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User Manual Version 3.0 Final Draft 1 | Users Manual | 1.32 MiB | December 02 2018 | |||
1 | RF Exposure Info | December 02 2018 | ||||||
1 | RF Exposure Info | December 02 2018 | ||||||
1 | RF Exposure Info | December 02 2018 | ||||||
1 | Test Report | December 02 2018 | ||||||
1 | Test Setup Photos | December 02 2018 | ||||||
1 | Cover Letter(s) | December 02 2018 | ||||||
1 | External Photos | December 02 2018 | ||||||
1 | Internal Photos | December 02 2018 | ||||||
1 | ID Label/Location Info | December 02 2018 | ||||||
1 | Cover Letter(s) | December 02 2018 |
1 | User Manual Version 3.0 Final Draft 1 | Users Manual | 1.32 MiB | December 02 2018 |
UserManual Contents IntendedUse..............................................................................................................43 1. 2. SafetyInformation.....................................................................................................43 3. RegulatoryInformation.............................................................................................43 4. Environmentofuse....................................................................................................43 5. Advice&SafetyWarnings..........................................................................................54 6. Conditionsofuse........................................................................................................65 7. ContentsoftheBox....................................................................................................65 8. TechnicalSpecifications&Requirements...................................................................76 9. DeviceDescription.....................................................................................................87 10. InstallMenteAutismapp..........................................................................................109 11. Registration..............................................................................................................119 12. HowtoUse.............................................................................................................1210 13. TheReport..............................................................................................................2014 14. Cleaning&MaintenanceInstructions.....................................................................2417 15. ContinuousSupport................................................................................................2720 16. WhattoExpect.......................................................................................................2821 17. BatteryOperating/SafetyInstructions....................................................................2922 18. SymbolsUsed..........................................................................................................3023 19. EMC........................................................................................................................3225 20. FCCStatement........................................................................................................3427 21. AdditionalStatement.....................................................Error!Bookmarknotdefined.28 22. ChangeRecord........................................................................................................3528 USERMANUAL 2 FigureContents Figure1DeviceLEDlegend............................................................................................88 Figure2PackagingandProductLabels.........................................................................99 Figure3:MenteAutismonPlayStore.............................................................................1010 Figure4:AppinstallationAcceptanceScreen.................................................................1010 Figure5:MenteAppCompletedInstallationScreen.......................................................1111 Figure6:MenteAppIcon...............................................................................................1111 Figure7:MenteAppSignIn...........................................................................................1212 Figure8:MenteAutismRegistration.............................................................................1212 Figure9MenteAutismFlexSensorinitialusePreparation..........................................1313 Figure10MenteAutismSensorConfiguration............................................................1313 Figure11Correctheadbandplacement.......................................................................1414 Figure12:MenteAutismSignin....................................................................................1414 Figure13:AppHomeScreen..........................................................................................1515 Figure14:ConnectingPopUp........................................................................................1515 Figure15:SuccessfulConnectionHomeScreen..............................................................1616 Figure16:FunctionalCheckScreen................................................................................1717 Figure17:SessioninProgressScreen.............................................................................1818 Figure18TopviewofMenteAutismdevicewith(A)Allsensorsdisconnectedand(B)All sensorsconnected..........................................................................................................1818 Figure19:TransferringDataPopUp..............................................................................1919 Figure20:UploadAvailabilityScreen.............................................................................1919 Figure21:MenteAutismAppNavigationMenu............................................................2020 Figure22:HistoryNavigationScreen.............................................................................2121 Figure23:MenteDailyReport.......................................................................................2222 Figure24:SessionOutcome...........................................................................................2323 Figure25DeformedSensors........................................................................................2626 