Table of Contents

Copyright and Declaration................................................................................. 1

Preface................................................................................................................... 3

Symbols..................................................................................................................4

NOTE......................................................................................................................5

1. Instrument Introduction.................................................................................. 7

1.1 Instrument Features............................................................................. 7

1.2 Intended use...........................................................................................8

1.3 Instrument Application..........................................................................8

1.4 Specifications.........................................................................................9

1.5 Structure and Principle...................................................................... 11

1.6 Appearance and Components......................................................... 12

2. Installation.......................................................................................................17

2.1 Unpacking.............................................................................................17

2.2 Charging Operation............................................................................17

2.3 Loading Thermal Print Paper........................................................... 20

2.4 Connect To Computer........................................................................21

3. Usage Precautions....................................................................................... 23

3.1 Sample Usage Precautions..............................................................23

3.2 Reagent Strips Usage Precautions................................................ 24

3.3 Instrument Usage Precautions........................................................ 25

4. The Instrument Use Procedures................................................................27

 4.1 Turning on / off.....................................................................................27

4.2 Routine Measurement....................................................................... 28

5. Instrument Checkup..................................................................................... 33

5.1 Checkup................................................................................................33

5.2 Checkup Operation............................................................................ 34

6. Function Introduction....................................................................................35

6.1 Function Introduction of Printer....................................................... 35

6.2 Function Introduction of Instrument................................................ 37

7. Maintenance...................................................................................................41

7.1 Precautions.......................................................................................... 41

7.2 Cleaning the strip holder（Daily）..................................................41

8. Storage and Transportation........................................................................ 43

8.1 Transportation......................................................................................43

8.2 Storage..................................................................................................43

9. Troubleshooting.............................................................................................44

Appendix 1: Abbreviation of Test Items................................................ 46

Appendix 2: Test results and unit comparison table.......................... 47

Appendix 3: Format of test results......................................................... 48

Copyright and Declaration

Copyright © URIT Medical Electronic Co., Ltd.

All contents in this manual were strictly compiled according to related

laws and regulations, as well as the specific condition of URIT-31 urine

analyzer which is covering all updated information before printing. URIT

is fully responsible for the revision and explanation of the manual. And it

also reserves the right to renovate the relevant contents without

separate notification.The demonstration pictures are for reference.

Subjecting to real object if any differences.

All information included in this introduction is protected by copyright. No

part of this introduction may be reproduced, stored or transmitted in any

form or by any means unless written authorization by URIT.

All instructions must be strictly followed in operation. In no event should

URIT be responsible for failures, errors and other liabilities resulting

from user's noncompliance with the procedures and precautions

outlined herein.

Limitation of Liability

URIT warrants for one year against manufacturing defects in materials

and workmanship from the date of purchase.

URIT assumes no liability in the following situations even during the

period of warranty.

1
1. Improper using, neglecting the maintenance or broken instrument.

2. Using reagents and its accessories not manufactured or

recommended by URIT.

3. Failure operation not under the instructions described in the manual.

4. Replacing accessories not specified by URIT, or after maintenance or

repair by a service agent not approved or authorized by URIT.

5. Maintenance or changing the instrument without the authorization

from URIT or its dealer.

6. The component has been dismounted or newly debug without the

authorization from URIT.

URIT Medical Electronic Co., Ltd.

Address: No.D-07 Information Industry District, High-Tech Zone, Guilin,

Guangxi 541004, P.R.China

Tel: +86(773)2288586

Fax: +86(773)2288560

Web: www.urit.com

Email: service@uritest.com

VERSION: 02/2022

2
Preface

This operation manual detailedly describes the installation, structure,

operation and maintenance of URIT-31 urine analyzer(Hereinafter we

simply call the URIT-31 urine analyzer as Instrument). Please carefully

read this manual before using the instrument and performing

measurements following the instructions which are presented in the

manual.

Caution

■ This instrument uses urine as the sample, which may carry

pathogenic microbes that can cause infectious disease. Please

wear protective gloves to prevent exposure to pathogenic

microbes during operation or maintenance

■ The instrument operator must have the clinical inspection

and related knowledge of infectious waste, and read the manual

carefully before operating the instrument.

■ Discard the used reagent strips, samples and gloves

according to local codes and regulations.

