FORA D10
BLOOD GLUCOSE
PLUS BLOOD PRESSURE
MONITORING SYSTEM
English
311-3224100-006
Version 4.0 2012/12
2
Thank you for choosing
D10
BLOOD GLUCOSE PLUS
BLOOD PRESSURE
MONITORING SYSTEM
This product can assist you in monitoring your blood glucose level as well
as your blood pressure. You can visit our website www.foracare.com/usa
to view other updated instructions or product information.
This owner’s manual contains important information that you must
know about your system. Please read it carefully and keep it for
future reference.
For other questions regarding this system, please contact your local
customer service. For all other questions, contact your health care
professional for assistance.
3
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
● Users need to adhere to Standard Precautions when handling
or using this device. All parts of the glucose monitoring system
should be considered potentially infectious and are capable
of transmitting blood-borne pathogens between patients and
healthcare professionals. For more information, refer to
“Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings 2007”,
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html
● The meter should be disinfected after use on each patient.
This Blood Glucose Monitoring System may only be used for
testing multiple patients when Standard Precautions and the
manufacturer’s disinfection procedures are followed.
● Only auto-disabling, single use lancing devices may be used
with this device.
For more information on the risk of blood-borne pathogen transmission from
blood glucose meter and lancing devices, please refer to:
1. “FDA Public Health Notication: 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
4
1. Use this device ONLY for the intended use described.
2. Do NOT use accessories which are not specied 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. This device does NOT serve as a cure for any symptoms or
diseases. The data measured is for reference only.
6. 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.
7. 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.
8. 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.
9. Do not use this device in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the
accurate operation.
10.Read all instructions thoroughly and practice the test before
using the product to test your blood glucose. Do all quality
control checks as directed and consult with a diabetes
healthcare professional.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
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TABLE OF CONTENTS
BEFORE YOU START 07
Warnings and Precautions 07
Detailed Information 08
ABOUT THIS SYSTEM 10
Intended Use 10
Principle of Measurement 11
Alternative Site Testing 12
Content of the System 14
Appearance and Key Function of the Monitor 15
LCD Screen 16
Test Strip 17
BEFORE USE 18
Battery Installation and Replacement 18
Setting the Monitor 20
BLOOD GLUCOSE MEASUREMENT 23
Important Information 23
Checking with FORA Control Solution 24
Important Control Solution Information 25
Performing a Control Solution Test 26
Testing Your Blood Glucose 29
Reading Your Result 35
Comparing Monitor and Laboratory Results 36
6
BLOOD PRESSURE MEASUREMENT 38
Suggestions Before Measuring 38
Correct Application of the Pressure Cuff 39
Testing Your Blood Pressure 40
MONITOR MEMORY 42
Viewing Results on the Monitor 42
Viewing the Average Blood Glucose Results 43
Viewing Results on a Personal Computer 44
TAKING CARE OF YOUR MONITOR & STRIPS 45
Caring for Your Meter 45
Storage 50
TROUBLESHOOTING 52
Error Message 52
Problem in Operation 54
SPECIFICATIONS 59
7
BEFORE YOU START
Warnings and Precautions
The FORA D10 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 for 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 take measurements 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 apply the cuff to areas other than your wrist.
8
Detailed Information
Reference Values
Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that keeping blood glucose levels
close to normal can reduce the risk of diabetes complications by
up to 60%*
1
. The results provided by this system can help you and
your healthcare professional monitor and adjust your treatment plan
to gain better control of your diabetes.
*1: ADA Clinical Practice Recommendations 2003.
Please consult your doctor to determine a target range that
works best for you.
Time of day
Fasting and before meal
2 hours after meals
Normal plasma glucose range for people
without diabetes (mg/dL)
Less than 100 mg/dL (5.6 mmol/L)
Less than 140 mg/dL (7.8 mmol/L)
Source: American Diabetes Association (2012). Clinical Practice Rec-
ommendations. Diabetes Care, 35 (Supplement 1): S1–S100.
9
Blood Pressure
Clinical studies show that the diabetes in adult 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 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 blood pressure accelerates hardening of the arteries, making the body becomes more
susceptible to apoplexy and coronary infarction. The WHO (World
Health Organization) published the following guidelines for blood
pressure range:
Source:1999 WHO/ISH guidelines for the management of hypertension.
*2: American Diabetes Association: The Diabetes-Heart Disease Link Sur
veying 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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ABOUT THIS SYSTEM
Intended Use
The FORA D10 system is a 2 in 1 system designed to measure
blood glucose outside of human body and to measure blood pressure non-invasively. It is intended for use in the home and in clinical
settings. It shall not be used for the diagnosis of diabetes and hypertension, or for the testing of newborns.
