Accu-Chek ACTIVE, Instructions For Use Manual

Page 1: ...08 05 Blood Glucose Meter Instructions for use R4 406 3400 V6 1 Man_05241430001_02_EN_148x105mm Black V6 2 Man_05241430001_02_EN_148x105mm Cyan V6 3 Man_05241430001_02_EN_148x105mm Magenta V6 4 Man_05241430001_02_EN_148x105mm Yellow V6 5 Man_05241430001_02_EN_148x105mm PMS 5445 V6 6 Man_05241430001_02_EN_148x105mm PMS 327 ...

Page 2: ...on the type plate of the meter you may encounter the following symbols shown here with their meanings 0088 This product fulfils the requirements of Directive 98 79 EC on in vitro diagnostic medical devices This product fulfils the legal require ments of the People s Republic of China on the use of certain substances in electronic products The explanation of any other symbols can be found in the in...

Page 3: ...als for monitoring patients blood glucose values Visually impaired persons must not use the meter Healthcare professionals must also read the instructions in Chapter 10 Testing blood glucose in more than one patient Informa tion for healthcare professionals Any object coming into contact with human blood is a potential source of infection see Clinical and Laboratory Standards Institute Protection ...

Page 4: ...y will provide you with all the information you need to operate trouble shoot and care for your meter It is important to remember that in order to keep your meter in tip top condition you need to comply with all instructions given in addition to following the correct operating procedures The meter is a precision instrument Improper handling can impair its operation We recommend you start by studyi...

Page 5: ...ly This symbol indicates a possible risk of injury or of damage to your own health or the health of others This symbol draws attention to actions that could result in damage to your meter i This symbol draws attention to important information All instructions appear in a coloured frame as shown below 1 Insert the test strip into the meter ...

Page 6: ...esults shown on the display screens in these Instructions for use are intended only as examples They show results in units of mg dL e g 128 mg dL dates in the day month format e g 18 5 and times in the 24 hour clock e g 15 27 Others can and will be shown on your meter s display screen Your meter can for example display results in mmol L e g 7 1 mmol L dates in the month day format e g 5 18 and tim...

Page 7: ...lance 14 2 Steps before testing 16 2 1 Checking the contents 16 2 2 Checking the unit of measurement for blood glucose 17 2 3 Removing the protective film from the battery 18 2 4 Performing a display check 19 3 Setting the time and date 21 3 1 Overview 22 3 2 Making settings 24 4 Coding 28 7 Contents ...

Page 8: ...g blood with the test strip outside the meter 36 Turning the meter off 39 Flagging test results 40 5 3 Checking the test result using the test strip control window 43 5 4 Symbols seen before during or after testing and what they mean 45 5 5 Notes on blood glucose testing 46 5 6 Evaluating results 49 Measuring range 50 Implausible results possible sources of error 51 8 Contents ...

Page 9: ...loading test results 64 If downloading is unsuccessful 69 7 Checking your meter 70 7 1 Preparing for a performance check 71 7 2 Carrying out a performance check 72 7 3 Possible sources of error during performance checks 79 8 Cleaning the meter 82 8 1 External parts 83 8 2 Test strip guide and measuring window 83 9 Contents ...

Page 10: ...ng blood glucose 93 10 2 Disinfecting the meter 95 11 Measurement and storage conditions 96 11 1 Temperature 96 11 2 Atmospheric humidity 98 11 3 Light conditions 98 11 4 Sources of interference 99 12 Symbols problems and error messages 100 12 1 Symbols shown in the display 101 12 2 Problems 107 12 3 Error messages 109 10 Contents ...

Page 11: ...a 116 14 Disposing of your meter 121 15 System components 122 16 Patents 123 17 Customer support and service 124 17 1 Information service and troubleshooting 124 17 2 Addresses 124 18 Alphabetical index 127 11 Contents ...

Page 12: ...ter 1 1 1 Your meter at a glance 1 Display 2 S button retrieving settings for time and date 3 Measuring window cover 4 Measuring window underneath the cover 5 Test strip guide 6 M button retrieving readings from the memory changing time date 7 Code chip 8 Infrared window ...

Page 13: ...14 13 12 9 10 11 13 Getting to know your meter 9 Code chip slot 10 Code chip inserted 11 Type plate 12 Battery compartment 13 Battery type CR 2032 14 Locking catch for opening the battery compartment ...

Page 14: ... volume checking To perform a test the meter requires 1 2 µL blood 1 µL microlitre 1 thousandth of a millilitre The meter detects if the applied amount is not suf ficient Flagging results You can flag results with different symbols which indicate particular situations during the test Memory The meter automatically saves up to 350 results with the time and date of the test and all other information...

Page 15: ...er has an infrared port enabling you to download stored test results to a computer Applying blood outside the meter When the meter prompts you to apply blood you can remove the test strip from the meter apply the blood and insert it back into the meter ...