3
Symbols

Consult instructions for use

EC REP Authorized Representative in the European Community

Electrical and electronic products recycling symbol

Protect from heat and radioactive sources

Environment-Friendly Fragile, handle with

Use Period care

Caution Biological risks

Manufacturer Serial number

Keep dry No rolling

Up Date of manufacture

In Vitro Diagnostic
Use by date
medical device

Direct current Alternating current

4
NOTE

 Leave at least 7 cm of space to the front and back side of the

instrument.

 When the temperature of working environment has changed,

leave it for one hour until it returns to the room temperature

before measurement.

 Install the instrument in a ventilated room where the

temperature is maintained between at 10°C~30°C and

humidity between at 30%~60%.

 Only the URIT reagent strips are allowed to use for this

instrument and please carefully read the introductions of the

reagent strips.

 Only the accompanying AC adapter is allowed.

 Turn off the power switch and unplug the power cord

immediately if the instrument gives off odor or smoke,

otherwise it will cause the fire, electric shock or injury. If this

happens, please contact the after-sale service department.

 Do not expose the instrument to corrosive and flammable

gas, direct sunlight or wind.

 The instrument should be placed on a level, stable and

vibration-free worktable.

5
 Do not repair or rebuild the instrument by yourself, in order

to avoid damage to the instrument or hurt people.

 Keep the instrument away from magnetic sources or devices

that generate the electromagnetic wave.

 Keep the instrument away from liquids, dust and physical

shocks or impacts.

 Before charging, please confirm that the instrument was

turned off. The battery should be fully charged 3 hours at

lower power. The charging time should not be too long.

Please remove the power adapter after the instrument is fully

charged. The excessive charging would affect battery life.

 After the instrument fully charged, please do not recharge it

again unless the instrument has been continuous use for at

least half an hour, it should not be too frequent charging to

avoid damage to the battery life.

6
1. Instrument Introduction

1.1 Instrument Features

■ Compact and portable

The instrument is light and portable,weight 180g alone. The Printer

weight 180g without the thermal printing paper.

■ Simple operation

Pressing the 【Start key】 or 【 】key and loading a reagent strip, the
instrument begins to perform the measurement. The result will be

displayed on the screen and printed out from the printer simultaneously.

■ Touch-Sensitive Screen

The touch-sensitive screen makes the operation more convenient.

■ Corrective features

1) Eliminating the effect of chromaturia by using the white color

correction test pad.

2) Correcting specific gravity based on the pH.

■ Convenient maintenance

Strip holder can be easily detached for daily cleaning. The detection

light doesn’t need to be replaced by using LED as light source.

■ Auto update of memory

Up to 1000 samples can be stored in memory. You can query, print, or

send test results to an external device via USB and Bluetooth interface.

7
When results exceed 1000, the oldest one will be deleted automatically

and the new data will be recorded.

■ Separation-Type Printer (Optional)

The result can be automatically printed after testing by using the Printer.

■ Normal work without external power supply

There is a rechargeable battery in the instrument. About 200 samples

can be continuously tested after the battery fully charged.

There is a rechargeable battery in the printer.About 400 samples can be

continuously printed after the printer fully charged.

1.2 Intended use

The instrument can be used in combination with urine reagent strips for

semi-quantitative or qualitative detection of biochemical components in

urine samples, which can provide reference for clinical examination and

diagnosis. The items that can be detected are Urobilinogen (URO),

Bilirubin (BIL), Ketone (KET), Blood (BLD), Protein (PRO), Nitrite (NIT),

Leukocyte (LEU), Glucose (GLU), Specific Gravity (SG), pH,

Microalbumin (MA), Creatinine (CR), Vitamin C (VC) and Calcium (Ca),

etc.

1.3 Instrument Application

The instrument applies to medical institutions for the urine test. The

instrument is for professional, in vitro diagnostic use ( ).The result

8
tested by the instrument can only be applied to screening some related

diseases in the group according to the detection results of human urine.

It can’t be used directly as evidence for diagnosing diseases.

1.4 Specifications

1.4.1 Instrument Specifications

 Reagent Strips: URIT 10G, URIT 11G, URIT 14G Urine Reagent

Strips produced by URIT Medical Electronic Co., Ltd.produced by

URIT Medical Electronic Co., Ltd. (The reagent strips type which

can be used have been set to the instrument by manufacturer

before delivery).

 Analytes: LEU、KET、NIT、URO、BIL、PRO、GLU、SG、BLD、

pH、VC、CR、Ca、MA and Urine Color.

 Measuring Principle: Reflectance photometry.

 Measurement Wavelength: 470nm, 550nm, 620nm, 720nm.

