FOR-A GD20FM01 Referenzhandbuch

Operations & Procedures Manual

Long Term Care

GD20

Thank you for purchasing the ForaCare GD20 Blood Glucose Monitoring System. This manual

provides important information to help you to 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 (888) 425-1149.

The FORA GD20 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 Manual and administering blood glucose tests.

TABLE OF CONTENTS

IMPORTANT SAFETY PRECAUTIONS

Interfering Substances / Regulatory Requirements

BEFORE YOU BEGIN

INTENDED USE

TEST PRINCIPLE

ALTERNATIVE SITE TESTING

METER OVERVIEW

Test Strip

Setting the Meter

QUALITY CONTROL TESTING

BLOOD GLUCOSE TESTING

CLEANING AND DISINFECTION PROCEDURES

METER MEMORY

DOWNLOADING RESULTS ONTO A COMPUTER

MAINTENANCE

Replacing the Battery

Meter Storage

Important Test Strip Information

Important Control Solution Information

SYSTEM TROUBLESHOOTING

Result Readings

Error Messages

Troubleshooting

SPECIFICATIONS

TRAINING TOOLS

Attachment 1: Training Checklist

Attachment 2: Training Quiz

Attachment 3: Quality Control Records Result

Notes

17-18

20-21

23-24

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

blood-borne pathogens between patients and healthcare professionals. For more information, refer to

“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Set-

tings 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 speciﬁed 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.

Regulatory Requirements

The Clinical Laboratory Improvement Amendments (CLIA) has classiﬁed tests of blood glucose as

tests that are waived. For all entities that conduct one or more tests, including waived tests

on materials derived from the human body for the purpose of providing information for the diagnosis,

prevention or treatment of any disease or impairment of, or the assessment of the health

of human beings, CLIA has stated that the entity conducting the tests shall meet certain Federal

requirements. If any entity conducts tests for the aforementioned purposes, then the entity, under

CLIA, is considered to be a laboratory and thus must register with the CLIA Program.

KEEP THESE INSTRUCTIONS

IN A SAFE PLACE

Interfering Substances

Interfering substances depend on the concentration. The interfering substances listed

below may produce elevated glucose test results (up to concentration levels noted).

Test Concentration

mg/dl

% Bias at

80±5 mg/dl

% Bias at

120±5 mg/dl

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 do not have any

symptoms of illness, ﬁrst repeat the test. If

the patient has symptoms or continue to get

results which are higher or lower than usual,

follow the treatment advice of the healthcare

professional.

Use only fresh capillary or venous 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 the 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 hyperglycaemic-hyperosmolar state, with or

without ketosis. Please consult the healthcare

professional before use.

INTENDED USE

This system is intended for use outside the

body (in vitro diagnostic use) by healthcare

professionals for multiple patient use in a pro-

fessional healthcare setting. Additionally, it is

intended to be used for the quantitative mea-

surement of glucose in fresh capillary blood

(from the ﬁnger, palm, forearm and upper arm)

or venous whole blood samples.

It should not be used for the diagnosis of

diabetes, or testing on neonates.

Alternative site testing should be done only dur-

ing steady–state times (when glucose is not

changing rapidly).

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 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.

ALTERNATIVE SITE TESTING

IMPORTANT:

There are limitations with AST (Alternative Site

Testing). The alternative site testing of the system

can be used in only during steady-state blood

glucose conditions. Please consult the doctor

before you perform AST on the patient.

Measurements from alternative site testing

should never be used to calibrate a continuous

glucose monitoring systems (CGMs) or entered

into insulin dose calculators for insulin dosing

recommendations.

What is AST?

Alternative site testing (AST) means that people

use parts of the body other than ﬁngertips to check

their blood glucose levels. This system provides

you to test on the palm, the forearm, the upper

arm, and with the equivalent results to ﬁngertip

testing.

What’s the advantage?

Fingertips feel pain more readily because they are

full of nerve endings (receptors).

At other body sites, since nerve endings were not

so condensed, patients will not feel as much pain

as at the ﬁngertip.

When to use AST?

Food, medication, illness, stress and exercise

can affect blood glucose levels. Capillary blood

at ﬁngertip reﬂects these changes faster than

capillary blood at other sites. Therefore when

testing blood glucose during or immediately after

meal, physical exercise, or any other event, take

blood sample from ﬁnger only. We strongly

recommend that you perform AST ONLY at the

following times:

•In a pre-meal or fasting state (more than 2

hours since the last meal).

