40 seconds, the analyzer starts the test. After the test is completed, the test result is printed out,

the strip table is moved out, and the analyzer returns to the main interface. To test the next sample,
needs to be pressed again.

● The strip to be tested must be placed before the strip table moves.
● If there is no strip on the strip holder, after the analyzer detects the strip holder, the screen displays “No

strip” or “Strip not in place”, and the strip holder moves out. Press to continue the test.
● During the test of the analyzer, the keyboard is in an invalid state, and the analyzer will not respond if
any key is pressed.
● Do not hit the strip table during the test. If the strip table is bumped, the screen will display “The strip
table is blocked”.

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Chapter 6 Cleaning & Maintenance

● Do not spill water, urine samples or other solutions on the machine or electric parts of the analyzer in
case of any damage.
● During operation, operators shall take preventive measures like wearing protective gloves and working
suits in case of infection due to touching the polluted area or solution. The operator shall rinse with water
and take disinfection measures after contact with the polluted or corrosive liquid due to carelessness.
● If the analyzer is installed with accessories which are not provided or recommended by the manufacturer
or the analyzer is not used in the manner specified by the manufacturer, the relating protection may be
weaken.
● During cleaning and maintenance, please check whether there are hazards caused by inefficiency of parts
filled with liquid.

6.1 Daily cleaning

In order to ensure the neat appearance of the analyzer, the outer surface of the analyzer should be cleaned
regularly as necessary. You can wipe the outer surface with a damp soft cloth or gauze, and if necessary, wipe the
analyzer with a soft dry cloth or a soft cloth dipped in a small amount of 75% alcohol. However, it cannot be
wiped with any organic solvent to avoid damage to the case. Wipe the LCD screen with a soft, non-abrasive cloth.
In order for the analyzer to operate normally and provide accurate test results, the strip holder must be kept clean.
The strip holder cleaning method is as follows:
Remove the strip holder from the strip table, rinse it with clean water, and wipe the strip holder with a soft, damp
cloth or soft absorbent paper.
Check whether the white benchmark surface is clean. If there is dust or stains, wipe it with a soft dry cloth.
The operator must pay attention to the following during the cleaning process:
(1) If hazardous substances leak on the surface of the equipment or enter the interior of the equipment, appropriate
disinfection should be taken. (You can use a soft cloth dipped in a small amount of 75% alcohol to wipe and
disinfect)
(2) Do not use cleaning agents or disinfectants that cause chemical reactions with equipment parts or materials
contained in the equipment and cause danger.
(3) If you have doubts about the compatibility of disinfectants or cleaning agents with equipment parts or
materials contained in the equipment, you should consult the manufacturer or its agent.

● Do not clean the analyzer while power is on.

● Do not wipe the analyzer with organic solvents that may corrode the analyzer, such as gasoline, paint
thinner, and benzene compounds.
● Do not clean the LCD screen with water.
● Do not wipe the strip holder with anything that will scratch the strip holder and white benchmark.
● Do not use any solvent to clean the white benchmark.
● If the white benchmark has obvious scratches, damage or contamination, please contact the supplier.

6.2 Regular cleaning

If there is dirt on the strip holder, you can clean it as follows:
(1) Prepare a small amount of 0.1 mol/L NaOH solution.
(2) Remove the strip holder and wipe it thoroughly with a cotton swab dipped in 0.1 mol/L NaOH solution.
(3) Rinse the NaOH solution on the strip holder with clean water.
(4) Dry the strip holder and white benchmark with a soft cloth.
(5) Install the strip holder.

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(6) Restart the instrument for self-testing.

● Do not expose the NaOH solution to the white benchmark.

● It is recommended that users clean the analyzer once a day in this way.

