Trividia Health TRUE METRIX GO User manual

Blood Glucose Monitoring System
Instructions For Use (IFU)
1IMPORTANT INFORMATION ABOUT YOUR SYSTEM
Please read complete System IFU and all product Instructions for Use before using the System.
INTENDED USE
TheTRUE 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.
TheTRUE METRIX GO System is intended for self-testing outside the body by people with diabetes at home and for multiple-patient use in professional
healthcare settings as an aid to monitor the effectiveness of diabetes control.
TheTRUE 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).
TheTRUE METRIX Test Strips are for use with theTRUE METRIX GO Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from
the fingertip or forearm and venous whole blood.
TheTRUE METRIX Control Solution is for use with the TRUE METRIX GO Meter andTRUE METRIXTest Strips to check that the meter and the test strip are working together
properly and that the test is performing correctly.
TheTRUE METRIX GO Meter measures the current, detects, analyzes and corrects for hematocrit and temperature, and calculates the glucose result.
© 10/2017 Trividia Health, Inc.
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.
IMPORTANT HEALTH and SAFETY INFORMATION
• Use of theTRUE 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.
2
Cleaning the meter and lancing device destroys most, but not necessarily
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.
5
Please check with a Doctor or Healthcare Professional before using the System.
• 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 ControlTest 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 onlyTRUE METRIX Test Strips and TRUE METRIX Control Solution with theTRUE 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.
CONTENTS
1Important Information About Your System
Intended Use
Important Health and Safety Information
References
2System Specifications
Operating Range / Chemical Composition
Expected Results
Symbols Chart
3Know Your System
Meter
Test Strip
Control Solution
To Attach/Remove Meter to Test Strip Vial
4Getting Started
Quality Control Testing
Automatic Self-Test
Control Test
Front page Back page
Front page
Front page
Front page
Back page
Back page
Back page
Back page
Back page
Back page
Back page
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
Color Codes:
Pink - Caution:
Provides information that is important for user
protection and about risks for inaccurate results.
Yellow - Important:
Provides important information on testing and
other issues relating to testing.
Blue - Notes:
Helpful hints
RF4AUT16 Rev. 51
Australian sponsor:
Trividia Health Australia Pty. Ltd
58 Gipps Street
Collingwood , VIC 3066
1800 001 351
www.trividiahealth.com.au

EXPECTED RESULTS
Expected Blood Glucose Results for people without diabetes:
Plasma Blood Glucose Result1
Before breakfast < 5.6 mmol/L
Two hours after a meal < 7.8 mmol/L
Importance of Blood Glucose Monitoring
A Doctor or Healthcare Professional determines how often to test glucose and what the target ranges are for
blood glucose results.
Having most blood glucose results within the target range shows how well a treatment plan is working to
control glucose levels. To slow or stop the complications from diabetes, keep glucose results within the target
range.
NEVER change a treatment plan without talking to a Doctor or Healthcare Professional.
2SYSTEM SPECIFICATIONS
① Display - Shows test results, messages, user prompts.
② Test Port - Insert Test Strip here, with contact blocks facing up.
③ Set Button - Turns meter on to view Average values and scroll through
Memory, sets up date/time, adds ALT Symbol, turns meter off.
④ Battery Tray - Holds battery (one non-rechargeable 3V lithium battery
#CR2032).
⑤ Meter Label - Contains serial number used to identify meter when
contacting for assistance.
⑥ Micro USB Port - Used with a cable to upload results to a computer.
⑦ Vial Lip Cover - Locks meter onto a vial of test strips.
3
4
7
6
5
Back of Meter
2
1
Front of Meter
3
4
6
1
2
5
Meter Full Display Screen
①Time, Date, Control Symbol (-C-), Alternate Site Symbol (-A-),
Average Symbol (7-, 14-, or 30-day)
②Test Result
③Memory Result
④Battery Symbol
⑤Units of measure -
Factory set to mmol/L or mg/dL, cannot be changed by user.
⑥ Drop Symbol
METER
TEST STRIP
Insert test strip into meter before touching Sample Tip to top of blood or control
solution drop. Allow drop to be drawn into the test strip until dashes appear in the
Display.
~Do not apply sample to top of test strip.
~Do not smear or scrape drop with test strip.
DO NOT insert Sample Tip into meter. This may damage meter.
