Owner`s Booklet - Nipro Diagnostics

Owner`s Booklet - Nipro Diagnostics
© 2015 Nipro Diagnostics, Inc. TRUEbalance and the Nipro Diagnostics logo
are trademarks of Nipro Diagnostics, Inc.
H4NPD03 Rev. 26
Fort Lauderdale, FL 33309 U.S.A.
balance
Manufactured by:
24/7 Customer Consultation
English or Spanish 1-800-803-6025
www.niprodiagnostics.com
Owner’s
Booklet
Libreta del
propietario
Atención al Cliente
las 24 horas, 7 días a la semana
Inglés o español 1-800-803-6025
www.niprodiagnostics.com
Fabricado por:
balance
Fort Lauderdale, FL 33309 EE. UU.
© 2015 Nipro Diagnostics, Inc.
TRUEbalance y el logotipo de Nipro Diagnostics son
marcas comerciales de Nipro Diagnostics, Inc.
H4NPD03 Rev. 26
balance
Dos pasos simples
INSERTE LA TIRA
DE PRUEBA
2
APLIQUE LA MUESTRA
DE SANGRE
2
APPLY BLOOD SAMPLE
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.
INSERT TEST STRIP
1
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.
1
Twosimple steps
balance
Welcome to the TRUEbalance®
Blood Glucose Monitoring System
Congratulations on your purchase of the
TRUEbalance Blood Glucose Monitoring System.
You now have a very simple and accurate way
to test your blood glucose (sugar) level, anytime,
anywhere. TRUEbalance is a no-coding system,
which means the Meter does not have to be coded
to each lot of Test Strips.
Our Commitment to You
Our goal is to provide you with quality healthcare
products and dedicated customer service. If you
have questions about using TRUEbalance products,
visit our web site at: www.niprodiagnostics.com.
Instructions for use of the System for more than
one person may be found in the Quality Assurance/
Quality Control Manual. The QA/QC Manual is
available on our website www.niprodiagnostics.com
or call 1-800-803-6025 or 1-954-677-4599.
CAUTION! Please read complete Owner’s
Booklet and all product Instructions for Use.
Expected Results for people without diabetes1:
Plasma Blood Glucose Result
Before eating
< 100 mg/dL
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Importance of Blood Glucose Monitoring
The more you know about diabetes, the better you will
be able to take care of yourself. A Doctor or Diabetes
Healthcare Professional will determine your target range
for your blood glucose results and how often to test.
Having the majority of your results within your target
range helps slow or stop complications of diabetes.
Having most blood glucose results within your target
range shows how well a treatment plan is working to
control glucose levels. NEVER change your treatment
plan without consulting with your Doctor or Diabetes
Healthcare Professional.
Use of the TRUEbalance in a manner not specified in
this Owner’s Booklet is not recommended and may
affect your ability to determine your blood glucose.
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FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
WARNING!
NEVER reuse Test Strips. NEVER wipe Test Strips
with water, alcohol or any cleaner. DO NOT attempt to
remove sample from Test Strips or clean Test Strips and
re-use. Reuse of Test Strips will cause inaccurate results.
DO NOT add a second drop of sample to the Strip.
Adding more sample gives an error message.
The TRUEbalance Blood Glucose Monitoring System is for
one person use ONLY. DO NOT share your Meter or your
Lancing Device with anyone, including family members.
ALL parts of your Blood Glucose Monitoring System could
carry blood-borne diseases after use, even after cleaning
and disinfection.2,3
For cleaning and disinfecting your Meter see Meter Care,
Cleaning/Disinfection. For cleaning and disinfecting your
Lancing Device see the Instructions for Use.
Caution!
We suggest cleaning and disinfecting the
Meter when visibly dirty. Wash your hands
thoroughly with soap and warm water after
handling the Meter, Lancing Device, or Test
Strips as contact with blood presents an
infection risk.
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IMPORTANT INFORMATION:
Health Related Information
DO NOT perform capillary blood glucose
testing on critically ill patients. Capillary blood
glucose levels in critically ill patients with reduced
peripheral blood flow may not reflect the true
physiological state. Reduced peripheral blood
flow may result from the following conditions (for
example):4
•shock
• severe hypotension
• severe dehydration
• hyperglycemia with hyperosmolarity, with or
without ketosis.
• 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, a dry
mouth, vomiting, and headache.
If you have any of these symptoms, check your
blood glucose. 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.
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Important Information
For the most accurate results using TRUEbalance:
• Read all instructions before testing.
• Meter displays results as plasma values.
• TRUEbalance is an in vitro (outside body)
quantitative system that is used for self-testing and
point-of-care (bedside) testing of human whole
blood only.
• Use only TRUEbalance Test Strips and TRUEcontrol
Glucose Control with TRUEbalance Meter.
