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This manual is applicable for H Series Urine Analyzer (Model: H-800), hereinafter called

“analyzer”.

Instructions

Dear users, thanks for purchasing H Series Urine Analyzer (Model: H-800).

Please read this User Manual carefully for correct operation. Any incorrect operation may affect the precision and
accuracy of test results, may damage analyzer or injure human body.

Please keep User Manual safe for future use.

Manufacture Date: Refer to the label.

Use Limit: 7 years.

Version: REV.06-2017.

Configuration No.: 001.


Warning

● The protective measures may not be effective if the analyzer is not operated according to the user manual.

● Do not pull the power cable with wet hands, otherwise electric shock may happen.

● Do not use broken wires and connecting cables. Do not pull, stamp on, twist or drag the wires and cables.
Otherwise fire may be caused.

● The analyzer should be operated in a good grounding condition.

● Confirm that input voltage is qualified. Use specified fuse box.

● Confirm that the analyzer switch is on [O] before power supply is connected.

● Do not use the analyzer in inflammable and explosive conditions.

● Do not touch the moving parts during testing to avoid accidents.

Biohazard

● Users should comply with the local and national regulations when discharging and disposing of reagents, waste
solution, waste samples, and consumables, etc.

● Samples, Control and waste solution have potential biological infectivity to irritate eyes, skin and mucosa.
Users should refer to the safety regulations for lab operation. Protective measures should be taken for users (Such
as lab protective clothes and gloves).

● Dispose of waste solution and consumables correctly.

● Do not use disposable goods repeatedly.


Notice

● The analyzer should be operated by medical laboratorial specialists, or physicians, nurses and lab assistants who
are specially trained.

● The analyzer poses biological, chemical risk; the operator must receive training and use personal protection
articles to reduce the risk.

● The operator must be trained before performing operation with danger, such as moving parts.

● Hospitals or clinical institutions should work out a maintenance plan and strictly follow it. Otherwise instrument
malfunction may be caused.

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

● Do not use reagent strips expired.

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

●When the transportation or storage temperature is fairly low or the relative humidity is more than 75%, keep the
analyzer in the normal work environment for 24 hours before power on and tests.
Statement

DIRUI has the final interpretation of the User Manual.

DIRUI is responsible for the security, reliability and performance of H Series Urine Analyzer (Model: H-800)
after the following requirements are met:

(1)Installation, debugging and repair are conducted by professionals from DIRUI.

(2)Relevant electrical equipment is in line with the national standards.

(3)Operation is subject to the User Manual.

All software interfaces are subject to change without notice.


User Manual

Contents

Chapter 1 H-800 Urine Analyzer Introduction ............................................................................1-1 

1.1 General Introduction ...................................................................................................................................... 1-1 

1.2 Technical Specifications ................................................................................................................................. 1-1 

1.3 Testing Principles ........................................................................................................................................... 1-2 


1.3.1 The Testing Principle of Reagent Strips ............................................................................................................................ 1-2 
1.3.2 The Testing Principle of Specific Gravity.......................................................................................................................... 1-2 
1.3.3 The Turbidity Testing Principle ......................................................................................................................................... 1-2 
1.3.4 Color.................................................................................................................................................................................. 1-3 

1.4 Structure .......................................................................................................................................................... 1-3 

1.5 Symbol ............................................................................................................................................................. 1-4 


Chapter 2 Analyzer Installation ....................................................................................................2-1 

2.1 Precautions ...................................................................................................................................................... 2-1 

2.2 Carton Opening .............................................................................................................................................. 2-1 


2.2.1 Items in Package A ............................................................................................................................................................ 2-1 
2.2.2 Items in Package B ............................................................................................................................................................ 2-2 
2.2.3 Items in Package C ............................................................................................................................................................ 2-2 
2.2.4 Items in Package D ............................................................................................................................................................ 2-3 

2.3 Installation....................................................................................................................................................... 2-3 


2.3.1 Connection of Sample Conveyer ....................................................................................................................................... 2-3 
2.3.2 Connection of Waste Liquid Tank and Washing Liquid Tank ............................................................................................ 2-4 
2.3.3 Set Printing Paper .............................................................................................................................................................. 2-4 
2.3.4 Connection of Power Wire ................................................................................................................................................ 2-5 
2.3.5 Connection to Computer.................................................................................................................................................... 2-5 
2.3.6 Connection of Stylus Printer.............................................................................................................................................. 2-5 
2.3.7 Connect with Barcode Reader ........................................................................................................................................... 2-5 
2.3.8 Installation of the Connecting Bridge (optional part) ........................................................................................................ 2-6 
2.3.9 Liquid Path Diagram ......................................................................................................................................................... 2-9 

2.4 First Run Check .............................................................................................................................................. 2-9 


2.4.1 Power-on Auto-check/Registration .................................................................................................................................... 2-9 
2.4.2 Test Strip Security Barcode Instruction ........................................................................................................................... 2-13 
2.4.3 Usage of Power-off Button .............................................................................................................................................. 2-14 
2.4.4 Key Note in Using ........................................................................................................................................................... 2-14 

2.5 Carrying Method .......................................................................................................................................... 2-14 


Chapter 3 Setup...............................................................................................................................3-1 

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3.1 General Introduction ...................................................................................................................................... 3-1 

3.2 Instruction of Keystroke ................................................................................................................................ 3-1 

3.3 Setup ................................................................................................................................................................ 3-3 


3.3.1 Set Sequence Number ....................................................................................................................................................... 3-3 
3.3.2 Set Date ............................................................................................................................................................................. 3-3 
3.3.3 Set Time ............................................................................................................................................................................ 3-5 
3.3.4 Set Printer .......................................................................................................................................................................... 3-6 
3.3.5 Set Language ..................................................................................................................................................................... 3-6 
3.3.6 Set Unit System ................................................................................................................................................................. 3-6 
3.3.7 Plus System ....................................................................................................................................................................... 3-7 
3.3.8 Abnormal Value ................................................................................................................................................................. 3-8 
3.3.9 Set Abnormal Value ........................................................................................................................................................... 3-8 
3.3.10 Set ID Number Display ................................................................................................................................................... 3-9 
3.3.11 Set Test Tube Rack Conveying Mode ............................................................................................................................ 3-10 
3.3.12 Set Baud Rate ................................................................................................................................................................ 3-10 
3.3.13 Set Computer Interface .................................................................................................................................................. 3-10 
3.3.14 Select Reagent Strip Type .............................................................................................................................................. 3-11 
3.3.15 Use Default Parameters ................................................................................................................................................. 3-11 
3.3.16 Set Scaler ....................................................................................................................................................................... 3-12 
3.3.17 Manufacturer Setup ....................................................................................................................................................... 3-12 
3.3.18 Reagent Setting ............................................................................................................................................................. 3-13 

Chapter 4 Record Recall and Clearance.......................................................................................4-1 

4.1 Data Recall ...................................................................................................................................................... 4-1 


4.1.1 Normal Result ................................................................................................................................................................... 4-1 
4.1.2 Control Result ................................................................................................................................................................... 4-5 
4.1.3 STAT Result ...................................................................................................................................................................... 4-6 

4.2 Delete Data ...................................................................................................................................................... 4-6 


Chapter 5 QC and Calibration ......................................................................................................5-1 

5.1 Calibration Strip Test..................................................................................................................................... 5-1 


5.1.1 Preparation before Calibration........................................................................................................................................... 5-1 
5.1.2 Check Calibration .............................................................................................................................................................. 5-1 

5.2 Refractometer Calibration ............................................................................................................................. 5-1 


5.2.1 Pre Calibration................................................................................................................................................................... 5-1 
5.2.2 Start Calibration ................................................................................................................................................................ 5-2 

5.3 Turbidimeter Calibration .............................................................................................................................. 5-3 


5.3.1 Pre Calibration................................................................................................................................................................... 5-3 
5.3.2 Start Calibration ................................................................................................................................................................ 5-3 

5.4 Control Measurement .................................................................................................................................... 5-4 

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5.4.1 Positive, Negative Control Measurement .......................................................................................................................... 5-4 


5.4.2 SG Control Measurement .................................................................................................................................................. 5-6 
5.4.3 Turbidity Control Measurement ........................................................................................................................................ 5-7 
5.4.4 Color Control Measurement .............................................................................................................................................. 5-7 

Chapter 6 Conventional Test .........................................................................................................6-1 

6.1 Preparation before Testing ............................................................................................................................ 6-1 


6.1.1 Reagent Strip ..................................................................................................................................................................... 6-1 
6.1.2 Testing Tube Requirement ................................................................................................................................................. 6-2 
6.1.3 Barcode Pasting Requirement ........................................................................................................................................... 6-2 
6.1.4 How to Use Cleaning Liquid ............................................................................................................................................. 6-3 
6.1.5 Check Cleaning Tank, Waste Liquid Tank and Thermal Printer ........................................................................................ 6-3 
6.1.6 Urine Sample ..................................................................................................................................................................... 6-4 

6.2 Test ................................................................................................................................................................... 6-4 


6.2.1 Conventional Test Operation ............................................................................................................................................. 6-5 
6.2.2 STAT Test Operation ......................................................................................................................................................... 6-7 
6.2.3 Note during Test Processing .............................................................................................................................................. 6-8 

Chapter 7 Analyzer Maintenance ..................................................................................................7-1 

7.1 The Required in Maintenance ....................................................................................................................... 7-1 

7.2 Cleaning of the Reagent Strip Feeder ........................................................................................................... 7-1 

7.3 Clean the Waste Box....................................................................................................................................... 7-2 

7.4 Clean Waste Solution Tank ........................................................................................................................... 7-2 

7.5 Clean Fiber Optic Sensor Mirror .................................................................................................................. 7-3 

7.6 Clean Barcode Reader.................................................................................................................................... 7-3 

7.7 Replace Injector .............................................................................................................................................. 7-3 

7.8 Clean the Worktable Panel and Stepping Gear Panel ................................................................................ 7-4 

7.9 Cleaning Refractometer and Turbidimeter.................................................................................................. 7-5 

7.10 Rinse Pipeline ................................................................................................................................................ 7-6 

7.11 Wearing Parts Replacement ........................................................................................................................ 7-6 

7.12 Maintenance before stopping use of analyzer ............................................................................................ 7-7 

7.13 Analyzer cleaning ......................................................................................................................................... 7-7 

7.14 Waste treatment ............................................................................................................................................ 7-8 

7.15 Handling of scraped analyzer ...................................................................................................................... 7-8 


Chapter 8 Transportation and Storage.........................................................................................8-1 

8.1 Transportation ................................................................................................................................................ 8-1 

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8.2 Storage ............................................................................................................................................................. 8-1 


Appendix A Manufacturer’s Warranty ....................................................................................... A-1 
Appendix B Computer Connection .............................................................................................. B-1 
Appendix C Output Value of H-800 Urine Analyzer.................................................................. C-1 
Appendix D Malfunction Information List ................................................................................. D-1 
Appendix E Reagent Consumption .............................................................................................. E-1 
Appendix F Performance Indexes ................................................................................................ F-1 
Appendix G Accessories List........................................................................................................ G-1 

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Chapter 1 H-800 Urine Analyzer Introduction

1.1 General Introduction


H Series Urine Analyzer (Model: H-800) can be used together with urine analysis reagent strips (Model: H10-800,
H11-800, H11-800MA, H12-800MA) and FUS series reagent strips (Model: FUS-10, FUS-11MA, FUS-12MA).
It can provide a qualitative or semi-quantitative urine test result for Urobilinogen, Bilirubin, Ketone, Creatinine,
Blood, Protein, Microalbumin, Nitrite, Leucocytes, Glucose, Specific Gravity, pH, Vitamin C, Color and
Turbidity (gravimeter unit is needed for color and turbidity).
The analyzer adopts the advanced “high luminosity four wavelength cold light source reflection determination”
technology. The analyzer has the specialties of resisting the interference of the ambient light and has longer
lifespan. It is of a higher accuracy, sensitivity, differential, stability and has revised the affects toward the test
result which is caused by acid-base scale, hematuria and abnormally colored sample. It could automatically finish
samples feeding, sampling, dripping, rinsing, strips feeding, waste strips collection, and accurate quantificational
dripping. And the automatic cleaning after each test could avoid cross contamination between tests. It also has the
function of STAT insertion and adopts a big LCD screen which facilitates the communication between operator
and analyzer. With internal, external, two bar code reader, the analyzer facilitates the management of record .The
software could be upgraded through card. It realizes bi-directional transmission through RS-232 port. The
analyzer could be connected with LIS.
The analyzer can be connected with Dirui FUS Series Urine Sediment Analyzer through connecting bridge,
forming urinalysis work station to test the urine visible component (such as white blood cell, red blood cell,
hyaloplasmic cast, pathologic cast, unsorted crystal, etc.)

1.2 Technical Specifications

Performance Specifications

Test Storage
Test Items Functions Dimensions Power N/W
Speed Capacity

Urobilinogen UBG Batabase Query


Bilirubin BIL Number Setting
Ketone KET Language Selection
Blood BLD Time Setting
Protein PRO Status Setting
Microalbumin MALB Date Format
Nitrite NIT Units Selection
Leucocytes LEU Threshold Setting
660mm
Glucose GLU 240 10000 Barcode Scanning ×587mm 300VA 55.7kg
tests/h records
Power of pH STAT Interposition ×570mm
hydrogen VC Auto Sampling
Vitamin C COLOR Urine Samples Auto Feeding
Color TURBIDITY Sample Auto Dripping
Turbidity SG Tube Auto Cleaning
Specific gravity Waste Strips Auto Collection
(When testing COLOR and
TURBIDITY, refractometer unit
is needed)

Normal Working Requirements:


(1)Ambient Temperature: 15℃~35℃;
(2)Relative Humidity: 75% or less;
(3)Atmospheric Pressure: 76kPa~106kPa;

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(4)Power: 100-240V~, 50/60Hz;


(5)Illumination Intensity: keep out of direct sunlight.