 Sample Supply Method: Manual dipping.

 Throughput: 60 tests / hour.

 Reaction Time: About 60s / test.

 Two Measuring Modes: Single measuring mode and continuous

measuring mode.

 Display: Touchscreen, which can display Reagent Strips type, test

number, Patient ID and test results, etc.

 Memory: Up to1000 samples.

9
 Specific gravity Correction: Automatically corrected based on pH

readings.

 Chromaturia Correction: Automatically corrected by color

correction test pad.

 Data Output: Test results can be transmitted to the computer via

the USB and Bluetooth interface.

 Operating Condition: Temperature: 5°C~40°C; Humidity: ≤ 80%.

 Measuring Condition: Temperature: 15°C~30°C; Humidity: ≤ 80%

(Recommended).

 Dimension: 120mm×83mm×31mm (L×W×H).

 Weight: 180g.

 Operating Voltage Range: 3.6V~4.2V.

 Power Supply: The instrument: 9V 1.5A. The adapter: Input:

100V-240V～, 50/60Hz.

 Power Consumption: 5W.

 Environment-Friendly Use Period: 10 years.

1.4.2 Printer Specifications

 Printer: Thermal line printer.

 Printer Paper: Thermal paper.

 Dimension: 110mm×80mm×38mm (L×W×H).

 Weight: 180g (without thermal paper).

 Operating Voltage Range: 7.2V~8.4V.

 Power Supply: Printer: 9V 1.5A. The adapter: Input:

10
 100V-240V～, 50/60Hz.

 Power Consumption: 13.5W.

 Environment-Friendly Use Period: 10 years.

1.5 Structure and Principle

As shown in Figure 1.1, the instrument is composed of the control

system, optical-electronic sensor system, mechanism and I/V convert,

etc.

Figure 1.1

The optical-electronic sensor system consists of a light source and a

light receptor. Light from light source falls on the reagent pads on the

11
strip. The absorbance and reflectance ability varies with the color

development of reagent pad. The degree of color development is

proportional to the concentration of the analyte in urine: if the color of

reagent pad is darker, more light will be absorbed and less light is

reflected. The reflectivity will be smaller, vice versa.

The reflected light is transmitted into the Optical-electronic sensor

system where the optical signals are transformed into electric signals.

The electronic signals vary with the reflected lights strength. The electric

signals are transformed to CPU by I/V convert and then processed by it.

Finally, Test results are printed out through the internal printer.

1.6 Appearance and Components

Instrument (figure 1.2)

12
Figure 1.2

13
Printer (figure 1.3)

Figure 1.3

No. Items Contents

Long press this key for 3 seconds to

start-up.

1 Start key After start-up, pressing the key to test

mode.

When turned on, long press for 3

14
 seconds to shutdown.

Displaying operational information, test

Touch-sensitive results and error code, etc.

2
screen A short tune should be heard when a

key is pressed to be active.

The instrument The red LED light by means it is

indicator light charging.

3
for charging The red LED light put out means it

status finishes charging.

The instrument
Used for charging and data
4 mini USB (micro
transmission.
USB) interface

The instrument The instrument system will be re-start

5
reset key after you push down this key.

Place reagent strip here for

6 Strip holder
measurement.

Open this cover to load a roll of printer

7 Printer cover
paper.

Printer USB Used for charging and data

8
interface transmission.

Indicator light The red LED light by means the printer

9
for Printer is charging.

15
 charging status The green LED light on means the

printer finish charging.

The blue LED light on means that the

printer is working.

Long press for 3 seconds to start-up.

After start-up press this key into paper

The printer
10 skip status.
power switch
When turned on, long press for 3

seconds to shutdown.

The printer The printer will be re-start after you push

11
reset key down this key.

16
2. Installation

2.1 Unpacking

Please check the instrument and accessories as below steps after

receiving the carton:

1）Carefully unpack the shipping carton and take out the instrument and

accessories.

2 ） Check the contents for quantity and visible signs of damage

according to the accompanying Packing List.

3 ） Please notify your local dealer immediately if any damage or loss

exists.

2.2 Charging Operation

Caution

1.There is a recharged battery in the instrument. Unauthorized

removing of the battery is forbidden to protect the instrument

from the potential damage. To replace the battery, please

contact your dealer.

2.The instrument can only be charged in the indoor operation.

