Accutrend Plus - Skolebutik.dk
Contents
1. Performing a measurement 44 Brief overview of the steps to be carried out 45 Important note Code strips Switching on the instrument Inserting the code strip Switching the code display Sample material Performing measurements in the professional sector Preparing to perform a measurement Performing a measurement Recommendations for the collection and measurement of capillary blood Blood Collection Starting the measurement Display of results Flagging measurements Contents Quality control recommendation 80 Prepaling to penormaCOntrol test siisii e i iani nnn 82 Performing a control test Applying the control solution Starting the measurement Display of results Memory 92 Displaying stored Measured Vales ai ccstisscccctstsecsscaisezacsesiceesasrttsaseeecsasciasndsgeietlasditaaseetdatatuesh A 92 Cleaning Cleaning the outer instrument components Cleaning the inner instrument components Cleaning the optical measuring system Error messages 102 Further information Ordering information Product limitations Contents Product specifications 112 Operatirig conditions and technical Cate s s tcisscssiseciecssssictesceeteestchatcebncoreesssacantencaesecebessteneuieslctepseshcbstechncecbtcenasdeneeeected 112 Sample material m Storage and transport conditions Disposal of instrument strips lancets and batteries Service information2. 34 2 The date and time as well as the set symbol now appear on the display To actually make or change settings press the Set button again located on the left side of the instrument To leave the set mode this is only possible if a date and time setting is made press the On Off button Note Ifthe meter display reads dEL ast you have entered the set mode incorrectly and reached a mode we do not recommend To exit this mode and enter the set mode correctly immediately turn off the meter by pressing and holding down the On Off button After the meter is powered off press the Set button twice to enter the set mode and then continue to the next step Instrument settings If the displayed setting is correct e g the date is correct and you want to change the time only you can continue directly to the next setting by pressing the Set button or Press the M button to change the currently flashing setting You can press the M button as many times as needed or keep it pressed until the desired setting value is reached Settings with only two options date or time format and beeper are turned on off or switched with the M button 35 Instrument settings 5 Press the Set button again to save the current setting and go to the next setting You can only move forward through the settings Moving backwards is not possible Corrections can only be made by repeating the settings The setting procedur
3. L Performing a measurement 64 Performing a measurement A flashing arrow now instructs you to open the measurement chamber flap to apply the blood Explanations on flagging this measurement events ev Odisplay or control flag are provided later in this chapter 7 Open the measurement chamber flap The flap firmly locks into place when it reaches a vertical position 65 Performing a measurement 66 Blood can be applied either The flashing drop symbol above the strip symbol now instructs you to apply the blood in the instrument or outside the instrument Performing a measurement Recommendations for the collection and measurement of capillary blood To obtain a suitable blood drop Wash your hands with warm water Ensi ure hands are warm and dry before lancing If needed massage your fingertip After lancing yourself try to obtain a sufficiently large free hanging drop with We out excessive pressing or squeezing ecommend obtaining the capillary blood from the side of the fingertip as this part is the least sensitive to pain For determination of cholesterol only wipe off the first drop of blood with a cotton ball and use the second drop of blood for the test 67 Performing a measurement Blood collection 8 Lance the outer side of the fingertip using the lancing device to obtain a large hanging drop of blood 68 Blood application in the instrum
4. starting on page 78 101 Error messages Error messages In certain circumstances error messages may appear on your display Generally you should first try the following solutions If the problem persists please contact your local customer support and service center 102 Error messages Display Error meaning and description Error Unknown barcode seme The barcode of test strips or code strips could not be H read HZ F Solution All strips Remove the strip and check the barcode for dirt Test strips Repeat the procedure with a new strip Check whether there may be interference caused by electromagnetic fields in the vicinity of the instrument Move meter away from such sources e g X ray equipment 103 Error messages Display Error meaning and description Error Strip code does not match stored code code The test strip belongs to a different test strip lot than the container which was last coded for this parameter codenr 2 jaN Solution Remove the strip and repeat using a test strip matching the last code for the test being attempted Code the instrument with the code strip corresponding to the test strips being used 104 Error messages Display Error meaning and description A Error Test strip is unusable WW a i HAN The test strip has already been used or is dirty Solution Remove and discard the strip Repeat the measurement using a new
5. used lancets and used batteries 113 Product specifications 114 Consider recycling of the meters and batteries at an appropriate facility Be aware the meter is potentially hazardous electronics scrap e scrap and should be disposed of accordingly The batteries are potentially hazardous also and should be disposed of accordingly Decontaminate the meter before recycling or disposing Wipe the outside of the meter with dilution of bleach solution one part bleach to nine parts water Users in professional environments i e healthcare professionals should follow their existing policies and procedures that govern the proper handling and disposal of potentially infectious waste electronics scrap e scrap and batteries 29 CFR 1910 1030 Bloodborne pathogens Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE Service information For technical assistance or information contact the Accu Chek Customer Care Service Center at 1 800 440 3638 24 hours a day 365 days a year Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 2009 Roche Diagnostics All rights reserved Alphabetical index A Addresses Service iNfOrMation cccccccseeccsseeessseeceeees 114 B Batt rieS menssnnis auna 28 SEN N Gan 28 disposal Of i si 113 Battery compartment lid Blood application checking 68 Blood collection oo eeccce
