AutoSense AutoSense Voice
Contents
1. 2012 10 19 5 31 53 See CONTENTS READ THIS BEFORE USING THE EQUIPMENT INTRODUCTION CONTENTS OF AUTOSENSE AND AUTOSENSE VOICE KIT AUTOSENSE METER EXPLAINED UNIQUE FEATURE OF AUTOSENSE VOICE FOR USERS OF PLASMA EQUIVALENT CALIBRATED METERS PRECAUTIONS TECHNICAL DATA PARTS OF THE METER ABOUT THE TEST STRIP Strip insertion and use BEFORE TAKING MEASUREMENTS BLOOD SAMPLING STRIP AUTOCODING MEASURING WITH THE METER Flagging and marking test results jtoSense amp AutoSense Voice 2 D 1 9201 2 beliv indd 2 KO CON O U FR 12 13 14 16 17 18 20 22 27 2012 11 13 15 32 05 MEMORY Storing data Recalling data from memory Average calculation OVERVIEW OF FUNCTION MENUS PC mode Setting date and time Alarm settings Switching to speaking function Deleting stored data Selecting unit of measurement Setting hypoglycemic limit BATTERY REPLACEMENT MAINTENANCE AUTOSENSE SYSTEM CHECKING Checking with Check strip Checking with CareSens control solution ERROR MESSAGES AND TROUBLESHOOTING MANUFACTURER S WARRANTY SYMBOLS D61 9201 2 beliv indd 3 29 29 30 31 32 32 33 35 36 37 38 39 40 44 45 45 47 49 56 57 gt et o n D 5 W D go gt lt et o V D W D 3 20121115 15 32 05 READ THIS BEFORE USING THE EQUIPMENT wrortant Before testing your blood with your AutoSense or AutoSense Voice Blood Glucose Monitoring System pl2. Strip Autocoding e Your AutoSense meter is calibrated to be used only with fresh capillary blood Venous blood or plasma is not suitable for accurate monitoring of glucose levels 11 D61 9201 2 beliv indd 11 2012 11 13 15 32 08 8 o gt TECHNICAL DATA AutoSense AutoSense Voice W T Batteries 1 pc 3 V type CR2032 2 pcs 3 V type CR2032 S Battery life 1 year or 1500 measurements 1 year or 1000 5 measurements lt Calibrated for AutoSense Test strip E Average test time 5 seconds A Required sample volume Min 0 5 ul capillary blood L Measuring range 1 1 33 3 mmol l 20 600 mg dl 9 Display Below 1 1 mmol l Lo above 33 3 mmol l Hi gt Memory capacity Last 500 results with time and date Strip autocode range 1 15 Coding system Autocoding Automatic switch on Upon insertion of test strip Automatic switch off In 2 minutes after the last button activation Operating temperature 10 C 40 C Relative humidity lt 90 Size 55 mm x 100 mm x 21 mm Weight 60 g 90 g with batterie s 12 D61 9201 2 beliv indd 12 2012 11 13 15 32 08 TT PARTS OF THE METERS IR data output interface OK ON OFF button Strip holder slot SET button D61 9201 2_ beliv indd 13 Strip ejector button R r Mn IoA asuasojny 9 ASuASOINy Battery holder 13 2012 11 13 15 32 08 itoSense 8 AutoSense Voice 14 D61 9201 2 beliv indd
3. error message indicate low temperature below 10 C e An upward pointing arrow icon and the E 9 error message indicate high temperature above 40 C lon 9suasojny 8 osuaSojny Flashing result with and thermometer mark e AutoSense keeps operating if external temperature is close to the operating limits 10 10 5 C or 39 5 40 C but the displayed result will flash indicating close to abnormal operational circumstances Be cautious with these test results as they might be inaccurate 53 D61 9201 2_ beliv indd 53 2012 11 13 15 32 44 mmm jtoSense 8 AutoSense Voice 54 D61 9201 2 beliv indd 54 Flashing result with mark e Result flashes and a sad face is displayed on screen if the result is below the set hypoglycemic limit Instrument constantly displays Lo e Code is not correct repeat test with a new strip and check autocode e Insufficient amount of blood was applied on the strip Repeat test with a bigger drop of blood Warning A If Lo is displayed as a result after testing it means that the measured value is too low it is out of measuring range Contact your healthcare professional immediately 2012 11 13 15 32 46 ie H If error messages cannot be eliminated by applying the recommendations above please contact your local distributor for advice Thank you for your Instrument constantly displays Hi e Code is not
4. then day will be displayed Similar to time setting these can be adjusted with the SET button and set with the OK button After the time and date are set switch the meter off by pressing the OK button The changes will be stored automatically 34 D61 9201 2 beliv indd 34 2012 11 13 15 32 24 me Note The meter switches off automatically in 2 minutes if you do not press any key Alarm settings The AutoSense and AutoSense Voice meters are able to alert the user with the alarm function featuring a flashing screen and sound effect if a blood glucose measurement has to be made Three different dates can be set by entering the Alr menu To enter this menu keep the OK button pressed after switching on the device until Alr is displayed The first Alr1 can be switched ON and OFF by pushing the SET button e f Alr1 ON has been activated press the OK button first before setting the hours with the SET button Press the OK button to proceed to minute setting and set the minute s with the SET button After setting the date for Alr1 press OK to acces Alr2 D61 9201 2_ beliv indd 35 SETUP HC r loA 9suasojny 8 asuaso Ny 35 2012 11 13 15 32 24 e f Alr1 OFF has been activated press the OK button to proceed to Alr 2 which can be set in the same way as Alr1 The same steps can be applied for Alr3