1.3 Testing Principles


1.3.1 The Testing Principle of Reagent Strips
This analyzer uses the method of colorimetry of light against electronic signal, according to color changes of
testing light against strip reflection pad to determine the biochemistry content of urine.
Four mono-light will scan the reaction area of strip, then, change the signal into electronic signal. Electronic
signal will execute A/D conversion, adopt the convert data to calculate the reflectivity to determine the
biochemistry content of urine.
Adopt double wavelength test mode in the application. That is to obtain the final test data by the ratio of the
reflectivity (reflectivity refers to the reflex of mono-light on the strip pad).
Tm  C r
R
Tr  C m

In equation:
R Test data of strip pad
Tr Reflection signal of testing light against strip reflection pad
Cr Reflection signal of reference light against strip reflection pad
Tm Reflection signal of testing light against compensation pad
Cm Reflection signal of reference light against compensation pad

1.3.2 The Testing Principle of Specific Gravity


The LED light goes through a slot and lens device to be light beam. The light beam goes through one prism which
contains urine sample, then goes to the detector. The reflective index changes with the specific gravity of urine
sample in prism, thus, the relevant light to detector changes relatively. The calculation is as below:
SGX=(SGH-SGL)(KX-KL)/(KH-KL)+SGL
In equation:
SGX Sample solution specific gravity
SGH High concentration solution specific gravity
SGL Low concentration solution specific gravity
KX Sample solution position coefficient
KH High concentration solution position coefficient
KL Low concentration solution position coefficient

The specific gravity of sample solution changes with the sample temperature, the relation temperature changes
3℃, the specific gravity changes 0.001.
1.3.3 The Turbidity Testing Principle
The LED light from turbidimeter goes through the sample, and detects how much light was scattered by the
granule in sample from the angle of 45° by the incident light. This is called scattering method. Turbidity contains
three levels: “clear”, “slight cloudy”, “cloudy”, and “heavy cloudy”. Corresponding descriptions are as follows:
Note:
“clear”: the test result<200NTU;
“slight cloudy”: the test result between 200NTU-600NTU;
“cloudy”: the test result between 600NTU-800NTU;
“heavy cloudy”: the test result >800NTU.

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The scattering calculation is as follows:


T= (SS/TS- SW/TW)/K
In equation:
T Turbidity level
SS Urine sample scattering level
TS Urine sample beaming light level
SW Cleaning liquid scattering light level
TW Cleaning liquid beaming light level
K Coefficient factor

1.3.4 Color
Color uses RGB color sensor to test. Using the white light LED irradiating the sample. After transmission, the
color sensor tests R, G, B value, and then based on R, G, and B value to get sample color.

1.4 Structure
This analyzer is composed of: control system, photic system, liquid path system, mechanical system and input &
output system.
Control System: includes main boards, drive boards, printing boards, monitoring modules and built-in softwares.
Liquid Path System: includes syringes, hydraulic pressure motors, pumps, solenoid valve and tubes to perform
sampling, allocation and cleaning.
Mechanical System: includes housing, frame, strip selection unit, strip conveying unit, sampling unit, gravimeter
unit(optional) and sample feeding unit.
Input & Output System: includes touch screen, LCD, thermal printer, external printer to control the commands
input, and test result output.
The figures below are the front view and back view of the analyzer (Figure 1-4-1, Figure 1-4-2).

6
2

3
4

Figure 1-4-1 Front Image

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15

14

13

8
12

9 10 11

Figure 1-4-2 Back Image


1 Built-in thermal printer 2 LCD 3 Sample conveyer 4 STAT stand 5 Power switch
6 Strip feeder 7 Barcode reader 8 Liquid level sensor port 9 waste tank joint (DRAIN)
10 Cleaning liquid tank joint (WASH) 11 Fan 12 Power cable socket 13 Computer parallel port
14 Computer serial port 15 Fan

1.5 Symbol
Table 1-5-1

Symbol Meaning

BIOLOGICAL RISKS

LASER, DANGER SYMBOL

ALTERNATING CURRENT

IN VITRO DIAGNOSTIC MEDICAL DEVICE

BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

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Symbol Meaning

PROTECTIVE GROUND

MANUFACTURER

CAUTION, REFER TO THE ACCOMPANYING FILES OR MARK DETAILED WARNING


OR MATTERS NEEDING ATTENTION

THE DEVICE MEETS THE REQUIREMENTS OF DIRECTIVE 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

REMINDER ID
Unprofessionals are prohibited to open

“ON”(POWER)

“OFF”(POWER)

The symbols above are involved in the analyzer, test strips, calibrators.

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Chapter 2 Analyzer Installation

2.1 Precautions
(1)Installation of analyzer by professionals is advised.
(2)If installed by yourself, please read the user manual carefully and take appropriate actions.
(3)Put the analyzer on a stable, flat and vibration-free surface which can bear at least 56kg.
(4)Do not place the analyzer in a place where chemicals and caustic gas and strong electromagnet are located.
(5)Keep the analyzer away from direct sunlight, humidity or high temperature.
(6)Before move the analyzer, please disassemble it into host and sample conveyer.
(7)Keep the back of the analyzer 20cm away from the wall to make sure the ventilation of the analyzer works
well.
(8)Please do not dismantle or refit the analyzer.
(9)Please do not put any bottle with liquid in it on the analyzer in case of liquid leaking into the analyzer when the
bottle overturns.
(10)Temperature 15℃~35℃, Optimal environment temperature 20℃~25℃, relative humidity≤ 75%.
(11)Keep a good ventilation status. If need be, a ventilation device can be used. However, do not make the device
blow the analyzer directly. Otherwise, the test accuracy would be affected.

2.2 Carton Opening


Take out urine analyzer and its accessories from the packages A, B, C, D then check them with the packing list. If
any damage found, please contact the supplier.
2.2.1 Items in Package A

1 2
1 Host 2 Operation and maintenance illustration
Figure 2-2-1

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2.2.2 Items in Package B

1 2
1 Sample conveyer 2 Barcode reader subassembly
Figure 2-2-2

2.2.3 Items in Package C

1 2 3 4 5

6 7 8 9 10 11

12 13 14 15 16
1 waste liquid tank 2 reagent strip 3 printing paper 4 calibration strip box (prepared with 3 calibration strip)
5 serial port cable 6 fuse 7 brush 8 power wire 9 screw 10 CD
11 disposable plastic tube 12 liquid sensor port 13 routine test tube rack 14 cleaning liquid tank
15 barcode reader 16 user manual
Figure 2-2-3

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2.2.4 Items in Package D

1-2 3-7 8
1,2 Cleaning liquid(condensed type) 3 Calibration liquid for specific gravity 4 Calibration liquid for Turbidity
5 Turbidity QC liquid 6 Color QC liquid 7 specific gravity QC liquid
8 Cleaning liquid for turbidimeter and Gravimeter
Figure 2-2-4

If analyzer does not install refractometer, turbidimeter and reflective color sensor, Items 3, 4, 5, 6, 7, 8 are
not included in package D.

2.3 Installation
2.3.1 Connection of Sample Conveyer
(1)Remove the four foot stands mounted under the wood boxes after take out the sample conveyer as Figure 2-3-1
shows:

Cover

Wooden box

Figure 2-3-1
(2)Remove the boxes of both sides, and dismantle upper cover components of sample conveyer (As Figure 2-3-1
shows, hold the left and right side of the cover with both hands to lift.);
(3)Mount the stand bolts on the installation holes of baseboard and screw the nut down to fix it firmly as Figure
2-3-2 shows:

Nut

Bolt

Figure 2-3-2
(4)Thereafter, remove two red nylon ties fixing the left and right pushers (as Figure 2-3-3 shows).

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Nylon tie

Figure 2-3-3
(5)Please fix the barcode reader subassembly with screws in the place illustrated as Figure 2-3-4.

Figure 2-3-4
(6)Put the conveyer in front of the analyzer and connect the two plugs to the host with sockets in the conveyer.

After install the sample conveyer, please take down the red ties between the left side of sample conveyer
and sample rack after take down sample assimilator on the host, or the analyzer will not operate
appropriately.
2.3.2 Connection of Waste Liquid Tank and Washing Liquid Tank

Before installation of waste liquid pipe and washing liquid pipe, please remove the waste liquid pipe and
washing liquid pipe from the back cover side of analyzer.
2.3.2.1 Connection of Waste Liquid Tank
Please connect the other side of waste liquid pipe with waste liquid tank cover and keep the inserted length of
waste liquid pipe as long as 40 to 50 mm. Then fix the cover to the tank. The waste liquid pipe is 2 M long. If the
waste liquid tank is near to the analyzer, operator could cut off certain waste liquid pipe to adjust the distance. Do
not twist the waste liquid pipe and insert it into tank, it may cause block. Put the tank vertically on the ground.

The difference in height between the waste liquid tank and analyzer waste liquid outlet should be no less
than 0.5m.
2.3.2.2 Connection of Cleaning Liquid Tank
Before connecting cleaning liquid tank, please remove the cover of cleaning liquid tank, replace with cover
assembly of the cleaning liquid tank carried in the package, and seal the cleaning liquid tank tightly. Connect the
cleaning liquid pipe (10 in Figure 1-4-2 ) to the joint on the cover.
2.3.3 Set Printing Paper
(1)Select thermal printing paper with width of 57mm and diameter less than 50mm.

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(2)Unlock the printer cover and open it.


(3)Put the paper roll in the groove and make the paper drilled through under the pulley 2, then roll the knob 1 to
educe printing paper and then replace the cover. (When the analyzer works, it could educe the printing paper
automatically.)

Figure 2-3-5

2.3.4 Connection of Power Wire


Connect the power wire with one side in (12 in Figure 1-4-2), the other side connect to electricity power supply,
make sure the power is safely grounded.
Power Requirement:
(1)Voltage: 100-240V~, 50/60Hz;
(2)Power: 300VA;
(3)Fuse: F2AL250V 5mm×20mm.

● The socket connecting to the power cable must be grounded safely.


● The socket unit should be placed near the analyzer for an easy power-cut operation.
2.3.5 Connection to Computer
The analyzer can be connected to computer via the serial port cable to transfer data. Connect one end of the serial
port cable to the serial port at the back of the analyzer (14 in Figure1-4-2), and the other end to the serial port of
the computer.
2.3.6 Connection of Stylus Printer
The analyzer can be connected with a needle computer to transfer data via communication cable. Insert one end of
communication cable into communication port on the back of analyzer, and insert the other end into the print
parallel port on the back of analyzer (13 in Figure1-4-2).

The analyzer can be connected with EPSON LQ1600K series, EPSON LQ300K series needle printers and
PANASONIC1121 series needle printers.
2.3.7 Connect with Barcode Reader
Take out the barcode reader from the box, connect the data cable of bar code reader(Figure 2-3-6), and connect the
other end of the data cable (RS-232 port) with the barcode reader port of the analyzer.(7 in Figure1-4-2)

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Figure 2-3-6

2.3.8 Installation of the Connecting Bridge (optional part)


This analyzer and Dirui FUS Series Urine Sediment Analyzer can constitute Automatic Urinalysis System through
HUF Connecting Bridge. If installation of HUF Connecting Bridge is necessary, please follow the steps below:
(1)After installation of FUS Series Urine Sediment Analyzer, remove the two screws on the right cover of the
sample feeder, then take down the cover, as Figure 2-3-7 shows:

Fixed Screws

Sample feeder cover

Figure 2-3-7
(2)Remove the feeder cover of FUS Series Urine Sediment Analyzer (as Figure 2-3-7 shows, hold the right and
left side of the cover with both hands and pull upward), place fixing block 1 under the feeder, align it with the
installing holes and fix the screws, as Figure 2-3-8 shows:

Fix Block 1

Figure 2-3-8
(3)Remove the fixing baffle on the left of the analyzer feeder’s cover, as Figure 2-3-9 shows:

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Sample feeder cover

Figure 2-3-9
(4)Remove the sample feeder cover of the analyzer, place fixing block 4 under the sample feeder, align it with the
installing hole, and tighten the screws, as Figure 2-3-10 shows:

Fix Block 4

Figure 2-3-10
(5)Install the cover of feeder of Urine Sediment Analyzer and the analyzer respectively. Place the connecting
bridge between FUS Series Urine Sediment Analyzer and the analyzer (the side with switch should be placed
close to the operator). The load path on the left of the connecting bridge, and the installing column at the bottom
of the connecting bridge should be aligned with the gap on the right of the sample feeder and the installing hole at
the bottom of the sample feeder, as Figure 2-3-11 shows:

FUS Series Urine


Online Status Switch
Sediment Analyzer

Figure 2-3-11
(6)Put down the left baffle of the analyzer sample feeder, and insert it into the gap on the right of the connecting
bridge load path, insert the locating pin on the right of the connecting bridge into the locating hole of the analyzer
sample feeder. Insert the connecting cable of FUS Series Urine Sediment Analyzer and the analyzer sample feeder
into the socket of the connecting bridge, as Figure 2-3-12 shows:

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Online status switch

Connecting cable of FUS


Connecting cable of
Series Urine Sediment
H Series Urine Analyzer
Analyzer

Figure 2-3-12
(7)Place a tube rack on the sample feeder of H-800 Urine Analyzer, manually push the rack into the sample feeder
of analyzer through the connecting bridge. No clamping stagnation will be fine. If clamping stagnation happens,
remove the connecting bridge cover (the side with a switch), loosen the screws on the left and right of the fixing
block (as Figure 2-3-13 shows) and adjust the connecting bridge position back and forth until no clamping
stagnation exists. Install the connecting bridge cover to finish the connection between Urine Sediment Analyzer
and the analyzer.