6.3 Sterilization
Because the strip holder is in frequent contact with urine samples, it should be sterilized.
One of the following solutions can be used for disinfection:
(1) 2% glutaraldehyde solution.
(2) 5% sodium hypochlorite solution.
The disinfection steps are as follows:
(1) Inject a 10 cm high disinfectant solution into a suitable container.
(2) Immerse the strip holder in the disinfectant and ensure that the white benchmark does not touch the
disinfectant.
(3) Soak for 10 minutes.
(4) After taking out, rinse the disinfectant on the strip holder with clean water.
(5) Dry the strip holder and white benchmark with a soft cloth.
(6) Install the strip holder.
(7) Restart the instrument for self-testing.

Do not expose the disinfectant to the white benchmark.

6.4 Maintenance before stopping using analyzer

Before discontinuing use due to maintenance or handling, the analyzer should be treated as follows:
(1) Take out the discarded strip on the strip holder.
(2) Clean and disinfect the strip holder. For detailed operation, please refer to 6.2 and 6.3.
(3) Wipe the strip holder with a damp cloth or soft absorbent paper.

6.5 Handling of wastes

The analyzer will generate disposable test tubes, discarded strips, discarded samples and other waste during
normal operation.
According to relevant national laws and regulations, waste must be disinfected:
(1) Disposable test tubes and discarded strips after use should be uniformly stored in containers with contaminants,
and shall be treated by high pressure sterilization or high temperature incineration.
(2) Providing the rest urine sample and waste liquid may involve bacteria, viruses and other infectious substances,
the following measures shall be taken to prevent environmental pollution: add 100mL of 10g/L peracetic acid or
some bleaching powder in a large vessel (such as plastic bucket, ceramic pool, etc.), then pour out the remaining
samples and waste liquid into the vessel, and leave the mixture for disinfection for more than 1h before discharge.

The waste generated by the operation of the analyzer has the risk of biological and chemical pollution,
please handle it as required.

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Chapter 7 Transportation of Storage

7.1 Transportation
The transportation of the analyzer is specified in the contract, during which fierce vibration and extrusion shall be
prevented, and also the analyzer shall be handled gently during loading/unloading.

7.2 Storage
Store the analyzer in a clean and ventilated room, free of chemicals and corrosive gas, and with ambient
temperature of -40℃~55℃ and relative humidity not more than 93%.

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Appendix A Letter of Guarantee

Dear user,
Thanks for using Urine Analyzer (model: HC-300). Our company will offer the following services:
(1) Technical consultation at any time
(2) One-year free warranty for the complete machine from the date of purchase; and
(3) Paid services in the following cases:
a) The product out of warranty.
b) Product damage due to an accident or improper use.
c) Product damage due to non-compliance with the instructions or repair without permission.
With the development of technologies, the company will also provide update service of the analytical system.

Please contact us according to the following information:

After-sales Service Unit: Dirui Industrial Co., Ltd.
Address: 3333Yiju Road, New & High Tech. Development Zone, Changchun Post Code: 130103
International Customer Service Hotline: +86 400 808 7597
International Customer Service E-mail: service@dirui.com.cn
Domestic Customer Service Hotline: 400 811 6695, 400 811 6605
Domestic Fax: 0431-85100405
Domestic Customer Service E-mail: service.ch@dirui.com.cn

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Appendix B Connection of Analyzer & Computer

The analyzer is connected to the computer through the RS-232 standard interface, and the communication
protocol is as follows:
Baud rate 9600 or 1200
Data bit 8 bits
Stop bit 1 bit
Verification none
Hardware handshake none
Start character 02H
2 bytes space 20H
3 bytes space ABH
Line break 0DH0AH
Ending character 03H

Connection between analyzer and computer:

Computer Analyzer

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Data communication format:

(1)SI, Conventional and Plus communication format (barcode scanning off):
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 U B G SP × × × × × × × × × × × × × × × × CR LF
SP B I L SP × × × × × × × × × × × × × × × × CR LF
SP K E T SP × × × × × × × × × × × × × × × × CR LF
(SP C R E SP) CR LF
SP B L D SP × × × × × × × × × × × × × × × × CR LF
SP P R O 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 A L B SP) × × × × × × × × × × × × × × × × CR LF
(SP C a SP SP) CR LF
ETX

