Trividia Health TRUEbalance User manual

Call for assistance
Monday - Friday,
8AM-8PM Eastern Standard Time
English or Spanish 1-800-803-6025
www.trividiahealth.com
© 2021 Trividia Health, Inc. TRUEbalance and the
Trividia Health logo are trademarks of Trividia Health, Inc.
H4TVH03 Rev. 44
Owner’s
Booklet
Manufactured by:
Llame para recibir ayuda
Lunes - Viernes,
8AM-8PM EST
Inglés o español 1-800-803-6025
www.trividiahealth.com
© 2021 Trividia Health, Inc.
TRUEbalance y el logotipo de Trividia Health son
marcas comerciales de Trividia Health, Inc.
Libreta del
propietario
Fabricado por:
balance
balance
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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.
APPLY BLOOD SAMPLE
1 2
Two simple steps
INSERT TEST STRIP
Solo para referencia rápida; no se pretende que sea un
sustituto del instructivo completo. Lea toda la Libreta
del propietario y las Instrucciones para el uso del
producto antes de realizar pruebas.
APLIQUE LA MUESTRA
DE SANGRE
1 2
Dos pasos simples
INSERTE LA TIRA
DE PRUEBA
balance
balance
C
M
Y
CM
MY
CY
CMY
K
TB_OB_CVR_H4TVH03r44.pdf 2 5/13/21 07:30

Know Your System
Meter
➀Button - Decrease numbers in Set Up;
remove Control Symbol; move backward by
time/date when viewing results in Memory.
➁Button - Select settings; view Morning
Average values; view results in Memory.
➂Button - Increase numbers in Set Up; add
Control Symbol; move forward by time/date
when viewing results in Memory.
➃Display - Shows test results, messages, user
prompts, and other information.
➄Test Port - Insert TRUEbalance Test Strip here.
8
Top of Meter
1 32
5
4
Front of Meter
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➅Data Port - For data download to a computer
using the usb cable. Contact Customer Care at the
number located on cover for more information.
Caution! Do not try to recharge battery by
plugging usb cable into a power outlet.
Meter will be destroyed.
➆Battery Compartment - Use one
non-rechargeable 3V lithium battery (#CR2032),
positive (“+”) side up.
Note: See Changing Battery for details.
➇Meter Label - Contains telephone number for
assistance.
➈Serial Number Label - Identifies Meter when
calling for assistance.
9
7
68
9
6
Right Side of Meter
Back of Meter
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10
Display
1. Time, Date, 14/30 Day Average.
2. Result in Memory.
3. 14- or 30-Day Morning Average.
4. Test result.
5. Battery Symbol (see Display Messages).
6. Temperature Symbol (see Display Messages).
7. Drop Symbol - Apply blood or
Glucose Control.
8. Control Symbol (see Control Test).
9. Unit of Measure.
Note: Factory Set. Cannot be changed by user.
10.Time is P.M.
Note: “ AM” does not appear. “PM” is not an
option if factory set for 24-hour clock.
3
4
2
1
765
8
9
10
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11
➀ Contact End - Insert into Meter with Contacts
(metallic blocks) facing up before adding sample.
➁Sample Tip - Touch sample (blood or Glucose
Control) to edge of Tip.
Placement of Sample to Test Strip
Correct Incorrect
• Allow sample (blood or Glucose Control drop) to be
drawn into Sample Tip.
Caution! Holding the Test Strip Sample Tip to the
blood sample too long after the Meter
begins testing may cause inaccurate results.
• Do not smear or scrape drop with Strip.
• Do not apply more sample to Strip
after removing from drop.
Note: Do not apply blood or Glucose
Control to top of Test Strip.
Do not insert Sample Tip with
sample into Meter for testing.
May damage Meter.
Test Strip
1 2
Front of Test Strip
Contacts
Face Up
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May 30, 2022
2
2
3
1
Test Strip Vial Label
➀Lot Number (LOT) - Used for identification
when calling for assistance.
➁Expiration Dates (EXP) - Write date first
opened on vial label. Discard vial and unused
Test Strips 120 days after written date or date
printed next to EXP, whichever comes first.
➂Control Range - Range of numbers in which
Control Test result must fall to assure System is
working properly.
Caution! Use of Test Strips or Glucose Control
past the Expiration Dates may give
incorrect test results. Discard out-of
date products and test with new
products.
12
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13
Glucose Control Bottle Label
➀Lot Number (LOT) - Used for identification
when calling for assistance.
