Evocheck GM700S User manual

101-3GM780-0M0 EN
Rev. Date: July/2017
0197
Blood Glucose
Monitoring
System
GM700S
USER S MANUAL
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
http: //www.bionime.com
E-mail: [email protected]
BIONIME GmbH
Tramstrasse 16, 9442
BerneckSwitzerland
E-mail: [email protected]
四色印刷
Blood Glucose Monitoring System
www.pharmevo.biz
A product of
www.pharmevo.biz
E-mail: [email protected]
A product of

Preface
32
Preface
The Blood Glucose Monitoring System GM700S 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 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.
The Blood Glucose Monitoring System GM700S is manufactured and supported by
Bionime Corporation. If you have any questions or concerns, please contact your local PharmEvo
Customer Service or email to . [email protected]
Thank you for selecting the Blood Glucose Monitoring System . 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
reduce complications from the disease. The easy-to-use Blood Glucose Monitoring
System provides accurate, reliable test results to help you better manage your diabetes.
The Blood Glucose Monitoring System 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 fingertip.
GM700S
GM700S
GM700S

- Avoid contact with dripping or splashing liquids.
- The minimum blood sample size to test using the Blood Glucose Monitoring System
is 0.75 µL: ( ) GM700S
54
Caution Caution
Blood sample size above 3.0 µL might contaminate the test strip port and the meter.
Blood sample size below 0.75 µL 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 procedures. Please refer to the section
"Caring for Your Meter" on page 44.
- Users should wash their hands thoroughly with soap and water before and after
handling the meter, lancing device, or test strips.
0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL
- 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
- Please perform the quality control test regularly to make sure the test results are accurate.
GM700S GS700 Other brands’
test strips should not be used under any circumstances. The use of other brands’ strips may give
inaccurate results.
The System GM700S is intended for in vitro diagnostic use only. The test results using
fresh capillary whole blood samples from the fingertip, are calibrated to be equivalent to plasma
testing.
- Venous, neonatal or arterial blood testing should be performed by healthcare professionals.
GM700S
- If Blood Glucose Meter GM700S and Test Strips are exposed to a temperature outrange
environment, please wait 30 minutes before testing.
- Follow all environmental protection regulations when disposing of batteries.
GM700S
(Refer to page 35).
- The Meter can only be used with Test Strips .
-
- The System is intended for self-testing. It should not be used to diagnose
diabetes mellitus.
The system has been tested with neonatal blood. As a matter of good clinical practice, be caution
of the interpretation of neonate glucose value below 50 mg/dL (2.8 mmol/L). Please follow the
recommendations for follow-up care that have been set by your intuition for critical glucose values
in neonates. Once patient is suspected as rare disease (ex galactosemia), the glucose result
should based on laboratory test.

76
Table of Contents Table of Contents
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
Error Messages and Troubleshooting.................................................................................................
Limitations...........................................................................................................................................
Specifications......................................................................................................................................
Warranty...............................................................................................................................................
Customer Service................................................................................................................................
Expected Blood Glucose Values ...............................................
Component Manufacturer Information................................................................................................
Meter...........................................................................................................................
.........................................................
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.......................................................................................................
Setting Markers.................................................................................................................................
View Window Appearance.................................................................................................................
Understanding Test Results and Messages......................................................................................
GM700S
GM700S
GM700S
GS700
GS700
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GM700S
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9＊
53 ＊2
6 ＊
1
Contents
Your Blood Glucose Monitoring System GM700S 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 GM700S:
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 Insert ＊
5. Blood Glucose Meter GM700S ( 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. Disposable Sterile Lancets ( 10 pcs ) ＊
10. Carrying Case ( not shown )＊
11. Instructions for the lancing device ( not shown )＊
(＊ Different packages have different bundled items. Some of packages might not include ＊ items.)
4 ＊
7 ＊
8 ＊
The Blood Glucose Monitoring System GM700S The Blood Glucose Monitoring System GM700S
GM700S

GM700S
1110
The Blood Glucose Meter GM700S
Right Button ( )
Battery Cover Meter Battery
The Blood Glucose Meter GM700S
Left Button ( )
Main Button ( )
Display Window
Test Strip Port
2D barcode
with serial
number

1312
The Blood Glucose Meter GM700S The Blood Glucose Meter GM700S
Indicates a test result stored in memory
Indicates a test result not included into the
average results of the meter
Indicates the average result
Indicates a control solution test result
Unit of test result
Test result
Warns when the batteries are low or must be
replaced
Indicates when to apply the blood sample
Appears after you insert test strip into meter
Appears when an error occurs
Current date under time mode or testing date
under memory mode
Warns when the operational temperature limit is
exceeded during testing
Indicates the time in 12H format
Displays current time or testing
time under memory mode
under time mode
Manufacturing use only
indicates a meal marker with test result

