Advocate Duo Blood Pressure Glucose Monitor Manual

Important Notice To Readers of This Manual

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.

Advocate Duo™ TD-3223A/B Blood Glucose plus Blood Pressure Monitoring System

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

Diabetic Supply of Suncoast, Inc. For all non system health related questions you should contact your health care professional for assistance.

47-3223A-001
Version: 1.0 2006/11/14

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. Do not use the device near a mobile phone or microwave oven, or it may cause inaccurate results.

KEEP THESE INSTRUCTIONS

Table of Contents Table of Contents

BEFORE YOU START 04
Warnings and Precautions
04
Health Information
05
ABOUT THIS SYSTEM
07
Intended Use 07
Principle of Measurement 07
Major Features 07
Alternative Site Testing 08
Contents of the System 10
Appearance and Key Function of the Monitor 11
LCD Display 12
Appearance of the Test Strip 13
PREPARATIONS BEFORE USE 14
Battery Installation and Replacement 14
Setting the Monitor 16
BLOOD GLUCOSE MEASUREMENT 18
Important Information 18
Possible Interferences 18
Calibration 19
Checking with Advocate™ Control Solution 21
Important Control Solution Information
22
Do a Control Solution Test
23
Testing Your Blood Glucose
25
Reading Your Result
29
Comparing Monitor and Laboratory Results
30
BLOOD PRESSURE MEASUREMENT
32
Suggestions Before Measuring
32
Correct Application of the Pressure Cuff
32
Testing Your Blood Pressure 33
Reading Your Result 35
MONITOR MEMORY 36
Viewing Results on the Monitor 36
Viewing Results on a Personal Computer 38
TAKE CARE OF YOUR MONITOR & STRIP 39
Cleaning 39
Storage 39
PROBLEM-SOLVING GUIDE 42
Error Message 43
Problem in Operation 44
SPECIFICATIONS 47
SYMBOL INFORMATION 48
WHEN/WHAT DO YOU HEAR 49
Blood Glucose Measurement 49
Blood Pressure Measurement 50
SUMMARY OF OPERATION 51
Warranty/Customer Care 51
Page 3

Warnings and Precautions

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.

BEFORE YOU START

Page 4
Do NOT apply the cuff to body areas other than the wrist.

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%*.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.

Time of day

Glucose range for people without diabetes
(mg/dL)/(mmol/L)
Here are guidelines for Non Diabetics.
(mg/dL)/(mmol/L)

Before breakfast (70-105)/(3.9-5.8) (mg/dL)/(mmol/L )

Between 2 and 4 AM Greater than (70)/(3.9) Before lunch or dinner (70-110)/(3.9-6.1)
1 hour after meals Less than (160)/(8.9) 2 hours after meal Less than (120)/(6.7)

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 5

Blood Pressure

Blood 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:

diastolic

Source: 1999 WHO/ISH guidelines for the management of hypertension.
*2:American Diabetes Association: The Diabetes-Heart Dis-ease Link Surveying Attitudes, Knowledge and Risk (2002).
grade 3 hypertension-severe: systolic-over 180 diastolic over 110
grade 2 hypertension-moderate: systolic 160-180 diastolic 100-110
grade 1 hypertension-mild: systolic 140-160 diastolic 90-100
high-normal: systolic 130-140 diastolic 85-90
normal: systolic 120-130 diastolic 80-85
optimal: systolic less than 120 diastolic less than 80
Page 6

ABOUT THIS SYSTEM

Intended Use

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 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 glu cose or blood pressure at a time) to avoid any interference problems.

Major Features

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 7

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 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 8

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 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.

Do NOT use AST if:

You think your blood glucose is low.
If you are aware of being hypoglyceemic.
Your AST results do not match the way you feel.
You are testing for hyperglycemia.
Your routine glucose results are often fluctuating.
If 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 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 9

Contents of the System

A blood glucose plus blood pressure monitor
Owner’s manual
Sporty carrying bag
First time using guide
Advocate Glucose Meter
WARRANTY CARD

The 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 10

Appearance and Key Function of the Monitor

Test Slot is where you insert the test strip.
Talking Symbol indicates that the monitor has speaking function.
M Button is used to enter the memory and to assist setting.
Button is a power button for blood pressure measurement.
Position Symbol reminds you to put the device at the same level as your heart when measuring blood pressure.
Code Button is for code selection when calibrating.
Data Port is for cable connection.
Set Button is used to set up the monitor.
Speaker is where voice comes from.
Wrist Cuff is used to wrap around your wrist when measuring blood pressure.
Battery Compartment.
Page 11
LCD Display
1 2 3
Memory Mode Symbol
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
4
5
6
7
8
9
10
Temperature Symbol
Test Result & Error Message
Day Average Result
Pulse Rate
Battery Symbol
Result Indicators
Code
Date & Time
Page 12

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 cell where the reaction takes place.