(2) SI, Conventional and Plus communication format (barcode scanning on):
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 C R E SP) CR LF
SP B L D SP × × × × × × × × × × × × × × × × CR LF
SP P R O 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 A L B SP) × × × × × × × × × × × × × × × × CR LF
(SP C a SP SP) CR LF
ETX

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Notes:
The above two tables list the communication format of the 11 tests of the analyzer. If there are less than 11
test items, the line corresponding to the name of the item not tested is not output.

(3)CT200 communication format (11 items):

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
STX CR LF
# × - × × × SP SP SP SP SP SP × × - × × - × × CR LF
U B G SP × × × × × × × × × × × × × × × × CR LF
B I L SP × × × × × × × × × × × × × × × × CR LF
K E T SP × × × × × × × × × × × × × × × × CR LF
B L D SP × × × × × × × × × × × × × × × × CR LF
P R O SP × × × × × × × × × × × × × × × × CR LF
N I T SP × × × × × × × × × × × × × × × × CR LF
L E U SP × × × × × × × × × × × × × × × × CR LF
G L U SP × × × × × × × × × × × × × × × × CR LF
S G SP SP × × × × × × × × × × × × × × × × CR LF
P H SP SP × × × × × × × × × × × × × × × × CR LF
V C SP SP × × × × × × × × × × × × × × × × CR LF
(A L B SP) × × × × × × × × × × × × × × × × CR LF
ETX

(4)DR200 communication format:

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
STX CR LF
SP N O . × × × SP SP × × － × × － × × × × CR LF
SP SP SP SP SP SP SP SP SP SP SP × × : × × : × × CR LF
CR LF
SP p H SP SP × × × × × × × × × × × × × × CR LF
SP N I T SP × × × × × × × × × × × × × × CR LF
SP G L U SP × × × × × × × × × × × × × × CR LF
SP V C SP SP × × × × × × × × × × × × × × CR LF
SP S G SP SP × × × × × × × × × × × × × × CR LF
SP B L D SP × × × × × × × × × × × × × × CR LF
SP P R O SP × × × × × × × × × × × × × × CR LF
SP B I L SP × × × × × × × × × × × × × × CR LF
SP U R O SP × × × × × × × × × × × × × × CR LF
SP K E T SP × × × × × × × × × × × × × × CR LF
SP W B C SP × × × × × × × × × × × × × × CR LF
SP A L B SP × × × × × × × × × × × × × × CR LF
CR LF
ETX

Note:
When the strip is 11MA(N) or 11MA, the line of VC only shows the test item, no output content.
STX=0X02 CR=0X0D LF=0X0A SP=0X20
SP1=0XAB ETX=0X03 -=0X2D X=any ASCII character

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Appendix C Analyzer Output

Conventional SI
Item Abbr. Plus
Plus on Plus off Plus on Plus off
Normal 0.2 mg/dL 0.2 mg/dL Normal 3.4μmol/L 3.4μmol/L Normal
Normal 1 mg/dL 1 mg/dL Normal 17 μmol/L 17 μmol/L Normal
Urobilinogen UBG 1+ 2 mg/dL 2 mg/dL 1+ 34 μmol/L 34 μmol/L 1+
2+ 4 mg/dL 4 mg/dL 2+ 68 μmol/L 68 μmol/L 2+
3+ >=8 mg/dL >=8 mg/dL 3+ >=135 μmol/L >=135 μmol/L 3+
Neg Neg Neg Neg Neg
1+ 1 mg/dL 1 mg/dL 1+ 17 μmol/L 17 μmol/L 1+
Bilirubin BIL
2+ 3 mg/dL 3 mg/dL 2+ 51 μmol/L 51 μmol/L 2+
3+ >=6 mg/dL >=6 mg/dL 3+ >=103 μmol/L >=103 μmol/L 3+

