GM100 Instructions for use-EN(101-3GM100-013)-未建外

GM100 Instructions for use-EN(101-3GM100-013)-未建外
4.
Blood Glucose Monitoring System
Instructions for Use
Preface
GM100 Blood Glucose Monitoring
Thank you for choosing the
System. Please read this manual thoroughly before testing. It provides all
information you need to use the product. Please only purchase test strips in
your country. Use of test strips from different countries might get
deviated test results under such circumstance. We hereafter call
GM100 Blood Glucose Monitoring System as GM100 BGMS,
GM100 Blood Glucose Meter as GM100 meter, and
GS100 Blood Glucose Test Strip as GS100 test strip for short.
It is recommended to monitor blood glucose regularly. To prevent derived
complications effectively, it is recommended to monitor blood glucose regularly.
GM100 BGMS accurate and easy-to-use, is your reliable assistant for diabetes
management.
GM100 BGMS was manufactured and supported by Bionime Corporation and
its authorized representative. If you have any question or concern, please
contact your Bionime authorized representative or Customer Service at 886 4
24951268 ( GMT+08:00, 08:30~17:30 ). We will provide best assistance and
solutions for you.
1.
- Before using the GM100 BGMS to test your blood glucose, please read
instructions and run the Quality Control Test.
- Please run the Quality Control Test regularly to make sure the entire system
functions properly.
- The GM100 meter is only compatible with the GS100 test strip. Please do not
use other test strips because they may cause inaccurate results.
- GM100 BGMS is intended for self-testing. It should not be used to diagnose
diabetes mellitus.
- GM100 BGMS has not been validated for use on neonates. Therefore, it's not
intended for use of neonates.
- GM100 BGMS is not intended for arterial blood testing .
- Do the test at least 30 minutes after moving into a different location with
significant change in temperature.
- Dispose of used batteries properly.
- Please note the meter kit contains small parts like test strips which could result
in a choking hazard for children.
- Prevent water from entering the meter. Never immerse the meter or hold it
under running water.
- The minimum blood sample size for testing is 1.4µL :( )
Sample Size Example
1.0µL
1.4µL
2.0µL
3.0µL
4.0µL
We suggest you use a sample between 1.4~2.5µL. A blood sample size above
4.0µL is too large. A blood sample size below 1.4µL may give an inaccurate test
result. In this case, repeat the test with a new test strip.
Intended Use
GM100 BGMS is intended for in vitro diagnostic use ( for self-testing ) only
( outside the body ) and coding is not required. The testing result is
calibrated to plasma equivalent with fresh capillary whole blood samples from
the fingertip, palm or forearm. You may consult your healthcare professional for
instructions how to use the system correctly. Our customer support staff is also
available to assist you.
2.
Precautions
5.
GS100 Test Strips
GM100 meter is designed to use with GS100 test strip only. Please note that
misuse of other test strips might cause unexpected damage or produce
inaccurate test results.
Sample Entry
Apply a drop of blood or Control Solution
here. The test request is only 1.4µL of blood.
Package of Meter Kit
1. GM100 Meter (with one CR2032
battery installed)
2. GS100 Test Strips (0/10/25 pcs) *
3. Control Solution *
4. GM100 meter Instructions for Use
5. GS100 Test Strips Package Insert *
6. GD500 Lancing Device *
7. Disposable Lancets (10pcs) *
8. Instructions for the lancing device *
9. Log Book
10. Warranty Card + Emergency Card
11. Carrying Case *
( Different packages have different bundled items. Some of packages might not
include * items.)
2*
1
3*
Hand Bar
Grip here to insert
test strip into meter.
Indication Symbol
Insert strip with indication
symbol up and toward meter.
View Window
This window is yellow before applying
blood sample. It gradually turns red
when filled with blood.
4
Electrode Contacts
Sensing signal output terminals.
6. Set the time and date when the batteries are replaced. See Setting the Date,
Time and Unit section. Prior test results are still stored in the memory.
