FOR-A MD Bedienungsanleitung

Owner's Manual

Manual del Propietario

Blood Glucose Monitoring System

Sistema de vigilancia de glucose sanguinea

Version 2.0 2018/08 311-4272200-014

English

Dear FORA MD

System Owner:

Thank you for purchasing the FORA MD Blood Glucose Monitoring

System. This manual provides important information to help you to use

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

the instructions in this Owner's Manual and any package inserts for test

strips and control solution.

This system is intended to be used by healthcare professionals for

multiple patients in a professional healthcare setting (i.e. hospitals,

doctor’s ofce, etc.)

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

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

assistance outside of these hours, please visit www.foracare.com.

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

● Users need to adhere to Standard Precautions when handling or using this

device. All parts of the glucose monitoring system should be considered

potentially infectious and are capable of transmitting bloodborne

pathogens between patients and healthcare professionals. For more

information, refer to “Guideline for Isolation Precautions: Preventing

Transmission of Infectious Agents in Healthcare Settings 2007”, http://

www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.

● The meter should be disinfected after use on each patient. This Blood

Glucose Monitoring System may only be used for testing multiple

patients when Standard Precautions and the manufacturer's disinfection

procedures are followed.

● Only auto-disabling, single use lancing devices may be used with this

device.

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

2. Do NOT use accessories which are not specied by the manufacturer.

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

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

data measured is for reference only.

5. Before using this device to test blood glucose, read all instructions

thoroughly and practice the test. Carry out all the quality control checks as

directed.

6. 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.

7 . Use of this instrument in a dry environment, especially if synthetic

materials are present (synthetic clothing, carpets etc.) may cause

damaging static discharges that 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. Proper maintenance and periodically control solution test are essential to

the longevity of your device. If you are concerned about your accuracy of

measurement, please contact the place of purchase or call the Customer

Service for assistance.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS

BEFORE YOU BEGIN 08

Important Information 08

Intended Use 09

Test Principle 09

Contents of System 10

Meter Overview 11

Display Screen 12

Test Strip 13

Speaking Function 14

Setting the Meter 15

THE FOUR MEASURING MODES 19

BEFORE TESTING 20

Checking the Code Number 20

Control Solution Testing 21

Performing a Control Solution Test 21

TESTING WITH BLOOD SAMPLE 24

Preparing the Puncture Site 26

Performing a Blood Glucose Test 27

METER MEMORY 30

DOWNLOADING RESULTS 32

MAINTENANCE 33

Battery 33

Caring for Your Meter 35

Meter Storage 38

Caring for Your Test Strips 38

Important Control Solution Information 39

SYSTEM TROUBLESHOOTING 40

Result Readings 40

Error Messages 41

Troubleshooting 43

DETAILED INFORMATION 44

Reference Values 44

SPECIFICATIONS 46

FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT 47

BEFORE YOU BEGIN

Important Information

• Severe dehydration and excessive water loss may cause readings

which are lower than actual values.

• Use only fresh whole capillary blood samples from the nger to test

your patient's blood glucose.

• We do not recommend using this product on severely hypotensive

individuals or patients in shock. Readings which are lower than

actual values may occur for individuals experiencing a hyperglycemic-

hyperosmolar state, with or without ketosis.

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

monitoring system.

Intended Use

This system is intended for use outside the body (in vitro diagnostic

use) by professionals for multiple-patient use in professional healthcare

settings as an aid in monitoring the effectiveness of diabetes control.

It is intended to be used for the quantitative measurement of glucose

(sugar) in fresh capillary whole blood samples drawn from the ngertips.

It should not be used for the diagnosis of or screening for diabetes

mellitus, or testing on neonates.

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

the visually impaired.

The system is only used with single-use, auto-disabling lancing devices.

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 FAD–dependent glucose dehydrogenase

(FAD-GDH) from E. coli.

Your new FORA MD system kit includes:

Contents of System

Test strips, control solutions or safety lancets are not included in the

kit. They can be purchased separately. Please make sure you have

those items needed for a blood glucose test beforehand.

NOTE

If any items are missing from your kit or opened before use, please contact

your local customer service or place of purchase for assistance.

1 432

Meter

Protective Wallet

Quick Start User Guide/Warranty Card

Owner’s manual

2 x 1.5V AAA alkaline batteries

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