5. ABOUT THE TEST STRIP Contact bars Confirmation window Edge to apply blood sample Your AutoSense meter is designed ONLY for in vitro use with an AutoSense Test strip Other strips will not provide an accurate result When inserting a new strip always check if the code on the vial of strips you are using matches the code that appears on the display The code does not match that on the vial DO NOT use the strip to measure your blood glucose value If the code numbers do not match your measured result will be incorrect see Strip Autocoding Each vial of strips is also labeled with an expiry date Always use the strips within 3 months from the date of opening and never use the strips if they have expired 14 2012 11 13 15 32 09 me Before testing always ensure that both the meter and the strips are at room temperature al Note The AutoSense Test strip reacts with blood glucose generating a current The intensity of the current is proportional to the blood glucose concentration The AutoSense meter detects the generated microcurrent and calculates the glucose concentration AutoSense Test strips are sensitive to heat and mechanical damage do not use the strips if you suspect that such damage may have occurred Always keep the strips in their original package and close the vial each time after removing a strip Of BSUaSO NY X asuasojny Do not expose the strips to direct sunlight or store
6. After setting Alr3 switch off the meter by pressing the OK button The changes will be stored automatically Oo Note The meter switches off automatically in 2 minutes if you do not press any key c SETUP Switching to speaking function utoSense 8 AutoSense Voice Your AutoSense Voice meter speaks in 3 different B languages by default English German and Turkish To E Li switch between languages or to switch off the speaker enter the loudspeaker switching menu Keep the OK button pressed after switching on the device until SEt and a loudspeaker icon is displayed Then release the OK button Using the SET button select EnG for English GEr for German or Tr for Turkish Select OFF to switch off the loudspeaker The actual setting is always displayed Press the OK button to store the 36 setting after which meter will switch off D61 9201 2 beliv indd 36 20121113 15 32 25 me Oo Note If the speaking function is switched on the loudspeaker icon will be displayed all the time Deleting stored data All stored data can be deleted in dEL mode Switch the meter on with the OK button and keep it pressed until dEL is displayed and then release the OK button To avoid data loss by mistake press SET first and press the OK button immediately after to delete the meter memory The meter switches off automatically after memory deletion Oo IMPOR
7. correct repeat test with a new strip and check autocode Warning A If Hi is displayed as a result after testing it means that the measured value is too high it is out of measuring range Contact your healthcare professional immediately Battery icon is displayed e Batteries are running low Replace batteries confidence in purchasing our product D61 9201 2 beliv indd 55 gt lt et o G 5 W go gt lt et o v 5 W 55 2012 11 13 15 32 47 MANUFACTURER S WARRANTY 77 Elektronika Kft provides warranty for the AutoSense Blood Glucose Meter against defects in materials and workmanship for a period of 5 years from the date of purchase The warranty is void if the instrument is misused poorly maintained or is tampered with Liability under this warranty is limited to the repair of defective parts or at the discretion of 77 Elektronika Kft replacement of the instrument The right to rescind the purchase agreement exists only if the replacement is also found to be defective Claims other than these will not be entertained utoSense amp AutoSense Voice The warranty is not valid if damage results from misuse maltreatment tampering human error and the use of extreme force This warranty is valid only if the date stamp and signature of the dealer are recorded on the warranty card on the date of purchase The warranty period is not to be extended by any claim m
8. it influences the accuracy of the meter while it calculates glucose concentration The code number can be any number from 1 to 15 If the code numbers do not match DO NOT use the strip to measure your blood glucose value toSense amp AutoSense Voice In case you have an AutoSense Voice meter the meter can also read out the code if the speaking function is switched on 20 D61 9201 2 beliv indd 20 20121113 133212 me E from 1 to 15 e f the code displayed upon insertion of a new strip does not match the code printed on the vial DO NOT use the strip to measure your blood glucose value A WARNING After strip insertion AutoSense meter displays the strip s code number until a sample droplet is applied Verify that the code displayed matches the code number on the vial of test strips each time you use your meter gt S D IMPORTANT o e Verify that the code displayed matches the code number on D the vial of test strips each time go you use your meter The meter gt will autocode each strip The JUTA code number can be any number z 2014 07 a 5 lt 21 D61 9201 2 beliv indd 21 20121115 15 32 12 Ei E MEASURING WITH THE METER Before you start the test check that everything you might need is ready meter test strip lancing device some tissues Now put your meter on a clean flat surface Wash your hands thoroughly 1 Switch AutoSense
9. the SET button after switching the meter on to enter MEMORY mode The result of the last measurement will be displayed The date and time of the measurement will be displayed on the upper line of the display Scroll through the stored memory records with the SET button The meter stops scrolling when you reach the earliest saved record Results that have been marked after measurement will be displayed with an exclamation mark when recalled toSense 8 AutoSense Voice By pressing the OK button meter will enter the Average calculation mode Pressing the OK button will return you to the test screen 30 D 1 9201 2 beliv indd 30 2012 11 13 15 32 21 me Average calculation AutoSense is able to calculate the average glucose level of the last 7 14 30 60 90 days test results The calculated average contains all test results from the selected periods except those that have been marked However this function operates accurately only if the date and time have been set precisely To study the average value of your glucose level first enter the MEMORY menu by pressing the SET button after switching on the device In the MEMORY menu press the OK button to display the average glucose level of the last 7 day period Use the SET button to switch between the averages of the different periods Pressing the OK button will return you to the test screen a Note If there is no test resul