Figure26RehydrationMethod....................................................................................2626 Figure27RehydratedSensor.......................................................................................2626 USERMANUAL 3 IntendedUse 1. MenteAutismisanactivemedicaldeviceintendedtoreadbrainactivityofpatientsdiagnosedwithAutism SpectrumDisorder(ASD)toprovideahomebasedtherapeuticmeanstorelaxthemind.Thisisdonethrough readingofthevariouswaveformsofbrainactivityaugmentedinarealtimesonifiedneurofeedbacktherapy.The therapyisdeliveredthroughsonifiedneurofeedbacktransmittedviaearphonesthatareconnecteddirectlyto the headband. Mente Autism the ages of 3 and 12. Afterinitialsetup,MenteAutismcanberuntogetherwithatabletrunningtheMenteAutismsoftware. for children between targeted is 2. SafetyInformation MenteAutismisaClassIIadeviceaccordingtotheclassificationintheCouncilDirective93/42/EECformedical devices.MenteAutismisintendedfornoncontinuoususe. ItconformstothefollowingStandardsandDirectives:
Directive93/42/EECformedicaldevices,withamendmentsby2007/47/EC SubsidiaryLegislation427.44,MaltaMedicalDevicesRegulations,LegalNotice210of2008 ISO13485 EN606011 EN6060112 EN60601111 IEC60601226 R&TTECouncilDirective1999/5/EC Thisproductuserguideandmanualisavailableinanumberoflanguages. Contactyourlocaldistributorshouldyourequireacopyofthismanualinanotherlanguage. 3. RegulatoryInformation Manufacturer:
AATMedicalLtd BlockLS3,MaltaLifeSciencesPark,SanGwannIndustrialEstate, SanGwann,SGN3000Malta Tel:+35621330588 Email:info@mentetech.com Brand:
Model:
MenteAutism MEN03 4. Environmentofuse TheMenteAutismsystemhasbeendesignedforuseinahomeand/orclinicalenvironmentinaccordancewith specificationsasexplainedinSection6ConditionsofUse. USERMANUAL 4 5. Advice&SafetyWarnings EachMenteAutismsystemshouldideallybeusedbyoneusertoavoidthepossibilityofskinrelated infection.Wherethisisnotthecase,besuretofollowthecleaninganddisinfectinginstructionsin thismanual. ListeningtoMenteAutismtherapyathighvolumesabovethesafetylimitof105dbAcanresultin auditorydamage.Besuretouseearphonesatanappropriatevolumesoasnottoharmtheusers hearing.Theidealvolumeis85dB. The device should not be used by anyone who does not have a clear diagnosis of AutismSpectrumDisorder. Useonlyunderthesupervisionofanadulttoavoidasphyxiationordetachingandswallowingof sensors,andtoavoidthechildswitchingofforremovingtheheadbandinthemiddleofasession. Cleantheheadbandandsensorsregularlyusingaclothdampenedwithalcoholtoavoidbuildup ofbacteriaasdescribedinSection13. Cleanusersforeheadusingalcoholwipespriortostartingasessiontoenhanceconductivityandto avoidtransferofdirt,oilsorbacteriatotheheadband. Makesurethatthereisnohairbetweentheskinandthedrypadsensorsontheforehead.Thisis importantbecausehaircouldinterferewiththesignalbeingpickedupbytheelectrodes. DonotuseorweartheMenteAutismdevicewhilecharging.Asasafetyfeature,thisdevicedoes notworkwhilechargingasaninternalsystempreventsthis. MenteAutismsessionsshouldbecarriedoutasearlyaspossibleinthemorning.Thiswillensure thattheuserfullybenefitsfromtheeffectsofthetherapyduringtheday. Donotperformmorethanone40minutesessionaday.Multiplesessionsmaycauseheadaches anddisruptsleeppatterns. Sessionsmustbedoneeverydayforbenefitstobecomeapparentandconsistent. ItisimperativethatMenteAutismisusedwiththeearphonesprovided. ItisrecommendedthatmetalframedspectaclesarenotusedwhileusingMenteAutism.Iftheuser optstowearmetalframedspectacles,makesurethatthemetaldoesnottouchtheMenteAutism electrodes.Metalcanactasaconductorofanyelectricalleakages. Whenapopupappearsrequestingthatyoupositionasensorproperly,checkthatallthesensors aremakinggoodcontactwiththelocationsindicatedinthediagramsprovided. Checkthattheprovidedearphonesarefunctioningproperlyonaregularbasis,atleastonceaweek. The therapy consists of auditory stimulation and if sound cannot reach the user properly, the therapyisnoteffective. Whentakingtheheadbandoffafterasession,smallpressuremarksmightbevisibleontheusers forehead.Thesearetheresultofthesensorsputtingpressureontheforeheadastheheadbandis tightened.Thesepressuremarkswilldisappearafterafewminutes. Ensurethatyoursoftwareisuptodate.AATMedicalmayissuesoftwareupdatestoimprovethe performanceofthesystemandtointroducenewfeatures. Nomodificationofthisequipmentisallowed.Warrantyisforfeitedifthedeviceistamperedwith. Donotpointspraysornebulisersatthedevice;keepthedeviceclearofthesesubstances. USERMANUAL 5 Keepthedeviceawayfromsourcesofheatoropenflames. Useofthisequipmentadjacenttoorstackedwithotherequipmentshouldbeavoidedbecauseit could result in improper operation. If such use is necessary, this equipment and the other equipmentshouldbeobservedtoverifythattheyareoperatingnormally. PortableRFcommunicationsequipment(includingperipheralssuchasantennacablesandexternal antennas)shouldbeusednocloserthan30cm(12inches)toanypartoftheMenteAutismdevice and components (including earphones). Otherwise, degradation of the performance of this equipmentcouldresult. Keepthedeviceawayfromchildrenandpetswhennotinuseto minimizetheriskofmechanical damageduetomishandling. ItishighlyrecommendedthatashortEEGtestiscarriedoutinanappropriatecentreandthedigital file(.edfor.bdf)isuploadedbyamedicalprofessionalaccordingtoourQEEGprotocoldocument available on the medical professional dashboard. This will indicate whether the patient would benefitfromtheuseofMenteAutism. UseonlytheUSBadapterprovidedtochargethedevice.Othercommerciallyavailableadapters maynotmeetthesafetyrequirementsforusewithmedicaldevices.Donotchargethedeviceby connectingittoalaptoporcomputer. EnsurethattheMenteAutismdeviceisonlyswitchedonwhenitisalreadyplacedontheusers head. 6. Conditionsofuse Mente Autism must be used in normal temperature and pressure conditions (temperature range: 540C, humidity1593%,atmosphericpressure7001060hPa). 7. ContentsoftheBox Aprintedneopreneheadband,towhichthefivedetachablesensorsprovidedaretobeattachedonthe inner side. The sensors are internally connected to casing that holds the Mente Autism EEG chipset, WiFimoduleandbattery.TheheadbandcanbesecuredwithVelcrofrombothsidesoftheband,and shouldbecentredontheheadusingthebuckleatthebackoftheband,withthereferencemarkeratthe frontoftheband. Asmallboxwithfivesensors:threepaddedsensorstobeappliedatthefrontoftheheadandtwohard flexiblesensorstobeappliedatthebackofthehead. AUSBadapter,withmultipleconnections,andcableareprovidedtochargethedevice. Apairofinearearphoneswitha3.5mmjackisalsoincluded.Theseareintendedtobepluggedinthe casingpriortothedaily40minutesessionforthechildtoengagemoredeeplyinthetherapy,astheir auditorysystemisfullydedicatedtotheauditorystimulationgeneratedbytheMenteAutismdevice. NOTE:Theearphonesprovidedhave the followingcharacteristics:
