TAIDOC TECHNOLOGY 326000M00 Blood Glucose + Blood Pressure Monitoring System User Manual Fora comfort 3260 Manual
TAIDOC TECHNOLOGY CORP. Blood Glucose + Blood Pressure Monitoring System Fora comfort 3260 Manual
Manual
1
Fora Comfort 2 in 1 Blood Glucose plus Blood
Pressure Monitoring System
Version 1.0
2007/09/03
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IMPORTANT SAFETY 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 strips and control solutions which are not supplied by the
manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered any
damage.
5. Before using any 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
BEFORE YOU START 05
Warnings and Precautions 05
Health Information 06
ABOUT THIS SYSTEM 08
Intended Use 08
Principle of Measurement 08
Alternative Site Testing (AST) 09
Content of the System 11
Appearance and Key Function of the Monitor 12
LCD Display 14
Appearance of the Test Strip 15
PREPARATIONS BEFORE USE 16
Battery Installation and Replacement 16
Setting the Monitor 18
HOW TO MEASURE BLOOD GLUCOSE 21
Coding the Monitor 22
Checking the Code 23
Checking the System with Control Solutions 24
Important Control Solution Information 25
Doing a Control Solution Test 26
Testing Your Blood Glucose 28
Special Message 35
Comparing Monitor and Laboratory Results 36
HOW TO MEASURE BLOOD PRESSURE 37
Suggestions before Measuring 37
Test Your Blood Pressure 38
HOW TO USE THE MEMORY FEATURES 40
Viewing Memory in the Monitor 40
Deleting memory 41
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HOW TO TAKE CARE OF YOUR MONITOR 42
Cleaning 42
Storage 42
Monitor storage 42
Strip storage 43
Control storage 44
PROBLEM-SOLVING GUIDE 45
ERROR MESSAGE 46
Problem in Opertation 47
SPECIFICATIONS 49
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5
BEFORE YOU START
Warnings and Precautions
The Fora comfort 2 in 1 blood glucose plus blood
pressure monitoring system is designed for use on
individuals age 16 and above. It shall NOT be used:
1. To diagnose newborns with diabetes.
2. On infants or persons who cannot communicate.
This device does NOT serve as a cure of any symptoms
or disease. The data measured are only for reference.
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 fibrillation. 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 on anything besides your
arm.
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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
can reduce the risk of diabetes complications by up to 60%*1. The results you
get with the Fora comfort 2 in 1 blood glucose plus blood pressure monitoring
system can help you and your healthcare professional monitor and adjust your
treatment plan to gain better control of your diabetes.
Time of day Plasma glucose range (mg/dL)
for people without diabetes
Your target range
(mg/dL)
Fasting and before meal*1a 70-110 mg/dL
(3.9 – 6.1 mmol/L)
2 hours after meals*1b Less than 140 mg/dL
(7.8 mmol/L)
*1a: Sacks, DB in “Carbohydrates”, Burtis, CA, Ashwood, ER (ed), Tietz Textbook of
Clinical Chemistry, Philadelphia, WB Saunders Company, 1999.
*1b: ADA Clinical Practice Recommendations 2003
Please work with your doctor to determine a target range that works best for
you.
06
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Blood Pressure
Clinical studies show that the 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 trend tells whether your body is in good condition or not.
Human blood pressure naturally increases after reaching middle age.
This symptom is a result of continuous aging of the blood vessel. Further
causes include obesity, lack of exercise, and cholesterol (LDL) adhering to the
blood vessels. Rising of blood pressure accelerates hardening of the arteries,
and the body becomes more susceptible to apoplexy and coronary infarction.
The WHO (world health organization) published the guideline of 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)
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ABOUT THIS SYSTEM
Intended Use
The Fora Comfort TD-3260 2 in 1 Blood Glucose plus Blood Pressure
Monitoring System is indicated for the quantitative measurement of glucose in
fresh whole blood (capillary blood from the finger, 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 wrist based on the
Oscillometric method.
Both functions work separately (one measurement either blood glucose or
blood pressure at a time) to avoid any interference problems.
Major Features
The greatest feature of this system is that you can view results on the PC
through wireless connection using Zigbee Gateway technology. It provides a
simply way to transmit data into your PC.
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Alternative Site Testing (AST)
Important: There are limitations for doing AST.