6. Alphabetical index 115 10 Introduction Introduction The Accutrend Plus instrument The Accutrend Plus instrument is used for quantitative measurement of 2 blood parameters glucose and cholesterol The instrument is suitable for professional use as well as for self testing If you have any questions which are not answered by this manual call the ACCU CHEK Customer Care Service Center 24 hours a day 365 days a year at 1 800 440 3638 11 Introduction Test principle By means of a code strip the instrument reads the lot specific characteristics of the test strips currently in use This information is stored and must therefore only be read once per test strip container To ru strip is taken from the container and inserted into the instrument When inserted the ap strip is illuminated by an LED light emitting diode from below Before sample applicati na test an unused test plication area of the test on the reflection behavior of the test strip is determined by means of the light which is reflected from the application area blank value The blood sample is then applied to the application area and the measurement chambe constituent to be determined in the applied sample undergoes an enzymatic reaction w r flap is closed The ith formation of a dye The amount of dye formed increases with the concentration of the substance to be determined After a certain period of time dependent on the
7. color field scale on the label of the test strip container The color of the reaction area must approximately match the color assigned to your measurement result If there is a great deviation perform a meter function check Note the information provided in the test strip insert 75 Performing a meas If the displayed res to be unusually hig Solution chapter o preceding instructi f the new result also s f you do not want Open the measure urement ult particularly when blood glucose is measured does not match your state of health or seems this manual If this check confirn o flag the measurement result wi ment chamber flap and remove th powers off Proper 76 y dispose of the used lancet and instrument if necessary see the Cleaning chapter o Doctors and nursing staff must observe the disposa ns e g h or low check the meter function using a new test strip see the Control Check with Control proper functioning of the instrument read again the ons on performing a measurement Perform another measurement using a new test strip eems to be not plausible consul your doctor h an event or as a control the measurement is now complete est strip Press the On Off button until the instrument est strip according to local laws and guidelines Clean the this manual uidelines of the respective hospital or doctor s office Performing a measurement Flagging measur
8. left side with the accompanying explanation on the right All instructions which require you to perform an action in addition to very important information appear on a colored background This symbol draws attention to the possible risk of sustaining injury or of damaging your health and to possible application errors during measurement which may result in a health hazard 17 About this manual Example of an instruction The left column contains an illustration of the instrument 18 The right column states what you should do at this point for example 1 Press the On Off button 0 to power the instrument on for measurement Example of a display screen This column contains the illustration o screen 1A eA set codemem test crue CHOL 00A 28 28 amp amp 38 88 88 a display This column contains in About this manual formation relating to the display screen for example Every time the instrument is powered on you can check the display The all symbols that may ap Regularly check that al functioning correctly to instrument temporarily shows pear in the display display elements are prevent misinterpretations due to a defective display 19 The Accutrend Plus instrument The Accutrend Plus instrument Overview of instrument elements Display Shows measurement results information symbols and all stored measured results M button memory By pressing t
9. test strip 105 Error messages Display Error meaning and description FA Error Temperature The instrument or ambient temperature does not fall within the acceptable range for the selected test Solution Move the instrument to an environment which has an appropriate temperature and repeat the measurement after several minutes Do not artifically heat or cool the meter by any means 106 Error messages Display Error meaning and description ly Error Flap open displayed after instrument has been powered on The measurement chamber flap is not closed properly Solution Close the measurement chamber flap 107 Error messages Display Error meaning and description WS A Error Flap open displayed during measurement The measurement chamber flap is not closed properly Solution Close the measurement chamber flap 108 Error messages Display A Error meaning and description Error Flap not closed after blood application The measurement chamber flap was not closed properly after blood application the measurement was not started in time Solution Remove and discard the strip Repeat the measurement using a new test strip 109 Error messages Display Error meaning and description Error Internal error example shown 142 The instrument has detected an internal error k Me Solution Power the instrument off and on again Clean the st
10. 54 x 81x30 mm 6 1 x 3 2 x 1 2 inches Weights Approximately 140 g 4 9 oz without batteries Approximately 187 g 6 6 oz with batteries 112 Product specifications Sample material Sample type Fresh capillary blood for detailed information see package insert Sample volume A free hanging drop of blood Interactions See test strip insert Storage and transport conditions Temperature range 25 C to 70 C for meter only Relative humidity 10 to 85 no condensation Disposal of instrument strips lancets and batteries Any product coming in contact with blood is considered contaminated potentially infectious During normal testing any blood glucose meter may come in contact with blood Lancing devices may also be considered sharps Disposal of sharps is regulated by law in many jurisdictions The European Union has a requirement for improving waste management practices for certain electronic equipment but meters fall outside the scope of the European Directive 2002 96 EC This is not a requirement for the U S A however Roche is committed to recycling and sustainability Please consider the following points when disposing of your used testing materials Comply with any laws or ordinances relating to the disposal of sharps and or contaminated products Contact your local health department or other appropriate authorities for proper handling and disposal of used meters used test strips
