Medicare LIS SMART BG-102 User Manual - page 2
12. Understanding Your Test Result
14. Caring For Your Meter And Test Strip
15. Performance Characteristics
16. System Specifications
17. Display Messages And
Problem-Solving Guide
▪
Adjustable Lancing Device
Your lancing device and lancets are used for obtaining capillary blood samples from
the puncture site
▪
Lancet
3. Select and Lance a Puncture Site
*For Fingertip
Hold the prepared lancing device firmly against
the side of your fingertip. Press release button.
*For AST
Please refer to the “About Alternative Site
Testing (AST)” Section. Please consult your
healthcare professional before obtaining blood
from site other than your fingertip.
4. Obtain a Blood Sample : Gently massage your
finger or puncture site to obtain the required
blood volume. To perform the test, you need
only 0.3 μL of blood sample. Do not smear the
blood sample. To obtain best accurate result,
wipe off the first drop of blood and gently
squeeze another drop of blood.
5. Apply Blood Sample : Apply the blood sample
to the opening of absorbent channel of test strip
until the confirmation window is fully covered
with blood. Then the meter begins to count
down and displays the test result in 6 seconds.
1. Wash Your Hands and the Puncture Site :
Wash your hands in warm, soapy water.
Rinse and dry completely. Warm your
fingers to increase blood flow.
2. Insert Test Strip : Remove a new test strip from
vial. Be sure to tightly replace vial cap after
removing test strips. Insert test strip immedi
-ately into strip slot as illustrated. The meter
turns on automatically. When the blood symbol
is blinking, you are ready to perform a test.
1. Screw off the cap of lancing device. Insert a
lancet into the lancet holder and push down
until it is fully seated
2. Twist off the protective cap until it separates
from the lancet.
▪
Setting your Lancing Device
3. Replace the lancing device cap and set the
puncture depth to the desired number.
NOTE:
The depth selector offers 5 levels of skin
1-2 : for soft or thin skin
3 : for average skin
4-5 : for thick or calloused skin
4. Pull back the cocking control until it makes a
click, and then release. If it does not click, the
device may have been cocked when the lancet
was inserted.
6. Read Your Result :
The result is displayed in 6 sec. This is only for
reference.For any medical action or drug prescription,
please consult with your wealthcare perffactional.
7. Remove Strip to Turn Meter Off : Your blood
glucose result is automatically stored in the
meter memory. Turn the meter off by removing
the test strip. Discard the used strip and lancet
safely in a puncture resistant container
The normal blood glucode range is 70 to 105 mg/dL (3.9 to 5.8 mmol/L) for a fasting,
non-diabetic adult, but less than 140mg/dL (7.8 mmol/L) two hours after meals.
Consult your healthcare professional to find out your target blood glucose value.
If your blood glucose result seems unusually high or low ,or inconsistent with your
pervious result , check the following :
1.Was the blood sample applied immediately to the test strip after removing it from
the vial?
2.Was the volume of the blood sample sufficient?
3.Was the test strip vial cap tightly sealed?
4.Was the test strip used before the expiration date?
5.Were the test strips stored away from extreme temperatures in vey cold or hot
weather or from areas of hight humidity ?
The run a control test with Medicare control solution. if the control test result is within
the acceptable range. review testing procedure and repeat your blood glucose test
with a new test strip, if your blood glucose value is still inconsistent with your previous
results, glucose trend, or how you feel, contact your doctor immediately for help.
PBGM control solution contains a known amount of glucose that reacts with
PBGM test strips. By testing your control solution and comparing the test results
with the expected range printed on the test strip vial label, you can make sure that
the meter and the test strips are working properly together as a system and that
you are performing the test correctly. It is very important that you do this simple
check routinely to make sure you get accurate results.
▪
Why perform a control solution test?
1. To ensure that your meter and test strip are working properly together.
2. To allow you to practice testing without using your own blood.
▪
When should the control solution test be performed?
1. When you first get your PBGM meter. Before use this system to test your blood,
you can practice the procedure by using control solution. When you can do
three tests in a row that are within the expected range, you are ready to test
your blood.
