TRIVIDIA HEALTH 01 Self Monitoring Blood Glucose System Owner’s Manual
- June 16, 2024
- TRIVIDIA HEALTH
Table of Contents
01 Self Monitoring Blood Glucose System
Product Information: TRUE METRIX Self Monitoring Blood Glucose
System
Specifications:
-
Intended for quantitative measurement of glucose in fresh
capillary whole blood samples -
Designed for use by a single person and should not be
shared -
Intended for self-testing outside the body by people with
diabetes at home -
Not intended for diagnosis or screening of diabetes or for
neonatal use -
Alternative site testing should be done only during
steady-state times
Product Usage Instructions:
1. TRUE METRIX Self Monitoring Blood Glucose System:
The TRUE METRIX Self Monitoring Blood Glucose System is designed
for the quantitative measurement of glucose (sugar) in fresh
capillary whole blood samples drawn from the fingertip or forearm.
It is intended to be used by a single person and not to be
shared.
This system is intended for self-testing outside the body (in
vitro diagnostic use) by people with diabetes at home as an aid to
monitor the effectiveness of diabetes control.
It should not be used for the diagnosis or screening of diabetes
or for neonatal use. Alternative site testing should be done only
during steady-state times (when glucose is not changing
rapidly).
2. TRUE METRIX Self Monitoring Test Strips:
The TRUE METRIX Self Monitoring Test Strips are for use with the
TRUE METRIX Self Monitoring Meter to quantitatively measure glucose
(sugar) in fresh capillary whole blood samples drawn from the
fingertip or forearm. The TRUE METRIX Self Monitoring Meter
measures the current, detects, analyzes and corrects for hematocrit
and temperature and calculates the glucose result.
3. TRUE METRIX Control Solution:
The TRUE METRIX Control Solution is for use with the TRUE METRIX
Self Monitoring Meter and TRUE METRIX Self Monitoring Test Strips
to check that the meter and the test strip are working together
properly and the test is performing correctly.
FAQ (Frequently Asked Questions):
Q: What should I do if the test strip vial cap is not
securely closed or the product is damaged?
A: If the test strip vial cap is not securely closed or the
product is damaged, do not use the test strips for testing as it
may give inaccurate results. Contact Trividia Health Customer Care
at 1-800-803-6025 for replacement and
assistance.
Q: What type of battery does the TRUE METRIX Self
Monitoring Blood Glucose System use?
A: The system uses one non-rechargeable 3V lithium battery
(#CR2032), with the positive (+) side facing up. Refer to the user
manual for instructions on changing the battery.
Q: How can I upload data from the meter to a
computer?
A: The TRUE METRIX Self Monitoring Blood Glucose System has data
contacts on the meter that can be used to connect it with a
computer for data upload. Please refer to the user manual for
detailed instructions on how to perform data upload.
INTRODUCTION: TRUE METRIX® Self Monitoring Blood Glucose System TRUE METRIX is
a simple, accurate way to test your whole blood glucose (sugar) level,
anytime, anywhere. Our goal is to provide quality healthcare products and
dedicated customer service. For questions about TRUE METRIX products, visit
our web site at: www.trividiahealth.com.
The TRUE METRIX Self Monitoring Blood Glucose System is intended for the
quantitative measurement of glucose (sugar) in fresh capillary whole blood
samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring
Blood Glucose System is intended to be used by a single person and not to be
shared.
The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-
testing outside the body (in vitro diagnostic use) by people with diabetes at
home as an aid to monitor the effectiveness of diabetes control.
The TRUE METRIX Self Monitoring Blood Glucose System should not be used for
the diagnosis or screening of diabetes or for neonatal use. Alternative site
testing should be done only during steady-state times (when glucose is not
changing rapidly).
1
The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX
Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh
capillary whole blood samples drawn from the fingertip or forearm. The TRUE
METRIX Self Monitoring Meter measures the current, detects, analyzes and
corrects for hematocrit and temperature and calculates the glucose result.
The TRUE METRIX Control Solution is for use with the TRUE METRIX Self
Monitoring Meter and TRUE METRIX Self Monitoring Test Strips to check that the
meter and the test strip are working together properly and the test is
performing correctly.
Importance of Blood Glucose Monitoring The more you know about diabetes, the
better you will be able to care for yourself. A Doctor or Healthcare
Professional determines how often you should test and what your target ranges
are for blood glucose results. Having most blood glucose results within your
target range shows how well your treatment plan is working to control glucose
levels. Keeping results within your target range helps slow or stop
complications from diabetes. NEVER change your treatment plan without
consulting a Doctor or Healthcare Professional.
2
IMPORTANT INFORMATION: For the most accurate results using TRUE METRIX Self
Monitoring Blood Glucose System: · Read all product instructions for use
before testing. · Use of TRUE METRIX Self Monitoring Blood Glucose
System in a manner not specified in this Owner’s Booklet is not recommended
and may affect ability to determine true blood glucose levels. · TRUE METRIX
Self Monitoring Blood Glucose System is an in vitro (outside body)
quantitative system that is used for self-testing of human whole blood only. ·
Alternative site (forearm) testing should not be used to calibrate continuous
glucose monitors (CGMs). · Alternative site (forearm) testing should not be
used for insulin dose calculations. · Use only TRUE METRIX Self Monitoring
Blood Glucose Test Strips and TRUE METRIX Control Solution with the TRUE
METRIX Self Monitoring Blood Glucose 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. DO NOT attempt to
remove blood or control solution from test strips or clean test strips and re-
use. Reuse of test strips will cause inaccurate results. · NEVER add a second
drop of sample to test strip. Adding more sample gives an error message. ·
Perform Control Tests before performing a blood glucose test for the first
time.
