OSANG Healthcare ILM-0001A-RF User Manual

• 03 •

Dear LipidProTM lipid profile and glucose measuring
system Owner

Thank you for your choosing the LipidProTM lipid profile and glucose
measuring system. This instruction for use includes important informa-
tion you need know about the LipidPro

TM

lipid profile and glucose
measuring system. Please read itcarefully. Our goal for LipidProTM lipid
profile and glucose measuring system is attributed to provide the best
quality healthcare products coupled with superior customer service.

Indications For Use

LipidProTM system is intended for in home (self-testing) or health care
professionals and for testing outside the body (in vitro diagnostic use
only). LipidProTM system which consists of meter and test strips,
measures total cholesterol (TC), high density lipoprotein cholesterol
(HDL-C), triglyceride (TG) and glucose in capillary whole blood.
Cholesterol measurements are used in the diagnosis and treatment of
disorders involving excess cholesterol in the blood and lipid and lipopro-
tein metabolism disorders. Lipoprotein measurements are used in the
diagnosis and treatment of lipid disorders (such as diabetes mellitus),
atherosclerosis and various liver and renal diseases. Triglyceride
measurements are used in the diagnosis and treatment of patients with
diabetes mellitus, nephrosis, liver obstruction, other diseases involving
lipid metabolism, or various endocrine disorders. Calculated LDL choles-
terol values are reported only when triglycerides are ≤ 350 mg/dL; when
triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not
reported.

Glucose measurement is for the quantitative measurement of the
concentration of glucose in capillary whole blood that can be taken from
the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or
thigh by diabetic patients or health care professionals as an aid in the
management of diabetes. Glucose measurment is not to be used for the
diagnosis of or screening for diabetes or for neonatal use. Alternate site
testing should be done during steady- state times when glucose is not
changing rapidly.

LP-CL1-1B0-01 Rev. 2010-02

Catalog number: CL-LP1-1A0-01

TEL : [phone]

• 02 • • 03 •

Dear LipidProTM lipid profile and glucose measuring
system Owner

Thank you for your choosing the LipidProTM lipid profile and glucose
measuring system. This instruction for use includes important informa­tion you need know about the LipidPro

TM

lipid profile and glucose
measuring system. Please read itcarefully. Our goal for LipidProTM lipid
profile and glucose measuring system is attributed to provide the best
quality healthcare products coupled with superior customer service.

Indications For Use

LipidProTM system is intended for in home (self-testing) or health care
professionals and for testing outside the body (in vitro diagnostic use
only). LipidProTM system which consists of meter and test strips,
measures total cholesterol (TC), high density lipoprotein cholesterol
(HDL-C), triglyceride (TG) and glucose in capillary whole blood.
Cholesterol measurements are used in the diagnosis and treatment of
disorders involving excess cholesterol in the blood and lipid and lipopro­tein metabolism disorders. Lipoprotein measurements are used in the
diagnosis and treatment of lipid disorders (such as diabetes mellitus),
atherosclerosis and various liver and renal diseases. Triglyceride
measurements are used in the diagnosis and treatment of patients with
diabetes mellitus, nephrosis, liver obstruction, other diseases involving
lipid metabolism, or various endocrine disorders. Calculated LDL choles­terol values are reported only when triglycerides are ≤ 350 mg/dL; when
triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not
reported.

Glucose measurement is for the quantitative measurement of the
concentration of glucose in capillary whole blood that can be taken from
the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or
thigh by diabetic patients or health care professionals as an aid in the
management of diabetes. Glucose measurment is not to be used for the
diagnosis of or screening for diabetes or for neonatal use. Alternate site
testing should be done during steady- state times when glucose is not
changing rapidly.

• 04 • • 05 •

How to use Instructions for use

This guide includes all the information you need to use LipidProTM for self-testing
use. For additional information and specific information for each individual test.
Please make sure you read the strip instructions for use included with the test
strips.

If you experience any difficulty or have any question, while using LipidPro

TM

Lipid

profile and glucose measuring system please, visit our website at

www.infopiausa.com

Customer Service is available 24 hours a day, 7 days a week, 365 days a year.
Please Call Customer Support toll free : 1-888-446-3246

Test Principle

LipidProTM lipid profile and glucose measuring system has two kinds of test
principle according to test items: one for Lipid profile and the other for glucose.

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 is, the higher the lipid level is.

