Trividia Health TRUE METRIX PRO User manual

Use only with TRUE METRIX®PRO
Blood Glucose Test Strips
Call for assistance
Monday - Friday,
8AM-8PM Eastern Standard Time
English or Spanish
1-800-803-6025
www.trividiahealth.com
© 2021 Trividia Health, Inc.
TRUE METRIX PRO and the Trividia Health
logo are trademarks ofTrividia Health, Inc.
RE4TVHP03 Rev. 54
Owner’s
Booklet
Manufactured by:
Fort Lauderdale, FL 33309 U.S.A.
PRO
Professional Monitoring
Blood Glucose System
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Notes
Fast Test Guide
Expected Results for people without diabetes:
Plasma Blood Glucose Result1
Before eating < 100 mg/dL
2 hours after eating < 140 mg/dL
For quick reference only, not intended as a substitute for
complete instructions. Please read entire Owner’s Booklet
and product Instructions for Use before testing.
INSERT
TEST STRIP
1 2
APPLY
BLOOD SAMPLE
2 simple steps
Professional Monitoring
Blood Glucose System
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INTRODUCTION:
TRUE METRIX® PRO
Professional Monitoring Blood Glucose System
TRUE METRIX PRO is a simple, accurate way to test
whole blood glucose (sugar) level, anytime, anywhere.
Our goal is to provide quality healthcare products and
dedicated customer service. For questions about TRUE
METRIX PRO products, visit our web site at:
www.trividiahealth.com.
Trividia Health, Inc. recognizes the importance of
practicing safe and reliable testing using the TRUE
METRIX PRO. Each patient should have specic blood
glucose target ranges that are determined by their Doctor
or Diabetes Healthcare Professional. Having most blood
glucose results within the patient’s target range shows
how well a treatment plan is working to control glucose
levels. Keeping results within the patient’s target range
helps slow or stop complications from diabetes.
e TRUE METRIX PRO Professional Monitoring
Test Strips are for use with the TRUE METRIX PRO
Professional Monitoring Meter to quantitatively measure
glucose (sugar) in fresh capillary whole blood samples
drawn from the ngertip or forearm, or venous whole
blood collected only in sodium heparin vacutainer
tubes. e TRUE METRIX PRO meter measures the
current, detects, analyzes and corrects for hematocrit and
temperature, and calculates the glucose result.
1
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IMPORTANT SAFETY INFORMATION:
For the most accurate results using TRUE METRIX PRO:
• Read all product instructions for use before testing.
• Use of TRUE METRIX PRO in a manner not specied
in this Owner's Booklet is not recommended and may
aect ability to determine true blood glucose levels.
• TRUE METRIX PRO is an in vitro (outside the body)
quantitative system for multiple patient use testing of
human whole blood only.
• Do not use for the diagnosis of or screening for
diabetes mellitus or for measuring blood glucose in
newborns.
• ONLY use auto-disabling single use lancing devices/
lancets to obtain capillary blood sample.
• 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.
• DO NOT use venous whole blood collected in
sodium uoride (grey top), lithium heparin, or
EDTA vacutainer tubes for testing, as this may cause
inaccurate results.
2
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3
• Use ONLY TRUE METRIX PRO Test Strips and TRUE
METRIX Control Solution with the TRUE METRIX
PRO Meter.
• Remove only one test strip at a time from test strip
vial. Recap vial immediately.
• NEVER reuse test strips. NEVER wipe test strips with
water, alcohol or any cleaner. DO NOT attempt to
remove blood or control sample 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 rst time.
• Perform Control Tests with more than one level of
control solution. ree 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 dierent levels of control
solution.
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4
IMPORTANT INFORMATION (cont.):
WARNING!
Healthcare Professionals should adhere to standard
precautions and disinfection procedures when handling
or using this device for testing. ALL parts of the TRUE
METRIX PRO Professional Monitoring Blood Glucose
System are considered potentially infectious, and capable
of transmitting blood-borne pathogens between patients
and healthcare professionals.
