17127

05
 CONTENTS

1. GENERAL DESCRIPTION OF SYSTEM

1.1 General Introduction ····································································································································································································· 3
1.2 Introduction of Optical System ·············································································································································································· 3
1.3 Principles of Urinalysis Strips ·············································································································································································· 3-4
1.4 Main Functions ··················································································································································································································· 4
1.5 References ····························································································································································································································· 4

2. INSTALLATION
2.1 Technical Specifications ······························································································································································································ 6
2.2 Unpacking ····························································································································································································································· 7
2.3 Installation ···························································································································································································································· 7
2.4 Operation ····························································································································································································································· 11
2.5 Care and Maintenance ······························································································································································································· 11
2.6 Disposal of the Analyzer ··························································································································································································· 11

3. CONTROLS USED FOR OPERATING SYSTEM

3.1 External Structure ··········································································································································································································13
3.2 Main Function ···················································································································································································································13

4. SHORT OPERATING INSTRUCTIONS ······························································································································15

5. ROUTINE WORKING PROCEDURES

5.1 System Initializing ··········································································································································································································17
5.2 System Configuration ·································································································································································································18
5.3 ID Management ············································································································································································································· 22
5.4 Calibration ·························································································································································································································· 24
5.5 Measurement ··················································································································································································································· 27
5.6 Data Management ········································································································································································································ 30
5.7 Color & Clarity ···················································································································································································································31

6. APPENDIX
6.1 Communication ·············································································································································································································· 36
6.2 Adjusting URiSCAN® Optima ············································································································································································· 37
6.3 Program for the Sensitivity of Each Parameter ······································································································································· 39
6.4 Quality Controls ············································································································································································································ 42
6.5 Troubleshooting Guide ····························································································································································································· 43
6.6 Error Code ··························································································································································································································· 45
6.7 Product List for URiSCAN® Optima ································································································································································ 47
6.8 Safety Information ······································································································································································································· 48
6.9 Information Regarding CLIA Waiver ································································································································································ 49
6.10 CLIA Waived Laboratories ···················································································································································································· 49
6.11 Technical Assostance ······························································································································································································· 49
6.12 Shipment inspection sheet ················································································································································································· 50
 GENERAL DESCRIPTION OF SYSTEM SECTION 1.

Indications for Use:

The URiSCAN® Optima urine chemistry test system consists of URiSCAN® Optima Urine analyzer and
URiSCAN® urine test strips. The intended use of the URiSCAN® Optima Urine analyzer is to read the
color change on the test pads found on the URiSCAN® urine test strips and to display and print the
results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
URiSCAN® Optima urine chemistry test system is intended for prescription use only, in professional and
in point-of-care settings.

SECTION 1.
GENERAL DESCRIPTION OF SYSTEM

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 SECTION 1. GENERAL DESCRIPTION OF SYSTEM

Diagnostics
Blood, Bilirubin, Urobilinogen, Ketones,
Protein, Nitrite, Glucose, pH, S.G, Leucocytes, Ascorbic acid, Albumin and Creatinine test pads. SECTION 2.
INSTALLATION

Barcode reader

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 SECTION 2. INSTALLATION INSTALLATION SECTION 2.

CORP.
Urine Strip analyzer

URiSCAN Optima DC 12V, 3.5A, 42VA

AC/DC Adaptor AC 100-240 V, 50 / 60 Hz, 1.2 A

Indoor use
Altitude up to 2000 m
Pollution degree 2

URiSCAN® Optima should be used at temperature range between 20℃ and 28℃
and relative humidity range between 10% and 70%. The atmospheric pressure
should be from 900 to 1600 mbar.

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 SECTION 2. INSTALLATION INSTALLATION SECTION 2.

Host Computer and Barcode Reader

For routine maintenance, clean the strip holder if sediment is seen, using soft gauze and distilled water.

CORP.

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 SECTION 2. INSTALLATION INSTALLATION SECTION 2.

White
check bar

Silicon
pad

Precaution for using URiSCAN® urinalysis test strips

The following precautions should be taken when testing URiSCAN® urinalysis test strip.
- Calibration procedure in 5.4 Calibration should be performed when changing Lot number of the
urinalysis strip. If not, the user could get inaccurate test results. Whenever test results are in doubt,
- If testing cannot be done within an hour after voiding, refrigerate the specimen immediately and
let it return to room temperature befor testing.
- For more information about the use and storage of urinalysis strips, see the urinalysis strip
instructions for use insert.