3.Be sure to use the equipment supplied power adapter. It may

lead to an abnormal working conditional, damaging, even a fire,

17
explosion or other dangerous when an improper adapter was

used.

4.The power adapter is only allowed to charge the battery

inside the instrument. It should be taken down from the power

outlet when the battery is fully charged. When the battery is

fully charged, please do not frequent charging. Excessive

charging will shorten battery life.

5.The instrument becomes hot during charging. This is a

normal condition and will not affect the instrument's lifespan or

performance.

6.The using of the instrument is prohibited when charging, so

as not to affect battery life.

7.It will take about 3 hours to charge the fully uncharged

battery. If the charging time is far more than that time and the

charging status indicator remained unchanged, it indicates the

failure in the instrument. Please immediately disconnect the

power and contact your dealer.

8.If you think the battery or power adapter has been damaged,

or when the instrument is not charging properly, contact your

dealer. Never use a damaged battery or power adapter.

9.The battery lever will gradually reduce if the instrument is

long term non-use. It is recommended to charge at least once

every half a year to avoid the full depletion of the battery which

18
 might cause the battery can’t be charged.

10.The battery belongs to the consumable category. The

charge and discharge cycles are about three hundred

times.The battery level will gradually decrease as the charge

cycles goes by. The charging time and working time will

therefore be shortened. It needs to change the battery when the

working time of the instrument significantly shorter than the

normal one. Please contact your dealer.

2.2.1 Instrument Charging Operation

Charging with adapter

1）Confirming the instrument battery power is insufficient. Confirming the

instrument was turned off.

2 ） Putting one side of the micro USB cable to the instrument’s micro

USB. Connecting another side of the mini USB (micro USB) cable to the

AC adapter USB interface.

3）Connecting the AC adapter plug to AC 100V~240V 50/60Hz.

4）The instrument indicator light for charging status lighting up means it

is charging. And the light putting out means it finish charging.

5 ） After charging, please remove the AC adapter from the electrical

outlet and disconnecting the mini USB cable from the instrument.

2.2.2 Printer Charging Operation

1 ） Confirming the printer battery power is insufficient. The blue LED

continuous will flash after the printer starts up in this situation. Turning

19
off the printer and confirming its status.

2 ）Connecting the USB cable one side to the printer mini USB (micro

USB)interface, and connect the USB data cable another side to the AC

adapter USB interface.

3）Connect the AC adapter plug to AC 100V~240V 50/60Hz.

4）The printer state indicator light lighting up means it is charging. The

light puts out means it finishes charging.

5 ） Please remove the AC adapter from the electrical outlet and

disconnect the mini USB (micro USB) cable from the printer after

charging.

2.3 Loading Thermal Print Paper

Printer cover

Print paper

storage area

Paper exit

Rubber roller

Figure 2.1

1）As is shown in figure 2.1, opening the printer cover in the direction of

upward, 2）Using your fingers slight lift the printer rubber roller toward

your direction, and then upward remove the printer rubber roller.

20
3）Loading the paper roll, put the printer rubber roller upward the printer

clip, then use your fingers downward slightly push it into the clip.

4）Please make the paper roll extends from the printer paper exit and put

the paper roll into printing paper roll storage area, then closed the printer

cover.

Caution

1. Pay attention to the positive and negative of thermal printing

paper. Print characters display only in the front of the paper roll,

if installed backwards, the characters will not be printed.

2. Please leave enough length of print paper when installing in

order to make the paper roll extends from the print paper exit.

3. Please supply the print paper timely when it runs out.

4. Before loading the print paper, be sure to check the print paper

whether dry. It needs to be changed if the print paper is moisture,

which might cause the print paper jam.

5. Please re-install if print paper jamming.

2.4 Connect To Computer

To communicate the instrument with your computer, please use

the USB data cable to connect them.

You need to install the USB driver at the first time. Installation method is

as follows:

21
①Starting up and entering the system setup interface. Click the restore

factory key, enter the password "6666", into the upgrade interface and

do not press any key. Please use the USB data cable to connect the

instrument with your computer, and wait for the computer system

automatic install hard disk, after the installation is complete in the "my

computer" will appear "removable disk", please copy the USB driver file

to your computer from the "removable hard disk".

②Right click on the "my computer", in the pop-up menu please choose

"properties" → "hardware" → "device manager" → "port", right click on

the "update driver".

③Select “from a list or specify the location to install (advanced)(S) ".

④Select "don't search. I want to choose to install the driver (D)".