Page 16: ...ore testing 2 2 1 Checking the contents Check that the contents of the package are complete You will find a list with the contents on the box If anything is missing please contact your customer support and service centre see Chapter 17 ...

Page 17: ...displays the unit you are accustomed to You can find the unit of measurement that your meter displays on the type plate on the back of your meter If you do not know which is the right unit for you ask your doctor The unit of measurement that your meter displays cannot be changed If the wrong unit is printed on the type plate please consult your dealer or pharmacy A wrong unit of measurement could ...

Page 18: ...tective film to prevent the battery from becoming drained prema turely Before using the meter remove the protective film You will see the film projecting from the battery compartment on the back of the meter 1 Simply pull the film vertically out of the meter You do not need to open the battery compart ment to do this i For how to change the battery see chapter 9 ...

Page 19: ...e time for more than 3 seconds You can check if all of the display elements are properly displayed by carrying out a full display check 1 With the meter turned off press the M and S buttons at the same time until the meter is switched on automatically more than 3 sec onds ...

Page 20: ...hown here If any of the display elements are missing or the unit shown for the blood glucose results is not the correct one please ask your dealer pharmacy to exchange the meter 3 Press any button to terminate the display check and turn off the meter mg dL meter mmol L meter ...

Page 21: ... results is very restricted or cannot be performed at all So that test results are saved with a time and date you must set the time and date and if required change the format in which they are displayed When you set the time and date for the first time the factory defaults are displayed The settings are made in the following order default in brackets 1 Time and date format 24 hour display with day...

Page 22: ... hold it down for more than 3 seconds until the depicted display appears When set up appears in the display you can make changes to the time and date Changing settings Press the M button Holding down the M button increases the number quickly For a detailed description of how to set the time and date see Chapter 3 2 ...

Page 23: ...next setting Press the S button briefly Turning the meter off at any time Press the M and S buttons briefly at the same time First confirm your last change with the S button since the change will otherwise be lost If you do not press any buttons the meter turns off automatically after approx 30 seconds In this case all changes are lost and the original settings remain unchanged ...

Page 24: ...from 0 00 to 23 59 date in the day month format DD MM 12 hour format 35 time from 12 00 to 11 59 followed by am or pm date in the month day format MM DD When you change the time and date format the time and date are changed accordingly 1 Press the M button briefly to switch from one format to the other 2 Press the S button to go to the time ...

Page 25: ...The hours flash in the upper left corner of the display 1 Press the M button to set the hours 2 Press the S button to go to the minutes The minutes flash in the display 3 Press the M button to set the minutes 4 Press the S button to go to the year ...

Page 26: ... the upper right corner of the display 1 Press the M button to set the year 2 Press the S button to go to the month The month flashes in the upper right corner of the display 1 Press the M button to set the month 2 Press the S button to go to the day Setting the date ...

Page 27: ...d date Final display The day flashes in the display 3 Press the M button to set the day 4 Press the S button and you will see the final display 1 Check that time and date are correct 2 Press any button to turn off the meter ...

Page 28: ...you open a new pack of test strips you must replace the old code chip from the meter with the new one from the pack Code chips from other packs may contain informa tion that is incorrect for your new test strips and can therefore lead to incorrect test results Incorrect results can cause the wrong therapy recommendation to be made and so lead to serious adverse health effects ...

Page 29: ...mber on the label of the test strip container The three digit number on the code chip e g 689 must match the three digit number on the label Leave the meter turned off 2 Gently slide the code chip into the slot on the side of the meter You must feel the code chip lock into place ...

Page 30: ...Chek Active test strips that belong to the code chip a lancing device to collect blood a lancet for the lancing device 1 Read the package insert which came with the test strips 2 Wash your hands with warm water and soap and dry them well before you start to perform the test This helps remove any residues from the skin e g from food drinks or skin cream which can disturb the test This also stimulat...

Page 31: ...om the container and close the container again immediately 2 Hold the test strip so the arrows printed on it and the orange square face upwards 3 Without bending it gently push the test strip into the test strip guide in the direction of the arrows You should feel the test strip lock into place ...

Page 32: ...isplay check approx 2 seconds 4 Check that all the segments of the numeric display mg dL meter or mmol L meter are displayed If segments are missing please contact your cus tomer support and service centre see Chapter 17 Following the display check the code number is displayed 689 is just an example ...

Page 33: ... If the numbers do not match even though the code chip in the meter is the one that belongs to the test strip container please contact your customer sup port and service centre Following the code number the test strip symbol and the flashing blood drop appear on the display The meter is now ready to perform a blood glucose test ...

