SensoCard user manual
Contents
1. us In vitro Diagnostic Medical Device sf 10 CONTENTS MPORTANT READ THIS BEFORE USING THE EQUIPMENT NTRODUCTION PACKING LIST SENSOCARD METER EXPLAINED UNIQUE FEATURE OF SENSOCARD PLUS FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER MPORTANT PRECAUTIONS TECHNICAL DATA PARTS OF SENSOCARD METER ABOUT TEST STRIP Strip insertion and use BEFORE STARTING MEASUREMENT BLOOD SAMPLING STRIP CODE SETTING Setting strip code with Code card Setting strip code manually co co 11 12 13 15 16 17 18 19 22 MEASURING WITH THE METER MEMORY Storing data Recalling data from memory Average calculation OVERVIEW OF FUNCTION MENUS SETTING DATE AND TIME PC MODE SELECTING MEASUREMENT UNIT mmol l mg dl DELETING DATA STORED IN MEMORY SWITCHING TO SPEAKING FUNCTION BATTERY REPLACEMENT MAINTENANCE SENSOCARD SYSTEM CHECKING Checking with Check strip Checking with CareSens control solution ERROR MESSAGES AND TROUBLESHOOTING MANUFACTURER S WARRANTY SYMBOLS 2 IMPORTANT READ THIS BEFORE USING THE EQUIPMENT Before testing your blood with SensoCard or SensoCard Plus Blood Glucose Monitoring System please read this user manual carefully For the safe and easy operation studying of the Instructions For Use of the meter and accessories finger pricker test strip is necessary Should you miss studying this manual you will not be familiar with the proper use of the sy2. SensoCard Plus Important m f the instrument does not work after battery replacement replace the batteries again press and hold the OK button down for about 15 20 seconds then replace batteries If batteries are replaced in 60 seconds date and time not needed to be reset After 60 seconds date and time should be reset Code number and test data are stored and they will not be lost due to battery replacement They will be available after battery replacement as well Electrostatic discharge may interfere with the meter In the case of unusual effects turn off reset errors follow the instructions in the Error messages and Troubleshooting chapter MAINTENANCE If SensoCard is used according to this Instructions For Use only minimal maintenance is necessary However to always have accurate test results we recommend you to perform the following operations f necessary use a wet cloth for cleaning the whole surface of instrument After maintenance check functionality For more details see chapter SensoCard system checking 42 Warning Protect the inside of the meter from water m Never immerse the meter or hold it under running water Avoid disassembling the meter repairs should be done exclusively by authorised service Keep in touch with your local distributor s technical service if you need assistance contact them SENSOCARD SYSTEM CHECKING Checking the m
3. 13 SensoCard Test strips are sensitive to heat and mechanical damage do not use strips if you suspect such danger may occur Always keep the strips in their original package close the vial each time when you removed a strip Do not expose the vial of strips to direct sunlight or store it near any heating device radiator etc Unused strips which are stored in the original capped vial under the circumstances described in this chapter remain stable until the expiration date indicated on bottle label Test strip must be shipped and stored at 8 30 46 86 F Avoid both freeze and extreme heat A Important Read the Instructions for use of SensoCard Test strip before you start to use it Always note the date of the first opening of the vial of strips and use the strips within three months from that date Use the removed strip immediately and always close the vial carefully Ifthe strips were stored below or above room temperature wait at least 30 minutes before opening the vial 14 Strip insertion and use The strip must be inserted into meter s strip holder with the black side facing upwards and with the squared end pointing towards the device The meter will turn on automatically by inserting the test strip Always ensure that the strip is fully and securely inserted into the centre of the strip holder Make sure that enough blood 0 5 ul is applied to reagent area located at the tip of the arrowh
4. 39 BATTERY REPLACEMENT SensoCard meter is powered by 1 pce while SensoCard Plus 2 pcs of round cell batteries type CR2032 Other types of batteries are not allowed to be used under the guarantee terms and conditions When the batteries are getting low a battery icon is displayed on the screen It indicates that batteries are needed to be replaced soon When battery icon is displayed the meter is still operating accurately but replacement of batteries should be done not later than finishing the next 10 test measurements Find inside two batteries in SensoCard Plus but only one battery in SensoCard After battery icon is displayed SensoCard Plus tells you every time you witch off the meter to replace batteries If 10 test measurements are done after the first appearance of the battery icon the error message E 6 will be displayed on the screen when the meter is switched on It means that it is not allowed to perform any more tests until the batteries are changed 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 isolated part of the cover upwards Replace the old discharged batteries with new ones Make sure the and poles are properly positioned Click the battery cover back into its place then check the equipment s ability to operate by switching the meter on SensoCard