PRECAUTION
- Danger of explosion might happen if the battery is incorrectly replaced.
- Please follow the local regulation and discard a used battery properly.
7.
Setting Up Your Meter-Setting the Date, Time, and Unit ……
You can enter Setting Mode by below two ways.
1. Reload battery
After removing the battery, please press the main button for several times
until no signal on screen, then follow the battery installation steps to load
battery. The meter will do self test. Press the main button to close the test
and enter Setting Mode.
2. With Battery inserted
Press the main button first to turn on the meter. Then press and hold the main
button for 5 seconds (the meter will be turned off during this period, please
keep pressing) until you hear a beep, indicating you have successfully
entered Setting Mode. The display screen will show setting data.
NOTE
- When you keep pressing the main button for 2 seconds, the display on
screen will turn off. Please don't care it. Keep pressing the main button
till entering setting data.
- Quick press the main button allows you to change setting while hold it
for 2 seconds will confirm the setting. However, if you press and hold
the main button over 5 seconds it will escape from setting mode and
return to time screen.
1. Year setting
With the year format blinking, press the main button to adjust
it. Then hold the same button for 2 seconds to confirm it.
Meantime, it will shift to next digit for setting. Repeat the above
action until the year setting is completed. Then it will move to
month setting.
2. Month setting
With the month blinking, press the main button until the
current month appears. Then hold the same button for 2
seconds to confirm it and move to day setting.
3. Day setting
With the day blinking, press the main button to adjust it. Then
hold the same button for 2 seconds to confirm it. Meantime, it
will shift to next digit for setting. Repeat the above action until
the day setting is completed. Then it will move to time format
setting.
4. Time format 12/24H selection
With the time format blinking, press the main
button to adjust it. Then hold the same button
for 2 seconds to confirm it and move to hours
setting.
Test Strips
5*
PRECAUTION
- Re-cap the test strip vial immediately after removing a test strip.
- Do not reuse test strips.
- Do not use expired test strips.
- Record the date of opening a new test strip vial for the first time. Discard
the vial of teststrips after 3 month from opening.
- Store the test strips in a cool and dry location. Do not expose to direct
sunlight or heat.
- For detailed information, please refer to the GS100 Test Strips
Package Insert.
2007-06
7*
6*
3.
The
8*
Meter
6.
Test Strip Port
Insert test strip here until you
hear a click.
Main Button
For operating the meter,
please check details in
following sections.
Model Number
101-1GM100-010
Display Window
Show your test result,
messages and relative
information.
Meter Serial
Number
Battery Cover
Slide cover to
change battery.
Plastic Tape
Pull it off to activate meter.
(If time and date of your meter has been set
in advance, the plastic tape will be removed.
Hence, please discard this step)
Battery Installation
Your meter comes with one CR2032, 3volt, battery installed. One
new battery will provide power to perform about 1000 tests under
normal use. Before using it, please pull off the plastic tape and
press the main button to activate the meter. (If time and date of
your meter has been set in advance, the plastic tape will be
removed. Hence, please discard this step)
1. Turn the meter over. Press and push battery
cover to open.
2. Install the battery. Be sure to put battery in
correct direction.
3. Slide the battery cover back until it snaps into place.
4. The meter performs a self-test and all symbols on the display
will blink.
5. Press any button to exit the self-test and enter Setting Mode.
5. Hour setting
With the hour blinking, press the main button until the current
hour appears. Then hold the same button for 2 seconds to
confirm it and move to minute setting.
6. Minute setting
With the minute blinking, press the main button
to adjust it. Then hold the same button for 2
seconds to confirm it. Meantime, it will shift to
next digit for setting. Repeat the above action
until the minute setting is completed. Then it will
move to measurement of unit setting.
7. Setting the unit of measurement
With minimole per liter (mmol/L) blinking or
milligrams per deciliter (mg/dL), press the main
button to switch. Then hold the same button for 2 seconds to confirm it.