Do not apply more sample to the test strip after testing begins.
1. Contact End - Insert test strip into meter with contacts (blocks) facing up.
2. Sample Tip - Touch Tip to top of drop of sample after Drop Symbol appears
in the meter Display.
12
1. Lot Number ( ) - Use for identification when contacting for assistance.
2. Use By Dates ( )
3. Control Test Range - Range of numbers where ControlTest result must fall
to assure the system is working properly.
Write date first opened on vial label. Discard vial and unused test strips if either
the open vial Use By date or the date printed next to on vial label has passed,
whichever comes first. See the test strip Instructions for Use for open vial Use By
date. Use of test strips past the Use By Dates may give incorrect test results.
Discard out-of-date products and test with new products. Ranges printed on
test strip vial label are for Control Test results only and are not suggested levels
for blood glucose.
Test Strip Vial Label
(Example only and does not reflect actual Control Test ranges)
- ABC1234
- 2018/10/31
1 72-90 mg/dL 4.0-5.0 mmol/L
2 150-200 mg/dL 8.3-11.1 mmol/L
3 301-398 mg/dL 16.7-22.1 mmol/L
May 30, 2018
{
3
1
2
2
Test Strip Vial Label
CONTROL SOLUTION
Control Solution Bottle Label (example)
May 30, 2018
3
1 22
1. Lot Number ( ) - Use for identification when contacting for assistance.
2. Use By Dates ( )
3. Control Solution Level (1, 2 or 3)
Write date first opened on bottle label. Discard bottle and unused control
solution if either 3 months after first opening or date printed next to on bottle
label has passed, whichever comes first. Use of control solution past the Use By
Dates may give incorrect test results. Discard out-of-date products and test
with new products. Do not drink control solution.
Use the contact information at the bottom of the page for information on how
to obtain different levels of control solution.
TO ATTACH/REMOVE METER TO TEST STRIP VIAL
To attach:
1. Set test strip vial on flat surface with
vial lip facing to the left.
2. WithTest Port facing front, place
bottom of meter firmly on vial top.
Meter must be seated flat on top of
vial cap.
3. Holding the vial, twist the meter 1/4
turn clockwise.TheTest Port area on
the meter should cover the vial lip if
attached properly.
Test Port
Vial Lip
To remove:
1. Holding the vial, twist the meter 1/4
turn counterclockwise.
2. Lift off meter off the vial top.
The meter may also be used for testing
without attaching to the vial.
Result Range: 1.1-33.3 mmol/L
Sample: 0.5 microliter (0.5 µL) fresh capillary whole blood from the fingertip or forearm and
venous blood drawn in only sodium heparin blood collection tubes.
Test Time: Results in as little as 4 seconds
Result Value: Plasma equivalent values
Assay Method: Electrochemical
Power Supply: One 3V lithium battery #CR2032 (non-rechargeable)
Battery Life: Approximately 1,000 tests or 1 year
Automatic shut-o: After two minutes of non-use
Weight: 18 grams
Size: 4.1 cm x 3.5 cm x 2.2 cm
Memory Size: 500 results
Operating Range (Meter & Test Strips For Blood Testing)
Relative Humidity: 10%-90% (Non-condensing)
Temperature: 5°C-40°C
Hematocrit: 20%-70%
Altitude: Up to and including 3109 metres
Use within specified environmental conditions only.
Chemical Composition
Test Strips: Glucose dehydrogenase-FAD (Aspergillus species), mediators, buffers and stabilizers.
Control Solution: Contents: water, d-glucose, buffers, viscosity enhancing agent, salts, dye and preservatives.
FRONT PAGE
3KNOW YOUR SYSTEM
SYMBOLS:
Biological Risk
Sterile
Do Not Resterilise
Single Use Only
Control Solution
Control Level
Serial Number
Caution!
Use By Date
Keep Dry
Attention!
Read Instructions for Use.
Storage Temperature Range
Storage Humidity Range
Lot Number
For in vitro
Diagnostic Testing Only
Authorised Representative
Manufactured By
Date of Manufacture
Single Patient Use Only
%
%

If Control Test result is still outside range after a second Control Test, do not use
the system for testing blood. Use the contact information at the bottom of the
page for assistance.
~If test strip is removed before testing is finished, an error message appears.
Discard old test strip and retest using a new test strip.