⑤Choose "install from the disk (H)..." - "browse". And find the USB

driver which copy to the computer before, then open and install it.

After the installation is complete, please choose "device manager" →

"Port", and will display a new COM Port. Use this COM port as the port

of computer receiving software.

NOTE: When using USB interface to communicate with a

computer, it must be operated in sequence: first open the

instrument, and then connected to the computer before you can

finally open the communications software to send data to the

computer properly.

22
3. Usage Precautions

3.1 Sample Usage Precautions

1）Be careful to take samples.

Urine samples may carry pathogenic microbes that can cause infectious

diseases. Take the utmost care when handling urine. Wear protective

gloves to avoid exposure to urine samples.

2）Use fresh urine samples (Collect within one hour).

Samples must be measured within one hour, otherwise, keeping them in

the refrigerator to avoid deterioration.

3）Samples should be returned to detect the ambient temperature.

Allow the refrigerated samples to return to the room temperature before

measurement. The results might be lower than the normal one if the

measurement is conducted immediately.

The newly collecting sample need to be returned to detect ambient

temperature before testing. If not recovery was tested, the results may

be on the high side.

4）Mixing each sample well before measurement. Do not

centrifugal separation.

The centrifuge might lead to the sediment of some element,which could

cause the wrong results of some test item.

5）Sample volume should be enough to entirely soak all reagent

23
pads on the strip.

The normal test can’t be conducted if there are not enough samples.

6）Using the collected sample directly.

Do not add preservative, disinfectant or detergent to samples.

7）Keeping samples away from direct sunlight.

Samples via direct sunlight go bad and affect test results.

8）Sample containing ascorbic acid will affect test results.

When testing the sample which contains ascorbic acid may cause the

occult blood and glucose readings lower than the actual value.

9）Drug-administered urine and visual hematuria can affect test

results.

Drug-administered urine and visual hematuria can affect test results and

may not get the accurate test results.

3.2 Reagent Strips Usage Precautions

1）Please use the specific reagent strips.

Only the URIT reagent strips are allowed to use. Carefully reading

introduction of the reagent strips before use.

2）Please confirm before use.

Checking the expiration date of reagent strips before use. Do not use

the expired strips or strips that have discolored pads even if they are

within the expiration date.

3）Reagent strips should be prepared before the test.

24
Only taking out the required number of reagent strips from the bottle

before measuring samples, and cap the bottle immediately. Exposing

the reagent strips to air for a long time will deteriorate the compositions

of the reagent strips.

4）Do not touch the reagent pads on the reagent strips.

Do not touch the reagent pads on the reagent strips in case of affecting

the test result.

5）Setting proper type of reagent strip.

Setting proper type of reagent strip before measurement. If the reagent

strip is different from the setting type, the result will be affected.

6）Please keep desiccant.

Do not discard the desiccant in the reagent strip bottle before using up

all reagent strips, otherwise, the reagent strip may go bad because of

absorbing the moisture in the air.

3.3 Instrument Usage Precautions

1）Please pay attention to the instrument’s battery power during the

use procedure.

Caution

The accuracy of the test results will not be guaranteed if the test

is conducted at a low power situation.

Confirming the battery level through observing the battery icon on the

25
display of the instrument.

Battery power is enough.

Battery power is reduced slightly, but still can work.

Low power, please charge.

Icon flash. Battery power is insufficient, and the instrument

will not work. Please charge at once!

Battery abnormality, please contact your dealer.

2 ） When the blue LED to the printer flashes continuously that

means the printer battery is insufficient, please charge.

26
4. The Instrument Use Procedures

4.1 Turning on / off

4.1.1 Turning on the power

1）Instrument: Keeping pressing the【Start key】for 3 seconds to

turn on the power.

The display screen of the instrument will show the welcome interface

and the instrument starts self-checking. The strip holder will extend to

the front of the instrument.

2）Printer: Keeping pressing the【Start key】for 3 seconds to turn on

the power.

The printer status indicator blue LED lights up.

4.1.2 Turning off the power

1）Instrument: Keeping pressing the【Start key】for 3 seconds to

turn off the power.

The strip holder will retract inside the instrument and the display screen

will be turned off.

2）Printer: Keeping pressing the【Start key】for 3 seconds to turn off

the power.

The printer state indicator blue LED puts out.

NOTE: The instrument will automatically turn off if it is inactive

27
 for five consecutive minutes.

4.2 Routine Measurement

4.2.1 Precautions

Please read the following matters carefully and prepare samples to do

the tests.

