While we've made every effort to make this manual accurate. The OCR software used to convert printed material into a screen reader usable format can often cause errors. Therefore we strongly urge users of this material to keep this in mind as you make use of this manual.
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 contactDiabetic Supply of Suncoast, Inc. For all non system health related questions you should contact your health care professional for assistance.
47-3223A-0011. 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. Do not use the device near a mobile phone or microwave oven, or it
may cause inaccurate results.
The Advocate Duo™ TD-3223A/B System is designed for use on individuals age16and above. It shall NOT be used: To diagnose newborns with diabetes. On infants or persons who cannot communi - cate. This device does NOT serve as a cure of any symptoms or diseases. 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 near a mobile phone or microwave oven or it may cause inaccurate results. Do NOT use the device for purposes other than measuring blood glucose and blood pressure for human beings.
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%*.1The results you get with the Advocate Duo™ TD-3223A/B system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
Source: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), 138. *1: American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).
Page 5Blood Pressure Clinical studies show that the adult diabetes is often accompanied by elevating 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 pres sure 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:
The Advocate DuoTM TD-3223A/B 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 testing of newborns.
Principle of MeasurementBlood 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 glu cose or blood pressure at a time) to avoid any interference problems.
The greatest feature of this system is itsspeaking function (with a talking symbol on the monitor), which is an acoustic aid for users especially with visual disability. Please note that this function is optional. If the monitor does not have , it will not provide speaking function.
Another unique feature is its internal established code. Not only does it simplify the glucose test, but it also provides you and your doctor with more precise and accurate test results.
Page 7Alternative site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels. This system allows 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.
Page 8Food, 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 to 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.
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 glu cose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.
If you would like to obtain blood from sites other than the finger, replace the lancet device cap with the clear cap. The clear cap for AST is an optional accessory, please contact your local customer service.
NOTE: We suggest that before getting a drop of blood rub the pucture site about 20 seconds before penetration.
Page 9The above products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only Advocate Duo™ TD-3223 test strips and Advocate™ control solution with your Advocate Duo™ TD-3223A/B Monitor.
NOTE ! 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.
Page 10Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the absorbent hole of the test strip and is automatically drawn into the reaction cell where the reaction takes place.
1. Battery Symbol appears with your test result. This means it is about time to change the batteries although still 30 more measurements can be made.
2. Error message“ ” shows together with flashing “ ” and “ low”. This means you must change the batteries before making any measurements.
Page 14Step 1 Press the buckle on battery cover and lift up to remove cover.
Step 2 Replace with two new 1.5V AAA alkaline batteries and close the cover.
Please remember: When “ ” appears, the monitor cannot speak but beeps instead. Do not use different type/brand name or used batteries together. Use only the new ones in required size and type. Replacing the batteries does not affect previously stored test results. But the settings may need to be updated again. 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).
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.
Discard batteries according to your local regulations.Time, date, units, memory deletion, speaking function (optional) can be set in the monitor. Two keys are involved: Set button and M button.
step 1: press the set button to start setting.
step 2: year flashes first.
step 3: press the M button to make changes. press the set button to next.
step 4: date flashes. follow step 3 for changes.
step 5: time flashes. follow step 3 for changes.
step 6: unit of glucose concentration flashes. follow step 3 for changes.
step 7: unit of blood pressure flashes. follow step 3 for changes.
step 8: unit of temperature flashes. follow step 3 for changes.
step 9: (M) memory flashes. if you would like to skip this step, press set button
to next. if you would like to delete memory, press M button again so that "del" and
M will both flash. press M button again to delete all memory. "clr/all" appears and
then the monitor automatically goes to the next step.
Page 16
step 10: speaking volume number flashes. follow step 3 for changes.
step 11: language flashes. follow step 3 for changes.
Please remember: Number can be advanced faster by holding down the M button.
While setting speaking volume, number 0 indicates that the speaking
function is off, where “
” does not display. Number 1 to 7 indicates
speaking volume from low to high and “
” is displayed.
If the monitor does not contain speaking function, it will be automatically
shut down after Step 9.
Step 10 and Step 11 are only for the monitor with speaking function.
*3: The mg/dL unit is standard in the United States. The mmol/L unit is
standard in Canada.
