RIGHTEST GM550 Alpha Blood Glucose Monitoring System User Manual
- June 6, 2024
- RIGHTEST
Table of Contents
GM550 Alpha Blood Glucose Monitoring System
BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Tel: +886 4 2369 2388 Fax: +886 4 2261 7586 Email: [email protected] http://www.bionime.com Made in Taiwan
Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Email: [email protected]
101-3GM551-060 E N
Rev. Date: 2021-06
Blood Glucose Monitoring System
ALPHA
User’s Manual
Preface
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].
2
Intended Use
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.
3
Caution
– 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.
4
Caution
– The minimum blood sample size for testing is 0.75 µL 🙁 )
Sample Size Example
0.75 µL 1.0 µL 1.5 µL
2.0 µL
3.0 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.
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.
5
Table of Contents
About RIGHTEST ALPHA System RIGHTEST ALPHA Blood Glucose Monitoring System
RIGHTEST ALPHA Meter RIGHTEST ALPHA Test Strip
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
6
Quality Control
8
“Lo” and “Hi” readings
10
Quality Control Test
14
Review Your Test Memory
Performing a Quality Control Test Maintain the products
16
Recalling Test Result and Average
18
22
Error Messages and Trouble Shooting
Specification
Limitations
23
Customer Service
27
Warranty
29
Table of Contents
30 31
33 35 39
42 46 48 49 50
7
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
includeitems.)
8
RIGHTEST ALPHA Blood Glucose Monitoring System
1
2
3
4
5
6
7
9
RIGHTEST ALPHA Meter
Display Window Show your test result, messages and relative information.
Left Button ( ) For operating the meter, please check details in following
sections. 10
Test Strip Port Insert test strip here until you hear a click.
Main Button ( ) For operating the meter, please check details in following
sections. Right Button ( ) For operating the meter, please check details in
following sections.
RIGHTEST ALPHA Meter
Battery Cover Slide cover to change batteries.
Meter Label
Meter Battery
Do not put battery here.
11
RIGHTEST ALPHA Meter
12
RIGHTEST ALPHA Meter
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
Manufacturing use only
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
13
RIGHTEST ALPHA Test Strip
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.
Sample Entry Apply a drop of blood or control solution here. The test request
is only 0.75 µL of blood.
Noble Metal Electrodes Electrochemical sensor
Indication Symbol Insert strip with indication symbol up and toward meter.
Hand Bar Grip here to insert test strip into meter.
View Window This window is yellow before applying blood sample. It gradually
turns red when filled with blood.
14
RIGHTEST ALPHA Test Strip
Electrode Contacts Sensing signal output terminals.
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.
15
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.
16
Meter activation and Battery Change
1. Turn the meter over. Press and push battery cover to open.
4. The meter performs a self test.
2. Install the battery. Be sure to put battery in correct way with the “+” symbol up.
3. Slide the battery cover back until it snaps into place.
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.
PRECAUTION – Please follow the local regulations and discard a used battery properly.
17
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit
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.
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.
18
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.
19
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit
4. Time format 12/24H selection
4a)
4b)
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 5)
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
7a)
7b)
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.
20
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit
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).
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”.)
NOTE – When the meter is idle for more than 2 minutes, the meter will leave
setting mode and power
off automatically.
21
Turning On / Off the Meter
1. How to turn on the Meter Press the Main button or Insert a test strip.
2. Manual Power off If you want to turn off the meter, please keep pressing
the Main button for 4 seconds.
3. Auto Power off The meter will power off automatically if you don’t operate
it over 2 minutes.
22
Performing a Blood Test
Depth adjustable cap Lancet carrier
Release button
1
Plunger Hub
1. Wash your hand with warm soapy water and dry thoroughly. 3
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.
5
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.
2 4 6
23
Performing a Blood Test
7. Choose a depth of penetration by rotating the top portion of 7
8
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
9
10
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).
24
Performing a Blood Test
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.
11
12
13a
13b
13c
14
25
Performing a Blood Test
15. Pull off the depth adjustable cap. Without touching the used
15
disposable lancet, stick the lancet tip into the protective cover.
16
2
1
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
18
17. Discard the used disposable lancet into an appropriate punctureproof or biohazard container.
18. Replace the depth adjustable cap after finishing the test.
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.
26
Alternative Site Testing (AST)
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.
3a
Palm
3c Pressing for a few seconds
3b Forearm
4 Releasing button
27
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).
28
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.
29
“Lo” and “Hi” readings
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.
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.
30
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.
Control Solution Range:
Control Solution Range: 79 – 120 mg/dL 4.4 – 6.7 mmol/L
Example of Control Solution Range printed on your test strip vial label.
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.
31
Quality Control Test
The possible reasons your RIGHTEST Control Solution results are out of the
range : – Your RIGHTEST Control Solution has expired or has been opened more
than 3 months. – 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.
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.
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.
Example of Expiration Date:
Exp. Date YYYY-MM-DD
32
Performing a Quality Control Test
1. Take one test strip from vial and close the vial cap immediately.
1
2
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
4. You will see blinking ” ” symbol and ” ” symbol on the screen, prompting you to apply Control Solution.
5 OPEN
5. Gently invert the bottle of RIGHTEST Control Solution several times, 6
7
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
8
top of the cap.
