PRO Manual - Rev01 - 20150518 - ENG PDF

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
SYSTEM OVERVIEW
1 / URiSCAN PRO Operator’s manual

SYSTEM OVERVIEW SECTION 1
1.1 General Introduction

URiSCAN® PRO Urine Analyzer is designed for use with URiSCAN® 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.
Also, even users who are unfamiliar with this kind of instrument can easily operate the Urine Analyzer
without additional training.
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.
Optical Lens CCD

Analog-to Digital Converter

CPU
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
URiSCAN PRO Operator’s manual / 2

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®11 Strip

Vt. C Leucocytes S.G pH Glucose Nitrite Protein Ketones Bilirubin Blood
Compensation area Urobilinogen

SYSTEM OVERVIEW SECTION 1
1.4 Main Functions

 Auto memory function
3,000 test results are stored automatically.
 Calibration Data
30 control data per each URiSCAN® test strip (selectable during testing)
 Easy access to review tested results stored in database
Area print
Special data print
 Test parameters
4 ~ 11 parameter URiSCAN® Strip
 Program in eight languages
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

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
INSTALLATION

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-86oF)
Humidity 10%-70%
□Storage Condition
Temperature 0oC-40oC (32 oF-104oF)
Humidity 10%-85%
□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

2.2 Unpacking
Upon receipt of URiSCAN® 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.
Carefully unpack the unit and check for completeness. Included in the carton should be the following:
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 serial communication 1EA
(Maximum length 3m)
Bar code reader 1EA
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.

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® 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.
URiSCAN® 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® PRO
Insert one end of power cord into back of URiSCAN® 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
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).
- Interface with Host Computer
URiSCAN® PRO can interface with sample ID and test results to a host computer.
- Interface with Bar Code Reader
Sample ID can be registered via keyboard on the instrument or bar code reader.

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.

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]

2.4 OPERATOR
2.4.1. Precaution for using URiSCAN PRO
The following precautions should be taken when operating or working near URiSCAN® PRO
- Do not use dangerous substances such as toxic, radioactive or contaminated material.

- 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® PRO are warranted at all times if it is operated under the
following environmental conditions:
- Indoor use.
- Main supply voltage fluctuation up to ±10% of the nominal value.
- In locations with temperatures between 2 oC and 30oC.
- In locations where the relative humidity is lower than 70%.
- In locations free from dust or vapors of solvents and acids.
- In locations free from vibrations.

2.5 Care and Maintenance

Warning :Disconnect URiSCAN® PRO from the power source before attempting any
cleaning or maintenance procedures.
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.
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
CONTROLS USED FOR

OPERATING SYSTEM

3.1 External Structure
Printer lever
TFT TOUCH LCD
Guide Plate
(Strip holder)

<Rear Side View>
< Front View> <Upper Side View>
<Left Side View> <Right Side View>

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

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 connecting with 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
SHORT OPERATING
INSTRUCTIONS

SHORT OPERATING INSTRUCTIONS SECTION 4
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® Strip Vial.
ID MANAGEMENT ----- Press “ID manager” icon at the main menu
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

ROUTINE WORKING
PROCEDURES

ROUTINE WORKING PROCEDURES SECTION 5
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® test strip
item.
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.

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® PRO before delivery, users should
check and set up the system configuration before measurement to get accurate results.
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.
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]

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

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

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.

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
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® 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”.

5.2.3.3 ID print
This is to print out the registered sample’s IDs. If it is at ‘On’, URiSCAN® PRO will print ‘ID for
measuring’, ‘Remain ID’ and ‘Error ID’ before measuring those samples.
‘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.
‘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.
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.

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.

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.

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

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

[F 5.4.5] Calibration Success
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
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.
Date :Apr-01-2011 Calibration Error
Time : 00:00:00 Retry Calibration
Success Calibration !
P39- 10 strip [39123]
BLD == 500
BIL == 500
URO == 502
KET == 500
PRO == 501
NIT == 500
GLU == 502
[F 5.4.6] Calibration Success [F 5.4.7] Calibration Fail
Press “History” at the calibration menu.

[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.

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
ID for Measuring Error ID Remain ID
0000111122223333 2 -34567890123452 123123123123

34567890123452
[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)
[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 already calibrated)
[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.

[F 5.5.7] No Tray
Test results will be shown as the following screen and also it will be printed out automatically.
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
[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.