• Do not use for diagnosis of diabetes or for testing
blood glucose in newborns.
• The TRUEbalance is recommended for testing of
human capillary whole blood only. TRUEbalance is
not recommended for use with venous samples.
• Perform Quality Control Testing before performing
a blood test for the first time.
Note: Three levels of TRUEcontrol Glucose Control
Solution are available for Quality Control
Testing. We recommend testing at least 2 levels
of Control. Contact place of purchase or call for
assistance to obtain Control.
• Set date and time for correct Morning Average values.
• 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.
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Health Related Information
For Healthcare Professionals:
If comparing results between TRUEbalance and a lab
system, perform a TRUEbalance blood test within 30
minutes of lab test. Results from TRUEbalance are
considered accurate if within +/– 20% of lab results.5
If patient has recently eaten, fingerstick results from
TRUEbalance can be up to 70 mg/dL higher than
venous lab results.6 Do not use venous blood with
TRUEbalance.
Instructions for use of the System for more than
one person may be found in the Quality Assurance/
Quality Control Manual. The QA/QC Manual is
available on our website www.niprodiagnostics.com
or call 1-800-803-6025 or 1-954-677-4599.
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Table of Contents
Fast Test Guide...............................................inside front cover
Introductory Information...................................................... 1-6
Table of Contents........................................................................ 7
Know Your System
Meter....................................................................................... 8-10
Test Strip ...................................................................................11
Test Strip Vial Label.................................................................12
Control Bottle Label..................................................................13
Getting Started
Quality Control Tests...............................................................14
Automatic Self-Test..............................................................15
Control Test..................................................................... 16-19
Testing your Blood
How to Obtain a Blood Sample........................................ 20-21
How to Test Blood Glucose............................................... 22-23
System Out of Range Warning Messages..............................24
Set Up (Time, Date).............................................................. 25-26
Memory
Morning Averages (14 and 30 Day).......................................27
Viewing Results in Memory....................................................28
Care, Cleaning/Disinfection and Troubleshooting
Caring for TRUEbalance.................................................... 29-30
Changing Battery.......................................................................31
Troubleshooting........................................................................32
Display Messages............................................................. 33-35
System Specifications....................................................................36
Chemical Composition................................................................37
Meter Warranty.............................................................................38
References.......................................................................................39
Notes...............................................................................................40
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Know Your System
Front of Meter
Meter
Top of Meter
1
2
4
3
5
➀
Button - Decrease numbers in Set Up;
remove Control Symbol; move backward by
time/date when viewing results in Memory.
➁
Button - Select settings; view Morning
Average values; view results in Memory.
➂
Button - 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.
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Back of Meter
9
Right Side of Meter
6
7
6
8
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.
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Display
1
2
10
3
4
9
5
6
7
8
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.
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Test Strip
Front of Test Strip
1
2
➀ Contact End - Insert into Meter with Contacts
(metallic blocks) facing up before adding sample.
➁ Sample 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.
Contacts
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Face Up
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Test Strip Vial Label
1
2
3
May 30, 2017
2
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.
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Glucose Control
May 30, 2017
Glucose Control Bottle Label
3
1 2
➀Lot Number (LOT) - Used for identification
when calling for assistance.
➁Expiration 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.
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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.
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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.
Full
Display
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.
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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 TRUEtest 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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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
May 30, 2017
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.
Contacts
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Face Up
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6. Press
. Control Symbol
appears in Meter Display.
Note: If you decide not to perform
a Control Test, press
to
remove Control Symbol.
0
09
001
LB NE 20
U
9J
7. Turn Control bottle upside
down. Squeeze one drop of
Control onto a clean tissue.
Wipe off bottle tip.
9
10 00
00 E 2
LB UN
9J
8. Gently squeeze a drop on a small
piece of unused aluminum foil
or clear plastic wrap. Dispose
after use.
Control
Symbol
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.
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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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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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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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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.
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Contacts
Face
Up
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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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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.
Full Display
Hour
Note: “PM” does not display if Meter
is factory set to 24-hour clock.
Press
to set.
3. The minutes flash.
To change, press
the minutes. Press
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PM
or
to select
to set.
Minutes
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Set Date
4. The month (number) flashes.
To change, press
or
to
select the month. Press
to set.
5. The day (number) flashes.
To change, press
or
to
select the day. Press
to set.
6. The year flashes
To change, press
or
to
select the year. Press
to set.
Day
Year
Month
Exit Set-up
To review settings, press
. Make changes as
needed, per instructions above.
Press and hold until Display goes blank.
Options are saved. Meter turns off.
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Memory
Morning Averages (14 and 30 Day)
For Morning Average values, only the earliest
blood test result performed between 4:00 am - 9:59
am (according to Meter clock) is used. Meter clock
must be set correctly (see Set Up) for accurate
Morning Average values.