Figure 2-3-13

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2.3.9 Liquid Path Diagram

Figure 2-3-14

2.4 First Run Check


After installation, you should do the first run check. If there is any question or error appeared, please contact
distributor.
2.4.1 Power-on Auto-check/Registration
(1)Power-on Auto-check
After switching on the analyzer, the display will show “Auto-checking…”. The analyzer will do an auto-check.
After passing the auto-check, the display will pop up “Instrument not register.” (Figure 2-4-1)

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Instrument not register

Enter

Figure 2-4-1
(2)Register

Press to enter the registration interface as the figure below shows:

R Code:

7 8 9
4 5 6
1 2 3
0
Figure2-4-1(a)

Please input the Registration No. provided by the supplier and press to confirm. After “Valid Input” pops

up, press to return to the menu interface as the figure shows:

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FUS strips

Maintenance

QC and Calibration

Test Memory

Set Up

Figure 2-4-1(b)

Press , and the instrument shows:

Confirm Save?

Y N

Figure 2-4-1(c)

Press Y to confirm saving, then the instrument is registered successfully as the figure shows below; Press
N to cancel the registration.

H12-800MA

No. 0291

ID 0120

Menu

STAT

Start
26℃ 2010-11-20 14:46

Figure 2-4-1(d)

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If the registration number you input is wrong, “Invalid number” will pop up after pressing . Click the
confirming key to return to the previous page as Figure 2-4-1(a) shows.
(3)Unregister

As to the unregistered instrument, press the key before “Menu” to enter the menu screen (Figure 3-3-2) and

press the Set Up key to enter the “Set Option” screen (Figure 3-3-3), and then press to switch to the
screen as the figure shows:

Set Option

Strip Type-12 MA parameters

Use Default Parameters?

Set Scaler

Manufacturer Setup

Figure 2-4-1(e)

Press and the screen shows as the figure 2-4-1(a), the operation is the same as that above. After registration,

the key in figure 2-4-1(e) will disappear.

a)If the Register ID includes capitals, press in the right corner of the figure 2-4-1(a) and switch to figure
2-4-1(f):

A B C D E F

G H I J K L

M N O P Q R

S T U V W X

Y Z

Figure 2-4-1(f)

b)Press the corresponding ID numbers; if small letters are needed, press to switch keyboard as the figure
below shows:

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a b c d e f

g h i j k l

m n o p q r

s t u v w x

y z

Figure 2-4-1(g)
Press the corresponding small letters.

● The unregistered analyzer will prompt “instrument not register” after every 10 sample tests.
● “Informal result” will show on the report of unregistered analyzer.
2.4.2 Test Strip Security Barcode Instruction

After analyzer power on, press key, and a form will pop up as Figure 2-4-2 shows:

Enter ID:

7 8 9
4 5 6
1 2 3
0
Figure 2-4-2

Enter the valid barcode on the test strip canister manually or by scanning, and press key, in Figure 2-4-2.
After the analyzer displays “Input valid”, tests can be carried out normally.
The existence of the following situations may occur in the process of entering the barcode:

(1)If the barcode entered has been used, press key, and a prompt “Used Check Code” will pop up.

(2)When entering manually, if entering barcode error occurs, press key, and a prompt “Invalid Check
Code” will pop up.

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(3)If entered barcode is overdue (test strip is out of expiry date), press key, and a prompt “Expired Check
Code” will pop up.

● Anti-fake barcode can be input one by one or continuously.


● 120 strips can be tested after one anti-fake barcode input. The strips number will be displayed under

of main menu, the number will change as the input strip number increases.

● Test cannot be carried out when the number under is 0000. Test can be recovered after one
anti-fake barcode input.
2.4.3 Usage of Power-off Button

Click in Figure 2-4-1(d) after daily tests. The screen will display “Washing……”. Cut off the power
supply when the screen displays “Please Turn Off The Power”.
2.4.4 Key Note in Using
(1)Place the strips in the corresponding place (Place the unused strips back into the strip bottle after daily tests and
tighten the bottle to ensure the test accuracy. The strips in the analyzer should not be placed more than 24 hours.)
(2)Place the tube with sample on the tube rack, and then place the tube rack on the feeder.
(3)Press “Start”, the analyzer will carry out test automatically, the printer will print the test report automatically
after test (Do Not touch the screen during test.)
(4)Some of the keys on the screen will be “Unavailable” during test.
(5)If the display is not consistent with the expected, or the value is not consistent with the expected, please refer to
relevant setting.

2.5 Carrying Method


(1)Remove the detergent bottles at the back of the analyzer.
(2)Drain the liquid in the flow paths.
(3)Keep the analyzer up-right during carrying.
(4)Avoid vibration during carrying process, if happened, check and debug the analyzer prior to use.

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Chapter 3 Setup

3.1 General Introduction


The analyzer using touch screen to realize user friendly interface, and display screen shows the setup selection,
initial value and touch key. User just needs to click the corresponding key to complete setup.
For preventing damage to the screen, please do not use any hard or sharp object to touch it.

3.2 Instruction of Keystroke


The corresponding meanings for function keys on the screen are as follows:
(1)Name: Return key

Icon:
Function: Return to upper menu or cancel current modification and return to upper menu.
Position: Right corner of screen.

Description: If there isn’t key, this key is used to roll back to the upper menu. If there is this key

, this key is to ignore the modification at current menu, and roll back to upper menu.
(2)Name: Enter key

Icon:
Function: To execute current modification and exit the current screen.
Position: Bottom of screen.

Description: This key is used together with this key . Press this key , to keep the modification (e.g.

serial number, date, time ), then exit the current menu. If press this key , it will ignore the modification for
the current menu, then, exit the current operation, the setup of analyzer does not change.
(3)Name: This key is rolling back pages or cursor left moving.

Icon:
Function: This is used to switch to the upper menu, and it is only valid when there is a previous operation, or it
will only flash the current menu, or it can move the cursor left for one step (only valid when user inputs numbers).
Position: Right side of screen.
(4)Name: This is used to move to next operation page or cursor right moving.

Icon:
Function: To move into next page; or it can move the cursor right for one step (only valid when user inputs
numbers). If cursor is at the very right side of screen, this key is invalid.
Position: Right side of screen.
(5)Name: Cursor up moving key

Icon:
Function: To move cursor one row up.
Note:
This key is used to check the last record in record menu. (e.g. the above record of current record. )
Position: Right side of screen.

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(6)Name: Cursor down moving key

Icon:
Function: To move cursor one row down.
Note:
This key is used to check the next record in record menu. (e.g. the below record of current record.)
Position: Right side of screen.
(7)Name: Cursor left moving key.

Icon:
Function: To move the cursor left for one digit. This key will only show on the screen which user could input
Figures.
Position: Right side of screen.
(8)Name: Cursor right moving key

Icon:
Function: To move the cursor right for one digit. This key will only show on the screen which user could input
Figures.
Position: Right side of screen.
(9)Name: Delete key

Icon:
Function: Delete the numbers in the position of cursor.
Position: Bottom of screen
(10)Name: Number key

Icon: 0 1 2 3 4 5 6 7 8 9
Function: Input corresponding numbers.
(11)Name: Printing key

Icon:
Function: Print the current test record showed on the screen.
Position: Right side of screen.
(12)Name: Submenu key

Icon:
Function: Press this key, it will show the content of submenu corresponding to the current menu.
(13)Name: Cycling option key

Icon:
Function: Press this key, the corresponding setup will be cycled with several internal options.
(14)Name: Confirm

Icon: Y
Function: Confirm or cancel the current option it means “Yes”. When you operate some important operation. (e.g.
save the changed initial value, analyzer will prompt to remind user to confirm this operation.)

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(15)Name: Cancel key

Icon: N
Function: Cancel the current operation, it means “no”. This key appears with Y on the same menu, press this
key, it means that user canceled the current operation.

3.3 Setup
3.3.1 Set Sequence Number
Press the key “No.” on the main screen (Figure 2-4-1(d)) to enter into its corresponding submenu (Figure 3-3-1):

Enter SEQ: 0143

7 8 9
4 5 6
1 2 3
0
Figure 3-3-1

Press number key to input sequence number. Press to confirm the modification and return to upper menu in

Figure 2-4-1(d); the system starts using the new sequence number. Press to cancel the modification and
back to main menu (2-4-1(d)). The system keeps primary sequence number.
The sequence number displayed on the screen is for next ready-to-test sample. The sequence number will
automatically plus one after each successful test for reagent strip. (Note: The sequence number does not include
STAT test; it sets serial numbers separately).

● Sample number cannot be set as 0.


● Sample number can be maximally input as 9999.
3.3.2 Set Date
Press the key “Menu” in the main menu(Figure 2-4-1(d)) to enter into “Menu” interface ( in Figure 3-3-2), Press

the key in front of “Set up” to enter into “Set option” in Figure 3-3-3, Press the key in front of
“Date”, screen shows as Figure 3-3-4:

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FUS strips

Maintenance

QC and Calibration

Test Memory

Set Up

Figure 3-3-2

Set Option

Date

Time

Printer-Internal

Language-English

Figure 3-3-3

Set Date

Date Format-YY MM DD

Figure 3-3-4
(1)Set date

Press the key in front of “Set Date” in Figure 3-3-4, screen shows as Figure 3-3-5:

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Input Date: yyyy -mm-dd


2010-11-20

7 8 9
4 5 6
1 2 3
0
Figure 3-3-5
The date “2010-11-20” showed on the top screen is the current date, operator could enter the relevant numbers by
pressing number keys to modify the date, or moving the cursor to the place need change to modify the date. Press

the key to confirm and return to upper menu. Press the key to quit and back to upper menu.
(2)Set date format

Press the key in front of “Date Format” in Figure 3-3-4, the date format switches according to the
following table.
Table 3-3-1

1 YY MM DD
2 MM DD YY
3 DD MM YY

3.3.3 Set Time

Press the key in front of “Time” in Figure 3-3-3, screen shows as Figure 3-3-6:

Input Time:
hh: mm: ss
08:00:00

7 8 9
4 5 6
1 2 3
0
Figure 3-3-6

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The time “08:00:00” showed on the top screen is current time. Operator could input relevant numbers by pressing
the number keys to modify the time, or moving the cursor to the place need change to modify the time. Press the

key to confirm the modification and return to upper menu; Press the key to quit and back to upper
menu.
3.3.4 Set Printer

Press the key in front of: “printer” in Figure 3-3-3, change the printer type according to the following table.
Table 3-3-2

1 Internal
2 External
3 None

“Internal” means the result will be printed out with internal thermal printer; “External” means the result will be
printed out with external printer connect with analyzer; “None” means the result will not be printed out.
3.3.5 Set Language

Press the key in front of “Language” in Figure 3-3-3, refer to Table 3-3-3 to change language setup.
Table 3-3-3

1 English
2 Spanish
3 Hungarian
4 Portuguese
5 Russian
6 Polish
7 Italian

3.3.6 Set Unit System

Press the key in Figure 3-3-3, the screen shows as Figure 3-3-7:

Set Option

Result Unit - SI

Plus System – ON

Abnormal Value - ON

Set Abnormal Value

Figure 3-3-7

Press the key in front of “Result unit”, select the unit according to the following table.

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Table 3-3-4

1 SI
2 Conventional
3 Plus System
4 DR200
5 DR800

The unit system can be selected as the following four types: international, routine, semiotic and DR200
when the analyzer incorporates FUS series Urine Analyzer. While unit system cannot be selected as DR800
because the communication format of DR800 is inconsistent with other unit system.
3.3.7 Plus System

Press the key in front of “Plus system” in Figure 3-3-7 to switch the “ON” and “OFF” of the system.
(1)When “Plus system” is “on”.
When “Result unit” is “Conventional”, the printed result is as Figure 3-3-8.
When “Result unit” is “SI”, the printed result is as Figure 3-3-9.
When “Result unit” is “Plus system”, the printed result is as Figure 3-3-10.

2005-11-03 11:40 26℃ 2005-11-03 11:40 26℃ 2005-11-03 11:40 26℃


MEAS No. 0011 MEAS No. 0011 MEAS No. 0011
ID ID ID
PORT No. 01-01 PORT No. 01-01 PORT No. 01-01
*UBG 3+ >=8mg/dL *UBG 3+ >=135umol/L *UBG 3+
*BIL 3+ >=6mg/dL *BIL 3+ >=103umol/L *BIL 3+
*KET 3+ 5mg/dL *KET +- 0.5mmol/L *KET +-
*BLD 2+ Ca80Ery/uL *BLD 2+ Ca80Ery/uL *BLD 2+
*PRO 3+ >=300mg/dL *PRO 3+ >=3.0g/L *PRO 3+
*NIT Pos *NIT Pos *NIT Pos
*LEU 3+ >=Ca500Leu/uL *LEU 3+ >=Ca500Leu/uL *LEU 3+
*GLU 1+ 100mg/dL *GLU 1+ 5.6mmol/L *GLU 1+
SG >=1.030 SG >=1.030 SG >=1.030
PH <=5.0 PH <=5.0 PH <=5.0
VC 25mg/dL VC >=5.7mmol/L VC >=5.7
Color colorless Color colorless Color colorless
Turbid clear Turbid clear Turbid clear

Figure 3-3-8 Figure 3-3-9 Figure 3-3-10


(2)When “Plus system” is “Off”;
When “Result unit” is “Conventional”, the printed result is as Figure 3-3-11;
When “Result unit” is “SI”, the printed result is as Figure 3-3-12;
When “Result unit” is “Plus system”, the printed result is as Figure 3-3-13.

