OPTIMA Manual

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URiSCAN
URiSCAN optima
URINE ANALYZER
- Operator’s Manual -
YD (2012-01/ Rev.03) Printed in Korea

1. 1. GENERAL DESCRIPTION OF SYSTEM
1.1 General Introduction …………………………..…… 3
1.2 Introduction of Optical System ……………………. 4
1.3 Principles of Urinalysis Strips ………..…………… 5
1.4 Main Functions ………………………..…………… 6
2. INSTALLATION
2.1 Te c h n i c a l Sp e c i f i c a t i o n s … … … … … … … … … … … . . 8
2.2 Unpacking …………………………………………… 9
2.3 Installation …………………………..………………… 10
2.4 Operation ……………………………...………………. 13
2.5 Care and Maintenance ……………...……………….. 14
2.6 Disposal of the Analyzer ……………...……………… 14
3. CONTROLS USED FOR OPERATING SYSTEM

3.1 E x t e r n a l St r u c t u r e … … … … … … … . . … … … … … … … 1 6
3.2 Main Functions ……………………...………………… 17
4. SHORT OPERATING INSTRUCTIONS ……...…...…...………....…. 19
5. ROUTINE WORKING PROCEDURES
5.1 System Initializing …………..………………………… 22
5.2 System Conf igur at i o n … … … . . . … … … … … … … … … . 24
5.3 ID Management ………………..……………………… 28
5.4 Calibration …………………..……………………….… 31
5.5 Measurement ………………..………………………… 33
5.6 Data Management …………..………………………… 36
5.7 Color & Clarity ………………….……………………… 38
6. APPENDIX
6.1 Communication ……………...………………………… 44
6.2 Adjusting URiSCAN ® optima …………………………. 45
6.3 Program for the Sensitivity of Each Parameter …… 49
6.4 Value of the Initial Standard R% ……………..……… 52
6.5 Quality Controls ……………………………………… 54
6.6 Tr o u b l e s h o o t i n g G u i d e … … … … … … … … … … … … 5 5
6.7 Calibration Error Code ………………………...……… 57
6.8 Product List for URiSCAN ® optima …………………… 58
6.9 Summary of Wavier Studies Users ……….………… 58
6.10 Shipment Inspection Sheet ………...……..………………...…..60
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GENERAL DESCRIPTION OF SYSTEM
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URiSCAN optima OPERATOR’S MANUAL / 3
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1.
1.1 General Introduction
URiSCAN® optima Urine Analyzer is designed for use with URiSCAN® urine test
strips. Through ease of use, systematic data management and high technology,
the Optima 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
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* 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
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® optima 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
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1.4 Main Functions
p Auto memory function
2000 test results are stored automatically.
p Easy access to review tested results stored in database

Area print
Special data print
p Program in five languages

English, German, Italian, Spanish and Chinese
p Self-adjustable relevant voltage (110V or 220V AC 50/60Hz)
p Communication interface
Serial communication – Host computer
USB communication – Bar code and external printer
p Selection of reading time

Routine test mode : 100 sec. reading
Quick test mode : 6 sec. reading
p Simple & easy to clean

Strip holder
p Urine color & clarity reading

Auto reading for urine color & manual reading for clarity
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INSTALLATION
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2.
2.1 Technical Specifications
□ Manufacturer YD Diagnostics CO.,Ltd.
□ Type of Product Urine analyzer
□ Model Name URiSCAN® optima
□ Operation Mode Semi-automatic urine analyzer
□ Materials ABS resin
□ Dimension
Size 210mm(W) X 240mm(D) X 90mm(H)
Weight 970g (2.13 lb)
□ Electrical Input
Rated Voltage 110V ~ 220V
Rated Frequency AC 50/60Hz
Rated Power 42W
□ Operating Conditions
Temperature 20 oC-28 oC (68 oF-82 oF)
Humidity 10%- 70%
□ Storage Conditions
Temperature 0 oC-40 oC (32 oF-104 oF)
Humidity 10%-70%
□ Measurement Method
Type Reflectance photometers
Measurement Cycle Routine test mode 100 seconds
Quick test mode 6 seconds
Memory Capacity 2,000 tests
Light Source LED
Sensor CCD color image sensor
Result Display 4.3” TFT LCD
□ Printer High speed thermal-printer 203dpi (8dots/mm)
□ Host- Communication Bi-directional RS 232C interface for data transfer to Host
□ Peripherals Bar code reader, External printer
□ Safety Standard EN 61010-1, EN 61010-2-101:2002
□ EMC Standard EN 61326-2-6:2006
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2.
2.2 Unpacking
Upon receipt of URiSCAN® optima, 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® optima instrument assembly

