AutoSense AutoSense Voice
Contents
1. 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 O CON DW B 12 13 14 16 17 18 20 22 27 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 29 29 30 31 32 32 33 35 36 37 38 39 40 44 45 45 47 49 56 57 4 READ THIS BEFORE USING THE EQUIPMENT portant Before testing your blood with your AutoSense or AutoSense Voice Blood Glucose Monitoring System please read this user manual carefully g 8 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 e2. 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 setting after which meter will switch off c SETUP 1 Note If the speaking function is switched on the loudspeaker icon will be displayed all the time 4 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 DD IM PORTANT 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 amp AutoSense Voice Selecting unit measurement mmol l mg dl _Note Changing the unit of measurement will not affect 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 Your AutoSense meter can display the measured results in 2 units of measurement mmol l or mg dl Contact your healthcar
3. e Verify that the code displayed matches the code number on the vial of test strips each time you use your meter The meter will autocode each strip The code number can be any number 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 JM 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 21 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 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 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 into the middle of the strip holder The black side of strip must face up
4. see pictures Sufficient amount of blood Insufficient amount of blood Note The meter will switch on automatically upon insertion of the test strip 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 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 55 255 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 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 them please read the following instructions e Before using them wash your hands thoroughly with warm water and dry them before pricking thereby stimulating the blood flow e Prick the side of your
5. 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 9 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 Note The insertion of a test strip will switch on the AutoSense automatically 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 blood should fill up the reagent zone 23 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 mmo
6. fingertip However any other part of your palm or forearm may be pricked 4 e 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 WARNING Excessive rubbing may influence the measurement results e Read the Instructions for Use for the lancing device before using it e Dirt or contaminants on the finger or an insufficient amount of blood may lead to inaccurate results 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 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 In case you have an AutoSense Voice meter the meter can also read out the code if the speaking function is switched on IM PORTANT
7. measuring range Contact your healthcare professional immediately 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 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 results 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 e Electromagnetic interference and electrostatic discharge may interfere with the meter Do not use it near highly radiant devices e g mobile phones microwave ovens e Do not perform the test with a damaged test strip e Ensure that the test strip is inserted properly Improper positioning of the test strip will lead to an inaccurate test result e Do not move or remove test strip during measurement e 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 e 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 Flagging and marking test resul
8. memory i e after memory deletion or before the first use of a new device no average value will be displayed 9 31 OVERVIEW OF FUNCTION MENUS g 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 2 AutoSense Voice meter memory data delete dEL measurement unit selection SEt and hypoglycemic limit setting Hyp These modes will appear in the listed sequence as you keep the OK button depressed To enter a function mode release the OK button when the desired function tag is displayed PC mode In PC mode stored data can be downloaded to a PC To download data an additional adapter a LiteLink IR adapter is needed to establish a data communication connection between your PC and the AutoSense meter The LiteLink adapter and data communication control program is shipped separately upon the buyer s request 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 until 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 autom
9. not press any key 4 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 Alrl can be switched ON and OFF by pushing the SET button e If Alrl 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 35 e lf Alrl 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 After setting Alr3 switch off the meter by pressing the OK button The changes will be stored automatically T Note The meter switches off automatically in 2 minutes if you do not press any key Switching to speaking function Your AutoSense Voice meter speaks in 3 different E languages by default English German and Turkish To E Ll 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
10. out with the supplied Check strip or with CareSens 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 Checking with Check strip Press the OK button and keep it pressed until CHK is displayed then release the OK button 4 A flashing strip icon will be displayed indicating that the meter is waiting for strip insertion 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 Oo IM PORTANT e Do not apply blood 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 Pre
11. vial each time after removing a Strip Do not expose the strips to direct sunlight or store 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 weorranr Read the AutoSense Test strip Instructions for Use before using them w 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 e ifthe strips are stored below or above room temperature wait at least 30 minutes before opening the vial Strip insertion and use The strip must be inserted into the meter s strip holder with the black side facing upwards and the square 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 at the end of the strip should be filled up completely if a sufficient amount of blood has been applied
12. RTS OF THE METERS IR data output interface OK ON OFF button Strip ejector button Strip holder slot SET button Battery holder 13 ABOUT THE TEST STRIP Contact bars Confirmation window Edge to apply blood sample amp AutoSense Voice 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 Before testing always ensure that both the meter and the strips are at room temperature 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
13. atically when the data transfer is completed 4 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 SEE time is displayed 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 When time is set press the OK button again to proceed to date setting In the upper right corner the month 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 G Note The meter switches off automatically in 2 minutes if you do
14. ct your healthcare professional immediately Instrument constantly displays Hi e Code is not correct repeat test with a new strip and check T autocode Warning 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 4 Battery icon is displayed e Batteries are running low Replace batteries If error messages cannot be eliminated by applying the recommendations above please contact your local distributor for advice Thank you for your confidence in purchasing our product 93 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 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 rec
15. e 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 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 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 displayed when the meter is switched on It means that you may not perform more tests until the batteries have been replaced 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 r9 amp AutoSense Voice ALR OSE Beal Diris bin jr J AFi ar Painter pja ite MH ey E CE an a Ki jibes bay Taste hem AutoSense 42 Ee A a FT ot ees aa a ep ay Se E tt B AutoSense Voice 1 IMPORTANT If the meter does not func