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 CONTRALS USED FOR OPERATING SYSTEM SECTION 3.

SECTION 3.
CONTROLS USED FOR
OPERATING SYSTEM

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 SHORT OPERATING INSTRUCTIONS SECTION 4.

SECTION 4. - Scan Module Error > Scan Module connection failed.

- Strip Holder Error > There is no Strip Holder in the device.
SHORT OPERATING INSTRUCTIONS - White Check Bar Error > White Check Bar in the strip holder is either discolored or contaminated.
- Printer Error > Printer connection failure or there is no thermal print paper.

immediately for routine mode or after 90 seconds for quick mode,

URiSCAN® Optima OPERATOR'S MANUAL / 15

 ROUTINE WORKING PROCEDURES SECTION 5.

SECTION 5.
ROUTINE WORKING PROCEDURES

If the instrument detects any faults, warning message will be shown on the LCD during the system
initializing as [F 5.1.3], [F 5.1.4].

[F 5.1.3] Scan Module Error [F 5.1.4] White Check bar Error

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

[F 5.1.4] Scan Module Error : Contact YD Diagnostics CORP. or its distributor in your country when you
experience the same Scan Module Error repeatedly during system initialization.
[F 5.1.5] White Check Bar Error : Visually check White Check Bar and clean it if contaminated
(please refer to "Cleaning the White Check Bar," under section 5.4 Calibration in the operating manual).
If not discolored or contaminated, please contact YD diagnostics CORP. or its distributor in your country.

Optima
8 languages: English, German, Italian, Russian, Spanish, Portuguese, Korean and Chinese
(depending on model). See [F.5.2.7]

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

Optima Optima

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

four
and Operator ID Use.

Optima

Operator ID setting
- EN(Enable) : Use the Operator ID function.
- DIS(Disable) : Do not use the Operator ID function.
For CLIA-Waived settings, the Operator ID function should always be ENABLED.

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

5.4 Calibration
inspect the surface for dust, fore , or scu
- URiSCAN Optima Self Calibration strip
URiSCAN® Optima a

- User Calibration
Calibration procedure should be performed by the user when:
- Changing an item
- Changing product lot number
- Test results are in doubt or different result is
The white check bar is tested on a reference spectrophotometer. The instrument performs a “self-test” obtained than expected using quality control solutions.
and calibration each time it is turned on. Each time a test is run, the analyzer re-calibrates using
a white check bar. Reflectance measurements from the bar must match the factory set calibration.
Calibration procedure must be done to balance the reflectance
rate in accordance with the reagent strip and environmental
next section influnece.
- Cleaning the White Check Bar
URiSCAN® Optima fo
strip holder

BIOHARZARD
Wear personal protective equipment. Use universal precautions. For recommended
precautions when you work with biohazardous materials, see section 6.8 Safety Information.
fo
1. Remove the insert from the strip holder.
2. Remove the strip holder by pulling it slowly out of the analyzer.
3. Drain the strip holder, if necessary.
4. Examine the white check bar on the strip holder for dirt or discoloration.
C UTION
Do not touch the white check bar while you examine it or after you clean it. Your fingerprints
or lint on the ar could cause unreliable test results. When you examine the white check bar,
do it carefully under good lighting.
orm the f
strip holder at the end opposite the

r.

C UTION
Do not pu h the fully into the analyzer. The might jam and prevent you
from using the analyzer.
pad
6. form the f

C UTION
Do not scratch the white check bar. Severe mark could cause errors.
Do not use solvents of any kind to clean the bar. They could destroy the bar.

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

If the error occurs, See section 6.6, Error code. using URiSCAN® urinalysis test strips
If calibration fails, you can not use the Measure function. testing URiSCAN® urinalysis test strip.
- of the
Press "History" at the calibration menu. urinalysis Wh
Calibration data is displayed by selecting the type as shown on [F 5.4.7]
Select the calibration data you want, and press "Next" button.
The calibration data will be displayed as [F 5.4.8] and let it return to room temperature befor testing.
- For more information about the use and storage of urinalysis strips, see the urinalysis strip
instructions for use insert.

90

[F 5.4.7] Calibration History [F 5.4.8] Calibration Data

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

and S.G

- Albumin, Creatinine : 90 sec

If the error occurs, See section 6.6, Error code.

3. Strip Type Change : At the main menu, press "Measure" button.

Press "Chg.Lot" button to change the strip type for testing. See [F 5.5.8]
The strip type are displayed as [F 5.5.8] only if the final calibration is done successfully.