Page 34: ...have approx 90 seconds to apply blood to the test strip After this the meter turns itself off 1 Prick the side of a fingertip with your lancing device 2 Encourage a drop of blood to form by gently massaging your finger towards the fingertip 3 Apply the drop of blood to the centre of the orange field and then remove your finger from the test strip ...

Page 35: ...n progress The test is complete after approx 5 seconds and the result appears on the display The meter automati cally saves the result Now you can turn the meter off see Turning the meter off or flag the result see Flagging test results or go to the saved test results see Chapter 6 1 ...

Page 36: ...od drop symbols are displayed 1 Remove the test strip from the meter The test strip and blood drop symbols flash in the display Now you have approx 20 seconds to apply blood to the test strip and to re insert it into the meter If you do not re insert the test strip within this time the meter displays the error message ...

Page 37: ...e 3 Encourage a drop of blood to form by gently massaging your finger towards the fingertip 4 Apply the drop of blood to the centre of the orange field 5 Push the test strip back into the test strip guide in the direction of the arrows You should feel the test strip lock into place ...

Page 38: ... test is in progress The test is complete after approx 10 seconds and the result appears on the display The meter auto matically saves the result Now you can turn the meter off see Turning the meter off or flag the result see Flagging test results or go to the saved test results see Chapter 6 1 ...

Page 39: ...1 Remove the test strip from the meter The meter turns itself off You can dispose of used test strips in your house hold waste If you do not remove the test strip and do not press any buttons the meter turns off automatically after approx 30 seconds ...

Page 40: ...mbol is intend ed for test results that you have measured before your meals The After Meals flag apple core symbol is intended for test results that you have measured after your meals The General flag asterisk symbol You can define the meaning of this flag yourself For exam ple you can use it for test results that you have obtained from alternative sites or after physical activities The Control fl...

Page 41: ...flag is displayed The flags appear in the following order 1 Before meals 2 After meals 3 General 4 Control If you decide to not flag the test result press the S button repeatedly until no further symbol is dis played No flag Press briefly Control bottle General asterisk After meals apple core Before meals apple ...

Page 42: ...esting blood glucose After choosing the desired flag you can turn the meter off see Turning the meter off or go to the saved test results see Chapter 6 1 In both cases the test result is saved with the flag ...

Page 43: ...isplayed result Before the test There is a round coloured control window on the back of the test strip 1 Compare the colour of this window with the coloured dots on the label of the test strip container The colour of the control window must match the colour of the top coloured dot 0 mg dL 0 mmol L If the control window is a different colour you must no longer use the test strip ...

Page 44: ...pare the colour of the control window on the back of the test strip with the coloured dots on the label of the test strip container If you find there is a noticeable disparity repeat the test If you cannot obtain a match even after several tests contact your customer support and service centre Only the test results displayed by the meter should be used for therapeutic decisions The colour compari ...

Page 45: ... result The result is lower than 10 mg dL 0 6 mmol L may indicate that your blood glucose is very low possibly a severe hypoglycemia Follow the relevant instructions given by your doctor immediately and repeat the test instead of a result The result is higher than 600 mg dL 33 3 mmol L The test strips are past their expiry date The battery is almost empty The temperature during the test was outsid...

Page 46: ...he display does not match the code number on the test strip container do not perform blood glucose tests Incorrect coding produces incorrect results Use only test strips with an expiry date which has not been exceeded Test strips with an expiry date that has already passed can produce incorrect results If the expiry date has passed the symbol will be displayed in the test strip symbol Check the ex...

Page 47: ... strip container through handling test strips with moist hands or if the container is left open the drying agent loses its effect Unusable test strips may lead to incorrect results If you have not applied blood to the test strip in the available time and the meter has turned off Remove the test strip and dispose of it Start the blood glucose test again with a new test strip If you have removed the...

Page 48: ...s Please also note the following points as incorrect results or error messages can otherwise occur Do not bend the test strip while inserting it into the meter Do not to bend or move the test strip before or while applying blood or while the test is per formed Do not apply blood to the test strip before the drop symbol flashes in the display If or are not shown completely during the default displa...

Page 49: ...you remove the test strip before this time the meter turns itself off 5 6 Evaluating results If the displayed test result reflects the way you feel continue as instructed by your doctor If the displayed test result does not reflect the way you feel please perform a performance check with an Accu Chek Active control solution see Chapter 7 Repeat the blood glucose test afterwards If the latest test ...

Page 50: ...l L If the result is lower than 10 mg dL 0 6 mmol L is displayed instead of a result may indicate that your blood glucose is very low possibly a severe hypoglycemia Follow your doctor s instructions immediately and repeat the test If the result is higher than 600 mg dL 33 3 mmol L is displayed instead of a result Repeat the test ...

Page 51: ...st If you have taken all of these points into account and still obtain implausible results or error messages contact your customer support and service centre Did you take the test strip from the container to which the code chip in the meter belongs yes Did you perform the test according to the instructions for use yes Did you wash your hands with warm water and soap Did you dry your hands thorough...