Please consult your healthcare professional before you do AST.
What is AST?
Alternative site testing (AST) means that
people use parts of the body other than
fingertips to check their blood glucose
levels. This system provides you to test
on the palm, the forearm, the upper arm,
the calf, or the thigh with the equivalent
results to fingertip testing.
What’s the advantage?
Fingertips feel pain more readily
because they are full of nerve endings
(receptors). At other body sites, since
nerve endings were not so condensed,
you will not feel as much pain as at the
fingertip.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose levels.
Capillary blood at fingertip reflects these changes faster than capillary blood at
other sites. Therefore when testing blood glucose during or immediately after
meal, physical exercise, or any other event, take blood sample from your finger
only.
We strongly recommend you do AST ONLY 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.
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Do NOT use AST if:
You think your blood glucose is low.
You are unawareness of hypoglycemia.
Your AST results do not match the way you feel.
You are testing for hyperglycemia.
Your routine glucose results are often fluctuating.
You are pregnant.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood
extraction has a significant influence on the glucose value obtained.
Blood from the site without rubbing exhibits a measurably different glucose
concentration than blood from the finger. When the puncture site was rubbed
prior to blood extraction, the difference was significantly reduced.
Please follow suggestions below before getting a drop of blood:
Rub the puncture site about 20 seconds before penetration.
Use a clear cap (included in the kit) instead while setting the lancing device.
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Content 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 the same
brand-name test strips and a control solution with the blood glucose and blood
pressure monitor.
CAUTION
Check your system to be sure that it is unopened prior to use and that it
contains all parts listed above. If either of these conditions occurred, please
return your system to the place of purchase.
Please note that Fora comfort test strips, lancets, TaiDoc control
solution are optional and are not included in the standard kit. Please ask
your local agent for help.
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1. Blood glucose and blood
pressure monitor
x1 6. A clear cap X1
2. Pressure cuff x1 7. Carry bag X1
3. Owner’s manual X1 8. Zigbee gateway adaptor X1
4.Quick using card X1
5. Lancing device x1
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Appearance and Key Function of the Monitor
12
Test Slot
For Feature 1
Blood Glucose
Tes t
Zigbee Indicator
For Feature 5
Wireless
Connection
Memory Button
For Feature 3
Memory Recall
Power Button
For Feature 2
Blood Pressure Test
RF Button
For Feature 5
Wireless Connection
Set Button
For Feature 4
Monitor Setting
LCD Display
Test result is
displayed with
symbols and
simple messages.
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LCD Display
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15
Appearance of the Test Strip
Your 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 chamber where the reaction takes place.
See pages 21-36, How to measure blood glucose, for complete instructions.
NOTE
We recommend that you should hold the test strip by the Test Strip Handle only
when you perform blood glucose test. Do not hold the Absorbent Hole in order
to avoid contamination.
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PREPARATIONS BEFORE USE
Battery Installation and Replacement
Your monitor comes with batteries already installed. When replacing, use
ONLY 1.5V AA size alkaline batteries for best performance and longest life.
Low Power Signal
The monitor will remind you when the power is getting low by displaying two
different messages:
1. Battery Symbol appears while you perform tests
(Fig. 1).This means it is about time to change the batteries
although still 30 more measurements can be made.
2. Battery Symbol flashes by itself and the monitor
cannot perform any measurement (Fig. 2). This means you
must change the batteries immediately.
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(Fig. 1)
(Fig. 2)
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Make sure the monitor is off before replacing the batteries.
STEP 1- Press the edge of the battery cover
and pull up (Fig. 3). Lift the battery cover and
remove the batteries inside.
STEP 2- Insert four 1.5V AA size alkaline
batteries. Make sure the + (positive)
and–(negative) marks match as indicated in
the battery compartment (Fig. 4). If inserted
correctly, you will hear a "beep".
CAUTION
1. Do not use different type, date or brand name batteries together. Use only
new batteries of the required size and type.
2. Replacing the batteries does not affect previous test results stored in the
monitor. But you may need to update the settings.
3. Batteries might leak chemicals if not used for a long time. Remove the
batteries if you are not going to use the device for an extended period (i.e. 3
months or more).
4. As with all small batteries, the batteries should be kept away from small
children who still put things in their mouths. If they are swallowed, promptly
see a doctor for help.
