OSANG Healthcare ILM-0001A-RF Lipid profile and glucose measuring system for self testing User Manual Manua Cover

Infopia Co.,Ltd. Lipid profile and glucose measuring system for self testing Manua Cover

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LipidProTM Testing System
Instructions for use
Testing items:
• Total Cholesterol
• HDL-Cholesterol
• Triglyceride
• Calculated LDL-Cholesterol
• Blood Glucose Test
CL-LP1-1A0-01
LP-CL1-1B0-01 Rev. 2008-10
Dear LipidProTM Testing System Owner
Thank you for your choosing the LipidProTM Testing System. This instruction for
use includes important information you need know about the LipidProTM Testing
System. Please read it carefully.
Our goal for LipidProTM Testing System is attributed to provide the best quality
healthcare products coupled with superior customer service.
Important information
The LipidProTM Testing 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 profile includes 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.
• 3 •
LipidProTM Testing System
Test Principle
How to use Instructions for use
LipidProTM Testing System has two kinds of test principle according to test items:
one for blood glucose and the other for lipid profile.
This guide includes all the information you need to use LipidProTM for 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.
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 LipidProTM meter and displayed as your blood glucose
result.
• 4 •
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 LipidProTM call :
Infopia Customer Service
Hours : 09:00 AM - 06:00 PM
Monday - Friday
Tel. +82-31-423-6170
Fax. +82-31-423-6171
Email : sales@infopia21.com
• 5 •
LipidProTM Testing System
Contents
LipidProTM Testing System Kit Contents
1. Learning the System
LipidProTM Testing System Kit Contents
LipidProTM Testing Meter
LipidProTM Testing Meter Display
LipidProTM Test Strip Information
10-13
2. Setting Your Meter
Battery Use
Setting Mode
Before Testing-Coding the Meter
Before Testing
Checking the System with Control Solution
14
15-16
17-19
20
21-24
3. Testing Your Blood Glucose
Testing Your Blood - Preparation
Collecting a Drop of Blood
Testing Your Blood
25
26
27-28
29-30
31-38
Quick reference of test procedure
Test Procedure
Glucose test strip Discard Function
Alternate site testing
39
40
Performing a Blood Test using an Alternate Site
4. Reviewing Your Results
5. Deleting your Results
6. LipidProTM Testing System Software
7. Cleaning Your Meter and Maintenance
8. Troubleshooting
9. Product Specifications
10. Warranty
11. Declaration of Conformity
• 6 •
41
42-45
46
47
48
49-51
52-54
55
56
1. LipidProTM Meter
2. Instructions for Use
3. Warranty Card
4. Carrying Case
5. Two AAA batteries
6. Lancing Device
7. Lancet
Your LipidProTM Testing 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 Total choresterol test strip
- LipidProTM Triglyceride test strip
- LipidProTM glucose test strip
- LipidProTM glucose control solution
- Log book for test record of glucose
- LipidProTM HDL-choresterol test strip
- LipidProTM lipid profile test strip
- Capillary rod
- LipidProTM lipid control solution
• 7 •
LipidProTM Testing System
LipidProTM Testing Meter
LipidProTM Testing Meter Display
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
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
Caution
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 electromagetic radiation, as these may interfere with the proper
operation of the meter.
• 8 •
Average Test Results
Control Solution Sysmbol
Day & Month
• 9 •
LipidProTM Testing System
LipidProTM Test Strip Information
LipidProTM Test Strip Information
Use only LipidProTM Test Strips with your LipidProTM meter.
5. Glucose test strip
Front -
Target to apply blood
Confirmation Window
Glucose
Ribs that guide the strip
into the meter
Blood application and Test
area
This test strip is for glucose.
Back -
Caution
Contact Bar
The part for holding strip
1. Lipid Profile test strip
Front Back -
This test strip enables to test TC, HDL, TG
and calculated LDL.
2. HDL-Cholesterol test strip
Front -
This test strip is for HDL-Cholesterol.
Back -
3. Total Cholesterol test strip
Front -
This test strip is for Total Cholesterol.
Back -
4. Triglyceride test strip
Front -
Glucose
This test strip is for Triglyceride.
Back • 10 •
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
LipidProTM 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 LipidProTM 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 LipidProTM 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.
