BIONIME Rightest Elsa User manual

User’s Manual
ELSA
Blood Glucose Monitoring System
101-3GM111-0D0 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

Thank you for choosing the RIGHTEST ELSA Blood Glucose Monitoring System. Please read this
manual thoroughly before testing. It provides all the information you need to use your product.
The RIGHTEST ELSA Blood Glucose Meter must only be used with RIGHTEST ELSA Blood Glucose
Test Strips and Control Solution GC570. Use of other test strips or control solutions may lead to
incorrect results.
Please only purchase test strips in the same country as which you purchased your meter. Use of
test strips from different countries may result in inaccurate test results.
You are recommended to monitor blood glucose regularly. The RIGHTEST ELSA Blood Glucose
Monitoring System is accurate and easy-to-use making it your reliable diabetes management
assistant.
The RIGHTEST ELSA Blood Glucose Monitoring System is manufactured and supported by Bionime
Corporation. If you have any questions or concerns, please contact Bionime Customer Service or
send an email to [email protected].
The RIGHTEST ELSA Blood Glucose Monitoring System is designed for in vitro diagnostic (fortesting
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,
palmand 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

54
Caution Caution
- The minimum blood sample size for testing is 0.75 µL ( )
Blood samples larger than 3.0 µL may contaminate the test strip port and the meter.
Sample sizes below 0.75 µL will produce Er4. If this occurs, repeat the test with a new test strip.
Sample Size Examples
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
"Product Maintenance" section on page 38.
- Users should wash their hands thoroughly with soap and water before and after touching
the meter, lancing device or test strips.
0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL
- Before using the RIGHTEST Blood Glucose Monitoring System to test your blood glucose, please
read all of the information provided and conduct all of the recommended tests including the
quality control test (see page 33).
- Please perform the quality control test regularly to make sure test results are accurate.
- The RIGHTEST ELSA Blood Glucose Meter can only be used with RIGHTEST ELSA Blood
Glucose Test Strips. Test strips from other brands should not be used under any circumstances.
Doing so may give inaccurate results.
- If your meter or test strips are exposed to temperatures 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 itt 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.

76
Table of Contents Table of Contents
30
31
About RIGHTEST Blood Glucose Monitoring System
Contents of the RIGHTEST Blood Glucose Monitoring System
RIGHTEST Meter
RIGHTEST Test Strip
Preparing for a Test
Activating the Meter and Changing the Battery
Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit
Turning the Meter On/Off
Testing Procedure
Performing a Blood Glucose Test
Alternative Site Testing (AST)
Viewing Window Appearance
8
10
14
16
18
22
23
27
29
Quality Control
" Lo " and " Hi " Readings
Quality Control Test
Reviewing Stored Results
Performing a Quality Control Test
Recalling Results and Viewing the Average Result
Product Maintenance
Error Messages and Troubleshooting
Specification
Limitations
Customer Service
Warranty
38
42
45
47
48
49
33
35

98
Contents of the RIGHTEST Blood Glucose Monitoring System Contents of the RIGHTEST Blood Glucose Monitoring System
Your RIGHTEST ELSA 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 ELSA Blood Glucose Monitoring System:
1. RIGHTEST ELSA 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 ELSA 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.)
7＊
3＊2
4＊
1
5＊ 6＊

1110
RIGHTEST Meter RIGHTEST Meter
Test Strip Port
Insert test strips here.
Display Window
Shows your test result, messages and
other information.
Main Button
Used to operate the meter. Please see
the following sections for further
details.
Battery Cover
Slide off to change the battery.
Meter Label

1312
Indicates a test result stored in memory
Indicates the average result
Indicates a control solution test result
Test result units
Test result
Low battery warning. Battery may need
replacing
Prompt to apply a blood sample
Test strip
Appears if an error has occurred
Current Date (in Time mode) or Test Date
(in Memory mode)
Indicates temperature is too high for testing
Time in 12H format
Current Time (in Time mode) or Test Time
(in Memory mode)
For manufacturing purposes only
Indicates the average result on a specified
day
RIGHTEST Meter RIGHTEST Meter

