OSANG Healthcare ILM-0001A-RF Lipid profile and glucose measuring system for self testing User Manual Lipidpro FDA MeterManual Eng

Infopia Co.,Ltd. Lipid profile and glucose measuring system for self testing Lipidpro FDA MeterManual Eng

Contents

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 LipidProTM 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 : 1-888-446-3246
• 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 informa-
tion you need know about the LipidProTM 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.
• 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 LipidProTM 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 LipidProTM 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 compari-
son 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
LipidProTM 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
HDL
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 electromag-
netic 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 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:
- 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 HDL-
Cholesterol 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
R2
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
R2
0.9938
Triglyceride
Sample Type
Capillary
slope
1.0169
y-interceptor
-0.2810
R2
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 LipidPro
TM
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%)
• 18 • • 19 •
Setting Your Meter
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 LipidPro
TM
.
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.
Setting Your Meter
Setting Mode
It is recommended to set your LipidPro
TM
meter properly before using.
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.
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.
By pressing
▲▼
, adjust year and press MODE
( ) button.
By pressing ▲▼, adjust date, month and time, and
then press MODE ( ) button.
• 20 • • 21 •
Setting Your Meter Before Testing – Coding the meter
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.
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.
Press RFID(
▼
) button for 3 or more seconds.
Place the RFID-tag on the strip bottle to the area
of the RFID symbol( ) on the meter.
• Coding for Lipid Profile test
By pressing
▲▼
, select tem-
perature unit and press MODE ( )
button.
By pressing
▲▼
, select average date and press
MODE ( ) button.
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 2 alarms).
By pressing
▲▼
,
select print ON/OFF and press
Mode( ). If you select ‘ON’ and press Mode( )button
to active it. If you select print, this setting mode is
completed.
By pressing Up(
▲
) or Down(
▼
)
button, select testing unit and press
Mode( ) button.
• 22 • • 23 •
Before Testing – Coding the meter Before Testing – Coding the meter
• Coding for Glucose test
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 representa-
tive 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 52 ).
1. Firmly insert the glucose test strip into the test
port of LipidPro
TM
meter, and then the power
will automatically turn on with the code number,
temperature and time.
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.
Once it recognizes the code number, the meter
displays the code value and test item(s) for 2
second and return to the stand-by status.
Check the code number on the display on the
meter with that on the strip bottle.
1504
C20
• 24 • • 25 •
Checking the system with control solution Checking the system with control solution
Caution
Please check the expiry date on the instructions for use provided with each
control solution.
Total Cholesterol strip or Lipid profile test strip in Total Cholesterol test area
should be used only Total Cholesterol control level 1, level 2.
HDL Cholesterol strip or Lipid profile test strip in HDL Cholesterol test area
should be used only HDL Cholesterol control level 1, level 2.
Triglyceride strip or Lipid profile test strip in triglyceride test area should be
used only triglyceride control level 1, level 2.
Glucose test strip should be used only Glucose control solution Low, Normal
and High.
It is recommended that the control solution is stored at room temperature
before testing.
Please keep the control solution range card until you use up the applicable
strip.
Quality control by control solution
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. It is available online at
www.infopiausa.com or call at 1-888-446-3246.
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
The LipidPro
TM
‚ Control Solutions are sold separately.
The TC(Level 1, Level 2), TG(Level 1, Level 2), HDL(Level 1, Level 2) and
Glucose(Low, Normal and High) control solutions can be obtained though.
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.
• Lipid Profile test
Testing procedure
1. Press RFID(▼) button for 3 or more seconds.
2. Place of the RFID-tag on the strip bottle to the
area of the RFID symbol on the meter.
• 26 • • 27 •
Checking the system with control solution 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 for lipid profile
are at the temperature of 18-30°C(64-86°F) and those for glucose at
10~40°C(50~104°F).
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.
• 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
1. Shake the control solution before use.
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
Up(▲) button and the meter displays the symbol of control
solution( ).