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.
33
Performing a Quality Control Test
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.
9
CLOSE
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
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.
35
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.
36
Maintain the products
Cleaning and Disinfecting frequency: at least once a week.
1
2
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.
3
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).
2 min
3. Allow the surface to remain wet for 2 minute.
4. Allow to air dry.
NOTE – Clean and disinfect the outside of the device only. Do not remove
battery cover when
cleaning and disinfecting.
37
Maintain the products
Cleaning and Disinfecting frequency: at least once a week.
1
To clean the lancing device:
1. Thoroughly wipe the entire surface of the lancing device with
disinfecting wipes listed above to clean any possible dirt, dust,
blood and other body fluids
To disinfect the lancing device: 2. Take another disinfecting wipe and wipe
the Lancing device
thoroughly (Note: All blood and body fluids should be cleaned from surface
before performing disinfecting procedure). 3. Allow the surface to remain wet
for 2 minute.
2 3 2 min
CAUTION – Users should wash their hands thoroughly with soap and water after
handling the meter,
lancing device or test strips.
If you have any questions or concerns, please contact your RIGHTEST ALPHA
Blood Glucose Monitoring System authorized distributor or contact your local
Bionime customer service.
38
Recalling Test Result and Average
The RIGHTEST ALPHA Meter is able to store 500 test results with time and date
automatically. If your meter has stored 500 results, which is the maximum
memory of the meter, the newest test result will replace the oldest one. To
recall your test memory, start the meter without test strip inserted. 1. Press
the main button to switch from the time mode to the Memory screen. First
you will see the “mem” symbol on the up per left corner of the display. When
you press the right button, the latest result will be displayed. By pressing
the right button sequentially former test results will be shown in historical
order.You will see the sequence number on the lower right corner and the year
on the lower left corner of the display followed by date and time of the
measurement.
Note The right button is for reviewing the tests with sequence number
increasing, and the left button is for reviewing tests with sequence number
decreasing. The sequence no “1” is the latest result while sequence no “500”
is the oldest test result.
2. To finish reviewing memory tests, press main button again, and you will
enter the Average screen. By pressing the right button, the display shows
“AVG” on the upper right corner of the display and the average value for the
actual day. By sequencely pressing the right or left button you will get to
the 1-day, 7-days, 14-days, 30-days and 90-days average of your blood glucose
values. You will see the number of the calculated days on the lower left
corner and the number of the calculated readings on the lower right corner. 39
Recalling Test Result and Average
3. Non-Averaging set and canceled: You may select the unwanted or doubtful
test results, to exclude them from the average calculation, after your every
test. After you finished your test in the test mode, you can exclude the
unwanted result. Keep pressing the right butten until you see the symbol “NO
AVG” in the top right cornetr of the screen. By keeping the right button
pressed and pressing the main button simultaneously to confirm the value as
“Non average”. Now this value is flagged by the symbol “NO AVG” in the up per
right corner of the screen. If you want to cancel this non-averaging setting,
you have to stay in the test mode. First keep pressing the right button until
the “NO AVG” symbol changes to “AVG” in the up per right corner of the screen.
To confirm this original status you again simultaneously press the main button
to confirm the “AVG” status. Now the value will be stored as a regular value
and included in the average values.
40
Recalling Test Result and Average
NOTE – The average function is related to the time setting. You must set the
time right and have enough time
intervals on the basis of current inquiry time, to make sure that the average
test results will show. Use the 14-day average for example; if your current
inquiry time is 1/30, then that you must check that you have tested blood
glucose in the past 14 days before 1/30, including today. If not, the 14-day
average will show no figure. – The Non-averaging/re-averaging function only
works in the test mode and when you get the value. In the mem mode, you can
not perform this action. – Your Control Solution results will be automatically
non-averaged without selecting, but still can be recalled. The Control
Solution Test results will show with “CS” symbol under memory screen.
4. Quick Searching: If you want to see all values automatically displayed in
sequence, first enter the memory mode. Then keep pressing the right or left
button for 2 seconds. (right button is for searching the tests the latest
value to the oldest one; by using the left button you can scroll from the
oldest to the latest one). Anytime you want to stop just release the pressed
button. It will stop and display the current displayed value. You can use this
way to find a particular reading you want to check.
5. Reading right after test: If you just finish the test, press the main
button to enter the mem (memory) screen and review the latest test result.
PRECAUTION – You have to set the time and date to activate the average function.
37
– The ” ” , ” ” results, Control Solution results and test results tested under abnormal temperature <
10°C (50°F), > 40°C (104°F) will be excluded from average calculations.
41
Error messages and Trouble shooting
Er1 – The inserted test strip has been used or damp. Please use a new test
strip from vial.
Er2 – Meter has malfunctioned. Reinstall the batteries and do the Quality
Control Test to check if the meter works properly.
Er3 – Signal transmission is disrupted, repeat the test with a new test strip.
Er4 – Applied blood volume is insufficient, please repeat the test with a new
test strip.
