FOR-A D15 User manual

FORA D15
BLOOD GLUCOSE
PLUS BLOOD PRESSURE
MONITORING SYSTEM
English
311-0000000-005
Version 3.0 2009/08

2
Thank you for choosing
D15
BLOOD GLUCOSE PLUS
BLOOD PRESSURE
MONITORING SYSTEM
Dear FORA D15 System Owner:
This manual contains important information you must know about
the system. Please read it thoroughly and carefully.
This product can assist you in monitoring your blood glucose level
as well as your blood pressure.
For other questions regarding this system, please contact our
customer service team at 1-866-469-2632. 24 hours, 7 days/week.
You can also visit www.foracare.com for helpful information.

3
IMPORTANT SAFTY INSTRUCTIONS
READ THIS BEFORE USING
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 manufacturer.
4. Keeptheequipmentanditsexiblecordawayfromhotsurfaces.
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 has been
damaged.
7. Before using product to test your blood glucose, read all
instructions thoroughly and practice the test. Do all quality control
checks as directed and consult with a diabetes healthcare
professional.
KEEP THESE INSTRUCTIONS

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TABLE OF CONTENTS
IMPORTANT INFORMATION 06
Warnings and Precautions 06
Health Information 07
ALTERNATIVE SITE TESTING (AST) 09
INTRODUCTION TO THE SYSTEM 11
Intended Use 11
Principle of Measurement 11
Major Features 12
Contents of the System 13
Appearance and Key Function of the Monitor 14
Monitor Display 15
Test Strip 16
BEFORE USE 17
Battery Replacement 17
Setting the Monitor 19
BLOOD GLUCOSE MEASUREMENT 21
Important Information 21
Coding the Monitor 22
Control Test 23
Important Control Solution Information 24
Performing a Control Solution Test 25
Test Procedure 28

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Comparing Monitor and Laboratory Results 32
Risk Message 34
BLOOD PRESSURE MEASUREMENT 35
Suggestions Before Measuring 35
Correct Application of the Pressure Cuff 35
Testing Your Blood Pressure 37
USING THE MONITOR MEMORY 39
Viewing Results on the Monitor 39
Deleting Memory 41
VIEWING RESULTS ON A PERSONAL COMPUTER 42
TAKING CARE OF YOUR MONITOR AND TEST STRIPS 48
Cleaning 48
Storage 48
TROUBLESHOOTING GUIDE 51
Error Message 52
Operating Problem 53
SPECIFICATIONS 58
FCC STATEMENT 60

6
IMPORTANT INFORMATION
Warnings and Precautions
• The FORA D15 System is designed
for use on individuals age 16 and above.
It shall NOT be used under any
circumstances on newborns, infants
or persons who cannot communicate.
• ThisdevicedoesNOT serve as a cure
of any symptoms or diseases. The
data measured are for reference only.
Always consult your physician to have
the results interpreted.
• This device is NOT able to measure
in the presence of common arrhythmia,
such as arterial or ventricular premature
 beatsorarterialbrillation.Itmayproduce
reading error.
• DoNOT use the device for purposes
other than measuring blood glucose
and blood pressure for human beings.
• DoNOT wrap the pressure cuff around
anything other than your arm.

7
Health Information
Blood Glucose
Blood glucose monitoring plays an important role in diabetes control.
A long-term study showed that keeping blood glucose levels
close to normal value can reduce the risk of diabetes complica-
tions by up to 60%*1. The results you get with the FORA D15 system
can help you and your healthcare professional monitor and adjust
your treatment plan to gain better control of your diabetes.
*1: American Diabetes Association position statement on the Diabetes
Control and Complications Trial (1993).
* Source:American Diabetes Association (2008). Standards of Medical Care
in Diabetes. Diabetes Care, 31 (Supplement 1): S12–S54.
Time of day
Fasting and
before meal
2 hours after
meals
Plasma glucose range (mg/dL)
for people with diabetes*
70-130 mg/dL
(3.9-7.2 mmol/L)
Less than 180mg/dL
(10 mmol/L)
Your target range
(mg/dL)
NOTE
Please work with your doctor to determine a target range that works best
for you.