• 11 •
LipidProTM Testing System
LipidProTM Test Strip Information
LipidProTM Test Strip Information
LIMITATIONS OF SYSTEM (for lipid profile test):
LIMITATIONS OF SYSTEM (for Glucose test):
Lipid Profile Test Strips provide accurate results when the following constraints
are observed:
• Do not use neonate samples
The LipidProTM 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 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 LipidProTM‚ is 100 ~ 400 mg/dL (2.5910.36mmol/L) for total cholesterol, 25~80mg/dL (0.65- 2.08mmol/L) for HDLcholesterol and 70~600 mg/dL (0.80-0.86mmol/L) for Triglyceride.
• 12 •
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 LipidProTM Glucose
Testing is 10 to 600 mg/dL (0.6-33.3mmol/L).
• 13 •
LipidProTM Testing System
Setting Your Meter
Setting Your Meter
Battery Use
Setting Mode
It is recommended to set your LipidProTM meter properly before using.
The LipidProTM requires two(2) AAA 1.5 volt alkaline batteries.
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.
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
LipidProTM on.

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.
By pressing ▲▼, adjust year and press
MODE ( ) button.
By pressing ▲▼, adjust date, month and
time, and then press MODE ( ) button.
Caution
Caution
Remove both batteries from the battery compartment and dispose of them
according to your institution's guidelines.
Make sure that the date and time are set properly to enable your data to be
stored and downloaded properly.
• 14 •
• 15 •
LipidProTM Testing System
Setting Your Meter
Before Testing - Coding Your Meter
By pressing ▲▼, select testing
unit and press MODE ( ) button.
LipidProTM 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
By pressing ▲▼, select temperature unit and press MODE
( ) button.
Press RFID (▼) 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.
• 16 •
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.
• 17 •
LipidProTM Testing System
Before Testing - Coding Your Meter
Before Testing-Coding the Meter
•Coding for Glucose test
Once it recognizes the code number, the meter displays the code value for 1 second and return to the
stand-by status.
1. Firmly insert the glucose test strip into the
test port of LipidProTM meter, and then the
power will automatically turn on with the
code number, temperature and time.
Make sure the code number matches the code on
the strip bottle.
2. Make sure the code number on the display of the meter correspond with that on
the test strip bottle. The color tag of the
back on the test strip automatically recognizes the code number in this system.
Caution
1. If the code is not displayed after 3 seconds, pull the test strip out of the port
and re-start the procedure from the beginning.
2. If the code on the display and on the test vial does not match, try another new
strip. If the mismatch persists, please contact your local representative for
help.
3. If the meter does not power on, pull the test strip out of the port and re-insert
the test strip.
4. Avoid testing under direct sunlight, for a more accurate test result.
5. If you apply your sample too early, Error message will appear on the
display(refer to page 49 ).
• 18 •
• 19 •
LipidProTM Testing System
Before Testing
Checking the system with control solution
Quality control by control solution
Check the expiry date before performing a control solution test. Do not
use if expired.
Control testing, also known as quality control testing, is used to ensure all the
parts of the test system are working properly together and the test results are
accurate and reliable within the limits of the system. As a quality control, or control solution, commercial human serum control can be used. It is available online
at sales@infopia21.com or call at +82-31-423-6170 of Infopia Customer
Service.
The users should follow their facility's policies on when controls should be tested
(for example: with each new Test strip lot; monthly as a continued check on storage conditions;whenever issues (storage,operator,or other) are identified or
there are questions about the results).
The control solution should be used
•Whenever you suspect the meter or test stirp is not functioning properly.
•If your blood glucose test results are not consistent with your symptoms or if
you think they are not accurate.
•If you have dropped the meter
•For quality control in the point of care
•For Teaching or learning the system
Caution
Once the control solution for glucose test is opened, it expires after 3
months, while if the control solution for lipid profile is mixed with distilled
water, it expires after 3 days.
LipidPro™ control solution is sold separately.
It is recommended that the control solution is stored at room temperature
before testing.
•Lipid Profile test
Testing procedure
1. Press ▼ button and the meter enters RFID
mode.
2. Place of 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 2cm.
The meter will revert back to stand-by status if there is no operation within 5 seconds.
