User manual
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| Document Description | User manual |
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GM782
BIONIME GmbH
Tramstrasse 16, 9442 Berneck
Switzerland
E-mail: info@bionime.ch
0197
101-3GM782-XXX
EN
Rev. Date: September/2014
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
Blood Glucose Monitoring System GM782
USER’S MANUAL
Preface
Preface
TM
Thank you for selecting the Rightest Blood Glucose Monitoring System GM782 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
TM
reduce complications from the disease. The easy-to-use Rightest Blood Glucose Monitoring
System GM782 provides accurate, reliable test results to help you better manage your diabetes.
TM
The Rightest Blood Glucose Monitoring System GM782 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.
TM
The Rightest Blood Glucose Monitoring System GM782 is a personal blood glucose monitoring
system to be used for self-testing only. It is not recommended for multiple 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.
Venous, arterial, and neonatal blood testing is limited to healthcare professional use only.
The RightestTM Blood Glucose Monitoring System GM782 is manufactured and supported by
Bionime Corporation. If you have any questions or concerns, please contact your local Bionime
Customer Customer Service or call us at +886-0800-371-688 GMT+08:00, 08:30~17:30.
Caution
Caution
TM
- Before using the Rightest Blood Glucose Monitoring System GM782to test your blood glucose,
please read all of the instructions and conduct all of the tests including the quality control test
(Refer to page 37).
- Please perform the quality control test regularly to make sure the test results are accurate.
- The RightestTM Blood Glucose Meter GM782 can only be used with RightestTM Blood Glucose
Test Strips GS700. Other brands’ test strips should not be used under any circumstances. The
use of other brands’ strips may give inaccurate results.
- The RightestTM Blood Glucose Monitoring System GM782 is intended for in vitro diagnostic use
only. The RightestTM Blood Glucose test results using fresh capillary whole blood samples from
the fingertip, palm and forearm are calibrated to be the equivalent to that of plasma testing.
Venous, neonatal or arterial blood may also be used only if drawn by healthcare professionals.
- The RightestTM Blood Glucose Monitoring System GM782 is intended for self-testing. It should not
be used to diagnose diabetes mellitus.
- If the RightestTM Blood Glucose Meter GM782 and Test Strips GS700 are exposed to a substantial
change in temperature, please wait 30 minutes before measurement.
- Follow all environmental protection regulations when disposing of batteries.
- Avoid contact with dripping or splashing liquids.
- The minimum blood sample size to test using the RightestTM Blood Glucose Monitoring System
GM782 is 0.75µL: ( )
Sample Size Example
0.75µL
1.0µL
1.5µL
2.0µL
3.0µL
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.
The system has been tested with neonatal blood. As a matter of good clinical practice, caution is
advised in the interpretation of neonate glucose value below 50 mg/dL. Please follow the
recommendations for follow-up care that have been set by your intuition for critical glucose values
in neonates. Results for neonates exhibiting symptoms of galactosemia should be confirmed by
laboratory tests.
Important Safety Notes:
- Users should wash their hands thoroughly with soap and water before and after handling
the meter, lancing device, or test strips.
Table of Contents
Table of Contents
TM
About the Rightest Blood Glucose Monitoring System GM782
TM
The Rightest Blood Glucose Monitoring System GM782............................................................
TM
The Rightest Blood Glucose Meter GM782 ................................................................................ 10
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The Rightest Blood Glucose Test Strip GS700.............................................................................. 14
Before Testing
Meter Activation and Battery Change...............................................................................................
Setting Up Your Meter - Setting the Date, Time and Volume.............................................................
Turning On/Off the Meter....................................................................................................................
TM
Handling the Rightest Blood Glucose Test Strip GS700 ..............................................................
Testing Procedure
Getting Ready for Testing...................................................................................................................
Performing a Blood Glucose Test.......................................................................................................
Setting Markers.................................................................................................................................
Alternative Site Testing.......................................................................................................................
View Window Appearance.................................................................................................................
Understanding Test Results and Messages......................................................................................
16
18
22
23
25
26
31
34
36
37
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...........................................................................
Federal Communications Commission (FCC)Statement..................................................................
Component Manufacturer Information...............................................................................................
