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AC_CP_LCM_Manual_EN

1. If the result that was most recently saved is flagged by the bottle b symbol as being a performance result see Chapter 7 it is announced in the same way as any blood glucose test result There is no acoustic signal to identify it as a performance result Likewise there is no acoustic signal to identify a result flagged by an asterisk as being a special result see Chapter 4 7 The 14 and 30 day averages and the lowest and highest results within these two periods see Chapter 5 3 are not announced acoustically in Acoustic Mode but only displayed If no result has been saved just three horizontal bars are displayed There is no acoustic announcement Acoustic Mode 127 6 5 Announcement of symbols and error messages When the batteries will soon be exhausted or the last test strip in a drum has been used The meter issues an acoustic warning This con sists of two short beeps sounded three times in succession es saaa The warning is given at different times e Batteries are almost empty the battery symbol il wird angezeigt is displayed see Chapter 9 This acoustic warning is sounded when you turn the meter on e You have used the last test strip in the drum End and drum symbol flash see Chapters 2 3 and 12 2 The acoustic warning is given after you have pressed the Test button to turn the meter off If error messages E with a number or the EEE see Chapter 12 2 are displayed these are ann
2. Checking your meter gt Subsequently hold the meter directly above a waste bin with the test strip pointing downwards gt Press the Test button to turn the meter off The used test strip drops out Before the meter turns off it shows you the number of test strips remaining in the drum see Chapter 2 3 2 gt Wipe the tip of the dropper with a clean dry paper towel and close the bottle tightly Notes The control solution you apply to washable object must come from a suspended drop Do not use the drop if it has run down the outside of the tip of the dropper This may lead to results that are too high Control solution that is to be drawn up by the test strip must just have been freshly applied to the object The control solution must not be left exposed on the surface for any length of time If it is the control solution may give results that are too high Results flagged as performance s with the bottle symbol are not included in the calculation of averages and lowest and high est results 136 Checking your meter You can dispose of empty or only partly used bottles of control solution together with your regular household waste Please refer also to the notes in Chapters 4 3 and 4 4 7 3 Possible causes of error during performance of performance checks 7 If the result is outside the stated range perform a second performance check If the result of this second check is outside the con
3. Protective cap on lancet Introduction mE l 1 3 Main features Docked lancing device The meter comes with an attached Accu Chek Softclix Plus lancing device You can leave it docked onto the meter to collect blood or if you prefer you can undock it Test strip drum instead of individual test strips You never need to touch a test strip Simply insert a drum with 17 test strips into the meter Easy to operate Turn the meter on apply blood read the result press the button to eject the test strip Self coding Every test strip drum has its own bar code The meter is automatically coded whenever you insert a new drum a process which provides the meter with information on the specific characteristics of the test strips Indication of the number of test strips remaining Each time you turn on the meter off it shows you the number of test strips remaining in the drum 16 Introduction Reliability The meter checks each test strip If it finds a defective strip it lets you know before you apply blood Blood volume checking The meter can tell when you have applied sufficient blood approxi mately 1 5 uL 1 microlitre 1 thousandth of a millilitre It waits until then before starting the measurement If the measurement does not start you may apply more blood Alarm clock function The meter can remind you to test your blood glucose You can set an acoustic signal to remind you at three different times Hy
4. The cap snaps into place with an audible CLICK Testing blood glucose Notes Dropping the lancing device with a lancet inserted may loosen the lancet in its holder In that case the lancet is no longer prop erly lodged and cannot be used to obtain blood In rare cases the lancet may even protrude from the cap Ina case such as this you might injure yourself on the lancet There fore take great care not to touch the front of the cap Should you drop the lancing device please pick it up with care Remove the cap from the lancing device Take care to avoid the lancet so as not to injure yourself Always eject and dispose of the lancet if the lancing device has been dropped see Chapter 4 5 Afterwards re attach the cap without inserting a lancet Press the plunger all the way down twice Only then insert a lan cet again For blood collection the cap must be on the lancing device With out this cap the lancing device cannot be primed nor can the lancet be triggered Instead the lancet is ejected when you press the plunger Testing blood glucose 4 3 Testing blood glucose 4 3 1 Turning the meter on gt gt Press the Test button to turn the meter on Following the display check see Chapter 2 2 2 a test strip is automati cally advanced and the test strip symbol and drop symbol flash in the display You now have about 5 minutes in which to draw up blood with the test strip 78 Testing blood g
5. 163 197 Test button 12 Test principle 196 Test strip guide 12 Test strip drum 12 disposal of 32 inserting or replacing 24 partly used 31 use by period 33 Test strips 12 disposal of 91 ejecting 90 indication of the number remaining 36 symbol 84 170 use by date 29 Testing causes of error 99 healthcare professionals 150 procedure 78 Thermometer symbol 164 170 Troubleshooting 181 Turning off meter after testing 90 automatic 23 43 88 91 106 117 198 Closing settings 43 exiting memory 105 Turning on meter retrieving results 102 settings 42 44 testing 78 Type plate 14 U Unit of measurement mmol L and mg dL 20 Use by date control solution 138 test strips 29 Use by period test strip drum 33 cannot be calculated 34 expired 33 210 Alphabetical index
6. 3 2 The meter turns off automatically when you have not pressed a button for 60 seconds 106 Using the meter as an electronic notebook 5 3 Average highest value and lowest value for 7 14 and 30 days The meter can display the averages of results from the last 7 14 or 30 days Also you can request that the lowest and highest values be dis played for these 3 periods All results falling within the relevant period are included in the calculation The current day is always included in the calculation If more than 500 test results were saved during this period the calculation will be based on the last 500 gt With the meter turned off press the M button The meter turns on without advancing a test strip Follow the display check see Chapter 2 2 2 the most recently saved result is displayed together with the time date and mem mem is short for memory Using the meter as an electronic notebook 107 Press the M and S buttons at the same time The average of the results from the last 7 days is displayed The number of results used in the calculation is displayed at top left in this example 30 The number of days for which the average was calculated is dis played at top right in this example 7 gt Again press the M and S buttons together to move to the other aver ages The 7 day average is followed by the 14 day and 30 day averages and then again by the 7 day average 108 Us
7. 3 Off Level You are here Date gt gt Hypo indicator The time and the date that are currently set are displayed The hour flashes at top left of the display 24 hour format Ea Settings 12 hour format gt Press the M button repeatedly or press and hold it down until the required hour is displayed gt Press the S button to save the chosen setting The minute setting comes next The minutes flash at top left of the display 24 hour format 12 hour format Settings gt Press the M button repeatedly or press and hold it down until the The month flashes at top right of the display required minutes are displayed Press the S button to save the chosen setting 24 hour format The date setting comes next DD MM 3 8 Setting the date Beep tone or Brightness Acoustic Mode of the display 12 hour format i Low Medium High 24 hour 12 hour MM DD Time and date gt Year gt format e Alarm clock T Time amulian gt Hypo indicator Press the M button repeatedly or press and hold it down until the Hours Minutes ethan Off Level required month is displayed gt Press the S button to save the chosen setting You are here The day setting comes next EJ Settings Settings 57 The day flashes at top right of the display 24 hour format DD MM 12 hour format MM DD gt Press the M button repeatedly or press and hold it down until the
8. 90 day use by period Once a drum has been in the meter for 90 days its use by period has expired The next time you turn the meter on to perform a test the drum symbol bottle symbol and hourglass symbol are displayed to highlight the fact gt Insert a new test strip drum Note The test strips in this drum cannot be used You must not use these test strips as they may produce incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce serious adverse health effects Initial steps before testing 33 The meter is unable to calculate the 90 day use by period if e you insert a partly used drum in the meter even if it is the same one you have just removed e the year date and time settings are lost when you replace the bat teries see Chapter 9 and a partly used drum remains in the meter The meter has no way of telling you in these cases when the drum was first inserted or how long the partly used drum has already been in the meter If the meter cannot calculate the use by period and you turn the meter on to perform a test the following symbols appear in the display Ea Initial steps before testing e Flashing test strip and flashing drop indicating that you may now apply blood or control solution e Drum indicating that the use by period cannot be calculated e Flashing bottle requesting you to perform a performance check in order to check the test strips
9. C without batteries and without a test strip drum 25 C to 70 C with batteries and without a test strip drum 10 C to 50 C with batteries and with a test strip drum 2 C to 30 C 25 C to 70 C 20 to 85 relative humidity 20 to 85 relative humidity Sea level to 4000 m 500 results together with time and date aver 13 ages highest and lowest value for 7 14 and 30 days 121 x 57 x 32 mm 125 x 64 x 32 mm Weight Display window Automatic power off Power supply Battery life Interface Safety class LED IRED Electromagnetic compatibility approx 147 g with lancing device batteries and test strip drum OLED Organic Light Emitting Diode display after 60 seconds or 5 minutes depending on operating status 2 batteries type AAA LR 03 AM 4 or Micro or 2 NiMH rechargeable batteries type AAA approx 1000 results or approx 1 year less when the brightness of the display is set to level 3 high or in Acoustic Mode owing to the higher power consumption or when rechargeable batteries are used Infrared interface Ill Class 1 This device meets the electromagnetic immu nity requirements according to EN ISO 15197 Annex A The chosen basis for the immunity tests on electrostatic discharge was basic standard IEC 61000 4 2 198 Technical data Performance evaluation EN ISO 15197 Technical data In addition it meets the electromagnetic emissions requirement
10. again and repeat the test You pulled the test strip out of the meter Press the Test button to turn the meter off Only remove the test strip from the meter by pressing the Test button to turn the meter off There is condensation in the meter Press the Test button to turn the meter off Leave it to dry at room tempera ture Symbols error messages and troubleshooting 189 Meaning The batteries are empty or a meter error has occurred Turn the meter off and then on again by pressing the Test button If the error message appears again the batteries may be empty Insert new batteries If the error message is again repeated when the meter turns on please con tact your local customer support and service centre The meter was exposed to a strong electromagnetic field Press the Test button to turn the meter off Move somewhere else or turn off the source of the field You bent or moved the test strip during the test either while you were drawing up blood or contro solution with it or during the test gt gt 190 Symbols error messages and troubleshooting Error message Meaning gt gt Turn the meter off and then on again by pressing the Test button Repeat the test with a new test strip e You drew up blood or control solution too soon with the test strip i e before the test strip symbol and drop symbol were flashing in the display Turn the meter off and then on again by pressing th
11. before testing Initial steps before testing 23 2 3 Inserting or replacing the test strip drum If your meter is brand new and unused it will contain a mock drum an empty drum without a label which you must remove and replace with a test strip drum Read the package insert that came with the test strip drums If the meter is on press the Test button to turn it off gt Wait for the motor to stop Set into the back of the meter to the left of the lancing device is a recess The upper part of this recess belongs to the drum compartment cover Drum compartment cover Recess 24 Initial steps before testing gt Place your thumb into this recess and lift up the drum compartment cover Irrespective of whether a test strip drum is inserted or not gt Press the red drum release button Initial steps before testing 25 The pin holding the test strip drum in position retracts with an audible CLICK If there is a test strip drum in the meter gt Tip the meter forwards The test strip drum drops out Initial steps before testin g gt Insert a new test strip drum in the meter as illustrated the two rows of bar code must be nearest the display window P Close the drum compartment cover and push it shut There will be an audible CLICK The meter turns on and rotates the test strip drum until the first test strip is in the correct position At the same time the meter r
12. blood glucose without assistance from a sighted person An intimate knowledge of how results are represented as beeps and how to distinguish results from other beeps is crucial to reliably recog nizing the result The chapters that now follow deal with beep tones in greater depth In addition training software the BeepLearn Programm to help you inter pret results announced in the form of beeps is available on CD from your local customer support and service centre Practise listening to beeps from actual tests or from the training soft ware together with a sighted person until you can clearly recognize and interpret the results and other beeps you will hear If you have problems vizualizing the results from the beeps it is best not to use Acoustic Mode 120 Acoustic Mode There are two types of beep tone differing in pitch Warnings have a higher tone Tone 2 represented below a than the other beep tones Tone 1 represented below as The following table shows which tone sounds for which event Meter ready to test Chapter 6 2 Tone 1 Start of testing Chapter 6 2 Announcement of the result Tii Gaand Signal that results are due to be Chapters 6 3 and announced 6 4 Announcement of an error mes Chapters 6 2 and oy Notification that the batteries are warnin almost exhausted Chapter 6 5 l 9 Notification that the drum is Chapter 6 5 empty Acoustic Mode 121 6 1 Beep tones at power on When Aco
13. change settings Recess for docking the lancing device Test button Use this button only if you want to test your blood glucose or per form a performance check or wish to turn the meter off Pull the button downwards towards the drum compartment cover The but ton tips downwards and the meter turns on This pull tip mechanism stops the meter turning on inadvertently Drum compartment Drum release button Test strip guide Measuring window Test strip Test strip drum Drum compartment cover M Button Press this button to retrieve results stored in the meter s memory available as replacement part Introduction 13 i Battery compartment cover Infrared window for sending results to a PC for instance Batteries type AAA LR 03 AM 4 Micro Battery compartment Type plate available as replacement part 14 Introduction Control window shows the number of strips remaining Lancing device Slide button for undocking the lancing device 1 2 The Accu Chek Softclix Plus lancing device at a glance QS Pin hole opening for lancet Plunger The plunger is a multifunction Cap Dutton used to prime trigger Comfort Dial for depth selec an eject the aoe tion you change the depth by Window showing the penetra rotating the cap tion depth setting Locating notch 3 Lancet holder fae 0 Locating line Lancet