The time, date, unit of measurement and unit of temperature can ONLY
be changed in the setting mode. Therefore, when you perform testing,
those parameters are not possible to be changed.
1. Do not use expired test strips and control solutions for test. Failure to do so will lead to error reading.
2. Test results below 60mg/dL*
4 (3.3mmol/L) indicates hypoglycemia,
which means abnormally low glucose level. If higher than 240*5 mg/dL(13.3mmol/L), symptoms of hyperglycemia might occur. Consult your
physician when a result above occurs.
3. Apply only capillary whole blood sample to the absorbent hole. Applying
other substances to the absorbent hole will cause inaccurate results.
4. If you have symptoms that are not consistent with your blood glucoseor pressure level AND you have followed all instructions described inthe owner’s manual, contact your healthcare professional.
1. Severe dehydration and excessive water loss may cause false low results.
2. A red blood cell percentage (hematocrit) that is extremely high (above60%) or low (less than 20%) may cause false results.
3. Elevated blood triglyceride, reducing substances such as uric acidand ascorbic acid at normal blood concentration, or acetaminophen,
dopa, methyldopa, L-dopa, and tolbutamide at normal blood concen-
trations do not significantly affect the test results.
When using the system for the first time, or before using a new vial of test strips, you will need calibration, which can be easily done by selecting the code number from the monitor. Code selection can be approached when the monitor is off, or when the monitor has a test strip inserted. Only test blood glucose when the codes are identical, so the test results will be accurate.
Step 1Directly press the Code button.
“Code” and “SEL” appear first. Next, a
flashing code number shows.
Step 2While the code number is flashing, press the Code button to
advance one number until the correct
code appears.
Step 3 Press the M button to set the code or wait 5 seconds for auto-save.
” appears, which indicate that calibration is complete. The monitor will automatically turn off after showing “ OFF ”.
Page 19Step 1 Insert the test strip and wait until the code number flashes.
Step 2 Press the Code button to select code number while the number is
flashing.
Step 3 Press the M button to set the code or wait 5 seconds for auto-save.
Then blood drop symbol flashes. You
can apply test sample now.
Warning!
It is important to make sure that the LCD displayed code is the same
as the code on the test strip vial before testing. Failure to do so will get
inaccurate results.
Advocate™ 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.
When you use this system to test your blood for the first time, practicethe procedure using control solution. When you can do three tests ina row that are within the expected range, you are ready to test yourblood.
To routinely check the monitor and test strips, perform a single test for each level of control solution supplied at least once a week.
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 TAKE CARE OF YOUR MONITOR & STRIP section of this
manual).
When you want to practice running the test.
If you drop the monitor.
Use only Advocate™ 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
(20-25°C/68-77°F) 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 30°C
(86°F). Do not refrigerate.
PLEASE NOTE
The control solution range printed on the test strip vial is for Advocate™
control solution only. It is used to test monitor and test strip performance.
It is not recommended range for your blood glucose level.
Step 1 Insert Test Strip and Check the Code Number
Be sure the code number on the display
matches the code number on the test strip vial. If the code numbers
do not match, please refer to “page
19~20” for the correct code selection.
Step 2 Press the M button
After blood drop symbol flashes, press the M button and then “CTL” appears
on the display. With the “CTL” sign on
the display, the monitor will NOT store
your test result in memory.
WARNING!
Contact bars must be inserted all the way into the monitor 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.
Shake the control solution vial well before
squeezing. Discard the first drop,
wipe off the dispenser tip and squeeze
the second one into a fingertip.
Step 4 Apply Control Solution
Move your finger (with control solu tion
on it) close to the absorbent hole.
The drop is auto-drawn into the test strip. The monitor begins to count
down.
To avoid contamination, please do not
directly apply the control solution into
the test strip.
Step 5 Read and Compare the Result
Compare the result with the range printed on the test strip vial. The result should fall within this range.
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. Contact your local customer service for help.
Page 24Wash and dry your hands first before starting. To test your blood glucose, you will need: the monitor, test strips, the lancing device, and lancets.
Step 1 Set the lancing device
Remove the cap of the lancing device.
Insert a lancet into the lancet holder
and push down firmly until it is fully
seated.
Twist the protective disk until it separates
from the lancet.