Impedance:1632 Sensitivity:Atleast96dB/mW Frequencyresponse:2020000Hz Theydonotmakeanycontactwithanysensorwhenworn Theydonothaveametalframe Aquickstartanddailyusageguide,providingaquickexplanationongettingstartedwithMenteAutism aswellasanexplanationfordailyuseofMenteAutism. USERMANUAL 6 AnactivationcardwithaPINcodeandserialnumberthatmatchestheserialnumberontheheadband andpackaging.Thiscardistoberetainedinasecurelocationasthecardcontainsalldetailspertainingto theindividualdevice. AfabricpouchinwhichthecontentsoftheMenteAutismpackagecanbeplacedforeasytransportand storage. 8. TechnicalSpecifications&Requirements BrainActivityMonitoringFunctionality NumberofInputChannels:4 Bandwidth:0.140Hz SamplingRate:250Hz Resolution:24bit MeasurementNoise:for65HzBandwidth(gainof8V/V)24nV/Hz AmplifierInputImpedance:>500M Operatingfrequencyrange:(2.4122.462)GHz,Channel1to11 OtherTechnicalSpecifications Communication:WiFi TXpower:
18.0dBm@1DSSS 14.5dBm@54OFDM RXSensitivity:
95.7dBm@1DSSS 74.0dBm@54OFDM WiFiStandard:802.11b/g/n WiFiSecurity:WPA Output:Auditoryneurofeedbackrepresentation,htmlonlinereport OperatingTime:Daily40minutesessions Dimensions:(enclosure)56x42x23mm Weight:<100g OtherRequirements:
An Android tablet or smartphone with a stable connection to the Internet for downloading/installing the software,registeringMenteAutismanduploadingreportdatatoasecurecloudserver. AATMedicalrecommendsatabletorsmartphonewiththefollowingminimumspecifications:
CPU:MT8321,Quadcore@1.3GHzCortex SIMLocationandType:1xstandardSIM(3G) A7 RAM:1GB InternalStorage:8GB Resolution:1024x600pixels OperatingSystem:Android5.1,Lollipopor higher ApplicationStore:GooglePlay Internetbrowser:Chrome
/1xstandardSIM(2G) 3G/UMTS/WCDMAfrequencies:900/2100 MHz GSM/GPRS/EDGEfrequencies:850/900/
1800/1900MHz SMS/MMS:Yes WiFi:Yes,802.11b/g/n GPS:Yes BatteryLifeVideoPlayback:345min NOTE:AnInternetconnectionisusedtoregisterthedevice,logintoyouraccount,uploadsessiondatatothe cloudsystem,viewdailyreports,submitatechnicalsupportrequest,updateyourprofiledetailsandviewthe Resourcessection.AnInternetconnectionisnotrequiredtoperformtheMenteAutismtherapysessions themselves. USERMANUAL 7 9. DeviceDescription Headband 1) NeoprenebandwithVelcrostrapsandbuckle 2) 3paddedsensorstobeappliedatthefrontofthehead 3) 2hardflexiblesensorstobeappliedatthebackofthehead 4) Referencemarkerinthemiddleofthebandforcorrectsensorplacement 5) FabricLabelwithDeviceSerialNumber NOTE:TheSerialNumberincludesthedevicecode,batchcodeandproductnumber. Sensors 1) Detachablefromtheneopreneheadband 2) Allsensorsareconnectedontheinsideoftheband 3) 2typesincluded:
a. Paddedsensorforuseontheforehead b. Hardflexiblesensorforuseatthebackofthehead 4) TypeBFappliedpart 5) Deliverphysiologicalreadingsfromtheusertothedevice Battery Internallypoweredsource 1) Enclosedincase 2) 3) Changingofbatterybyauthorisedpersonnelonly 4) Chargingofbatteryonlybyprovidedcharger HeadbandCase 1) On/Offpushbutton 2) LEDindicators LED Colour Red Orange Orange(Flashing) Description Charging,notherapy Treatmentpaused Hardwarefault:
1Flash:ErrorrelatedtoRTCproblem 2Flash:ErrorrelatedtoSDCardunitproblem 3Flash:ErrorrelatedtoWiFiStationmode 4Flash:ErrorrelatedtoWiFiAPmode 5Flash:ErrorrelatedtoEEGfrontendinitialisation 6Flash:Errorrelatedtobatterycheckinitialisation Green Deviceonandconnected totablet/phone,notcharging Green(Flashing) Device inhotspotmodeand searchingfornetwork Figure1DeviceLEDlegend NOTE: Do not connect USB wire to the connector when the device is on or when wearing the device. Thedevicewillnotoperatewhilecharging. 3) CEmarkwithNotifiedBodynumber:Shownonthebottomofthecasing. USERMANUAL 8 4) Enclosures in Mente Autism are protected against the ingress of solid foreign objects of 12.5mm diameterandgreater,andisprotectedagainstverticaldropswhentheenclosureistiltedatanangleup to15fromitsnormalposition.ClassificationisIP22. WARNING:Donotopenortamperwithcase.Attemptingtoopenthecasewill voidthedevicewarranty. Openingofcasecanleadtopermanentdamagetothedeviceandcanonlybedonebyauthorisedpersonnel. PackagingLabel ProductLabel Figure2PackagingandProductLabels NOTE:ItemSerialNumberandIdentificationCodenumbershownherearefictitiousandforinformation purposesonly.RefertoSection17entitledSymbolsUsedforsymboldescription. USERMANUAL 9 10. InstallMenteAutismapp 1. FromtheAndroidsmartphoneortablet,gotoPlayStoreandsearchforMenteAutismapp Figure3:MenteAutismonPlayStore 2. ClickInstallandapopupwillbedisplayed,clickAcceptandwaituntiltheappdownloadsandinstalls ontheAndroidsmartphoneortablet. Figure4:AppinstallationAcceptanceScreen USERMANUAL 10 3. OncetheMenteAutismappisinstalled,clickonOpentoopentheMenteAutismappandaniconwill becreatedontheAndroidsmartphoneortablet.YoucanalsoclickontheicontoopentheMente AutismApp. Figure5:MenteAppCompletedInstallationScreen Figure6:MenteAppIcon 11. Registration 1. OpentheMenteAutismapp,tapontheRegisternowlink.Registerbyenteringthedetailsfoundon theactivationcardandyourpersonaldetailsintheformprovided. USERMANUAL 11 Figure7:MenteAppSignIn Figure8:MenteAutismRegistration 2. After registering, an activation email will be sent to the email address you provided. Clickonthelinktoactivateyouraccount.Registrationisnowcomplete. 12. HowtoUse a. ChargingtheDevice Priortoinitialuseofthe MenteAutismdevice,plugintheUSBcableprovided withtheMenteAutism headbandtotheUSBpoweradapterprovidedandchargeitcompletely(approximatelya3hourcharge time). NOTE:WhentheUSBchargingcableispluggedintotheMenteAutismdevicetheindicationlightontheMente Autismdeviceshouldturnred.Oncefullycharged,theredlightwillautomaticallyswitchoff.Thedevicewill notoperatewhilechargingtoensureusersafety. USERMANUAL 12 i. b. SensorPreparation DrypadSensors Thedrypad sensors may need hydration before theyare usedforthefirst time andatregular intervals.FollowtheSensorServicingstepsinSection13,Cleaning&MaintenanceInstructions. FlexSensors Placethesensorsbetweenyourthumbandyourindexfingerasperthephotosbelow.Pressgently withyourthumbtoopenandflexthesensor.Donotflexthesensorexcessivelytopreventany damagetothesensor.Thelegsofthesensorswilleasilybreakiftheyarebenttowardstheircentre ratherthantheirnaturaloutwarddirection.Usethephotosshownasaguide.Repeatthisprocess foratleast10timesincreasingthepressureslightly.Makesurethesensorisvisiblymoreopenat theend.Thecoatingsattheendofthesensorlegsaredesignedtoberubbedonskinandwillwear downonmoreabrasivesurfacesreducingsensorlifetime. ii. Figure9MenteAutismFlexSensorinitialusePreparation c. SensorAttachment Attach all sensors to the headband by connecting the snap of the sensor to the designated connectors intheband. Figure10MenteAutismSensorConfiguration d. HeadbandPlacing Theheadbandmaynowbeplacedonthechildshead:
