URISCAN PRO - Manual Completo (Ingles)

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URiSCAN PRO 
URINE ANALYZER 
 
- Operator’s Manual - 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
YM-027 
 
 
 
CONTENTS 
SECTION 1 SYSTEM OVERVIEW 
1.1 General Introduction …………………………………….………………… 2 
1.2 Introduction of Optical System ………………………….…………..……… 2 
1.3 Principles of Urinalysis Strips ………………….………………….……… 3 
1.4 Main Functions ……………………………………………………..……… 4 
1.5 References ………………….………………………………………..……… 5 
SECTION 2 INSTALLATION 
2.1 Technical Specifications ………………………………..…………………… 7 
2.2 Unpacking …………………………………………...……………………… 8 
2.3 Installation ……………………………………….…………………………… 9 
2.4 Operation …………………………………………………………………… 12 
2.5 Care and Maintenance ……………………………………………………… 13 
2.6 Disposal of the analyzer ………………………...………………………… 13 
SECTION 3 CONTROLS USED FOR OPERATING SYSTEM 
3.1 External Structure …………………..……………………………………… 15 
3.2 Description of each part and overview …………………...……………… 18 
SECTION 4 SHORT OPERATING INSTRUCTIONS …………..…………… 20 
SECTION 5 ROUTINE WORKING PROCEDURES 
5.1 System Initializing …………………………………………………………… 22 
5.2 System Configuration ……………………………………………………… 23 
5.3 ID Management ……………………...…………………………………… 29 
5.4 Calibration ……………………………...…………………………………… 32 
5.5 Measurement ………………………………………………………………… 35 
5.6 Data Management ………………..………………………………………… 38 
5.7 Color & Clarity ………………...………………………………………… 39 
SECTION 6 APPENDIX 
6.1 Communciation ……………………….…….……………………………… 44 
6.2 Adjusting URiSCAN® PRO ………………………………………………… 45 
6.3 Touch Screen Calibration ..…………………………...…………………… 50 
6.4 Program for the Sensitivity of Each Parameter ………...……………… 51 
6.5 Value of the Initial Standard R% ………………………………………… 55 
6.6 Quality Controls ……………………………….…………………………… 58 
6.7 Troubleshooting Guide ……………………….……………………………… 59 
6.8 Error Code ……………………………….………………………………… 61 
6.9 Product List for URiSCAN PRO ………...………………………………… 62 
6.10 Summary of Waiver Studies ………………..……………………………… 63 
6.11 Shipment inspection sheet …….………………...………………………… 64 
 
SECTION 1 SYSTEM OVERVIEW 
 
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SYSTEM OVERVIEW 
 
SYSTEM OVERVIEW SECTION 1 
 
 URiSCAN PRO Operator’s manual / 2 
1.1 General Introduction 
URiSCAN® PRO Urine Analyzer is designed for use with URiSCAN®
Also, even users who are unfamiliar with this kind of instrument can easily operate the Urine Analyzer 
without additional training. 
 urine test strips. Through ease 
of use, systematic data management and high technology, the PRO Urine Analyzer allows for 
standardization of urine test results with accuracy and reproducibility, resulting in more efficient 
laboratory diagnosis. 
 
1.2 Introduction of Optical System 
Each element of the urine will be absorbed into each test portion of the strip and the subsequent 
chemical and enzymatic reactions will change the color of the test paper accordingly. The degree of 
color will be proportional to the concentrations of each element in the urine. The CCD (Charge 
Coupled Device) will play the role of measuring and indicating the extent and route of the color. 
 
In short, the CCD is a state-of-the-art device that analyzes the ratios of the composition of the 
primary colors of light, and precisely reads out the extent of change in the color of the test paper. It 
will give you more precise, objective and consistent test results than the conventional color 
concentration measuring devices using the LED. 
 
 
 
 
 
 
 
Test Strip 
* CCD (Charge Coupled Device) : Color Image Sensor / R.G.B X 5400(pixel) 
* R. G. B.: Three primary colors of light (Red, Green and Blue) 
* Wave Length : Red - 630nm /Green - 540nm / Blue - 460nm 
 
Optical Lens CCD 
CPU 
Analog-to Digital Converter 
 
LED 
 
SECTION 1 SYSTEM OVERVIEW 
 
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1.3 Principles of Urinalysis Strips 
Urinalysis is the general and basic method used in healthcare settings for the detection and 
confirmation of early disease along with other diagnostic references. 
 
There are three basic methods of urinalysis: 
* The visual evaluation of the color of the urine sample 
* The determination of urinary substances by use of urinalysis test strips 
* The re-confirmation of the presence of urinary substances by microscopic examination 
Of the 3 methods, the use of urinalysis test strips is most widely used for the accurate and rapid 
determination of the presence or absence of certain urinary substances. The results from a urine 
chemistry analyzer are more accurate and objective than a visual comparison of color change, which 
can be subjective based on each user’s color perception. 
URiSCAN® urinalysis test strips manufactured by YD Corp. are available to test 13 parameters. 
URiSCAN® 
 
PRO urine analyzer can read test strips with 4 to 13 test parameters. 
U41 URiSCAN®
Vt. C Leucocytes S.G pH Glucose Nitrite Protein Ketones Bilirubin Blood 
11 Strip 
 
 
 Compensation area Urobilinogen 
 
 
 
 
 
 
 
SYSTEM OVERVIEW SECTION 1 
 
 URiSCAN PRO Operator’s manual / 4 
1.4 Main Functions 
 Auto memory function 
3,000 test results are stored automatically. 
 Calibration Data 
30 control data per each URiSCAN® 
 Easy access to review tested results stored in database 
test strip (selectable during testing) 
Area print 
Special data print 
 Test parameters 
4 ~ 11 parameter URiSCAN®
 Program in eight languages 
 Strip 
English, Russian, Spanish, German, Italian, Portuguese, Chinese, Korean 
 Self-adjustable relevant voltage (AC 100 - 240V, 50/60Hz) 
 Communication interface 
Serial communication – Host computer 
USB communication – Bar code and external printer 
 Selection of reading time 
Routine test mode : 720 tests / hour 
Measurement cycle: 5 sec. 
 Simple & easy to clean 
Separable guide plate and rake 
 Urine color & clarity reading 
 Auto reading for urine color &manual reading for clarity 
 
SECTION 1 SYSTEM OVERVIEW 
 
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1.5 References 
 : Conformity European(CE) mark 
 : IN VITRO DIAGNOSTIC MEDICAL DEVICE 
 : CONSULT INSTRUCTIONS FOR USE 
 : Waste Electrical and Electronic Equipment(WEEE) mark 
 : AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 
 : CAUTION, CONSULT ACCOMPANYING DOCUMENTS 
 : MANUFACTURER 
 : DATE OF MANUFACTRUE 
 : BIOLOGICAL RISKS 
 : SERIAL NUMBER 
 : CATALOGUE NUMBER 
INSTALLATION SECTION 2 
 
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INSTALLATION 
 
SECTION 2 INSTALLATION 
 
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2.1 Technical Specifications 
□Manufacturer YD Diagnostics CORP. 
□Type of Product Urine analyzer 
□Model Name URiSCAN PRO 
□Operating Mode Semi-automatic urine analyzer 
□Material Plastic, Metal 
□Dimension & Weight 
Dimension 463mm(W) X 370mm(D) X 173mm(H) 
Weight 4.7Kg (10.36 lb) 
□Electric Input AC/DC Adaptor : AC 100V - 240V, 50/60Hz 
URiSCAN PRO : DC 12V, 3.5A 
□Rated Frequency AC 50/60 Hz 
□Rated Power 42 VA 
□Operating Condition 
Temperature 2oC-30oC (35 oF-86o
Humidity 10%-70% 
F) 
□Storage Condition 
Temperature 0oC-40oC (32 oF-104o
Humidity 10%-85% 
F) 
□Measurement Method 
Principle Reflectance Photometers 
Throughput 720 tests / hour 
Measurement Cycle 5 sec. 
Memory Capacity Patient:3,000 tests + Control data: 1,000 tests + 
Calibaration data 30 tests 
Light Source LED 
Sensor CCD color image sensor 
Result Display 7” TFT LCD 
□Printer High speed thermal-printer 203dpi(8dots/mm) 
□Host-Communication RS 232C, USB 
□Peripherals Barcode reader, External printer 
□Safety Standard EN 61010-1:2012, EN 61010-2-101:2002 
□EMC Standard EN 61326-1:2013, EN 61326-2-6:2006 
 
INSTALLATION SECTION 2 
 
 URiSCAN PRO Operator’smanual / 8 
2.2 Unpacking 
Upon receipt of URiSCAN® 
Carefully unpack the unit and check for completeness. Included in the carton should be the following: 
PRO, examine the exterior carton for damage. In the event of shipping 
damage, a claim must be filed with the transportation carrier within 10 days of receipt. Save all 
packaging for inspection. 
 
