Trividia Health TRUE METRIX PRO Owner's Booklet

Trividia Health TRUE METRIX PRO Owner's Booklet

Blood glucose system
Hide thumbs Also See for TRUE METRIX PRO:

Advertisement

Quick Links

TMX_PRO_OB_CVR_RE4TVHP03r54.pdf
C
M
Y
CM
MY
CY
CMY
K
Manufactured by:
Fort Lauderdale, FL 33309 U.S.A.
© 2021 Trividia Health, Inc.
TRUE METRIX PRO and the Trividia Health
logo are trademarks of Trividia Health, Inc.
RE4TVH
1
5/11/21
14:14
P
03 Rev. 54
Professional Monitoring
Blood Glucose System
Owner's
Booklet
Use only with TRUE METRIX
®
PRO
PRO
Blood Glucose Test Strips
Call for assistance
Monday - Friday,
8AM-8PM Eastern Standard Time
English or Spanish
1-800-803-6025
www.trividiahealth.com

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the TRUE METRIX PRO and is the answer not in the manual?

Questions and answers

Summary of Contents for Trividia Health TRUE METRIX PRO

  • Page 1 Monday - Friday, 8AM-8PM Eastern Standard Time English or Spanish 1-800-803-6025 www.trividiahealth.com Manufactured by: Fort Lauderdale, FL 33309 U.S.A. © 2021 Trividia Health, Inc. TRUE METRIX PRO and the Trividia Health logo are trademarks of Trividia Health, Inc. RE4TVH 03 Rev. 54...
  • Page 2 TMX_PRO_OB_CVR_RE4TVHP03r54.pdf 5/11/21 14:14 Notes Professional Monitoring Blood Glucose System Fast Test Guide 2 simple steps INSERT APPLY TEST STRIP BLOOD SAMPLE 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. Expected Results for people without diabetes: Plasma Blood Glucose Result Before eating...
  • Page 3: Introduction And Important Information

    INTRODUCTION: TRUE METRIX® PRO Professional Monitoring Blood Glucose System TRUE METRIX PRO is a simple, accurate way to test whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about TRUE METRIX PRO products, visit our web site at: www.trividiahealth.com.
  • Page 4 For the most accurate results using TRUE METRIX PRO: • Read all product instructions for use before testing. • Use of TRUE METRIX PRO in a manner not specified in this Owner's Booklet is not recommended and may affect ability to determine true blood glucose levels.
  • Page 5 • Use ONLY TRUE METRIX PRO Test Strips and TRUE METRIX Control Solution with the TRUE METRIX PRO Meter. • Remove only one test strip at a time from test strip vial. Recap vial immediately. • NEVER reuse test strips. NEVER wipe test strips with water, alcohol or any cleaner.
  • Page 6 IMPORTANT INFORMATION (cont.): WARNING! Healthcare Professionals should adhere to standard precautions and disinfection procedures when handling or using this device for testing. ALL parts of the TRUE METRIX PRO Professional Monitoring Blood Glucose System are considered potentially infectious, and capable of transmitting blood-borne pathogens between patients and healthcare professionals.
  • Page 7 Ensure the test strip vial cap is securely closed. If the product is damaged or the vial cap is not closed, DO NOT use the test strips for testing; product may give inaccurate results. Contact Trividia Health Customer Care at 1-800-803-6025 for replacement and assistance. TMX_PRO_OB_GutsENG_RE4TVHP03r54.indd 5 TMX_PRO_OB_GutsENG_RE4TVHP03r54.indd 5...
  • Page 8: Table Of Contents

    How to Test Control Solution ..........15 Blood Glucose Testing Obtaining a Blood Sample............19 How to Test Blood ..............22 TRUE METRIX PRO System and Laboratory Testing ..25 System Out of Range Warning Messages .......26 Meter Set Up Set Time / Date ................27 Set Event Tags, Ketone Test Alert and Test Reminders ..29...
  • Page 9: Description Of System Meter

