FOR-A V12 User manual

Owner’s Manual
Blood Glucose Monitoring System

311-4247200-022
Version 1.0 2013/05
Thank you for choosing the
V12 NO-CODING
BLOOD GLUCOSE
MONITORING SYSTEM
Dear FORA V12 No-Coding System Owner:
This manual contains important information you must know about
the system. Please read it thoroughly and carefully.
For other questions regarding this system, please contact your local
Customer Care Line. For all other questions, contact your healthcare
professional for assistance.
English

4
IMPORTANT SAFETY INSTRUCTIONS
READ THIS BEFORE USING
● 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 clean-
ing and disinfection.
For more information, please visit
1.“FDA Public Health Notication: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne Patho-
gens: 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
The following basic safety precautions should always be taken.
1.Close supervision is necessary when the device is used by, on,
or near children, handicapped persons or invalids.
2.Use the device only for the intended use described in this
manual.
3.Do NOT use accessories which are not supplied by the manu-
facturer.
4.Do NOT under any circumstances use the device on neonates
or infants.

5
5.Do NOT use the equipment where aerosol sprays are being
used, or where oxygen is being administered.
6.Do NOT use device if it is not working properly, or if it has suf-
fered any damage.
7.Read all instructions thoroughly and practice the test before us-
ing the product to test your blood glucose. Do all quality control
checks as directed and consult with a diabetes healthcare
professional.
8.This device does NOT serve as a cure for any symp-
toms or diseases. The data measured is for reference
only.
9. 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.
10. Use of this device in a dry environment, especially
if synthetic materials are present (synthetic clothing,
carpets etc.) may cause damaging static discharges
that may cause erroneous results.
11. Do not use this device in close proximity to sources
of strong electromagnetic radiation, as these may
interfere with the accurate operation.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

6
TABLE OF CONTENTS
IMPORTANT INFORMATION 08
ABOUT ALTERNATIVE SITE TESTING (AST) 09
INTRODUCTION TO THE SYSTEM 11
Intended Use 11
Principle of Measurement 11
Contents of the System 12
Appearance and Key Function of the Meter 13
Meter Display 14
Speaking Function 15
Test Strip 16
BEFORE USE 17
Setting the Meter and Deleting the Memory 17
THE TWO MEASURING MODES 20
CONTROLTEST 21
Important Control Solution Test Information 22
Performing a Control Solution Test 23
TESTING BLOOD SUGAR 25
Test Procedure 26
Expected Test Results 31
COMPARING METER AND LABORATORY RESULTS 32
USING THE METER MEMORY 33
Viewing Results On the Meter 33
Viewing Results On a Personal Computer 36

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MAINTENANCE 37
Battery Replacement 37
Caring for Your Meter 39
Caring for Your Lancing Device 41
Caring for Your Test Strips 42
PROBLEM-SOLVING GUIDE 43
Special Message 44
Error Message 45
Operational Problem 46
SPECIFICATIONS 48
SUMMARY OF OPERATION 49

8
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
immediately.
If your blood glucose results are lower or higher than usual, and
you do not have symptoms of illness, rst repeat the test. If you
have symptoms or continue to get results higher or lower than
usual, follow the treatment advice of your healthcare professional.
Use only capillary whole blood sample to test your blood glucose.
Using other substances will cause wrong results.
If you are experiencing symptoms that are inconsistent with your
blood glucose test results and you have followed all instructions
described in this owner’s manual, call your healthcare professional.
Inaccurate results may occur in severely hypotensive individuals
or patients in shock. Readings which are lower than actual values
may occur for individuals experiencing a hyperglycemic-hyperosmolar
state, with or without ketosis. Critically ill patients should not be
tested with blood glucose meters.
Please refer to your test strip package insert for additional important
information.

9
Alternative Site Testing (AST)
Important: There are limitations for doing AST (Alternative Site
Testing).
* AST results should not be used for CGM calibration.
* AST results should not be used for insulin dosing calculations.
Please consult your health care profes-
sional before you do AST.
What is AST?
Alternative site testing (AST) refers to
when individuals check their blood glucose
levels using areas of the body other than
the ngertip. This system allows AST at the
palm, the forearm, the upper arm, the calf
or the thigh with results as reliable as those
obtained from ngertip testing.
What’s the advantage?
Fingertips feel pain more readily because they are full of nerve end-
ings (receptors). Since nerve endings are not so condensed at other
body sites, tests performed there will be less painful.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glu-
cose levels.
Capillary blood at the ngertip reects these changes faster than
capillary blood at other sites. Therefore, when testing blood glucose
during or immediately after a meal or physical exercise, results from
AST and ngertip may be signicantly different.