2. Once a week (to make sure that you continue to get accurate results).
3. When you begin using a new vial of test strips.
4. Whenever you suspect that the meter or test strips are not working properly.
5. When your blood glucose test results are not consistent with how you feel, or
when you think your results are not accurate.
6. When test strips are exposed to extreme environmental conditions.
7. If you drop the meter.
8. when replace the battery.
▪
Important Control Solution Information
1. Check the expiration date on the control solution bottle. Do not use if expired.
2. Control solution, meter, and test strips should come to room temperature
(68-77 oF/20-25oC) before testing.
3. Shake the bottle before use, discard the first drop of control solution after
squeezing, wipes off the dispenser tip to avoid contaminations. These steps
ensure you will get a good sample and an accurate result.
4. Record the discard date on the bottle when you open a new bottle of control solution.
NOTE :
1. There are two levels of control solution (normal and high) available to
purchase. Please contact with your local distributor when required.
2. The control solution range printed on the test strip vial is for PBGM Control
Solution only. It is used to test meter and strip performance. It is not
recommended range for your blood glucose level.
1.In Medicare mode
2.Insert Test Strip : Insert a new test strip into the
strip slot, the meter will activate.
3.See detailed Medicare-user guide.
Squeeze a drop of Control Solution : Shake
control solution bottle well. Remove the cap.
Squeeze bottle, discard the first drop and wipe off
the dispenser tip with a clean tissue paper or
cotton swab. Squeeze a drop on a clean non-
absorbent surface.
▪
How to Perform a Control Test
Apply Control Solution : Apply the drop to the
opening of the strip absorbent channel until the
confirmation window is filled. The meter begins to
count down.
Check if the test result is in range: After the meter
counts down from 6 to 1, the test result shows up.
Compare the test result with the range printed on
the test strip vial. The result should fall within the
printed range.
After the test, touch test solution map, the display
“0”, it is delete the test blood glucose values, are
not stored in memory, this will not affect your
blood sugar curve values.
Important :
1. The meter when used alone, each time control solution test, the test results
will be stored in the meter's memory. Its control solution test results will affect
your future confusion and memory back and read and calculate the mean
blood glucose values.
2. DO NOT APPLY THE CONTROL SOLUTION DIRECTLY TO THE TEST
STRIP! Overdosed solution may give inaccurate result.
3. Repeat test if test result falls outside the control range stated on the test strip
label. If subsequent test remains to produce unacceptable result, the meter or
test strip may be faulty. DO NOT use the system. Contact us or your local
distributor for help.
To avoid the meter and test strips getting dirt, dust or other contaminants,
please wash and dry your hands thoroughly before use.
▪
Cleaning
Your meter does not require special maintenance. As long as no blood or control
solution comes in direct contact with the meter, there is no special cleaning
required.
To clean the meter exterior, wipe with a cloth moistened with tap water or a mild
cleaning agent, then dry the device with a soft and dry cloth. Do not flush with
water.
Do not use organic solvents to clean the meter. Your meter is a precision instru-
ment. Please handle it with care.
ACCURACY:≧ 95% of the individual glucose results fall within ± 15 mg/dL(0.83
mmol/L) at glucose concentration
at glucose concentration ≧75 mg/dL(or 4.2 mmol/L), compared with glucose
analyzer YSI 2300.
PRECISION :
CVs(%) of intermediate precision and repeatability where less than 5%
▪
Storage
1. Meter Storage
* Storage condition: -20
o
C~50
o
C (-4
o
F~122
o
F), below 90% relative humidity.
* Avoid dropping and strong impact.
* Avoid direct sunlight and humidity.
2. Strip Storage
* Storage condition: 4
o
C~40
o
C (39
o
F~104
o
F), and 10~85% relative humidity.
Do not refrigerate.
* Store your test strips in their original vial only. Do not transfer to other
container.
* Store test strip packages in a cool and dry place. Keep away from direct
sunlight and heat.
* After removing a test strip from the vial, immediately replace the vial cap and
close it tightly.
* You may touch the test strip anywhere with clean, dry hands when removing it
from the vial or inserting it into the meter.
* Use each test strip immediately after removing it from the vial.
* Do not bend, cut, or alter a test strip in any way.
