Rightest GT200 User manual

101-3GM750-XXX EN
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]om
Made in Taiwan
User’s Manual
GT200
Rev. Date: 2019-10
Blood Glucose Monitoring System
143x100mm
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]
0197

32
PrefacePreface
RIGHTEST GT200 Blood Glucose Monitoring System is a personal blood glucose monitoring system
to be used for self-testing only. It is not recommended for multiple users.
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.
Thank you for selecting Blood Glucose Monitoring System. This manual provides RIGHTEST GT200
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 RIGHTEST GT200
Monitoring System provides accurate, reliable test results to help you better manage your diabetes.
RIGHTEST GT200 in vitro Blood Glucose Monitoring System is designed for 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.
The testing result is calibrated to be plasma equivalent for test with fresh capillary, venous, arterial
and neonatal whole blood samples.
RIGHTEST GT200 Blood Glucose Monitoring System is manufactured and supported by Bionime
Corporation. If you have any questions or concerns, please contact your local Bionime Customer
Service or email to [email protected] .

54
Caution Caution
- Before using the Blood Glucose Monitoring System to test your blood glucose, please RIGHTEST
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.
- Blood Glucose Meter can only be used with Blood Glucose RIGHTEST GT200 RIGHTEST GT200
Test Strips. Other brands’ test strips should not be used under any circumstances. The use of
other brands’ strips may give inaccurate results.
- Blood Glucose Monitoring System is intended for in vitro diagnostic use only. RIGHTEST
RIGHTEST 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.
- Blood Glucose Monitoring System is intended for self-testing. It should not be used to RIGHTEST
diagnose diabetes mellitus.
- Wait to test at least 30 minutes after entering another location of a different ambient temperature.
- Follow all environmental protection regulations when disposing of batteries.
- 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.
- 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, 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 (galactosemia), the glucose result should
based on laboratory test.
- The minimum blood sample size to test using RIGHTEST Blood Glucose Monitoring System is
0.75 µL: ( )
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 will be displayed if the sample size is too small. In this case, repeat the test with a new test strip.
Sample Size Example 0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL

76
About RIGHTEST Blood Glucose Monitoring System
RIGHTEST Blood Glucose Monitoring System...................................................................................
RIGHTEST Blood Glucose Meter.........................................................................................................
RIGHTEST 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....................................................................................................................
Turning On / Off the Backlight..............................................................................................................
Handling RIGHTEST Blood Glucose Test Strip..................................................................................
Testing Procedure
Getting Ready for Testing....................................................................................................................
Performing a Blood Glucose Test........................................................................................................
Alternative Site Testing........................................................................................................................
View Window Appearance..................................................................................................................
Understanding Test Results and Messages.......................................................................................
Quality Control
About Quality Control Testing.............................................................................................................
Performing a Quality Control Test.......................................................................................................
Understanding Control Test Results..................................................................................................
Test Memory
Recalling Test Results........................................................................................................................
Recalling Average Test Results..........................................................................................................
Maintain the Products........................................................................................................................
Error Messages and Troubleshooting................................................................................................
Limitations..........................................................................................................................................
Specifications.....................................................................................................................................
Warranty..............................................................................................................................................
Customer Service...............................................................................................................................
Expected Blood Glucose Values Without Diabetes...........................................................................
Component Manufacturer Information...............................................................................................
Table of Contents Table of Contents
8
10
14
16
18
22
23
24
26
27
32
34
35
37
40
42
43
44
46
51
54
55
57
58
59
60

9
8
Contents
Your Blood Glucose Monitoring System consists of several items. Please identify each RIGHTEST
item, learn its name and how it is used.
Below are the items included in your Blood Glucose Monitoring System: RIGHTEST
1. Getting Started Guide
2. User's Manual (includes Log Book, Warranty Card, Emergency Card )
3. Blood Glucose Test Strip Package InsertRIGHTEST GT200 ＊
4. Package Insert RIGHTEST Control Solution GC700 ＊
5. Blood Glucose Meter ( with 2 CR2032 batteries installed )RIGHTEST GT200
6. Blood Glucose Test strips ( 10/25 pcs )RIGHTEST GT200 ＊
7. Level 2 is provided in your starter kitRIGHTEST Control Solution GC700 ＊( )
8. Lancing Device ＊
9. Clear Cap ＊
10. Disposable Sterile Lancets ( 10 pcs ) ＊
11. Carrying Case ( not shown ) ＊
12. Instruction for the lancing device ( not shown )＊
( Different packages have different bundled items. Some of packages might not include items.)＊ ＊
RIGHTEST Blood Glucose Monitoring SystemRIGHTEST Blood Glucose Monitoring System
2 3＊1
4＊
5
6＊ 7＊ 8＊
9＊
10＊

