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INTRODUCTION TO 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 (from the finger, the palm,

the forearm, the upper arm, the calf and the thigh). 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.

AST in this system can be used only during steady-state blood glucose
conditions described in the section of “About Alternative Site Testing
(AST).”

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.

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Содержание TD-4234

Страница 1: ...TD 4234 311 4234100 005 Version 2 0 2010 04 OWNER S MANUAL BLOOD GLUCOSE MONITORING SYSTEM ...

Страница 2: ...his manual contains important information you must know about the system Please read it thoroughly and carefully For other questions regarding this system please contact your local customer service or place of purchase For all other questions please consult your healthcare professional TD 4234 ...

Страница 3: ...the equipment in liquid nor put it where it could fall into liquid If the equipment becomes wet unplug it before touching it 6 Do not let the equipment or its flexible cord come into contact with surfaces which are too hot to touch 7 Do not use the equipment where aerosol sprays are being used or where oxygen is being administered 8 Do not use device if it is not working properly or if it has suff...

Страница 4: ...Meter 11 Indicators for Main Control Mode 12 Test Strip 13 BEFORE USE 14 Battery Recharge 14 Indicators for System Setting Mode 15 Modify Meter Settings 16 Alarm Function 19 Display Self Checks 20 CONTROL TEST 21 Important Control Solution Information 22 Performing a Control Solution Test 23 TESTING YOUR BLOOD GLUCOSE 26 Testing Your Blood Glucose 27 Expected Test Results 32 COMPARING METER AND LA...

Страница 5: ...ll Mode 35 Viewing Results on the Meter 37 VIEWING RESULTS ON A PERSONAL COMPUTER 41 TAKING CARE FOR YOUR METER AND TEST STRIPS 43 Cleaning 43 Storage 43 PROBLEM SOLVING GUIDE 44 Special Message 47 Error Message 48 Operational Problem 49 SPECIFICATIONS 51 ...

Страница 6: ...only capillary whole blood sample to test your blood glucose Using other substances will cause wrong results If you are experiencing symptoms that are inconsistent with your blood glucose test results and you have followed all instructions de scribed in this owner s manual call your healthcare professional Inaccurate results may occur in severely hypotensive individuals or patients in shock Readin...

Страница 7: ...ingertip testing What s the advantage Fingertips feel pain more readily because they are full of nerve endings receptors Since nerve endings are not so condensed at other body sites tests performed there will be less painful When to use AST Food medication illness stress and exercise can affect blood glucose levels Capillary blood at the fingertip reflects these changes faster than capillary blood...

Страница 8: ...lts are often fluctuating 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 a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger When the puncture site is rubbed prior to blood extraction the difference is mar...

Страница 9: ...hould not be used for the diagnosis of diabetes or for the testing of newborns AST in this system can be used only during steady state blood glucose conditions described in the section of About Alternative Site Testing AST 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 cur...

Страница 10: ...solution with the blood glucose meter Your system includes A meter Lancing device a clear cap forAST First time user guide Owner s manual Carrying bag Warranty card Daily log book Control solution Test stirp Lancet 1 2 3 5 8 9 9 10 10 4 7 6 NOTE 1 Please make sure that all products listed above are included and sealed in the package before using this system If you find any imperfection in our prod...

Страница 11: ...on automatically after insertion STRIP EJECTION BUTTON is where the used strip will be automatically ejected after you push up the button UP BUTTON adjusting increment and change main sub function DOWN BUTTON adjusting decrement and change main sub function M BUTTON is used to turn on and navigate through settings MINI USB PORT is for data transmission 1 3 2 5 6 7 4 7 1 3 7 2 4 5 6 ...

Страница 12: ...enter the Main Control Mode Press Up or Down button to select the below desired mode Glucose Measuring Mode Perform your glucose tests Memory Recall Mode Review your glucose test results in the meter memory System Setting Mode Set up the meter such as date time the unit of measurement and memory deletion PC Linking Mode Connect the meter to PC for data transmission or recharge the battery through ...