➁ Expiration Dates (EXP) - Write date first
opened on bottle label. Discard bottle if either
3 months after opening or date printed next to
EXP on bottle label has passed, whichever comes
first.
➂Control Level (0, 1, or 2) - Three levels of
TRUEcontrol Control are available. We
recommend testing at least 2 levels of Control.
Contact place of purchase or call for assistance
to obtain Control.
12
3
May 30, 2022
Glucose Control
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Getting Started
The Meter turns on automatically when a Test
Strip Contact End is inserted into the Test Port or
when is pressed (see Set Up and Memory).
The Meter turns off automatically after the Test
Strip is removed from the Test Port or after 2
minutes of non-use.
Meter comes with pre-set time and date. Before
using the Meter for the first time or after a battery
change, check the time and date and update as
needed (see Set Up).
The TRUEbalance is a no-coding system, which
means that the Meter does not have to be coded to
each lot of Test Strips.
14
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15
Quality Control Testing
To assure you are getting accurate and reliable
results, TRUEbalance offers two kinds of quality
control tests. These tests let you know that your
TRUEbalance System is working properly and your
testing technique is good.
Automatic Self-Test
An Automatic Self-Test is performed
by the Meter each time a TRUEbalance
Test Strip is inserted correctly into the
Test Port.
Insert a Strip into the Test Port. 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 for
assistance (see 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
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16
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 the vial of Strips,
• When opening a new vial of Strips,
• If results seem unusually high or low,
• If a vial has been left opened or exposed to extreme
heat or cold, or humidity,
• If Meter damage is suspected (Meter was dropped,
crushed, wet, etc.)
Note: Three levels of TRUEcontrol Glucose Control
Solution are available for Quality Control Testing.
It is important to perform Control Tests with more
than one level of Control to assure your System
is working properly and your testing technique
is good. Contact place of purchase or call for
assistance to obtain Control.
Caution! Control 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 Glucose Control.
Only the most current Control Test result is
stored in Memory.
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17
How to Test Glucose Control
Use ONLY TRUEcontrol Glucose Control Solution
with the TRUEbalance Meter.
1. Wash hands with soap and water, dry
thoroughly. Allow Control, vial of Strips and
Meter to adjust to room temperature
(68-77ºF). Write date first opened on Control
Label and/or Strip vial label.
2. Check dates on Control label and Strip vial label.
Do not use Control if 3 months past written opened
date or past date printed next to EXP, whichever
comes first. Do not use Strips 120 days past written
opened date or past date printed next to EXP,
whichever comes first. Discard out-of-date products
and use new products if either date has passed.
3. Swirl or invert bottle gently to mix
Control. DO NOT SHAKE!
4. Remove Strip from vial. Recap vial
immediately.
Note: Use Strip quickly after removal from
vial. Strips that have been left out
of vial too long will give an error
message. If error message appears
in Display, discard old Strip and
test with new Strip.
5. Insert Test Strip Contact End
(Contacts facing up) into Test Port.
Meter turns on. Keep Strip in Meter
until testing is finished.
May 30, 2022
Contacts
Face Up
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18
6. Press . Control Symbol
appears in Meter Display.
Note: If you decide not to perform
a Control Test, press to
remove Control Symbol.
7. Turn Control bottle upside
down. Squeeze one drop of
Control onto a clean tissue.
Wipe off bottle tip.
8. Gently squeeze a drop on a small
piece of unused aluminum foil
or clear plastic wrap. Dispose
after use.
9. With Strip still in Meter, touch
edge of Sample Tip to drop of
Control and allow drop to be
drawn into Strip. Remove Strip
from drop when Meter beeps.
Note: If Meter does not beep and begin
countdown soon after placing Sample Tip
to Control drop, discard Strip. Repeat test
with new Strip. If problem persists, see
Troubleshooting.
LB0010
9 JUNE 2009
LB0010
9 JUNE 2009
Control
Symbol
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19
10. Compare result to Control range
printed on Strip vial label.
If result is in range, System
can be used for testing blood.
If result does not fall within
range, repeat test using a new
Strip.
Note: Control Test result shows the
Control Symbol in the Display.
Note: When using the meter for the first time,
check the unit of measure in the meter
Display after performing a control or blood
test. Result must display in the correct unit
of measure (mg/dL). If the result does not
display in the correct unit of measure, DO
NOT use the meter and DO NOT use the
meter result to determine treatment.
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 cover for
phone number).
11. Remove Strip from Meter and discard. Meter
turns off. Recap Control bottle tightly.
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20
How to Obtain a Blood Sample
Refer to Lancing Device “Instructions for Use” for detailed
instructions.