39
42
44
45
46
48
49
53
54
56
57
58
59
60
The RightestTM Blood Glucose Monitoring System GM782
The RightestTM Blood Glucose Monitoring System GM782
Contents
TM
Your Rightest Blood Glucose Monitoring System GM782 consists of several items. Please
identify each item, learn its name and how it is used.
3＊
GM782
4＊
TM
Below are the items included in your Rightest Blood Glucose Monitoring System GM782:
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 ＊
TM
4. Rightest Control Solution GC700 Package Insert ＊
TM
5. Rightest Blood Glucose Meter GM782 ( with 1 CR2032 batteries installed )
TM
6. Rightest Blood Glucose Test strips GS700 ( 10/25 pcs )＊
TM
7. Rightest Control Solution GC700 ＊(Normal Level is provided in your starter kit)
TM
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 )＊
6＊
7＊
8＊
10＊
9＊
(＊ Different packages have different bundled items. Some of packages might not include ＊ items.)
The RightestTM Blood Glucose Meter GM782
The RightestTM Blood Glucose Meter GM782
Test Strip Port
GM782
Display Window
GM782
Main Button (
Battery Cover
Left Button (
Right Button (
Meter Battery
2D barcode
with serial
number
10
11
The RightestTM Blood Glucose Meter GM782
12
The RightestTM Blood Glucose Meter GM782
Indicates a test result stored in memory
Indicates when to apply the blood sample
Indicates a test result not included into the
average results of the meter
Appears after you insert test strip into meter
Indicates the average result
Appears when an error occurs
Indicates a control solution test result
Current date under time mode or testing date
under memory mode
Unit of test result
Warns when the operational temperature limit is
exceeded during testing
Test result
Indicates the time in 12H format
Warns when the batteries are low or must be
replaced
Displays current time under time mode or testing
time under memory mode
indicates a meal marker with test result
Manufacturing use only
indicates that the Bluetooth is turned off
indicates that the Bluetooth is turned on
13
The RightestTM Blood Glucose Test Strip GS700
The RightestTM Blood Glucose Test Strip GS700
The RightestTM Blood Glucose Meter GM782 can only be used with RightestTM Blood Glucose Test
Strips GS700 and RightestTM Control Solution GC700. The use of other test strips or control
solutions can lead to incorrect results.
Sample Entry
Apply a drop of blood or control solution here.
The test request is only 0.75 µL of blood.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
14
Hand Bar
Grip here to insert
test strip into the
strip port of auto
code key.
View Window
This window is yellow
before applying blood
sample. It gradually turns
red when filled with blood.
Electrode Contacts
Sensing signal output terminals.
PRECAUTION
- Close the RightestTM Blood Glucose Test Strip GS700 vial immediately after removing a
test strip.
- Do not reuse RightestTM Blood Glucose Test Strip GS700.
- Do not use expired RightestTM Blood Glucose Test Strip GS700.
- When you open a new vial of RightestTM Blood Glucose Test Strip GS700, record the date
on the vial. Discard the vial of test strips after 4 months from opening.
- Store the RightestTM Blood Glucose Test Strip GS700 in a cool ( 39-86°F or 4-30°C ) and
dry location (< 90% relative humidity). Do not expose to direct sunlight or heat.
- If the RightestTM Blood Glucose Meter GM782 and Test Strips are exposed to a substantial
change in temperature, please wait 30 minutes before measurement.
- For detailed information, please refer to the RightestTM Blood Glucose Test Strip GS700
Package Insert.
15
Meter Activation and Battery Change
Meter Activation and Battery Change
TM
Your Rightest Blood Glucose Meter GM782 comes with one CR2032, 3volt, batteries installed.
one new batteries will provide power to perform approximately 1000 tests under normal use. Press
the main button or insert a strip to activate your meter.
GM782
GM782
GM782
1. Turn the GM782 Blood
Glucose Meter over. Press
and slide the battery cover
to open.
2. Install the batteries. Be sure
to put the batteries in the
correct direction (polarity
(+) facing up).
3. Slide the battery cover back
until it snaps into place.
4. The RightestTM Blood Glucose Meter GM782 will enter Self-Testing Mode automatically when
replacing the battery (all symbols will appear on the screen).