14. freeze Turn the meter off Move to a place where the temperature is between 10 C and 40 C and wait for the temperature of the meter to adjust to this temperature When the meter is turned The meter was exposed to a tempera on the date is shown as ture below 10 C and the batteries 1 01 and the time as are beginning to freeze 0 00 or 12 00 Press the Test button to turn the meter off Move to a place where the tem perature is between 10 C and 40 C and wait for the temperature of the meter to adjust to this tempera ture gt gt Symbols error messages and troubleshooting 183 Error message gt gt 184 Symbols error messages and troubleshooting Meaning e The year time and date have not been set Set these as described in Chapter 3 The test strip drum in the meter is empty Insert a new test strip drum e The bar code information from the test strip drum has been lost Press the Test button to turn the meter off Open and close the drum compart ment cover The meter rotates the drum and reads the bar code When you next turn on the meter to perform a test the drum symbol and flashing bottle symbol are displayed gt gt Error message dd Meaning Perform a performance check You may use up all the test strips remain ing in the drum The 90 day use by period will no longer be calculated for this drum The drum symbol will therefore be displayed each
15. gt Perform a performance check see Chapter 7 If the result from the performance check is within the stated concentra tion range you can still use the test strips remaining in the drum If the result is outside the range you need to insert a new drum Following the performance check the bottle symbol disappears from the display If you do not perform a performance check the flashing bottle symbol appears with every test until you insert a new drum The drum symbol continues to be displayed with each test in order to draw your attention to the fact that the meter cannot calculate the use by period All results are saved along with the drum symbol The drum symbol only disappears when you insert a new drum Initial steps before testing Ea 2 3 2 Indication of the number of test strips remaining Each time you turn on the meter off with the Test button it shows you the number of test strips remaining in the drum When you hold down the Test button the number of remaining strips continues to be dis played In this example there are still 12 test strips in the drum When you release the Test button the meter turns off Notes If the test strip drum contains three or fewer test strips following a test the number the test strip symbol and drum symbol flash in the display window If you press the Test button only briefly when turning the meter off the number of test strips remaining is displayed only briefly or not at al
16. out a time and date tion to the fact that the meter cannot cal m memory only contains results that culate the use by period The symbol only are not included in the calculation disappears when you insert a new test e g performance results strip drum All results are saved along with no results were saved in the period the drum symbol If you do not perform a in question e g all results in mem performance check the flashing bottle ory are more than 7 days old symbol appears with every test until you insert a new drum gt 178 Symbols error messages and troubleshooting Symbols error messages and troubleshooting 179 gt gt Symbol Meaning m the date that it is set is in the past m you changed the time and date then performed a test and after wards re set the time and date but have not performed any more tests since then The result is lower than 0 6 mmol L 10 mg dL The result is greater than 33 3 mmol L 600 mg dL You have turned the meter on in order to download the results The meter is downloading results Decimal point displayed by mmol L meters and is part of the result e g 8 2 mmol L is displayed as 8 2 180 Symbols error messages and troubleshooting 12 2 Problems and error messages causes and troubleshooting recommendations If you receive frequent error messages please contact your local cus tomer support and service centre If this happens The me
17. required day is displayed Press the S button to save the chosen setting The alarm clock settings come next EJ Settings 3 9 Setting alarms Beep tone or Brightness Time and date Acoustic Mode of the display format On Off Acoustic Mode Low Medium High 24 hour 12 hour Time gt Date Hypo indicator Off 1 2 and 3 hour min Off Level Hours Minutes Month Day You are here You can use the meter s alarm clock function to remind you to test your blood glucose at pre defined times You can set three alarms The meter beeps for 20 seconds at the appointed time every day The meter then turns off again You can turn the beep tone off earlier Do this by pressing any of the three buttons The meter then turns off A test strip is not advanced While it is beeping the meter displays the following Settings 59 Two steps are involved in entering the setting First you define whether the alarm clock function is basically to be turned on Gn or off GFF When it is on you can enter or change the alarm times All alarms symbol are factory set to off GFF flashes in the display gt gt Press the M button to turn the alarm clock function on Un is dis played If you press the M button again DF F reappears and the alarm clock function is turned off Press the S button to save the chosen setting 60 Settings If you have turned the alarm clock functio
18. set the alarm times for Alarm 2 and Alarm 3 proceed as described for Alarm 1 The hypo indicator setting comes next 64 Settings Notes You do not have to set all three alarm times you can set just one or two times When you have set your alarm times and the hour for the next alarm flashes e press the S button repeatedly until you reach the hypo indica tor setting see Chapter 3 10 or e f you do not wish to set a hypo indicator press the Test but ton to turn the meter off You can turn off individual alarms by setting their time to 0 00 24 hour format or 12 00 a m 12 hour format Any other time means that the alarm clock function is turned on for this time To set the alarm clock function for midnight you must therefore set the time to one minute to midnight 23 59 or 11 59 p m or to one minute after midnight 0 01 or 12 01 a m Settings 65 The meter can only remind you to perform a blood glucose test when the year time and date have been set in the meter If you lose the year time and date settings while replacing the batteries see Chapter 9 you must re enter these in order for the alarms to be active The settings for the alarms themselves will not have been lost If you have turned the alarm clock function on the meter will always beep to remind you to test your blood glucose even if the beep tone itself is turned off The beep tone setting has no influ ence on the alarm clock fu
19. symbol The test strip symbol and drop symbol are flashing The time date and blood glucose results shown in the display illustra tions are intended only as examples They will not necessarily be the same as those shown by your own meter The meter that is used for illustration in this manual displays blood glucose results in mmol L see Chapter 2 2 and has been set to 24 hour format see Chapter 3 6 Your meter on the other hand may show blood glucose test results in mg dL and or be set to 12 hour format Introduction 19 i 2 initial steps before testing 2 1 Checking the contents Check that your monitoring kit is complete The package contents are listed on the box If anything is missing please contact your local customer support and service centre Details are given at the end of this User s Manual 2 2 Checking the blood glucose unit Blood glucose results can be displayed in two different units of mea surement mmol L or mg dL Consenquently Roche sells two different versions of the same meter If you do not know which is the right unit for you ask your doctor gt Check that your meter displays the unit that is right for you Check the unit by referring to the type plate and to the display window during a display check see below Note The unit that your meter displays cannot be changed If the wrong unit is printed on the type plate please consult your dealer or pharmacy Using the wrong unit can ca
20. the test strip gt Wait until the test strip symbol and drop symbol flash in the display and the meter beeps only when the beep tone is turned on gt Hold the meter so the test strip pointing downwards see illustra tion Ea Testing blood glucose gt Immediately after the drop of blood has formed Hold the front edge of the test strip against the drop of blood so the black notch is touching the drop of blood The test strip draws up blood gt Move the finger away from the test strip as soon as the hourglass symbol x is displayed and the meter beeps only when the beep tone is turned on Testing blood glucose The test strip has then drawn up enough blood and measurement Notes starts The hourglass symbol x indicates that the meter is busy mea l 4 suring Do not touch the test strip unless you are applying blood Resi dues e g of skin cream food or drink on the skin can find their way onto the strip and may produce incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce adverse health effects Take care not to bend the test strip either before or you draw up blood Do not bend or move the test strip while the test is in progress Bending or moving the test strip can produce an incor rect result or cause an E 5 see Chapter 12 2 error message to be displayed Measurement is complete after approx 5 seconds The result is dis played and the m
21. turned on or a strong light source is too close to the two infrared windows Remove the device or light source and start the download again e An object for instance is blocking communication between the two infrared ports Remove the object and start the download again e Aerror occurred at the receiving end Read the relevant manual s If you already have a hardware or software product from Roche Diagnostics to enable you to send and evaluate results it may not recognize more recent meters so the results will not be down loaded You may need a more recent software version for your hardware or software product In this case please contact your local customer support and service centre Data transfer does not follow the IrDA standard IrDA stands for Infrared Data Association Using the meter as an electronic notebook 119 6 Acoustic Mode Acoustic Mode is intended for persons who are visually impaired When Acoustic Mode is turned on the meter guides you through the testing process using beep tones it also outputs the result as a series of beeps The meter beeps additionally when the batteries are almost exhausted the test strip drum is empty or an error message is displayed Chapter 3 3 describes how to turn Acoustic Mode on Visually impaired persons need a sighted person to instruct them in the use of the meter and to assist them with all aspects of its operation Visually impaired persons must not test their
22. up blood with the test strip Did you draw up blood with the test strip immediately after yes the drop of blood formed Testing blood glucose Has the test strips use by date expired see label on the test no strip drum next to the g symbol Are the test strip guide and measuring window clean yes Have you paid attention to the sources of error stated in the yes package insert that came with the test strip drums If you have checked these points and still receive error messages or doubt the results are correct please call your local customer support and service centre If your meter has been dropped you may receive error messages or results you doubt are correct If it has again please call your local cus tomer support and service centre 100 Testing blood glucose 5 Using the meter as an electronic notebook 5 1 Memory Your meter has a 500 value memory for saving results together with the time and date only when you have set the time and date You do not need to save the results manually The meter does it all for you The most recent result always occupies memory location 1 the preceding one location 2 etc up to location 500 When all of the locations are occupied and a new test is performed the result in location 500 is erased the other results are shifted one place back in time and the most recent result is saved in memory location 1 In addition to the result the time and the date your m
23. C E oss ACCU CHEK SOFTCLIX and SAFE T PRO are trademarks of Roche Roche Diagnostics GmbH D 68298 Mannheim Germany www accu chek com 0 5049474001 01 03 07 ACCU CHEK Compact Plus BLOOD GLUCOSE MONITORING SYSTEM User s Manual On the packaging on the type plate of the meter and on the lancing device you may encounter the following symbols shown below They have the following meanings Consult instructions for use Caution refer to accompanying documents Please refer to safety related notes in the instructions for use accompany ing this instrument Store at Use by Expiry date For single use only Sterilized through irradiation Manufacturer Catalogue number Lot number For in vitro diagnostic use Blood glucose meter This product fulfils the requirements of Directive 98 79 EC on in vitro diagnostic medical devices Lancing device and lancets These products fulfil the requirements of Directive 93 42 EEC on medical devices Last update 2007 03 Explanations of further symbols are given in the User s Manuals package inserts accompanying the components Intended use Accu Chek Compact Plus Blood Glucose Meter Meter for quantitative determination of blood glucose values in fresh capillary blood using Accu Chek Compact test strips Suitable for self testing The meter may be used may be used by people with diabetes to test their own blood glucose as we
24. Guidelines for testing chemical disinfectants and the Anforderungskatalog Requirements catalogue of the DGHM Deutsche Gesell schaft f r Hygiene und Mikrobiologie e V German Society for Hygiene and Microbiology based on the DGHM standard methods for testing chemical disinfection methods and have been found to be efficacious by the Desinfektionsmittel Kommission Disinfectants Com mission of the DGHM in collaboration with representatives of the following professional associations DGKH Deutsche Gesellschaft f r Krankenhaushygiene e V German Soci ety for Hospital Hygiene GHU Gesellschaft f r Hygiene und Umweltmedizin e V Ger man Society for Hygiene and Environmental Medicine DVV Deutsche Vereinigung zur Bekampfung der Viruskrankheiten e V German Association for the Control of Viral Dis eases and DVG Deutsche Veterinarmedizinische Gesellschaft e V German Veterinary Society 162 Blood glucose testing in a multi patient setting 11 Measurement and storage conditions The reliability of your meter and lancing device as well as the accuracy of your results is influenced by a number of factors Pay close attention to the following points A meter that has been dropped can produce false results 11 1 Temperature range e Without the batteries and without the test strip drum the meter may be stored at between 25 C and 70 C e With the batteries and without the test strip drum the meter may be s
25. O Si 16 1 4 Display illUstrations ccccecsessecesesesessssssesssssseessseeeees 19 2 Initial steps before testing ccccceessssssssesesssseseessseeees 2 1 Checking the Content ciiise 2 2 Checking the blood glucose unit DOA pepali e 222 Display GNECK sectei ceschseech ste csctetvescetstese tus tease 2 3 Inserting or replacing the test strip CrUM cccseeeeees 24 2 3 1 Test strip drum use by period 33 2 3 2 Indication of the number of test strips remaining 36 3 SGUUNGS icpin paepae piein 3 1 Changing settings General rules 3 2 3 3 3 4 3 5 3 6 3 7 3 8 3 9 Turning the Meter ON cccccsesescssesescsssseecssseesssseessseeersas Setting beep tone or Acoustic Mode Setting the brightness of the display Setting he yed s aS Setting the time date format Setting the tim Setting the Mate nnani Setting the alarm clock function ccccceceeseeteeeesesseeeseeees 3 10 Setting the hypo indicator sisisi 8 Contents 4 Testing blood glucose ccceceseseeeseeeeeeeeseeeeeeeeeeeeteeeeees 70 4 1 Preparing to test blood QIUCOSE cececcceceeeseeteeeeees 70 4 2 Preparing the lancing device ececcceceeceeeseeeeeseeeeeees 70 4 2 1 Undocking the lancing device from the meter 73 4 2 2 Docking the lancing device onto the meter 74 4 2 3 Inserting the lancet ecececeseeeseeeseseseseseseeeees 75 4 3 T