Page 52: ... label and also the symbol on your meter s display no Is the test strip guide and measuring window clean yes Did you measure within the correct tempera ture range 10 40 C yes Did you observe the storage conditions for the meter and test strips see Chapter 11 and the package insert that came with the test strips yes Did you take the sources of error into ac count that are referred to in the package...

Page 53: ... saves all test results If all the memory locations are occupied the oldest test result is deleted to create space for the new one when you perform a new test In addition to the results the time and the date your meter also saves other information that is important for the test This includes all symbols which are displayed with the result except the battery symbol and the flags with which you mark...

Page 54: ...om the memory 1 With the meter turned off press the M button You can also go directly to the saved results after a test To do so press the M button while the result is displayed Press briefly The last saved latest result is displayed with the time date and ...

Page 55: ...n number is displayed When you release the button the corresponding result is displayed If you keep the S button pressed the occupied memory locations are displayed in quick succession Once you release the button the corresponding result is displayed After the oldest result in the memory the latest result is displayed again ...

Page 56: ...56 Using the meter as a diary Turning the meter off again 3 Press the M button briefly You can directly switch from the saved results to the test by inserting a test strip into the meter Press briefly ...

Page 57: ...ary No result in the memory Time and date not set If there are no results saved in the meter the display shown next to this text appears If the time and date were not set at the time of testing 0 00 and 0 0 are displayed instead ...

Page 58: ...7 days 2 for the last 14 days 3 for the last 30 days 2 Only results which have been flagged with Before Meals 1 for the last 7 days 2 for the last 14 days 3 for the last 30 days 3 Only results which have been flagged with After Meals 1 for the last 7 days 2 for the last 14 days 3 for the last 30 days Then the 7 day average for all results is displayed again The following results are not included i...

Page 59: ...th the meter turned off press the M button briefly You can also briefly press the M button directly after a test while the result is being displayed Press briefly The last saved latest result is displayed together with the time date and ...

Page 60: ... the averages from within the last saved result but also from within each saved result Press briefly at the same time The first average the 7 day average of all results is displayed The number of days taken into account for the calculation of the average is displayed in the upper right corner of the display ...

Page 61: ...The averages are displayed in the order shown next to this text Averages before meals are flagged with Averages after meals are flagged with Order of the averages 7 14 30 number of days taken into account all results Results flagged with Before Meals Results flagged with After Meals 7 14 30 7 14 30 7 14 30 ...

Page 62: ...ss briefly From within each average you can either go back to the saved results or turn the meter off 4 Press the S button briefly to go back to the saved results The result which was shown before the average was calculated is displayed again Or 4 Press the M button briefly to turn the meter off ...

Page 63: ... last 5 days are used to calculate the averages for all three periods 7 14 and 30 days In the event that you changed the date or time performed a test and then re set the date time only those test results that the meter saved in uninter rupted chronological order will be taken into account If the chronological order has been interrupted the earlier results will not be taken into account You can sw...

Page 64: ... to a special analysis system The infrared port is located at the front of the meter Roche Diagnostics offers a variety of special hard ware and software products for analysing your data and which enhances the integrated notebook func tions of your meter With these products you and your doctor can manage your data more effectively and using the graph and table views you can better understand your ...

Page 65: ...and evaluat ing test results it may not recognise more recent meters and the results will therefore not be down loaded You may need a more recent software version for your hardware or software product In this case please contact your customer support and service centre Your test results can only be fully analysed if all of the results have been saved with the date and time i e if you have set the ...

Page 66: ... are using There you will find all the information needed for down loading data 2 Prepare the receiving end software product or hardware for downloading the test results 3 With the meter turned off press and hold the M button for more than 3 seconds until flashes in the display Press for more than 3 seconds ...

Page 67: ...the receiving end Position the two infrared ports so that they are facing to wards one another 5 If necessary start the test result download at the receiving end software product or hardware The meter automatically downloads all of the results from its memory While the data is downloaded does not flash ...

Page 68: ... Using the meter as a diary Press briefly If the meter was not turned off automatically by the receiving end when the download was completed is displayed 6 Press the M button briefly to turn the meter off ...

Page 69: ...uce the distance between the two infrared ports to 5 20 cm and position them so they are facing one another Another device with an infrared source turned on or a strong light source is too close to one of the infrared ports Remove the device or light source Communication between the two infrared ports is blocked e g by an object Remove the object The infrared port is dirty Clean the port see Chapt...

Page 70: ...nstead of blood Also read the instrcutions in Chapter 5 Perform a performance check using Accu Chek Active control solutions whenever you open a new pack of test strips after you change the battery after you clean the test strip guide and the meas uring window if you are in doubt about a test result Please ask your customer support and service centre where you can obtain the control solutions ...

