Fora G40 Le manuel du propriétaire

Taper
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
EN-2
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.
EN-3
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.
EN-4
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.
EN-6
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 devices 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 devices 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 Suisses 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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
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

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


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
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
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
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
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

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





  
  
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