1. Start with Meter off. Press and
release
. Display shows 14 day
Morning Average value and then 30
day Morning Average value.
14 Day
2. Meter switches between 14 and 30
Average
day Morning Average values for 2
minutes before turning off.
3. If there are no Morning Average
values, 3 dashes are displayed.
4. Press and release
to view results in 30 Day
Average
Memory. Press and hold
to turn
Meter off, or Meter turns off after 2
minutes of inactivity.
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No
Averages
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Viewing Results in Memory
Memory stores 365 results, which are displayed
from most recent to oldest. The oldest result is
removed from Memory when Memory is full and a
new result is added.
1. Start with Meter off. Press and
release
. Meter displays date and
time followed by 14 and 30 Day
Morning Averages. Press
again to
Memory
view most recent result in Memory.
2. Press
and release to advance
to the first blood glucose result in
Memory.
3. Press
and release again to view the
latest Control Test result. The control
test result shows the Control Symbol
in Display. Only one Control Test
result is stored in Memory.
4. Continue to press and release
Control
to advance through the blood
Symbol
glucose results. Holding
scrolls
through the results quickly. Press
and release the
to reverse
through the results.
5. Press and hold
to turn Meter off. Meter
also turns off automatically after 2 minutes of
inactivity.
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Caring for TRUEbalance
• Store System (Meter, Glucose Control, Test Strips) in
Carrying Case to protect from liquids, dust and dirt.
• Store System in a dry place at room temperature
(36°-86°F). DO NOT REFRIGERATE OR FREEZE.
• Do not keep meter in an area where it may be crushed
(i.e. back pocket, drawer, bottom of bag, etc.).
Meter Care, Cleaning/Disinfection
Cleaning removes blood and soil, disinfecting
removes infectious agents.
To Clean the Meter (removing blood or soil):
-We suggest cleaning your Meter when visibly dirty.
Never put Meter in liquids or allow any liquids to
enter the Test Port.
-Wipe Meter with a clean, lint-free cloth dampened
with 70% Isopropyl alcohol.
- Let Meter air dry thoroughly before using to test.
- Do not use bleach to clean the Meter.
For assistance contact Customer Care using the phone
number on the cover of the Owner’s Booklet.
For Healthcare Professionals, please refer to the
Quality Assurance/Quality Control Manual for
instructions on Meter Care, Cleaning/Disinfection.
The QA/QC Manual is available on our website
www.niprodiagnostics.com or call 1-800-803-6025
or 1-954-677-4599.
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Glucose Control Care
• Write date opened on Control label. Discard 3
months after opening or after date printed next
to EXP, whichever comes first.
• After use, wipe bottle tip clean and recap tightly.
• Store at room temperature (36°-86°F).
DO NOT REFRIGERATE OR FREEZE.
Test Strip Care
• Store Strips in original vial only. Do not transfer
old Strips to new vial.
• Write date opened on vial. Discard unused
Strips from vial 120 days after opening or after
date printed next to EXP, whichever comes first.
Use of Strips past either date may give incorrect
results.
• Close vial immediately after removing Strip.
Use Strip quickly after removal from vial. Never
store Strips outside of vial. Store in a dry place
at room temperature below 86°F. DO NOT
REFRIGERATE OR FREEZE.
• Do not reuse Strip.
• Do not bend, cut or alter Strips in any way.
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Changing Battery
Replace battery when Low or Dead
Battery Symbol appears in Display or
Low Dead
Meter does not turn on.
1. Lift tab on Battery Cover.
2. Turn Meter over, tap gently
to loosen and remove battery.
3. Insert new battery, positive (“+”)
side up. Close cover.
Note: Use non-rechargeable 3V
lithium battery (#CR2032).
4. Discard old battery in appropriate container.
5. Turn Meter on. If Meter will not turn on, check that
battery was installed properly. If not, reinsert battery
and try again. Call for assistance 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!
Battery is not rechargeable. Battery might explode if
mishandled or incorrectly replaced. Do not dispose
of battery in fire. Do not disassemble or attempt to
recharge battery. Dispose according to local/country
specific regulations.
Note: Replacing battery may affect date and time
settings. Check date and time by going to Set Up
and scrolling through the time/date settings by
pressing
.
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Troubleshooting
1) After inserting Test Strip, Meter does not turn on.
Reason
Strip inserted upside
down or backwards
Strip not fully
inserted
Strip Error
Dead or no battery
Battery in backwards
Action
Remove Strip.
Re-insert correctly.
Remove Strip. Re-insert
Strip fully into Meter.
Repeat with new Strip.
Replace battery.
Battery positive (“+”)
side must face up.
Call for assistance.
Meter Error
2) After applying sample, test does not start/
Meter does not beep or begin countdown.