~Do not put control solution drop on top of test strip.
~If meter does not begin testing soon after drawing up sample, discard test strip.
Repeat with a new test strip. If problem persists, see Troubleshooting.
~Removing the test strip before result is displayed cancels the test. An error
message appears and the result is not stored in Memory. Retest with a new test
strip and do not remove before result is displayed.
If an error message appears, the meter will not perform a
test. See Troubleshooting or contact for assistance.
4GETTING STARTED
The meter comes with pre-set time and date. Before using the meter for the first
time or after a battery change, check time and date and update as needed.
The meter turns on when:
~ a test strip is inserted into theTest Port, or
~ when Set Button is pressed and released (see Meter Memory and Time/Date
Set Up).
Meter turns off when:
~ the test strip is released from the meter,
~ the Set Button is pressed and held for 3 seconds, or
~ after 2 minutes of non-use.
Testing Checklist:
✔
Check meter for damage (cracked Display, missing button, etc.). If damage is
seen, do not use meter. Use the contact information at the bottom of the page for
assistance.
✔Check test strip vial for damage (cracked or broken vial). Discard damaged vial
and contents (test strips). Use a new vial of test strips for testing.
✔Write date first opened on test strip vial label. Discard vial and unused test strips
if either the open vial Use By date or the date printed next to on vial label has
passed, whichever comes first. See the test strip Instructions for Use for open vial
Use By date.
✔For Control Test, make sure you have clean tissues available. A small piece of
plastic wrap, aluminum foil or waxed paper may be used for control solution
sample drop in the Control Test.
✔Check control solution bottle for any leaks or broken cap. Discard damaged bottle
and open a new one for testing.
✔Write date first opened on control solution bottle label. Discard bottle if either 3
months after first opening or date printed next to has passed, whichever comes
first.
1. Insert test strip
into Test Port.
2. Full Display
appears. Check
for missing
segments.
3. Drop Symbol
begins to blink.
Meter may be
used for testing.
CONTROL TEST
We recommend performing ControlTests:
• before using the meter for the first time,
• for practice to ensure your testing technique is good,
• when opening a new vial of test strips,
• occasionally as a vial of test strips is used,
• if results seem unusually high or low,
• if the test strip vial has been left opened, exposed to extreme heat, cold, or
humidity,
• whenever a check on the performance of the system is needed,
• if meter damage is suspected (meter was dropped, crushed, wet, etc.).
Performing a Control Test with more than one level of control solution is
recommended to ensure that the system is working properly. Three levels of TRUE
METRIX Control Solution are available. Use contact information at the bottom of the
page for more information on how to obtain levels of control solution.
Use ONLY TRUE METRIX Control Solution for Control Test.
Ranges printed on test strip vial label being used are for Control Test results only
and are not suggested levels for blood glucose.
Do not drink control solution.
- ABC1234
- 2018/10/31
1 72-90 mg/dL 4.0-5.0 mmol/L
2 150-200 mg/dL 8.3-11.1 mmol/L
3 301-398 mg/dL 16.7-22.1 mmol/L
May 30, 2018
4. Gently swirl or
invert control
solution bottle to
mix.
DO NOT SHAKE.
5. Remove one
test strip from
vial. Close vial
immediately.
Use test strip
quickly after
taking it out of
the vial.
6. Insert test strip firmly into Test
Port. Meter turns on.
Keep test strip in meter until
testing is finished. Do not add
control solution to test strip
before inserting into meter.
LB0010
9 JUNE 2009
7. Remove cap from control solution
bottle. Gently squeeze a drop onto
a clean tissue.Wipe off bottle tip
and discard tissue. Gently squeeze
a drop onto a small piece of unused
aluminum foil, clear plastic wrap, or
waxed paper for testing.
May 30, 2018
1. Gather and check supplies.
See Getting Started -Testing Checklist.
2. Allow control solution,
vial of test strips and
meter to adjust to room
temperature for 10
minutes.
3. Wash hands. Dry
thoroughly.
How To Test Control Solution
Control Solution LabelTest Strip Label
Use By Dates
1 72-90 mg/dL 4.0-5.0 mmol/L
2 150-200 mg/dL 8.3-11.1 mmol/L
3 301-398 mg/dL 16.7-22.1 mmol/L
12. After result is shown, remove test strip from meter and discard. Meter turns
off. Recap control solution bottle tightly.