5. Discard batteries according to your local regulations.
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(Fig. 3)
(Fig. 4)
18
Setting the Monitor
Your monitor comes with the time, date, units and ambient temperature preset.
These options may be changed any time to fit your needs. They also need to
be set again when you change the batteries.
How to set the monitor?
.
18
STEP 1- Start with the Monitor Turned Off.
Press the S button to enter the Setting Mode.
STEP3 - Press the S button to select what you
would like to change. The selected one will be
flashing. Press the M button to make the
change.(Fig 7)
STEP 2- The year will appear first.(Fig. 6)
STEP 4- The date and day will appear
automatically. Press the M button to select
the changes you made and press the S
button move on to next step.(Fig 8)
(Fig. 5)
(Fig. 6)
(Fig. 7)
(Fig. 8)
(Fig. 5)
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STEP 5- The hour and minute will appear
automatically. Press the M button to select the
changes you made and press S button move on to
next step.(Fig. 9)
STEP 6- The blood glucose unit*3 will appear
automatically. Press the M button to select the
changes you made and press the S button move
on to next step.(Fig. 10)
STEP 6- The blood pressure unit will appear
automatically. Press the M button to select the
changes you made and press the S button move
on to next step.(Fig.11)
STEP 7- The ambient temperature will appear
automatically. Press the M button to select the
changes you made and press the S button move
on to next step.(Fig 12)
STEP 8- You may also press the button any
time to turn off the monitor and exit the Setting
Mode.(Fig.13)
(Fig. 9)
(Fig. 10)
(Fig. 11)
(Fig. 12)
(Fig. 13)
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NOTE
The time, date, unit of measurement and unit of temperature can ONLY be
changed in the setting mode. Therefore, when you perform a glucose
testing or blood pressure testing, those parameters are not possible to be
changed.
*3: 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.
While the monitor is in the setting mode, if no button is pressed for 3
minutes, the monitor will turn off automatically.
You may also press the button any time to turn off the monitor and exit
the Setting Mode.
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HOW TO MEASURE BLOOD GLUCOSE
Important Information and Possible Interferences
Severe dehydration and excessive water loss may cause false low results. If
you believe you are suffering from severe dehydration, consult a healthcare
professional immediately.
Test results below 60 mg/dL*4 (3.3 mmol/L) mean low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL*5 (13.3 mmol/L) mean
high blood glucose (hyperglycemia). If you get results below 60 mg/dL or
above 240 mg/dL, and do not have symptoms, first repeat the test. If you
have symptoms or continue to get results that fall below 60 mg/dL or above
240 mg/dL, follow the treatment advice of your healthcare professional.
Apply only capillary whole blood sample to test your blood glucose. Applying
other substances will cause wrong results.
If you are experiencing symptoms that are not consistent 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. Inaccurate low results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose plus blood pressure monitor.
Please refer to your test strip package insert for additional important
information.
*4: Kahn, R., and Weir, G.: Joslin’s Diabetes Mellitus, 13th ed. Philadelphia:
Lea and Febiger (1994), 489.
*5: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and
Febiger (1989), 261-263.
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Coding the Monitor
You must code the monitor every time you begin to use a new vial of test strips.
Test results may be wrong if the code number displayed on the monitor does
not match the number printed on the strip vial.
Step 2- Remove the code strip, the LCD display will show
“OK”.
This tells you that the monitor has finished coding and is
ready for blood glucose testing.(Fig.15)
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 wrong results.
22
Step 1- Insert the code strip when the
monitor is off. Wait until the code number
appears on the LCD display .(Fig.14)
Make sure the code number on LCD
display, on the code strip, and on strip
vial are identical.
(Fig. 14)
(Fig. 15)
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Checking the Code
When you start measuring blood glucose, check the code number first.
If it does not match, please code the monitor as described in the previous
page.
CAUTION
If the code number displayed on the monitor does not match the number
printed on the vial, test results will be wrong.
23
(Fig. 17) (Fig. 18)
(Fig.19)
(Fig. 16)
STEP1- With the monitor off, insert a test strip into
the Test Slot. Make sure you insert the end with
the contact bars first and facing up. Contact bars
must be inserted all the way into the monitor for
an accurate result (Fig. 16).