 
Save the original packing until the unit has been shown to be operating properly. If any of these items 
are missing, contact your supplier directly. 
 
 
 
 
 
URiSCAN® PRO instrument assembly 
URiSCAN PRO 1Unit 
Thermal printer paper (57mm width) 1Roll 
Adopter and power cord 1EA 
Guide plate 2EA 
RAKE 2EA 
Operator’s manual 1EA 
 
Optional Accessories 
RS232C cable for ser ia l communicat ion 1EA 
 (Maximum length 3m) 
Bar code reader 1EA 
 
SECTION 2 INSTALLATION 
 
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2.3 Installation 
Verify that the unit is rated for the proper voltage by checking the panel on the back. Check that the 
proper power cord has been received. The serial number of the unit is also located on the back panel. 
Precaution : URiSCAN® 
URiSCAN
PRO should not be used at temperatures colder than 2 °C and at 
humidity over 70%. The atmospheric pressure should be from 900 to 1600 mbar. 
® 
 
PRO should be placed on a level, stable surface near a grounded electrical outlet and 
installed on an inner area of a table 12 cm from any edge for safely purposes. The surface should be 
clean and free of dust to ensure that the feet grip the surface firmly. Allow sufficient clearance on all 
sides of the unit for proper ventilation. 
2.3.1 Installing URiSCAN® 
Insert one end of power cord into back of URiSCAN
PRO 
® PRO. Plug the other end of the power cord 
into the wall socket. Turn on URiSCAN® 
 
PRO using the button on the rear of the instrument. 
2.3.2 Interface with Host Computer, Bar Code Reader and External Printer 
 
 
 
- Interface with Host Computer 
URiSCAN® 
- Interface with Bar Code Reader 
PRO can interface with sample ID and test results to a host computer. 
Sample ID can be registered via keyboard on the instrument or bar code reader. 
 
URiSCAN® PRO can interface with a host 
computer and peripheral devices so as to 
improve the workstation. 
The instrument can be connected with a host 
computer(RS232C port), barcode reader and 
external printer(LPT or USB port). 
 
INSTALLATION SECTION 2 
 
 URiSCAN PRO Operator’s manual / 10 
Precaution : All peripheral devices for interface must conform with generally recognized 
technology standards. Please contact Quality Assurance Dept. of YD Diagnostics CO.,Ltd. if 
you have any question regarding peripheral devices. 
2.3.3 Feeding Thermal Printing Paper 
After the system installation, check the printer paper. If there is no paper, then follow the 
instructions below to feed the paper. 
[Fig 2.3.3.1] 
To insert the paper roll, open the printer cover by 
pulling up the lever as shown on Fig. 2.3.3.1. 
 
 
 
 
[Fig 2.3.3.2] 
Insert the paper roll into printer case so that the 
paper roll goes up from the bottom. 
 
 
 
 
[Fig 2.3.3.3] 
Make sure that about 2 inches of paper is left 
outside of printer head, then close the printer cover. 
 
 
SECTION 2 INSTALLATION 
 
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2.3.4 Cleaning the guide plate 
It is recommended to clean the guide plate daily for better performance and accuracy. 
 
* How to separate the guide plate 
 
[Fig 2.3.4.1] 
1. Separate the guide plate by pulling it from the 
instrument as shown on [Fig 2.3.4.1] 
 
2. Clean it with DW (Distilled Water) and dry it 
before installation. 
 
 
 
[Fig 2.3.4.2] 
3. Insert the guide plate until it reaches the ends 
with ticking sound as shown on [Fig 2.3.4.2] 
 
 
 
 
INSTALLATION SECTION 2 
 
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2.4 OPERATOR 
 
2.4.1. Precaution for using URiSCAN PRO 
The following precautions should be taken when operating or working near URiSCAN® 
- Do not use dangerous substances such as toxic, radioactive or contaminated material. 
PRO 
- In case of contamination remember to decontaminate before cleaning. The user is 
responsible for the decontamination operations if dangerous substances are spilled. 
- Do not use explosive or inflammable materials. 
- Do not use materials that can interact with a strong chemical reaction. 
- Service and repair must only be performed by qualified professionals. 
- Avoid using the system in a wet or humid place. 
- Do not install the system in places subject to humidity, excessive day light and air containing 
dust, salt, or sulfur contents. In addition, the system shall not be installed near chemicals or a 
place subject to gas leakage. 
- Avoid placing the system on slopes or vibrating surfaces. Do not subject the system to 
impact during delivery. 
- Select a place that is not affected by high frequency, electronic waves, or voltage variations 
- Keep the system flat with the screen facing up at all times. Do not stand the system up or 
place upside down 
 
2.4.2 Environmental Conditions 
Performance and safety of URiSCAN® 
- Indoor use. 
PRO are warranted at all times if it is operated under the 
following environmental conditions: 
- Main supply voltage fluctuation up to ±10% of the nominal value. 
- In locations with temperatures between 2 oC and 30o
- In locations where the relative humidity is lower than 70%. 
C. 
- In locations free from dust or vapors of solvents and acids. 
- In locations free from vibrations. 
 
SECTION 2 INSTALLATION 
 
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2.5 Care and Maintenance 
Warning :Disconnect URiSCAN® 
For routine maintenance, clean the strip holder daily or more often if sediment is seen, using soft 
gauze and distilled water. Avoid scratching the guide plate. 
PRO from the power source before attempting any 
cleaning or maintenance procedures. 
 
2.6 Disposal of the analyzer 
Used analyzer should be disposed according to the safety regulations applicable at your facility. 
 
 
 
 
CONTROLS USED FOR OPERATING SYSTEM SECTION 3 
 
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CONTROLS USED FOR 
OPERATING SYSTEM 
 
SECTION 3 CONTROLS USED FOR OPERATING SYSTEM 
 
15 / URiSCAN PRO Operator’s manual 
3.1 External Structure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printer lever 
 
Guide Plate 
(Strip holder) 
 
 
TFT TOUCH LCD 
CONTROLS USED FOR OPERATING SYSTEM SECTION 3 
 
 URiSCAN PRO Operator’s manual / 16 
 
 
<Rear Side View> 
 
 
 
 
 
 
 
< Front View> <Upper Side View> 
 
 
 
 
 
 
 
<Left Side View> <Right Side View> 
 
 
SECTION 3 CONTROLS USED FOR OPERATING SYSTEM 
 
17 / URiSCAN PRO Operator’s manual 
Parts No. Description Specification Remark 
1 COVER_BOTTOM MOLD, ABS 
2 COVER_TOP(L) MOLD, ABS 
3 COVER_TOP(R) MOLD, ABS 
4 WASTE_TRAY MOLD, ABS 
5 STRIP_TRAY MOLD, ABS 
6 PRINT_COVER MOLD, ABS 
7 LCD 7” TFT LCD 
8 GUIDE_PLATE MOLD, ABS 
9 Product LABEL 120*73 
10 External Terminal LABEL 214*13 
11 COM CONNECTOR RS232 FEMALE 
12 BARCODE CONNECTOR RS232 MALE 
13 LPT CONNECTOR LPT 25PIN 
14 USB HOST CONNECTOR USB B TYPE 
15 USB DEVICE CONNECTOR USB A DUAL TYPE 
16 DC12V CONNECTOR DC12V 2.5 pi 
17 POWER SWITCH ROCKER SWITCH 2P ON-OFF 
 
 
CONTROLS USED FOR OPERATING SYSTEM SECTION 3 
 
 URiSCAN PRO Operator’s manual / 18 
3.2 Description of each part and overview 
URiSCAN PRO consists of Internal Printer, Touch LCD, Waste Tray, External Connection 
Terminal and Guide Plate(Strip holder). 
 
