Fora GD20 Operation Manual

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GD20

Operations & Procedures Manual

Long Term Care

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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.

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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

17-18

20-21

Notes

23-24

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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 speciﬁ 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.

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Interfering Substances

Interfering substances depend on the concentration. The interfering substances listed below may produce elevated glucose test results (up to test concentration levels noted).

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

Levo - Dopa 0.7 0.02 - 0.28

Methyl - Dopa 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

* The NaF/Koxalate concentration is the standard concentration in a blood collection tube.

Regulatory Requirements

The Clinical Laboratory Improvement Amendments (CLIA) has classiﬁ ed 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

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BEFORE YOU BEGIN

INTENDED USE

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, ﬁ rst 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 whole blood samples to test

patient’s blood glucose. Using other substances

will lead to incorrect results.

Test Concentration

mg/dl

This system is intended to be used for the

quantitative measurement of glucose (sugar)

in fresh whole blood samples (from the ﬁ nger,

palm, forearm and upper arm). 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. Alternative

site testing should be done only during

steady–state times (when glucose is not

changing rapidly).

% Bias at

80±5 mg/dl

% Bias at

120±5 mg/dl

TEST PRINCIPLE

Your system measures the amount of sugar

(glucose) in whole blood. The glucose testing is

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.

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.

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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.

so condensed, patients will not feel as much pain

as at the ﬁ ngertip.

When to use AST?

Food, medication, illness, stress and exercise

can affect blood glucose levels. Capillary blood

at ﬁ ngertip reﬂ ects these changes faster than

capillary blood at other sites. Therefore when

testing blood glucose during or immediately after

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.

meal, physical exercise, or any other event, take

blood sample from ﬁ nger 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.

What is AST?

Alternative site testing (AST) means that people

use parts of the body other than ﬁ ngertips 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 ﬁ ngertip

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

• You are testing for hypoglycemia.

• The patient’s routine glucose results are often

ﬂ uctuating.

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METER OVERVIEW

Display Screen

910

SET

BATTERY

CR2032

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

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Test Strip Setting the Meter

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.

Conﬁ rmation Window

This is where you conﬁ rm 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 ﬁ rmly until it will go no

further.

Before using the meter for the ﬁ rst 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 ﬂ ashing,

SET

CR2032

BATTERY

ATTENTION: Test results might be wrong if the contact bar is not fully inserted into the test slot.

NOTE

This system uses enzyme of glucose

dehydrogenase (GDH).

press M to select

the correct year. Press SET.

With the month ﬂ ashing, press M to select

the correct month. Press SET.

With the day ﬂ ashing, press M to select the

correct day. Press SET.

2. Setting the time format

Press and release M to select the desired time

format --- 12h or 24h. Press SET to conﬁ rm.

3. Setting the time

With the hour ﬂ ashing, press M to select the

correct hour. Press SET to conﬁ rm.

The FORA GD20 meter should only be used

with FORA GD20 Test Strips. Using other test

strips with this meter will produce inaccurate

results.

With the minute ﬂ ashing, press M to select

the correct minute. Press SET to conﬁ rm.

4. Deleting the memory

With “dEL” and a ﬂ ashing “ ” symbol on the

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display, press M and select “No” to keep the results

in memory then press SET to skip.

QUALITY CONTROL TESTING

Quality control testing using the FORA Control

To delete all the results, press M to 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 M to turn on or turn off to set the ﬁ rst

reminder alarm.

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

hour. When the hour is ﬂ ashing, press M to add an

hour. Press SET to conﬁ rm. Now adjust the

minutes. Press M to add one minute. Hold M

longer to add faster. Press SET to conﬁ rm and go

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.

You Should Perform a Control Solution Test

Before testing with the FORA GD20 Blood

Glucose Monitoring System for the ﬁ rst time.

When you open a new vial of test strips.

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, ﬁ nd

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 M to 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 M to

switch off the meter.

NOTE

These parameters can ONLY be changed in the

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.

IMPORTANT:

Depending on different state regulations, control solution testing may be required on a daily basis. Refer to your facility procedures for further details.

setting mode.

If the meter is idle for 3 minutes during the

setting mode, it will automatically switch off.

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NOTE

WARNING:

Only use the control solutions for FORA GD20

test strips.