Neg Neg Neg Neg Neg

+- 5 mg/dL 5 mg/dL +- 0.5 mmol/L 0.5 mmol/L +-
Ketone KET 1+ 15 mg/dL 15 mg/dL 1+ 1.5 mmol/L 1.5 mmol/L 1+
2+ 40 mg/dL 40 mg/dL 2+ 3.9 mmol/L 3.9 mmol/L 2+
3+ >=80 mg/dL >=80 mg/dL 3+ >=7.8 mmol/L >=7.8 mmol/L 3+

Neg Neg Neg Neg

Neg
+- Ca10 Ery/μL Ca10 Ery/μL +- Ca10 Ery/μL +-
Ca10 Ery/μL
Blood BLD 1+ Ca25 Ery/μL Ca25 Ery/μL 1+ Ca25 Ery/μL 1+
Ca25 Ery/μL
2+ Ca80 Ery/μL Ca80 Ery/μL 2+ Ca80 Ery/μL 2+
Ca80 Ery/μL
3+ >= Ca200 Ery/μL >= Ca200 Ery/μL 3+ >=Ca200Ery/μL 3+
>= Ca200Ery/μL
Neg Neg Neg Neg Neg
Trace Trace Trace Trace Trace Trace Trace
Protein PRO 1+ 30 mg/dL 30 mg/dL 1+ 0.3 g/L 0.3 g/L 1+
2+ 100 mg/dL 100 mg/dL 2+ 1.0 g/L 1.0 g/L 2+
3+ >=300 mg/dL >=300 mg/dL 3+ >=3.0 g/L >=3.0 g/L 3+

Neg Neg Neg Neg Neg

Microalbumin MALB 15mg/dL 15mg/dL 0.15g/L 0.15g/L 0.15 g/L
>15mg/dL >15mg/dL >0.15g/L >0.15g/L >0.15g/L

Neg Neg Neg Neg Neg

(Nitrite) NIT
Pos Pos Pos Pos Pos

Neg Neg Neg Neg Neg

+- Ca15 Leu/μL Ca15 Leu/μL +- Ca15 Leu/μL Ca15 Leu/μL +-
Leukocytes LEU 1+ Ca70 Leu/μL Ca70 Leu/μL 1+ Ca70 Leu/μL Ca70 Leu/μL 1+
2+ Ca125 Leu/μL Ca125 Leu/μL 2+ Ca125 Leu/μL Ca125 Leu/μL 2+
3+ >=Ca500 Leu/μL >=Ca500 Leu/μL 3+ >=Ca500 Leu/μL >=Ca500 Leu/μL 3+
Neg Neg Neg Neg Neg
1+ 100 mg/dL 100 mg/dL 1+ 5.6 mmol/L 5.6 mmol/L 1+
Glucose GLU 2+ 250 mg/dL 250 mg/dL 2+ 14 mmol/L 14 mmol/L 2+
3+ 500 mg/dL 500 mg/dL 3+ 28 mmol/L 28 mmol/L 3+
4+ >=1000 mg/dL >=1000 mg/dL 4+ >=56 mmol/L >=56 mmol/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
Specific Gravity 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
5.5 5.5 5.5 5.5 5.5
6.0 6.0 6.0 6.0 6.0
6.5 6.5 6.5 6.5 6.5
pH 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
>=9.0 >=9.0 >=9.0 >=9.0 >=9.0
0 mg/dL 0 mg/dL 0 mmol/L 0 mmol/L 0 mmol/L
10 mg/dL 10 mg/dL 0.6 mmol/L 0.6 mmol/L 0.6 mmol/L
Vitamin C VC 25 mg/dL 25 mg/dL 1.4 mmol/L 1.4 mmol/L 1.4 mmol/L
50 mg/dL 50 mg/dL 2.8 mmol/L 2.8 mmol/L 2.8 mmol/L
>=100 mg/dL >=100 mg/dL >=5.7 mmol/L >=5.7 mmol/L >=5.7mmolL