URiSCAN® optima 1Unit
Thermal printer paper (57mm width) 1Roll
Adaptor and Power cord 1EA
Strip holder 1EA
Calibration block 5EA
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.
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2.
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® optima should not be used at temperatures colder

than 20°C and at humidity over 70%. The atmospheric pressure should be from
900 to 1600 mbar.
URiSCAN® optima 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® optima
Insert one end of power cord into back of URiSCAN® optima. Plug the other end of the
power cord into the wall socket. Turn on URiSCAN® optima using the button on the front
of the instrument.
2.3.2 Interface with Host Computer, Bar Code Reader and External Printer
URiSCAN® optima 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(USB port).
- Interface with Host Computer

URiSCAN® optima 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.
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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.
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2.
[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 Strip Holder
It is recommended that the silicon insert of the strip holder be cleaned daily for better
performance and accuracy.
To remove silicon insert for cleaning:

- Press “Maintenance” icon.
- Enter password “1111111.” Press “ENTER.”
- Press “OPEN”
[Fig 2.3.4.1]
1. Take out the silicon insert as

shown in Fig. 2.3.4.1
[Fig 2.3.4.2]
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2.
2. Wash the silicon insert of the strip
holder with DW (Distilled Water)
and place it out to dry as shown in
Fig. 2.3.4.2 to dry it.
[Fig 2.3.4.3]
3. After it is completely dry, place

the silicon insert in the home
position as shown in Fig. 2.3.4.3.
and then press “Close” on the
maintenance menu.
※ Silicon insert direction.
Up
Strip holder I
n
Silicon
s
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D
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Down Check point
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2.
If the strip holder is contaminated by urine or test results shows incorrectly, wash the
strip holder. If the strip holder has become defective, change the strip holder.
[Fig 2.3.4.4]
1. With the strip carrier base

secured, gently pull the strip holder
bottom toward you to remove it
from the strip carrier base as
shown in Fig. 2.3.4.4
[Fig 2.3.4.5]
2. Wash the strip holder with DW
(Distilled Water) and place the strip
holder as shown in Fig. 2.3.4.5 to
dry it.
[Fig 2.3.4.6]
3. After it is completely dry, place the
strip holder in the home position as
shown in Fig. 2.3.4.6. While securing
the strip carrier base, gently push the
strip holder in until it is flush with the
strip carrier base, and then press
“Close” on the maintenance menu.
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2.4 Operation
The power button is located at the front of the instrument. Press the button gently to turn
it on. To turn it off, press the button for more than one second.
Pr Precaution : This product is recommended for use only in hospital and clinical
laboratory or professional setting for the purpose of urine testing.
Environmental Conditions
Performance and safety of URiSCAN® optima 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 20 oC and 28 oC.
- 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.
Precaution for using URiSCAN optima

The following precautions should be taken when operating or working near URiSCAN®
optima.
- 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
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- Keep the system flat with the screen facing up at all times. Do not stand the
system up or place upside down
Warning : Use this product only under the environmental conditions
described above.
2.5 Care and Maintenance
Warning :Disconnect URiSCAN® optima 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 strip holder.
2.6 Disposal of the analyzer
Used analyzer should be disposed according to the safety regulations applicable at your
facility.
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CONTROLS USED FOR

OPERATING SYSTEM
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3.
3.1 External Structure
PRINTER
STRIP HOLDER COVER

TFT TOUCH LCD
STRIP HOLDER
POWER BUTTON
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3.
3.2 Main Functions
URiSCAN® optima consists of printer, Touch LCD and strip holder as described
above. The main functions are,
i TFT LCD display with touch screen