The test strip consists of the following parts:

Contact Bars
Insert this end of the test strip into the monitor. Push it in firmly until it will go no further.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Confirmation Window
This is where you confirm if enough blood has been applied to the absorbent hole of the strip.
Absorbent Hole
Apply a drop of blood here, the blood will be sucked automatically. The minimum required blood volume is 0.7 microliter.
See pages 25~28, Testing Your Blood Glucose, for complete instructions.
Page 13

PREPARATIONS BEFORE USE

Battery Installation and Replacement

Use ONLY 1.5V AAA size alkaline batteries for best performance and longest life.
When the power is getting low, the monitor will remind you by displaying two different messages:

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 14

PREPARATIONS BEFORE USE

Make sure the monitor is off when replacing the batteries.

Step 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.
Page 15

Setting the Monitor

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.

Page 17

BLOOD GLUCOSE MEASUREMENT

Important Information

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.

Possible Interferences

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.

*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.
Page 18

BLOOD GLUCOSE MEASUREMENT

Calibration

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.

Selecting code when the monitor is off

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 19

Selecting code when the monitor has a test strip inserted

Step 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.

Checking with Advocate™ Control Solutions

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.

How often the control solution test should be performed?

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 should the control solution test 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 TAKE CARE OF YOUR MONITOR & STRIP section of this manual).
When you want to practice running the test.
If you drop the monitor.

Page 21

Important Control Solution Information

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.

Page 22

Do a Control Solution Test

Take a test strip out with clean and dry hands first.

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.

Page 23
109~165 Normal
Step 3 Obtain Control Solution

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.

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. Contact your local customer service for help.

Page 24

Testing Your Blood Glucose

Wash 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!
To reduce the chance of infection: Never share a lancet or the lancing device with anyone.

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 25

Step 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 26

Step 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.

Warning!

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.

Page 27

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.

Warning!

The used lancet and the used test strip may be potentially biohazardous. Please discard it carefully according to your local regulations.

Page 28

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
(1.1 mmol/L).
low flashes when your result is between 20 and 69 mg/dL (1.1 to 3.8 mmol/L). It indicates that the result is below reference range.
appears when your result is at reference range from 70 and 120 mg/dL (3.9 to 6.6 mmol/L).
“Lo” or “ low ” symbol indicates hypoglycemia (low blood glucose).You should immediately treat hypoglycemia as recommended by your health- care professional.
flashes when your result is between 121 and 239 mg/dL ( 6.7 to 13.3 mmol/L). It indi - cates that the result is higher than reference range.
KETONE? flashes together with when your result is equal or higher than 240 mg/dL (13.3 mmol/L). This indicates there is a possibility of ketone accumulation if you are Type 1 diabetes.
Please seek immediate medical assistance.
appears when your result is above measurement limit, which is higher than 600 mg/dL (33.3 mmol/L).
Page 29

Comparing Monitor and Laboratory Results

Test 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.

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
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.

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
Page 31

Suggestions Before Measuring

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.

Correct Application of the Pressure Cuff

Slide the cuff onto your wrist. Wrap the cuff comfortably around your wrist.

0.6 cm to 1.3 cm
(1/4 to ½ inch)
below the ball of thumb
Warning!

The 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.
Page 32

Testing Your Blood Pressure

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.

Page 33

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.

Page 34

Reading Your Result

Your blood pressure result comes with indicators that transfer special messages for your reference.

Message What it means
appears when your result is at reference

range: 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.

Page 35

MONITOR MEMORY

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 Monitor
Recall the Stored Test Results:

Step 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.

Page 36

Read the Average of Blood Glucose Results:

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.

The average of glucose tests. Result indicator.
The average was calculated from the test results of the last 7 days.
14 glucose tests have been performed in the last 7 days.

Memory Symbol Interpretation: The average of 14 glucose tests performed in the last 7 days is 98 mg/dL.

1
2
3
4 5

When using the monitor for the first time, “---” appears, showing that there is not any test result stored in memory.

Please remember:
1.The control solution results are NOT stored in the memory (please also go to page 23 WARNING for information).
2.If you’d like to exit from the memory, press the button to turn off the monitor or wait without pressing for 3 minutes for auto-shut down.
Page 37

View Results on a Personal Computer

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.

Please remember:
While the monitor is connected to the PC, it is unable to perform a blood glucose or blood pressure test.
Page 38

TAKE CARE OF YOUR MONITOR & STRIP

To avoid the monitor and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.

Cleaning

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.

Storage

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.

Page 39

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.

Page 40

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.

