BIONIME Rightest ALPHA User manual

101-3GM551-060 EN
Rev. Date: 2021-06
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Email: EmergoVig[email protected]
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
Email: [email protected]om
http://www.bionime.com
Made in Taiwan
User’s Manual
ALPHA
Blood Glucose Monitoring System

Thank you for choosing the RIGHTEST ALPHA Blood Glucose Monitoring System. Please read this
manual thoroughly before testing. It provides all information you need to use the product.
The RIGHTEST ALPHA Blood Glucose Meter must only be used with RIGHTEST ALPHA Blood
Glucose Test Strip and RIGHTEST Control Solution. The application of other Test Strips or control
solutions can lead to incorrect results.
We hereafter call RIGHTEST ALPHA Blood Glucose Meter as RIGHTEST ALPHA Meter, and
RIGHTEST ALPHA Blood Glucose Test Strip as RIGHTEST ALPHA Test Strip for short.
It is recommended to monitor blood glucose regularly. RIGHTEST ALPHA Blood Glucose Monitoring
System is accurate and easy-to-use and is thus your reliable assitant for diabetes management.
RIGHTEST ALPHA Blood Glucose Monitoring System is manufactured and supported by Bionime
Corporation. If you have any question or concern, please contact your local Bionime Customer
Service or email to [email protected].
The RIGHTEST ALPHA Blood Glucose Monitoring System is designed for in vitro diagnostic (for
testing outside the body) use only and can be used by home user and healthcare professional.
The system can test glucose concentration in fresh capillary whole blood (drawn from fingertip, palm
and forearm). The glucose result displayed is calibrated into the plasma glucose testing equivalent.
The system is not intended for screening or diagnoses of diabetes mellitus.
Preface
32
Intended Use

- Before using RIGHTEST ALPHA Blood Glucose Monitoring System to test your blood glucose,
please read all of the info and conduct all of the tests including the quality control test.
- We recommended you to perform the quality control test regularly to ensure the test results are
accurate.
- The RIGHTEST ALPHA Meter can only be used with RIGHTEST ALPHA Test Strip. Other brands' test
strips should not be used under any circumstances. The use of other brands' strips may give
inaccurate results.
- If RIGHTEST Meter and Test Strips are exposed to temperature environments out of range for the
meter – below 10°C (50°F) or above 40°C (104°F) – please wait at least 30 minutes before testing
again.
- Follow all environmental protection regulations when disposing of batteries, strips and lancets.
- RIGHTEST Blood Glucose Monitoring System has not been validated for use on neonates. DO NOT
use it test for neonates.
- RIGHTEST Blood Glucose Monitoring System is NOT intended for arterial blood testing.
- Avoid contact with dripping or splashing liquids.
- Once patient is suspected as rare disease (e.g. galactosemia), the glucose result should basedon
laboratory test.
54
Caution Caution
- The minimum blood sample size for testing 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 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 0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL
Important Safety Notes
- All parts of the kit are considered biohazardous and can potentially transmit infectious
diseases, even after following the cleaning and disinfecting procedures. Please refer to the
section "Maintain the products" on page 35.
- Users should wash their hands thoroughly with soap and water before and after handling the
meter, lancing device, or test strips.

76
About RIGHTEST ALPHA System
RIGHTEST ALPHA Blood Glucose Monitoring System
RIGHTEST ALPHA Meter
RIGHTEST ALPHA Test Strip
Table of Contents Table of Contents
16
18
22
8
10
14
Being Ready for Test
Meter activation and Battery change
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit
Turning On / Off the Meter
Testing Procedure
Performing a Blood Test
Alternative Site Testing (AST)
View window appearance
23
27
29
Quality Control Test 31
Quality Control
"Lo" and "Hi" readings
Error Messages and Trouble Shooting
Specification
Limitations
Customer Service
Warranty
42
46
48
49
50
Review Your Test Memory
Performing a Quality Control Test
Maintain the products
Recalling Test Result and Average
33
39
35
30