2,3
Only use auto-disabling,
single-use lancing devices/lancets to obtain capillary
blood. For more information on standard precautions and
practices please refer to http://www.cdc.gov/hicpac/
2007ip/2007isolationprecautions.html.
• Multiple patient use devices such as blood glucose
meters should be used on only one patient and not
shared. If dedicating blood glucose meters to a single
patient is not possible, the meters must be properly
cleaned and disinfected aer every use following the
guidelines found in Meter Care, Cleaning/Disinfecting.
• Healthcare Professionals should wear gloves when
cleaning and disinfecting the meter. Wash hands aer
taking o gloves. A new pair of gloves should be worn
before testing each patient.
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IMPORTANT INFORMATION (cont.):
• If the patient is showing symptoms of low or high
blood glucose, check their blood glucose. If any result
seems higher or lower than expected, repeat the test
with a new test strip. Contact the Doctor or Diabetes
Healthcare Professional with any unusual results.
~ Low blood glucose (hypoglycemia) symptoms may
include trembling, sweating, intense hunger,
nervousness, weakness or trouble speaking.
~ High blood glucose (hyperglycemia) symptoms may
include intense thirst, a need to urinate oen, a dry
mouth, vomiting, or headache.
• is device has not been validated for use in the
critically ill.
• 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.
• Follow facility protocols to verify blood glucose
results with laboratory results for patients who are
unresponsive or unable to communicate.
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
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6
Phone Number, Fast Test Guide, Expected Results ............Cover
Introduction and Important Information................................ 1
Description of System
Meter ............................................................................................. 7
Test Strip..................................................................................... 10
Control Solution ........................................................................12
Quality Control Testing
Automatic Self-Test ...................................................................13
Control Test................................................................................14
How to Test Control Solution.................................................. 15
Blood Glucose Testing
Obtaining a Blood Sample........................................................19
How to Test Blood.....................................................................22
TRUE METRIX PRO System and Laboratory Testing.........25
System Out of Range Warning Messages ...............................26
Meter Set Up
Set Time / Date...........................................................................27
Set Event Tags, Ketone Test Alert and Test Reminders......... 29
Meter Memory
View Averages (7-, 14-, and 30-day)........................................33
View Memory .............................................................................34
Care, Cleaning/Disinfecting and Troubleshooting
Caring for TRUE METRIX PRO.............................................35
Changing Battery.......................................................................39
Troubleshooting.............................................................................40
Messages .....................................................................................41
System Safety Information and Electromagnetic Compatibility..... 44
System Specifications/Chemical Composition.......................... 46
Warranty.........................................................................................47
References.......................................................................................48
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7
Description of System
Meter
①“ ◀ ” Button
Decrease numbers in Meter Set Up; remove ALT
Symbol; move backward by date/time when viewing
results and Averages in Memory; scroll through Event
Tags to mark results (if feature on).
②“ • ” Button
Turn meter on to view Average values, to view results
in Memory, to access Meter Set Up, and turn on Event
Tags in Meter Memory.
③“ ▶ ” Button
Increase numbers in Meter Set Up; add ALT Symbol;
move forward by date/time when viewing results and
Averages in Memory; turn on Event Tags in Meter Set
Up.
Top of Meter
1 32
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①Display Screen
Shows results, messages, user prompts, information.
②Test Port
Insert TRUE METRIX PRO Test Strip here, contact
blocks facing up.
③Strip Release Button
Releases test strip aer testing for disposal.
④Battery Door
Use one non-rechargeable 3V lithium battery
(#CR2032), positive (“+”) side up
(see Changing Battery).
⑤Meter Label
Contains serial number of meter.
⑥Data Contacts
Connects meter with computer for data upload.
8
2
1
Front of Meter
3
4
5
Back of Meter
6
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9
Full Display Screen
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.)
3
4
2
1
7
6
5
8
910 11 12
13
14
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10
①Contact End - Insert into Test Port with contact
blocks facing up .