The LCD for reviewing the data and current status.
i Internal printer
Prints the results by high-speed thermal print method.
i External connection terminal

RS232C port for interface to USB port of host computer.
USB port for barcode reader and external printer.
USB port for flash drive.
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SHORT OPERATING
INSTRUCTIONS
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4.
Short Operating Instructions
POWER ON
Press the button at the front panel to power on, then the display will show a phrase "YD
Diagnostics". 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 5 seconds to check self-configuration.
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.
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 a test of an emergency sample by pressing “Emergency” button.
MEASUREMENT ----- Press “Measure” icon at the main menu

1. Routine test mode: Reads test strip in 100 sec.
2. Quick test mode: Reads test strip in 6 sec.
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. Select the test mode
and place the test strip on the strip holder, then press “Start” button. Test results will be
displayed on LCD in 100 seconds or 6 seconds respectively on Routine mode or Quick mode.
Test results will be printed out. Test results also can transfer to host computer and external
printer.
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COMMUNICATION ----- Press “Setting” icon at the main menu

URiSCAN® optima has a serial interfacing system to connect with a host computer.
COLOR & CLARITY ----- Press “Color” icon at the main menu
URiSCAN® optima can report urine color and clarity.
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ROUTINE WORKING
PROCEDURES
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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 5
seconds.
[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 ‘Home’ 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 on the LCD during the system initializing as [F 5.1.4].
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[F 5.1.3] ‘Home’ menu [F 5.1.4] Initial Complete
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5.
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® optima 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] ‘Home’ menu [F5.2.2] ‘Setting’ menu
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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® optima supports
both conventional units (mg/dL) and SI units (mmol/L). See [F.5.2.4]
[ 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]
8. Set Language URiSCAN® optima system is programmed to function in

5 languages: English, German, Italian, Spanish and Chinese
(depending on model). See [F.5.2.7]
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[ F 5.2.5] LCD Backlight [ F 5.2.6] ‘Buzzer’ setting [ F 5.2.7] ‘Language’ selection
5.2.1 Set Time
[ F 5.2.8] 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]
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5.2.2 Set Comm.
URiSCAN® optima 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:
Data Format
y Baud Rate (bps) : 9600
y Data Bit (bit) : 8-bit code
y Parity Bit (bit) : None
y Stop Bit (bit) : 1 stop bits
[F 5.2.9] Set Communication
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.
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®
optima 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.
[F 5.2.10]’ Set Printer’ menu
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5.
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® optima 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 “Emergency” button. URiSCAN® optima manages sample’s ID with two parts –
Serial ID and Sample ID.
Serial ID Number
The serial number is assigned automatically according to the measured sample's
order. Press “ID Manager” icon at ‘Home’ 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.
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[ F 5.3.1] ID Manager [ F 5.3.2]Serial ID reset [ F 5.3.3]Operator ID
Sample ID Number
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 bar code reader to register
the sample ID with up to 13 digit number. Sample ID
can be deleted by touching the button - “Delete” or
“Clear”.
The instrument can store up to 100 ID numbers. After

ID inputting through touching LCD, press “Enter”
button for the confirmation, then you can enter the
next sample’s ID number.
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 [F 5.3.4] Add ID
the quantity of ID numbers registered.
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
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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.
[ F 5.3.5] Add / Insert ID [ F 5.3.6] Delete select ID [ F 5.3.7] Clear
If you want to measure an emergency sample after you

finish the registration of all the samples’ IDs, press
“Emergency” button, then the mark “Emergency” will be
displayed on the LCD to show that it is an emergency
test. Dip a strip into the emergency specimen and blot
the strip on soft tissue in order to remove excessive
urine. Place test strip on the strip holder and enter the
emergency sample’s ID with touch LCD or barcode
reader. The original inputted ID will be displayed with
your next strip.
Operator ID Number
You can register the operator’s ID by touching
“Operator ID” at ‘ID manager’ menu and touch the LCD
to register
[ F 5.3.8] Emergency test
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5.
the operator ID with up to 10 digit number. You can switch from alphabetical to
numeric by touching “Mode 123” button.
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.
Calibration procedure must be done to balance the