10
We strongly recommend you do AST in the following intervals:
˙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 correspond with the way you feel.
˙Your routine glucose results are often uctuating.
˙You are pregnant.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to
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 different glucose concentration than blood from the n-
ger. When the puncture site is rubbed prior to blood extraction, the
difference is markedly reduced.
Please follow suggestions below before puncturing the skin:
˙Rub the puncture site approximately 20 seconds before penetration.
˙Use a clear cap (included in the kit) while setting the lancing device.

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INTRODUCTION TO THE SYSTEM
Intended Use
The system is intended for use outside the body (in vitro diagnostic
use). It should be used only for testing glucose (sugar) and only
with fresh capillary whole blood samples (from the nger, the palm,
the forearm, the upper arm, the calf and the thigh). It should not be
used for the diagnosis of diabetes or for the testing of newborns. It
is intended to be used by a single person and should not be shared.
AST in this system can be used only during steady-state blood glu-
cose conditions described in the section of “About Alternative Site
Testing (AST)”.
Principle of Measurement
The test is based on the measurement of electrical current gener-
ated by the reaction of glucose with the reagent of the strip. The
meter measures the current and displays the corresponding blood
glucose level. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
This system uses enzyme of GOD: glucose oxidase (GOD) from
A. niger.

12
Contents of the System
The system consists of three main products: the blood glucose me-
ter, test strips, and a control solution. These products have been
designed, tested, and proven to work together as a system to pro-
duce accurate blood glucose test results. Use only the FORA V12
No-Coding Blood Glucose Test Strips and a control solution with the
blood glucose meter.
Your system includes:
A meter
Owner’s manual
Warranty card
First time user guide
Daily log book
Carrying bag
Lancet device (a clear cap
for AST)
Batteries
1
2
3
5
8
4
7
6
1 32
5
8
4
7
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PLEASE NOTE
1. Please make sure that all products listed above are contained and
sealed in the package before using this system. If you nd any imperfection in
our products, please return the whole system to the place of purchase.
2. Test strips, control solutions and lancets are optional. They are not
included in the standard kit. Please contact the Customer Care Line at
1-888-307-8188 or place of purchase for availability.

13
Appearance and Key Function of the Meter
TEST SLOT is where you insert the test strip. The meter will turn
on automatically after insertion.
LCD SCREEN guides you through the test using symbols and
simple messages.
MAIN BUTTON located in front of the meter with "M" on it, is
used to tum on the meter, enter the memory mode and control
steps of setting.
SET BUTTON (in the back) located in the battery compartment,
is used to set up the meter.
DATA PORT located at the side, is for cable connection.
1
3
3
2
2
5
5
4
4
1

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Meter Display
VOICE SYMBOL
Indicates speaking function is on/off.
LOW BATTERY SYMBOL
Appears when the battery power is
low.
TEST RESULT AREA
Displays glucose results.
UNIT OF MEASUREMENT
KETONE WARNING
Appears when the test result is equal
or higher than 240mg/dL.
DAY AVERAGE
Indicates that the displayed test result
is an average.
FACE SYMBOL
Appears when memory deletion
completed.
MEMORY SYMBOL
Appears when you review the memory.
8
10
12
10
12
9
11
13
14
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13
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TEST STRIP SYMBOL
Appears when the meter is turned
on.
BLOOD DROP SYMBOL
Flashes when it is ready to apply
the sample.
TEMPERTURE SYMBOL
Appears when ambient tem-
perature is outside operating
temperature.
CTL SYMBOL
Appears when doing a
control test and indicates
that the result won’t be
stored in the memory.
DATE
TIME
1
1
3
3
2
2
5
5
8
4
4
7
7
6
6
9

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WHEN does the meter speak? WHAT does the meter speak?
Thank you for using this product.
Please relax during measurement.
When you turn on the meter.
Room temperature out of range,
unable to measure.
When room temperature is outside
operating range, which is 50ºF to
104ºF (10ºC to 40ºC).
When the meter is ready to test.
(symbol appears on display).
When the test is completed. (result
appears on display).
When the test result is outside
measurement range, which is 20-600
mg/dL.
Please apply blood into the strip.
The blood glucose is (number) milligram
per deciliter.
The blood glucose out of range,
unable to measure.
NOTE
FORA V12 No-Coding blood glucose monitoring system contains some
speaking functions but has not been validated for use by visually impaired
users.
Speaking Function
When a voice symbol is on the screen, it means that the meter
provides speaking function. It “speaks” step by step that could lead
you to test your blood glucose in order. The following table tells you
when and what the meter “speaks”. Those messages can also be found
in the nal section of this manual, “SUMMARY OF OPERATION”.