* Keep the strip vial away from children since the cap and the test strip can be a
potential choking hazard. If swallowed, please seek medical assistance immed
iately.
3. Control solution storage
* Storage condition: Store the control solution tightly closed at temperatures
below 86
o
C (30
o
C). Do not refrigerate
Model Name
Assay Method
Test Sample
Test Result
Alternative Site Testing
Sample Size
Measuring Time
Measuring Range
Acceptable Hematocrit Range
Operating Condition
Storage/Transportation Condition
Memory Capacity
Power Supply
Battery Life
Automatic shut-off
Dimensions
Weight
PBGM
Electrochemical biosensor
Capillary Whole Blood
Referenced to plasma glucose value
YES (palm, forearm, upper arm, calf, or thigh)
0.3 μL
6 seconds
20 – 600 mg/dL (1.1-33.3 mmol/L)
20~60%
10°C~40°C(50°F~104°F), between 10-85% R. H.
4°C~40°C(39°F~104°F), between 10-85% R. H
100 test results with time and date
One 3-volt Lithium Battery (battery type CR2032)
Approximately 1,000 tests
In 3 minutes
47 x 48 x 13 mm
20g
11. Prerforming Blood Test
The following is a summary of some display messages and symbols.
These messages help to identify certain problems but do not appear in all cases
when a problem has occurred.
Improper use may cause an inaccurate result without producing an error message.
In the event of a problem, refer to information under ‘‘action to take’’.
1. Microsoft and Windows, are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
2. Apple, Apple store, iOS, iPad, iPhone, iCloud..are either registered trade-
marks or trademarks of Apple Computer, Inc. in the United States and/or
other countries.
3. GOOGLE Driver Android Google play, are either registered trademarks or
trademarks of Apple Computer, Inc. in the United States and/or other coun-
tries.
4. This software or user guide described other company and product names
are trademarks of their respective companies or companies or registered
trademark holders.
10. Prepare For Blood Sampling
If some parts of the display are
not working. Contact your local
distributor for help
DISPLAY
DESCRIPTION
Display check
The meter is ready for blood
applying into test strip.
Blinking Blood
Display result
Test result
High or low blood glucose levels
can indicate a possibly serious
medical condition. If this is not
confirmed by the way you feel,
review proper testing procedure
and perform a control test.
Repeat blood test, if the display
still appears, please call medi-
cal assistance immediately.
Replace battery now.
Battery is dead.
The meter is not working. Move
to an area with temperature
between 10
o
C to 40
o
C (50
o
F -
104
o
F) and wait at least 30
minutes. Do not artificially heat
or cool the meter.
You have to:
1.Repeat test with a new test
strip.
2.Contact your local distributor
for help.
The meter is connected to mobile
devices,
The meter is waiting for Medicare.
Medicare software and meter to
do mutual recognition,will show
Lin.When link success , auto-
matic adjust setting the date and
time of meter.
Meter into Medicare mode
Automatic shut-off
ACTION TO TAKE
Test result is higher
than 600 mg/dL
(33.3 mmol/L).
Test result is lower
than 20 mg/dL (1.1
mmol/L)
Temperature is below
the operating range
Temperature is above
the operating range.
Maybe:
1.Used strip or moist
ened strip
2.Defective meter.
when the jack of
meter insert mobile
device
Meter linking
Medicare
Meter in Medicare
mode
Meter OFF mode
Date and time are
not set and calibration
Before starting measurements,
please install the batteries, do
download the Medicare auto-
matically set the date time.
No responses
when the test strip
is inserted into the
meter
Maybe:
1.Battery is dead.
2.Wrong test strip is
inserted.
3.Meter is defective.
You have to:
1.Replace battery.
2.Insert the test strip correctly.
3.Contact your local distributor
for help.
No responses
when blood sample
is applied to the
test strip.
Maybe:
1.Blood sample is not
sufficient.
2.Meter is defective.
You have to:
1.Repeat test with sufficient
sample.
2.Contact your local distributor
for help.
13. Control Solution Testing
18. Trademark
1. Lancet is for single use only.
2. Keep lancing device and lancets clean.
3. Use caution when removing the used lancet from the device and when disposing
the used lancet.