Page 41

TROUBLESHOOTING

Note To Users of This Section: Symbols used in the printed manual can not be reproduced by the OCR software and screen reader. You should keep this in mind when using this section.

PROBLEM-SOLVING GUIDE

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 42

If 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 Message
Message Cause What to Do
Batteries are dead.
Replace the batteries immediately.
Appears when environmental temperature is below system operation range : 10ºC
System operation range is 10~40°C (50~104°F).
Repeat the test after the monitor and test strip have reached the above temperature.
Appears when environmental temperature is above system operation range : 40ºC
Unable to detect systolic pressure
Refit cuff tightly and correctly.
Relax and repeat measurement.
Unable to detect diastolic pressure
Cuff pressure is not enough.
Used strip insertion.
Repeat the test with a new strip.
Blood glucose value is under measurement range :
20mg/dL Repeat and Seek immediate medical assistance.
Blood glucose value is over measurement range :
600mg/dL
Page 43
1. Blood Glucose Measurement
What happened?
The monitor does not display a message after inserting a test strip.
POSSIBLE CAUSE WHAT TO DO
Batteries exhausted Replace the batteries.
Batteries incorrectly installed or absent .
Check that the batteries ar 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. Contact local customer service

What happened?

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.
Sample was applied
. when flashing blood Symbol was not displayed
flashing
Repeat the test with a new test strip. Apply sample only when appears on the display .
Defective monitor. Contact local customer service
What happened?
If you turned off the monitor but it makes a beeping sound.
POSSIBLE CAUSE WHAT TO DO

The strip is still inside the slot . Remove the strip. If you need to test blood glucose, insert an unused strip.

Page 44

What happened?

If the control solution test result is out of range.
POSSIBLE CAUSE WHAT TO DO
Error in performing the test Read the instruction thoroughly and repeat the test again.
Improper code number
Check if the code number on the display matches the code number on the test strip vial
Do not shake the control solution vial very well.
Shake the control solution vigorously and repeat the test again.
Expired or contaminated control solution.
Check the expire date or the discarded date of the control solution.
Control solution that is to warm or too cold.
, and test strips should come to room temperature before testing.
temperature (20-25ºC/68-77ºF)
Control solution, monitor
Test strip deterioration Repeat the test with a new test strip.
Monitor malfunction. Contact local customer service
Page 45
2. Blood Pressure Measurement
What happened?
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 ar correctly installed.
What happened?

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 .
What happened?

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 .
What happened?

Cuff inflates again during measuring.

POSSIBLE CAUSE WHAT TO DO
Cuff is not fastened. Fasten the cuf f again.

Normal 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 46

SPECIFICATIONS

Model number: TD-3223 A/B
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
0 00
System operating condition: -20C a 60C,(4F – 140F)0 , below 85% R.H.
Monitor storage condition: 4°C to 40°C(39°F to 104°F), below 95% R.H.
Strip storage condition: 4°C to 40°C, (39°F to 104°F) below 85% R.H.
KETONE? warning: glucose value over 240 mg/dL
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
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

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.

Page 47

SYMBOL INFORMATION

Symbol Referent
Invitro diagnostic medical device
Do not re-use
Consult instructions for use
Keep away from sunlight
Keep dry
Temperature limitation
Use by
Date of manufacture
Batch code
Manufacturer
Serial number
Caution, consult accompanying documents
Biological risks
Page 48

WHEN/WHAT DO YOU HEAR

(Special for the monitor with speaking function)

When 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 Measurement
Insert a test strip to begin.
Welcome music.
The room temperature is 27.6 degree Celsius
Thank you for using this product. .
Please relax during measurement.
The code number is 63.
Please apply blood into the strip.
Ending music
The blood glucose is 117 mil ligram per deciliter.
Page 49

Blood Pressure Measurement

Welcome music.
Thank you for using this product.
Please relax during measurement.
The device is in inflation.
The device is in deflation with flashing symbol.
The systolic blood pressure is 146 millimeters of mercury.
The diastolic blood pressure is 82 millimeters of mercury.
The heart rate is 68 beats per minute.
Ending music
Press to start.
Page 50

Advocate Duo Warranty Registration Information

Customer Care

Call us with Questions or Comments about your Advocate Blood Glucose Monitor. We are here to help. 9am - 5pm EST., Mon - Fri.

Toll Free 1-866-373-2824
www.dsosi.com
Important

Before 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.

Warranty

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 by
Diabetic Supply of Suncoast, Inc.
URB Brasilia H-15 Ste 11
Vega Baja, PR 00693
866-373-2824
www.dsosi.com
REF # 305
Return To The Product Text Manuals Page Return To The Advocate Duo Product Page

Created on ... May 16, 2007