FOR-A MD Referenzhandbuch

BLOOD GLUCOSE MONITORING SYSTEM

Operations & Procedures Manual

Long-Term Care

Thank you for purchasing the FORA MD Blood Glucose Monitoring System. This

manual provides important information to help you use the system properly. Before

using this product, please read the following contents thoroughly and carefully.

If you have other questions regarding this product, please contact the place of purchase

or call Customer Service at 1-888-307-8188.

The FORA MD is intended for multi-patient use in a long-term care setting. Please note

that the following procedures are provided only as a model to help your facility establish

its own policy and procedures. Your own policy may differ depending upon the existing

procedures. Please consult with the Director of Nursing for further guidance.

CAUTION: Please carefully read the User’s Manual and all product instructions before

using this Long-Term Care and Home Health Care Manual and administering blood

glucose tests.

TABLE OF CONTENTS

IMPORTANT SAFETY PRECAUTIONS 06

Interfering Substances 07

BEFORE YOU BEGIN 08

INTENDED USE 08

TEST PRINCIPLE 08

METER OVERVIEW 09

Display Screen 09

Test Strip 10

Speaking Function 10

Setting the Meter 11

BEFORE TESTING 12

Checking the Code Number 12

Control Solution Testing 13

Performing a Control Solution Test 13

BLOOD GLUCOSE TESTING 14

Preparing the Puncture Site 14

Performing a Blood Glucose Test 15

CLEANING AND DISINFECTION PROCEDURES 16

Caring for Your Meter 16

METER MEMORY 18

Reviewing Test Results 18

Reviewing Blood Glucose Day Average Results 19

MAINTENANCE 19

Battery 19

Replacing the Battery 20

Meter Storage 20

Important Test Strip Information 20

Important Control Solution Information 21

SYSTEM TROUBLESHOOTING 20

Result Readings 20

Error Messages 21

Troubleshooting 21

SPECIFICATIONS 22

TRAINING TOOLS 23

Attachment 1: FORA MD Blood Glucose Monitoring System Training Checklist 23

Attachment 2: FORA MD Blood Glucose Monitoring System Training Quiz 24

Attachment 3: FORA MD Blood Glucose Monitoring System Quality Control Results Record 25

Notes 26

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 should 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. DO NOT under any circumstances use the device on neonates or infants.

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 blood glucose, read all instructions thoroughly and practice the test.

Carry out all the quality control checks as directed.

7. 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.

Interfering Substances

Interfering substances depend on concentration. The interfering substances listed below will have no

effect up to the limiting concentration level noted.

* The NaF/K-oxalate concentration is the standard concentration in a blood collection tube.

Substance Limiting Concentration

(mg/dL)

Therapeutic /

Physiological Concentration Range

(or Upper Limit) (mg/dL)

Acetaminophen 6.25 0.45 - 3

Ascorbic Acid 5 2

Bilirubin (Unconjugated) 20 0 - 2

Dopamine 1.25 0.03

Levodopa 0.7 0.02 - 0.28

Methyldopa 1.875 0.1 - 0.5

Glutathione Reduced 23 47 - 100 (Intracellular)

Pralidoxime Iodide 5 ~10 ( IV Dose 500mg)

Tolazamide 12.5 1.6

Uric Acid 10 .2 - 8

Mannitol 5000 0.0128

Mannose 125 1.15

Xylose 3.125 N/A

*Na-Fluoride/K-Oxalate < 250 250

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

BEFORE YOU BEGIN

Severe dehydration and excessive water loss

may cause readings which are lower than actual

values. If the patient is suffering from severe

dehydration, consult a healthcare professional

immediately.

● If the patient’s blood glucose results are lower

or higher than usual, and does not have any

symptoms of illness, rst repeat the test. If the

patient has symptoms or continues to get

results which are higher or lower than usual,

follow the treatment advice of a healthcare

professional.

● Use only fresh whole blood samples to test

patient’s blood glucose. Using other substances

will lead to incorrect results.

● If the patient has symptoms that are

inconsistent with the blood glucose test results

and you have followed all the instructions given

in this owner’s manual, contact a healthcare

professional.

● 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. Please consult a healthcare

professional before use.

INTENDED USE

This system is intended to be used for the

quantitative measurement of glucose (sugar)

in fresh whole blood samples (from the nger).

This system is intended for multiple-patient use

in professional healthcare settings as an aid to

monitor the effectiveness of diabetes control.

It should not be used for the diagnosis of

diabetes, or testing on neonates.

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.

METER OVERVIEW

Bluetooth Switch

Activates the Bluetooth function.

Test Strip Ejector

Eject the used strip by pushing up this

button.

Bluetooth Indicator

Downloads test results with a Bluetooth

connection.

Display Screen

M Button

Test Slot with Strip Indication Light

Insert test strip here to turn the meter on for

testing.

Battery Compartment

SET Button

Enter SET mode and conrm the meter

settings.

Low Battery Symbol

Test Strip Symbol

Blood Drop Symbol

Code

Volume Symbol

Test Result

Ketone Warning

Error Warning

Memory Symbol

Measurement Modes

Date

Time

Day Average

Reminder Alarms

Measurement Unit

Display Screen

3 2 145

11 12

Absorbent Hole

Touch a drop of blood here, blood will be

automatically drawn in.

Test Strip Handle

Hold this part to insert the test strip into the

slot.

Contact Bars

Insert this end of the test strip into the meter.

Push it in rmly until it will go no further.

Conrmation Window

This is where you conrm if enough blood

has been applied to the absorbent hole in the

strip.

Test Strip Speaking Function

FORA MD “speaks” aloud with voice instructions

to guide you through the process of blood glucose

testing. The following table tells you when and

what the meter “says”.

ATTENTION:

The front side of test strip should face

up when inserting the test strip.

Test results might be wrong if the contact

bar is not fully inserted into the test slot.

NOTE:

The FORA MD meter should only be used with FORA MD

Test Strips. Using other test strips with this meter can produce

inaccurate results.

WHEN

does the meter talk?

WHAT

does the meter say?

Using the meter

Insert test strip when

the meter is ready to

test. (symbol appears

on display)

1. Thank you for using this product.

Please relax during

measurement.

2. The Code Number is 10.

3. Please apply blood into the strip.

When the test is

completed. (result

appears on display)

Your blood glucose is (number)

(milligrams per deciliter/millimoles

per liter).

When the test result

is < 20 mg/dL.

The blood glucose is out of range

unable to measure.

When the test result

is > 600 mg/dL.

The blood glucose is out of range

unable to measure.

Recall the Stored

Test Results.

Your blood glucose is (number)

(milligrams per deciliter/millimoles

per liter).

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