3
IMPORTANT INFORMATION (cont.):
· Perform Control Tests with more than one level of control solution. Three
levels of TRUE METRIX Control Solution are available for Control Tests. Call
1-800-803-6025, Monday – Friday, 8AM-
8PM EST, for assistance in obtaining control solution.
· The TRUE METRIX Self Monitoring Blood Glucose System is for one person use
ONLY. DO NOT share your meter or lancing device with anyone, including family
members. Do not use on multiple patients!!
· ALL parts of your blood glucose monitoring system could carry blood-borne
pathogens after use, even after cleaning and disinfecting.2, 3
· Cleaning and disinfecting the lancing device and the meter destroys most,
but not necessarily all, bloodborne pathogens.
· Wash your 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.
· If the meter is being operated by a second person who provides testing
assistance, the meter and lancing device should be cleaned and disinfected
prior to use by the second person.
· It is important to keep the meter and the lancing device clean and
disinfected. For instructions on how to clean and disinfect the meter and
lancing device, see Meter Care, Cleaning and Disinfecting and Lancing Device
Cleaning and Disinfecting.
4
IMPORTANT INFORMATION (cont.): · If you have symptoms of low or high blood
glucose,
check your blood glucose immediately. If your result does not match the way
you feel, repeat the test. If your results still do not match the way you
feel, call your 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. · Do not use for diagnosis of or screening of
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.
WARNING: Upon opening the test strip carton, examine the product for missing,
damaged or broken parts. 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.
5
Phone Number, Fast Test Guide, Expected Results …………Cover Introduction and
Important Information………………………….. 1 Know Your System
Meter ………………………………………………………………………………… 7 Test Strip
…………………………………………………………………………10 Control Solution ………………………………………………………………12
Getting Started Quality Control Testing……………………………………………………15 Automatic Self
Test…………………………………………………………..15 Control Test……………………………………………………………………..16 How
to Test Control Solution…………………………………………..17 Testing Blood Obtaining a Blood
Sample………………………………………………..21 How to Test Blood……………………………………………………………25 TRUE
METRIX System and Laboratory Testing ………………29 System Out of Range Warning
Messages ………………………….30 Meter Set Up Set Time / Date…………………………………………………………………31
Set Event Tags, Ketone Test Alert and Test Reminders………33 Meter Memory View
Averages (7-, 14-, and 30-day)………………………………….36 View Memory
…………………………………………………………………..37 Care, Cleaning/Disinfecting and Troubleshooting
Caring for TRUE METRIX ………………………………………………38 Changing
Battery……………………………………………………………..44 Troubleshooting………………………………………………………………. 45
Messages ………………………………………………………………………….46 System Safety Information and
Electromagnetic Compatibility…49 System Specifications/Chemical Composition
…………………………51 Meter Warranty……………………………………………………………………52
References…………………………………………………………………………… 52
6
Know Your System Meter
Top of Meter
1 23
” ” 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).
” · ” Button Turn meter on to view Average values, to view results in Memory,
to access Meter Set Up, to turn on Event Tags in Meter Set Up.
” ” Button Increase numbers in Meter Set Up; add ALT Symbol; move forward by
date/time when viewing results and view Averages in Memory; scroll through
Event Tags to mark results (if feature on).
7
Front of Meter
Back of Meter
4 1
5
3
2
6
Display Screen
Shows results, messages, user prompts, information. Test Port
Insert TRUE METRIX Test Strip here, contact blocks facing up. Strip Release
Button
Releases test strip after testing for disposal. Battery Door
Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up
(see Changing Battery). Meter Label
Contains serial number of meter. Data Contacts
Connects meter with computer for data upload.
8
Full Display Screen
1
2
3
4
5
6
7 14
8
13
9 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. Alternate Site (ALT) Symbol 10. Drop Symbol – Apply blood or
control solution 11. Temperature Symbol 12. Test Reminder Symbol 13. Ketone
Test Alert Symbol 14. Unit of Measure (Note: Factory set to mg/dL,
cannot be changed by user.)
9
Test Strip
Top of Test Strip
2
1
Contact End – Insert into Test Port with contact blocks facing up.
Sample Tip – Bring Tip of test strip to top of sample drop (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.
Sample Placement
Correct
Incorrect
· Allow sample drop to be drawn into Sample Tip until test-
ing begins (meter beeps and dashes move across Display).
· Do not smear or scrape drop with test strip.
· Do not apply more sample to test strip after testing begins.
· Do not apply blood or control solution to top of test strip.
Do not insert Sample Tip with sample into Test Port.
May damage meter.
10
May 30, 2023
Test Strip Vial Label
1 2
2
3
Lot Number (LOT) – Used for identification when calling for assistance.
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. See the
test strip Instructions for Use for open vial expiration date.
Caution!
Use of test strips or control solution past the Expiration Dates may give incorrect test results. Discard out-of-date products and test with new products.
