Trividia Health TRUENESS AIR User manual

Use only with TRUENESSTM
Blood Glucose Test Strips
Customer Consultation • Monday - Friday,
8AM-8PM Eastern Standard Time
English or Spanish
1-800-803-6025
www.trividiahealth.com
© 2024 Trividia Health, Inc.TRUENESSTM and the
Trividia Health logo are trademarks of Trividia
Health, Inc.The Bluetooth® word mark and logos
are registered trademarks owned by Bluetooth
SIG, Inc. and any use of such marks byTrividia
Health, Inc. is under license.
Other trademarks and
trade names are those of
their respective owners.
P/N: 36301324-A.9
Release date: 2024/02/01
ZEA4TVH35 Rev. 1
Owner’s Booklet
Manufactured for:
Fort Lauderdale, FL 33309 U.S.A.
NESS™ AIR
TRUE
Blood Glucose
Monitoring System

Expected Results for people without diabetes:
Plasma glucose for people without diabetes1
Before eating < 100 mg/dL
2 hours after a meal < 140 mg/dL
Fast Test Guide
For quick reference only, not intended as a substitute for
complete instructions. Please read entire Owner’s Booklet
and product Instructions for Use before testing.
INSERT TEST STRIP
1 2 APPLY BLOOD SAMPLE
2 simple steps
NESS™ AIR
TRUE
Blood Glucose
Monitoring System
Table Of Contents
Introduction to the TRUENESS
™
AIR Blood Glucose Monitoring System..............1
Intended Use.....................................................................................................................2
Description........................................................................................................................2-3
Test Principle.....................................................................................................................3
Limitations.........................................................................................................................4
Important Safety Instructions.........................................................................................5-6
About the TRUENESS
™
Blood Glucose Test Strip.......................................................7
Important TRUENESS
™
Blood Glucose Test Strip Information................................8
Knowing Your TRUENESS
™
AIR Blood Glucose Meter..............................................9
TRUENESS
™
AIR Blood Glucose Meter Display..........................................................10
Setting Up Your TRUENESS
™
AIR Blood Glucose Meter...........................................11-13
Power Saving.....................................................................................................................14
Control Solution Testing.................................................................................................14-15
Performing a Control Solution Test...............................................................................16-18
Performing a Blood Glucose Test..................................................................................19-23
Using the TRUENESS
™
AIR Blood Glucose Meter Memory......................................24-27
TRUE MANAGER AIR APP..........................................................................................27-29
Cleaning and Disinfection of Your System...................................................................30-31
Performance Characteristics...........................................................................................31-32
System Specications.......................................................................................................33
Caring for Your TRUENESS
™
AIR Blood Glucose Meter............................................34
Battery................................................................................................................................35-36
System Troubleshooting..................................................................................................37-42
Important Information about TRUENESS
™
AIR Blood Glucose Meter....................43-46
Cybersecurity/Electromagnetic Compatibility/Wireless............................................47-52
Limited Warranty and References..................................................................................53

1
INTRODUCTION:
TRUENESS™
AIR Blood Glucose Monitoring System
Dear TRUENESS™ AIR Blood Glucose Monitoring System
Owner:
TRUENESS™ AIR Blood Glucose
information about the System and how it operates. Please read
ank you for choosing the
Monitoring System. is Owner's Booklet contains important
it carefully before using your new System.
TRUENESS™ AIR Blood Glucose Monitoring System ise
e
e
e
e
e
designed for easy, user-friendly and convenient operation. It
only needs a small volume of sample (1μL). e
blood glucose test strip does not require coding. is feature
saves time and avoids errors due to improper coding. e
TRUENESS™
memory allows you to save up to 600 test results. All these
advantages make the
TRUENESS™ AIR Blood Glucose
Monitoring System an excellent blood glucose monitoring tool.
TRUENESS™ AIR Blood Glucose Monitoring System ise
designed to help you and your healthcare professional monitor
instructions for the correct use of your system. Please read it
your blood glucose levels. is Owner's Booklet provides the
carefully before use.
If you need assistance, please call Customer Care
at 1-800-803-6025, Monday-Friday 8AM-8PM EST. Please call
your healthcare professional when Customer Care is closed,
or visit our website at www.trividiahealth.com.
2
Intended Use
TRUENESS™ AIR Blood Glucose Monitoring System
is intended for use in the quantitative measurement of
glucose in capillary whole blood from the nger. It is
intended to be used by people with diabetes mellitus at
home as an aid in monitoring the eectiveness of their
diabetes control program.
TRUENESS™ AIR Blood Glucose Monitoring System
is intended to be used by a single patient and should not be
shared. It is for in vitro diagnostic use only.
TRUENESS™
TRUENESS™
AIR Blood Glucose Monitoring System is
not intended for the diagnosis of, or screening for diabetes.
It is not intended for use on neonates.
Description
Note: TRUEdraw Lancing Device, TRUEplus Lancets,
Blood Glucose Control Solutions,
Blood Glucose Meter, and
Blood Glucose Test Strips are sold separately.
e meter package contains 1 blood
glucose meter and 2 AAA alkaline batteries.
Blood Glucose Monitoring System is
for self-testing outside the body (in vitro diagnostic use).
TRUENESS™ AIR
TRUENESS™
AIR
TRUENESS™
AIR TRUENESS™
TRUENESS™ AIR Blood Glucose Monitoring System
is comprised of the
TRUENESS™ AIR blood glucose
meter and the
TRUENESS™ blood glucose test strip.