10. the batteries are replaced after 60 seconds Test data are stored and will not be lost due to battery replacement IQ BSUBSO NY 8 ASuAGOINy Electrostatic discharge may interfere with the meter In case of unusual effects turn off reset errors follow the instructions in Error messages and Troubleshooting 43 D61 9201 2 beliv indd 43 2012 11 13 15 32 34 MAINTENANCE If AutoSense is used according to the Instructions for Use only minimal maintenance is necessary However to obtain always accurate test results we recommend performing the following actions e f necessary use a wet cloth to clean the surface of the meter e After maintenance check the functionality of the device For more details refer to AutoSense system checking A WARNING e Protect the inside of the meter from water toSense amp AutoSense Voice e Never immerse the meter or hold it under running water e Avoid disassembling the meter repairs should be carried out exclusively by authorized service personnel e Keep in touch with your local distributor s technical service contact them if you require assistance 44 D61 9201 2 beliv indd 44 2012 11 13 15 32 34 me AUTOSENSE SYSTEM CHECKING Checking the measuring accuracy of the meter is recommended after every maintenance operation A check test of your AutoSense can be carried out with the supplied Check strip or with CareSen
11. 4 e If screen cannot be seen properly because it is dim or all A graphics are displayed simultaneously the meter is very S 500 Ma cold or too warm ell c Be e Allow meter to reach room temperature gradually Screen is too dim or screen persistence occurs utoSense 8 AutoSense Voice E O error message e If this error message remains on screen after turning meter on the meter has become damaged Remove the batteries and keep the OK button pressed for 15 20 seconds replace the batteries and switch on the meter If E O appears again please contact your local distributor 50 D61 9201 2 beliv indd 50 2012 11 13 15 32 39 he D61 9201 2 beliv indd 51 E 1 error message e Code error Please ensure that the proper AutoSense test strip is used with the meter E 3 error message e Used strip is inserted Repeat measurement with new test strip Check strip has been inserted replace it with a test strip e Strip was inserted incorrectly e Blood was applied before strip insertion Repeat measurement with a new test strip E 4 error message e Strong external light Do not expose the meter to direct sunlight IQ BSUBSO NY 8 AaSUaSO NY 51 2012 11 13 15 32 40 E 5 error message e Strong electromagnetic field e g mobile phone or high intensity electrostatic discharge is interfering with the meter Repeat the measurement e Meter is damaged Check the meter
12. TANT You can exit the memory delete mode without data loss by pressing the OK button or by pressing the buttons in any order other than SET then gt et o n D 5 W D go gt lt et o V D W lt 37 D61 9201 2_ beliv indd 37 2012 11 13 15 32 26 OK Data will not be lost either if the meter switches off automatically after 2 minutes In case the memory contains no data a display with horizontal bars is displayed when switching to average calculation mode Selecting unit measurement mmol l mg dl Your AutoSense meter can display the measured results in 2 units of measurement mmol l or mg dl Contact your healthcare professional to check which unit is preferred in your country toSense amp AutoSense Voice ay Note Changing the unit of measurement will not affect your test results only the way they are displayed For example 1 mmol l is equivalent to approximately 18 mg dl Thus depending on which measurement unit you select 5 4 mmol l or 97 mg dl will be displayed for the same blood glucose level To choose between the units of measurement keep the OK button pressed after switching on the meter until SEt and mmol l with mg dl 38 D61 9201 2_ beliv indd 38 2012 11 13 15 32 28 me is displayed Only the most recent active unit will be displayed after you enter this menu Switch between the 2 units mmol l and mg dl with the SET button
13. When the desired unit has been selected store your setting by pressing the OK button The meter will switch off automatically Setting hypoglycemic limit Your AutoSense meter is able to alert the user by displaying an unhappy face if a measured blood glucose level exceeds a specified limit To enter this menu keep the OK button pressed after switching on the device until Hyp is displayed gt et o n D 5 W D go gt lt et o V D N lt After entering this menu different limits can be set using the SET button In sequence these limits are OFF 3 3 4 3 8 4 2 mmol l After selecting the desired limit value store your setting by pressing the OK button The meter will switch off automatically 39 D61 9201 2 beliv indd 39 20121115 15 32 29 BATTERY REPLACEMENT Your AutoSense meter is powered by a CR2032 round cell battery 1 pc while AutoSense Voice is powered by 2 CR2032 batteries The use of other types of batteries is not permitted under the guarantee terms and conditions When the batteries run low a battery icon is displayed It indicates that the batteries need to be replaced soon toSense amp AutoSense Voice The meter will still operate accurately when the battery icon is displayed but batteries should be replaced no later than the end of the next 10 test measurements After the battery icon is displayed AutoSense Voice will remind you to replace
