Nipro TrueResult Manuel utilisateur
24/7 Customer Consultation
English or Spanish
1-800-803-6025
1-954-677-9201
www.niprodiagnostics.com
© 2014 Nipro Diagnostics, Inc.
TRUEtest, TRUEresult and the Nipro Diagnostics logo
are trademarks of Nipro Diagnostics, Inc.
E4NPD03 Rev. 25
Owner’s
Booklet
Use only with TRUEtest™
Blood Glucose Test Strips
Manufactured by:
Fort Lauderdale, FL 33309 U.S.A.
Scan this code with your smart phone
for additional TRUEresult 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
1-954-677-9201
www.niprodiagnostics.com
© 2014 Nipro Diagnostics, Inc.
TRUEtest, TRUEresult y el logotipo de Nipro Diagnostics
son marcas comerciales de Nipro Diagnostics, Inc.
E4NPD03 Rev. 25
Libreta del
propietario
Usar solo con tiras de prueba de
glucosa en la sangre TRUEtest™
Fabricado por:
Fort Lauderdale, FL 33309 EE. UU.
APPLY BLOOD SAMPLE
1 2
Twosimple steps
INSERT TEST STRIP
Fast Test Guide
Expected Results for people without diabetes:
Plasma Blood Glucose Result1
Before eating < 100 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.
APLIQUE LA
MUESTRA DE SANGRE
1 2
Dos pasos simples
INSERTE LA
TIRA DE PRUEBA
Guía de prueba rápida
Resultados esperados para personas sin diabetes:
Resultado de glucosa en plasma/sangre1
Antes de comer < 100 mg/dl
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.
INTRODUCTION:
TRUEresult®Blood Glucose Monitoring System
TRUEresult 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 TRUEresult products, visit our
web site at: www.niprodiagnostics.com.
Caution! Please read complete Owner’s Booklet and all
product Instructions for Use.
Additional instructions for use of the System in a
professional multi-patient setting are included in
the Quality Assurance/Quality Control Manual.
e QA/QC Manual is available on our website
www.niprodiagnostics.com, or call 1-800-803-6049
or 1-954-677-4599.
Importance of Blood Glucose Monitoring
e more you know about diabetes, the better you will be
able to care for yourself. A Doctor or Diabetes Healthcare
Professional will determine how oen 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 a 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 Diabetes Healthcare Professional.
Use of TRUEresult in a manner not specified in this
Owner’s Booklet is not recommended and may aect ability
to determine true blood glucose levels.
1
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
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 Strip. Adding
more sample gives an error message.
e TRUEresult Blood Glucose Monitoring System is for
one person use ONLY. DO NOT share your Meter or your
Lancing Device with anyone, including family members.
DO NOT use on more than one person. ALL parts of your
Blood Glucose Monitoring System could carry blood-borne
diseases aer use, even aer 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 the Meter when visibly
dirty. Wash your hands thoroughly with soap
and warm water aer handling the Meter,
Lancing Device, or Test Strips as contact with
blood presents an infection risk.
2
3
FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
•
DO NOT use the TRUEresult System to test your
blood glucose if you are undergoing peritoneal
dialysis (dialysis through the abdomen/stomach area).
• DO NOT use the TRUEresult System to test
your blood glucose if you are receiving medical
treatment that contains sugars such as maltose or
xylose (Extraneal®, Icodial®, immunoglobulins such
as Octagam®, or Orencia®).
e treatments listed above may cause false high
glucose results when testing with the TRUEresult
System.4
Before using the TRUEresult System, check with
your Doctor or Healthcare Professional if you think
you may be receiving any of these treatments.
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.
- 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 oen, a dry
mouth, vomiting, and headache.
FOR HEALTHCARE PROFESSIONALS
IMPORTANT HEALTH and SAFETY
INFORMATION:
DO NOT use the TRUEresult System for patients
receiving the following treatments:
•
Peritoneal dialysis using solutions containing
icodextrin (Extraneal
®
, Icodial
®
) that is metabolized to
maltose,
•
Injections or infusions of solutions containing
galactose or maltose, including some human
immunoglobulin preparations (Octagam
®
, WinRho
®
,
SDF Liquid, HepaGam B
™
),
•
Xylose absorption testing,
•
Intravenous solutions containing maltose,
•
Any drugs that contain or metabolize to maltose,
galactose, or xylose (Orencia
®
, Adept
®
, Bexxar
®
).