 TFT LCD 
The window for reviewing the data and current status. 
Internal Printer 
Printing the results by high-speed thermal print method. 
 External Connection Terminal 
RS232C port & USB port : for connectingwith PC & Barcode Reader 
LPT port & USB port : for connecting with external printer 
 
Guide Plate (Strip Holder) 
Consist of moving belt, Stepping Motor, Guide Plate, Photo coupler and infrared light sensor. 
Strip Waste Tray 
The tested strips will be collected into this tray. When 150 strips are accumulated, warning 
message pops up. When this strip waste tray is not installed its original position, “No Tray” 
message pops up. 
 
SECTION 4 SHORT OPERATING INSTRUCTIONS 
 
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SHORT OPERATING 
INSTRUCTIONS 
 
SHORT OPERATING INSTRUCTIONS SECTION 4 
 
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Short Operating Instructions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Power On 
Press the button at the front panel to power on, then the display will show a phrase "YD". 
The system will start a self-check with the words “System Initializing”. 
SYSTEM INITIALIZING 
The system checking is carried out by itself and if the instrument detects certain faults, the 
display will show a warning message. It takes about 10 seconds to check self-
configuration. 
- Scan Module Error >Fail to connect with Scan Module. 
- Printer Error >Fail to connect with printer or no printing paper 
- Feeder Motor Error >Fail to initialize Feeder Motor 
- Carrier Motor Error >Fail to initialize Carrier Motor. 
SYSTEM CONFIGURATION----- Press “Setting” icon at the main menu 
The system has been factory installed before delivery. The current date, time, printer 
status, signal buzzers, unit and language must be set up prior to test. 
CALIBRATION----- Press “Calibration” icon at the main menu 
Enter the lot number of the urine reagent strip to be measured. Perform the calibration. 
- Use the reagent strip dipped in distilled water. 
Calibration procedure should be performed when, 
- Changing an item 
- Changing product lot number 
- Test results are in doubt or different result is obtained than expected using quality 
control materials. 
* Lot number is printed on the URiSCAN®
ID MANAGEMENT ----- Press “ID manager” icon at the main menu 
 Strip Vial. 
A sample ID number or alphabetical name can be entered by touch screen, PC or 
barcode reader (ID number only). The sample ID can be entered not only before 
measurement but also during test. 
MEASUREMENT----- Press “Measure” icon at the main menu 
- Normal Measure: measure patient sample. 
- Control Measure: measure control material 
Dip a strip into the urine sample and place the strip on the strip guide plate after removing 
excess urine on the soft tissue. Sensor reads the strip and starts measurement. Test 
results can transfer to host computer and results will be transferred on testing. 
 
Communication----- Click “Setting” icon in the main menu 
The URiSCAN PRO has a serial interface to connect with a host computer. 
COLOR & CLARITY----- Click “Color” icon in the main menu Click 
URiSCAN PRO can report color and clarity function 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
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ROUTINE WORKING 
PROCEDURES 
 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 22 
5.1 System Initializing 
 
When the instrument is turned on, the system initializing begins automatically. This procedure is 
performed to check the system of the instrument. It takes about 10seconds 
 
 
[F 5.1.1] Intro [F 5.1.2] Initial Complete! 
 
After successful system checking, the instrument displays the “Initial Complete!” message for 2 
seconds and goes to ‘Main’ menu automatically. 
If the instrument detects any faults, warning message will be shown on the LCD For example, if the 
printer paper is not installed properly, a warning message will be shown like below [F 5.1.4] 
 
[F 5.1.3]Main Screen [F 5.1.4]System Initializing Screen 
“Strip Lot” on the top of the screen is the LOT number of the latest calibrated URiSCAN®
Tray count shows the total number of strip tested after installing the waste tray. Until 150 tests, it 
shows “Green” color, after 150 tests, it shows “Red” color. 
 test strip 
item. 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
23 / URiSCAN PRO Operator’s manual 
PRECAUTION : Make sure that power connector doesn’t come out. 
 
Warning : In case of any hazard please turn off the power switch first, then disconnect the 
main power cord immediately. Therefore the power cord should be always 
easily accessible. 
 
5.2 System Configuration 
Although the factory-installed configuration is set on URiSCAN®
Press “Setting” icon at ‘Home’ menu [F5.2.1] to set up the system configuration. You can enter each 
menu by touching the text or its line. 
 PRO before delivery, users should 
check and set up the system configuration before measurement to get accurate results. 
 
You can return to ‘Home’ menu by pressing “Home” button. 
 
 
[ F 5.2.1] Main Screen [F5.2.2] ‘Setting’ Menu 
 
1. Set Time This menu is to set current time and date. See 5.2.1 
 
2. Set Comm. This menu is to set the external serial communication. See 5.2.2 
 
3. Set Printer This menu is to set the printer. See 5.2.3 
 
4. Set Barcode This menu is to set a barcode reader. ‘On’ or ‘Off’ See [F.5.2.3] 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 24 
 
5. Set Unit This menu is to set the measurement unit. URiSCAN®
 
 PRO supports both 
conventional units (mg/dL) and SI units (mmol/L). 
 
[ F 5.2.3] ‘Barcode Reader’ setting [ F 5.2.4] ‘Unit’ setting 
 
6. LCD Backlight This menu is to adjust the brightness of LCD backlight. See [F.5.2.5] 
 
7. Set Buzzer This menu is to adjust volume of buzzer. See [F.5.2.6] 
 
 
[ F 5.2.5] LCD Brightness [ F 5.2.6] ‘Buzzer’ Setting 
 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
25 / URiSCAN PRO Operator’s manual 
8. Set Language URiSCAN®
 
 PRO system is programmed to function in 8 languages : English, 
Russian, Spanish, German, Italian, Portuguese, Chinese, Korean. See [F.5.2.7] 
 
[ F 5.2.7] ‘Language’ Select 
 
5.2.1 Set Time 
Touch each button to select - Month, Date, Year, Hour, Minute and Second. Enter the number for 
current date, year and time. The time is displayed in the 24-hour clock format. See [F.5.2.8] 
 
[F 5.2.8] Set Time 
 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 26 
5.2.2 Set Comm. 
URiSCAN®
 
 PRO has a serial interfacing system to connect with a host computer. Touch “SET 
COMM.” at “Setting” menu [F5.2.2] and set the format to activate the interface with the host computer 
as below: 
[F 5.2.9] Set Communication 
Data Format 
 Baud Rate (bps) : 9600 
 Data Bit (bit) : 8-bit code 
 Parity Bit (bit) : None 
 Stop Bit (bit) : 1 stop bits 
After setting, press “Save” button to implement. 
 
 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
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5.2.3 Set Printer 
Before measurement, the printer system must be set ‘On' to print the test result. You can enter this 
menu by touching the button - “SET PRINTER” at “Setting” menu [F5.2.2]. This menu is composed of 
six subsequent menus. 
 
 
[F 5.2.10]’ Set Printer’ menu 
After setting, press “Save” button to implement. 
5.2.3.1 Internal Printer, External Printer 
The instrument has an internal thermal printer. Press “Internal printer” to turn it “On” or “Off”. It should 
be “On” to activate the internal thermal printer. URiSCAN®
After setting, press “Save” button to implement. 
 PRO can also be connected with an 
external USB printer. Press “External Printer” at “Set Printer” menu to print the test result through the 
external printer. 
 
5.2.3.2 Data print 
Set “On” for the immediate print of every test. If it is set “Off”, the test results will not be printed out 
even if both internal and external printers are “On”. 
After setting, press “Save” button to implement. 
 
 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCANPRO Operator’s manual / 28 
5.2.3.3 ID print 
This is to print out the registered sample’s IDs. If it is at ‘On’, URiSCAN®
‘ID for measuring’ : It is to confirm the sample’s ID before measurement. The system will print it out 
as soon as you start measurement. 
 