14. ade under this warranty 56 D 1 9201 2 beliv indd 56 2012 11 13 15 32 49 me SYMBOLS IVD C 1011 CE 1020 i gt H E Bupa In vitro diagnostic medical device 98 79 EEC IVD directive AutoSense meter 0120 93 42 EEC MDD directive lancing device and lancets Manufacturer Consult instructions for use Warning Serial number Direct current Storeage temperature limitation Biological risk Use by date for lancing device and lancets Date of manufacture D61 9201 2_ beliv indd 57 gt et o n D 5 W D go gt lt et o V D W D 57 2012 11 13 15 32 49 Notes Sense 8 AutoSense Voice 58 D61 9201 2 beliv indd 58 2012 11 13 15 32 52 Notes asuasojny 9 asuasoiny 59 D61 9201 2 beliv indd 59 20121115 15 32 52 wi Manufacturer U 77 ELEKTRONIKA Kft 1116 Budapest Feh rv ri t 98 HUNGARY Tel 36 1 206 1480 Fax 36 1 206 1481 E mail sales e77 hu Website www e77 hu Your local distributor U o gt U W G U N O ded gt eL o U W UW N Meter serial number Service records D61 9201 2 60 D61 9201 2 beliv indd 60 2012 11 13 15 32 52
15. be added or removed immediately after a measurement They cannot be changed when recalling from the memory 6 After completing the measurement the test strip can be removed from the meter Press the ejector button on the topof the meter to eject the strip The test result will be displayed for 2 minutes until the strip is removed or the meter switched off The meter will automatically store the result together with the actual test date and time However it is recommended that you always record the test result in a diabetes diary before switching the meter off asuasoiny 8 asuasoiny 25 D61 9201 2 beliv indd 25 2012 11 13 15 32 16 The used strip and lancet are contaminated with blood Be careful and AN follow the relevant local instructions when you discard the used strip and lancet If an error message appears refer to Error messages and Troubleshooting WARNING e If Lo is displayed as a result after testing it means that the measured value is too low it is out of measuring range Contact your healthcare professional immediately e If Hi is displayed as a result after testing it means that the measured value is too high it is out of measuring range Contact your healthcare professional immediately e Incorrect high or low results may have serious medical consequences If your blood glucose is unusually high greater than 16 mmol l or low lower than 3 mmol l or if you question your result
16. d 27 27 2012 11 13 15 32 18 Mark 8 Premeal Postmeal Mark 8 Postmeal Sport activity Mark amp Sport activity Premeal 8 Sport activity Postmeal amp Sport activity Mark amp Postmeal 8 Sport activity The last status is the unmarked or unflagged state After selecting one flag and or marking combination it can be saved in the meter memory by pressing the OK button After the OK button is pressed the meter will switch off automatically utoSense 8 AutoSense Voice After sport activity 28 Premeal amp Sport activity Postmeal amp Sport activity D61 9201 2 beliv indd 28 20121113 153218 me MEMORY AutoSense is able to store 500 measurements with time and date data Storing data Your AutoSense meter automatically stores each test result when it switches off If the memory is full the oldest result will be discarded while the new result will be added False or control measurement results can be marked thus are not calculated in the average glucose level of the last 7 14 30 60 90 day periods loy 9suasojny 8 asuaso Ny Results can be marked after measurements by pressing the SET button An exclamation mark will appear on the lower left corner of the display when recalling saved marked results 29 D61 9201 2 beliv indd 29 20121113 15 32 20 Recalling data from memory Stored data can be retrieved from the memory by selecting MEMORY mode Press
17. ease read this user manual carefully For safe and easy operation close study of the Instructions for Use of the meter and its accessories lancing device test strip is necessary Should you neglect to study this manual you will not be familiar with the proper use of the equipment utoSense 8 AutoSense Voice Always consult your diabetes healthcare professional This advice applies to all blood glucose monitoring systems Always use the equipment only for the purpose described in this manual Do not use accessories that are not supplied or recommended by the manufacturer or distributor Do not use the equipment if it does not function properly Ship and store the meter at 20 C to 50 C 4 F to 122 F 4 D61 9201 2 beliv indd 4 2012 11 13 15 32 05 me INTRODUCTION Thank you for choosing the AutoSense Blood Glucose Monitoring System It has been carefully designed for easy reliable and accurate monitoring of your blood glucose level This blood glucose meter meets international standards for the applicable EMC Emectromagnetic Compatibility emission electrostatic discharge and radio frequency radiation This manual is for both AutoSense and AutoSense Voice meters The only difference between them is the speaking ability of AutoSense Voice Therefore if not specifically indicated all instructions are relevant to both meters 1 Note In this manual if AutoSense is cited it ref