5. Press any button 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.
CAUTION
- Please follow the local regulation to properly discard a used battery.
16
17
Setting Up Your Meter - Setting the Date, Time and Volume
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
GM782 will perform a self-test. Press the main button to exit the self-test and enter the Setting
Mode.
2. With Battery Inserted
Press the main button to turn on the RightestTM Blood Glucose Meter GM782. 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.
Setting Up Your Meter - Setting the Date, Time and Volume
1)
1. Year setting
With the year format blinking, press the Left or Right button until you see the
current year. Press the Main button to confirm. Once the year is confirmed,
the Month Setting will appear.
2)
2. Month setting
With the month blinking, press the Left or Right button until you see the
current month. Press the Main button to confirm. Once the month is
confirmed, the Day Setting will appear.
3)
NOTE
- Use the Left and Right buttons to select your setting data and press the main button to
confirm each selection. After confirming all of the settings, you will return to the Time
Mode.
18
3. Day setting
With the day blinking, press the Left or Right button until you see the current
day. Press the Main button to confirm. Once the day is confirmed, the Time
Setting will appear.
19
Setting Up Your Meter - Setting the Date, Time and Volume
4. Time format 12/24H selection
With the time format blinking, press the Left or Right
button to switch between 12H and 24H. Press the Main
button to confirm. Once confirmed, the Hour Setting will
appear.
5. Hour setting
With the hour blinking, press the Left or Right button
until you see the current hour. Press the Main button to
confirm. Once the hour is confirmed, the Minute Setting
will appear.
6. Minute setting
With the minutes blinking, press the Left or Right button
until you see the current minute. Press the Main button
to confirm. Once the minute is confirmed, the Volume
Setting will appear.
20
4a)
4b)
5)
6)
Setting Up Your Meter - Setting the Date, Time and Volume
7. Volume Setting
With the volume blinking, press the Left or Right button
to turn the volume on or off. Press the Main button to
confirm and finish the settings.
8. Setting the Unit of Measurement
With milligrams per deciliter (mg/dL) or millimoles per
liter (mmol/L) blinking, press the Left or Right button to
switch. Then press the Main button to confirm it and
finish the settings.
9. Ending setting
After measurement of unit setting, for confirmation you
will hear a beep (if volume is turned on). All the settings
are saved and completed and will return to time screen.
(If Volume is turned off, the display will directly return to
time screen without a sound of “beep”.)
7a)
7b)
8a)
8b)
9)
NOTE
- If you do no change any settings during Meter Set-up for over 2 minutes, the RightestTM
Blood Glucose Meter GM782 will leave setting mode and power off automatically.
21
Turning On / Off the Meter
1. How to turn on the RightestTM Blood Glucose Meter GM782
Press the Main button or Insert a test strip.
2. Manual Power off
To power off the RightestTM Blood Glucose Meter GM782, press and hold the Main button for 3
seconds.
Handling the RightestTM Blood Glucose Test Strip GS700
TM
How to handle the Rightest Blood Glucose Test Strip GS700.
TM
Inserting the Rightest Blood Glucose Test Strip GS700:
TM
1. Hold the Rightest Blood Glucose Test Strip GS700 between your thumb
and middle finger with the view window "
" facing up.
2. Put your forefinger on the side of the strip as shown.
3. Auto Power off
The RightestTM Blood Glucose Meter GM782 will power off automatically after 2 minutes if no
buttons are pressed or no strip is inserted.
3. Insert the RightestTM Blood Glucose Test Strip GS700 into test strip port
until it clicks and firmly stops.
22
GM782
23
Handling the RightestTM Blood Glucose Test Strip GS700
Removing the RightestTM Blood Glucose Test Strip GS700:
1. Hold the RightestTM Blood Glucose Test Strip GS700 as shown.
2. Rotate the RightestTM Blood Glucose Test Strip GS700 counterclockwise
and pull up simultaneously.
GM782
Before performing a blood glucose test,
prepare the items below :
- RightestTM Blood Glucose Meter GM782
- RightestTM Blood Glucose Test Strips GS700
(Please check the expiration date on the test strip
vial. Do not use expired test strips)
- RightestTM Lancing device GD500
- Sterile lancet
- Alcohol swab (optional)
GM782
3. Take the RightestTM Blood Glucose Test Strip GS700 out of the test strip
port.
