Biocare Accurate Check AG50X, Owner'S Manual

Page 1: ...BLOOD GLUCOSE MONITORING SYSTEM OWNER S MANUAL AG50E ...

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Page 3: ...BLOOD GLUCOSE MONITORING SYSTEM OWNER S MANUAL Ver 1 0 2010 04 311 4227000 005 AG50E ...

Page 4: ...se monitoring plays an important role in diabetes con trol A long term study shows 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 system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes A warranty registration card is included with yo...

Page 5: ...nly capillary whole blood sample to test your blood glucose Using other substances will cause wrong re sults If you are experiencing symptoms that are inconsistent with your blood glucose test results and you have fol lowed all instructions described in this owner s manual call your healthcare professional Inaccurate results may occur in severely hypotensive in dividuals or patients in shock Readi...

Page 6: ...splay Segments 12 Test Strip 13 Important Test Strip Information 14 BEFORE TESTING 15 Display Self Checks 15 About the Control Solution 15 Important Control Solution Test Information 16 TESTING YOUR BLOOD SUGAR 17 Getting a Drop of Blood 17 Step by Step Test Procedure 20 USING THE METER MEMORY 22 VIEWING RESULTS ON A PERSONAL COMPUTER 24 COMPARING METER AND LABORATORY RESULTS 25 ...

Page 7: ...OF YOUR METER 31 Maintenance 31 Battery Replacement 31 PROBLEM SOLVING GUIDE 33 Result indicator 34 Error Message 35 Operational problem 36 SPECIFICATIONS 38 Performance Characteristics 38 EXPECTED TEST RESULTS 39 SYMBOLS INFORMATION 40 SUMMARY OF OPERATION 41 ...

Page 8: ...nt results to fingertip testing What s the advantage Fingertips feel pain more read ily because they are full of nerve endings receptors At other body sites since nerve endings weren t so condensed you won t 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 tha...

Page 9: ... 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 has not been rubbed exhibits a measurably different glucose concentra tion than blood from the finger When the puncture site was rubbed prior to blood extraction the difference was signifi cant...

Page 10: ...name test strips and a control solution with the blood glucose meter Your system includes A meter test strips sterile lancets Owner s manual Sporty carrying bag Quick start user guide A lancing device A clear cap daily log book 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 sys...

Page 11: ... SCREEN guides you through the test using symbols and simple messages MAIN BUTTON located in front of the meter with M on it is used to turn on the meter enter the memory mode and navigate through settings SET BUTTON in the back located in the battery com partment is used to set up the meter DATA PORT located at the side is for cable connection ...

Page 12: ...L SYMBOL Appears when doing a control test and indicates that the result won t be stored in the memory MEASUREMENT UNIT Appears with the test result either in mmol L or in mg dL KETONE WARNING Appears when the test result is equal or higher than 13 3mmol L 240mg dL SMILE SYMBOL Appears when the test result is within refer ence range DATE TIME MEMORY SYMBOL Appears when you review the memory DAY AV...

Page 13: ...Blood Sugar for complete in structions 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 This is where you confirm if enough blood has been applied to the absorbent hole of the strip Absorbent Hole Apply...

Page 14: ...e when removing it from the vial or inserting it into the meter Use each test strip immediately after removing it from the vial Write the discard date on the vial label when you first open it Discard remaining test strips 3 months after first opening date Apply only blood sample or control solution to the ab sorbent hole Applying other substances to the absorbent hole will cause inaccurate results...

Page 15: ...stem 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 perform 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 ex pected range you are ready to...

Page 16: ... plus 3 months on the control solution vial Discard after 3 months Store the control solution tightly closed at temperatures 2 C 30 C 35 6 F 86 F Do not refrigerate The control solution range printed on the test strip vial is for our control solution only It is used to test meter and test strip performance It is not a recommended range for your blood glucose level NOTE Whenever you suspect that th...

Page 17: ...the lancets and the Lancing Device STEP 1 Insert a Lancet in the Adjustable Lancing Device Pull off the cap of the lancing device Insert a lancet into the lancet holder and push down firmly until it is fully se cured Twist the protective disk off the lancet Replace the cap by aligning the arrow on the cap with the release button Select the depth of penetration by turn ing the adjustable tip in eit...

Page 18: ...4 Select and Lance a Puncture Site Fingertip Press the lancing device s tip firmly against the lower side of your fingertip Press the release button to prick your finger then a click indicates that the puncture is complete Pull the cocking control back until it clicks You will see a color change inside the release button when it is ready Sites other than fingertip Please refer to the section of Ab...

Page 19: ...ults it is rec ommended that the first drop of blood should be discarded with a clean tissue paper or cotton Use the second drop of blood for testing The required blood sample is 0 7 microlitre in volume actual size STEP 6 Remove the Lancet Take the lancet out carefully Place the disk on a hard surface and push the ex posed tip into the protective disk Always use caution when removing the lancet D...

Page 20: ...t 0 7 microliter in volume actual size or you may get an inaccurate test result When appears on the display apply blood to the absorbent hole of the test strip where it meets the narrow channel Do not push your finger against the test strip or try to apply a smeared sample The blood should be completely filled the confirmation window before the meter begins to count down If not do not try to add m...

Page 21: ... result will automati cally be stored in the meter memory Turn the meter off by removing the test strip Discard the used test strip carefully to avoid contamination NOTE If you do not apply a blood sample within 1 minutes the meter will automatically turn off You must remove the test strip and insert it back again to restart the test procedure ...