(* This meter for some countries is fixed at mmol/L or mg/dL and is not able
to be changed freely. In this case, please skip this step and go to next step
directly.)
Turning on /off the Meter
1. How to turn on the Power
1) Press the main button
2) Insert one piece of test strip
2. Manual Power off
If you want to turn off the meter, please keep pressing the main button for 2
seconds.
3. Auto Power off
The meter will power off automatically if you don't operate it over 2 minutes.
8.
Performing a Blood Test
Depth adjustable cap
Release button
Plunger
Lancet carrier
Hub
1. Hold the adjustable cap in one hand and hold the hub in the other hand.
Bend the cap towards the down side. When a gap appears between the cap
and hub, pull them off in opposite directions.
2. Pull off the depth adjustable cap.
3. Insert a new disposable lancet firmly into lancet carrier.
4. Twist off and set aside the protective cover of the disposable lancet.
5. Replace the depth adjustable cap.
1
2
3
4
5
6. Choose a depth of penetration by rotating
6
the top portion of the depth adjustable cap
until the setting depth matches the window.
Settings are based on skin type "
" for
soft or thin skin; "
" for average skin;
"
" for thick or calloused skin.
7
7. Hold the hub in one hand and pull on the plunger in the other hand. The
device will be cocked. Release the plunger, it will automatically move back
to its original position near the hub.
8. Wash your hands with warm
soapy water and dry thoroughly.
9. Take one strip from the vial.
Re-cap the vial cap immediately.
8
9
10
10. Insert the strip into the strip port on meter with the indication symbol facing
up.
11. While the blood drop symbol flashing, you are ready to apply the blood
sample.
11
12
12. Place the lancing device against the pad of
your fingertip and press the release button.
The best puncture sites are on the middle or
ring fingers. Press the release button.
13. Touch and hold the drop to the edge of
sample entry until you hear a " beep " and the
view window is totally filled with blood. If the
view window is not totally filled with blood or
the test does not start. Please discard the test
strip and repeat the test with a new test strip.
13
14
14. You will see the countdown mode on the
screen. After 8 seconds, the test result
appears.
15. Pull off the depth adjustable cap. Without touching the used disposable
lancet, stick the lancet tip into the protective cover.
16. Hold the release button in one hand and pull on the plunger in the other
hand will safely eject the used disposable lancet.
17. Discard the used disposable lancet into an appropriate puncture-proof or
biohazard container.
18. Replace the depth adjustable cap after finishing the test.
15
16
1
2
17
18
8. Ending setting
After confirming the measurement unit, you'll hear a sound of " beep ". All the
settings are saved and completed and will return to time screen.
NOTE
- When you do not do any settings of meter for over 2 minutes, the meter
will leave setting mode and power off automatically.
- Any time you would like to escape from the setting mode, please press
and hold the main button for over 5 seconds. Meantime, all the current
settings will be saved.
PRECAUTION
Do not touch your blood drop to the sample entry on the strip until you
see the " " appear. The meter is performing an internal test and will
display " " and "
" if you apply blood too soon. Then you will waste
a test strip.
View window appearance
11. Quality Control Test
Insufficient blood sample
Enough blood sample
PRECAUTION
- Check the expiration date printed on the package every time you use a
test strip. Do not use expired test strips.
- Use each test strip immediately after removing from the vial.
- Do not reuse test strips.
- Do the test at least 30 minutes after moving into a different location with
significant change in temperature.
- Place the blood drop only on the sample entry of the test
strip.
- Please don't drip or inject the blood sample directly by
syringe to the entry port of test strip. Doing this might
contaminate the meter or cause damage and is not
recommended.
Blood glucose test results are shown on the meter as mmol/L or mg/dL ,
depending on which unit of measurement you have chosen. ( * This meter for
some countries is fixed at mmol/L or mg/dL and is not able to be changed
freely.) Consult your healthcare professional before making any changes to your
diabetes medication program.