5. ge Manufacturer wk Temperature range A Biological risk T Expiry date Manufacturer uid 77 ELEKTRONIKA Kft Ww 1116 Budapest Feh rv ri t 98 HUNGARY Tel 36 1 206 1480 Fax 36 1 206 1481 E mail sales e 7 hu www e hu Your local distributor Meter serial number Service records VERSION 2 1 2006 05 56 T1 Elektronika Kft HUNGARY Feh rv ri t 98 H 1116 Budapest Tel 4 36 1 206 1480 Fax 36 1 206 1481 E mail sales e77 hu D45 9201 3 www e77 hu v 2 1 2006 05
6. card Automatic switch on upon insertion of test strip Automatic switch off in 2 minutes after the last button activation Operating temperature 10 40 C Relative humidity 9096 RH Size 45 x 90 x 7 mm 55x90 x 15 mm Weight with batteries 64g 96 g 11 PARTS OF SENSOCARD AND SENSOCARD PLUS METERS 1 OK button 6 Code card slot 2 Up button T Battery holder 3 Down button 8 IR data output interface 4 Display 9 Loud speaker only in SensoCard Plus 5 Strip holder slot 10 Strip ejector button 8 2 f 9 ABOUT TEST STRIP 3 Reagent window 1 Flat wire conductor 2 Reagent zone SensoCard is designed ONLY for in vitro use with SensoCard Test strip No other strips will give you an accurate result Always check if the 3 digit code on the bottle of strips you are using matches the 3 digit code you have entered in your meter If they are not the same your measuring result will be incorrect see section Strip code setting later Each vial of strips is labeled also with a date of expiry Always use the strips within three months from the date of opening and never use the strips if they are expired Before testing always make sure both meter and strips are at room temperature Note SensoCard Test strip reacts with blood glucose forming a current The intensity of the current is proportional to blood glucose concentration SensoCard meter detects generated micro current and calculates glucose concentration
7. displays but also tells the result in human voice If Up button is pressed the meter tells you the result again Meter will display Lo if the measured value is under 1 1 mmol l 20 mg dl and Hi if the value is above 33 3 mmol l 600 mg dl 5 When the result has appeared it is possible to mark it with the Down button If Down button is pressed again the mark disappears Marked results will be neglected in case of average glucose level calculation of the last 7 14 28 days tests results For more information see chapter Memory Storing data Note Marks can only be added or removed right after the measurement They cannot be changed when recalling them from memory 26 6 After completing the measurement test strip can be removed from the meter Push the ejector button downwards on the left side of the meter to eject the strip Test result can be seen on the screen for 2 minutes or until the strip is removed or the meter is switched off Meter will automatically store the result in the memory together with actual date and time However it is recommended always to record the test result in a diabetes diary before turning meter off A Used strip and lancet are contaminated with blood Be careful follow the relevant local instructions when you throw used strip and lancet away In case of any error message refer chapter Error messages and Troubleshooting SensoCard 27 A Warning High or low results which ar
8. glucose level of the last 7 14 28 day long time periods Results can be marked after measurements only by pressing the Down button An exclamation mark will also appear on the display s lower left side when recalling marked results from memory Recalling data from memory Stored data can be retrieved from memory by selecting MEMORY mode Press the Up button on the right side of SensoCard after 1509 1305 switching the meter on to enter MEMORY mode Result of the last measurement will appear on the screen Date and time of the measurement will be displayed in the upper line of the display Scroll among stored memory records with the help of the Up and Down buttons When you reach the earliest memory record meter stops scrolling Those results that were marked after measurement will be displayed with exclamation mark when recalled By pressing the OK button meter will enter the Average calculation mode Press the OK button again to return to test mode 30 Average calculation SensoCard is able to calculate the average glucose level of the last 7 14 28 days tests results Calculated average contains all test results from the selected 7 14 or 28 day long time periods except the marked ones However this function only operates accurately if date and time are precisely set To study the average value of your glucose level enter first the MEMORY menu by pressing the Up button after switching on the device In the MEM
