Fora G40 Le manuel du propriétaire

Blood Glucose Monitoring System

Système de contrôle de la glycémie

Owner’s Manual

Manuel de l’utilisateur

COMFORT check G40

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EN-1

Safety Information

Read the following Safety Information thoroughly before using the device.

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

• Do NOT use accessories which are not specied by the

manufacturer.

• Do NOT use the device if it is not working properly or if it is

damaged.

• Do NOT use the equipment in places where aerosol sprays are

being used or where oxygen is being administered.

• Do NOT under any circumstances use the device on newborns,

infants, or people who cannot communicate.

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

The data measured is for reference only. Always consult your doctor

to have the results interpreted.

• 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.

• 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.

• 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.

• Do not use this instrument in close proximity to sources of strong

electromagnetic radiation, as these may interfere with the accurate

operation.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

Important Information

• Severe dehydration and excessive water loss may cause readings

which are lower than actual values. If you believe you are suering

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, rst repeat the test. If

you have symptoms or continue to get results which are higher or

lower than usual, follow the treatment advice of 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 owner’s manual, contact your 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.

• The measurement unit used for indicating the concentration

of blood glucose can have mg/dL or mmol/L. The approximate

calculation rule for conversion of mg/dL in mmol/L is:

mg/dL Divided by 18 = mmol/L

mmol/L Times 18 = mg/dL

For example:

1) 120 mg/dL ÷ 18 = 6.6 mmol/L

2) 7.2 mmol/L x 18 = 129 mg/dL approximately

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Meter Overview

1

4

2

3

5

6

FrontSide Back

1. Test Slot

2. Display Screen

3. Test Strip Ejector

4. M Button

5. SET Button

6. Battery compartment

Introduction

Intended Use

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

diagnostic use) by people with diabetes at home and by health

care professionals in clinical settings as an aid to monitoring the

eectiveness of diabetes control. It is intended to be used for

the quantitative measurement of glucose (sugar) in fresh whole

blood samples (from the nger, palm, forearm and upper arm).

It should not be used for the diagnosis of diabetes, or testing on

newborns.

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.

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Screen Display

1. Blood drop symbol 8. Memory symbol

2. Test strip symbol 9. Time

3. Low battery symbol 10. Date

4. Measurement unit 11. Alarm

5. Control solution mode 12. General testing mode

6. Day average 13. Ketone warning

7. Face/Low/High symbol 14. Test result

Getting Started

Initial Setup

Before using your meter for the 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:

Enter the Setting Mode

Start with the meter o (no test strip inserted). Press SET to turn

on the meter.

BATTERY

SETSET

CR2032

Step 1: Setting the date.

With the year ashing, press M until the correct year appears.

Press SET.

With the month ashing, press M until the correct month

appears. Press SET.

With the day ashing, press M until the correct day appears. Press

SET.

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Step 2: Setting the time format.

Press and release M to select the desired time format --- 12h or

24h. Press SET.

Step 3: Setting the time.

With the hour ashing, press M until the correct hour appears.

Press SET.

With the minute ashing, press M until the correct minute

appears. Press SET.

Step 4: Deleting the memory.

With “dEL” and “ ” symbol on the display, press M and select

“no” to keep the results in memory then press SET to skip.

To delete all the results, press M and select “YES”. Then press SET

button to delete all memory. “OK” is displayed in themeter, which

indicates that all data stored is deleted.

BATTERY

SET

CR2032

Step 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 o to

set the rst reminder alarm.

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

hour is ashing, press M to add an hour. Press SET to conrm and

go to minutes, press M to add one minute. Hold M longer to add

faster. Press SET to conrm and go to the next alarm setting.

BATTERY

SET

CR2032

If you do not want to set an alarm, press SET to skip this step.

EN-5

If you want to turn o an alarm, 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 o. If you do not want to test at this

time, press M to switch o the meter.

Press SET to turn o the meter. The meter repeats all your

settings before shutdown.

Congratulations! You have completed all settings!