98
7＊
32
4＊
1
5＊ 6＊
RIGHTEST ALPHA Blood Glucose Monitoring System
Your RIGHTEST ALPHA Blood Glucose Monitoring System consists of several items. Please identify
each item and make sure you understand how to use them.
The following items are included in your RIGHTEST ALPHA Blood Glucose Monitoring System:
1. RIGHTEST ALPHA Blood Glucose Meter (with 1 CR2032 battery installed)
2. Instruction documents (Getting Started and User's Manual (includes Log Book, Warranty Card,
Emergency Card))
3. RIGHTEST ALPHA Blood Glucose Test strips (10/25 pcs)(with Insert)＊
4. RIGHTEST Control Solution GC570 (with Insert) ＊
5. RIGHTEST Lancing Device GD500 (with Insert) ＊
6. Clear Cap ＊
7. Disposable Sterile Lancets (10 pcs) ＊
8. Carrying Case (not shown)＊
(＊Different packages have different bundled items. Some of packages might not include＊items.)
RIGHTEST ALPHA Blood Glucose Monitoring System

1110
Left Button ( )
For operating the meter, please
check details in following sections.
Main Button ( )
For operating the meter, please
check details in following sections.
RIGHTEST ALPHA Meter
Display Window
Show your test result, messages
and relative information.
Test Strip Port
Insert test strip here until you hear a
click.
Right Button ( )
For operating the meter, please
check details in following sections.
Battery Cover
Slide cover to change
batteries.
Meter Label
RIGHTEST ALPHA Meter
Meter Battery
Do not put
battery here.

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
Test strip
Indicate error happens
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 under time mode or Testing time
under memory mode
Manufacturing use only
RIGHTEST ALPHA Meter RIGHTEST ALPHA Meter

1514
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 meter.
Sample Entry
Apply a drop of blood or control solution here.
The test request is only 0.75 of blood. µL
Electrode Contacts
Sensing signal output terminals.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
The RIGHTEST ALPHA Meter must only be used with RIGHTEST ALPHA Test Strip and RIGHTEST
Control Solution.
The application of other Test Strips or control solutions can lead to incorrect results.
PRECAUTION
- Close the test strip vial immediately after taking out a test strip.
- Do not reuse test strips. Test strip can be only used once.
- Do not use expired test strips.
- Every time when you open a new vial of test strips, please write the opening date on the
label. Use test strips within 3 months after opened or until the expiration date printed on the
label (whichever comes first).
- Store the test strips in 4 - 30°C (39 - 86°F) and with 10 - 90% relative humidity. Do not
expose to direct sunlight or heat.
- For detailed information, please refer to the RIGHTEST ALPHA Test Strip Insert.
- If the RIGHTEST ALPHA Meter or strips are exposed to a substantial change in temperature.
please wait at least 30 minutes before testing again.
RIGHTEST ALPHA Test Strip RIGHTEST ALPHA Test Strip

1716
Meter activation and Battery Change
1. Turn the meter over.
Press and push battery
cover to open.
PRECAUTION
- Please follow the local regulations and discard a used battery properly.
4. The meter performs a self test.
5. Press any button to exit the self-test and enter Setting Mode.
6. Set the time and date when the batteries are replaced. See Chapter "Setting up your meter -
setting the time, volume and date". Test results are still stored in the memory.
3. Slide the battery cover
back until it snaps into
place.
2. Install the battery. Be sure
to put battery in correct way
with the "+" symbol up.
Meter activation and Battery change
Your meter comes with 1 CR2032, 3 volt, batteries installed. A new batteries will provide power to
perform about 1,000 tests under normal use. You can press the main button or insert a strip to
activate your meter.

1918
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.
You can enter 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 batteries. The meter will do self test. Press
the main button to exit the self 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 first show backlight, then 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.
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit Setting Up Your Meter- Setting the Time Date, Volume and Test Unit
1. Year setting
With the year format blinking, press the Left or Right button to adjust it. Then
press the Main button to confirm it. Then it will move to Month setting.
2. Month setting
With the month blinking, press the Left or Right 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 Left or Right button until the current day
appears. Then press the Main button to confirm it and move to Time format
setting.
1)
2)
3)

2120
4. Time format 12/24H selection
With the time format blinking, press the Left or Right 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 Left or Right 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 Left or Right button to
adjust it. Then press the Main button to confirm it.
Meantime, it will shift to next digit for setting.Then it will
move to volume setting.
7. Volume setting
With the volume blinking, press the Left or Right button to
turn it on or off. Then press the Main button to confirm and
finish the setting.
NOTE
- When the meter is idle for more than 2 minutes, the meter will leave setting mode and power
off automatically.
9. Ending setting
After test 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 of Test Unit
With milligrams per deciliter (mg/dL) or millimole 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 (*According to different regulations in different
countries/regions, the unit of the meter may be fixed at
mg/dL or mmol/L and cannot be changed. In this case,
please skip this step and go directly to the next step).
4a) 4b)
5) 6)
7a) 7b)
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit Setting Up Your Meter- Setting the Time Date, Volume and Test Unit