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2005-11-03 11:40 26℃ 2005-11-03 11:40 26℃ 2005-11-03 11:40 26℃


MEAS No. 0011 MEAS No. 0011 MEAS No. 0011
ID ID ID
PORT No. 01-01 PORT No. 01-01 PORT No. 01-01
*UBG >=8mg/dL *UBG >=135umol/L UBG 3+
BIL 3+
*BIL >=6mg/dL *BIL >=103umol/L KET +-
*KET 5mg/dL *KET 0.5mmol/L BLD 2+
PRO 3+
*BLD Ca80Ery/uL *BLD Ca80Ery/uL NIT Pos
*PRO >=300mg/dL *PRO >=3.0g/L LEU 3+
GLU 1+
*NIT Pos *NIT Pos SG >=1.030
*LEU >=Ca500Leu/uL *LEU >=Ca500Leu/uL PH <=5.0
VC >=5.7
*GLU 100mg/dL *GLU 5.6mmol/L Color colorless
SG >=1.030 SG >=1.030 Turbid clear
PH <=5.0 PH <=5.0
VC 25mg/dL VC >=5.7mmol/L
Color colorless Color colorless
Turbid clear Turbid clear

Figure 3-3-11 Figure 3-3-12 Figure 3-3-10

3.3.8 Abnormal Value

Press the key in front of “Set Abnormal Value” in Figure 3-3-7 to switch “ON” and “OFF”.
When the testing value reaches or exceeds the critical value that set by operator, “*”will be marked before the
item. In Figure 3-3-8 to 3-3-12 when “Set Abnormal Value” is “Off”, there is no“*”in the printed test result in
Figure 3-3-13.
3.3.9 Set Abnormal Value

Press the key in front of “Set Abnormal Value” in Figure 3-3-7, screen shows as follows:

UBG 1+ 34μmol/L

BIL 1+ 17μmol/L

KET +- 0.5mmol/L

BLD +- Ca10 Ery/μL

Figure 3-3-14

Press the key in Figure 3-3-14 to set the protein, nitrite, leucocyte and glucose, screen shows as Figure
3-3-15:

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PRO Trace

NIT Pos

LEU +- Ca15Leu/uL

GLU 1+ 5.6mmol/L

Figure 3-3-15

Press the key in front of each item, the value switchs according to the following table:
Table 3-3-5
Name
Urobilinogen Bilirubin Ketone Blood Protein Nitrite Leucocyte Glucose
No.
1 17μmol/L 17μmol/L 0.5mmol/L Ca10Ery/μL Trace Pos Ca15Leu/μL 5.6 mmol/L

2 34μmol/L 51μmol/L 1.5mmol/L Ca25Ery/μL 0.3g/L Ca70Leu/μL 14 mmol/L

3 68μmol/L >=103μmol/L 3.9mmol/L Ca80Ery/μL 1.0g/L Ca125Leu/μL 28 mmol/L


>=56
4 >=135μmol/L >=7.8mmol/L >=Ca200Ery/μL >=3.0g/L >=Ca500Leu/μL
mmol/L

When one or some item of test result reaches or exceeds the set value of 3-3-14 and 3-3-15, “*” will be displayed
in front of the item when output result. As Figure 3-3-16 shows.
When one or some item of test result reaches or exceeds the set value of 3-3-14 and 3-3-15, but “*” is not
displayed in front of the item when output result. Set “Abnormal value mark-OFF” to be “Abnormal value
mark-ON” in Figure 3-3-7 (print report is taken H11-800 as example.)

2005-11-03 11:40 26℃


MEAS No. 0011
PORT No. 01-01
*UBG 1+ 34μmol/L
*BIL 1+ 17μmol/L
*KET +- 0.5mmol/L
*BLD +- Ca10Ery/uL
PRO Neg
NIT Neg
LEU Neg
GLU Neg
SG >=1.030
PH <=5.0
VC >=5.7mmol/L
Color colorless
Turbid clear

Figure 3-3-16

3.3.10 Set ID Number Display

Press the key in Figure 3-3-7, screen shows as Figure 3-3-17:

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Set Option

ID -ON

Rack Feed – Offline

Baud Rate -9600

PC Interface –ON

Figure 3-3-17

Press the key in front of “ID”, change the “ON” or “OFF” of ID in output result. If the “ID” is “OFF” no
bar code will be printed in tested result (Figure 3-3-16). If the “ID” is “ON”, then the printed result will show the
bar code (Figure 3-3-8 to 3-3-13).
3.3.11 Set Test Tube Rack Conveying Mode

Press the key in front of “Rack Feed” in Figure 3-3-17, it switches according the following table.
Table 3-3-6

1 Offline
2 Online

“Offline” means no connection to other analyzers.


“Online” means the analyzer can be connected to FUS Series urine sediment analyzer. The tube rack can be
transmitted to the sample conveyer of urine sediment analyzer directly for testing, and the data tested by urine
analyzer can be transmitted to urine sediment analyzer.

All analyzer factory settings are “offline” mode. The supplier’s authorization is needed to make the
analyzer and FUS Series urine analyzer online.
3.3.12 Set Baud Rate

Press the key in front of “Baud Rate” in Figure 3-3-17, baud rate switches according to following table.
Table 3-3-7

1 9600
2 4800
3 1200
4 19200

3.3.13 Set Computer Interface

Press the key in front of “PC Interface” in Figure 3-3-17 to switch the “ON” and “OFF”.
When the computer interface is “On”, analyzer could send data to computer through communication interface;
when the computer interface is “off”, analyzer does not send data to computer.

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3.3.14 Select Reagent Strip Type

Press the key in Figure 3-3-17, screen shows as follows:

Set Option

Strip Type –11 parameters

Use Default Parameters?

Set Scaler

Manufacturer Setup

Figure 3-3-18

Press the key in front of “Strip Type” in Figure 3-3-18, it switches according to the following table.
Table 3-3-8

1 12 MA PARAMETERS
2 11 PARAMETERS
3 10 PARAMETERS
4 11 MA PARAMETERS

The strip type has been set before leaving factory, and any change could be done after getting supplier’s
authorization.
3.3.15 Use Default Parameters

Press the key in front of “Use Default parameters” in Figure 3-3-18, screen shows as follows:

Use Default Parameters?

Y N

Figure 3-3-19

Press the key Y to confirm, all the inner parameters will recover to original setup and return to Figure 3-3-18;

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Press the key N to cancel.


After the setup, it returns to main menu, screen shows as Figure 3-3-20:

Confirm Save?

Y N

Figure 3-3-20

Press the key Y to confirm, press the key N to cancel.


3.3.16 Set Scaler

Press the key in front of “Set Scaler” in Figure 3-3-18, screen shows as Figure 3-3-21:

UBG
0700 0490 0340 0230

7 8 9
4 5 6
1 2 3
0
Figure 3-3-21

The Scaler has been set by manufacturer, please get supplier’s authorization if any change needed.
3.3.17 Manufacturer Setup

Press the key in front of “Manufacturer Setup” in Figure 3-3-18, screen shows as Figure 3-3-22:

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Please Input Password

7 8 9
4 5 6
1 2 3
0
Figure 3-3-22
User cannot use or change the setting has been set by the manufacture (for manufacturer use only).

Press the key to quit and return to upper menu.


3.3.18 Reagent Setting

Press the key before “Menu” in the main screen (figure 2-4-1(d)), the screen will display as the figure

3-3-2 shows. If press , you can switch between “H strips” and “FUS strips”:
(1) H strips: H10-800, H11-800, H11-800MA, H12-800MA.
(2) FUS strips: FUS-10, FUS-11, FUS-11MA, FUS-12MA.

Setup the strip series and strip types prior to testing.

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Chapter 4 Record Recall and Clearance

4.1 Data Recall

Press the key in front of “Test Memory” in Figure 3-3-2, screen shows as Figure 4-1-1:

Normal Result

Control Result

STAT Result

Delete Data

Figure 4-1-1
Operator can inquire Normal Result, Control Result and STAT Result, and could make record clearance
operation.
4.1.1 Normal Result

Press the key in front of “Normal result” in Figure 4-1-1, screen shows as Figure 4-1-2:

Recent Result

Specify Meas Date

Specify Meas No.

Specify Meas ID

Figure 4-1-2
(1)Recent result

Press the key in front of “Recent result” in Figure 4-1-2, screen shows the latest test record, as Figure 4-1-3
(take 11 reagent strip using for example to explain):

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2007-07-23 09:13 26℃


ID
Meas No. 0011 01-01
UBG
BIL Normal 3.4µmol/L
KET Neg
BLD Neg
PRO Neg
NIT Neg
* LEU Neg
GLU 2+ Ca125 Leu/µL
SG Neg
PH >=1.030
VC <=5.0
Color 0.6mmol/L
Turbid colorless
clear

Figure 4-1-3

Press the key to return to upper menu;

Press the key to show the former record of current one (the sequence number is the present result on screen
minus one);

Press the key to show the later record of current one (the sequence number is the present result on screen
plus one);

Press the key to print the current record;

Press the key , screen shows as Figure 4-1-4:

Enter ID:

7 8 9
4 5 6
1 2 3
0
Figure 4-1-4

a)Press the Figure keys to modify current ID No.; If there is capital letters in the ID No., please press key
in the right bottom corner to enter into capital letter interface shown as Figure 4-1-5:

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A B C D E F

G H I J K L

M N O P Q R

S T U V W X

Y Z

Figure 4-1-5
b)Press corresponding capital letters directly to input ID No.; If there is small letters in the ID No., please press

key in the right bottom corner to enter into small letter interface shown as Figure 4-1-6:

a b c d e f

g h i j k l

m n o p q r

s t u v w x

y z

Figure 4-1-6

c)Press corresponding small letters directly to input ID No.; Press key to confirm the modification and

return to upper menu; Press key to cancel the modification.


(2)Specify measuring date

Press the key in front of “specify Meas Date” in Figure 4-1-2, screen shows as Figure 4-1-7.

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Input Date yyyy -mm-dd


2007-08-20

7 8 9
4 5 6
1 2 3
0
Figure 4-1-7

Press the number key to check out the specific date, press to cancel the modification and return to upper
menu.
(3)Specify Meas No.

Press the key in front of “Specify Meas No.” in Figure 4-1-2, screen shows as Figure 4-1-8:

Enter SEQ:0000-0000

7 8 9
4 5 6
1 2 3
0

Figure 4-1-8

When first run of this program, the SEQ will show 0000-0000; if not, it shows the last SEQ with last time
operation.

Operators could input corresponding numbers to check up. Press the enter key to confirm the modification

screen shows as Figure 4-1-9; Press the key to cancel the checkup and back to upper menu. Take 11
reagent strip using for example to explain and screen shows as follows.

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2007-07-23 09:13 26℃


ID
Meas No. 0011 01-01
UBG
BIL Normal 3.4µmol/L
KET Neg
BLD Neg
PRO Neg
NIT Neg
* LEU Neg
GLU 2+ Ca125 Leu/µL
SG Neg
PH >=1.030
VC <=5.0
Color 0.6mmol/L
Turbid Colorless
clear

Figure 4-1-9

You can use batch printing in Figure 4-1-8 operation as:


User can input the first digit and the last digit of potential checking sample (the first digit must be less than the last

digit), press to confirm, then screen displays the record of input the first digit of sample, press key
to start batch printing. The range of printing is between the first digit and the last digit.
(4)Specify Meas ID

Press key in front of “Specify Meas ID” in Figure 4-1-2, screen shows as Figure 4-1-4.Input the potential

checking ID No. (please reference the steps in 4.1.1) press to confirm the checking, press to cancel
checking and back to upper menu.
4.1.2 Control Result

Press key in front of “Control Result” in Figure 4-1-1, screen shows as Figure 4-1-10:

Control Result-Neg

Control Result-Pos

Figure 4-1-10

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(1)Press key in front of “Control Result-Pos” in Figure 4-1-10, shown as Figure 4-1-11:

Recent Result

Specify Meas Date

Specify Meas No.

Specify Meas ID

Figure 4-1-11
Users could check positive QC results according to date, sequence number and ID No. as 4.1.1 shows specificly.

(2)Press key in front of “Control Result-Neg” in Figure 4-10, screen shows as Figure 4-1-11. User could
check negative QC results according to date, sequence number and ID No. Operation method shown as 4.1.1.

QC test result does not display the rack number.


4.1.3 STAT Result
Operation method is the same as Normal result in 4.1.1.

4.2 Delete Data

Press the key in front of “Delete data” in Figure 4-1-1, screen shows as follows:

Normal Result

Control Result

STAT Result

Delete All

Figure 4-2-1
(1)Delete normal result

Press the key in front of “normal result” in Figure 4-2-1, screen shows as follows:

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Confirm Delete?

Y N

Figure 4-2-2

Press the key Y , and system will clear the normal result and return to upper menu; Press the key N ,
system return to upper menu in execution of clearance.
(2)Delete control results

Press key in front of “Control Result” in Figure 4-2-1, screen shows as Figure 4-2-3:

Control Result-Neg

Control Result- Pos

Figure 4-2-3

a)Press key in front of “Control Result-Pos” in Figure 4-2-3, screen shows as Figure 4-2-2. Press key
Y to delete history record and return to upper menu; Press key N to cancel the delete operation and
return to upper menu.

b)Press key in front of “Control Result-Neg” in Figure 4-2-3, screen shows as Figure 4-2-2.Users could
delete negative QC record.
(3)Delete STAT result
The same as “Delete normal result”.
(4)Delete all
The same as “Delete normal result”.

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Chapter 5 QC and Calibration

5.1 Calibration Strip Test

● Please do not dip calibration strips into water or other liquid.