8. With test strip still in meter,
touch Sample Tip to top of drop.
Allow drop to be drawn into test
strip.
9. Remove test strip from drop when
dashes appear across the meter
Display. Meter is testing.
10. After testing is finished, result
appears in the meter Display
with the Control Symbol.
11. Compare result to ControlTest Range
printed on the test strip vial label for
the control solution you are testing. If
result is in range, system can be used for
testing blood.
If result is not within range, perform
Control Test again.
Test Strip Vial Label
(Examples only and do not represent
actual Control Test ranges)
Control Solution
Bottle Label
QUALITY CONTROL TESTING
To assure accurate and reliable results, TRUE METRIX GO offers two kinds of quality
control tests, an Automatic Self-Test and a Control Test. These tests let you know
that your system is working properly and your testing technique is good.
AUTOMATIC SELFTEST
The Automatic Self-Test lets you know if the meter and the Display are working
properly. The Automatic Self-Test does not take the place of running a Control Test.
How To Test Control Solution, cont.

How to Test Blood, cont.
If you wish to mark the result as
alternate site, press the Set Button
before the meter turns off. -A-
appears in the meter Display.
4. After testing, recap and remove
used lancet from lancing device.
Discard used lancet into an
appropriate waste container.
The used lancet may be biohazardous. Please discard it carefully into an
appropriate waste container.
Allow blood drop to form before attempting to apply to the test strip.
3. Set lancing device aside. To
help blood drop form, lower
hand to waist level and
gently massage from palm to
fingertip.
1. Select area to be lanced.Wash hands (and
forearm for alternate site testing) with soap
and warm water, rinse and dry thoroughly.
2. Place end of lancing device
equipped with lancet against
fingertip. Lance fingertip.
From Fingertip
3. Place end of lancing device
equipped with a lancet firmly
against forearm. Press trigger
button. Apply firm pressure on
lancing device for 10 seconds.
2. Rub area vigorously or apply
a warm dry compress to
increase blood flow.
From Forearmor
then
11. Remove test strip from meter and
discard into an appropriate waste
container. Meter turns off. Result is
stored in the Memory.
Used test strips and lancets may be considered biohazardous.
Please discard them carefully into an appropriate waste container.
~If test strip has been out of the vial too long before testing, an error message
appears. Remove and discard old test strip. Use new test strip for testing.
~Do not place blood drop on top of test strip.
~Removing the test strip before result is displayed cancels the test. An error
message appears. Result is not stored in Memory. Retest with a new test strip.
Do not remove before result is displayed.
8. With test strip in Meter, touch
Sample Tip to top of blood drop
after Drop Symbol appears in
the Display. Allow blood to be
drawn into the test strip.
9. Remove test strip from
drop when dashes appear
across the meter Display.
Meter is testing.
10. After testing is finished, result
appears in the meter Display.
Record result in log book.
7. Lance fingertip (or forearm). Allow blood drop to form (see Obtaining a
Blood Sample).
Fingertip Testing
Forearm Testing
- ABC1234
- 2018/10/31
1 - 72-90 mg/dL 4.0-5.0 mmol/L
2 - 150-200 mg/dL 8.3-11.1 mmol/L
3 - 301-398 mg/dL 16.7-22.1 mmol/L
May 30, 2018
4. Remove one test strip from vial.
Close test strip vial immediately.
Use test strip quickly after taking it
out of the vial.
5. Insert test strip firmly
intoTest Port. Meter
turns on.
6. Wait until Drop Symbol appears in the
Display.
Keep test strip in meter until testing is
finished. Do not add blood to test strip
before inserting into meter.
HOW TO TEST BLOOD
1. Check supplies (see Getting
Started - Testing Checklist).
2. Allow vial of test strips and
meter to adjust to room
temperature for 10 minutes.
3. Wash hands (and forearm
for alternate site testing) in
warm, soapy water. Rinse
well and dry thoroughly.
Test Strip Label
Use By Dates
or
TRUE METRIX GO SYSTEM AND LABORATORY TESTING
When comparing results betweenTRUE METRIX GO System and a laboratory
system, TRUE METRIX GO blood tests should be performed within 30 minutes of
a laboratory test. If you have recently eaten, fingerstick results from theTRUE
METRIX GO System can be up to 3.9 mmol/L higher than venous laboratory
results.