18. ers to both AutoSense and AutoSense Voice meters To get the best from your AutoSense meter please take the time to become familiar with it Please read and understand the instructions in this manual before using your OAsaSUuASOINY X suasojny 5 D 1 9201 2 beliv indd 5 2012 11 13 15 32 06 meter Follow the instructions provided in Maintenance to prolong the lifespan and accuracy of your meter This manual should tell you everything you need to know about operating your AutoSense meter however it is recommended that you visit a medical doctor specializing in diabetes treatment if you require more advice Keep this manual in a safe place so that you can access and refer to it any time Please contact your local distributor if you have any technical questions not addressed in this manual CONTENTS OF AUTOSENSE AND AUTOSENSE VOICE KIT E AutoSense or AutoSense Voice Blood Glucose Meter B Instructions for Use m Illustrated Instructions for Use B Lancing device M Disposable microbiologically sterile lancets 8 pcs B Check strip 1 pc utoSense 8 AutoSense Voice All parts are microbiologically clean 6 D61 9201 2 beliv indd 6 2012 11 13 15 32 06 me AUTOSENSE METER EXPLAINED AutoSense indicates blood glucose concentration by checking the reaction between chemical reagents and the blood drop on the test strip The reaction triggers the generation of a current in the te
19. lood on the Check strip e Protect Check strips against physical damage and keep them ina safe place If a Check strip is damaged or lost contact your local distributor for advice Checking with CareSens control solution Press the OK button and keep it pressed until CHK is displayed then release the OK button A flashing strip icon will be displayed indicating that the meter is waiting for strip insertion Insert an AutoSense Test strip and push it gently into the end position Compare the displayed code with code printed on the vial that held the strip If the codes differ insert another strip D61 9201 2_ beliv indd 47 loA 9suasojny 8 su sozny 47 2012 11 13 15 32 36 mmm The black side with the manufacturer s logo should face upwards Shake the control solution bottle well before use Apply a drop of CareSens control solution to the reagent area of the test strip which is at the tip of the arrowhead shaped end of the strip The meter will perform the measurement and display the result in the active unit of measurement mmol l or mg dl Lij 5797 3254 z Check if the displayed result is within the range of La 162 234 k ots L1 or L2 values indicated on the label of the AutoSense Test strip vial If the result is within the range your meter is functioning properly utoSense 8 AutoSense Voice If the result of the self test is outside the given value ra
20. lood should fill up the reagent zone 23 D61 9201 2 beliv indd 23 2012 11 13 15 32 14 completely see picture in Strip insertion and use paragraph in About Test Strip An insufficient amount of blood might result in significant inaccuracy or failure of the test 3 The flashing blood drop icon will stop flashing when the blood droplet touches the strip A flashing horizontal bar in the middle of the display indicates that the meter is performing the test The measurement is performed automatically Do not move or touch the strip during this time 4 On average measurements are made 5 seconds after which the result is automatically displayed AutoSense Voice not only displays but also vocalizes the result in a human voice The meter will display Lo if the measured value is below 1 1 mmol l 20 mg dl and Hi if the value exceeds 33 3 mmol l 600 mg dl toSense amp AutoSense Voice 5 When the result is displayed you may mark and or flag it with the SET button If the SET button is pressed again the next marking flagging combination appears For more information refer to Flagging and marking test results 24 D61 9201 2 beliv indd 24 20121113 133215 _ SRE Marked results will be neglected in case of average glucose level calculation from the last 7 14 30 60 90 days test results For more information refer to Memory Storing data Oo Note Marks can only
21. meter on either by inserting a test strip into the strip holder or by pressing the OK button Upon insertion of a test strip a code number will appear on the display Compare the displayed code with the code printed on the vial label It is also recommended to check the strips expiration date toSense amp AutoSense Voice If the meter is switched on by pressing the OK button on the lower right side of the display a strip icon will instruct you to insert the test strip Take a test strip and holding it by its arrowhead shaped end insert it firmly 22 D61 9201 2 beliv indd 22 2012 11 13 15 32 14 EEREN E TT 5 into the middle of the strip holder The black side of strip must face up and it must be inserted all the way into the holder so that the manufacturer s logo is visible at the entrance of the strip holder If the strip has been inserted correctly the display changes a code number appears on the display until a blood droplet is applied to the strip After that a flashing blood drop icon will appear on the display indicating that the meter is waiting for the blood sample ab Note The insertion of a test strip will switch on the AutoSense automatically lO BSUaSO NY asUasO Ny 2 Prick your finger and gently squeeze out a small droplet of blood 0 5 ul is sufficient Apply the blood droplet laterally to the tip of the arrowhead shaped end of the test strip The b