Replace and screw the lancing device
cap until it is snug but not too tight. Adjust
depth of penetration: 1-2 for soft
or thin skin, 3 for average skin, 4-5 for
thick or calloused skin. For AST, use
clear cap instead of lancing device
cap to get a drop of blood easily.
Slide the ejection/cocking control back until it clicks. If it does not click, the lancing device may have been cocked when the lancet was inserted.
Warning!Always use a new, sterile lancet. Lancets are for single use only. Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device.
Page 25Step 2 Insert the test strip and check the code number
Take a test strip out with clean and dry
hands first.
Insert a test strip with contact bars end
first and the “ ” side of the test trip
facing up into the test slot. The monitor
turns on automatically. The sequences
of LCD display are shown below.
The code number and flashing
will
be kept for 3 minutes until the drop of
blood is applied.
Be sure the code number on the display
matches the code number on
the test strip vial. If the code numbers
are different, please refer to section
of “ Calibration”, for the procedure of
coding.
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.
Page 26Step 3 Get a drop of blood
Select the puncture site either in finger
or limbs. Clean the puncture site with
70% alcohol cotton and let it air dry.
Fingertip
Hold the lancing device firmly against
the side of your finger. Press the re lease
button. You will hear a click, indicating
that the puncture is complete.
Site other than FingertipFollow the section of “Alternative Site
Testing” to obtain blood.
After penetration, gently massage the
punctured area to obtain blood. But
pay attention NOT to smear the blood
sample. It is recommended to discard
the first drop of blood with a clean tissue
paper or cotton and use the second
drop of blood for testing. Since the
first drop of blood usually contains tissue
fluid and serum, which may affect
the test result.
Choose a different spot each time you test. Repeated punctures in
the same spot may cause soreness and calluses.
Before you decide to do AST, please consult your health professional
first.
Step 4 Apply blood into the
test strip
When flashes on the display, hold and
touch the absorbent hole of test strip to
the drop of blood until the confirmation
window is completely filled.
Step 5 Read a result
Your test result appears after the monitor
counts to 0. This blood glucose result
displays along with Date/Time and
is automatically stored in the monitor
memory. Turn the monitor off by re moving
the test strip. Discard the used
test strip carefully to avoid contamination.
Step 6 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.
The used lancet and the used test strip may be potentially biohazardous. Please discard it carefully according to your local regulations.
Page 28Test results from the monitor and laboratory are both expressed in plasma- equivalent units. However, 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 guide-lines below.
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.
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
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
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
meter result to be different from a laboratory result.
1. Avoid caffeine, tea, alcohol, and cigarettes 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 conditions.
6. Keep the records for your physician as reference.
7. Blood pressure varies from two hands naturally. Always measure your
blood pressure on the same wrist.
Slide the cuff onto your wrist. Wrap the cuff comfortably around your wrist.
0.6 cm to 1.3 cmThe top margin of the monitor should be about 0.6 cm to 1.3 cm (1/4 to ½ 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 firmly against the hook material.
Always apply the wrist cuff first before turning on the device. Failure to do so will damage the device.Step 1 Sit down for at least 10
minutes before measuring.
Step 2 Apply the wrist cuff according to page 32.
Step 3 Press the 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.
Step 4 Measurement is in prog ress.
After power on, all symbols in the display will appear with a long “beeping ” sound.
Then the cuff begins to inflate automatically.
You will see number increasing in
the display.
After the cuff pressure is reached, the cuff
begins to deflate. You will see number decreasing
and flashing in the display.
Step 5 Read a result.
The monitor displays the systolic pressure,
diastolic pressure, and heart rate
along with Date/Time. Press
button to switch off. Or it will switch off automatically
after 3 minutes.
Please remember: It is extremely important that you put the device at the same level of
the heart. If the device is put relatively lower (higher) than the heart,
your measurement will be higher (lower) than the actual value.
If a higher pressure value is needed, the monitor will stop deflation
and inflate again.
If you press the
button during the measurement, the monitor will turn
off immediately.
Your blood pressure result comes with indicators that transfer special messages for your reference.
Message What it meansrange: systolic pressure between 100 and 140
mmHg; diastolic pressure between 70 and 90
mmHg.
and the “abnormal” result both flash
when your result is below reference range:
systolic pressure less than 100 mmHg; dia -
stolic pressure less than 70 mmHg.
and the “abnormal” result both flash
when your result is higher than reference
range: systolic pressure over 140 mmHg;
diastolic pressure over 90 mmHg.