Using the TRUEresult System when receiving the
above treatments may cause false high glucose
results. False high results may lead to inappropriate
therapy, which may result in coma or death. For more
information, see www.fda.gov/BiologicsBloodVaccines/
SafetyAvailability/ucm154213.htm.
Additional instructions for use of the System in a
professional multi-patient setting are included in
the Quality Assurance/Quality Control Manual.
e QA/QC Manual is available on our website
www.niprodiagnostics.com, or call 1-800-803-6049
or 1-954-677-4599.
4
Safe Practices Recommendations for Healthcare
Professionals:
• At patient admission/presentation and
periodically throughout the patient’s stay at the
facility, assess the presence and use of therapies
containing interfering drugs (see previous page).
• Use only laboratory methods for monitoring
blood glucose levels in patients receiving
interfering drugs.
• If there are pre-print order sets for patients
receiving interfering drugs, include a prescription
to test blood glucose using only laboratory
methods.
• Establish facility protocols to verify point-of-care
(bedside) blood glucose results with laboratory
results for patients who are unresponsive or
unable to communicate.
5
Other Important Information for Healthcare
Professionals:
e most accurate results come from using fresh,
capillary whole blood from the fingertip or forearm.
Venous whole blood drawn into EDTA (purple top
tube) or heparin (green top tube) may be used. Mix
tube contents gently before using.
When comparing results between TRUEresult and a
laboratory system, perform a TRUEresult blood test
within 30 minutes of laboratory test. Results from the
TRUEresult System are considered accurate if within
20% of laboratory results.5If the patient has recently
eaten, fingerstick results from the TRUEresult System
can be up to 70 mg/dL higher than venous laboratory
results.6
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 ow may not
reect the true physiological state. Reduced peripheral
blood ow may result from the following conditions
(for example):7
• shock
• severe hypotension
• severe dehydration
• hyperglycemia with hyperosmolarity, with or
without ketosis.
6
IMPORTANT INFORMATION:
For the most accurate results using TRUEresult:
• Read all instructions before testing.
• TRUEresult is an in vitro (outside body)
quantitative system that is used for self-testing and
point-of-care testing of human whole blood only.
• Meter displays results as plasma values.
• Use only TRUEtest Test Strips and TRUEtest
Glucose Control with TRUEresult Meter.
• Do not use for diagnosis of diabetes or for
testing blood glucose in newborns.
• Perform Control Tests before performing a blood
glucose test for the first time (see Getting Started).
Note: ree 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.
• Remove only one Strip at a time from vial when
testing. Recap vial immediately aer removing
Strip.
• When using the meter for the first time, check
the unit of measure in the meter Display aer
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.
7
8
Phone Number, Fast Test Guide, Expected Result .....................
............................................................................................see covers
Introduction and Important Information .......................... 1-7
Table of Contents.......................................................................... 8
Know Your System
Meter...................................................................................... 9-10
Meter Display............................................................................11
Test Strip ..................................................................................12
Test Strip Vial Label ................................................................13
Glucose Control Bottle Label .................................................14
Getting Started
Quality Control .................................................................. 15-16
Control Test ........................................................................ 17-20
Testing your Blood
Obtaining a Blood Sample................................................ 21-22
Testing Blood Glucose....................................................... 23-24
System Out of Range Warning Messages.............................25
Meter Set Up
Time and Date .................................................................... 26-27
Alert and Reminders.......................................................... 28-30
Meter Memory
Viewing Averages (7, 14 and 30-day) ...................................31
Viewing Results ........................................................................32
Care, Cleaning/Disinfection and Troubleshooting
Caring for TRUEresult ...................................................... 33-34
Changing Battery......................................................................35
Troubleshooting...........................................................................36
Display Messages............................................................ 37-38
System Specifications/Chemical Composition ........................39
Meter Warranty............................................................................40
References......................................................................................40
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