26. aken and so produce adverse health effects Only open the drum compartment cover when the meter is turned off and the motor is not running Opening the drum compartment cover when the meter is turned on may result in damage to the meter Handle the test strip drums with care Only remove a test strip drum from its container when you intend to use it The container protects the aluminium foil on the drum from damage There is a label on the container the drum came in The left por tion may be peeled off On it is the concentration table for the Accu Chek Compact Autocontrol control solutions The stated concentrations are valid only for the test strips contained in this drum You need this table to check your meter see Chapter 7 You may for instance wish to stick the peel off label in your notebook or diary When conducting a quality control test always check that the peel off label with the concentration table belongs to the test strip drum that is currently in the meter Ew Initial steps before testing If you insert a partly used drum in the meter the meter rotates the drum so the dot appears in the control window on the back When you subsequently turn on the meter to perform a test and e you have re inserted a same drum you previously removed The meter immediately rotates the drum to the first chamber that contains a test strip and ejects the strip e you have used up the previous drum or have replaced one partly us
27. aluation system The meter has an inbuilt infrared port permitting wireless data down loading to a suitably equipped PC handheld computer PDA or special evaluation systems Roche Diagnostics offers a variety of special hardware and software that extend the integrated notebook functions of your meter These products enable you and your doctor to manage your data more effec tively and through their graph and table views make it easier for you to understand your self testing data Depending on the type of analysis you intend to perform you will require a special software product and or special hardware products For further information please contact your local customer support and service centre 114 Using the meter as an electronic notebook The infrared port is located at the front end of the meter S gt Be sure to read the operating instructions supplied with the software and hardware you are using These will include instructions on how to download your data Make the receiving end software product or hardware ready to download the results Using the meter as an electronic notebook 115 gt With the meter turned off press the M and S buttons at the same time The meter turns on Following the display check see chapter 2 2 2 the following screen appears Using the meter as an electronic notebook gt Position the meter 5 20 cm away from the infrared window of the receiving end Point
28. and service 203 D Data downloading 114 day symbol 108 174 Disinfectants 162 Disinfecting meter 158 Display 12 illustrations 19 169 number of strips remaining 36 setting the brightness 48 symbols in the 168 Display check 21 45 78 102 Disposal batteries 149 control solution 137 lancet 94 meter 200 test strip drum 32 test strips 91 Downloading results 114 causes of error 118 Drop symbol 84 170 Drum compartment 12 Drum compartment cover 12 Drum release button 12 25 Drum symbol 172 176 E E and number symbol 184 EEE symbol 195 Electromagnetic compatibility 198 End symbol 29 184 Error messages 181 in Acoustic Mode 128 206 Alphabetical index F Flagging result 96 H HI symbol 98 180 Highest value 107 Hourglass symbol 86 174 Humidity 166 197 Hypo indicator setting 67 symbol 67 173 hypo symbol 67 173 l Infection risk 4 150 Infrared window 14 115 Intended use lancing device 5 meter 4 L Lancet 15 disposal of 94 ejecting 92 inserting 75 Alphabetical index Lancing device ataglance 15 Cleaning 144 docking 74 obtaining blood using the 80 priming 81 replacing with a blanking plate 152 undocking 73 Light conditions 165 Light source interfering 165 Liquids for cleaning lancing device 144 meter 140 LO symbol 98 180 Lowest value 107 M Mbutton 12 42 102 Measurement conditions 163 Measuring range 98 196 Measuring time 86 197 Measuring win
29. and slide it in the direction of the arrow gt Lift off the cover b gt Remove the used batteries Changing the batteries ra i gt Insert two new batteries type AAA LR 03 AM 4 or micro The minus ends of the batteries must match up with the minus marks in the battery compartment gt Re attach the battery compartment cover The three hooks on the underside of the cover must engage with the slots along the edge of the battery compartment The cover is then just loosely held in position gt Slide the battery compartment cover back into place It locks with an audible CLICK 146 Changing the batteries Notes A fresh pair of batteries has enough power either for about 1000 tests or for one year s worth of tests If you have changed the brightness of the display to level 3 high or set Acoustic Mode to on the battery life will be shorter When you replace the batteries your results always remain saved The year time and date settings only remain saved as long as e you do not take longer than two minutes to change the bat teries e you do not press any button when the batteries are not inserted you do not open the drum compartment while there are no batteries inserted e you turn the meter off before removing the batteries If one of the above conditions is not met you will need to re enter the year time and date If you do not enter the year time and date all future res
30. apters 3 3 and 6 As soon as the test strip symbol and drop symbol flash in the dis play you have approx 5 minutes to draw up with the test strip If you have not drawn up blood within this time i e measurement has not started the meter turns off automatically In this case press the Test button so as to eject the test strip see Chapter 4 4 and dispose of the strip Start the blood glucose test again with a new test strip 88 Testing blood glucose Testing blood glucose 4 4 Ejecting the test strip gt Hold the meter over a waste bin with the test strip pointing down wards Press the Test button to turn the meter off The used test strip drops out Before the meter turns off it shows you the number of test strips remaining in the drum see Chapter 2 3 2 90 Testing blood glucose Notes W Always turn the meter off by pressing the Test button so as to i eject the test strip Do not pull the test strip out If you do pull the used test strip out blood can enter the meter and contaminate it Do not push an ejected test strip back into the test strip drum This includes any unused test strips that you have ejected by accident These test strips can produce incorrect results Incor rect results can cause the wrong therapeutic decision to be taken and so produce serious adverse health effects If you do not turn the meter off it turns off automatically after approximately 60 seconds The test strip
31. ause 1 long beep eeeere e The result 72 mg dL is announced as follows 1 long beep for 0 hundreds pause 7 beeps pause 2 beeps Results that are lower than 0 6 mmol L or 10 mg dL and are displayed as L are announced acoustically as 0 0 0 and 0 decimal point 0 respectively Results that are higher than 33 3 mmol L or 600 mg dL and are dis played aH are announced acoustically as 9 9 9 and 9 9 deci mal point 9 respectively Acoustic Mode 125 Note Information or warnings in the form of symbols e g drum symbol or hypo symbol see Chapter 12 1 that are displayed together with the result are not announced acoustically 6 4 Announcement of results and average values from memory Only the last most recent result that was saved can be announced acoustically If you press the M button to turn the meter on you first hear the long power on beep followed by the beep sequence 1 2 3 and then the most recent result Only the average for the last 7 days is announced acoustically The low est and highest results within this period are not announced acousti Cally The announcement follows the same pattern as any result that is announced directly following a test 126 Acoustic Mode If the 7 day average cannot be calculated three horizontal bars are displayed This is signalled acoustically with 3 long beeps representing 3 zeroes
32. centration range as well please check the following points Did you perform the performance check as described above yes Did you wipe the tip of the dropper before you applied control yes solution to the surface of the washable object Did you use a suspended drop of control solution yes Was there prolonged contact between the control solution and no the washable object Did you bend the test strip either before or while you were no drawing up control solution Did you wait for the test strip symbol and drop symbol to flash yes in the display before drawing up control solution with the test strip Checking your meter 137 Did you compare the result with the concentration data spe yes cifically relating to the control solution you used Did you perform the test within the correct temperature range yes 10 C to 40 C Has the 90 day use by period for the test strip drum expired no see Chapter 2 3 1 and possibly the clock symbol a5 in the meter s display Have you observed the proper storage conditions for the yes meter test strips and control solutions see Chapter 11 and the package inserts that came with the test strips and control solutions Checking your meter If you give the correct response to all these questions and the results are still outside the stated concentration range please call your local cus tomer support and service centre If your meter has been dropped you may receive erro
33. cotton swab lightly moistened with cold water or 70 ethanol Place your thumb into his recess below the drum compartment cover and fold the drum compartment cover upwards Cleaning the meter and lancing device Notes W 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 liquid you are using for cleaning Doing so may damage the meter s internal components and stop it from working properly W Make sure that no liquid enters the meter Avoid scratching the measuring window as doing so could impair its measuring func tion gt Wipe the measuring window and the area surrounding it with a cot Make sure that the drum compartment cover is tightly closed If it ton swab lightly moistened with cold water or 70 ethanol is not properly closed the meter will not turn on when you press the Test button gt Remove any fluff or lint that may remain Allow areas you have wiped time to dry thoroughly Healthcare professionals using the meter to test several patients blood glucose must also read the directions in Chapter 10 3 gt Fold the drum compartment cover down and press it shut There will relating to disinfection be an audible CLICK gt Perform a performance check see Chapter 7 142 C
34. dow 12 mem symbol 102 175 Memory 101 197 Memory location number 101 106 Memory results 101 Meter ataglance 12 checking 129 cleaning 140 disinfecting 158 disposal of 200 storage 163 turning off 43 90 105 turning on 44 78 102 mg dL symbol 20 172 mmol L symbol 20 172 N n symbol 108 175 NiMH batteries 148 P Patents 202 Performance check 129 causes of error 137 Performance evaluation 199 Penetration depth 80 setting 81 Penetration depth setting 15 window 15 80 Plunger lancing device 16 71 Problems 181 R Release button lancing device 14 73 test strip drum 12 25 Result average 107 downloading to e g a PC 114 flagging 96 highest value 107 lowest value 107 retrieving from memory 102 S S button 12 42 103 set symbol 41 174 Settings 38 Acoustic Mode 45 alarm clock function 59 beep tone 45 brightness of the display 48 changing rules 41 closing 43 208 Alphabetical index date 56 factory defaults 39 following battery replacement 39 40 147 hypo indicator 67 order 41 time 54 time and date format 52 turning the meter on 44 year 50 Setting the date 56 Setting the time 54 Setting the time and date format 52 Setting the year 50 Sources of electromagnetic inter ference 166 Sources of interference electromagnetic 166 light 165 Storage conditions 163 Symbols 167 during testing 95 System components 201 Alphabetical index T Technical data 196 Temperature
35. e three horizontal bars are displayed instead of a numeri cal value HA Using the meter as an electronic notebook If the memory contains both results that were saved together with the time and date and results that were saved without this information the averages and respective lowest and highest val ues will only be calculated from results saved with the time and 5 date that come chronologically before the first result without the time and date Example The meter saved 150 results over a period of 50 days The result in memory location 51 was saved without the time and date The results in memory locations 1 to 50 which were saved together with the time and date cover a 20 day period For calculation of the 7 and 14 day averages those results are included that are within the period in question The 30 day average is calculated from all 50 results even if these only covered a 20 day period The results after the result without the time and date memory location 52 and higher are no longer available for calculation of averages even if they were saved with the time and date If you turn on the meter off with the Test button it shows you the number of test strips remaining in the drum see Chapter 2 3 2 The meter turns off automatically when you have not pressed a button for 60 seconds Using the meter as an electronic notebook 113 5 4 Downloading test results to a PC handheld computer or a special ev
36. e tests were only performed in the last 5 days In addition either no other results were saved or the results 0 9 that were saved are more than 30 days old Consequently the results for the last 5 days are used for calculating the average the lowest value and the highest value for all three periods 7 14 and 30 days m H 9 7 day period Using the meter as an electronic notebook Using the meter as an electronic notebook 111 If a large number of results were saved within one period calcu lation of the average may take a while mem flashes in the display while the calculation is in progress Gi If no results were saved in memory for the period in question three horizontal bars are displayed instead of a numeri cal value If for example the results are more than 7 days old the average lowest value and highest value cannot be calculated for 7 days The meter can only perform the necessary calculations as long as the results were stored together with the time and date If you have not entered the time and date three horizontal bars are displayed instead of the numerical values In the event that you changed the date or time then performed a test and afterwards re set the date time the meter only includes results it saved in uninterrupted chronological order If the chron ological order was interrupted the earlier results are ignored If you have not performed any tests since you made the chang
37. e Test button Repeat the test with a new test strip Only draw up blood or control solution with the test strip when the test strip sym bol and drop symbol are flashing in the display You pulled the test strip out of the meter during testing Turn the meter off and then on again by pressing the Test button Repeat the test with a new test strip Only remove the test strip from the meter by pressing the Test button to turn the meter off Symbols error messages and troubleshooting 191 Error message Meaning The test strip is stuck or the test strip drum does not rotate Press the Test button to turn the meter off Open the drum compartment cover and if applicable pull out the test strip Press the red drum release button and remove the test strip drum Insert the test strip drum again and close the drum compartment cover The meter rotates the drum and reads the bar code When you next turn on the meter to perform a test the drum symbol and flashing bottle symbol are dis played Perform a performance check You may use all the test strips remaining in the drum The 90 day use by period will no longer be calculated for this drum The drum symbol will therefore be displayed each time you perform a test until you insert a new test strip drum KA Symbols error messages and troubleshooting Error message Meaning e The meter has been exposed to severe differences in temperature e The ambient tem
38. e against using rechargeable batteries if the brightness of the display is set to level 3 high or if Acoustic Mode is set to on 148 Changing the batteries Changing the batteries g 10 Blood glucose testing in a multi patient setting Information for healthcare professionals Only professionals working in doctors practices hospitals and diabetes training centres and nursing staff are allowed to perform blood glucose tests on more than one patient using the same Accu Chek Compact Plus meter When using the meter always follow the recognized procedures for han dling objects that are potentially contaminated with human material Practise the health and safety policy of your laboratory or institution Also to stop your meter becoming contaminated please follow the directions printed on the next few pages Notes Patients and healthcare workers are potentially at risk of becom ing infected when the same Accu Chek Compact Plus meter is used to test blood glucose in several patients Any object coming into contact with human blood is a potential source of infection see Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLS document M29 A3 2005 150 Blood glucose testing in a multi patient setting Any patient with an infection or suffering from an infectious disease and any patient who is a carrier of a multiresis
