Blood Glucose Monitoring System

BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,

Rev. Date: 2017-06

Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
http: //www.bionime.com
E-mail: [email protected]

BIONIME GmbH
101-3GM782-011
GM700SB
Tramstrasse 16, 9442 Berneck
Switzerland
EN
USER’S MANUAL
E-mail: [email protected] 0197
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Thank you for selecting the Rightest Blood Glucose Monitoring System GM700SB. This manual The Rightest Blood Glucose Monitoring System GM700SB is a personal blood glucose
provides all the information you need to operate this product for accurate test results. Please read monitoring system to be used for self-testing only. It is not allowed for muitiple users.
this entire manual before you start any testing.
The testing result is calibrated to be plasma equivalent for test with fresh capillary, venous, arterial
For people living with diabetes, it is important to regularly monitor blood glucose levels to effectively and neonatal whole blood samples. Capillary samples may be drawn from the fingertip, palm and
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reduce complications from the disease. The easy-to-use Rightest Blood Glucose Monitoring forearm, and in the case of neonates, the heel. You may consult your healthcare professional for
System GM700SB provides accurate, reliable test results to help you better manage your diabetes. instructions on how to use the system correctly. Our customer support staff is available to assist
you as well.
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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 A healthcare professional should be contacted when Customer Service is not available.
fresh capillary whole blood from either the fingertip, palm or forearm.
Please forward your warranty card to customer support to activate your warranty coverage.
Venous, arterial, and neonatal blood testing is limited to healthcare professional use only. TM
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 [email protected] .
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- Before using the Rightest Blood Glucose Monitoring System GM700SB to test your blood - Avoid contact with dripping or splashing liquids.
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glucose, please read all of the instructions and conduct all of the tests including the quality control - The minimum blood sample size to test using the Rightest Blood Glucose Monitoring System
test (Refer to page 42). GM700SB is 0.75µL: ( )
- Please perform the quality control test regularly to make sure the test results are accurate. Sample Size Example
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- The Rightest Meter GM700SB can only be used with Rightest Test Strips GS700. Other
Blood sample size above 3.0µL might contaminate the test strip port and the meter.
brands’ test strips should not be used under any circumstances. The use of other brands’ strips
Blood sample size below 0.75µL may cause an inaccurate result or may prevent a meter reading.
may give inaccurate results.
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An Er4 reading will be displayed if the sample size is too small. In this case, repeat the test with a
- The Rightest System GM700SB is intended for in vitro diagnostic use only. The test resultsusing new test strip.
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.
TM Important Safety Notes:
- If theRightest Meter and Test Strips are exposed to a substantial change in temperature, please
- All parts of the kit are considered biohazardous and can potentially transmit infectious
wait 30 minutes before measurement. diseases, even after following the cleaning and disinfecting procedures. Please refer to the
- Follow all environmental protection regulations when disposing of batteries. section " Caring for Your Meter" on page 48.
- You may manually turn off the Bluetooth when you are in the radio-restricted area (like on the airplane). - Users should wash their hands thoroughly with soap and water before and after handling
the meter, lancing device, or test strips.
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About the Rightest Blood Glucose Monitoring System GM700SB Understanding Test Results and Messages...................................................................................... 38
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The Rightest Blood Glucose Monitoring System GM700SB.........................................................
TM 8 Quality Control
The Rightest Blood Glucose Meter GM700SB..............................................................................
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The Rightest Blood Glucose Test Strip GS700.............................................................................. 14 About Quality Control Testing............................................................................................................. 39
Performing a Quality Control Test....................................................................................................... 42
Before Testing Understanding Control Test Results................................................................................................... 44
Meter Activation and Battery Change............................................................................................... Test Memory
16
Setting Up Your Meter - Setting the Date, Time and Volume............................................................. Recalling Test Results........................................................................................................................
18 45
Turning On/Off the Meter.................................................................................................................... 22 Recalling Average Test Results..........................................................................................................
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Handling the Rightest Blood Glucose Test Strip GS700 .............................................................. 23
Caring for Your Meter........................................................................................................................... 48
Testing Procedure Error Messages and Troubleshooting................................................................................................ 49
Setting Markers.................................................................................................................................. 25 Limitations.......................................................................................................................................... 53
Getting Ready for Testing................................................................................................................... 26 Specifications..................................................................................................................................... 54
Performing a Blood Glucose Test....................................................................................................... 27 Warranty.............................................................................................................................................. 56
Upload Data....................................................................................................................................... Customer Service............................................................................................................................... 57
32
Turn On / Off Bluetooth......................................................................................................................
33 Expected Blood Glucose Values Without Diabetes............................................................................ 58
Alternative Site Testing.......................................................................................................................
34 Component Manufacturer Information............................................................................................... 59
View Window Appearance................................................................................................................. 36
Contents NOTE
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Your Rightest Blood Glucose Monitoring System GM700SB consists of several items. Please - GM700SB can concomitant use with mobile App, please refer to the "Instruction for
identify each item, learn its name and how it is used. mobile App" for detailed information.
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Below are the items included in your Rightest Blood Glucose Monitoring System GM700SB:
1. Getting Started Guide
2. User's Manual (includes Log Book, Warranty Card, Emergency Card )
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3. Rightest Blood Glucose Test Strip GS700 Package Insert ＊
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4. Rightest Control Solution GC700 Package Insert ＊ 700SB

