101-3GM782-011
EN
Rev. Date: 2017-06
BIONIME GmbH
Tramstrasse 16, 9442 Berneck
Switzerland
E-mail: info@bionime.ch
0197
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
http: //www.bionime.com
E-mail: info@bionime.com
USER’S MANUAL
Blood Glucose Monitoring System
GM700SB
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The Rightest Blood Glucose Monitoring System GM700SB is a personal blood glucose
monitoring system to be used for self-testing only. It is not allowed for muitiple users.
The testing result is calibrated to be plasma equivalent for test with fresh capillary, venous, arterial
and neonatal whole blood samples. Capillary samples may be drawn from the fingertip, palm and
forearm, and in the case of neonates, the heel. 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.
A healthcare professional should be contacted when Customer Service is not available.
Please forward your warranty card to customer support to activate your warranty coverage.
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The Rightest Blood Glucose Monitoring System GM700SB is manufactured and supported by
Bionime Corporation. If you have any questions or concerns, please contact your local Bionime
Customer Service or email to rightest@bionime.com .
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Thank you for selecting the Rightest Blood Glucose Monitoring System GM700SB. This manual
provides all the information you need to operate this product for accurate test results. Please read
this entire manual before you start any testing.
For people living with diabetes, it is important to regularly monitor blood glucose levels to effectively
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reduce complications from the disease. The easy-to-use Rightest Blood Glucose Monitoring
System GM700SB provides accurate, reliable test results to help you better manage your diabetes.
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The Rightest Blood Glucose Monitoring System GM700SB is designed for in vitro diagnostic use
only (for self-testing by a single user outside the body). Testing requires only a small amount of
fresh capillary whole blood from either the fingertip, palm or forearm.
Venous, arterial, and neonatal blood testing is limited to healthcare professional use only.
- Before using the Blood Glucose Monitoring System to test your blood
glucose, please read all of the instructions and conduct all of the tests including the quality control
test (Refer to page 42).
- Please perform the quality control test regularly to make sure the test results are accurate.
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- The Rightest Meter GM700SB can only be used with Rightest Test Strips GS700. Other
brands’ test strips should not be used under any circumstances. The use of other brands’ strips
may give inaccurate results.
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- The Rightest System GM700SB is intended for in vitro diagnostic use only. The test resultsusing
fresh capillary whole blood samples from the fingertip, palm and forearm are calibrated to be
equivalent to plasma testing.
- Venous, neonatal or arterial blood testing should be performed by healthcare professionals.
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- The Rightest System GM700SB is intended for self-testing. It should not be used to diagnose
diabetes mellitus.
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- If theRightest Meter and Test Strips are exposed to a substantial change in temperature, please
wait 30 minutes before measurement.
- Follow all environmental protection regulations when disposing of batteries.
- Youmay manually turn offthe Bluetooth
when you are in the radio-restricted area (like on the airplane).
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Rightest GM700SB
- Avoid contact with dripping or splashing liquids.
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- The minimum blood sample size to test using the Rightest Blood Glucose Monitoring System
GM700SB is 0.75µL: ( )
Blood sample size above 3.0µL might contaminate the test strip port and the meter.
Blood sample size below 0.75µL may cause an inaccurate result or may prevent a meter reading.
An Er4 reading will be displayed if the sample size is too small. In this case, repeat the test with a
new test strip.
Sample Size Example
Important Safety Notes:
- All parts of the kit are considered biohazardous and can potentially transmit infectious
diseases, even after following the cleaning and disinfecting procedures. Please refer to the
section " Caring for Your Meter" on page 48.
- Users should wash their hands thoroughly with soap and water before and after handling
the meter, lancing device, or test strips.
Understanding Test Results and Messages......................................................................................
Quality Control
About Quality Control Testing.............................................................................................................
Performing a Quality Control Test.......................................................................................................
Understanding Control Test Results...................................................................................................
Test Memory
Recalling Test Results........................................................................................................................
Recalling Average Test Results..........................................................................................................
Caring for Your Meter...........................................................................................................................
Error Messages and Troubleshooting................................................................................................
Limitations..........................................................................................................................................
Specifications.....................................................................................................................................
Warranty..............................................................................................................................................
Customer Service...............................................................................................................................
Expected Blood Glucose Values Without Diabetes........................................................................... .
Component Manufacturer Information...............................................................................................