9. on CD 34 Switch the meter on with the OK button and keep it pressed until n r PC mode appears Release the button Target LiteLink adapter s IR interface with SensoCard meter s IR output To start data transfer press the Up or Down button on SensoCard When data transfer is finished meter will switch off automatically 35 SELECTING MEASUREMENT UNIT mmol l mg dl SensoCard meter is able to display measured results in two measurement system units mmol l or mg dl Contact your healthcare professional to check which unit is preferred in your Country AN Note Changing of measurement unit doesnt effect test results only the way it is displayed 1 mmol l equals to about 18 mg dl So for the same blood glucose level 5 4 mmol l or 97 mg dl will be displayed depending on which measurement unit is selected To choose between the two measurement units after switching on the meter keep pressed the OK button until SEt and mmol l with mg dl is displayed on the screen 36 me After entering this menu only the recently active unit will appear on the screen Switch between the two possible units mmol l and mg dl with the help of the Up and Down buttons When the desired unit is selected store your setting by pressing the OK button Meter will switch off automatically 37 DELETING DATA STORED IN MEMORY All data in memory can be deleted in dEL mode After deletion default data se
10. ORY menu press the OK button to display the average glucose level of the last 7 day period Use the Up and Down buttons to switch between the average of the last 7 14 and 28 day long time periods By pressing the OK button you will return to test screen Note If there is no test result in the memory after memory deletion or before the first test of a new device no average value will be displayed 31 OVERVIEW OF FUNCTION MENUS By keeping the OK button pressed after switching on meter will offer alternatively six functional modes calibration screen CAL data download screen time set screen SEt mem ory data delete screen dEL measurement unit selection screen SEt and switching to speaking function screen SEt in case of SensoCard Plus meter These function modes will follow each other as you keep pressed the OK button in the same order as they were mentioned above To enter one of the function modes release the OK button when the desired function s tag is displayed SETTING DATE AND TIME SensoCard meter is used world wide therefore it works both with a 12 and a 24 hour system It is not able to recognise leap years Time is displayed in the upper left corner while date appears in the upper right corner of screen 32 Lr JL ri Switch meter on with the OK button and keep it pressed Select the time setting menu by releasing the OK button when SEt time appears on the scree
11. de displayed on LCD matches the code number on the vial of test Strips each time you use your meter The code needs to be entered only once for each vial of test strips The meter will memorise the code until you change it W f your Code card is broken or missing please follow instructions for Setting strip code manually in this chapter 18 Setting strip code with Code card 1 Switch the meter on with the OK button or by inserting a SensoCard Test strip into the strip holder After the initial full screen the actual code value will appear on the LCD A large 3 digit alpha numerical value CODE caption and a strip icon with a flashing arrow will be displayed The code value displayed on the screen must be compared to the code value printed onto the label of the SensoCard Test strips vial If they are not the same go on with the code setting process Do nat viet sips outage s bese Blood Glucose ME nosercenetien est stp conta approimaty quien chine 45 10 200407 Botte Sica 042 Cat No SCT 0901 1 028 Important to set code Qj 08 2006 2 Press the Down button on the right side of meter to enter the code setting function A simple animation displayed on the screen will request the Code card to be inserted into its slot on the left bottom side of the meter A m l CODE 3 Insert and remove Code card in Code card slot with one expressed move without interruptio
12. de setting is not correct Check and set the proper code value 15 Battery symbol appears on display m Batteries are 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 53 MANUFACTURER S WARRANTY 77 Elektronika warrants SensoCard blood glucose meter against defects in materials and workmanship for a period of three years from the date of purchase The warranty is lost if the instrument is misused poorly maintained or is tampered with Liability under this war ranty is limited to the repair of defective parts or at the discretion of 77 Elektronika Kft to the 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 dealt with The warranty is not valid if the damage results from misuse maltreatment tampering human error and the use of extreme This warranty is valid only if the date the stamp and the 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 made under this warranty 54 SYMBOLS C 0197 98 79 EEC IVD directive SensoCard meter 0120 93 42 EEC MDD directive lancet In vitro diagnosticum Information inside Warning