Page 71: ...that belong to the code chip Accu Chek Active control solution Control 1 low glucose concentration or Control 2 high glucose concentration the concentration table for the control solutions see label on the test strip container A performance check is in its main steps the same as a normal test except that you apply control solution to the test strip instead of blood ...

Page 72: ...lutions 2 Take a test strip from the test strip container and close it again immediately 3 Hold the test strip so that the arrows printed on it and the orange square face upwards 4 Without bending it gently push the test strip into the test strip guide in the direction of the arrows until you feel it lock into place ...

Page 73: ...splay check approx 2 seconds 5 Check that all the segments of the numeric display mg dL meter or mmol L meter are displayed If segments are missing please contact your cus tomer support and service centre see Chapter 17 Following the display check the code number is displayed 689 is just an example ...

Page 74: ... even though the code chip in the meter belongs to the test strip container please contact your customer support and service centre Following the code number the test strip symbol and the flashing blood drop symbol appear in the display Now you have approx 90 seconds to apply control solution to the test strip After this time the meter turns itself off ...

Page 75: ...ove any dried on residues 9 Invert the bottle and hold it downwards at an angle Squeeze it gently until a small drop which is free of any air bubbles is suspended from the tip 10 Apply one drop to the centre of the orange field without touching it with the tip of the dropper The field must be completely covered with solution ...

Page 76: ... seconds and the result appears on the display The meter automatically saves the result To distinguish this performance check from blood glucose test results at a later date you need to flag it as a performance check While the test result is displayed 11 Press the S button briefly 4 times The symbol for control is displayed see also Chapter 5 Flagging test results section ...

Page 77: ...ntainer The result must be within the specified concentra tion range Make sure that you compare the test result with the concentration data that corresponds to the relevant control solution that you used 1 or 2 and to the unit of measurement your meter displays mg dL or mmol L Accu Chek Active Control mg dL mmol L 1 37 67 2 1 3 7 2 134 181 7 4 10 0 Control solution used Unit of measurement ...

Page 78: ...78 Checking your meter 13 Then remove the test strip from the meter The meter turns itself off You can dispose of used test strips in your house hold waste ...

Page 79: ...ective corrections when you perform the next test If you have taken all of these points into account and the results are still outside the specified concentration range contact your customer support and service centre If a performance check produces results that are outside the specified concentration range it is no longer certain that the meter and test strips are functioning properly Blood gluco...

Page 80: ... tip of the dropper before you applied control solution to the test strip yes Did you apply a suspended drop of control solution yes Did you apply only one drop of control solution yes Were there air bubbles in the drop no Did you wait for the drop symbol to flash in the display before applying control solution yes Was the orange field completely covered with control solution yes Did you bend or m...

Page 81: ...only 3 months and must not be used after this period yes Did you observe the proper storage condi tions for the meter the test strips and the control solution see Chapter 11 and the package inserts yes Has the expiry date of the test strips or the control solution elapsed see the label on the test strip container next to the symbol and the label on the bottle next to the symbol and eventually the ...

Page 82: ...instructions on disinfection in Chapter 10 2 Use only cold water or 70 ethanol to clean the meter Any other cleaning agents may damage the meter or impair its measuring function Use a lightly moistened cloth or a lightly moistened cotton swab Do not spray anything onto the meter and do not immerse it in the cleaning liquid Internal components could become damaged and thus impair the proper functio...

Page 83: ...mois tened with cold water or 70 ethanol 8 2 Test strip guide and measuring window You only need to clean the test strip guide and measuring window if you notice that the test strip guide or the meas uring window located beneath the cover are visibly dirty if the error message or is displayed A dirty measuring window may be the cause ...

Page 84: ...4 Cleaning the meter 1 Pull the cover of the measuring window straight towards you 2 Wipe the cover and the test strip guide from the outside and the inside using a lightly moistened cloth or cotton swab ...

Page 85: ...g area using a lightly moistened cloth or a cotton swab Make sure that no liquid enters the meter Avoid scratching the measuring window as doing so could impair its measuring function 4 Remove any fluff or lint that may remain 5 Allow areas you have wiped time to dry thor oughly ...

Page 86: ... cover straight and centred onto the meter 7 Slide it closed until it audibly clicks into place In doing so the guides on the inside of the cover and on the meter must be perfectly aligned 8 Carry out a performance check see Chapter 7 ...

Page 87: ...e type CR 2032 With a new battery you can perform approx 1000 tests or test for approx one year When you change the battery your results always remain saved Time and date only remain saved as long as you change the battery within one minute you do not press any button while the battery is removed you do not insert a test strip in the test strip guide without the battery inserted you insert the bat...