When using a new bottle of control solution,

write the opening date on the bottle label. Each

bottle of control solution is stable for use within 90

days after ﬁ rst opening (replace cap tightly after

each use). Discard all remaining open solutions

after 90 days.

Shake the control solution bottle several times

before use, discard the ﬁ rst drop of control

solution and wipe off the dispenser tip to ensure a

pure sample and an accurate result.

Equipment Needed:

1. FORA GD20 Blood Glucose Meter

2. FORA GD20 (GDH) Control Solutions

3. FORA GD20 Test Strips

When doing a control solution test, you need to Press C to mark it so the test result will not be stored in the memory. Failure to do so will mix up the control solution test with a blood glucose test result in the memory.

3. Apply control solution

Shake the control solution vial

thoroughly before use.

Squeeze out a drop and wipe it

off, then squeeze out another

drop and place it on the tip of the

vial cap.

Hold the meter to move the sample area of the

test strip to touch the drop. Once the conﬁ rmation

window ﬁ lls completely, the meter will begin

counting down.

4. FORA GD20 Meter Record Sheet

Performing a Control Solution Test

1. Insert the test strip to turn on the meter

Insert the test strip into the meter. Wait for the

meter to display the test strip and blood drop

symbols.

2. Press C to mark this test as a control solution test

With “CTL” displayed, the meter will not store your

test result in memory. If you press the C button

again, the “CTL” will disappear and this test is no

To avoid contaminating the control solution, do not

directly apply control solution onto a strip.

4. Read and compare the result

After counting down to 0, the control solution

test result will appear on the display. Compare

this result with the range printed on the test strip

vial. It should fall within

this range. If not, please

read the instructions

again and repeat

the control solution test.

109~165

longer a control solution test.

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5. Record the results.

Preparing the Puncture Site

Record the control solution test results in the

System Quality Control Results Record sheet or

as instructed by your facility.

Out-of-range results

If you continue to have test results fall outside the

range printed on the test strip vial, the meter

and/or strips may not be working properly.

Please check the Troubleshooting section for

possible causes and actions. If a problem still

persists, contact Customer Service at

(888) 425-1149 for assistance.

BLOOD GLUCOSE TESTING

If a single meter is used to test multiple patients,

the meter must be cleaned and disinfected using

the instructions as speciﬁ ed in this manual after

Stimulating blood perfusion by rubbing the

puncture site before blood extraction has a

signiﬁ cant inﬂ uence on the glucose value obtained.

Please follow the suggestions below before obtaining a drop of blood:

Wash and dry your hands before starting.

1. Put on a new pair of gloves.

2. Select the puncture site.

3. Clean the puncture site using cotton moistened

with 70% alcohol and let it air dry.

4. Rub the puncture site for about 20 seconds

before penetration.

Fingertip testing

Press the lancing device’s tip ﬁ rmly against the

lower side of patient’s ﬁ ngertip.

each use, whether or not blood contamination is

suspected.

Equipment Needed:

1. FORA GD20 Blood Glucose Meter

2. FORA GD20 Test Strips

3. Safety lancet

4. Gloves

5. Alcohol wipe or swab

Only auto-disabling, single use lancing devices

should be used with this device.

Blood from sites other than the ﬁ ngertip

When lancing the palm, forearm and upper arm

avoid lancing the areas with obvious veins because

of excessive bleeding.

NOTE

Choose a different spot each time you test.

Repeated punctures at the same spot may cause

soreness and calluses.

It is recommended that you discard the ﬁ rst drop

of blood as it might contain tissue ﬂ uid, which may

affect the test result.

When cleaning the puncture site, make sure

alcohol is throughly dry before puncture site is

lanced. Testing with alcohol remaining on skin can

cause higher results.

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Performing a Blood Glucose Test

Consult manufacturer’s instructions for additional

information regarding the use of the FORA GD20

Blood Glucose Meter.

1. Verify physician’s order.

2. Identify the patient.

3. Explain procedure.

4. Provide privacy.

5. Wash hands.

6. Put on non-sterile gloves.

7. Ensure that the meter and test strips are at

room temperature. If there is a temperature

change, the meter and test strips should sit at

room temperature for 10 to 12 minutes.

8. Verify that the vial of test strips has not expired

wicked and after the conﬁ rmation window is

ﬁ lled, the meter will begin counting down.