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Blood Pressure
Clinical studies show that adult diabetes is often accompanied by
elevated blood pressure. People with diabetes can reduce their
heart risk by managing their blood pressure along with diabetes
treatment*2. Knowing your routine blood pressure patterns can help
determine whether or not your body is in good condition. Human
blood pressure naturally increases after reaching middle age. This
symptom is a result of continuous aging of the blood vessel. Other
causes include obesity, lack of exercise, and cholesterol (LDL)
adhering to the blood vessels. Rising of blood pressure accelerates
hardening of the arteries, making the body become more
susceptibletoapoplexyandcoronaryinfarction.TheWHO(world
health organization) published the following guideline for blood
pressure range:
Source:1999 WHO/ISH guidelines for the management of hypertension.
*2: American Diabetes Association: The Diabetes-Heart Disease Link
Surveying Attitudes, Knowledge and Risk (2002).
80
120
130
140
160
180
85 90 100 110
Optimal
High-Normal
Normal
Grade 1 Hypertension (“mild”)
Grade 2 Hypertension (“moderate”)
Grade 3 Hypertension (“severe”)
(mmHg)
Systolic
Diastolic

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ALTERNATIVE SITE TESTING (AST)
Important: There are limitations for doing AST.
Please consult your healthcare professional before you begin AST.
What is AST?
Alternative site testing (AST) refers
to when individuals check their blood
glucose levels using areas of the body
otherthan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
endings (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
glucose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.

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We strongly recommend you perform AST ONLY during the following
intervals:
• Inapre-mealorfastingstate(morethan2hourssincethelast
meal).
• Twoormorehoursaftertakinginsulin.
• Twoormorehoursafterexercise.
Do NOT use AST if:
• Youthinkyourbloodglucoseislow.
• Youareunawareofhypoglycemia.
• YourASTresultsdonotcorrespondthewayyoufeel.
• Youaretestingforhyperglycemia.
• Yourroutineglucoseresultsareoftenuctuating.
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
nger.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 FORA D15 Blood Glucose plus Blood Pressure Monitoring
System is intended for the quantitative measurement of glucose in
freshcapillarywholeblood(fromthenger,thepalm,theforearm,
the upper-arm, the calf and the thigh) for self testing by persons with
diabetes in the home or by healthcare professionals in healthcare
facilities. The system is also intended to be used to measure
non-invasively the systolic and diastolic blood pressure and pulse
rate of an adult individual over age 16, at home.
Principle of Measurement
Blood glucose is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip.
The monitor 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.
Blood pressure is measured non-invasively at the arm based on the
Oscillometric method.
Both functions work independent of each other (one measurement,
either blood glucose or blood pressure, at a time) in order to avoid
any interference problems.

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Major Features
Four subtypes of FORA D15 were developed. Each uses a slightly
different method of data transmission as the following table
indicates.
MODEL
FORA D15c
FORA D15b
FORA D15z
FORA D15g
DATA TRANSMISSION FUNCTION
You can view results on the PC
through cable connection.
You can view results on the PC
through a wireless connection using
Bluetooth technology.
You can view results on the PC
through a wireless connection using
Zigbee Gateway technology.
Data Transmission Function: You
can transmit results to the Tele-
health System through cable con-
nection using Telehealth Gateway
technology.
FORA
Telehealth
System
INTERNET

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Contents of the System
These products have been designed, tested, and proven to work
together as a system to produce accurate blood glucose test results.
Use only FORA D15 test strips and FORA control solution with your
FORA D15 Monitor.
1
PLEASE NOTE
• Ifyoursystemhasbeenopenedpriortouseand/ordoesnotcontainall
parts listed above, please return it to the place of purchase.
• PleasenotethatRS232CableformodelFORAD15c,BluetootAdapter
for FORA D15b, Zigbee Gateway Adapter for FORA D15z, Telehealth
Gateway for FORA D15g, test strips, control solutions and lancets are
not included in the standard kits. Please contact Toll Free Customer Care
at 1-866-469-2632 or place of purchase for availability.
910
11 12
3
7
2
8
13
15 1614
1
2
3
5
8
4
7
6
9
10
11
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Blood glucose plus blood
pressure monitor
Pressure cuff
25 test strips (Optional)
Code strip
Control solution (Optional)
25 sterile lancet (Optional)
Lancing device with a clear cap
Quick start user guide
Owner’s manual
Daily logbook
Protective Carrying Case
Warranty card
13
14
15
16
Bluetooth Adapter for FORA D15b (Optional)
RS232 Cable for FORA D15c (Optional)
Zigbee Gateway for FORA D15z (Optional)
Telehealth Gateway for FORA D15g (Optional)
Your system includes:
4 5 6