22. n vocalized by the device is required as it is self explanatory Just follow the instructions as you hear them and you will use AutoSense Voice without any difficulty Audio data is available in 2 languages by default English and German itoSense amp AutoSense Voice Note AutoSense Voice always emits a typical beeping sound when switching off 8 D61 9201 2 beliv indd 8 2012 11 15 15 32 07 me FOR USERS OF PLASMA EQUIVALENT CALIBRATED METERS This section refers only to users with a plasma equivalent calibrated meter If your meter is plasma equivalent calibrated then Plasma equivalent calibrated is printed on the label on the back of your meter Blood glucose measurements can be made either from whole blood or from plasma the liquid portion of blood without red blood cells lon 9suasojny 8 su sozny Both methods are widely used although neither is more accurate than the other is However there is a slight difference between the results obtained from the 2 samples Plasma measurement values are generally 10 15 higher than their whole blood equivalents Thus if a plasma result is 221 mg dl the whole blood reading may be within the 190 mg dl to 200 mg dl range Due to the slight difference the resulting values obtained from the different methods cannot be compared simply 9 D61 9201 2 beliv indd 9 2012 11 13 15 32 07 The plasma calibrated AutoSense meter dis
23. nge e Perform self test again e Check if the code displayed is the same as the code on the AutoSense Test strip vial 48 D61 9201 2 beliv indd 48 2012 11 15 15 32 37 me e Check the meter with Check strip as well e See chapter Maintenance and or Error messages and troubleshooting for further advice If the test result value is still outside the given range contact your local distributor and reguest assistance ERROR MESSAGES AND TROUBLESHOOTING When using your AutoSense meter error messages consisting of the letter E followed by a number or letter might appear on the display The cause of these errors may be incorrect use of the meter or a problem with the meter In case of an error message generated by pressing any button the meter will switch off automatically IMPORTANT Do not continue a test if an error message is displayed OAsaSUuASOINy X asuasojny This section lists error messages explains their meanings and the possible reasons for a malfunction 49 D61 9201 2 beliv indd 49 2012 11 13 15 32 38 Instrument is not working e Batteries are discharged and must be replaced e If the batteries are not running low remove them and keep the OK button pressed for 15 20 seconds and then replace the batteries e Check that the battery poles are correctly positioned and MEME SETUP that the battery cover is closed properly ETHES 7
24. ntil PC appears and release the OK button e Target LiteLink s IR interface with the AutoSense meter IR output e Press the SET button to start the data transfer The meter will switch off automatically when the data transfer is completed loA 9suasojny 8 asuaso Ny Setting date and time Your AutoSense meter is used worldwide therefore it works with both a 12 and a 24 hour system The time is displayed in the upper left corner while the date appears in the upper right corner of the screen Switch the meter on with the OK button and keep it pressed Select the time setting menu by releasing the OK button when SEt time is displayed 33 D 1 9201 2 beliv indd 33 2012 11 13 15 32 24 After entering the time setting menu the year will be displayed in the upper left corner of the screen This can be modified with the SET button By pressing and holding down the button years can be set in fast mode After setting the year press the OK button to proceed to hour setting You can set hours in the same manner the year As you scroll the hours the clock mode changes at each rollover between 12 and 24 hour clock modes After setting the hours press the OK button to switch to the minute setting function and use the SET button to modify the displayed minute value toSense 8 AutoSense Voice When time is set press the OK button again to proceed to date setting In the upper right corner the month
25. plays the blood glucose measurement as obtained from plasma Therefore the glucose content displayed by the meter is the glucose content that would be in the plasma Thus the measurement can be easily compared with the results obtained from a laboratory that uses plasma for readings ly IMPORTANT The plasma calibrated AutoSense meter uses only whole blood for reading To obtain a result for plasma the plasma calibrated AutoSense meter converts the result of the whole blood measurement to plasma glucose value toSense amp AutoSense Voice Paul D Orazio Robert W Burnett Niels Fogh Andersen Approved IFCC Recommendation on Reporting Results for Blood Glucose IFCC SD WG SEPOCT Document Stage 1 Draft 9 September 2003 10 D61 9201 2 beliv indd 10 2012 11 13 15 32 07 me PRECAUTIONS Always operate your AutoSense Blood Glucose Meter according to the instructions provided hereafter If the equipment is used in a manner not recommended by this manual the warranty provided by the manufacturer may be voided It is essential to read and follow the information below e AutoSense is designed to be used ONLY with an AutoSense Test strip and no other strips 100 PSUaSONY 8 asuaso Ny e When inserting a new strip always check if the code on the vial of strips you are using matches the code that appears on the display If it does not DO NOT use the strip to measure your blood glucose value see
26. s repeat the test more carefully with a new strip Consult your healthcare professional before making significant changes to your diabetes medication program Do not ignore physical symptoms utoSense 8 AutoSense Voice 26 D61 9201 2 beliv indd 26 2012 11 15 15 32 17 me Flagging and marking test results At t add Electromagnetic interference and electrostatic discharge may interfere with the meter Do not use it near highly radiant devices e g mobile phones microwave ovens Do not perform the test with a damaged test strip Ensure that the test strip is inserted properly Improper positioning of the test strip will lead to an inaccurate test result Do not move or remove test strip during measurement Do not perform the test in extreme conditions External temperatures that differ from the specified operating temperature range or too high humidity e g a humid bathroom might affect the accuracy of the test result If the meter has been stored in a place that is too cold or too warm wait at least 30 minutes before use to ensure the meter and strip have reached room temperature Of BSUaSO NY X asuasojny he end of each measurement special flags and marks can be set to information to each measurement The SET button can define 11 different flag and marking combinations By pushing the SET button the following combinations can be set one in sequence Mark Premeal D61 9201 2 beliv ind
