BIONIME RIGHTEST Max User manual

101-3GM770-020 EN
User’s Manual
Max
Rev. Date: 2019-05
0197
Blood Glucose Monitoring System
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
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]

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Indication for use
Thank you for using our product, 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 level to effectively
reduce complications from diabetes. The easy-use RIGHTEST Max Blood Glucose Monitoring
System provides accurate, reliable test results to help you better manage your diabetes.
You may consult your healthcare professional for instructions on how to use the system correctly.
Our customer service information is on the cover, our staff is willing to assist you as well. Please
contact healthcare professional if emergency or our service is not available. Please forward your
warranty card to customer support to activate your warranty coverage.
RIGHTEST Max Blood Glucose Monitoring System is made and supported by Bionime Corporation.
If you have any questions or concerns, please contact your local Bionime Customer Service or
email to [email protected]
RIGHTEST Max Blood Glucose Monitoring System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh whole blood samples from capillary. The testing result is
calibrated to plasma equivalent with whole blood from capillary, vein, artery and neonates. Capillary
whole blood can be sampled from the fingertip, palm or forearm, and in the case of neonates, the
heel.
RIGHTEST Max Blood Glucose Monitoring System is intended for self-testing outside the body (in
vitro diagnostic use), they can be used as an aid of diabetes control for home user or professional.
RIGHTEST Max Blood Glucose Monitoring Systems should not be used for the diagnosis of, or
screening for diabetes. Alternative site testing should be done only during steady - state times
(when glucose is not changing rapidly).
RIGHTEST Max Control Solution is for use with RIGHTEST Max Blood Glucose Meter and
RIGHTEST Max Blood Glucose Test Strip to check that the meter and test strips are working
together properly and that the test is performing correctly.
Scan the QR code to view the guide video.
Preface

54
Caution Caution
- Before using RIGHTEST Max 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 (Refer to page 45).
- Please perform the quality control test regularly to make sure the test results are fine.
- RIGHTEST Max Blood Glucose Meter can only be used with RIGHTEST Max Blood Glucose Test
Strip. Other brands’ test strips should not be used under any circumstances. The use of other
brands’ strips may give inaccurate results.
- RIGHTEST Max Blood Glucose Monitoring System is intended for in vitro diagnostic use only. The
testing result is calibrated to plasma equivalent with whole blood from capillary, vein, artery and
neonates. Capillary whole blood can be sampled from the fingertip, palm or forearm.
- Venous, neonatal or arterial blood testing should be performed by healthcare professionals.
- RIGHTEST Max Blood Glucose Monitoring System is NOT intended for diagnosis of diabetes
mellitus.
- If RIGHTEST Meter and Test Strips are exposed to temperature environments out of range for the
meter – below 6°C (43°F) or above 44°C (111°F) – please wait 30 minutes before testing again.
- Follow all environmental protection regulations when disposing of batteries, strips and lancets.
- Avoid contact with dripping or splashing liquids.
- The minimum blood sample size to test using RIGHTEST Max Blood Glucose Monitoring System
0.75 : ( )µL
- Please follow the recommendations for follow-up care that have been set by the professional
medical staff for critical glucose values in neonates.
- As a matter of good clinical practice, be caution of the interpretation of neonate glucose value
below 50 mg/dL (2.8 mmol/L).
- Once patient is suspected as rare disease (e.g. galactosemia), the glucose result should based
on laboratory test.
Sample Size Example
Blood sample size above 3.0 might contaminate the test strip port and the meter.µL
Sample below 0.75 will cause Er4. In this case, repeat the test with a new test strip.µL
0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL

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Limitations
Caution
- RIGHTEST Max Blood Glucose Monitoring System is not intended for serum or plasma testing.
- Do not use at altitudes greater than 10,000 feet (3,048 meters).
- Hematocrit levels below 10% may cause falsely high reading. Hematocrit levels over 70% may
cause falsely low reading. If you do not know your hematocrit level, consult your doctor or nurse.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- 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 Max blood glucose test strip insert.
- Not for screening or diagnosis of diabetes mellitus.
- These test strips should not be used with meters to test critically ill patients.
- 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 before you
perform AST testing.
- Alternative site testing should not be used to calibrate continuous glucose monitoring systems
(CGMS).
- To avoid potential electromagnetic or other interference, keep meter away from electromagnetic
radiation sources such as X-ray or MRI.
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 51.
- Users should wash their hands wholly with soap and water before and after touching the
meter, lancing device, or test strips.

Table of Contents Table of Contents
About RIGHTEST Max Blood Glucose Monitoring System
RIGHTEST Max Blood Glucose Monitoring System............................................................................
RIGHTEST Max Blood Glucose Meter.................................................................................................
RIGHTEST Max Blood Glucose Test Strip...........................................................................................
Before Testing
Meter Activation and Battery Change ...............................................................................................
Set Up Your Meter ..............................................................................................................................
Turning On / Off the Meter ..................................................................................................................
Handling RIGHTEST Max Blood Glucose Test Strip...........................................................................
Testing Procedure
Getting Ready for Testing ...................................................................................................................
Performing a Blood Glucose Test .......................................................................................................
Setting Markers ..................................................................................................................................
Recalling Test Results ........................................................................................................................
Recalling Average Test Results ..........................................................................................................
Alternative Site Testing........................................................................................................................
View Window Appearance..................................................................................................................
Understanding Test Results and Messages.......................................................................................
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12
16
18
20
26
27
29
30
35
36
38
40
42
43
Quality Control
About Quality Control Testing.............................................................................................................
Performing a Quality Control Test.......................................................................................................
Understanding Control Test Results...................................................................................................
Other Information
Maintain the Products.........................................................................................................................
Error Messages and Troubleshooting................................................................................................
Specification.......................................................................................................................................
Warranty..............................................................................................................................................
Customer Service................................................................................................................................
Expected Glucose Values...................................................................................................................
Component Manufacturer Information...............................................................................................
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50
51
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60
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63
64
65
9
8

RIGHTEST Max Blood Glucose Monitoring SystemRIGHTEST Max Blood Glucose Monitoring System
7＊
2 3＊1
4＊5＊6＊
Your RIGHTEST Max Blood Glucose Monitoring System consists of several items. Please identify
each item, learn its name and how it is used.
The items in RIGHTEST Max Blood Glucose Monitoring System:
1. User Documents (Getting Started Guide, User's Manual, Log Book, Warranty Card, Emergency
Card).
2. RIGHTEST Max Blood Glucose Meter (with battery installed)
3. RIGHTEST Max Blood Glucose Test strips 10 or 25 pcs (with Package Insert)
4. RIGHTEST Max Control Solution (with Package Insert)
5. RIGHTEST Lancing Device (with Package Insert)
6. Clear Cap
7. Disposable Sterile Lancets (10 pcs)
8. Carrying Case (not shown)
＊Different packages have different bundled items. Contact distributor for more details.
(＊- product sold separately)
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RIGHTEST Max Blood Glucose Meter
Up Button ( )
Down Button ( )
Main Button ( )
Display Window
Test Strip Port
RIGHTEST Max Blood Glucose Meter
Battery Cover
Do not put
battery here.
Meter Battery
Pen press to
open the
Cover.
Meter label
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RIGHTEST Max Blood Glucose Meter RIGHTEST Max Blood Glucose Meter
Indicates a control solution test result.
Unit of test result.
Indicates when to apply the blood sample.
Appears after you insert test strip into meter.
Current date under time mode or testing date
under memory mode.
Warns when the operational temperature limit is
exceeded during testing.
Indicates the time format is 12H.
Displays current time under time mode or testing
time under memory mode.
Warns when the battery is low or must be
replaced.
Indicates a meal marker with test result.
Indicates that the Bluetooth is enabled
( meter ).Bluetooth only
Indicates a test result stored in memory. Indicates a testing result is waiting for transmission.
(Bluetooth meter only)
Test result.
Indicates the alarm setting.
Indicates the average result.
Appears when a test result is above 240 mg/dL
to suggest ketone testing.
The blood glucose result is within the target
range.
The blood glucose result is below the target range.
The blood glucose result is above the target range.
Indicates wake up.
exercise marker with test result.
Before sleep marker with test result.
Indicates midnight.
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Manufacturing use only.

