Dear Advocate™ TD-4223 A/B System Owner: You have chosen one of the best blood glucose monitoring systems. This manual contains important information you must know about the system. Please read it thoroughly and carefully. The greatest feature of this system is its speaking function (with a talking symbol on the meter), which is an acoustic aid for users especially with visual disability. Please note that this function is optional. If the meter does not have , it will not provide speaking function.
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.
TABLE OF CONTENTS IMPORTANT SAFETY INSTRUCTIONS 1 IMPORTANT INFORMATION 4 ABOUT ATERNATIVE SITE TESTING (AST) 6 INTRODUCTION OF THE SYSTEM 8 Intended Use 8 Principle of Measurement 8 9 Contents of the System Appearance and Key Function of the Meter 10 Meter Display Segments 11 Speaking Function 12 Appearance of the Test Strip 13 PRERPARATION BEFORE USE 14 Setting the Meter and Deleting the Memory 16 21 BEFORE TESTING Checking the Display 21 Calibration 21 Checking with Advocate™
COMPARING METER AND LABORATORY RESULTS 37 USING THE METER MEMORY 39 Viewing Results on the Meter 39 Viewing Results on a Personal Computer 43 CARING FOR YOUR METER AND TEST STRIPS 45 Cleaning 45 Storage 45 PROBLEM-SOLVING GUIDE 48 Result Indicator 49 Error Message 50 Problem in Operation 51 SPECIFICATIONS 53 SYMBOL INFORMATION 54 WARRANTY/CUSTOMER CARE 55 3
IMPORTANT INFORMATION 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. 1 Test results below 60 mg/dL* (3.3 mmol/L) mean low blood glucose (hypoglycemia). Test results greater 2 than 240 mg/dL* ( 13.3mmol/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.
The following WILL NOT affect results: Elevated blood triglyceride, reducing substances such as uric acid and ascorbic acid when occurring in expected blood concentration, or acetaminophen, dopa, methyldopa, L-dopa and tolbutamide occurring in expected blood concentrations. This system may be used at altitudes up to 10,742 feet (3,275 m) without an effect on test results. *1. Kahn, R., and Weir, G,: Joslin’s Diabetes Mellitus, 13th ed. Philadelphia: Lea and Febiger (1994), 489. *2 Krall, L.P.
ABOUT 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 pam, l the forearm, the upper arm, the calf, or the thigh with the equivalent results to fingertip testing.
We strongly recommend you do AST ONLY in the fol lowing 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 awareness of being hypoglycemia. 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.
INTRODUCTION OF THE SYSTEM Intended Use The system is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples. The system is intended for use in the home and in clinical settings. It should not be used for the diagnosis of diabetes or for the testing of newborns.
Contents of the System The system should be used with three main products: the blood glucose meter, test strips, and a control solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only the Advocate test strips and Advocate TM control solution with your AdvocateTM TD-4223 A/B Monitor. TM Your system includes: 1. A Meter 2. Owner’s manual 3. Sporty carrying case 4. Quick reference guide 5.
Appearance and Key Function of the Meter TEST SLOT Is where you insert the test strip. The meter will turn on automatically after insertion. TD-4223 LCD DISPLAY Guides you though the test using symbols and simple messages. CODE CODE BUTTOM Located in front of the meter, is for code selection. MAIN BUTTOM Located in front of the meter with “m” on it, is used to turn on the meter, enter the memory mode and control steps of setting. TALKING SYMBOL Indicate that the meter contains speaking function.
Meter Display Segments VOICE SYMBOL TEST STRIP SYMBOL Indicates speaking function is on/o ff. Appears when the meter is turned on. TEST RESU LT AREA Displays glucose results. A decimal point appears when the measurement unit is mmol/L . BLOOD DRO P SYMBOL Flashes when it is ready to apply the sample. LOW BA TTER Y SYMBOL CODE Appears when the bat- Appears with the code number cur rently in use. tery power is lo w.
Speaking Function When a talking symbol is on the meter, it means that the meter provides speaking function. It “speaks” step by step and leads you through a blood glucose test. The following table tells you when and what the meter “speaks”. Those messages can also be found in the end section of this manual “SUMMARY OF OPERATION”. WHEN does the meter speak? WHAT does the meter speak? When meter is turned on A welcome music plays. Thank you for using this product. Please relax during measurement .
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 meter. Push it in firmly until it will go no further. Test Strip Handle Hold this part to insert the test strip into the slot.
PREPARATION BEFORE USE Battery Replacement Your meter comes with two batteries. 1.5V AAA size alkaline The meter will alert you when the power is getting low by displaying two different messages: 1. The symbol appears together with other display messages: the meter is functional and the result remains accurate, but it is time to change the batteries. 2. The symbol appears with the E-b symbol and “low”: the batteries can not provide enough power to do a test. You must change the batteries immediately.
To replace the batteries, make sure that the meter is turned off. 1. Press the edge of the battery cover and lift it up to remove. 2. Remove the old batteries and replace with two 1.5V AAA size alkaline batteries. Make sure that the positive “+” side is facing up. 3. Close the battery cover. If the batteries are inserted correctly, you will hear a "beep". 1 3 2 WARNING As with all small batteries, the batteries should be kept away from small children who still put things in their mouths.