Other lancets and lancing devices that are cleared can be
used with Blood Glucose Monitoring
System.
e lancing device and lancets are manufactured for
Trividia Health, Inc. ey may be used with the
43
TRUENESS™ AIR
TRUENESS™
AIR
Blood Glucose Monitoring System.
Use only SUPER SANI-CLOTH ® Germicidal Disposable
Wipes (EPA Reg. No. 9480-4) for cleaning and disinfecting
Test Principle
A glucose test is based on the measurement of electrical
current caused by the reaction of glucose with the FAD
glucose dehydrogenase enzyme on the electrode of the test
tip of the test strip through capillary action. Glucose in the
strip. e blood or control solution sample is drawn into the
sample reacts with the FAD glucose dehydrogenase enzyme
and generates electrons, which produce an electrical current.
TRUENESS™ AIR blood glucose meter measures the
electrical current and calculates the glucose result. e
e
glucose result is displayed by the meter in mg/dL units.
Limitations
▶For in vitro diagnostic use only.
▶For self-testing.
▶Not for use on the critically ill.
▶Not for neonatal use.
▶Not for screening or diagnosis of diabetes mellitus.
▶Not for alternative site testing (AST) use.
▶Xylose: Do not perform test during or soon aer xylose
absorption testing. High xylose level in the blood will cause
inaccurate results.
▶Severe dehydration and excessive water loss may cause
false low results. If you believe you are suering from severe
dehydration, consult a healthcare professional immediately.
▶Inaccurate results may occur in severely hypotensive
individuals or patients in shock.
▶Inaccurate results may also occur in individuals
experiencing a hyperosmolar-hyperglycemic-state (HHS).
▶For single patient use only and should not be shared.
▶NOT intended for use in healthcare or assisted-use
settings such as hospitals, physician oces, or long-term
care facilities, including for routine assisted testing or as
part of glycemic control procedures.
▶e meter and lancing device are for single patient use!
DO NOT share them with anyone including other family
members! DO NOT use on multiple patients. Use of this
device on multiple patients may lead to transmission of
Human Immunodeciency Virus (HIV), Hepatitis C Virus
(HCV), Hepatitis B Virus (HBV), or other blood borne
pathogens.
the meter and
TRUEdraw lancing device. e wipes can
be purchased at: Amazon.com, Ocedepot.com or
Walmart.com.