STEP2- The monitor will display “CHK” and
the strip symbol (Fig. 17). Then the ambient
temperature will be shown (Fig. 18).
STEP3- Then the code number and flashing blood drop
appears. Check if the number shown on the monitor
matches the number on the test strip vial (Fig. 19). If it
matches, you can proceed with your test.
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Checking the System with Control Solutions
TaiDoc control solutions contain 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, it is able to check 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 you get accurate results.
How often the control solution test should be performed?
When you use this system to test your blood for the first 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.
For routinely check the monitor and test strips, perform a single test for each
level of control solution at least once a week.
When the control solution test should be performed?
When you first 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 not consistent with how you feel, or
when you think your results are not accurate.
When your test strips are exposed to extreme environmental conditions (See
Storage section of this manual).
When you want to practice running the test.
If you drop the monitor.
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Important Control Solution Information
Use only TaiDoc control solutions.
Check the expiry date on the control solution vial. Do not use if expired.
Control solution, monitor, and test strips should come to room temperature
(68-77℉/20-25℃) before testing.
Shake the vial, discard the first drop of control solution, and wipe off the
dispenser tip to ensure a good sample and an accurate result.
Use only for 90 days after first opening. Record the discard date (date
opened plus 90 days) on the control solution vial. Discard after 90 days.
Store the control solution tightly closed at temperatures below 86℉ (30℃).
Do not refrigerate.
NOTE
The control solution range printed on the test strip vial is for Taidoc control
solution only. It is used to test monitor and test strip performance. It is not
recommended range for your blood glucose level.
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Doing a Control Solution Test
TAKE A TEST STRIP OUT WITH CLEAN AND DRY HANDS FIRST.
.
Be sure the code number on the display is the same as the code number on
the test strip vial. If the code numbers are not identical, please see “Coding the
Monitor” section of this manual.
NOTE
Contact bars must be inserted all the way into the meter or you may get an
inaccurate test result.
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.
26
(Fig.20)
STEP1- Insert Test Strip
Insert a test strip with contact bars end first and facing
up,into the test slot.The monitor turns on automatically and
displays the followings in sequence:
“CHK” and “ ” Îambient temperatureÎcode number
and flashing“ ”(Fig.20)
STEP 2- Press the M button
While the “ ” symbol appears on the
display, press the M button (Fig.21) and
then “CTL” will appear on the display
(Fig.22). With the “CTL” sign on the
display, the meter will not store your test
result in memory. If you decide not to
perform a control solution test, press the
M button again, and the “CTL” sign will
disappear. (Fig.22) (Fig.21)
27
Out-of-range results
If test results fall outside the range printed on the test strip vial, check the
section of “Problem in Operation” in troubleshooting guide and repeat the test.
If you continue to get out-of-range results, it means that the system may not be
working properly. Do NOT test your blood. Please contact your local agent for
help.
27
(Fig.24)
(Fig.25)
STEP 3- Obtain control solution
Shake the control solution vial well. Remove
the cap. Squeeze the vial, discard the first
drop, and wipe off the dispenser tip to prevent
contamination. Squeeze the vial again to get
another drop and place on a clean surface
(Fig. 23).
STEP 4- Apply Control Solution
Move the monitor to meet the absorbent hole of the test
strip and the drop will be automatically drawn into the
test strip (Fig 24).
Remove the monitor until the confirmation window is
filled. The monitor begins to count down.
To avoid contamination 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.
(Fig.23)
STEP 5 – Read and Compare the Result
After counting to 0, the test result of control
solution is shown on the screen. Compare this
result with the range printed on the test strip
vial. It should fall within this range (Fig. 25).
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Testing Your Blood Glucose
Be sure to read carefully this section and the test strip package insert found in
the test strip box before testing. Make sure you have all items needed to test:
A. Monitor
B. Test Strips
C. Lancing Device
D. Sterile Lancet.
E. Clear Cap
A. B. C. D.
E.
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WASH AND DRY YOUR HANDS FIRST BEFORE STARTING.
( Fig. 27)
WARNING
To reduce the chance of infection:
Never share a lancet with anyone.
Always use a new, sterile lancet. Lancets are for single use only.
Avoid getting lotion, oil, dirt, or debris in or on the lancets and the sampler.