27. s control solution The CareSens control solution can be obtained from the manufacturer upon request an additional charge applies for the manufacturer address and phone number refer to the end of this manual To perform system checking follow the steps of one of the checking options below gt et o n D 5 W D go gt lt et o V D W lt Checking with Check strip Press the OK button and keep it pressed until CHK is displayed then release the OK button A flashing strip icon will be displayed indicating that the meter is waiting for strip insertion 45 D61 9201 2 beliv indd 45 2012115 15 32 35 U o gt U W G U N O ded gt eL o U W UW W o 46 Insert the Check strip included in your AutoSense package into the strip holder with the Check label facing upwards The meter will perform the measurement and display the result of the check If the displayed value is within the given range printed on the label affixed to the Check strip holding pocket the meter is operating perfectly Remove the Check strip and switch the meter off If the result of the self test is outside the stated value range perform the self test again If test result value is still outside the stated range contact your local distributor and request assistance D61 9201 2_ beliv indd 46 20121113 15 32 35 a IMPORTANT e Do not apply b
28. should be filled up completely if a sufficient amount of blood has been applied see pictures Sufficient amount of blood Insufficient amount of blood Note The meter will switch on automatically upon insertion of the test strip A BSUBSOWNNY 8 OSUJSOINY BEFORE TAKING MEASUREMENTS Readings might be affected by e Skin contaminants Always wash and dry your hands thoroughly before taking your blood sample and using AutoSense meter Wash your hands with warm water as this stimulates blood flow If you have difficulties obtaining your blood sample try dangling your arm downwards before pricking your finger This helps to increase blood flow 17 D61 9201 2 beliv indd 17 20121115 153211 e Severe dehydration may lead to low measurement values e An abnormally high concentration of vitamin C ascorbic acid may lead to high measurement values e The hematocrit red blood cell volume level in the blood may influence the measured results If the hematocrit level is exceeds 55 gt 55 the measurement results may be too low however if the hematocrit level is below 30 lt 30 the meter may display unusually high results e Incase of dialysis the hematocrit level may vary This may influence the displayed glucose level toSense amp AutoSense Voice BLOOD SAMPLING It is recommended to use the lancing device and disposable lancets packed together with the meter to prick your finger If you use
29. st strip s reagent zone and this current is conducted to the meter The current correlates with the blood glucose concentration Therefore the meter determines blood glucose concentration by measuring the extent of current flow The entire measuring process is controlled by a microprocessor inside the AutoSense meter lon 9suasojny 8 BsussoINy The microprocessor also controls the internal calibration of the device and if any failure is detected during operation a relevant error message is displayed see Error messages and Troubleshooting AutoSense automatically stores measured data together with the current date and time The memory capacity is large enough to store the data from the last 500 tests The stored data can also be uploaded to a host computer via IR interface with an additional device LiteLink shipped separately upon request 7 D 1 9201 2 beliv indd 7 2012 11 13 15 32 07 UNIQUE FEATURE OF AUTOSENSE VOICE This feature is a great help for people who may have problems reading the characters displayed on the screen By using the speaking function of AutoSense Voice the possibility of misreading caused by poor sight can be reduced significantly AutoSense Voice also vocalizes the important instructions and values displayed on the screen The clear and simple sentences spoken by the device make AutoSense Voice an extremely easy to use blood glucose meter No further explanation of the informatio
30. t in the memory i e after memory deletion or before the first use of a new device no average value will be displayed OAsaSUuASOINy 8 asuasojny 31 D61 9201 2 beliv indd 31 20121115 15 32 22 OVERVIEW OF FUNCTION MENUS By keeping the OK button pressed after switching on the meter will display the 8 alternative function modes check CHK data download PC time set SEt alarm settings Alr speaking function SEt for AutoSense Voice meter memory data delete dEL measurement unit selection SEt and hypoglycemic limit setting Hyp These modes will appear in the listed seguence as you keep the OK button depressed To enter a function mode release the OK button when the desired function tag is displayed itoSense amp AutoSense Voice PC mode In PC mode stored data can be downloaded to a PC SETUP To download data an additional adapter a LiteLink IR adapter is needed to establish a data communication E connection between your PC and the AutoSense meter L The LiteLink adapter and data communication control program is shipped separately upon the buyer s request 32 D61 9201 2 beliv indd 32 2012 11 13 15 32 23 me The PC side data management program and manuals containing all information on data downloading installation and operational settings are provided on CD e Switch the meter on with the OK button and keep it pressed u
