Prodigy Autocode Manual de usuario

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Owner’s Manual

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

2 3

Dear Prodigy®Meter Owner:

Thank you for choosing the Prodigy AutoCode®meter

as your blood glucose monitoring system. Please

read this manual carefully as it contains important

information about your new Prodigy®system. A

warranty registration card is included with your system.

Please return the completed card to us or complete

warranty online at www.prodigymeter.com.

Prodigy®meters are designed to help you and your

healthcare professionals monitor your blood glucose

levels. This owner’s manual will help you learn how to

use your Prodigy®meter effectively. Customer Care is

available 24 hours, 7 days a week by calling toll free

1.800.243.2636. All questions concerning test results

should be directed to your healthcare professional.

Prodigy®meters have the latest technology for

blood glucose monitoring and are made with quality

components. All Prodigy®meters are easy to use, give

you fast, accurate test results with a minimal sample of

blood, have large, easy-to-read display screens, and are

lightweight and portable for your convenience.

Prodigy®meters:

• Require No Coding, allowing you to save time

and avoid human error due to improper coding.

• Allow you to perform Alternate Site Testing (AST).

• Have memory and data management capabilities.

Prodigy’s®free software gives you and your

healthcare professionals powerful graphic tools to

manage your diabetes.

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

4 5

Table of Contents

Letter to Meter Owner..................................................2-3

Table of Contents ..........................................................4-5

Important Safety Instructions......................................6-8

Important Health-Related Information................... 9-10

Alternate Site Testing (AST)....................................11-13

About Prodigy®Test Strips ......................................14-16

Key Functions of the Test Strip................................. 14

Important Test Strip Information........................ 15-16

Introduction to Prodigy®Meters ............................17-18

Intended Use.............................................................. 17

Test Principle ........................................................ 17-18

Contents of the Prodigy AutoCode®Meter................18

Setting up the Prodigy AutoCode®Meter ............19-28

Key Functions of the Meter....................................... 19

Meter Display ...................................................... 20-21

Speaking Function..................................................... 22

Setup Steps........................................................... 23-28

Control Solution Testing..........................................29-36

Performing a Control Solution Test .................. 32-36

Performing a Blood Glucose Test ..........................37-46

Preparing the Lancing Device............................ 37-39

Getting a Blood Sample ..................................... 39-41

Tips for Applying Blood without Sight ............. 41-43

Applying Blood to the Test Strip........................ 44-46

Using the Meter Memory........................................47-49

Specications..................................................................50

Viewing Results on a Personal Computer ..................51

Caring for your Prodigy®Meter..............................52-56

Cleaning your System ............................................... 52

Lancing Device .......................................................... 52

Disinfecting your System .................................... 52-53

Storing your System .................................................. 53

Battery ........................................................................ 54

Low Battery ........................................................... 54-55

Battery Replacement........................................... 55-56

System Troubleshooting .........................................57-63

Special Messages ................................................ 57-58

Error Messages .................................................... 58-59

Troubleshooting Guide....................................... 60-63

Information About your Prodigy®Meter...............64-72

Comparing Meter and Laboratory Results....... 64-66

Performance Characteristics .................................... 66

Expected Test Results................................................ 67

Unexpected Test Results..................................... 68-69

Accuracy of Meter Measurements .................... 70-72

Symbols Information .....................................................73

Warranty Information ....................................................74

Limited Lifetime Warranty ........................................ 74

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

6 7

Important Safety Instructions

Read this before using your Prodigy®meter. The

following basic safety precautions should always

be taken.

• Your Prodigy®meter, test strips, lancets and

lancing device are for single patient use only.

Do not share them with anyone, including

other family members. Do not use on

multiple patients.

• Close supervision is necessary when the

device is used by, on, or near children,

handicapped persons or invalids.

• Use the device only for the intended use

described in this manual.

• Do not use test strips and control solutions

with your Prodigy®meter that are not

supplied by Prodigy®.