[F 5.5.8] Chg.Lot

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

Optima

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 SECTION 5. ROUTINE WORKING PROCEDURES ROUTINE WORKING PROCEDURES SECTION 5.

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 SECTION 5. ROUTINE WORKING PROCEDURES

SECTION 6.
APPENDIX

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

2400, 4800,

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

6.2.2 Erase all saved data (test data & serial ID)

User can erase all saved test data and the serial ID by using "Erase saved data" button.

[F 6.2.3] *

6.2.3 Factory Reset

[F 6.2.4]

6.2.4 Open and Close

[F 6.2.3] [F 6.2.4]

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

Reported Result
Test Abbreviation Normal System Plus System
Conv. Units S.I Units Block
Neg.(0 mg/L) 10 mg/L -
30 mg/L 30 mg/L 1+
Albumin ALB
80 mg/L 80 mg/L 2+
150 mg/L 150 mg/L 3+
10 mg/dL 0.9 mmol/L +-
50 mg/dL 4.4 mmol/L 1+
Creatinine CRE 100 mg/dL 8.8 mmol/L 2+
200 mg/dL 17.7 mmol/L 3+
300 mg/dL 26.5 mmol/L 4+
< 30 mg/g < 3.4 mg/mmol < 30 mg/g
(Normal) (Normal)
Albumin to
Creatinine ACR 30-300 mg/g 3.4-33.9 mg/mmol 30-300 mg/g
(Abnormal) (Abnormal)
Ratio
> 300 mg/g > 33.9 mg/mmol > 300 mg/g
(High Abnormal) (High Abnormal)

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

6.4 Quality Controls 6.5 Troubleshooting Guide

It is recommended to use
commercially available liquid, ready-to-use controls intended for monitoring urine strip results including
albumin and creatinine.

Perform two levels of controls under the following conditions :

For details about the operation of analyzer, See section 4, SHORT OPERATING INSTRUCTIONS.

To conduct quality control testing :

Wet each of the pads on a new urine strip with level 1 or Negative control solution. Blot off excess liquid
and place strip on strip holder. Press start. Obtain results. Then wet each of the pads on another new urine
strip with Level 2 control solution and repeat as with Level 1 solution. Compare QC results to the QC
manufacturer's acceptable results list. If the QC results are not acceptable, do not test the patient samples Set the printer to 'on' at
until you solve the problem. Repeat QC tests until you have acceptable results. Setting/Set Printer.

If the performance check falls outside of the stated values, the following sources of error may have
occurred :

For recommendations and technical questions, call your local technical support provider or distributor,
or e-mail: [email protected]

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

6.6 Error Code

Error Code Error Description Solution

1. At the main menu, press "Measure" icon.

2. The strip holder will move out of the
instrument automatically.
Dry Strip
3. Dip a strip into the urine specimen and
- Occurs when the urine sample is not
10-9 remove excessive urine by gently blotting
soaked
the strip against a paper towel.
into the test strip
4. Place the strip immediately on the strip
holder
5. Press “Start” button
1. At the main menu, press "Measure" icon.
2. The strip holder will move out of the
Re-Calibrate using clean strip instrument automatically.
holder, clean white check bar 3. Dip a strip into the urine specimen and
and fresh distilled water. remove excessive urine by gently blotting
Strip Loading Error
the strip against a paper towel.
10-12 - If you do not position the strip
4. Place the strip immediately on the strip
correctly on the strip holder
holder (make sure that the top of the
strip touches the guide at the top of
the platform, with a little bit of the strip
hanging over the end of the platform.)
5. Press “Start” button
1. At the main menu, press "Measure" icon.
2. The strip holder will move out of the
instrument automatically.
3. Dip a strip into the urine specimen and
Reverse Strip remove excessive urine by gently blotting
10-13
- When the strip is upside down the strip against a paper towel.
4. Place the strip immediately on the strip
holder (make sure that the strip is placed
pad-side up.)
5. Press “Start” button
Strip Type
10-15 - An incorrect type of urine test strip is 1. Use the correct URiSCAN urine test strips.
Place the test strip in correct used.
position on the strip holder 1. At the main menu, press "Measure" icon.
and conduct the test again. 2. The strip holder will move out of the
instrument automatically.
3. Remove the strip holder from the
Calibration Block
equipment
10-16 - The white check bar for calibration in
4. Clean the white check bar with distilled
the strip holder is contaminated
water
5. Place the strip holder in its original
position.
6. Click “Home” button