5
Important Safety Instructions
Read this section before using your
TRUENESS™ AIR
TRUENESS™
AIR
Blood Glucose Monitoring System.
Always take the following basic safety precautions:
▶Insucient sample may cause inaccurate test results.
▶If you have symptoms that do not reect your blood
glucose test results, and you have followed all instructions
described in this booklet, call your healthcare professional.
▶DO NOT change your treatment based on a single result
that does not match how you feel.
▶DO NOT use other brands of blood glucose test strips
and control solutions with the blood
glucose meter.
▶ Before using any product to test your blood glucose level,
read all instructions and practice a test. Do all quality
control checks as directed and consult your diabetes
healthcare professional.
▶ Keep the test strip vial and control solution bottle away
from children. e test strip vial, test strip, and control
solution bottles can be choking hazards. Do not drink the
control solution.
▶ All parts of this package are considered biohazardous
once they have been used for a blood test. ey can
potentially transmit infectious diseases, even aer cleaning
and disinfection.
▶ If your blood glucose result is below 70 mg/dL (or a low
glucose level per your healthcare professional's instruction),
or the meter displays “LO” (less than 40 mg/dL), retest with
6
TRUENESS™ AIR
TRUENESS™
AIR
a new test strip. If you get a similar result, call your
healthcare professional immediately.
▶ If your blood glucose result is above 200 mg/dL
(or a high glucose level per your healthcare professional's
instruction), or the meter displays “HI” (greater than
600 mg/dL), retest with a new test strip. If you get a similar
result call your healthcare professional immediately.
▶ Close supervision is necessary when the device is used by,
on, or near children or people with physical limitations that
may impair correct use of the system.
▶ Use the Blood Glucose Monitoring
System only for the intended use as described in this
Owner's Booklet.
▶ DO NOT use the Blood Glucose
Monitoring System if it is not working properly, or if it has
suered any damage.
For further information, please refer to:
Person Poses Risk for Transmitting Blood-borne Pathogens: Initial Communication”,
“FDA Public Health Notication: Use of Fingerstick Devices on More than One
at https://wayback.archive-it.org/7993/20170111013014/http:/www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
CDC website on “Infection Prevention during Blood Glucose Monitoring and Insulin
Administration", at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.
html

7
About the TRUENESS™ Blood Glucose Test Strip
TRUENESS™ blood glucose test strip is intended to
be used with the TRUENESS™ AIR blood glucose meter
to measure the amount of blood glucose in fresh capillary
TRUENESS™ blood glucose test strip
used with the TRUENESS™
provides a complete test system that is intended for
AIR blood glucose meter
in vitro
diagnostic use by people with diabetes. e
TRUENESS™
blood glucose test strips do not require coding. Please refer
to the “Performing a Blood Glucose Test” section for
complete instructions.
TRUENESS™ blood glucose test strip consists of the
following parts:
8
Important TRUENESS™ Blood Glucose Test Strip
Information
▶ Keep your test strips in the original vial. Do not transfer
them to any other vial or container.
▶ Before handling the test strip, wash your hands with soap
and water and dry them. Hold the sides of the test strip
when removing it from the vial or inserting it into the
meter.
▶ Only remove the test strip from the vial when you are
ready to perform a test. Firmly recap the vial immediately
▶ Only apply blood or control solution to the tip of the test
not place blood on any other part of the test strip.
▶ When using a new vial of test strips, write the date opened
the written date or once the printed expiration date has
.
▶ Do not use the test strips beyond the expiration date
printed on the vial.
WARNING:
vial and the test strip can be a choking hazard.
▶ Store the test strip in a cool dry place between 41
℉ -
86
℉ (5 ℃ -30 ℃ ), and 10% - 85% relative humidity.
Keep away from direct sunlight and heat.
DO NOT FREEZE.

9
Knowing Your TRUENESS™ AIR Blood Glucose Meter
Key Functions of the TRUENESS™ AIR Blood Glucose Meter
LCD Display
The display shows results,
messages and test results
stored in memory
Left arrow-Adjust the setting
1) Scroll through test results
Power/Set/OK button
2) Set options
Right arrow-Adjust the setting
1) Scroll through test results
2) Select Before Meal or After Meal symbol
3) Enter the Date-Time and beep setting
Test strip port
Insert the test strip here.
Test strip ejector Battery Door
10
TRUENESS™ AIR Blood Glucose Meter Display
1. Battery symbol
2. Bluetooth symbol
3. Test result or error message
4. Temperature symbol
5. Audio symbol
7. Date and time
8. Sequence number of test result
9. Drop Symbol-Apply blood or control solution
10. Control Symbol-Result is from control solution
11. Ketone test alert symbol
12. Unit of measure (Factory set to mg/dL; cannot be changed
by user)
For assistance obtaining other components, please call 1-800-803-6025.