Your monitor stores the most recent 450 test results, and also provides the average of the blood glucose test results currently stored. Please follow the steps listed below to review those results.
View Results on the MonitorStep 1 When the monitor is “off”, press and release the M button.
“01”appears first, followed by the latest result of blood glucose/blood
pressure along with date and time.
Step2 Press the M button once by once to recall the rest results
stored in the monitor consecutively.
Step3 After viewing the oldest test result , push down the M button
again to resume to the latest test result.
Step 1When the monitor is off, keep pressing the M button for 3
seconds. The 7-day average of blood glucose results will be shown
first.
Step 2 Press the M button once by once to review the 14-, 21-, 28-,
60-and 90-day average in order.
Step 3 After viewing the 90-day average , push down the M button
again to resume to the 7-day average.
Memory Symbol Interpretation: The average of 14 glucose tests performed in the last 7 days is 98 mg/dL.
1When using the monitor for the first time, “---” appears, showing that there is not any test result stored in memory.
Please remember:Results in memory can be transmitted to the personal computer. Health Care System Software and an Interface Cable are required before installation. The software can be downloaded from: www.dsosi.com. The interface cable is an optional accessory. Please contact your local customer service for purchasing.
Step1 Install Software
Install Health Care System Software on your Computer by following the
instructions provided on Advocate’s website: www.dsosi.com.
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. Then “PCL” and time will appear
in the display, indicating that the monitor is ready to transmit data.
Step3 Transmit Data
Follow the instructions provided in the software to transmit data. Results
transmitted will include date and time. Remove the cable and the monitor
will automatically turn off.
To avoid the monitor and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
1.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.
2.Do not use organic solvents to clean the monitor and cuff.
3.The cuff can be cleaned by wiping with a moistened cloth and soap.
Do not immerse in water.
1. Monitor Storage
Storage condition: -20°C~50°C,
below 95% relative humidity.
Always store or transport the monitor in its original bag.
Avoid dropping and strong impact.
Avoid direct sunlight and humidity.
Do not disassemble, modify or try to
repair the monitor or wrist cuff by your
self.
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.
2. Strip Storage
Storage condition: 4°C-40°C,(39°F/104°F)
below 85% relative humidity.
Do NOT refrigerate.
Store your test strips in the 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.
3. Control solution storage
Storage condition: Store the control solution
tightly closed at temperatures below
30°C(86°F). Do NOT refrigerate.
Record the discard date (date opened
plus 90 days) on the control solution
vial. Discard after 90 days.
Following is a summary of some display messages and symbols. 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 pro ducing an error message or a symbol. In the event of a problem, refer to the information under TROUBLESHOOTING.
Never try to disassemble the monitor in any circumstances. If you encounter any error messages not listed be low or if you have followed the actions recommended below but the problem remains unsolved, please call the customer service for support.
Page 42If you follow the action recommended but the problem still exists, or error messages other than the ones below appear, please call your local customer service. Do not try to repair by yourself.
Error MessageThe strip is still inside the slot . Remove the strip. If you need to test blood glucose, insert an unused strip.
Page 44Normal action. If user’s blood pressure is higher than the previous value, the device would automatically pump to a higher pressure until it reaches a suitable pressure. Keep relaxed and wait for the measurement .
Page 46The 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.
Page 47When a talking symbol is on the monitor, it means that the monitor provides speaking function. The following pictures tell you when and what the monitor “speaks”.
Blood Glucose MeasurementCall us with Questions or Comments about your Advocate Blood Glucose Monitor. We are here to help. 9am - 5pm EST., Mon - Fri.
Toll Free 1-866-373-2824Before using these products carefully read the owner’s manual. For in vitro diagnostic use only. Store at room temperature below 86F (30C). Keep out of direct sunlight and humidity.
The Advocate Duo is warranted to be free of defects in material and workmanship for the period of one (1) year from the date of purchase. The warranty is not transferable. This warranty does not apply to the performance of an Advocate Meter that has been damaged by accident or has been altered, misused, tampered with, or abused in any way.
Distributed byCreated on ... May 16, 2007