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

switch o automatically.

Before Testing

Control Solution Testing

FORA Control Solution contains a known amount of glucose that

reacts with test strips and is used to ensure your meter and test

strips are working together correctly.

Do a control solution test when:

9 you suspect the device or test strips are not working properly.

9 your blood glucose test results are not consistent with how

you feel, or if you think the results are not accurate,or

9 you have dropped or think you may have damaged the meter.

Performing a Control Solution Test

Step 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.

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Step 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 and it should fall within this range. If not,

please read the instructions again and repeat the controlsolution

test.

CODE

109~165

Note:

• The control solution range printed on the test strip vial is for control

solution use only. It is not a recommended range for your blood

glucose level.

• See the Meter Maintenance section for important information

about your control solutions.

Out-of-range results:

If you continue to have test results fall outside the range printed on

the test strip vial, the meter and strips may not be working properly.

Do NOT test your blood. Contact the local customer service or place

of purchase for help.

Step 2: Press M to mark this test as a control solution test.

If you press M again, the “QC” will disappear and this test is no

longer a control solution test.

Step 3: Apply control solution.

Shake the control solution vial thoroughly before use. Squeeze

out a drop and wipe it o, then squeeze out another drop and

place it on the tip of the vial cap. Hold the meter to move the

absorbent hole of the test strip to touch the drop. Once the

conrmation window lls completely, the meter will begin

counting down. To avoid contaminating the control solution do

not directly apply control solution onto a strip.

EN-7

Testing Your Blood Glucose

Test Strip Appearance

Absorbent Hole

Apply a drop of blood

here. The blood will be

automatically absorbed.

Conrmation Window

This is where you con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 rmly

until it will go no further.

Front

ATTENTION:

The front side of test strip should face up when inserting test strip.

Test results might be wrong if the contact bar is not fully inserted into

the test slot.

Note:

The FORA COMFORT check G40 meter should only be used with

FORA COMFORT check G40 Test Strips.

To reduce the chance of infection:

• Never share a lancet or the lancing device.

• Always use a new, sterile lancet. Lancets are for single use only.

• Avoid getting hand lotion, oils, dirt, or debris in or on the lancets

and the lancing device.

Preparing the Lancing Device for Blood

Testing

Please follow the instructions in the lancing device insert for

collecting a blood sample.

Preparing the Puncture Site

Stimulating blood perfusion by rubbing the puncture site before

blood extraction has a signicant inuence on the glucose value

obtained. Blood from a site that has not been rubbed exhibits

a measurably dierent glucose concentration than blood from

the nger. When the puncture site was rubbed prior to blood

extraction, the dierence was signicantly reduced.

Please follow the suggestions below before obtaining a drop

of blood:

• Wash and dry your hands before starting.

• Select the puncture site either at ngertips or another body

EN-8

• It is recommended to discard the rst drop of blood as it might

contain tissue uid, which may aect the test result.

Alternative Site Testing

Important: There are limitations with AST (Alternative Site

Testing). Please consult your health care professional before

you perform AST.

What is AST?

Alternative site testing (AST) means that people use parts of

the body other than the ngertips to check their blood glucose

levels. This system allows you to test on the palm, the forearm or

the upper arm

parts (please see section “Alternative Site Testing” (AST) on how

to select the appropriate sites).

• Rub the puncture site for about 20 seconds before penetration.

Fingertip Testing

Press the lancing device’s tip rmly against the side of your

ngertip. Press the release button to prick your nger, then a

click indicates that the puncture is complete.

Blood from Sites Other Than the Fingertip

Press the lancing device’s tip rmly against the side of your

ngertip. Press the release button to prick your nger, then a

click indicates that the puncture is complete.

1

2

Note:

• Choose a dierent spot each time you test. Repeated punctures at

the same spot may cause soreness and calluses.

• Please consult your health care professional before you begin AST.

EN-9

What is the advantage?