39. e meter with the test strip pointing downwards see illustra tion 10 gt Immediately after the drop of blood has formed Hold the front edge mmmmm of the test strip against the drop of blood so the black notch is touching the drop of blood The test strip draws up blood gt Move the test strip away from the drop of blood as soon as the hourglass symbol x is displayed and the meter beeps only when the beep tone is turned on The test strip has then drawn up enough blood and test starts b gt When the result is displayed hold the meter upright over a waste bin and press the Test button to turn it off The used test strip drops out Blood glucose testing in a multi patient setting 155 Notes Always hold the meter so the test strip is pointing downwards when you are drawing up blood with the test strip If you hold it so the test strip is pointing upwards or sideways or you lay the meter down with the test strip still in blood can enter the meter and contaminate it Hold the meter with the test strip pointing downwards until the result is displayed measuring time approx 5 seconds and you have ejected the test strip Wrong Test strip point ing upwards To test blood glucose you require approximately 1 5 uL of blood Avoid producing large drops of blood on the patient s finger Where the drops of blood are too large the meter may come into contact with the blood Wipe off any large drops of blood Test us
40. eads the bar code that provides it with information on the specific characteristics of the test strips After that the meter turns off Initial steps before testing 27 A dot appears in the small control window on the back of the meter This indicates that you have just inserted a test strip drum When you per form a blood glucose test the meter counts the number of test strips that you have used and displays the number of strips remaining When all the test strips in a drum have been used up the dot reappears in the small contro window gt Insert a new test strip drum 28 Initial steps before testing If you do not insert a new drum the following message appears the next time you turn on the meter End and the drum symbol are flashing to indicate that the test strip drum is empty Notes Use only test strips that are not beyond their expiry date Test strips that have expired can produce incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce serious adverse health effects The expiry date is printed on the pack and on the removable label on the drum con tainer next to the pg symbol Initial steps before testing 29 Use only new test strips Make sure the aluminium foil the silver ends is intact on both sides Your blood glucose results may be incorrect if you use a damaged drum Incorrect results can cause the wrong therapeutic decision to be t
41. ed drum with another partly used one The meter may search all chambers until it finds the first one that contains a test strip The fewer test strips the drum con tains the longer the process takes If the meter immediately rotates the drum to one of the chambers near the end you can tell by the noise of the motor that rotates the drum the drum may ultimately still contain test strips even though the meter regards it as empty You can still use the test strips by inserting the drum again Initial steps before testing 31 If you insert a partly used test strip drum the meter cannot cal culate the use by period for that drum The next time you perform a test the drum symbol and flashing bottle symbol are displayed to highlight the fact see Chapter 2 3 1 Use only Accu Chek Compact test strip drums Other test strips cannot be used to perform tests If you insert a different test strip drum error message E22 is displayed see Chapter 12 2 Make sure that the drum compartment cover is tightly closed If it is not properly closed the meter will not turn on when you press the Test button All you see is the display check screen briefly FGG D You can dispose of used test strip drums with your regular household waste Ea Initial steps before testing 2 3 1 Test strip drum use by period When you insert a new drum the meter starts to count the number of days the drum has been in the meter Each drum must be used within a
42. ented by one Pressing and holding down the button increments the numeral quickly From the highest selectable value pressing the M button auto matically takes you to the lowest one m Inthe case of settings where there are a number of options such as the beep tone setting pressing the M button presents each option in turn e Press the S button to save the chosen setting and move on to the next setting e You can change the settings at any time Press the S button repeat edly until the setting you wish to change is displayed flashing 42 Settings e From the last setting Hypo indicator pressing the S button takes you back to the first setting Beep tone Acoustic Mode e You can close the settings screen at any time by pressing the Test button All settings you have entered up to that point are saved Notes O O Always turn the meter on with the S button when you intend to change the settings If you turn the meter on with the Test button and there is a drum in the meter a test strip will be advanced If you turn on the meter off with the Test button it shows you the number of test strips remaining in the drum see Chapter 2 3 2 The meter turns off automatically after approximately 60 seconds if you do not press a button All settings you have confirmed up to that point with the S button are retained Settings that you have not confirmed with the S button are lost and the original setting rema
43. esting blood glucose HSM GG NRA es 78 4 3 1 Turning the meter ON eececeeseeeseseseseeeseeeeeeees 78 4 3 2 Obtaining blood eeeeeeeeeeeceeeseeeseeeeeeeeeeeeeseseeteees 80 4 3 3 Drawing up blood with the test strip eee 84 4 4 Ejecting the test Strip ce ceseeeeseseeeeeseeeeeeeseeeseseseeeseeeeees 90 4 5 Ejecting the used lantet 92 4 6 Symbols you see before during or after testing and whatithey MeaNna a a 95 4 7 Flagging special results ecececeeceseseeeseeeseseseseeeseeesees 96 4 8 Evaluating results rrisni issin 97 4 8 1 Measuring TANGO ciscsescscssissscecceeecoessbencessnesscensetie dee 98 4 8 2 Implausible results possible causes of error 99 5 Using the meter as an electronic notebook Sal MOMON save csvownnnanniatebasunnaiaaad 5 2 Retrieving results from Memory ccceceeeeeeeeeeeeeeeeeeeeee 5 3 Average highest value and lowest value for 7 14 ANG SOM AYS sess scetecceens thee eesti ens 107 5 4 Downloading test results to a PC handheld computer Or a special evaluation system cccececeeeeeeeeeeeeeeeeeeeees 114 Contents 9 10 ACOUSTIC MOE ii c0 cccscscssissczpeacuensicinsieeisieeseepeicnsieieenssisiane 120 6 1 Beep tones at POWEI OM cececececeeseseseseeseeeseseseeetere 6 2 Beep tones during blood glucose testing 6 3 Announcement of the result following a test 008 123 6 4 Announcement of results a
44. esult as a series of beeps see Chapter 6 a a Acoustic Mode turned on The beep tone is factory set to on On 4 Beep tone turned on S w aa lt ae Beep tone turned off Settings gt Press the M button to move to the next option gt Press the S button to save the chosen setting The brightness setting comes next Notes When you select Acoustic Mode One you hear a beep The beep tone setting has no influence on the alarm clock func tion If you have turned the alarm clock function on see Chapter 3 9 the meter will always beep to remind you to test your blood glucose even if the beep tone itself is turned off Settings 47 3 4 Setting the brightness of the display You are here Time and date format Beep tone or Acoustic Mode On Off Acoustic Mode Year niedrig mittel hoch 24 hour 12 hour Alarm clock Time Date Hypo indicator gt gt function gt YP Hours Minutes Month Day Off 1 2 and 3 Off Level hour min You can use this setting to adjust how bright you wish the displayed symbols and numerals to be There are three brightness levels low medium and high The brightness is factory set to medium shown by the at top right of the display window 48 Settings Medium brightness level 2 cet ve aiala cet Low brightness level 3 High brightness level gt Press the M button to move to the n
45. eter also saves all other information that is relevant to that test For example results flagged as performance s see Chapter 7 are displayed together with the bottle symbol el Results obtained at a temperature outside the per mitted range are displayed with the thermometer symbol E Please refer to Chapter 12 1 for a complete list of symbols which may be displayed Using the meter as an electronic notebook 101 5 2 Retrieving results from memory gt With the meter turned off press the M button The meter turns on without advancing a test strip Follow the display check see Chapter 2 2 2 the most recently saved result is displayed together with the time date and mem Time and date at the time of performing a test 1 102 Using the meter as an electronic notebook Retrieving results from memory mmoliL Press the M button once to move towards the next older result saved With the M button you can move back until you reach the oldest result max 500 results If you press and hold down the M button the results are fast scrolled starting slowly and then speeding up To move back again towards the most recently saved results gt Press the S button To fast scroll press and hold down the S button Using the meter as an electronic notebook 103 By pressing the S button you can scroll back to the most recent result You can exit memory at any time Memory location 1 To do this press t
46. eter beeps only when the beep tone is turned on At the same time the meter automatically saves the result to memory Allowing the test strip to draw up blood too early i e before the test strip symbol and drop symbol flash can produce an incorrect result or cause error message E 5 see Chapter 12 2 to be dis gt Wipe the puncture site with a clean dry tissue played Turn the meter off with the Test button so as to eject the test strip We recommend covering the puncture site to keep dirt out see Chapter 4 4 and dispose of the strip Repeat the blood glu cose test with a new test strip 86 Testing blood glucose Testing blood glucose Always hold the meter so the test strip is pointing downwards If the test does not start despite the fact that you have held the when you are drawing up blood with the test strip If you hold it drop of blood against the test strip the test strip drew up too little 4 so the test strip is pointing upwards or sideways or you put the blood In this case you can within a certain period draw up more mmmmmm meter down on a surface with the test strip still in it blood can blood with the test strip see the package insert that came with enter the meter and contaminate it the test strip drums If the meter beeps not once but several times when displaying the result either the hypo indicator is turned on and the result is below the limit see Chapter 3 10 or Acoustic Mode is turned on see Ch
47. even one more test When the batteries are so low that no more tests can be performed just the bat tery symbol appears briefly for 3 seconds in the display Then the meter turns off Insert two batteries new or recharged Symbols error messages and troubleshooting 171 Meaning See under Combinations of symbols The unit your meter uses to display the blood glucose result either mmol L or mg dL depending on the meter The meter cannot calculate the use by period for this test strip drum e because you inserted a partly used test strip drum e because you opened the drum com partment cover e because the year time and date set tings were lost when you changed the batteries and at this time the drum was partly used see Chapter 9 gt gt HHA Symbols error messages and troubleshooting Symbol gt gt vl Meaning Only in a new meter that has not yet been used to perform tests There is no test strip drum in the meter or the mock drum has been left inserted Insert a new test strip drum see Chapter 2 3 This result is a performance result See under Combinations of symbols After testing You have turned on the hypo indicator and the displayed result is below the level you set You are in the hypo indicator setting In memory The result is below the limit that was set at the time of testing Symbols error messages and troubleshooting 173 Symbol Meaning 9 Cet You are in the sett
48. ext option The brightness of the display window changes to the setting you have selected gt Press the S button to save the chosen setting The year setting comes next Settings 49 3 5 Setting the year You are here Beep tone or gt Brightness Time and date Acoustic Mode of the display format On ff Acoustic Low Medium High 24 hour 12 hour Mode Alarm clock Time Date Hypo indicator gt gt function gt P Hours Minutes Month Day off 1 2and3 Off Level hour min The year that is currently set flashes at top right of the display Press the M button repeatedly or press and hold it down until the required year is displayed gt Press the S button to save the chosen setting Settings The time and date format setting comes next Notes The year you have set is not displayed during testing nor together with the result nor when you look at saved results in memory It is only displayed when you are in the settings How ever having the correct year setting is still important because without it the meter will not be able to recognize February 29th in a leap year The correct year setting is also needed to unambigu ously identify your blood glucose test results when you download them to a computer for analysis or further processing The year can be set from the year of production to the year of production plus 32 Settings 51 3 6 Setting the time date format Y
49. h the way you feel please perform a performance check with an Accu Chek Compact Autocontrol solution and a new test strip You can only do this while the result is displayed and as long as you see Chapter 7 Then perform another blood glucose test If the have not yet turned the meter off new test result still does not agree with the way you feel please No other symbol Asterisk contact your doctor AN Do not change your treatment based on just one result mmoltL mmoltL While the result is displayed Press the S button The asterisk appears in the display Testing blood glucose Testing blood glucose 4 8 1 Measuring range Your meter measures blood glucose within a defined range 0 6 33 3 mmol L or 10 600 mg dL Values below this range are displayed as The result is less than 0 6 mmol L 10 mg dL Values above this range are displayed as The result is greater than 33 3 mmol L 600 mg dL These results are not used to calculate averages see Chapter 5 3 Testing blood glucose 4 8 2 mplausible results possible causes of error If your meter repeatedly displays error messages or you doubt the test results are correct please check the following points Did you perform the test as directed see Chapter 4 3 yes Did you massage your finger only gently in the direction of the yes fingertip Did you wait for the test strip symbol and drop symbol to flash yes in the display before drawing
50. he Test button Most recent result saved j l i 9 The meter turns off Memory location 2 Gy t0 Memory location 3 Notes Always turn the meter on with the M button if you intend to review results held in memory fm i A 8 If you turn the meter on with the Test button and there is a drum y i in the meter a test strip will be advanced Memory location 499 If no result has been saved in the meter just three horizontal bars mi i 9 are displayed Memory location 500 Oldest result If the beep tone Gn i or Acoustic Mode Gng is turned on a beep sounds each time e when you reach the oldest memory location containing a result i e the highest numbered location see Chapter 5 1 and you press the M button e when you reach the most recently saved result again and you press the S button 1 104 Using the meter as an electronic notebook Using the meter as an electronic notebook If the time and date were not set at the time of testing then the memory location number is displayed instead of the time and date If the memory contains both results that were saved together with the time and date and results that were not saved with this information then you will see results shown together with their time and date as well as results shown only with their memory location number If you turn on the meter off with the Test button it shows you the number of test strips remaining in the drum see Chapter 2