13. e incorrect may have serious medical consequences If your blood glucose is unusually high greater than 16 mmol 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 Electromagnetic interference and electrostatic discharge may interfere with meter Do not use near highly radiant devices eg mobile phone microwave oven Do not perform test with damaged test strip m Make sure that the test strip is inserted properly Improper position of test strip will cause inaccurate test result m Do move or remove test strip during measurements Do not perform test at extreme conditions Different external temperature from the specified operating temperature range or too high humidity eg humid bathroom might effect the accuracy of test result m When the meter was stored in a too cold or warm place wait for at least 30 minutes until meter and strip reach room temperature 28 MEMORY SensoCard is able to store up to 500 measurements with related times and dates Storing data SensoCard meter automatically stores each test result when it switches off If memory is full the oldest result will be lost while the new result will be added False or control measurement s result can be marked thus not to be calculated in the average
14. ead end of the strip The little reagent window at the end of the strip should fill up completely if sufficient amount of blood is applied sufficient amount of blood insufficient amount of blood Note On insertion of test strip meter will turn on automatically 15 BEFORE STARTING MEASUREMENT Readings might be effected by m Skin contaminants Always wash and dry your hands thoroughly before taking your blood sample and using SensoCard Wash your hands with warm water this also stimulates blood stream If you have difficulties in obtaining your blood sample try hanging your arm down before pricking your finger It helps to increase the blood flow Severe dehydration may lead to low measurement results m Abnormally high concentration of Vitamin C Ascorbic Acid may lead to high results m Hematocrit red blood cells volume level in blood also has an influence on measurement result If the hematocrit level is over 55 255 the measurement results may be too low if however the hematocrit level is below 30 lt 30 the meter may yield unusu ally high results In case of dialysis the hematocrit level of blood may vary This may influence the displayed glucose level 16 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 too Before using them please make sure to wa
15. easuring accuracy of the meter is recommended after every maintenance Check test of SensoCard can be carried out by supplied Check strip or with CareSens control solution CareSens control solution can be obtained from Manufacturer upon user s request for additional charge see exact address and phone number of manufacturer at the end of this manual To perform system checking please follow the steps of one of the checking possibilities below 43 Checking with Check strip LAL Press OK button and keep it pressed until CAL appears on the screen then release it Strip icon will be displayed together with flashing arrow icon indicating that the meter is waiting for strip insertion Insert Check strip which is included in SensoCard package into strip holder with the Check label facing upwards Meter will perform the measurement and display the result of the check 44 If the displayed value is within the given range that is indicated on the label affixed to the Check strip holding pocket the meter is operating perfectly Remove Check strip and switch the meter off If the result of the self test is not in the given value range perform the self test again If test result s value is still out of given range contact your local distributor and ask for help Important m Do not apply blood on the Check strip Protect Check strips against physical damage and keep them in a safe place I
16. er entering this menu function modify the value of the first digit with the Up and Down buttons By pressing the OK button the first digit will be set and the second digit will be flashing indicating that now its value can be modified Use the Up and Down buttons to adjust the value of the second digit similarly to what you did with the first one and then press OK when you are ready Now the last digit should be flashing After you have set the value of the last digit as well store the new code by pressing OK The meter will return to the test screen where the new code value will be displayed Compare this code value with the code value affixed to the strips vial label If they are the same you are ready to perform blood glucose test if not repeat the code setting procedure again Note If no buttons are pressed for 2 minutes the meter automatically turns off and the actual code value remains the same as before 23 MEASURING WITH THE METER Before you start the test make sure you have everything ready you might need meter test strip finger pricking device some tissues Now put your meter on a clean flat surface Wash your hands thoroughly 1 Switch SensoCard on either by inserting test strip into its strip holder or by pressing the OK button By pressing the OK button test screen appears on the display Compare the displayed code value with the code value indicated on the strips vial label It is recommended to check the strips