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Appendix D Fault Information List

No. Fault Phenomenon Fault Reason Removal Method

The power supply is not (1)Check whether the power supply is normal;
1 The screen has no display. connected. (2)If it cannot be solved, please contact the
Mainboard CPU fault. supplier.
(1)Check the front end of the strip table. If there
are obstacles, remove them.
The strip table is not in The motor movement is
2 (2)Check the mechanical operation part. If there
place. blocked.
are obstacles, remove them.
(3)Click the “Start” key, and test again.
The screen displays “Strip (1)Place a strip.
3 No strip on strip table
Missed”. (2)Press the “Start” key to continue testing.
(1)Error in position for strip (1)Take a new strip and place correctly.
The screen displays “Strip
4 (2)Strip not completely (2)Immerse the strip completely in the sample.
error”.
immersed in sample (3)Press the “Start” key to continue testing.
Check white benchmark, make sure that there is
5 2-33 Low white benchmark
no foreign matter, and reboot the instrument.

Check white benchmark, make sure that there is

6 2- 34 High white benchmark
no foreign matter, and reboot the instrument.

Keep the ambient light of the instrument away

7 2-32 Ambient light fault
from external strong light interference.

8 No Paper for printer No printing paper installed Install printing paper.

The standard strip test White benchmark block dirty (1)Wipe clean the white benchmark block.
9 value is beyond the Luminotron aging (2)Replace the strip holder.
reference range. Standard strip dirty (3)Replace the standard strip.

10 The memory is full. 5000 records are stored. Clear records.

11 2-35 Oblique strip Check the strip placing position. Test again.

Check whether the motor runs smoothly, and

12 2-1 – 2- 15 Motor running error whether the wire harness is connected correctly.
Reboot the instrument.

13 2-16 2-20 660nm luminotron gain error

14 2-17 2-21 610nm luminotron gain error

Please contact the supplier.
15 2-18 2-22 572nm luminotron gain error

16 2-19 2-23 525nm luminotron gain error

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Appendix E Performance Indicators

E.1 Dry chemistry test repeatability
The coefficient of variation of the reflectivity test result of the analyzer is ≤1.0%.
E.2 Accuracy when with the matching urinalysis strips
The difference between the test result and the corresponding reference solution label value shall not exceed one
order of magnitude in the same direction, and no reverse difference shall occur. The positive reference solution
must not show a negative result, and the negative reference solution must not show a positive result.
E.3 Dry chemistry test stability
Within 8 hours after the analyzer is turned on and preheated, the coefficient of variation of the reflectivity test
result should be ≤1.0%.

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Appendix F List of Spare Parts

List of spare parts (including spare parts, accessories and consumables)

Cycle of Way of
Name of Part Position Remarks
Replacement Replacement
Strip holder Instrument’s front end outlet 5 years
Strip Strip holder Timely
Thermal printer paper Built-in printer Timely 2.3.1
Standard strip Standard strip box Timely

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Appendix G Statement on Electromagnetic Compatibility

The product meets the requirements in IEC 61326-1:2012 and IEC 61326-2-6:2012. For requirements of
immunity refer to Table G-1.
Table G-1 Requirements of Electromagnetic Compatibility Immunity Test

EMC Performance Applicable

Port Test items Test value
standard criterion or not

Air discharge: ±2kV, ±4kV,

Electrostatic IEC
±8kV B Applicable
discharge (ESD) 61000-4-2
Contact discharge: ±2kV, ±4kV

Radiated
IEC 3V/m, 80MHz～2.0GHz,
Shell electromagnetic A Applicable
61000-4-3 80%AM
fields

Rated
IEC
power-frequency 3A/m, 50Hz A Applicable
61000-4-8
magnetic field

0% for 1 cycle; B
IEC
Voltage sag 40% for 5 cycles; B Applicable
61000-4-11
70% for 25 cycles C