11. Accutrend Plus cobas User s Manual Date of issue January 2009 2009 Roche Diagnostics All rights reserved ACCU CHEK ACCU CHEK MULTICLIX ACCUTREND COBAS and SAFE I PRO are trademarks of Roche The system fulfills the Canadian and U S safety requirements UL LISTED in accordance with UL 3101 1 and CAN CSA C22 2 no 1010 1 This instrument complies with DIN EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use General requirements and was in a perfect safety condition when it left the factory Installation use and maintenance of the Accutrend Plus instrument is the full responsibility of the user The packaging material the identifi following symbols or abbreviations Consult instructions fo cation plate of the instrument and the manual may contain the which are listed below with their meaning use Caution refer to accompanying documents Refer to safety related notes in the manual accompanying this ins Store at Use by date Manufacturer EMD JI 5 m Catalog number So Batch number IVD In vitro diagnostic med This product fulfills the A MA rument ical device requirements of the European Directive 98 79 EC on in vitro diagnostic medical devices The Accutrend Plus instrument The Accutrend Plus instrument Thank you for your purchase of the Accutrend Plus instrument The Accutren
12. L ev DaD gt P D JINI Q yt ES codenr 20 00 am ono D A PIM UAT Operating the instrument 5 Replace and close the battery compartment lid 6 Power the instrument on to test the function of the new batteries 7 Check that the display functions correctly by comparing it to the diagram on the left to prevent misinterpretations due to defective display elements Tip To make the display screen appear for a longer time hold down the On Off button when powering on The display screen is then shown for the time the button is pressed 31 Operating the instrument Instrument settings Brief overview of the instrument settings The following table provides an overview of the available settings Setting Options Default setting Date format Day Month Year 31 12 00 Month Day Year Month Day Year 12 31 00 Time format 24 hour time format 24h 12h 12 hour time format 12h with am pm Beeper On On Off Default setting describes the instrument setting at the time of shipping 32 Instrument settings General procedure for setting up the instrument set mode You make all settings using the Set and M buttons as described below The instrument must be powered off before you can activate the set mode 1 Press the Set button on the left side of the instrument to power the instrument on in set mode 33 Instrument settings set mr am rt mT UE raat ADE
13. ame Bacillol plus is recommended Do not use any disinfectant sprays or tissues or cotton balls which are dripping wet as the liquid may enter the instrument and damage it 97 Cleaning Cleaning the outer instrument components Ensure the instrument is powered off Wipe the outside of the instrument with a lightly moistened lint free cotton cloth In the professional sector the outside of the instrument can be cleaned with Bacillol plus Cleaning the inner instrument components 1 Open the measurement chamber flap 2 Remove the the test strip guide by slightly pushing it forward and then pulling it upwards 98 Cleaning 3 Ifneeded you can rinse the strip guide separately from the instrument under warm running water Dry the strip guide with a clean cloth 99 Cleaning 100 Cleaning the optical measuring system Clean the easily accessible areas of the optical measuring system under the strip guide with a lint free pad or a moistened cotton ball Make sure that no liquid enters the instrument Do not insert any objects into the instrument Allow the instrument to dry thoroughly Cleaning 6 Donotputthe strip guide back in the instrument until itis completely dry Press the front end of the strip guide slightly downwards until you feel it click into place 7 Close the measurement chamber flap The instrument is now ready for operation again Perform a function check see description
14. area use the M button 3 Press the M button to show the next oldest measured value within one memory area When you press the button the place of the measured value within the memory is displayed here 02 the actual value is not shown until you release the button When you hold down the M button older memory places 02 03 04 and so on continually appear in the display until you release the button Then the measured value in the last displayed memory place is shown 95 Memory Special cases mem CHOL 96 mem CHOL Ifthe entire memory is empty three dashes will appear in the display Ifthe entire memory area of a test parameter is empty two dashes will appear in the display Ifa single measured value is stored incorrectly one dash will appear in the display Cleaning Cleaning A clean optical measuring system is a basic prerequisite for determining precise measured values Therefore clean the instrument regularly and immediately after it becomes dirty Always power off the instrument before cleaning it Use only the following items for cleaning Ordinary lint free cotton balls Ordinary lint free tissues Ordinary disinfecting tissues Mild soap suds as well as 70 ethanol or isopropyl alcohol are suitable for cleaning When used in the professional sector e g doctor s offices a mixture consisting of 1 propanol 2 propanol and glutaraldehyde brand n
15. d Glucose Control High Level rend Cholesterol Control Low Level rend Cholesterol Control High Level Quality control recommendation 81 Quality contro recommendation Preparing to perform a control test 82 Get the test strip container for the required measurement e g cholesterol Make sure the code strip belonging to these test strips is at hand unless the instrument has already been coded for this test strip lot Get the proper control solutions for the test strips The following description assumes that the instrument has already been coded for the test strips used here If this is not the case see the Inserting the code strip section of this manual Quality control recommendation Performing a control test 1 Place the instrument on a level surface or hold it inyour hand If required switch on the instrument by pressing the On Off button 83 Quality control recommendation 1A N N After switching on the instrument check the following set code mem test displays GLUC CHOL 2 Check that the whole display is functioning ita g ARAA Pm AAAA 3 code CHOL d iesSb 4 Te 10 38 te 7 84 correctly to prevent misinterpretations due to defective display elements Are date and time correct If the measured val ues are to be stored with time information enter the correct settings see the Setting the date section of this manual Does the battery symbol appear If it a
16. d Plus instrument is used for quantitative measurement of two blood parameters glucose and cholesterol The reflectance photometric measurement is performed using test strips specific for each of these blood parameters For detailed information about the two tests see the package inserts of the respective test strips Note This manual contains all the information needed to use the instrument and keep it ready to operate Please read this manual carefully before using the instrument Familiarize yourself with the required preparations and the measurement procedure before performing the first measurement Also read the package inserts of the test strips to be used Last update January 2009 Contents Contents The Accutrend Plus instrument 5 Introduction The Accutrend Plus instrument Test principle Checking the contents Safety information Operating conditions Integrated control functions About this manual Page layout The Accutrend Plus instrument Overview of instrument elements Display and symbols POW P nonnina rusts sneasSdnaralevesstsdaptaccngen aiit NEE ia REG iiia Operating the instrument 27 Insening DAMENES issnin aaa rr a NAAA n aare ERARE 28 Contents Instrument settings Brief overview of the instrument settings General procedure for setting up the instrument set mode Setting the date format Setting the date Setting the time forma Setting the time Setting the beeper