• 20 •
• 21 •
LipidProTM Testing System
Checking the system with control solution
3. Check the code number on the display of the
meter with that on the strip bottle.
4. Insert the test strip and press mode button.
Press ▲ button and the meter displays the
symbol of control solution.
5. Press mode (
) button again and the symbol of sample blood is blinking.
6. Take a drop of control
solution on clean bowl
(ex. Aluminium foil).
7. Apply the prepared control solution to the test
strip by using capillary
rod.
Checking the system with control solution
Testing tips:
• Please make a test after reading the instructions for use of control
solution thoroughly.
• Keep clean of the test area on the meter.
• Keep test strips and control solutions in proper condition according to
the instructions for use provided, such as expiry date, storage condition
and so forth.
• Before testing, make sure that the test strips and the meter are at the
temperature of 18-30℃(64-86℉).
Caution
If your control solution test falls out of range, please follow the next steps before
contacting customer support:
•Check the expiry dates on all the products you are using. Be sure you are
using LipidProTM control solution.
•Try another control solution test.
•If this test falls out of range, try another control solution test with a new
unopened bottle of strips.
•After following the appropriate steps and the control solution test still falls out of
range, do not perform a test. Please contact the Infopia customer service at
+82-31-423-6170 or sales@infopia21.com.
•The control solution range is not the recommended range for your test.
•Discard the used control solution and the test strips carefully according to the
local regulations.
•Glucose test
Testing procedure
8. The test result will come after 1~2 minutes.
• 22 •
1. Shake the control solution before use.
• 23 •
LipidProTM Testing System
Checking the system with control solution
Testing Your Blood - Preparation
Blood testing
2. Discard the 1st drop of control solution, this will
eliminate any residue.
3. Place a drop of control solution on a clean, dry
surface(ex. The lid of the test strip vial).
4. Insert a test strip into the port firmly and press
▲ button. The symbol of control solution will
appear on the display of meter. This will allow
you to differentiate between a control solution
test and an actual blood test for future reference.
5. Dip the test strip into the control solution.
6. Results appear in 3 seconds. Compare the
result to the range printed on the test strip vial,
the results should fall within that range.
• 24 •
A strip instructions for use is included with each box of test strips.
Please read the test strip package insert along with this section completely and
carefully before testing.
Testing supplies
To perform a blood test you need:
•LipidProTM meter
•Test strips
•Sterile lancet
•Capillary rod
•Lancing device
Caution
1)To reduce the chance of infection.
•The Lancing Device and sterile lancets should NOT be shared with others.
•Always use a new, sterile lancet.
•Lancets are for single use only.
•Avoid getting hand lotion, oils, dirt, or debris in or on the Lancets and the
Lancing Device
2) Do not operate the meter in direct light.
3) Practice using the lancing device and become accustomed with its use.
Wash your hands with warm, clean water and soap. Dry your hands
completely before testing.
• 25 •
LipidProTM Testing System
Collecting a Drop of Blood
Testing Your Blood
Performing Your Test
1. Lipid Profile test
Capillary blood process
When you collect the sample, please use the capillary rod provided with the test
strip package. Make sure enough sample has been collected to the capillary rod.
1. Unscrew the lancing device
tip and insert a lancet
firmly into the carrier.
2. Pinch the lancet and twist
off the protective cover.
Do not discard the cover.
3. The tip of the lancing
device offers 5 different
levels of skin penetration.
To select the best depth :
Use 1-2 for soft or thin
skin, 3 for average skin, 45 for thick or calloused
skin.
[ adequate ]
[ inadequate ]
Caution:
If blood is stained outside the sample area, carefully wipe the stain out
with a tissue. Do not allow the wiping tissue to touch the open end of
the sample area of the collecting leg.
2. Glucose test
4. Hold the tip in one hand
and pull
on the sliding
barrel with other hand. Pull
the ends apart and you will
feel a click. This indicates
that the lancing device is in
a locked position ready
for lancing.
5. Release the sleeve. It will
automatically contract and
move back to its original
position near the trigger
hub.
3. The tip of the lancing
device offers 5 different
levels of skin penetration.
To select the best depth :
Use 1-2 for soft or thin
skin, 3 for average skin, 45 for thick or calloused
skin.
