ForaCare GD40 User manual

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Owner’s Manual
Manual del Usuario
For Self-Testing
para automonitoreo
Blood Glucose Monitoring System
Sistema de vigilancia de glucose sanguinea
GD40

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Version 1.0 2012/09 311-4272000-005
English
Dear ForaCare GD40
System Owner:
Thank you for purchasing the ForaCare GD40 Blood Glucose Monitoring
System. This manual provides important information to help you to use
the system properly. Before using this product, please read and follow
the instructions in this Ownerʼs Manual and any package inserts for test
strips and control solution.
Regular monitoring of your blood glucose levels can help you and your
doctor gain better control of your diabetes. Due to its compact size
and easy operation, you can use the ForaCare GD40 Blood Glucose
Monitoring System to easily monitor your blood glucose levels.
If you have questions, just call ForaCare Customer Care Service Center
toll-free at 1-866-469-2632. We are here for you 24 hours a day, 7 days a
week. You can also visit www.foracare.com.

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IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
●The meter and lancing device are for single patient use. Do not share them
with anyone including other family members! Do not use on multiple
patients!
●All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed cleaning and
disinfection.
For more information, please visit
1.“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication”(2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
2.“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses
Risk for Transmitting Bloodborne Pathogens”(2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

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1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or if it is damaged.
4. Do NOT use the equipment in places where aerosol sprays are being used
or where oxygen is being administered.
5. Do NOT under any circumstances use the device on neonates.
6. This device does NOT serve as a cure for any symptoms or diseases. The
data measured is for reference only.
7. 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.
8. 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.
9. 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.
10. 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

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TABLE OF CONTENTS
BEFORE YOU BEGIN 08
Important Information 08
Intended Use 09
Test Principle 09
Meter Overview 10
Display Screen 11
Test Strip 12
Setting the Meter 13
THE FOUR MEASURING MODES 17
BEFORE TESTING 18
Calibration 18
How to Code Your Meter 18
Checking the Code Number 19
Control Solution Testing 20
Performing a Control Solution Test 20
TESTING WITH BLOOD SAMPLE 23
Preparing the Lancing Device for Blood Testing 23
Preparing the Puncture Site 24
Performing a Blood Glucose Test 25
METER MEMORY 28
DOWNLOADING RESULTS ONTO A COMPUTER 30

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MAINTENANCE 32
Battery 32
Caring for Your Meter 34
Meter Storage 37
Caring for Your Test Strips 37
Important Control Solution Information 38
SYSTEM TROUBLESHOOTING 39
Result Readings 39
Error Messages 40
Troubleshooting 41
DETAILED INFORMATION 42
Reference Values 42
SPECIFICATIONS 43
FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT 44

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BEFORE YOU BEGIN
Important Information
•Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional immedi-
ately.
•If your blood glucose results are lower or higher than usual, and you
do not have any symptoms of illness, first 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 capillary blood samples from the finger to test
your blood glucose. Use only heparin (sodium heparin) for anticoagu-
lation of whole blood. 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 ownerʼs manual, contact your healthcare professional.
•We do not recommend using this product on severely hypotensive in-
dividuals or patients in shock. Readings which are lower than actual
values may occur for individuals experiencing a hyperglycemic-hyper-
osmolar state, with or without ketosis. Please consult the healthcare
professional before use.

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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 profession-
als in clinical settings as an aid in monitoring the effectiveness of
diabetes control. It is intended to be used for the quantitative mea-
surement of glucose (sugar) in fresh capillary whole blood samples
drawn from the fingertips. It should not be used for the diagnosis of or
screening for diabetes mellitus.
It should not be used for the diagnosis of or screening for diabetes, or
testing on neonates.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip. The
meter measures the current, calculates the blood glucose level, and
displays the result. The strength of the current produced by the reac-
tion depends on the amount of glucose in the blood sample.
This system uses enzyme of FAD–dependent glucose dehydrogenase
(FAD-GDH) from E. coli.