i. ii. iii. Thebandshouldbeplacedontheheadwiththewhitereferenceline,locatedontheoppositesideof themiddlefrontsensor,placedinthemiddleoftheforehead,inlinewiththeusersnose. EnsuretheloweredgeoftheheadbandisjustabovetheeyebrowsasinFigure11Figure15below. TightlysecuretheheadbandusingtheVelcrostraps.Ensurethatthebuckleisplacedinthecentreof thebackofthehead. iv. Makesurethattheheadbandfitssecurelyandthatallsensorsaremakinggoodcontactwiththeskinat thepositionsindicatedinFigure18Figure23. PlugintheearphonesprovidedtothecasingontheMenteAutismdevice. v. USERMANUAL 13 NOTE:Thedeviceshouldalwaysbeplacedontheheadbeforebeingswitchedon.Onceitisswitchedon,the devicecanbemovedtoachievethecorrectpositioning. Figure11Correctheadbandplacement e. Pairingthedevice Thedevicemaybepairedwiththeappasfollows:
i. Switchonthesmartphoneortabletandopentheapp.Ifsigninginisrequired,insertyourusername andpasswordandtapthe'SignIn'button. Figure12:MenteAutismSignin Oncesignedin,youwillberedirectedtotheappshomescreen.SwitchontheMenteAutismheadband
(whenitisplacedonthehead)bypressingthepowerbuttonandfromtheapp,clickonConnectbutton. ii. USERMANUAL 14 Figure13:AppHomeScreen iii. ApopupwillbedisplayedandwaituntiltheMenteAutismappconnectstotheMenteAutismWiFi hotspot.TheLEDindicatorwillstartblinkinggreen. Figure14:ConnectingPopUp NOTE:EnsurethattheAndroidtabletorsmartphoneis connectedtotheMenteAutismdevicehotspot asper yourdeviceserialnumber.IftheapptakeslongtoconnecttotheMenteAutismdevicehotspot,connectto itmanually. USERMANUAL 15 iv. When both the Mente Autism device and tablet/smartphone are successfully connected, the LED indicatoronthedevicewillchangefromablinkinggreentoasolidgreen.Also,thewirelesssymbolon thetoprighthandcorneroftheappchangesfromredtogreenandthebatterylifeoftheheadband willbedisplayed.Thismeansthatthedeviceandtheapparepaired. Figure15:SuccessfulConnectionHomeScreen f. PreTherapyChecks Tapon'StartSession'.Thiswilltakeyoutoascreenshowingthefunctionalchecksthatareperformedbythe devicebeforeinitialisingasession.Pretherapychecksinclude:
SignaltestEnsuresthesignalcanbereadproperly. BiastestEnsuresthatthebiassensor(middlesensor)isconnectedproperly. NoisetestEnsuresallequipmentisconnectedandworkingproperly. BatterycheckEnsuresthereisenoughchargeforafullsession. AudiocheckEnsurestheearphonesareconnectedtotheMenteAutismheadband SensorImpedancecheckEnsurethatEEGsensorsareconnectedproperlytousershead NOTE:Thedevicehasthecapabilityofperformingselftestingforverificationoffunctionality.Priortothe startofeachsession,theinputsareshortedtogetheranddataissampledfromthesensors.Theinformation gatheredisusedtodeterminethelevelofnoiseappearingattheinputsandhenceistermedtheNoiseTest. Topassthetest,therecordedsignalmusthaveapeaktopeakvoltagelessthan2V.Similarly,thedeviceis capableofoutputtingtoeachoftheinputsaprecise1.95mVsquarewavesignal.Informationgatheredfrom theinputswhilstundergoingthistestisusedtoconfirmboththeamplitudeandoffsetofthesignalsbeing measured,henceverifyingthecalibrationofthedevice.ThistestistermedtheSignalTest.Topassthetest, therecordedsignalmustnotvarymorethan5%fromtheappliedsignal. USERMANUAL 16 g. SettingtheVolumeLimit Setthedesiredvolumeforthetherapysessionbyvaryingthevolumelimitontheappwhiletheuserlistensto thesoundbeinggeneratedbythedevice. NOTE:Thevolumecannotbevariedoncethetherapyhasbeenstartedandthereforecaremustbetakento ensurethattheusercanhearthesoundsproperlyandattherightvolumebeforeproceeding. h. StartSession Withallcheckscompleted,theStartbuttonwillbecomeavailableandtheusermaystartthetherapy. Figure16:FunctionalCheckScreen NOTE: If the noise and signal check remain red after restarting the device, please contact authorised personnel. i. Duringtherapyusage Oncethetherapybegins,theusercanmovearoundandtheappdoesnotneedtorelatetotheMenteAutism WiFihotspot.Itisonlyrequiredtomonitortheprogressofthetherapythroughtheappthustheusermuststay closetothetablet/smartphonedevice.Throughoutthesession,MenteAutismperformsimpedancechecksto ensuregoodsensorcontact.Ifaproblemisencountered,apopupwillappearontheappaskingyoutoadjust thesensorscontactwiththehead.Themisplacedsensorwillbemarkedinredintheimageprovided,andwill turnbacktogreenonceasuitableimpedancevalueisobtained.Theearphoneconnectionisalsomonitored.A similar popup will appear if the earphones are not connected to Mente Autism. When such problems are encountered,theLEDonthedevicewillturntoorange.Anyissuesduringtherapywillbepromptedontheapp, withthesystembeingpauseduntiltheissueisacknowledgedandresolved.Ifasensorisnotconnectedproperly USERMANUAL 17 orifthereisaproblemwiththetherapy,thelightonthedevicewillturnorange.Atthatpoint,aparentorcarer shouldreconnecttotheapptoseewhatiswrong. NOTE:Ifanyofthesensorpositionschecksareindicatedasred,pleaseadjustsensorpositionuntilallsensors aremarkedgreen. NOTE:Iftheaudiocheckisred,pleasemakesurethattheinearheadphonesarepluggedintotheMente Autismdevice. Figure17:SessioninProgressScreen Sensorlocationon headband Sensorlocationrelativeto typical1020EEGsetup 1 2 3 4 Fp1 O1 Fp2 O2 Figure18TopviewofMenteAutismdevicewith(A)Allsensorsdisconnectedand(B)Allsensorsconnected j. SessionEnding Afteracompletesession,theappwillshowapopupthatthesessionhasbeensuccessfullycompleted.TapOK andtheappwillredirectyoutothehomescreen.Thenthedevicewillautomaticallystarttransferringthedata fromMenteAutismtothetablet/smartphoneandapopupwillbedisplayed.Waituntilthetransferringofdata isready. USERMANUAL 18 Figure19:TransferringDataPopUp NOTE:DonotturnofftheMenteAutismheadbandwhiledataisbeingtransferredfromMenteAutism to tablet/mobileandkeeptheMenteAutismheadbandandappclosetoeachother. Once