NIPRO Diagnostics True balance User manual

24/7 Customer Consultation
English or Spanish 1-800-803-6025
www.niprodiagnostics.com
© 2011 Nipro Diagnostics, Inc.
TRUEbalance and the Nipro Diagnostics logo
are trademarks of Nipro Diagnostics, Inc.
H4NPD03 Rev. 22
Owner’s
Booklet
balancebalance™
Manufactured by:
Fort Lauderdale, FL 33309 U.S.A.
Scan this code with your smart phone
for additional TRUEbalance information.
Always refer to the Owner’s Booklet
for detailed product information.
Atención al Cliente
las 24 horas, 7 días a la semana
Inglés o español 1-800-803-6025
www.niprodiagnostics.com
© 2011 Nipro Diagnostics, Inc.
TRUEbalance y el logotipo de Nipro Diagnostics
son marcas comerciales de Nipro Diagnostics, Inc.
H4NPD03 Rev. 22
Libreta del
propietario
balancebalance™
Fabricado por:
Fort Lauderdale, FL 33309 EE. UU.

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
balancebalance™
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
balancebalance™

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 < 110 mg/dL
Two hours after meals < 140 mg/dL
1
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2
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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3
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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4
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.
5
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6
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.6Do not use venous blood with
TRUEbalance.
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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
7
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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 - Contact Customer Care at the
number located on cover for more information.
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, 2012
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.
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, 2012
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 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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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. Do not use Strips 120 days past written
opened date or past date printed next to EXP.
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.
Mayo 30 de 2012
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
Control
Symbol
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