Page 88: ...88 Changing the battery The battery compartment is located on the back of the meter 1 Push the locking catch downwards and remove the battery compartment cover 2 Remove the used battery ...

Page 89: ... the battery 3 Place the new battery in the compartment with the symbol facing upwards 4 Re attach the battery compartment cover so the two prongs on its lower edge engage with the slots in the battery compartment ...

Page 90: ... into place audibly Never throw batteries into a fire They may explode i Dispose of used batteries in an environmen tally friendly way at a collection depot or through your dealer i Remove the battery if you will not be using the meter for a longer period of time ...

Page 91: ...ways follow the recognised procedures for handling objects that are potentially contaminated with human material Practise the health and safety policy of your laboratory or institu tion Please also follow the instructions on the following pages to prevent the meter becoming contaminated Any patient with an infection or suffering from an infectious disease and any patient who is a carrier of a mult...

Page 92: ...h human blood are potential sources of infection see Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI document M29 A3 2005 Residues of water or disinfectant on the skin can dilute the drop of blood and so produce incorrect results Dispose of used lancets or disposable lancing devices and used ...

Page 93: ...op of blood cannot spread so easily 3 Use only lancing devices approved for use by healthcare professionals 4 Use a lancing device with adjustable penetration depth settings 5 Select a penetration depth to suit the nature of the patient s skin Start with a shallow depth setting 6 Select a puncture site along the side of a finger tip 7 Turn the finger so that the chosen puncture site is facing upwa...

Page 94: ... of blood to form by gently massaging the finger towards the fingertip A proper drop of blood must form 10 Apply the drop of blood to the test strip We recommend that you apply the blood to the test strip while it is outside the meter see Chapter 5 2 section Applying blood with the test strip outside the meter ...

Page 95: ...at least once a day after use Remember to also clean recesses grooves and gaps Cotton swabs wipes and cloths lightly moistened with disinfectant are all suitable for disinfecting the meter Use a mixture of 1 propanol 2 propanol and glutaral dehyde known in some countries under the brand Bacillol plus Allow areas you have wiped time to dry thoroughly Make sure that no liquid enters the meter Do not...

Page 96: ...ust be between 10 and 40 C If the temperature is at the limits of the permitted range between 5 and 10 C or between 40 and 45 C you can still perform a test The thermometer symbol will however be displayed see also Chapter 12 1 Do not use results obtained at the limits of the permitted temperature range as a basis for making therapeutic decisions as they could be incorrect Incorrect results can ca...

Page 97: ... damaged and provide incorrect results Incorrect results can cause the wrong therapy recommenda tion to be made and so lead to serious adverse health effects Keep the meter without battery at a temperature between 25 and 70 C Keep the meter with battery at a temperature between 10 and 50 C At temperatures above 50 C the battery could leak and damage the meter At temperatures below 10 C the battery...

Page 98: ...ter If this has occurred do not turn the meter on Allow the meter to slowly cool down or warm up Never keep it in a moisture prone area e g a bathroom 11 3 Light conditions Do not perform a test when the meter and the test strips are exposed to direct sunlight Go to a shaded place or shade the meter for example with your body If the meter is exposed to too much light tests cannot be performed In t...

Page 99: ...nlight studio lighting etc These may stop the meter from function ing correctly and lead to error messages 11 4 Sources of interference Strong electromagnetic fields may interfere with the proper operation of the meter Do not use the meter in close proximity to a strong electromagnetic field To avoid electrostatic discharge do not use the meter in a very dry environment especially one in which syn...

Page 100: ... in previous chap ters On the following pages you will find a complete overview of symbols and error messages what they mean and what actions you should take Please pay attention to all symbols and messages when you use the meter They provide you with important informa tion If you do not recognise a symbol or do not understand an error message please refer to this chapter for an explanation Otherw...

Page 101: ...splay 1 You are in the test result memory Either a saved test result or an average is being displayed 2 The battery is almost empty When the symbol first appears in the display you can perform approx 50 more tests When the battery is so low that no more tests can be performed the meter turns itself off immediately ...

Page 102: ...ng The meter is exposed to too much light 6 flashing A test is in progress or an average is being calculated 7 General flag 8 or The unit your meter uses to display the blood glucose result either mg dL or mmol L 9 10 The test strips are past their expiry date Change the test strips and code chip Check the time and date settings as the meter compares these against the expiry date encoded in the co...

Page 103: ...e test strip 12 The number being displayed is the code number flashing together with The code chip has not been correctly inserted into the meter Remove the code chip and re insert it There is no code chip in the meter Insert the code chip belonging to the Accu Chek Active test strips you are currently using 13 After Meals flag 14 Before Meals flag 15 While the test is performed the temperature is...