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5. Rightest Blood Glucose Meter GM700SB ( with 1 CR2032 battery installed )
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6. Rightest Blood Glucose Test strips GS700 ( 10/25 pcs )＊
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7. Rightest Control Solution GC700 ＊(Normal Level is provided in your starter kit)
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8. Rightest 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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4. The RightestTM Blood Glucose Meter GM700SB will enter Self-Testing Mode automatically when
replacing the battery (all symbols will appear on the screen).
5. Press any button under any picture to exit the self-test and enter Setting Mode.
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.
You can enter the Setting Mode two ways.

1. Replace the Battery

After removing the battery, press the main button several times until there is no signal on screen,
then follow the battery installation steps to replace battery. The RightestTM Blood Glucose Meter
GM700SB will perform a self-test. Press the main button to exit the self-test and enter the Setting
Mode.
2. With Battery Inserted
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.
 NOTE
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- If you do no change any settings during Meter Set-up for over 2 minutes, the Rightest Blood
NOTE Glucose Meter GM700SB will leave setting mode - and power off automatically.
- The date and time will be corrected in every APP synchronization. - Meter default is set according to your local preference.
1

3
 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 " ".

Rotate

R
12. After inserting a test strip, the “ “ icon will flash on 12a 12b
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,
discard the test strip and repeat with a new RightestTM
Blood Glucose Test Strip GS700.
15. Countdown Mode will begin on the display window. 16
CAUTION
After 5 seconds, your test result will appear. - 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
16. Pull off the depth adjustable cap. Without touching display " " and " " if you apply blood too soon. If this occurs, please repeat the test
the used disposable lancet, insert the lancet tip into with a new test strip.
the protective lancet cover. - Record the opening date of a new test strip vial. Discard the vial of test
17 18 strips 4 months after opening.
17. Hold the release button in one hand (see picture 18, - Always keep the metal contacts of the test strip port clean. If any dust or
step 1) and pull on the plunger with the other hand impurities are present, please clean with a small, soft brush.
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- The Rightest Blood Glucose Monitoring System GM700SB and Rightest Lancing
(see picture 18, step 2) to safely eject the used
device GD500 are intended for a single user only. Do not share these devices with anyone,
disposable lancet.
including other family members.
- All parts of this kit are considered biohazards and can potentially transmit infectious
18. Discard the used disposable lancet into an 19 diseases, even after you have performed the cleaning and disinfecting procedure.
appropriate puncture-proof or biohazard container. - Users should wash hands thoroughly with soap and water after handling the meter, lancing
device, and test strips.
19. Replace the depth adjustable cap after finishing the
test.
Bluetooth is always ON and when mobile App turn on, it will automatically pair with your mobile Turn off Bluetooth function
device. Press on the right or left button for 2 seconds to turn off the Bluetooth function.
Once the connection successfully pairs, test results will start uploading to the connected mobile
When the Bluetooth function is off, the " " will not be shown on the screen.
device.
When the test result uploading has completed, Bluetooth will disconnect from mobile App
automatically.