 PRO will print ‘ID for 
measuring’, ‘Remain ID’ and ‘Error ID’ before measuring those samples. 
 
‘Error ID’ : It is to indicate the missing ID during the measurement. It will be printed at the 
standby mode. 
 
‘Remain ID’ : It is to indicate ID that has not been tested after register. It will be printed when 
return to ‘Home’ menu. 
 
5.2.3.4 Number 
This is to set the number of copies for each test-result. The system can print up to two copies during 
measurement and up to 9 copies at ‘Data’ menu. See 5.6. 
After setting, press “Save” button to implement. 
 
5.2.3.5 Operator ID print 
This is to print out the registered Operator ID. If it is at ‘On’, the Operator ID will be printed out. 
After setting, press “Save” button to implement. 
 
 
 
 
 
 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
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5.3 ID Management 
ID management consists of three functions - ID register and Serial ID reset and Operator ID. You can 
register patient’s ID through touching LCD or barcode reader. ID can be registered before 
measurement and also during measurement simply by using barcode reader or on-board touch 
screen keyboard .URiSCAN®
 
 PRO manages sample’s ID with two parts – Serial ID and Sample ID. 
[ F 5.3.1] ID manager 
 
Serial ID Number 
The serial number is assigned automatically according to the measured sample's order. Press “ID 
Manager” icon at main menu, then the below menu [F5.3.1] will be displayed. You can set the start 
number for serial ID by pressing Serial ID reset. 
 
[ F 5.3.2]Serial ID reset [ F 5.3.3]Control ID reset 
Control ID Number 
The control ID number is increased automatically according to the measured sample's order. Press 
“ID Manager” icon to call the ID Manager screen as shown on the above [F5.3.1]. Press “Control ID” 
button to initialize it. 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 30 
Sample ID 
This is for setting the individual sample's ID number. Press the “ID Register” at ‘ID Manager’ menu 
[F5.3.1] and touch the LCD or use barcode reader to register the sample ID with up to 13 digit 
number. Sample ID can be deleted by touching the button -“Delete” or “Clear” 
 
Press “Add” or “Insert” button in order to input sample ID and then press “Enter” button to register. 
The maximum of 100 ID can be registered. 
Press “Esc” button to go back to “ID Manager” menu 
 
You may scroll up and down with screen touch, and insert new ID with “Insert” button at the line 
above the ID you select. The ID selection will be made by your touch on any ID. The number at the 
top-center of the LCD shows the quantity of ID numbers registered 
 
[F 5.3.4] Add ID 
You can also delete the registered ID numbers. Drag the screen to find the sample’s ID for deletion, 
then press “Delete” button to delete it. A warning message will be displayed as [F 5.3.6]. If you want 
to delete the ID, press “OK” to delete it. The remaining ID numbers will be displayed. 
If you want to register the sample ID after you finish the registration of all the samples IDs, you can 
register the ID during the measurement by using the touch screen. 
 
 
 
 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
31 / URiSCAN PRO Operator’s manual 
Operator ID Number 
You can register the operator’s ID by touching “Operator ID” at ‘ID manager’ menu and touch the 
LCD to register the operator ID with up to 10 digit number. You can switch from alphabetical to 
numeric by touching “Mode 123” button 
 
 
[ F 5.3.5]Operator ID 
 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 32 
5.4 Calibration 
Calibration procedure should be performed when, 
- Changing an item 
- Changing product lot number 
- Test results are in doubt or different result is obtained than expected using quality control 
solutions. 
 
Touch “Calibration” icon at ‘Home’ menu. Enter the urine test strips’5-digit lot number and press 
“Enter.” See [ F 5.4.1] 
Dip the urine reagent strip into distilled water and blot the strip on absorbent paper towel to remove 
excess liquid. Place the reagent strip on the strip holder, then press “Start” button. 
If the calibration has finished successfully, the success message will be shown and the calibration 
data will be printed out. [F 5.4.5] User can use this data for quality control. 
 
[ F 5.4.1] Calibration [ F 5.4.2] Lot No 
 
[F 5.4.3] Calibration Insert strip [F 5.4.4] Calibration processing 
 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
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[F 5.4.5] Calibration Success 
 
While proceeding calibration, if any fault is detected by sensor, a warning message will be shown on 
the display and printer paper. In this case, the user must retry calibration procedure. 
 
[F 5.4.6] Calibration Success [F 5.4.7] Calibration Fail 
 
Press “History” at the calibration menu. 
 
Calibration Error 
Retry Calibration 
Date :Apr-01-2011 
Time : 00:00:00 
Success Calibration ! 
P39- 10 strip [39123] 
BLD == 500 
BIL == 500 
URO == 502 
KET == 500 
PRO == 501 
NIT == 500 
GLU == 502 
 
 
 
 
 
Calibration Range 
BLD : 500~515, BIL : 500~515, URO : 500~515, KET : 500~515, PRO : 500~515, NIT : 500~515, 
GLU : 500~515, pH : 500~515, SG : 500~515, LEU : 500~515, VTC : 500~515 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 34 
 
 
[F 5.4.8] Calibration Data 
Calibration data is displayed by selecting the type as shown on [F 5.4.8] 
The last calibration of the URiSCAN®
 
 strip type is normal, it is able to change LOT number by 
pressing “Save” button. 
 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
35 / URiSCAN PRO Operator’s manual 
5.5 Measurement 
Touch “Measure” icon at ‘Home’ menu [F 5.5.1]. Either “Normal Measure” or “Control Measure” can 
be selected as shown on [F 5.5.2] 
 
[F 5.5.1] ‘Home’ menu [F 5.5.2] Measure menu 
1. Patient Measure : Dip a strip into the urine specimen and remove excess urine by gently 
blotting the strip against a paper towel. Verify all pads have been saturated and place the strip 
immediately on the Guide Plate. The instrument reads the test strip in 100 seconds. 
2. Control Measure : the same test procedure as normal measure. 
When the sample ID is already registered and the internal printer is set on, “ID for measuring” is 
printed as the following. See 5.2.3.3. ID Print 
 
[F 5.5.3] Print ‘ID for measuring’, ‘Error ID’ and ‘Remain ID’ 
The instrument shows a testing status on progress bar during measurement, and measuring mode 
is displayed. 
After initialization of the strip feeder, the strip sensor on the analyzer is ready to recognize a urine 
test strip. Dip a strip into the urine specimen and remove excess urine by gently blotting the strip 
against a paper towel and place a urine test strip on the guide plate. When the sensor recognizes 
a strip, it automatically moves to the measurement point every 5 sec. interval with playing a beep. 
When a beep sounds, the next strip can be placed on the guide plate. The total measurement time 
per each strip is 100 seconds. (a buzzer volume can be adjusted by an operator at “Set Buzzer” in 
the setting menu) 
ID for Measuring 
 
0000111122223333 
34567890123452 
 
Remain ID 
 
123123123123 
Error ID 
 
2 -34567890123452 
 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 36 
 
[F 5.5.4] Patient test mode [F 5.5.5] Control test mode 
On the measurement screen, the current position of each strip can be monitored. The sample ID can 
be entered during this process (only the strip which were alreadycalibrated) 
 
[F 5.5.6] Empty ID 
If ID is not entered, ID appears as “Empty ID” as shown on [F 5.5.6] 
When the strip type is changed, input the new strip LOT by touching “Strip Lot”. (Only the calibrated 
strip can be tested). After changing the strip LOT, the next strip placed on the guide plate is applied. 
“Measure Count” shows the total number of test. It can be initialized by touching the counter 
initialization button on the left. 
If the waste tray is ejected during measurement, the measurement will be automatically stopped, and 
show “No Tray” message. When inserted, it will continue to measure. 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
37 / URiSCAN PRO Operator’s manual 
 
[F 5.5.7] No Tray 
Test results will be shown as the following screen and also it will be printed out automatically. 
 