51. ing the drop of blood that forms again at the puncture site Wrong Drop of blood too large Blood glucose testing in a multi patient setting Residues of water or disinfectant on the skin can dilute the drop of blood and so produce false results Always turn the meter off by pressing the Test button so as to eject the test strip Do not pull the test strip out If you do pull the used test strip out blood can enter the meter and contaminate it Dispose of used lancets or disposable lancing devices according to local health and safety regulations The test strip cannot properly draw up blood that has spread over the skin Wrong Drop of blood that has spread If you collect blood from an earlobe be sure that the blood is on top and not hanging from the earlobe Hold the earlobe or posi tion the patient so the puncture site is on top Blood glucose testing in a multi patient setting 10 3 Disinfecting the meter The Accu Chek Compact Plus meter may be disinfected Disinfection is performed according to the degree of soiling see When to disinfect What to disinfect The following parts of the meter may become contaminated e the area around the test strip guide e the lower edge of the drum compartment cover e the measuring window e the casing In order to disinfect the lower edge of the drum compartment cover and measuring window you need to open the drum compartment cover First make su
52. ing the meter as an electronic notebook For each of these three periods you can ask the meter to display the lowest and the highest values 5 Lowest value Average Highest value mmoltL When one of the three averages is displayed gt Press and hold down the M button to view the lowest value gt Press and hold down the S button to view the highest value As long as you hold the M button or S button down the lowest blood glucose value and the highest blood glucose value respectively which you obtained within the period in question is displayed along with its time and date If for instance the 7 day average was shown then the lowest or highest value relates to the last 7 days Using the meter as an electronic notebook 109 When you release the button the display reverts to the average You can exit from the average value screen at any time gt To do this press the Test button The meter turns off mi 9 Notes 1aayiperiod Results flagged as performance s with the bottle symbol are Lowest value AO ee EOF atest ae not included in the calculations Results shown as being 1 1 or H are not included in the average 9 calculations but are displayed as the lowest and highest values respectively 14 day period estate O ka rH The meter calculates the average value the lowest value and the highest value for a period even when the saved results cover a shorter period Exampl
53. ings 11 a You have turned on at least one alarm or you are in the alarm clock setting alz Optical warning while the alarm sounds 4 F for 20 seconds say 13 x The test strip has drawn up enough blood or control solution and test is starting 174 Symbols error messages and troubleshooting Symbol Meaning 15 MEM You are in memory Either the saved result or one of the averages highest or lowest results is being displayed NS During averaging when the calculation is MN taking a while 17 n When an average is displayed from mem ory the symbol is followed by the number of tests n included in the calculation Symbols error messages and troubleshooting HA 12 1 2 Combinations of symbols The following combinations of symbols have meanings of their own Symbols 4 6 7 176 Symbols error messages and troubleshooting Meaning The 90 day use by period for the test strip drum has expired see Chapter 2 3 1 The test strips cannot be used Insert a new test strip drum You must not use these test strips as they may produce incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce serious adverse health effects See symbol combination 4 6 7 After the symbol combination 4 6 7 appeared you performed a performance check so the bottle symbol is no longer displayed gt gt Symbols gt gt 6 7 Meaning In memory The test strip you
54. ins Settings 43 3 3 2 Turning the meter on 3 3 Setting beep tone or Acoustic Mode You are here Brightness Year Time and date of the display gt gt format On Off Acoustic Low Medium High 24 hour 12 hour Mode Alarm clock Time Date 3 Hypo indicator gt gt function gt YP Hours Minutes Month Day Off 1 2 and 3 Off Level hour min This setting enables you to turn the beep tone on or off and to activate Acoustic Mode When the beep tone is turned on you hear a beep during testing e when the meter is ready to test so you can draw up blood or control The meter turns on without advancing a test strip solution with the test strip e when the test strip has drawn up sufficient blood or control solution and measurement has started e when the result is displayed e when the hypo indicator is turned on and the result is below the level you have set gt With the meter turned off press the S button Following the display check see Chapter 2 2 2 the current beep tone setting 3 is flashing e when the meter displays an error message 44 Settings Settings 45 There are two types of beep tone differing in pitch The pitch for a hypo indicator or an error message is higher than that heard in the other cases listed above When Acoustic Mode is turned on the meter guides you through the testing process using the beep tones mentioned above it also announces the r
55. l Ea Initial steps before testing If you have not performed a test since last replacing the drum the meter cannot tell how many test strips there are left in the drum This is e g the case when after you have changed the drum you start by changing settings or retrieve results from memory If you then press the Test button to turn the meter off only three horizontal bars are displayed instead of the number of test strips remaining Only when you have performed a test with the newly inserted drum does the meter display the number of test strips remaining each time you turn the meter off with the Test button Initial steps before testing 37 3 Settings You can change the settings of your meter to turn the beep tone or Acoustic Mode on or off to set the brightness of the display to select the time and date format the year the time and the date and to activate the alarm clock function and the hypo indicator Beep tone When the beep tone is set to on it provides user support during testing by marking the start of each step acoustically Acoustic Mode When Acoustic Mode is turned on the meter guides you through the testing process using beep tones it also outputs the result as a series of beeps Alarm clock function You can set the meter to remind you to test your blood glucose at pre defined times Hypo indicator You can set a personal hypo indicator level If your result is below this level the meter aler
56. lancing device or lancets from Roche Diagnostics See the next section for contact details 17 Local customer support and service 203 17 2 Addresses 204 Local customer support and service 18 Alphabetical index A Acoustic Mode 120 setting 45 Alarm clock function beep tone 59 setting alarms 59 symbol 60 174 turning off individual alarms 65 Alternative sites 70 201 AST cap 70 201 Asterisk symbol 96 174 At a glance lancing device 15 meter 12 symbols 167 average symbol 108 174 Averages 107 B Barcode 16 Batteries changing 145 disposal of 149 life 147 198 symbol 145 171 types 14 146 198 Alphabetical index 205 Batteries rechargeable 148 Battery compartment 14 Battery compartment cover 14 Beep tone alarm clock function 59 announcement of results using 123 126 during testing 45 123 in Acoustic Mode 121 pitch 46 121 setting 45 symbol 44 174 Bell symbol 60 174 Blanking plate 152 Blood drawing up with test strip 84 obtaining 80 too little drawn up 89 volume 17 196 Bottle symbol 35 134 173 176 Brightness display 48 c Causes of error downloading of results 118 performance check 137 test 99 18 Checking meter 129 Cleaning lancing device 144 meter 140 Clock symbol 33 176 Control solution 129 concentration table 130 135 disposal of 137 drawing up with test strip 133 use by date 138 Control window test strip drum 14 28 Customer support
57. layed and the meter beeps provided the beep tone is turned on The test strip has then drawn up enough control solution and testing starts The hourglass symbol x indicates that the meter is busy mea suring The meter automatically detects that the test strip has drawn up control solution The bottle symbol amp c appears additionally in the display when test starts Measurement is complete after approx 5 seconds The result is dis played and the meter beeps provided the beep tone is turned on The meter at the same time saves the result together with the bottle symbol The saved result is thus recognizable as being a performance result 134 Checking your meter Immediately after the result is displayed gt Compare the result with the concentration table printed on the peel off label attached to the drum container The result must be within the concentration range stated The concentration table has two rows and two columns Rows 1 and 2 contain concentration data for two different control solutions G1 and G2 the columns are for the two different units of measurement mmol L and mg dL Make sure you compare the result with the concentration data stated for the control solution you used and the unit of measurement your meter displays Accu Chek Compact Autocontrol mmol L mg dL Unit of Fo 1 7 3 4 31 61 measurement 7 1 9 6 127 172 The figures shown are for illustration only Control solution used
58. leaning the meter and lancing device Cleaning the meter and lancing device 8 2 Cleaning the lancing device Clean your lancing device regularly to keep it in good working condition If any blood gets on it always wipe this away immediately Clean the outside of the lancing device only Wipe it once a week with a cloth lightly moistened with 70 ethanol or 70 isopropanol available from your pharmacist In addition thoroughly wipe the inside of the cap using a cotton bud lightly moistened with one of the two cleaning fluids Notes W After cleaning allow the lancing device time to dry thoroughly Never dip the lancing device in cleaning liquid Doing so may damage the meter s internal parts so affecting its operation W Use only 70 ethanol or 70 isopropanol to clean the lancing device Other cleaning agents may attack the plastic and stop the lancing device from operating properly a Cleaning the meter and lancing device 9 Changing the batteries When the battery symbol first appears in the display the batteries are running low With the batteries you can perform about 50 more tests However we recommend that you replace the batteries as soon as pos sible By then the batteries will have been heavily drained and change able conditions e g cold surroundings can affect their performance even further gt If the meter is on press the Test button to turn it off gt Press lightly on the battery compartment cover
59. ll as for blood glucose determination by healthcare practitioners in a professional setting Healthcare professionals must observe additionally the directions in Chapter 10 Blood glucose testing in a multi patient setting Any object coming into contact with human blood is a potential source of infection see Clinical and Laboratory Standards Insti tute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI document M29 A3 2005 Za Intended use Accu Chek Softclix Plus Lancing Device Lancing device with adjustable depth setting for obtaining capillary blood from a fingertip or earlobe and when a special AST cap is used from alternative sites such as the ball of the thumb The lancing device is intended only for self monitoring by a single person It must not be used to sample blood from more than one person as this poses an infection risk Intended use Ls About this User s Manual Please read this User s Manual carefully and completely before testing blood glucose for the first time If you have any questions please con tact your local customer support and service centre see Chapter 17 This User s Manual will help you get to know your meter and lancing device step by step It will provide you with all the information you need to operate and care for your meter and lancing device and to deal with any errors that might occur Remember that in orde
60. lucose Notes While the display test is running you may press the Test button to LA turn the meter off again If you do a test strip is not advanced If additional lines appear during the display test or parts of sym bols are missing please contact your local customer support and service centre If the numeric display 88 5 mmol L meter or B88 mg dL Messgerat is affected the meter may not show your test results correctly Testing blood glucose 4 3 2 Obtaining blood The best place for obtainig capillary blood is from a fingertip or an ear lobe We recommend using the side of the fingertip as this causes the least amount of pain You can choose the penetration depth from a possible 11 settings rang ing from 0 5 to 5 5 Your chosen penetration depth is visible in the win dow e g The larger the number the greater the penetration depth The half settings e g 2 5 are identified by a dot The setting 2 5 is set when the dot is between 2 and 3 in the window For technical rea sons the setting 5 5 is not identified by a dot Setting 5 5 is set when you rotate the cap beyond setting 5 and the cap snaps into place 80 Testing blood glucose gt Rotate the Comfort Dial cap until you reach your chosen setting The cap snaps into place at each penetration depth setting We recommend a low setting e g 2 if you are using the lancing device for the first time To sample blood you first need
61. n on the setting for the first alarm time comes next The following screen is displayed 24 hour format 12 hour format If you have turned the alarm clock function off the setting for the hypo indicator comes next The following screen is displayed see Chapter 3 10 Settings 61 3 Setting alarm times The procedure for setting the alarm time is the same for each alarm Alarm 1 is used below for illustrative purposes The number t and sub sequently 2 and 3 in the display stand for Alarms 1 2 und 3 The factory setting is 0 00 24 hour format or 12 00 a m 12 hour for mat This time means that alarm 1 is turned off Only when you set a different alarm time is Alarm 1 turned on First the hour is set and then the minutes The hour flashes at top left of the display 24 hour format 12 hour format Settings 3 Press the M button repeatedly or press and hold it down until the a required hour is displayed gt Press the S button to save the chosen setting The minute setting comes next The minutes flash at top left of the display 24 hour format 12 hour format gt Press the M button repeatedly or press and hold it down until the required minutes are displayed gt Press the S button to save the chosen setting Settings The setting for Alarm 2 comes next and then for Alarm 3 Alarm 2 24 hour format Alarm 3 24 hour format 12 hour format To
62. nction If you turn the alarm clock function off entirely GFF the alarm times you have set remain saved nevertheless If the meter is already on when an alarm is due whether for a blood glucose test or some other reason the alarm is sup pressed The alarm sounds as soon as you turn the meter off or it turns off automatically The alarm does not sound until then ie 66 Settings 3 10 Setting the hypo indicator Beep tone or Brightness Time and date Acoustic Mode of the display d yea d format On Gif Acoustic Low Medium High 24 hour 12 hour Mode Time Date Alarm clock gt gt function gt Hours Minutes Month Day w min 3 You are here To help you to recognize a possible hypo you can set the meter to let you know when your test result indicates a low blood glucose You can select what blood glucose level you want this indicator to have As soon as a test result is below the level you have set you see the flashing hypo symbol displayed along with the result If the beep tone Gn is turned on you hear 5 short double beeps in addition to the beep you hear when the result is displayed The 5 short double beeps are not heard when the beep tone is set to off or Acoustic Mode Un is set to on Settings 67 You can choose between the following hypo indicator levels e 3 3 mmol L 60 mg dL e 3 9 mmol L 70 mg dL e 4 4 mmol L 80 mg dL The hypo indicator hypo symbol is factory set to
63. nd average values from MEMO fesse iesceiveseiccesicecgesssoviceecesesrseriensteessestesnccnesaceee 126 6 5 Announcement of symbols and error messages 128 Checking your mete ccccccscssecsssssessssssessssesessssessesssesees 129 7 1 What you need 7 2 Performing a performance CHECK cccccseceeeseeseeeers 131 7 3 Possible causes of error during performance of performanc CheCkS iats ecccst ct dee ieee et nena 137 Cleaning the meter and lancing device 0c00008 140 8 1 Cleaning the mete cccssscssssssssssssesssesssssesssrees 140 8 2 Cleaning the lancing device cceeeecesessssesesesseesseeees 144 Changing the batteries ccccccssesssssesssssessssessesseesees 145 Testing blood glucose in several patients Directions for healthcare professionals cccceeeeeeeeeeeeeees 150 10 1 Replacing the lancing device with a blanking plate 152 10 2 Testing blOOd QIUCOSE ccscceecesecseeeeseereeestereteneeertere 154 10 3 Disinfecting the meter cccsseeseseseseseceseeeeeenenenae 158 10 4 Suitable disinfectants ccccccceeeeeeeeeeeeeeeees 162 10 Contents 11 12 Measurement and storage conditions 0 00eee 163 11 1 Temperature range ccccceceeceseseeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeees 163 11 2 Light conditions ee TAS HUMAY e2s 2 stcacteven r S 11 4 L