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.
The enzyme glucose oxidase on the blood glucose test strip reads specifically
with the blood glucse. The current generated is converted and displayed as blood
glucose value. The LipidPro glucose test System is plasma-calibrated to allow
easy comparison of results with laboratory methods. Blood glucose meter which
is calibrated against a whole blood method may have different results in compari­son to LipidPro glucose test System. The laboratory system used for calibration
of the LipidPro glucose test System is YSI 2300 STAT plus which is equipped with
a glucuse oxidase system.

• 06 • • 07 •

LipidProTM lipid profile and glucose measuring
system Kit Contents

1. LipidProTM Meter 5. Two AAA batteries

2. Instructions for Use 6. Lancing Device

3. Warranty Card 7. Lancet

4. Carrying Case

Your LipidProTM lipid profile and glucose measuring 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

- LipidProTM Brand Test Strips

- LipidProTM Brand Control Solutions

- Capillary Rods

- Control Solution Range Cards

Contents

1. Learning the System

LipidProTM Testing System Kit Contents ----------------------------------- 7
LipidPro

TM

Testing Meter ------------------------------------------------------ 8
LipidProTM Testing Meter Display ------------------------------------------- 9
LipidProTM Test Strip Information ------------------------------------------- 10

2. Setting Your Meter

Battery Use --------------------------------------------------------------------- 18
Setting Mode ------------------------------------------------------------------- 19
Before Testing – Coding the meter ---------------------------------------- 21
hecking the System with Control Solution ------------------------------- 24

3. Testing Your Blood

Instruction for Lancing Device ---------------------------------------------- 29
Testing Your Blood – Preparation ------------------------------------------32
Quick reference of test procedure ----------------------------------------- 34
Test procedure -----------------------------------------------------------------36
Glucose test strip Discard Function ---------------------------------------44
Alternate site testing ----------------------------------------------------------45
Performing a Blood Test using an Alternate Site -----------------------46

4. Reviewing Your Results ---------------------------------------------------47

5. Deleting Your Results ------------------------------------------------------49

6. Printing Your Results ------------------------------------------------------- 49

7. LipidPro™ Software and Thermal printer ----------------------------50

8. Cleaning Your Meter and Maintenance -------------------------------51

9. Troubleshooting -------------------------------------------------------------52

10. Product Specifications ---------------------------------------------------55

11. Warranty ----------------------------------------------------------------------58

12. Declaration of Conformity -----------------------------------------------59

TC

HD

L

TG

MEM

• 08 • • 09 •

LipidProTM Testing Meter DisplayLipiProTM Testing Meter

1. Do not use LipidProTM meter 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 LipidProTM meter near cellular or cordless telephones,
walkie talkies, garage door openers, radio transmitters, or other
electronic or electrical equipment that are sources of electromag­netic radiation, as these may interfere with the proper operation of
the 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,
inclukding time and message

Up button(ƞ(

Maneuvering button for choice of function in each mode

Down(Ơ( button

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

Blood glucose

Total cholesterol

Triglyceride

HDL-cholesterol

LDL-cholesterol

Blood insertion for glucose test

Blood insertion for lipid profile test

Sample blood

Serum

Control Solution Symbol

Displaying code number of Test Strips

Short of batteries

Alarm

Testing unit

Temperature & date of test

Hour & Date of test

Average Test Result(only for glucose)

Month & Day

MTH

• 10 • • 11 •

LipiProTM Test Strip Information

Target to apply blood

This test strip is for glucose.

color coding label

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

This test strip colored red is for Total
Cholesterol.

This test strip colored blue is for HDLCholesterol.

This test strip colored green is for
Triglyceride.

Confirmation Window

Contact Bar

Front -

Back -

Use only LipidProTM Test Strips with your LipidProTM meter.
*Note: Please read the individual Package insert of LipidPro test strip for complete detail

information.

5. Glucose test strip

Caution

1. Store the LipidProTM 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:

- LipidPro™test strips below 64ºF (18ºC) or above 86ºF (30ºC).

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.

LipidProTM Test Strip Information

Front -

Back -

Front -

Back -

Front -

Back -

Front -

Back -

1. Lipid Profile test strip(Black)

2. Total Cholesterol test strip((Red)

3. HDL-Cholesterol test strip(Blue)

4. Triglyceride test strip(Green)

Ribs that guide the
strip into the meter

Total Cholesterol

test area

HDL-Cholesterol

test area

Triglyceride

test area

The part for holding
strip

Blood application and
Test area

• 15 •

Accuracy:

The accuracy results obtained with the LipidPro

TM

lipid profile and glucose measuring system
were compared to glucose results obtained with the Hitachi Glucose Auto meter 747, a
laboratory instrument. Glucose levels were measured on 160 patients at three different
clinical centers.