4
SYSTEM OUT OF RANGE WARNING MESSAGES
Meter reads blood glucose levels from 1.1-33.3 mmol/L.
If blood test result is less than 1.1 mmol/L, “Lo”appears in meter Display. If
blood test result is greater than 33.3 mmol/L,“Hi”appears in meter Display.
ALWAYS repeat test to confirm Low (“Lo”) and High (“Hi”) results.
If results still display“Lo” or“Hi”, call a Doctor or Healthcare Professional
immediately.
~“Lo” results are included in the Average as 1.1 mmol/L.
~“Hi” results are included as 33.3 mmol/L.
5TESTING BLOOD
OBTAINING A BLOOD SAMPLE
Refer to lancing device’s Instructions for Use for more detailed instructions on using
the lancing device.
Important Notes Regarding Forearm Testing
3
~Forearm testing results cannot be used for continuous glucose meter calibration or
for insulin dose calculations.
~Check with a Doctor or Healthcare Professional to see if forearm testing is
appropriate.
~Results from forearm are not always the same as results from fingertip.
~Some lancing devices include a special end cap for alternate site (forearm)
testing. Check lancing device Instructions for Use.
~Use fingertip instead of forearm for more accurate results:
• Within 2 hours of eating, exercise, or taking insulin,
• If blood sugar may be rising or falling rapidly,
• If routine results are often fluctuating,
• If the patient is ill or under stress,
• If forearm results do not match how you feel,
• If blood sugar may be low or high,
• If symptoms of low or high blood sugar are not evident.
Wash hands thoroughly with soap and warm water before and after handling
the meter, lancing device, lancets or test strips.
If the meter or lancing device is being operated by a second person who gives
testing assistance, the meter and the lancing device should be cleaned before
use by another person.
For instructions on how to clean the meter, see Meter Cleaning.
ALL parts of the system could carry blood-borne pathogens after use, even
after cleaning.
2
Cleaning the meter and lancing device destroys most, but not
necessarily all, blood-borne pathogens.
Do not reuse lancets.
Reuse of devices labeled for single-use may result in product contamination and
infection.
Used test strips and lancets are considered biohazardous.
Dispose used test strips and lancets carefully into an appropriate waste
container.
To help prevent false high results, wash hands before using the system to test
blood, especially after fruit has been handled.

8SYSTEM CARE
7METER MEMORY
VIEW AVERAGES 7,14,30DAY
Averages allows you to view the average of all blood glucose results within a 7-,
14-, or 30 day period.
1. With meter off, press and
release Set Button.
2. Display scrolls through the 7-, 14-, and
30-day Averages. Meter turns off after 2
minutes if Set Button is not pressed.
If there are no average values, three dashes are
displayed for 7-, 14-, and 30-day Averages.
7-Day 14-Day 30-Day
VIEW MEMORY
Memory stores 500 results which are displayed from most recent to oldest.When
Memory is full, the oldest result is replaced with the newest result.
1. After meter displays the Averages,
press and release Set Button again.
2. The most recent result is shown
with the Memory Symbol.
3. Continue to press and release the Set
Button to scroll through results.
~Blood test results are shown
with the Memory Symbol, the
time and date.
~Only the last Control Test is
saved in Memory. The Control
Test result will show the
Control Symbol in the lower
left corner of the Display.
~Alternate Site Blood Test
results are shown with the
Alternate Site Symbol in
the lower left corner of the
Display.
Do not use meter and contact for assistance if:
~Meter Display appears cloudy or any display segments are missing,
~Markings on meter, including back meter label, are coming off or missing,
~Set Button is hard to push on meter or does not work (see Meter Memory),
~Unable to insert test strip into Test Port.
~If Automatic Self-Test gives an error message.
3.
Wipe meter with a clean, lint-free cloth dampened with 70% isopropyl alcohol.
4. Let meter air dry thoroughly before using to test.
5. Do not use bleach to clean the meter. For assistance use the contact
information at the bottom of the page.
~ Make sure no liquids enter the Test Port or any other opening in the meter.
~ Do not spray meter with any cleaning agents.
~ If the meter remains attached to the test strip vial during cleaning, make sure
that the vial cap is closed before cleaning.