Please follow your local regulations and discard used strips properly.
Getting Ready for Testing
GM782
Depth adjustable cap
Lancet carrier
Release button
Base
Plunger
GM782
24
25
Performing a Blood Glucose Test
Performing a Blood Glucose Test
1. Hold the depth adjustable cap in one hand and hold the
base with the other hand. Bend the cap down. When a
gap appears between the cap and base, pull the cap
and base 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.
6. Choose a depth of penetration by rotating the top portion
of the depth adjustable cap until your desired setting is
visible in the window. Settings are based on skin type
" for soft or thin skin; "
" for average skin;
" for thick or calloused skin.
26
7. Hold the base in one hand and pull on the plunger with
the other hand. The device will be cocked. Release the
plunger and it will automatically move back to its original
position near the base.
8. Wash your hands with warm soapy water and dry
thoroughly.
TM
9. Take one Rightest Blood Glucose Test Strip GS700
from the vial. Close the vial cap immediately.
TM
10. Insert the strip into the test strip port of the Rightest
Blood Glucose Meter GM782 with the view window facing
up.
11. Once the strip is inserted, all symbols will appear on your
meter display and will be accompanied by a beep (if
volume is turned on).
NOTE
TM
- The Rightest Blood Glucose Meter GM782 will
automatically detect the Code number on the test
strip. You do not have to check the Code number on
the meter display and strip vial.
10
GM782
11
27
Performing a Blood Glucose Test
Performing a Blood Glucose Test
12. 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.
12
13
16. Pull off the depth adjustable cap. Without touching the
used disposable lancet, insert the lancet tip into the
protective lancet cover.
13. Place the lancing device against your fingertip and
press the release button.
82
GM7
14b
14a
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.
17. Hold the release button in one hand (see picture 17, step
1) and pull on the plunger with the other hand (see
picture 17, step 2) to safely eject the used disposable
lancet.
16
17
18
19
82
GM7
18. Discard the used disposable lancet into an appropriate
puncture-proof or biohazard container.
19. Replace the depth adjustable cap after finishing the test.
15. Countdown Mode will begin on the display window. After
5 seconds, your test result will appear.
14c
28
15
29
Performing a Blood Glucose Test
CAUTION
- Do not apply your blood drop to the sample port on the strip until you see the "
" appear.
TM
The Rightest Blood Glucose Meter GM782 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.
TM
TM
- The Rightest Blood Glucose Monitoring System GM782 and Rightest Lancing device
GD500 are intended for a single user only. Do not share these devices with anyone,
including other family members.
- Users should wash hands thoroughly with soap and water after handling the meter, lancing
device, and test strips.
Setting Markers
According to actual life status, you can set meal markers with test result.
You have to perform meal marker setting immediately after the meter displays the reading of your
test result.
1. After test, the test result is displayed on the screen with time, date and flashing “
”.
2. Keep pressing the Right button to choose between the “
” (before meal), “
” (after
meal), ”
” (no marker) and “
” then press main button to confirm and save this record.
Before meal: You execute this blood glucose test before a meal.
After meal: You execute this blood glucose test after a meal.
(Blank) no marker: regular test or definition by user.
No average: You will exclude this test result from average calculation.
Please refer to "Excluding test results from the average calculation"on
page 44 for more information.
30
31
Upload Data
Airplane Mode
After the marker setting, Bluetooth will turn itself on and start to pair with your mobile device or PC.
Once the connection successfully pairs, test results will start uploading to the connected mobile
device or PC.
When the test result uploading has completed, Bluetooth will turn itself off.
Turn on Airplane Mode
Press on the right or left button for 3 seconds to turn it on. When airplane mode is on, you'll see
“
” on the screen. In Airplane Mode, the Bluetooth feature for test results uploading is turned off.
Airplane Mode
The “
” symbol appears in the left corner on screen.
Bluetooth pairing.
The symbol of Bluetooth “
” flashes.
Data uploading.
The GM782 meter is now uploading test results
to your mobile device or PC.
NOTE
1.Users don't need to manually turn the Bluetooth on.
2.The meter only stays in pairing mode for 20 seconds, and then turns Bluetooth off
and returns to Time Mode.