1514
Viewing Window
This window is yellow before applying
a blood sample. It turns red when
filled with blood.
Handle
Grip here when
holding the strip.
Sample Entry
Apply a drop of blood or control solution here.
The test request is only 0.75 uL of blood.
Electrode Contacts
Sensing signal output terminals.
Noble Metal Electrodes
Electrochemical sensor.
Indication Symbol
Insert strips with the indication
symbol pointing towards the meter.
RIGHTEST Test Strip RIGHTEST Test Strip
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 ELSA Test Strip Insert.
- If the RIGHTEST ELSA Meter or Test Strip strips are exposed to a substantial change in
temperature, please wait at least 30 minutes before testing again.

1716
Activating the Meter and Changing the Battery
1. Turn the meter over.
Press and slide down the
battery cover to open.
PRECAUTION
- Please follow local regulations to discard used batteries properly.
4. The meter will perform a self-test.
5. Press the main button to exit the self-test and enter the Settings mode.
6. Set the time and date when the batteries are replaced. See "Setting Up Your Meter - Setting the
Time, Volume and Date". Test results are still stored in the memory.
3. Slide the battery cover
back on until it snaps into
place.
2. Install the battery.
Make sure the battery is
inserted the correct way up.
Activating the Meter and Changing the Battery
Your meter comes with 1 CR2032 3V battery installed. A new battery will provide sufficient power to
perform about 1,000 tests under normal use. Press the main button or insert a strip to activate your
meter.
NOTE
For some meters, first remove the the plastic tape then press the main button to activate the
meter.

1918
NOTE
- Pressing and holding the main button for 3 seconds will switch the display off. Continue
holding down the button until the display turns back on and shows the settings.
- Scroll through each setting by pressing the main button.
You can enter the Settings Mode in two ways:
1. Reload the battery
After removing the battery, press the main button several times until there is no signal on screen,
then re-install a battery. The meter will perform a self-test. Press the main button to exit the self test
and enter the Settings Mode.
2. With the battery inserted
Press the main button to turn on the meter. Press and hold the main button for 7 seconds. You will
hear a beep (if volume is turned on) and be taken to the Settings mode. The display screen will
show the settings.
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. Set the year
With the year blinking, tap the button to scroll to the next number. Press and
hold the button to confirm and move to the next setting.
2. Set the month
With the month blinking, tap the button to scroll to the next number. Press
and hold the button to confirm and move to the next setting.
3. Set the day
With the day blinking, tap the button to scroll to the next number. Press and
hold the button to move to the next setting.
1)
2)
3)

20
4. Set Time Format (12/24H)
With the time format blinking, tap the Main button to
adjust it. Press and hold the button to confirm and move
to the hour setting.
5. Set the hour
With the hour blinking, tap the Main button until the
current hour appears. Press and hold the button to
confirm and move to the minute setting.
6. Set the minute
With the minute blinking, tap the Main button to adjust it.
Press and hold the button to confirm and move to the next
setting.
7. Set the volume
With the volume blinking, tap the Main button to turn it on
or off. Press and hold the button to confirm and move to
the units setting.
NOTE
- If you do not adjust the settings for 2 minutes, the meter will exit the Settings mode and
power off.
- The default units of your RIGHTEST Meter are set according to your region.
Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit Setting Up Your Meter - Setting the Time, Date, Volume and Test Unit
9. Finish the settings
After all the settings are complete the display will return to the time screen.
7a) 7b)
8. Set the units
Tap the main button to switch between mg/dL and mmol/L.
Press and hold the button to confirm and move to the next
setting (*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)
21
8a) 8b)

22
1. How to turn on the Meter
Press the Main button or insert a test strip.
2. Manually power off
Press the Main button for 3 seconds.
3. Auto power off
The meter powers off automatically after 2 minutes of inactivity.
Turning the Meter On/Off
Hub
Lancet carrier
Plunger
Release button
Depth adjustable cap
1. Hold the depth adjustable cap with one hand and hold the
hub with the other. Bend the device and apply pressure at
the join until it gently pops open.
2. Pull apart both ends to separate the cap from the hub.
3. Push a new disposable lancet into the lancet carrier. Make
sure it is held securely in place.
4. Twist off and set aside the protective cover of the
disposable lancet.
5. Reattach the depth adjustable cap.
1
2 3
4 5
Performing a Blood Glucose Test
23