②Sample Tip - Touch Tip to top of drop of sample
(blood or control solution) aer 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 testing begins (meter beeps and dashes move
across Display) .
• Do not smear or scrape drop with test strip.
• Do not apply more sample to Sample Tip aer testing
begins.
• Do not apply blood or control to top of test strip.
Do not insert Sample Tip with sample into Test Port.
May damage meter.
Test Strip
12
Top of Test Strip
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①Lot Number (LOT) - Used for identification
when calling for assistance.
②Expiration 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 rst. See the test strip Instruc-
tions 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.
③Control Test Range - Range of numbers in
which Control Test result must fall to assure the
system is working properly.
11
Test Strip Vial Label
1
2
3
May 30, 2022
2
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12
Control Bottle Label
①Lot Number (LOT) - Used for identification
when calling for assistance.
②Expiration Dates (EXP) - Write date first opened
on bottle label. Discard bottle if either 3 months
aer rst opening or date printed next to EXP on
bottle label has passed, whichever comes rst.
③Control Solution Level (1, 2, or 3) - We
recommend testing at least 2 levels of control
solution. Call 1-800-803-6025, Monday - Friday,
8AM-8PM EST, for assistance in obtaining
dierent levels of control solution.
Control Solution (Control)
12
3
May 30, 2022
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Contact Blocks
Face Up
13
Quality Control Testing
To assure accurate and reliable results,
TRUE METRIX PRO oers two kinds
of Quality Control Tests. ese tests
ensure that TRUE METRIX PRO is
working properly and testing technique
is good.
Automatic Self-Test
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.
e 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 for assistance
(see Booklet cover for phone number).
Caution! If any segments are missing in the Display
when meter is first turned on, do not use the
meter for testing. Call for assistance.
Full Display
Drop Symbol
Error Message
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14
Control Test
We recommend performing Control Tests to check the
performance of the system.
Control Tests should be performed:
• Before using the System for the rst time,
• For practice to ensure testing technique is good,
• When opening a new vial of test strips,
• If results seem unusually high or low, based on
patient's condition,
• If a vial has been le opened or exposed to extreme
heat or 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.).
Note: It is important to perform Control Tests with more
than one level of control solution. ree 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
dierent levels of control solution.
Caution! Ranges printed on test strip vial label are for
Control Test results only and are not to be used
for management of patient’s blood glucose.
Do not drink control solution.
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How to Test Control Solution
Use ONLY TRUE METRIX Control Solution with
the TRUE METRIX PRO Meter and Test Strips.
1. Check dates on control solution label
and test strip vial label. Do not use
control solution or test strips if
Expiration Dates have passed.
(Control solution - 3 months aer
rst opening or date next to EXP on
bottle label; test strips – aer 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.
3. Gently swirl or invert control solution bottle to
mix.
DO NOT SHAKE!
4. Remove one test strip from vial. Close strip vial
immediately. Use test strip quickly aer removal
from vial.
15
May 30, 2022
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16
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.
6. Wait until Drop Symbol appears in
Display. Keep test strip in meter until
testing is finished.
Note: If 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
o 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 aer use.
LB0010
9 JUNE 2009
Contact Blocks
Face Up
Drop Symbol
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9. With test strip still in meter, touch
edge of Sample Tip to top of drop of
control solution. Allow drop to be
drawn into test strip. Remove test
strip from drop when meter beeps.
10. Dashes appear across the Display to
show meter is testing.
Note:If meter does not beep and begin
testing soon aer 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.
Note: Control Test result shows the
Control Symbol in the Display.
17
Meter testing
(Example only.
Does not represent actual
Control Test ranges.)
Control Symbol
Test Strip
Vial Label
Control Solution
Bottle Label
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CAUTION! If Control Test result is outside range,
test again. If result is still outside range,
system should not be used for testing
blood. Call for assistance (see Booklet
cover for phone number).
12. Aer 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 o.
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.
18
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