System accuracy results for glucose concentration <75 mg/dL

System accuracy results for glucose concentration ≥ 75 mg/dL

Alternate site :

Alternate site glucose test results obtained from alternative sites were comparend to the
glucose results obtained with the Hitachi Glucose Auto meter 747(reperence method), a
laboratory instrument. Glucose levels were measured at three different clinical centers.

Test results of DORSAL HAND were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

24/27 (93%)

Within ± 10mg/dL

27/27 (100%)

Within ± 15mg/dL

27/27 (100%)

Within ± 5mg/dL

4/5 (80%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

Within ± 5mg/dL

84/133 (63%)

Within ± 10mg/dL

119/133 (89%)

Within ± 15mg/dL

129/133 (97%)

Within ± 20mg/dL

133/133 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5mg/dL

84/133 (63%)

Within ± 10mg/dL

119/133 (89%)

Within ± 15mg/dL

129/133 (97%)

Within ± 20mg/dL

133/133 (100%)

Test results of VENTRAL HAND were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

4/5 (60%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5mg/dL

111/145 (77%)

Within ± 10mg/dL

143/145 (99%)

Within ± 15mg/dL

145/145 (100%)

Within ± 20mg/dL

145/145 (100%)

• 12 • • 13 •

LipiProTM Test Strip Information

Total Cholesterol

*NOTE: Please read individual Package of LipidProTM test strip for complete detail information.

LIMITATIONS OF SYSTEM (for Lipid profile test):

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

• Do not use neonate samples

1) Physicians - Please note the following interferences that may affect the results:

- For is with capillary whole blood.

- Extremes in hematocrit may affect test results. Hemartocrit levels less than 30% may
cause falsely high reading and hematocrit level greater than 55% may cause falsely low
reading.

- Interference: 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.

- Use LIpidPro system

TM

at the frequency your doctor recommends testing for total

cholesterol, HDL-cholesterol, and triglyceride.

Performance Characteristics:

The performance or 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 Lipid Pro™ is 100 ~ 400mg/dL for Total Cholesterol, 25~80mg/dL for HDL­Cholesterol and 70 ~ 600mg/dL for Triglyceride.

1) Accurracy

The accuracy lipid profile results obtained with the LipidPro™‚ test system were compared to
results obtained with Reference device. Lipid profile levels were measured on 1200 capillary
whole blood specimens at three different centers.

Precision

- The precision Total Cholesterol, HDL-cholesterol and Triglyceride test results were
measured with Three level venous whole blood samples for 20 days.

- The precision Total cholesterol, HDL-cholesterol and Triglyceride test results were
measured with two control solutions for 20 days.

Sample Type

Capillary

slope

1.0013

y-interceptor

2.2025

R

2

0.9933

Total Cholesterol

Mean Conc. (mg/dL)

SD (mg/dL)

CV (%)

120.0

1.9

1.6

231.8

3.2

1.4

349.7

4.0

1.1

Triglyceride

Mean Conc. (mg/dL)

SD (mg/dL)

CV (%)

130.0

1.9

1.4

357.2

5.0

1.4

530.1

6.1

1.2

Total Cholesterol

Mean Conc. (mg/dL)

SD (mg/dL)

CV (%)

150.3

2.2

1.5

250.6

3.6

1.4

HDL-Cholesterol

Mean Conc. (mg/dL)

SD (mg/dL)

CV (%)

59.9

1.3

2.1

29.9

0.8

2.7

Triglucerode

Mean Conc. (mg/dL)

SD (mg/dL)

CV (%)

120.5

2.9

2.4

250.5

2.8

1.1

HDL-Cholesterol

Lipid Profile

Mean Conc. (mg/dL)

SD (mg/dL)

CV (%)

30.9

0.8

2.5

51.9

1.1

2.1

73.0

1.6

2.2

HDL-Cholesterol

Sample Type

Capillary

slope

0.9935

y-interceptor

-1.2036

R

2

0.9938

Triglyceride

Sample Type

Capillary

slope

1.0169

y-interceptor

-0.2810

R

2

0.9938

Mean

SD
CV

TC

118 .9

2.1

1.8

TG

128.5

2.2

1.7

Level 1 Level 2 Level 3

HDL

31.5

0.7

2.3

TC

236.0

3.4

1.4

TG

357.6

4.3

1.2

HDL

50.2

1.1

2.2

TC

348.0

5.