Page 22: ...urned off press the M button twice The 7 day average will appear indicating that you are in the memory mode If you continue to press the M button the 14 21 28 60 and 90 day 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 show ing that there are no test results in memory The 7 day average is calculated from the blood ...

Page 23: ... dis played Press the M button once and the next most recent test result will appear Each time you press and release the M but ton the meter will recall up to your last 450 test results in order When the memory is full the oldest result will be dropped as the newest is added After reaching the last set of result End will appear on LCD screen and the meter will turn off automatically STEP 3 Exit th...

Page 24: ...all Health Care System Software on your Computer by following the instructions provided on TaiDoc s website http www taidoc com STEP 2 Connect to Personal Computer Connect the interface cable to a serial Port of your com puter 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 monitor is ready to transmit data STEP ...

Page 25: ...Limitations To make an ac curate 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 me ter 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...

Page 26: ...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 dehydration may also cause a meter result to be different from a laboratory result References 1 Surwit R S and Feinglos M N Diabetes Forecast 1988 April...

Page 27: ... with the meter off Then press the set button located in the battery compartment The meter is now in the setting mode STEP 1 Set the Year The year appears first with the number flashing Press and release the M button to advance one year To move faster hold the M button down With the correct year on the display press the set button and the date will appear on the display with the month segment flas...

Page 28: ... ton down With the correct hour on the dis play press the set button and the minutes setting will start flashing STEP 5 Set the Minutes Press and release the M button to advance one minute To move faster hold the M but ton down With the correct minute on the display press the set button and the current unit of measurement will start flashing STEP 6 Select mmol L or mg dL Press and release the M bu...

Page 29: ...mg dL unit is standard in the United States STEP 8 Delete Memory dEL and flashing symbol appear on the display If you don t want to delete memory press the set button again to skip this step If you d like to delete ALL memory press M button Both dEL and will flash Press the M button again to delete ALL memory The meter then displays indicating that the memory is deleted STEP 7 Select C or F Press ...

Page 30: ...30 Set up is all completed Press the set but ton to turn off the meter OFF will be dis played before shut down ...

Page 31: ...with water and mild detergent can be used to wipe down the outside of the meter You meter is a precision instrument Please handle it with care Battery Replacement Your meter comes with two 1 5V AAA alkaline batteries The meter will alert you when the power is getting low by displaying two different messages 1 With symbol appears on the display the meter is functional and the result re mains accura...

Page 32: ...ever the time date and units settings may need to be updated As with all small batteries the batteries should be kept away from small children If they are swallowed promptly see a doctor for help STEP1 Press the buckle on bat tery cover and lift up to remove cover STEP2 Remove the old battery and replace with two 1 5V AAA alkaline batteries STEP3 Close the battery cover ...

Page 33: ...prob lems but do not always appear in all cases when a problem has occurred Improper use may cause an inaccurate re sult without producing an error message or a symbol In the event of a problem refer to the information under action If you follow the action recommended but the problem still persists please call the dealer for service ...

Page 34: ...1 1 mmol L Lo or symbol indicates hypoglycemia low blood glu cose You should immediately treat hypoglycemia as recom mended by your healthcare professional appears when your result is equal or greater than 120 mg dL 6 6 mmol L It indicates that the result is higher than reference range KETONE appears together with when your result is equal or higher than 240 mg dL 13 3 mmol L This indicates there ...

Page 35: ...elow system operation range System operation range is 10 40 C 50 104 F Re peat the test after the meter and test strip have reached the above temperature Appear when environmental tem perature is above system operation range Remove the strip after applying blood to the absor bent hole Re test with a new test strip Problem with cali bration Check the test strip and re test Problem with the meter Re...

Page 36: ...contact bars end first and facing up Defective meter Please call the dealer for service Situation The test does not start after applying the sam ple PROBABLE CAUSE WHAT TO DO Insufficient blood sample Repeat the test using a new test strip with larger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after auto matic shutdown 3 minutes after last user...

Page 37: ...rol solution vigorously and repeat the test again Expired or contaminated control solution Check the expiration date or the discarded date of the control solution Control solution that is too warm or too cold Control solution moni tor and test strips should come to room temperature 68 77 F 20 25 C before testing Test strip deterioration Repeat the test with a new test strip Monitor malfunction Con...

Page 38: ...arning Operating condition 10 C 40 C below 85 R H noncondensing Meter Storage Transportation condition 20 C to 60 C below 95 R H Measurement units Either mg dL or mmol L Measurement range 20 600mg dL 1 1 33 3mmol L The specifications may be changed without prior notice Performance Characteristics Accuracy 15mg dL when glucose 75mg dL 20 when glucose 75mg dL Precision This study shows the CV correl...

Page 39: ... range for people without diabetes mg dL Fasting and before meal Less than 100 mg dL 5 6 mmol L 2 hours after meals Less than 140 mg dL 7 8 mmol L Source American Diabetes Association 2008 Clinical Practice Recommendations Diabetes Care 31 Supple ment 1 S1 108 ...

Page 40: ...ore use Keep away from sunlight Keep dry Temperature limitation Use by Batch code Manufacturer Serial number Caution consult accompanying documents Authorized representative in the CE mark European Community Do not use if package is damaged Use within 3 months after opening Sterilized using irradiation 3 M ...

Page 41: ...ly turn on and display room temperature followed by the flashing STEP 2 Apply Sample Touch and hold the drop of blood to the absorbent hole of test strip until confir mation window is completely filled STEP3 Obtain Accurate Results In 7 Seconds The meter will begin to count down At this time if you find confirmation window does not fill completely do not add blood to the strip Discard the strip an...

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