Страница 13: ...e 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 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 s...

Страница 14: ... the USB adapter to the side of the meter 2 Plug the USB adapter to a wall outlet or connect the other end of USB cable to the USB port on your personal computer 3 The recharge symbol shows when bat tery is recharging After the battery is fully charged remove the USB cable and then the meter will return to Main Control Mode It will automatically turn off if left idle for 2 minutes NOTE Recharging ...

Страница 15: ...sily Time and Date Setting Set the date and time for the meter Clock Alarm Setting Set the hour and minute of the alarm for the meter Unit of Measurement Setting Set the unit of measurement for the meter Memory Deletion Delete the memory record for the meter Exit Mode Exit the system setting mode Meaning You can do this Indictor 12 25 14 52 12 25 14 52 12 25 14 52 12 25 14 52 Glucose Unit is mg dL...

Страница 16: ... Setting indicator Press M button to enter the setting Step2 Press Up or Down button to increase or decrease the year Press M button to continue the setting Step3 Press Up or Down button to set date format MM DD or DD MM Press M button to continue the setting Step4 Repeat step 2 and 3 to set the month date 12 24 hour hour and minutes After finishing these settings press M button to return to Syste...

Страница 17: ...o System Setting Mode Unit of Measurement Setting Step1 Press Up or Down button to select Unit of Measurement Setting indicator Press M button to enter the setting Step2 Press Up or Down button to select mg dL or mmol L Step3 After finishing the setting press M button to return to System Setting Mode Clear Memory N Clear Memory Y Glucose unit is mg dL Glucose unit is mmol 12 25 14 52 12 25 14 52 G...

Страница 18: ...ged 3 Your meter displays 7 14 day averages which you can access from the meter memory These averages are calculated from results obtained during the 7 14 day preceding the current date and time settings When the date and time are changed the 7 14 averages may change 4 The meter will turn off automatically without any action in two minutes 5 You can go back to the previous step by pressing M butto...

Страница 19: ...th the time blinking You can directly insert a new strip to perform a blood glu cose test now or simply press the M button to turn it off Step1 Press Up or Down button to select alarm 1 on off Then press M button to set the alarm 1 Step2 The hour will start flashing first and you can change the value by pressing Up or Down button Then press M button and proceed to the next step Step3 The minute wi...

Страница 20: ...lly and displays a message Did you eat any thing within 4 hours Please press Up or Down button to select Yes for PC mode or No for AC mode and then press M button to confirm it If you select Yes the screen displays as below If you select No the screen displays as below Yes No 038 M Confirm Change Did you eat any thing within 4 hours No No 038 M Confirm Change Did you eat any thing within 4 hours ...

Страница 21: ...ractice the procedure using control solution When you can do three tests in a row that are within the expected range you are ready to test your blood For routinely check the meter and test strips perform a single test for each level of control solution at least once a week When should the control solution test be performed When you first get your meter When you begin using a new vial of test strip...

Страница 22: ...nd wipe off the dispenser tip to ensure a clean sample and an accurate result Use only within 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 36 to 86 F 2 to 30 C Do not freeze NOTE The control solution range printed on the test strip vial is for control solutio...

Страница 23: ... button to select Yes No and then press M button to confirm it The AC PC mode with code number will appear Press Up or Down button to select QC Quality Control the screen will display as following Be sure the code number on the display is the same as the code number on the test strip vial Yes M Confirm Change Did you eat any thing within 4 hours No 038 No 038 WARNING Contact bars must be inserted ...

Страница 24: ...nd place this drop on the top of cap Step3 Apply Control Solution While holding the meter move the absorbent hole of the test strip to touch the drop of control solution Then the drop will be automatically absorbed Once the confirmation window fills completely the meter will begin to count down To avoid contaminating the control solution with the contents of the test strip you have to place a drop...

Страница 25: ...ange Out of range results If test results fall outside the range printed on the test strip vial check Operating Problem section 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 the place of purchase for help 109 165 mg dL 120 QC ...