● Three calibration strips (two for 12 items, one 13 items) are prepared with analyzer.
● Please contact with supplier if the strip is contaminated or damaged, and do not continue to use it.
● In order to get the accurate result, calibration of analyzer every one or two weeks is recommended.
● Please open the front door and take the strips out after calibration, then keep the strips well.
5.1.1 Preparation before Calibration
(1)Please take out all the left strips in the sealed feeder and put them into bottle, then cap the bottle well.
(2)Put the calibration strip into the sealed feeder as the marked direction, the analyzer could calibrate.
5.1.2 Check Calibration

Press key “Menu” in main menu (Figure 2-4-1(d)) to enter into “Menu” interface (Figure 3-3-2). Press key
in front of “QC and Calibration” to enter into “set option”, shown as Figure 5-1-1:

Set Option

Check Calibration

Controls

Calibrate Refractometer

Calibrate Turbidimeter

Figure 5-1-1

Press the key in front of “Check Calibration”, and “Check Strip Testing…” will be displayed on the screen,
and the analyzer comes to calibrating status.
If it passed calibration, the test result is “Calibration OK”, or the result is “Calibration Not OK”.
If the calibration failed, please perform the calibration test again. Contact Dirui customer service dept or
distributor if it failed again.

5.2 Refractometer Calibration


5.2.1 Pre Calibration
(1)High specific gravity calibration liquid: pour 1.040 high specific gravity calibration liquid into the first tube.
(not lower than the mark on the rack.)
(2)Low specific gravity calibration liquid: pour distilled water into the second tube (not lower than the mark on
the rack.) as the low specific gravity calibration liquid.
(3)Place the high specific gravity liquid tube into the first position of tube rack and low specific gravity liquid into
the second position of the rack, and then place the rack on the right of the sample feeder.

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5.2.2 Start Calibration

In Figure 5-1-1, press key in front of “Calibrate Refractometer”, and the screen shows as below:

High SG
1.040

7 8 9
4 5 6
1 2 3
0
Figure 5-2-1
When the screen shows the high specific gravity value 1.040 as Figure 5-2-1 (High specific gravity calibration
value should be input as the given value in the Calibrator instructions). After inputting the high specific gravity

value, press key to enter the low specific gravity value input interface, shown as Figure 5-2-2:

Low SG
1.000

7 8 9
4 5 6
1 2 3
0
Figure 5-2-2

1.000 should be input as the low specific gravity calibration liquid value, then press key, and the analyzer
will calibrate the refractometer. If the calibration passed, the screen will show “calibration passed”, or it will show
“calibration failed”.

● Refractometer should be calibrated once a month. If calibration failed two times, please clean the
refractometer according to the instruction in the user manual. After cleaning, if the calibration still failed,
please contact the local supplier.
● If a wrong calibration value is input, the analyzer will show “Input Error”. User should input the correct
calibration value again.

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5.3 Turbidimeter Calibration


5.3.1 Pre Calibration
(1)High specific gravity calibration liquid: pour 400NTU high specific gravity calibration liquid into the first tube
(not lower than the mark on the rack).
(2)Low specific gravity calibration liquid: pour distilled water into the second tube as the low specific gravity
calibration liquid (not lower than the mark on the rack).
(3)Place the high specific gravity liquid tube into the first position of the tube rack and low specific gravity liquid
into the second position of the rack, and then place the rack on the right of the sample feeder.
5.3.2 Start Calibration

In Figure 5-1-1, press key in front of “Calibrate turbidimeter”. The screen shows Figure 5-3-1:

High Turbid Solution


400

7 8 9
4 5 6
1 2 3
0
Figure 5-3-1

Input 400 as the high turbidity value and press key to confirm (High turbidity calibration value should be
input as the given value in the instructions), then enter the low turbidity calibration value interface, shown as
Figure 5-3-2:

Low Turbid Solution


000

7 8 9
4 5 6
1 2 3
0
Figure 5-3-2

“000” should be input as the low turbidity value, then press key after input, and analyzer will start the

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calibration of the turbidimeter. If calibration passed, the screen will show “calibration passed”, or it will show
“calibration failed”.

● If the analyzer shows the warning message “calibrate turbidimeter”, please perform calibration as above
described. If calibration failed two times, please clean the turbidimeter according to the instructions in the
user manual. After cleaning, if the calibration still failed, please contact the local supplier.
● If a wrong calibration value is entered, the analyzer will show “Input Error”. User can input the correct
calibration value again.
● If turbidity is heavy turbidity, it will affect the color and SG testing values. In that case, the color and SG
values are just for reference. If “abnormal value” option is “ON”, the test result will be printed “*” mark
in front of turbidity and “!” mark will be printed in front of specific gravity and color.
● If analyzer does not install hardware of refractometer, turbidimeter and color sensor, it is no need to
perform SG Control measurement, turbidity tontrol measurement, color control measurement and
refractometer calibration, turbidimeter calibration.

5.4 Control Measurement


5.4.1 Positive, Negative Control Measurement
To make sure the accuracy of the test result, DIRUI positive and negative QC liquid of H-800 Urine Analyzer can
be used for QC test.
(1)Before everyday assays
(2)Replacing with a new bottle of strips
(3)Operator changes
(4)Query to test result occurs
5.4.1.1 Strips Preparation
There should be enough strips in the strip feeder.
5.4.1.2 QC Liquid Preparation
Prepare the QC liquid according the requirements in the QC instructions.
Inject QC liquid until over the mark line on the tube rack at least.
5.4.1.3 Control Test

Please put the control liquid tubes into the rack in order, and press key in front of “Controls” in Figure
5-1-1. The screen shows as Figure 5-4-1:

Run Control- Negative

Run Control- Positive

Run Control- Negative- Positive

Figure 5-4-1

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(1)Press the key in front of “Run Control-Positive” in Figure 5-4-1. The screen shows as Figure 5-4-2:

Control No. Pos 0005

Start

Figure 5-4-2

Press key in front of “Control No. Pos” in Figure 5-4-2. The screen shows as Figure 5-4-3:

Enter SEQ:0001

7 8 9
4 5 6
1 2 3
0
Figure 5-4-3

User could manually input a positive QC sequence number within the scope of 1~500. Press key to
confirm, and it is the sequence number for the current QC test.

Press key in front of “Start” in Figure 5-4-2. The screen shows as Figure 5-4-4:

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Measuring…

Stop

Figure 5-4-4
(2)Negative QC test: please refer to the operation method as 5.4.1.3(1) Run Control-Positive.
Test results will be printed out after the testing. Please refer to the target results in the instructions.

(3)Negative/Positive QC test: Press the key before “Run Control-Negative-Positive” (figure 5-4-1), the
screen will display as the figure below shows:

Control No.Neg 0001

Control No.Pos 0001

Start

Test order Control Negative Contr


ol-Positive

Figure 5-4-5
The Negative Control No. and Positive Control No. can be manually input.
Place two tubes, one is filled with Negative Control and the other Positive Control, into the tube rack, and then

press before “Start”, a test for Negative/Positive QC will be performed.


If the QC failed, please use control liquid of another lot number and perform the QC test again. If it stilled failed,
contact Dirui customer service dept or distributor.
5.4.2 SG Control Measurement
To make sure the accuracy of the test result, DIRUI specific gravity QC liquid can be used for QC test in the
following situations.
(1)One test for a month
(2)Query to test result
5.4.2.1 QC Liquid Preparation
Prepare the QC liquid according to the requirements in the QC instructions.
Inject QC liquid until over the mark line on the tube rack at least.

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5.4.2.2 SG Control Test

If there is refractometer installed, press the key in figure 5-4-1, the screen will show as the figure below:

Run Control- SG

Run Control- Turbid

Run Control- Color

Figure 5-4-6

Press key in front of “Run Control-SG” in Figure 5-4-6 as Figure 5-4-4 shows.
Test results will be printed out after the testing. Please refer to the target results in the instructions of Control-SG.
If the QC failed, please use control liquid of another lot number and perform the QC test again. If it stilled failed,
contact Dirui customer service dept or distributor.
5.4.3 Turbidity Control Measurement
The QC liquid preparation and test method are the same as 5.4.2. The Turbidity Control measurement should be
performed every month as a period. If there is any question to the test result, you can perform Control
measurement at any time.
5.4.4 Color Control Measurement
The QC liquid preparation and test method are the same as 5.4.2.The Turbidity Control measurement should be
performed every month as a period. If there is any question to the test result, you can perform Control
measurement at any time.

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Chapter 6 Conventional Test

● The sample volume should be not lower than scale mark on tube.
● Do not test the distilled water. The distilled water has lower electricity conductivity. If testing distilled
water, it may result that liquid sensor does not have sufficient conductivity, which may cause the analyzer
report warning of no sample.
● If the bubble level is higher than 5mm inside the testing sample, please wait until the bubble settled below
5mm to perform test.
● For avoiding being injured, operator should keep away from probe.
● Do not test ropy sample, it may block the probe.
● If there is some obvious urine blood sample, please place this sample to the last position of last tube rack.
After analyzer automatically absorbed the urine blood sample, press the “stop” button on screen, then, the
analyzer will automatically cleaned. After that, please proceed to the next normal testing.
● Waste tank should be placed on ground to keep it vertically and keep the waste liquid flowing smoothly.

6.1 Preparation before Testing


6.1.1 Reagent Strip
Reagent strips absorb urine easily, allowing reagent strip pads to react with urine sufficiently. This improves test
precision and shortens test time. However, reagent strips get damp easily, a common problem for all reagent strips.
Damp reagent strips may affect test accuracy, and even lead to incorrect test results. To prevent reagent strips
from getting damp, follow the operation below:
(1)Desiccant and Strip Placement
Open the reagent bottle, and put reagent strips in the sealed chamber according to the direction in Figure 6-1-1.
Take out the desiccant from the reagent strip bottle and put it in the desiccant box or the upper cover. One bag of
desiccant should be placed as one bottle of strips is placed. Four bags of desiccant can be placed in the sealed strip
tank. Two in the desiccant box; two in the upper cover of the sealed chamber.

● The order of placing desiccant is decided by the user.


● Take out desiccant inside when opening a bottle of reagent strips. Place the desiccant in the upper cover
and the desiccant box of the sealed strip tank in order. Replace the original desiccant in turn.
● There is a bag of desiccant in each reagent strip bottle. 4 bags of desiccant can be placed in the sealed
chamber.
● After placing strips, close the cover of the sealed chamber.

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Desiccant

Upper cover of sealed


chamber

Desiccant box (2 bags of desiccant


inside)

Black pad of reagent strip

Sealed chamber (strips


inside)

Figure 6-1-1
(2)Reagent Strip Storage
The capacity of the strip tank is 200 pieces. Strips and desiccant cannot be laid in the tank for more than 24 hours
accumulatively, so as to prevent the strips from getting damp, and ensure test accuracy. Put the remaining strips
and desiccant back in the strip bottle every day after work, and close the lid well.
If the quantity of tests is small, one bottle of strips can be placed in the sealed chamber in several times. The
remaining strips can be stored in the strip bottle, and close the lid well.
Do not expose strips and desiccant to the air for long.

● The reagent strips applicable to the analyzer should be Dirui reagent strips for urinalysis (model:
H10-800, H11-800, H11-800MA, and H12-800MA) and FUS reagent strips for urinalysis (model: FUS-10,
FUS-11MA, and FUS-12MA). To ensure accurate test results, do not use strips of other models.
● Check strip types before use. Strip selection function should be in use after receiving the supplier’s
authorization.
6.1.2 Testing Tube Requirement
(1)The testing tube diameter should be Φ15, and length less than or equal to 100 mm disposable plastic tubes.
Make sure that the testing tube height do not over pass the analyzer’s left front door lower edge. (Please check the
Figure 6-1-2.)
(2)The open end of test tube must be regular, and no deformity is allowed.

Figure 6-1-2

6.1.3 Barcode Pasting Requirement


(1)Barcode types: CODE39, CODE93, CODE128, CODE bar, Cross25.

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(2)Barcode size: The printed edge of barcode should not be less than 12mm, in order to avoid any unreadable
situation when the tube is turning (Figure 6-1-3).The Digital number of barcode should be more than 4 but less
than 15;
(3)The width of start blank and finish blank should be no less than 3mm.

Barcode width

Start blank Finish blank

Barcode effective length

Figure 6-1-3
(4)Barcode sticker requirement:
a)Barcode should be pasted flat;
b)Barcode should be pasted to the correct position (the lower edge of barcode shall not pass the mark of rack
edge), in order to get readable data (Figure 6-1-4) When the test tube stored in the rack, make sure that all the
barcode labels could be viewed in front vertically;
c)When barcode is CODE39 small letter, the ID result shows on screen and printing would be corresponding
capital letter after “+”; when check the result, it cannot be input “+”, thus, this result could only be checked by
SEQ, not by ID.
Example: ID number is 36Fa, the corresponding result is 36F+A, “+” takes one digit.

Figure 6-1-4

6.1.4 How to Use Cleaning Liquid


Please pour the condensed cleaning liquid into the 10L cleaning liquid tank which prepared with analyzer. Then,
use the distilled water to clean the cleaning liquid bottle and pour the water into tank. After that, please fill up the
10L tank with distilled water until the marker on tank. Stir evenly before use.

● Each bucket of cleaning liquid could be used for 2800 strips under consecutive testing situation.
● Please use the cleaning liquid manufactured by Dirui. The company is not responsible for any inaccurate
results because of use of the cleaning liquid manufactured by other companies.
6.1.5 Check Cleaning Tank, Waste Liquid Tank and Thermal Printer
(1)Cleaning liquid tank: Make sure there is enough cleaning liquid.
(2)Waste liquid tank: Accurately install this tank.

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For waste liquid disposal, refer to section 7.14.