Fingertips feel pain more readily because they are full of nerve

endings (receptors). At other body sites, since nerve endings

are not so condensed, you will not feel as much pain as on the

ngertips.

When to use AST?

Food, medication, illness, stress and exercise can aect blood

glucose levels. Capillary blood at the ngertip reects these

changes faster than capillary blood at other sites. Thus, when

testing blood glucose during or immediately after a meal,

physical exercise, or any other event, take a blood sample from

your 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 taking insulin.

• Two hours or more after exercise.

Do NOT use AST if:

• You think your blood glucose is low.

• You are unaware of hypoglycemia

• You are testing for hyperglycemia

• Your AST results do not match the way you feel.

• Your routine glucose results are often uctuate.

Performing a Blood Glucose Test

Step 1: Insert the test strip to turn on the meter.

Wait for the meter to display the test strip “ ” and blood

drop “ ” symbol.

Step 2: Obtaining a blood sample.

Use the pre-set lancing device to puncture the desired site. After

penetration, discard the rst drop of blood with a clean cotton

swab. Gently squeeze the punctured area to obtain another drop

of blood. Be careful NOT to smear the blood sample.

The volume of blood sample must be at least 0.7 microliter (μL)

of volume. ( actual size).

Step 3: Apply the sample.

Hold the blood drop to touch the absorbent hole of the test strip.

Blood will be drawn in and after the conrmation window is

completely lled, the meter begins counting down.

EN-10

Step 5: Eject the used test strip and remove the lancet.

To eject the test strip, point the strip at a disposal container for

sharp items. The meter will switch itself o automatically after

the test strip is ejected.

Step 6: Always follow the instructions in the lancing device

insert when removing the lancet.

WARNING!

The used lancet and test strip may be biohazards. Please discard

them carefully according to your local regulations.

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 o. You must remove and

reinsert the test strip to start a new test.

• The conrmation window should be lled with blood before the

meter begins to count down. NEVER try to add more blood to the

test strip after the drop of blood has moved away. Discard the used

test strip and retest with a new one.

• If you have trouble lling the conrmation window, please contact

your health care professional or the local customer service for

assistance.

Step 4: Read your result.

The result of your blood glucose test will appear after the meter

counts down to 0. This blood glucose result will automatically be

stored in the memory.

EN-11

Meter Memory

The meter stores the 450 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 o:

Reviewing Test Results

Step 1: Press M.

“ ” will appear on the display. Press M again, and the rst

reading you see is the last blood glucose result along with date,

time and the measuring mode.

Step 2: Press M to recall the test results stored in the meter each

time you press.

Step 3: Exit the meter memory.

After the last test results, press M again and the meter will be

turned o.

Reviewing Blood Glucose Day Average

Results

Step 1: Press M.

When“ ”appears on the display, keep pressing M for 3

seconds until the ashing “ ” appears. Release M and

then your 7-day average result measured in general mode will

appear on the display.

Step 2: Press M to review 14-, 21-, 28-, 60- and 90- day average

results.

Step 3: Exit the meter memory.

Keep pressing M and the meter will turn o after displaying the

last test result.

Note:

• Any time you wish to exit the memory, keep pressing M for 5

seconds or leave it without any action for 3 minutes. The meter will

EN-12

switch o automatically.

• Control solution results are NOT included in the day average.

• If using the meter for the rst time, “---” displays when you recall the

test results or review the average result. It indicates that there is no

test result in the memory.

Maintenance

Battery

Your meter comes with one 3V CR2032 lithium battery.

Low Battery Signal

The “ ” symbol appears along with display messages: The

meter is functional and the result remains accurate, but it is time

to change the battery.

The “ ” symbol appears with E-b, Error and low: The

power is not enough to do a test. Please change the battery

immediately.

Replacing the Battery

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

Step 1: Press the edge of the battery cover and lift it up to

remove.

Step 2: Remove the old battery and replace with one 3V CR2032

lithium battery.

Step 3: Close the battery cover. If the battery is inserted

correctly, you will hear a “beep” afterwards.