The talking functions on the meter is not intended for use by visually
impaired users.
AST of this system can be used only during steady-state blood glucose conditions as described in the section of “Alternative Site Testing (AST)".
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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 wrist based on
the Oscillometric method.
Both functions work separately independent of the other (one measurement either blood glucose or blood pressure at a time) in order
to avoid any interference problems.
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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 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 glu-
cose levels.Capillary blood at the ngertip reects these changes
faster than capillary blood at other sites. Therefore, when testing
blood glucose during or immediately after a meal or physical exer-
cise, results from AST and ngertip may be signicantly different.
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We strongly recommend you perform AST ONLY during the follow-
ing intervals:
• In a pre-meal(more than 2 hours since the last meal) or fasting
state.
• 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 unawareness of hypoglycemia.
• Your AST results do not correspond with 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 signicant inuence on the glucose value
obtained. Blood from the site without rubbing 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) instead while setting the
lancing device.
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Contents of the System
The products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
Use only FORA D10 test strips and FORA control solution with your
FORA D10 Monitor.
Blood glucose plus
blood pressure monitor
2 x 1.5V AAA alkaline
batteries
Lancing device
Clear cap
Owner’s manual
Daily log book
Protective storage case
Warranty card
Quick start user guide
1
2
3
5
8
4
7
6
9
1 32
5
8
4
7
6
9
NOTE
• If your system has been opened prior to use or does not contain all
items listed above, please return your system to the place of purchase.
• Please note that strips, control solutions (low, normal and high) and
lancets are optional. Those are not included in the standard kit. Please
contact the Customer Service at 1-888-307-8188, 1-866-469-2632 or
place of purchase for availability.
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Appearance and Key Function of the Monitor
Test Slot is where you insert test strip.
Talking Symbol indicates that the monitor has speaking
function.
M Button is used to enter memory and assist setting.
ON/OFF Button is a power button for blood pressure
measurement.
2 in 1 Symbol is a 2 in 1 system designed to measure blood
glucose and blood pressure.
Data Port is for cable connection.
Set Button is used to set up monitor.
Speaker is where voice comes from.
Wrist Cuff is used to wrap around wrist when measuring blood
pressure.
Battery Compartment.
1
3
2
5
8
10
4
7
6
9
1
5
3
4
2
10
7
6
9
8
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LCD Screen
Memory Mode Symbol
Temperature Symbol
Test Result & Error Message
Day Average Result
Pulse Rate
Battery Symbol
Ketone Indicator
Code
Date & Time
10
14
12
16
11
15
13
17
18
Voice Symbol
Blood Drop Symbol
Test Strip Symbol
Good Symbol
Systolic Pressure
Units for Blood Glucose
Units for Blood Pressure
Diastolic Pressure
Control Mode Symbol
1
3
2
5
8
4
7
6
9
14
16
15
13
17
18
1
32
10
5
8
4
7
6
9
12 11
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Test Strip
NOTE
The FORA D10 monitor should only be used with FORA D10 Test Strips.
Using other test strips with this meter can produce inaccurate results.
Absorbent Hole
Apply a drop of blood here.
The blood will be
automatically absorbed.
Conrmation Window
This is where you conrm 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.
ATTENTION:
Test results might be wrong if the contact
bar is not fully inserted into the test slot.
The front side of the
test strip should face
up when inserting
the test strip.
Front Back
1
4
3
2
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BEFORE USE
Battery Installation and Replacement
Use ONLY 1.5V AAA size alkaline batteries for best performance
and optimal lifespan.
When the power is getting low, the monitor will remind you by displaying two different messages:
1. Battery Symbol “ ” appears with your
test result to indicate that only 30 more
measurements (either glucose tests or
blood pressure tests) can be made be fore power runs out.
2. Error message “E-b” shows together
with ashing “ ” and “low” to indicate
that you must change the batteries be fore making any measurements.
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Make sure the monitor is off when replacing the batteries.
Please remember:
• When “ ” appears, the monitor will automatically turn down the
volume for energy saving.
• Do not replace batteries with used batteries or those of a differ-
ent type/brand name. Use only new ones in required size and
type/brand.
• Replacing the batteries does not affect previously stored test re-
sults; however,the settings may need to be updated again.
• Batteries might leak chemicals if unused for a long period of
time. Remove the batteries if you are not going to use the device
for an extended period (i.e.3 months or more).
• Batteries should be kept away from small children. If they are
swallowed, promptly see a doctor for help.
• Discard batteries according to your local regulations.
Step1
Press the buckle on battery
cover and lift up to remove cover.
Step2
Replace with two new 1.5V AAA
alkaline batteries. Align the positive and negative terminals of the
batteries with the positive (+) and
negative (-) signs engraved inside
the battery compartment and close
the cover.