the data has been transferred successfully to thetablet/smartphone, a number will be shown on the Uploadbutton. SwitchofftheMenteAutismheadbandandconnectthetabletorsmartphonetoaninternetconnection. Figure20:UploadAvailabilityScreen PressontheUploadbuttontouploadthedatatotheCloudserverandapopupwillbedisplayed.Waituntilthe datahasbeensuccessfullyuploaded.NowthesessionreportcanbefoundintheHistorytab. USERMANUAL 19 NOTE:IfnoInternetconnectionisavailable,thedatacanbeuploadedlatertotheCloudserverhoweverthe reportwillnotbeavailable.Theappcanstoreamaximumof3sessionsinternally. k. PowerDown Thedevicewillautomaticallypowerdownifidlefor5minutes.Shouldyouwishtopoweroffthedevice manually,simplyholddowntheon/offswitchforafewsecondsuntilthegreenLEDturnsoff. l. LoggingOff IfyouwouldliketoLogOutfromyourprofile,taponthetoplefthandicontoopentheMenteAutismApp NavigationMenuandthentaponSignOut. Figure21:MenteAutismAppNavigationMenu 13. TheReport AvalidsessionproducesadailyreportthatcanbeviewedontheappundertheHistorytaborontheuser dashboardviawww.mentetech.comwebsite. USERMANUAL 20 Figure22:HistoryNavigationScreen NOTE:Bydefault,theHistorytabwilldisplaythelatestdailyreport. NOTE:ThedailyreportcanbeexportedinPDFformatviatheuserdashboard. Thefollowingisanexplanationofwhatthereportcontains. USERMANUAL 21 Figure23:MenteDailyReport Details of the user appear at the top of each report. These include name, age, gender and medical condition,aswellassessionnumberanddate.Thissectionisonlyincludedonthepdfformatonline. Fourtypesofwaveformsandtheirrolesindeterminingastateofmindaredescribed.Theyareassociated withauniquecolourthatisusedtodistinguishthemthroughoutthereport. USERMANUAL 22 Figure24:SessionOutcome Thesechartsindicatethepreandpostlevelsofbrainwaveactivityforalpha,beta,deltaandthetaas calculatedfromthetrendline.Prevaluesrepresentthebrainwavelevelsatthestartofthesessionand postvaluesrepresentthoseattheendofthesession. NOTE:Donotbealarmediftheresultsdonotshowadecreaseindeltaandthetaimmediately,especiallyin thefirstfewweeks.Thebrainisadynamicsystemwhichneedstimetoadapttothetherapy. USERMANUAL 23 Thissectioncontainsadviceaboutdeviceusetoensureoptimumresultsfromthetherapy.Thissectionis onlyincludedonthepdfformatonline. ThelastreportpagealsoincludesanAddedNotesSectiontoallowtheparentorcarertoinputsession details. NOTE:Avalidsessionisasessionwhichisgreaterthan10minutesandthathasatleast10minutescontinuous withoutinterruptionatanypointintime.Thedailyreportisgeneratedonlongestvalidsessionofthatday. NOTE:An invalidsessionisasessionwhichis less than10 minutes and thattherewas nota 10minute continuouswithoutaninterruption. 14. Cleaning&MaintenanceInstructions GeneralCleaning Thesensorsmustberemovedfromtheirsnapsafteruseandstoredintheboxprovided. Thesensorsshouldonlybeconnectedtothedeviceforuseandshouldbestoredinacoolplace,away fromdirectsunlight. Thesensorscanbecleanedwithalcoholwipesof70%concentrationorlessbyrubbinggentlyincircular motions.Donotsoakthesensorsinalcoholorwater. Theearphonesmustberemovedfromthedeviceafteruseandstoredintheboxprovided.Theearphones shouldonlybeconnectedtothedeviceforuse. Theearphonesmustberegularlycleanedandmaintainedtolastlongerandperformbetter. Cleaningoftheearphonescanbedonewithalcoholwipeswith70%orlessconcentration,andthisshould bedonebeforestoring. Theheadbandfabricshouldalsobecleaneddailyusingthesamealcoholconcentration(70%orless), especiallytheinsideoftheheadbandwherecontactismadewiththeskin. NOTE:Ensurethatthedeviceisturnedoff,withthesensorsremovedfromtheheadband,beforecleaningis performed. Disinfection Disinfectionofthefabricheadbandisalsorecommended.Whenthedeviceisusedbyonepersononly,itis recommendedtodisinfectitonceaweek.Whentheproductisuseddailybymultipleusers,suchasinaclinic setting, the headband, sensors and earphones should be disinfected each time the device is used. It is recommendedthatdisinfectionisdoneusingabaseofsodiumhypochlorite(forexample,a10%bleachsolution withactivesodiumhypochloriteatabout0.6%concentration)solution,intheformofwipesorspray.Thishas proventobesafeforbothelectrodesandheadband. USERMANUAL 24 NOTE: Avoid cleaning the white reference mark and the Mente Autism logo on the headband with the cleaningsolutionasthesemaybeerasedovertime. Itisalsopossibletousedisinfectionproductswhicharenotspecificallylistedinthissectionbutwhich havesimilaractiveingredientstothosementionedaboveandaremarketedformedicaluse. Todisinfect,mixthesodiumhypochloritedisinfectantwithcleanwaterasindicatedbythemanufacturer;
dampenaclothwiththecleaningsolutionobtainedandwipetheheadbandandelectrodesgently.Whenwiping theheadband,dothisslowlyincircularmovements.Wipeespeciallytheinternalpartoftheheadbandthat encounterstheskin.Donotspraythecleaningsolutiondirectlyontotheheadbandbecauseifliquidentersthe deviceenclosure,itmightcauseamalfunction.Itisimportanttoletthedevicedrycompletelybeforeuse. NOTE:Disinfectantscontainingmercury,phenols,bromine,iodine,zinc,tinandorganometalliccompounds shouldbeavoided. NOTE:Donotusesteamsterilizationastheelectrodesandcableinsulationmightnotwithstandtheheat. NOTE:Itisimportantthatnowater/cleaningagent/alcoholenterstheelectrodesand/ordevicecase.Ensure thattheclothbeingusedisonlyslightlywettominimisetheriskofthecleaningagentflowingintothedevice. NOTE:Theuseofincorrectsolutionconcentrationsortheimmersionofatransducertoagreaterdepthorfor alongerperiodthanindicatedintheinstructionscoulddamagethedevice. NOTE:Alwaysuseprotectivegogglesandgloveswhencleaninganddisinfectingofanydeviceorequipment. NOTE:Ifusingapremixedsolution,alwaysrespectthedisinfectantsUSEBYdate. Storage AftereachMenteAutismsession,storethedeviceinacooldryplace.ItisrecommendedthatMenteAutismis stored in the pouch provided with its original packaging. Sensors and earphones should be stored in their respectivecases. MaintenanceandServicing General maintenance: For Mente Autism to remain in good operable condition, it is necessary to take the followingprecautionarymeasures:
