Trividia Health TRUENESS AIR Owner's Booklet
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Trividia Health TRUENESS AIR Owner's Booklet

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TRUE
Owner's Booklet
Use only with TRUENESS
TM
Blood Glucose Test Strips
Customer Consultation • Monday - Friday,
8AM-8PM Eastern Standard Time
English or Spanish
1-800-803-6025
www.trividiahealth.com
Manufactured for:
Fort Lauderdale, FL 33309 U.S.A.
© 2024 Trividia Health, Inc. TRUENESS
TM
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 by Trividia
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
NESS
AIR
™
Blood Glucose
Monitoring System

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Summary of Contents for Trividia Health TRUENESS AIR

  • Page 1 Fort Lauderdale, FL 33309 U.S.A. © 2024 Trividia Health, Inc. TRUENESS 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 by Trividia Health, Inc.

  • Page 2: Table Of Contents

    Table Of Contents TRUE NESS ™ ™ Introduction to the TRUENESS AIR Blood Glucose Monitoring System....1 Blood Glucose Intended Use........................2 Monitoring System Description........................2-3 Test Principle........................3 Fast Test Guide Limitations.........................4 2 simple steps Important Safety Instructions..................5-6 ™ About the TRUENESS Blood Glucose Test Strip............7 ™...

  • Page 3: Intended Use

    Intended Use INTRODUCTION: TRUENESS AIR Blood Glucose Monitoring System TRUENESS AIR Blood Glucose Monitoring System ™ ™ is intended for use in the quantitative measurement of Dear TRUENESS AIR Blood Glucose Monitoring System ™ glucose in capillary whole blood from the nger. It is Owner: intended to be used by people with diabetes mellitus at TRUENESS...

  • Page 4: Test Principle

    Limitations Trividia Health, Inc. ey may be used with the For in vitro diagnostic use only. TRUENESS Blood Glucose Monitoring System. ™ For self-testing. Not for use on the critically ill. Other lancets and lancing devices that are cleared can be Not for neonatal use.

  • Page 5: Important Safety Instructions

    Important Safety Instructions a new test strip. If you get a similar result, call your healthcare professional immediately. Read this section before using your TRUENESS ™ If your blood glucose result is above 200 mg/dL Blood Glucose Monitoring System. (or a high glucose level per your healthcare professional's Always take the following basic safety precautions: instruction), or the meter displays “HI”...

  • Page 6: About The Trueness

    About the TRUENESS Blood Glucose Test Strip Important TRUENESS Blood Glucose Test Strip ™ ™ Information TRUENESS blood glucose test strip is intended to ™ ℉ Store the test strip in a cool dry place between 41 be used with the TRUENESS AIR blood glucose meter ™...

  • Page 7: Knowing Your Trueness

    Knowing Your Blood Glucose Meter AIR Blood Glucose Meter Display TRUENESS TRUENESS ™ ™ TRUENESS Key Functions of the ™ Blood Glucose Meter Battery Door LCD Display Test strip ejector Test strip port The display shows results, Insert the test strip here. messages and test results stored in memory 1.

  • Page 8: Setting Up Your Trueness

    Setting Up Your TRUENESS AIR Blood Glucose Meter STEP 3: How to Set the Year ™ Press the “OK” button when the LCD displays “yES’ , the last adjust it to your local time zone. Check the date and time each two digits of the year ashes.

  • Page 9: Power Saving

    STEP 5: Repeat steps 3-4 to set up day, hour and minutes 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.

  • Page 10: Performing A Control Solution Test

    Important Information Performing a Control Solution Test Use only TRUENESS control solution and test strips with Check the expiration and written opened dates on your control ™ solution bottle and blood glucose test strip vial. Discard any expired your TRUENESS AIR blood glucose meter.
  • Page 11 STEP 4: Apply the control solution Unexpected Results: 1. Gently swirl and invert the control solution bottle to mix If the test result falls outside the control range that is printed and remove the cap. DO NOT shake the control solution. on the test strip vial for the control level you are using, check the Troubleshooting Guide located in the System 2.

  • Page 12: Performing A Blood Glucose Test

    Performing a Blood Glucose Test How to Test Blood STEP 1: WARNING! Take a test strip out of the test strip vial. Immediately close the vial lid. 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.
  • Page 13 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. STEP 6: • Used or contaminated lancets present a serious infection hazard that can lead to dangerous infections if not properly stored or disposed.