5. In 5 seconds the symbol of sample blood is blinking.
6. Place a drop of solution on a clean, dry
surface (for example: the lid of your test
strip vial).
7. Apply the prepared control solution to the
test strip by using capillary rod.
8. Apply the control solution to the test area.
Caution : If you want to test all three test items (TC, HDL
and TG), please collect the control solution with
each capillary rod.
Caution : Whenever you change the test strip vial, Please
follow the code recognition procedure.
9. The test results will be displayed in about 2 minutes.
1504
• 28 • • 29 •
Checking the system with control solution
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 Up(▲)
button. The symbol of control solution( ) will appear
on the display of meter. This will allow you to differenti-
ate between a control solution test and an actual
blood test for future reference.
5. Apply the test strip to 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.
INSTRUCTIONS FOR LANCING DEVICE
PRECAUTIONS
• Never use a lancet that has been used by someone else. This could lead to
contamination.
• If the lancing device is to be used by another person, the unit must be properly
disinfected and a new tip and lancet must be used.
• Do not leave the lancet in the device after use.
• A new lancet must only be placed into the lancing device directly before testing.
• This device has many small parts and could be a choking hazard for children if
swallowed.
• In the case of hospital use, hospitals need to consult their own infection control
protocols in order to avoid any contamination.
• Always dispose of the used lancet in a biohazard garbage container.
Depth Indicator/Adjustable Tip Lancet Holder
Clear Tip
Ejection System Sliding Barrel
Release Button
COMPONENTS
ɋɍ
Ɍ
Ɍ
Ɍ
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• 30 • • 31 •
HOW TO USE
Wash your hands carefully with warm water to increase the circulation of the
blood into the fingers.
Dry hands thoroughly until the finger to be pricked is completely dry. Please read
the following steps with corresponding illustrations to understand how to use the
lancing device.
1. Unscrew the tip of the lancing device by turning it
counter-clockwise while holding the base firmly.
2. With two fingers, pull out the lancet carrier and hold
it in place.
3. While holding the lancet carrier, insert a new sterile
lancet into the bottom of lancet carrier.
5. Put the tip of the lancing device back on and turn it
clockwise.
4. Twist the cap of the lancet off. RECOMMENDED AVAILABLE LANCETS
Some general sterilized lancets are BD-Ultra Fine, Cleanlet Fine, E-Z Ject, G-P
Lite, Microlet, Monolet, One Touch, Soft Touch, Therasense, Ultra TLC and Unilet
GP.
Note: Some less known lancets may not work properly with the lancing device
due to their dimensions.
Please, contact your supplier to make sure you are using proper lancets.
6. Hold the tip firmly in one hand then pull out the
sliding barrel with the other hand. This will cock the
lancing device.
7. Place the lancing device in place. Hold the lancing
device firmly against the side of the finger, with the
cap resting on the finger. (The harder it is pressed
the deeper the puncture.) Press the release button
to take a sample.
8. Unscrew the tip of the lancing device by turning it
counter-clockwise.
9. Push the lancet ejector forward with the thumb and
simultaneously pull out the sliding barrel to dispose
of the used lancet in a proper biohazard container.
Click
• 32 • • 33 •
Testing Your Blood - Preparation
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.
Place your fingertip to the top edge of
glucose test strip.
2. Glucose test
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.
completely
filled
poorly
filled
[ Correct ] [Incorrect ]
Correct : Completely filled Incorrect : Poorly filled
Testing Your Blood - Preparation
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.
Blood testing
A strip instructions for use is included with each box of test strips.
Please read the strip instructions for use along with this section completely and
carefully before testing.
Testing supplies
To perform a blood test you need:
• LipidPro
TM
meter
• Test strips
• Sterile lancet
• Capillary rod
• Lancing device
[ Correct ] [Incorrect ]
• 34 • • 35 •
Quick reference of test procedure -Lipid test Quick reference of test procedure -Glucose test
1) After coding the meter, insert the test strip
and press Mode ( ) button
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.
4) Test results appear in 3 seconds.
2) Prick the finger with a lancing device for
the sample blood.