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

Data # / Total # of data
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.

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.

* 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

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

* 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 want to 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
APPENDIX

APPENDIX SECTION 6
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
Female Male
9pin RS-232 9pin RS-232
connector
Urine Analyzer PC Host
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.

SECTION 6 APPENDIX
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® PRO

User may adjust the factory-installed value of instrument for convenience by touching the
“Maintenance” icon.
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
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
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
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® PRO urine test strip. But User can change the order of the test results as one
requires.
From the Maintenance menu, enter password, then select “Change Test Order.” Touch “User order
use” to set to “On.”
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
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
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
Touch Point
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.

SECTION 6 APPENDIX
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
neg 5 10 50 250 RBC/µL
(Conv. Units)
Concentration
neg 5 10 50 250 RBC/µL
(SI Units)
Ranges 0~4 5*~7 8~29 30~140 141<
Bilirubin
Results - + ++ +++
Concentration
neg 0.5 1.0 3.0 mg/dL
(Conv. Units)
Concentration
neg 9 17 50 µmol/L
(SI Units)
Ranges 0~0.4 0.5*~0.7 0.8~1.9 2.0<

APPENDIX SECTION 6
Urobilinogen
Results ± + ++ +++ ++++
Concentration
norm 1.0 4.0 8.0 12.0 mg/dL
(Conv. Units)
Concentration
norm 16 66 131 197 µmol/L
(SI Units)
Ranges 0.1~1.0 2.0*~2.9 3.0~6.0 7.0~10.0 11.0<
Ketones
Results - ± + ++ +++
Concentration
neg 5 10 50 100 mg/dL
(Conv. Units)
Concentration
neg 0.1 1 5 10 mmol/L
(SI Units)
Ranges 0~4 5*~7 8~29 30~74 75<
Protein
Results - ± + ++ +++ ++++
Concentration
neg 10 30 100 300 1000 mg/dL
(Conv. Units)
Concentration
neg 0.1 0.3 1 3 10 g/L
(SI Units)
Ranges 0~29 30*~60 61~80 81~200 201~600 601<

SECTION 6 APPENDIX
Nitrite
Results - +
Concentration
neg pos
(Conv. Units)
Concentration
neg pos
(SI Units)
Ranges 0~0.04 0.05<*
Glucose
Results - ± + ++ +++ ++++
Concentration
neg 100 250 500 1000 2000< mg/dL
(Conv. Units)
Concentration
neg 5.5 14 28 55 111 mmol/L
(SI Units)
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
5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0
(Conv. Units)
Concentration
5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0
(SI Units)
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
S.G.
Results >1.005 1.010 1.015 1.020 1.025 1.030<
Concentration
>1.005 1.010 1.015 1.020 1.025 1.030<
(Conv. Units)
Concentration
>1.007 1.008~12 1.013~17 1.018~22 1.023~29 1.030<
(SI Units)
Ranges
Leucocytes
Results - ± + ++ +++
Concentration
neg 10 25 75 500 WBC/µL
(Conv. Units)
Concentration
neg 10 25 75 500 WBC/µL
(SI Units)
Ranges 0~9 10*~17 18~60 61~300 301<
Ascorbic acid
Results - + ++ +++
Concentration
neg 10 25 50 mg/dL
(Conv. Units)
Concentration
neg 0.6 1.4 2.8 mmol/L
(SI Units)
Ranges 0~9 10*~16 17~35 36<

SECTION 6 APPENDIX
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. Change R% for BIL. Change R% for URO.
- neg <= [ 11 ] - neg <= [ 20 ] +- norm <= [ 19 ]
+- 5 <= [ 28 ] + 0.5 <= [ 28 ] + 1.0 <= [ 32 ]
+ 10 <= [ 50 ] ++ 1.0 <= [ 34 ] ++ 4.0 <= [ 42 ]
++ 50 <= [ 70 ] +++ 3.0 > [ 34 ] +++ 8.0 <= [ 51 ]
+++ 250 > [ 70 ] ++++ 12.0 > [ 51 ]
4. Ketones 5. Protein 6. Nitrite
Change R% for KET. Change R% for PRO. Change R% for NIT.
- neg <= [ 16 ] - neg <= [ 16 ] - neg <= [ 10 ]
+- 5 <= [ 23 ] +- 10 <= [ 22 ] + pos > [ 10 ]
+ 10 <= [ 32 ] + 30 <= [ 35 ]
++ 50 <= [ 44 ] ++ 100 <= [ 45 ]
+++ 100 > [ 44 ] +++ 300 <= [ 55 ]
++++ 1000 > [ 55 ]