Control Test Range – Range of numbers in which Control Test result must fall to assure the system is working properly.
Note: Examples only. Do not represent actual Control Test ranges.
11
May 30, 2023
Control Solution (Control)
Control Solution Bottle Label 3
12
Lot Number (LOT) – Used for identification when calling for assistance.
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.
Control Solution Level (1, 2, or 3) – We recommend testing at least 2 levels
of control solution. Contact
1-800-803-6025, Monday – Friday, 8AM-
8PM EST, for assistance with obtaining different levels of control solution.
12
Getting Started Meter comes with pre-set time and date. The Event Tag feature,
Ketone Test Alert, and all Test Reminders are off. Before using the meter for
the first time or after a battery change, check the time, date, Event Tags,
Alert and Reminders, and update as needed (see Meter Set Up).
The meter turns on when a test strip is inserted into the Test Port or when ”
· ” Button is pressed (see Memory and Meter Set Up).
Meter turns off when the test strip is released or removed from the meter, ” ·
” Button is pressed, or after 2 minutes of non-use.
Turning the Ketone Test Alert on sets a reminder to check your ketones per
your treatment plan when a blood glucose result is over 240 mg/dL.
Test Reminders are set like an alarm clock to sound a tone for 10 seconds to
remind you to test. Up to four Test Reminders per day may be set.
13
Getting Started (cont.)
Event Tags allow you to tag your blood glucose results to link to the
following events:
Before meal test was taken just before a meal, After meal test was taken 2
hours after the start of a meal, Exercise test was taken during or after
exercise, Medications medication taken may have affected test result, Sick
test was taken when sick, Other any other reason that the test is unique or
different in some way (example: stress, drinking alcohol). In your logbook,
note the reason that the test result was tagged. Seeing a result with an Event
Tag in the meter Memory reminds you that there is more about this test result
in your log book.
Tagging results helps track the effect specific events may have on your blood
glucose test results. Event Tagging may assist you and your Doctor or
Healthcare Professional with managing diabetes.
14
Quality Control Testing
To assure you are getting accurate and reliable results, TRUE METRIX offers
two kinds of quality Control Tests. These tests let you know that your System
is working properly and your testing technique is good.
Automatic Self-Test
Contact Blocks Face Up
An Automatic Self-Test is performed by the meter each time a test strip is inserted correctly into the Test Port.
Insert a test strip into the Test Port.
Full Display
The meter is working properly if:
~ the full Display appears, then
~ the time appears in the upper part of the Display, and then,
~ the Drop Symbol begins to blink.
If an error message appears in the Display, the meter will not perform a test.
See Troubleshooting or call
1-800-803-6025, Monday – Friday, 8AM-
8PM EST.
Drop Symbol Error Message
Caution!
If any segments are missing in the Display when meter is first turned on, do not use the meter for testing. Call 1-800-803-6025, Monday – Friday, 8AM- 8PM EST.
15
Control Test
We recommend performing Control Tests for practice before using your meter for
the first time to test your blood.
Control Tests should be performed:
· For practice to ensure your testing technique is good,
· Occasionally as you use a vial of test strips,
· When opening a new vial of test strips,
· If results seem unusually high or low,
· If a vial has been left opened or exposed to extreme heat or cold, or
humidity,
· Whenever a check on performance of the system is needed,
· If meter damage is suspected (meter was dropped, crushed, wet, etc.)
Note: It is important to perform Control Tests with more than one level of
control solution. Three levels of TRUE METRIX Control Solution are available
for Control Tests. Call 1-800-803-6025,
Monday Friday, 8AM-8PM EST, for assistance in obtaining different levels of
control solution.
Caution!
Ranges printed on test strip vial label are for Control Test results only and are not suggested levels for your blood glucose. Do not drink control solution.
16
May 30, 2023
How to Test Control Solution Use ONLY TRUE METRIX Control Solution with the
TRUE METRIX Self Monitoring 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. (Control solution – 3 months after first opening
or date next to EXP on bottle label; test strips – after open vial expiration
date (see test strip Instructions for Use) or date next to EXP on vial label.)
Discard expired products and use new products. 2. Allow control solution, vial
of test strips and meter to adjust to room temperature. Write date first
opened on both control solution bottle label and test strip vial label when
using for the first time. 3. Gently swirl or invert control solution bottle to
mix. DO NOT SHAKE! 4. Remove one test strip from vial. Close test strip vial
immediately. Use test strip quickly after removal from vial.
17
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. Release and discard old test strip. Use new test strip for testing.
Contact Blocks Face Up
6. Wait until Drop Symbol appears in
Display. Keep test strip in meter until
testing is finished.
Drop Symbol
Note: If test strip is removed before testing is finished, an error message appears. Release and discard old test strip. Use new test strip for testing.
7. With cap removed, turn control solution bottle upside down. Squeeze one
drop of control solution onto a clean tissue. Wipe off bottle tip and discard
tissue.
8. Gently squeeze a drop of control solution onto a small piece of unused
aluminum foil or clear plastic wrap. Dispose after use.
Discard Control Solution Drop on
Tissue
18
9. With test strip still in meter, touch Sample Tip of test strip 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.
Meter testing
Note: If meter does not beep and begin testing soon after drawing up sample,
release and discard test strip. Repeat test with new test strip. If problem
persists, see Troubleshooting.