2322
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 4 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
Hub
Lancet carrier
Plunger
Release button
Depth adjustable cap
1. Wash your hand with warm soapy water and dry thoroughly.
2. 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.
3. Pull the cap and hub off in opposite directions, remove the
cap.
4. Insert a new disposable lancet firmly into lancet carrier.
5. Twist off and set aside the protective cover of the disposable
lancet.
6. Replace the depth adjustable cap.
21
3 4
5 6
Performing a Blood Test

2524
Performing a Blood Test
78
7. 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.
8. 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.
9. Take one strip from the vial. Close the vial cap immediately.
10. Insert the strip into the strip port of the meter with the view
window facing up. The meter confirms the insertion of the
strip with a beep (if volume is turned on).
9 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 filled with blood. If the View Window is not
completely filled with blood, the test will 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.
12
Performing a Blood Test
11
13a
14
13b
13c

27
26
Performing a Blood Test
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.
17. Discard the used disposable lancet into an appropriate puncture-
proof or biohazard container.
18. Replace the depth adjustable cap after finishing the test.
17
15
1
2
16
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.
- Every time when you open a new vial of test strips, please write the opening date on the label. Use
test strips within 3 months after opened or until the expiration date printed on the
label (whichever comes first).
- 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.
18
Alternative site testing-palm or forearm blood sampling
1. Choose Clear Cap and follow step 1 - 5 on page 23.
2. Massage the puncture area of palm or forearm for a few
seconds.
3. Immediately after massaging the puncture area, press and
hold the lancing device with the Clear Cap against palm or
forearm.
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. Follow step 9 - 18 on page 24 - 26 to complete the test and
discard the used disposable lancet.
Alternative Site Testing (AST)
Palm
Forearm
Pressing for
a few seconds Releasing
button
3a 3b
3c 4

29
28
Alternative Site Testing (AST)
PRECAUTION
- Consult your healthcare professional before sampling from your palm or forearm.
- Test results using samples from the palm or forearm may vary at times when glucose is
changing rapidly (e.g. drinking, eating, using medication, exercise). In such circumstances,
only fingertip blood samples should be used.
- Fingertip samples may show rapid changes in glucose faster than palm or forearm
samples.
- Since blood flow from the palm or forearm may be slower than from the fingertip, use the
clear cap on the lancing device to observe the size of the acquired blood droplet.
- DO NOT test from the palm or forearm if testing for insulin dosage calculation or
hypoglycemia (low blood glucose).
- Palm or forearm results should not be used to calibrate continuous glucose monitors
(CGMs).
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 taking out from the vial.
- Do not reuse test strips.
- If RIGHTEST Meter or Test Strips is exposed to temperature environments out of range for
the meter – below 10°C (50°F) or above 40°C (104°F) – please wait at least 30 minutes
before testing again.
- 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.

31
30
The RIGHTEST ALPHA Meter displays results between 10 - 600 mg/dL
(0.6 and 33.3 mmol/L). If your 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
" " result, you should immediately contact your healthcare professional.
If your test result is above the high end of the system's detection range 600 mg/dL
(33.3 mmol/L), " " will appear on the screen. Please repeat your test with a new
test strip. If you still get " " result, you should immediately contact your healthcare
professional.
"Lo" and "Hi" readings
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.
Quality Control Test
Please use RIGHTEST Control Solution GC570 tested with RIGHTEST ALPHA Blood Glucose Monitoring
System under Control Solution Mode. If the test result is within the Control Solution Range printed on the
strip vial label, the RIGHTEST ALPHA Blood Glucose Monitoring System passes Quality Control Test.
That means your RIGHTEST ALPHA Blood Glucose Monitoring System is working correctly.
Example of Control Solution Range
printed on your test strip vial label.
Control Solution Range:
When could a Quality Control Test be performed ?
Whenever you want to check if your system is working properly or not.
Whenever you want to practice testing and check correct procedure.
- To prepare for your initial blood glucose test.
- To check the RIGHTEST ALPHA Test Strip when you open a new vial of strips.
- To check your RIGHTEST ALPHA Meter after it has been dropped, damaged or exposed to
liquids.
- When you suspect that your test results are inaccurate, or if your test results are not consistent with
the way you feel.
Control Solution Range:
79 - 120 mg/dL
4.4 - 6.7 mmol/L