•Two hours or more after aking insulin.

•Two hours or more after exercise.

Do NOT use AST if:

•Your patient has frequent low blood glucose.

•The AST results do not match the way the

patient feels.

•You are testing for hyperglycemia.

•You are testing for hypoglycemia.

•The patient’s routine glucose results are often

ﬂuctuating.

METER OVERVIEW Display Screen

BATTERY

SET

CR2032 7

123

910

Blood sample symbol

Test strip symbol

Low battery symbol

Test result

Measurement unit

Memory symbol

Day average

Reminder alarm

Time

Date

Control solution mode

Ketone warning

Error

Test Strip Setting the Meter

NOTE

This system uses enzyme of glucose

dehydrogenase (GDH).

The FORA GD20 meter should only be used

with FORA GD20 Test Strips. Using other test

strips with this meter will produce inaccurate

results.

Before using the meter for the ﬁrst time or if you

change the meter battery, you should check and

update these settings. Make sure you complete

the steps below and have your desired settings

saved.

Entering the Setting Mode

Start with the meter off

(no test strip inserted).

Press SET to turn on the

meter.

1. Setting the date

With the year ﬂashing,

press M to select

the correct year. Press SET.

With the month ﬂashing, press Mto select

the correct month. Press SET.

With the day ﬂashing, press Mto select the

correct day. Press SET.

2. Setting the time format

Press and release Mto select the desired time

format --- 12h or 24h. Press SET to conﬁrm.

3. Setting the time

With the hour ﬂashing, press Mto select the

correct hour. Press SET to conﬁrm.

With the minute ﬂashing, press Mto select

the correct minute. Press SET to conﬁrm.

4. Deleting the memory

With “dEL” and a ﬂashing “ ” symbol on the

BATTERY

SET

CR2032

BackFront

The front side of the

test strip should face

up when inserting

the test strip.

Absorbent Hole

Apply a drop of blood here.

The blood will be

automatically absorbed.

Conﬁrmation Window

This is where you conﬁrm if

enough blood has been

applied to the absorbent

hole in the strip.

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 ﬁrmly until it will go no

further.

ATTENTION:

Test results might be wrong if the

contact bar is not fully inserted into

the test slot.

display, press Mand select “No” to keep the results

in memory then press SET to skip.

To delete all the results, press Mto select “Yes”.

Then press SET to delete All results. ”OK” is dis-

played in the meter, which means that all data

stored is deleted.

5. Setting the reminder alarm

You may set up any or all of the reminder alarms

(1-4). The meter displays “On” or “OFF” and ,

press Mto turn on or turn off to set the ﬁrst

reminder alarm.

Press Mto select “On”, then press SET to set the

hour. When the hour is ﬂashing, press Mto add an

hour. Press SET to conﬁrm. Now adjust the

minutes. Press M to add one minute. Hold M

longer to add faster. Press SET to conﬁrm and go

to the next alarm setting.

If you do not want to set an alarm, press SET to

skip this step. If you want to turn off an alarm, ﬁnd

the alarm number by pressing SET in the setting

mode, press M to change from “ON” to “OFF”. At

the time of your alarm, the meter will beep and

automatically turn on.

You can press Mto silence the alarm and insert

a test strip to begin testing. If you do not press M,

the meter will beep for 2 minutes then switch off.

If you do not want to test at this time, press Mto

switch off the meter.

Quality control testing using the FORA Control

Solution is required to check the performance

of the FORA GD20 Blood Glucose Monitoring

System. The FORA Control Solution checks if the

meter and test strips are working correctly as a

system and if the system is being utilized correctly.

This section explains how to take a control

solution test in order to verify the performance of

FORA GD20 Blood Glucose Monitoring System.

Before testing with the FORA GD20 Blood

Glucose Monitoring System for the ﬁrst time.

When you open a new vial of test strips.

Whenever you suspect the meter or test strips

may not be functioning properly.

If test results appear to be unusually high or low

or are inconsistent with clinical symptoms.

To check your technique.

When the FORA GD20 meter has been dropped

or you think you may have damaged the meter.

QUALITY CONTROL TESTING

You Should Perform a Control Solution Test

NOTE

These parameters can ONLY be changed in the

setting mode.

If the meter is idle for 3 minutes during the

setting mode, it will automatically switch off.

IMPORTANT:

Depending on different state regulations,

control solution testing may be required on a

daily basis. Refer to your facility procedures for

further details.

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