BATTERY

SET

CR2032

BATTERY

SET

CR2032

BATTERY

SET

CR2032

Note:

• Replacing the battery does not aect the test results stored in the

memory.

EN-13

• As with all small batteries, these batteries should be kept away from

small children. If swallowed, promptly seek medical assistance.

• Battery might leak chemicals if unused for a long time. Remove

the battery if you are not going 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.

Caring for Your Meter

To avoid the meter and test strips attracting dirt, dust or other

contaminants, please wash and dry your hands thoroughly

before use.

Cleaning

• To clean the exterior of the device, wipe it with a cloth

moistened with tap water or a mild cleaning agent, then dry

the device with a soft dry cloth. Do NOT rinse with water.

• Do NOT use organic solvents to clean the meter.

Meter Storage

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

relative humidity.

• Always store or transport the device in its original storage case.

• Avoid dropping and heavy impact.

• Avoid direct sunlight and high humidity.

Meter Disposal

The used meter should be treated as contaminated and may

carry a risk of infection during measurement. The batteries in

this used meter should be removed and the meter should be

disposed in accordance with local regulations.

The meter falls outside the scope of the European Directive

2002/96/ EC-Directive on waste electrical and electronic

equipment (WEEE).

Caring for Your Test Strips

• Storage conditions: 2°C to 30°C (35.6°F to 86°F), 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 and dry place. Keep away

from direct sunlight and heat.

• After removing a test strip from the vial, 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 rst opened

it. Discard remaining test strips after 6 months.

• Do not use test strips beyond the expiry 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 since the cap and the

test strip may be a choking hazard. If swallowed, promptly see

a doctor for help.

For further information, please refer to the test strip package

insert.

EN-14

Important Control Solution Information

• Use only FORA control solutions with your meter.

• Do not use the control solution beyond the expiry date or

3 months after 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 (20°C to 25°C / 68°F to 77°F). Make sure

your control solution, meter, and test strips are at this specied

temperature range before testing.

• Shake the vial before use, discard the rst drop of control

solution, and wipe o the dispenser tip to ensure a pure

sample and an accurate result.

• Store the control solution tightly closed at temperatures

between 2°C and 30°C (35.6°F and 86°F). Do NOT freeze.

System Troubleshooting

If you follow the recommended action but the problem persists,

or error messages other than the ones below appear, please call

your local customer service. Do not attempt to repair by yourself

and never try to disassemble the meter under any circumstances.

Result Readings

APPEARS WHEN GLUCOSE

< 20 mg/dL (1.1mmol/L)

20–69 mg/dL (1.1–3.8 mmol/L)

70-119 mg/dL (3.9-6.6 mmol/L)

120-239 mg/dL (6.7-13.3 mmol/L)

≥ 240 mg/dL (13.3 mmol/L)

> 600 mg/dL (33.3mmol/L)

Error Messages

MESSAGE WHAT IT MEANS WHAT TO DO

Appears when the

batteries cannot

provide enough power

for a test.

Replace the batteries

immediately.

Appears when a used

test strip is inserted.

Repeat with a new test

strip.

Remove the strip after

applying blood to the

absorbent hole.

Re-test with a new test

strip.

EN-15

Appears when ambient

temperature is below

system operation

range.

System operation range

is 10°C to 40°C (50°F to

104°F). Repeat the test

after the meter and test

strip are in the above

temperature range.

Appears when ambient

temperature is above

system operation

range.

Problem with the

meter.

Repeat the test with a

new test strip. If the meter

still does not work, please

contact the customer

service for assistance.

Troubleshooting

1. If the meter does not display a message after inserting a test

strip:

POSSIBLE CAUSE WHAT TO DO

Batteries exhausted. Replace the batteries

Test strip inserted upside

down or incompletely.

Insert the test strip with contact bars

end rst and facing up.

Defective meter or test

strips.

Please contact customer services.