32
Turn off Airplane Mode
Press on the right or left button for 3 seconds to turn it
off. Once Airplane Mode be turned off, meter will start
checking and uploading the test results using Bluetooth
feature.
33
Alternative Site Testing
Alternative site testing: palm or forearm blood sampling
Alternative Site Testing
Palm
Forearm
- To perform alternative site testing, install the clear cap for
your RightestTM Lancing Device GD500. ( For detailed
information, refer to the instruction manual for the
RightestTM Lancing Device GD500. )
- To increase the blood flow, massage the intended puncture
area of your palm or forearm for a few seconds.
- Immediately after massaging the intended puncture area,
press and hold the lancing device with the clear cap
against palm or forearm.
Pressing for
a few seconds
Releasing
button
- Press the release button.
- Continue holding the lancing device against your palm or forearm and gradually increase pressure
for a few seconds until the blood sample size is sufficient. (DO NOT test on the palm or forearm if
you are testing for hypoglycemia (Low blood glucose).
34
CAUTION
- Test results may vary if blood samples are taken from different sites or under certain
conditions where glucose levels are changing rapidly such as: following a drink, a meal,
an insulin dose or exercise. In these cases, only the 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 in glucose faster than palm or forearm
samples.
- Consult your healthcare professional before sampling from your palm or forearm.
- Since the blood flow in the forearm and palm is slower than in the fingertip, use the clear
cap provided with the RightestTM Lancing Device GD500 when testing sites other than
fingertip.
- If you use the normal lancing device for your palm or forearm, the blood sample may not
be sufficient for meter operation.
- Periodically compare the test system to a laboratory test system that is known to be well
maintained and monitored by a healthcare provider.
35
View Window Appearance
Understanding Test Results and Messages
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.
If your blood glucose result is unusually high or low, or if you question your test results, repeat the
TM
test with a new Rightest Blood Glucose Test Strip GS700.
TM
You can also run a Quality Control Test with the Rightest Control Solutions GC700 to check your
RightestTM Blood Glucose Meter GM782 and RightestTM Blood Glucose Test Strip GS700 (Refer to
“Performing a Quality Control Test” on page 40) .
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
expired RightestTM Blood Glucose Test Strips GS700.
- Use each RightestTM Blood Glucose Test Strip GS700 immediately after removing it from
the vial.
TM
- 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.
36
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 in this manual, contact your healthcare professional
immediately.
Follow local regulations or consult your health care provider for appropriate disposal of used test
strips and lancets.
37
Understanding Test Results and Messages
TM
The Rightest Blood Glucose Meter GM782 displays results between 10
and 600 mg/dL.
If the test result is below 10 mg/dL , “
” will appear on the screen. Please
repeat your test with by a new test strip.
If you still get a “
” result, contact your healthcare professional.
If the test result is above 600 mg/dL, “
” will appear on the screen. Please
repeat your test again with a new test strip.
If you still get a “
” result, contact your healthcare professional.
About Quality Control Testing
What is a Quality Control Test ?
To ensure proper monitoring function, it is necessary to regularly perform a quality control test.
TM
TM
Use one of the Rightest Control Solutions GC700 when testing your Rightest Blood Glucose
Monitoring System GM782 in the Control Solution Mode. If the test result is within the Control
TM
Solution Range printed on the strip vial label, the Rightest Blood Glucose Monitoring System
TM
GM782 passes the Quality Control Test and your Rightest Blood Glucose Monitoring System
GM782 is working properly.
Control Solution Range:
Example of Control Solution Range
printed on your test strip vial label.
Control Solution Range mg/dL
Low:
Normal:
High:
28-48
107-145
315-426
NOTE
- Normal of RightestTM Control Solution GC700 is provided in your starter kit. If you want to
purchase, High or another Normal control solutions, please contact customer service.
38
39
About Quality Control Testing
About Quality Control Testing
When should a Quality Control Test Be Performed ?
TM
TM
- To ensure that your Rightest Blood Glucose Meter GM782 and Rightest Blood Glucose Test
Strip GS700 are working properly.
- To confirm that you are following the correct testing procedures.
- To prepare for your initial blood glucose test.