11
Setting Up Your TRUENESS™ AIR Blood Glucose Meter
adjust it to your local time zone. Check the date and time each
time the batteries are replaced. Reset the date and time if they
are not correct.
STEP 1: Insert the Batteries
Refer to "Battery" section for instructions.
Open the Battery Cover on the back of the meter. Insert two
AAA alkaline batteries as indicated by the “+” and “-” symbols.
Meter automatically enters into set up mode.
STEP 2: How to Enter the Setup Mode
enters into the setup mode. Press “>” or “<” to choose "yES" to
set time or date. Press “>” or “<” to choose "no" to enter into
Sound setting mode.
12
STEP 3: How to Set the Year
Press the “OK” button when the LCD displays “yES’, the last
two digits of the year ashes. Press “>” or “<” to change the
year.
STEP 4: How to Set the Month
into the month setup mode and the month number ashes.
Press “>” or “<” to adjust the month. Press “OK” to conrm
and enter day setup mode.
Year:
Month:

Aer nished setting the minutes, the Meter automatically
enters beeper setting mode. e display shows “On” and
“ ”. Press “ ” or “ ” to choose “On” or “O”. Press “OK” to
conrm your selection. e meter turns o automatically. e control solution helps determine if the meter and test strip
are working properly. A control test also helps you practice proper
testing technique. e control solution is a water-based solution
containing a certain amount of glucose. It reacts with the test strip
when used in place of blood. e control solution gives results
within the corresponding range for its level printed on the test
strip vial label. You can use Level 1 or Level 2 TRUENESS™ control
solution with your TRUENESS™ AIR blood glucose meter and
TRUENESS™ blood glucose test strips.
13
STEP 5: Repeat steps 3-4 to set up day, hour and minutes
STEP 6: How to Set Sound
Note: If the batteries are replaced, it may cause the date and time
to reset. Resetting the date and time does not change the time
stamps of previous test results.
Day Hour Minute
14
Power Saving
▶ Meter automatically turns o aer 3 minutes if no blood or
control sample is applied while in test mode.
▶ Aer testing blood or control sample, the result is displayed
for one (1) minute if the test strip remains in the meter.
If the test strip is removed, the meter immediately turns o.
▶ Meter automatically turns o if there is no activity within
one minute while in setup mode, test results review mode,
and control solution test review mode.
Control Solution Testing
ere are two levels of control solution with dierent
concentrations of glucose: Level 1 and Level 2. Each test strip lot
has its own control ranges for Levels 1 and 2 printed on the test
strip vial.
Caution: e control solution ranges printed on the test strip
vial are not recommended ranges for your blood glucose.
and the ambient temperature for the test, wait at least 30
minutes before testing to allow the meter, control solution and
test strips to adjust to the ambient temperature.

15
Important Information
▶ Use only
TRUENESS™ control solution and test strips with
your
TRUENESS™AIR blood glucose meter.
▶ Check the expiration date on the control solution bottle. Do
not use if expired.
▶ When using a new bottle of control solution, write the date
opened on the control solution bottle. Discard the bottle 3
months aer the date written or once the printed expiration
▶ Control solution is for in vitro diagnostic use only.
Why Perform a Control Solution Test?
▶ Ensures your meter and test strip are working properly.
▶ Allows practice testing without using blood.
When Should You Perform a Control Solution Test?
▶ When you begin using a new vial of test strips.
▶ When the test strip has been exposed to extreme
environmental conditions.
▶ If you drop the meter.
▶ If you suspect your results.
▶ Aer cleaning and disinfection of your meter.
▶ It is recommended to perform a Control Solution Test once a week.
Storage and Handling
▶ Close the control solution bottle cap tightly aer each use.
▶ Store the control solution at temperatures between
34 -86 (1 -30 ).
▶ DO NOT FREEZE.
WARNING!
temperature and the ambient temperature for the test, wait
at least 30 minutes before testing to allow the meter and test
strips to adjust to the ambient temperature.
16
Performing a Control Solution Test
Check the expiration and written opened dates on your control
solution bottle and blood glucose test strip vial. Discard any expired
test strip vial or control solution bottles. DO NOT apply blood while
in Control Solution Testing Mode, it will cause an E-8 Error message.
STEP 1: Wash your hands
Wash your hands with soap and water. Be sure to dry your hands
before performing a test.
STEP 2: Insert a test strip into the meter
Start with the blood glucose meter o. Insert
a test strip with the printed side facing up
and contact end toward the meter. Push the
test strip into the meter Test Strip Port until
it stops.
STEP 3: Enter Control Solution Testing Mode
IMPORTANT: Press “<”, the meter will
enter into control solution testing mode
and display the control symbol .
Caution: DO NOT smear or scrape the
control solution onto the test strip. DO
NOT apply control solution to the test
strip when the test strip is out of the
meter. DO NOT move meter or test strip
during test countdown. DO NOT apply
control solution while in Blood Testing
Mode, it will cause an E-8 Error message.