17. e can be terminated at any time by pressing the On Off button The settings made up to that point are saved 36 Instrument settings Setting the date format In the first step you set the date format the entire date flashes In the following illustrations flashing display elements are represented by a beam circle The following date formats are available 31 12 00 Day Month Year 12 31 00 default setting Month Day Year 1 Press the M button to select the date format Each time you press the button the flashing formats 37 12 00 and 12 31 00 appear in alternation When the desired format is displayed do the following set N 7 2 Press the Set button to save this setting The te Hi I display then automatically switches to the mode Z ji X for setting the current date 37 Instrument settings Setting the date With the next three settings you first enter the year then the month and finally the day 1 Press the M button to change the currently set flashing figure and to set the current year 2 Press the Set button to save the displayed year The display then automatically switches to the mode for setting the current month z 3 Ifyou use the instrument without any date set all measured values will be stored without date information FD td 7X c3 E J set Fa Vit n la pan A ZN 38 Instru
18. e test strip Apply blood per test strip lot 45 Performing a measurement al 4 l 5 Ti i Start measurement by closing the Display of measurement results measurement chamber flap 46 Performing a measurement Important notes Always operate the instrument at the acceptable test specific temperatures see also the test strip inserts For cholesterol 18 30 C 64 86 F For glucose 18 32 C 64 90 F place the instrument on a level surface or hold it steady in your hand make sure that all display elements are displayed during the self test read the test strip inserts keep the test strip guide and housing clean see the Cleaning chapter of this manual Note Ifyou would like to do a total cholesterol test after you finish your glucose test or vice versa get a blood drop from a different finger 47 Performing a measurement Never touch or remove the test strip during actual measurement this is possible before starting the measurement when blood is applied outside the instrument delay starting the measurement after blood application subject the instrument to sudden movements during a measurement store the instrument and strips at extreme temperatures see the Product specifications chapter of this manual and test strip inserts store the instrument and test strips under humid or damp conditions without suitable protection see the Product specifications chapter of thi
19. e the following guidelines Operate the instrument only within the acceptable temperature range This range is test dependent For cho este e For glucose Use the instrumen In order to pe rform rol 18 30 C 64 86 F 18 32 C 64 90 F only at a relative humidity of 85 or less a measurement place the instrument on a level surface or hold it in your hand Electromagnetic interference Strong elect close to sou omagnetic fields may impair the function of the instrument Do not use the instrument ces of strong electromagnetic radiation 15 Introduct ion Integrated control functions The Accutrend Plus instrument has numerous integrated or available control functions including the following Anautomatic ch Anautomatic ch Anautomatic ch memory eck of the electronic components and functions when the instrument is powered on eck of the ambient temperature before and during the measurement eck of the test strip to make sure that the code information necessary for measurement is in e Acheck of the optical system and the overall function by means of control solutions For more information refer to the Qua 16 ity control recommendation section of this user s manual About this manual About this manual Page layout The page layout of this manual enables you to easily locate the most important information Where illustrations are used they always appear on the
20. easurement Performing a measurement Get the test strip container for the required measurement Check the expiration date of the test strip Always use test strips before their expiration date has passed Make sure the code strip belonging to these test strips is at hand unless the instrument has already been coded with this code strip Note Environmental influences e g air humidity and light on the test strips may damage test strips and lead to false measurements or error messages Do not remove the test strips from the strip container until immediately before performing a measurement 59 Performing a measurement 60 4 Prepare the lancing device by inserting a new lancet Self testers Do not lance yourself before being instructed to do so in the course of this description In the professional multi patient sector you should use a suitable single use lancing device to prevent cross contamination We recommend the Accu Chek Safe T Pro or Accu Chek Safe T Pro Plus single use lancing device We recommend the Accu Chek Multiclix lancing device for self testers Performing a measurement t n W Perforr Check the following displays befo measurement 1 Are date and time correct If values are to be stored with ti ming a measurement fter it is switched on and coded the instrument expects you to insert the test strip From the barcode on the everse side the i
21. eeeeeeee 74 Life Ve ro l arS AA E A 77 pErfOrMINg esccssssseeeesseceessssseteeseeeeestsneeess 58 61 piepaNN gsi 59 SaN si rit 72 What YOU NCCC esccsssseeesessecessssttnsessseessssneees 51 Measurement compartment Cover 23 Measurement compartment flap 21 23 MEMON einan e 92 96 displaying measured values 92 0 On Off button 0 eeeeessseseseseesseeeeeseeeeeeeeenseeeneees 21 Operating conditions 00 0 eee 15 112 Operating the instrument 0eeeeeee 31 35 Ordering information esses 11 P Power SUPDIY csssssecccssccsssssesecseseccenstessceeeecesenssess 26 Protection against infections 14 Q Quality control recommendation 80 91 display Of reSUItS oe eeeeeessseeeeessseseseseeeteeeeeeeee 91 P NING sssseescsssesesseesseeseeesenteteeesneees 83 87 PED ANNO 2 ensien 82 starting the measurement eeee 89 What YOU NEC ssssssssseeeessesecessssetnseeeeeeseteee 81 Reflectance photomety ssssscsseeees 12 S Sample material v 2 2 121 121 1 Scope of delivery Service INFOFMALION ssssssssecseceeeeeeeeeeeeeeeeeeeees 114 SeH HUON senasa erteee tree 21 Alphabetical index SENINI Se e 32 43 Aiea ees teen a EA 38 date format a eeeescscsessseeeeeeeeceessennneeeeeeeseee 37 general procedure eesssssccssseeeeeees 33 36 OVEIVIEW scans ann a 32 DOG DEM ee OaE 43 aE E E E E 42