29
(Fig.26)
STEP 1- Set the Lancing Device
Remove the cap of lancing device. Insert a
lancet into the lancet holder and push down
firmly until it is fully seated.(Fig.26)
Remove the protective disk.Replace the
lancing Device cap.( Fig. 27)
Replace the lancet device cap.Turn the cap
unit it is snug but not too tight.(Fig.28)
(Fig.28)
The adjustable tip offers 5 levers of skin
penetration. Twist the adjustable tip in either
direction until the number lines up with the
Arrow:
1-2 for soft or thin skin, 3 for average skin,
4-5 for thick or calloused skin. (Fig. 29)
(Fig.29)
30
The lancing device is now ready for use. Set aside for later use.
30
Slide the ejection /cocking control back
until it clicks. If it does not click the device
may have been cocked when the lancet
was inserted.(Fig. 30)
(Fig.30)
■
Blood from sites other than the fingertip
A clear cap, together with the kit, makes it easier
to get a drop of blood for AST. When you want to
obtain blood from sites other than the finger,
replace the lancet device cap with the clear cap
(Fig.31) Turn the clear cap until it is snug but not too
tight.
(Fig.31)
31
STEP 2- Insert Test Strip
Make sure the code number showed on the screen
is the same as the code number printed on the test
strip vial. If the code numbers are different, please
refer to section of “Coding the Monitor”, for the
procedure of coding( Fig 33).
31
Insert a test strip with contact bars end first and facing up, into
the test slot(Fig.32). The monitor turns on automatically and
displays the followings in sequence:
CHK and” ” Î ambient temperature Î code number and
flashing “ ”
(Fig.32)
(Fig.33)
32
STEP 3- Get a Drop of Blood
Select the puncture site either in finger or in other parts (AST). Clean the
puncture site with 70% alcohol cotton and let it air-dry.
WARNING
1. Choose a different spot each time you test. Repeated puncture in the same
spot may cause soreness and calluses.
2. The first drop of blood usually contains tissue fluid and serum, which may
affect the test result. It should be discarded.
32
■ Fingertip
Hold the Lancing Device firmly against the side
of your finger. Press the release button. You will
hear a click, indicating that the puncture is
complete(Fig. 34).
■ Site other than fingertip
Please refer to the section of” About AST” for
available punctured sites.
After penetration, discard the first drop of blood with
a clean tissue paper or cotton. Then gently squeeze
the punctured area to obtain blood. But be attention
NOT to smear the blood sample. The volume of
blood sample must be at least 0.7 microliter( actual
size)(Fig.35).
(Fig.34)
(Fig.35)
33
STEP 4- Apply Blood into the Test Strip
STEP 5- Obtain an accurate result in 7 seconds
The result of your blood glucose test is
shown after the meter counts to 0. This
reading is automatically stored in the
monitor (Fig.37).
PLEASE NOTE
1. Do not push your finger (with blood on it) against the test strip or try to apply
a smeared sample on the test strip.
2. If you do not apply blood sample within 3 minutes, or if you accidentally turn
off the monitor by pressing the button, the monitor will alert you with
flashing test strip symbol and continuous beeping. You will need to turn the
monitor off by removing the test strip.
3. The blood should be completely filled the confirmation window before the
monitor begins to count down. If you find that the confirmation window is not
filled with blood when the monitor is counting, NEVER try to add more blood
to the test strip. Discard the test strip and retest with a new one.
4. To start a blood pressure test after performing a blood glucose test, make
sure that the test strip is removed from the monitor. Then turn the monitor
off and refer to "HOW TO MEASURE BLOOD PRESSURE".
33
When “ “is flashing on the screen, apply your
blood to the absorbent hole of the test strip until
the confirmation window is fully covered with
blood(Fig. 36). The monitor then begins to count
down automatically.
(Fig.36)
(Fig.37)
34
STEP 6- Remove the Lancet
(Fig. 38)
34
WARNING
The used lancet and the used test strip may be potentially biohazard. Please
discard it carefully according to your local regulations.
Always use caution when removing the lancet.
Take the lancet out carefully. Place the disk on a
hard surface and push the exposed tip into the
protective disk(Fig. 38).
35
Special Messages
MESSAGE WHAT IT MEANS ACTION
Appears when your result is
below measurement limit,
which is less than 20 mg/dL.