IMPORTANT :
The meter and lancing device are for single patient use.
Do NOT share them with anyone including other family members !
Do NOT use on multiple patients !
Important Lancing Device and Lancets Information
12. Understanding Your Test Result
14. Caring For Your Meter And Test Strip
15. Performance Characteristics
16. System Specifications
17. Display Messages And
Problem-Solving Guide
Adjustable Lancing Device
Your lancing device and lancets are used for obtaining capillary blood samples from
the puncture site.
Lancet
3. Select and Lance a Puncture Site
*For Fingertip
Hold the prepared lancing device firmly against
the side of your fingertip. Press release button.
*For AST
Please refer to the “About Alternative Site
Testing (AST)” Section. Please consult your
healthcare professional before obtaining blood
from site other than your fingertip.
4. Obtain a Blood Sample : Gently massage your
finger or puncture site to obtain the required
blood volume. To perform the test, you need
only 0.3 μL of blood sample. Do not smear the
blood sample. To obtain best accurate result,
wipe off the first drop of blood and gently
squeeze another drop of blood.
5. Apply Blood Sample : Apply the blood sample
to the opening of absorbent channel of test strip
until the confirmation window is fully covered
with blood. Then the meter begins to count
down and displays the test result in 6 seconds.
1. Wash Your Hands and the Puncture Site :
Wash your hands in warm, soapy water.
Rinse and dry completely. Warm your
fingers to increase blood flow.
2. Insert Test Strip : Remove a new test strip from
vial. Be sure to tightly replace vial cap after
removing test strips. Insert test strip immedi
-ately into strip slot as illustrated. The meter
turns on automatically. When the blood symbol
is blinking, you are ready to perform a test.
Important Lancing Device and Lancets Information
6. Read Your Result :
The result is displayed in 6 sec. For any medical
action or drug prescription, please consult with your
wealthcare perffactional.
7. Remove Strip to Turn Meter Off :
Your blood glucose result is automatically stored in
the meter memory. Turn the meter off by removing
the test strip. Discard the used strip and lancet
safely in a puncture resistant container
The normal blood glucose range is below 100 mg/dL (5.6 mmol/L) for a fasting,
non-diabetic adult, but less than 140 mg/dL (7.8 mmol/L) two hours after meals.
Consult your healthcare professional to find out your target blood glucose value.
If your blood glucose result seems unusually high or low,or inconsistent with your
pervious result , check the following :
1. Was the blood sample applied immediately to the test strip after removing it
from the vial?
2. Was the volume of the blood sample sufficient?
3. Was the test strip vial cap tightly sealed?
4. Was the test strip used before the expiration date?
5. Were the test strips stored away from extreme temperatures in vey cold or hot
weather or from areas of hight humidity ?
The run a control test with Medicare control solution. if the control test result is
within the acceptable range. review testing procedure and repeat your blood
glucose test with a new test strip, if your blood glucose value is still inconsistent
with your previous results, glucose trend, or how you feel, contact your doctor
immediately for help.
REFERENCE:
*American Diabetes Association Website (http://www.diabetes.org)
Medicare control solution contains a known amount of glucose that reacts with
Medicare test strips. By testing your control solution and comparing the test
results with the expected range printed on the test strip vial label, you can make
sure that the meter and the test strips are working properly together as a system
and that you are performing the test correctly. It is very important that you do this
simple check routinely to make sure you get accurate results.
Why perform a control solution test ?
1. To ensure that your meter and test strip are working properly together.
2. To allow you to practice testing without using your own blood.
When should the control solution test be performed ?
1. When you first get your Medicare LiS Smart meter. Before use this system to
test your blood, you can practice the procedure by using control solution. When
you can do three tests in a row that are within the expected range, you are
ready to test your blood.
2. Once a week (to make sure that you continue to get accurate results)
3. When you begin using a new vial of test strips.
4. Whenever you suspect that the meter or test strips are not working properly.
5. When your blood glucose test results are not consistent with how you feel,
or when you think your results are not accurate.
6. When test strips are exposed to extreme environmental conditions.
7. If you drop the meter.
8. when replace the battery
Important Control Solution Information
1. Check the expiration date on the control solution bottle. Do not use if expired.
2. Control solution, meter, and test strips should come to room temperature
(68-77°F/20-25°C) before testing.