17
STEP 4: Apply the control solution
1. Gently swirl and invert the control solution bottle to mix
and remove the cap. DO NOT shake the control solution.
2. Squeeze the bottle and discard the rst drop. Wipe the bottle
tip with a clean tissue.
3. Squeeze one drop of control solution onto a clean piece of
aluminum foil or plastic wrap.
4. With the test strip still in the meter, touch
the tip of the test strip to the control
solution drop until the meter beeps. Make
Note: If sample is not applied within 3 minutes
Reinsert test strip and retest.
6. Check if the test result is in range.
Compare the test result with the
corresponding level's control range printed
on the test strip vial you are using.
Note: If the test results in an E-8 error, repeat
test with new test strip making sure that the
meter is set to control mode by pressing the
“<” button.
7. Press Eject button and eject the test strip
into a trash container. Discard the used
test strip carefully as medical waste.
control solution test result with the control symbol .
If the meter does not display the control symbol, re-do the
test.
18
Unexpected Results:
If the test result falls outside the control range that is printed
on the test strip vial for the control level you are using,
check the Troubleshooting Guide located in the System
Troubleshooting section of this booklet and repeat the test.
Results that fall outside the control range may indicate:
▶ Error in performing the test
▶
C ontrol solution has not been mixed well
▶ Expired or contaminated control solution
▶
C ontrol solution that is too warm or too cold
▶ Expired or deteriorated test strip
▶ Meter malfunction
Caution: Do not use test strips or control solution that are past
the discard date, expired, or have been damaged, as your results
may be inaccurate.
Contact Customer Care:
If your test strip has been damaged or if you continue to get
out-of-range results, it means that the
TRUENESS™ AIR
blood glucose monitoring system or the control solution may
not be working as they should.
DO NOT use the meter or test strips to test your blood
glucose level.If you are unable to resolve the problem, contact
Customer Care at 1-800-803-6025, Monday – Friday 8AM-
8PM EST. Please call your healthcare professional when
Customer Care is closed.

20
How to Test Blood
STEP 1:
Take a test strip out of the test strip vial.
Immediately close the vial lid.
STEP 2:
Fully insert the test strip into the meter
Test Strip Port until it stops.
Tip: Insert TRUENESS™blood glucose
test strip with the printed side facing
up and contact end toward the meter.
Caution: DO NOT insert and remove
the test strip repeatedly.
Apply
sample here
Insert this end
into meter
FRONT BACK
STEP 3:
When the blood glucose meter screen
press “ >”to mark the test as Before Meal
.
Tip: If you do not choose Before Meal or
result.
19
Performing a Blood Glucose Test
WARNING!
and the ambient temperature for the test, wait at least 30
minutes before testing to allow the meter and test strips to
adjust to the ambient temperature.
Obtaining a Blood Sample
From Fingertip
Please discard it carefully according to your Healthcare
Professional's instructions.
• Lancing device and meter are intended only for a single user and
should not be shared with anyone, including your family members.
• Check the expiration date of the sterile lancet before testing.
Do not use if expired.
• Sterile lancets are for single use only. DO NOT re-use.
• To help prevent false high results, wash hands before using
the system to test blood, especially aer fruit has been handled.
STEP 4:
Make sure the lancing device is pressed
rmly to your nger. Lance nger and
allow a blood drop to form. Images for
lancing device are for illustration purposes
only. Your lancing device may look dierent.
Refer to lancing device Instructions for Use
for detailed instructions on using the
lancing device to obtain a blood drop.
Prepare ngertip by washing hands in warm, soapy water.
Rinse well. Dry thoroughly. Refer to lancing device
Instructions for Use for detailed instructions on cleaning
and disinfecting the ngertip.
Place end of lancing device equipment with a lancet against
tip of nger. Lance ngertip.
Set lancing device aside. To help blood drop form, lower
hand to waist level, gently massaging nger from palms to
ngertip. Allow blood drop to form before attempting to
apply to the test strip. Apply sample to test strip Sample Tip.
Recap and remove used lancet from lancing device