TM
- To check the Rightest Blood Glucose Test Strip GS700 when you open a new vial of strips.
TM
- To check your Rightest Blood Glucose Meter GM782 after it has been dropped, damaged or
exposed to liquids.
- If you suspect that your test results are inaccurate, or if your test results are not consistent with the
way you feel.
- To practice testing.
Required Items for Quality Control Tests
To perform a quality control test, prepare the items below :
TM
- Rightest Blood Glucose Meter GM782
TM
- Rightest Blood Glucose Test Strips GS700
TM
- Rightest Control Solution GC700
40
CAUTION
- Each time you open a new bottle of control solution, write the expiration date on the label.
The RightestTM Control Solution GC700 is good for 3 months after opening the bottle, or
until the expiration date printed on the label, whichever comes first.
Example
Exp. Date 2014-06
- Wipe the bottle cap with a clean tissue before tightly closing the bottle of control solution.
- Close the bottle of control solution tightly immediately after using.
- Check the expiration date before use. (Refer to the RightestTM Control Solution GC700
Package Insert).
- Keep control solution bottles out of reach of children.
41
Performing a Quality Control Test
Performing a Quality Control Test
TM
1. Take one Rightest Blood Glucose Test Strip GS700 from the vial
and close the vial cap immediately.
9. Tightly replace the cap on the RightestTM 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 RightestTM Blood Glucose Test
Strip GS700 vial label.
TM
2. Insert the strip into the test strip port of the Rightest Blood
Glucose Meter GM782 with the view window facing up.
3. While the blood drop icon is flashing on the display window, press
and hold the Main button for at least 3 seconds until the "
symbol appears.
4. You will see the blinking " " icon and "
" icon on the screen,
GM782
OPEN
TM
prompting you to apply the corresponding level of Rightest
Control Solution GC700.
TM
42
GM782
5. Shake the bottle of Rightest 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. The screen will display the count time starting from 5 (you will hear a
beep if the volume is turned on).
CLOSE
CAUTION
- Your Control Solution Test results will not be included in the average calculations, however,
they can still can 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 43-111°F (6-44°C).
- Before " " and "
" appear, do not touch the control solution to the sample port on the
strip. The RightestTM Blood Glucose Meter GM782 is performing an internal check.
Touching the control solution to the sample port before prompted will result in an error
message: "
" and " " and be accompanied by beeps (if volume is turned on).
- 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.
GM782
43
Understanding Control Test Results
Recalling Test Results
Your control solution test results should fall within the control solution range printed on the test strip
vial label. If the results are within the range, the RightestTM Blood Glucose Monitoring System
GM782 is working correctly.
TM
The Rightest Blood Glucose Meter GM782 is able to automatically store a maximum of 500 test
results with time and date. If your meter has stored 500 results, the newest test result will replace
the oldest one.
Example of control solution range printed on your test strip vial label
Low
Normal
High
40~60 mg/dL
88~120 mg/dL
250~340 mg/dL
Possible reasons your Control Solution results are out of the range :
- Your RightestTM Control solution GC700 is expired or was first opened more than 3 months ago.
- Your RightestTM Blood Glucose Test Strip GS700 has expired.
- You left the cap of the Blood Glucose Test Strip vial or the control solution off for a period of time.
- You did not perform the test procedure correctly.
- The RightestTM GM782 Blood Glucose Meter or RightestTM Blood Glucose Test Strip GS700 have
malfunctioned.
If RightestTM Control Solution GC700 results are out of range, your RightestTM Blood Glucose
Monitoring System GM782 may not be working properly. Repeat the Quality Control Test. If your
TM
control solution results are still out of range, do not use Rightest Blood Glucose Meter GM782
to test your blood glucose. Please contact customer service.
44
To recall your test memory, start the meter without a test strip inserted.
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 latest test
result will appear with the number “1”.
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 using the RightestTM
Control Solution GC700. The control solution test result will not be used when
recalling test average results.
45
Recalling Average Test Results
The RightestTM Blood Glucose Meter GM782 provides several average test results. View the 1-day,
7-days, 14-days, 30-days, 60-days and 90-days average test results for better blood glucose
monitoring.
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.
4. Excluding test results from the average calculation:
You may exclude the test result from average calculation right after each test.