[F 5.5.8] Test result on the screen [F 5.5.9] Printed test result 
After measurement, press “Esc” button to go back to “Home” menu. When “ESC” button is not 
pressed, it will automatically go to previous menu when a strip sensor doesn’t recognize the strip for 
60 sec. 
Please note that you must set up the instrument before conducting a measurement. Please refer to 
Section 5.2 System Configuration described in detail. 
Reaction &measurement time for visual evaluation of urinalysis strips are 
- Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Glucose, pH and S.G : 60sec. 
- Leucocytes: 90 ~ 120 sec. 
Strip Disposal : Used test strip should be disposed according to the safety regulations 
applicable at your facility. 
Date :Mar – 01 - 2011 
Time: 00 :00 : 00 
ID : 0001 – 
Ward: 
Name: 
 BLD - neg 
 BIL - neg 
 URO +- norm 
 KET - neg 
 PRO - neg 
 NIT - neg 
 GLU - neg 
p.H 5.0 
 S.G <=1.005 
 LEU - neg 
 COL LT. Yellow 
 CLA Clear 
 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 38 
5.6 Data Management 
Touch “Data” icon at ‘Home’ menu [F5.6.1], then the following menu [F5.6.2] will be displayed. 
 
[ F 5.6.1]‘Home’ menu [ F 5.6.2]‘Data’ menu 
 
5.6.1 Data View 
Touch “Data View” to view and print test results. Press “Previous” button to review previous results, 
and press “Next” button for the next results. Results [F 5.6.2] will be displayed including 
measurement time and sample’s ID. 
To print the data displayed on the screen, touch ‘Print’ button at ‘Data’ menu [F5.6.2] Use the 
buttons “Previous / Next” to find a result you want to print. 
The memory capacity is upto 3,000 tests and you can simply print test results by pressing “PRINT” 
button. If necessary, the number of copies for printing can be settled at ‘Set Printer’ menu, up to 9 
copies. See 5.2.3.4 Set Printer for more information. 
 
5.6.2 Area Print 
This menu is to print more than one test result at a time by specifying the printing area –‘Start’ and 
‘End’. Press ‘Start’ at the first line to call the number pad and input the first data. Press ‘End’ at the 
second line to call the number pad and input the last ‘Data” 
Select the type of data you want to print - “All”, “Abnormal” or “Abnormal list”. It will change one to the 
other repeatedly by pressing the “Data” button. Press ‘Print’ button to print the selected area and 
type of data. 
 
Data # / Total # of data 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
39 / URiSCAN PRO Operator’s manual 
All : print out test results for all specimens 
Abnormal : print out test results for all specimens classified as “Abnormal” 
Abnormal list : print out sample’s ID and test portions for all specimens classified as “Abnormal”. 
 
[ F 5.6.3]‘Area Print’ Menu 
5.7 Color & Clarity 
URiSCAN®
 
 PRO can report urine color and clarity. Press “Color” icon at ‘Home’ menu to go Color 
and Clarity options. 
[F5.7.1] ‘Home’ menu [F5.7.2] ‘Color’ menu 
5.7.1. Color 
Press “Color” button on the menu to report urine color. 
[1. Color] In order to report urine color, select the appropriate option: 
1) Off : when you do not need to report urine color. 
2) Manual : when you want to report urine color manually. 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 40 
* To report urine color manually : 
If the color of urine is different than the default color, press “Color” button during 
measurement. The screen below [F5.7.3] will appear. 
 
[F5.7.3] Input Color 
3) Auto: When you want to have the report of urine color read by analyzer automatically . 
The analyzer can report with the following colors : 
DK.Yellow, Yellow, LT.Yellow, DK.Orange, Orange, DK.Red, Red, Green, DK.Green, 
Brown, DK.Brown, Others. 
[2. Set Color] 
1) To set the default color 
2) To display an abnormal urine color with a shade 
3) To change the color name 
 
1) To set the default color 
a. Basic default color is indicated with ( D). 
b. If you want to change the basic default value, touch the text corresponding to the desired 
default color and press the “Default” button. 
 
2) To display an abnormal urine color with a shade 
a. Abnormal color is indicated with (Ab). 
b. To select abnormal urine color(s), touch the text corresponding to the desired abnormal 
color. Then, press the “Abnormal” button. For example, if you select Brown and press 
“Abnormal” button, Brown is displayed as an abnormal urine color. You can choose all 
SECTION 5 ROUTINE WORKING PROCEDURES 
 
41 / URiSCAN PRO Operator’s manual 
colors except the default color. To remove any color from the abnormal list, follow the 
above procedure again. 
 
3) To change the color name 
 If you want to change the color name, e.g., from “Yellow” to “Straw”, touch the text 
corresponding to the color you wish to change. After that, press the “Name” button. Then the 
keypad will be displayed. 
Input new characters one by one with touch keypad. You can move to the next character with -
> key. When finished, press “Save” button to save. The number of characters is limited to 12. 
1) “Enter” button is used to save the chosen name. 
2) “Cancel” button is used to escape from the menu. 
3) Space key is used to add the space or move to the right side. 
4) Clear key is used to delete the words while moving to the left side. 
 
5.7.2. Clarity 
Press “Clarity” button on the menu to report urine clarity. 
 
[F5.7.5] Input Clarity 
[1. Clarity] In order to report urine clarity, select the appropriate option: 
1) Off : If you do not need to report urine clarity 
2) Manual : If you want to report urine clarity manually 
ROUTINE WORKING PROCEDURES SECTION 5 
 
 URiSCAN PRO Operator’s manual / 42 
* To report urine clarity manually: 
If the color of the urine is different than the default clarity, press “Color” button 
during measurement. Input the color manually and press “Save” button. See 
[F5.7.3] 
If the clarity of the urine is different than the default clarity, press “Color” button 
during measurement. Input the clarity manually and press “Save” button. See [Fig 
5.7.5] 
[2. Set Clarity] 
1) To set the default clarity 
2) To display an abnormal urine clarity with a shade 
3) To change the clarity name 
1) To set the default clarity 
a. Basic default color is indicated with (D). 
b. If you want to change the basic default value, press the text corresponding to the desired 
default clarity. For example, if you want the changed default value to be Mucous, you can 
press “Mucous”. Then, press “Default”. 
 
2) To display an abnormal urine clarity with a shade 
a. Abnormal color indicated with (Ab). 
b. To select abnormal urine clarity(ies), touch the text corresponding to the desired abnormal 
clarity. Then, press the “Abnormal” button. For example, if you select “Bloody” and press 
“Abnormal” button, “Bloody” is displayed as abnormal urine clarity. You can choose all 
clarities except the default clarity. To remove any clarity from the abnormal list, follow the 
above procedure again. 
 
3) To change the clarity name 
If you wantto change the clarity name, e.g., from “Clear” to “Normal”, touch the text 
corresponding to the clarity you wish to change. After that, press the “Name” button. 
Next procedure is same as color name change. See 5.7.1
SECTION 6 APPENDIX 
 
43 / URiSCAN PRO Operator’s manual 
 
 
 
 
 
 
 
APPENDIX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 44 
6.1 Communciation 
6.1.1 Host Communication 
 a) Data format 
 Baud rate (bps) : 9600, 19.2K, 38.4K, 57.6K, 115.2K 
 Data bit (bit) : 7 or 8-bit code 
 Parity bit (bit) : None, Odd, Even 
 Stop bit (bit) : 1 or 2 stop bits 
 b) Hardware connection 
 
 
 
 
 
 
 
 
 
c) Download protocol structure 
 Start character 
 Data field (optional) 
 CR (OxOD) 
 LF (OxOA) 
Data transmission order is the same as Print Out order. The end of each line is sent as Line 
Feed(LF) and Carriage Return(CR). The frame identification encodes the purpose of the 
transmitted block and provides the receiver with additional information at the start of the block. 
 
Urine Analyzer PC Host 
Female 
9pin RS-232 
connector 
Male 
9pin RS-232 
 
SECTION 6 APPENDIX 
 
45 / URiSCAN PRO Operator’s manual 
Other data rather than the communication control protocol (Start Code, end, LF, CR) are 
transmitted as ASCii Code. 
6.1.2 Barcode Reader Communication 
Either USB or RS-232C serial type barcode scanner can be used. 
6.1.3 Parallel Communication 
Parallel communication is used for an external printer. It consists of 25 pin adopter. 
 