reflectance rate in accordance with the reagent strip
and environmental influence.
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 [ F 5.4.1] Calibration
blot the strip on absorbent paper towel to remove excess liquid. Place the reagent
strip on the strip holder, then press “Start” button. See [ F 5.4.2]
If the calibration has finished successfully, the success message will be shown and
the calibration data will be printed out. [F 5.4.4] User can use this data for quality
control.
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5.
[F 5.4.2] Calibration with DW strip [F 5.4.3] Calibration [F 5.4.4] 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
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
p.H == 500
S.G == 501
LEU == 500
[F 5.4.5] Calibration Success [F 5.4.6] Calibration Fail
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5.
5.5 Measurement
Touch “Measure” icon at ‘Home’ menu[F 5.5.1] to start test, then the strip holder will
move out of the instrument automatically. Touch “Routine / Quick” button to select
Test mode at ‘Measurement’ menu[F 5.5.2]. It is toggled by touching the button –
Routine or Quick test mode.
[F 5.5.1] ‘Home’ menu [F 5.5.2] Measurement menu
1. Routine Test : 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 strip holder. Press “Start.” The instrument
reads the test strip in 100 seconds.
2. Quick Test : Dip a strip into the urine specimen and remove excessive urine.
Place the strip on the strip holder AFTER 100 seconds. In this mode, [Q] is shown at
the end of the ID line. Press “Start.” The instrument reads the strip in 6 seconds.
If any sample’s IDs were registered and the internal printer was set ‘On’, “ID for
Measuring” will be printed out as below. (See 5.2.3.3 ID print)
ID for Measuring Error ID Remain ID
0000111122223333 2 -34567890123452 123123123123

34567890123452
123123123123
[F 5.5.3] Print ‘ID for measuring’, ‘Error ID’ and ‘Remain ID’
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5.
The instrument will show a progress bar for about 100 Sec on Routine test mode
and 6 Sec on Quick test mode during the test.
[F 5.5.4] Routine test mode [F 5.5.5] Quick test mode
Test results will be shown on the display and also it will be printed out if the printer
status is set『On』.
Date : Mar – 01 - 2011

Time: 00 : 00 : 00
ID : 0001 – [Q]
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 5.5.6] Test result on the screen [F 5.5.7] Printed test result

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5.
The strip holder will come out after the measurement and the message “Remove
Strip and Place Test Strip” will be shown at the lower end of the LCD. Press
“Continue” button, when ready for the next test.
Once a measurement is done, you can return to “Measure” menu by pressing “Stop”
button. The test data will be stored in the instrument and loaded to the HOST while
working.
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 : 60 sec.
- Leucocytes: 90 ~ 120 sec.
Strip Disposal : Used test strip should be disposed according to the

safety regulations applicable at your facility.
®
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5.
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 up to 2,000 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.
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5.
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# [F5.6.3]’ of the printing area. Press ‘End’ at
the second line to call the number pad and input the last
‘Data# [F5.6.3]’ of the printing area you want.
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.
[ F 5.6.3] ‘Area Print’ Menu
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”.
®
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5.
5.7 Color & Clarity
URiSCAN® optima 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.
®
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5.
[F5.7.3] Input Color
With this display [F5.7.3], select urine color by touching the name of
color and then press “Save” button. The color will be displayed and
printed with the results when measurement is completed.
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, LT.Orange,
DK.Red, Red, LT.Red, LT.Green, Green, DK.Green, LT.Brown,
Brown, DK.Brown, Others.
[2. Set Color] After selecting Color in [F5.7.2], the “Set Color” option [F5.7.4] allows
the user:
1) To set the default color
2) To display an abnormal urine color with a shade
3) To change the color name
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5.
[F5.7.4] Set Color
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.
®
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5.
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.
[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 clarity of the urine is different than the default clarity, press
“Color” button during measurement. The screen to the right will
appear :
[F5.7.5] Input Clarity
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5.
At this display, select urine clarity by touching the text you want.
Then, the clarity will be displayed and printed with the results when
measurement is completed.
[2. Set Clarity] The “Set Clarity” option allows the user:
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
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6.
•
•
•
•
•
•
•
•
•
•
APPENDIX
®
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6.
6.1 Communication
6.1.1 Host Communication
a) Data format
y Baud rate (bps) : 9600, 19.2K, 38.4K, 57.6K, 115.2K
y Data bit (bit) : 7 or 8-bit code
y Parity bit (bit) : None, Odd, Even
y Stop bit (bit) : 1 or 2 stop bits
b) Hardware connection
Female Male
9pin RS-232 9pin RS-232
connector connector
Female Male
Urine Analyzer PC Host
c) Download protocol structure