64. nduct ing the performance check always check sure that the peel off label with the concentration table belongs to the test strip drum that is currently in the meter Note 130 Checking your meter 7 2 Performing a performance check gt Read the package insert that came with the control solutions Press the Test button to turn the meter on Following the display check see Chapter 2 2 2 a test strip is automati Cally advanced and the test strip symbol and the drop symbol flash in the display Checking your meter 1311 You now have about 5 minutes in which to draw up control solution with the test strip gt Take a bottle of control solution gt Open it and wipe the tip of the dropper with a clean dry paper towel in order to remove any dried on residues gt Invert the vial and hold it downwards at an angle Squeeze it gently until a small drop is suspended from the tip Hold the meter so the test strip pointing downwards see illustra at tion ay a gt Apply the drop to the surface of a clean easily washable object made of glass porcelain or stainless steel e g a plate or spoon gt Hold the tip of the test strip to the drop of control solution 132 Checking your meter Checking your meter The test strip draws up the control solution through the black notch gt Move the test strip away from the control solution as soon as the hourglass symbol x is disp
65. ng device with a special transparent AST cap which is included in the pack or is available through your local customer support and service centre Read additionally the instructions that come with the AST cap before you sample blood from alternative sites 70 Testing blood glucose You can choose one of 11 different penetration depth settings to suit your own skin type You can use the lancing device either docked with the meter or undocked The lancing device has a plunger at the top see illustration in Chapter 1 2 This plunger has three functions e priming the lancing device e triggering the lancet to sample blood e ejecting the used lancet You can perform all of these functions using just one hand To activate a function just press the plunger down To sample blood you first need to insert a lancet and then set the pene tration depth Testing blood glucose Notes 4 2 1 Undocking the lancing device from the meter The Accu Chek Softclix Plus lancing device is intended only for If you wish to use the lancing device undocked from the meter detach it 4 patient self monitoring by a single person The lancing device as follows must not be used on more than one patient due to the risk of infection Healthcare professionals testing blood glucose in a multi patient setting must not use the Accu Chek Softclix Plus lancing device to sample blood and should therefore remove the lancing device from the meter The lanci
66. ng device may be replaced with a blank ing plate see Chapter 10 1 Only use Accu Chek Softclix lancets in your Accu Chek Softclix Plus lancing device Using any other lancets may damage the lancing device or impair its function This may result in injury gt Push the slide button in the direction indicated by the arrow 1 and hold it there gt Withdraw the lancing device in the direction indicated by the arrow 2 72 Testing blood glucose Testing blood glucose 4 2 2 Docking the lancing device onto the meter 4 2 3 Inserting the lancet gt Hold the meter so it is horizontal with the recess for docking the b gt Remove the cap from the lancing device lancing device pointing upwards gt Place the flat face of the lancing device on the lower end of the recess with the plunger facing towards the slide button gt Slide the lancing device forward along the meter in the direction indicated by the arrow until it locks with an audible CLICK The guides along the inside of the recess must engage with the grooves along the lancing device Slide a new lancet into the lancet holder and push it in until you hear it CLICK into place 74 Testing blood glucose Testing blood glucose gt Remove the protective cap from the lancet with a twisting motion Press the cap back on the lancing device The locating notch in the cap 1 must be directly aligned with the locating line on the lancing device 2
67. o turn the meter off and allow the test strip to drop out If the test strip does not drop out remove it manually even if you feel some resis tance The test strip drew up too little blood 12 or control solution Turn the meter off and then on again by pressing the Test button Repeat the test with a new test strip and a larger amount of blood or control solu tion gt gt Symbols error messages and troubleshooting 187 Error message gt gt 188 Meaning e You drew up blood or control solution too soon with the test strip i e before the test strip symbol and drop symbol were flashing in the display Turn the meter off and then on again by pressing the Test button Repeat the test with a new test strip Only draw up blood or control solution with the test strip when the test strip sym bol and drop symbol are flashing in the display You bent or moved the test strip during the test either while you were drawing up blood or control solution with it or during the test Turn the meter off and then on again by pressing the Test button Repeat the test with a new test strip gt gt Symbols error messages and troubleshooting Error message gt gt Meaning The test strip that was advanced is defective Hold the meter upright so the test strip is pointing downwards Press the Test button to turn the meter off and allow the test strip to drop out Press the Test button to turn the meter on
68. ocal sources of interference eceeeeeeeeeeeeeeeeees 166 Symbols error messages and troubleshooting 12 1 Symbols shown in the display eecceeseeeeeeeeeeeees 12121 Single SyMbOSiwanncacnianansnndaamianaas 12 1 2 Combinations of symbols c c 12 1 3 Symbols appearing in the numeric field 12 2 Problems and error messages causes and troubleshooting recommendations ccccccececeeeeeeeee 181 13 Technical Gata cn nieces eden einem 196 14 Disposing of the meter cccccececeseteeeteeeeeeseeeeeeteeeeeeees 200 15 System components cccccccccceeceeeteteteeeteeeeeeeeeeeeeeeeetees 201 NG Patents vecesi ki eel a i Sa 202 17 Local customer support and service cceeee 203 17 1 Advice and troubleshooting eceececeeceeeeeeseeeeeeeees 203 V2 AGGrOSSOS sionais eaea a aaa ASAA 204 18 Alphabetical index ccccccccccceceseseteteeeeeeeeeeeeeeeeeeeeeeees 205 Contents 11 1 Introduction The meter is supplied with batteries already inserted The time and date are already set You may need to adjust these settings to your own time zone see Chapter 3 1 1 The Accu Chek Compact Plus blood glucose meter at a glance Front 000 Tip of the test strip where blood is drawn up 12 Introduction Display window S button Press this button to
69. off GFF flashes in the display Settings gt Press the M button to move to the next option gt When your chosen level is displayed press the Test button to turn the meter off The hypo indicator is then set to this level Notes The hypo indicator is only reliable if your hypo indicator level has been properly selected Therefore we strongly recommend that you talk to your healthcare professional about what blood glucose level is your hypo level before you set the indicator This function is no substitute for hypoglycaemia training by your doctor or dia betes team The hypo indicator level may vary from person to person There fore we recommend leaving the hypo indicator function turned off when using the meter in a professional setting Settings 69 4 Testing blood glucose 4 1 Preparing to test blood glucose You will need the following items to carry out the test e the meter with a test strip drum inserted e the lancing device to sample blood e a lancet for the lancing device gt Wash your hands with warm water and soap and dry well This helps ensure proper hygiene and stimulates blood flow 4 2 Preparing the lancing device You use the lancing device to sample blood from a fingertip or earlobe or from other alternative sites If you wish to sample blood from alter native sites such as the base of the thumb forearm upper arm calf or thigh you must replace the normal black cap on the lanci
70. ong therapeutic decision to be taken and so produce serious adverse health effects AN Keep the lancing device without a lancet inserted Never expose the lancing device to high temperatures e g in a hot car High temperatures can cause parts of the lancing device to become warped so impairing its operation 11 2 Light conditions All displayed numbers and symbols appear yellow Bright light shining on the display may make them difficult to read Shield the meter if nec 11 essary using your body for instance _ W Keep the meter away from very strong light sources e g direct sunlight studio lighting spot lights etc These may interfere with the proper functioning of the meter and cause error mes sages to be displayed Measurement and storage conditions Heal 11 3 Humidity Only test blood glucose at a relative humidity of between 20 and 85 Keep the meter and lancing device at a relative humidity of between 20 and 85 Sudden changes in temperature cause condensation to form in or on the meter If this happens do not turn the meter on Make sure that it returns to ambient temperature slowly Never keep it in a room that is likely to harbour condensation e g a bathroom 11 4 Local sources of interference Strong electromagnetic fields may interfere with the proper oper ation of the meter Do not use the meter in close to sources of strong electromagnetic radiation To avoid electrostatic discha
71. ou are here Beep tone or gt Brightness Acoustic Mode of the display On Off Acoustic Mode Year Low Medium High 24 hour 12 hour Alarm clock function Time gt Date gt gt Hypo indicator Off 1 2 and 3 Hours Minutes Month Day hour min Off Level You can choose between two formats In 24 hour format the time is dis played from 0 00 to 23 59 If you select this format the date is dis played in the format DD MM day month no year In 12 hour format the time is displayed from 12 00 to 11 59 with a m or p m If you choose this format the date format changes to MM DD month day no year The time and date format is shown together with the current time and the current date setting If the format is changed the way the time and date are displayed also changes Ea Settings The time and date format that is currently set flashes in the display The factory setting is 24 hour format 24h FE Ihm 1 Tad i L E a 0 gt Press the M button to select 12 hour format 2h is displayed If you press the M button again 24h reappears and 24 hour format is set gt Press the S button to save the chosen setting The time setting comes next Settings 53 3 7 Setting the time Beep tone or Brightness Time and date Acoustic Mode of the display fa year il format On Off Acoustic Low Medium High 24 hour 12 hour Mode Alarm clock function Month Day emi
72. ounced by two short beeps sounded four times in succession This sequence is sounded only once and is not repeated The same sequence of beeps is sounded for all error messages In other words they are not differentiated acousti cally 128 Acoustic Mode 7 Checking your meter To ensure your results are always dependable you should periodically check the performance of your meter Do this by running a performance check using the Accu Chek Compact Autocontrol solutions each time e after you have opened a new pack of test strip drums e after you have replaced the batteries e after your meter has displayed the bottle symbol requesting you to perform a performance check e after you have cleaned the measuring window of the meter e if your result does not agree with how you feel Please ask your local customer support and service representative where you can obtain the control solutions Checking your meter 129 7 1 What you need To perform a performance check you need the following items e meter with a test strip drum inserted e Accu Chek Compact control solution Autocontrol G1 low glucose concentration or Autocontrol G2 high glucose concentration e Concentration table for the control solutions see label on the con tainer the test strip drum came in Sa The concentration table for the control solutions can be found on the peel off label attached to the drum container When co
73. ow areas you have wiped time to dry thoroughly strip guide Any residues of blood remaining on the measuring window or in the test strip guide may get onto the test strip and The meter test strip guide and measuring window must be thoroughly contaminate it cleaned and disinfected at least once a day after use Carefully check all recesses grooves and gaps as well as the blanking plate W Make sure that no liquid enters the meter Avoid scratching the measuring window as scratches could impair its measuring function W Do not spray anything onto the meter and do not immerse it in liquid Doing so may damage the meter s internal components and stop it from working properly 160 Blood glucose testing in a multi patient setting Blood glucose testing in a multi patient setting 10 4 Suitable disinfectants Use only disinfectants of proven effectiveness quoted in official guide lines e g Clinical and Laboratory Standards Institute Protection of Lab oratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLS document M29 A3 2005 Use alcohol based surface disinfectants with virucidal activity Suitable agents are those for instance based on alcohols aldehyde cleavers and quaternary compounds Use them according to manufacturer s instruc tions List of disinfection methods that have been tested in accordance with the Richtlinien f r die Pr fung chemischer Desinfektionsmittel
74. ow lancing device pointing upwards 2 gt Slide the blanking plate over the recess from the left along the meter in the direction indicated by the arrow The guides along the inside of the recess must engage with the grooves along the blanking plate The blanking plate is properly attached when it locks into place with an audible CLICK HA Blood glucose testing in a multi patient setting Blood glucose testing in a multi patient setting 153 10 2 Testing blood glucose gt Wear protective gloves gt Wash or disinfect the patient s finger and allow it to dry thoroughly The drop of blood does not spread so easily over dry skin gt Use only a lancing device that is approved for use by healthcare professionals gt Use a lancing device with adjustable penetration depth settings gt Select a penetration depth to suit the nature of the patient s skin Start with a shallow depth setting gt Select a puncture site along the side of a fingertip gt Turn the finger so the chosen puncture site is facing upwards and keep it facing upwards The drop of blood cannot then spread so easily gt Lance the side of the fingertip gt Using gentle pressure massage the finger towards the fingertip to encourage a drop of blood to form A proper but nevertheless small drop of blood approx 1 5 pL must form 154 Blood glucose testing in a multi patient setting Correct Drop of blood approx 1 5 pL gt Hold th
75. perature or the tem perature within the meter is too low below 6 C or too high above 44 C for a test Press the Test button to turn the meter off Move to a place where the temperature is between 10 C and 40 C and wait for the temperature of the meter to adjust to this temperature e The test strip drew up too little blood or control solution Turn the meter off and then on again by pressing the Test button Repeat the test with a new test strip Only draw up blood or control solution with the test strip when the test strip sym bol and drop symbol are flashing in the display Symbols error messages and troubleshooting 193 Error message Meaning Error message Meaning e There is no test strip drum in the In memory the result in memory cannot meter be displayed All other results in memory can continue to be retrieved with the M or S button Press the Test button to turn the meter off Insert a new test strip drum see Chapter 2 3 e The bar code on the test strip drum is damaged A meter error has occurred Turn the meter off and then on again by pressing the Test button If the error mes sage persists please contact your local customer support and service centre You can no longer perform tests with test strips from this drum Insert a new drum e You inserted a test strip drum from a different blood glucose measuring system Press the Test button to turn the meter off Inse