21
STEP 5:
While the meter screen displays the
blood sample to the tipof the Test Strip
Reaction Zone.
Allow the blood to be drawn into the test
Attention: Hold the tip of the test strip to the blood drop until the meter beeps.
Attention:
• e cap of the lancet is a single sterile barrier system. Do not use the lancet if the cap
has been previously removed from the device.
• Used or contaminated lancets present a serious infection hazard that can lead to
dangerous infections if not properly stored or disposed. Please discard them carefully
according to your healthcare professional’s instructions or dispose them in an appropriate
trash container.
• If you did not produce a large enough blood sample, gently massage your nger.
DO NOT SQUEEZE YOUR FINGER. Refer to Lancing Device Instructions for Use to
adjust the puncture depth and lance again.
end of the test strip. If blood is not applied within 3 minutes of inserting a test strip, the
meter turns o. Reinsert the test strip and start test as in Step 5.
Caution:
DO NOT smear or scrape the blood onto the test strip.
DO NOT apply blood to the test strip when the test strip is out of the
meter.
DO NOT move meter or test strip during test countdown.
DO NOT expose the blood drop to the air for a long time.
DO NOT apply blood sample before a blood drop symbol ashes on
the display.
STEP 6:
displays the test result.
Caution
If a test result exceeds 250 mg/dL, "KT" symbol will be
displayed on the screen to remind you to perform a ketone test.
22
Caution: Used lancets and test strips are biohazardous. Please discard them carefully
according to your healthcare professional’s instructions or dispose them in an
appropriate trash container.
Note:
device, or the test strip.
STEP 7:
Eject the test strip into a trash container.
Discard the used test strip carefully to
avoid contamination.

24
Unmarked Aer meal Before meal
Using the TRUENESS™AIR Blood Glucose Meter Memory
results and control solution test results with the date and time in
its memory. You can review the individual results by entering the
memory mode.
STEP 1: Enter the Memory Mode
press and hold the “OK” button
to turn on the meter.
displayed.
23
Understanding Your Result
appears along with the unit of measure, date, and time.
If your test result is above 600 mg/dL, the screen displays “HI”.
If your test result is below 40 mg/dL, the screen displays “LO”.
Caution: If a test result exceeds 250 mg/dL, "KT" symbol will be
displayed on the screen to remind you to perform a ketone test.
If you cannot test due to a problem with your testing supplies, contact
Customer Care at 1-800-803-6025, Monday-Friday 8AM-8PM EST.
Please call your healthcare professional when Customer Care is closed.
Failure to test could delay treatment and/or lead to serious medical
conditions.

25
STEP 2: Reviewing the Blood Glucose Test Results
Press the “<” button to view all the blood glucose results in
displayed in the upper right hand corner of the screen. Press
the “>” button to view all/before meal/aer meal test result
averages for the past 7, 14, 30, and 90 days. e Average of days
that you are viewing is displayed in the upper right hand corner
of the screen. If no blood glucose test results have been stored,
the meter displays " ".
Blood Glucose
Test Result
No Blood
Glucose Test
Result
26
eal Averages
B
efore Meal Averages:
7 day average 14 day average 30 day average 90 day average
7 day average 14 day average 30 day average 90 day average
7 day average 14 day average 30 day average 90 day average
Averages of All Results
Note: “LO” results are included in the Average as 40 mg/dL.
“HI” results are included as 600 mg/dL