(3)Thermal printer paper: Open the printer cover to check out if there is any paper. If the printing paper shows
pink color, it means that the paper is going to be finished. Please change a new roll.
6.1.6 Urine Sample
(1)Paste barcode tag on the tube (Figure 6-1-4).
(2)Inpour urine sample: Inpour urine sample into test tube with no less than the marker on tube.
(3)Place the test tube with urine sample in the rack. Please insert the test tubes into the bottom of tube rack
vertically.
(4)Tube Rack Placement: Place the tube rack on the right of the sample feeder (right side of the STAT port), as
Figure 6-1-5 shows.

Figure 6-1-5
(5)Cautions about urine sample
a)Before testing, make sure the urine sample is mixed well, but do not use centrifugal analyzer, or it will affect
the sensitivity of testing result.
b)Please use fresh urine sample. If no test performed after one hour of urine sample collected, please seal the
urine sample and refrigerate. Please restore the samples to room temperature before assay.
c)Please do not add preservative, disinfector or detergent.
d)Keep away from direct sunshine.
e)If urine sample contains V.C, it may affect the result to be lower than the true value.

6.2 Test
After self-testing, screen shows as Figure 6-2-1:

H12-800MA

No. 0291

ID 0120

Menu

STAT
V
Start 26℃ 2010-11-20 14:46

Figure 6-2-1
In the Figure, “2010-11-20 14:46” and “26℃” are current date, time and temperature.

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6.2.1 Conventional Test Operation


6.2.1.1 Internal Barcode Routine Test

Conventional test: Place the test tube rack on the right of the sample feeder, and then press the key in front
of “Start” in Figure 6-2-1, the analyzer will begin test and print out the record automatically.
6.2.1.2 External Barcode Routine Test
Put the tube rack on the conveyer, Press “ID” key in Figure 6-2-1, screen shows as Figure 6-2-2:

*0291
0292
0293
0294
0295
0296
0297
0298
0299
0300
0301
0302
0303
0304
0305
0306
0307
0308
0309
0310

Figure 6-2-2

Meanwhile, test sample sequence No. is at the left side, manual input is needed for the No. with“*”. Press

key, key to move cursor to select the desired ID sample No. needed manual input, and press key to
switch into next page.

(1)Input ID No. manually: Press when the cursor moves to the desired No. as Figure 6-2-3 shows.

Input ID:

7 8 9
4 5 6
1 2 3
0
Figure 6-2-3

Input ID. Press key at the right corner of bottom to switch to the capital letter interface if there is capital

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letter in ID as Figure 6-2-4 shows.

A B C D E F

G H I J K L

M N O P Q R

S T U V W X

Y Z

Figure 6-2-4

Directly input ID corresponding small letters; If there is small letter in ID, press key at the right corner of
bottom to enter into small letter interface as Figure 6-2-5 shows.

a b c d e f

g h i j k l

m n o p q r

s t u v w x

y z

Figure 6-2-5

Directly input ID corresponding small letters; press to confirm to return to upper menu. Meanwhile, the
cursor will stop at next sample No. so that operator can continue to input next sample ID No.

If ID needs to be modified manually, move the cursor to the No. selected in the Figure 6-2-2, and press to

enter Figure 6-2-3 interface to reinput ID in Figure 6-2-3. Press to confirm if no No. is needed, (delete
origin ID No.)

If the original ID No. need to be deleted. Move the cursor to the selected sample No. in Figure 6-2-3, press ,

and press to delete the original ID No.

Press to cancel ID setup.


(2)Input ID No. by scanning: Use the external barcode reader to scan the barcode, the scanned barcode will be
displayed behind the corresponding sample No. The interface will turn page automatically for continuous

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scanning. After input of ID, press to return main menu, and press “Start” to test.

Manually, 100 test sample ID No. are available before test, which is displayed on five pages, 20 ones for one
page.
6.2.1.3 The Change of Sample No. in the Process of Testing

After clicking “start”, if the probe is not in the rinse status and the in front of “No.” is not selected, the next
sample No. can be changed.
6.2.2 STAT Test Operation
For STAT sample inserts to a routine test, testing method is as follows:
Infuse urine sample into a test tube then insert the tube into STAT stand of the sample feeder. Push the stand (as
per arrow direction) to locked place (Figure 6-2-6).

Figure 6-2-6

Press the key in front of “STAT” in Figure 6-2-1, screen shows as Figure 6-2-7:

No. 0015

Start

Cancel

ID

Figure 6-2-7
Operator could input serial number (within the scope of 1-5000) or ID number of the STAT sample to begin or
cancel the test.
(1)Input STAT number

Press the key in front of “No.” in Figure 6-2-7, screen shows as Figure 3-3-1. Operation method is as 3.3.1
sequence number setup.
(2)Input ID number

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Press key in front of “ID” in Figure 6-2-7, you can manually input sample ID number, the input method is
the same as “ID recall” in Chapter 4, 4.1.1.
(3)Start

Push the STAT rack to locked place and press the key “ ” in front of “Start” in Figure 6-2-7, shows as Figure
6-2-8:

Measuring…

Stop

Figure 6-2-8
Single STAT test begins, After testing, it will print out the record automatically.
(4)Cancel

Press the key in front of “Cancel” in Figure 6-2-8 to cancel the test of single STAT sample and return to
main menu (Figure 6-2-1).
After the test, pull back the STAT stand; after moving the STAT stand from the locking position, remove the tube.
After the STAT test, it will return to conventional tests.
6.2.3 Note during Test Processing
(1)Do not pull back STAT port directly, for fear it may damage the port.
(2)Do not move the tube rack during the test, for fear it may disturb the test sequence.
(3)Do not close to probe during the test, for fear being injured.
(4)If the washing liquid being used up during the test, the analyzer will display “Please add washing liquid” and
stop testing. Please add more washing liquid into the tank. Press the key “Enter” to go back to the main menu,
then press “Start” to retest.
(5)If press the key “Stop” during the test, analyzer will stop after testing the dipped strips. After stop, the rack will
automatically return to initial position.
(6)Strip should be placed according to the direction marked on the feeder, or strip will block the strip feeder when
the direction is wrong, analyzer will not operate normally.
(7)Strip should be placed flatly in the feeder, or it will block the operation. If there is any strip blocking during
operation, please open the feeder cover and re-place strips in feeder to continue test.
(8)When the solid precipitation occurs in the sample for visual, artificial mixing is recommended.

There is 1% occasion that strip may block the feeder, please remove that strip; the analyzer will operate
normal again.

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Chapter 7 Analyzer Maintenance

● Urine has potential infectivity. Take protective action while cleaning.


● Dispose of waste strips and samples according to clinical laboratory rules.
● Don’t spill water, urine samples and other liquid over the mechanical parts or electrical parts of the
analyzer, so as to avoid damaging it.
● While working, the operator needs to take protective action, wearing protective gloves and putting on
working clothes to avoid being infected by contaminated liquid. In case of contact with contaminated liquid,
wash with water and perform sterilization immediately.
● If the accessories used by the analyzer is not manufactured or recommended by the manufacturer, or the
analyzer is not used in the manner specified by the manufacturer, the protection offered by the analyzer
may be weakened.
● During cleaning and maintenance, failure of spare parts holding liquid may lead to danger.

7.1 The Required in Maintenance


The required in maintenance: brush, absorbent cotton, protective gloves, distilled water.

7.2 Cleaning of the Reagent Strip Feeder


The analyzer can reach 1000 tests, and “Please clean strip feeder” hint will be displayed on the screen after test,
and press “Confirm” key, and bumming will be heard. The hint “Please clean board” pops up on the screen, and
press “Confirm” on the screen to return to menu.
When hint “Please clean strip feeder” pops up, clean it as following steps:
(1)Open the cover of the feeder.
(2)Take out the remaining reagent strips, place them in a clean and dry reagent strip bottle, and seal the bottle
well.
(3)Clean the inner sides of the feeder with a brush, and make the wheel clean (Figure 7-2-3).
(4)Close the cover of the strip feeder well.
(5)Open the upper right cover (Figure 7-2-1), then pull out the baffle on the right (Figure 7-2-1) and lay down the
feeder (Figure 7-2-2).
(6)Clean the wheel grooves with a brush, and make sure they are clean (Figure 7-2-4).
(7)Set the strip feeder and right baffle upright, and close the strip feeder cover well.

1 cover

Strip feeder

2 baffle

Figure 7-2-1 Figure 7-2-2

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wheel
groove

Figure 7-2-3 Figure 7-2-4

7.3 Clean the Waste Box


The waste box should be cleaned daily.
(1)The capacity of waste box is 500 strips.
(2)Urine has potential infectivity; protective measures should be taken when cleaning up.
(3)Please dispose the waste strips according to the clinical laboratorial regulation.
Cleaning method:
(1)Dispose the reagent strips in waste strip box.
(2)Using water to wash waste box.
(3)Clean the box and dry it.
(4)Disinfect the waste box.
(5)Install the waste strip box (Figure 7-3-1).

Figure 7-3-1

For waste strip disposal refer to section 7.14.

7.4 Clean Waste Solution Tank


Waste solution tank should be cleaned weekly.
(1)Dump the waste solution after everyday test or when the tank is full.
(2)Urine has potential infectivity; protective measures should be taken when cleaning up.
(3)Please dispose the waste solution according to the clinical laboratorial regulation.

For waste liquid disposal refer to section 7.14.

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7.5 Clean Fiber Optic Sensor Mirror


Barcode reader scan window

Fiber Optic Sensor mirror

Figure 7-5-1
Fiber Optic Sensor should be cleaned weekly in order to avoid the miss-reading result caused by interfacial dust
on it.
Clean the Fiber Optic sensor reflective mirror with absorbent cotton, otherwise the reflective mirror may cause
miss-reading. (Refer to Figure 7-5-1)

7.6 Clean Barcode Reader


Barcode reader scan window should be cleaned weekly in order to avoid the miss-reading or non-reading result
caused by interfacial contamination or dust on it.
Clean the barcode reader scan window with absorbent cotton, otherwise the barcode reader may cause
miss-reading. (Refer to Figure 7-5-1)

The analyzer uses a laser barcode reader. Don’t stare at the scan window of the barcode reader when
power on.

7.7 Replace Injector


When the injector runs for more than 500000 times, the alarm prompt will pop up, shown as Figure 7-7-1:

Figure 7-7-1
For ensuring accurate sample dripping, please replace the injector properly.

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Injector

Figure 7-7-2

Press key after replacing injector, the running time of injector will be zero cleared. When the injector runs

for more than 500000 times once again, it will alarm. Click key at the upper right corner to exit. But
when conducting test, the analyzer will still alarm.

7.8 Clean the Worktable Panel and Stepping Gear Panel

Press key in front of “Menu” in main menu when a prompt “Please rinse the panel” pops up and press
“Confirm” to return to main interface, screen shows as Figure 7-8-1:

FUS strips

Maintenance

QC and Calibration

Test Memory

Set Up

Figure 7-8-1

Press key in front of “Maintenance” in Figure 7-8-1, screen shows as Figure 7-8-2:

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Set Option

Clean Work Table

Wash Refractometer Turbidimeter

Figure 7-8-2

Press key in front of “Clean Work Table” in Figure 7-8-2; analyzer is under status of cleaning. Open the
left door, stepping gear panel automatically move up to highest point and probe runs to the other side far away
from operator. Clean worktable and stepping gear panel with absorbent cotton and water then dry them.
Mainly clean these 3 reinforcing bars.

Figure 7-8-3

Do not use hard tools such as hard brush to scrub the work table to avoid affecting its service life.

7.9 Cleaning Refractometer and Turbidimeter


Refractometer and Turbidimeter should be cleaned monthly or analyzer has alarm prompt.
Pour refractometer and turbidimeter cleaning liquid into the supplied tube, no less than 8mL, then, put this tube

into STAT position, then press key in Figure 7-8-2, the cleaning starts as shown:

Washing……

Stop

Figure 7-9-1

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● Clean the refractometer and turbidimeter once every month.


● Every time performing the cleaning program, analyzer will clean refractometer and turbidimeter three
times. Thus, the cleaning liquid should be no less than 8mL.
● Please use the cleaning liquid for refractometer and turbidimeter manufactured by Dirui. The company
is not responsible for any inaccurate results because of use of cleaning liquid of other companies.
● Every time start analyzer, it will self check refractometer and turbidimeter. If the blank liquid value is
out of range, the analyzer will be warning. Please clean the refractometer and turbidimeter. If the blank
value is still out of range after three times cleaning, please absorb cleaning liquid into refractometer and
turbidimeter to dip in 30 minutes, and then start cleaning program. If it is still out of range, please contact
supplier.

7.10 Rinse Pipeline


Rinse pipeline should be cleaned monthly or analyzer has alarm prompt.

Please press in front of “Maintenance” in Figure 7-8-1 in term of no refractometer, turbidimeter and color
sensor prepared with the analyzer and the screen will show as Figure 7-10-1.

Setup

Rinse panel

Rinse pipeline

Figure 7-10-1
Inpour the cleaning liquid of the detergent container with no less than 8mL into the cuvette, and insert it into

STAT port, and then press key in front of “Rinse pipeline” to get pipeline and probe rinsed after the
complete placement of the cuvette.

7.11 Wearing Parts Replacement


(1)Change the soft rope and the plastic axletree.

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Plastic axletree (total 9) Vertical soft rope

Horizontal soft rope

Figure 7-11-1
The nine plastic axletrees of vertical, horizontal and driving soft rope used by the analyzer are wearing parts, so
their elasticity will be reduced for long-time use and abrasion, and plastic axletree will be abrased. Replacement
of the vertical, horizontal soft rope and the nine plastic axletrees should be implemented once every 2 years in
order to avoid the measuring value inaccuracy caused by decrease of rope elasticity.
(2)Change the filter of cleaning liquid.

