OSANG Healthcare ILM-0001A-RF Users Manual

CL-LP1-1A0-01

LP-CL1-1B0-01 Rev. 2008-10

LipidProTM Testing System

Instructions for use

Testing items:

• Total Cholesterol

• HDL-Cholesterol

• Triglyceride

•

Calculated LDL-Cholesterol

• Blood Glucose Test

• 3 •

Dear LipidPro

TM

T esting System Owner

Thank you for your choosing the LipidPro

TM

Testing System. This instruction for

use includes important information you need know about the LipidPro

TM

Testing

System. Please read it carefully.

Our goal for LipidPro

TM

Testing System is attributed to provide the best quality

healthcare products coupled with superior customer service.

Important information

The LipidProTMTesting System is intended for use of outside the body (in vitro

diagnostic use only). It should be used for testing lipid profileand monitoring glu­cose level in a sample. The lipid profileincludes total cholesterol, HDL-choles­terol (often called good cholesterol), LDL-cholesterol (often called bad choles­terol) and triglycerides.

This meter is available in two types of strips: one type of strips is measuring glu­cose level by the method of electrochemistry and the other is testing lipid profile
by the spectroscopy method.

LipidProTM Testing System

• 4 • • 5 •

T est Principle How to use Instructions for use

This guide includes all the information you need to use LipidProTMfor self testing

or professional use. For additional information and specific information for each
individual test, please make sure you read the package insert included with the
test strips.

If you have questions about this system, please contact Infopia Customer
Service. Customer Service assistance is available 09:00 AM - 06:00 PM,
Monday through Friday. If you need help interpreting your test results, please
contact your healthcare provider.

For questions or assistance with LipidPro

TM

call :
Infopia Customer Service
Hours : 09:00 AM - 06:00 PM
Monday - Friday
Tel. [phone]
Fax. [phone]
Email : [e-mail]

LipidPro

TM

Testing System has two kinds of test principle according to test items:

one for blood glucose and the other for lipid profile.
Lipid profile test result is based on a reading of reflection density. When the

blood is applied, the color changes in test area through an enzyme reaction.
The meter records this change in color and converts the measurement signal to
the displayed result using the data previously entered via the code. The deeper
the color, the higher the lipid level.

Glucose in the blood sample will react to the electrodes in the glucose test strip,
generating an electrical current that will stimulate a chemical reaction. This reac­tion is measured by LipidPro

TM

meter and displayed as your blood glucose

result.

• 7 •

LipidPro

TM

T esting System Kit Contents

Your LipidProTMTesting System has been sealed to protect the contents.

If you find your seal has been broken, please return it to the place of purchase.
Required but not provided

- LipidPro

TM

Total choresterol test strip - LipidProTMHDL-choresterol test strip

- LipidPro

TM

Triglyceride test strip - LipidPro

TM

lipid profile test strip

- LipidPro

TM

glucose test strip - Capillary rod

- LipidPro

TM

glucose control solution - LipidProTMlipid control solution

- Log book for test record of glucose

1. LipidPro

TM

Meter

2. Instructions for Use

3. Warranty Card

4. Carrying Case

5. Two AAA batteries

6. Lancing Device

7. Lancet

LipidProTM Testing System

• 6 •

1. Learning the System
LipidProTMTesting System Kit Contents 7

LipidProTMTesting Meter 8

LipidProTMTesting Meter Display 9

LipidProTMTest Strip Information 10-13

2. Setting Your Meter
Battery Use 14
Setting Mode 15-16
Before Testing-Coding the Meter 17-19
Before Testing 20
Checking the System with Control Solution 21-24

3. Testing Your Blood Glucose
Testing Your Blood - Preparation 25
Collecting a Drop of Blood 26
Testing Your Blood 27-28

Quick reference of test procedure 29-30

Test Procedure 31-38

Glucose test strip Discard Function 39
Alternate site testing 40

Performing a Blood Test using an Alternate Site 41

4. Reviewing Your Results 42-45

5. Deleting your Results 46

6. LipidProTMTesting System Software 47

7. Cleaning Your Meter and Maintenance 48

8. Troubleshooting 49-51

9. Product Specifications 52-54

10. Warranty 55

11. Declaration of Conformity 56

Contents

• 9 •

LipidProTM Testing System

• 8 •

LipidPro

TM

T esting Meter Display

Test item is blood glucose
Test item is TC(Total Cholesterol)
Test item is TG(Triglyceride)

Test item is HDL(High Density Lipoprotein)
Test item is LDL(Low Density Lipoprotein)
Blood insertion for glucose test
Sample blood
Blood insertion for cholesterol test

Displaying code number of Test Strips
Short of batteries
Alarm
Testing unit
Temperature & date of test
Hour & Data of test
Average Test Results
Control Solution Sysmbol
Day & Month

LipidProTMT esting Meter

Strip Connector

Glucose strip measurement connector

Strip discard function

Strip discard function by push toward outside

LCD Screen

Display measurement level of glucose, TC, HDL, TG,
including time and message

Up button

Maneuvering button for choice of function in each mode

Down button

Maneuvering button for choice of function in each mode
& RFID operation button

Mode button

Memory mode, Setting mode, Cholesterol measurement
mode, On and off button.