(0.7 μL blood sample required)

13. Read the result.

and/or that the vial has not been opened for

longer than 90 days. Discard the vial of test

strips if it has expired and/or has been opened

for more than 90 days.

9. Cleanse area that is to be punctured with an

alcohol swab. Allow area to dry.

10. Insert a test strip in the meter.

11. Lightly hold lancet device against the skin and

lance the area. Obtain a blood sample (a

hanging drop of blood).

14. Eject the used test strip.

15. Clean and/or disinfect the meter following

the cleaning and disinfecting procedures in

this manual.

16. Remove gloves and wash hands.

NOTE

Do not press the punctured site against the test

strip or try to smear the blood.

If you do not apply a blood sample to the test

strip within 3 minutes, the meter will automatically

turn off. You must remove and reinsert the test

strip to start a new test.

The conﬁ rmation window should be ﬁ lled with

blood before the meter begins to count down.

NEVER try to add more blood to the test strip after

12. Make contact with the blood sample to the

sample area of the test strip. Blood will be

the blood sample has moved away. Discard the

used test strip and retest with a new one.

If you have trouble ﬁ lling the conﬁ rmation

window, please contact Customer Service at

(888) 425-1149.

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CLEANING AND DISINFECTION PROCEDURES

Their product offerings include:

• Super Sani-Cloth“ Germicidal Wipe - ideal

Cleaning & Disinfecting the FORA GD20 Blood Glucose Meter

It is Links Medical Product’s policy to advise heal

care professionals to clean and disinfect blood

glucose meters between each resident test in order

to avoid cross-contamination issues. Whether your

facility uses an alcohol based solution or a bleach

based solution should depend upon your individual

resident requirements and your facility’s disinfection

protocol.

Links Medical Product’s cleaning and disinfecting

guidelines are as follows:

FORA GD20 Cleaning Guidelines: Use a lint free

cloth dampened with soapy water or isopropyl

(70% - 80%) to clean the outside of the blood

glucose meter.

NOTE: Lint free cloth should not be dripping wet

when cleaning the meter.

disinfection for most residents and hard surfaces.

• Sani-Cloth“ Bleach Germicidal Disposable Wipe -

ideal disinfection for residents with C-Diff.

Both germicidal wipes mentioned above are EPA

registered wipes that are compliant with the CDC

guideline for disinfection and sterilization in

healthcare facilities and are readily available

through major medical distributors. When using any

disinfection wipe, take extreme care not to get liquid

in the test strip dock or key code parts of the

meter. With all recommended glucose meter

cleaning methods, it is crucial that the FORA GD20

meter be completely dry before testing a resident’s

glucose level. Please follow the disinfectant product

label instructions to ensure proper drying time.

While there are many other options for

disinfecting blood glucose meters, Links Medical

Products has not tested the effectiveness of these

products on the FORA GD20 meter. If you use a

product or method other than those that we’ve

FORA GD20 Disinfecting Guidelines: To

disinfect the meter, dilute 1 mL of household bleach

(5% - 6% sodium hypochlorite solution) in 9 mL of

water to achieve a 1:10 dilution (ﬁ nal concentration

of 0.5% - 0.6% sodium hypochlorite). The solution

can then be used to dampen a paper towel (do not

saturate the towel). Then use the damped towel to

thoroughly wipe down the meter.

Please note that there are commercially available

1:10 quaternary/alcohol wipes and bleach wipes

from a variety of manufactures. Professional

Disposables Inc (PDI) is an example of a

manufacturer that offers both of these options.

recommend above, you should document

accordingly in your cleaning protocol.

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METER MEMORY

The meter stores the 448 most recent blood

glucose test results along with respective dates

and times in its memory. To enter the meter

memory, start with the meter switched off.

DOWNLOADING RESULTS ONTO A COMPUTER

You can use the meter with an interface cable and

the Health Care Software System to view test

results on your personal computer. To learn more

about the Health Care Software System or to

Reviewing Test Results

1. Press and release M.

will appear on the display.

Press M again, and the ﬁ rst reading

you see is the last blood glucose

result along with date and time.

2. Press M repeatedly to recall the test results

stored in the meter.

3. Exit the meter memory.

After the last test results, press M again and the

meter will be turned off.