You have to perform this exclusion immediately after the meter displays the reading of your test
result. Press the Right or Left button to choose "NO AVG" then press the main button to confirm.
The test result is now excluded from averaging.
46
Recalling Average Test Results
5. Quick Searching:
To view test results in sequential order automatically, enter the Memory Mode. Press the Right or
Left button for 2 seconds. (The Right button is for viewing from the most current to the oldest test
results. The Left button is for viewing from the oldest to the most current test results). Release the
button to stop at any particular test result.
NOTE
- The Average function requires that the correct time and date is set. 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.
- To exclude test results from average calculation, you need to remain in Test Mode and
perform the exclusion right after you get the test result. Once you move to MEM Mode,
Average Mode or Time Mode, you will not be able to perform the exclusion.
- The "Lo", "Hi" results, control solution test results and test results under abnormal
temperature < 43°F (6°C), > 111°F (44°C) will be excluded from average calculations.
47
Error Messages and Troubleshooting
Caring for Your Meter
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 your meter is dropped or damaged, perform a quality control test with the
control solution before performing a blood glucose test.
Cleaning Meter
Clean the outside of the meter with a damp cloth and mild soap/detergent. Do not get the test strip
port wet.
Temperature Error
1. In order to get accurate testing results, please test between 43-111 °F ( 6-44 °C).
2. When the temperature is below 43 °F (6 °C) or over 111 °F (44 °C), the meter will
not function and the "
" symbol will blink.
3. If the RightestTM Blood Glucose Meter GM782 and Test Strips are exposed to a
substantial change in temperature, please wait 30 minutes before measurement.
Cleaning Test Strip Port
If your test strip port is stained with blood, control solution or any liquid, please use a dry tissue or
alcohol swab to clean it immediately. Do not use anything wet to clean it. Perform a quality control
test to ensure the RightestTM Blood Glucose Meter GM782 is working properly.
48
49
Error Messages and Troubleshooting
Battery Error
1. The "
" and "
" symbols appear and the meter will not function when
the battery is low. Change the batteries immediately.
Strip Error
1. When the test strip is inserted incorrectly, the meter will beep 4 times while the
" symbol flashes. Do not apply a sample on the test strip. Please reinsert the unused test strip correctly (refer to “Handling the RightestTM Blood
Glucose Test Strip GS700“ on Page 23 for more information).
2. If, after performing the required steps, the "
" and flashing "
symbols appear on the screen, it means the RightestTM Blood Glucose Test
Strip GS700 has been inserted incorrectly more than twice. Please, re-insert
the unused test strip again after reviewing the steps on how to insert a test
strip correctly on p.23 or call Customer Service for support. This error message
can also indicate that you may have used the wrong test strips. Please check
the test strip vial to ensure you are using the RightestTM Blood Glucose Test
Strip GS700.
Sampling Error
Please do not apply the blood to the sample port of the test strip before the
meter displays "
". Discard the test strip If the meter shows "
".
50
Error Messages and Troubleshooting
Er1 - The inserted test strip has been used or damaged. Please use a new test
strip.
Er2 - The meter has malfunctioned. Do a Quality Control Test or reinstall the
batteries to check if the meter works properly.
Er3 - The signal transmission is disrupted. Repeat the test using a new test strip.
Er4 - The blood sample volume is insufficient. Repeat the test using a new test
strip.
Er5 - An issue calibrating the Meter has occurred. Please follow the steps below:
(1) Remove the test strip from the meter.
(2) Turn off the meter (press and hold the Main button for 3 seconds).
(3) Press the main button to turn ON the meter.
If after turning on the Meter, you do not see Er5, your meter is functioning
properly and able to perform a test.
If one of the above error messages still appears, please contact Bionime
Customer Service.
Meter Malfunction
If the RightestTM Blood Glucose Meter GM782 will not turn on, please follow the steps below:
1. Open the battery cover and remove the batteries.
2. Wait for 5 minutes and reinsert the batteries as described as instructed on page 16, (Meter
Activation and Changing the Battery).
The meter should work normally after finishing the above steps. If the meter still does not work,
please contact your local Bionime customer service.