32 33
If Control Solution results are out of range, your Bionime BGMS may not be working properly. Repeat
the Quality Control Test. If your RIGHTEST Control Solution results are still out of range, STOP using
the BGMS to test your blood glucose and contact your Bionime Customer service.
Quality Control Test
PRECAUTION
Each time you open a new bottle of RIGHTEST Control
Solution, write the opening date on the label. RIGHTEST
Control Solution is good for 3 months after opened, or
until the expiration date printed on the label, whichever
comes first.
The your Control Solution results are out of the range :possible reasons RIGHTEST
- our RIGHTEST Control Solution has expired or has been opened more than 3 months.Y
- You left the cap of the tst strip vial or the control solution opened for a long time.
- You didn't perform the test procedure correctly.
- Malfunction of the meter or the test strip.
Example of Expiration Date:
Exp. Date YYYY-MM-DD
Performing a Quality Control Test
1. Take one test strip from vial and close the vial cap immediately.
2. Insert the strip into the test strip port of the Meter with the view
window facing up.
3. While the blood drop symbol flashing, press and hold the main
button for over 3 seconds until the " " symbol appears.
4. You will see blinking " " symbol and " " symbol on the screen,
prompting you to apply Control Solution.
5. Gently invert the bottle of RIGHTEST Control Solution several times,
to mix it thoroughly before use.
6. Place a drop of Control Solution on the top of the cap.
7. Gently touch sample entry of the strip with the Control Solution on the
top of the cap.
OPEN
8. When you hear a beep (if volume is turned on) please wait for the test result. The
screen will display the countdown number from 5.
12
5
67
4
8
7

35
CLOSE
Performing a Quality Control Test
9
PRECAUTION
- Your Control Solution results will not be calculated for average reading but still can be
recalled. The Control Solution Test result will be shown with " " symbol on the screen.
- Our suggestion environment for Control Solution Test is 15 - 40°C.
- Before " " and " " appears, please don't touch the Control Solution to the sample entry
on strip because the meter is still in an internal check. If you do so, the meter will show " "
and " ", and be accompanied by beeps (if volume is turned on)
- Don't drip the Control Solution to sample entry of the strip directly, doing
so may cause the contamination of the control solution or meter.
- Don't touch the tip of the control solution bottle. If you have touched it,
please clean up with water.
34
Maintain the products
9. Close the control solution cap immediately after use, and make sure to close it
tightly
10. The Control Solution result appears. Compare your Quality Control Test result to
the Control Solution Range printed on the test strip vial label.
Indirect transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis
C Virus (HCV) during the delivery of healthcare services has been increasingly reported. Persons
using blood glucose monitoring systems have been identified as one risk group due to sharing of
lancets, lancing devices, and blood glucose meters.
The cleaning procedure is to remove dust, blood and body fluid from the surface and should be
performed whenever the meter or lancing device is visibly dirty. The disinfecting procedure is
necessary to kill pathogens such as HIV, HBV and HCV on the device.
NOTE: The cleaning procedure can only remove visible contaminates from surfaces. Only the
disinfecting procedure can eliminate non-visible pathogens.
If the meter is being operated by a second person who is providing testing assistance to the user, the
meter and lancing device should be decontaminated prior to use by the second person.
The following disinfecting wipe has been tested and may be used to clean and disinfect the meter
and lancing device.
CAVIWIPES DISINFECTING TOWELETTES, manufacturer: Metrex. It is with Isopropanol as the active
ingredient, have been shown to be safe for use with the meter and lancing device.

37
Maintain the products
36
Maintain the products
Maintaining
Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the carrying
case when not in use. If your meter is dropped or damaged, perform a quality control test with the
control solution before performing a blood glucose test.
2
1
3
2 min
NOTE
- Clean and disinfect the outside of the device only. Do not remove battery cover when
cleaning and disinfecting.
Cleaning and Disinfecting frequency: at least once a week.
To clean the meter:
1. Thoroughly wipe the entire surface of the meter with disinfecting
wipes listed above to clean any possible dirt, dust, blood and other
body fluids.
To disinfect the meter:
2. Take another disinfecting wipe and wipe the meter thoroughly (Note:
All blood and body fluids should be cleaned from surface before
performing the disinfecting procedure).
3. Allow the surface to remain wet for 2 minute.
4. Allow to air dry.