Page 104: ... for performance check 17 Additional time information if 12 hour time format is set 18 Symbols appearing in the numeric field In the numeric field mg dL meter or mmol L meter the following symbols can appear together with a flashing The code chip has not been correctly inserted into the meter Remove the code chip and re insert it There is no code chip in the meter Insert the code chip belonging to...

Page 105: ...rmance checks no test results were saved in the period in ques tion e g all results in memory are more than 7 days old the date set is in the past you changed the time and date and then per formed a test Then you re set the time and date and have not performed any more tests since The result is lower than 10 mg dL 0 6 mmol L may indicate that your blood glucose is very low possibly a severe hypogl...

Page 106: ...splayed by mmol L meters and is part of the result e g 8 2 mmol L is displayed as together with No results have been saved together with The result has been lost from memory flashing You have turned the meter on to download test results The meter is downloading test results The meter has finished downloading test results ...

Page 107: ...ry You have inserted the battery the wrong way round Remove the battery and place it in the battery compartment as specified The ambient temperature is low and the battery is almost empty Ensure that the ambient temperature is between 10 and 40 C and wait for the meter to warm up Insert a new battery The electronics have become damp through condensation Allow the meter to dry slowly The meter is d...

Page 108: ...ng to freeze Turn the meter off Ensure that the ambient tem perature is between 10 and 40 C and wait for the meter to adapt to that temperature The time is shown as 0 00 or 0 00am and the date as 0 0 The meter was exposed to a temperature below 10 C and the battery is beginning to freeze Turn the meter off Ensure that the ambient temperature is between 10 and 40 C and wait for the meter to adapt t...

Page 109: ...the situation either by briefly pressing the M or S button or by removing the test strip from the meter If these error messages occur frequently contact your customer support and service centre If your meter has been dropped it can also lead to error messages In this case also contact your cus tomer support and service centre ...

Page 110: ...place You removed the test strip from the meter in order to apply blood and did not re insert it within 20 seconds Dispose of the test strip even if blood has not been applied yet Start the blood glucose test from the beginning with a new test strip A code chip from another blood glucose system has been inserted into the meter The code chip does not belong to the Accu Chek Active test strips Remov...

Page 111: ...other blood glucose system has been inserted into the meter The code chip does not belong to the Accu Chek Active test strips Remove the code chip and insert the code chip that belongs to the Accu Chek Active test strips you are currently using The measuring window is dirty Clean the measuring window see Chapter 8 The test strip is bent or is not positioned straight and flat in the test strip guid...

Page 112: ...the orange square face up wards Without bending it gently push the test strip into the test strip guide in the direction of the arrows until you feel it lock into place You applied blood or control solution to the test strip too soon i e before the drop symbol flashed in the display Repeat the test with a new test strip The test strip was bent or moved while testing was in progress Repeat the test...

Page 113: ... test strip was bent or moved while testing was in progress Repeat the test with a new test strip You did not insert the test strip correctly or completely Hold the test strip so that the arrows printed on it and the orange square face up wards Without bending it gently push the test strip into the test strip guide in the direction of the arrows until you feel it lock into place ...

Page 114: ...m the beginning If the error message appears again the meter is defec tive Please contact your customer support and service centre You applied too little blood or control solution to the test strip Repeat the test with a new test strip and a larger amount of blood or control solution ...

Page 115: ...s and error messages The ambient temperature or the temperature of the meter is too low or too high for a test Ensure that the ambient temperature is between 10 and 40 C and wait for the meter to adapt to that temperature ...

Page 116: ...ith the Accu Chek Active test strips Blood glucose concentrations may be tested in whole blood or plasma Although you always apply whole blood to the test strip your meter displays blood glucose results that relate either to whole blood or to plasma To see whether your blood glucose meter displays results relating to whole blood or to plasma see the package insert that came with your test strips T...

Page 117: ...eter when blood is applied depends on concentration approx 10 seconds if the test strip is outside the meter when blood is applied depends on concentration Power supply 1 battery type CR 2032 Battery life approx 1000 tests or approx 1 year Automatic power off after 30 or 90 seconds depending on operating status Memory 350 test results with time and date as well as 7 14 and 30 day averages ...

Page 118: ...ttery with battery 10 to 40 C 25 to 70 C 10 to 50 C Atmospheric humidity during testing during storage up to 85 relative humidity up to 93 relative humidity Altitude sea level to 4000 m Dimensions 104 5 51 5 22 mm Weight without battery with battery approx 55 g approx 60 g ...

Page 119: ...eets the electromagnetic immunity requirements as per ISO 15197 Annex A The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000 4 2 In addition it meets the electromagnetic emissions requirements as per EN 61326 Its electromagnetic emission is thus low Interference from other electrically driven equipment is not to be anticipated ...

Page 120: ...t ability and control solution reproducibility The system is calibrated with venous blood containing various glucose concentrations The reference values for this were obtained using the hexokinase method For method comparison the results were compared with results obtained using the hexokinase method with deproteination automatic analyser The hexokinase method is traceable to a NIST standard The A...