51
Error Messages and Troubleshooting
Limitations
TM
CAUTION
A blood sample should ONLY be applied to the test strip after the test strip has been
inserted correctly and the Meter's screen is showing the image of the test strip and a blood
drop flashing symbol. If the blood drop flashing symbol is NOT showing on the screen, do
not apply a sample to the test strip. Please re-insert the unused test strip correctly. The
screen MUST show the image of the test strip accompanied by the blood drop symbol
flashing (this symbol take 3 seconds to show after correctly inserting the test strip) in order
for a sample to be applied. Please consult your User Manual and/or contact Customer
Service for support on how to correctly insert a RightestTM Blood Glucose Test Strip GS700.
52
- Rightest Blood Glucose Monitoring System GM782 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
(≧6 mg/dL), Dopamine (≧ 2.5 mg/dL),
L-Dopa (≧ 3 mg/dL), Xylose (≧ 20 mg/dL) and Uric Acid (≧ 20 mg/dL).
- 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.
53
Specification
Specification
Measurement Technology
Dehydrogenase Electrochemical Sensor
Hematocrit
10-70%
Sample
Capillary, Venous, Arterial and Neonatal whole blood
Power Supply
One CR2032 Battery (3 Voltage)
Minimum Sample Volume
0.75 microliters
Battery Life
Measuring Range
10 - 600 mg/dL
Meter Dimension
Test Time
5 seconds
Meter Weight
43 ± 5g with batteries
Memory Capacity
500 blood glucose test results with date and time
Monitor
LCD
Power Saving
Turns off automatically 2 minutes after last user action. To
turn off manually, press the button "
" for 3 seconds.
Display Area
34 mm x 27.5 mm
Operating Temperature
43 - 111°F (6 - 44°C )
Meter Storage/ Transportation Conditions
14 - 140°F ( -10 - 60°C )
Operating Relative Humidity
10 - 90%
Test Strip Storage/ Transportation Conditions
39 - 86°F ( 4 - 30°C ), < 90% relative humidity
54
Approximately 350 standard tests
82 mm x 45 mm x 15.5 mm
55
Warranty
Bionime Corporation warrants that this product 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 RightestTM Blood Glucose Meter GM782 that
has been altered, misused, tampered with or abused in any way.
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. If you have any questions or in
case of problems with the products, please contact your local Bionime customer service.
This warranty applies only to the original purchaser of the RightestTM Blood Glucose Monitoring
System GM782.
Description of used symbols
Please complete and return the enclosed warranty card.
Different models have different specifications. This warranty applies only to the RightestTM Blood
Glucose Monitoring System GM782; other models are not covered with this warranty card.
NOTE
- During blood glucose measurement, the RightestTM Blood Glucose Meter GM782 itself may
come into contact with blood. All parts of the RightestTM Blood Glucose Monitoring System
GM782 are considered biohazardous and can potentially transmit infectious diseases.
Please follow your local regulations to properly dispose of the used RightestTM Blood
Glucose Monitoring System GM782 after removing the batteries.
56
IVD
For in vitro diagnostic use
Manufacturer
LOT
Lot number
Expiry date
Method of sterilization using irradiation
Temperature limitation
EC Representive
For single use only
CE-mark (with No. of notified body)
Consult the instruction for use
Caution (consult instructions foruse and warnings)
57
Expected Glucose Values Without Diabetes
Federal Communications Commission (FCC) Statement
Expected glucose values without diabetes ⁽¹⁾
Status
Fasting
Two Hours after meals
Federal Communications Commission (FCC) Statement
Range (mg/dL)
<100
<140
References
1) American Diabetes Association: Standard of Medical Care in Diabetes 2011, Diabetes Care,
Vol.34, supplement 1, S11-S61, January 2011.
15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user's
authority to operate the equipment.
15.105(b)
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) this device may not cause harmful interference and
2) this device must accept any interference received, including interference that may cause undesired operation of the device.
RF Exposure:
To comply with the FCC RF exposure compliance requirements, this device and its antenna must not be co-located or operating in
conjunction with any other antenna or transmitter.
58
59
Component Manufacturer Information
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. (CE0197)
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. (CE0197)
EC- Rep: EMERGO EUROPE, Molenstraat 15, 2513 BH The Hague, The Netherlands
60
61
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