y Start character
y Data field (optional)
y CR (OxOD)
y LF (OxOA)
The frame identification encodes the purpose of the transmitted block and provides
the receiver with additional information at the start of the block.
®
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6.
®
6.2 Adjusting URiSCAN optima
User may adjust the factory-installed value of instrument for convenience by touching
the “Maintenance” icon.
- Enter factory password, “1111111” press “ENTER.”

- You will see the Maintenance menu, shown in [F 6.2.1].
[F 6.2.1] Maintenance menu
6.2.1 How to Change Password

User must enter password to :
- Change Password
- Change R%
- Change Test Order
- Erase saved data
- Factory Reset
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.
®
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6.
[F 6.2.2] Change password
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
®
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6.
[F 6.2.5] Select R% [F 6.2.6] R% Input
Touch the R% value you wish to change, enter the new value, then press “ENTER.”
To return to the initial standard R%, Press “Factory reset” in he “Maintenance” menu.
6.2.3 How to Change Test Order
URiSCAN® optima is factory programmed to print out test results in the same order as
the test pads found on URiSCAN® optima 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.
®
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6.
[F 6.2.7] Change Test Order
®
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6.
[F 6.2.8] Erase saved data [F 6.2.9] Factory Reset
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 Open and Close

You can use Open and Close buttons to clean the strip holder. From the Maintenance
menu, enter password, then select “Open” to open the strip holder and “Close” to close
the strip holder.
®
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6.
6.3 Program for the Sensitivity of Each Parameter
The following tables describe sensitivity of each test parameter according to its
concentration.
®
Stands for the sensitivity, it is the first positive result detected by URiSCAN optima.
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<
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<
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6.
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<
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
>5.2 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<
(SI Units)
Ranges
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
®
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6.
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<
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6.
6.4 Value of the Initial Standard R%
The following is the initial standard R% (reflection rate) of URiSCAN® optima. User may
adjust R% in the range of +/- 20.
1. Blood 2. Bilirubin 3. Urobilinogen
Change R% for BLD. Change R% for BIL. Change R% for URO.

- neg <= [ 15 ] - neg <= [ 20 ] +- norm <= [ 30 ]
+- 5 <= [ 30 ] + 0.5 <= [ 35 ] + 1.0 <= [ 40 ]
+ 10 <= [ 60 ] ++ 1.0 <= [ 50 ] ++ 4.0 <= [ 60 ]
++ 50 <= [ 90 ] +++ 3.0 > [ 50 ] +++ 8.0 <= [ 75 ]
+++ 250 > [ 90 ] ++++ 12.0 > [ 75 ]
4. Ketones 5. Protein 6. Nitrite
Change R% for KET. Change R% for PRO. Change R% for NIT.

- neg <= [ 20 ] - neg <= [ 20 ] - neg <= [ 15 ]
+- 5 <= [ 30 ] +- 10 <= [ 30 ] + pos > [ 15 ]
+ 10 <= [ 45 ] + 30 <= [ 50 ]
++ 50 <= [ 70 ] ++ 100 <= [ 70 ]
+++ 100 > [ 70 ] +++ 300 <= [ 90 ]
++++ 1000 > [ 90 ]
®
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6.
7. Glucose 8. pH 9. Specific Gravity
Change R% for GLU. Change R% for pH. Change R% for S.G.