3) Collecting the sample blood to the
capillary rod.
Make sure the enough sample has been
collected to the capillary rod.
4) Contact the capillary rod with the sample
to the test area of the strip so as to start
the test.
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, lancets and capillary rods.
•
It is required to insert the blood sample on the Lipid Pro test strip within 3 minutes
while the blood inserting icon is blinking.
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.
• 36 • • 37 •
Test Procedure Test Procedure
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.
In 5 seconds the meter automatically enters into
testing mode.
The symbol of blood is blinking.
Please apply the sample to the total cholesterol
test area of test strip until you hear beep sound.
Then, the symbol, disappears.
Please apply the sample to the HDL-cholesterol
test area of test strip until you hear beep sound.
Then, the symbol, disappears.
Please apply the sample to the triglyceride test
area of test strip until you hear beep sound.
Then, the symbol, disappears.
The meter displays , blinking in order,
which means it is under test.
Total cholesterol is displayed with 3 times of
buzzing sound.
In the case of LDL-cholesterol, if density of
triglyceride is over 350mg/dL, and/or TC, HDL,
TG measurement range are displayed as
Hi(above the measurement range) or Lo(below
the measurement rage, it cannot be measured.
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.
1. Lipid test - Test for multi items
• 38 • • 39 •
Test Procedure Test Procedure
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. In 5 seconds
the meter automatically enters into testing mode.
The symbol of blood is blinking.
Please apply the sample to the test area of test
strip until you hear beep sound.
The meter displays , blinking in order,
which means it is under test.
When the test is completed (in about 2 minutes),
the meter displays the test result of with
the symbol.
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. In 5 seconds the
meter automatically enters into testing mode.
2. Test for each single item
1) Total Cholesterol test
2) HDL-Cholesterol test
The meter displays the code number and the
testing symbols ( ) together. In 5 seconds the
meter automatically enters into testing mode.
• 40 • • 41 •
Test Procedure Test Procedure
The symbol of blood is blinking.
Please apply the sample to the test area of test
strip until you hear beep sound.
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.
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 symbol of blood is blinking.
Please apply the sample to the test area of test
strip until you hear beep sound.
3) Triglyceride test
The symbol of blood is blinking.
• 42 • • 43 •
Test Procedure Test Procedure
The meter displays , blinking in order,
which means it is under test.
When the test is completed (in about 2~4
minutes), the meter displays the test result of
with the symbol.
When the test strip is inserted, the meter displays
the code number for 3 seconds.
Once the sample is applied, the meter displays 3,
2, 1 in order.
Then, the meter completes the test with the test
result.
3. Glucose test
• 44 • • 45 •
Glucose test strip Discard Function Alternate site testing
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. Important Information About Using Alternative Sites Testing :
- Alternate sites where you can test are dorsal hand, ventral palm, upper arm,
forearm, calf, and thigh.
- Under certain conditions, blood glucose test results obtained using samples
taken from your alternate sites may differ significantly from fingertip samples.
Do not use alternate sites when your blood glucose is changing rapidly such as
following a meal, as insulin dose, or associated with physical exercise.
- When blood glucose is changing rapidly, fingertip samples show these changes
more quickly than alternate sites samples.
- When your blood glucose is falling, testing with a fingertip sample may identify
a hypoglycemic (low blood glucose) level sooner than a test with a alternate
sites sample.
- Use alternate sites samples only for testing prior to or more than two hours after
meal, insulin doses, or physical exercise.
- Testing performed within two hours after meals, insulin doses, or physical
exercise or whenever you feel that your glucose levels may be changing rapidly
should be done from the fingertip.
- You should also use fingertip testing whenever you have a concern about
hypoglycemia (insulin reactions) such as when driving a car, unawareness (lack
of symptom to indicate a sp ainrsticuulinla rrley aifc ytiooun )s, uafsfe fro
rfreoamrm h tyepsotignlgyc memayic fail to detect hypoglycemia.