3. Shake the bottle before use, discard the first drop of control solution after
squeezing, wipes off the dispenser tip to avoid contaminations. These steps
ensure you will get a good sample and an accurate result.
4. Record the discard date on the bottle when you open a new bottle of control solution.
1. Call up Medicare Smart BGM App on your
mobile device, and connect your meter to
mobile device.
2. After connecting the meter and mobile device,
insert test strip to strip slot, the meter will
activate.
3. Squeeze a drop of Control Solution : Shake
control solution bottle well. Remove the cap.
Squeeze bottle, discard the first drop and
wipe off the dispenser tip with a clean tissue
paper or cotton swab. Squeeze a drop on a
clean non-absorbent surface.
How to Perform a Control Test
4. Apply Control Solution : Apply the drop to the
opening of the strip absorbent channel until
the confirmation window is filled. The meter
begins to count down.
5. Check if the test result is in range: After the
meter counts down from 6 to 1, the test result
shows up. Compare the test result with the
range printed on the test strip vial. The result
should fall within the printed range.
6. Tap the control solution icon, the reading will
become “0” as figure which means your
control solution reading has been deleted.
7. Remove the used strips from meter.
Important:
1. When you do the control solution test with meter alone (NOT connected with
your mobile device under APP program), the control test result will be stored in
the meter. We recommend you do the control solution ONLY under APP
program and delete the control solution reading every time when you finish
test.
2. Please refer to your Medicare Mobile APP instruction manual for details about
control solution setting.
3. Repeat test if test result falls outside the control range stated on the test strip
label. If subsequent test remains to produce unacceptable result, the meter
or test strip may be faulty. DO NOT use the system. Contact us or your local
distributor for help.
To avoid the meter and test strips getting dirt, dust or other contaminants,
please wash and dry your hands thoroughly before use.
Cleaning
Your meter does not require special maintenance. As long as no blood or control
solution comes in direct contact with the meter, there is no special cleaning
required.
To clean the meter exterior, wipe with a cloth moistened with tap water or a mild
cleaning agent, then dry the device with a soft and dry cloth. Do not flush with
water.
Do not use organic solvents to clean the meter. Your meter is a precision instru-
ment. Please handle it with care.
ACCURACY:
95 % of the measured glucose values shall fall within either ±15 mg/dL (± 0.83
mmol/L) of the average measured values of the reference measurement proce-
dure at glucose concentrations
glucose concentrations ≧ 100 mg/dL ( ≧ 5.55 mmol/L).
PRECISION:
CVs (%) of intermediate precision and repeatability were less than 5%.
Storage
1. Meter Storage
* Storage condition: -20
o
C~50
o
C (-4
o
F~122
o
F), below 90% relative humidity.
* Avoid dropping and strong impact.
* Avoid direct sunlight and humidity.
2. Strip Storage
* Storage condition: 4
o
C~40
o
C (39
o
F~104
o
F), and 10~85% relative humidity.
Do not freeze.
* Store your test strips in their original vial only. Do not transfer to other
container.
* Store test strip packages in a cool and dry place. Keep away from direct
sunlight and heat.
* After removing a test strip from the vial, immediately replace the vial cap and
close it tightly.
* You may touch the test strip anywhere with clean, dry hands when removing it
from the vial or inserting it into the meter.
* Use each test strip immediately after removing it from the vial.
* Do not bend, cut, or alter a test strip in any way.
* Keep the strip vial away from children since the cap and the test strip can be a
potential choking hazard. If swallowed, please seek medical assistance immed
iately.
3. Control solution storage
* Storage condition: Store the control solution tightly closed at temperatures
between 4°C (39°F) and 30°C (86°F). Do not freeze.
Model Name
Assay Method
Test Sample
Test Result
Alternative Site Testing
Sample Size
Measuring Time
Measuring Range
Acceptable Hematocrit Range
Operating Condition
Storage/Transportation Condition
Memory Capacity
Power Supply
Battery Life
Automatic shut-off
Dimensions
Weight
LiS Smart
Electrochemical biosensor
Capillary Whole Blood
Referenced to plasma glucose value
YES (palm, forearm, upper arm, calf, or thigh)
0.3 μL
6 seconds
20~600 mg/dL (1.1~33.3 mmol/L)
20~60%
10°C~40°C (50°F~104°F), 10~85% R. H.