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Appearance and Key Function of the Monitor
RF Indicator
lights up red or green to assist in data
transmission.
Only for FORA D15b & FORA D15z
Memory Button
is used to enter the system memory
and adjust settings.
Button
is a power button for blood pressure
measurement.
RF Button
assists you in wireless data
transmission.
For model FORA D15b & FORA D15z
1
2
3.1
3.2
4
5
Set Button
is used to set up monitor.
LCD Screen
displays test results are
displayed with symbols and
simple messages.
Test Slot
is where you insert the test strip.
Air Tube
Arm Cuff
Air Plug
Air Plug
(Connect to the air jack)
Air Jack
8
10
11
7
6
9
10
11
9
8
7
2 4
5
3.1
3.2
1
6

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Monitor Display
Date & Time
Test Result Area
Test results are displayed here. (A
decimal point appears when the unit of
measurement is millimoles per litre.)
Blood Drop Symbol
Flashes when it is ready to apply the
sample.
Ketone Warning
Appears when glucose result is above
240mg/dL (13.3mmol/L).
Test Strip Message
Appears when the monitor is ON or the
test strip has not been inserted.
1
3
2
4
5
10
14
12
11
15
13
Memory
Appears when you review the
memory.
Pulse Symbol
Pulse Rate
Day Average
Indicates that the displayed test
result is an average.
Temperature Message
Appears with the ambient
temperature after test strip
insertion.
Low Battery
Appears when the battery is low or
must be replaced.
Diastolic Pressure
Symbol
Units of Measurement
mmol/L or mg/dL (mmHG or Kpa)
will appear with the test result.
Systolic Pressure Symbol
Code
Appears with the code number of
the test strips currently in use.
8
7
6
9
15
14
13
10
11
12
2
3
4
1
5 6 78 9

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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 monitor.
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 and the blood
will be absorbed automatically.
NOTE
Always hold the test strip by the Test Strip Handle when inserting it into the
monitor. Be careful not to touch the Absorbent Hole as it may contaminate
the sample.
Please see section,
“Testing Your Blood Sugar”, for complete instructions.

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BEFORE USE
Battery Replacement
Your meter comes with two 1.5V AAA alkaline batteries. The meter
will alert you when the power is low by displaying two different mes-
sages:
1.Withbatteryexhaustedsymbol“”appears
on the display: the meter is functional and the
result remains accurate for another 30 mea-
surements, but battery should be replaced.
2.Withbatteryexhaustedsymbol“”ashes
on the display: the batteries can not provide
enough power for a test. You must replace the
batteries immediately.

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To replace the battery, make sure that the meter is turned off.
Step1
Press the buckle on the battery
cover and lift it up to remove cover.
Remove old batteries.
Step2
Insert four 1.5V AA size alkaline
batteries. Make sure the + (positive)
and – (negative) marks match in the
symbols in the battery compartment.
If inserted correctly, you will hear a
“beep”.
PLEASE NOTE
• Donotusedifferenttype,dateorbrandnamebatteriestogether.
Use only new batteries of the required size and type.
• Replacingthebatteriesdoesnotaffectprevioustestresultsstoredin
the monitor; however, the settings may need to be updated.
• Batteriesmightleakchemicalsifunusedforalongperiodoftime.
Remove the batteries if you are not going to use the monitor for an
 extendedperiod(i.e.3monthsormore).
• Batteriesshouldbekeptawayfromsmallchildren.Ifswallowed,
promptly seek medical assistance.
• Discardbatteriesaccordingtoyourlocalregulations.

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Setting the Monitor
Your monitor comes with the time, date, memory deletion, voice vol-
ume and language preset. If you need to change the time or replace
the batteries, you may have to enter the setting mode and reset.
Please set the time, date, memory deletion, voice volume and
language according to the following steps.
Step1
Press the S button to start
setting.
Step3
Press the M button to make
changes. Press the S button
to advance to the
nextsetting.
Step2
Yearashesrst.
Step4
Date willash.FollowStep3
for changes.

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NOTE
• Thetime,date,unitofmeasurementandunitoftemperaturecanONLY
be changed in the setting mode. Therefore, these parameters cannot
be changed while performing a glucose or blood pressure test.
• ThemonitorwillturnoffautomaticallyifleftidleintheSettingModefor
3 minutes.
• Youmayalsopressthe“”buttonatanytimetoturnoffthemonitor
 andexittheSettingMode.
• Themilligramperdeciliter(mg/dL)isthestandardunitintheUnited
States. The millimole per liter (mmol/L) is the standard unit in Canada.
Use of the wrong unit of measure may cause you to misinterpret your
blood glucose level, and may lead to incorrect treatment.
Step5
Time ashes.FollowStep3for
changes.
Step7
Unit of blood pressure will
ash.FollowStep3forchanges.
Step6
Unit of glucose concentration
willash.FollowStep3for
changes.
Step8
Temperaturewillash.
Follow Step3 for changes.