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Meter Overview
Test Slot
Insert test strip here to turn the meter on for testing.
M Button
Enter the meter memory and silence a reminder alarm.
Display Screen
Test Strip Ejector
Eject the used strip by pushing up this button.
Data Port (for GD40a only)
Download test results with a cable connection.
SET Button
Enter SET mode and confirm the meter settings.
Battery Compartment
1
2
3
5
7
6
4
Front
Rear
Side Back
Top
4
5
3
26
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1

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Display Screen
Blood drop symbol
Code
Test Result
Ketone warning
Error Warning
Memory symbol
Measurement modes
1
2
3
5
4
6
7
Date
Test strip symbol
Low battery symbol
Measurement unit
Reminder alarms
Day average
Time
8
10
13
14
9
12
11
1
3
4
2
5
6
7
8
14
13
12
11
10
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Test Strip
Test Strip Handle
Hold this part to
insert the test strip
into the slot.
Confirmation Window
Confirm if enough blood
has been applied to the
absorbent hole of the
strip.
Contact Bars
Insert this end of the test
strip into the test strip
slot.
Absorbent Hole
Touch to a drop of
blood here, blood will
be automatically
drawn in.
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 ForaCare GD40 meter should only be used with ForaCare GD40 Test Strips.
Using other test strips with this meter can produce inaccurate results.

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Before using your meter for the first time or if you change the meter
battery, you should check and update these settings. Make sure you
complete the steps below and have your desired settings saved.
► Entering the Setting Mode
Start with the meter off (no test strip
inserted). Press SET to turn on the meter.
Step 1
Setting the date
With the year flashing, press until the
correct year appears. Press SET button.
With the month flashing, press until the
correct month appears. Press SET button.
With the day flashing, press until the
correct day appears. Press SET button.
Setting the Meter

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Step 3
Setting the time
With the hour flashing, press until the
correct hour appears. Press SET button.
With the minute flashing, press until the
correct minute appears. Press SET button.
Step 4
Deleting the memory
With “dEL”and a flashing “”symbol on
the display, press and select “No”to keep
the results in memory then press SET to
skip.
Step 2
Setting the time format
Press and release to select the
desired time format --- 12h or 24h.
Press SET button.

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To delete all the results, press . and select “Yes”to delete the
results in memory, then press SET to confirm. “OK”and “”are
displayed on the meter, which indicates that all data stored is deleted.
Press to select “On”, then press SET to set the hour. When the
hour is flashing, press to add an hour. Press SET to confirm and go
to minutes, press to add one minute. Hold longer to add faster.
Press SET to confirm and go to the next alarm setting.
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 to
turn on or turn off to set the
first reminder alarm.

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If you do not want to set an alarm, press SET to skip this step.
If you want to turn off an alarm, find the alarm number by pressing
SET in the setting mode, press to change from “ONʼto “OFF”.
At the time of your alarm, the
meter will beep and automati-
cally turn on. You can press to
silence the alarm and insert a test
strip to begin testing.
If you do not press , the meter will beep for 2 minutes then
switch off.
If you do not want to test at this time, press to switch off the
meter.
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 off
automatically.
Congratulations! You have completed all settings!

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THE FOUR MEASURING MODES
Modes Use when
any time of day without regard to time since last
meal
no food intake for at least 8 hours
2 hours after a meal
testing with the control solution
You can switch between each mode by:
Step 1
Start with the meter switched off. Insert a test
strip to turn on the meter, the screen will display
flashing blood drop and “Gen”.
Step 2
Press to switch between General, AC, PC and
QC mode.
The meter provides you with four modes for measuring, General, AC,
PC and QC.
General (dis-
plays as “Gen”)

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BEFORE TESTING
Calibration
You must calibrate the meter every time you begin to use a new vial of
test strips by setting the meter with the correct code. Test results may
be inaccurate if the code number displayed on the monitor does not
match the number printed on the strip vial.
Step 1
Insert the code strip when the
meter is off. Wait until the code
number appears on the display.
How to Code Your Meter
03
Code 03
NOTE
Make sure the code number on display, code strip, and test strip vial are the
same.

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You need to make sure that the
code number displayed on the
meter matches the number on the
test strip vial before you proceed.
If it matches, you can proceed with
your test. If the codes do not match,
please stop testing and repeat the
calibration procedure. If the problem
persists, contact Customer Service
for help.
Warning
It is important to make sure that the LCD displayed code is the same as the
code on the test strip vial before testing. Failure to do so will get inaccurate
results.
Checking the Code Number
Step 2
Remove the code strip, the display will show “OK”.
This tells you that the meter has finished coding and
is ready for blood glucose testing.
Code 03

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Control Solution Testing
Our 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:
•you first receive the monitor
•at least once a week to routinely check the monitor and test strips
•you begin using a new vial of test strips
•you suspect the monitor or test strips are not working properly
•your blood glucose test results are not consistent with how you feel,
or if you think the results are not accurate
•practicing the testing process, or
•you have dropped or think you may have damaged the monitor.
Step 1
Insert the test strip to turn on the
meter
Insert the test strip into the meter.
There will be a strip light indicat-
ing the test strip is inserted into
the test slot. Wait for the meter
to display the test strip and blood
drop symbols.
Performing a Control Solution Test