- neg <= [ 15 ] pH 5.0 <= [ 20 ] <=1.005<= [ 15 ]
+- 100 <= [ 25 ] pH 5.5 <= [ 28 ] 1.010<= [ 35 ]
+ 250 <= [ 50 ] pH 6.0 <= [ 45 ] 1.015<= [ 65 ]
++ 500 <= [ 60 ] pH 6.5 <= [ 55 ] 1.020<= [ 80 ]
+++ 1000 <= [ 75 ] pH 7.0 <= [ 100 ] 1.025<= [ 110 ]
++++ 2000 > [ 75 ] pH 7.5 <= [ 170 ] >=1.030 > [ 110 ]
pH 8.0 <= [ 195 ]
pH 8.5 <= [ 210 ]
pH 9.0 > [ 210 ]
10. Leucocytes 11. Color 12. Color Degree
Change R% for LEU. Change R% for COL. Change R% for COL.DEG

- neg <= [ 10 ] Straw <= [ 15 ] Other <= [ 300 ]
+- 10 <= [ 20 ] LT.Color <= [ 40 ] Red <= [ 25 ]
+ 25 <= [ 35 ] Color <= [ 80 ] Brown <= [ 54 ]
++ 75 <= [ 55 ] DK.Color > [ 80 ] Orange <= [ 75 ]
+++ 500 > [ 55 ] Yellow <= [ 100 ]
Green <= [ 160 ]
Other <= [ 160 ]
®
SECTION
6.
6.5 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. With each new shipment of reagent strips and every 30 days to check the storage of
the reagent strips:
b. When using a new bottle of reagent strips:
c. When training instrument operators:
d. Whenever test results are in doubt:
Several liquid, ready-to-use control solutions are available for instrument/ reagent strip
performance check. These controls provide positive or defined reactions when used
with URiSCAN® strips for urinalysis. If the performance check falls outside of the stated
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. Carefully repeat
the instrument/reagent strip performance check procedure as described above.
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® optima 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.
6.6 Troubleshooting Guide
TROUBLE CAUSES REMEDIES

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

The printed letters a) The condition of printing a) Remove the poor part of the
look dim. paper roll may be poor. paper and then reload.
b) The paper roll b) Replace the roll with the
recommended by recommended one.
manufacturer is not
used.
Letters are printed a) The dots on the thermal a) Ask for Service to have the head
partially. head of the printer may replaced.
be damaged in part.
®
SECTION
6.
TROUBLE CAUSES REMEDIES

Test result is too a) The quality of test strip a) Replace the test strip and
high or low uniformly. deteriorated. conduct the test again.
b) The current test strip b) Check if test items and lot
and the one used for numbers match and calibrate the
calibration may differ test strip again.
in terms of quality or lot
number.
c) The calibration block c) Try the test using the urine
may be spoiled or poor control. Re-Calibrate using new
quality water could Calibration block and fresh
have been used during distilled water.
calibration.
The test results are a) A test strip deteriorated a) Use a new test strip for
irregular. by moisture or direct light calibration and testing.
may have been used.
b) The test strip may have b) Remove the impeding materials.
been spoiled by other - Clean the strip holder.
impeding material. - Do not use any test strip fallen
c) Excessive amounts of on the floor.
urine may have - Immerse the test strip fully.
remained on test strip. - Have the excessive amounts of
urine absorbed on to a paper
towel.
The test strip is a) The test strip may be a) Replace the test strip.
jammed at the poor (bent or larger than
measuring point. specified)
b) The test strip may have b) Place the test strip on the strip
not been loaded on the holder and conduct the test
strip guide plate again.
correctly.
®
SECTION
6.
6.7 Error Code
6.7.1 Calibration Error Code
6.7.1.1 Strip Error
- Retry Calibration.
10-12 Strip loading
10-13 Reverse Strip
10-14 No Strip
10-15 Strip type
10-16 Calibration block
6.7.1.2 D.W Strip Error

- You might have used other materials as Saline, Water, Urine etc. 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
6.7.2 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
®
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6.
®
6.8 Product List for URiSCAN optima
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 10 SGL strip
Nitrite, Glucose, pH, S.G, Leucocytes