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About the Blood Glucose Monitoring System
The Blood Glucose Monitoring System .........................................................
The Blood Glucose Meter ..............................................................................
The Blood Glucose Test Strip ..............................................................................
Before Testing
Meter Activation and Battery Change...............................................................................................
Setting Up Your Meter - Setting the Date, Time and Volume.............................................................
Turning On/Off the Meter....................................................................................................................
Handling the Blood Glucose Test Strip ..............................................................
Testing Procedure
Getting Ready for Testing...................................................................................................................
Performing a Blood Glucose Test.......................................................................................................
Upload Data
Turn On / Off Bluetooth
Alternative Site Testing.......................................................................................................................
View Window Appearance.................................................................................................................
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GM700SB
GM700SB
GM700SB
GS700
GS700
Setting Markers..................................................................................................................................
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700SB
Contents
Your Blood Glucose Monitoring System GM700SB consists of several items. Please
identify each item, learn its name and how it is used.
Below are the items included in your Blood Glucose Monitoring System GM700SB:
1. Getting Started Guide
2. User's Manual (includes Log Book, Warranty Card, Emergency Card )
3. Blood Glucose Test Strip GS700 Package Insert ＊
4. Control Solution GC700 Package Insert ＊
5. Blood Glucose Meter ( with 1 CR2032 battery installed )
6. Blood Glucose Test strips GS700 ( 10/25 pcs )＊
7. Control Solution GC700 ＊(Normal Level is provided in your starter kit)
8. Lancing Device ＊
9. Clear Cap ＊
10. Disposable Sterile Lancets ( 10 pcs ) ＊
11. Carrying Case ( not shown )＊
12. Instruction for the lancing device ( not shown )＊
13 Instruction for mobile App (not shown)
(＊ Different packages have different bundled items. Some of packages might not include ＊ items.)
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GM700SB
.
NOTE
- GM700SB can concomitant use with mobile App, please refer to the "Instruction for
mobile App" for detailed information.
4. The Blood Glucose Meter
5. Press any button under any picture to exit the self-test and enter Setting Mode.
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replacing the battery (all symbols will appear on the screen).
6. You must set the time and date when replacing the battery. See Chapter “Setting Up Your Meter Setting the Date, Time, and Volume" on page 18. Test results are still stored in the memory.
GM700SB will enter Self-Testing Mode automatically when
1000
You can enter the Setting Mode two ways.
1. Replace the Battery
2. With Battery Inserted
After removing the battery, press the main button several times until there is no signal on screen,
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then follow the battery installation steps to replace battery. The Rightest Blood Glucose Meter
will perform a self-test. Press the main button to exit the self-test and enter the Setting
Mode.
When the meter is “ON”, hold down the main button for 7 seconds. During this time the screen
will go blank until you hear a beep. After the beep, the meter will turn on into the Setting Mode.
The display screen will show setting data.
GM700SB
NOTE
- If you do no change any settings during Meter Set-up for over 2 minutes, the Blood
Glucose Meter will leave setting mode - and power off automatically.
- Meter default is set according to your local preference.
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NOTE
- The date and time will be corrected in every APP synchronization.
2
3
1
Rotate
According to actual life status, you can set meal markers with test result.
You have to perform meal marker setting before testing.
1. Before test, press the Left or Right button to choose between the “ ”(before meal), ” ”,
and “ ” (after meal) then press main button to confirm and do the test after setting.
2. If you don't set the marker in 15 seconds, the default marker will be "
".
R
12. After inserting a test strip, the “ icon will flash on
the screen. Pressing the Right button to choose
between the before meal), after meal) and
” then press main button to confirm. Then a
blood drop icon will appear on the display window and
will be accompanied by a beep (if volume is turned
on). Apply the blood sample within 2 minutes.
13. Place the lancing device against your fingertip and
press the release button.
14. Touch and hold the blood drop to the edge of sample
port until the view window is filled with blood. If the
view window is not completely filled with blood the test
will not start. If the blood sample was insufficient,
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discard the test strip and repeat with a new Rightest
Blood Glucose Test Strip GS700.
“
“ “( “ “(
“
12a
12b
CAUTION
- Do not apply your blood drop to the sample port on the strip until you see the " " appear.
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The Rightest Blood Glucose Meter GM700SB is performing an internal test and will
display " " and " " if you apply blood too soon. If this occurs, please repeat the test
with a new test strip.
