BIONIME Rightest GM700 User manual

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]
101-3GM700-022 EN
Rev. Date: February/2017
BIONIME GmbH
Tramstrasse 16, 9442 Berneck
Switzerland
E-mail: [email protected]
GM700
Blood Glucose Monitoring System GM700

TM
Thank you for selecting the Rightest Blood Glucose Monitoring System GM700. Please read this
manual thoroughly before testing. This User Manual provides all the necessary information needed to
obtain correct test results.
TM TM
The Rightest Blood Glucose Meter GM700 must only be used with Rightest Blood Glucose Test
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Strip GS700 and Rightest Control Solution GC700. The application of other Test Strips or control
solutions can lead to inaccurate test results.
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We hereafter call Rightest Blood Glucose Monitoring System GM700 as Rightest GM700 BGMS,
TM TM TM
Rightest Blood Glucose Meter GM700 as Rightest GM700 Meter, and Rightest Blood Glucose
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Test Strip GS700 as Rightest GS700 Test Strip for short.
It is recommended to monitor blood glucose regularly. By testing accurately and frequently,
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complications can be reduced. The Rightest GM700 BGMS, combines simple instruction and
design with accurate testing results to provide a more reliable, user-friendly diabetes management
system.
Preface
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Preface
The Blood Glucose Monitoring System GM700 is intended for in vitro diagnostic use
(outside the body only). It is to be used for self-testing in the home or professional, clinical use.
The system is used for monitoring of blood glucose levels. Venous, arterial, and neonatal blood
testing is limited to healthcare professional use only.
GM700 Meters, Lancing Device, and Lancets are suggested to be used by personal
monitoring blood glucose use at home, but not suggested by 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.
The Blood Glucose Monitoring System GM700 is manufactured by Bionime Corporation.
If you have any question or concern, please contact your local Bionime Customer Service or call us at
886 0800 371 688 GMT+08:00, 08:30~17:30.
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- Before using the GM700 BGMS to test your blood glucose, read all the instructions in
this user's manual and practice the tests including the quality control test. (Read all notes and
precautions carefully)
- Please do the quality control test regularly to make sure the test results are accurate.
- The GM700 Meter can only be used with GS700 Test Strips. The use of other
brands of strips is not advised and may result in inaccurate testing.
- The GM700 BGMS is intended for in vitro diagnostic use only. The testing result is
calibrated to be plasma equivalent for test with fresh capillary whole blood samples from the
fingertip, palm and forearm.
- The GM700 BGMS is intended for self-testing or professional use. It should not be used
to diagnose diabetes mellitus. It should also not be used to diagnose neonate hypoglycemia.
- Wait to test at least 30 minutes after entering another location of a different ambient temperature.
- Pay attention to the environment protection policy when disposing of batteries.
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Precaution Precaution
Use a minimum of 0,75µL to test blood glucose levels. Blood sample size above 3.0µL may
contaminate the Auto-Code Key.
Blood sample size below 0.75µL may result in Er4. In this case, repeat the test with a new test strip.
Sample Size Example 0.75µL 1.0µL 1.5µL 2.0 µL 3.0µL
- Using appliance in tropical and / or temperate climate.
- Keep the test strips, control solution or vial cap away from children. They may cause a choking
hazard. If a test strip or vial cap is swallowed, contact your physician immediately.
- Prevent water from entering the meter. Never immerse the meter or hold it under running water.
- The minimum blood sample size for testing is 0.75µL :( )
- A drop of blood is required to perform a blood glucose test. Capillary blood can be used, while
venous, neonatal or arterial blood may also be used only if drawn by healthcare professionals.
- 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.
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Table of Contents Table of Contents
Caring for Your Meter
Error Messages and Trouble shooting
Limitations
Specifications
Warranty
Customer Service
Expected Values
Parts of Critical Component
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Quality Control
About Quality Control Testing
Performing a Quality Control Test
Understanding Control Test Results
Recalling Test Results
Recalling Average Test Results
Caring for Your Meter
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About the Blood Glucose Monitoring System
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Rightest Blood Glucose Monitoring System GM700
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Rightest GM700 Meter
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Rightest GS700 Test Strip
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The Rightest GM700 Auto Code Key
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Testing Procedure
Preparing for Testing
Performing a Blood Test
Alternative Site Testing (AST)
View Window appearance
Comprehending Test Results and Messages
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Preparing to test
Battery Installation
Setting Up the Meter
Turning On/Off the Meter
Function Screens and Button Operations
Handling the GS700 Test Strip
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9 *
2 *
5 * 6 * 8 *
7 *
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GM5 50
GM550
GM550
(*Different packages have different bundled items. Some packages might not include * items.)
The GM700 BGMS consists of several items. Please identify each item of the system and
learn the name and function of each item.
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Rightest Blood Glucose Monitoring System GM700
Package of System Kit
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Rightest GM700
These items are included in the GM700 BGMS:
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1. Rightest GM700 Meter(with 1 CR2032 battery installed)
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2. Rightest GS700 Test Strips (0/10/25 pcs)*
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3. Rightest GM700 Getting Started Guide
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4. Rightest GM700 User Manual
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5. Rightest GS700 Test Strip Package Insert*
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6. Rightest GD500 Lancing Device*
7. Clear cap*
8. Disposable Sterile Lancets (10 pcs)*
9. Instructions for the lancing device*
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10. Rightest Control Solution GC700 Package insert (not shown)*
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11. Rightest Auto code key (combined on the meter)
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12. Rightest Control Solution GC700 (not shown)*
13. Carrying Case (not shown)*
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Battery Cover
Slide cover to change
battery.
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Rightest GM700 Meter
Display Window
Show your test result, messages
and relative information.
Test Strip Port
Insert test strip here until you hear a
click.
Product name
Meter Serial Number
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Rightest GM700 Meter
Meter Battery
Down Button ( )
For operating the meter,
please check details in
following sections.
Up Button ( )
For operating the meter,
please check details in
following sections.
Main Button ( )
Press to turn on/off meter or go into
setting model.
Auto Code Key
®

