Trividia Health TRUE METRIX GO Instructions For Use Manual

F
R 4AUT16 Rev. 51
1 Important Information About Your System

Intended Use

Important Health and Safety Information
References
2 System Specifications
Operating Range / Chemical Composition
Expected Results
Symbols Chart
3 Know Your System
Meter

Test Strip

Control Solution

To Attach/Remove Meter to Test Strip Vial
4 Getting Started

Quality Control Testing

Automatic Self-Test

Control Test

INTENDED USE
The TRUE METRIX GO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn
from the fingertip or forearm, or venous whole blood collected in only sodium heparin blood collection tubes.
The TRUE METRIX GO System is intended for self-testing outside the body
healthcare settings as an aid to monitor the effectiveness of diabetes control.
The TRUE METRIX GO System should not be used for the diagnosis or screening of diabetes or for neonate (newborn) use. Alternate site (forearm) testing should be
done only during steady-state times (when glucose is not changing rapidly).
The TRUE METRIX Test Strips are for use with the TRUE METRIX GO Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from
the fingertip or forearm and venous whole blood.
The TRUE METRIX Control Solution is for use with the TRUE METRIX GO Meter and TRUE METRIX Test Strips to check that the meter and the test strip are working together
properly and that the test is performing correctly.
The TRUE METRIX GO Meter measures the current, detects, analyzes and corrects for hematocrit and temperature, and calculates the glucose result.
Please read complete System IFU and all product Instructions for Use before using the System.
Color Codes:
Pink - Caution:
Provides information that is important for user
protection and about risks for inaccurate results.
IMPORTANT HEALTH and SAFETY INFORMATION
• Use of the TRUE METRIX GO System in a manner not specified in this System Instructions for Use is not recommended and may affect the ability to determine true
blood glucose levels.
• All meter brands perform differently. Test results from one meter brand to another may vary. This is why test results from your meter should only be compared to a
lab instrument and not to another meter brand.
• Wash hands thoroughly with soap and warm water before and after handling the meter, lancing device, lancets, or test strips as contact with blood presents an
infection risk.
• To help prevent false high results, wash hands before using the system to test blood, especially after fruit has been handled.
• ALL parts of the system could carry blood-borne pathogens after use, even after cleaning.
all, blood-borne pathogens.
• For instructions on how to clean the meter, see Meter Cleaning.
• If the meter is being operated by a second person who gives testing assistance, the meter and the lancing device should be cleaned before use by the second
person. The second person should wear disposable gloves when performing testing. It is important to keep the meter and lancing device clean.
• Alternate site (forearm) testing should not be used to calibrate continuous glucose monitors (CGMs) or used for insulin dose calculations.
• Alternate site (forearm) testing should be done only during steady-state times (when glucose is not changing rapidly).
• The System has not been tested with animals. Do not use to test blood glucose on pets.
• If there are symptoms of low or high blood glucose, check blood glucose immediately. If the result does not match how you feel, repeat the test. If the results still
do not match the way you feel, call a Doctor or Healthcare Professional immediately.
~ Low blood glucose (hypoglycemia) symptoms may be trembling, sweating, intense hunger, nervousness, weakness, and trouble speaking.
~ High blood glucose (hyperglycemia) symptoms may be intense thirst, a need to urinate often, dry mouth, vomiting, and headache.
• Since any meter may fail, break, or be misplaced, always have a backup meter.
• Do not use for diagnosis of or screening for diabetes or for neonatal use.
• Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals
experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
• Do not use the TRUE METRIX GO System during a xylose absorption test. Blood samples containing xylose concentrations >0.4 mmol/L may falsely raise glucose
results. Please check with a Doctor or Healthcare Professional before using the System.
5
• Ascorbic acid (Vitamin C) greater than normal or therapeutic levels may cause significant interference resulting in inaccurate result.
• Uric acid can interfere with this device at normal and disease levels, when uric acid concentrations are greater than 0.3 mmol/L. For people with diabetes, certain
conditions (including gout or kidney disease) may cause the blood level of uric acid to rise. This may cause significant interference resulting in inaccurate glucose
results and the blood glucose results may be not reliable. Please check with a Doctor or Healthcare Professional before using the System.
For best results using the TRUE METRIX GO System:
• Read all product instructions for use before testing.
• Perform a Control Test before performing a blood glucose test for the first time. Contact place of purchase or use the contact information at the bottom of the page
for information on how to obtain different levels of control solution.
• Capillary whole blood from the fingertip or forearm may be used for testing with the TRUE METRIX GO System. Forearm testing should be used only during steady-
state blood glucose conditions. Venous blood collected in only sodium heparin blood collection tubes may be used. Mix well before use.
• DO NOT use venous whole blood collected in sodium fluoride blood collection tubes. Blood samples containing sodium fluoride may cause false low glucose results
or blood results may be read as control solution.
• Use only TRUE METRIX Test Strips and TRUE METRIX Control Solution with the TRUE METRIX GO Meter.
• Remove only one test strip at a time from the test strip vial. Recap vial immediately after removing the test strip.
NEVER reuse test strips.
NEVER try to wipe test strips with water, alcohol, or any cleaner to remove blood or control solution to reuse test strips. Reuse of test strips will cause inaccurate results.
NEVER add a second drop of sample (blood or control solution) to the test strip. Adding more sample to the test strip after testing begins gives an error message.
Do not bend, cut, or alter test strips in any way.
REFERENCES
1. Joslin Diabetes Center. Goals for Blood Glucose Control [Electronic Version]. Retrieved June 8, 2015 from http://www.joslin.org/info/Goals-for-Blood-Glucose-Control.html.
2. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication Update 11/29/2010 [Electronic Version].
Retrieved February 22, 2012 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
3. U.S. Food and Drug Administration. Blood Glucose Meters, Getting the Most Out of Your Meter. [Electronic Version]. Retrieved July 6, 2009 from www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.htm.
4. Larsson-Cohn U: Difference between capillary and venous blood glucose during oral glucose tolerance tests. Scand J Clin Lab Invest 36:805-808, 1976.
5. Data on file.
6. European Committee for Standardization. In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Reference number EN ISO
15197:2015(E). Brussels: European Committee for Standardization; 2015.
© 10/2017 Trividia Health, Inc.
Blood Glucose Monitoring System
Instructions For Use (IFU)
CONTENTS
Front page
Front page
Front page
Front page
1 IMPORTANT INFORMATION ABOUT YOUR SYSTEM
Yellow - Important:
Provides important information on testing and
other issues relating to testing.
5 Testing Blood

Obtaining a Blood Sample

How to Test Blood

System Out of Range Warning Messages

System and Laboratory Testing
6 Meter Setup
Time/Date Setup
7 Meter Memory
View Averages (7-, 14-, -30 day)
View Memory
8 System Care
Control Solution Care
Blood Glucose Test Strip Care
Meter Care and Cleaning

Changing Battery

9 Performance Characteristics
10 Troubleshooting
11 Messages
12 System Safety Information

Electromagnetic Compatibility

by people with diabetes at home and for multiple-patient use in professional
Blue - Notes:
Helpful hints
Cleaning the meter and lancing device destroys most, but not necessarily
2
Back page
Back page
Back page
Back page
Back page
Back page
Back page
Back page
Australian sponsor:
Trividia Health Australia Pty. Ltd
58 Gipps Street
Collingwood , VIC 3066
1800 001 351
www.trividiahealth.com.au