22. ements When the display test completes the last stored code displays If no code has been stored in the instrument so far you will onthe left see the display shown The flashing codenr symbol instructs you to insert a code strip 53 Performing a measurement Inserting the code strip Hold the code strip with thu mb and index finger in the white area located at the end of the strip Do not touch the printed area on either side Insert the code strip smooth guide up to the stop in the d ly into the test strip irection of the printed arrows Withdraw it immediately afterwards Leave the measurement chamber flap closed during this procedure If the instrument reads the barcode information correctly a short beep confi rms successful coding if beeper is enabled Performing a measurement The three digit code number which is also printed on the reverse side of the code strip and on the test strip container is shown in the display code If any problems occur during coding the meter Ppl displays an error message see Error Messages yy chapter of this manual If an error occurs repeat Di insertion of the code strip after a few seconds S rig The flashing strip symbol prompts you to insert the test strip eso ted 55 Performing a measurement Switching the code display You can switch between the display of the stored code numbers for information pu
23. ements You can add additional information to measurements for example to characterize a particular value with regard to special circumstances e g meals or exercise In addition you can flag measurements carried out with control liquids as controls You can flag a measured value at different points in time At the start of the measurement after inserting the test strip When the test result is displayed You cannot flag a value while measurement is in process 77 Performing a measurement Flagging the measurement as a control You flag measurements as controls when they have been performed using a control solution as described in the following chapter 14 Press the M button after inserting the test strip or when the result is displayed to flag the measurement as a control bottle symbol Pressing the M button again turns the flag off be st CHOL evil CHOL ev dib d b codenr 38 ed eo 3 35 2 3 8 78 Performing a measurement Assigning additional information to a measurement Optionally you can assign one of nine different events to a measurement The event 0 represents no flagging If used you must define the events and their respective event numbers yourself Make sure that your assignments are unique and reproducible 15 Press the Set button after inserting the test strip or when the result is displayed to flag the measurement with an event Pressing the Set button i
24. end that you keep it until the container of strips has been used completely Store the code strip in the external packaging and not in the test strip container The imprint on the code strip may impair the test strip quality leading to incorrect measurement results Each code strip belongs to one particular test strip container or lot If possible store the test strip container together with the code strip in the external packaging in order to have the latter at hand for recoding the instrument if needed e g after battery replacement due to completely dead batteries 51 Performing a measurement Switching on the instrument 52 Place the instrument on a level surface or hold it inyour hand Power on the instrument by pressing the On Off button Note To power the instrument off again press and hold the On Off button until the meter shuts off A set code mem test Guc CHOL ev fn aan OOO 28 88 a AARAA AJAT a code lt a A codenr gt 44 J 12 3 8 Per correctly to prevent misin defective display elements forming a measurement 2 Check that the whole display is functioning erpretations due to Also always check the ba ery condition after the display test When the ba ery symbol is shown with a measurement screen except during the display test you will only be able to perform a few more measur
25. ent Performing a measurement Apply a large hanging drop of blood directly from the finger to the yellow sample application area of the test strip Do not touch the application area with the finger The drop of blood must be applied to the test strip immediately after lancing the fingertip Blood which is applied later may lead to an incor rect result For cholesterol testing wipe away the first drop and immediately apply the second drop 69 Performing a measurement Alternative blood application outside the device 10 Withdraw the test strip after opening the flap leave it open 11 Apply the free hanging drop of blood directly from the finger to the yellow sample application area of the test strip Refer to the insert of the respective test strip Do not touch the application area with your skin 12 With the measurement chamber flap open insert the test strip back into the instrument Performing a measurement Checking the applied blood gt N A The application area must be completely w covered with blood example A otherwise incorrect values may be obtained Cee If too little blood is applied example B do not try to spread it or apply a second drop as this may lead to a false measurement Repeat the measurement with a new test strip 71 Performing a measurement Starting the measurement 13 Close the measurement chamber flap This starts the actual measurement 72 P
26. erforming a measurement The time needed to evaluate the sample varies depending on the test parameter This time is shown inthe display and counted down to 0 The measurement times of the individual test parameters test are ce For glucose 12 seconds For cholesterol 180 seconds test mi oi 2 he evi The last 4 seconds of the measurement time are 10 E each accompanied by one short beep if beeper is enabled Completion of the measurement and i 05 the subsequent display of results are indicated by a longer beep 73 Performing a measurement Display of results test test CHOL ev CHOL ev Ean 12 3 08 M1 12 3 08 74 When measurement is finished the result is displayed If you are measuring glucose perform the plausibility check described on the next page Measu measu Hi ab Lo be When rement results which fall outside the meter rement range are displayed as ove the measurement range or ow the measurement range he result is displayed the ev 0 event no event is displayed For an explanation on how to use the event display to apply additional information tothe esult see the next section Accutrend Glucose REF 05213185160 50 Tests Performing a measurement Plausibility check after glucose measurement Remove the test strip and turn it with the bottom side upwards Compare the reaction area on the bottom side of the strip with the
