BIONIME RIGHTEST GT333 User manual

101-3GM236-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
GT333
Rev. Date: 2019-10
Blood Glucose Monitoring System
143x100mm
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]
0197

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PrefacePreface
Thank you for selecting RIGHTEST GT333 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 RIGHTEST GT333 Blood Glucose Monitoring
System provides accurate, reliable test results to help you better manage your diabetes.
RIGHTEST GT333 Blood Glucose Monitoring System is perfect for both self-testing and professional
use. Designed for in vitro diagnostic use only, testing requires just a small amount of fresh capillary
whole blood from either the fingertip, palm or forearm.
RIGHTEST GT333 Blood Glucose Monitoring System is intended for self testing outside the body
( in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of
diabetes control. RIGHTEST GT333 Blood Glucose Monitoring System should not be used for the
diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done
only during steady - state times (when glucose is not changing rapidly).
RIGHTEST GT333 Blood Glucose Monitoring System is manufactured and supported by Bionime
Corporation. If you have any questions or concerns, please contact with your local distributor or
visit our website at www.bionime.com. We will make every effort to assist you.
Please contact with your healthcare professionals while you feel seriously ill or customer service is
not available.
Please forward your warranty card to RIGHTEST Diabetes Customer Support Center.

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Caution Caution
Sample Size Example 0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL
- Before using RIGHTEST Blood Glucose Monitoring System to test your blood glucose, please
read all of the instructions.
- Please perform the quality control test regularly to make sure the test results are accurate.
- RIGHTEST GT333 Blood Glucose Meter can only be used with RIGHTEST GT333 Blood Glucose
Test strip and RIGHTEST GC570 Control Solution. Other product should not be used under any
circumstances. The use of other test strips may give inaccurate results.
- RIGHTEST Blood Glucose Monitoring System is intended for in vitro diagnostic use only.
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.
- RIGHTEST Blood Glucose Monitoring System is intended for self-testing. It should not be used to
screen for or diagnose diabetes mellitus.
- If RIGHTEST Blood Glucose Meter and Test Strips are exposed to a substantial change in
temperature, please wait 45 minutes before measurement.
- Follow all environmental protection regulations when disposing of batteries.
- RIGHTEST Blood Glucose Monitoring System is not for use on neonates and should not be used
in the critically ill.
- A proven clinical laboratory method employing hexokinase or glucose oxidase should be used as
the comparative method.
- Healthcare professionals should evaluate their technique and their patients' technique regarding
the use of the RIGHTEST Blood Glucose Monitoring System regularly. To accomplish this, it is
recommended that blood glucose monitoring results be compared with a concurrently obtained
laboratory measurement on the same blood sample.
- The range of blood sample size please refer to strip insert.
Too much blood might contaminate the test strip port and the meter. Too little blood may cause an
error or may prevent a meter reading.
Important Safety Notes:
- RIGHTEST Blood Glucose Meter and Lancing Device are for single patient use.
Do not share them with anyone including other family members.
- All parts of the kit are considered biohazardous and can potentially transmit infectious
diseases, even after following the Maintain the Products. Please refer to the section
"Maintain the Products".
- Users should wash their hands thoroughly with soap and water before and after handling
the meter, lancing device, or test strips.

- Blood glucose meter readings may be significantly lower than "true glucose levels" in a
hyperglycemic hyperosmolar state, with or without ketosis.
- Caution is advised when glucose values are below 50 mg/dL or above 250 mg/dL. Consult a
Physician as soon as possible, if values in this range are obtained.
- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated
results.
- Storage of strips near bleach as well as bleach containing products will affect the results of
RIGHTEST Blood Glucose Test strip.
- Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3,048 meters) above
sea level.
- Do not perform the blood glucose test at temperatures below 10°C(50°F) or above 40°C(104°F),
nor below 10% or above 90% relative humidity.
- To avoid potential electromagnetic or other interference, keep meter away from electromagnetic
radiation sources such as X-ray or MRI.
- For interfered substances (e.g. Hematocrit range, interference) please refer to strip insert.
- Patients going through oxygen therapy may yield falsely low results.
- RIGHTEST Blood Glucose Test strip are designed for use with capillary whole blood samples. Do
not use serum or plasma samples.
Limitation
- Not for screening or diagnosis of diabetes mellitus.
- Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-
osmolar patients.
- Not for neonatal use.
- DO NOT test on alternative site (palm, forearm) if you are testing for insulin dose
calculations or for Continuous Glucose Monitoring (CGM) devices calibration, or
hypoglycemia (Low blood glucose).
- Alternate site testing should only be done during steady-state times (when glucose is not
changing rapidly).
Limitation
76