Page 121: ...ry please dispose of your used meter according to the regulations applicable in your country For information about correct disposal please contact your local council or authority The meter falls outside the scope of the European Directive 2002 96 EC Directive on waste electrical and electronic equipment i Dispose of used batteries in an environmen tally friendly way at a collection depot or throug...

Page 122: ...components in addition to the meter Accu Chek Active test strips Use only these test strips when you test blood glucose using the Accu Chek Active meter Accu Chek Active control solutions Use only these control solutions when you carry out performance checks using the Accu Chek Active meter and the respective test strips ...

Page 123: ...123 Patents Patents 16 US 5 366 609 US 5 424 035 US 5 463 467 US 5 889 585 US 6 055 060 US 6 906 802 ...

Page 124: ...ll help you solve any problems you might be experiencing with the meter or test strips from Roche Diagnostics For the customer support and service addresses see the next section 17 2 Addresses Roche Diagnostics Scientific Office PO Box 159 Dokki 23 Iran Street Dokki Guiza CAIRO Egypt http www accu chekarabia com Productos Roche Interamericana S A 2a Avenida 2 67 Zona 10 Apartado Postal 1675 01010 ...

Page 125: ...ker Ben Zeid Street Shmeisani P O Box 1066 11118 AMMAN Jordan http www accu chekarabia com Roche Diagnostics M Sdn Bhd 2A Jalan 13 1 46200 Petaling Jaya Selangor Darul Ehsan Malaysia Toll Free Line 1 800 88 1313 Roche Pakistan Ltd 37 C Block 6 P E C H S P O BOX 20021 Karachi 75400 Islamic Republic of Pakistan Roche Philippines Inc Diagnostics Division 2252 Don Chino Roces Ave 1231 Makati City Phil...

Page 126: ... Box 1927 Randburg 2125 South Africa Accu Chek Care Line 080 DIABETES dial 080 34 22 38 37 Roche Diagnostics Thailand Ltd 18th Floor Rasa Tower 555 Phaholyothin Road Chatuchak Chatuchak Bangkok 10900 Thailand Customer Service Line 66 0 2791 2222 Roche Diagnostics Regional Office Gulf Caterpiller building Salahedin Str Deira DUBAI 2nd entrance 3rd floor Off 4 3 P O Box 11397 DUBAI United Arabic Emi...

Page 127: ...nging 87 life 87 117 removing protective film 18 symbol 45 87 101 type 13 87 117 Battery compartment 13 88 Blood applying to test strip with test strip inside the meter 34 with test strip outside the meter 36 too little applied 114 volume 14 117 Bottle symbol 40 76 104 C Causes of error downloading of results 69 performance check 79 test 51 Checking meter 70 Cleaning 82 code symbol 103 104 Code ch...

Page 128: ...setting 26 day symbol 60 102 Disinfection 95 Display 12 example 6 symbols in the 101 Display check 20 32 Disposal battery 90 121 meter 121 test strips 39 78 Downloading results 64 causes of error 69 Drop symbol 33 103 E E and number display 110 EEE display 114 Electromagnetic compatibility 119 End display 68 Error messages 100 109 exp symbol 46 52 102 Expiry date control solution 81 test strips 52...

Page 129: ...4 Intended use 3 L Light conditions 98 Lo display 45 50 105 M M button 12 Measurement conditions 96 Measuring range 50 117 Measuring time 35 38 117 Measuring window 12 cleaning 83 85 Memory 53 memory symbol 54 101 105 Memory results 53 Meter checking 70 cleaning 83 disinfecting 95 disposal of 121 overview 12 storage 96 turning off 23 39 56 turning on 22 31 54 66 ...

Page 130: ...6 106 Performance analysis 120 Performance check causes of error 79 flagging 76 procedure 70 Problems 107 R Result averages 58 downloading 64 flagging 40 retrieving from memory 54 S S button 12 Settings date and time 21 changing overview 22 date 26 factory defaults 21 order 21 time 25 time and date format 24 year 26 ...

Page 131: ...ents 122 T Technical data 116 Temperature 96 118 Testing causes of error 51 healthcare professionals 93 procedure 30 Test principle 116 Test strip guide 12 cleaning 83 84 Test strips disposal of 39 78 expiry date 52 81 symbol 33 36 102 103 Thermometer symbol 45 103 Time and date format setting 24 Time setting 25 ttt display 97 115 Turning off after testing 39 78 automatic 34 39 69 closing settings...

Page 132: ...132 Alphabetical index Turning on changing settings 22 downloading results 66 retrieving results 54 testing 31 Type plate 13 17 U Unit of measurement for results mg dL mmol L 17 102 Y Year setting 26 ...

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