27. esssseesssseesesseesssseeesssesessseee 68 Blood Parameters cssscccccssccsststseeeseceeesees 12 Buttons OMO DUNO ssid icici aictnnntaiienl 21 M BUON eenen Na 2 Set DUON sea 2 Alphabetical index Cc Capillaty plod sasssa 67 recommendations for collection 67 CIS ANN Jenssen 97 101 cleaning agents sesane 97 instrument Components ese 98 99 optical Measuring System eeee 100 Code switching the display esses 56 Code strips inserting s OVEIVIEW e lansaria ans ee Contents packaging ssssssscsscssseeeeeeeeeeeeeeee 13 Control solution DPI eraa E 88 115 116 Alphabetical index D DIE Ee aE 38 40 Date format scccccsssssssssssssssssveesennnmnmesesseseeee 37 DISPIAY zrnech d 21 SVIMIDOIS asien 24 25 Display Of results eeececcccessseeeeeeeeeeee 74 91 Display eSt st nn S 55 DISPOSAL araceas 113 E Error Messages ssccsssseetesseseecseseeeeeees 102 110 F Flagging measurements s ss11 11 111 1112 77 l Infections protection against 14 Instrument disposal of overview SWITCHING Oferen 52 Integrated control fUNCTIONS esses 16 L Lancing device eecesssseseteseccccssesseetteesececenanetteee 67 LED light emitting diode eee 12 M M DURLOM sc sninen a 21 MGASUFEMENT sse scictecscesccenmrnnninncrnnes 51 86 brief overi Wairani asais 45 display of results ooo eeeeeececseesetteeeee
28. his button you can retrieve all stored values and together with the Set button you can change the instrument settings On Off button By pressing this button you power the instrument on and off Measurement chamber flap To apply the sample open this flap To start the measurement close the flap The Accutrend Plus instrument Test strip guide Insert the test strip here Set button By pressing this button you access the various instrument settings which are changed using the M button You also use this button to switch between the different test parameters to show the currently stored code numbers before measurement or to review results when in memory mode 21 The Accutrend Plus instrument 22 G Battery compartment lid Provides access to the battery compartment 4 AAA 1 5 alkaline batteries H Measurement chamber cover with test strip guide You can remove this cover to clean the test strip guide and optics cover The Accutrend Plus instrument 23 The Accutrend Plus instrument Display and symbols A B gt An set ak mem test aaue CHOL ev no apai codenr a pm 38 03 Ba Every time the instrument is powered on you should check the display The instrument temporarily shows all symbols that may appear in the display Regularly check that all display elements are functioning correctly to prevent misinterpretations due to a defective display The symbols i
29. mand pm or vice versa gt WUN yN If you use the instrument without any time set all measured values will be stored Vly 3 3 hT am without time information DUIRT EN iry 10 Press the Set button to save the desired setting and to continue setting the beeper 42 Instrument settings Setting the beeper After setting the time you can set the beeper by choosing On or OFF We recommend that you always leave the beeper enabled If the beeper is enabled you will hear a beep in the following situations When the instrument detects that the test strip is inserted When the result appears When an error occurs 2 11 Press the M button to switch between OFFand eet 1 On default setting pn 12 Press the Set button to save the selected A setting The display briefly displays End and Ls automatically goes to test mode 43 Performing a measurement Performing a measurement What you need Your Accutrend Plus instrument Test strips for the desired measurements with the related code strip Accutrend Glucose Accutrend Cholesterol Lancing device For healthcare professionals a device suitable for use in a professional multipatient setting must be used e g Accu Chek Safe T Pro or Accu Chek Safe T Pro Plus Alcohol wipe or pad if required 44 Performing a measurement Brief overview of the steps to be carried out Te Code the instrument once Insert th
30. ment settings 3 The default month flashes Press the M button until the desired month is displayed 4 Press the Set button to save the setting The display then automatically switches to the mode for setting the current day 39 Instrument settings set set 40 5 The default day flashes Press the M button until the desired day is displayed Press the Set button to save the selected setting and to continue setting the time format The display then automatically switches to the mode for setting the time format Instrument settings Setting the time format Now select the time format to be used either the international format 24h display or the Anglo American format 12h display with am or pm default setting 7 Press the M button to switch between the 24h set and 12h displays 8 Press the Set button to save the desired setting and to continue setting the time The display then automatically switches to the mode for setting the current time set N L 1 Sr aa i yor 41 nstrument settings Setting the time First enter the current hour and then the minutes 9 Press the M button to change the currently flashing figure The next time the Set button is set pressed the minutes can be set again with the M button Ifyou have selected the 72h time format and set the time 12 xx is reached the display switches rin aw between a
31. n as with performing a measurement using blood also be applied outside the instrument as described on page 68 88 Quality control recommendation Starting the measurement 11 Close the measurement chamber flap This starts the actual measurement 89 Quality control recommendation 90 The measurement time varies depending on the test parameter This time is shown in the display and counted down to 0 The measurement times of the individual test parameters are For glucose 12 seconds For cholesterol 180 seconds The last four seconds of the measurement time are each accompanied by one short beep if beeper is enabled Completion of the measurement and the subsequent display of results is indicated by a longer beep Display of results Quality control recommendation When measurementis finished the result is displayed ow check whether the displayed result falls within the acceptable range Target values which should be obtained can either be ound on the labels or on the package inserts for the test strips or control solutions If the value is outside the range repeat the control check If the second esult is again outside this range contact your local customer support and service center Repeat steps 1 11 using either the glucose or cholesterol high level control 91 Memory Memory The Accutrend Plus instrument has two memory areas each of which can be used