6.2 Adjusting URiSCAN®
User may adjust the factory-installed value of instrument for convenience by touching the 
“Maintenance” icon. 
 PRO 
User must enter password to : 
- Change Password 
- Change R% 
- Change Test Order 
- Erase saved data 
- Factory Reset 
Input password “1111111” (factory installed password) and press “ENTER” button. 
The following “Maintenance” menu screen appears. 
 
[F 6.2.1] Maintenance menu 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 46 
6.2.1 How to Change Password 
 
Factory installed password is [1111111]. 
User may change password as follows. Press “Maintenance” icon. Then, press “Change password” 
button. After entering, enter the old password and press “ENTER” button. Then, enter new password 
and press “Save” button. 
 
 
[F 6.2.2] Change password 
SECTION 6 APPENDIX 
 
47 / URiSCAN PRO Operator’s manual 
6.2.2 How to Adjust R% 
R% program is factory-installed. User can adjust this parameter. From the Maintenance menu, enter 
password then select “Change R%”.Press the button to select test parameter, which is to be adjusted, 
then touch “Change”. 
 
 
[F 6.2.3] Password input [F 6.2.4] Select parameter 
 
[F 6.2.5] Select Grade [F 6.2.6] R% Input 
 
Touch the R% value you wish to change, enter the new value, then press “ENTER.” In addition, the 
grade can be adjusted by pressing grade part on the screen. Press “Reset Grade” button to return 
to the default value. Press “Save” button after adjusting. 
To return to the initial standard R%, Press “Factory reset” in he “Maintenance” menu. 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 48 
6.2.3 How to Change Test Order 
URiSCAN® PRO is factory programmed to print out test results in the same order as the test pads 
found on URiSCAN® 
From the Maintenance menu, enter password, then select “Change Test Order.” Touch “User order 
use” to set to “On.” 
PRO urine test strip. But User can change the order of the test results as one 
requires. 
Press the parameter name then the “Up” or Down” button to change the order of that test parameter. 
Stop at the desired test parameter. 
After setting the order of all the test parameters, press “Save” button to save changed order. 
 
[F 6.2.7] Change Test Order 
 
 
[F 6.2.8] Erase saved data [F 6.2.9] Factory Reset 
SECTION 6 APPENDIX 
 
49 / URiSCAN PRO Operator’s manual 
6.2.4 Erase saved data 
User can erase saved test data and initialize serial ID by using Erase saved data button. From the 
Maintenance menu, enter password, then select “Erase saved data”. After pressing the button, a 
warning message will appear. To continue, press the OK button. See [F 6.2.8] 
 
6.2.5 Factory Reset 
User can reset all settings to the original factory settings by using Factory Reset button. 
It erases all the saved data and allows the machine to return to all factory installed settings. From the 
Maintenance menu, enter password, then select “Factory Reset.” A warning message will appear. To 
continue, press the OK button. See [F 6.2.9] 
 
6.2.6 How to check Mechanical Operation 
User can use the buttons on the maintenance menu to check the mechanical operation of the device 
such as initialization of the feeder position, carrier 1 step move, Optic forward & backward. 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 50 
6.3 Touch Screen Calibration 
 
Users can do calibration for Touch screen 
Power on the analyzer while touching the LCD 
Touch the white point precisely 
Touch the white point when the white point is moved to other spots in the screen with alarm 
 
 
 
 
 
 
 
 
 
 
 
 
 
Do it once again to apply the touch calibration into the system and wait for 5 seconds. After that, new 
touch calibration is adjusted. 
* Do not touch the LCD for 5 seconds. 
 
Touch Point 
SECTION 6 APPENDIX 
 
51 / URiSCAN PRO Operator’s manual 
6.4 Program for the Sensitivity of Each Parameter 
 
The following tables describe sensitivity of each test parameter according to its concentration. 
 
『*』means the sensitivity standard, the first positive result detected by URiSCAN®
 
 PRO 
Blood 
Results - ± + ++ +++ 
Concentration 
(Conv. Units) 
neg 5 10 50 250 RBC/µL 
Concentration 
(SI Units) 
neg 5 10 50 250 RBC/µL 
Ranges 0~4 5*~7 8~29 30~140 141< 
 
Bilirubin 
Results - + ++ +++ 
Concentration 
(Conv. Units) 
neg 0.5 1.0 3.0 mg/dL 
Concentration 
(SI Units) 
neg 9 17 50 µmol/L 
Ranges 0~0.4 0.5*~0.7 0.8~1.9 2.0< 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 52 
Urobilinogen 
Results ± + ++ +++ ++++ 
Concentration 
(Conv. Units) 
norm 1.0 4.0 8.0 12.0 mg/dL 
Concentration 
(SI Units) 
norm 16 66 131 197 µmol/L 
Ranges 0.1~1.0 2.0*~2.9 3.0~6.0 7.0~10.0 11.0< 
 
Ketones 
Results - ± + ++ +++ 
Concentration 
(Conv. Units) 
neg 5 10 50 100 mg/dL 
Concentration 
(SI Units) 
neg 0.1 1 5 10 mmol/L 
Ranges 0~4 5*~7 8~29 30~74 75< 
 
Protein 
Results - ± + ++ +++ ++++ 
Concentration 
(Conv. Units) 
neg 10 30 100 300 1000 mg/dL 
Concentration 
(SI Units) 
neg 0.1 0.3 1 3 10 g/L 
Ranges 0~29 30*~60 61~80 81~200 201~600 601< 
 
 
SECTION 6 APPENDIX 
 
53 / URiSCAN PRO Operator’s manual 
Nitrite 
Results - + 
Concentration 
(Conv. Units) 
neg pos 
Concentration 
(SI Units) 
neg pos 
Ranges 0~0.04 0.05<* 
 
Glucose 
Results - ± + ++ +++ ++++ 
Concentration 
(Conv. Units) 
neg 100 250 500 1000 2000< mg/dL 
Concentration 
(SI Units) 
neg 5.5 14 28 55 111 mmol/L 
Ranges 0~49 50*~175 176~375 376~750 751~1499 1500< 
 
pH 
Results 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 
Concentration 
(Conv. Units) 
5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 
Concentration 
(SI Units) 
5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 
Ranges >5.2 5.3~5.7 5.8~6.2 6.3~6.7 6.8~7.2 7.3~7.7 7.8~8.2 8.3~8.7 8.8< 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 54 
S.G. 
Results >1.005 1.010 1.015 1.020 1.025 1.030< 
Concentration 
(Conv. Units) 
>1.005 1.010 1.015 1.020 1.025 1.030< 
Concentration 
(SI Units) 
>1.007 1.008~12 1.013~17 1.018~22 1.023~29 1.030< 
Ranges 
 
Leucocytes 
Results - ± + ++ +++ 
Concentration 
(Conv. Units) 
neg 10 25 75 500 WBC/µL 
Concentration 
(SI Units) 
neg 10 25 75 500 WBC/µL 
Ranges 0~9 10*~17 18~60 61~300 301<Ascorbic acid 
Results - + ++ +++ 
Concentration 
(Conv. Units) 
neg 10 25 50 mg/dL 
Concentration 
(SI Units) 
neg 0.6 1.4 2.8 mmol/L 
Ranges 0~9 10*~16 17~35 36< 
 
 
SECTION 6 APPENDIX 
 
55 / URiSCAN PRO Operator’s manual 
6.5 Value of the Initial Standard R% 
 
Following is the initial standard R% (reflection rate) of URiSCAN®
 
 Pro. Following range values 
are not immutable, so users may adjust R% a little bit in the range of ± 20. 
1. Blood 2. Bilirubin 3. Urobilinogen 
Change R% for BLD. 
 - neg <= [ 11 ] 
 +- 5 <= [ 28 ] 
 + 10 <= [ 50 ] 
 ++ 50 <= [ 70 ] 
 +++ 250 > [ 70 ] 
Change R% for BIL. 
 - neg <= [ 20 ] 
 + 0.5 <= [ 28 ] 
 ++ 1.0 <= [ 34 ] 
 +++ 3.0 > [ 34 ] 
Change R% for URO. 
 +- norm <= [ 19 ] 
 + 1.0 <= [ 32 ] 
 ++ 4.0 <= [ 42 ] 
 +++ 8.0 <= [ 51 ] 
 ++++ 12.0 > [ 51 ] 
4. Ketones 5. Protein 6. Nitrite 
Change R% for KET. 
 - neg <= [ 16 ] 
 +- 5 <= [ 23 ] 
 + 10 <= [ 32 ] 
 ++ 50 <= [ 44 ] 
 +++ 100 > [ 44 ] 
 