a. CleanMenteAutismdailyanddisinfectasinstructeddependingonthenumberofpeopleusingit. b. Avoid stretching the headband. The band should fit around the forehead and be secured with the Velcrostrapswithoutstretchingthem(similarly,itshouldnotbetootight). c. Avoidmishandlingofthebandandenclosure.Forthisreason,itshouldbekeptawayfromchildrenand petswhennotinuseandstoredsecurely. d. Avoidchargingthedeviceexcessivelydeviceistobechargedonlywhenrequired,asindicatedon software.Onceitischargeditshouldbedisconnectedandstored.Itshouldbeonlychargedusingthe USBadapterprovided. e. Uploadthedataregularly,ideallyaftereachsession.Uploadofdataisimportantsothatalluserreports anddataaresavedonthecloudsystem. SensorServicing:Forthesensorstoremainingoodoperablecondition,itisnecessarytotakethefollowing precautionarymeasures:
a. AllsensorsshouldberemovedattheendofeverysessionandstoredinthedesignatedSensorCase providedwiththedevice. b. Thesensorsshouldonlybeattachedpriortoatherapysession. c. Generalinspectionofthesensorsshouldbedonepriortoeverysession,toensurethatthesensorsare ingoodconditionforuse. Ingeneral,thedrypadsensorsshouldberehydratedwithtapwaterbyplacethemonadampsponge onceeverytwoweeks.Ifthecontactsurfaceisdeformed(seeimagesbelow),rehydrationisrequired. e. Forthebestresults,itisrecommendedthatthesetofsensorsischangedeveryeightmonths. d. USERMANUAL 25 Figure25DeformedSensors NOTE:RehydrationProcessDrypadsensorsarebestrehydratedbyplacingthemfacedownonadamp spongefor1015minutes.Drypadsensorsarerehydratedwhenthecontactsurfaceisplump(seeimages below):
Figure26RehydrationMethod Figure27RehydratedSensor Troubleshooting:
PleaserefertothetroubleshootingsectionontheUserDashboardunderTechnicalSupportsectionorforany otherproblems,fillinthetechnicalsupportform,availablebothonlineandthroughtheMenteAutismApp,and submitittothetechnicalteam. Servicing:
Whenyouencounterthefollowingproblems,contactyourlocaldistributorforservicing.Ifneeded,youwillbe providedwithatemporaryreplacementdeviceuntilyoursisrepaired.Ifthedamageisnotrepairable,review theproductwarrantywithyourlocaldistributortodefinenextsteps.Someservicingexamplesinclude:
a. b. c. d. e. Iftheon/Offswitchbecomesjammed,ortheLEDlightdoesnotlightupwhenthedeviceisswitched on, service repair personnel will replace the enclosure with a new one and attach it to existing headband. Ifoneormoresensorsarebroken,newsensorscanbepurchasedfromauthoriseddistributors,andmay beattachedaspernormalsensorconnectioninstructions. Iftheheadbandistorn,servicerepairpersonnelwillreplacetheheadband(withwiresandelectrodes) withanewoneandattachittoexistingdeviceenclosure. Ifthedeviceenclosurebreaks,servicerepairpersonnelwillreplacetheenclosurewithanewoneand attachtoexistingheadband. Ifboththeenclosureandheadbandaredamaged,e.g.,ifthedevicehasbeensubmergedinwater,the distributorwillreplacewithanewdevicedependingonthewarranty. Mente Autism should only be serviced by trained personnel appointed by the manufacturer. Contact your local distributor for more information. Service personnel are provided with all technical data needed for properservicingandmaintenance,uponrequest.Termsofpaymentforrepairandreplacementdependonthe warranty. USERMANUAL 26 LifeExpectancy The deviceslifeexpectancy dependsmostly on itsrechargeablebattery.Ithasa lifeexpectancyofat least 500fullcycles(charginganddischarging).Thus,itisrecommendedtochargethedeviceonlywhenrequired todosotomaximiselifespan. Disposal IfyouneedtodisposeofMenteAutismforanyreasonorifithasreacheditsendofservicelife,pleasereturn thedevicewithalloriginalcontentstotherespectivedistributororcontactAATMedicalLtdforproperdisposal of the device. Before returning the device, it should be cleaned and disinfected and placed in its original packagingorinasimilarcardboardboxthatisproperlysealedandlabelled.Thecourierusedtotransportthe devicesshouldbelicensedtocarrysuchdevices,i.e.,wasteelectricalandelectronicequipmentincludingLithium IonBatteries.ThedistributorwillreturnthereceiveddevicetoAATMedicalLtdwhichinturnwilldeliveritto theappropriatedisposalsitewhichprocesseselectricalandelectronicwasteaspertheDIRECTIVE2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on waste electrical and electronic equipment(WEEE). 15. ContinuousSupport Dataaccessoption The Mente Autism system ensures that users and their carers receive continuous regular support from our Supportteam.OurSoftwaredepartmentissuesregularupdateswhichwilleitherautomaticallyupdateyour softwareversionornotifyandinstructyouhowtodoso.Thesesoftwareupdatesareissuedinresponsetothe regularfeedbackandsuggestionsprovidedbyusers,aswellasnewfeaturesandperformanceoptimisationof MenteAutism. DuringRegistration,theuserisrequiredtoentertherequestedpersonaldetails.Followingthis,theuserisasked toreadandacceptthetermsandconditionsofuse.ThiswillallowAATMedicalLtdtomonitortheusersprogress;
uponrequest,adetailedreportthatsummarisesthisprogresscanbeprovidedtotheuser. Inappsupport Theapplicationitselfalsogivestheoptiontoreviewdailyprogress.ThisisavailablefromtheHistoryscreen, whereyoucanaccesssummaryreportsofallthesessionsdone. WebsiteSupportFeatures Byloggingintothewebsiteatwww.mentetech.comandusingyourUsernameandPassword,youcanaccess severalusefulfeatures. Youcanviewandaccesssessionreportsafteruploadingthedatafromtherespectivedevice. Manuals,guidesandothermaterialcanalsobedownloadedfromtheResourcessectionofthedashboard. Thewww.mentetech.comwebsitecanalsobeaccessedbyqualifiedclinicalprofessionalswhocanaccessthe usersdataforanalysis(subjecttousers/carerspermission)aswellasrawEEGandthedailyreports. NOTE: It is advised that data represented by the Raw EEG is always interpreted by a qualified medical professional. NOTE:ItishighlyrecommendedthatbeforepurchasingMenteAutism,ashortEEGtestiscarriedoutinan appropriatecentreandthedigitalfile(.edfor.bdf)isuploadedbyamedicalprofessionalaccordingtothe QEEGprotocoldocumentavailableonthemedicaldashboard.Thiswillindicatewhetherthepatientwould benefitornotfromtheuseofMenteAutism. Toincludeaclinicianintheportal,theusermustsendarequesttotheClinicianviathedashboard.Uponrequest approval,theUsersdatawillbemadeavailabletotheMedicalProfessional. USERMANUAL 27 NOTE:Userscansendrequeststoregisteredclinicians.However,theycanalsorecommendunregistered clinicianstobeaddedtotheMentedatabase. Feedback TheAATMedicalteamistrainedtohelpyoumaximiseusageoftheMenteAutismsystemandobtainthebest possibleresults.Wedesignanyproductiterationswithourusersinmind.Therefore,wegreatlyappreciateyour commentsandfeedback.BycompletingthesimplequestionnairesentfromtimetotimethroughtheMente Autismapporbyemail,youcanhelpguideusonwhatcouldbedonetoimproveourproducts.Yourfeedback