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Setting the Monitor
Time, date, units, memory deletion and speaking function (optional)
can be set in the monitor. Two keys are involved: Set button and M
button.
Step1
Press the Set button to start setting.
Step3
Press the M button
to make changes.
Press the Set button
to next.
Step5
Time ashes. Follow
Step3 for changes.
Step2
Year ashes rst.
Step4
Date ashes. Follow
Step3 for changes.
Step6
Unit of blood pressure ashes. Follow
Step3 for changes.
21
Step7
Memory ashes.
• If you’d like to skip this step, press the Set button to next.
• If you’d like to delete memory, press theM button again so
that “dEL” and will both ash. Press the M button again to
delete ALL memory. “CLr/ALL” appears and the monitor will
automatically go to next step.
Step8
Voice volume number ashes.
Follow Step3 for changes.
Step9
Lanauage ashes. Follow
Step3 for changes.
22
Please remember:
• Number can be advanced faster by holding down the M button.
• While setting speaking volume, number 0 indicates that the speak-
ing function is off. “ ” will not display. Numbers 1 to 7 indi cate speaking volume from low to high. They will be displayed
together with “ .”
• If the monitor does not contain speaking function, it will automati-
cally shut down after Step 8.
• Step 8 and Step 9 are only for users who desire to use speak-
ing function.
• The time, date and unit of measurement can ONLY be changed
in the setting mode. Therefore, these parameters cannot be chang ed while performing tests.
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BLOOD GLUCOSE MEASUREMENT
Important Information
1. Severe dehydration and excessive water loss may cause inac curate results. If you believe you are suffering from severe dehydra tion, consult a healthcare professional immediately.
2. 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 from your healthcare profess-
ional.
3. Apply only capillary whole blood sample to test your blood gluc-
ose. Applying other substances will cause inaccurate results.
4. 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 profes sional.
5. Severely hypotensive individuals, patients in shock and individu als in a hyperglycemic-hyperosmolar state, with or without keto sis, may experience inaccurate results.
6. Please refer to your test strip package insert for important ad ditional information.
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Checking with FORA Control Solution
FORA control solution contains a known amount of glucose that reacts with test strips. By comparing your control solution test results
with the expected range printed on the test strip vial label, you can
ensure that the monitor and the test strips are working together as
a system and that you are performing the test correctly. It is very
important that you do this simple check routinely to make sure your
results are accurate.
How often should the control solution test be performed?
• When you use this system to test your blood for the rst time,
practice the procedure using control solution. When you can do
three tests in a row that are within the expected range, you are
ready to test your blood.
• To routinely check the monitor and test strips, perform a single
test for each level of control solution at least once a week.
When should the control solution test be performed?
• When you rst get your monitor.
• When you begin using a new vial of test strips.
• Whenever you suspect that the monitor or test strips are not
working properly.
• When your blood glucose test results are inconsistent with how
you feel, or when you think your results are inaccurate.
• When you want to practice running the test.
• If you drop the monitor.
25
Important Control Solution Information
• Use only FORA control solutions.
• Check the expiration date on the control solution vial. Do not use
if expired.
• Control solution, monitor, and test strips should come to room
temperature (68°F-77°F/20°C-25°C) before testing.
• Shake the vial, discard the rst drop of control solution, and wipe
off the dispenser tip to ensure a good sample and an accurate
result.
• Use for only 3 months after rst opening. Record the rst opening
date on the control solution vial. Discard after 3 months.
• Store the control solution with lid tightly closed at temperatures
between 36°F-86°F (2°C-30°C). Do not freeze.
NOTE
The control solution range printed on the test strip vial is for FORA control
solution only. It is used to test evaluate monitor and test strip performance.
It is not recommended range for your blood glucose level.
26
Performing a Control Solution Test
Step1
Take a test strip out with clean, dry
hands rst.
Step2
Insert the Test Strip to Turn On the Me-
ter. Insert the test strip into the meter and
wait for the meter to display “
” and a
blood symbol “
”.
Step3
Press the M button. After blood drop
symbol ashes, press the M button. “CTL”
will appear on the display. With the “CTL”
sign on the display, the monitor will NOT
store your test result in memory.
Step4
Obtain control solution. Shake the con-
trol solution vial well. Remove the cap.
Squeeze the vial, discard the rst drop,
and wipe off the dispenser tip to prevent
contamination. Squeeze the vial again to
27
get another drop and place the drop on
the top of the cap.
Step5
Apply control solution. While holding
the monitor, move the absorbent hole of
the test strip to touch the drop of control
solution. Then the drop will be automatically drawn into the test strip. Make sure
the conrmation window lls completely.