Biological risks

1. Putting on protective gloves to avoid exposure to pathogenic

microbes.

2. Disposing of used samples, reagent strips and gloves

according to local regulations.

Caution

1. The instrument should be placed on a level, stable and

vibration-free worktable.

2. Do not touch the moving part of the strip holder, to avoid

injury

3. Do not move or vibrate the instrument during measurement.

Otherwise, the erroneous test result will occur. Even more the

reagent strip may be blocked inside the instrument.

4.2.2 Preparing samples

Please prepare samples according to the following steps.

28
 Caution

The sample volume must be

enough to soak all pads

entirely on the reagent strip.

Figure 4.1

1）Collect urine sample in a container.

2）Mix the sample well.

Caution

Stop centrifugal separation. The centrifugal separation may lead

to haemocyte precipitation and get inaccurate results.

4.2.3 Preparing reagent strips

Please refer to the package insert of reagent strips for specific

information about how to handle reagent strips.

1）Take out as many reagent strips as you need from the reagent

strip bottle.

2）Cap the bottle immediately.

4.2.4 Measuring samples

After you prepare the samples and reagent strips, please soaking the

reagent strips with samples and then do the tests. The soaking time

29
should use seconds as the unit, so you should read the following steps

completely to understand the operation steps.

Caution

To avoid hindering the movement of strip holder, leave at least 7

cm to the front and back side of the instrument.

1）Open the cover.

2）Prepare some blotting papers at hand for later use.

It is used to remove the excess samples from the reagent strips.

3 ） Take out a reagent strip and hold it but do not dip it into the

sample at this time.

4）Press the【Start key】or【 】key。

The 3-second countdown timer will start and three short beeps will

sound. ( If you want to terminate the test, anytime just press the【Start

key】or【 】before the countdown to【30】seconds, the instruments

will be terminated.)

5）Please rapidly putting the reagent strip into the sample for

soaking when the hint sound starts and take the reagent strip out

of the sample when the hint sound end.

Caution

The reagent strip should be soaked into the sample for 2

30
 seconds exactly. The accurate test result will not be obtained if

the socking time is too long or too short.

6）Remove excessive urine by using tissue papers.

Caution

It may result in cross-contamination between the remained urine

and the next test strip if there is no siphoning of the excess urine

at the before one.

7）Before the countdown turns to 【30】, placing the reagent strip

on the strip holder.

Slide the reagent strip along the grooves of strip holder as far as it will

go.

Caution

1. Before the countdown turns to 【30】, placing the reagent strip

on the strip holder.

2. Be sure to place the reagent strip on the strip holder correctly.

Incorrect position of reagent strip will affect the accuracy of test

results.

8）Test result will be displayed after the strip holder re-move to the

front of the instrument.

The test result will be printed out if the printer is working.

The test results will be transported to the computer if the instrument is

31
connected to the computer.

9）Take the used reagent strip out of the strip holder and discard it

according to local regulations.

Biological risks

Discard the used reagent strip according to local regulations.

Caution

Wipe the strip holder with soft fabric if urine adheres to it.

4.2.5 When the measurement is completed

Cleaning the strip holder after all measurements. Getting more details,

please refer to chapter 7.2.

32
5. Instrument Checkup

5.1 Checkup

There are two check strips that come with the instrument. Use either

one to check the performance of the instrument and compare the

obtained results with the range printed on the check strip container. If

the obtained results fall outside the range, use another check strip to

repeat the test. If you continue to get out-of-range results, the

instrument may not be working properly. Do not use the instrument.

Please contact your local dealer.

We suggest you do the quality control (You can purchase the quality

control material from URIT) if the following situations appear:

① Use new urine reagent strip.

② Instrument replacing operators.

③ Have doubt for the test results.

Caution

1. The check strip is only used for the daily check.

2. Please do not soak the check strip into any liquid.

3. Please keep the check strip clean.

4. Usually only need to use either one, another one for backup

33
 use.

5. Compare the obtained results with the range printed on the

check strip container. If the obtained results inside the range

that means the instrument can be normal use; if not please

check the check strip is all right or not.

6. The range printed on the check strip container can only be

used as the basis for judging instruments are in good

condition, not as a reference for clinical diagnosis.

5.2 Checkup Operation

Please make sure the instrument is on the standby screen and reagent

strip type is 11G. Place the check strip on the strip holder and Press the

【Start key】or【 】key to start the test.