11
10
RIGHTEST Blood Glucose Meter RIGHTEST Blood Glucose Meter
Left Button ( )
Main Button ( )
Display Window
Test Strip Port
Right Button ( )
Battery Cover
Meter Label
Backlight
Battery
Meter Battery
+
+

12 13
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
test strip
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 under time mode or
testing time under memory mode
Manufacturing use only
RIGHTEST Blood Glucose Meter RIGHTEST Blood Glucose Meter

15
14
RIGHTEST GT200 RIGHTEST GT200 Blood Glucose Meter can only be used with Blood Glucose
Test Strips and .RIGHTEST Control Solution GC700
The use of other test strips or control solutions can lead to incorrect results.
RIGHTEST Blood Glucose Test Strip
Hold here to
insert test strip
into meter.
Sample Port
Apply blood/control solution here.
Noble Metal Electrodes
Electrochemical sensor
View Window
Electrode Contacts
RIGHTEST Blood Glucose Test Strip
PRECAUTION
- Close the RIGHTEST Blood Glucose Test Strip vial immediately after removing a test strip.
- Do not reuse RIGHTEST Blood Glucose Test Strips.
- Do not use expired RIGHTEST Blood Glucose Test Strips.
- Use each test strip immediately after removing from the vial.
- For detailed information as validity period after open and storage environment, please
refer to RIGHTEST Test Strips Insert.

16 17
Meter Activation and Battery Change Meter Activation and Battery Change
1. Turn the RIGHTEST Blood
Glucose Meter over. Press
and slide the battery cover
to open.
3. Put the battery cover
back until it snaps into
place.
2. Install the batteries. Be sure
to put the batteries in the
correct direction (polarity (+)
facing up).
Your RIGHTEST Blood Glucose Meter comes with 2 CR2032, 3 volt, batteries installed. 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.
PRECAUTION
- Please follow the local regulation to properly discard a used battery.
4. RIGHTEST Blood Glucose Meter 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.
NOTE
For some meter please pull off the plastic tape and press the main button to activate the
meter.

18 19
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.
Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Date, Time and Volume
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. 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. 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.
1)
2)
3)
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. RIGHTEST Blood Glucose Meter 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 RIGHTEST 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.

20 21
Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up 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.
5)
6)
4a) 4b)
NOTE
- If you do no change any settings during Meter Set-up for over 2 minutes,
RIGHTEST Blood Glucose Meter will leave setting mode and power off
automatically.
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)

22 23
1. How to turn on RIGHTEST Blood Glucose Meter
Press the Main button or Insert a test strip.
2. Manual Power off
To power off RIGHTEST Blood Glucose Meter, press and hold the Main button for 4 seconds.
3. Auto Power off
RIGHTEST 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 Turning On / Off the Backlight
1. Turn on the backlight
Press and hold the Main button for 2 seconds.
2. Manually turn off the backlight
With the backlight on, press and hold the Main button for another 2 seconds.
3. Auto shutoff
RIGHTEST Blood Glucose Meter backlight will turn off automatically after 10 seconds if no
buttons are pressed.

24 25
Handling RIGHTEST Blood Glucose Test Strip
1
2
3
How to handle RIGHTEST Blood Glucose Test Strip.
Inserting RIGHTEST Blood Glucose Test Strip:
1. Hold RIGHTEST 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.
3. Insert RIGHTEST Blood Glucose Test Strip into test strip port until it clicks and
firmly stops.
Handling RIGHTEST Blood Glucose Test Strip
Removing the RIGHTEST Blood Glucose Test Strip:
1. Hold the RIGHTEST Blood Glucose Test Strip as shown.
2. Rotate the RIGHTEST Blood Glucose Test Strip counterclockwise and pull
up simultaneously.
3. Take the RIGHTEST Blood Glucose Test Strip out of the test strip port.
Please follow your local regulations and discard used strips properly.
1
2
3
Rotate