APPENDIX SECTION 6
7. Glucose 8. pH 9. Specific Gravity
Change R% for GLU. Change R% for pH. Change R% for S.G.
- neg <= [ 13 ] pH 5.0 <= [ 26 ] <= 1.005 <= [ 15 ]
+- 100 <= [ 23 ] pH 5.5 <= [ 34 ] 1.010 <= [ 25 ]
+ 250 <= [ 33 ] pH 6.0 <= [ 43 ] 1.015 <= [ 35 ]
++ 500 <= [ 45 ] pH 6.5 <= [ 65 ] 1.020 <= [ 50 ]
+++ 1000 <= [ 57 ] pH 7.0 <= [ 94 ] 1.025 <= [ 70 ]
++++ 2000 > [ 57 ] pH 7.5 <= [ 135 ] >= 1.030 > [ 70 ]
pH 8.0 <= [ 185 ]
pH 8.5 <= [ 195 ]
pH 9.0 > [ 195 ]
10. Leucocytes 11.Ascorbic Acid 12. Color
Change R% for LEU. Change R% for VTC. Change R% for COL.
- neg <= [ 7 ] - neg <= [ 20 ] Straw <= [ 10 ]
+- 10 <= [ 15 ] + 10 <= [ 65 ] LT.Color <= [ 20 ]
+ 25 <= [ 25 ] ++ 25 <= [ 110 ] Color <= [ 40 ]
++ 75 <= [ 32 ] +++ 50 <= [ 110 ] DK.Color >[ 40 ]
+++ 500 > [ 32 ]

SECTION 6 APPENDIX
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
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® Pro analyzer with reagent strip
b. When using a new bottle of reagent strips
c. When changing instrument operator
d. Whenever test results are in doubt
For performance check of URiSCAN® Pro with URiSCAN® reagent strips, prepare ready-to-use
control solutions like UriTrol Urinalysis controls from YD, and do performance check.
The controls provide positive or defined reactions when used with URiSCAN® reagent strips for
urinalysis. If the performance check falls outside of the expected values, the following sources of
error may have occurred
a. Improper technique or instrument setup. Check that reagent strip being used corresponds to
the reagent strip name given on the status print out.
b. Deterioration of the reagent strip test areas due to exposure to light, ambient moisture or
heat. Obtain a fresh bottle of the URiSCAN® reagent strips being used and repeat the
instrument/reagent strip performance check procedure.
c. Deterioration of the control solution. Obtain fresh control solution and repeat
instrument/reagent strip performance check procedure.
d. URiSCAN® PRO instrument malfunction. Perform an initial instrument check. If
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.

SECTION 6 APPENDIX
6.7 Troubleshooting Guide
TROUBLE CAUSES REMEDIES
The device will not a) The connection part for a) Reconnect the power source.
work even though power source maybe loose.
b)* Ask for Service.
power source is on.
b) The fuse may be cut due to
electric load and impact.
The test result does a) The thermal paper may not a) Reload the thermal paper, so
not print. be loaded correctly. that its front side (the side
which is scratched black by a
fingernail) faces forward. The
b) The printer setting maybe
paper should roll from the
'off'
bottom up.
b) Set the printing environment

at 'on' under System
Configuration
* Ask for Service
The printed letters a)The condition of printing a) Remove the poor part of the
look dim. paper roll maybe poor. paper and then reload.
b) The paper roll

b) Replace the roll with the
recommended by manufacturer
recommended one.
is not used.
Letters are printed a) The dots on the thermal a) Ask for Service to have the
partially. head of the printer may be head replaced.
damaged in part.