17. expiration date as well In the lower right side of the screen a strip icon and a flash ing arrow will instruct you to insert the test strip Take a test strip and holding it by its arrow head shaped end insert it firmly into the middle of the strip holder The black side of strip must be face up and it must be inserted all the way into the holder so that the manufacturer s logo will be seen at the entrance of the strip holder 24 If the strip is in its right place the screen changes instead of the flashing arrow a flashing blood drop icon appears on the LCD indicating that the meter is waiting for blood dropping Note SensoCard can be switched on by inserting test strip as well 2 Prick your finger and gently squeeze out a small droplet of blood 0 5ul is enough Apply the blood droplet to the tip of the arrow head shaped end of test strip laterally Blood should fill up the reagent zone completely see picture in the Strip insertion and use paragraph of the chapter About Test Strip Insufficient amount of blood might result significant inaccuracy or the failure of the test 25 3 Flashing blood drop icon disappears from the screen after the blood droplet reaches the strip Flashing clock icon shows that the meter is performing the test Do not move or touch strip during measuring time 4 On the average measurements take 5 seconds after the result is displayed on the screen SensoCard Plus not only
18. f Check strip is damaged or lost contact your local distributor for advice Checking with CareSens control solution r Press OK button and keep it pressed until CAL appears on the L L Screen then release it Strip icon will be displayed together with flashing arrow icon indicating that the meter is waiting for strip insertion Compare displayed code value with code value written on the vial of SensoCard Test strips If code values are not the same please set the correct code value before continuing see Strip code setting chapter for details Insert the SensoCard Test strip and push it gently until the end position The black side with the manufacturer s logo should be facing upwards 46 Shake control solution bottle well before use Drop CareSens control solution to the reagent area of test strip which is at the tip of the arrowhead shaped end of the test strip Meter will perform measurement and display the result in the active unit mmol l or mg dl Check if displayed result is within the range of L1 or L2 value indicated on the label of SensoCard Test strip s vial If the result is within the range your meter works perfectly N IMPORTANT Do not vore test stips outside Ris Dotie Glucose Test Srip eas If the result of self test is not in the given value range W perform self test again check if the code value displayed on LCD is the same as the code value written o
19. he microprocessor also controls the internal calibration of the device and if any failure is detected in the operation a relevant error message is displayed see section Error messages and Troubleshooting SensoCard automatically stores measured data together with the current date and time The memory capacity is large enough to store the data of the last 500 tests Stored data can also be uploaded to a host computer via IR interface with the help of an additional device named LiteLink shipped separately upon request 6 UNIQUE FEATURE OF SENSOCARD PLUS This feature is a great help for those people who may have problems with reading displayed characters from the screen By using the speaking function of the device possibility of misreadings caused by poor sight can be reduced significantly All the important instructions and values that are displayed on the screen are also told by SensoCard Plus Clear and simple sentences of the device make SensoCard Plus a very easily usable blood glucose meter There is no need for further explanation of the sentences told by the device as they are self explaining sentences Just follow the instructions as you hear them and you will use SensoCard Plus without any difficulty Data telling is available in two languages by default English and German Note SensoCard Plus always gives a typical beeping voice when switching off FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER This section