Страница 26: ...he lancing device TESTING YOUR BLOOD GLUCOSE 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 Blood Glucose Meter Test Strip Lancing Device Sterile Lancet Clear Cap For AST use 1 3 2 4 5 Cap Cocking Control Release Button Lancet Holder Ejector Arrow Depth Indicator Adjustable Tip Lancing ...

Страница 27: ...igning the arrow on the cap with the release button Select the depth of penetration by turn ing the adjustable tip in either direction so that the arrow on the cap points to the desired depth Pull the cocking control back until it clicks You will see a color change in side the release button when it is ready Set the lancing device The Lancing Device offers you 5 depths of skin penetration Shallow ...

Страница 28: ...he display is the same as the code number on the test strip vial 14 58 12 25 No M Confirm Change Did you eat any thing within 4 hours Yes M Confirm Change Did you eat any thing within 4 hours No 038 No 038 Blood from sites other than the fingertip Substitute the lancing device cap with the clear cap for alternative site testing Pull the cocking control back until it clicks When lancing the forearm...

Страница 29: ...ture site with 70 using cotton moistened with 70 alcohol and let it air dry Fingertip testing Press the lancing device s tip firmly against the lower side of your fingertip Press the release but ton to prick your finger then a click indicates that the puncture is complete Sites other than fingertip Please refer to the section Alternative Site Testing for possible puncture sites After penetration d...

Страница 30: ...onfirmation 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 confirmation window contact the place of purchase for help Step4 Apply Blood into the Test Strip Apply your blood to the absorbent hole of the test strip until the confirmation hole is fully covered The...

Страница 31: ...ithout any action in two minutes Step7 Remove the Lancet Always use caution when removing the lancet Safely dispose of the used lancet by placing the protective disk on a hard surface and pushing the exposed tip into the disk Remove the lancet by pulling the cap off first Then slide the ejector forward to remove the used lancet WARNING The used lancet and the used test strip are potentially biohaz...

Страница 32: ...p you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes Source American Diabetes Association 2008 Clinical Practice Recom mendations Diabetes Care 31 Supplement 1 S1 108 Please consult your doctor to determine a target range that works best for you Time of day Fasting and before meal Less than 100 mg dL 5 6 mmol L Less than 140 mg dL 7 ...

Страница 33: ... limitations To make an accurate comparison between meter and laboratory results follow the guidelines below Before you go to the lab Perform a control solution test to make sure that the meter is working properly Fast for at least eight hours before doing comparison tests if possible Take your meter with you to the lab While at the lab Make sure that the samples for both tests the meter test and ...

Страница 34: ...than blood drawn from a vein venous sample used for a lab test 4 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 dehydration may also cause a meter result to be different from a laboratory result 3 Surwit R S and Feinglos M N Diabetes Forecast 1988 April 49 51 4 ...

Страница 35: ...or Memory Recall Mode help you to review your results stored in the meter easily Glucose Results View the individual test results in the memory 7 day Average Result View the 7 day average of the test results in the memory 14 day Average Result View the 14 day average of the test results in the memory Glucose Trend Report for 7 day Average Results View each 7 day average results in glucose trend re...

Страница 36: ...36 Glucose Trend Report for 14 day Average Re sults View each 14 day average results in glucose trend report Exit Mode Exit the memory recall mode Meaning You can do this Indictor 14 52 12 25 ...

Страница 37: ... enter glucose results reviewing Step2 Press Up or Down button to view the test results The latest test result will appear first The meter will review up to your last 400 test results in order When the memory is full the oldest result is deleted as the newest is added Step3 After reviewing the result press M button to return to Memory Recall Mode 14 52 14 52 Memory Recall 14 52 mg dL PC 193 008 8t...

Страница 38: ... confirm it Step3 The day average is calculated from the blood glucose results obtained during the last 7 days or 14 days depends on which Average Result indicator you select Step4 After reviewing the result press M button to return to Memory Recall Mode 14 52 Memory Recall 14 52 Memory Recall 14 52 14 52 AC mode memory AC PC Glucose result 7 day average 5 test results Unit of measurement AC mode ...