1312
Indicates a test result stored in memory
Indicates a test result, not joining into the Average
function of this meter
Indicates with the average result
Indicates a control solution test result
Unit of test result
Test result
Warns when the battery is low or must be replaced
Tell 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
Indicates if the environmental temperature is
exceeded during testing
Indicates the time in 12H format
Current time or Testing time under
memory mode
under time mode
Manufacturing use only
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Rightest GM700 Meter TM Rightest GM700 Meter
Transfer data via bluetooth

PRECAUTION
- Re-cap the test strip vial immediately after taking out a test strip.
- Do not reuse test strips.
- Do not use expired test strips.
- Record the date of opening a new test strip vial for the first time. Discard the vial of test
strips after 4 months from opening.
- Store the test strips in a cool (4-30℃) and dry location (< 90% relative humidity). Do not
expose to direct sunlight or heat.
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- For detailed information, please refer to the Rightest GS700 Test Strip Package Insert.
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- If the Rightest GM700 meter and strips are exposed to a high temperature difference,
please wait 30 minutes before measurement.
- Keep test strips and vial out of reach of children.
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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.
Electrode Contacts
Sensing signal output terminals.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
TM TM TM
The Rightest GM700 Meter must only be used with Rightest GS700 Test Strips and Rightest
Control Solution GC700.
The application of other Test Strips or control solutions can lead to incorrect results.
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Rightest GS700 Test Strip TM
Rightest GS700 Test Strip

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The GM700 Auto Code Key
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Auto Code Key is designed to automatically detect the Code of strip to make each lot of strips work
well on the meter. Therefore, the Auto Code Key is not necessary to replace every time.
Auto Code Key also contains the test strip port for inserting the test strip.
Battery Installation
The meter will automatically turn off after 2 minutes of nonuse to save battery power. Your test
memories are still saved.
1. Turn the meter over. Press
and push battery cover to
open.
3. Slide the battery cover
back until it snaps into
place.
PRECAUTION
- If your auto code key is damaged or polluted, please contact your customer service to
proceed exchanging and installation.
- Do not remove the auto code key until it is malfunctioned.
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The Rightest GM700 meter kit comes with one CR2032, 3 volt, battery installed in the meter.
New battery will provide power to perform approximately 1000 tests with normal use. The low battery
symbol " " will appear on meter display if your battery runs low. Replace the battery as soon as
possible after the battery symbol appears.
2. Install the battery. Check to
make sure battery is in the
correct position.

4. The meter will then do an electronic test immediately. The screen will begin flashing as soon as the
battery is installed.
5. Press the Main button to close the electronic test of the meter, and enter the setting mode.
6. To set the time and date, see “Setting Up the Meter” chapter.
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Battery Installation
PRECAUTION
- Check to ensure the batteries are properly installed to decrease the danger of explosion.
- Replace only with the same or equivalent type of battery.
- Please follow the local regulation and discard a used battery properly.
NOTE
- When you keep pressing the main button for 3 seconds, the display on screen will turn off.
Please don't care it. Keep pressing the main button till entering setting data.
- Quick press the main button allows you to change setting. However, if you want to return to
the time mode, you need to go through all the settings first by pressing quickly the main
button.
Setting Up the Meter
You can enter the setting mode by below two ways:
1. Reload battery
After removing the battery, please press the main button for several times until no signal on screen,
then follow the battery installation steps to load battery. The meter will do self test. Press the main
button to exit the electronic test and enter Setting Mode.
2. With Battery inserted
Press the main button first to turn on the meter. Then press and hold the main button for 7 seconds
(the meter will be turned off during this period, please keep pressing) until you hear a beep,
indicating you have successfully entered Setting Mode. The display screen will show setting data.