Caution
Use a new sterile lancet every time you test.
Do not use lancet if protective cover has been removed or damaged.
Never share a lancet with anyone.
completely
filled
Incorrect : Poorly filled
• 26 •
Correct : Completely filled
Maintaining your Lancing Device
•Unscrew the lancing device tip. Carefully stick the protective disk cover back on the used
lancet.
•Grip the holder firmly and pull the lancet safely out of holder. Screw the tip back on the
lancing device.
•Properly discard the used lancet. Clean the lancing device if blood or stain remains.
Place your fingertip to the top edge of glucose
test strip.
correct
poorly
filled
• 27 •
incorrect
LipidProTM Testing System
Testing Your Blood
Quick reference of test procedure -Lipid test
This is for professtional use
venouse whole blood and serum process for Lipid Profile test
For venous whole blood and serum, acceptable anti-coagulants are
EDTA, heparin, citrate and fluoride/oxalate, and these samples may be
stored at 4℃~ 20℃ (39℉~ 68℉) for three days.
Please follow the procedure below.
1. Allow blood sample to reach room temperature.
2. Anti-coagulated blood should be mixed well prior to testing.
3. Remove the stopper from the holder and collect the sample of 5 ul by
using pipette.
1) After code recognition, press mode (
ton again
) but-
2) Prick the finger with a lancing device for the
sample blood.
Optional method
- Take out a drop of blood sample on a clean container.
- Collect the sample of 5 ul by using capillary rod, instead of pipette.
3) Collecting the sample blood to the capillary
rod.
4. Apply the sample to the test strip.
4) Make sure the enough sample has been collected to the capillary rod.
5) Contact the capillary rod with the sample to
the test area of the strip so as to start the test.
Caution:
Do not freeze the samples, but store at 4℃ instead and test quickly.
Please test freshly collected samples. If the samples are not fresh,
LPL(lipoprotein lipase) or LCAT(lecithin cholesterol acyltransferase)
may affect the form of lipoprotein.
• 28 •
Caution
•If the test result is out of the test range, the Hi/Lo message will be shown on the LCD.
•Safely discard used test strips and lancets.
• 29 •
LipidProTM Testing System
Quick reference of test procedure -Glucose test
1) Insert the glucose test strip. Code number
is automatically displayed. Compare with
code number printed on test strip vial. If
not identical discard the test strip and
restart.
2) Prick the finger with a lancing device for
the sample blood.
3) Apply blood sample until confirmation
window is completely filled. Meter automatically begins to countdown. If the
countdown does not start, do not add
more blood to the test strip! Discard the
test strip a restart testing.
Test Procedure
1. Lipid test - Test for multi items
Press mode ( ) button after a test strip is
inserted and confirm if the meter recognizes
the right test strip by checking out the corresponding symbol on its display.
The meter displays the code number and
the testing symbols (
together and then, press mode button.
The symbol of blood is blinking.
4) Test results appear in 3 seconds.
Please apply the sample to the first test area
of test strip until you hear beep sound.
Then, the symbol,
disappears.
Caution
•If the test result is out of the test range, the Hi/Lo message will be shown on the LCD.
•Safely discard used test strips and lancets.
• 30 •
• 31 •
LipidProTM Testing System
Test Procedure
Test Procedure
Please apply the sample to the second test
area of test strip until you hear beep sound.
Then, the symbol,
disappears.
Please apply the sample to the third test
area of test strip until you hear beep sound.
Then, the symbol,
disappears.
2. Test for each single item
1) Total Cholesterol test
Press mode (
) button after a test strip is
inserted and confirm if the meter recognizes
the right test strip by checking out the corresponding symbol on its display.
The meter displays the code number and
the testing symbols (
) together and
then, press mode button.
The meter displays
, blinking in
order, which means it is under test.
The symbol of blood is blinking.
In the case of LDL-cholesterol, if density of
triglyceride is over 350mg/dL, it can't be
measured.
Please apply the sample to the test area of
test strip until you hear beep sound.
In order to check each test item, please press up or down button. You can
check out each result of Total Cholesterol, HDL-Cholesterol and Triglyceride.
• 32 •
• 33 •
LipidProTM Testing System
Test Procedure
Test Procedure
The meter displays
, blinking in
order, which means it is under test.