Setting the Meter and Deleting the Memory Your meter comes with the time, date, unit of measurement and unit of temperature preset. However if you replace the batteries, you may need to reset the setting of the meter. Start with the meter off. Then press the Set button located in the battery compartment. The meter is now in the setting mode. You can start setting up the meter. STEP 1. Set the Year The year will appear first, with the year setting flashing. Press and release the button to advance one year.
STEP 2. Set the Month Press and release the button until the correct month appears. To move faster, hold the button down. With the correct month on the display, press the Set button and then the day segment flashes. STEP 3. Set the Day Press and release the button until the correct day appears. To move faster, hold the button down. With the correct day on the display, press the Set button and then the hour segment flashes. STEP 4. Set the Hour Press and release the button to advance one hour.
STEP 5. Set the Minutes Press and release the button to advance one minute. To move faster, hold the button down. With the correct minute on the display, press the Set button and then the current unit of measurement starts flashing. STEP 6. Select mg/dL or mmol/L Press and release the button to select the unit of measurement you want to use. Press the Set button and then the current unit of temperature flashes. The milligram per deciliter (mg/dL) is the standard unit in the United States.
STEP 8. Delete the Memory When “dEL” and blinking “ ” symbol is displayed, if you do not want to delete memory, press the Set button again to skip this step. If you would like to delete ALL memory, press button, both “dEL” and “ ” will flash. Press the button again to delete ALL memory. “---” and “ ” are displayed on the meter, following “ ” means that all data stored are deleted. The memory of this meter is empty now.
STEP 9. Select Speaking Function The meter displays “VOL”, “ ” and flashing number. Press the button to select speaking volume from 0 to 7. Then press the Set button to proceed to the next step. Number 0 indicates that the speaking function is turned off, where “ ” does not display on LCD during testing. Number 1 to 7 indicates speaking volume from low to high, where “ ” displays on LCD during testing. STEP 10. Select Languages L1 /L2 and “ ” display on LCD. Press the button to select.
BEFORE TESTING Checking the Display Each time you insert a test strip, the meter displays ”CH” and ” ”. This tells you that the system is performing several self-checks. TD-4223 CODE 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 correct code from the meter. It is important to make sure that the LCD displayed code is the same as the code on the test strip vial before you proceed.
A) Calibrate when the meter is off, directly press the CODE button. Press the Code Button. With “Code” and “SEL” appear first, the flashing code number shows. Press the CODE button to advance one number until the correct code appears. Press the button to set the code. The symbol “ ” and “ OFF ” appear, which indicate that calibration is complet. The meter will turn off automatically. B) Calibrate when the meter has a test strip inserted. STEP 1. Insert the Test Strip Start with the meter off.
STEP 2. Match the Code Number Compare the flashing number with the code number on the test strip vial. If two numbers match, press the button or wait 5 seconds to fix the code. Then date, time and the flashing “ ” appear on the screen, indicating that you can directly begin testing. If they do not match, follow STEP 3 . TD-4223 CODE 63 STEP 3. Select a Correct Code While the code number is still flashing, press the CODE button to advance one number.
the meter 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.
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, meter, 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.
STEP 2. Press the button While the “ ” symbol appears on the display, press the button and then “CTL” will appear on the display. 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 button again, and the “CTL” sign will disappear. TD-4223 CODE TD-4223 CODE STEP 3. Obtain Control Solution Shake the control solution vial well. Remove the cap.
STEP 4. Apply Control Solution Move your finger (with control solution on it) to meet the absorbent hole of the test strip and the drop will be automatically drawn into the test strip. Remove your finger until the confirmation window is filled. The meter begins to count down. To avoid contaminating the control solution with the content of the test strip, you have to place a drop of control solution on a clean surface or on your finger tip first. Then touch the test strip to the drop. STEP 5.
TESTING YOUR BLOOD Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test: A. Blood Glucose Meter B. Test Strip C.Lancing Device D.Sterile Lancet C A TD-4223 B D CODE WARNING To reduce the chance of infection: Never share a lancet or the lancet device with anyone. Always use a new, sterile lancet. Lancets are for single use only.
Testing Procedure Wash and dry your hands first before starting. STEP 1. Set the Lancing Device Screw off the cap of 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 the lancet device cap. Turn the cap until it is snug but not too tight. The adjustable tip offers 5 levels of skin penetration.
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. Blood from sites other than the fingertip A clear cap 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. Turn the clear cap until it is snug but not too tight, and then slide the ejection/ cocking control back until it clicks.
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. 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. Sites other than fingertip Please refer to the section of “About AST” for available punctured sites.
STEP 4. Apply Blood into the Test Strip 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. The meter then begins to count down automatically. TD-4223 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 meter.
STEP 6. Remove the Lancet 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. WARNING The used lancet and the used test strip may be potentially biohazard. Please discard it carefully according to your local regulations.
Expected Test Results 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% *3 The results you get with the Advocate™ TD-4223A/B. system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
COMPARING METER AND LABORATORY RESULTS Test results from the meter and laboratory are both expressed in plasma-equivalent units. However, the result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter 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.
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* 1. 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*2. Therefore, it is best to fast for eight hours before doing comparison tests.
USING THE METER MEMORY View Results on the Meter Your meter stores the 450 most recent blood glucose test results with date and time in its memory. It also provides you with 7, 14, 21, 28, 60 and 90-day averages of your blood glucose test results. You can review the test results in memory with these easy steps. STEP 1. Enter the Memory Mode With the meter turned off, press the button twice. The 7-day average will appear, indicating that you are in the memory mode.
It also indicates how many blood glucose tests have been performed within this period, e.g., 14 (14 tests in the last 7 days). The 14 day average is calculated from the blood glucose results obtained during the last 14 days. It also indicates how many blood glucose tests have been performed, e.g., 28 (28 tests in the last 14 days). It is all the same to the 21, 28, 60, and 90- day average. STEP 2. Recall Test Results After the 90 day average, the most recent test result with date and time will be shown.
When reaching the last set of result, “End” and “ “ will be shown on LCD display, and the meter will be turned off automatically. STEP 3. Exit the Memory Mode Keep pressing the button for 5 seconds to turn off the meter.
PLEASE NOTE The control solution results are NOT 26 WARNING also go to page stored in the memory (please for information). The list of past results and the result average are for blood glucose results only. When pressing the button to recall the test results, the meter will display date, time and the unit of measurement frst. If you do not press the button within 1minute, the blinking “ ” and “ will appear.
Viewing Results on a Personal Computer Results in memory can be transmitted to the personal Interface Cable are required before installation. The software can be downloaded from www.dsosi.com. The interface cable is an optional accessory. To learn more about Health Care System Software or to obtain an Interface Cable separately, please contact customer service. STEP 1. Install Software Install Health Care System Software on your computer by following the instructions provided on Advocate™'s website: www.
STEP 3. Transmit Data Follow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the cable and the meter will automatically turn off. PLEASE NOTE While the monitor is connected to the PC, it is unable to perform a blood glucose test.
CARING FOR YOUR METER AND TEST STRIPS To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. Cleaning Your meter does not require special maintenance. As no blood or control solution comes in contact with the meter, there is no special cleaning required. 1. To clean the meter 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.
Avoid dropping and strong 223 TD-4 impact. E COD Avoid direct sunlight and humidity. TD-4 CODE 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 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.
Use each test strip immediately TD-4 after removing it from the vial. Write the discard date (the date CO DE 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.
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 producing an error message or a symbol. In the event of a problem, refer to the information under action. Never try to disassemble the meter in any circumstances.
Result Indicator Special symbols and messages appear together with your test result. Message What it means appears when your result is at reference range from 70 to 119 mg/dL(3.9 and 6.6 mmol/L ) appears when your result is between 20 to 69 mg/dL(1.1 and 3.8 mmol/L ). It indicates that the result is below reference range. appears when your result is below measurement limit, which is less than 20 mg/dL (1.1 mmol/L ) Lo or symbol indicates hypoglycemia (low blood glucose).
Error Message Message 50 What it means Appear when the batteries can not provide enough power for a test . Appear when inserting a used test strip . Appear when envi ronmental temperature is below system operation range. Appear when envi ronmental temperature is above system operation range. Actio n Replace the batteries Immediatel y. Test with a new test strip . System operation range is 10~40°C (50~104°F).Repeat the test after the meter and test strip have reached the above temperature.
Problem in Operation 1. If the meter does not display a message after inserting a test strip: PROBABLE CAUSE Battery exhausted. Battery incorrectly installed or absent . Test strip inserted upsidedown or incompletely. Defective meter. WH AT TO DO Replace the battery . Check that the battery is cor rectly installed. Insert the test strip correctly - and “ ” facing up. Please call the dealer for service. 2. If the test does not start after applying the sample: PROBABLE CAUSE Defective test strip.
3. If the control solution test result is out of range: POSSIBLE CAUSE W HA T TO D O 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. Shake the control solution vigorously and repeat the test again. Do not shake the control solution vial very well. Expired or contaminated control solution. Control solution that is too warm or too cold.
SPECIFICATIONS Model No.:TD-4223 A/B Dimension&Weight: 96mm(L) x 20mm(W) x 45mm(H) / 68g Power source: two 1.5V AAA alkaline batteries Battery life: Over 1,000 determinants Display: Large LCD Memory: 450 measurement results with date and time Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Sleeping mode: Power consumption less than 80uA Auto turn-off after 3 minutes without action Temperature warning Operating condition: 10°C~40C, (50°F~104°F) below 85% R.H.
SYMBOL INFORMATION Symbol Referent In vitro diagnostic medical device Do not re-use Consult operating instruction Keep away from sunlight Keep dry Temperature limitation Use by Date of manufacture Batch code Manufacture Serial Number Caution, consult accompanying documents Biological risks 54
Advocate 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 -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 86 F (30 C). Keep out of direct sunlight and humidity.