2. If the test does not start after applying the sample:

POSSIBLE CAUSE WHAT TO DO

Insucient blood sample. Repeat the test using a new test strip

with larger volume of blood sample.

Defective test strip. Repeat the test with a new test strip.

Sample applied after

automatic switch-o (2

minutes after last user

action).

Repeat the test with a new test strip.

Apply sample only when ashing “ ”

appears on the display.

Defective meter. Please contact customer services.

3. If the control solution testing result is out of range:

POSSIBLE CAUSE WHAT TO DO

Error in performing the

test.

Read instructions thoroughly and

repeat the test again.

Control solution vial was

poorly shaken.

Shake the control solution vigorously

and repeat the test again.

Expired or contaminated

control solution.

Check the expiry date of the control

solution.

Control solution that is too

warm or too cold.

Control solution, meter, and test strips

should be at room temperature (20°C

to 25°C / 68°F to 77°F) before testing.

Defective test strip. Repeat the test with a new test strip.

Meter malfunction. Please contact customer services.

EN-16

Symbol Information

Symbol Referent Symbol Referent

For in vitro diagnostic

use Do not reuse

Consult instructions

for use Temperature limitation

Use by

0123

CE Mark

Batch code Manufacturer

Serial number Battery

Keep away from

sunlight

Disposal of waste

equipment

Keep Dry Sterilized using

irradiation

6M

Use within 6 months

after opening

Do not use if package

is damaged

Humidity limitation Caution

3V 3 Volts DC Dispose of the

packaging properly

after use

Model number

Authorised

representative in the

European Union

Medical device

Detailed Information

The device provides you with plasma equivalent results.

Time of day Normal plasma glucose range for

people without diabetes

Fasting and before meal < 100 mg/dL (5.6 mmol/L)

2 hours after meals < 140 mg/dL (7.8 mmol/L)

Source: American Diabetes Association (2012). Clinical Practice

Recommendations. Diabetes Care, 35 (Supplement 1): S1-100.

Please consult your doctor to determine a target range that

works best for you.

EN-17

Specications

Dimension & Weight 92.35(L) x 53(W) x 16.8(H) mm, 43.6g

Power Source One CR2032 lithium battery

Display LCD

Memory 450 measurement results with respective

date and time

Features

Auto electrode insertion detection

Auto sample loading detection

Auto reaction time count-down

Auto switch-o after 3 minutes without

action

Temperature warning

Operating Condition 10°C to 40°C (50°F to 104°F), below 85%

R.H. (non-condensing)

Storage/Transportation

Condition

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

R.H

Measurement Units mg/dL or mmol/L

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-, IEC/

EN 61326-2-6, EN 301 489-17, EN 300 328.

WARRANTY TERMS AND CONDITIONS

With respect to disposable products, ForaCare Suisse warrants

to the original purchaser that, at time of delivery, each standard

product manufactured by ForaCare Suisse shall be free from

defects in material and workmanship and, when used for

the purposes and indications described on the labeling, is t

for the purposes and indications described on the labeling.

All warranties for a product shall expire as of the product

expiration date, or if none, after two (2) year from the original

date of purchase, as long as it has not been modied, altered, or

misused. ForaCare Suisse warranty hereunder shall not apply if:

(i) a product is not used in accordance with its instructions or

if it is used for a purpose not indicated on the labeling; (ii) any

repairs, alterations or other work has been performed by the

buyer or others on such item, other than work performed with

ForaCare Suisse’s authorisation and according to its approved

procedures; or (iii) the alleged defect is a result of abuse,

misuse, improper maintenance, accident or the negligence

of any party other than ForaCare Suisse. The warranty set

forth herein is conditioned upon proper storage, installation,

use and maintenance in accordance with applicable written

recommendations from ForaCare Suisse.

The warranty furnished hereunder does not extend to damaged

items purchased hereunder resulting in whole or in part from the

use of components, accessories, parts or supplies not furnished

by ForaCare Suisse.

AR-1









 











































 





 































  

  

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