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

6.7 Product List for URiSCAN® Optima

Error Code Error Description Solution No Product Test Parameters

Albumin
10-18 1 U12 4 Hemo/GPH strip Blood, Glucose, Protein, pH
- Calibration failed
Creatinine
10-19 2 U22 5 Hemoketo/GPH strip Ketones, Glucose, Protein, pH, Blood
- Calibration failed
Ascorbic acid
10-22
- Calibration failed 3 U25 6L strip Glucose, Protein, Nitrite, pH, Blood, Leucocytes
Leucocytes
10-23 Blood, Billirubin, Urobilinogen, Ketones, Protein,
- Calibration failed 4 U26 8 strip
Nitrite, Glucose, pH
S.G
10-24
- Calibration failed Blood, Billirubin, Urobilinogen, Ketones, Protein,
5 U27 7 strip
pH Glucose, pH
10-25
- Calibration failed
Blood, Billirubin, Urobilinogen, Ketones, Protein,
Glucose Re-try calibration with new D.W., or 6 U37 9 SG strip
10-26 Nitrite, Glucose, pH, S.G
- Calibration failed Re-try calibration using the new Strip.
Nitrite Blood, Billirubin, Urobilinogen, Ketones, Protein,
10-27 7 U39 10 SGL strip
- Calibration failed Nitrite, Glucose, pH, S.G, Leucocytes
Protein Blood, Billirubin, Urobilinogen, Ketones, Protein,
10-28 8 U41 11 strip
- Calibration failed Nitrite, Glucose, pH, S.G, Leucocytes, Ascorbic acid
Ketones Leucocytes, Nitrite, Urobilinogen, Protein,
10-29 9 U774 10 SGL strip
- Calibration failed pH, Blood, S.G, Ketones, Billirubin, Glucose
Urobilinogen
10-30 Leucocytes, Nitrite, Blood, pH, Creatinine,
- Calibration failed 10 U62 10 ACR strip
S.G, Ketones, Albumin, Protein, Glucose
Bilirubin
10-31
- Calibration failed Ascorbic acid, Leucocytes, Nitrite, Blood, pH, Creatinine,
11 U63 11 ACR strip
Blood S.G, Ketones, Albumin, Protein, Glucose
10-32
- Calibration failed
12 U64 2ACR strip Albumin, Creatinine
Scan 1. Power off and then power on
Occurs when there is no response from
Module 2. When the error message still appears,
Scan Module
Error contact the service center
Occurs when there is no paper inside the
Print Error 1. Install thermal printer paper.
printer
1. Place the strip holder and then power on
No Strip The strip holder is not placed on the
2. If the same error persists, contact the
Holder analyzer
service team.
1. Optima cannot measure ‘Fluorescent’
ATYPICAL Fluorescent urine
urine.
1. Check time and date are correctly set in
This Strip
Use the expired urine test strip the Uriscan Optima.
is expired.
2. Use the unexpired urine test strip

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 SECTION 6. APPENDIX APPENDIX SECTION 6.

6.8 Safety Information 6.8.4 References

1. Centers for Disease Control. Update: Universal precautions for prevention of transmission of human
Read the following safety information for your protection in the laboratory: immunodeficiency virus, hepatitis B virus and other bloodborne pathogens in healthcare settings.
1988. MMWR, 37:377-382, 387, 388.
6.8.1 Protecting yourself from Biohazards 2. Clinical and Laboratory Standards Institute (formerly NCCLS).
The established guidelines for handling laboratory biohazards are based on the guidelines developed Protection of Laboratory Workers from Occupationally Acquired Infections;
by the Centers for Disease Control, the Clinical and Laboratory Standards Institute, and the Occupational Approved Guideline - Third Edition. Wayne, PA: Clinical and Laboratory Standards
Safety and Health Administration. Institute; 2005. CLSI Document M29-A3. [ISBN 1-56238-567-4].
Use these safety guidelines for general information only. It is not intended to replace or supplement 3. Federal Occupational Safety and Health Administration.
your laboratory or hospital biohazard control procedures. Bloodborne Pathogens Standard. 29 CFR 1910. 1030.
By definition, a biohazardous condition is a situation involving infectious agents biological in nature,
such as the hepatitis B virus, the human immunodeficiency virus, and the tuberculosis bacterium. These
infectious agents may be present in human blood, blood products, and other body fluids 6.9 Information Regarding CLIA Waiver
6.8.2 Recognizing Sources of Contamination URiSCAN Optima urine analyzers are CLIA waived only when used with YD Diagnostics Reagent Strips,
When you handle potentially infectious agents, keep in mind the following major sources of manufactured by YD Diagnostics.
contamination: URiSCAN ACR strips are CLIA waived when run on the URiSCAN Optima urine analyzers. A certificate
- Hand-to-mouth contact of CLIA waiver is required to perform these tests in a waived setting. To obtain a certificate of waiver,
- Hand-to-eye contact contact your state department of health or visit the CMS web site for an application, Form CMS-116.
- D irect contact with superficial cuts, open wounds, and other skin conditions that might permit Failure to adhere to the instructions for use, including instructions for limitations, intended use, and
absorption into subcutaneous skin layers performing quality control testing, is off-label use, resulting in these tests being categorized as high
- Splashes or aerosol contact with skin and eyes complexity and subject to all CLIA regulations.