76. po indicator function In order to look out for unusually low results you can set a hypo indica tor level hypo threshold If a result is below the level you have set a symbol in the display and an acoustic signal provided it is set to on prompt you to check your result carefully to see if you are heading towards a possible hypo low blood glucose Downloading data to a computer The meter has an infrared window enabling you to download results to a computer running the appropriate software or to special analysis sys tems Introduction 17 l Acoustic Mode Acoustic Mode is intended for persons who are visually impaired When Acoustic Mode is turned on the meter guides the user through the test ing process using beep tones it also outputs the result as a series of beeps For more information see Chapter 6 Visually impaired persons need a sighted person to instruct them in the use of the meter and to assist them with all aspects of its operation Visually impaired persons must not test their blood glucose without assistance from a sighted person 18 Introduction 1 4 Display illustrations Throughout this User s Manual you will see examples of what the dis play looks like Any elements that are shown surrounded by a halo in these examples flash in the display Example You have turned on the meter to perform a blood glucose test In the display you see the time and date plus the test strip symbol and the drop
77. r messages or results you doubt are correct If it has again please call your local cus tomer support and service centre Note If a performance check produces results that are outside the stated concentration range it is no longer certain that the meter and test strips are functioning properly Blood glucose tests may then deliver incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce serious adverse health effects Checking your meter 139 8 Cleaning the meter and lancing device 8 1 Cleaning the meter Your meter uses an optical measuring method that relies heavily on all of its components being clean Owing to the way the test strip works the meter does not normally come into direct contact with blood Regu lar cleaning is therefore largely unnecessary In the event of the meter becoming soiled through improper use cleaning it may become neces sary Wipe away any soiling from the case or display with a cloth lightly moistened with cold water or 70 ethanol Clean the test strip guide and measuring window thoroughly if e the test strip guide has become visibly soiled e error message E 5 is displayed see Chapter 12 2 and the soiled measuring window is the cause 140 Cleaning the meter and lancing device Do this as follows gt If the meter is on press the Test button to turn it off gt Wait for the motor to stop Wipe the test strip guide with a
78. r to keep your meter and lancing device in good working condition you need to follow the correct operating procedures and also observe certain other instruc tions The meter and lancing device are precision instruments and improper handling can impair their operation This User s Manual features three symbols to draw your attention to important information Please read these points with special care This symbol indicates a possible risk of injury or of damage to your own health or to the health of others W This symbol draws attention to actions that could result in dam age to meter or to the lancing device This symbol draws your attention to other important information 6 About this User s Manual Other symbols are used too They have the following meaning gt This symbol is a prompt for you to do something such as turn the meter on e This symbol signifies a list m This symbol signifies a list within a list We recommend that you start by getting to know all of the features of your meter and lancing device see Chapter 1 1 and 1 2 Try out all of the steps described in this manual and also practise using the meter and lancing device About this User s Manual EA Contents T WNOUUGHON scp ccccc ceccees ee tisrenetsitetieseatiaaaiee 12 1 1 The Accu Chek Compact Plus blood glucose meter at ANG PAPEETE TEE A EAA AAEN EA 12 1 2 The Accu Chek Softclix Plus lancing device at a glance 15 1 3 Main foatUr
79. re the meter is turned off 158 Blood glucose testing in a multi patient setting gt Place your thumb into his recess below the drum compartment cover and fold the drum compartment cover upwards Once you have opened the drum compartment cover you will see beneath it the small measuring window and have access to the lower edge of the drum compartment cover Blood glucose testing in a multi patient setting Cotton buds wipes and cloths lightly moistened with disinfectant are all When to disinfect suitable for disinfecting the meter e Each time after you have tested a patient s blood glucose gt Allow areas you have wiped time to dry thoroughly gt wipe the area around the test strip guide If you find blood on the cloth wipe also the test strip guide itself and Fold the drum compartment cover down and press until it closes It the measuring window locks with an audible CLICK gt Ensure that the drum compartment cover is properly closed gt Remove any fluff or lint that may remain e f there is blood on the meter wipe the meter e f blood has entered the meter Notes wipe the area around the test strip guide the lower edge of the The test strip guide and measuring window must always be kept drum compartment cover and the measuring window 10 clean When you turn the meter on to perform a test the test strip aa is advanced over the measuring window and out through the test gt All
80. rge do not use the meter in a very dry environment especially one in which synthetic materials are present 166 Measurement and storage conditions 12 Symbols error messages and troubleshooting In addition to test results the time and the date your meter also dis plays other symbols and error messages Some of these routine display messages have already been explained in earlier chapters Following is a complete summary of all symbols and messages what they mean and what actions you should take when they appear When you use your meter please watch out for any symbols and error messages that are displayed They provide you with important informa tion If you do not recognize a symbol or do not understand an error message please refer immediately to this chapter for an explanation Otherwise you run the risk of wrongly interpreting your results On some of the pages that follow you will see a double arrow gt gt It sig nifies the following e when it appears on the right at the bottom of the page the description continues on the next page e when it appears on the left at the top of the page this is the con 12 tinuation of the description from the last page ae ae Symbols error messages and troubleshooting 167 12 1 Symbols shown in the display 17 gt fi Am Hi u i at par fa a 18 15 le wud i lt 5 iA Symbols error messages and troubleshooting Symbols may be displayed singly or se
81. rt an Accu Chek Compact test strip drum see Chapter 2 3 194 Symbols error messages and troubleshooting Symbols error messages and troubleshooting KA 13 Technical data Meter type Accu Chek Compact Plus Model GT Catalogue No Serial No See type plate on the back of the meter Test principle Determination of glucose in fresh capillary blood by reflectance photometry When using different specimen material please refer to the package insert that came with the Accu Chek Compact test strips Blood glucose concentrations may be mea sured in whole blood or in plasma Although you always draw up whole blood with 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 please read the package insert that came with your test strips There you will also find information on how the system works on the test principle and on reference methods Measuring range 0 6 33 3 mmol L 10 600 mg dL Sample size approx 1 5 uL 1 uL microlitre 1 thousandth of a millilitre 196 Technical data Measuring time System operating temperature Storage temperature Meter Lancing device Humidity during testing during storage Altitude Memory Dimensions without lancing device with lancing device Technical data approx 5 seconds depending on concentra tion 10 C to 40
82. s according to EN 61326 Its electromagnetic emission is thus low Interference from other electrically pow ered equipment is not to be anticipated The performance data for the Accu Chek Compact Plus system Accu Chek Compact Plus meter together with Accu Chek Compact test strips were determined using capillary blood from diabetic patients method compar ison accuracy venous blood repeatability and control solutions reproducibility The system is calibrated with venous blood con taining various levels of glucose The refer ence values are obtained using the hexoki nase method The method comparison was conducted by comparing the results from the system with those of the hexokinase method with deproteination using an automatic ana lyzer The hexokinase method is traceable to an NIST standard traceability The Accu Chek Compact Plus system complies with the requirements of 14 Disposing of the meter During blood glucose testing the meter may come into contact with blood Used meters therefore carry a risk of infection Please dispose of your used meter after removing the batteries according to local regu lations For information about correct disposal please contact your local council or authority The meter is not subject to EC Directive 2002 96 EC on waste electrical and electronic equipment 200 Disposing of the meter 15 System components Use only Accu Chek Compact test strips for testing with the Acc
83. tant organism must be assigned his her own meter This applies also if a patient is suspected of being one of the above and for as long as the suspicion exists the meter must not be used to test any other patient The Accu Chek Softclix Plus lancing device is intended only for patient self monitoring by a single person It must not be used to collect blood in a multi patient setting as it does not incorporate any features to guard against cross infec tion Healthcare professionals testing blood glucose in a multi patient 10 setting must not use the Accu Chek Softclix Plus lancing device to sample blood and should therefore remove the lancing device from the meter The lancing device may be replaced with a blank ing plate see Chapter 10 1 The hypo indicator level may vary from person to person There fore we recommend leaving the hypo indicator function turned off when using the meter in a professional setting Blood glucose testing in a multi patient setting 10 1 Replacing the lancing device with a blanking plate Instead of the lancing device you can use a blanking plate which is available from your local customer support and service centre Undock the lancing device from the meter as follows gt Push the slide button in the direction indicated by the arrow 1 and hold it there P Hold the meter so it is horizontal with the recess for docking the gt Slide the lancing device out in the direction indicated by the arr
84. te see Chapter 5 4 can not be statistically analyzed or if they can then only to a limited extent If the year date and time settings are lost as a result of a battery replacement the meter displays the following settings e Year year of manufacture 20XX e g 2007 e Time 0 00 or 12 00 a m depending on the time and date format you selected previously e Date 1 01 as day month D MM or month day M DD depending on the time and date format you selected previ ously In the sections set out below you will find e a description of the general rules for changing settings e descriptions of individual settings and how to change them 40 Settings 3 The descriptions of settings proceed in the order in which they appear in the meter Beep tone or Brightness Acoustic Mode of the display Time and date gt Year gt fanaa a gt Alarmclock a Time Date aera Hypo indicator 3 1 Changing settings General rules The appearance of SEt in the display window indicates that the meter is in settings mode and that you can change these Settings The procedure for changing the settings is as follows e The settings have a fixed sequence and are displayed consecutively see illustration on the previous page e Press the S button to call up the settings screen A test strip is not advanced e Press the M button to change the setting that is currently flashing m Numerals such as the year are increm
85. ter will not turn on it means e The batteries normal or rechargeable are empty or none are inserted Insert batteries new or recharged e You inserted the batteries the wrong way round Remove the batteries and re insert them as shown in the battery com partment If the batteries were in the meter the wrong way round for longer than two minutes the year time and date are now lost Re enter them see Chapter 3 gt gt Symbols error messages and troubleshooting 181 If this happens gt gt HA Symbols error messages and troubleshooting it means e The drum compartment cover is not properly closed Close the drum compartment cover It must close with an audible CLICK The ambient temperature is low and the batteries are almost empty Move to a place where the tempera ture is between 10 C and 40 C and wait for the temperature of the meter to adjust to this temperature Insert batteries new or recharged Condensation has affected the elec tronics Allow the meter to dry slowly The meter is defective Please contact your local customer support and service centre If this happens it means The meter is turned on The display is defective but the display is blank Please contact your local customer support and service centre The clock has stopped or The meter was exposed to a temperature the clock is slow below 10 C and the batteries are begin ning to
86. the two infrared windows towards one another If necessary start downloading at the receiving end software prod uct or hardware During the download both arrows flashed alternately During the down load only those results that are new to the receiving end i e those have not yet been downloaded are sent lt gt Once downloading has finished the arrows stop flashing and the meter is automatically turned off by the receiving end If the meter is not turned off press the Test button to turn it off Using the meter as an electronic notebook 117 Notes Your results can only be fully analysed if all of the results have been saved together with the date and time i e as long as you have set the date and time The results remain in the meter s memory following download ing You cannot perform a test while results are being downloaded If data transfer does not occur the arrows do not start to flash or was incomplete the meter turns itself off automatically after approximately 5 minutes This is what might have happened See e A download error occurred Start the download again e The infrared windows are too far apart or not properly facing one another Reduce the distance between the two infrared ports to 5 20 cm and position them so they are pointing towards one another Start the download again 118 Using the meter as an electronic notebook e Another device with an infrared source
87. then remains in the meter The next time you turn the meter on it ejects this test strip and automatically turns off again You can dispose of used test strips with your regular household waste Testing blood glucose 4 5 Ejecting the used lancet If the lancet does not drop out gt Keep the plunger pressed down gt Remove the cap from the lancing device Hold the lancing device upright above a waste bin gt Hook the edge of the white collar of the cap behind the platform of the lancet A cut out area on the inside of the lancet holder makes it easy to hook the lancet platform see illustration gt Press in the plunger until it CLICKS gt Use the white collar to pull the lancet out The lancet drops out Press the cap back on the lancing device 92 Testing blood glucose Testing blood glucose Notes Make sure the lancet has dropped out Inadvertently leaving the lancet in the lancing device may result in personal injury Carefully dispose of used lancets so that the needles cannot cause injury You must remove the cap to eject the lancet If you leave the cap in place pressing the plunger will prime the lancing device 94 Testing blood glucose 4 6 Symbols you see before during or after testing and what they mean You may see the following symbols displayed before during or after a test For further information please see Chapter 12 1 The beep tone Un or Aco
88. through European Patents 0565970 0782838 and Japanese Patent 2702374 Your purchase entitles you to use your Accu Chek Soft clix Plus lancing device in combination with Accu Chek Softclix and Accu Chek Softclix XL lancets As required by statute Roche will refrain from pursuing its patent rights against private persons using the Accu Chek Softclix Plus lancing device in combination with lancets from other manufacturers for non commercial purposes Acquisition of the Accu Chek Softclix Plus lancing device is not associated other than through the aforementioned statutory limitation on the effect of the pat ent with any entitlement and in particular with any tacit permission for the acquirer to use third party lancets Roche reserves the right to assert its patent rights against any manufacturer offering lancets for the Accu Chek Softclix Plus lancing device 202 Patents 17 Local customer support and service 17 1 Advice and troubleshooting If you need advice on how to operate the Accu Chek Compact Plus meter or the Accu Chek Softclix Plus lancing device if you seem to be obtaining implausible results or if you suspect that the meter test strips lancing device or lancets might be defective please contact your local customer support and service centre Do not attempt to repair or modify the meter or lancing device yourself When you call our staff will help you solve any problems you might be experiencing with the meter test strips