Filter

Figure 7-11-2
To avoid the filter of cleaning liquid from being blocked due to long-turn use, 2 more filters are prepared with the
analyzer for the convenience of its changing, and replacing it every 6 months is advised.

7.12 Maintenance before stopping use of analyzer


Before stopping use due to repair or treatment, the following should be performed for the analyzer:
(1)Take out the remaining strips from the strip feeder, put them in a clean, dry strip bottle, and tighten the cap
well.
(2)Take out the waste box, discard the strips in the box, and wash it with water and sterilize it. For detailed
operation, refer to 7.3.
(3)Dump the waste liquid in the waste tank. Take protective action while dumping it.
(4)Clean the worktable and stepping board according to 7.8.
(5)Clean the refractometer and turbidimeter according to 7.9.
(6)Clean the pipeline according to 7.10.
(7)Remove the cleaning liquid pipe from the cleaning liquid tank. Perform power on and off for 3 to 4 times to
empty the pipeline.

7.13 Analyzer cleaning


To keep the analyzer clean and tidy, the surface should be cleaned regularly. Use moistened soft cloth or gauze to

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wipe the surface. A small amount of 75% alcohol can be used when necessary. However, organic solvent cannot
be used to avoid destroying the shell.
The operator must pay attention to the following matters:
(1)If dangerous substances leak onto the surface or into the instrument, appropriate sterilization should be
performed. (soft cloth with a small amount of 75% alcohol can used for wiping and disinfection)
(2)Don’t use detergent or disinfectant which will react with the spare parts or the materials contained in the
instrument to cause danger.
(3)Consult the manufacturer or distributor about any questions about the compatibility between disinfectant or
detergent and the spare parts or the materials contained in the instrument.

7.14 Waste treatment


The analyzer while working will produce used disposable test tubes, waste strips, waste samples, and other waste
materials.
According to the state laws and regulations, wastes must be sterilized:
(1)The used disposable test tubes and waste strips should be stored in the container with the mark of pollutant, and
then autoclaved or incinerated.
(2)The remaining urine samples may contain infectious substances such as bacteria and viruses. To avoid
contamination of the environment, proceed as follows: put 100mL of 10g/L peroxyacetic acid or an appropriate
amount of bleaching powder in a large container (such as plastic bucket, ceramic pool, etc.) and then pour the
remaining samples and wastes into the container. Before discharge, they should be mixed and sterilized for more
than 1 hour.

The risk of biological and chemical contamination of the waste discharged from the analyzer should be
handled as required.

7.15 Handling of scraped analyzer


Expired instruments cannot be discarded at will. They should be taken back and treated by the manufacturer.

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Chapter 8 Transportation and Storage

8.1 Transportation
The detailed transportation requirements are governed by the contract. Avoid hard shock and pressure during
transportation, and place the analyzer gently.

8.2 Storage
The analyzer should be stored in an indoor place which is clean, free from corrosive gas, with good ventilation.
The ambient temperature ranges within -40℃~50℃, and relative humidity 80% or less.

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Appendix A Manufacturer’s Warranty


Dear users:
Thank you for purchasing H Series Urine Analyzer. We would like to offer you the following service:
(1)Technical consultations are provided at any time.
(2)Free of charge maintenance within one year after purchase.
(3)Maintenance will be charged in the following conditions:
a)Products that exceed the guaranty period.
b)Damage that is caused by accidental factor or improper use.
c)Damage that is caused by your own repair without our company’s permission.

If you need any technical support, please contact us according to the following address and telephone:
Register/Manufacturer: DIRUI INDUSTRIAL CO., LTD.
Register/Manufacturer Address:
95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of
China
Headquarters Address:
3333 Yiju Street, New & High Tech. Development Zone, Changchun, Jilin 130103, the People’s Republic of
China
Factory Address:
95 Yunhe Street, New & High Tech. Development Zone, Changchun, Jilin 130012, the People’s Republic of
China
Tel: 400 811 6695, 400 811 6605
Website: http://www.dirui.com.cn
E-mail: dirui@dirui.com.cn
Telephone for complaint: +86(431)81935326 +86(431)85177245
Fax: +86(431)85173354

After-Sale Service From: DIRUI INDUSTRIAL CO., LTD.


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: +86(431)85100405
Domestic customer service e-mail: service.ch@dirui.com.cn

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Appendix B Computer Connection


Through RS-232 standard interface port, the analyzer is connected with computer. Communication protocol
shows as follows:
Baud rate 9600, 4800, 1200, 19200 optional
Data bit 8
Stop bit 1
Calibration none
Hardware handle none
Start character 02H
Single byte space 20H
Double byte space 40H
Newline character 0DH0AH
Ending character 03H

The connection between the analyzer and computer:


computer analyzer

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ID“ON” barcode reader communication format (International unit, Routine unit, Semiotic system)
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 A L B SP × × × × × × × × × × × × × × × × CR LF

SP N I T SP × × × × × × × × × × × × × × × × CR LF

SP L E U SP × × × × × × × × × × × × × × × × CR LF

SP G L U SP × × × × × × × × × × × × × × × × CR LF

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

SP P H SP SP × × × × × × × × × × × × × × × × CR LF
SP V C SP SP × × × × × × × × × × × × × × × × CR LF
SP C a SP SP × × × × × × × × × × × × × × × × CR LF
SP A : C SP × × × × × × × × × × × × × × × × CR LF
SP(!) C o l o r SP SP : × × × × × × CR LF
SP(*) C l a r i t y : × × × × × × × × × CR LF
CR LF
ETX

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ID“OFF” barcode reader communication format (International unit, Routine unit, Semiotic system)
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 A L B SP × × × × × × × × × × × × × × × × CR LF

SP N I T SP × × × × × × × × × × × × × × × × CR LF

SP L E U SP × × × × × × × × × × × × × × × × CR LF

SP G L U SP × × × × × × × × × × × × × × × × CR LF

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

SP P H SP SP × × × × × × × × × × × × × × × × CR LF
SP V C SP SP × × × × × × × × × × × × × × × × CR LF
SP C a SP SP × × × × × × × × × × × × × × × × CR LF
SP A : C SP × × × × × × × × × × × × × × × × CR LF
SP(!) C o l o r SP SP : × × × × × × CR LF
SP(*) C l a r i t y : × × × × × × × × × CR LF
CR LF
ETX

Note:
When 12MA in strip option is selected, for the test items, please refer to the following table. When 10 items,
11Vc or 11MA is selected, the lines of corresponding test items will not be presented.

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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:
SP(*)---SP OR *
STX=0X02 CR=0X0D LF=0X0A
SP=0X20 ETX=0X03 X=ASCII character

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Appendix C Output Value of H-800 Urine Analyzer


Routine unit system International unit system
Item Ab. Symbolic system
“+”system on “+” system off “+” system on “+” system 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
1+ 2 mg/dL 2 mg/dL 1+ 34 μmol/L 34 μmol/L 1+
Urobilinogen UBG
2+ 4 mg/dL 4 mg/dL 2+ 68 μmol/L 68 μmol/L 2+
3+ >=8 mg/dL >=8 mg/dL 3+ >=135 >=135 μmol/L 3+
μmol/L
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 >=103 μmol/L 3+
μmol/L
Neg Neg Neg Neg Neg
+- 5 mg/dL 5 mg/dL +- 0.5 mmol/L 0.5 mmol/L +-
1+ 15 mg/dL 15 mg/dL 1+ 1.5 mmol/L 1.5 mmol/L 1+
Ketone KET
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 >=7.8 mmol/L 3+
mmol/L
10 mg/dL 10 mg/dL 0.9 mmol/L 0.9 mmol/L 0.9
50 mg/dL 50 mg/dL 4.4 mmol/L 4.4 mmol/L 4.4
Creatinine CRE 100 mg/dL 100 mg/dL 8.8 mmol/L 8.8 mmol/L 8.8
200 mg/dL 200 mg/dL 17.7 mmol/L 17.7 mmol/L 17.7
300 mg/dL 300 mg/dL 26.5 mmol/L 26.5 mmol/L 26.5
Neg Neg Neg Neg Neg
+- Ca10 Ery/μL Ca10 Ery/μL +- Ca10 Ery/μL Ca10 Ery/μL +-
1+ Ca25 Ery/μL Ca25 Ery/μL 1+ Ca25 Ery/μL Ca25 Ery/μL 1+
Blood BLD
2+ Ca80 Ery/μL Ca80 Ery/μL 2+ Ca80 Ery/μL Ca80 Ery/μL 2+
3+ >= Ca200 >= Ca200 3+ >= Ca200 >= Ca200 3+
Ery/μL Ery/μL Ery/μL Ery/μL
Neg Neg Neg Neg Neg
Trace Trace Trace Trace Trace Trace Trace
1+ 30 30 mg/dL 1+ 0.3 g/L 0.3 g/L 1+
Protein PRO 2+ mg/dL 100 mg/dL 2+ 1.0 g/L 1.0 g/L 2+
3+ 100 mg/dL >=300 mg/dL 3+ >=3.0 g/L >=3.0 g/L 3+
>=300
mg/dL
10 mg/L 10 mg/L 10 mg/L 10 mg/L 10
MAL 30 mg/L 30 mg/L 30 mg/L 30 mg/L 30
Microalbumin
B 80 mg/L 80 mg/L 80 mg/L 80 mg/L 80
150 mg/L 150 mg/L 150 mg/L 150 mg/L 150
Neg Neg Neg Neg Neg
Nitrite NIT
Pos Pos Pos Pos Pos
Neg Neg Neg Neg Neg Neg Neg
+- Ca15 Leu/μL Ca15 Leu/μL +- Ca15 Leu/μL Ca15 Leu/μL +-
1+ Ca70 Leu/μL Ca70 Leu/μL 1+ Ca70 Leu/μL Ca70 Leu/μL 1+
Leukocytes LEU 2+ Ca125 Leu/μL Ca125 Leu/μL 2+ Ca125 Ca125 Leu/μL 2+
3+ >=Ca500 Leu/μL >=Ca500 3+ Leu/μL >=Ca500 3+
Leu/μL >=Ca500 Leu/μL
Leu/μL
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+
Specific
SG 1.000~1.050 1.000~1.050 1.000~1.050 1.000~1.050 1.000~1.050
Gravity

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Routine unit system International unit system


Item Ab. Symbolic system
“+”system on “+” system off “+” system on “+” system off
<=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 mmol/L
0 mg/dl 0 mmol/L 0
10 mg/dl 0.6 mmol/L
10 mg/dl 0.6 mmol/L 0.6
25 mg/dL 1.4 mmol/L
VC VC 25 mg/dL 1.4 mmol/L 1.4
50 mg/dL 2.8 mmol/L
50 mg/dL 2.8 mmol/L 2.8
>=100 mg/dL >=5.7 mmol/L
>=100 mg/dL >=5.7 mmol/L >=5.7

<=4mg/dL <=4mg/dL <=1.0 mmol/L <=1.0 mmol/L <=1.0


10mg/dL 10mg/dL 2.5 mmol/L 2.5 mmol/L 2.5
Calciuresis Ca 20mg/dL 20mg/dL 5.0 mmol/L 5.0 mmol/L 5.0
30mg/dL 30mg/dL 7.5 mmol/L 7.5 mmol/L 7.5
>=40 mg/dL >=40 mg/dL >=10.0l mmol/L >=10.0 mmol/L >=10.0
<3.4mg/mmol <3.4 Normal
<30mg/g <30mg/g <3.4mg/mmol
Normal
Normal Normal Normal
3.4-33.9 3.4-33.9
30-300 mg/g 30-300 mg/g 3.4-33.9 mg/mmol
A:C mg/mmol Abnormal
Abnormal Abnormal Abnormal
Abnormal >33.9
>300 mg/g >300 mg/g >33.9 mg/mmol
>33.9 mg/mmol High
High abnormal High abnormal High abnormal
High abnormal abnormal
colorless colorless colorless colorless colorless
dark red dark red dark red dark red dark red
red red red red red
light red light red light red light red light red
blue blue blue blue blue
dark blue dark blue dark blue dark blue dark blue
green green green green green
dark green dark green dark green dark green dark green
yellow yellow yellow yellow yellow
Color
dark yellow dark yellow dark yellow dark yellow dark yellow
light yellow light yellow light yellow light yellow light yellow
brown brown brown brown brown
dark brown dark brown dark brown dark brown dark brown
orange orange orange orange orange
dark orange dark orange dark orange dark orange dark orange
purple purple purple purple purple
dark purple dark purple dark purple dark purple dark purple
others others others others others
clear clear clear clear clear
Turbidity slight cloudy slight cloudy slight cloudy slight cloudy slight cloudy
heavy cloudy heavy cloudy heavy cloudy heavy cloudy heavy cloudy

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Appendix D Malfunction Information List

No. Malfunction indication Solutions


Communication error of strip
1 Check whether this is caused by the loosen cable and pins of the strip feeder.
feeder
2 Please add washing liquid Add in more washing liquid, press “start” to retest.
Incorrect position of the test tube Reset test tube rack and press “start”. This is usually caused by late placement
3
rack of tube rack.
Communication error of tube
4 Repower up the analyzer.
rack transmission plate
1. Check whether the direction of the placed strip is right or not. Reset the
strips comply with the indication mark.
2. Check whether there is a strip or test pad blocked in the feeder.
5 Strip feeder stuck
3. Check whether the strips placement is in order or not.
4. 1% strip blocking is normal; take out the blocked strip, and the analyzer
will start normally.
1. Clear the worktable panel and gear panel, make sure the smoothness of the
Incorrect position of strips plate.
6
(reporting will print “strip slant”)
2. Check the strip type.
7 Waste strip box is full Clear up the waste box.
1. Check whether there is air bubble in the hydraulic pressure tube, whether
the tube is leaking or any visual sundries like gore exists in the urine sample.
Replace airproof loop or tube tie-in.
2. Make sure the sample top level is over the mark on the rack
8 Incorrect solution dripping
3. Make sure using the specialized washing liquid.
4. Check whether the probe is blocked.
5. If there is a strip that does not have dipping, it might be: a. no dipping, b.
pump gas leaking.
Probe up and down moving
9
problem Check whether the connection cable is loose, repower up the analyzer. If the
Probe front and back moving problem still exists, contact the supplier.
10
problem
11 Malfunction of syringe pump Please contact the supplier.
Up and down engine sensor
12
problem
Photo-coupler of Strip conveying
13 Please contact the supplier.
motor problem
Photo-coupler of Strip pushing
14
motor problem
Incorrect strip placing position or strip blocked in the feeder; please take out
15 Strip missing
the incorrect strip and retest.
Incorrect strip direction or strip feeder problem. If this phenomenon repeats,
16 Strip error
please contact the supplier.
No strips, please add strip xx 1. Check whether there is a strip blocked in the feeder.
17
(strip type). 2. If the problem remains, please contact the supplier.
1. No barcode pasted on tube.
2. Barcode is not compatible with this analyzer.
18 No barcode reading 3. Barcode does not paste on the correct position.
4. Barcode reader broke down.
5. ID is switched off.
19 Abnormal ambient light Analyzer should not be testing under direct sunshine.