24
Performing a Blood Glucose Test
67
6. Rotate the clear top part of the cap to adjust the depth. Check the number of lines visible in the
viewing window. More lines corresponds to a greater depth. Try " " for soft or thin skin,
" " for average skin, or " " for thick or calloused skin.
7. Pull back the plunger until you hear a click. The device is now primed. Let go of the plunger. It will
return to its original position.
8. Wash your hands with warm soapy water and dry them thoroughly.
9. Take one strip from the vial. Re-cap the vial cap immediately.
10. Insert the test strip into the test strip port. The meter confirms a strip has been inserted with a beep
(if the volume is turned on).
8910
11. A blood drop symbol appears and is accompanied by a
further beep (if volume is turned on). Apply a blood
sample within 2 minutes.
12. Place the lancing device against your fingertip and press
the release button.
13. Touch and hold the blood droplet to the test strip sample
entry port until you hear a beep (if volume is turned on)
and the Viewing Window is filled with blood. If the Viewing
Window is not completely filled with blood or the test does
not start, discard the test strip and repeat the test with a
new strip.
14. You will see a countdown on the screen. After 5 seconds,
the test result will appear.
12
Performing a Blood Glucose Test
11
13b
13c 14
25
13a

Performing a Blood Glucose Test
15. Remove the cap from the lancing device. Do not touched the
used lancet. Press the lancet tip into the protective cover.
16. Hold down the release button and pull back the plunger to eject
the lancet.
17. Discard the lancet into a suitable sharps biohazard container.
18. Reattach the depth adjustable cap after finishing the test. 17
15 12 16
PRECAUTION
- Do not apply your blood drop to the sample entry port on the strip until you see " " appear. The
meter is performing an internal test and will display " " and " " if you apply blood too soon. If
this occurs, 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, clean with a small soft brush, otherwise the meter
may not work correctly when you insert a test strip.
18
Alternative Site Testing (AST)
Alternative Site Testing: Palm or Forearm Blood Sampling
1. Install the clear cap and follow steps 1 to 5 on page 23.
2. Massage the target area on the palm or forearm for a few
seconds to increase blood flow.
3. Immediately after massaging, press and hold the lancing
device against the target area.
4. Press the release button.
5. After pressing the release button, continue holding the
lancing device against the skin. Gradually push the device
against your skin with increasing pressure until the blood
droplet is of sufficient size.
6. Follow steps 9 to 18 on page 24 - 26 to complete the test
and discard the used disposable lancet.
3a) 3b)
3c) 4)
Press for a few
seconds
26 27
Palm
Forearm
Push the
release button

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).
Viewing Window Appearance
Make sure your blood sample covers the whole
area of the Viewing Window. 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 Appropriate 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.
28 29

30
The RIGHTEST Meter displays results between 10 and 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. Repeat your test with by a new test strip. If " " still appears
contact your healthcare professional immediately.
If your test result is above 600 mg/dL (33.3 mmol/L), " " will appear on the screen.
Repeat your test with a new test strip. If you " " still appears, contact your
healthcare professional immediately.
" Lo " and " Hi " Readings
NOTE
- If your blood glucose result is unusually high or low and you have doubts about the
accuracy, 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 remains unusual, contact your healthcare
professional immediately.
- If you are having symptoms that are not consistent with your test results and you are sure
that you have followed all the instructions in this manual, contact your healthcare
professional immediately.
Quality Control Test
Use RIGHTEST Control Solution to test the RIGHTEST System in Control Solution Mode. If the test
result is within the Control Solution Range printed on the strip vial label, the RIGHTEST System
passes Quality Control Test. Your RIGHTEST System is working correctly.
Control Solution Range:
When could a Quality Control Test be performed?
- Whenever you want to check whether your system is working properly.
- Whenever you want to practice testing and check the correct procedure.
- To prepare for your initial blood glucose test.
- To check the RIGHTEST Blood Glucose Test Strips when you open a new vial of strips.
- To check your RIGHTEST Blood Glucose 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:
83 - 113 mg/dL
4.6 - 6.3 mmol/L
31