Forearm
Ventral Palm
Fingertips
Calf
Dorsal Hand
Upper Arm
Thigh
Caution
1. If you push the discard button forward too much, it may be
damaged.
2. Do not give strong impact to meter.
Note : This alternate site testing is applied to glucose testing only.
• 46 • • 47 •
Performing a Blood Test using an Alternate site Reviewing Your Results
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.
- Consult your healthcare professional(doctor) before you begin using
the alternate site
Every test result is stored with its date and time of test.
The meter stores up to 200 memories regardless of test items.
When the test results is over the capacity memory, the recent test result
will replace with the oldest test result.
How to enter into Memory Mode
In order to enter into Memory mode, please press the MEM(▲) button in
standby mode.
By using ▲▼, you can recall lipid profile and glucose test results. Press
the mode button after you select between lipid profile and glucose test
results you would like to review.
When there is no memory in the meter
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 0.3μg minimum sample
volume is required.
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.
Press Mode ( ) button.
Press Mode ( ) button.
Press ▲▼ Button for reviewing the test result.
Caution
The deleted test results can’t be recovered. Please be careful in
deleting the test results.
• 48 • • 49 •
Reviewing Your Results Deleting Your Results
Printing Your results
Press Up(▲) button and the meter displays the
average data and the symbol ( ) you had set
previously.
please press ▲▼, button for reviewing.
Note:
Control solution reading are not included in the
average.
Lipid Profile test results
Glucose
deleting individual test result
To delete any individual test result in the memory
press ▲ or ▼ button for 3 or more seconds, while
the test result to delete is displayed. Then, is
blinking. After the third beep sound the test result
is deleted.
If the print is set “ON”, press ▼ button in 3 or
more seconds can be print memory results.
deleting all test results
To delete all test results press ▲ and ▼ button at
the same time for 3 or more seconds, while any
test result is displayed.
Then, ALL is displayed and is blinking. After
the third beep sound all test results are deleted.
Printing test result
Press ▼ button in 3 or more seconds can be print
memory results. (If the print is set “ON”)
• 50 • • 51 •
The Lipid ProTM results can be transmitted to a personal computer.
Lipid ProTM software and an interface cable are required for transmitting
results of lipid profile and glucose measurement system to a personal
computer.
The software is available free of charge from http://www.infopia21.com
Interface(PC)cable and Thermal printer can be bought from your local
distribute prorvider.
Lipid proTM Software and Thermal Printer
TC
HDL
TG
MEM
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 64~86ºF(18~30ºC ).
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.
Lancing Device:
Clean the lancing 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.
Cleaning Your Meter and Maintenance
• 52 • • 53 •
Troubleshooting
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
contaminated or reused.
(Only for Blood glucose
measurement)
Please insert a new test strip and perform
your test again.
This message appears
when the blood is not
enough (Only for Blood
glucose measurement)
Please insert a new test strip and apply
the sufficient sample blood.
This message appears
when strip signals
without any Blood or
Control solution or other
sample applying.
(Only for Blood glucose
measurement)
Please insert a new test strip and perform
your test again.
Message Probable cause Action required
Troubleshooting
This message appears
when blood sample is
input before the symbol
for blood blinks.
Please wait for the meter displays the icon
blinking before applying your blood
sample.
This message appears
when the color bar of the
strip is dirty or not good
or there is too much
light.
Please insert a new test strip and perform
your test again.
Avoid testing under direct sunlight.
This message appears
when Lipid strip is
removed during the test
or measured value of TC
is over 600mg/dL
Test again with a new strip if the strip is
removed during the test. Unless the strip
is removed during the test, the test result
is out of measurable range. Please
consult your physician.
Problem with transmit of
PC or Printer.
Check your connection port of PC/printer
and reconnection. If the problem is still
unsolved, Please contact your local
representative or customer support.
The test result is higher
than the following.
Glucose : more than
600mg/dL
TC : more than 400mg/dL
TG : more than 600mg/dL
HDL : more than 80mg/dL
Please retest with a new test strip. If the
problem persists, please contact your
local representative or customer support.