If your blood glucose result is unusually high or low, or if you question your
testing results, repeat the test with a new test strip. You can also run a Quality
Control Test with to check your meter and test strip. If the test result still remains
unusually high or low, contact your healthcare professional immediately.
If you are experiencing symptoms that are not consistent with your blood
glucose test results and you have made sure to follow all instructions of this
manual, contact your healthcare professional immediately.
10. Recalling Test Result & Average
The GM100 meter is able to store 150 test results with time and date
automatically. If your meter has stored 150 results, which is the maximum
memory of the meter, the newest test result will replace the oldest one.
To recall your test memory, start with the meter without test strip inserted.
1. Press the main button to switch to screen to memory function,
you will see ”AVG” symbol on the up left corner of the screen.
The display sequence will be 1-day, 7-day,14-day, 30-day, 90day average, and then memory 1 reading, memory 2
reading,…until memory 150 reading which will show ”MEM”
on the up right corner of the screen.
2. Under average screen, the number on the down right corner
of the screen means how many days of readings have been
calculated as the average while the number on the down left
corner of the screen means how many readings have been
counted in. Under memory screen, it will show the sequence
number on the down left corner and then display date and
time.
3. Quick Searching: you could also quick press the main button
twice, and then it will automatically display the average and
memory by sequence. Anytime you want to stop it, you could just press the
main button again. It will stop and display the reading right at the moment
you press the main button. You could just apply the way above; especially
when you find a particular reading you want to check with.
4. Reading right after test: if you just finish the test and press the main button
to review. The display sequence will be the latest reading, 1-day, 7-day, 14day, 30-day, 90-day average, and the memory 2 reading until the oldest one
(memory 150 reading).
The GM100 meter displays results between 0.6 and 33.3 mmol/L
( 10 and 600 mg/dL ). If your test result is below 0.6 mmol/L ( 10
mg/dL ), "
" will appear on the screen. Please repeat your test
again by a new test strip. If you still get "
" result, you should
immediately contact your healthcare professional.
If your test result is above the high end of the system's detection
range 33.3 mmol/L ( 600 mg/dL ), "
" will appear on the screen.
Please repeat your test again by a new test strip. If you still get
"
" result, you should immediately contact your healthcare
professional.
PRECAUTION
- You have to set the time and date to activate the average function.
- The "
","
" results, the Control Solution results and the test result
made out of normal temperature range ( <10℃, >40℃ ) are not
calculated in the average.
Please use Control Solution tested with GM100 BGMS under Control Solution
Mode. If the test result is within the Control Solution Range printed on the strip
vial label, the GM100 BGMS passes Quality Control Test. That means your
GM100 BGMS is working correctly.
Entering Control Solution Mode
Insert the strip into the strip port on meter. While the blood drop symbol
flashing, press and hold the main button for over 5 seconds. Then you will
see "
" symbol blinking on the screen indicating that you've successfully
entered the Control Solution Mode.
Control Solution Range
Test Strips
Control Solution Range
4.4-5.9 mmol/L
79-107 mg/dL
Example of Control Solution Range
printed on your test strip vial label.
When should perform a Quality Control Test ?
Before doing a blood glucose test with your meter for the first time.
When you open and start using a new test strip vial.
When your meter is dropped or splashed with liquids.
Whenever you think your test result does not consistent with the way you feel.
Whenever you want to check if your system is working properly or not.
Whenever you want to practice testing and check correct procedure.
The possible reasons your Control Solution results are out of the range :
- Your Control Solution has expired or after 3 months since opened.
- Your test strip has expired.
- You leave the cap off the vial of test strips or Control Solution for a long time.
- You didn't perform the test procedure correctly.
- Malfunction of the meter.
If Control Solution results are out of the range, your GM100 BGMS may not be
working properly. Repeat the Quality Control Test. If your Control Solution results
outside the range still exist, do not use the GM100 BGMS to test your blood
glucose. And contact Bionime authorized representative or Customer Service.