Cholesterol Testing part

Cholesterol strip inserting part

Buzzer sound print part

Printing part for Warning sound, Fixed sound and
buzzer sound

Battery Cover

Purpose for Battery replacement and fixed cover

Caution

1. Do not use LipidProTMmeter in a dry environment, especially if synthetic materials

are present. Synthetic clothes, carpets, etc., may cause damaging static discharges
in a dry environment.

2. Do not use LipidProTMmeter near cellular or cordless telephones, walkie talkies,

garage door openers, radio transmitters, or other electronic or electrical equipment
that are sources of electromagetic radiation, as these may interfere with the proper
operation of the meter.

• 11 •

LipidProTM Testing System

• 10 •

Glucose

LipidProTMT est Strip Information LipidPro

TM

T est Strip Information

Use only LipidPro

TM

Test Strips with your LipidProTMmeter.

1. Lipid Profile test strip

Caution

1. Store the LipidPro

TM

test strip vials in a cool and dry place.Keep out of

direct sunlight . Do not freeze.

2. Store test strips in their original vial only. Do not mix the test strips in new
vials or in any other container.

3. Immediately replace the vial cap and close tightly after removing the
LipidPro

TM

test strip

4. Make a note of the discard date which is three months from the date you
first open a new vial of strips. Throw LipidPro

TM

test strip and vial away

after the discard date.

5. Avoid getting dirt, food, and water on the test strip. Do not handle test
strips with wet hands.

6. Do not use the test strips after the expiry date printed on the package or
vial since it may cause inaccurate results.

7. Do not bend, cut, or alter the test strip.

8. LipidPro™ test strips are for single use only. Do not re-use.

9. Do not test at the following temperature condition:

- Lipid Profile strip : below 18℃(64℉) or above 30℃(86℉).

- glucose strip : below 10℃(50℉) or above 40℃(104℉)

10. Do not test with humidity below 10% or above 90%.

11. Refer to additional information in the LipidPro

TM

test strip package.

12. Avoid getting dirt, food, and water on the color-coding label (backside of

glucose test strip).

13. Discard the used test strips carefully according to the local regulations.

Target to apply blood
Confirmation Window

Contact Bar

Ribs that guide the strip
into the meter

Blood application and Test
area

The part for holding strip

This test strip enables to test TC, HDL, TG
and calculated LDL.

3. Total Cholesterol test strip
This test strip is for Total Cholesterol.

4. Triglyceride test strip

This test strip is for Triglyceride.

5. Glucose test strip

Glucose

This test strip is for glucose.

Front -

Back -

2. HDL-Cholesterol test strip
This test strip is for HDL-Cholesterol.

Front -

Back -

Front -

Back -

Front -

Back -

Front -

Back -

• 13 •

LipidProTM Testing System

• 12 •

LipidPro

TM

T est Strip Information LipidPro

TM

T est Strip Information

LIMITATIONS OF SYSTEM (for lipid profile test):

Lipid Profile Test Strips provide accurate results when the following constraints
are observed:

• Do not use neonate samples

Physicians -

Please note the following interferences that may affect the results:

• Extremes in hematocrit may affect test results. Hematocrit levels less than 30

% may cause falsely high reading and hematocrit levels greater than 55 %
may cause falsely low reading. If you do not know your hematocrit level, con­sult your healthcare professionals.

• Interferences: Acetaminophen, uric acid, ascorbic acid (vitamin C), and other

reducing substances (when occurring in normal blood or normal therapeutic
concentrations) do not significantly affect results. However, abnormally high
concentrations in blood may cause inaccurately high results.

• Antiglycolysis and anticoagulants in blood samples may affect the test results

• Total cholesterol may be decreased by dopamine and gentisic acid.

• HDL-cholesterol may be decreased by dopamine.

• Triglyceride may be decreased by dopamine and Methyldopa.

