BIONIME Rightest GM100 사용 지침

{카테고리_이름} BIONIME Rightest GM100에 대한 사용 지침을 온라인으로 검색하거나 PDF를 다운로드하세요. BIONIME Rightest GM100 2 페이지. Blood glucose monitoring system
BIONIME Rightest GM100에 대해서도 마찬가지입니다: 사용 지침 (2 페이지)

BIONIME Rightest GM100 사용 지침
Blood Glucose Monitoring System
Instructions for Use
®
Rightest
GM100
Preface
®
Thank you for selecting the
Rightest
Blood Glucose Monitoring System. Please read this
manual thoroughly before you start testing. It provides all the information you need to use
the product. You will get a correct test result by the following instruction of this manual.
It is quite important for you to monitor blood glucose regularly. A derived complication can
®
thus be effectively reduced. Through the assistance of
Rightest
Monitoring system, which provides considerate design and accurate results, your diabetes
management can become more reliable and ease-to-use.
®
The
Rightest
Blood Glucose Monitoring System is manufactured by Bionime Corporation
and supported by its authorized representative. If you have any questions or concerns,
please contact your authorized distributor, in the USA and Canada please contact Bionime
USA toll-free at 1 (888) 481-8485 (Monday through Friday 8:00 AM to 5:00 PM PST).
1.
Intended Use
Rightest ® Blood Glucose Monitoring System is intended for In Vitro diagnostic use (
The
for self-testing ) only ( outside the body ) and
coding is not required.
The testing result is
calibrated to be plasma equivalent for test with fresh capillary whole blood samples from
the fingertip, palm or forearm. You may consult your healthcare professional for instructions
on how to use the system correctly. Our customer support staff is available to assist you as
well.
2.
Package of Meter Kit
®
1. Rightest
Meter
7.
Clear Cap
*
2. Rightest
®
Test Strips (0/10/25 pcs) *
8. Disposable Sterile Lancets (10pcs) *
®
3. Rightest
Control Solutions
(Normal
9. Instruction for the lancing device *
Level) *
10. Log Book
4. Rightest
®
Instructions for Use
11. Warranty Card + Emergency
®
5. Rightest
Blood Glucose Test Strip
12. CR2032 Battery (Inserted into the
Package Insert *
meter)
®
6. Rightest
Lancing Device *
13. Carrying Case *
( Different packages have different bundled items. Some of packages might not include *
items.)
1
2 *
3 *
4
Test Strips
5 *
7 *
8 *
6 *
3.
®
The
Rightest
Meter
Test Strip Port
Insert test strip here until you
hear a click.
Display Window
Shows test results,
messages and related
Model Number
information.
Meter Serial
Number
Main Button
Press to turn on/off meter.
Battery Cover
Switch different function
Slide cover to
screen.
change battery.
Press and hold down until
enter to the setting mode.
Plastic Tape
(There will be a power-off
Pull it off to activate meter.
period during this process.)
4.
Precautions
- Before using the Rightest ® System to test your blood glucose, please read all the
instructions and practice performing a test including a quality control test.
- Please do the quality control test regularly to make sure the test results are accurate.
- The
Rightest
®
GM100 Blood Glucose Meter can only be used with the
GS100 Blood Glucose Test strips. The use of any other brand strips should not be used
under any circumstances. The use of other brands of strips may produce inaccurate
results.
- The
Rightest
®
Blood Glucose Monitoring System is intended for self-testing. It should
not be used to diagnose diabetes mellitus.
®
-
Rightest
Blood Glucose Monitoring System has not been validated for use on
neonates. Therefore, it's not intended for use on neonates.
- This meter can be only tested with capillary whole blood. Please don't test with arterial
blood.
- 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.
Blood Glucose
- The minimum blood sample size for testing is 1.4µL :(
1.0
µL
1.4
µL
Sample Size Example
Please take a minimum of 1.4µl to do the test on glucose monitoring system.
Blood sample size above 4.0µL might contaminate the test strip port.
Blood sample size below 1.4µL might cause inaccurate test result or might not start on
meter measurement. In this case, repeat the test with a new test strip.
PRECAUTION
The unit of measure must be fixed to " mg/dL ". When your display shows " mmol/L
" during setting or test, please contact customer service. Use of the wrong unit of
measure may cause you to incorrect treatment.
®
5.
The
Rightest
T est Strip ( GS100 T est Strip )
Rightest ® GM100 is designed to use with GS100 strip only. Please note that misuse of
other strips might cause unexpected damage or produce inaccurate test results.
Sample Entry
Noble Metal Electrodes
Apply a drop of blood or control solution here.