Caution!
The Lancing Device is for single patient use
ONLY. For cleaning/disinfecting your Lancing
Device see Lancing Device Care in the Lancing
Device Instructions for Use. Wash your hands
thoroughly with soap and warm water after
handling the Meter, Lancing Device, or Test Strips.
Contact with blood presents an infection risk.
• Never share lancets or lancing device.
• Lancets are for single use only. Do not re-use.
From Fingertip
1. Prepare fingertip by washing hands in warm, soapy water.
Rinse well. Dry thoroughly.
2. Place end of Lancing Device
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 Test Strip.
Always recap, remove and discard used Lancet in appropriate
container when testing is complete.
Note: Used Strips and lancets are considered biohazardous.
Dispose used Strips and lancets in approved biohazard
container.
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21
For Forearm Testing
1. Select area to be lanced. Wash with soap and
warm water, rinse and dry thoroughly.
2. Rub area vigorously or apply a warm compress
to increase blood flow.
3. Place end of Lancing Device firmly
against forearm. Press trigger button.
Apply firm pressure on lancing
device for 10 seconds.
Note: Some lancing devices include a special end
cap for alternate site testing. Check lancing
device Instructions for Use.
Important Notes Regarding Forearm Testing7
• Check with your Doctor or Diabetes 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.
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22
How to Test Blood Glucose
Always check your supplies before using. Check
Meter for damage (damaged or cracked Display,
missing or damaged buttons). If any damage is
seen, do not use Meter. Call for assistance. Check
Strip vials for damage. Discard any vials that
appear cracked or broken.
1. Check dates on Strip vial being used. Do not
use if 120 days past written date or date printed
next to EXP, whichever comes first.
2. Wash hands (and forearm for alternate site
testing). Rinse well and dry thoroughly.
3. Remove Strip from vial. Recap vial
immediately.
Note: Use Strip quickly after removal from vial.
Strips that have been left out of vial too
long will give an error message when used.
Discard old Strip and use
new Strip for testing.
4. With Meter off, insert Test
Strip Contact End (Contacts
facing up) into Test Port.
Meter turns on. Keep Strip
in Meter until testing is
finished.
Contacts
Face
Up
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23
5. Wait until Drop Symbol appears in Display.
6. Lance fingertip or forearm. Allow drop to form.
7. With Test Strip still in Meter, touch
edge of Sample Tip to blood drop and
allow blood to be drawn into Strip.
Remove Test Strip Sample Tip from
sample drop immediately after the
Meter beeps and starts to countdown on
Meter Display.
Caution! Holding the Test Strip Sample Tip to the blood
sample too long after the Meter begins testing may
cause inaccurate results.
Note: If Meter did not beep and begin countdown soon after
touching blood drop to Sample Tip, discard Strip.
Repeat test with new Strip and new blood drop. If
problem persists, see Troubleshooting.
8. After countdown, result is displayed with
date and time. Remove Strip and discard.
Result is stored in Memory. Meter turns off.
Note:
When using the meter for the first time, check the unit of
measure in the meter Display after performing a control
or blood test. Result must display in the correct unit of
measure (mg/dL). If the result does not display in the
correct unit of measure, DO NOT use the meter and DO
NOT use the meter result to determine treatment.
9. Record result in log book.
Note: Used Strips and lancets are considered biohazardous.
Dispose of used Strips and lancets in approved
biohazard container.
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24
System Out of Range Warning Messages
CAUTION!
TRUEbalance measures blood
glucose results from 20-600 mg/dL.
If blood glucose result is less than
20 mg/dL, “Lo” appears in Meter
Display.
If blood glucose result is greater
than 600 mg/dL, “Hi” appears in
Meter Display.
Always repeat test to confirm Low (“Lo”) and
High (“Hi”) results. If results still display “Lo”
or “Hi”, call your Doctor or Diabetes Healthcare
Professional immediately.
Note: “Lo” results are included in the Morning
Average as 20 mg/dL. “Hi” results are
included as 600 mg/dL.
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Set Up (Time/Date)
1. Start with Meter off. Do not insert Test Strip.
Press and hold . Date/Time
appears in display. Release after
full Display appears and Meter
beeps.
Set Time
2. The hour flashes.
To change, press or on top of
Meter to select the hour. Like many
alarm clocks, to set “PM”, scroll
through hours until “PM” appears
in Display.
Note: “PM” does not display if Meter
is factory set to 24-hour clock.
Press to set.
3. The minutes flash.
To change, press or to select
the minutes. Press to set.
25
Full Display
Hour
PM
Minutes
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