RIGHTEST GT333 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....................................................................................................................
Bluetooth function................................................................................................................................
Auto Code / Detecting Limit................................................................................................................
Handling RIGHTEST GT333 Blood Glucose Test strip........................................................................
Testing Procedure
Getting Ready for Testing....................................................................................................................
Performing a Blood Glucose Test........................................................................................................
Setting Markers....................................................................................................................................
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..........................................................................................................
Caring for Your Meter
Maintain the Products........................................................................................................................
Error Messages and Troubleshooting................................................................................................
Rightest CARE App............................................................................................................................
Specifications.....................................................................................................................................
Warranty..............................................................................................................................................
Customer Service...............................................................................................................................
Expected Blood Glucose Values Without Diabetes...........................................................................
Component Manufacturer Information...............................................................................................
Table of Contents Table of Contents
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GT33 3
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RIGHTEST Blood Glucose Monitoring System
Contents
Your RIGHTEST GT333 Blood Glucose Monitoring System consists of several items. Please
identify each item, learn its name and how it is used.
Below are the items included in your RIGHTEST Blood Glucose Monitoring System:
1. RIGHTEST GT333 Blood Glucose Monitoring System (with 2 AAA batteries installed)
2. User's Manual (includes Log Book, Warranty Card, Emergency Card) ＊
3. RIGHTEST GT333 Blood Glucose Test strip Package Insert ＊
4. RIGHTEST Control Solution GC570 Package Insert ＊
5. Getting Started Guide ＊
6. RIGHTEST GT333 Blood Glucose Test strip (10/25 pcs)＊
7. RIGHTEST Control Solution GC570 ＊
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) ＊
(＊Different packages have different bundled items. Some of packages might not include＊items.)
RIGHTEST Blood Glucose Monitoring System
12

13
12
Left Button ( )
Main Button ( )
Display Window
Test Strip Port
Right Button ( )
Battery Cover
Meter label
Meter Battery
RIGHTEST Blood Glucose Meter RIGHTEST Blood Glucose Meter

14 15
Indicates a test result stored in memory
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 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
Appears after you insert test strip into meter
Indicates a meal marker with test result
Indicates that the Bluetooth is turned on

17
16
RIGHTEST GT333 Blood Glucose Meter can only be used with RIGHTEST GT333 Blood Glucose
Test strip and RIGHTEST Control Solution GC570. 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.
Indication Symbol
insert strip with indication
symbol up and toward meter.
View Window
PRECAUTION
- Close RIGHTEST Blood Glucose Test strip vial immediately after removing a test strip.
- Do not reuse RIGHTEST Blood Glucose Test strip.
- Do not use expired RIGHTEST Blood Glucose Test strip.
- When you open a new vial of RIGHTEST Blood Glucose Test strip, record the date on the
vial.
- Store RIGHTEST Blood Glucose Test strip between 4-30°C (or 39-86°F) and in a location
with 10-90% relative humidity. Do not expose to direct sunlight or heat.
- If RIGHTEST Blood Glucose Meter and Test Strips are exposed to a substantial change in
temperature, please wait 45 minutes before measurement.
- For detailed information, please refer to RIGHTEST GT333 Blood Glucose Test strip
Package Insert.
Electrode Contacts
RIGHTEST Blood Glucose Test strip

18 19
Meter Activation and Battery Change Meter Activation and Battery Change
Your RIGHTEST Blood Glucose Meter comes with 2 AAA batteries installed. New batteries will
provide power to perform approximately 1000 tests under normal use with one data transfer. Press
the main button or insert a strip to activate your meter.
1. Turn RIGHTEST Blood Glucose
Meter over. Press and slide the
battery cover to open.
3. Slide the battery cover
back until it snaps into
place.
2. Install the batteries.
Be sure to put the batteries
in the correct direction.
CAUTION
- Please follow the local regulation to properly discard a used battery.
- Risk of explosion if battery is replaced by an incorrect type.
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". Test results are still stored in the memory.

20 21
Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Date, Time and Volume
1)
2)
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.
You can enter the Setting Mode two ways.
1. Replace the Battery
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.
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.