32. n the display have the following meaning AER Close measurement chamber flap fa Pen measurement chamber flap a Beeper turned on t Temperature warning Error C Battery warning batteries almost dead Flagged as a function check with o ecntalseldion ev Flag for specific events event 0 9 24 The Accutrend Plus instrument set Set mode code Code display mem Memory mode test Test mode measurement GLUC Test parameter glucose CHOL Test parameter cholesterol d Test strip flashes insert Test strip and blood drop apply blood sec Measurement time in seconds codenr Display of the code number ain In the morning pm In the afternoon with 12h time format set with 12h time format set mg dL Unit for glucose and cholesterol 25 The Accutrend Plus instrument Power To save power the instrument powers itself off after 2 minutes unless a button is pressed or a new test strip is inserted When the instrument turns itself off all test results obtained so far remain in the memory With a set of fresh batteries you will normally be able to perform approximately 1 000 measurements When the battery warning is displayed for the first time approximately 50 measurements can still be performed but replace the batteries as soon as possible When replacing batteries you must insert new batteries within 2 minutes to keep the set date and time If this time period is exceeded you must re ene
33. ncreases the displayed event number tes test _ test in increments of one After event 9 the event ae oT mak display is reset to 0 Fb 2 FY case codenr i a iiei a ae 79 Quality control recommendation Quality control recommendation To ensure that the instrument is functioning properly you should regularly use two levels of control solutions for a function check For each test parameter separate control solutions are available Make a habit of carrying out a function check in the following situations If you leave the cap off the container of test strips When you open a new container of test strips Before using your meter for the first time If you drop the meter When your glucose test does not agree with the way you feel When you want to check the way you are performing your blood glucose or total cholesterol test When you want to check the performance of the meter and test strip f you have repeated a test and the result is still higher or lower than expected A function check is performed in the same way as a regular measurement except that control solutions are used instead of blood 80 What you need Your Accutrend Plus instrument Test strips for the desired measurements with the related code strip Accu Accu rend Glucose rend Cholesterol Control solutions for the respective test parameter Accu Accu Accu Accu rend Glucose Control Low Level ren
34. nstrument detects which test parameter is to be measured and which code ip Ifthe code strip has not been read yet an error message is displayed after inserting the is needed for the test est strip re performing the he measured me information enter the correct settings refer to the Instrument Settings chapter of this manual Does the battery symbol appear If it appears only few more measurements can be performed Replace the batteries as soon as possible refer to the Operating the Instrument chapter of this manual 61 Performing a measurement 3 Nowtake the test strip from the test strip container Close the container immediately after removing strip to protect the desiccant and strips otherwise the test strips may become unusable before their expiration date Liquids must not enter the test strip container 4 ith glucose test strips check the reaction area onthe back of strip for discoloration before starting measurement If you detect discoloration this test strip is unusable For detailed information see the test strip package insert 62 Performing a measurement Hold the test strip with thumb and index finger so that the sample application area is facing upwards Insert the test strip into the test strip guide up to the stop When the test strip reaches the correct position you will hear two beeps short long if beeper is enabled 63 5m a i mr ch
35. ppears except during the display check at start up only a few more measurements can be performed Replace the batteries as soon as possible see the nserting batteries section of this manual Quality control recommendation Now take the test strip from the test strip container Close the container immediately after removing strip to protect the desiccant and strips otherwise the test strips may become unusable before their expiration date Hold the test strip with thumb and index finger so that the printed measurement parameter is facing upwards Insert the test strip into the test strip guide until it stops When the test strip reaches the correct position you will hear two beeps short long if beeper is enabled 85 Quality contro recommendation 8 Press the M button to flag the measurement as a control bottle symbol is displayed test A test CHOL evi CHOL ev cb 7 eib codenr a as 38 ied eo 86 Quality control recommendation 9 Open the measurement chamber flap The flap firmly locks into place when it reaches a vertical position 87 Quality contro recommendation Applying the control solution 10 Apply a large free hanging drop of either the glucose or cholesterol low level control solution directly from the bottle to the test strip Ensure that neither the bottle nor your fingers touch the application area The application area must be completely covered The sample ca
36. rip guide and optics area If the error still persists the instrument is defective Call your local customer support and service center 110 Further information Further information Ordering information Please contact your specialist supplier Item Description Cat No Accutrend Glucose Test Strips 50 test strips for determining blood glucose 05213185160 Accutrend Glucose Control Control solution to be used with Accutrend Glucose test strips 05213231160 Accutrend Cholesterol Test Strips 25 test strips for determining cholesterol in the blood 05213312160 Accutrend Cholesterol Control Control solution to be used with Accutrend Cholesterol test strips 05219957001 Accutrend Plus instrument kit Meter kit 05346754160 Product limitations Please read the insert packaged with the test strips or control solutions for detailed information on product data and limitations 111 Further information Product specifications Operating conditions and technical data Temperature range for Cholesterol 18 30 C measurement Glucose 18 32 C Relative humidity 10 85 easurement range Blood glucose 20 600 mg dL Cholesterol 150 300 mg dL emory 100 measured values optional with date time and additional event information per test parameter Battery operation 4x AAA 1 5 V alkaline batteries umber of measurements Approximately 1 000 measurements with new batteries Protection class III Dimensions 1
37. rposes 1 The code number last stored or used is displayed after powering on the instrument Press the Set button to switch to the code number for the other parameter Each time you press the button the display shows the code number of the test strips in succession Note This display is for information purposes only You do not need to display the test parameter to be measured 56 Performing a measurement Sample material Fresh capillary blood is used as sample material You need a free hanging blood drop for measurement For more information on sample material refer to the test strip package insert Note that all handling of blood samples represents a risk of infection Therefore take the correspond ing safety measures such as wearing disposable gloves while working 57 Performing a measurement Performing measurements in the professional sector 58 Protection against infections There is a potential risk of infection Medical staff and other people using the Accutrend Plus instrument to perform measurements for more than one patient must be aware that any object coming into contact with human blood is a potential source of infection Use gloves Apply blood outside the instrument see the Performing a Measurement chapter of this manual Dispose of used test strips in a clinical waste bin Follow all other locally applicable guidelines and regulations on health and safety Preparing to perform a m