27
STEP 3: Reviewing the Control Solution Test Results
Press the “OK” button to view your control solution test results
solution test results appear along with the control symbol. Press
“<” or “>” button to view all the control solution results in
displayed in the upper right hand corner of the screen. If no
control solution test results been stored, the meter displays
To view the blood glucose results again, press the “OK” button.
results, press and hold the "OK" button until the meter turns
“ ”.
Control Solution
Result
No Control
Solution Result
test results and control solution test results. If these numbers
are exceeded, any new result causes the oldest result in
memory to be deleted.
28
Receives blood glucose test data and control solution data from the Meter.
Only displays data and trends.
No two-way communications (from App to the Meter).
CAUTION: e TRUENESS AIR Meter has not been tested for use with any other
App other than compatible TRUE MANAGER AIR APP.
e manufacturer is not responsible for any erroneous results from the use of other APPs.
TRUE MANAGER AIR APP
Download the TRUE MANAGER AIR APP
Step 1: On your compatible smartphone or tablet, go to the
App Store or the Google Play store.
Step 2: Search for the TRUE MANAGER AIR APP.
Step 3: Install the TRUE MANAGER AIR APP.
1. Press and hold the "OK" button until the meter turns on.
2. Follow your mobile device's App instructions in order to
locate the TRUENESS™
AIR meter (look for a device named
THIAIR). Enter the last 6 digits of the meter serial number
connectivity. Once both devices are paired, you can have the
(found on the meter back label) into the mobile device. is
is the meter's PIN number. Wait for mobile device to conrm
App on the mobile device upload test results stored in the meter
memory.
Pairing (Connecting) Meter with Mobile Device
Pairing enables the meter to upload test results from the
meter's memory when requested by an App (application) on a
the mobile device must be within 10 feet of each other for the
results to upload.
How to use the TRUE MANAGER AIR APP
Step 1: Open the APP.
Step 2: Click the Sync icon “ ” to pair your meter with
your smartphone or tablet (see Pairing (Connecting)
Meter with Mobile Device section below).
Step 3: e test results will be uploaded automatically.

3029
Attention:
•
with Bluetooth.
• Keep the meter powered on in Memory mode when uploading data.
• If a test strip is inserted into the meter during the uploading of results to the App,
the results stop uploading. You must re-start the upload from the App installed on
the mobile device.
• To make sure that test results are secure, only let trusted people (doctor, family, etc.)
connect your meter to a mobile App.
• Keep meter serial number private.
• Allowing other people to upload results to a mobile App that is not yours could
result in a loss of privacy of your data.
TRUENESS™ AIR
Cleaning and Disinfection of Your System:
e blood glucose meter has been tested
and proven robust to the recommended cleaning and
disinfection procedures. If meter deterioration occurs
(e.g., foggy LCD screen, failure to detect inserted test strip,
faded or missing LCD screen segments, false high or false
low results for blood glucose test or control solution test),
stop using the meter and contact Customer Care at
1-800-803-6025, Monday – Friday 8AM-8PM EST.
Please call your healthcare professional when Customer
Care is closed.
Clean the meter and lancing device to remove blood, skin
oils, dirt, and dust aer each use. Clean and disinfect the
meter and lancing device at least once per week to eliminate
infectious agents.
e wipes below have been shown to be safe and eective
for use with the
TRUENESS™ AIR blood glucose meter:
SUPER SANI-CLOTH ® Germicidal Disposable Wipes
(EPA Reg. No. 9480-4). ey can be purchased at:
Attention: Used wipes should be disposed of according to
local regulations for infectious waste disposal.
Meter Cleaning Procedure
Step 1: Use one area of a new wipe to wipe 3 times horizontally
with moderate pressure on the entire meter surface. en, using
another unused area of the same wipe, wipe 3 times vertically
on the entire meter surface again. One time is counted as one
back and forth action (for example, le to right to le).
Step 2: Allow the meter to air dry at room temperature. We
recommend cleaning the meter at least once per week.
3. If Bluetooth cannot connect to the App, please check whether
the mobile device’s Bluetooth is on. If yes, please turn o the
meter, press and hold the “OK” button to restart the meter to
reconnect Bluetooth. If it remains unconnected aer 3 attempts,
please call Customer Care at 1-800-803-6025, Monday-Friday
8AM-8PM EST or visit our website at www.trividiahealth.com.