Electrochemical sensor
The test request is only 1.4
Indication Symbol
View Window
Insert strip with indication symbol up
This window is yellow before applying
and toward meter.
blood sample. It gradually turns red when
filled with blood.
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 strip vial for the first time. Discard the vial of
strips 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 Rightest
Insert.
6.
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. The low battery symbol "
" will keep appearing
on your display if your battery runs low. Please keep spares on hand and
replace the battery soon when a battery symbol appears.
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.
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.
Rightest
®
7.
Setting Up Your Meter-Setting the Date, Time
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
2.0
µL
3.0
µL
4 µL
.0
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.
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
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.
µL
of blood.
4. Time format 12/24H selection
With the time format blinking, press the main button to
Hand Bar
adjust it. Then hold the same button for 2 seconds to
Grip here to insert
confirm it and move to hours setting.
test strip into meter.
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
Electrode Contacts
confirm it. Meantime, it will shift to next digit for setting.
Sensing signal output terminals.
Repeat the above action until the minute setting is
completed. Then it will move to average-day setting.
7.
Ending setting
After confirm the Average-day setting
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
®
GS100 Test Strip Package
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.
Turning on /off the Meter
1. Auto Power off
The meter will power off automatically if you don't operate it over 2 minutes.
2. Manual Power off
If you want to turn off the meter, please keep pressing the main button for 2 seconds.
3. How to turn on the Power
1) Press the main button.
2) Insert one piece of test strip.
Performing a Blood Test
8.
The Rightest
®
blood glucose monitoring system gives you an opportunity to obtain blood
samples from fingertip, palm or forearm.
1. Pull off the depth adjustable cap.
2. Insert a new disposable lancet firmly into lancet carrier.
3. Twist off and set aside the protective cover of the disposable lancet.
4. Replace the depth adjustable cap.
5. Choose a depth of penetration by rotating the top portion of the depth adjustable cap
until the setting depth matches the window. Settings are based on skin type "
soft or thin skin; "
" for average skin; "
1
6. Hold the hub in one hand and pull on the plunger in
the other hand. The device is now loaded. Release
the plunger, it will automatically move back to its
original position near the hub.
7. Wash your hands with warm soapy water and dry
thoroughly.
8. T ake one strip from the vial. Re- cap the vial cap
immediately.
9. Insert the strip into the strip port on meter with the
indication symbol facing up.
10. While the blood drop symbol flashing, you are ready
to apply the blood sample.
11. Place the lancing device against the pad of your
fingertip and press the release button. The
puncture sites are on the middle or ring fingers.
Then
Press the release button.
12. 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. You will see the countdown mode on the screen. After 8 seconds, the test result
appears.
12
hold the
14. Pull off the depth adjustable cap. Without touching the used disposable lancet, stick
the lancet tip into the protective cover.
15. Hold the release button in one hand and pull on the plunger in the other hand. This
will safely eject the used disposable lancet.
16. Discard the used disposable lancet into an appropriate puncture-proof or biohazard
container.
17. Replace the depth adjustable cap after finishing the test.
14
seconds to
PRECAUTION
- For detailed information of installing clear Cap of lancing device, please check the
instruction manual for the lancing device.
- Be careful to load the lancing device to avoid being pierced by the needle.
- Do not touch your blood drop to the sample entry on the strip until you see the
, you'll hear a
"
" appear. The meter is performing an internal test and will display "
"
" if you apply blood too soon.
Alternative site testing-palm or forearm blood sampling
1. Using the clear cap, follow the above listed steps 1
through 4.
2. Massage the puncture area of palm or forearm for a
few seconds.
3.
Immediately after massaging the puncture area, press
and hold the lancing device with the
palm or forearm.
4. Then press the release button.
5. Continue holding the lancing device against palm or
forearm and gradually increase pressure for a few
seconds until the blood sample size is sufficient.
( Refer to Instruction manual for the lancing device )
PRECAUTION
- The glucose test results of blood samples taken from different sites might be
varied in certain conditions such as your glucose is changing rapidly following a
drink, a meal, an insulin dose or exercise. In these cases, only fingertip should be
used.
- DO NOT test on the palm or forearm if you are testing for hypoglycemia (Low
blood glucose).
- Fingertip samples can show the rapid change of glucose faster than palm or
forearm samples.
- As the blood flow taken from forearm is slower than fingertip or palm, we
recommend using a special lancing device with Clear Cap for testing sites other
than finger.
" for
- If you use normal lancing device for palm or forearm the blood sample might be
" for thick or calloused skin.
not enough for meter.
2
3
4
5
6
7
8
9
10
11
best
13
15
16
17
2
1
" and
Then you will waste a test strip.
clear cap
against
Pressing for
Releasing
button
a few seconds