• Do not use the device if it is not working

properly, or if it has suffered any damage.

• Before using any product to test your blood

glucose, read all instructions thoroughly

and practice the test. Do all quality control

checks as directed and consult with a

diabetes healthcare professional.

• Keep the test strip vial away from children;

the vial cap and the test strips can be a

potential choking hazard.

• Never chew or swallow a test strip. If this

occurs, please seek medical assistance

immediately.

• All parts of this kit are considered

biohazardous and can potentially transmit

infectious diseases, even after you have

performed cleaning and disinfection.

• These devices are intended to be used for

patient self-monitoring and should not be

used to collect blood from more than one

person as this poses a risk of transmitting

blood-borne pathogens such as Hepatitis B

or HIV.

For further information, please refer to:

“FDA Public Health Notication: 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/

ucm224025.htm

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

“CDC Clinical Reminder: Use of Fingerstick

Devices on More than One Person Poses Risk

for Transmitting Blood-borne Pathogens” (2011)

http://cdc.gov/injectionsafety/Fingerstick-

DevicesBGM.html

DO NOT CHANGE YOUR TREATMENT BASED ON A

SINGLE RESULT THAT DOES NOT MATCH HOW YOU

FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT

COULD BE INCORRECT.

Important Health-Related Information

Severe dehydration and excessive water loss

may cause false low results. If you believe you

are suffering from severe dehydration, consult a

healthcare professional immediately.

Under normal blood concentrations and

conditions, the following should not signicantly

affect results:

• Elevated blood triglycerides

• Reducing substances such as uric acid and

ascorbic acid

• Acetaminophen

• Dopa

• Methyldopa

• L-dopa

• Tolbutamide

If you are experiencing symptoms that are not

consistent with your blood glucose test results

and you have followed all instructions described

in this owner’s manual, contact your healthcare

professional.

8 9

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

Test results below 60 mg/dL (3.3 mmol/L) indicate

low blood glucose (hypoglycemia). Test results

greater than 240 mg/dL (13.3 mmol/L) indicate

high blood glucose (hyperglycemia). If your

results are below 60 mg/dL or above 240 mg/dL,

repeat the test, and if the results are still below 60

mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3

mmol/L), consult your healthcare professional

immediately.

Inaccurate results may occur in severely

hypotensive individuals or patients in shock.

Inaccurate results may occur for individuals

experiencing a hyperglycemic-hyperosmolar

state. Please refer to the test strip package insert

for additional important information.

Alternate Site Testing (AST)

There are important limitations to Alternate Site

Testing (AST). Please consult your healthcare

professional before performing AST.

What is AST?

Alternate Site Testing (AST)

means you can use parts

of the body other than

your ngertips to check

your blood glucose levels.

Prodigy®meters allow you to

test on your palm, forearm,

upper arm, calf or thigh.

See Figure 1.

What is the Advantage?

Fingertips feel pain more

readily because they are full of

nerve endings (receptors). At other body sites,

nerve endings are not so numerous and you will

not feel as much pain as you will experience at

the ngertip.

Figure 1

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PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

When to use AST?

Food, medication, illness, stress and exercise can

affect blood glucose levels. Capillary blood at

the ngertip reects these changes faster than

capillary blood at other sites. Therefore, if you

are testing your blood glucose level during or

immediately after a meal, physical exercise or

stressful event, take the blood sample from your

ngertip only.

Use AST only:

vTwo hours or more after your last meal.

vTwo hours or more after taking insulin.

vTwo hours or more after exercise.

vDuring a relaxed and calm state.

Do not use AST if:

vYou have reason to believe you have

hypoglycemia or hyperglycemia.

vYour routine glucose results are often

uctuating.

vYou are pregnant.

*To increase accuracy when using AST, rub

the puncture site before extracting blood. An

alternate site device is required to perform AST. If

you do not have an alternate site device but would

like to use one, please contact Customer Care at

1.800.243.2636.