1514
The Blood Glucose Meter G 700S can only be used with Blood Glucose Test
Strips GS700 and Control Solution GC700. The use of other test strips or control solutions
can lead to incorrect results.
M
PRECAUTION
- Close the Blood Glucose Test Strip GS700 vial immediately after removing a test
strip.
- Do not reuse Blood Glucose Test Strip GS700.
- Do not use expired Blood Glucose Test Strip GS700.
- When you open a new vial of Blood Glucose Test Strip GS700, record the date
on the vial. Use test strips within 4 months after first opening or until the expiration date
printed on the label (whichever comes first).
- Store the Blood Glucose Test Strip GS700 in a cool ( 4-30 °C or 39-86 °F ) and
dry location (< 90% relative humidity). Do not expose to direct sunlight or heat.
- If the Blood Glucose Meter GM700S and Test Strips are exposed to a
temperature outrange environment, please wait 30 minutes before testing.
- For detailed information, please refer to the Blood Glucose Test Strip GS700
Package Insert.
The Blood Glucose Test Strip GS700
View Window
This window is yellow
before applying blood
sample. It gradually turns
red when filled with blood.
Hand Bar
Grip here to insert
test strip into the
strip port of auto
code key.
Sample Entry
µL
Apply a drop of blood or control solution here.
The test request is only 0.75 of blood.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
The Blood Glucose Test Strip GS700
Electrode Contacts
Sensing signal output terminals.

1716
Meter Activation and Battery Change
Your Blood Glucose Meter comes with one CR2032, 3 volt, battery installed.
new battery will provide power to perform approximately 1,000 tests under normal use. Press the
main button or insert a strip to activate your meter.
GM700S one
17
Meter Activation and Battery Change
1. Turn the
over. Press
and slide the battery cover
to open.
GM700S Blood
Glucose Meter
CAUTION
- Please follow the local regulation to properly discard a used battery.
4. The Blood Glucose Meter
5. Press any button to exit the self-test and enter Setting Mode.
GM700S
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.
will enter Self-Testing Mode automatically when
3. Slide the battery cover back
until it snaps into place.
2. Install the battery. Be sure
to put the battery in the
correct direction (polarity
(+) facing up).

19
18
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.
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,
then follow the battery installation steps to replace battery. The Blood Glucose Meter
will perform a self-test. Press the main button to exit the self-test and enter the Setting
Mode.
Press the main button to turn on the Blood Glucose Meter . 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.
GM700S
GM700S
Setting Up Your Meter - Setting the Date, Time and Volume Setting Up Your Meter - Setting the Date, Time and Volume
1. Year setting
, press the Left or Right button until you see the
current year. Press the Main button to confirm.
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.
With the year format blinking
Once the year is confirmed,
the Month Setting will appear.
Once the month is
confirmed, the Day Setting will appear.
Once the day is confirmed, the Time
Setting will appear.
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.
1)
2)
3)

2120
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.
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.
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 confirmed, the Hour Setting will
appear.
Once the hour is confirmed, the Minute Setting
will appear.
Once the minute is confirmed, the Volume
Setting will appear.
5)
6)
Setting Up Your Meter - Setting the Date, Time and Volume
4a) 4b)
NOTE
- If you do not change any settings during Meter Set-up for over 2 minutes, the
Blood Glucose Meter GM700S will leave setting mode and power off automatically.
- Your Meter default unit is set as "mg/dL".
Setting Up Your Meter - Setting the Date, Time and Volume
7a)
8a)
7b)
8b)
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”.)
9)

2322
1. How to turn on the Blood Glucose Meter
Press the Main button or Insert a test strip.
2. Manual Power off
To power off the Blood Glucose Meter , press and hold the Main button for 3
seconds.
3. Auto Power off
GM700S
GM700S
GM700S The Blood Glucose Meter will power off automatically after 2 minutes if no
buttons are pressed or no strip is inserted.
Turning On / Off the Meter Handling the Blood Glucose Test Strip GS700
How to handle the ood Glucose Test Strip .
Inserting the Blood Glucose Test Strip :
1. Hold the Blood Glucose Test Strip between your thumb and
middle finger with the view window " " facing up.
2. Put your forefinger on the side of the strip as shown.
Bl GS700
GS700
GS700
3. Insert the Blood Glucose Test Strip into test strip port until
it clicks and firmly stops.
GS700
1
2
3
GM700S