20. n 4 The meter returns automatically to the test screen where the recently set code value is displayed showing that it has been stored in SensoCard Now the meter is ready to perform the blood glucose test with the new code value Blood Glucose Test Srip Weagest Cemgesbea tach st stip contains approximate oxttase 2710 Haze Tubes choro 45 7 Ute 156 9 Botte S ra gd 239 AN Warning SensoCard waits for the insertion of the Code card for 60 seconds If the Code card is not inserted within 60 seconds the meter displays an E C error message and the actual code value remains the same as before In this case please repeat the coding process again 21 Setting strip code manually When the Code card is missing or it is damaged you may want to set the strip code manually The range of the available code values covers 1 UU6 Digits that can be set vary between 0 U 18 unique values each 0 1 2 3 4 5 6 7 8 9 A C E F H L PU The value of the third digit can vary between 0 6 only if the first two digits values are U In order to set the code manually follow the instructions below Press the Down button on the right side of meter and when the code requesting animation is displayed press the Down button again A large 3 digit alphanumerical code value will appear on the screen with flashing first digit 22 Code value can be adjusted digit by digit Aft
21. n After entering the time setting menu only hours will be dis played in the upper left corner of the screen Hours can be modified with the help of the Up and Down buttons By press ing and holding down the buttons hours can be set in fast mode As you scroll hours clock mode changes at each rolling over between 12 hour clock mode and 24 hour clock mode After setting the hours press the OK button to switch to minutes setting function and use the Up and Down buttons for adjusting here as well 33 When time is set press the OK button again to go on to date setting In the upper right corner first month then day will be displayed They can be adjusted with the Up and Down buttons and set with the OK button similarly to time setting After time and date are set the meter can be switched off by pressing the OK button Changes will be stored automatically Note meter switches off automatically in 2 minutes if you do not press any key PC MODE In PC mode data stored in meter s memory can be downloaded to PC based computer To download data an additional adapter called LiteLink IR adapter is needed to establish data communication connection between PC and SensoCard meter LiteLink adapter together with data communication control program is shipped separately upon buyer s request Data management program on PC side and manuals containing all information on data downloading installation operational settings are attached
22. n SensoCard Test strip s vial check meter with Check strip as well W see chapter Maintenance and or Error messages and troubleshooting for further advice If test result value is still out of the given range contact your local distributor and ask for help ERROR MESSAGES AND TROUBLESHOOTING When using SensoCard meter some error messages consisting of a letter E followed by a number or letter might appear on the display The cause of these errors may be that you are not doing something correctly or that there is a problem with the meter In case of an error message pressing any button the meter will switch off automatically 48 A Important Do not continue test if an error message is displayed This chapter lists error messages explains their means and possible reasons causing mal functioning 1 Instrument is not working m Batteries are discharged and need to be replaced mf the batteries are not low remove them and keep the OK button pressed for about 15 20 seconds then place the batteries back m Check that the battery poles are correctly positioned and that the battery cover is closed properly 2 Meter is very cold or too warm Wm Allow meter to gradually reach room temperature 49 3 H EEHEHE E O error message If this error message remains on screen after turning meter on the meter has got damaged Please remove the batteries and keep the OK button pressed about 15 20 seconds the batte
23. refers only to users who have plasma equivalent calibrated meter If your meter is plasma equivalent calibrated than Plasma equivalent calibrated is written on the label at the back side of your meter Laboratory blood glucose measurements can be made either from whole blood samples or from plasma samples liquid portion of blood without red blood cells Both methods are widely used neither is more accurate than the other However there is a slight difference between the results obtained from the two samples Values of plasma measurements are usually 1096 to 1596 higher than their whole blood equivalents So if plasma result is 221 mg dl you may have your whole blood reading within the range of 190 mg dl to 200 mg dl Because of the slight difference result values obtained from the different methods cannot be simply compared Plasma calibrated SensoCard meter displays the result of blood glucose measurement as it had been obtained from the plasma reading So the glucose content that is displayed by the meter is the glucose content that would be in the plasma Therefore results of the measurements can be easily compared with the results obtained from a laboratory using plasma for readings 8 Important It is important to know that Plasma calibrated SensoCard uses only whole blood for reading To get plasma result Plasma calibrated SensoCard converts the result of the whole blood measurement to plasma glucose value Paul D Orazio Rober