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Setting Up the Meter
1. Year setting
With the year format blinking, press the Up or Down button until the current
year appears. Then press the Main button to confirm it and move to Month
setting.
2. Month setting
With the month blinking, press the Up or Down button until the current month
appears. Then press the Main button to confirm it and move to Day setting.
3. Day setting
With the day blinking, press the Up or Down button until the current day
appears. Then press the Main button to confirm it and move to Time format
setting.
1)
2)
3)
4a) 4b)
5) 6)
7a) 7b)
Setting Up the Meter
4. Time format 12/24H selection
With the time format blinking, press the Up or Down
button to adjust it. Then press the Main button to confirm
it and move to hour setting.
5. Hour setting
With the hour blinking, press the Up or Down button until
the current hour appears. Then press the Main button to
confirm it and move to minute setting.
6. Minute setting
With the minute blinking, press the Up or Down button
until current minute appears. Then press the Main button
to confirm it and move to volume setting.
7. Volume setting
With the volume blinking, press the Up or Down button to
turn it on or off. Then press the Main button to confirm
and move to measurement of unit setting.

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NOTE
- When you do not do any settings of meter for over 2 minutes, the meter will leave setting
mode and power off automatically.
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- Your Rightest GM700 Meter is ready to use at the first time. The meter default is set
according to your local preference.
Setting Up the Meter
1. How to turn on the Meter
Press the Main button or Insert a test strip.
2. Manual Power off
If you want to turn off the meter, please keep pressing the Main button for 3 seconds.
3. Auto Power off
The meter will power off automatically if you don't operate it over 2 minutes.
Turning On/Off the Meter
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”.)
8. Setting the Unit of Measurement
With milligrams per deciliter (mg/dL) or millimoles per liter
(mmol/L) blinking, press the Up or Down button to switch.
Then press the Main button to confirm it and finish the
settings.

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Function Screens and Button Operations
4. Non-Averaging set and canceled:
You may select the unwanted or doubtful test results, to exclude them from the average
calculation, after your every test.
After you finished your test in the test mode, you can exclude the unwanted result. Keep pressing
the Down button until you see the symbol “NO AVG” in the top left corner of the screen. By
keeping the Down button pressed and pressing the Main button simultaneously to confirm the
value as “Non average”. Now this value is flagged by the symbol “NO AVG” in the upper left corner
of the screen.
If you want to cancel this non-averaging setting, you have to stay in the test mode. First keep
pressing the Down button until the “NO AVG” symbol changes to “AVG” in the upper left corner of
the screen. To confirm this original status, you again simultaneously press the main button to
confirm the “AVG” status. Now the value will be stored as a regular value and included in the
average values.
Function Screens and Button Operations
Switching the Function Screens
1. Press the " " button to switch function screens including Memory, Average and Time in
sequence.
Memory Average Time
5. QUICK Searching:
If you want to see all values automatically displayed in sequence, first enter the memory mode.
Then keep pressing the Up or Down button for 2 seconds. (Up button is for searching the tests the
latest value to the oldest one; by using the Down button you can scroll from the oldest to the latest
one). Anytime you want to stop, just release the pressed button. It will stop and display the current
displayed value. You can use this way to find a particular reading you want to check.
2. Under the Memory function, press Up or Down button to search for stored testing data.
3. Under the Average function, press Up or Down button to search for average data of 1-day, 7-days,
14-days, 30-days, 60-days, and 90-days.

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Handling The Rightest GS700 Test Strip
Inserting the Test Strip:
1. Hold the test strip between thumb and middle finger with the indication
symbol facing upright.
2. Put the forefinger on the side of the test strip as shown.
NOTE
This is the most effective way to insert the strip.
3. Insert the test strip into the test strip port until it snaps firmly into place.
Removing the test strip:
1. Hold the test strip in the same position as inserted.
2. Rotate the test strip counterclockwise and pull up at the same time.
NOTE
Pulling the test strip in a counterclockwise direction will easily remove the
test strip from the meter.
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Handling The Rightest GS700 Test Strip
3. Take the test strip completely out of test strip port. Follow local regulations
and discard the used test strip accordingly.
NOTE
If directions are followed properly, the auto code key will not be
contaminated by the blood sample.

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Preparing for Testing
Before Performing a Blood Glucose test,
prepare the items below:
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- Rightest GM700 Meter
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(with Rightest GM700 Auto Code Key installed)
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- Rightest GS700 Test Strips.
(Check the expiration date on the vial. Do not use
expired test strips.)
- Approved Lancing Device
- Sterile Lancet
- Alcohol Swab (optional)
PlungerHubLancet carrier
Release button
Safe switch
Depth adjustable cap
Performing a Blood Test
1. Hold the adjustable cap in one hand and hold the
hub in the other hand. Bend the cap towards the down
side. When a gap appears between the cap and hub, pull
them off 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.
depth 1 2
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6. Choose a depth of penetration by rotating the top portion
of the depth adjustable cap until the setting depth matches
the window. Settings are based on skin type
" " for soft or thin skin;
" " for average skin;
" " for thick or calloused skin.