31. the batteries each time you switch off the meter If 10 test measurements are made after the battery icon first appears the error message E 6 will be 40 D61 9201 2 beliv indd 40 2012 11 13 15 32 30 me displayed when the meter is switched on It means that you may not perform more tests until the batteries have been replaced D IMPORTANT Keep meter switched off while replacing batteries The battery holder is located on the back side of the meter The battery cover can be opened by pushing the narrow part of the cover upwards Replace the old discharged batteries with new ones Ensure that the and poles are properly positioned Click the battery cover back into place and then check the equipment by switching on the meter OMsasuaSOINy 8 su sony 41 D61 9201 2 beliv indd 41 2012 11 13 15 32 31 m Sense amp AutoSense Voice TTT Sa a 5 Ma tee f dL d Lea ba sasa prem S Ahi Mikir Ta ag ew latipe bet E esser AutoSense AutoSense Voice 42 D 1 9201 2 beliv indd 42 2012 11 13 15 32 32 PN me IMPORTANT If the meter does not function after battery replacement remove batteries again press and hold the OK button for 15 20 seconds and then replace batteries again If batteries are replaced in 60 seconds the date and time need not be reset The date and time should be reset if
32. them please read the following instructions 18 D61 9201 2 beliv indd 18 20121113 15 32 11 me A WARNING D61 9201 2 beliv indd 19 Before using them wash your hands thoroughly with warm water and dry them before pricking thereby stimulating the blood flow Prick the side of your fingertip However any other part of your palm or forearm may be pricked Wipe off the blood that emerges initially after pricking and then collect one drop without pressing your finger too hard Pressing your finger pad from the lower part upwards will help you to produce a blood drop IQ BSUBSO NY 8 ASuAGOINy Excessive rubbing may influence the measurement results Read the Instructions for Use for the lancing device before using it Dirt or contaminants on the finger or an insufficient amount of blood may lead to inaccurate results 19 2012 11 13 15 32 12 STRIP AUTOCODING Together your AutoSense meter and AutoSense Test strip form an accurate measuring system The AutoSense meter has an autocoding system to ensure that the meter and the strips work together properly The meter automatically reads the code on the back of the strip after a strip is inserted the code is assigned individually to each vial of strips Manual coding of the meter is not needed When inserting a new strip always check if the code on the vial of strips that you are using matches the code that appears on the display
33. them near any heating device radiator etc Unused strips that are stored in the original capped vial under the circumstances described in this section will remain stable until the expiration date indicated on vial label The test strips must be shipped and stored at 1 C 30 C 34 F 86 F Avoid both freezing and extreme heat 15 D61 9201 2 beliv indd 15 20121115 15 32 10 T IMPORTANT Read the AutoSense Test strip Instructions for Use before using them Always note the date when the vial is first opened and use the strips within 3 months from that date Use the removed strip immediately and always close the vial carefully immediately after removing a strip If the strips are stored below or above room temperature wait at least 30 minutes before opening the vial utoSense 8 AutoSense Voice Strip insertion and use The strip must be inserted into the meter s strip holder with the black side facing upwards and the sguare end pointing towards the device The meter will switch on automatically upon the insertion of the test strip Always ensure that the strip is completely and securely inserted into the center of the strip holder Ensure that enough blood 0 5 ul is applied to the reagent area located at the tip of the arrowhead shaped end of the strip The reagent window 16 D61 9201 2 beliv indd 16 2012 11 13 15 32 10 EE E at the end of the strip
34. with Check strip refer to AutoSense system checking E 6 error message e Batteries are running low Replace the batteries e High intensity electrostatic discharge may be affecting the L L meter Remove the batteries and keep the OK button TT LUIT pressed for 15 20 seconds Replace the batteries and switch on the meter If E 6 appears again change the batteries E error message e Insufficient amount of blood was applied to the strip Repeat test with a bigger drop of blood QU O gt QU W G U WY O ded gt lt o U W U N o e High intensity electrostatic discharge may be affecting the meter Repeat the measurement e Hematocrit level of sample is too high or too low Repeat test with a fresh drop of blood e Test strip is damaged Repeat test with another strip D61 9201 2 beliv indd 52 2012 11 13 15 32 42 he E 8 error message e Test was not performed properly Repeat test with a new test strip and be more careful when performing each step E 9 error message e External temperature is too high or low outside the 10 C 40 C range Wait at least 30 minutes before using the device until it fully reaches room temperature AutoSense is able to detect the external temperature If it detects values that differ from its operational reguirements the following error messages will be displayed e A downward pointing arrow icon and the E 9
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