24. ries and turn on the meter If E 0 appears again please contact your local distributor E 2 error message Strip has been removed from the instrument during measurement E 3 error message Used strip is inserted Repeat measurement with new test strip Check strip is inserted instead of test strip Replace it with a test strip Strip is not correctly inserted Blood was applied before strip insertion Repeat measurement with new test strip E 5 error message Strong electromagnetic field e g mobile phone or high intensity electrostatic discharge interfere with the meter Repeat the measurement 50 Meter is damaged Check the meter with Check strip see SensoCard system checking chapter E 6 error message Batteries are low Replace the batteries High intensity electrostatic discharge may influence the meter Please remove the batteries and keep the OK button pressed about 15 20 seconds Replace the batteries and turn on the meter If E 6 appears again please change the batteries E 7 error message Insufficient amount of blood was applied on strip Repeat test with bigger drop of blood High intensity electrostatic discharge may influence the meter Please repeat the measurement E 8 error message Test wasn t performed properly Repeat test with new test strip and be more careful when performing each step 51 10 E 9 error message W External temperature is too high or low out of the range 10 40 C Wait a
25. sh your hands thoroughly with warm water and then dry them before pricking Thereby you stimulate the blood stream Use the side of the finger tip for pricking however alternatively every other part of your palm can be pricked also Wipe off the blood that disperses first after pricking and then collect one drop without pressing your finger too hard Pressing your finger pad from the lower part up will help you to produce a blood drop Warning Excessive rubbing may influence measurement results m Read the lancing devices instructions for use before you start to use it m Dirt or contaminants on finger or insufficient amount of blood may lead to inaccurate measurement results 17 STRIP CODE SETTING Your SensoCard meter and SensoCard Test strip form together an accurate measuring system To assure that the meter and the strips work together properly the SensoCard meter must be coded to the strips what are used actually Coding the meter means entering the code value which is assigned individually to each vial of strips The code is a three digit alphanumerical number affixed to the strips vial which influences the accuracy of the meter while it calculates glucose concentration There are two ways how you can enter strip code by using Code card included for every vial of strips or setting the code value manually which is printed onto the label of the strips vial Important m Verify that the co
26. sit your medical doctor specializing in diabetes treatment if you need further advice Keep this manual in a safe place so that you can find and consult it any time If you have any technical questions not included in this manual please contact your local distributor 4 INTRODUCTION Content of SensoCard kit SensoCard blood glucose meter D45 8001 x Instruction For Use D45 9201 x Instruction For Use in pictures D45 9202 x Lancing device ALT 4451 x 8 pcs Disposable microbiologically sterile lancets ALT 4414 x 1 pce Check strip D45 4001 x Content of SensoCard Plus kit SensoCard Plus blood glucose meter D46 8001 x Instruction For Use D45 9201 x Instruction For Use in pictures D46 9202 x Lancing device ALT 4451 x 8 pcs Disposable microbiologically sterile lancets ALT 4414 x 1 pce Check strip D45 4001 x All parts are microbiologically clean SENSOCARD METER EXPLAINED SensoCard 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 is in correlation with blood glucose concentration Therefore the meter can determine blood glucose concentration by measuring the extent of current flow The whole measuring process is controlled by a microprocessor inside the SensoCard meter T