Caution

Please do not soak the check strip into any liquid. If the strip

holder has liquid on it, please wipe up, avoid contaminating the

check strip.

34
6. Function Introduction

6.1 Function Introduction of Printer

The instrument and printer can be connected to the mini USB (micro

USB) cable or Bluetooth interface. The “ ” will show in the instrument

status bar when the instrument is open printer function and the printer

has been successfully connected to the instrument. As is shown in

figure 6.1, the test results will be printed out.

Figure 6.1

35
No. Items Content

The sample ID (up to 13 digits) should be

preset before measurement. If no sample ID

1 Sample ID
has been set, no information will be

displayed here.

Measurement The measurement number (up to 4 digits) of

2
number the sample.

Date and The date and time when the measurement

3
Time was performed. 。

The abbreviations of measured items. An

asterisk (*) will appear at the head of the

4 Item Names
item name when the test result of the item is

abnormal.

The first column: “-” stand for Negative, “+”

stand for Positive. There is a slight

difference from the daily hospital. That is:

The instrument use “+ 2” stand for “+ +”, “+

5 Test results 3” stand for “+ + +”.

The second column: Qualitative and

Semi-quantitative values of measured

items. Give the doctor as a reference

through a Semi-quantitative value. The

36
 qualitative symbol is "+ 3" that shows a high

density and is often greater than a certain

value. For example: KET +3

≥8.0mmol/L.

6.2 Function Introduction of Instrument

6.2.1 Function Introduction of Reagent Strip

The current reagent strip type will display on the upper left of the

standby screen, click here to select the type of reagent strip: 10G, 11G,

14G.

6.2.2 Function Menu

Please click【 】key under the standby screen into function menu, the

menu has the following functions button:

1）【NO】: The display screen window will pop up a digital keyboard for

editing the current serial number after you click this button.

2）【ID】: The display screen window will pop up a digital keyboard for

editing the current ID number after you click this button.

3）【Time】: The display screen window will pop up a digital keyboard

for editing the current system time after you click this button.

4）【Printer】: You can choose to open or close the printer function. The

instrument will default open the Bluetooth transmission function when

the printer function is set to close.

5）【 Mode 】 :You can choose the instrument work mode is single

37
measuring mode or continuous measuring mode.

6）【Language】: You can choose the system language.

7）【Initialize】: The instrument will enter the password interface after

you click this button, please input the password “0000” and then click

“OK”, after that the instrument will restore factory.

8）【Color】: Open or close the color detection function.

9）【 Unit 】 : You can choose the unit is SI unit or Conv. unit.(See

Appendix 2)

10）【 Sensitivity 】 : The instrument will enter the sensitivity setting

interface after you click this button.

The positive and linear rate can be adjusted by clicking the name of the

corresponding item number to the right in the sensitivity settings screen.

After adjusting the power button, pressing 【 Start key 】 to exit the

screen. icon will appear on standby interface which indicates that

the sensitivity has to be modified.

The positive rate: if the instrument to determine the current adjustment

item the measured reflectivity greater than the second file in Appendix 1

to the corresponding reflectance density value, the automatic offset

adjustment value, and then converted into concentration values, "+"

indicates increased reflectivity, density values of the test results to the

negative direction of the shift, lower positive rate; "-" indicates a

decrease reflectance density value of the test results to the positive

direction of the shift, high positive rate; linear: in any case, the

38
instrument automatically compensates for adjustment value, and then

converted into concentration values, "+" indicates increased reflectivity,

"-" indicates reduced reflectance (The adjustable range in Adjust option

is from +10 to -10, this figure is just a relative value of adjustable range,

not a percentage).

NOTE: There is only one kind of compensate for every item. 0

means no adjustment。

Caution

It's recommended that operator should collect enough QC test

data before using the function of sensitivity adjustment, and

check the conformance with clinical test after adjustment.

6.2.3 Reviewing Results

On the standby screen, pressing the 【 】key to enter the reviewing

interface.

The reviewing interface will display the instrument store test results,

click 【↑】or【↓】 to view the last or next test result, long press 【↑】

or【↓】to view the last or next ten test results. The instrument will print or

output current test result through the Bluetooth interface after you click

【 】 key and the instrument will output current test result through the

USB interface after you click 【 】 key. The instrument will go back

standby screen after you click the【 】.

6.2.4 Test Function

39
The instrument will begin to do the test after you click【 】 key under
the standby screen and display the test result after the test is complete.