This indicates hypoglycemia
(low blood glucose.)
You should immediately treat
hypoglycemia as
recommended by your
healthcare professional.
Appears when your result is
above measurement limit,
which is higher than 600
mg/dL.
This indicates severe
hyperglycemia (high blood
glucose).
You should seek immediate
medical assistance.
KETONE appears when
your result is equal or higher
than 240 mg/dL.
This indicates there is a
possibility of ketone
accumulation if you are Type
1 diabetes.
Please seek immediate
medical assistance.
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Comparing Monitor and Laboratory 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 monitor 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.
It is best to fast for at least eight hours before doing comparison tests.
Take your monitor with you to the lab.
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 have a variation from the result because blood glucose levels can
change significantly over short periods, especially if you have recently eaten,
exercised, taken medication, or experienced stress*6. In addition, if you have
eaten recently, the blood glucose level from a finger 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*7.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 fluid (severe dehydration) may also
cause a monitor result to be different from a laboratory result.
References
*6: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51.
*7: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz
Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994),
959.
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HOW TO MEASURE BLOOD PRESSURE
Suggestions before Measuring
Avoid caffeine, tea, alcohol, and cigarette at least 30 minutes before
measurement.
Wait 30 minutes after exercising or bathing before measurement.
Sit or lie down for at least 10 minutes before measuring.
Do not measure when feeling anxious or tense.
Take a 5-10 minute break between measurements. This break can be
longer if necessary, depending on your physical conditions.
Keep the records for your physician as reference.
Blood pressure varies from two hands naturally. Always measure your
blood pressure on the same arm.
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Testing Your Blood Pressure
(Fig. 40)
(Fig. 41)
( Fig. 42)
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STEP 2- Connect the air plug of
the tubing to the air jack at the side
of the monitor (Fig. 39) .
SETP 1 Please sit and take a rest at least 10 minutes before measuring.
STEP 3- Assemble the cuff as Figure
40. The smooth cloth is on the inside
of the cuff loop and the metal D-ring
will not touch your skin (Fig. 40) ..
STEP 4- Hold your left arm in front of you
with your palm facing up. Slide the cuff
onto your left arm, above your elbow. The
red line on the edge of the cuff should be
approximately 0.8 to 1.2 inch (2 cm to 3
cm) above your elbow. Align the tubing
over the main arteries at the inside of your
arm (Fig. 41).
STEP 5-Place your elbow on a table or
other object.relax your hand with the plam
facing up.relax and make sure the cuff is
the same height as your heart.press the
button.remain still and do not talk or
move during the measurement (Fig 42).
(Fig.39)
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WARINING
It is extremely important that the cuff is at the same level of the heart. If the cuff
is relatively lower (higher) than the heart, the blood pressure measured will be
higher (lower) than the actual value. A 15 cm difference in height may result in
an error of 10 mmHg.
( Fig. 43)
(Fig. 44)
(Fig. 45)
NOTE
If you press the button during the measurement, the monitor will turn off.
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STEP 6- All the LCD display symbols will
appear with a long “beep” sound (Fig. 43).
Then cuff begins to inflate automatically.
STEP 7- After the cuff pressure is reached,
the cuff begins to deflate. When detecting
pulse, the Pulse Symbol “ ” will flash,
along with a beeping sound during
measurement (Fig. 44).
STEP 8- After the measurement, the
monitor displays the systolic pressure,
diastolic pressure, and heart rate (Fig. 45).
Press the button to switch off. Or it will
switch off automatically after 3 minutes.
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HOW TO USE THE MEMORY FEATURES
Viewing Memory in the Monitor
Your monitor stores the most 352 recent results of blood glucose and blood
pressure with date and time in its memory. You can review the test results in
memory with these easy steps.
STEP 1- When the monitor is off, press the M Button
once. You will see the average of the blood glucose
results (Fig. 46).
(Fig. 46)
STEP 2- Press the M Button again to recall the
readings measured previously. The other results will
be displayed in the order of time and date taken. You
will see the number of the result stored, followed by
the result (Fig. 47). When the memory is full, the
oldest results are deleted as new ones are added.
Note
1. When using the monitor for the first time, or when there are
no test results in memory, you will only see flashing “ ”.
This means that there are no test results in memory (Fig. 48).