    Description of System Meter Top of Meter ① “ ◀ ” Button Decrease numbers in Meter Set Up; remove ALT Symbol; move backward by date/time when viewing results and Averages in Memory; scroll through Event Tags to mark results (if feature on). ②...
  • Page 10 Back of Meter ① Display Screen Shows results, messages, user prompts, information. ② Test Port Insert TRUE METRIX PRO Test Strip here, contact blocks facing up. ③ Strip Release Button Releases test strip after testing for disposal. ④ Battery Door Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up...
  • Page 11 Full Display Screen 10 11 12 1. Result is from Memory 2. Time, Date 3. Time is AM/PM 4. Event Tag Symbols 5. Result is from 7-, 14-, or 30-day Average 6. Test Result 7. Control Symbol 8. Battery Symbol 9.
  • Page 12: Test Strip

    Test Strip Top of Test Strip ① Contact End - Insert into Test Port with contact blocks facing up. ② Sample Tip - Touch Tip to top of drop of sample (blood or control solution) after Drop Symbol appears in the Display. Note: Insert test strip into meter before touching Sample Tip to blood or control solution drop.
  • Page 13 Test Strip Vial Label ① Lot Number (LOT) - Used for identification when calling for assistance. ② Expiration Dates (EXP) - Write date first opened on vial label. Discard vial and unused test strips if either the open vial expiration date or the date printed next to EXP on vial label has passed, whichever comes first.
  • Page 14: Control Solution

    Control Solution (Control) Control Bottle Label ① Lot Number (LOT) - Used for identification when calling for assistance. ② Expiration Dates (EXP) - Write date first opened on bottle label. Discard bottle if either 3 months after first opening or date printed next to EXP on bottle label has passed, whichever comes first.
  • Page 15: Quality Control Testing

    Quality Control Testing To assure accurate and reliable results, TRUE METRIX PRO offers two kinds of Quality Control Tests. These tests ensure that TRUE METRIX PRO is working properly and testing technique is good. Automatic Self-Test Contact Blocks Face Up...
  • Page 16: Control Test

    Control Test We recommend performing Control Tests to check the performance of the system. Control Tests should be performed: • Before using the System for the first time, • For practice to ensure testing technique is good, • When opening a new vial of test strips, •...
  • Page 17: How To Test Control Solution

    How to Test Control Solution Use ONLY TRUE METRIX Control Solution with the TRUE METRIX PRO Meter and Test Strips. 1. Check dates on control solution label and test strip vial label. Do not use control solution or test strips if Expiration Dates have passed.
  • Page 18 5. Insert test strip into Test Port. Meter turns on. Note: If test strip has been out of the vial too long before testing, an error message appears upon insertion of the test strip into the meter. Contact Blocks Face Up Release and discard old test strip.
  • Page 19 9. With test strip still in meter, touch edge of Sample Tip to top of drop of control solution. Allow drop to be drawn into test strip. Remove test strip from drop when meter beeps. 10. Dashes appear across the Display to show meter is testing.
  • Page 20 CAUTION! If Control Test result is outside range, test again. If result is still outside range, system should not be used for testing blood. Call for assistance (see Booklet cover for phone number). 12. After result is shown, Strip Release Button flashes. Hold meter with test strip pointing down.
  • Page 21: Blood Glucose Testing Obtaining A Blood Sample

    DO NOT use sodium fluoride (grey top) vacutainer tubes. This may cause false low glucose results. Caution! • ALL parts of the TRUE METRIX PRO blood glucose monitoring system could carry blood-borne pathogens after use, even after cleaning and disinfecting.
  • Page 22 Tips for Fingertip Sampling 1. Select fingertip. Clean area with soap and warm water, rinse or use an approved disinfectant to clean the area. Dry thoroughly. 2. Lance finger. 3. To help blood drop form, lower the hand to a level below the heart and gently massage the finger from palm to fingertip.
  • Page 23 Tips for Forearm Sampling Important Notes Regarding Forearm Testing • Check with the patient's Doctor or Diabetes Healthcare Professional to see if forearm testing is appropriate for the patient. • Results from the forearm are not always the same as results from the finger.
  • Page 24: How To Test Blood