11. Compare meter result to Control Test range printed on test strip vial label for level of control solution you are using. If result is in range, System can be used for testing blood. If result does not fall within range, repeat test using a new test strip.
Control Solution Bottle Label
Test Strip Vial Label
Note: Control Test result shows the Control Symbol in the Display.
19
Control Symbol
(Example only. Does not represent actual
Control Test ranges.)
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
1-800-803-6025, Monday Friday, 8AM-8PM
EST.
12. After result is shown, Strip Release Button flashes. Hold meter with test
strip pointing down. Press Strip Release Button to release and discard test
strip into appropriate container. Meter turns off.
Note: Removing test strip before result displays 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.
20
Testing Blood Obtaining a Blood Sample WARNING! · The TRUE METRIX Self
Monitoring Blood Glucose
System is for one person use ONLY. DO NOT share your meter or lancing device
with anyone, including family members. Do not use on multiple patients!! · ALL
parts of your blood glucose monitoring system could carry blood-borne
pathogens after use, even after cleaning and disinfecting.2 · Cleaning and
disinfecting the lancing device and the meter destroys most, but not
necessarily all, bloodborne pathogens. · Wash your 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. · If the
meter is being operated by a second person who provides testing assistance,
the meter and lancing device should be cleaned and disinfected prior to use by
the second person. · It is important to keep the meter and the lancing device
clean and disinfected. For instructions on how to clean and disinfect the
meter and lancing device, see Meter Care, Cleaning and Disinfecting and
Lancing Device Cleaning and Disinfecting.
21
Obtaining a Blood Sample (cont.) Refer to lancing device Instructions for Use
for detailed instructions. · Never share lancets or lancing device. Lancets
are for
single use only. Do not re-use. · Do not use venous blood for testing. · To
help prevent false high results, wash hands before
using the system to test blood, especially after fruit has been handled. From
Fingertip 1. Prepare fingertip by washing hands with soap and warm water.
Rinse and dry thoroughly. Disinfect the clean skin with an antiseptic (e.g.,
70% alcohol). 2. Place end of lancing device device equipped with a lancet
against tip of finger. Lance fingertip. 3. Set lancing device aside. To help
blood drop form, lower hand to waist level, gently massaging finger from palm
to fingertip. Allow blood drop to form before attempting to apply to the test
strip. Apply sample to test strip Sample Tip. 4. Recap and remove used lancet
from lancing device. The used lancet may be biohazardous. Please discard it
carefully according to your Doctor or Healthcare Professional’s instructions.
22
From Forearm Important Notes Regarding Forearm Testing4 · Check with your
Doctor or Healthcare Professional
to see if forearm testing is right for you. · Results from forearm are not
always the same as
results from fingertip. · Use fingertip instead of forearm for more
accurate results: ~ Within 2 hours of eating, exercise, or taking insulin, ~
If your blood sugar may be rising or falling rapidly or
your routine results are often fluctuating, ~ If you are ill or under stress,
~ If your forearm test results do not match how you feel, ~ If your blood
sugar may be low or high, ~ If you do not notice symptoms when blood sugar is
low or high. 1. Select area to be lanced. Wash with soap and warm
water, rinse and dry thoroughly. Disinfect the clean skin with an antiseptic
(e.g., 70% alcohol). 2. Rub area vigorously or apply a warm dry compress to
increase blood flow. 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. Apply sample to test strip Sample Tip.
23
4. Recap and remove lancet from lancing device.
Caution!
The used lancet may be biohazardous. Please discard it carefully according to your Doctor or Healthcare Professional’s instructions.
24
How to Test Blood
1. Check Meter time and date before each glucose test. With meter off, press
and hold the ” · ” Button until the full Display is shown and a series of
beeps sound. Release ” · ” Button. If time and date are incorrect, see Meter
Set Up to set the correct time and date.
2. 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.
3. Wash hands (and forearm for alternative site testing). Rinse well and dry
thoroughly.
4. Remove one test strip from vial. Close vial immediately. Use test strips
quickly after removal from vial.
5. With meter off, insert test strip Contact End (blocks facing up) into Test
Port. Meter turns on. Keep test strip in meter until testing is finished.
To mark test as alternative site (forearm) result, press ” ” Button. ALT
Symbol appears in Display. Press ” ” Button to remove ALT Symbol. Wait until
Drop Symbol appears in Display.
25
ALT Symbol
Drop Symbol
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. Release and
discard old test strip. Use new test strip for testing.
6. Lance fingertip or forearm. Allow drop to form (see Obtaining a Blood
Sample).
7. With test strip still in meter, touch Sample Tip of test strip to top of
blood drop and allow blood to be drawn into test strip. Remove test strip from
blood drop immediately after the meter beeps and dashes appear across the
Display
Note: If meter does not begin testing soon after touching drop to test strip,
discard test strip. Repeat test with new test strip and new blood drop. If
problem persists, see Troubleshooting.
Dashes appear across Display to show meter is testing.
26
8. After the test is finished, result is displayed. The Strip Release Button flashes.
To mark the result with an Event Tag,
make sure that Event Tags are turned on Test Result
(see Set Event Tags, Ketone Alert and Test
Reminders). The Event Tag icons flash.
Press “” or “” Button to go to the
correct Event Tag. Press ” · ” Button to
mark the test result with an event (icon stops flashing).