27. stem Always consult with 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 Never use accessories which are not supplied or recommended by the manufacturer or distributor Never use the equipment if it is not working properly Ship and store the meter at 20 60 C 4 140 F v INTRODUCTION Thank you for choosing SensoCard blood glucose monitoring system It has been carefully designed to enable you to easily reliably and accurately monitor your blood glucose level This meter meets the International Standards belong to the applicable EMC emission electrostatic discharge radio frequency radiation This manual belongs to both SensoCard and SensoCard Plus meters The only difference between them is the talking ability of SensoCard Plus So if it is not specially indicated all instructions are relevant to both meters Note In this manual if SensoCard is written it refers to both SensoCard and SensoCard Plus meters To get the best from your SensoCard meter please take the time to become familiar with Read and understand the instructions in this manual before using your meter Follow the instructions included in the Maintenance section to prolong life and accuracy of your meter This guide should tell you everything you need to know about operating SensoCard meter however it is recommended that you vi
28. t 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 IMPORTANT PRECAUTIONS Always operate SensoCard blood glucose meter according to the instructions described hereafter If the equipment is used in a manner not recommended by this manual the warranty provided by the manufacturer may be lost It is essential to read and follow the information below m SensoCard is designed to be used ONLY with SensoCard Test strip and no other strips Always check if the 3 digit code on the vial of strips you are using matches the 3 digit code appearing on the meter s screen If it does not then enter the code into the meter see the Strip code setting section m SensoCard meter is calibrated to be used only with fresh capillary blood No venous blood or plasma is suitable for accurate monitoring of glucose level 10 TECHNICAL DATA SensoCard SensoCard Plus Batteries 1 pce 3V type CR2032 2 pcs 3V type CR2032 Battery lifetime 1 year or 1500 measurements 1 year or 1000 measurements Calibrated for SensoCard Test Strip Average test time 5 sec Sample volume needed min 0 5 ul capillary blood Measuring range 1 1 33 3 mmol l 20 600 mg dl Display under 1 1 mmol l Lo above 33 3 mmol l Hi Memory capacity last 500 results with time and date Strip code range 1 UU6 alphanumerical Coding system internal with Code
29. t least 30 minutes before using the device until it completely reaches room temperature SensoCard is able to check external temperature If it detects values not conforming to its operational requirements the following error messages will be displayed An arrow icon directed downward and the E 9 error message together indicate low temperature below 10 C An arrow icon directed upward and the E 9 error message together indicate high temperature above 40 C 11 E C error message This error message may appear during using Code card There might be one of the following problems W Code card is damaged Please check the integrity of Code card If you can find any mechanical damage on Code card contact your local distributor Code card insertion or removal was not continuous Insert and remove Code card with a bit quicker expressed move 52 Code card insertion or removal was too slow Repeat Code card insertion without interruption 12 Flashing result m If temperature gradient is too high SensoCard still keeps on operating but the displayed result will be flashing indicating the abnormal operational circumstances Be cautious with these test results they might be inaccurate 13 Instrument shows Lo constantly Code setting is not correct Check and set the proper code value m Insufficient amount of blood was applied on the strip Repeat test with a bigger drop of blood 14 Instrument shows Hi constantly Co
30. tting will be restored set by Manufacturer _ D 1 5 4 mmol l LI L L Switch meter on with the OK button and keep it pressed until dEL appears on the screen then release the button MEM To avoid data loss by mistake memory deletion will only be executed if after entering this menu first Down button and right after Up button is pressed After deletion meter switches off automatically Important It is possible to exit from the memory delete mode without loosing data by pressing the OK button or by pressing the buttons in any order other than first Down button then Up button Data will not be lost either if meter switches off automatically after 2 minutes 38 SWITCHING TO SPEAKING FUNCTION SensoCard Plus meter can speak in two different languages by default English and German To switch between these two languages or to switch loud speaker off enter loud speaker Switching menu To enter this menu after turning on the device keep pressed the OK button until SEt and the sign of a loud speaker is displayed on screen Then release OK button Select GEr to set German language or select EnG to set English with the help of the Up and Down buttons Choose OFF to switch off loud speaker Always the actual setting is displayed on the screen Store your setting by pressing OK button Meter will switch off Note If speaking function is switched on the sign of loud speaker will be displayed on the screen all the time
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