3231
Performance Characteristics
Accuracy for Home Use by Lay-Users
Your
TRUENESS™ AIR meter results may vary slightly from
technology.
in a clinical study used the
TRUENESS™ AIR meter to mea-
sure their blood glucose levels. For example, in this study, the
TRUENESS™ AIR meter displayed results within 15% of their
actual blood glucose level in 345 out of 354 measurements as
compared to an approved lab instrument.
level and the TRUENESS AIR meter result
Within
±5%
Within
±10%
Within
±15%
Within
±20%
Percent (and number) of samples 52.3%
(185/354)
82.2%
(291/354)
97.5%
(345/354)
99.7%
(353/354)
Mean,
mg/dL
43.4
102.3
132.1
212.5
339.8
1.8
3.5
4.2
6.3
9.7
4.0%
3.5%
3.3%
3.0%
2.9%
Pooled Standard Deviation,
mg/dL
Pooled Coecient of Variation,
%
Precision:
Within Run Precision (300 Venous Blood Tests per glucose level)
Control Level
1
2
3
4
5
Mean, mg/dL
45.0
98.2
137.8
204.1
381.7
Pooled Standard
Deviation, mg/dL
1.9
2.5
3.3
4.2
9.2
Pooled Coecient of
Variation, %
4.3%
2.6%
2.4%
2.1%
2.4%
Intermediate Precision (300 Control Solution Tests per Glucose Level)
Meter Disinfection Procedure
e disinfection procedure helps to eliminate infectious agents.
Meter disinfection should be performed at least once per week.
Step 1:
Aer cleaning the meter, use an unused wipe to cover
the entire meter surface for 2 minutes. Make sure all external
surfaces of the meter remain wet for 2 minutes.
Step 2: Allow the meter to air dry at room temperature.
e meter can be cleaned and disinfected up to 520 times, with
cleaning and disinfection at least for 5 years.
NOTE:
To clean and disinfect the lancing device, refer to the Lancing
Device Instructions for Use for detailed instructions.
Please contact Customer Care if you have any questions at
1-800-803-6025, Monday – Friday 8AM-8PM EST.
▶ If the lancing device button fails to work, stop using the
device and contact Customer Care at 1-800-803-6025,
Monday – Friday 8AM-8PM EST.
▶ Clean and disinfect the meter and lancing device prior to
handling if a second person assists you with testing.
▶ Wash hands thoroughly with soap and water aer handling
the meter, lancing device, or test strips.

33 34
Caring for Your TRUENESS™AIR Blood Glucose Meter
TRUENESS™ AIR blood glucose meter does not require
professional maintenance services.
▶ Avoid getting dirt, dust, blood, control solution, foods, or
liquids inside the meter.
solution in the carrying case at room temperature in a dry
place.
▶ DO NOT FREEZE.
▶ Do not store in the bathroom or kitchen.
▶ Your
TRUENESS™ AIR blood glucose meter is a precision
instrument. Handle with care.
Sample Volume 1 μL
Sample Type Fresh capillary whole blood
Results Value Plasmaequivalent values
Assay Method Electrochemical
Meter Storage
Conditions -4℉-131℉(-20°C-55°C) (RH≤95%)
Dimensions 3.65 in. (L) x 2.11 in. (W) x 0.89 in. (H)
(92.8 mm (L) x 53.5 mm (W) x 22.5 mm (H))
Weight 1.89 oz (53.5 g) with batteries
Power Source 2 AAA alkaline batteries
Battery Life Approximately 1,000 tests
Displa Ly CD
Memory 600 test results including blood glucose
test results and control solution test
results
Operating Range
Temperature: 50℉-104℉ (10°C-40°C)
Relative Humidity:
10%-90% RH (non-condensing)
Hematocrit:15%-60%
Altitude: Up to 10,100 feet (3,078 meters)
Results Range: 40-600 mg/dL

35
Battery
Your
TRUENESS™ AIR blood glucose meter is powered
by 2 AAA alkaline batteries. You can nd replacement
batteries in most stores. e meter shows a battery symbol
only when the batteries are low.
Low Battery
to indicate the condition of the meter batteries. When
these messages appear, there is not enough power to
perform a test. Replace the batteries as soon as possible.
Changing the Batteries
To replace the batteries, make sure the meter is turned o.
Step 1: With the meter turned o, push down on the Battery
Door and slide to open.
36
Step 2: Remove the used batteries from the meter and replace
them with 2 new AAA alkaline batteries. Install the batteries
according to the “+” and “–” symbols in the battery compart-
ment. Check that you have placed the batteries correctly and
close the Battery Door.
Step 3:
meter’s test result memory. e unit of measure remains as
mg/dL.
WARNING! As with all small objects, keep batteries away
from small children. If a battery is swallowed, seek medical
help right away.