Event Tags are as follows:
Event Tag (Before Meal Icon
– shown)
Before meal test was taken just before a meal,
Top of Meter
After meal test was taken 2 hours after the start
of a meal,
Exercise test was taken during or after exercise,
Medications medication taken may have
affected test result,
Sick test was taken when sick,
Other any other reason that the test is unique or
different in some way (example: stress, drinking
alcohol). In your logbook, note the reason that
the test result was tagged. Seeing a result with an
Event Tag in the meter Memory reminds you that
there is more about this test result in the log book.
Record result in log book.
27
9. Hold meter with test strip pointing down. Press test strip Release Button
to discard test strip in the appropriate container. Meter turns off. Result is
stored in Memory with date and time.
Note: Removing test strip before result displays cancels the test. An error
message appears and result is not stored in Memory. Retest with a new test
strip and do not remove before result is displayed.
Caution!
The used lancet and test strip may be biohazardous. Please discard them carefully according to your Doctor or Healthcare Professional’s instructions.
28
TRUE METRIX Self Monitoring Blood Glucose System and Laboratory Testing When
comparing results between TRUE METRIX Self Monitoring Blood Glucose System and
a laboratory system, TRUE METRIX Self Monitoring Blood Glucose System blood
tests should be performed within 30 minutes of a laboratory test. If you have
recently eaten, fingerstick results from the TRUE METRIX Self Monitoring Blood
Glucose System can be up to 70 mg/ dL higher than venous laboratory results.5
29
System Out of Range Warning Messages
WARNING!
Meter reads blood glucose levels from 20-600 mg/dL.
If test result is less than 20 mg/dL, “Lo” appears in Display.
If test result is greater than 600 mg/dL, “Hi” appears in Display.
ALWAYS repeat blood tests to confirm Low (“Lo”) and High (“Hi”) results. If
blood results still display “Lo” or “Hi”, call your Doctor or Healthcare
Professional immediately.
Note: “Lo” results are included in the Average as 20 mg/dL. “Hi” results are included as 600 mg/dL.
If blood glucose test result is greater than
240 mg/dL, and Ketone Test Alert is turned
on, “Ketone” appears in Display with glucose
result (see Ketone Test Alert).
Ketone Test
Alert
Caution When a Ketone Test Alert is shown in the meter
Display, it does not mean that ketones have
been detected in your blood. Perform a ketone test per your treatment plan, as prescribed by
your Doctor or Healthcare Professional.
Note: Ketone Test Alert can be turned on or off during Meter Set Up.
30
Meter 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.
1. With meter off, press and hold ” · ” Button until the full Display is
shown and a series of beeps sound (after about 10 seconds). Release ” · ”
Button. Meter goes into Set Up.
Set Time/Date 2. The hour flashes. To change, press
” ” or ” ” Button on top of the meter to select the hour. Like many alarm
clocks, to set “AM” or “PM”, scroll through the hours until “AM” or “PM”
appears in the Display. Press ” · ” Button to set. 3. The minutes flash. To
change, press ” ” or ” ” Button to select the minutes. Press ” · ” Button to
set.
31
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. Press ” · ” Button to set.
6. The year flashes. To change, press ” ” or ” ” Button to select the year.
Press ” · ” Button to set.
Note: Meter beeps every time a setting is confirmed (” · ” Button is pressed).
32
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.
1. After setting the year, press ” ” or ” ” Button to turn Event Tags on or off. Press Top of Meter
” · ” Button to set, then the Meter goes to
set Ketone Test Alert.
Ketone Test Alert
When a blood glucose result is over
240 mg/dL, the Ketone Test Alert is a
reminder to check your ketones per your
treatment plan.
2. Press ” ” or ” ” Button to turn Alert Ketone Test
on or off. Press ” · ” Button to set, then
Alert
the Meter goes to set Test Reminder.
Caution!
When a Ketone Test Alert is shown in the Display, it does not mean that
ketones have been detected in your blood. Perform a ketone test per your
treatment plan, as prescribed by your Doctor or Healthcare Professional.
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). To turn Reminder on,
press ” ” Button. Press ” ” Button to Test Reminder turn Reminder back to off.
Press ” · ” Button to set.
2. When “on” is chosen, press ” · ” Button. The hour flashes. Press ” ” or ”
” Button to set the hour. To set AM/PM, scroll (press ” ” or ” ” Button) until
“AM” or “PM” is next to correct time. Press ” · ” Button to set.
3. The minutes flash. Press ” ” or ” ” Button to set the minutes. Press ” · ”
Button to set. Meter goes to the next Test Reminder.
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.
If battery dies or is replaced, Ketone Test Alert and Test Reminders may have to be reset.
Test Reminder Symbol
35
Meter Memory
View Averages (7-, 14-, and 30-day)
The Averages feature allows you to view the average of all your blood glucose
results within a 7-, 14-, or 30-day period. Control Test results are not
included in the Averages.
You can review the average of your glucose results from the last 7-, 14-, or
30-days.
1. With meter off press and release ” · ” Button. Display scrolls through 7-,
14-, and 30-day Average values.
7-Day Average
2. Meter turns off after 2 minutes if no buttons are pressed.
14-Day Average
Note: If there are no Average values, three dashes are displayed for 7-, 14-, and 30-day Averages.