Reason
Action
Sample drop too small
Repeat test with new
Strip and larger drop.
Sample applied after
Repeat test with new
two minute shut-off
Strip and apply drop
after Meter beeps.
Problem with Test Strip Repeat with new Strip.
Problem with Meter
Call for assistance.
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Messages
Display
Reason
Action
Temperature
Error
Temperature
change too quick
Wait 10 minutes
for Meter and Test
Strips to reach
room temperature
before testing.
Temperature
Too Cold
Meter
temperature less
than 50ºF
Move Meter and
Test Strips to area
between
50º-104ºF before
testing.
Temperature
Too Hot
Meter temperature
greater than
104ºF
Move Meter and
Test Strips to area
between
50º-104ºF before
testing.
Sample Not
Detected or
Using Wrong
Test Strip
Retest with
new or correct
Strip and larger
sample.
Used Test Strip
or Test Strip
outside of vial
too long.
Repeat with new
Strip. If error
persists, call for
assistance.
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Messages (continued)
Display
Reason
Action
Meter Error
Call for
assistance.
Test Strip Error,
Very high blood
glucose result
(higher than
600 mg/dL)
Retest with new Strip. If error
persists, call for assistance.
If you have symptoms such
as fatigue, excess urination,
thirst, or blurry vision, follow
your healthcare professional’s
advice for high blood glucose.
Test Strip
Removed
During Test
Retest with new
Strip. If error
persists, call for
assistance.
Meter
Error
Call for
assistance.
Meter
Error
Call for
assistance.
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Messages (continued)
Display
Reason
Action
Communication
Error
Turn Meter off
and on again. If
error persists, call
for assistance.
Low Battery
About 50 tests
can be done
before battery
must be replaced.
Dead Battery
Replace battery.
WARNING!!
WARNING!!
Retest with
new Strip.
If result is still
“Hi” or “Lo”
contact Doctor
immediately.
Out of range - Hi
Result > 600 mg/dL
Out of range - Lo
Result < 20 mg/dL
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System Specifications
Result Range: 20-600 mg/dL
Sample Size: Minimum 1 microliter (1 µL)
Sample: Fresh capillary whole blood or Glucose Control
Test Time: 10 seconds
Result Value: Plasma values
Assay Method: Electrochemical
Reference Method: Yellow Springs Instrument (YSI)
Power Supply: One 3V lithium battery
#CR2032 (non-rechargable)
Battery Life: Approximately 1,100 tests or 1 year
Automatic shut-off: After two minutes of non-use
Weight: 1.66 ounces
Size: 3.52” x 2.15” x 0.67”
Memory Size: 365 blood glucose results,
1 Control Test result
Operating Range (Meter & Test Strips):
Relative Humidity: 10-90% (Non-condensing)
Temperature: 50°F-104°F
Hematocrit: 30-55%
Note: Use within specified environmental
conditions only.
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Chemical Composition
TRUEbalance Test Strips: Glucose Oxidase
(Aspergillus sp.) 2.5 Units, Mediators, Buffers and
Stabilizers.
TRUEcontrol Glucose Control: Contents:
Volume: 3 mL. Water - 73%, D-glucose - 0.09 0.20%, Viscosity Enhancing Agent - 25%, Inorganic
Salts - 1.8%, Amaranth - 0.08%, and Preservatives
- 0.03%.
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TRUEbalance Limited Lifetime Warranty
Nipro Diagnostics, Inc. provides the following Warranty to the
original retail purchaser of the TRUEbalance Meter:
1)Nipro Diagnostics Inc. warrants this Meter to be free of defects
in materials and workmanship at the time of purchase. If the
meter is ever inoperative, Nipro Diagnostics, 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)Nipro Diagnostics, 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 Nipro Diagnostics, Inc. Customer Care Representative will
be able to provide detailed information regarding procedures for
returning your Meter, if necessary.
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References
1. American Diabetes Association. Diagnosis and Classification
of Diabetes Mellitus. Diabetes Care, Volume 36, Supplement 1,
January 2013.
2. FDA Public Health Notification: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Blood Borne
Pathogens: Initial Communication (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices.
3. CDC Clinical Reminder: Use of Fingerstick Devices on More than
one Person Poses Risk for Transmitting Bloodborne Pathogens
(2010) http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html.
4. Atkins, S. H., Dasmahapatra, A., Jaker, M.A., Chorost, M. I.,
Redd, S., Fingerstick Glucose Determination in Shock. Annals of
Internal Medicine, 114:1020-1024, 1991.
5.Data on file.
6.Larsson-Cohn U: Difference between capillary and venous blood
glucose during oral glucose tolerance tests. Scand J Clin Lab Invest
36:805-808, 1976.
7. U.S. 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.htm.
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Notes:
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