    How to Test Blood 1. Check dates on test strip vial being used. Do not use if either the open vial expiration date (see test strip Instructions for Use) or the date printed next to EXP on vial label has passed, whichever comes first. 2.
  • Page 25 6. Obtain the blood sample. Allow drop to form (see Obtaining a Blood Sample). 7. With test strip still in meter, touch Tip of test strip to top of blood drop and allow blood to be drawn into test strip. Remove Sample Tip from blood drop immediately after the meter beeps and dashes appear across the meter Display.
  • Page 26 10. Hold meter with test strip pointing down. Press Strip Release Button to discard test strip in the appropriate container. Meter turns off. Result is stored in Memory with date and time. 11. Discard all biohazard materials into appropriate container. Wash hands after taking off gloves. Note: Removing test strip before result displays cancels the test.
  • Page 27: True Metrix Pro System And Laboratory Testing

    TRUE METRIX PRO blood tests should be performed within 30 minutes of laboratory test. If a patient has recently eaten, fingerstick results from the TRUE METRIX PRO System can be up to 70 mg/dL higher than venous laboratory results. TMX_PRO_OB_GutsENG_RE4TVHP03r54.indd 25 TMX_PRO_OB_GutsENG_RE4TVHP03r54.indd 25...
  • Page 28: System Out Of Range Warning Messages

    System Out of Range Warning Messages WARNING! Meter reads glucose levels from 20-600 mg/dL. If blood test result is less than 20 mg/dL, “Lo” appears in Display. If blood test result is greater than 600 mg/dL, “Hi” appears in Display. ALWAYS repeat test to confirm Low (“Lo”) and High (“Hi”) results.
  • Page 29: Meter Set Up

    Meter Set Up Note: Setting up the time, date, Event Tags, Ketone Test Alert and Test Reminders may not be suitable for a multiple patient use of the system. Check with the facility procedures and policies before performing Set Up. Note: If the meter turns off at any time during Set Up, go back to Step #1 under Meter Set Up and begin again.
  • Page 30 4. The month (number) flashes. To change, press “ ▶ ” or “ ◀ ” Button to select the month. Press “ • ” Button to set. 5. The day (number) flashes. To change, press “ ▶ ” or “ ◀ ” Button to select the day.
  • Page 31: Set Event Tags, Ketone Test Alert And Test Reminders

    Set Event Tags, Ketone Alert and Test Reminders Meter comes with Event Tags, Ketone Test Alert and all Test Reminders off. Note: If the meter turns off at any time during Set Up, go back to Step #1 under Meter Set Up and begin again. Event Tags Event Tags are used to mark a test result that was taken during a specific event.
  • Page 32 Ketone Test Alert When a blood glucose result is over 240 mg/dL, the Ketone Test Alert is a reminder to check the patient's ketones per the treatment plan prescribed by the Doctor or Diabetes Healthcare Professional. Ketone Test Alert 2. Press “ ▶ ” or “ ◀ ” Button to turn Alert on or off.
  • Page 33 Test Reminder Up to four Test Reminders per day may be set. Reminder sounds at set time for 10 seconds. Meter comes with all Test Reminders off. To set the Test Reminders: 1. After pressing “ • ” Button to set Ketone Test Alert, Display shows first Reminder setting (A-1).
  • Page 34 4. Turn Reminders on and repeat setting the time for next 3 Reminders (if needed). Exit Set-Up Press and hold “ • ” Button until meter turns off. Meter also turns off after 2 minutes of non-use. Set-up choices are saved. Note: If Test Reminders are set, the Alert Symbol appears in all Displays.
  • Page 35: Meter Memory

    Meter Memory Note: The use of the Memory features (Averages, test results) may not be suitable for a multiple patient use of the system. Check with the facility procedures/ policy before use. View Averages (7-, 14-, and 30-Day) The Averages feature allows the viewing of the average of all blood glucose results 7-Day performed on the meter within a 7-, 14-, or...
  • Page 36: View Memory

    View Memory Meter Memory stores 500 results. Once Memory is full, the oldest result is replaced with the newest result. 1. Press and release “ • ” Button. Meter Memory Symbol displays 7-, 14-, and 30-day Averages. Press and release “ • ” Button again to view most recent Control Test result in Memory.
  • Page 37: Care, Cleaning/Disinfecting And Troubleshooting