The meter begins counting down.
Step6
Read and compare the result. Compare
the result with the range printed on the
test strip vial. The result will fall within this
range.
To avoid contaminating the control solution with the content of the
test strip, you have to place a drop of control solution on a clean
surface. Then touch the test strip to the drop.
109~165
Normal
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Out-of-range results
If test results fall outside the printed range, check the “Operating
Problem” section in troubleshooting guide and repeat the test. If
your results continue to be out-of-range, the system may not be
working properly. Do NOT test your blood. Please contact the Customer Service at 1-888-307-8188, 1-866-469-2632 for help.
WARNING!
• Contact bars must be inserted all the way into the monitor or your test
results may be inaccurate.
• Every time you perform a control solution test, you must enter into the
“CTL” test mode so that the test result will not be stored in the monitor
memory. Failure to do so will confuse the blood glucose test result with
the control solution test result in memory.
29
Testing Your Blood Glucose
Potential Biohazard!
Healthcare professionals using this system on multiple patients
should follow the infection control procedure approved by their facility. All products or objects which come in contact with human blood,
even after cleaning, should be handled as if capable of transmitting
viral diseases.
WARNING!
To reduce the chance of infection:
• Always wear gloves and follow your facility’s biohazard control policy and
procedures when performing tests involving patient blood samples.
• Wear a new pair of clean gloves before testing each patient. Change
gloves between patients.
• Wear protective glasses and/or other protective clothing if necessary.
• Never share a lancet or the lancing device.
• Only auto-disabling, single use lancing devices may be used with this
device.
• Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the
lancing device.
Sharing the lancing device and lancets may increase the risk
of contracting infectious diseases. Please follow the infection
control procedure of lancing device approved by your facility.
30
Preparing the puncture site
Stimulating blood perfusion by rubbing the puncture site prior to
blood extraction has a signicant inuence 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 was rubbed prior to blood extraction, the difference
was signicantly reduced.
We recommend you perform disinfection procedures between each
patient. Please refer to the section Cleaning and Disinfection Procedures for complete instructions. After disinfection, used gloves
should be removed and hands washed before proceeding to the
next patient.
Please refer to the following practice guidelines for more information
about the correct procedure:
● Biosafety in Microbiological and Biomedical Laboratories (BMBL)
found at http://www.cdc.gov/biosafety/publications/bmbl5/
● “Protection of Laboratory Workers From Occupationally Acquired
Infections; Approved Guideline-Third Edition” Clinical and
Laboratory Standards Institute (CLSI) M29-A3.
31
Please follow the suggestions below before obtaining a drop
of blood:
● Wash and dry your hands before starting. Put on a new pair
of gloves.
● Rub the puncture site for about 20 seconds before penetration.
● Select the puncture site either at the ngertips.
● Clean the puncture site using cotton moistened with 70% alcohol
and let it air dry.
For healthcare professionals:
● Always wear gloves and follow your facility’s biohazard control
policy and procedures when performing tests involving patient
blood samples.
● Use a new pair of gloves when performing a patient test. Change
gloves between patients.
● Wear protective glasses and/or other protective clothing if neces
sary.
NOTE
• Choose a different spot each time you test. Repetitive punctures in the
same spot may cause soreness and calluses.
• It is recommended that discard the rst drop of blood as it might contain
tissue uid, which may affect the test result.
32
Please remember:
The monitor will be auto-shut down after 3 minutes without action.
To restart the test procedure, remove the test strip and insert it back
again.
Step1 Insert the test strip
Take a test strip out with clean and dry
hands.
Insert test strip face up with contact bars
end rst into the test slot. The monitor will
turn on automatically. The LCD screen will
display the sequences shown below.
A ashing “ ” will be displayed for 3 minutes until the drop of blood is applied.
33
WARNING!
• Choose a different spot each time you test. Repetitive punctures in the
same spot may cause soreness and calluses.
• Before you decide to begin AST, please consult your health professional.
Step2 Get a drop of blood.
Select the puncture site (either the nger or an
alternative site). Clean the puncture site with 70%
alcohol cotton and let it air dry.
► Fingertip testing
Hold the lancing device rmly against the side of
your nger. Press the release button. You will hear
a click, indicating that the puncture is complete.
►Alternative Site Testing
Follow the section “Alternative Site Testing” on
pages 11 and 12.
After penetration, gently massage the punctured
area to obtain blood. Be careful NOT to smear
the blood sample.
The rst drop of blood usually contains tissue uid and serum, which may affect the test result. For
this reason, discard the rst drop of blood with a
clean tissue paper or cotton and use the second
drop of blood for testing.