Above, if error screen still appears contact your local Bionime Customer
Service.
42
Error messages and Trouble shooting
Battery Error
1a)
1. The ” ” symbol is blinking when the battery power is low. Please change the
meter battery as soon as you can. You can still do the test.
2. The ” ” and ”
” symbols are blinking when the battery is too low. Meter
can not do the strip test. Please change the meter battery immediately.
1b)
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Error messages and Trouble shooting
Temperature Error In order to get accurate test result, perform testing
between 10 – 40°C (50 – 104°F).
1. When the ambient temperature is 0 – 9°C (32 – 49°F) or 41 – 50°C (105 –
122°F) 1a) the ” ” warning symbol will be blinking (1a), you still can do the
test but the test result is only for reference, because the test result under
these ranges of temperature might not be correct. In the memory screen this
value will be flagged with ” ” symbol (1b). Repeat the test at an area with
temperature between operating range (10 – 40°C or 50 – 104°F).
1b)
2. If the RIGHTEST ALPHA Blood Glucose Meter and Test Strips are exposed to a
substantial change in temperature, or out of recommended operating temperature
– below 10°C (50°F) or above 40°C (104°F) – move them back to recommended
condition and wait at least 30 minutes before testing again.
3. When the temperature is below 0°C (32°F) or over 50°C (122°F), Meter can
not 3) do the test and the ” ” symbol will blink with ” ” symbol displaying on
screen in this condition. Please move the meter to environment with
temperature between 10 – 40°C (50 – 104°F) and repeat the test after 30
minutes.
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Error messages and Trouble shooting
Sampling Error Please don’t apply the blood drop to the sample entry of the
strip before the meter displays ” “. If you do so, the meter will display ” ”
and ” ” accompanied by beeps (if volume is turned on). Please discard the test
strip and repeat the test with a new test strip.
Meter Malfunction If the meter can not be started, please follow the steps
below: 1. Open the battery cover, remove the batteries. 2. Wait for 5 minutes
and insert the batteries as described “Meter activation and Battery change”
on page 16 – 17. The meter should be working normally after finishing above
steps. If not, please contact your local Bionime customer service.
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Specification
Measurement Technology Measurement Calibration Measuring Range Test Time
Memory Capacity Power Saving Operating Temperature Operating Relative Humidity
Power Supply Meter Battery Life 46
Oxidase Electrochemical Sensor Plasma 10 – 600 mg/dL (0.6 – 33.3 mmol/L) 5 seconds 500 blood glucose test results with date and time Turn off automatically 2 minutes after last user action / Press the ” ” button for 3 seconds. 10 – 40°C (50 – 104°F) 10 – 90% 1 CR2032 battery About 1,000 tests
Specification
Meter Dimension Meter Weight Monitor Display Area Meter Storage Conditions Sample Minimum Sample Volume Hematocrit Test Strip Storage / Transportation Conditions
90.6 mm x 46 mm x 16.5 mm 53.0 ± 5 g with battery LCD display 46.6 mm x 33 mm
-10 – 60°C (14 – 140°F)
Refer to RIGHTEST ALPHA Strip insert
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Limitations
– RIGHTEST ALPHA Blood Glucose Monitoring System is not intended for serum or
plasma test. – Inaccurate test results may be obtained at high altitude more
than about 3,048 meters (10,000 feet)
above sea level. – Test results may be falsely low if the patient is severely
dehydrated, in shock, or in a hyperosmolar
state (with or without ketosis). – Patients going through oxygen therapy may
yield falsely low results. – These test strips should not be used with meters
to test critically ill patients or neonates. – The blood glucose test result
may be affected by high blood concentration of interference
ingredients, if you need more detail information about interference
ingredients, please see RIGHTEST ALPHA Test Strip Insert. – Alternative site
testing (AST) should only be performed during steady-state times (when glucose
is not changing rapidly). – Please refer to the (Alternative site testing
(AST)) chapter if you want to test on palm or forearm. – 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). – To avoid potential electromagnetic or
other interference, keep meter away from electromagnetic radiation sources
such as X-ray or MRI. – Keep your meter away from dust, water or any liquid.
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Customer Service
We sincerely like to provide complete, considerate services to our customers.
Please review all the instructions to make sure you are performing the steps
correctly. If you have any questions or in case of problems with the RIGHTEST
ALPHA products, please contact your local Bionime customer service.
Description of used symbols
Consult the instructions for use
For single use only
Lot number
Humidity limitation
Manufacturer
EU Representive
CE-mark (with No. of notified body)
Direct Current Biological risks Importer
Method of sterilization using irradiation
Temperature limitation
Expiry date
For in vitro diagnostic use
Caution (consult the instructions for use and warnings)
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Warranty
The manufacturer warrants that your RIGHTEST ALPHA Meter will be free from
defects in materials and workmanship for five years from the date of purchase.
This warranty does not apply to the performance of a RIGHTEST ALPHA Meter that
has been altered, misused, tampered with or abused in any way. This warranty
applies only to the original purchaser of the meter. Please complete and
return the enclosed warranty card to your local Bionime affiliate.
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