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30
Performing a Blood Test
7. Hold the hub in one hand and pull on the plunger in the
other hand. The device will be cocked. Release the plunger,
it will automatically move back to its original position near
the hub.
8. Wash your hands with warm soapy water and dry
thoroughly.
9. Take one strip from the vial. Re-cap the vial cap immediately.
10. Insert the strip into the strip port of the meter with the
indication symbol facing up. The meter confirms the
insertion of the strip with a beep (if volume is turned on).
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9
NOTE
The meter will automatically detect Code number on
strip. You don't have to check the Code number on the
meter display and strip vial.
10
11. A blood drop symbol appears and is accompanied by a
further beep (if volume is turned on). Now you can apply
the blood sample within 2 minutes.
12. Place the lancing device against your fingertip and press
the release button.
13. Touch and hold the drop to the edge of sample entry until
you hear a " beep " (if volume is turned on) and the View
Window is totally filled with blood. If the View Window is
not totally filled with blood or the test does not start,
please discard the test strip and repeat the test with a new
test strip.
14. You will see the countdown mode on the screen. After 5
seconds, the test result appears.
15. Pull off the depth adjustable cap. Without touching the
used disposable lancet, stick the lancet tip into the
protective cover.
16. Holding the release button in one hand I (see picture 16,
step 1) and pulling on the plunger in the other hand (see
picture 16, step 2) will safely eject the used disposable
lancet.
12
Performing a Blood Test
13a
14
13b
13c
15
1
2
16
11

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Performing a Blood Test
17. Discard the used disposable lancet into an appropriate
puncture-proof or biohazard container.
18. Replace the depth adjustable cap after finishing the test.
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PRECAUTION
- Do not apply your blood drop to the sample entry on the strip until you see the " appear. The
meter is performing an internal test and will display " " and if you apply blood too
soon. Please repeat the test with a new test strip.
- Record the date of opening a new test strip vial for the first time. Discard the vial
of test strips after 4 months from opening.
"
" "
- Always keep the metal contact points of the test strip entry point clean. If any dust
or impurities are present, please clean with a small soft brush, otherwise the meter
may not work correctly when you insert a test strip.
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Alternative Site Testing (AST)
Alternative site testing-palm or forearm blood sampling
Pressing for
a few seconds
Releasing
button
1. Choose Clear Cap and follow step 1~5 on page 29.
2. Massage the puncture area of palm or forearm for a few
seconds.
3.
Clear Cap
4. Then press the release button.
5. Continue holding the lancing device against palm or
forearm and gradually increase pressure for a few seconds
until the blood sample size is sufficient.
6.
Immediately after massaging the puncture area, press and
hold the lancing device with the against palm or
forearm.
Follow step 9~18 on page 30~32 to complete the test and
discard the used disposable lancet.
3a) 3b)
4) 5)
Palm
Forearm

Alternative Site Testing (AST) 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 Enough blood sample
PRECAUTION
- 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 from the vial.
- Do not reuse test strips.
- If moving to a location with a different ambient temperature, wait at least 30 minutes before
testing.
- Apply the blood drop only on the sample entry 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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PRECAUTION
- DO NOT test on the palm or forearm if you are testing for hypoglycemia (Low blood
glucose).
- Fingertip samples can show the rapid change of glucose faster than palm or forearm
samples.
- As the blood flow taken from forearm is slower than fingertip or palm, we recommend using
the GD500 lancing device with Clear Cap for testing sites other than fingertip.
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View Window appearance Comprehending Test Results and Messages
Blood glucose test results are shown on the meters as your preset measurement unit.
If obtained blood glucose results are unusually high or low or results are of a questionable nature,
repeat the test with a new test strip.
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If problems or questions persist, run a Quality Control Test with the Rightest Control Solutions
GC700.
If the test result still remains unusually high or low, contact a healthcare professional immediately.
If experiencing symptoms that are not consistent with blood glucose test results, and directions have
been followed properly, contact a healthcare professional immediately.
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PRECAUTION
- Place the blood sample only to the sample entry of the test strip.
- Keep the Auto Code Key dry and clean. If excessive sample is obtained, clean the Auto Code
Key immediately to prevent contamination.
- Pose the finger and the test strip in a comfortable position.
- Follow local regulations and discard the used test strip and lancet properly.
- If the meter is idle for over a 2 minute span, it will automatically power off. Manual power
down can be achieved by pressing the Main button for 3 seconds.