6. Make sure that the system is working properly
by performing an Automatic Self-Test. See
Automatic Self-Test under Getting Started.
7. Wash hands
thoroughly after
cleaning the meter.
How to Clean the Meter
1. Wash hands
thoroughly with
soap and water or
wear disposable
gloves.
2. To Clean: Make sure that the meter is off and
a test strip is not inserted. Remove meter from
test strip vial.
Meter may remain attached to the test strip vial
during cleaning. Ensure that vial cap is completely
closed before attempting to clean the system.
CHANGING BATTERY
1. Remove meter from
top of test strip vial by
holding the vial and
twisting the meter ¼ turn
counterclockwise. Lift
meter from vial top.
2. Turn meter over until the meter label
is facing up. Pull BatteryTray out until
battery is exposed.
3. Holding the Battery Tray over your hand,
press on edge of battery until battery
drops out.
4. Insert new battery into Battery
Tray with“+”side facing up. Slide
Battery Tray back into meter.
If meter does not turn on, open Battery Tray and check that the battery was inserted
with the “+” side facing up. Close Battery Tray and repeat Step 5. If meter still does
not turn on, use the contact information at the bottom of the page for assistance.
Battery may explode if mishandled. Do not dispose of battery in fire. Do not take
apart or attempt to recharge battery. Dispose according to local regulations.
5. Turn meter back over and
press Set Button to turn
meter on.
BACK PAGE
TIME/DATE SET UP
6METER SETUP
Hours Minutes
Month Day Year
3. After the correct hour appears,
the number flashes for about
10 seconds before going to the
minutes.
4. Repeat steps 2-3 to set up
minutes, month, day and year.
Pressing and releasing the Set Button only makes the numbers increase by one. Once
the number reaches its limit, it resets to the lowest number. Pressing and holding the
Set Button scrolls the numbers. Release Set Button when desired number is reached.
1. Start with the meter off. Press
and hold the Set Button until the
full Display appears and begins to
blink. Release Set Button.
2. The time appears and the hour
begins flashing. Change the
number by pressing the Set
Button until the desired number
appears.
If meter turns off at any time during Set Up, go back to Step #1 and begin again.
• Store system (meter, control solution, test strips) in carrying case to protect
from liquids, dust and dirt.
• Store in a dry place at room temperature 4°C-30°C and
at 10%-80% relative humidity (Non-condensing). DO NOT FREEZE.
• Allow system to sit at room temperature for
10 minutes before testing.
TRUE METRIX CONTROL SOLUTION CARE
• Write date first opened on control solution bottle label. Discard bottle and
unused control solution if either 3 months after first opening or date printed
next to on label has passed, whichever comes first.
• After each use, wipe bottle tip clean and recap tightly.
• Store at room temperature 2°C-30°C. DO NOT FREEZE.
TRUE METRIX BLOOD GLUCOSE TEST STRIP CARE
• Store test strips in original vial only. Do not transfer test strips to new vial or
store test strips outside of vial.
• Write date first opened on test strip vial label. Discard vial and unused test
strips if either the open vial Use By date or the date printed next to on vial
label has passed, whichever comes first. See the test strip Instructions for Use
for open vial Use By date. Use of test strips past the Use By dates may give
incorrect results.
• Close vial immediately after removing test strip. Store
in a dry place at room temperature 4°C-30°C and at
10%-80% relative humidity (Non-condensing). DO NOT FREEZE.
METER CARE AND CLEANING
Cleaning removes blood and soil from the meter.
~If the meter is being operated by a second person who provides testing
assistance, the meter and lancing device should be cleaned prior to use by the
second person.
~Do not clean the meter during a test.
80%
10%
80%
10%

If error message still appears, any other error message appears, or
troubleshooting does not solve the problem, contact for assistance.
Display Reason Action
Invalid
Hematocrit
Repeat with new test strip, using
capillary whole blood from the finger
or forearm or venous whole blood
collected only in a sodium heparin
blood collection tube.
If error persists, contact for assistance.
Temperature
Error
•
Too Cold/ Too Hot
Move meter and test strips to area
between 5°C-40°C;
wait 10 minutes for system to reach
room temperature before testing.
Sample Not
Detected or
Sample Drop on
Top of Test Strip
Retest with new test strip and
larger sample.
Make sure SampleTip of test strip
touched top of sample drop.