34
Step3
Apply blood into the test strip. When “ ” ashes
on the display, hold and touch the absorbent hole
of test strip to the drop of blood until the conrmation window is completely lled.
Step4
Read a result. Your test result, along with Date/
Time, appears after the monitor counts down to
0. It will automatically be stored in the monitor
memory. Turn the monitor off by removing the test
strip. Discard the used test strip carefully to avoid
contamination.
Step5
Discard lancet. Remove the lancing device cap
and the lancet. Place the disk on a hard surface
and push the exposed needle tip into the protective disk. Always use caution when removing
the lancet.
WARNING!
The used lancet and test strip may be potentially biohazardous. Please
refer to your healthcare provider and discard them carefully. Or contact our
local customer service for more information.
35
Reading Your Result
Your glucose test result comes along with indicators that transfer
special messages for your reference.
MESSAGE WHAT IT MEANS
Appears when your result
is below measurement
limit, which is less than 20
mg/dL.
Appears when your result
is above measurement
limit, which is higher than
600 mg/dL.
KETONE? appears when
your result is equal to or
higher than 240 mgl/dL.
ACTION
This indicates hypoglyce-
mia (low blood glucose.)
You should immediately
treat hypoglycemia as
recommended by your
healthcare professional.
This indicates severe
hyperglycemia (high blood
glucose). You should
seek immediate medical
assistance.
This indicates there is
a possibility of ketone
accumulation for type 1
diabetes patients. Please
seek immediate medical
assistance.
?
36
Comparing Monitor and Laboratory Results
The meter provides you with whole blood equivalent results. The
result you obtain from your monitor may differ somewhat from your
laboratory result due to normal variation. Monitor results can be affected by factors and conditions that do not affect laboratory results
in the same way. (See test strip package insert for typical accuracy
and precision data, and for important information on limitations.) To
make an accurate comparison between meter and laboratory results, follow the guidelines below.
Before you go to the lab:
• Perform a control solution test to make sure that the monitor is
working properly.
• Fast for at least eight hours before doing comparison tests.
• Don’t forget to take your monitor with you.
While at the lab:
Make sure that the samples for both tests (the monitor test and the
lab test) are taken and tested within 15 minutes of each other.
• Wash your hands before obtaining a blood sample.
• Never use your monitor with blood that has been collected in a
gray-top test tube.
• Use fresh capillary blood only.
You may still experience variations in the results because blood glu-
cose levels can change signicantly over short periods, especially
if you have recently eaten, exercised, taken medication or experienced stress*
4
. For example, if you have just eaten, the blood glu-
37
cose level from a nger stick can be up to 70 mg/dL(3.9 mmol/L)
higher than blood drawn from a vein (venous sample) used for a
lab test.*
5
Therefore, it is best to fast for eight hours before doing comparison
tests. Factors such as the amount of red blood cells in the blood (a
high or low hematocrit) or the loss of body uid (severe dehydration)
may also cause a meter result to differ from a laboratory result.
*4: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51.
*5: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.),
Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders
Company (1994), 959.
38
BLOOD PRESSURE MEASUREMENT
Suggestions Before Measuring
1. Avoid caffeine, tea, alcohol, and smoking for at least 30 minutes
before measurement.
2. Wait 30 minutes after exercising or bathing before measurement.
3. Sit down for at least 10 minutes before measuring.
4. Do not measure when feeling anxious or tense.
5. Take a 5-10 minute break between measurements. This break
can be longer if necessary, depending on your physical condi tions.
6. Keep the records for your physician as reference.
7. Blood pressure naturally varies from one hand to the other.
Always measure your blood pressure using the same wrist.
39
Correct Application of the Pressure Cuff
Slide the cuff onto your wrist. Wrap the cuff
comfortably around your wrist.
The top margin of the monitor should be
about 0.6 cm to 1.3 cm (1/4 to 1/2 inch) below the ball of thumb. When the cuff is positioned correctly, fold the loose end back
and secure it in place by pressing the pile
material rmly against the hook material.
0.6 cm to 1.3 cm
(1/4 to 1/2 inch)
below the ball of thumb
WARNING!
Always apply the wrist cuff before turning on the device. Failure to do so
will damage the device.
40
Testing Your Blood Pressure
Step1
Sit down for at least 10 minutes before
measurement.
Step2
Apply the wrist cuff according to page
Step3
Press the ON/OFF button and place your
arm in front of your chest. Relax and make
sure the device is at the same height as
your heart. Holding your left elbow with
your right hand helps you hold still during
measurement. Remain still and do not talk
or move during the measurement.
Step4
Measurement is in progress. Once the
monitor is on, all symbols on the display
will appear, accompanied by a long “beeping” sound.
The cuff will begin to inate automatically.
You will see number increasing on the display.
