Nipro True2go User manual
© 2014 Nipro Diagnostics, Inc.
TRUE2go, TRUEtest, TRUEresult and the
Nipro Diagnostics logo are trademarks of
Nipro Diagnostics, Inc.
F4NPD03 Rev. 24
24/7 Customer Consultation
English or Spanish
1-800-803-6025
1-954-677-4599
www.niprodiagnostics.com
Owner’s
Booklet
Use only with TRUEtest™
Blood Glucose Test Strips
Manufactured by:
Scan this code with your smart phone
for additional TRUE2go information.
Always refer to the Owner’s Booklet
for detailed product information.
© 2014 Nipro Diagnostics, Inc.
TRUE2go, TRUEtest, TRUEresult y el
logotipo de Nipro Diagnostics son marcas
comerciales de Nipro Diagnostics, Inc.
F4NPD03 Rev. 24
Atención al Cliente
las 24 horas, 7 días a la semana
Inglés o español
1-800-803-6025
1-954-677-4599
www.niprodiagnostics.com
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
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.
Guía de prueba rápida
1
INTRODUCTION:
TRUE2go™ Blood Glucose Monitoring System
TRUE2go 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 TRUE2go 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.
The QA/QC Manual is available on our website
www.niprodiagnostics.com, or call 1-800-803-6025
or 1-954-677-4599.
Importance of Blood Glucose Monitoring
The more you know about diabetes, the better you will be
able to care for yourself. A Doctor or Diabetes Healthcare
Professional will determine how often you should test
and what your target ranges are for blood glucose results.
Having most results within your target ranges shows how
well a treatment plan is working to control glucose levels.
Keeping results within your target ranges helps slow or
stop complications from diabetes.
NEVER change your treatment plan without consulting a
Doctor or Diabetes Healthcare Professional.
Use of TRUE2go in a manner not specified in this
Owner’s Booklet is not recommended and may affect the
ability to determine true blood glucose levels.
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.
The TRUE2go 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 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 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.
2
3
FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
•
DO NOT use the TRUE2go System to test your blood
glucose if you are undergoing peritoneal dialysis
(dialysis through the abdomen/stomach area).
• DO NOT use the TRUE2go 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®).
The treatments listed above may cause false high
glucose results when testing with the TRUE2go
System.4
Before using the TRUE2go 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 often, a
dry mouth, vomiting, and headache.
4
FOR HEALTHCARE PROFESSIONALS
IMPORTANT HEALTH AND SAFETY
INFORMATION:
DO NOT use the TRUE2go 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 TRUE2go System when receiving
the above treatments may cause false high
glucose results.4False 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.
The QA/QC Manual is available on our website
www.niprodiagnostics.com, or call 1-800-803-6025
or 1-954-677-4599.
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
The 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 TRUE2go and a
laboratory system, perform a TRUE2go blood test
within 30 minutes of laboratory test. Results from
TRUE2go are considered accurate if within 20%
of laboratory results.5If patient has recently eaten,
fingerstick results from TRUE2go can be up to 70
mg/dL higher than venous laboratory results.6
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):
7
• shock
• severe hypotension
• severe dehydration
• hyperglycemia with hyperosmolarity, with or
without ketosis.
6
IMPORTANT INFORMATION:
For the most accurate results using TRUE2go:
• Read all instructions before testing.
• TRUE2go 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 TRUE2go 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: 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.
• When carrying your TRUE2go System with you, do not
leave it where the storage temperature printed on vial
label may be exceeded (car, trunk, briefcase, etc).
• Remove only one Strip at a time from vial when testing.
Recap vial immediately after removing Strip.
• 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.
7
8
Phone Number, Fast Test Guide, Expected Results....................
............................................................................................see covers
Introduction and Important Information.............................. 1-7
Table of Contents.......................................................................... 8
Know Your System
Meter............................................................................................ 9
Test Strip ..................................................................................10
Test Strip Vial Label ................................................................11
Glucose Control Bottle Label .................................................12
Attach/Remove TRUE2go Meter to Test Strip Vial ...........13
Getting Started
Quality Control .................................................................. 14-15
Control Test ........................................................................ 16-19
Testing your Blood
Obtaining a Blood Sample................................................ 20-21
Testing Blood Glucose....................................................... 22-23
System Out of Range Warning Messages.............................24
Meter Memory
Viewing Results in Memory ...................................................25
Care, Cleaning/Disinfection and Troubleshooting
Caring for TRUE2go.......................................................... 26-27
Changing Battery................................................................ 28-29
Troubleshooting .......................................................................30
Display Messages............................................................ 31-32
System Specifications/Chemical Composition ........................33
Meter Warranty............................................................................34
References......................................................................................35
Table of contents
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