When the test is completed (in about maximum 2 minutes), the meter displays the test
result of
with the symbol.
The symbol of blood is blinking.
Please apply the sample to the test area of
test strip until you hear beep sound.
2) HDL-Cholesterol test
Press mode (
) button after a test strip is
inserted and confirm if the meter recognizes
the right test strip by checking out the corresponding symbol on its display.
The meter displays the code number and
the testing symbols (
) together and
then, press mode button.
• 34 •
The meter displays
, blinking in
order, which means it is under test.
When the test is completed (in about maximum 2 minutes), the meter displays the test
result of
with the symbol.
• 35 •
LipidProTM Testing System
Test Procedure
Test Procedure
3) Triglyceride test
Press mode (
) button after a test strip is
inserted and confirm if the meter recognizes
the right test strip by checking out the corresponding symbol on its display.
The meter displays the code number and
the testing symbols (
) together and
then, press mode button.
The meter displays
, blinking in
order, which means it is under test.
When the test is completed (in about maximum 2 minutes), the meter displays the test
result of
with the symbol.
The symbol of blood is blinking.
Please apply the sample to the test area of
test strip until you hear beep sound.
• 36 •
• 37 •
LipidProTM Testing System
Test Procedure
Glucose test strip Discard Function
3. Glucose test
When the test strip is inserted, the meter
displays the code number for 3 seconds.
The symbol of blood is blinking.
1. After checking your test result, slide the ejector button twice forward to
remove the test strip from the meter.
2. Discard the used strip and lancet to a proper place, according to the local regulation.
Once the sample is applied, the meter displays 3, 2, 1 in order.
Then, the meter completes the test with the
test result.
• 38 •
Caution
1. If you push the discard button forward too much, it may be damaged.
2. Do not give strong impact to meter.
• 39 •
LipidProTM Testing System
Alternate site testing
Performing a Blood Test using an Alternate site
Note : This alternate site testing is applied to glucose testing only.
Important :
We recommend that you test on your fingertip if you are testing for hypoglycemia (low blood glucose) or if you have a history of reoccurring hypoglycemia.
Upper Arm
Forearm
Dorsal Hand
Ventral Palm
Thigh
Fingertips
Calf
The LipidProTM Testing System gives you the ability to obtain a blood sample for
testing your glucose level from different areas of your body. The figure shown
above displays the areas where you can test using your LipidProTM Testing
System.
To ensure accurate results when lancing your forearm, upper arm, hand, thigh,
or calf, wash the test site with soap and water.
Make sure there is no cream or lotion on the test site.
Thoroughly dry your hands and test site.
You may test your blood glucose from your forearm, upper arm, palm(ventral
palm or dorsal hand), fingertips, thigh, or calf.
It is recommended that alternate site testing be used when glucose values are
stable: before meals and before bedtime. However, when blood glucose is
changing, blood from the finger tip may show these changes sooner than blood
from other sites.
• 40 •
Caution
- To ensure accurate results when lancing your arm (Upper arm or forearm), leg (calf or thigh) or palm (ventral palm or dorsal hand), wash your
hand and test site with soap and water.
- To receive accurate test results, at least 0.3ul minimum sample volume is
required.
• 41 •
LipidProTM Testing System
Reviewing Your Results
Reviewing Your Results
Every test result is stored with its date and time of test.
1. Total Cholesterol
Following is the memory capacity of each test item in the meter.
•Glucose
100 memories
•TC
50 memories
•HDL
50 memories
•TG
100 memories
•LDL
50 memories
Press mode (
When the test results is over the capacity memory, the recent test result will
replace with the oldest test result.
) button.
Press ▲▼ for reviewing the rest result.
In order to enter into Memory mode, please press mode button when no test
strip is inserted.
2. HDL-Cholesterol
When there is no memory in the meter
Press mode (
) button.
How to enter into Memory Mode
In order to enter into Memory mode, please press the mode button when no test
strip is inserted. By using ▲▼, you can recall each Total Cholesterol, HDLCholesterol, Triglyceride, LDL-Cholesterol and glucose. Press the mode button
after you select the item you would like to review.
• 42 •
Press ▲▼ for reviewing the rest result.