1.4

TG

529.0

6.0

1.1

HDL

71.2

1.5

2.1

• 14 • • 15 •

LipiProTM Test Strip Information

*NOTE: Please read individual Package of LipidProTM test strip for complete detail information.

LIMITATIONS OF SYSTEM (for Glucose test):

The LipidPro

TM

Glucose Test Strips provide accurate results when the following constraints

are observed:

• Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate low results low results may occur for individuals experiencing a hyperglycemic
hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with
blood glucose meters.

• Use only the LipidPro

TM

glucose test strips with the LipidProTM meter.

• Use fresh capillary whole blood only.

• Do not use neonate samples.

• The test strips are for siingle use only. Do not reuse.

• Dehydration may lower test results.

• 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 30 % may cause
falsely high reading. Hematocrit levels greater than 55 % may cause falsely low readings.

• 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 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.
Measurement Range: The measurement range of the LipidPro

TM

Glucose Testing is 20 to

600 mg/dL.

Accuracy:

The accuracy results obtained with the LipidPro

TM

lipid profile and glucose measuring system
were compared to glucose results obtained with the Hitachi Glucose Auto meter 747, a
laboratory instrument. Glucose levels were measured on 160 patients at three different
clinical centers.

System accuracy results for glucose concentration <75 mg/dL

System accuracy results for glucose concentration ≥ 75 mg/dL

Alternate site :

Alternate site glucose test results obtained from alternative sites were comparend to the
glucose results obtained with the Hitachi Glucose Auto meter 747(reperence method), a
laboratory instrument. Glucose levels were measured at three different clinical centers.

Test results of DORSAL HAND were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

24/27 (93%)

Within ± 10mg/dL

27/27 (100%)

Within ± 15mg/dL

27/27 (100%)

Within ± 5mg/dL

4/5 (80%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

Within ± 5mg/dL

84/133 (63%)

Within ± 10mg/dL

119/133 (89%)

Within ± 15mg/dL

129/133 (97%)

Within ± 20mg/dL

133/133 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5mg/dL

84/133 (63%)

Within ± 10mg/dL

119/133 (89%)

Within ± 15mg/dL

129/133 (97%)

Within ± 20mg/dL

133/133 (100%)

Test results of VENTRAL HAND were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

4/5 (60%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5mg/dL

111/145 (77%)

Within ± 10mg/dL

143/145 (99%)

Within ± 15mg/dL

145/145 (100%)

Within ± 20mg/dL

145/145 (100%)

• 16 • • 17 •

Precision:

Repeatability evaluation for venous blood samples.

Intermediate evaluation for control solutions.

Mean (mg/dL)

CV (%)

45.0

3.1

84.7

2.1

130.8

2.2

206.2

2.6

341.8

2.4

Mean (mg/dL)

CV (%)

49.7

2.3

100.5

1.7

300.3

0.7

Test results of VENTRAL HAND were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

4/5 (60%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5mg/dL

111/145(77%)

Within ± 10mg/dL

143/145 (99%)

Within ± 15mg/dL

145/145 (99%)

Within ± 20mg/dL

145/145(100%)

Test results of UPPER ARM were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

4/5 (80%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ±5%

1.9/145(75%)

Within ±10%

143/145 (99%)

Within ±15%

145/145 (100%)

Within ±20%

145/145(100%)

Test results of FORE ARM were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

4/5(80%)

Within ± 10mg/dL

5/5 (100 %)

Within ± 15mg/dL

5/5 (100 %)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ±5%

95/145(66%)

Within ±10%

137/145 (94%)

Within ±15%

143/145 (99%)

Within ±20%

145/145(100%)

Test results of THIGH were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

3/5(60%)

Within ± 10mg/dL

5/5 (100%)

Within ± 15mg/dL

5/5 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5mg/dL

103/145(71%)

Within ±10%

137/145 (94%)

Within ±15%

144/145 (99%)

Within ±20%

145/145(100%)

Test results of CALF were compared to the reference method.

System accuracy results for glucose concentration<75mg/dL

Within ± 5mg/dL

2/5(40%)

Within ± 10mg/dL

5/5 (100 %)

Within ± 15mg/dL

5/5 (100%)

System accuracy results for glucose concentration ≥ 75 mg/dL

Within ±5%

100/145(69%)

Within ±10%

138/145 (95%)

Within ±15%

145/145 (100%)

Within ±20%

145/145(100%)