 
 Change R% for PRO. 
 - neg <= [ 16 ] 
 +- 10 <= [ 22 ] 
 + 30 <= [ 35 ] 
 ++ 100 <= [ 45 ] 
 +++ 300 <= [ 55 ] 
 ++++ 1000 > [ 55 ] 
Change R% for NIT. 
 - neg <= [ 10 ] 
 + pos > [ 10 ] 
 
 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 56 
7. Glucose 8. pH 9. Specific Gravity 
 
Change R% for GLU. 
 - neg <= [ 13 ] 
 +- 100 <= [ 23 ] 
 + 250 <= [ 33 ] 
 ++ 500 <= [ 45 ] 
 +++ 1000 <= [ 57 ] 
 ++++ 2000 > [ 57 ] 
 
 
 
 
 
 Change R% for pH. 
 pH 5.0 <= [ 26 ] 
 pH 5.5 <= [ 34 ] 
 pH 6.0 <= [ 43 ] 
 pH 6.5 <= [ 65 ] 
 pH 7.0 <= [ 94 ] 
 pH 7.5 <= [ 135 ] 
 pH 8.0 <= [ 185 ] 
 pH 8.5 <= [ 195 ] 
 pH 9.0 > [ 195 ] 
 
Change R% for S.G. 
<= 1.005 <= [ 15 ] 
 1.010 <= [ 25 ] 
 1.015 <= [ 35 ] 
 1.020 <= [ 50 ] 
 1.025 <= [ 70 ] 
>= 1.030 > [ 70 ] 
 
10. Leucocytes 11.Ascorbic Acid 12. Color 
 
Change R% for LEU. 
 - neg <= [ 7 ] 
 +- 10 <= [ 15 ] 
 + 25 <= [ 25 ] 
 ++ 75 <= [ 32 ] 
 +++ 500 > [ 32 ] 
 
 
 
Change R% for VTC. 
 - neg <= [ 20 ] 
 + 10 <= [ 65 ] 
 ++ 25 <= [ 110 ] 
 +++ 50 <= [ 110 ] 
 
Change R% for COL. 
Straw <= [ 10 ] 
LT.Color <= [ 20 ] 
Color <= [ 40 ] 
DK.Color >[ 40 ] 
 
SECTION 6 APPENDIX 
 
57 / URiSCAN PRO Operator’s manual 
13. Color Degree 
 
Change R% for COL.DEG 
Other <= [300 ] 
Red <= [ 15 ] 
Brown <= [ 40 ] 
Orange <= [ 50 ] 
Yellow <= [ 90 ] 
Green <= [ 140 ] 
Other <= [ 140 ] 
 
 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 58 
6.6 Quality Controls 
 
Performance Check with Urine Control Solutions 
The following procedure provides a check on reagent strip performance and instrument operation. 
This procedure is intended to provide confidence that reagent strips are reacting and being read 
properly. Errors resulting from user techniques can also be detected. Perform two levels of 
controls under the following conditions: 
a. When operating new URiSCAN®
b. When using a new bottle of reagent strips 
 Pro analyzer with reagent strip 
c. When changing instrument operator 
d. Whenever test results are in doubt 
For performance check of URiSCAN® Pro with URiSCAN®
The controls provide positive or defined reactions when used with URiSCAN
 reagent strips, prepare ready-to-use 
control solutions like UriTrol Urinalysis controls from YD, and do performance check. 
®
a. Improper technique or instrument setup. Check that reagent strip being used corresponds to 
the reagent strip name given on the status print out. 
 reagent strips for 
urinalysis. If the performance check falls outside of the expected values, the following sources of 
error may have occurred 
b. Deterioration of the reagent strip test areas due to exposure to light, ambient moisture or 
heat. Obtain a fresh bottle of the URiSCAN®
c. Deterioration of the control solution. Obtain fresh control solution and repeat 
instrument/reagent strip performance check procedure. 
 reagent strips being used and repeat the 
instrument/reagent strip performance check procedure. 
d. URiSCAN®
the instrument/reagent strip performance check procedures cannot be successfully completed 
and an instrument malfunction or reagent strip problem is suspected, see Troubleshooting, or 
contact Technical Support for assistance. 
 PRO instrument malfunction. Perform an initial instrument check. If 
SECTION 6 APPENDIX 
 
59 / URiSCAN PRO Operator’s manual 
6.7 Troubleshooting Guide 
 
TROUBLE CAUSES REMEDIES 
The device will not 
work even though 
power source is on. 
a) The connection part for 
power source maybe loose. 
b) The fuse may be cut due to 
electric load and impact. 
 
a) Reconnect the power source. 
b)* Ask for Service. 
The test result does 
not print. 
a) The thermal paper may not 
be loaded correctly. 
 
b) The printer setting maybe 
'off' 
a) Reload the thermal paper, so 
that its front side (the side 
which is scratched black by a 
fingernail) faces forward. The 
paper should roll from the 
bottom up. 
b) Set the printing environment 
at 'on' under System 
Configuration 
 * Ask for Service 
The printed letters 
look dim. 
a)The condition of printing 
paper roll maybe poor. 
b) The paper roll 
recommended by manufacturer 
is not used. 
a) Remove the poor part of the 
paper and then reload. 
 
b) Replace the roll with the 
recommended one. 
Letters are printed 
partially. 
a) The dots on the thermal 
head of the printer may be 
damaged in part. 
a) Ask for Service to have the 
head replaced. 
 
 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 60 
 
TROUBLE CAUSES REMEDIES 
Test result is too high 
or low uniformly. 
a) The quality of test strip 
deteriorated. 
b) The current test strip and the 
one used for calibration may 
differ in terms of quality or lot 
number. 
c) The check strip may be 
spoiled or poor quality water 
could have been used during 
calibration. 
a) Replace the test strip and 
conduct the test again. 
b) Check if test items and lot 
numbers match and calibrate 
the test strip again. 
c) Try the test using the urine 
control. Re-Calibrate using new 
check strip and fresh distilled 
water. 
The test results are 
irregular. 
a) A test paper deteriorated by 
moisture or direct light 
may have been used. 
b) The test strip may have been 
spoiled by other impeding 
material. 
 
c) Excessive amounts of urine 
may have remained on test 
strip. 
a) Use a new test strip for 
calibration and testing. 
 
b) Remove the impeding 
materials. 
- Clean the strip holder. 
- Do not use any test strip fallen 
on the floor 
- Immerse the test strip fully. 
- Have the excessive amounts of 
urine absorbed into a tissue. 
The test strip is 
 Jammed at the 
measuring point. 
a) The test strip may be Poor 
(bent or larger than specified) 
b) The test strip may have 
not been loaded on the strip 
guide plate correctly. 
a) Replace the test strip. 
b) Place the test strip on the strip 
holder and conduct the test again. 
 
