Elektronika SensoCard, User Instructions

Page 1: ...SensoCard SensoCard SensoCard Plus Blood Glucose Meter Instructions for Use In vitro Diagnostic Medical Device IVD H u m a n V o i c e D a t a T e l l i n g SensoCard Plus 0197 ...

Page 2: ...NSOCARD PLUS 7 FOR USERS HAVING PLASMA EQUIVALENT CALIBRATED METER 8 IMPORTANT PRECAUTIONS 10 TECHNICAL DATA 11 PARTS OF SENSOCARD METER 12 ABOUT TEST STRIP 13 Strip insertion and use 15 BEFORE STARTING MEASUREMENT 16 BLOOD SAMPLING 17 STRIP CODE SETTING 18 Setting strip code with Code card 19 Setting strip code manually 22 1 SensoCard ...

Page 3: ...TIME 32 PC MODE 34 SELECTING MEASUREMENT UNIT mmol l mg dl 36 DELETING DATA STORED IN MEMORY 38 SWITCHING TO SPEAKING FUNCTION 39 BATTERY REPLACEMENT 40 MAINTENANCE 42 SENSOCARD SYSTEM CHECKING 43 Checking with Check strip 44 Checking with CareSens control solution 46 ERROR MESSAGES AND TROUBLESHOOTING 48 MANUFACTURER S WARRANTY 54 SYMBOLS 55 2 SensoCard ...

Page 4: ...is necessary Should you miss studying this manual you will not be familiar with the proper use of the system 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 u...

Page 5: ...s 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 ...

Page 6: ...ble 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 5 SensoCard ...

Page 7: ... of current flow The whole measuring process is controlled by a microprocessor inside the SensoCard meter The 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 ...

Page 8: ...hat 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 av...

Page 9: ...he results obtained from the two samples Values of plasma measurements are usually 10 to 15 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 ...

Page 10: ...t plasma result Plasma calibrated SensoCard 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 9 SensoCard ...

Page 11: ... information below 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 SensoCard meter is calibrated to be used only with fresh capillary blood No venous blo...

Page 12: ...pillary 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 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 ...

Page 13: ...S METERS 1 OK button 6 Code card slot 2 Up button 7 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 12 SensoCard 1 2 3 4 5 6 7 8 9 6 10 10 ...

Page 14: ...trip 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 gluc...

Page 15: ...rcumstances described in this chapter remain stable until the expiration date indicated on bottle label Test strip must be shipped and stored at 8 30 C 46 86 F Avoid both freeze and extreme heat 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 d...

Page 16: ...hat the strip is fully and securely inserted into the centre of the strip holder Make sure that enough blood 0 5 μl is applied to reagent area located at the tip of the arrowhead 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 Note On insertion of test strip meter will turn on automatically 15 SensoCard insuffici...

Page 17: ...our finger It helps to increase the blood flow Severe dehydration may lead to low measurement results Abnormally high concentration of Vitamin C Ascorbic Acid may lead to high results Hematocrit red blood cells volume level in blood also has an influence on measurement result If the hematocrit level is over 55 55 the measurement results may be too low if however the hematocrit level is below 30 30...

Page 18: ... 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 Read the lancing device s instr...

Page 19: ...s 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 by setting the code value manually which is printed onto the label of the strips vial Important Verify that the code displayed on LCD matches the code number on the vial of test strips each time you use your meter The code nee...

Page 20: ...tual 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 19 SensoCard Important to set code ...

Page 21: ... 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 3 Insert and remove Code card in Code card slot with one expressed move without interruption 20 SensoCard ...

Page 22: ...ady to perform the blood glucose test with the new code value 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 SensoCard Ready for measurement ...

Page 23: ...ach 0 1 2 3 4 5 6 7 8 9 A C E F H L P U 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 fl...

Page 24: ...t 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 n...

Page 25: ... the display Compare the displayed code value with the code value indicated on the strips vial label It is recommended to check the strips 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 bl...

Page 26: ...on by inserting test strip as well 2 Prick your finger and gently squeeze out a small droplet of blood 0 5μl 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 inacc...

Page 27: ... 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...

Page 28: ...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 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 chapte...

Page 29: ...tic 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 Make sure that the test strip is inserted properly Improper position of test strip will cause inaccurate test result Do not move or remove test strip during measurements Do not perform test at extreme conditions Different external temperature from...

Page 30: ... 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 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 29 SensoC...

Page 31: ... 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...

Page 32: ...rage value of your glucose level enter first the MEMORY menu by pressing the Up 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 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 t...

Page 33: ...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...

Page 34: ...r 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...

Page 35: ...itches 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 buy...

Page 36: ...d until 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 SensoCard ...

Page 37: ...ry Note Changing of measurement unit doesn t 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...

Page 38: ...nit 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 SensoCard ...

Page 39: ...oid 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 ...

Page 40: ...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...

Page 41: ...ayed 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 th...

Page 42: ...y 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 41 SensoCard SensoCard SensoCard Plus ...

Page 43: ...hey 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 recomm...

Page 44: ...NSOCARD SYSTEM CHECKING Checking the measuring 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 s...

Page 45: ...rip 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 SensoCard ...

Page 46: ...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 Do not apply blood on the Check strip Protect Check strips against physical damage and keep them in a safe place If Check strip is damaged or lost contact your local distributor for advice 45 SensoCar...

Page 47: ...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 ...

Page 48: ...ip 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 47 SensoCard ...

Page 49: ... 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...

Page 50: ... not working Batteries are discharged and need to be replaced If the batteries are not low remove them and keep the OK button pressed for about 15 20 seconds then place the batteries back Check that the battery poles are correctly positioned and that the battery cover is closed properly 2 Meter is very cold or too warm Allow meter to gradually reach room temperature 49 SensoCard ...

Page 51: ...ge Strip has been removed from the instrument during measurement 5 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 6 E 5 error message Strong electromagnetic field e g mobile phone ...

Page 52: ...pressed about 15 20 seconds Replace the batteries and turn on the meter If E 6 appears again please change the batteries 8 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 9 E 8 error message Test wasn t performed properly Repeat test with new test s...

Page 53: ...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 Code card is damaged Please check the integrity of Code card If you can find any mechanical damage ...

Page 54: ...ent shows Lo constantly Code setting is not correct Check and set the proper code value Insufficient amount of blood was applied on the strip Repeat test with a bigger drop of blood 14 Instrument shows Hi constantly Code setting is not correct Check and set the proper code value 15 Battery symbol appears on display Batteries are low Replace batteries If error messages cannot be eliminated by apply...

Page 55: ...on 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 ...

Page 56: ...ensoCard SYMBOLS 0197 98 79 EEC IVD directive SensoCard meter 0120 93 42 EEC MDD directive lancet In vitro diagnosticum Information inside Warning Manufacturer Temperature range Biological risk Expiry date ...

Page 57: ...77 ELEKTRONIKA Kft 1116 Budapest Fehérvári út 98 HUNGARY Tel 36 1 206 1480 Fax 36 1 206 1481 E mail sales e77 hu www e77 hu Your local distributor Meter serial number Service records VERSION 2 1 2006 05 56 SensoCard ...

Page 58: ...77 Elektronika Kft HUNGARY www e77 hu Fehérvári út 98 H 1116 Budapest Tel 36 1 206 1480 Fax 36 1 206 1481 E mail sales e77 hu D45 9201 3 2 1 2006 05 v ...