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Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Date, Time and Volume
5)
6)
4a) 4b) 7a) 7b)
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.
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.
NOTE
- If you do not change any settings during Meter Set-up for over 2 minutes, RIGHTEST
Blood Glucose Meter will leave setting mode and power off automatically.
- The meter default is set according to your local preference, if you have problem with it
call customer service.
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.
8a) 8b)

24 25
Turning On / Off the Meter
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 3 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.
Bluetooth function
Bluetooth default is with " " symbol when mobile App turn on, it will automatically
connect with your mobile device after user finished the pairing. Once connected
with the App, test results will start syncing with the connected mobile device. When
the sync is completed, the meter Bluetooth will disconnect automatically.
2) Data uploading.
The RIGHTEST Blood Glucose Meter is now
uploading test results to your mobile device.
1) Bluetooth pairing.
The symbol of Bluetooth
" " appears.

Auto Code / Detecting Limit
Bluetooth function
NOTE
1. The meter will automatically turn off the Bluetooth after all the blood glucose readings
have synced. In this case, the " " icon will disappear on the screen.
2. Animated " " symbol on the screen means the meter is transferring data.
3. No suggest to test blood sugar when the flight is strictly restrict the Bluetooth
connection. Please turn off you meter to avoid the auto-on of Bluetooth.
4. When the meter and App cannot connect to each other successfully, please reboot the
Bluetooth on both sides and try again.
If the issues still exist, please contact your local distributors
for further assistance.
12
Detecting Limit
RIGHTEST Blood Glucose Meter 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.
Auto code9.
1) 2)
Auto code
Auto Code
The RIGHTEST Blood Glucose Meter will automatically
detect the Code number on the strip. You do not have to
manually change the Code key or adjust the code number.
26 27

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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.
1
2
3
Handling RIGHTEST Blood Glucose Test strip
Removing RIGHTEST Blood Glucose Test strip:
1. Hold RIGHTEST Blood Glucose Test strip as shown.
2. Rotate RIGHTEST Blood Glucose Test strip counterclockwise and pull
up simultaneously.
3. Take RIGHTEST Blood Glucose Test strip out of the test strip port.
Please follow your healthcare professional's instructions and discard
used strips properly.
3
1
2
Rotate
Handling RIGHTEST Blood Glucose Test strip

30 31
Getting Ready for Testing
PlungerHub
Lancet carrier
Release button
Depth adjustable cap
Performing a Blood Glucose Test
12
3 4
56
Before performing a blood glucose test, prepare the
items below :
- RIGHTEST GT333 Blood Glucose Meter
- RIGHTEST GT333 Blood Glucose Test strip
(Please check the expiration date on the test strip
vial. Do not use expired test strips)
- RIGHTEST Lancing device
- Sterile lancet
- Alcohol swab (optional)
1. Hold the adjustable depth cap in one hand while
holding the hub in the other hand. Lift the cap until a
gap appears between the cap and hub.
2. Pull the two parts in opposite directions to remove
the adjustable depth 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. The adjustable cap with 7 depth levels allows you to
select the depth of penetration by rotating the cap
until the preferable depth display in the window.
Settings are based on skin type " " for soft or thin
skin; " " for average skin; " " for thick or
calloused skin.

Performing a Blood Glucose Test
32 33
Performing a Blood Glucose Test
13
78
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 RIGHTEST Blood Glucose Test strip from the
vial. Close the vial cap immediately.
10. Insert the strip into the test strip port of 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).
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.
9 10
11
12. After inserting a test strip, the " " icon will flash on
the screen. Pressing the Left or Right button to choose
between the " " (before meal), " " (after meal) and
" " (no marker) and then apply the blood sample
within 2 minutes (The meter will record the marker when
you apply a drop of blood).
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.
12
15
14b
14a
14c

CAUTION
- Do not apply your blood drop to the sample port on the strip until you see the " " appear.
RIGHTEST 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.
- 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.
- RIGHTEST Blood Glucose Monitoring System and RIGHTEST Lancing
Device 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 "Maintain the Products" for cleaning and disinfecting instructions.
34
Performing a Blood Glucose Test Performing a Blood Glucose Test
35
18
16
12
19
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.
17

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. Before test, the test result is displayed on the screen with time, date and flashing " ".
2. Press the Right or Left button to choose among " " (no marker), " " (before meal),
" " (after meal) apply a drop of blood and the system will automatically record the marker.
Before meal:You execute this blood glucose test before a meal.
After meal:You execute this blood glucose test after a meal.
NOTE
If markers has disappeared or not properly displayed, please contact your local distributor.
(Blank) no marker:regular test or definition by user.
Alternative Site Testing
Palm
Forearm
Pressing for
a few seconds
Releasing
button
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 manual for 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. (DO
NOT test on the palm or forearm if you are testing for hypoglycemia (Low blood
glucose).
36 37