Reviewing Blood Glucose Day Average

Results

obtain an interface cable separately, please visit

www.foracare.com or call (888) 425-1149 for

assistance.

1. Obtaining the required cable and installing

the software

To download the Health Care Software System,

please visit the FORA Care Inc. website at

www.foracare.com.

2. Connecting to a personal computer

Connect the cable to an interface port on your

computer. With the meter switched off, connect

the other end of the interface cable to the meter

data port. “PC” will appear on the meter display,

indicating that the meter is in communication

mode.

1. Press and release M.

When appears on the display,

keep pressing M for 3 seconds until

the ﬂ ashing “ ” appears. Release

M and then your 7-day average

result measured in general mode

will appear on the display.

2. Press M to review 14-, 21-, 28-, 60- and 90- day

average results stored in memory.

3. Exit the meter memory.

Keep pressing M and the meter will turn off after

displaying the last test result.

3. Data transmission

To transmit data, follow the instructions provided

with the software. Results will be transmitted with

date and time. Remove the cable and the meter

will automatically switch off.

WARNING:

While the meter is connecting to the PC, it will be

unable to perform a blood glucose test.

Page 16

MAINTENANCE

Battery

2. Remove the old battery and replace with a new

3V CR2032 lithium battery.

Your meter comes with one 3V CR2032 lithium

battery.

Low Battery Signal

The meter will display one of the messages below

to alert you when the meter's power is getting low.

1. The symbol appears along with a display

message: The meter is functional and the results

remain accurate, but it is time to change the

battery.

2. The meter displays E-b:

There is not enough power for a test.

Please change the battery

immediately.

Replacing the Battery

To replace the battery, make sure that the meter is turned off.

SET

CR2032

BATTERY

3. Close the battery cover. If the battery is

inserted correctly, you will hear a "beep"

conﬁ rming the battery has been properly

inserted.

SET

CR2032

BATTERY

1. Press the edge of the battery clip and lift it up

to remove.

SET

CR2032

BATTERY

NOTE

Replacing the battery does not affect the test

results stored in the memory.

Battery might leak chemicals if unused for a long

period of time. Remove the battery if you are not

planning to use the device for an extended period

(i.e., 3 months or more).

Properly dispose of the battery according to your

local environmental regulations.

Page 17

Meter Storage

Important Control Solution Information

Storage conditions: -4°F to 140°F (-2°C to

6°C), below 95% relative humidity.

Always store or transport the meter in its

original storage case.

Avoid dropping and heavy impact.

Avoid direct sunlight and high humidity.

Important Test Strip Information

Storage conditions: 35.6숳 to 89.6숳 (2삸 to 32삸),

below 85% relative humidity. Do not freeze.

Store your test strips in their original vial only.

Do not transfer to another container.

Store test strip packages in a cool dry place.

Keep away from direct sunlight and heat.

After removing a test strip from the vial,

Use only FORA control solutions with your

meter.

• Do not use the control solution beyond the

expiration date or 3 months after ﬁ rst opening.

Write the opening date on the control solution

vial and discard the remaining solution after 3

months.

It is recommended that the control solution test

be done at room temperature (68°F to 77°F) 20°C

to 25°C. Make sure your control solution, meter,

and test strips are at this speciﬁ ed temperature

range before testing.

Store the control solution tightly closed at

temperatures between 36°F and 86°F (2°C and

30°C). DO NOT FREEZE.

immediately close the vial cap tightly.

Touch the test strip with clean and dry hands.

Use each test strip immediately after removing

it from the vial.

Write the opening date on the vial label when you

ﬁ rst open it. Discard remaining test strips after 3

months (90 days).

Do not use test strips beyond the expiration date.

This may cause inaccurate results.

Do not bend, cut, or alter a test strip in any way.

Keep the strip vial away from children. The cap

and the test strip may be a choking hazard. If

swallowed, promptly seek medical attention.

For further information, please refer to the test

strip package insert.

Page 18

SYSTEM TROUBLESHOOTING

f you follow the recommended action but the

problem persists, or error messages other than the

ones below appear, please call (888) 425-1149 for

assistance. Do not attempt to repair yourself and

never try to disassemble the meter under any

circumstances.

Result Readings

MESSAGE

KEYTONE?