30-Day Average
36
No Average
View Memory
Meter Memory stores 500 results. When Memory is full, the oldest result is replaced with the newest result.
1. Press and release ” · ” Button.
Memory Symbol
Meter displays 7-, 14- and 30-day
Averages. Press and release ” · ” Button
again to view most recent Control
Test result in Memory. If there are no
results in Memory, dashes appear with Alternate Site
the Memory Symbol.
Symbol
2. Press ” ” Button and release to advance to the most recent blood test.
Press ” ” Button to scroll forward through results or ” ” Button to scroll
backwards through results.
Control Symbol
Test results marked as alternate site display ALT Symbol.
Control Test results display the Control Symbol. If no Control Test has been
done, Display shows dashes and the Control Symbol.
Test results above 240 mg/dL display Ketone Test Alert Symbol, when Ketone
Test Alert is turned on during Set Up.
Ketone Test Alert Symbol
Tests marked with an Event Tag shows the Event Tag icon in the Display.
Event Tag (Before Meal Icon
– shown)
37
Care, Cleaning/Disinfecting and Troubleshooting · 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 (40°F-86°F)
at 10%-80% relative humidity. DO NOT FREEZE. · Do not share your meter with
anyone, including family
members. · Allow system to sit at room temperature for 10
minutes before testing. · Do not keep meter in an area where it may be crushed
(i.e. back pocket, drawer, bottom of bag, etc.).
Meter Care, Cleaning and Disinfecting Cleaning removes blood and soil from the
meter. Disinfecting removes most, but not all possible
infectious agents (bacteria or virus) from the meter, including blood-borne
pathogens. · Clean and disinfect immediately after getting any blood on the
meter or if meter is dirty. · Clean and disinfect meter at least once a week.
Meter may be cleaned and disinfected once a week for up to 5 years. · If the
meter is being operated by a second person who provides testing assistance,
the meter and lancing device should be cleaned and disinfected prior to use by
the second person. Do not clean the meter during a test. · Cleaning (step #2)
must occur before disinfecting (steps #3 and #4).
38
To Clean and Disinfect the Meter: 1. Wash hands thoroughly with soap
and water. 2. To Clean: Make sure meter is off
and a test strip is not inserted. With ONLY Super Sani-Cloth® Wipes (EPA reg.
no. 9480-4), rub the entire outside of the meter using 3 circular wiping
motions with moderate pressure on the front, back, left side, right side, top
and bottom of the meter. Discard used wipes. (Environmental Protection
Agency.)
3. To Disinfect: Using fresh wipes, make sure that all outside surfaces of
the meter remain wet for 2 minutes. Make sure no liquids enter the Test Port
or an other opening in the meter.
Super Sani-Cloths may be purchased at the following places: · Amazon.com, ·
Officedepot.com
or visit your local Office Depot store, · Walmart.com
4. Let meter air dry thoroughly before using to test.
39
5. Wash hands thoroughly again after handling meter.
6. 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: · Meter display appears cloudy or any display segments
are missing, · Markings on meter, including back meter label, are
coming off or are missing, · Buttons are hard to push on the meter or do not
work, · Unable to insert test strip into Test Port, · Automatic Self-Test
gives an error message.
Note: Other disinfectants have not been tested. The effect of other
disinfectants used interchangeably has not been tested with the meter. Use of
disinfectants other than Super Sani-Cloth Wipes may damage meter.
Note: Super Sani-Cloth Wipes have been tested on the meter for a total of 260
cleaning and disinfecting cycles, which is equal to cleaning and disinfecting
the meter once a week for a 5 year period. The use life of the meter is 5
years.
40
Lancing Device Cleaning and Disinfecting Cleaning and disinfecting the lancing
device is a two-step process. The first step is Cleaning. Cleaning removes any
blood, liquids, dust or dirt. The second step is Disinfecting. Disinfecting
removes most, but not all possible infectious agents (bacteria or viruses),
including blood-borne pathogens. Cleaning must be done before Disinfecting.
Caution! Clean and disinfect the lancing device at least once a week. Lancing
device may be cleaned and disinfected once a day for up to 3 years. If blood
gets on the lancing device, clean and disinfect it before anyone else touches
it. If someone is helping you test your blood or performs a test on you, do
the cleaning and disinfecting before allowing anyone else to handle it.
1. Wash hands thoroughly with soap and water or wear disposable gloves.
2. To Clean: Using ONLY Super SaniCloth (EPA Reg. No. 9480-4), thoroughly
wipe the entire outside surface of the lancing device with one cloth by wiping
in circles 3 times. Discard the used cloth.
3. Repeat step 2 if the lancing device is not visually clean, or safely
dispose of it according to your state/local regulations.
(Environmental Protection Agency.)
41
4. To Disinfect: Remove a fresh Super Sani-Cloth and thoroughly wipe the
entire outside surface of the lancing device by wiping in circles 3 times.
Make sure that you go over the entire lancing device.
5. Using fresh cloths, if needed, make sure that all outside surfaces of the
lancing device stay wet for 2 minutes by patting with the cloth. Discard used
cloth. Let lancing device air dry completely before using.
6. Gently pull back Arming Barrel and press the Trigger Button. You will hear
a click if the lancing device is working properly.