4°C~40°C (39°F~104°F), 10~85% R. H
100 test results with time and date
One 3-volt Lithium Battery (battery type CR2032)
Approximately 1,000 tests
In 3 minutes
48 x 47 x 13 mm
20g
11.Prerforming Blood Test
10. Prepare For Blood Sampling
18. Trademark
mg/dL
1. Screw off the cap of lancing device. Insert a
lancet into the lancet holder and push down
until it is fully seated
2. Twist off the protective cap until it separates
from the lancet.
Setting your Lancing Device
3. Replace the lancing device cap and set the
puncture depth to the desired number.
NOTE:
The depth selector offers 5 levels of skin
1-2 : for soft or thin skin
3 : for average skin
4-5 : for thick or calloused skin
4. Pull back the cocking control until it makes a
click, and then release. If it does not click, the
device may have been cocked when the lancet
was inserted.
The following is a summary of some display messages and symbols.
These messages help to identify certain problems but do not appear in all cases
when a problem has occurred.
Improper use may cause an inaccurate result without producing an error message.
In the event of a problem, refer to information under ‘‘action to take’’.
If some parts of the display are not
working. Contact your local distribu-
tor for help
DISPLAY
DESCRIPTION
Display check
The meter is ready for blood
applying into test strip.
Blinking Blood
Display result
Test result
High or low blood glucose levels can
indicate a possibly serious medical
condition. If you get a "Hi" result,
repeat the test with a new strip. If the
result is still "Hi" contact your
healthcare provider immediately. If
you get a “Lo” result, contact your
healthcare provider immediately.
Replace battery now.
Battery is dead.
The meter is not working. Move to
an area with temperature between
10°C to 40°C (50°F - 104°F) and
wait at least 30 minutes. Do not
artificially heat or cool the meter.
You have to:
1.Repeat test with a new test strip.
2.Contact your local distributor for help.
The meter is connected to mobile
devices,
The meter is waiting for app.
Wait until the linking process is done.
Operate the meter with the app.
Meter is shutting off.
ACTION TO TAKE
Test result is higher than
600 mg/dL (33.3
mmol/L).
Test result is lower
than 20 mg/dL (1.1
mmol/L).
Temperature is below
the operating range.
Temperature is above
the operating range.
Maybe:
1.Used strip or moistened
strip
2.Defective meter.
When the jack of
meter insert mobile
device.
Meter linking app
Meter in app mode
Meter OFF mode
Date and time are
not set or calibrated
Launch the app, and connect the meter to the
mobile device to automatically set the date
time.
No responses when the
test strip is inserted into
the meter
Maybe:
1. Battery is dead.
2. Wrong test strip is inserted.
3. Meter is defective.
You have to:
1. Replace battery.
2. Insert the test strip correctly.
3. Contact your local distributor for help.
No responses when
blood sample is applied
to the test strip.
Maybe:
1. Blood sample is not sufficient.
2. Meter is defective.
You have to:
1. Repeat test with sufficient sample.
2. Contact your local distributor for help.
1. Microsoft and Windows, are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
2. Apple, Apple store, iOS, iPad, iPhone, iCloud..are either registered
trademarks or trademarks of Apple Computer, Inc. in the United
States and/or other countries.
3. GOOGLE Drive, Android, Google Play, are either registered
trademarks or trademarks of Apple Computer, Inc. in the United
States and/or other countries.
4. Other company and product names this software or user guide described
are trademarks of their respective companies or companies or registered
trademark holders.
1. Lancet is for single use only.
2. Keep lancing device and lancets clean.
3. Use caution when removing the used lancet from the device and when disposing
the used lancet.
IMPORTANT :
The meter and lancing device are for single patient use.
Do NOT share them with anyone including other family members !
Do NOT use on multiple patients !
Incorrect
Correct
13.Control Solution Testing
4 5
1 2
4
5