• 43 •
LipidProTM Testing System
Reviewing Your Results
Reviewing Your Results
3. TG Cholesterol
5. Glucose
Press mode (
) button.
Press ▲▼ for reviewing the rest result.
Press mode (
) button.
Press mode (
) button and the meter displays the
average data and the symbol (AVR) you had set previously. If you set 3 kinds of average data, please
press ▲▼, button for reviewing.
4. LDL Cholesterol
Press mode (
) button.
Press ▲▼ for reviewing the rest result.
• 44 •
• 45 •
LipidProTM Testing System
Deleting your Results
LipidProTM Testing System Software
deleting individual test result
To delete any individual test result in the memory
press ▲ or ▼ button for 3 seconds, while the test
result to delete is displayed. Then,
is blinking.
After the second beep sound the test result is deleted.
deleting all test results
You can transfer test results from the LipidProTM Testing System meter to a
computer.
You can download the software from our web site.
(http://www.infopia21.com)
You can purchase the computer communication cable separately from a local
representative.
User
PC
To delete all test results press ▲ and ▼ button at
the same time for 3 seconds, while any test result is
displayed. Then, ALL is displayed and
is blinking. After the third beep sound all test results are
deleted.
cable
Caution
The deleted test results can’t be recovered. Please be careful in deleting the test
results.
• 46 •
• 47 •
LipidProTM Testing System
Cleaning Your Meter and Maintenance
Meter
Your meter does not require special maintenance or cleaning. Avoid getting dirt,
dust, blood, control solution, or liquids on the meter, the test port, or data port.
Your meter operation temperature is 18℃~30℃(64~86ºF).
It is recommended that you store the meter in its carrying case after each use.
A cloth dampened with water and mild detergent can be used to wipe down the
outside of the meter. Your LipidProTM meter is a precision instrument. Please
handle it with care.
1) Do not disassemble or modify the meter.
2) Do not place the meter in places with high humidity.
3) Do not place the meter in polluted or dusty areas.
4) Do not expose the meter to impact, shock, vibration, inclination, etc. and keep
it in a safe place.
5) Do not place the meter with chemical products or with gases.
6) Keep it away from direct sunlight.
7) Close the vial, immediately after taking out the Test Sensor for the test.
8) Keep the Test Sensor away from children.
9) Keep the lancing device clean by using alcohol or soap and water.
10) The meter should be cleaned with soft cloth or paper tissue, in case of dirt.
Lancet Device:
Clean the lancet device and caps with soap and luke warm water. To disinfect
the lancet device, prepare a disinfectant solution of one part household bleach
to 10 parts water. Dampen a cloth with this solution and wipe the lancet device
thoroughly. Soak only the cap for at least 30 minutes in the disinfectant solution.
Do not soak the lancet device in liquid. Rinse the lancet device and cap with
water and dry thoroughly. Properly discard the used lancet.
• 48 •
Troubleshooting
Message
Probable cause
Action required
This message appears
when the hardware
defects. Ex) The Flash
ROM write/read function does not work.
Oxidization voltage is
out of range, etc.
Reboot the meter by placing the
batteries again when no test
strip is inserted. Please contact
your local representative or customer support when the problem
persists.
This message appears
when test strip may be Please insert a new test strip
contaminated
or and perform your test again.
reused. This message
appears when the raw
data of strip higher
than 8 before injection
blood.
This message appears Please apply the sufficient samwhen the sample blood ple blood to the test strip.
is insufficient amount
on the lipid test.
This message appears
when strip signals with- Please insert a new test strip
out any Blood or and perform your test again.
Control solution or
other sample applying.
This message appears
when the raw data of
test result is lower than
3.
• 49 •
LipidProTM Testing System
Troubleshooting
Message
Troubleshooting
Probable cause
Action required
Message
Probable cause
Action required
This message appears Please wait for the meter diswhen blood sample is plays the icon blinking before
input before the symbol applying your blood sample.
for blood blinks.
The test result is
lower than the following
glucose : less than 10mg/dL
( 0.6mmol/L )
TC : less than 100mg/dl
TG : less than 70mg/dl
HDL : less than 25mg/dl
This message appears Please insert a new test strip
when the color bar of and perform your test again.
the strip is dirty or not
good or there is too
much light. Action
required.