- Record the opening date of a new test strip vial. Discard the vial of test
strips 4 months after opening.
- Always keep the metal contacts of the test strip port clean. If any dust or
impurities are present, please clean with a small, soft brush.
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- The Rightest Blood Glucose Monitoring System GM700SB and Rightest Lancing
device GD500 are intended for a single user only. Do not share these devices with anyone,
including other family members.
- All parts of this kit are considered biohazards and can potentially transmit infectious
diseases, even after you have performed the cleaning and disinfecting procedure.
- Users should wash hands thoroughly with soap and water after handling the meter, lancing
device, and test strips.
15. Countdown Mode will begin on the display window.
After 5 seconds, your test result will appear.
16. Pull off the depth adjustable cap. Without touching
the used disposable lancet, insert the lancet tip into
the protective lancet cover.
17. Hold the release button in one hand (see picture 18,
step 1) and pull on the plunger with the other hand
(see picture 18, step 2) to safely eject the used
disposable lancet.
18. Discard the used disposable lancet into an
appropriate puncture-proof or biohazard container.
19. Replace the depth adjustable cap after finishing the
test.
19
16
18
17
NOTE
User should turn off meter or meter’s Bluetooth while traveling in flight. User can
still perform blood glucose testing while the Bluetooth function is off.
funcion
Please follow your airline flight safety instruction.
Bluetooth is always ON and when mobile App turn on, it will automatically pair with your mobile
device.
Once the connection successfully pairs, test results will start uploading to the connected mobile
device.
When the test result uploading has completed, Bluetooth will disconnect from mobile App
automatically.
Data uploading.
The GM700SB meter is now uploading test
results to your mobile device.
Bluetooth pairing.
The symbol of Bluetooth“ ” flas hes.
Turn off Bluetooth function
Press on the right or left button for 2 seconds to turn off the Bluetooth function.
When the Bluetooth function is off, the " " will not be shown on the screen.
Turn on Bluetooth function
Press on the right or left button for 2 seconds to turn on the Bluetooth function.
When the Bluetooth function is on, the " " will flash on the screen.
A
Make sure your blood sample covers the whole
area of the view window to get an accurate test
result. An insufficient blood sample will result in
an error message ("Er4"). If this occurs, repeat
the test with a new test strip.
Insufficient blood sample Sufficient blood sample
CAUTION
- Check the expiration date printed on the strip vial every time you use a test strip. Do not use
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expired Rightest Blood Glucose Test Strips GS700.
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- Use each Rightest Blood Glucose Test Strip GS700 immediately after removing it from
the vial.
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- Do not reuse Rightest Blood Glucose Test Strips GS700.
- Do not perform testing immediately after moving from one ambient temperature to another
(e.g. after coming indoors from the outside). Allow 30 minutes for the temperature of the
meter and the test strips to equilibrate.
- Apply the blood sample only on the sample port of the test strip.
- Please don't drip or inject the blood sample directly by syringe to the sample
entry of test strip. Doing this might contaminate the meter or cause damages
and is not recommended.
1. Take one Blood Glucose Test Strip GS700 from the vial
and close the vial cap immediately.
2. Insert the strip into the test strip port of the Blood
Glucose Meter GM700SB with the view window facing up.
3. While the before meal icon is flashing on the display window, press
and hold the Right or Left button for at least 3 seconds until the
" symbol appears.
4. You will see the blinking " " icon and " " icon on the screen,
prompting you to apply the corresponding level of
Control Solution GC700.
5. Shake the bottle of Control Solution GC700 well before
opening the cap. Place the cap on a flat surface.
6. Place a drop of control solution onto the top of the cap.
7. Gently touch the sample port of the strip with the control solution
from the top of the cap.
8.
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The screen will display the count time starting from 5 (you will hear
a beep if the volume is turned on).
"
9. Tightly replace the cap on the Control Solution GC700 bottle.
10. The control solution result will appear. Compare your Quality Control Test result to the
Control Solution Range printed on the Blood Glucose Test Strip GS700 vial
label.
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CAUTION
- Your Control Solution Test results will not be included in the average calculations, however, they
can still be recalled and viewed. The Control Solution Test result will be shown with the " " icon
on the screen.
- The Control Solution Test should be conducted between 6-44°C (43-111°F).
- Before " " and " " appear, do not touch the control solution to the sample port on the strip.