 
SECTION 6 APPENDIX 
 
61 / URiSCAN PRO Operator’s manual 
6.8 Error Code 
 
6.8.1 Calibration Error Code 
6.8.1.1 Strip Error 
- Retry Calibration. 
 10-12 
10-13 
10-14 
10-15 
10-16 
Strip loading 
Reverse Strip 
No Strip 
Strip type 
Calibration block 
 
6.8.1.2 D.W Strip Error 
- You might have used other materials as Saline, Water, Urine ect. Or D.W could be 
contaminated. Retry calibration with clean Distilled Water. 
- Strip may have discolored. Check the Base color of Strip pad. 
 10-23 Leucocytes 
 10-24 S.G 
 10-25 pH 
 10-26 Glucose 
 10-27 Nitrite 
 10-28 Protein 
 10-29 Ketones 
 10-30 Urobilinogen 
 10-31 Bilirubin 
 10-32 Blood 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 62 
6.8.2 Measure Error code 
Retry Measure. 
10-12 
10-13 
10-14 
10-15 
10-16Strip loading 
Reverse Strip 
No Strip 
Strip type 
Calibration block 
 
6.9 Product List for URiSCAN Pro 
No Product Test Parameters 
1 U12 4 Hemo/GPH strip Blood, Glucose, Protein, pH 
2 U22 5 Hemoketo/GPH strip Ketones, Glucose, Protein, pH, Blood 
3 U25 6L strip Glucose, Protein, Nitrite, pH, Blood, Leucocytes 
4 U26 8 strip 
Blood, Bilirubin, Urobilinogen, Ketones, Protein, 
Nitrite, Glucose, pH 
5 U27 7 strip 
Blood, Bilirubin, Urobilinogen, Ketones, Protein, 
Glucose, pH 
6 U37 9 SG strip 
Blood, Bilirubin, Urobilinogen, Ketones, Protein, 
Nitrite, Glucose, pH, S.G 
7 U39 10SGL strip 
Blood, Bilirubin, Urobilinogen, Ketones, Protein, 
Nitrite, Glucose, pH, S.G, Leucocytes 
8 U41 11 strip 
Blood, Bilirubin, Urobilinogen, Ketones, Protein, 
Nitrite, Glucose, pH, S.G, Leucocytes, Ascorbic acid 
 
 
SECTION 6 APPENDIX 
 
63 / URiSCAN PRO Operator’s manual 
6.10 Summary of Waiver Studies 
 
Summary of Waiver Studies by Untrained Users 
At 3 sites, 60 untrained users with no laboratory experience tested 21 masked, randomized samples 
using URiSCAN® PRO and URiSCAN® urine test strips. These samples cover 42 urinalysis 
results for 10 parameters found on URiSCAN® 10-parameter urine test strip: blood, bilirubin, 
urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity and leukocytes. The 21 samples 
were prepared from control solutions to obtain the following levels: blood (negative, 1+, 2+, 3+), 
bilirubin (negative, 1+, 2+), urobilinogen (trace, 1+, 2+, 3+), ketones (negative, trace, 1+, 2+, 3+), 
protein (negative, trace, 1+, 2+, 3+, 4+), nitrite (negative, positive), glucose (negative, trace, 1+, 2+, 
3+, 4+), pH (5.0, 6.0, 7.0, 8.0), specific gravity (1.005, 1.010, 1.020) and leukocytes (negative, 1+, 2+, 
3+). This study demonstrated that the accuracy of URiSCAN® Urine Analyzer and URiSCAN®
 
 strips 
in the hands of untrained users was comparable to the accuracy of the test system in the hands of 
professional users. 
Summary of Studies by Professional Users 
Professional users evaluated the performance of the predecessor of URiSCAN® PRO using 
URiSCAN® urine test strip. This evaluation was conducted at a university hospital setting, where the 
performance of URiSCAN® PRO in the areas of precision, accuracy, linearity and correlation with 
two other urinalysis instruments was analyzed. The results were excellent for within-run, between-run 
and between-day precision. Accuracy results were 80% for one of the test parameters, and 100% for 
all other test parameters in relation to known reference values. The assessment of linearity was 
satisfactory for each of the grades of test parameters examined, while the correlation between the 
results of URiSCAN® PRO and two other urinalysis analyzers was high. Given the results of these 
tests, it was concluded that URiSCAN® PRO can be used effectively in the clinical setting because 
of its excellent precision, accuracy, linearity and correlation with other urinalysis analyzers on the 
market. 
 
URiSCAN® PRO WARRANTY CERTIFICATE 
- URiSCAN® PRO is guaranteed by the manufacturer for a period of 1(one) year after the date of 
purchase against defects due to faulty workmanship or materials. The guarantee covers both piece 
parts and labor. Service under guarantee is only provided upon presentation of reasonable evidence 
(completed guarantee card or purchase receipt) that date of the claim is within the guarantee period. 
The guarantee is not valid if the defect is due to accidental damage, misuse or neglect and in case of 
alternations or repair carried out by unauthorized persons. 
APPENDIX SECTION 6 
 
 URiSCAN PRO Operator’s manual / 64 
6.11 Shipment inspection sheet 
 
Product Name : URiSCAN® PRO 
INSPECTION PLAN 1. Electronic Test (YDMF-107-07) 2. Mechanical Test (YDMF-107-07) 
3. Clinical Test (YDMF-107-07) 4. Packaging Check (YDMF-107-07) 
5. Operating Condition Test (YDMF-107-07) 
No Test Field Item Result 
1 Electronic Test - Electronic Test 
- Safety Test 
- System self Test 
- Automatic Calibration (Power-On) 
- Electromagnetic Interference 
- LCD display 
passed 
passed 
passed 
passed 
passed 
passed 
2 Mechanical Test - Motor Operation Test 
- Impact Strong Test 
- Noise & Vibration 
- Printer Operation Test 
passed 
passed 
passed 
passed 
3 Clinical Test - Urine Investigation (5-11 Item) 
- Q.C (by YD Diagnostics strip) 
passed 
passed 
4 Packaging Check - Insert (manual, power code, etc.) 
- Box 
passed 
passed 
5 Operating 
Condition Test 
- Temperature Range : 2℃ - 30℃ 
- Usage Voltage : AC 100 - 240V (50/60Hz) 
- Humidity Range : 10% - 70% 
passed 
passed 
passed 
Remark 
 
 
 
 
Analyst Certification / S.W.Lee 
Certificate Approval / E.Y.Kim 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
URiSCAN PRO 
URINE ANALYZER 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2015-04/ Rev.01) Printed in Korea 
	1.1 General Introduction
	1.2 Introduction of Optical System
	( Auto memory function
	( Easy access to review tested results stored in database
	( Program in eight languages
	English, Russian, Spanish, German, Italian, Portuguese, Chinese, Korean
	( Self-adjustable relevant voltage (AC 100 - 240V, 50/60Hz)
	( Communication interface
	( Selection of reading time
	( Simple & easy to clean
	( Urine color & clarity reading
	1.5 References
	/ : Conformity European(CE) mark
	/ : IN VITRO DIAGNOSTIC MEDICAL DEVICE
	/ : CONSULT INSTRUCTIONS FOR USE
	/ : Waste Electrical and Electronic Equipment(WEEE) mark
	/ : AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
	/ : CAUTION, CONSULT ACCOMPANYING DOCUMENTS
	/ : MANUFACTURER
	/ : DATE OF MANUFACTRUE
	2.1 Technical Specifications
	Controls Used for
	Operating System
	Short Operating
	Instructions
	Short Operating Instructions
	Routine Working
	Procedures
	5.1 System Initializing
	5.2 System Configuration
	5.2.2 Set Comm.
	5.2.3 Set Printer
	5.2.3.1 Internal Printer, External Printer
	5.2.3.2 Data print
	5.2.3.3 ID print
	5.2.3.4 Number
	5.2.3.5 Operator ID print
	5.3 ID Management
	5.5 Measurement
	5.6.1 Data View
	To print the data displayed on the screen, touch ‘Print’ button at ‘Data’ menu [F5.6.2] Use the buttons “Previous / Next” to find a result you want to print.
	5.6.2 Area Print
	5.7 Color & Clarity
	APPENDIX
	6.1 Communciation
	6.1.1 Host Communication
	6.1.2 Barcode Reader Communication
	6.1.3 Parallel Communication
	6.2 Adjusting URiSCANP®P PRO
	6.2.1 How to Change Password
	6.2.2 How to Adjust R%
	6.2.3 How to Change Test Order
	6.2.4 Erase saved data
	6.2.5 Factory Reset
	6.2.6 How to check Mechanical Operation
	6.3 Touch Screen Calibration
	6.4 Program for the Sensitivity of Each Parameter
	6.5 Value of the Initial Standard R%
	6.6 Quality Controls
	Performance Check with Urine Control Solutions
	6.7 Troubleshooting Guide
	6.8.2 Measure Error code
	Retry Measure.
	6.9 Product List for URiSCAN Pro
	6.10 Summary of Waiver Studies
	6.11 Shipment inspection sheet