FOR-A Premium V10a Manual de usuario

Blood Glucose Monitoring System

Sistema de vigilancia de glucose sanguinea

Owner’s Manual

Manual del Propietario

Dear FORA Premium V10

System Owner:

Thank you for purchasing the FORA Premium V10 Blood Glucose

Monitoring System. This manual provides important information to help

you use the system properly. Before using this product, please read and

follow the instructions in this Ownerʼs Manual and any inserts for the test

strips and control solution.

Regular monitoring of your blood glucose levels can help you and your

doctor gain better control of your diabetes. Due to its compact size and

easy operation, you can use the FORA Premium V10 Blood Glucose

Monitoring System to easily monitor your blood glucose levels.

If you have questions, just call ForaCareʼs Customer Care Service Center

toll-free at 1-888-307-8188 (8:30am-5:00pm PST, Mon.-Fri.). You can

also visit www.foracare.com.

Version 3.0 2018/03

311-4124100-010

English

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

●The meter and lancing device are for single patient use. Do not share them

with anyone including other family members or use on multiple patients!

●All parts of the kit are considered biohazardous and can potentially

transmit infectious diseases, even after you have cleaned and disinfected

the components in the kit.

For more information, please visit

1.“FDA Public Health Notiﬁcation: Use of Fingerstick Devices on More than One Person

Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication”(2010)

http://wayback.archive-it.org/7993/20170111013014/http://www.fda.gov/

MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

2.“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses

Risk for Transmitting Bloodborne Pathogens”(2010)

http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

1. Use this device ONLY for the intended use described.

2. Do NOT use accessories which are not speciﬁed by the manufacturer.

3. Do NOT use the device if it is not working properly or if it is damaged.

4. Do NOT use the equipment where aerosol sprays are being used or where

oxygen is being administered.

5. This device does NOT serve as a cure for any symptoms or diseases. The

data measured is for reference only.

6. Before using this device to test your blood glucose, read all of the

instructions thoroughly, practice the test with the meter and perform all

quality control checks as directed.

7. Please use this device in a dry environment, especially when synthetic

materials are present ( clothing, carpets etc.). These materials give off

static discharges, which may cause erroneous results.

8. Do NOT use this instrument in close proximity to sources of strong

electromagnetic radiation, as these may interfere with the accurate

operation.

9. Do not under any circumstances use the device on neonates or infants.

10. Keep the device and testing equipment away from young children. Small

items such as the battery cover, batteries, test strips, lancets and vial caps

are choking hazards.

11. Proper maintenance and periodically checking the meters quality through

control solution tests, are essential to the longevity of your device. If you

are concerned about the accuracy of your measurement, please contact

your local customer service or place of purchase for help.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS

BEFORE YOU BEGIN 07

Important Information 07

Intended Use 08

Test Principle 08

Contents of System 09

Meter Overview 10

Display Screen 11

Test Strip 12

Setting the Meter 13

THE FOUR MEASURING MODES 16

Control Solution Testing 17

Performing a Control Solution Test 17

TESTING WITH BLOOD SAMPLE 20

Preparing the Puncture Site 20

Alternative Site Testing 22

Performing a Blood Glucose Test 23

METER MEMORY 26

Reviewing Test Results 26

Reviewing Blood Glucose Day Average Results 27

Downloading Results onto a Computer 28

MAINTENANCE 29

Battery 29

Caring for Your Meter 30

Caring for Your Test Strips 33

Important Control Solution Information 34

SYSTEM TROUBLESHOOTING 35

Result Readings 35

Error Messages 36

Troubleshooting 38

DETAILED INFORMATION 39

SPECIFICATIONS 40

BEFORE YOU BEGIN

Important Information

●Severe dehydration and excessive water loss may cause readings

which are lower than actual values. If you believe you are suffering

from severe dehydration, consult a healthcare professional

immediately.

●If your blood glucose results are lower or higher than usual, and

you do not have any symptoms of illness, repeat the test. If you have

symptoms or continue to get results which are higher or lower than

usual, consult with your healthcare professional.

● Use only fresh whole blood samples to test your blood glucose. Using

other substances will lead to incorrect results.

●If you are experiencing symptoms that are inconsistent with your blood

glucose test results and you have followed all the instructions given in

this ownerʼs manual, contact your healthcare professional.

●We do not recommend using this product on severely hypotensive

individuals or patients in shock. Readings lower than actual values may

occur for individuals experiencing a hyperglycemic-hyperosmolar state,

with or without ketosis. Please consult a healthcare professional before

use.

●Critically ill patients should not be tested with a blood glucose

monitoring system.

Intended Use

The FORA Premium V10 Blood Glucose Monitoring System is intended

for use in the quantitative measurement of glucose in fresh capillary

whole blood from your finger and the following alternative sites: palm,

forearm and upper arm. It is intended for use by people with diabetes

mellitus at home as an aid in monitoring the effectiveness of diabetes

control program. It is not intended for the diagnosis of or screening for

diabetes mellitus, and is not intended for use on neonates.

It is intended to be used by a single person and should not be shared.

The alternative site testing in the FORA Premium V10 Blood Glucose

Monitoring System can be used only during steady-state blood glucose

conditions.

This meter has some speaking functions but is not intended for use by

the visually impaired.

Test Principle

Your system measures the amount of sugar (glucose) in whole blood.

The glucose testing is based on the measurement of electrical current

generated by the reaction of glucose with the reagent of the strip. The

meter measures the current, calculates the blood glucose level, and

displays the result. The strength of the current produced by the reaction

depends on the amount of glucose in the blood sample.

This system uses enzyme of glucose oxidase (GOD) from A. niger.

Intended Use

The FORA Premium V10 system kit includes:

Contents of System

Test strips, control solution, sterile lancets and lancing device may be

purchased separately. Please make sure you have those items needed

for a blood glucose test beforehand.

If you wish to transfer data from your meter to a computer (see

"Downloading Results onto your computer" p.28) , you will need to

purchase an RS232 cable, this cable is not provided in the kit. Please

contact your local customer service or place of purchase to obtain this

cable.

Meter

Owner’s Manual

Quick Start User Guide /

Warranty Card

Protective Wallet

Daily Log Book

Two AAA Batteries

NOTE:

If any items are missing from your kit or opened prior to use, or to obtain

test strips and control solution, please contact the place of purchase or call

Customer Service for assistance.

1 432

Meter Overview

Test Strip Slot

Insert test strip here to turn the meter on for testing.

Test Strip Ejector

Eject the used strip by sliding up this button.

Display Screen

M Button

Enter the meter memory and silence a reminder alarm.

Data Port

Download test results with a cable connection.

SET Button

Enter SET mode and conﬁrm the meter settings.

2 2

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