32
Quality Control Test
PRECAUTION
When you open a new bottle of Control Solution, write
the opening date on the label. Control Solution may be
used for 3 months after opening, or until the expiration
date printed on the label, whichever comes first.
Possible your Quality Control Test results are out of range: reasons
- our Control Solution has expired or or has been opened more than 3 months.Y
- Your test strip has expired.
- You left the cap of the test strip vial opened or the lid of the control solution off for a long time.
- You did not perform the test procedure correctly.
- Malfunction of the meter or the test strip.
If Control Solution results are out of range, your RIGHTEST system may not be working properly.
Repeat the Quality Control Test.If your Control Solution test results are still out of range, do not use
the system to test your blood glucose. Contact Bionime customer service.
Example of Expiration Date:
1. Take one test strip from vial. Recap the vial cap immediately.
2. Insert the test strip into the test strip port.
3. While the blood drop symbol is flashing, press and hold the main
button for 3 seconds until " " appears.
4. You will see a blinking " " and " " on the screen, prompting you
to apply Control Solution.
5. Shake the bottle of control solution before opening. Remove the cap
and place it on a flat surface.
6. Place a drop of control solution on the top of the cap.
7. Touch the sample port of the test strip to the drop of solution.
Performing a Quality Control Test
OPEN
8. When you hear a beep (if volume is turned on), wait for the test result to appear. The
screen will display a 5-second countdown.
1 2
67
8
4
33
Exp. Date YYYY-MM-DD
5

9. Tightly replace the cap on the Control Solution bottle.
10. Compare your Quality Control Test result to the Control Solution Range printed
on the test strip vial label.
Performing a Quality Control Test
CLOSE
9
PRECAUTION
- Your Control Solution results will not be calculated as part of the average reading but still
can be recalled. The Quality Control Test result will be shown with " " on the screen.
- The suggested environment for the Quality Control Test is 15 - 40°C.
- Before " " and " " appear, do not touch the Control Solution to the sample entry port. If
you do so, the meter will show " " and " ".
- Do not drip control solution directly into the sample entry port. Doing so may
contaminate or damage the meter.
- For detailed information on the validity period after opening and the storage
environment, please refer to RIGHTEST Control Solution GC570 Insert.
34
Recalling Results and Viewing the Average Result
The RIGHTEST Meter is able to store 500 test results with time and date automatically. If your meter
already has 500 results stored, the newest test result will replace the oldest one. To view results from
memory, turn on the meter without a trip inserted.
1. Press the main button to switch from Time and Date to the Memory screen.
"mem" will be be displayed in the upper right corner of the display. Press the
main button to display the latest result. Subsequent clicks of the main button
will show stored results in historical order. The sequence number and year will
be displayed at the bottom of the screen.
NOTE
The main button is used to cycle through tests with increasing sequence number.
Sequence number "1" is the latest result. "500" is the oldest.
35

37
Recalling Results and Viewing the Average Result
NOTE
- The average function is related to the time setting. You must set the time correctly and have sufficient
results stored in the memory in order for an average to be displayed. For example, in order to view a 14-
day average you must have at least one test result taken within the last 14 days stored in the memory.
Recalling Results and Viewing the Average Result
3. If you have just finished a test, press the main button to enter the Memory screen and review the
result.
PRECAUTION
- You must set the time and date to activate the average function.
- " " and " " results, control solution results and test results taken outside of the normal temperature
range (< 10˚C, > 40˚C) are not included in the average.
36
2. To finish reviewing results in the memory, press and briefly hold the main button to enter the
Average screen. "AVG" will be displayed in the upper left corner of the display. The average blood
glucose result for the day will be shown. Subsequent clicks of the main button will show the
average glucose result for the last 7-, 14-, 30-, 60- and 90-day periods.