7. Wash hands thoroughly again.
Caution! Other disinfectants have not been tested. The effect of other
disinfectants used interchangeably has not been tested with the lancing
device. Use of disinfectants other than Super Sani-Cloth may damage lancing
device. Do not use lancing device and call Customer Care for assistance at
1-800-803-6025, Monday – Friday, 8AM –
8PM EST, if:
~ Markings on lancing device are coming off, ~ Trigger Button is hard to push,
~ End Cap does not go back on,
~ Arming Barrel does not click when gently pulled back.
Super Sani-Cloth may be purchased at: Amazon.com, Officedepot.com (or your
local Office Depot store), Walmart.com, Super Sani-Cloth has been tested on
the lancing device for a total of 1,095 cleaning and disinfecting cycles,
which is equal to cleaning and disinfecting the lancing device once a day for
a 3-year period. Lancing device may be cleaned and disinfected up to 7 cycles
per week for 3 years.
42
TRUE METRIX Control Solution Care · Write date opened on control solution
bottle label.
Discard if either 3 months after first opening or date printed next to EXP on
bottle label has passed, whichever comes first. · After each use, wipe bottle
tip clean and recap tightly. · Discard any control solution bottles that
appear cracked or leaking. · Store at temperatures between 36°F-86°F. DO NOT
FREEZE.
TRUE METRIX Self Monitoring 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 expiration date or
the date printed next to EXP on vial label has passed, whichever comes first.
See the test strip Instructions for Use for open vial expiration date. Use of
test strips past expiration dates may give incorrect results. · Discard any
test strip vials that appear cracked or broken. · Close vial immediately after
removing test strip. Store in a dry place at room temperature (40°F-86°F) at
10%-80% relative humidity. DO NOT FREEZE. · Do not reuse test strip. · Do not
bend, cut or alter test strips in any way.
43
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: 1. Lift tab on Battery Door. 2. Turn meter over, tap
gently on the
palm of your other hand to loosen and remove battery. 3. Discard old battery
into appropriate container. 4. Insert new battery, positive (“+”) side facing
up. Close Battery Door.
Low
Tab Battery Door
Note: Use non-rechargeable 3V lithium battery (#CR2032).
5. Press ” · ” Button to turn meter on. Check time, date, Ketone Test Alert
and Test Reminders (see Meter Set Up). If meter does not turn on, check that
battery was installed properly. If not, remove and reinsert battery. Turn
meter on by pressing ” · ” Button. Call
1-800-803-6025, Monday – Friday, 8AM-
8PM EST, if problem persists.
Warning! Battery is not rechargeable. If you have a cable or a cradle for
downloading results to a computer, DO NOT plug the USB cable end into an
electrical outlet. Trying to recharge the battery or power the meter by
plugging into an electrical outlet will cause meter to catch on fire or melt.
Caution!
Batteries might explode if mishandled or incorrectly replaced. Do not dispose
of battery in fire. Do not take apart or attempt to recharge battery. Dispose
according to local regulations.
44
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 inserted
Remove test strip. Re-insert test strip fully into meter.
Test strip error
Repeat with new test strip.
Dead or no battery
Replace battery.
Battery in backwards Battery positive (“+”) side must face up.
Meter error
Call 1-800-803-6025, Monday Friday, 8AM-8PM EST.
2. After applying sample, test does not start/meter does not beep
or begin testing.
Reason
Action
Sample drop too small Repeat test with new test strip and larger drop.
Sample applied after two Repeat test with new
minute shut-off
test strip. Apply sample
within 2 minutes of
inserting test strip.
Problem with test strip Repeat with new test strip.
Problem with meter
Call 1-800-803-6025, Monday Friday, 8AM-8PM EST.
For assistance, call 1-800-803-6025,
Monday – Friday, 8AM-8PM EST.
45
Messages Display
Reason
Invalid Hematocrit
Temperature Error ·
Too Cold/ Too Hot
Action
Repeat with new test strip, using capillary whole blood from the finger or
forearm. If error persists, call
1-800-803-6025, Monday –
Friday, 8AM-8PM EST.
Move meter and test strips to area between
41°F-104°F; wait 10 minutes for system to reach room temperature
before testing.
Sample Not Detected or Using Wrong Test Strip
Retest with new test strip and larger
sample.
Used Test Strip, Repeat with new test strip. Make
Test Strip outside sure Sample Tip of test strip
of vial too long, touched top of sample drop. If error
Sample on top of persists, call 1-800-803-6025, Mon-
Test Strip.
day – Friday, 8AM-8PM EST.
Meter Error
Call 1-800-803-6025, Monday – Friday, 8AM-8PM EST.
46
Display
Reason
Test Strip Error, or very high blood glucose result (higher than 600 mg/dL)
Action Retest with new test strip. If
error persists, call 1-800-803-6025,
Monday – Friday, 8AM-8PM EST. If you have symptoms such as fatigue, excess
urination,
thirst, or blurry vision follow your Doctor or Healthcare Professional’s
advice for high blood
glucose.
Test Strip Removed During Test
Retest with new test strip. Make sure result
is displayed before removing test strip.
Communication Error
Call 1-800-803-6025, Monday – Friday, 8AM-8PM EST.
Low or Dead Battery
Low: About 50 tests can be done before battery dies. Dead: Battery Symbol
appears and beeps before
meter turns off.