PRECAUTION
Each time you open a new bottle of
Control Solution, write the discard date
on the label. Control Solution is good
for 3 months after opening the bottle,
or until the expiration date printed on
the label, whichever comes first.
Exp. Date 2012-06
Maintenance
Keep your meter and test strip free of dust, water or any other liquid. Store the
meter in the carrying case when not in use. If meter is dropped or damaged,
perform a Quality Control Test before doing a blood glucose test.
Use with Control Solution
1. Take one test strip from vial and Re-cap the
vial cap immediately.
2. Insert the test strip with view window, facing
up, into test strip port.
3. While the blood drop symbol flashing, press and hold the main button for
over 5 seconds until the "
" symbol appears.
OPEN
6. Drip a drop of Control Solution on the top of
the cap.
7. Gently touch sample entry of the strip with
the Control Solution on the top of the cap.
8. When you hear a beep, leave the meter on the
CLOSE
table while waiting for the test result.
The screen will display the countdown.
9. Tightly replace the cap on the Control Solution
bottle.
10. The Control Solution result appears. Compare your Quality Control Test
result to the Control Solution Range printed on the test strip vial label.
PRECAUTION
- Your Control Solution results will not be calculated for average reading
but still can be recalled. The Control Solution Test result will be shown
with " " symbol on the screen.
Specification
Measurement Technology
Oxidase Electrochemical Sensor
Sample
Capillary whole blood
Minimum Sample Volume
1.4 microliters
Measuring Range
0.6-33.3 mmol/L ( 10-600 mg/dL )
Test Time
8 seconds
Memory Capacity
150 blood glucose test results with date
and time
Turn off automatically after 2 minutes no use.
Or press the "
" button for 2 seconds.
Power Saving
Operating Temperature
10 ~ 40℃ ( 50 ~ 104℉ )
Operating Relative Humidity
10 - 90%
Hematocrit
30 - 55%
Power Supply
One CR2032 battery
Battery Life
About 1000 tests
Meter Dimension
95.0 mm x 43.8 mm x 13.0 mm
Meter Weight
43.0 g with batteries
Er2 - Meter has malfunctioned. Do the Quality
Control Test or reinstall the battery to see
if the meter works properly.
Monitor
LCD display
Display Area
39.0 mm x 38.0 mm
Er3 - Signal transmission is disrupted, repeat the test.
Above, if error screen still appears contact Bionime authorized
representative or Customer Service.
Meter Storage Conditions
-10 ~ 60℃ ( 14 ~ 140℉ )
Test Strip Storage Conditions
4 ~ 30℃ ( 39 ~ 86℉ ),< 90% relative
humidity
Cleaning Meter
Clean the outside of the meter with a damp cloth and mild soap/detergent.
Keep the test strip port from getting wet.
13. Error Message and Trouble Shooting
Er1 - The inserted test strip has been used or
damaged. Please use a new test strip from
vial.
Battery Error
1. The "
" symbol is blinking when the battery
power is low. Please change battery as soon
as you can. You can still do the test.
2. The "
" and "
" symbols are blinking
when the battery is too low. Meter can not do
the strip test. Please change the battery
immediately.
3. After changing the battery, perform a Quality Control Test.
Temperature Error
In order to get accurate test result, perform testing between 10~40℃
( 50~104℉ ).
12. Performing a Quality Control Test
4. You will see blinking "
" symbol and "
"
symbol on the screen prompting you to apply
Control Solution.
5. Shake the bottle of Control Solution well before
opening the cap. Then open the cap and put it
on the table.
- Before " " and "
" appears, please don't touch the Control Solution
to the sample entry on strip because the meter is still in an internal
check. If you do so, the meter will show "
" and " ".
- Don't drip the Control Solution to sample entry of the strip directly. The
reagent on strip might be sucked into the bottle of Control Solution and
might cause the degeneration of Control Solution.