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.

Bluetooth pairing. Data uploading.

The symbol of Bluetooth“ ” flashes. The GM700SB meter is now uploading test
results to your mobile device.
NOTE
User should turn off meter or meter’s Bluetooth funcion while traveling in flight. User can
still perform blood glucose testing while the Bluetooth function is off.
Please follow your airline flight safety instruction.
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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.
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1. Take one Rightest Blood Glucose Test Strip GS700 from the vial 9. Tightly replace the cap on the RightestTM Control Solution GC700 bottle.
and close the vial cap immediately. 10. The control solution result will appear. Compare your Quality Control Test result to the
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2. Insert the strip into the test strip port of the Rightest Blood Control Solution Range printed on the RightestTM Blood Glucose Test Strip GS700 vial
label.
Glucose Meter GM700SB with the view window facing up.
3. While the before meal icon is flashing on the display window, press CAUTION
and hold the Right or Left button for at least 3 seconds until the - 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
" " symbol appears.
on the screen.
4. You will see the blinking " " icon and " " icon on the screen, - The Control Solution Test should be conducted between 6-44°C (43-111°F).
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prompting you to apply the corresponding level of Rightest - Before " " and " " appear, do not touch the control solution to the sample port on the strip.
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Control Solution GC700. The Rightest Blood Glucose Meter GM700SB is performing an internal check. Touching the
TM control solution to the sample port before prompted will result in an error message: " " and
5. Shake the bottle of Rightest Control Solution GC700 well before " " and be accompanied by beeps (if volume is turned on).
opening the cap. Place the cap on a flat surface. - Do not drip the control solution on to the sample port of the test strip directly. The reagent on the
6. Place a drop of control solution onto the top of the cap. 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.
7. Gently touch the sample port of the strip with the control solution
- Keep the test strip port clean and dry. Clean immediately if the test strip port is stained or is overly
from the top of the cap. exposed to moisture.
8. The screen will display the count time starting from 5 (you will hear - Do not touch the tip of the control solution bottle. If the tip is touched, clean with water.
a beep if the 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 RightestTM
Control Solution GC700. The control solution test result will not be used when
recalling test average results.
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, 30- NOTE
days, 60-days or 90-days averages. - The Average function requires that the correct time and date is set. Test results must exist
3. The number shown in the lower right hand corner indicates how many test results have been during the desired time interval. For example: To get a 14-day average on 1/30/11, you
calculated. 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.
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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 [email protected] .
Expected Blood Glucose Values Without Diabetes Component Manufacturer Information

Blood Glucose Meter, Test Strip, Control Solution

Manufacturer: Bionime Corporation
Fasting Blood Glucose No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan
GLUCOSE LEVEL INDICATION Product complies with In Vitro Diagnostic Medical Device Directive 98/79/EC (CE 0197).
From 70 to 99 mg/dL (3.9 to 5.5 mmol/L) Normal fasting glucose EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck , Switzerland
From 100 to 125 mg/dL (5.6 to 6.9 mmol/L) Pre-diabetes (Impaired fasting glucose)
126 mg/dL (7.0 mmol/L) and above on more Diabetes Lancing Device
than one testing occasion
Manufacturer: Bionime Corporation
References No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan
Product complies with Medical Device Directive 93/42/EEC
1) Diabetes Information - American Association for Clinical Chemistry (AACC)[Electronic Version]
EC-Rep: Bionime GmbH, Tramstrasse 16, 9442 Berneck , Switzerland
Retrieved Dec. 21, 2015 form
www.labtestsonline.org/understanding/analytes/glucose/test.html
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