GM700S
25
24
Handling the Blood Glucose Test Strip GS700
Removing the Blood Glucose Test Strip :
1. Hold the Blood Glucose Test Strip as shown.
2. Rotate the Blood Glucose Test Strip counterclockwise
and pull up simultaneously.
GS700
GS700
GS700
3. Take the Blood Glucose Test Strip out of the test strip
port.
Please follow your local regulations and discard used strips properly.
GS700
1
2
3
Getting Ready for Testing
Before performing a blood glucose test,
prepare the items below :
- Blood Glucose Meter
- Blood Glucose Test Strips
(Please check the expiration date on the test strip
vial. Do not use expired test strips)
- Lancing device GD500
- Sterile lancet
- Alcohol swab (optional)
GM700S
GS700
PlungerBaseLancet carrier
Release button
Depth adjustable cap
GM700S
GM700S
GM700S

27
26
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.
1 2
34
56
Performing a Blood Glucose Test
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.
9. Take one Blood Glucose Test Strip GS700 from
the vial. Close the vial cap immediately.
10. Insert the strip into the test strip port of the
Blood Glucose Meter GM700S 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).
78
NOTE
- The 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.
Blood Glucose Meter GM700S
910
11
GM700S

29
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.
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 Blood
Glucose Test Strip GS700.
15. Countdown Mode will begin on the display window. After
5 seconds, your test result will appear.
13
15
Performing a Blood Glucose Test
14b
14c
14a
12 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 17, step
1) and pull on the plunger with the other hand (see
picture 17, 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.
18
16
1
2
17
19
28
GM700S
GM700S

31
30
Performing a Blood Glucose Test
CAUTION
- Do not apply your blood drop to the sample port on the strip until you see the " " appear.
The Blood Glucose Meter 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. Use test strips within 4
months after first opening or until the expiration date printed on the label
(whichever comes first).
- 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.
- The Blood Glucose Monitoring System GM700S and 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.
- Please refer to the section "Caring for Your Meter" on page 44 for cleaning instructions.
GM700S
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 42 for more information.

33
32
View Window Appearance View Window Appearance
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
expired Test Strips.
- Use each Test Strip immediately after removing it from the vial.
- Do not reuse Test Strips.
-
- Apply the blood sample only on the sample port of the test strip.
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.
- 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.
GM700S

3534
Understanding Test Results and Messages 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.
Use one of the Control Solutions GC700 when testing your Blood Glucose
Monitoring System GM700S in the Control Solution Mode. If the test result is within the Control
Solution Range printed on the strip vial label, the Blood Glucose Monitoring System
GM700S passes the Quality Control Test and your Blood Glucose Monitoring System
GM700S is working properly.
Control Solution Range:
Example of Control Solution Range
printed on your test strip vial label.
The Meter displays results between
10~600 mg/dL (0.6~33.3 mmol/L)
If the test result is below , “ ” 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 “ ” 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.
Blood Glucose GM700S
10 mg/dL (0.6 mmol/L)
600 mg/dL (33.3 mmol/L),
Control Solution Range mg/dL
Low: 20-48
Normal: 107-145
High: 315-426
NOTE
- If your blood glucose result is unusually high or low, or if you question your testing results,
repeat the test with a new test strip. You can also run a Quality Control Test to check your
meter and test strip. If the test result still remains unusually high or low, contact your
healthcare professional immediately.
- If you are experiencing symptoms that are not consistent with your blood glucose test
results and you have made sure to follow all instructions of this manual, contact your
healthcare professional immediately.

37
36
About Quality Control Testing About Quality Control Testing
CAUTION
- Each time you open a new bottle of control solution, write the expiration date on the label.
The Control Solution GC700 is good for 3 months after opening the bottle, or
until the expiration date printed on the label, whichever comes first.
- Wipe the bottle cap with a clean tissue before tightly closing the bottle of control solution.
- Close the bottle of tightly immediately after using.
- Check the expiration date before use (Refer to the Control Solution GC700
Package Insert).
- Keep control solution bottles out of reach of children.
Control Solution GC700
Example
Exp. Date 2017-10
When should a Quality Control Test Be Performed ?
- To ensure that your Blood Glucose Meter and Blood Glucose Test
Strip are working properly.
- To confirm that you are following the correct testing procedures.
- To prepare for your initial blood glucose test.
- To check the Blood Glucose Test Strip when you open a new vial of strips.
-
- To practice testing.
Required Items for Quality Control Tests
To perform a quality control test, prepare the items below :
- Blood Glucose Meter
- Blood Glucose Test Strips
- Control Solution GC700
GM700S
GS700
GS700
GM700S
GM700S
GS700
To check your Blood Glucose Meter 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.