16. e professional to check which unit is preferred in your country 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 SEE and mmol l with mg dl 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 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 4 39 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 BATTERY REPLACEMENT g Your AutoSense meter is powered by a CR2032 round cell battery 1 pc while AutoSense Voice is powered by 2 CR2032 batteries The us
17. ed 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 g 8 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 information 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 Note AutoSense Voice always emits a typical beeping sound when switching off 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 4 Blood glucose measurements can be made either from who
18. ed 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 M AutoSense or AutoSense Voice Blood Glucose Meter B Instructions for Use B Ilustrated Instructions for Use B Lancing device M Disposable microbiologically sterile lancets 8 pcs B Check strip 1 pc g 8 All parts are microbiologically clean 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 test 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 4 The entire measuring process is controlled by a microprocessor inside the AutoSense meter 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 measur
19. en 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 d IM PORTANT Do not continue a test if an error message is displayed This section lists error messages explains their meanings and the possible reasons for a malfunction 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 that the battery cover is closed properly Screen is too dim or screen persistence occurs e f screen cannot be seen properly because it is dim or all De olen graphics are displayed simultaneously the meter is very PI mg cold or too warm yuma t e Allow meter to reach room temperature gradually 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 0 appears again please contact your local distributor E 1 error message e Code error Please ensure that the proper AutoSen
20. ful when performing each step kg 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 requirements the following error messages will be displayed e A downward pointing arrow icon and the E 9 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 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 4 amp AutoSense Voice 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 AN If Lo is displayed as a result after testing it means that the measured value is too low it is out of measuring range Conta
21. l l 20 mg dl and Hi if the value exceeds 33 3 mmol 600 mg dl 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 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 Note Marks can only 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 9 The used strip and lancet are contaminated with blood Be careful and A 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 If Lo is displayed as a result after testing it means that the measured value is too low it is out of
22. le blood or from plasma the liquid portion of blood without red blood cells 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 The plasma calibrated AutoSense meter displays 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 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 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 PRECAUTIONS Always operate your AutoSense Blood Glucose Meter according to the instructions provided hereafter If the equipment is used in a
23. manner Q 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 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 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 Batteries Battery life Calibrated for Average test time Required sample volume Measuring range Display Memory capacity Strip autocode range Coding system Automatic switch on Automatic switch off Operating temperature Relative humidity Size Weight g 8 TECHNICAL DATA AutoSense AutoSense Voice 1 pc 3 V type CR2032 2 pcs 3 V type CR2032 1 year or 1500 measurements 1 year or 1000 measurements AutoSense Test strip 5 seconds Min 0 5 ul capillary blood 1 1 33 3 mmol l 20 600 mg dl Below 1 1 mmol l Lo above 33 3 mmol l Hi Last 500 results with time and date 1 15 Autocoding Upon insertion of test strip In 2 minutes after the last button activation 10 C 40 C lt 90 55 mm x 100 mm x 21 mm 60 g 90 g with batterie s PA
24. memory Stored data can be retrieved from the memory by selecting MEMORY mode Press 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 g 8 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 By pressing the OK button meter will enter the Average calculation mode Pressing the OK button will return you to the test screen 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 result in the
25. orded on the warranty card on the date of purchase The warranty period is not to be extended by any claim made under this warranty 56 SYMBOLS In vitro diagnostic medical device 4 98 79 EEC IVD directive AutoSense meter 0120 93 42 EEC MDD directive lancing device and lancets Manufacturer Consult instructions for use Warning 5 Serial number PERSE Direct current FJ Storeage temperature limitation Biological risk Use by date for lancing device and lancets Date of manufacture Bap g 8 aal Manufacturer wW 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 Meter serial number Service records D61 9201 2
26. quipment 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 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 dp Note In this manual if AutoSense is cited it refers 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 4 meter Follow the instructions provided in Maintenance to prolong the lifespan and accuracy of your meter This manual should tell you everything you ne
27. se test strip is used with the meter E 3 error message e Used strip is inserted Repeat measurement with new test strip e 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 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 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 meter Remove the batteries and keep the OK button pressed for 15 20 seconds Replace the batteries and switch on the meter If E 6 appears again change the batteries E 7 error message e Insufficient amount of blood was applied to the strip Repeat test with a bigger drop of blood 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 E 8 error message e Test was not performed properly Repeat test with a new Hi test strip and be more care
28. ss 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 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 Check if the displayed result is within the range of LI 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 If the result of the self test is outside the given value range e Perform self test again e Check if the code displayed is the same as the code on the AutoSense Test strip vial 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 request assistance 4 ERROR MESSAGES AND TROUBLESHOOTING Wh
29. tion after battery replacement remove batteries again press and hold the OK button for 15 20 seconds and then replace batteries again 4 If batteries are replaced in 60 seconds the date and time need not be reset The date and time should be reset if the batteries are replaced after 60 seconds Test data are stored and will not be lost due to battery replacement Electrostatic discharge may interfere with the meter In case of unusual effects turn off reset errors follow the instructions in Error messages and Troubleshooting MAINTENANCE lf 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 N WARNING Protect the inside of the meter from water 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 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
30. ts At the end of each measurement special flags and marks can be set to add 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 27 Mark amp Premeal Postmeal Mark amp Postmeal Sport activity Mark amp Sport activity Premeal amp Sport activity Postmeal amp Sport activity Mark amp Postmeal amp 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 10 38 fet After sport activity 0 38 i i Premeal amp Sport activity Postmeal amp Sport activity 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 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 Recalling data from
Download Pdf Manuals
Related Search