To terminate the test, the instrument【30】seconds before the countdown

at any time just press the start button 【Start key】 or 【 】key, the
instrument will stop testing.

Caution

The instrument is only used to choose the population-related

diseases according to the urine test results. It can not be

directly used as the basis for the diagnosis of disease.

40
7. Maintenance

7.1 Precautions

Biological risks

1. To avoid exposure to pathogenic microbes, put on protective

gloves during maintenance.

2. Dispose of used reagent strips, fabric, and protective gloves

according to local regulations.

7.2 Cleaning the strip holder（Daily）

During measurements, urine may adhere to the strip holder which will

contaminate the reagent strip. So, it is necessary to wash the strip

holder each day when all measurements are completed.

1）Turn on the power and wait for self-check of the instrument.

2）Please remove the strip holder from the holder base.

Hold the end of the strip holder, shown by the arrows in figure 7.1 slide

to the left, so that the bottom of the holder base hook strip frame after

removing the lock, then lift up the strip holder.

41
 Figure 7.1

3）Clean the strip holder.

Clean the strip holder and holder base by using mild detergent, and

wash the adhered urine off with running water. Use soft fabric to dry the

strip holder and holder base.

4）Put the strip holder on the holder base.

As is shown in figure 7.2, putting the strip holder hooks into the bottom

of the holder base and lock in,pushing it as is shown by the arrow to the

right place.

Figure 7.2

42
8. Storage and Transportation

8.1 Transportation

URIT-31 is a precise instrument. Transport it with utmost care and avoid

moisture, sunlight and collision.

Transportation Condition:-20°C~55°C, RH≤95%, 75kPa~106kPa

8.2 Storage

The packed instrument should be stored in a ventilated room. Do not

store the instrument with the toxicant, injurant and corrosive.

Storage Condition: -20°C~55°C, RH ≤95%, 75kPa~106kPa

43
9. Troubleshooting

The instrument must be handled carefully. Rough handling may disturb

internal calibration which might cause other malfunctions. The error

code will appear on the display if there is something wrong with the

instrument. And the error code will also be printed out if the printer is

attached. The table below presents the various error codes along with

possible causes and recommended remedies to quickly and easily solve

the problems. If the error code persists, contacting your local distributor.

Caution

If an error code appears, clear the error and retest the sample by

using a new reagent strip. Correct results may not be yielded if

the soaking-time of reagent strip is too long.

Caution

After the instrument scrapped, dealing with the waste electrical

and electronic equipment according to the local regulation.

44
 Troubleshooting Table

Code Possible Cause Remedy

Infrared LED light

Trouble-1 brightness value Check the white piece on

abnormal the strip holder is came off

Red LED light brightness or contaminated. Please

Trouble-2
value abnormal contact your local

Green LED light distributor if the problem

Trouble-3 brightness value still exists.

abnormal

Incorrect position of the Place the reagent strip on

Trouble-4
reagent strip. the strip holder correctly.

Please confirm you have

The reagent strip setting
Trouble-5 chosen the correct reagent
is not correct.
strip type.

There is no reagent strip Place a reagent strip on

Trouble-6
on the strip holder. the strip holder.

Transferring mechanism Check if the strip holder is

Trouble-7
or limitation failure. installed correctly.

45
Appendix 1: Abbreviation of Test Items

No. Full name Abbreviation

1 LEUKOCYTE LEU

2 KETONE BODY KET

3 NITRITE NIT

4 UROBILINOGEN URO

5 BILIRUBIN BIL

6 PROTEIN PRO

7 GLUCOSE GLU

8 SPECIFIC GRAVITY SG

9 BLOOD BLD

10 pH VALUE pH

11 ASCORBIC ACID (VITAMIN C) VC

12 CREATININE CR

13 CALCIUM Ca

14 MICROALBUMIN MA

46
Appendix 2: Test results and unit comparison table

47
Appendix 3: Format of test results

11G

Remark:

1) Digits denote serial numbers of ASCII code which are exported via

the serial port.

2) The second code is internal communication code, which can be taken

as a space code.

3) The black squares “■”denote test results. The blank spaces denote

48
space codes.

4) Other urine reagent strips types of data output format consistent with

the 11G output format, but the project sequence is different, the order of

the project on the order of the test paper tube.

COM port parameter setting

Baud rate: 9600 bps

Data bit: 8 bit

Stop bit: 1 bit

Parity bit: None

49