8 U41 11 strip
Nitrite, Glucose, pH, S.G, Leucocytes, Ascorbic acid
6.9 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® optima and URiSCAN® urine test strips. These samples cover 42
®
urinalysis results for 10 parameters found on CONSULT 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
CONSULT® Urine Analyzer and CONSULT® strips in the hands of untrained users was
comparable to the accuracy of the test system in the hands of professional users.
®
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6.
Summary of Studies by Professional Users
Professional users evaluated the performance of the predecessor of URiSCAN® optima using
URiSCAN® urine test strip. This evaluation was conducted at a university hospital setting,
where the performance of URiSCAN® optima 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® optima and two other
urinalysis analyzers was high. Given the results of these tests, it was concluded that
URiSCAN® optima 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® optima WARRANTY CERTIFICATE

- URiSCAN® optima 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.
®
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6.
6.10 Shipment inspection sheet
Product Name : URiSCAN® optima

INSPECTION PLAN 1. Electronic Test (YDMF-089-00) 2. Mechanical Test (YDMF-089-00)
3. Clinical Test (YDMF-089-00) 4. Packaging Check (YDMF-089-00)
5. Operating Condition Test (YDMF-089-00)
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 : 20℃ ~ 28℃ passed
Condition Test - Usage Voltage : 110 ~ 240V (50/60Hz) passed
- Humidity Range : 10% ~ 70% passed
Remark
®

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YD (2012-01/ Rev.03) Printed in Korea

3. CONTROLS USED FOR OPERATING SYSTEM

GENERAL DESCRIPTION OF SYSTEM

1.2 Introduction of Optical System

Optical Lens CCD

1.3 Principles of Urinalysis Strips

There are three basic methods of urinalysis:

URiSCAN® urinalysis test strips manufactured by YD Corp. are available to test

U41 URiSCAN® 11 Strip

Compensation area Urobilinogen

p Easy access to review tested results stored in database

p Program in five languages

p Self-adjustable relevant voltage (110V or 220V AC 50/60Hz)

p Selection of reading time

p Simple & easy to clean

p Urine color & clarity reading

URiSCAN® optima instrument assembly

Precaution : URiSCAN® optima should not be used at temperatures colder

URiSCAN® optima should be placed on a level, stable surface near a grounded

2.3.1 Installing URiSCAN® optima

URiSCAN® optima can interface with a host

- Interface with Host Computer

2.3.3 Feeding Thermal Printing Paper

To insert the paper roll, open

Make sure that about 2

2.3.4 Cleaning the Strip Holder

To remove silicon insert for cleaning:

1. Take out the silicon insert as

3. After it is completely dry, place

※ Silicon insert direction.

Down Check point

1. With the strip carrier base

Precaution for using URiSCAN optima

2.5 Care and Maintenance

Warning :Disconnect URiSCAN® optima from the power source before

2.6 Disposal of the analyzer

CONTROLS USED FOR

3.1 External Structure

STRIP HOLDER COVER

i TFT LCD display with touch screen

i External connection terminal

SYSTEM CONFIGURATION ----- Press “Setting” icon at the main menu

CALIBRATION ----- Press “Calibration” icon at the main menu

ID MANAGEMENT ----- Press “ID manager” icon at the main menu

MEASUREMENT ----- Press “Measure” icon at the main menu

COMMUNICATION ----- Press “Setting” icon at the main menu

[F 5.1.1] Intro [F 5.1.2] Initial Complete!

[F 5.1.3] ‘Home’ menu [F 5.1.4] Initial Complete

5.2 System Configuration

You can return to ‘Home’ menu by pressing “Home” button.

[ F 5.2.1] ‘Home’ menu [F5.2.2] ‘Setting’ menu

3. Set Printer This menu is to set the printer. See 5.2.3

[ 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.

7. Set Buzzer This menu is to adjust volume of buzzer. See [F.5.2.6]

8. Set Language URiSCAN® optima system is programmed to function in

[ F 5.2.5] LCD Backlight [ F 5.2.6] ‘Buzzer’ setting [ F 5.2.7] ‘Language’ selection

5.2.1 Set Time

[ F 5.2.8] Set Time

[F 5.2.9] Set Communication

5.2.3 Set Printer

Before measurement, the printer system must be set

5.2.3.1 Internal Printer, External Printer