Страница 39: ...Before Meal PC After Meal Press M button to confirm it Step3 Each 7 day 14 day average result on glucose trend report will display Step4 After reviewing the result press M button to return to Memory Recall Mode 14 52 Memory Recall 14 52 Memory Recall AC mode memory AC PC 14 52 14 52 Period 7 day 14 day average Glucose trend graph 1 2 3 1 erage Value is 221 08 215 08 600 300 140 80 20 T 3 2 recall ...

Страница 40: ...40 Exit Mode Please select the below screen when you want to exit System Setting Mode and turn to Main Control Mode NOTE The meter will turn off automatically without any action in two minutes ...

Страница 41: ...alth Care System Software on your Computer by following the instructions provided on TaiDoc s website http www taidoc com Step2 Enter the PC Linking Mode Press the M button to turn on the meter and then U RIGHT logo date and time appear Press M button again to select PC Linking Mode Press M button again to enter it Step3 Connect to Personal Computer Connect the USB cable to a serial port of your c...

Страница 42: ... data Results with respective date and time will be transmitted Remove the USB cable and then the meter will return to Main Control Mode It will automatically turn off if left idle for 2 minutes NOTE While the meter is connecting to the PC it is unable to perform a blood glucose test ...

Страница 43: ...pe 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 Storage 1 Monitor Storage Storage condition 4 to 140 F 20 to 60 C below 95 relative humidity Always store or transport the meter in its original storage case Avoid dropping and strong impact Avoid direct sunlight an...

Страница 44: ...al 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 Do not bend cut or alter a test strip in any way Keep the strip vial away from chi...

Страница 45: ...orage Storage condition Store the control solution with lid tightly closed at temperatures 2 to 30 C 36 to 86 F Do NOT freeze Record the discard date date opened plus 90 days on the control solution vial Discard after 90 days ...

Страница 46: ...mproper use may cause an inaccurate result without producing an error message In the event of a problem refer to the information under the row ACTION Never try to disassemble the meter under any circumstances If you encounter any error messages not listed below or if you have followed the actions recommended below but the problem persists unsolved please contact local customer ser vice for help ...

Страница 47: ...limit 20 mg dL 1 1 mmol L This indicates hypoglycemia low blood glucose You should immediately treat hypoglycemia as recommended by your healthcare professional Your result is above measurement limit 600 mg dL 33 3 mmol L This indicates severe hyperglycemia high blood glucose You should seek immediate medical assistance Out of range Lo Out of range Hi ...

Страница 48: ...y is low Recharge the battery immediately Appear when environmental temperature is below system operation range Meter malfunction System operation range is 10 40 C 50 104 F Repeat the test after the meter and test strip have reached the above temperature Please contact local customer service for assistance Charge the battery please None strip Temperature Strip has been Terrible error ...

Страница 49: ...peat the test with a new test strip Repeat the test with a new test strip Please contact the local customer service for help Operating Problem 1 If the meter does not display a message after inserting a test strip POSSIBLE CAUSE Batteries exhausted Test strip inserted upside down or incompletely Defective meter WHAT TO DO Recharge the battery Insert the test strip facing up with the contact bars e...

Страница 50: ...ip deterioration Monitor malfunction WHAT TO DO Read the instructions thoroughly and repeat the test Shake the control solution vigor ously and repeat the test again Check the expiration date or the dis carded date of the control solution Place control solution meter and test strips in room temperature 68 to 77 F 20 to 25 C before testing Repeat the test with a new test strip Please contact the lo...

Страница 51: ...g detection Auto reaction time countdown Operating Condition 10 to 40 C below 85 R H noncondensing Meter Storage Transportation Condition 20 to 60 C below 95 R H Shelf Life 3 years Measurement Units Either in mg dL or mmol L Measurement Range 20 to 600mg dL 1 1 to 33 3mmol L The device has been tested to meet the electrical and safety requirements of IEC 60601 1 EN 60601 1 IEC 61010 1 EN 61010 1 E...

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