26 27
Getting Ready for Testing
PlungerHub
Lancet carrier
Release button
Depth adjustable cap
Before performing a blood glucose test, prepare the
items below :
- RIGHTEST Blood Glucose Meter
- RIGHTEST Blood Glucose Test Strips
(Please check the expiration date on the test strip
vial. Do not use expired test strips)
- RIGHTEST Lancing device
- Sterile lancet
- Alcohol swab (optional)
Performing a Blood Glucose Test
1. Hold the depth adjustable cap in one hand and hold the
hub in the other hand. Bend the cap towards the down
side, until a gap appears between the cap and hub.
2. Pull the cap and hub off in opposite directions, remove
the 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
28 29
Performing a Blood Glucose Test
13
15
14b
12
14a
14c
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 RIGHTEST Blood
Glucose Test Strip.
15. Countdown Mode will begin on the display window. After
5 seconds, your test result will appear.
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 hub.
8. Wash your hands with warm soapy water and dry
thoroughly.
9. Take one RIGHTEST Blood Glucose Test Strip from the
vial. Close the vial cap immediately.
10. Insert the strip into the test strip port of the RIGHTEST
Blood Glucose Meter 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
- RIGHTEST Blood Glucose Meter will automatically
detect the Code number on the strip. You do not have
to check the Code number on the meter display and
strip vial.
11
10
9

30
Performing a Blood Glucose Test Performing a Blood Glucose Test
31
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 17
19
CAUTION
- Do not apply your blood drop to the sample port on the strip until you see the " " appear.
The screen will display " " and " " if you apply blood too soon. If this occurs, please
use a new test strip to test.
- Record the opening date of a new test strip vial. Discard the vial of test
strips 12 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.
- 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 "Maintain the Products" for more cleaning information.
12

32 33
Alternative Site Testing Alternative Site Testing
CAUTION
- Fingertip samples can show the rapid change in glucose faster than palm or forearm
samples.
- Test results may vary when user's glucose level is changing rapidly after condition as:
drinking, eating, insulin dosing 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).
- Consult your healthcare professional before sampling from your palm or forearm.
- As the blood flow taken from forearm is slower than fingertip or palm, we recommend
using the RIGHTEST lancing device with Clear Cap for testing sites other than fingertip.
- Periodically compare the test system to a laboratory test system that is known to be well
maintained and monitored by a healthcare provider.
Alternative site testing: palm or forearm blood sampling
- To perform alternative site testing, install the clear cap for your RIGHTEST
Lancing Device.(For detailed information, refer to the instruction for the
RIGHTEST Lancing Device.)
- 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.
- 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. See
caution before alternative site testing.
Palm
Forearm
Pressing for
a few seconds
Releasing
button

34 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. 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.
- 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.
Blood glucose test results are shown on Blood Glucose Meter as mg/dL or mmol/L.RIGHTEST
If your blood glucose result is unusually high or low, or if you question your test results, repeat the
test with a new Blood Glucose Test Strip.RIGHTEST
You can also run a Quality Control Test with the to check your RIGHTEST Control Solutions GC700
RIGHTEST GT200 RIGHTEST GT200 Blood Glucose 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 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
36
Understanding Test Results and Messages About Quality Control Testing
RIGHTEST Blood Glucose Meter displays results between 10 and
600 mg/dL (0.6 and 33.3 mmol/L).
If the test result is below 10 mg/dL (0.6 mmol/L) , " " 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 (33.3 mmol/L), " " 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.
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 RIGHTEST Control Solutions when testing your RIGHTEST Blood Glucose
Monitoring System in the Control Solution Mode. If the test result is within the Control Solution
Range printed on the strip vial label, RIGHTEST Blood Glucose Monitoring System passes the
Quality Control Test and your RIGHTEST Blood Glucose Monitoring System is working properly.
Control Solution Range:
Example of Control Solution Range printed on your test strip vial label.
NOTE
- If you want to purchase new control solutions, please contact your local Bionime distributor
or email to [email protected] .
Level 1
Level 2
Level 4
Control Solution Range mg/dL
Normal (Level2): 88 - 120 mg /dL
Hing (Level4): 250 - 340 mg/dL
mmol/L
4.9 - 6.7 mmol/L
13.9 - 18.9 mmol/L