    Wash hands after taking off gloves as contact with blood presents a risk of infection. We recommend using only one meter per patient. Caring for TRUE METRIX PRO • Store system (meter, control solution, test strips) in carrying case to protect from liquids, dust and dirt.
  • Page 38 To Clean and Disinfect the Meter: 1. Wash hands thoroughly with soap and water. Wear a clean pair of gloves. 2. Make sure meter is off and a test strip is not inserted. With ONLY Super Sani-Cloth® Wipes (or any disinfectant product with the EPA* reg.
  • Page 39 4. Let meter air dry thoroughly before using to test. 5. Verify that the system is working properly by performing an Automatic Self-Test (see Getting Started). Stop using the meter and call Customer Care for assistance at 1-800-803-6025, Monday - Friday, 8AM- 8PM EST, if: •...
  • Page 40 • Store at temperatures between 36°F-86°F. DO NOT FREEZE. TRUE METRIX PRO Test Strip Care • Store test strips in original vial only. Do not transfer old test strips to new vial or store test strips outside of vial.
  • Page 41: Changing Battery

    Changing Battery A low battery displays Battery Symbol while continuing to function. A dead battery displays Battery Symbol, beeps, and then turns off. To replace battery: Lift tab on Battery Door. Turn meter over. While holding meter in one hand with Battery Door facing down, tap meter gently on the palm of your other hand to loosen Battery...
  • Page 42: Troubleshooting

    Troubleshooting 1. After inserting test strip, meter does not turn on. Reason Action Test strip inserted upside Remove test strip. down or backwards Re-insert correctly. Test strip not fully Remove test strip. Re-insert inserted test strip fully into meter. Test strip error Repeat with new test strip.
  • Page 43: Messages

    Too Cold/ to reach room temperature Too Hot before testing. Sample Not Retest with new Detected or TRUE METRIX PRO Test Using Wrong Strip and larger sample. Test Strip Used Test Strip, Repeat with new test Test Strip out- strip. Make sure sample...
  • Page 44 Display Reason Action Retest with new test strip. If error persists, call for assistance. Test Strip If symptoms such Error or very as fatigue, excess high blood urination, thirst, glucose result or blurry vision are (higher than found, follow Doctor 600mg/dL) or Diabetes Healthcare Professional's advice...
  • Page 45 Display Reason Action Do not use meter for testing. Broken Call 1-800-803-6025, Display Monday - Friday, 8AM-8PM EST. WARNING!! Retest with new test WARNING!! strip. If result is still Out of Range “Hi” (High) - High Results > 600 mg/dL “Lo”...
  • Page 46: System Safety Information And Electromagnetic Compatibility

    System Safety Information and Electromagnetic Compatibility The TRUE METRIX PRO meter was tested and found to comply with the electromagnetic emission and immunity requirements as specified in IEC 60601-1-2 Edition 4.0. The meter's electromagnetic emission is low. The TRUE METRIX PRO has met the following...
  • Page 47 The electromagnetic environment should be evaluated prior to operation of the device. Do not use the TRUE METRIX PRO meter in a very dry environment, especially one in which synthetic materials are present. Do not use the TRUE METRIX PRO meter close to sources of strong electromagnetic radiation, as these may interfere with the proper operation of the meter.
  • Page 48: System Specifications/Chemical Composition

    Hematocrit: 20%-70% Altitude: Up to and including 10,200 feet. Note: Use within specified environmental conditions only. Chemical Composition TRUE METRIX PRO Test Strips: Glucose dehydrogenase-FAD (Aspergillus species), mediators, buffers and stabilizers. TRUE METRIX Control Solution: Water, d-glucose, buffers, viscosity enhancing agent, salts, dye and preservatives.
  • Page 49: Warranty

    TRUE METRIX PRO Limited Lifetime Warranty Trividia Health, Inc. provides the following Warranty to the original purchaser of the TRUE METRIX PRO Blood Glucose Meter: Trividia Health Inc. warrants this meter to be free of defects in materials and workmanship at the time of purchase.
  • Page 50: References

    References 1. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care, Volume 37, Supplement 1, January 2014. 2. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication. Available at https://wayback.archive-it.org/7993/20170111013014/ http://www.fda.gov/MedicalDevices/Safety/AlertsandNo- tices/ucm224025.htm.

Table of Contents