37.
41
After reaching the cuff pressure , the cuff
will begin to deate. You will see number
decreasing and “
” ashing on the dis-
play.
Step5
Read a result. The monitor displays the
systolic pressure, diastolic pressure and
heart rate, along with Date/Time. Press
ON/OFF button to turn off. Otherwise, it
will turn off automatically if left idle over 3
minutes.
Please remember:
• It is extremely important that you keep the device level with the
heart. If the device is lower (higher) than the heart, your measure ment will be higher (lower) than the actual value.
• If a higher pressure value is needed, the monitor will stop dea tion and inate again.
• If you press the ON/OFF button during the measurement, the
monitor will turn off immediately.
42
MONITOR MEMORY
Your monitor stores the 450 most recent results, in addition to calculating their average. Please follow the steps listed below to review
these results.
View Results on the Monitor
Step1
When the monitor is off, press
and release the M button. “01”
appears rst, followed by the latest recall of blood glucose/pressure measurements and their
respective dates and times.
Step2
Press the M button multiple
times to recall the stored results
one by one.
Step3
After viewing the oldest test
result, push the M button again
to return to the latest test result.
43
View the Average Blood Glucose Results
Step1
When the monitor is off,
press the M button for
3 seconds. The 7-day
average of blood glucose
results appears rst.
Step2
Press the M button multiple time to review the
14-, 21-, 28-, 60- and
90- day averages in order
one by one.
Step3
After viewing the 90-day
average, push down the
M button once more to
return to the 7-day average.
The average of glucose tests.
The average was calculated from the test
results over the last 7 days.
28 glucose tests have been performed in
the last 7 days.
Memory symbol interpretation: The average
of 28 glucose tests in the last 7 days is 98
mg/dL.
When using the monitor for the rst time, “---”
will appear, indicating that there are no test re-
sults in memory.
1
3
2
4
Please remember:
• The control solution results are NOT stored in the memory (please
go to WARNING on page 28 for more information). The list of past
results and the result average are for blood glucose results only.
• To exit from the memory, press the ON/OFF button to turn off the
monitor or leave it idle for 3 minutes for auto-shutdown.
1
2
3
4
44
Viewing Results on a Personal Computer
Stored results can be transmitted to a personal computer. Health
Care System Software and an interface cable are required before
installation. This software can be downloaded from the home page
of FORA Care. The interface cable is an optional accessory. Please
contact the Customer Service at 1-888-307-8188, 1-866-469-2632
for help.
To view results on your personal computer:
Step1
Install Software. Install Health Care System Software on your
computer by following the instructions provided on FORA Care’s
website: http://www.foracare.com/usa Users can download the software at FORA’s website.
Step2
Connect to Personal Computer. Connect the interface cable to a
serial port on the back of your computer. With the monitor turned off,
connect the interface cable to the data port located at the side of the
monitor. “PCL” will appear in the display, indicating that the monitor
is ready for transmitting data.
Step3
Transmit Data.
PCL
45
Follow the instructions provided in the software to transmit data (results along with dates and times). Remove the cable and the monitor will automatically turn off.
Please remember:
The monitor is unable to perform a blood glucose or blood pressure
test while connecting to the PC.
46
TAKING CARE OF YOUR MONITOR & STRIPS
To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
Caring for Your Meter
To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash hands thoroughly with soap and water before and after use.
Why the cleaning and disinfection should be performed
Cleaning and disinfection are different. Cleaning is the process of
removing dirt (e.g. food debris, grease, dust), disinfection is the process of killing germs (e.g. bacteria and viruses).
When to clean and disinfect the meter
Clean the meter when you see any dirt on it. You should disinfect the
meter at least once a week to prevent infection.
How to clean and disinfect the meter
The meter must be cleaned prior to the disinfection. Use one disinfecting wipe to clean exposed surfaces of the meter thoroughly
and remove any visible dirt, blood, or any other body uid with the
wipe. Use a second wipe to disinfect the meter by following the disinfecting procedure below. Do NOT use organic solvents to clean
the meter.
47
We recommend using the disinfecting wipes/towelettes below for
meter cleaning and disinfection because the active ingredients have
been tested to be effective against Hepatitis B Virus (HBV) for FORA
blood glucose meter.
Micro-Kill+™ (Micro-Kill Plus™) by Medline (EPA Reg. No.
59894-10-37549)
To obtain disinfecting wipes and other information, please contact
Medline at 1-800-MEDLINE (1-800-633-5463) or visit www.medline.
com. You can also purchase at www.amazon.com.
Disinfecting Procedures
1. Take out one disinfecting wipe from the package and squeeze
out any excess liquid in order to prevent damage to the meter.
