Nipro True2go Manual de usuario

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.

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

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.

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.

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.

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):

• shock

• severe hypotension

• severe dehydration

• hyperglycemia with hyperosmolarity, with or

without ketosis.

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.

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

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