Doing this might contaminate the meter via the
test strip port as well.
- Don't touch the Control Solution. If you have touched it,
please clean up with water.
1. When the ambient temperature is 0~9℃ ( 32~48℉) or
41~50℃ (106~122℉) the "
" warning symbol will be
blinking, you still can do the test but the test result is only for
reference because the test result under these ranges of
temperature might not be correct. Repeat the test at an area
with temperature between operating range. ( 10~40℃ or
50~104℉ )
2. When you move from the area with temperature outside the
operating range of test strip to another area with temperature
inside operating range of test strip, please wait for 30 minutes
before you do the test.
3. When the temperature is below 0℃ ( 32℉ ) or over 50℃
( 122℉ ), Meter can not do the test and the "
" symbol will
blink in this condition. Please move the meter to environment
with temperature between 10~40℃ ( 50~104℉ ) and repeat
the test after 30 minutes.
Sampling Error
Before "
" appears. Please don't apply the blood to the entry of
the strip because the meter is still doing internal check. If you do
so, the meter will show "
" and "
". Please remove the test
strip and insert a new one to do the test again.
Meter Malfunction
If you find the meter can't be switched on, please follow the steps below for
quick inspection.
1. Open the battery cover, take out the battery.
2. Wait for 5 minutes and reload the new battery.
The meter should be work normally after finishing above steps. If not, please
contact Bionime authorized representative or Customer Service.
Limitations
- GM100 BGMS is not intended for serum or plasma test.
- Inaccurate test results may be obtained at high altitude more than about
10,000 feet ( 3048 meters ) above sea level.
- Severe dehydration and excessive water loss may cause inaccurately low
results.
- GM100 BGMS has not been validated for use on neonates.
- The glucose test may be interfered under abnormal concentration of
Uric acid > 0.54 mmol/L ( > 9.0 mg/dL )
Cholesterol > 13 mmol/L ( > 500 mg/dL )
Customer Service
We sincerely like to provide complete, considerate services to our customers.
Please review all the instructions to make sure you are performing the steps
correctly. You are always welcome to contact us by call: 886 4 24951268
( GMT+08:00, 08:30~17:30 ), or by e-mail at info@bionime.com If you have
any question or advice.
Warranty
Bionime Corporation warrants that your GM100 Meter will be free from defects
in materials and workmanship for five years from the date of purchase.
This warranty does not apply to the performance of a GM100 Meter that has
been altered, misused, tampered with or abused in any way.
This warranty applies only to the original purchaser of the meter.
Please complete and return the enclosed warranty card to Bionime authorized
representative.
Different models have different specifications. Some of the models are not
included with the warranty card.
Parts of Critical Component
Blood Glucose Meter, Test Strip, Control Solution and Lancing Device
Manufacturer: Bionime Corp.
Product complied with In Vitro Diagnostic Medical Device Directive 98/79/EC.
( CE0197 )
EU Rep: BIONIME GmbH; Tramstrasse 16, 9442 Berneck / Switzerland
Disposable Sterile Lancets
Manufacturer: Suzhou SPR Medical Devices Development Co., Ltd.
EU Rep: EMDAR BV; Ijsselburcht 3, POB 5486, 6802EL Arnhem, The
Netherlands.(CE0197)
IVD
For in vitro diagnostic use
Manufacturer
Use by
Temperature limitation
LOT
Lot number
Do not reuse
Method of sterilization using irradiation
BIONIME CORPORATION
694, Renhua Road, Dali Dist.,
Taichung City 412, Taiwan
Tel: +886 4 24951268
Fax: +886 4 24952568
E-mail: info@bionime.com http://www.bionime.com
Bionime GmbH
Tramstrasse 16
9442 Berneck
Switzerland
101-3GM100-013
EN
9.
Make sure your blood sample covers the whole area of the View Window to get
an accurate test result. Insufficient blood sample will cause inaccurate test
result. Repeat the test with a new test strip.
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