Used Test Strip,
Test Strip Outside
of Vial Too Long
Repeat with new test strip.
If error persists,
contact for assistance.
Meter Error Contact for assistance.
Test Strip Error or
Very High Blood
Glucose Result
(higher than
33.3 mmol/L)
Retest with new test strip. If error
persists, contact for assistance.
If you have symptoms such as
fatigue, excess urination, thirst or
blurry vision, follow a Doctor or
Healthcare Professional’s advice for
high blood glucose.
Test Strip
Removed During
Test or Micro USB
Cable
Connected while
Testing
Unplug Micro USB cable. Repeat
with new test strip. Make sure
result is displayed
before removing test strip. If error
persists, contact for assistance.
Meter Error Contact for assistance.
Low or Dead
Battery
Low: About 50 tests can be done
before battery dies.
Dead: Battery Symbol appears
before meter turns off.
Change the battery.
Broken Display Do not use meter for testing.
Contact for assistance.
WARNING!!
Out of Range -
High Results
> 33.3 mmol/L
Out of Range -
Low Results
< 1.1 mmol/L
WARNING!!
Retest with new test strip. If result
is still“Hi”(High) or“Lo”(Low)
contact a Doctor or Healthcare
Professional immediately.
11 MESSAGES
9PERFORMANCE CHARACTERISTICS5
Reason Action
Test strip inserted upside down
or backwards
Remove test strip from meter. Re-
insert test strip correctly into the
meter.
Test strip not fully inserted Remove test strip from meter. Re-in-
sert test strip correctly into the meter.
Test strip error Remove test strip from meter. Repeat
with new test strip.
Meter is dead or there is not a
battery in the meter
Remove test strip from meter.
Replace battery in meter. Use new
test strip for testing.
Battery in the meter backwards Battery must be placed in meter with
positive (“+”) side facing up.
Meter error Contact for assistance.
1. After inserting test strip, meter does not turn on.
Reason Action
Sample drop too small Repeat test with new test strip and
larger sample drop.
Sample applied after two
minute shut-off
Repeat test with new test strip. Apply
sample within 2 minutes of inserting
test strip into meter.
Problem with test strip Repeat with new test strip. If testing
still has not begun, contact for
assistance.
Problem with meter Contact for assistance.
10 TROUBLESHOOTING
2. After applying sample, meter does not begin testing.
PRECISION: Precision describes the variation between results. There are two types of precision
results measured - repeatability (using blood) and intermediate precision (using control solution).
Repeatability: N=100
Mean (mmol/L) 1.3 2.1 4.1 7.7 11.4 16.4 27.6
SD (mmol/L) 0.05 0.08 0.13 0.25 0.38 0.53 0.75
%CV 4.2 3.8 3.2 3.3 3.3 3.2 2.7
Intermediate Precision: N=100
Mean (mmol/L) 2.1 6.4 17.7
SD (mmol/L) 0.1 0.2 0.6
%CV 4.2 3.4 3.3
SYSTEM ACCURACY: Diabetes experts have suggested that glucose meters should agree within
+0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L
and within +15% of the medical laboratory values at glucose concentrations at or above
5.55 mmol/L.6The tables below show how often healthcare professionals (HCP) and users
achieve these goals using capillary fingertip, capillary forearm, and venous blood samples when
glucose results are not fluctuating. The laboratory reference instrument is the Yellow Springs
Instrument (YSI).
FOR HEALTHCARE PROFESSIONALS
99.5% of TRUE METRIX GO fingertip values performed by healthcare professionals (HCP) fell
within ±0.83 mmol/L of the YSI results at glucose levels <5.55 mmol/L and within ±15% at
glucose levels >5.55 mmol/L.
Fingertip Capillary Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
Within
+0.56 mmol/L
Within
+0.83 mmol/L
94 / 156 (60.3%) 146 / 156 (93.6%) 155 / 156 (99.4%)
Fingertip Samples (HCP vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5% Within + 10% Within + 15%
227 / 444 (51.1%) 383 / 444 (86.3%) 442 / 444 (99.5%)
Fingertip Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
597/600 (99.5%)
Parkes Error Grid: 100% of individual fingertip glucose measured values performed by
healthcare professionals fell within Zone A of the Parkes Error Grid (PEG).