The ambient temperature is over 30℃
Place the meter at the temperature between 18 and 30℃ for
more than 10 minutes and test
again.
This
message
appears when Lipid
strip is removed during testing.
Test again with a new test strip
and make sure the test strip to
be inserted into the right port of
each item. Do not discard the
test strip from the meter during
the test.
The test result is
higher than the following.
more than 600mg/dL (33.3mmol/L)
TC : more than 400mg/dl
TG : more than 600mg/dl
HDL : more than 80mg/dl
• 50 •
The ambient tempera- Place the meter at the temperature is less than 18℃ ture between 18 and 30℃ for
more than 10 minutes and test
again.
• 51 •
LipidProTM Testing System
Troubleshooting
Product Specification
Inconsistent or unexpected test results
If you continue to get unexpected results, check your system with control solution. If you experience symptoms that are not consistent with your lipid and glucose results, first be sure you have followed all instructions in this Instructions for
use, then contact your doctor. Never ignore symptoms or make significant
changes to your control program without speaking to your doctor.
Devision
Product Specification
Devision
LipidProTM
test
Content
Glucose
test
Content
Sample type
Capillary whole blood
Testing Types
Glucose
Test range
10~600mg/dL
Sample volume
0.3uL
Testing time
3sec
Calibration
Plasma - Equivalent
Sample type
Capillary whole blood, Venous blood,
Plasma
Operating Humidity
10 ~ 90 %
Testing Types
Total cholesterol
HDL-cholesterol
Triglyceride
LDL-cholesterol
Storage Temperature
2~ 30℃ (36~86℉)
Hct influence
20 ~ 60%
Testing method
Enzymatic-colorimetric method
Standard Supported
ISO/IEC 15693
Testing range
Total cholesterol : 100~400mg/dL,
Triglyceride :70~600mg/dL,
HDL-cholesterol : 25~80mg/dL
Nominal Read/Write Range
< 2cm
Antenna
Integrated
Frequency
13.56 MHz
Testing time
About 1 ~ 2 minute
Calibration
Plasma_Equivalent
Sample volume
5uL
Operating Humidity
10 ~ 90 %
Storage Temperature
2 ~ 30℃ (36 ~ 86 ℉)
Hct influence
35 ~ 50%
• 52 •
RFID
• 53 •
LipidProTM Testing System
Product Specification
Warranty
Devision
Content
Measuring principle
Electrochemical, Spectroscopy
Storage memory
350
Operation Temperature
18 ~ 30℃ (36~86℉)
Operation Humidity
10 ~ 90%
Display Type
LCD
Size(W*D*H)
60.38 x 109 x 22.9 (mm)
Weight
77.5g (including battery)± 1g
Power supply
(AAA) 1.5V x 2
Battery life time
Running over 1,000 times
PC Port
The connection between Computer
and cable
Manufacturer's Warranty:
Infopia Co., Ltd., warrants to the original purchaser that this instrument will be
free from defects in workmanship for 3 years from the date of original purchase.
Limitations of Warranty:
This warranty is subject to the following exceptions and limitations:
1. Infopia Co., Ltd. shall not be required to replace any unit which are damaged or malfunction due to abuse, accidents, alteration, neglect, misuse,
maintenance by someone other than Infopia Co., Ltd., or failure to operate
in accordance with the instructions.
2. Infopia Co., Ltd. reserves the right to make changes in design without obligation to incorporate such changes into previously manufactured instruments.
3. Infopia Co., Ltd. has no knowledge of the performance of the instrument
when the test strip is altered or modified in any manner.
For warranty service :
Purchaser must contact the local representative for assistance and/or instructions for obtaining service of this instrument.
Important:
Speak to the Infopia Co., Ltd. local representative before returning your
instrument for any reason. She/he will give you the information needed to
resolve your problem correctly and efficiently.
• 54 •
• 55 •
LipidProTM Testing System
Declaration of Conformity
Memo
FCC
THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES.
Operation is subject to the following two conditions; (1) this device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
CAUTION: Changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
NOTE:
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of
the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which
the receiver is
connected.
- Consult the dealer or an experienced radio/TV technician for help.
• 56 •
• 57 •

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