16
Test Strip
This system measures the amount of sugar (glucose) in whole
blood. Blood is applied to the absorbent hole of the test strip and is
automatically drawn into the reaction cell where the reaction takes
place.
The test strip consists of the following parts:
Contact Bars
Insert this end of the test strip into the meter.
Push it in rmly until it will go no further.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Conrmation Window
This is where you conrm if enough blood
has been applied to the absorbent hole of the strip.
Absorbent Hole
Apply a drop of blood here,
The blood will be sucked automatically.
Please see section, “Testing Your Blood Sugar”, for complete instructions.

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BEFORE USE
Setting the Meter and Deleting the Memory
Your meter comes with the time, date, memory deletion, voice vol-
ume and language preset. If you need to set these parameters,
please follow below steps.
Start with the meter off. Then press the set button located in
the battery compartment. The meter is now in the setting
mode.
STEP 1. Set the Year
After pressing the set button, the year, a blinking
number, will be shown on the screen rstly.
Press and release the M button to plus one
year. You can also keep pushing down the M
button to proceed faster. When the correct
year is displayed on the screen, press the
set button and then a ashing number, which
stands for the month, is shown.
STEP 2. Set the Month
Press and release the M button until you see
the correct month. To move faster, keep push-
ing the M button down. When the desired
month is displayed, press the set button and
the date will ash.

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STEP 6. Delete Memory
“dEL” and ashing “ ” symbol appear
on the display. If you don’t want to delete
memory, press the set button again to skip
this step. If you’d like to delete ALL memory,
press M button. Both “dEL” and “ ” will
ash. Press the M button again to delete
all memory. The meter then displays " ",
which means that the memory is deleted.
STEP 3. Set the Date
Press and release the M button until you see the correct
date. To move faster, keep pushing the M button down.
When the desired date is displayed, press the set button
and then the hour will be shown on the screen.
STEP 4. Set the Hour
Press and release the M button until you see the correct
hour on the screen. To move faster, keep pushing the M
button down. When the desired hour is displayed on the
screen, press the set button and then the minute will ash.
STEP 5. Set the Minutes
Press and release the M button to advance one minute. To
move faster, hold the M button down. With the correct
minute on the display, press the set button and the memory
deletion will start ashing.

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STEP 8. Select Language
L1/L2 and “ ” display on LCD. Press the M button to
select one of the two languages.
Set-up is completed. Press the set button to turn off the
meter. “OFF” will be displayed before shut down.
˙The time, date, memory deletion, voice volume and languages can ONLY be
changed in the setting mode. Therefore, when you perform a glucose testing,
those parameters are not possible to be changed.
˙Your meter displays 7-, 14-, 21-, 28-, 60- and 90-day averages which you can
access from the meter memory. These averages are calculated from results
obtained during the 7-, 14-, 21-, 28-, 60- and 90-day preceding the current date
and time settings. When the date and time are changed, the 7-, 14-, 21-, 28-,
60- and 90-day averages may change.
˙While the meter is in the setting mode, it will turn off automatically without any
action in three minutes.
STEP 7. Select Speaking Function
The meter displays “VOL”, “ ” and ashing number. Press
M button to select speaking volume from 0 to 7. Then press
the set button to proceed to the next step.
Number 0 indicates that the speaking function is turned off. “ ” will not display
on LCD during testing. Numbers 1 to 7 indicates speaking volume from low to
high. At this time “ ” will be displayed on LCD during test.
NOTE

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You can switch between each mode by:
1. Start with the meter switched off. Insert a
test strip to turn on the meter, the screen
will display a ashing blood drop with date
and time.
2. Press M to switch to CTL mode.
The meter provides you with two modes for measuring, General and CTL.
THE TWO MEASURING MODES
MODES
General (Not display)
CTL
USE WHEN
any time of day without regard to time since last meal
testing with the control solution