RIGHTEST Max Blood Glucose Meter can only be used with RIGHTEST Max Blood Glucose Test
Strip and RIGHTEST Max Control Solution. The use of other test strips or control solutions can lead
to incorrect results.
RIGHTEST Max Blood Glucose Test Strip RIGHTEST Max Blood Glucose Test Strip
PRECAUTION
- Close the vial rapidly after taking out a test strip.
- Do not reuse RIGHTEST Test Strip.
- Do not use expired RIGHTEST Test Strip.
- Record the date of opening a new RIGHTEST Test Strip vial for the first time. Discard the
vial of test strips after 12 months from opening.
- Store RIGHTEST Test Strip in 4 - 30°C (39 - 86°F) and with < 90% relative humidity. Do not
expose to direct sunlight or heat.
- If RIGHTEST Meter and Test Strips are exposed to a temperature environments out of
range for the meter – below 6°C (43°F) or above 44°C (111°F) – please wait 30 minutes
before testing again.
- For detailed strip information, please refer to RIGHTEST Max Blood Glucose Test Strip
Insert.
Sample Entry
Apply a drop of blood or control solution here.
The test request is only 0.75 µL of blood.
Hand Bar
Grip here to insert
test strip into the
strip port of auto
code key.
View Window
This window is yellow
before applying blood
sample. It turns red when
filled with blood.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with the symbol facing up.
Electrode Contacts
Sensing signal output terminals.
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1918
Meter Activation and Battery Change
Your RIGHTEST Max Blood Glucose Meter comes with one CR2032, 3 volt, battery installed. One
new battery will provide power to perform approximately 1000 tests under normal use. Press the
main button or insert a strip to activate your meter.
Meter Activation and Battery Change
CAUTION
- Please follow the local regulation to properly discard a used battery.
4. RIGHTEST Blood Glucose Meter will enter Self-Testing Mode automatically when replacing the
battery (all symbols will appear on the screen).
5. Press any button to exit the self-test and enter Setting Mode.
6. You must set the time and date when replacing the battery. See Chapter " Setting Up Your Meter -
Setting the Date, Time, and Volume " on page 20. Test results are still stored in the memory.
2. Install the battery into the
chamber with electrode.
Be sure to put the battery
in the correct direction
(polarity (+)facing up).
1. Use a pen point to press the
bottom-right spot on the cover, at
the same time slide up the cover.
3. Slide the battery cover
back until it snaps into
place.

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You can enter the Setting Mode two ways.
1. Replace the Battery
After removing the battery, press the main button several times until there is no signal on screen,
then follow the battery installation steps to replace battery. Blood Glucose Meter will RIGHTEST
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 lood Glucose Meter. Hold down the main button for RIGHTEST B
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) 2) 3) 4a) 4b)
NOTE
- Use the Up or Down 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.
- After pressing the main button for 3 seconds, the will turn off its screen. Please meter
keep press the main button until the enter the setup mode.meter
Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Date, Time and Volume
1. Year setting
When the year blinks, press the Up or Down button to select the current year and press the main
button to conform the setup.
2. Month setting
When the month blinks, press the Up or Down button to select the current month and press the
main button to conform the setup.
3. Day setting
When the day blinks, press the Up or Down button to select the current date and press the main
button to conform the setup.
4. 12 or 24-hour format setup
When the time format blinks, press the Up or Down button to select the preferable time format
and press the main button to conform the setup.