The Blood Glucose Meter GM700SB is performing an internal check. Touching the
control solution to the sample port before prompted will result in an error message: " " and
" " .
- Do not drip the control solution on to the sample port of the test strip directly. The reagent on the
strip might leak into the bottle of control solution and may cause the degeneration of the control
solution. This could contaminate the meter via the test strip port.
- Keep the test strip port clean and dry. Clean immediately if the test strip port is stained or is overly
exposed to moisture.
- Do not touch the tip of the control solution bottle. If the tip is touched, clean with water.
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and be accompanied by beeps (if volume is turned on)
- If you have request for Quality Control Test, please connect Customer Service.
1. Press the Main button to switch from the Time Mode to Memory Mode. You
will see the “mem” icon in the upper left corner of the display. The testing
date-time, index number and year will be appeared with result.
2. Use either the Left or Right button on the side to review all previous results
with date and time. Results display from the most recent (Sequence no. “1”)
to the oldest (Sequence no. “500”) in the lower right hand corner of the
screen.
3. The Quality Control Test result can be recalled from the saved data. When
" appears next to the data, the test was performed by the
Control Solution GC700. The control solution test result will not be used when
recalling test average results.
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NOTE
- Test results must exist
during the desired time interval. For example: To get a 14-day average on 1/30/11, you
must have test results dated between 1/17 and 1/30. If no test results exist during that
time frame you will not receive an average.
- The "Lo", "Hi" results, control solution test results and test results under abnormal
temperature < 6°C (43°F), > 44°C (111°F) will be excluded from average calculations.
The Average function requires that the correct time and date is set
.
1. Press the Main button to switch the screen to Average Mode.
2. On the average screen, use either the Left or Right button to view 1-day, 7-days, 14-days, 30days, 60-days or 90-days averages.
3. The number shown in the lower right hand corner indicates how many test results have been
calculated.
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- Rightest Blood Glucose Monitoring System GM700SB is not intended for serum or plasma
testing.
- Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3048 meters) above
sea level.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- The glucose test may be invalid in the presence of abnormally high concentration:
Ascorbic acid ≧5 mg/dL (0.28 mmol/L), Xylose ≧20 mg/dL (1.33 mmol/L) and Uric Acid ≧20
mg/dL (1.19 mmol/L).
- Not for screening or diagnosis of diabetes mellitus.
- Not for use on critically ill patients in shock, dehydrated patients or hypo-osmolar patients.
- Alternative site testing (AST) should only be performed during steady-state times (when glucose is
not changing rapidly).
- Alternative site testing should not be used to calibrate continuous glucose monitoring systems
(CGMS).
- Alternative site testing should not be performed if testing for hypoglycemia (Low blood glucose).
- Results from alternative site testing should not be used in insulin dose calculation.
- Regarding potential electromagnetic or other interference, keep meter out of electromagnetic
radiation sources.
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. If you have any questions or in
case of problems with the products, please contact your local Bionime customer service or email
to rightest@bionime.com .
Expected Blood Glucose Values Without Diabetes
Blood Glucose Meter, Test Strip, Control Solution
Manufacturer: Bionime Corporation
No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan
Product complies with In Vitro Diagnostic Medical Device Directive 98/79/EC (CE 0197).
EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck , Switzerland
Lancing Device
Manufacturer: Bionime Corporation
No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan
Product complies with Medical Device Directive 93/42/EEC
EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck , Switzerland
Disposable Sterile Lancets
Manufacturer: SteriLance Medical (SuZhou) Inc.
No.68 LiTangHe RD, XiangCheng, SuZhou, JiangSu 215133, P.R. China
Product complies with Medical Device Directive 93/42/EEC (CE 0197).
EC- Rep: EMERGO EUROPE, Molenstraat 15, 2513 BH The Hague, The Netherlands
Component Manufacturer Information
References
Diabetes Information - American Association for Clinical Chemistry (AACC)[Electronic Version]
Retrieved Dec. 21, 2015 form
www.labtestsonline.org/understanding/analytes/glucose/test.html
1)
INDICATION
Normal fasting glucose
Pre-diabetes (Impaired fasting glucose)
126 mg/dL (7.0 mmol/L) and above on more
than one testing occasion
Diabetes
Fasting Blood Glucose
GLUCOSE LEVEL
From 70 to 99 mg/dL (3.9 to 5.5 mmol/L)
From 100 to 125 mg/dL (5.6 to 6.9 mmol/L)
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