APPENDIX SECTION 6
TROUBLE CAUSES REMEDIES
Test result is too high a) The quality of test strip a) Replace the test strip and
or low uniformly. deteriorated.
conduct the test again.
b) The current test strip and the b) Check if test items and lot
one used for calibration may
numbers match and calibrate
differ in terms of quality or lot
number. the test strip again.
c) Try the test using the urine
c) The check strip may be
control. Re-Calibrate using new
spoiled or poor quality water
could have been used during check strip and fresh distilled
calibration. water.
The test results are a) A test paper deteriorated by a) Use a new test strip for
moisture or direct light
irregular. calibration and testing.
may have been used.
b) The test strip may have been b) Remove the impeding

materials.
spoiled by other impeding
- Clean the strip holder.
material.
- Do not use any test strip fallen
c) Excessive amounts of urine on the floor
may have remained on test
- Immerse the test strip fully.
strip.
- Have the excessive amounts of
urine absorbed into a tissue.
The test strip is a) The test strip may be Poor a) Replace the test strip.
(bent or larger than specified)
Jammed at the b) Place the test strip on the strip
b) The test strip may have holder and conduct the test again.
measuring point.
not been loaded on the strip
guide plate correctly.

SECTION 6 APPENDIX
6.8 Error Code
6.8.1 Calibration Error Code
6.8.1.1 Strip Error
- Retry Calibration.
10-12 Strip loading
10-13 Reverse Strip
10-14 No Strip
10-15 Strip type
10-16 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
6.8.2 Measure Error code
Retry Measure.
10-12 Strip loading
10-13 Reverse Strip
10-14 No Strip
10-15 Strip type
10-16 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
Blood, Bilirubin, Urobilinogen, Ketones, Protein,

4 U26 8 strip
Nitrite, Glucose, pH

5 U27 7 strip
Glucose, pH

6 U37 9 SG strip
Nitrite, Glucose, pH, S.G

7 U39 10SGL strip
Nitrite, Glucose, pH, S.G, Leucocytes

8 U41 11 strip
Nitrite, Glucose, pH, S.G, Leucocytes, Ascorbic acid

SECTION 6 APPENDIX
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
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 passed
- Safety Test passed
- System self Test passed
- Automatic Calibration (Power-On) passed
- Electromagnetic Interference
passed
- LCD display
passed
2 Mechanical Test - Motor Operation Test passed
- Impact Strong Test passed
- Noise & Vibration passed
- Printer Operation Test passed
3 Clinical Test - Urine Investigation (5-11 Item) passed
- Q.C (by YD Diagnostics strip) passed
4 Packaging Check - Insert (manual, power code, etc.) passed
- Box passed
5 Operating - Temperature Range : 2℃ - 30℃ passed
Condition Test - Usage Voltage : AC 100 - 240V (50/60Hz) passed
- Humidity Range : 10% - 70% passed
Remark
Analyst Certification / S.W.Lee
Certificate Approval / E.Y.Kim

URiSCAN PRO
URINE ANALYZER
(2015-04/ Rev.01) Printed in Korea

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URiSCAN PRO

- Operator’s Manual - YM-027

SECTION 1 SYSTEM OVERVIEW

SECTION 5 ROUTINE WORKING PROCEDURES

1 / URiSCAN PRO Operator’s manual

1.1 General Introduction

1.2 Introduction of Optical System

Optical Lens CCD

* 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

URiSCAN PRO Operator’s manual / 2

1.3 Principles of Urinalysis Strips

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

U41 URiSCAN®11 Strip

Compensation area Urobilinogen

3 / URiSCAN PRO Operator’s manual

1.4 Main Functions

 Easy access to review tested results stored in database

Special data print

 Program in eight languages

English, Russian, Spanish, German, Italian, Portuguese, Chinese, Korean

 Self-adjustable relevant voltage (AC 100 - 240V, 50/60Hz)

USB communication – Bar code and external printer

 Selection of reading time

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

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: 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

5 / URiSCAN PRO Operator’s manual

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2.1 Technical Specifications

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URiSCAN® PRO instrument assembly

URiSCAN PRO 1Unit

(Maximum length 3m)

Bar code reader 1EA

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2.3.1 Installing URiSCAN® PRO

URiSCAN® PRO can interface with a host

The instrument can be connected with a host

- Interface with Host Computer

- Interface with Bar Code Reader

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2.3.3 Feeding Thermal Printing Paper

To insert the paper roll, open the printer cover by

Insert the paper roll into printer case so that the

Make sure that about 2 inches of paper is left

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2.3.4 Cleaning the guide plate

* How to separate the guide plate

1. Separate the guide plate by pulling it from the

2. Clean it with DW (Distilled Water) and dry it