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No. Malfunction indication Solutions


Use absorbent cotton to dry the white benchmark surface. Contact the
20 White benchmark high/low
supplier if the problem cannot be solved.
STAT port does not reach
21 Push the STAT port to the lock position
position
22 No sample on STAT port Place samples in the STAT port
23 Calibration not OK Please contact the distributor.
24 LED error Please contact the distributor.
25 Testing engine isolator error Please contact the distributor.
26 Cannot scan tube Please contact the distributor.
Please use the calibration liquid provided by manufacturer to calibrate the
27 Refractometer calibration
refractometer.
Please check whether all the cables are connected well. When all the cables
28 Refractometer calibration failed. are connected well, and the refractometer calibration still failed, please
contact supplier.
Please check whether all the cables are connected well. When all the cables
29 Turbidimeter calibration failed. are connected well, the turbidimeter calibration still failed, please contact
supplier.
Please use the cleaning liquid provided by the manufacturer to clean the
30 Cleaning refractometer
refractometer.
31 Refractometer abnormal Please contact the supplier.
Please use the calibration liquid provided by the manufacturer to calibrate the
32 Turbidimeter calibration
turbidimeter.
Please use the cleaning liquid provided by the manufacturer to clean the
33 Cleaning turbidimeter
turbidimeter.
34 Turbidimeter abnormal Please contact the supplier.
35 High or low temperature The analyzer required temperature 15-35℃.
Please check whether all the cables are connected well. When all the cables
36 Color sensor calibration failed are connected well, and the color sensor calibration still failed, please contact
supplier.
Please rinse strip selecting
37 Press “Enter” key to confirm and rinse the strip feeder.
machine
38 Please clean work table. Press “Enter” key to confirm and clean the work table.
Check whether the code switch of the strip selecting machine is correct, strip
39 Strip error.
selecting correct or not
40 Release Strip Failure Check whether the strip selecting machine is abnormal.
41 Drain pump Trouble Check the status of the rinsing bath optical coupler.
The right rack fails to reach the
42 Check the feeding status on the right side.
position.
43 Rack is full Rack is full.
44 Rack has been moved in testing. Rack has been moved in testing.
45 Please Input Check Code Input the strip barcode.
Communication error with Check whether the wires are connected well. If the color detector still alarms
46
color detector after well connection, contact the supplier.
Represents the strip barcode you input is valid. (For instance: when you input
47 Check Code Input Ok
a registration code and get this message, the code you input is valid.)
Represents the strip barcode you input is invalid. (For instance: when you
48 Invalid Check Code
input a registration code and get this message, the code you input is invalid.)

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No. Malfunction indication Solutions


49 Used Check Code Represents the code you input has been used.
50 Expired Check Code Represents the code you input has been expired.
51 Please change injector Press “ENTER” to replace the injector.

(1) Check the rack-feeding motor(No.127);


(2) Check the shifting block of the feeder.
52 Sampler Malfunction 0 (3) Check the feeder optical coupler (No.122)
(4) Check whether the test tube rack is in good condition.
(5) Contact the supplier.

(1) Check the rack-feeding motor (No.127);


(2) Check the shifting block of the feeder.
53 Sampler Malfunction 1 (3) Check the feeder optical coupler (No.128)
(4) Check whether the test tube rack is in good condition.
(5) Contact the supplier.

(1) Check the rack-feeding motor (No.127);

54 Sampler Malfunction 2 (2) Check the shifting block of the feeder.


(3) Check the feeder optical coupler (No.128)
(4) Contact the supplier.

(1) Check the rack-feeding motor (No.127);

55 Sampler Malfunction 3 (2) Check the shifting block of the feeder.


(3) Check the feeder optical coupler (No.128)
(4) Contact the supplier.
(1) Check the rack-feeding motor of the right shifting fork.
(2) Check the installation of the right shifting fork.
56 Sampler Malfunction 4 (3) Check the smoothness of the linear guide track.
(4) Check the optical coupler (No.122)
(5) Contact the supplier.
(1) Check the optical coupler (No.107, No. 113)
57 Sampler Malfunction 5
(2) Contact the supplier.
(1) Check the installation of the left shifting fork.
(2) Check the elasticity of the belt.
58 Sampler Malfunction 6 (3) Check whether there are any objects existing in the left disk
(4) Check the optical coupler (No.107)
(5) Contact the supplier.
(1)Check the power socket installation status of the connecting bridge.
59 Sampler Malfunction 7
(2) Check the optical coupler (JP7)
(1) Check whether the shifting optical coupler baffler before the STAT table
has been reset.
60 Sampler Malfunction 8
(2) Check the shifting optical coupler (No.142).
(3) Check the sensitivity of the shifting optical coupler baffler
(1) Clear the tested racks and other objects on the left groove.
61 Sampler Malfunction 9
(2) Check the optical coupler (No.107).
(1Check whether the power switch of the pre-storage tray is turned on.
Storage disk communication
62 (2) Check whether the two end plugs of the wire HYP-PDS1 are fixed.
abnormal
(3) Contact the supplier.
(1)Check whether the power switch of the reclaiming tray is turned on.
Storage disk communication
63 (2) Check whether the two end plugs of the wire HYP-SDS1 are fixed.
abnormal
(3) Contact the supplier.

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No. Malfunction indication Solutions


(1) Check the motor wire USJ6.
64 U5 chip or USJ6 wire abnormal
(2) Contact the supplier.
(1) Check the motor wire USJ5.
65 U4 chip or USJ5 wire abnormal
(2) Contact the supplier.
(1) Check the motor wire USJ4.
66 U3 chip or USJ4 wire abnormal
(2) Contact the supplier.
(1) Check whether the racks get stuck or have been removed during
conveying
67 Reclaiming disk entrance OC (2) Check the optical coupler and the coupler-related wires of the reclaiming
does not sense tube rack tray inlet connected by wire HYP-SDOP3 ;
(3) Contact the supplier.
(1) Check the rack-in-position optical coupler and the coupler-related wires of
Reclaiming disk rack-in-position the reclaiming tray connected by wire HYP-SDOP4.
68
OC abnormal
(2) Contact the supplier.
(1) Check the motor wire SDJ4.
69 U3 chip or SDJ4 wire abnormal
(2) Contact the supplier.
(1) Check the zero optical coupler and the coupler-related wires of the
Reclaiming disk rack-withdrawing motor on the reclaiming tray connected by wire
70 rack-withdrawing motor HYP-SDP2.
does not find zero
(2) Contact the supplier.
(1) Check the motor wire SDJ5.
71 U4 chip or SDJ5 wire abnormal
(2) Contact the supplier.
(1) Check the zero switch and the switch-related wires of the rack-conveying
72 Reclaiming disk rack-conveying motor connected by wire HYP-SDP3.
motor does not find zero (2) Contact the supplier.
(1) Check the motor wire SDJ6.
73 U5 chip or SDJ6 wire abnormal (2) Check whether the two end plugs of the wire HYP-SDS1 are fixed.
(3) Contact the supplier.
(1) Check the zero switch and the switch-related wires of the rack-conveying
Reclaiming bridge motor does motor connected by wire HYP- SBJ4.
74
not find zero
(2) Contact the supplier.
(1)Check whether the rack has been removed during conveying.
Storage disk rack-feeding switch
75 (2) Check the inlet switch and wire connected by wire HYP-PDSW2.
senses no tube rack
(3) Contact the supplier.
(1) Check the motor wire PDJ4.
76 U3 chip or PDJ4 wire abnormal
(2) Contact the supplier.
(1) Check the zero optical coupler and the coupler-related wires of the
77 Storage disk rack-conveying rack-conveying motor connected by wire HYP- PDP2.
motor does not find zero (2) Contact the supplier.
(1) Check the motor wire PDJ6.
78 U5 chip or PDJ6 wire abnormal
(2) Contact the supplier.
(1) Check the zero switch and the switch-related wires of the rack-conveying
Storage disk rack-feeding motor motor connected by wire HYP-PDP3.
79
does not find zero
(2) Contact the supplier.
(1) Check whether the racks get stuck during conveying.
Tube rack in-position OC does (2) Check the optical coupler and the coupler-related wires of the pre-storage
80
not sense tube rack tray outlet connected by wire HYP-PDJ13
(3) Contact the supplier.

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No. Malfunction indication Solutions


(1) Check whether the racks have been removed during conveying.
Storage disk rack-leaving OC (2) Check the rack-in-position optical coupler and the coupler-related wires
81
does not sense tube rack connected by wire USOP6
(3) Contact the supplier.
(1) Check whether the barcode reader wire USWDL has been connected with
82 Not find bar code reader the control panel.
(2) Contact the supplier.
(1) Check whether the optical fiber sensor wire USJ7 has been connected with
the control panel.
83 Optical fiber sensor error (2) Check the standard value (green) displayed on the optical fiber sensor, it
should be 75% of the light-through value (red).
(3) Contact the supplier.
(1) Check the microswitch and the switch-related wires connected by the
84 Counter balls have no movement sample conveying wire USWE and USWS.
(2) Contact the supplier.
(1) Check the zero switch and the switch-related wires of the rack-conveying
Rack-conveying motor does not motor connected by the wire USJ18.
85
find zero
(2) Contact the supplier.
(1) Check the microswitch and the switch-related wires connected by the
86 Counter balls are off all the time sample conveying wire USWE and USWS.
(2) Contact the supplier.
(1) Check the rack- in-position optical coupler and the coupler-related wires
Tube rack in-position OC keeps connected by wire USOP6.
87
sensing a tube rack
(2) Contact the supplier.
(1)Check the zero switch and the switch-related wires of the rack-conveying
Rack-feeding motor does not motor connected by the wire USJ18
88
find zero
(2) Contact the supplier.
(1) Check the zero switch and switch-related wires of the rack-withdrawing
Rack-withdrawing motor does motor connected by the wire USJ18.
89
not find zero
(2) Contact the supplier.
(1) Check the optical coupler and the coupler-related wires of the reclaiming
Reclaiming disk entrance OC tray outlet connected by wire HYP-SDOP3.
90
keeps sensing a rack
(2) Contact the supplier.

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Appendix E Reagent Consumption

Operation unit Detergent dosage unit(mL)


Power on 12
Start testing 12
Routine test between samples when densimeter is on (one sample) 3.95
Routine test between samples when densimeter is off (one sample) 4.2
Densimeter 36
Pipeline 36
Power off 24

Note:
No other notice is to be given if the manual has been changed for it is only used to provide with info.

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Appendix F Performance Indexes


F.1 Analyzer Repeatability
Analyzer reflectance test result coefficient of variation (CV, %) ≤1.0.
F.2 Applied Urinalysis Strips Accuracy
The difference between the test result and the labeled value of the corresponding reference solution should not
exceed one order of magnitude in the same direction. Opposite direction difference is not allowed. No negative
result for positive reference solution and no positive result for negative reference solution.
F.3 Analyzer Stability
Within 8 hours after power on, reflectance test result coefficient of variation (CV, %) ≤1.0.
F.4 Analyzer Carryover Rate
The analyzer tests the positive samples with the highest concentration results of each test item except for specific
gravity and pH, and then tests the negative samples. No positive result is allowed for negative samples.

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Appendix G Accessories List


The accessories list includes accessories, fittings, and consumables.
Replacement Replacement
Name Position Remarks
Cycle Method
Rinsing Pump Syringe Pump Unit 2 years 7.7
Detergent Filter Detergent Tube 6 months 7.11
Plastic Bearing Probe Unit 2 years 7.11
Strip- conveying
Strip Table 2 years 7.8
Unit
Soft Rope Probe Unit 2 years 7.11
Inspected or replaced by the
Contact the
Dripping Probe Probe Unit 2 years representative from the
service staff.
manufacturer or distributor only.

Sample Feeder Unit Inspected or replaced by the


Ball Bearing Contact the
2 years representative from the
Assembly (Counter ball) service staff.
manufacturer or distributor only.
Disposable Tube Sample Feeder Unit Timely
Cleaning Liquid Test about
Whole Machine 6.1.4 In consecutive testing mode
(Concentrated Type) 2800 strips
Strip Strip-selecting Unit Timely 6.1.1
Thermal Printing
Internal Printer Timely 2.3.3
Paper
Calibration Strip Strip-selecting Unit Timely 5.1.1

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