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PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

About Prodigy® Test Strips

Key Functions of the Test Strip

All Prodigy®meters measure the amount of sugar

in the blood, commonly referred to as blood

glucose. Blood is applied to the opening of the

absorbent channel on the end of the test strip

and is automatically drawn into the test strip.

The test strip consists of the following parts:

Absorbent Channel

Apply a drop of blood and it will be

drawn in automatically.

Conrmation Window

Shows whether enough blood has been drawn

into the test strip’s absorbent channel.

Test Strip Handle

Hold this part to insert the test strip into the test

strip port on the meter.

Contact Bars

Insert this end of the test strip into the meter.

Push it in rmly until it will not go any further.

Figure 2

Please refer to the “Performing a Blood Glucose Test”

section for complete instructions.

Important Test Strip Information

• Store test strip packages in a cool, dry place

between 39°F–104°F (4°C–40°C). Keep

away from direct sunlight and heat. Do not

refrigerate. Do not store in your car.

• Store your test strips in their original vial

only. Do not transfer them to a new vial or

any other container.

• With clean, dry hands you may touch the test

strip anywhere on its surface when removing

it from the vial or inserting it into the meter.

• Do not clean the testing site with alcohol.

Instead, wash the test site thoroughly with

soap and water only.

• Immediately use a test strip after removing it

from the vial, replace the vial cap and close it

tightly to prevent exposure to moisture.

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

• Only apply a blood sample or a control

solution sample to the test strip’s absorbent

channel. Applying other substances to the

test strip’s absorbent channel will cause

inaccurate results.

• Record the discard date on the vial label

when you rst open it. Discard remaining

test strips 90 days after the rst opening

date.

• Do not use test strips beyond the expiration

date printed on the package.

• After removing the test strip from the vial,

insert it directly into the meter. Do not lay

the test strip on any other surface.

Warning: Keep the test strip vial away from

children; the vial cap and the test strips can

be a potential choking hazard. Never chew or

swallow a test strip. If this occurs, please seek

medical assistance immediately.

Introduction to Prodigy® Meters

Intended Use

Prodigy®blood glucose monitoring systems

are intended for use outside the body (in vitro

diagnostic use only) and should only be used for

blood glucose (blood sugar) testing with fresh

capillary whole blood samples.

These systems are intended for use in the home

and in clinical settings and should not be used

for the diagnosis of diabetes or for the testing

of newborns. Consult your healthcare provider if

unusual readings occur.

Test Principle

Blood glucose is measured by an electrical

current that is produced when a blood sample

mixes with the reagent (special chemicals) of the

test strip. The electrical current changes with the

amount of glucose in the blood sample. Prodigy®

meters measure the strength of the electrical

current, calculate your blood glucose level

and then display your result in either mg/dL or

mmol/L.

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter

Owner’s Manual Owner’s Manual

Prodigy®meters, test strips and control solutions

have been designed, tested and proven to work

together as a system to produce accurate blood

glucose test results.

Important: Use only Prodigy®control solutions

and test strips with your Prodigy®meter. Using

other test strips and control solutions with this

meter can produce inaccurate results.

Contents of the Prodigy AutoCode Meter®

The Prodigy AutoCode®meter is available as a

meter only or as a meter kit. Please check the

“REF” number marked on the outside of the

box to see if you have purchased a “Meter” or a

“Meter Kit.” Please review the contents of your

purchase to conrm that all the components are

included as listed on the side of your meter box.

Setting up the Prodigy AutoCode Meter®

Key Functions of the Meter

Test Strip Slot

Insert the test strip here.

The meter will turn on

automatically.

LCD Display

Guides you through the

test using symbols and

simple messages.

Main Button

Turns the meter on or performs other

functions described in this manual.

Data Port

Port for USB cable connection to

your computer.

Set Button

Located on the back of the meter,

inside the battery compartment;

used to setup the meter.

Figure 3

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