  • Page 14: Using The Trueness

    Using the TRUENESS ™ AIR Blood Glucose Meter Memory Understanding Your Result results and control solution test results with the date and time in appears along with the unit of measure, date, and time. its memory. You can review the individual results by entering the memory mode.
  • Page 15 Averages of All Results 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.

  • Page 16: True Manager Air App

    No two-way communications (from App to the Meter). memory. 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.

  • Page 17: Cleaning And Disinfection Of Your System

    Cleaning and Disinfection of Your System: 3. If Bluetooth cannot connect to the App, please check whether the mobile device’s Bluetooth is on. If yes, please turn o the blood glucose meter has been tested TRUENESS ™ meter, press and hold the “OK” button to restart the meter to and proven robust to the recommended cleaning and reconnect Bluetooth.

  • Page 18: Performance Characteristics

    Step 2: Allow the meter to air dry at room temperature. Within Within Within Within e meter can be cleaned and disinfected up to 520 times, with level and the TRUENESS AIR meter result ±5% ±10% ±15% ±20% cleaning and disinfection at least for 5 years.

  • Page 19: Caring For Your Trueness

    Caring for Your TRUENESS AIR Blood Glucose Meter ™ TRUENESS AIR blood glucose meter does not require ™ professional maintenance services. Sample Volume Avoid getting dirt, dust, blood, control solution, foods, or Sample Type Fresh capillary whole blood liquids inside the meter. Results Value Plasma equivalent values solution in the carrying case at room temperature in a dry...
  • Page 20 Battery Step 2: Remove the used batteries from the meter and replace them with 2 new AAA alkaline batteries. Install the batteries Your blood glucose meter is powered TRUENESS ™ according to the “+” and “–” symbols in the battery compart- by 2 AAA alkaline batteries.
  • Page 21 System Troubleshooting Special Messages What it means: Special messages and error messages help to identify certain Low battery. A test cannot be performed. problems. However, improper use may cause an inaccurate Action: Replace the batteries. result without showing an error message. In the event of a problem, refer to the Troubleshooting Guide below.
  • Page 22 Troubleshooting Guide • A er inserting test strip, meter does not turn on. What it means: Meter internal error. Reason Action Action: Call Customer Care at 1-800-803- 6025, Monday – Friday 8AM-8PM EST. Test strip inserted upside down Remove test strip. Re-insert or backwards correctly.
  • Page 23 • Control test result is out of range Remove test strip. Insert the contact end of the test strip into Reason Action Test strip inserted incorrectly the meter until it stops. Printed side of test strip must face up. Read the instructions for use Testing error Reapply the blood sample.
  • Page 24 Important Information about TRUENESS AIR Blood Factors such as the amount of red blood cells in the blood (a ™ Glucose Meter high or low hematocrit) or the loss of bodily uids (severe dehydration) may also cause the TRUENESS AIR blood ™...
  • Page 25 Unexpected Test Results Caution: High Blood Glucose Test Results Unexpected test results can occur. If this happens, please If your test result is higher than expected, retest with a new test refer to the cautions below. strip. If the result continues to be higher than expected, contact your healthcare professional right away.
  • Page 26 Cybersecurity/Electromagnetic Compatibility/Wireless Cybersecurity/Electromagnetic Compatibility/Wireless e meter complies with the electromagnetic requirements of Caution: IEC 60601-1-2:2014+A1:2020. IEC 60601-1-2:2014+A1:2020. •Keep your Bluetooth pairing code from other people. •TRUENESS™ AIR meter cannot be updated or patched by user, so DO NOT accept • Essential Performance (accuracy of measurement value): any change or update to the Meter.
  • Page 27 Guidance and manufacturer’s declaration- Immunity Test Compliance Electromagnetic Electromagnetic Immunity Test Level Level environment – guidance Immunity Test Compliance Electromagnetic Power frequency magnetic Test Level Level environment – guidance Power frequency 30A/m, 30A/m, 50/60Hz acteristic of a typical location 50/60Hz IEC 61000-4-8 in a typical residential Wrong conclusions may...

  • Page 28: Air Blood Glucose Meter

    Quality of Service For transmitter maximum rated output power not listed in the above table, the recommended isolation distance D in meters TRUENESS AIR blood glucose Meter can transmit blood ™ (m) can be determined by the formula in the corresponding glucose data in an open environment within 10 meters through transmitter frequency column where P is the transmitter maximum rated output power provided by the transmitter...
  • Page 29 ™ AIR blood glucose monitoring system: 1. Trividia Health Inc. warrants this meter to be free of defects in materials and workmanship for 5 years from the date of purchase. If during this 5 year period, the meter does not work properly, Trividia Health will replace ™...

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