38. s manual and test strip inserts A Failure to comply with the above may lead to false results 48 Performing a measurement Code strips Test strips 49 Performing a measurement A Test strip top side CHOL in the example Contains the application area B Application area Apply the sample here C Test strip bottom side The imprinted barcode is used to identify the type and lot of the test strip D Reaction area Used to visually check whether blood was applied correctly 50 Code strip top side CHOL in the example Supplied with each test strip container Code strip bottom side The imprinted barcode contains lot specific information which is read and stored in the instru ment Performing a measurement Code strips The code strip provides the instrument with important information on the specific properties of the respective test strip The code strip is required at least when a new test strip container is opened and before the strips are used The properties of these test strips are then stored in the instrument The instrument stores the data of only one code strip per test parameter i e a total of two codes at a time Do not forget to have the code strip which is supplied with each new test strip container at hand before performing the first measurement Once the code strip data is stored in the instrument before a new test strip is used you normally do not need it any more but we recomm
39. ter the date and time Use only AAA alkaline batteries Measurement results including the related measurement date and time as well as all over instrument settings remain stored even when no batteries are inserted Please respect the environment and discard used batteries according to your local regulations and laws A Do not throw batteries onto an open fire There is a risk of explosion 26 Operating the instrument Before using the instrument for the first time perform the following steps 1 2 3 Insert batteries Set date time and beeper Insert code strip can also be done directly before performing the measurement Operating the instrument 27 Operating the instrument Inserting batteries 28 Operating the instrument Ensure the instrument is switched off and turn it over Open the battery compartment by slightly pressing the tab towards the center of the instrument Lift the lid upwards to remove it from the instrument Insert four batteries into the compartment according to the illustrations Please note the orientation of the battery head and terminals flat end Use only alkaline batteries 1 5 V AAA Always replace all four batteries at the same time because batteries with different capacities may impair the function of the instrument Do not use rechargeable batteries 29 Operating the instrument 1A eA set code mem test amp 5 GLUC CHO
40. test parameter the color intensity is m application area again from below using the LED The intensity of the reflected light is m detector reflectance photometry The measured value is determined from the signal s easured by illuminating the easured with a rength of the reflected light using the previously measured blank value and the lot specific information from th result is displayed and simultaneously stored in the memory 12 e code strip Finally the Checking the contents Accutrend Plus meter User s Manual Four 1 5 V AAA alkaline batteries Quick Reference Guide Carrying Case Warranty Card Introduction 13 Introduction Safety information A Protection against infection There is a potential risk of infection Medical staff and other persons using the Accutrend Plus instrument to perform measurements for more than one patient must be aware that any object coming into contact with human blood is a potential source of infection Use gloves When performing several measurements apply blood outside the instrument e Discard used test strips in a sharps container or sturdy container with lid Followall other locally applicable health and safety regulations Use a professional lancing device such as the Accu Chek Safe I Pro to prevent cross contamination 14 Introduction Operating conditions To ensure proper fu nctio n of your Accutrend Plus instrument observ
41. time OMate e 41 BO CDCl nenc kasi aieaauine 43 Storage conditions eeeseteeecceeeessteeteseeeeeeee 113 Switching ON oaaeeeessseeeeesesecceessseteteeseeeeesssntntteeeeeeseee 52 SYMDOIS eseeescscscssseeteeseeceesssneneeseeseeseee 5 6 24 25 T lechnical Gata scseiseisasteecartectirecscesiseess 112 Temperature Test principle Test strip guide Test strips INSOMUMG aa 45 OVEIVICW aaran 49 50 117 Alphabetical index 118 Patents US 5 463 467 US 5 424 035 US 5 334 508 US 5 206 147 US 5 240 860 US 5 382 523 US 5 521 060 US 5 268 269 US 6 506 575 US 5 281 395 C 0123 ACCU CHEK ACCU CHEK MULTICLIX ACCUTREND COBAS and SAFE T PRO are trademarks of Roche Manufactured for and distributed in the U S A by Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 Roche Diagnostics GmbH 68298 Mannheim Germany Made in Germany www roche com 05340454001 02 0109US
42. to store up to 100 measured values together with date time and event flags Ifyou have not set any date and time see the Setting the date section of this manual all measured values will be stored without date and time information Displaying stored measured values 1 Switch on the instrument directly in memory mode by pressing the M button or by pressing this button when the instrument is in testing mode You can exit memory mode at any time by pressing the On Off button D 92 Memory After the usual display test has been performed when switching on the instrument the last stored measured value is displayed GLUC The mem symbol indicates that the instrument is inmemory mode The date and time on the display match the time at which the measurement was performed and not the current time The colon in this time display does not flash in contrast to the current time display when not in memory mode ve ev c ET 1 ttn Bet ieg 93 Memory 2 Press the Set button to switch between the memory areas of the two test parameters Each time you press the Set button the last stored value of each memory area if any is displayed If the area contains no stored values two dashes are displayed mem GLUC N mem n CHOL ev gid IDD I 12 3 40 94 4 19 12 3 408 CHOL ev i B i m eo mem CHOL ev 93 fe 3d Memory To navigate within one memory
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