willhelpusdesignanddevelopfutureversionsoftheproduct. Additionally,theMenteAutismsoftwarehasafeaturewherebythedatauploadofthedevicewithitscloud systemenablestheAATMedicalteamtoeasilymonitorsessionreportsandensurethatthedesiredoutcomeis obtained. FrequentlyAskedQuestions AcomprehensivelistofFAQsisavailableonthewebsite,www.mentetech.com.Thislistisregularlyupdated. ContactingSupportatAATMedicalLtd CustomerswithsupportrequestsshouldfillinthesupportformontheuserdashboardorontheMenteAutism App.AlternativelytheycancontactthedistributororresellerfromwhomtheypurchasedMenteAutismwith theirquery,orcancontactAATMedicalLtddirectlyonsupport@mentetech.com. 16. WhattoExpect MenteAutismaffectseachchilddifferently.Generally,itmighttakeafewweeksforanypositiveeffectstobe observedinthechildsbehaviour,althoughsomeparentshavereportedimprovementsafterafewdays. AfterrepeateduseofMenteAutism,thechildisexpectedtofeelmorerelaxed.Asaconsequenceofthis,our experienceandreportsfromparentsandcarersrevealthatusersaremorerelaxedandshowimprovementin oneormoreofthebelow:
a. Greaterfocusandconcentration b. Betterunderstanding c. Betterspeechabilities d. Morecommunicative e. Improvedsocialskills f. Increasedshowofaffection g. Improvedacademicskills ReportsmaynotalwaysshowdecreasinglevelsofDeltaactivity,especiallyinthefirst4to8weeksofusing MenteAutism;thishappensuntilthebodyadaptstothedevice.Thisisperfectlyfineasthehumanbrainisa dynamicsystem. USERMANUAL 28 17. BatteryOperating/SafetyInstructions ChargingtheBattery:
Batterychargingwilldisabletheuseofthedevice,i.e.,whenthedeviceisONandpluggedinforcharging,the devicewillautomaticallyswitchOFFuntilrechargedandUSBconnectorunplugged.Thisistoensurepatient safety.Nonetheless,donotuseorweartheMenteAutismdevicewhilecharging. The battery charger must be connected to the micro USB connector located at the side of the MenteAutismcasing. ThebatterystateofchargeismeasuredbythesoftwarewhilethedeviceispoweredON. The charging LED located near the connector is red when charging and off (no light) when its fullycharged. It should be notedthatthebattery willbe overdischarged if the deviceis not usedfor a long time. Topreventoverdischarging,thebatteryshouldbechargedperiodically. Overdischarging may cause loss of cell performance, or damage battery function. Expectedlifecycle>500cycles>70%ofinitialcapacity. Chargingwithahighervoltagethanspecifiedmaycausedamagetocell. The usual time to charge a battery from the cutoff voltage to the maximum capacity is around 3hours,butitdependsoneveryspecificbattery(batterylifeandmemoryisafunctionoftime). ThesystemcanbeconnectedtoanyClass2electricalinstallation. OperatingTemperature StorageTemperature Charging:5C40C Discharging(DuringUse):5C40C 1yearat25C 70C Mente Autism Specifications Electrical Charging VoltageInputnominal:5VDC Voltageinputmin/max:4.25V 7V Powerinput:2.5W USERMANUAL 29 18. SymbolsUsed SO7010W001WarningsignalaccordingtoUNEEN606011=2008Partsmarkedwiththis symbolarenotprotectedagainstdefibrillator. DevicemanufacturersymbolaccordingtoUNEEN980 ISO70001641readinstructionsbeforeusesymbolaccordingtoUNEEN980 ISO7010M002Followinstructionsforusesymbol DateofManufacturingsymbolaccordingtoUNEEN980 Donotthrowawayingenericwastesymbol. WARNING!Whenyouwanttodisposeofthedevice,NEVERthrowitinthetrash,butgo to the RECYCLABLE POINT or the nearest waste collection for further treatment, thus contributingtoenvironmentalcare.Ideally,returndevicetodistributorwhowilldispose ofitappropriately. CEmarkeddevicecertifiedbytheNotifiedBodyn.0426oftheEuropeanCommunity. SO70002498SerialNumberaccordingtoUNEEN980 TypeBFAppliedpart ISO 70002606 do not use device if product or packaging have been damaged symbol accordingtoUNEEN980 Device isprotectedagainst the ingressofsolidforeign objectsof 12,5mm diameter and greater,anditisprotectedagainstverticallyfallingwaterdropswhenenclosureistiltedat 15o. Donotwash Donotiron Keepawayfromsunlight USERMANUAL 30 Keepawayfromrain ClassIIequipment Notmadewithnaturalrubberlatex ThedeviceshouldonlybestoredandusedwithintheTemperaturelimitsof25Cand70C ThedeviceshouldonlybestoredandusedwithintheHumiditylimitsof15%and93%
ThedeviceshouldonlybestoredandusedwithintheAtmosphericPressureLimitsof70kPa and106kPa Thedeviceisratedforaninputdirectcurrentvoltageof4.25V7Vand2.5Wmaximumpower rating Batchcode/Lotnumber On/OffPushButton Auxiliaryjackinputforearphones USBJackInput USERMANUAL 31 19. EMC MenteAutismissuitableforuseinaspecifiedelectromagneticenvironment.MenteAutismusersshouldensure thatitisusedinanelectromagneticenvironmentasdescribedbelow:
EmissionsTest Compliance ElectromagneticEnvironmentGuidance RFEmissions CISPR11 Group1 RFEmissions CISPR11 HarmonicEmissions IEC6100032 Voltagefluctuations/
flickeremissions IEC6100033 ClassB ClassA Complies Mente Autism only uses RF energy for its internal function. Therefore,itsRFemissionsareverylowandare not equipment. in nearby electronic likely to cause any interference MenteAutismissuitableforuseinallestablishments,including domestic establishments and those directly connected to the publiclowvoltagepowersupplynetworkthatsuppliesbuildings usedfordomesticpurposes. MenteAutismissuitableforuseinaspecifiedelectromagneticenvironment.MenteAutismusersshouldensure thatitisusedinanelectromagneticenvironmentasdescribedbelow:
ImmunityTest Electrostatic discharge(ESD) IEC6100042 IEC6060112 TestLevel 6kVcontact 8kVair ComplianceLevel 6kVcontact 8kVair Electricalfast transient/burst IEC6100044 Surge IEC6100045 2 kV for power supply lines 1 kV for input/
outputlines 2 kV for power supply linesN/A 1 kV differential mode 2kVcommonmode 1 kV differential mode N/A Voltagedips, shortinterruptions andvoltage variationson powersupply inputlines IEC61000411
<5%
(>95%dipin) for0,5cycles 40%
(60%dipin) for5cycles70%
(30%dipinU) for25cycles
<5%
(>95%dipin) for5secs
<5%
(>95%dipin) for0,5cycles 40%
(60%dipin) for5cycles70%
(30%dipin) for25cycles
<5%
(>95%dipin) for5secs NOTE:UistheA/Cmainsvoltagepriortoapplicationofthetestlevel. Electromagnetic Guidance Environment Floorsshouldbewood,concrete, or ceramic tile. If floors are covered with synthetic material, therelativehumidityshouldbeat least30%. Main power quality should be that of a typical commercial and/orhospitalenvironment. Main power quality should be that of a typical commercial and/orhospitalenvironment. Main power quality should be that of a typical commercial and/or hospital environment. If the user of Mente Autism requires continued operation duringpowermaininterruptions, it is recommended that the MenteAutismimageintensifieris poweredfromanuninterruptible powersupplyorabattery. USERMANUAL 32 MenteAutismissuitableforuseinaspecifiedelectromagneticenvironment.MenteAutismusersshouldensure thatitisusedinanelectromagneticenvironmentasdescribedbelow:
ImmunityTest IEC6060112 TestLevel ComplianceLevel Electromagnetic Guidance Environment ConductedRFIEC 6100046 Vrms 50kHzto80MHz 3Vrms RadiatedRFIEC 6100043 3V/m 80MHzto2,5GHz 3V/m 80MHzto1GHz Separation and mobile Portable RF communications equipment can interfere with Mente Autism type of communication. This cables, equipment, including should be kept distant from Mente Autism with at least the separation recommended the from distance calculated equation appropriate for the frequencyofthetransmitter. Recommended Distance d=1,2P d=1,2P 80 MHz to 800 MHz d=2,3P800MHzto2,5GHz WherePisthemaximumoutput power rating of the transmitter in watts (W) according to the transmittermanufactureranddis the separation distanceinmetres(m). Field strengths from fixed RF transmitters,asdeterminedbyan electromagnetic site survey (a), less should the be compliance each level frequencyrange(b). Interference may occur near equipment marked with the followingsymbol:
recommended than in
(a)Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthoutsidetheshieldedlocationinwhichMenteAutismisusedexceedsthe applicableRFcompliancelevelabove,MenteAutismshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasures maybenecessary,suchasreorientingorrelocatingMenteAutism.
(b)Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m. NOTE:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorption andreflectionfromstructures,objectsandpeople. MenteAutismisintendedtobeusedinacontrolledradiatedRFenvironment.MenteAutismuserscanhelp prevent electromagnetic interference by keeping a minimum distance between the portable RF device
(transmitter) and Mente Autism as recommended below, according to the maximum output power of the communicationsdevice. USERMANUAL 33 RatedMaximum OutputPowerof TransmitterWatts SeparationDistance Metres 150kHzto80MHz d=1,2P 150kHzto800MHz d=1,2P 800MHzto2,5GHz d=2,3P 0.01 0.1 1 10 100 0,12 0,38 1,2 3,8 12 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 23 Fortransmittersratedatamaximumoutputpowernotlistedabove,theseparationdistancecanbeestimated usingtheequationinthecorrespondingcolumn,wherePisthemaximumoutputpowerratingofthetransmitter inwatts(W)accordingtothetransmittermanufacturer. NOTE:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorption andreflectionfromstructures,objectsandpeople. 20. FCCStatement FCCID:2AN82MENTE003 ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowingtwoconditions:
(1)thisdevicemaynotcauseharmfulinterference,and
(2)thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation. ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttoPart 15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferencein aresidentialinstallation.Thisequipmentgenerates,usesandcanradiateradiofrequencyenergyand,ifnot installedandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications. However,thereisnoguaranteethatinterferencewillnotoccurinainstallation. Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedby turningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreof thefollowingmeasures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. Toassurecontinuedcompliance,anychangesormodificationsnotexpresslyapprovedbythepartyresponsible forcompliancecouldvoidtheusersauthoritytooperatethisequipment. RadioExposureStatement:
This equipment has been tested and shown to comply with FCC radiation exposure limits set forth for an uncontrolledenvironment(*).Usersmustfollowthespecificoperatinginstructionsinthismanualforsatisfying RF exposure compliance, especially with regard to positioning the equipment. No other than accessories described device.
(*furtherinformationaboutrelatedtestoftheequipmenttoapplicableFCClimitsandresultscanbeobtained fromthepublicFCCEquipmentAuthorizationsystemhomepagebyfilteringfortheFCCIDofthedevice.) manual used shall with this the be in USERMANUAL 34 MODIFICATION:
Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheusers authoritytooperatetheequipment. 21. ChangeRecord Issue 1.0 2.0 Date 06/09/2016 23/03/2017 ChangesMade Firstversion WiFi optionupdate USERMANUAL 35 AUTISM AATMedicalLtd BlockLS3,MaltaLifeSciencesPark, SanGwannIndustrialEstate, SanGwann,SGN3000Malta Tel:+35621330588 Email:info@mentetech.com www.mentetech.com AATMedicalLtdisawhollyownedsubsidiaryofNeurotechInternationalLtd. USERMANUAL 36
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-02-20 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-02-20
|
||||
1 | Applicant's complete, legal business name |
AAT Medical Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0026988097
|
||||
1 | Physical Address |
AAT Medical Ltd, Block LS3, Life Sciences Park
|
||||
1 |
San Gwann, N/A SGN3000
|
|||||
1 |
Malta
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
f******@us.tuv.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AN82
|
||||
1 | Equipment Product Code |
MENTE003
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D**** R******
|
||||
1 | Title |
Head of R&D
|
||||
1 | Telephone Number |
+356 ******** Extension:
|
||||
1 | Fax Number |
n/a********
|
||||
1 |
m******@mentetech.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
AAT Medical Ltd.
|
||||
1 | Name |
D******** R******
|
||||
1 | Physical Address |
Malta
|
||||
1 |
m******@mentetech.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/19/2018 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Mente Autism | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power Output listed is conducted. End-users must be informed of the operating requirements for satisfying RF exposure compliance. The highest reported SAR value is 0.1 W/kg (head). | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
TUV Rheinland of North America Inc.
|
||||
1 | Name |
D**** S****
|
||||
1 | Telephone Number |
(925)********
|
||||
1 | Fax Number |
925 2********
|
||||
1 |
d******@us.tuv.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.2040000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC