Advocate Meters TD-4223 User's Manual
Contents
1. 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 The mmol L is the standard unit in Canada STEP 7 Select C or F Press and release the button to select the unit of temperature you want to use Press the Set button and the meter will display dEL with flashing M symbol eee eee eee ee ee he 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 M button both AEL and M will flash Press the M button again to delete ALL memory and M are displayed on the meter following means that all data stored are deleted The memory of this meter is empty now dEL ia a ley T gt If your meter has a talking symbol on it please press the Set button to proceed to the next step If not you have completed the setting mode Press the Set button2. STEP 1 Install Software Install Health Care System Software on your computer by following the instructions provided on Advocate s website www dsosi com STEP 2 Connect to Personal Computer Connect the interface cable to a serial port of your computer With the meter turned off connect the Interface Cable to the Data Port of the meter PC will appear on the display indicating that the meter is ready to transmit data 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 I l While the monitor is connected to the PC it is unable to perform a l 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 m 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 Do not use organic solvents to clean the meter m Storage Meter Storage zn Storage condition 26C 60C TS below 95 relative humidity Always store or transport the meter i
3. Sees amp a a ee ee INTRODUCTION OF THE SYSTEM E 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 m Principle of Measurement The test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip The meter 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 m 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 control solution with your Advocate 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 Warranty Card Advocate Glucose Meter WARRANTY CARD H PI Check your system to be sure that it is unopened prior to use and that it contains all parts listed above If eith
4. 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 If you encounter any error messages not listed below or if you have followed the actions recommended below but the problem keeps unsolved please call the customer service for support E 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 low 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 Lo appears when your result is below measure ment limit which is less than 20 mg dL 1 1 mmol L Lo or low symbol indicates hypoglycemia low blood glucose You should immediately treat hypoglycemia as recommended by your healthcare professional high appears when your result is equal to or greater than 120mg dL 6 6 mmol L It indicates that the result is higher than reference range KETONE appears together with high when your result is equal or higher than 240m g dL 13 3 mmol L This indic
5. I I I i result with the control solution test result in memory I I I I I I I I I the CTL test mode so that the test result will not be stored in the i I I I I I STEP 2 Press the M 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 STEP 3 Obtain Control Solution Shake the control solution vial well Remove the cap Squeeze the vial discard the first drop and wipe off the dispenser tip to prevent contamination Squeeze the vial again to get another drop and place the drop on your fingertip first J A 2 Beet ee a T 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 ay Correct 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 Read and Compare the Result After counting
6. 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 Twist the adjustable tip in either direction until the number lines up with the Arrow 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin 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 gt 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 gt 0 Note The clear cap is an optional accessory please contact your local customer service The lancing device is now ready Set aside for later use STEP 2 Insert Test Strip Insert a test strip with contact bars end first and facing up into the test slot The meter turns on automatically and displays the following in sequence gt CH and s gt gt ambient temperature gt flashing code number gt date time flashing 4 and the code number Make sure the code number showed on the screen is the same as the code number printed in the test strip vial If the code numbers are diffe
7. order When the memory is full the oldest result is dropped as the newest is added When reaching the last set of result End and will be Fnd shown on LCD display and the meter will be turned off automatically J STEP 3 Exit the Memory Mode Keep pressing the button for 5 seconds to turn off the meter I The control solution results are NOT stored in the memory please also go to page 26 WARNING 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 minute the blinking E and 4 will appear In the meantime you can choose to insert a test strip to start testing your blood or press the M button again to review the stored test results Se gt If no button is pressed for 3 minutes the meter will show OFF I and turn off automatically x a eee eee eee ee ee le m 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
8. ADVOCATE 231 42242000 MANUAL Version 1 0 November 2006 Beet a E T 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 Another unique feature is its internal established code Not only does it simplify the glucose test it also provides you and your doctor with more precise and accurate test results 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 the testing of newborns Before using any product to test your blood glucose read all instructions thoroughly and practice the test Do all quality control checks as directed and consult with a diabetes healthcare professional These recommendations apply to all blood glucose monitoring systems and are supported by the Diabetes Educator Section of the Canadian Diabetes As
9. F LI Congratulations You have finished your meter setting _ 8 Tng s BEFORE TESTING Checking the Display Each time you insert a test strip the meter displays CH and e This tells you that the system is performing several self checks m 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 Only test blood glucose when the codes are identical so the test results will be accurate Calibration can be approached by pressing the CODE button when A the meter is off or B the meter has a test strip inserted Please calibrate the meter according to the following steps O aa aa aaa aE H If the code number displayed on the meter does not match the l number printed on the vial test results may be inaccurate 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 lM to set the code The symbol and OFF appear which indicate that calibration is complet The meter will turn off automatically SE
10. LBE _ OFF B Calibrate when the meter has a test strip inserted STEP 1 Insert the Test Strip Start with the meter off Insert a test strip into the test slot LCD displays CH and first the ambient temperature next and finally a flashing code number 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 STEP 3 Select a Correct Code J While the code number is still flashing p T press the CODE button to advance one number When the correct code appears press the button or wait Code 5 seconds to fix the code Then date 5J time and the flashing appear on the screen You can begin testing 2 25 DOU If you would like to turn off the meter remove the test strip and then OFF is displayed before shut down or wait 3 minutes for automatically shutting down m 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 meter and the test strips are working together as a s
11. abetes 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 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 Time of day Glucose range Your target range mg for people without dL mmol L hour after meals hour after meals Source Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 138 American Diabetes Association position statement on the Diabetes Control and Complications Trial 1993 _ 8 ngs 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 To make an accurate comparison between meter and laboratory results follow the guide lines below Before you go to the lab gt Perform a control solution test to make sure that the meter is working properly gt It is best to fast for at least eight hours before doing com
12. ates there is a possibility of ketone accumulation if you are Type 1 diabetes Please seek immediate medical assistance H appears when your result is above measure ment limit which is higher than 600 mg d L 33 3 mmol L E n ee ee E T T T Message What it means Actio n vide enough power for a test Appear when envi ronmental tempera ture is below system System operation range is operation range 10 40 C 50 104 F Repeat Appear when envi the test after the meter and ronmental tempera __ test strip have reached the ture is above system above temperature operation range Remove the strip af ter applying blood to Re test with a new test strip Review the instructions and Problem with the re test with a new test strip meter If the above steps do not work please contact the dealer rT Ff Ff 8 BEE m Problem in Operation 1 If the meter does not display a message after inserting a test strip Battery exhausted Replace the battery Battery incorrectly installed or Check that the battery is cor absent rectly installed Test strip inserted upside Insert the test strip correctly down or incompletely with the contact bars end first and facing up Defective meter Please call the dealer for service 2 If the test does not start after applying the sample WH AT TO DO Insufficient blood sample Repeat the test using a new test strip with la
13. d the first drop of control solution and wipe off the dispenser tip to ensure a good sample and an accurate result gt Useonlyfor 90 days after first opening Record the discard date date opened plus 90 days on the control solution vial Discard after 90 days gt Store the control solution tightly closed at temperatures below 30 C 86 F Do not refrigerate The control solution range printed on the test strip vial is for Advocate control solution only It is used to test meter and test strip performance It is not recommended range for your blood glucose E n E E 8B fb Fe E Doing a Control Solution Test STEP 1 Insert the Test Strip i Insert a test strip with contact bars end displays the following in sequence CH and g 29 gt ambient temperature gt flashing code number gt date time flashing 4 and the code number first and facing up into the test slot The meter turns on automatically and Nee Be sure the code number on the display is the same as the code number on the test strip vial If the code numbers do not match please see Calibration section of this manual Contact bars must be inserted all the way into the meter or you may get an inaccurate test result meter memory Failure to do so will confuse the blood glucose test I 1 gt 1 i 1 Ip Every time you perform a control solution test you must enter into i I
14. e swal lowed promptly see a doctor for help Sees amp fe a ee T m 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 To move faster keep pressing the Ml button until the desired number appears With the correct year on the display press the Set button and then the month segment flashes 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 To move faster hold the button down With the correct hour on the display press the Set button and then the minute segment flashes Beet S fe TE T fee
15. en begins to count down automatically STEP 5 Obtain an Accurate Result in 7 Seconds The result of your blood glucose test f is shown after the meter counts to 0 This reading is automatically stored in the meter I gt 1 i i gt i i i I i gt i i I i i 1 1 i i I i Do not push your finger with blood on it against the test strip or try to apply a smeared sample on the test strip If you do not apply a blood sample to the test strip within 3 minutes the meter will automatically turn off You must remove and reinsert the test strip to restart the test procedure The blood should completely fill the confirmation window before the meter begins to count down If you find that the confirmation window is not filled with blood when the meter is counting NEVER try to add more blood to the test strip Discard the test strip and retest with a new one If you have trouble filling the test strip please contact the customer service for help 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 o The used lancet and the used test strip may be potentially I NA A biohazard Please discard it carefully according to your local 1 regulations BeBe nE TE ee T ee m Expected Test Results Blood glucose monitoring plays an important role in di
16. er of these conditions occurred please return your system to the place of purchase m Appearance and Key Function of the Meter TEST SLOT ere Is where you insert the test strip The meter will turn on automatically after insertion LCD DISPLAY Guides you though the test using symbols and simple messages CODE BUTTOM Located in front of the MAIN BUTTOM Located in front of the TD 4223 meter with m on it is 4Coded 0 used to turn on the meter enter the memory mode and control steps of nee setting TALKING SYMBOL Indicate that the meter a contains speaking J function meter is for code selection SET BUTTON in the back located in the battery com partmen is used to set up the meter DATA D Located at the side is for cable connection Meter Display Segments TEST STRIP SYM BOL Appears when the meter is turned on BLOOD DROP SYMBOL Flashes when it is ready to apply the sample Appears with the code number cur rently in use TEMPERATURE SYMBOL Appears when ambi ent temperature is temperature CTL SYMBOL eee Appears when doing a control test and indicates that the result will not be stored in the memory yeodon eh Qi ng 2 i rt i i emperatur t etl dete outside operating it I t DAY AVERAGE Indicates that the di
17. 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 gt 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 and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 261 263 a E ee 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 pain 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 a not feel as much pain as at the fingertip When to use AST Food medication illness stress and exercise can affect blood glucose levels Capillary blood at fingertip reflects these changes faster than capillary blo
18. lts on the Meter Viewing Results on a Personal Computer CARING FOR YOUR METER AND TEST STRIPS Cleaning Storage PROBLEM SOLVING GUIDE Result Indicator Error Message Problem in Operation SPECIFICATIONS SYMBOL INFORMATION WARRANTY CUSTOMER CARE 39 39 43 45 45 45 48 49 50 51 53 54 55 Beet ee a T IMPORTANT INFORMATION gt 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 gt Test results below 60 mg dL 3 3 mmol L mean low blood glucose hypoglycemia Test results greater 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 If you have symptoms or continue to get results that fall below 60 mg dL or above 40 mg dL follow the treatment advice of your healthcare professional gt Apply only capillary whole blood sample to the absorbent hole Applying other substances to the absorbent hole will cause inaccurate results v If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this owner s manual call your healthcare professional v A red blood cell count hematocrit that is very high above 60 or very low below 20 can cause false results gt The
19. lucose 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 amp button twice The 7 day average will appear indicating that you are in the memory mode If you continue to press the amp button the 14 21 28 60 and 90day average will appear in order You can then review the last 450 tests in the memory When using the meter for the first time appears showing that there are no test results in memory The 7 day average is calculated from the blood glucose results obtained during the last 7 days 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 mM recent test result with date and time LU will be shown Press the button once and the next most recent test result will appear Each time you press and release the button the meter will recall up to your last 450 test results in
20. n its original storage case E E E engg gt Avoid dropping and strong impact gt Avoid direct sunlight and humidity gt Storage condition 4 C 40 C 39 F 104 F below 85 relative humidity Do not refrigerate gt Store your test strips in their original vial only Do not transfer to other container gt Store test strip packages in a cool and dry place Keep away from direct sunlight and heat gt After removing a test strip from the vial immediately replace the vial cap and close it tightly gt Touch the test strip with clean and dry hands gt Use each test strip immediately after removing it from the vial gt Write the discard date the date S opened plus 90 days on the vial label when you first open it Discard remaining test strips 90 days after first opening date gt Do not bend cut or alter a test N x strip in any way gt 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 gt Storage condition Store the control solution tightly closed at temperatures below 30 C 86 7 F Do NOT refrigerate gt Record the discard date date opened plus 90 days on the control solution vial Discard after 90 days Se ee n nm me T ee PROBLEM SOLVING GUIDE
21. od at other sites Therefore when testing blood glucose during or immedi ately after meal physical exercise or any other events take blood samples from your finger only _ ff ef 8 amp EEE We strongly recommend you do AST ONLY in the fol lowing intervals gt In a pre meal or fasting state more than 2 hours since the last meal gt Two hours or more after taking insulin gt Two hours or more after exercise Do NOT use AST if gt You think your blood glucose is low gt If you are awareness of being hypoglycemia gt Your AST results do not match the way you feel gt You are testing for hyperglycemia gt Your routine glucose results are often fluctuating gt 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 glucose concen tration 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 gt NOTE We suggest that before getting a drop of blood rub the pucture site about 20 seconds before penetration
22. out of range unable to measure After inserting test strip and completing code selection When the meter is ready to test symbol appears on display The code number is number Please apply blood into the strip When the test is completed The result appears on display The blood glucose is number Milligram Per Deciliter Millimole Per Liter When the test result is outside measurement range which is 20 600 mg dL The blood glucose out of range unable to measure When turn off the meter An ending music plays m 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 Confirmation Window 1 This is where you confirm if enough blood i has been applied to the absorbent hole of i the strip I I Absorbent Hole i Apply a drop of blood here The blood will be sucked in automatically am Please see pages 29 35 Testing Your Blood for com ple
23. parison tests gt Take your meter with you to the lab While at the lab Make sure that the samples for both tests the meter test and the lab test are taken and tested within 5 minutes of each other gt Wash your hands before obtaining a blood sample Never use your meter with blood that has been collected in a gray top test tube gt 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 2 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 Surwit R S and Feinglos M N Diabetes Forecast 988 April 49 5 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 994 959 _ ff ef 8 amp EEE USING THE METER MEMORY m View Results on the Meter Your meter stores the 450 most recent blood g
24. ply 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 5 Ste11 Vega Baja PR 0069 866 373 2824 www dsosi com REF 304
25. rent please refer to the section of Calibration for the procedure of coding 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 gt Fingertip Hold the Lancing Device firmly _ against the side of your finger Press LI gt k the release button You willheara o click indicating that the puncture is complete gt Sites other than fingertip Please refer to the section of About AST for available punctured sites After penetration discard the first drop of blood with a clean tissue paper or cotton Then gently squeeze O the punctured area to obtain blood Correct But be careful NOT to smear the blood sample The volume of blood sample must be at least 0 7 microliter actual size X Incorrect Choose a different spot each time you test Repeated punctures in the same spot may cause soreness and calluses professional first Since the first drop of blood usually contains tissue fluid and serum I gt I I i gt Before you decide to do AST please consult your health I I gt I i which may affect the test result it is recommended to be discarded 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 th
26. rger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after Repeat the test with a new automatic shutoff test strip Apply sample only 3 minutes after last user when flashing appears action on the display Defective meter Please call the dealer for service ial ge E ft BMY 3 If the control solution test result is out of range POSSIBLE CAUSE WHAT TO DO Read the instruction thor oughly and repeat the test again Error in performing the test Improper code number Do not shake the control solution vial very well Expired or contaminated control solution Control solution that is too warm or too cold 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 Check the expiration date or the discard date of the control solution Control solution meter and test strips should come to room temperature 20 25 C 68 77 F before testing Test strip deterioration Repeat the test with a new oe ia service eee E ee ee ee ee g SPECIFICATIONS Model No TD 4223 A B Dimension amp 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 Au
27. sociation 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 _ Ff ef 8 amp EEE TABLE OF CONTENTS IMPORTANT SAFETY INSTRUCTIONS IMPORTANT INFORMATION ABOUT ATERNATIVE SITE TESTING AST INTRODUCTION OF THE SYSTEM Intended Use Principle of Measurement Contents of the System Appearance and Key Function of the Meter Meter Display Segments Speaking Function Appearance of the Test Strip PRERPARATION BEFORE USE Battery Replacement Setting the Meter and Deleting the Memory BEFORE TESTING Checking the Display Calibration Checking with Advocate Control Solution Important Control Solution Information Doing a Control Solution Test TESTING YOUR BLOOD Testing Procedure Expected Test Results o OQ A a 11 12 13 14 14 16 21 21 21 23 25 26 29 30 36 COMPARING METER AND LABORATORY RESULTS 37 USING THE METER MEMORY Viewing Resu
28. splayed test result is an average MEMORY SYMBOL Appears when you review the memor y VOICE SYMBOL Indicates speaking function is on o ff eee E ee ee ee ee g TEST RESU LT AREA LOW BA TTERY Appears with the test result either in mmol L SMILE SYMBOL Appears when the test result is within refer Displays glucose results A decimal point appears when the measurement Appears when the bat tery power is lo w FACE SYMBOL LOW HIGH SYM Both are result indica tors They appear together with the test result which exceeds the reference range MEASUREMENT KET ONE WARNING Appears when the test result is equal or higher than 240mg dL Sees amp fe a ee ee m 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 Awelcome music plays Thank you for using this product Please relax during measurement When room temperature is detected When room temperature is outside operating range The room temperature is number degree Celsius Fahrenheit Room temperature
29. te instructions PREPARATION BEFORE USE Battery Replacement Your meter comes with two 1 5V AAA size alkaline batteries 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 Thefl symbol appears with the E b symbol and low the batteries _ L can not provide enough power to low do a test You must change the batteries immediately Replacing the batteries does not affect the meter s memory previ settings may need to be updated Batteries might leak chemicals if not used for a long time Remove the battery if you are not going to use the device for an extended period i e months or more I i R ous test results stored in memory However the time and date I I i gt I I I I I 1 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 o As with all small batteries the batteries should be kept away from small children who still put things in their mouths If they ar
30. to 0 the test result of control solution is shown on the screen Compare this result with the range printed on the test strip vial It should fall within this range 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 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 aia aN i D TD 4223 H rt B Mi 838 NUS iti T A A T T i To reduce the chance of infection gt Never share a lancet or the lancet device with anyone gt Avoid getting hand lotion oils dirt or debris in or on the lancets I i l I I I l I l gt always use a new sterile lancet Lancets are for single use only 1 l I l and the lancet device 1 I m Testing Procedure Wash and dry your hands first before starting STEP 1 Set the Lancing Device Screw off the cap of Lancing Device i Insert a lancet into the lancet holder 7 and push down firmly until it is fully seated Twist the protective disk until it separates from the lancet
31. to 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 noncondensing Storage Transportation condition 4 C 40 C 39 F 104 F below 85 R H Measurement Units Either mg dL or mmol L Measurement Range 20 600mg dL 1 3 33 3mmol L The device has been certifed 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 ETTE E TT SYMBOL INFORMATION In vitro diagnostic medical device Do not re use Consult operating instruction Keep away from sunlight Temperature limitation a e a ee Oa ee O Caution consult accompanying documents Biological risks 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 Warranty The Advocate Glucose Monitor 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 ap
32. to turn off the meter OFF is displayed before shut down The time date unit of measurement and unit of temperature can ONLY be changed in the setting mode Therefore when you perform a glucose testing those parameters are not possible to be changed Your meter displays 7 14 21 28 60 and 90 day averages which you can access from the meter memory These averages are calculated from results obtained during the 7 14 21 28 60 and 90 days preceding the current date and time settings When the date and time are changed the 7 14 21 28 60 and 90 days averages may change While the meter is in the setting mode if no button is pressed for 3 ST oN Ae oe rer es minutes the meter will turn off automatically Beat fe TE T fee STEP 9 Select Speaking Function The meter displays VOL qi 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 i does not display on LCD during testing Number 1 to 7 indicates speaking volume from low to high where i displays on LCD during testing STEP 10 Select Languages L1 L2 and q display on LCD L Press the button to select Two languages can be selected Press the Set button to turn off the meter OFF is displayed before shut down The setting mode is all completed ne
33. ystem 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 gt 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 gt To routinely check the meter and test strips perform a single test for each level of control solution supplied at least once a week When the control solution test should be performed gt When you first get your Glucose Meter gt When you begin using a new vial of test strips gt Whenever you suspect that the meter or test strips are not working properly gt When your blood glucose test results are not consistent with how you feel or when you think your results are not accurate gt When your test strips are exposed to extreme environmental conditions See Storage section of this manual gt When you want to practice running the test gt If you drop the meter m Important Control Solution Information gt Use only Advocate control solutions gt Check the expiration date on the control solution vial Do not use if expired gt Control solution meter and test strips should come to room temperature 20 25 C 68 77 F before testing gt Shake the vial discar
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