If error message still appears, any other error message appears, or
troubleshooting does not solve the problem, call
1-800-803-6025,
Monday – Friday, 8AM-8PM EST.
47
Display Reason
Broken Display
Action
Do not use meter for testing.
Call 1-800-803-6025, Monday – Friday,
8AM-
8PM EST.
WARNING!! Out of Range – High Results > 600 mg/dL
– Low Results < 20 mg/dL
WARNING!!
Retest with new test strip. If result is still “Hi” (High) or “Lo” (Low)
contact Doctor or Healthcare Professional immediately.
If error message still appears, any other error message appears, or
troubleshooting does not solve the problem, call
1-800-803-6025,
Monday – Friday, 8AM-8PM EST.
48
System Safety Information and Electromagnetic Compatibility
The TRUE METRIX 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 has met the following requirements of 60601-1-2, Edition 4:
EMC Test
Compliance Information
Radiated Emissions
CISPR 11 Class B limits
Conducted Emissions Voltage
Not applicable
Radiated RF EM Fields
10v/m, 80 MHz 2.7 GHz, 80% AM at 1 kHz
Proximity fields from RF wireless communications equipment
Per table 8.10
Power Frequency Magnetic Fields 30 A/m, 50 Hz and 60 Hz
Electrical Fast Transients / Bursts
Not applicable
Surges
Not applicable
Conducted Disturbances induced by Not applicable RF fields
Voltage Dips and Voltage Interruptions Not applicable
Electrostatic Discharge
+/-8kV contact ; +/15kV air discharges.
49
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 TRUE METRIX meter in a very dry
environment, especially one in which synthetic materials are present. Do not
use the TRUE METRIX meter close to sources of strong electromagnetic
radiation, as these may interfere with the proper operation of the meter. Do
not use electrical equipment, including antennas, closer than 12 inches to any
part of the TRUE METRIX meter, including cables specified by the manufacturer.
Blood Glucose Monitoring System Components · TRUE METRIX Self Monitoring Blood
Glucose Meter · TRUE METRIX Self Monitoring Blood Glucose Test Strips · TRUE
METRIX Control Solution · Lancing Device · Single Use Lancet Kit may contain
one or more of the components above. To obtain components, call
1-800-803-6025, Monday Friday, 8AM-
8PM EST. Other accessories may negatively affect EMC performance. No adverse
events to the Patient and Operator are anticipated due to electromagnetic
disturbances because all electrical components of the TRUE METRIX meter are
fully enclosed.
50
System Specifications Result Range: 20-600 mg/dL Sample Size: 0.5 microliter
(0.5 µL) Sample: Fresh capillary whole blood from the finger or
forearm, or control solution Test Time: Results in as little as 4 seconds
Result Value: Plasma values Assay Method: Amperometric Power Supply: One 3V
lithium battery
CR2032 (non-rechargeable) Battery Life: Approximately 1000 tests or 1 year
Automatic shut-off: After two minutes of non-use Weight: 1.66 ounces Size:
3.44″ x 2.16″ x 0.69″ Memory Size: 500 glucose results
Operating Range (meter & test strips): Relative Humidity: 10%-90% (Non-
condensing) Temperature: 41°F-104°F Hematocrit: 20%-70% Altitude: Up to and
including 10,200 feet
Note: Use within specified environmental conditions only.
Chemical Composition TRUE METRIX 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.
51
TRUE METRIX Self Monitoring Limited Lifetime Warranty
Trividia Health, Inc. provides the following Warranty to the original
purchaser of the TRUE METRIX Self Monitoring Blood Glucose Meter: 1. Trividia
Health Inc. warrants this meter to be free of defects in materials and
workmanship at the time of purchase. If the meter is ever inoperative,
Trividia Health, Inc. will replace the meter with an equivalent meter, at its
option, at no cost to the purchaser. Failure of the meter due to abuse or use
not in accordance with the instructions for use is not covered by this
Warranty. 2. This Warranty does not include the battery supplied with the
meter. 3. Do not take the meter apart. This action will void the Warranty and
cause the meter to display false results. 4. The duration of any implied
Warranty, including any implied Warranty of merchantability or fitness for a
particular purpose shall be limited to the lifetime in use with the original
user in accordance with any state law to the contrary. 5. Trividia Health,
Inc. disclaims liability for incidental or consequential damages for breach of
any expressed or implied Warranty, including any implied Warranty of
merchantability or fitness for a particular use with respect to the meter.
Some states do not allow the exclusion or limitation of incidental or
consequential damages, so the above limitations or exclusion may not apply. 6.
This Warranty gives the user specific legal rights, and the user may also have
other rights which vary state to state. Your Trividia Health, Inc. Customer
Care Representative will be able to provide detailed information regarding
procedures for returning your meter, if necessary.
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/AlertsandNotices/ucm224025.htm. 3. Infection
Prevention during Blood Glucose Monitoring and Insulin Administration.
Available at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html.
4. Food and Drug Administration. Blood Glucose Meters, Getting the Most Out of
Your Meter. [Electronic Version]. Retrieved December 22, 2009 from http://www.
fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/
ucm109371.html. 5. Larsson-Cohn U: Difference between capillary and venous
blood glucose during oral glucose tolerance tests. Scand J Clin Lab Invest
36:805-808, 1976.
52
RE4TVH35 Rev. 50 EN
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