2. The control solution results are NOT stored in the memory
(please also go to page 26 NOTE for information). The list of
past results are for blood glucose results and blood pressure
results and the result average are for blood glucose results.
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(Fig. 48)
(Fig. 47)
STEP 3- Press the button to turn off the monitor and exit the memory mode.
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HOW TO USE THE MEMORY FEATURES
Deleting Memory
To clear the memory, with the monitor turned off, press
and hold the M Button for 3 seconds. “CLr/ALL” then
appears and indicates that ALL the memories stored in
the monitor will be cleared (Fig. 49).
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(Fig. 49)
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HOW TO TAKE CARE OF YOUR MONITOR
Cleaning
To clean the monitor exterior, wipe with a cloth moistened with tap water or a
mild cleaning agent, then dry the device with a soft and dry cloth. Do not
flush with water.
Do not use organic solvents to clean the monitor and cuff.
The cuff can be cleaned by wiping with a moistened cloth and soap. Do not
immerse in water.
Storage
1. Monitor Storage
Storage conditions: -20℃~60℃, 10%~95%
relative humidity.
Always store or transport the monitor in its original
storage case.
Avoid dropping and strong impact.
Avoid direct sunlight and humidity.
Do not disassemble, modify or try to repair the
monitor or wrist cuff by yourself.
Do not over-wring the cuff and turn the cuff inside
out.
If you are not going to use the monitor for an
extended period, please remove the batteries
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2. Strip Storage
Storage condition: 4oC-40oC, below 85% relative
humidity. Do NOT refrigerate.
Store your test strips in their original vial only. Do not
transfer to other container.
Store test strip packages in a cool and dry place.
Keep away from direct sunlight and heat.
After removing a test strip from the vial, immediately
replace the vial cap and close it tightly.
Touch the test strip with clean and dry hands.
Use each test strip immediately after removing it from
the vial.
Write the discard date (the date opened plus 90 days)
on the vial label when you first open it. Discard
remaining test strips 90 days after first opening date.
Do not bend, cut, or alter a test strip in any way.
Keep the strip vial away from children since the cap
and the test strip may be a choking hazard. If
swallowed, promptly see a doctor for help.
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3. Control solution storage
Storage condition: Store the control solution tightly
closed at temperature below 30℃ (86 ). ℉Do NOT
refrigerate.
Record the discard date (date opened plus 90 days) on
the control solution vial. Discard after 90 days.
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PROBLEM-SOLVING GUIDE
Following is a summary of some display messages. These messages help to
identify certain problems but do not appear in all cases when a problem has
occurred. Improper use may cause an inaccurate result without producing an
error message. In the event of a problem, refer to the information under action.
Never try to disassemble the monitor in any circumstances. If you
encounter any error messages not listed below or if you have followed
the actions recommended below but the problem keeps unsolved, please
call the customer service for support.
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ERROR MESSAGE
Message Cause What to Do
Err.00 Weak pulse.
Err.02 Monitor can not figure out
systolic pressure.
Err.04 Monitor can not figure out
diastolic pressure or it is out
of range.
Refit cuff tightly, relax, and repeat
measurement as shown in "Applying
the Pressure Cuff".
Err.22 Invalid coding. Insert the code strip and try coding
again.
Err.24 Used strip insertion. Use a new strip.
Err.25 Ambient temperature is
below operating
temperature.
Err.26
A
mbient temperature is over
operating temperature.
Please operate this monitor between
10℃ ~40℃
Lo Blood glucose value lower
than 20 mg/dL
Hi Blood glucose value higher
than 600 mg/dL
Follow directions in “HOW TO
MEASURE BLOOD GLUCOSE” and
test again. Please seek immediate
medical assistance.
Err.05
Err.06
Err.09
Err.10
Err.11
Err.15
Err.20
Err.28
Those messages indicate internal problems with the monitor. You
cannot fix by yourself.
Please contact your local agent for help.
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Problem in Operation
Please check the chart below for problems you may encounter during
measurement and what to do. If you follow “What to Do” but the problem still
exists, please contact Customer Service Line for help.
Blood Glucose Function
If no message appears after inserting a test strip:
Possible Cause What to Do
Batteries exhausted. Replace the batteries.
Batteries incorrectly installed or
absent.