2. Wipe all meter’s exterior surface display and buttons. Hold the
meter with the test strip slot pointing down and wipe the area
around the test slot but be careful not to allow excess liquid to
get inside. Keep meter wet with disinfection solution contained
in the wipe for a minimum of 2 minutes for Micro-Kill+™ wipes.
3. Remove the wipe. Allow the meter surface to dry completely.
4. Discard the used wipes and never reuse them. Wash your hands
thoroughly with soap and water after handling the meter, lancing
device and test strips to avoid contamination.
This device has been validated to withstand up to 5,000 cleaning
and disinfection cycles using the recommended disinfecting wipe/
towelette. The tested number of cycles is estimated by 5 cleaning
48
and disinfection cycles per day over 5 years, the expected life of
the device.
The meter should be replaced after the validated number of cleaning and disinfection cycles or the warranty period, whichever comes
rst.
• Stop using the meter if you see any signs of deterioration, for
example: LCD display cracks or becomes cloudy, buttons no
longer function, or outer casing cracks.
Please contact the Customer Service at 1-888-307-8188 or
1-866-469-2632 for a replacement meter if any of the signs of
deterioration are noticed.
• Improper system cleaning and disinfection may result in meter
malfunction. Stop using the meter if you see any signs of
malfunction, for example: meter cannot be turned on, meter has
error message, reading not consistent with your feeling.
If you have a question, please contact the Customer Service at
1-888-307-8188 or 1-866-469-2632 for assistance.
49
NOTE
• Do NOT clean and disinfect the meter while performing tests.
• Please follow the instructions on the package label of Micro-Kill+™ disin
fecting wipe.
• If the meter is being operated by a second person, the meter and lancing
device should be decontaminated prior to use by the second person.
• Do NOT allow cleaning and disinfecting solution to get in the test slot,
battery compartment, or strip-ejection button.
• If you do get moisture in the test strip slot, wipe it away with a corner of
tissue.
• Always dry the meter thoroughly before using it.
• Do NOT spray the meter directly with cleaning solutions especially those
containing water (i.e. soapy water), as this could cause the solution to
enter the case inside and damage the electronic components or circuitry.
50
2. Strip Storage
• Storage condition: 39.2-104°F(4-40°C), below
85% humidity. Do NOT freeze.
• Store your test strips in their original vial only.
Do not transfer to other container.
Storage
1. Monitor Storage
• Storage condition: -4°F to 140°F (-20°C to 60°C), below 95%
rela tive humidity.
• Avoid dropping the monitor.
• Avoid direct sunlight.
• Always store or transport the monitor in its original storage case.
• Do not disassemble, modify or try to repair the monitor or wrist
cuff by yourself.
• Do not over-wring the cuff or turn it inside out.
• If you are not going to use the monitor for an extended period,
please remove the batteries.
51
• Store test strip packages in a cool, dry place.
Keep away from direct sunlight and heat.
• After removing a test strip from the vial, imme-
diately replace the vial cap and close it tightly.
• Touch the test strip with clean, dry hands.
• Use each test strip immediately after removing
it from the vial.
• Write the rst opening date on the vial label
when you rst open it. Discard remaining test
strips after 3 months.
• Do not bend, cut or alter a test strip in any
way.
• Keep the strip vial away from children as the
cap and the test strip may be a choking hazard.
If swallowed, promptly see a doctor for help.
3. Control solution storage
• Storage condition: Store the control solution
with lid tightly closed at temperatures below
36-86°F( 2-30°C). Do NOT freeze.
• Record the rst opening date on the control
solution vial. Discard after 3 months.
52
TROUBLESHOOTING
If you follow the action recommended 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.
Error Message
CAUSE
Batteries are dead.
Appears when environmen-
tal temperature is below
system operation range.
Appears when environmen-
tal temperature is above
system operation range.
MESSAGE WHAT TO DO
Replace the batteries
immediately.
System operation range
is 50°F to104°F(10°C to
40°C). Repeat the test after
the monitor and test strip
have reached the above
temperature.
53
CAUSE
Unable to detect systolic
pressure.
Unable to detect diastolic
pressure.
Cuff pressure is insufcient.
Used strip insertion.
Weak pulse.
Cuff leakage.
Cuff pressure is over 300
mmHg.
Deation error.
Problem with calibration.
MESSAGE WHAT TO DO
Ret cuff tightly and
correctly. Relax and repeat
measurement.
Repeat the test with a new
strip.
Ret cuff tightly and cor-
rectly, relax and repeat
measurement as shown in
page 37.
Review instructions and
retest with a new strip.
54
Problem in Operation
1. Blood Glucose Measurement
What happened?
The monitor does not display a message after inserting a test strip.
What happened?