6.8.3 Preventing Contamination

To prevent accidental contamination in a clinical laboratory, strictly adhere to the following procedures: 6.10 CLIA Waived Laboratories :
- wear gloves while servicing parts of the analyzer that have contact with body fluids such as serum,
plasma, urine, or whole blood. Test positive and negative quality controls with new lots, new shipments of reagents, and when you
-Wash your hands before going from a contaminated area to a noncontaminated area, or when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days.
remove or change gloves. Run QC tests to ensure reagent strips integrity; train new users; confirm test performance; and when
- Perform procedures carefully to minimize aerosol formation. patients` clinical conditions or symptoms do not match. Also, run QC tests per Section 5, Routine
- Wear facial protection when splatter or aerosol formation are possible. working procedures. Liquid ready-to-use controls are available. Do not use water as a negative control.
- Wear personal protective equipment such as safety glasses, gloves, lab coats or aprons when working For recommendations and technical questions, call Technical Support at 800-365-6146 or e-mail info@
with possible biohazard contaminants. yd-diagnostics.com, or visit www.yd-diagnostics.com.
- Keep your hands away from your face. Compare QC results to the QC manufacturer`s acceptable results list. If the QC results are not acceptable,
- Cover all superficial cuts and wounds before starting any work. do not test the patient samples until you solve the problem. Repeat QC tests until you have acceptable
- Dispose of contaminated materials according to your laboratory’s biohazard control procedures. results.
- Keep your work area disinfected. All other laboratories: For best results, confirm performance of reagent strips at the start of each day and
whenever a new bottle is first opened by testing with commercially-available negative and positive
- Disinfect tools and other items that have been near any part of the analyzer sample path or waste area
controls that include values for microal-bumin and creatinine. These control specimens may also be
with 10% bleach.
randomly hidden in each batch of specimens tested. Each laboratory should establish its own goals for
- Do not eat, drink, smoke, or apply cosmetics or contact lenses while in the laboratory. adequate standards of performance, and should question handling and testing procedures if these
- Do not mouth pipette any liquid, including water. standards are not met. For information, contact YD Diagnostics.
- Do not place tools or any other items in your mouth.
- Do not use skin exposed to biohazards for personal cleaning such as rinsing coffee cups or washing
hands.
6.11 Technical Assostance
For technical support, contact your local technical support provider or distributor. In the US call:
800-365-6146 or e-mail: [email protected] or visit www.yd-diagnostics.com.

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 SECTION 6. APPENDIX MEMO

6.12 Shipment inspection sheet

Product Name : URiSCAN® Optima

1. Electronic Test (YDMF-089-00)
2. Mechanical Test (YDMF-089-00)
INSPECTION PLAN 3. Clinical Test (YDMF-089-00)
4. Packaging Check (YDMF-089-00)
5. Operating Condition Test (YDMF-089-00)
No Test Field Item Result
- Electronic Test passed
- Safety Test passed
- System self Test passed
1 Electronic Test
- Automatic Calibration (Power-On) passed
- Electromagnetic Interference passed
- LCD display passed
- Motor Operation Test passed
- Impact Strong Test passed
2 Mechanical Test
- Noise & Vibration passed
- Printer Operation Test passed
- Urine Investigation (5-11 Item) passed
3 Clinical Test
- Q.C (by YD Diagnostics strip) passed
- Insert (manual, power code, etc.) passed
4 Packaging Check
- Box passed
- Temperature Range : 20℃ - 28℃ passed
Operating
5 - Usage Voltage : AC 110 - 240V (50/60Hz) passed
Condition Test
- Humidity Range : 10% - 70% passed

Remark

Analyst Certification / S.W.Lee

Certificate Approval / E.Y.Kim

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 MEMO

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