Performance Characteristics:

The performance of the lipid profile test strips has been evaluated in laboratory
and in clinical tests (Please refer to strip instructions for use in for more details).
Testing Range: The test range of LipidPro

TM

‚ is 100 ~ 400 mg/dL (2.59-

10.36mmol/L) for total cholesterol, 25~80mg/dL (0.65- 2.08mmol/L) for HDL-

cholesterol and 70~600 mg/dL (0.80-0.86mmol/L) for Triglyceride.

LIMITATIONS OF SYSTEM (for Glucose test):

The LipidPro

TM

Glucose Test Strips provide accurate results when the following

constraints are observed:

• Do not use neonate samples.

• Inaccurate results may occur when in shock, hypotensive, hyperglycemic, or

hyperosmolar state, with or without ketosis.

• Glucose test strips used above altitudes of 10,000 feet will have an effect on
test results.

Physicians

- Please note the following interferences that may affect test results:

• Extremes in hematocrit may affect test results. Hematocrit levels less than 20
% may cause falsely high reading. Hematocrit levels greater than 60 % may
cause falsely low readings. If you do not know your hematocrit level, consult
your healthcare professionals.

• Interferences: Acetaminophen, Uric and, Ascorbic acid (Vitamin C), and other
reducing substances when occurring in normal blood or normal therapeutic
concentrations do not significantly affect results. However, abnormally high
concentrations in may cause inaccurately high results.

• Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000
mg/dl do not significantly affect the results. Values beyond these levels
should be interpreted with caution.

• Blood samples that contain a high concentration of dissolved oxygen may
lower the test result.

• EDTA containing tube is recommended as an anticoagulant tube.

Performance Characteristics:

The performance of the glucose test strips has been evaluated in laboratory and
in clinical tests (Please refer to strip instructions for use for more details).
Measurement Range: The measurement range of the LipidPro

TM

Glucose

Testing is 10 to 600 mg/dL (0.6-33.3mmol/L).

• 15 •

LipidProTM Testing System

• 14 •

Setting Y our Meter

Setting Mode

The meter enters setting mode with a beep
sound by pressing the mode button for 3 or
more seconds in the stand-by status. Press
mode ( ) button for the next step.

By pressing ▲▼, adjust year and press

MODE ( ) button.

By pressing ▲▼, adjust date, month and

time, and then press MODE ( ) button.

Battery Use

The LipidPro

TM

requires two(2) AAA 1.5 volt alkaline batteries.

When to replace the batteries:

The meter will give you an indication on the display that the batteries need to be
changed. When the display reads battery sign, no more tests can be run until
the batteries are changed. Always replace the batteries with high quality alkaline
batteries. It is recommended to keep a spare set of batteries on hand. To extend
battery life, remove the Test Strip as soon as a result is displayed.

How to install /replace the batteries:

1. Open the battery door on the back of the LipidProTM.

2. Remove old batteries from the compartment and safely discard.

3. Insert the new batteries into the battery compartment as marked on the
inside compartment.

4. Replace the battery door. To make sure the batteries were installed correct­ly, push either one of the two buttons on the front of the meter to turn the
LipidPro

TM

on.

<Follow Action>

1. Check your meter with the control solution

2. Perform your test again

3. If you are experiencing symptoms that are not consistent with your test results
of glucose or cholesterol, call your healthcare professional.

Setting Y our Meter

Caution

Remove both batteries from the battery compartment and dispose of them
according to your institution's guidelines.

Caution

Make sure that the date and time are set properly to enable your data to be
stored and downloaded properly.

It is recommended to set your LipidPro

TM

meter properly before using.

• 17 •

LipidProTM Testing System

• 16 •

Setting Y our Meter Before T esting - Coding Y our Meter

By pressing ▲▼, select tem-
perature unit and press MODE
( ) button.

By pressing ▲▼, select average date and press

MODE ( ) button. (3 average date is avail­able.)

By pressing ▲▼, select Alarm ON/OFF and

press MODE ( ) button. If you select Alarm
ON, you can set the time by pressing ▲▼ and

press MODE ( ) button(you can set 5 alarms).
If you select Alarm OFF, this setting mode is
completed.

By pressing ▲▼, select testing

unit and press MODE ( ) but­ton.

LipidPro

TM

has two coding systems:
Lipid Profile test - each vial of test strip has RFID-tag which enables the meter to
recognize its code number automatically.
Glucose test - each test strip has color-tag on the back of the strip which
enables the meter to recognize its code number automatically.

Coding for Lipid Profile test

Press RFID (▼) button.

Place the RFID-tag on the strip bottle to the area of
the RFID symbol on the meter.

Caution

The radiation of RFID recognition is within 2 cm.
The meter will be back to stand-by status if there is no operation within 5
seconds.