Appears when the result is below the measurement limit of 20 mg/dL (1.1 mmol/L).

Appears when the result is equal to or higher than 240 mg/dL (13.3 mmol/L). This inndicates the possibility of ketone accumulation for type 1 diabetes.

Appears when the result is above the measurement limit of 600 mg/dL (33.3 mmol/L).

WHAT IT MEANS

Appears when inserting a used test strip.

Test strip was removed after applying a blood sample prior to glucose test completion.

Problem with the meter.

Appears when the environmental temperature is below system operation range: 50°F (10°C).

Appears when the environmental temperature is above system operation range: 104°F (40°C).

Re-test using a new test strip.

Review the instructions and re-test with a new test strip. If the above steps do not work, please contact Customer Service.

System operation range is 50°F to 104°F (10°C to 40°C). Repeat the test after the meter and test strip have reached the appropriate temperature.

Error Messages

MESSAGE

WHAT IT MEANS WHAT TO DO

Appears when the battery can not provide enough power for a test.

Replace the battery immediately.

Troubleshooting

1. If the meter does not display a message after

inserting a test strip:

POSSIBLE CAUSE

Battery exhausted.

Test strip inserted upside down or incorrectly.

Defective meter.

Replace the battery.

Insert the test strip correctly with the contact bars end ﬁ rst and facing up.

Please contact Customer Service at (888) 425-1149.

WHAT TO DO

Page 19

SPECIFICATIONS

2. If the test does not start after applying the

sample:

POSSIBLE CAUSE

Insufﬁ cient blood sample.

Defective test strip.

Sample applied after automatic switch-off (3 minutes after last user action).

Defective meter.

Re-test using a new test strip with larger volume of blood.

Re-test with a new test strip.

Re-test with a new test strip. Apply sample only when " " appears on the display.

Please contact Customer Service at (888) 425-1149.

WHAT TO DO

3. If the control solution testing result is out of

range.

Model No.: TD-4251

Dimension & Weight: 86.9mm(L) x 51mm(W) x

15.8mm(H), 42.2g

Power Source: one CR2032 lithium battery

Display: LCD

Memory: 448 measurement results with

respective date and time

External output: RS232 PC interface

Auto electrode insertion detection

Auto sample loading detection

Auto reaction time count-down

Auto switch-off after 3 minutes without action

Temperature warning

Operating Condition: 50°F to 104°F (10°C to

40°C), below 85% R.H. (non-condensing)

Storage/Transportation Conditions:

Meter: -4°F to 140°F (-20°C to 60°C), below 95%

POSSIBLE CAUSE

Error in performing the test.

Control solution vial was porly shaken.

Expired or contaminated control solution.

Control solution that is too warm or too cold.

Defective test strip.

Meter malfunction.

WHAT TO DO

Read the instructions thoroughly and repeat the test again.

Shake the control solution vial and repeat the test again.

Check the expiration date or the discard date of the control solution.

Control solution, meter, and test strips should come to room temperature (68°F to 77°F(20°C to 25°C) before testing.

Re-test with a new test strip.

Please contact Customer Service at (888) 425-1149.

R.H.

Test strip: 35.6°F to 89.6°F (2°C to 32°C), below

85% R.H. Do not freeze.

Measurement Units: mg/dL

Measurement Range: 20 to 600mg/dL (1.1 to

33.3mmol/L)

This device has been tested to meet the electrical

and safety requirements of: IEC/EN 61010-1, IEC/

EN 61010-2-101, EN 61326-1, IEC/EN 61326-2-2.

Distributed by: Manufactured by:

ForaCare Inc. 893 Patriot Dr., Suite D, Moorpark, CA 93021

9247 Research Drive · Irvine, CA Toll Free: (888) 425-1149 (8:00am-5:00pm PST, Mon.-Fri.) www.linksmed.com

Page 20

Attachment 1:

FORA GD20 Blood Glucose Monitoring System Training Checklist

Use the following checklist to assess the trainee’s understanding and knowledge of the

following areas:

Area

Knowledge

Equipment

Task

Clinical Use of Device

Knows key features of FORA GD20 meter.

Understands different test types - ﬁ nger, AST, quality control, preferred sample type and sample volume.

Principles of quality testing and QC materials.

Only uses FORA GD20 test strips and FORA control solution with the FORA GD20 meter.