Message Probable cause Action required
• 54 • • 55 •
Troubleshooting
The test result is lower
than the following.
Glucose : less than
20mg/dL
TC : less than 100mg/dL
TG : less than 70mg/dL
HDL : less than 25mg/dL
Please retest with a new test strip.
If the problem persists, please contact
your local representative or customer
support.
Lipid profile : The
ambient temperature is
over 86ºF(30ºC).
Glucose : The ambient
temperature is over
104ºF(40ºC)
Place the meter at the temperature
between 64~86ºF(18~30ºC) for lipid
profile test and 50~104ºF(10~40ºC) for
glucose test for more than 10 minutes and
test again
Lipid profile : The
ambient temperature is
less than 64ºF(18ºC)
Glucose : The ambient
temperature is less than
50ºF(10ºC)
Place the meter at the temperature
between 64~86ºF(18~30ºC) for lipid
profile test and 50~104ºF(10~40ºC) for
glucose test for more than 10 minutes and
test again.
This message appears
with 3 times of beep
sound if the mode button
is pressed while no test
strip of lipid profile is
inserted.
Please make sure to insert a test
strip of lipid profile when performing
the test.
Please recognize the code and retest
(refer to page 21)
This message appears
with 3 times of beep
sound with ‘CODE’ and
‘Er’ on the display are
none memory code
and/or unrecognized
strip used.
Message Probable cause Action required
Product Specifications
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 Infopia Customer Service. Never ignore symptoms or make
significant changes to the control program.
Product Specication
Devision Content
Sample type
Measuring principle
Testing Types
Testing method
Testing range
Testing time
Calibration
Sample volume
Operating Humidity
Operating Temperature
Storage Humidity
Storage Temperature
(meter, Strip)
HCT Range
Capillary whole blood, Serum, Venous blood
Spectroscopy
Total cholesterol HDL-cholesterol
Triglyceride LDL-cholesterol
Enzymatic-colorimetric method
Total cholesterol : 100~400mg/dL,
Triglyceride : 70~600mg/dL,
HDL-cholesterol : 25~80mg/dL
About 2mins
Plasma_Equivalent
7uL
10 ~ 90 %
64 ~ 86ºF(18 ~ 30ºC)
10 ~ 90 %
36 ~ 86ºF(2 ~ 30ºC)
30 ~ 55%
Lipid Profile
Test
• 56 • • 57 •
Product Specification
Devision Content
Glucose
test
RFID
Sample type
Measuring principle
Testing Types
Test range
Sample volume
Testing time
Calibration
Operating Humidity
Operating Temperature
Storage Humidity
Storage Temperature
HCT Range
Standard Supported
Nominal Read/Write Range
Antenna
Frequency
Capillary whole blood, Serum, Venous blood
Electrochemical
Glucose
10~600 mg/dL
0.3uL
3sec
Plasma - Equivalent
10 ~ 90 %
50~104ºF(10~40)ºC
10 ~ 90 %
36 ~ 86ºF(2 ~ 30)ºC
30 ~ 55%
ISO/IEC 15693
< 2cm
Integrated
13.56 MHz
Product Specification
Size(W*D*H) 61*109*23(mm)
Weight 77.5g (including battery)± 1g
Power supply (AAA) 1.5V x 2
Battery life time
PC Port
Running over 1,000 times
For cable connection between PC
(or thermal printer) and Meter.
Devision Content
• 58 • • 59 •
Warranty
Manufacturer's Warranty:
INFOPIA USA, LLC 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 USA, LLC 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
USA, LLC or failure to operate in accordance with the instructions.
2. INFOPIA USA, LLC reserves the right to make changes in design
without obligation to incorporate such changes into previously
manufactured instruments.
3. INFOPIA USA, LLC 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 USA, LLC local representative before return-
ing your instrument for any reason. She/he will give you the informa-
tion needed to resolve your problem correctly and efficiently.
Declaration of Conformity
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.
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.
Caution
Changes or modifications not expressly approved by the party
responsible for compliance could void the user's authority to operate
the equipment.

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