98.2% of TRUE METRIX GO forearm values performed by healthcare professionals (HCP) fell
within ±0.83 mmol/L of the YSI results at glucose levels <5.55 mmol/L and within ±15% at
glucose levels >5.55 mmol/L.
Forearm Capillary Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
Within
+0.56 mmol/L
Within
+0.83 mmol/L
28 / 62 (45.2%) 53 / 62 (85.5%) 60 / 62 (96.8%)
Forearm Capillary Samples (HCP vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5% Within + 10% Within + 15%
74 / 156 (47.4%) 132 / 156 (84.6%) 154 / 156 (98.7%)
Forearm Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
214 / 218 (98.2%)
Parkes Error Grid: 99.1% of individual forearm glucose measured values performed by
healthcare professionals fell within Zone A and 0.9% in Zone B of the Parkes Error Grid (PEG).
Venous Blood
99.1% of TRUE METRIX GO venous values performed by healthcare professionals (HCP) fell within
±0.83 mmol/L of the YSI results at glucose levels <5.55 mmol/L and within ±15% at glucose
levels >5.55 mmol/L.
Venous Samples (HCP vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
Within
+0.56 mmol/L
Within
+0.83 mmol/L
61 / 90 (67.8%) 85 / 90 (94.4%) 90 / 90 (100%)
Venous Samples (HCP vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5% Within + 10% Within + 15%
66 / 130 (50.8%) 122 / 130 (93.8%) 128 / 130 (98.5%)
Venous Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
218/220 (99.1%)
Parkes Error Grid: 100% of individual venous glucose measured values performed by
healthcare professionals fell within Zone A of the Parkes Error Grid (PEG).
FOR CONSUMERS
99% of TRUE METRIX GO fingertip values performed by users fell within ±0.83 mmol/L of the YSI
results at glucose levels <5.55 mmol/L and within ±15% at glucose levels >5.55 mmol/L.
Fingertip Samples (User vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
Within
+0.56 mmol/L
Within
+0.83 mmol/L
13 / 17 (76.5%) 17 / 17 (100%) 17/17 (100%)
Fingertip Samples (User vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5% Within + 10% Within + 15%
46 / 83 (55.4%) 73 / 83 (88.0%) 82/83 (98.8%)
Fingertip Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
99/100 (99.0%)
Parkes Error Grid: 100% of individual fingertip glucose measured values performed by users
fell within Zone A of the Parkes Error Grid (PEG).
98.2% of TRUE METRIX GO forearm values performed by users fell within ±0.83 mmol/L of the
YSI results at glucose levels <5.55 mmol/L and within ±15% at glucose levels >5.55 mmol/L.
Forearm Samples (User vs. YSI) for glucose concentrations <5.55 mmol/L
Within
+0.28 mmol/L
Within
+0.56 mmol/L
Within
+0.83 mmol/L
13 / 31 (41.9%) 22 / 31 (71.0%) 31/31 (100%)
Forearm Samples (User vs. YSI) for glucose concentrations >5.55 mmol/L
Within + 5% Within + 10% Within + 15%
34 / 78 (43.6%) 64 / 78 (82.1%) 76 / 78 (97.4%)
Forearm Samples for glucose concentrations between 1.1-33.3 mmol/L
Within +0.83 mmol/L or +15%
107/109 (98.2%)
Parkes Error Grid: 100% of individual forearm glucose measured values performed by users fell
within Zone A of the Parkes Error Grid (PEG).
USER PERFORMANCE EVALUATION: A study evaluating glucose values from fingertip
capillary blood samples obtained by 100 lay persons showed the following results:
100% within +0.83 mmol/L of the medical laboratory values at glucose concentrations
below 5.55 mmol/L and 98.8% within +15% of the medical laboratory values at glucose
concentrations at or above 5.55 mmol/L. ELECTROMAGNETIC COMPATIBILITY
This meter meets the electromagnetic immunity requirements as per EN ISO 15197:2015.
It meets the electromagnetic emissions requirements as per EN 61326 series. Interference
from the meter to other electronically driven equipment is not anticipated. The
electromagnetic environment should be evaluated prior to operation of the device.
Do not use the meter in a very dry environment, especially one in which synthetic
materials are present. Do not use the meter close to sources of strong electromagnetic
radiation, as these may interfere with the proper operation.
12 SYSTEM SAFETY INFORMTION
Use contact information at the bottom of the page for assistance.