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7a) 7b) 8a) 8b)5) 6)
Set Up Your Meter - Set Up the Date, Time and Volume Set Up Your Meter - Set Up the Meal Glucose Range
9. Before Meal Blood Glucose Range Setting
The before meal mark and the lower limit bar will be displayed, and the blood glucose value will
blink. Press the up / down button to adjust the value to the target value and then press the main
button to confirm. Please follow the same way to set up the upper limit for before meal.
10. After Meal Blood Glucose Range Setting
The after meal mark and the lower limit bar will be displayed, and the blood glucose value will
blink. Press the up / down button to adjust the value to the target value and then press the main
button to confirm. Please follow the same way to set up the upper limit for after meal.
5. Hour setting
When the hour blinks, press the Up or Down button to select the current hour and press the main
button to conform the setup.
6. Minute setting
When the minute blinks, press the Up or Down button to select the current minute and press the
main button to conform the setup.
7. Volume Setting
When the " OFF " blinks, press the Up or Down button to turn the volume on or off and press the
main button to confirm the setup.
8. Measurement Unit Setting
When the milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L) blinks, press the Up or
Down key to select the preferable measurement unit and press the main button to confirm the
setup.
NOTE
- The upper / lower limit marker is only for reminding. You may consult your doctor for
further assistance.
- Tight blood glucose control for ADA: close to a normal (nondiabetic) blood glucose level
as you safely can. Ideally, this means levels between 70 and 130 mg/dL (3.8 and 7.2
mmol/L) before meals, and less than 180 mg/dL (10.0 mmol/L) two hours after starting a
meal.
9a) 10a)
9b) 10b)

2524
NOTE
- When the meter is idle for more than , the meter will leave setting mode and 30 seconds
power off automatically.
- Meter default is set according to your local preference.
Set Up Your Meter - Ketone Reminder
11)12)
12. Setup complete
After the setup is complete, the meter will beep to notify the user and return to time mode.
Please notice that the meter will only beep when the volume is set to on.
11. Ketone Reminder Setting
Ketone test reminder is default set to off. This is only
recommended for Type 1 diabetes users.
By pressing the up / down button to enable the Ketone
reminder and press the main button to confirm.
If your blood glucose test result is more than 240 mg/dL (13.3 mmol/L), the Ketone test
reminder well appear when it is on. When " " appears, it means that you may need a
ketone test. Please contact your doctor immediately.
Set Up Your Meter - Set Up the Time Alarm
This feature reminds the user when to perform a test. There are 8 sets of alarm
available per day. The meter will beep when the alarm is triggered and it will be
triggered up to 3 times. Insert the test strip or press main button, button will turn
off the alarm. The volume must be set to on so that the meter can beep.
1. Enter the reminder setting function
When the meter is " ON ", long press the up or down button 3 seconds till
entering to time alarm setting.
2. Choose the alarm set
User can set 8 alarms from " 1 " to " 8 ". Choose the number with up or down
button when " 1 " flashing, then press the main button to confirm.
3. Turn on / off the alarm
Choose " On " or " Off " with the up or down button, then press the main
button to confirm.
4. Set the alarm clock
Press the up or down button to adjust when the hour blinking, then press the
main button to confirm. Press the up or down button to adjust when the
minute blinking,then press the main button to confirm .
5. Finish the alarm setting
To finish the alarm setting, hold the main key for few seconds, meter will save
your setting when exit the setting screen.