Check that the batteries are correctly
installed.
Test strip inserted upside down or not
completely inserted.
Insert the test strip correctly
With the contact bars end first and
facing up.
Defective monitor. Please contact your local customer
service for help.
If the test does not start after applying the sample:
Possible Cause What to Do
Insufficient blood sample. Repeat the test with a new test strip
and a larger sample.
Defective test strip. Repeat the test with a new test strip.
Defective monitor. Please contact your local customer
service for help.
If you accidentally touch the button during glucose measurement, or if you
do not apply a drop of blood in 3 minutes, the monitor will turn off with a
beeping sound. Please remove the strip from the slot.
If you remove the strip form the slot before the monitor finishes count down,
the result will not be accurate. Please use a new strip to test again.
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Blood Pressure Function
If there is no display after pushing the button.
POSSIBLE CAUSE WHAT TO DO
Batteries exhausted. Replace the batteries.
Batteries incorrectly installed
or absent.
Check that the batteries are
correctly installed.
What happened?
If the heart rate is higher/lower than user’s average.
POSSIBLE CAUSE WHAT TO DO
Moving during measurement. Repeat measurement.
Measuring right after
exercise.
Rest at least 30 minutes
before measurement.
If a result is higher/lower than user’s average measurement.
POSSIBLE CAUSE WHAT TO DO
May be not in correct position
during measuring.
Adjust to a correct position to
measure.
Blood pressure naturally
varies from time to time.
Keep in mind for next
measurement.
If the cuff inflates again during measuring.
POSSIBLE CAUSE WHAT TO DO
Cuff is not fastened. Fasten the cuff again.
Normal action. If user’s blood pressure is higher than the
previous value, the device would automatically pump to a
higher pressure by until it reaches a suitable pressure. Keep
relax and wait for the measurement.
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SPECIFICATIONS
System Performance
Power source: Four 1.5V AA alkaline batteries
Size of monitor w/o cuff: 137mm (L) x 90 mm (W) x 54 mm (H)
Memory: 352 measurement results with date& time
Power saving: Automatic power off if idle for 3 minutes
System operating condition: 10℃-40 (50℃-104℉), below 85% RH
System storage condition: 4 to 40 (39℃℃-104℉), below 85% RH
Blood Glucose Measurement Performance
Measurement unit: mg/dL or mmol/L
Linear range: 20-600 mg/dL (1.1 -33.3 mmol/L)
Precision: ±5 % (CV)
Accuracy: ±15mg/dL when glucose <75mg/dL
±20% when glucose 75mg/dL≧
Ketone warning: glucose value is over 240 mg/dL
Blood Pressure Measurement Performance
Pressure range: 0-300 mmHg
Heart rate range: 40-199 beat per minute
Measurement unit: mmHg or KPa
Accuracy of pressure: ±3mmHg or ±2% of reading
Accuracy of heart rate: ±4% of reading
Maximum inflation pressure: 300 mmHg
Typ. RF Characteristics
Receive sensitivity: -90dBm
Max. Transmit power: 0dBm
Transmit power: 3.6V
Maximum input signal: -10dBm
RSSI range: -95 to -10dBm
RF Port impedance-SMA
Connector: 50 ohm
VSWR (max): 2:1
The device has been certified 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
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FCC STATEMENT
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of
the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
Operation of this equipment is subject to the following two conditions:
(1) This device may not cause harmful interference.
(2) This device must accept any interference received, including interference
that may cause undesired operation.
FCC RF Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment. End users must follow the specific operating
instructions for satisfying RF exposure compliance. This transmitter must not
be co-located or operating in conjunction with any other antenna or transmitter.
NOTE
The changes or modifications not expressly approved by the party responsible
for compliance could void the user’s authority to operate the equipment.
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Manufacturer: U.S.A Agent
TaiDoc Technology Corporation Fora Care Inc.
4F, No.88, Sec. 1, Kwang-Fu Rd. 223E Thousand Oaks Blvd. Suite 121,
San-Chung, Taipei County, Taiwan Thousand Oaks, CA, 91360
TEL: 886-2-66358080 Customer Care Line:
FAX: 886-2-66355959 805-230- 3068
Hours of Operation: 9 am- 4 pm PDT
At all other times, you should contact your health care professional for
assistance.
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