Voltage IEC
5%, duration: 250 cycles C Applicable
interruption 61000-4-11
AC
power IEC
Pulse train ±1kV(5/50ns,5kHz) B Applicable
supply 61000-4-4

IEC Line to ground: ±2kV

Surge B Applicable
61000-4-5 Line to line: ±1kV

Radio-frequency IEC
3V, 150kHz～80MHz, 80%AM A Applicable
conduction 61000-4-6

IEC
Pulse train ±1kV(5/50ns, 5kHz) B ——
61000-4-4
DC
IEC Line to ground: ±2 kV
power Surge B ——
61000-4-5 Line to line: ±1kV
supply
Radio-frequency IEC
3V, 150kHz～80MHz, 80%AM A ——
conduction 61000-4-6

IEC B
Pulse train ±0.5kV(5/50ns, 5kHz)
61000-4-4
I/O ——
signal
Radio-frequency IEC A
3V, 150kHz～80MHz, 80%AM
conduction 61000-4-6

IEC
I/O Pulse train ±1kV(5/50ns,5kHz) B ——
61000-4-4
signal
to main
power Radio-frequency IEC
3V, 150kHz～80MHz, 80%AM A ——
conduction 61000-4-6

Remark: “——” means the item is not applicable according to the standard stipulations.

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For emission test requirements refer to Table G-2.

Table G-2 Emission Test Requirements

Applicable or
Test items EMC standard Test value
not

Meets the limit value of Class A, Group 1 of CISPR

Conducted emission CISPR 11 Applicable
11.

Meets the limit value of Class A, Group 1 of CISPR

Radiated emission CISPR 11 Applicable
11.

Harmonic current Meets the requirements in Class A of IEC

IEC 61000-3-2:2001 ——
emission 61000-3-2:2001.

Voltage fluctuation
IEC 61000-3-3:2005 Meets the requirements in IEC 61000-3-3:2005. ——
and flicker

Remark: “——” means the item is not applicable according to the standard stipulations.

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Appendix H Name and content of hazardous substances in the product

Harmful materials
Name of part Hexavalent Polybrominated Polybrominated
Lead Mercury Cadmium
chromium biphenyls diphenyl ethers
(Pb) (Hg) (Cd)
(Cr (VI) ) (PBB) (PBDE)
LCD screen ○ ○ × ○ ○ ○

Main control
× ○ × ○ ○ ○
board

Sampling board × ○ ○ ○ ○ ○

Electrical
○ ○ × ○ ○ ○
interface board
○: Indicates that the content of the hazardous substance in all homogeneous materials of the part is below the limit requirement
specified in IEC 32321-2.
×: Indicates that the content of the hazardous substance in at least one homogeneous material of the part exceeds the limit
requirement specified in IEC 32321-2, but is within the allowable use range.

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Appendix I Software Information

I.1 Overview
The software is to realize the system control operation, system application operation and system fault diagnosis
and processing of the urine analyzer. The software system is used to control the operation of the instrument,
monitor the status of the instrument, standardize the instrument operation process, and realize the automation of
instrument operation and result processing. In accordance with the Regulation (EU) 2017/746 and MDCG
2019-11, the software belongs to in vitro diagnostic medical device software. The software is part of the in vitro
diagnostic medical device. The intended purpose of the software is the same as that of the analyzer. The main
control board responds to user commands through the human-computer interaction interface (display screen), and
executes the corresponding test process. The main control board shows the collected data and instrument status to
the user through the human-computer interaction interface (display screen) to complete the user command.
I.2 Software information
Software name: HC-300 Urine Analyzer Software
Model and specification: HC-300 Urine Analyzer
Manufacturer: DIRUI INDUSTRIAL CO., LTD.
Production address: 3333 Yiju Road, New & High Tech. Development Zone Changchun, Jilin 130103, the
People’s Republic of China
Item Embedded Software
Issued Software Version main control program version: V10

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