27
Handling RIGHTEST Blood Glucose Test Strip
How to handle RIGHTEST Blood Glucose Test Strip.
Inserting RIGHTEST Blood Glucose Test Strip:
1. Hold RIGHTEST Max 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 the picture shown.
3. Insert RIGHTEST Blood Glucose Test Strip into test strip port until it clicks
and firmly stops.
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 30 seconds if no buttons are
pressed or no strip is inserted.
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1
2
3

29
Getting Ready for Testing
Before performing a blood glucose test,
prepare the items below :
- RIGHTEST Max Blood Glucose Meter
- RIGHTEST Max 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)
PlungerHubLancet carrier
Release button
Depth adjustable cap
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 local regulations and discard used strips properly.
Handling RIGHTEST Blood Glucose Test Strip
28
1
2
3

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30
Performing a Blood Glucose Test
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11
NOTE
- RIGHTEST Blood Glucose Meter will automatically detect the Code
number on the test strip. You do not have to check the Code number
on the meter display and strip vial.
Performing a Blood Glucose Test
1. Wash your hands 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.
1
34
56
27. 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.
8. 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.
9. Take one RIGHTEST Max Blood Glucose Test Strip from
the vial. Close the vial cap immediately.
10. Insert the strip into the test strip port of RIGHTEST Max
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).
10
9

Performing a Blood Glucose Test
15. Countdown Mode will begin on the display window.
After 5 seconds, your test result will appear.
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.
19
15 16
17 18
Performing a Blood Glucose Test
14c
14b
13
12b
12a
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32
12. After inserting a test strip, the " " icon will flash
on the screen. Pressing the Up or Down button to
choose between the " "(before meal), " "(after
meal), " "(midnight), " "(bedtime), " "(exercise),
" "(wake up) 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
Glucose Test Strip.
14a

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Setting Markers
Before meal: you test the blood glucose before meal.
After meal: you test the blood glucose after meal.
Regular test or definition by user.
Midnight: you execute the blood glucose test in midnight.
Bedtime: you execute the blood glucose test before sleep.
Exercise: you execute the blood glucose test after exercise.
Wake up: you execute the blood glucose test when you awake up.
Performing a Blood Glucose Test
CAUTION
- Do not apply your blood drop to the sample port 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. If this occurs, please repeat the test with a new test strip.
- Record the opening date of a new test strip vial. Discard the vial of test
strips 12 months after first opening.
- Always keep the metal contacts of the test strip port clean. If any dust or
dirt is present, please clean with a small, soft brush.
- All parts of this kit are considered biohazards and can potentially transmit infectious
diseases, even after you have performed the cleaning and disinfecting procedure.
- Users should wash hands wholly with soap and water after handling the meter, lancing
device, and test strips.
- Please refer to the section " Maintain the Products " on page 51 for surface cleaning.
- Do not reuse lancets. Discard used lancets properly.
According to actual life status, you can set meal markers with test result.
You have to perform meal marker setting before testing.
1. After inserting a test strip, the " " icon will flash on the screen. Pressing the Up or Down
button to choose between the " " (before meal), " " (after meal), " " (midnight), " "
(bedtime), " " (exercise), " " (wake up) 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).

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Recalling Test Results
3. The Quality Control Test result can be recalled from the saved data.
When " " appears next to the data, the test was performed by the control
solution. The control solution test result will not be used when recalling test
average results.
4. Quick Searching:
To view test results in sequential order automatically, enter the Memory Mode. Press the up or
down button for 2 seconds. (The up button is for viewing from the most current to the oldest test
results. The down button is for viewing from the oldest to the most current test results). Release
the button to stop at any particular test result.
The RIGHTEST Max Blood Glucose Meter is able to automatically store a
maximum of 500 test results with time and date. If your meter has stored 500
results, the newest test result will replace the oldest one.
To recall your test memory, start the meter without a test strip inserted.
1. Press the Main button to switch from the Time Mode to Memory Mode. You will
see the " " icon in the upper left corner of the display. The latest test result
will appear with the number " 1 " .
2. Use either the up or down button on the side to review all previous results with
date and time. Results display from the most recent (Sequence no. " 1 ") to the
oldest (Sequence no. " 500 ") in the lower right hand corner of the screen.
Recalling Test Results