Understands the important features, beneﬁ ts and limitations of the FORA GD20 system.

Knows the proper method of disposing of used test strips, lancet and gloves according to facility procedures.

Understands the displayed error messages and corresponding actions to take.

Understands the appropriate steps to take for troubleshooting.

Knows the actions to be taken when the results are abnormally high or low.

Understands the information required to be documented by law and by institution.

Identify the essential equipment used with the FORA GD20 system.

Locates the serial number, test strip port, test strip ejector, M, C and SET buttons on the meter.

Locates the expiration date, ﬁ rst opening date, lot number and control solution ranges on the test strip vial. Locates sample area, conﬁ rmation window, contact bars and test strip handle on the test strips.

Locates the expiration date, ﬁ rst opening date and lot number on the control solution bottle.

Knows the proper storage conditions of the meter, test strips and control solutions.

( √ )

Knows how to maintain the meter.

Demonstrates proper safety lancet technique when collecting a blood sample.

Demonstrates the correct blood testing procedures using the FORA GD20 Blood Glucose Monitoring System.

Demonstrates the correct test strip insertion technique.

Performs quality control tests at speciﬁ c times and determines if the results are acceptable. Takes appropriate action if there is a problem.

Practical

Training Completed by:

The trainee must complete the training of the FORA GD20 Blood Glucose Monitoring System before performing glucose testing on residents.

Demonstrates the proper cleaning and disinfecting techniques for the FORA GD20 meter.

Performs meter set up, memory retrieval and data transmission operations.

Demonstrates the proper actions to take for inaccurate results.

Name of Trainee Date

Name of Instructo Sr ignature of Instructor

Page 21

Attachment 2:

FORA GD20 Blood Glucose Monitoring System Training Quiz

Complete the following questions to assess your understanding about using the

FORA GD20 Blood Glucose Monitoring System to perform blood glucose tests on residents.

No.

Questions

The FORA GD20 Blood Glucose Monitoring System uses: a). GOD (glucose oxidase) enzyme b). GDH (glucose dehydrogenase) enzyme

The FORA GD20 Blood Glucose Monitoring System can test samples from: a). Finger b). AST (Alternative Sites Testing) c). Control solutions d). All of the above

The FORA GD20 Blood Glucose Monitoring System requires a blood volume of: a). 0.3μL b). 0.7μL d). 1.0μL

You should perform a control solution test when: a). You think the meter or test strip may be working incorrectly b). You drop the meter c). You have repeated a test and the test result is still lower or higher than expected d). All of the above

Answer

After the control solution and test strip vials have been opened, when do you discard the remaining materials?

a). 30 days b). 90 days c). 6 months d). 1 year

When performing a quality control test, how do you apply the control solution onto the test strip?

a). Place a drop directly onto the test strip b). Place a drop on a clean surface and then contact the drop with the test strip c). Place a drop on your ﬁ nger and then contact the drop with the test strip d). Shake the control solution vial and squeeze out a drop onto the tip of the vial cap, then touch test strip to drop

When do you clean and disinfect the meter?

a). After each use b). Daily c). Weekly d). Monthly

Page 22

If you saw the following massage on the meter's display, what action should you take?

a). Replace the battery b). Re-test with a new strip c). Repeat the test when the room temperature is within 50°F to 104°F

The test strips should be stored:

a). At 35.6°F to 89.6°F (2°C to 32°C), below 85% humidity b). At -4°F to 140°F (-20°C to 60°C), below 95% humidity c). In the freezer d). In a different container than the original vial

Quiz Completed by:

Name of Trainee Date Score

Page 23

action

Corrective

Level 3 Control

lot # range result

Normal (W2) High (B3)

Level 2 ControlLevel 1 Control

lot # range result

Low (Y1)

lot # range result

date

Test strip

expiration

lot #

Test

strip

(Y/N)

Meter

cleaned

FORA GD20 Blood Glucose Monitoring System Quality Control Results Record

Attachment 3:

Date Time Station/shift Operator

Meter #: Month/Year: Results reviewed by:

Page 24

Notes:

Page 25

Notes:

Page 26

Distributed by:

9247 Research Drive · Irvine, CA

Toll Free: (888) 425-1149

(8:00am-5:00pm PST, Mon.-Fri.)

www.linksmed.com