You turned off the monitor but it makes a beeping sound.
POSSIBLE CAUSE
The strip is still inserted.
WHAT TO DO
Remove the strip. If you need to
test blood glucose, insert an unused
strip.
POSSIBLE CAUSE
Batteries exhausted.
Batteries incorrectly installed or
absent.
Test strip inserted upside down or
not completely inserted.
Defective monitor.
WHAT TO DO
Replace the batteries.
Check to see if the batteries are
correctly installed.
Insert the test strip correctly with the
contact bars end rst.
Contact the customer service at
1-888-307-8188, 1-866-469-2632
for help.
55
What happened?
The test does not start after applying the sample.
POSSIBLE CAUSE
Insufcient blood sample.
Defective test strip.
Sample was applied at a time when
“ ” was not ashing on the display.
Defective monitor.
WHAT TO DO
Repeat the test with a new test strip
and a larger sample.
Repeat the test with a new test
strip.
Repeat the test with a new test
strip. Apply sample only when “ ”
appears on the display.
Contact the customer service at
1-888-307-8188, 1-866-469-2632
for help.
56
What happened?
If the control solution test result is out of range.
POSSIBLE CAUSE
Error in performing the test.
Control solution vial shaken poorly.
Expired or contaminated control
solution.
Control solution that is too warm or
too cold.
Test strip deterioration.
Monitor malfunction.
WHAT TO DO
Read the instructions thoroughly
and repeat the test.
Shake the control solution vigor-
ously and repeat the test again.
Check the expiration and discard
dates of the control solution.
Allow control solution, monitor and
test strips to come to room tempera-
ture (68°F-77°F/20°C-25°C) before
testing.
Repeat the test with a new test
strip.
Contact the customer service at
1-888-307-8188, 1-866-469-2632
for help.
57
2. Blood Pressure Measurement
What happened?
Heart rate is higher/lower than user’s average.
POSSIBLE CAUSE
Moving during measurement.
Measuring right after exercise.
WHAT TO DO
Repeat measurement.
Rest at least 30 minutes before
measurement.
What happened?
No display after pushing the “ ” button.
POSSIBLE CAUSE
Batteries exhausted.
Batteries incorrectly installed or
absent.
WHAT TO DO
Replace the batteries.
Check that the batteries are cor-
rectly installed.
58
What happened?
Cuff inates again during measuring.
POSSIBLE CAUSE
Cuff is not fastened.
Normal action.
WHAT TO DO
Fasten the cuff again.
What happened?
A result is higher/lower than user’s average measurement.
POSSIBLE CAUSE
May be not in correct position while
measuring.
Blood pressure naturally varies from
time to time.
WHAT TO DO
Adjust to the correct position to
measure.
Keep in mind for next measure-
ment.
If user’s blood pressure is higher than the default
value, the device will automatically pump to a higher
pressure. Stay relaxed and wait for the measure-
ment.
59
SPECIFICATIONS
Device name: FORA D10
Power source: Two 1.5V AAA size alkaline batteries
Size of monitor w/o cuff: 6.3(L) x 7.5(W) x 4.0(H) cm
Weight of monitor w/o cuff and batteries: 158g
Memory: 450 measurement results with date& time
Power saving: Automatic power off if idle for 3 minutes
System operating condition:
50°F to 104°F(10°C to 40°C), below 85% R.H.
Monitor storage condition: -4°F to 140°F(-20°C to 60°C), below 95% R.H.
Strip storage condition: 39.2°F to 104°F(4°C to 40°C), below 85% R.H.
KETONE warning: glucose value over 240 mg/dL
Measurement unit: mg/dL
Linear range: 20-600 mg/dL
Precision: ±5 %(CV)
Accuracy:
±15mg/dL when glucose＜75mg/dL; ±20% when glucose ≧75mg/dL
Pressure Range: 0-300 mmHg
Heart Rate Range: 40-199 beats per minute
Measurement unit: mmHg or KPa
Accuracy of Pressure: ±3mmHg or ±2% of reading
Accuracy of Heart rate: ±4% of reading
Maximum ination pressure: 300 mmHg
This device has been tested to meet the electrical and safety requirements of:
IEC 60601-1, EN 60601-1, IEC 61010-1, EN 61010-1, EN 61010-2-101, EN
60601-1-2, EN 61326
60
Performance characteristics
Accuracy
Within ±15 mg/dL (0.83 mmol/L) at glucose concentration < 75 mg/dL
(4.2 mmol/L) and within ±20% at glucose concentration ≥ 75 mg/dL (4.2
mmol/L).
Precision
CVs (%) of intermediate precision and repeatability are less than 5%.
The product has been tested to meet the requirements of ISO 15197.
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