89. time you perform a test until you insert a new test strip drum The bar code on the test strip drum is damaged You can no longer perform tests with test strips from this drum Insert a new drum The test strip drum does not rotate Press the Test button to turn the meter 12 off Open the drum compartment EE cover and press the red drum release button Close the drum compartment cover again gt gt Symbols error messages and troubleshooting 185 Error message gt gt 186 Symbols error messages and troubleshooting Meaning The meter rotates the drum and reads the bar code When you next turn on the meter to perform a test the drum symbol and flashing bottle symbol are displayed Perform a performance check You may use all the test strips remaining in the drum The 90 day use by period will no longer be calcu lated for this drum The drum symbol will therefore be displayed each time you perform a test until you insert a new test strip drum e The bar code on the test strip drum is damaged You can no longer perform tests with test strips from this drum Insert a new drum Error message Meaning The measuring window is dirty Press the Test button to turn the meter off Clean the measuring window see Chapter 8 1 and repeat the test with a new test strip At test strip is stuck in the meter Hold the meter upright so the test strip is pointing downwards Press the Test button t
90. to prime the lancing device gt Press the plunger all the way down The plunger returns about a third of the way The lancing device is now primed Testing blood glucose Notes Use a new lancet each time you take blood This not only reduces the risk of infection but also helps ensure virtually pain free blood sampling W Do not prime the lancing device until you are ready to collect a blood sample Keeping the lancing device in this primed state can cause parts to become misshapen through tension impairing its operation The amount of blood that emerges at the puncture site depends on the penetration setting and the pressure used to hold the lancing device against the skin If the amount of blood you obtain is too small try again applying more pressure this time If you still obtain insufficient blood repeat the procedure with progres sively deeper settings If too much blood emerges reduce the penetration depth gt Gently but firmly press the front end of the lancing device against the chosen puncture site You will feel the slightly raised ring against your skin This is the pin hole through which the tip of the lancet emerges Press the plunger all the way down This triggers the lancet which penetrates the skin gt Using gentle pressure massage the finger towards the fingertip to encourage a drop of blood to form Ea Testing blood glucose Testing blood glucose 4 3 3 Drawing up blood with
91. tored at between 10 C and 50 C W At temperatures above 50 C the batteries could leak and damage the meter At temperatures below 10 C the batteries do not have enough power to keep the internal clock functioning e With the batteries and with the test strip drum the meter may be stored at between 2 C and 30 C e For blood glucose tests and performance checks the permitted range is from 10 C to 40 C Measurement and storage conditions 163 e Blood glucose tests may be performed at the limit of the permitted range between 6 C and 10 C or between 40 C and 44 C When the temperature is at the limit of the permitted range the thermometer symbol flashes in the display Do not use results obtained at the limits of the permitted temperature range as a basis for making therapeutic deci sions The results may be incorrect Incorrect results can cause the wrong therapeutic decision to be taken and so pro duce serious adverse health effects e Tests cannot be performed at temperatures below 6 C and above 44 C In this event the following message is displayed e Keep the lancing device at temperatures between 25 C and 70 C 164 Measurement and storage conditions Never try to speed up warming or cooling of your meter e g by placing it on a radiator or in a refrigerator Doing so can damage the meter and cause it to give incorrect results Incorrect results can cause the wr
92. ts you to the fact that you are possibly heading towards a hypo The meter is supplied with batteries already inserted The time and date are already set You may need to adjust these settings to your own time zone You can perform blood glucose tests without adjusting any of the set tings All settings are the default factory settings see next page EJ Settings 3 When you turn the meter on for the first time it has the following pre a settings These are factory defaults that you can change e Beep tone on Acoustic Mode off e Brightness of the display medium e Year current year e g 2007 e Time and date format 24 hour format 24 hour format is associated with the date format day month DD MM e Time current time based on Central European Time e Date current date based on Central European Time e Alarm clock function off e Hypo indicator off Notes If the year time and date settings were lost as a result of a bat tery replacement see Chapter 9 and you fail to reset these the meter displays the time as 0 00 and the date as 0 00 in 24 hour format as well as in 12 hour format when you perform a test In memory the results are saved not with the time and date but with their memory location see Chapter 5 2 Without the time and date the meter is not able to calculate averages nor the low est and the highest values see Chapter 5 3 Results sent to a Settings El PC for instance without the time and da
93. u Chek Compact Plus meter These are available from your pharmacist Use only Accu Chek Compact Autocontrol solutions to perform perfor mance checks on your Accu Chek Compact Plus meter Only use Accu Chek Softclix lancets in your Accu Chek Softclix Plus lancing device The lancets are available in various pack sizes If you wish to sample blood from alternative sites such as the base of the thumb forearm upper arm calf or thigh you need a special trans parent AST cap to sample using the Accu Chek Softclix Plus lancing device It is available through your local customer support and service centre For healthcare professionals we recommend the Accu Chek Softclix Pro lancing device with special Accu Chek Softclix Pro lancets or the Accu Chek Safe T Pro Plus or Accu Chek Safe T Pro Uno disposable lancing devices System components 201 16 Patents Accu Chek Compact Plus Meter EP 732 590 EP 738 666 EP 742 436 EP 1 189 064 US 5 463 467 US 5 720 924 US 5 863 800 US 6 707 554 US 6 475 436 WO 2004 003549 Accu Chek Softclix Plus Lancing Device US 4 924 879 US 2004 0092996 US 2005 00908580 US Re 35 803 Patent information Roche has been granted patent protection in the USA for the Accu Chek Softclix Plus lancing device and its use in combination with Accu Chek Softclix and Accu Chek Softclix XL lancets US Patents 4 924 879 and Re 35 803 Similar patent protection also exists in other countries especially
94. ults will be displayed and saved without the time and date In that case Changing the batteries 147 the test results saved in memory will be numbered consecutively Never throw batteries into a fire This is dangerous because they so you can still recognize the order in which they were saved may explode see Chapter 5 2 If the year time and date have been lost the meter rotates the drum in order to re read the bar code Remove the batteries if you will not be using your meter for any length of time When you insert the batteries again remember to set the year time and date You can also use rechargeable NiMH batteries If you do please i Think of the environment Dispose of used batteries sensibly note the following e The number of tests you can perform with recharged batteries is considerably less than with ordinary batteries e To be ready to test at any time you need to keep two rechargeable batteries in reserve which you can charge while the first pair are in the meter e Recharged batteries lose their charge during storage e When the battery symbol first appears you can perform significantly fewer than 50 further tests With old and exhausted rechargeable batteries you may not be able to perform even one more test e The performance and useful life of rechargeable batteries depends to a large extent on the quality of the battery charger you are using e Owing to the higher power consumption we advis
95. unced as 1 3 8 Acoustic Mode 123 Each digit is represented by the corresponding number of beeps e g 4 beeps for the number 4 Zero is represented by a long beep The result is announced three times in succession Each result is pre ceded by two short beeps Altogether therefore you hear result result result mmol L meters First the tens are announced then the units then the decimal point and finally the tenths There is a short pause between each group of beeps The tens are always announced even when the result is below 10 The tens in this case are represented by 1 long beep signifying zero The decimal point is represented by 1 very short beep Examples e The result 13 8 mmol L is announced as follows 1 beep pause 3 beeps pause 1 very short beep pause 8 beeps ecn t esnan e The result 4 0 mmol L is announced as follows 1 long beep for 0 tens pause 4 beeps pause 1 very short beep pause 1 long beep 124 Acoustic Mode mg dL meters First the hundreds are announced then the tens and finally the units There is a short pause between each group of beeps The hundreds are always announced even when the result is below 100 The hundreds in this case are represented by 1 long beep signifying zero Examples e The result 180 mg dL is announced as follows 1 beep pause 8 beeps p
96. use you to misinterpret the test results 20 Initial steps before testing 2 2 1 Type plate The type plate on the back of your meter indicates which unit your meter uses 2 2 2 Display check You can check the unit your meter uses by performing a display check Press and hold down the M button The meter turns on While you hold down the M button you first see the display check screen mmol L meter or mg dL meter The unit is shown in the bottom right corner of the display Initial steps before testing If you continue to hold down the M button you then see the following Notes screen after approximately 2 seconds f If additional lines appear during the display test or parts of the numeric display or of a symbol are missing please contact your local customer support and service centre If the numeric display 88 8 mmol L meter or BBB mg dL meter is affected the meter may not show your test results correctly mg dL meter or The meter automatically turns off after 60 seconds even if you keep the M button pressed You can perform a display check whenever you wish If there are results already saved in memory the most recently saved result is displayed when you release the M button When you release the M button your meter is in memory mode As long as no results have yet been saved three bars are displayed iS Press the Test button to turn the meter off Initial steps
97. used for this test was unusable the 90 day use by period had expired see Chapter 2 3 1 The result in memory may be incorrect Incorrect results can cause the wrong therapeutic deci sion to be taken and so produce serious adverse health effects The meter is unable to calculate the use by period for the test strip drum and is asking you to perform a performance check e because you have just changed the batteries the year time and date set tings have been lost see Chapter 9 12 and at the same time a partly used drum remains in the meter gt gt Symbols error messages and troubleshooting 177 Symbols Meaning 12 1 3 Symbols appearing in the numeric field gt gt e because you have just inserted a A screen showing 88 8 mmol L meter or 858 mg dL Messgerat partly used test strip drum may also include the following symbols e because you have just opened the drum compartment cover Symbol Meaning Perform a performance check see Chap i In memory ter 7 If the test produces a correct result e No results present in memory you may continue to use the test strips If the result is incorrect you need to insert a new drum Following the performance m you have not set the time and date check the bottle symbol disappears from the display The drum symbol continues to be displayed in order to draw your atten e Averaging is not possible because memory only contains results with
98. ustic Mode Une is set to on M You have turned on at least one alarm While the result is displayed You have turned the hypo indicator on The result is below the indicator level you set If the beep tone Gn t is turned on you hear 5 beeps in addition to the beep you hear when the result is displayed fe hypo 2 The batteries are running low wa ZAS The use by period for the test strip drum has expired s You inserted a partly used test strip drum Cd The temperature is outside the permitted range of 10 C to 40 C The meter is asking you to perform a performance check Sues We Sb h m 8 PNS Aw S The test strip has drawn up control solution and the meter has flagged the result as a performance check Testing blood glucose Lo Instead of a result If you press the S button again the asterisk disappears again ro The result is above 33 3 mmol L 600 mg dL The result is saved together with the asterisk as long as the asterisk is ya Instead of a result displayed and you press the Test button to turn the meter off a lA The result is below 0 6 mmol L 10 mg dL 4 8 Evaluating results 4 7 Flagging special results If the displayed test result agrees with the way you feel follow You can flag special results e g results obtained from alternative site your doctor s advice If the displayed test result does not agree testing or after exercise with an asterisk 2 wit
99. ustic Mode is set to on you hear a long beep after you turn on the meter This is irrespective of which button you use to turn the meter on e the Test button in order to perform a test see Chapter 4 3 1 e the S button in order to change settings see Chapter 3 e the M button in order to retrieve results from memory see Chap ter 5 e the M and S button in order to send results see Chapter 5 4 If you press the Test button or M button to turn the meter on you first hear the long power on beep followed by 6 further beeps spaced as 1 2 3 A Acoustic Mode 6 2 Beep tones during blood glucose testing Following the power on beep and the 1 2 3 sequence of beeps you will hear the following while you test blood glucose e a single beep when the meter is ready to test so you can let the test strip draw up blood or control solution e a single beep when the test strip has drawn up sufficient blood or control solution and test is starting e several beeps each time the meter displays an error message see Chapter 6 5 6 3 Announcement of the result following a test In Acoustic Mode whenever your meter displays a result following a blood glucose test it also announces the result as a series of beeps The result is not treated as an entity but is broken down into individual dig its Examples e The result 7 6 mmol L is announced as 0 7 decimal point 6 e The result 138 mg dL is anno
100. veral at once When several sym bols are displayed each symbol can have its own meaning Alterna tively the combination of symbols may mean something In the following example you see a display screen with several symbols This screen appears when you have turned on the meter to perform a blood glucose test Here each symbol has its own meaning The symbols shown along with the time and date mean z You can draw up blood or control solution with the test strip 12 now i The batteries are running low HM You inserted a partly used test strip drum 5 The beep tone or Acoustic Mode is set to on Symbols error messages and troubleshooting 169 In the tables presented below you will first see the meanings of symbols that appear singly or have the same meaning when they appear together with other symbols These are followed by the meanings of combinations of symbols and of symbols that appear in the numeric field 12 1 1 Single symbols Symbol Meaning l al 4 Draw up blood or control solution with the ED test strip now A Symbols error messages and troubleshooting Symbol Meaning The batteries are running low When the symbol first appears in the dis play you can perform about 50 more tests If you use NiMH rechargeable batteries instead of normal batteries fewer than 50 more tests can be performed If the rechargeable batteries are old and exhausted it may not be possible to per form

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