BIOSENCY Bora band BB100 User Manual
Oximeter & heart rate and respiratory rate sensors
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Table of Contents
Troubleshooting
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- Page 1 Connected device Connected device Oximeter & heart rate and Oximeter & heart rate and respiratory rate sensors respiratory rate sensors Bora band® Model BB100 User manual User manual BORA-Band-IFU-EN-8.0 - 08/2024 VERSION 8.0 August 2024...
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Page 3: Table Of Contents
TABLE OF CONTENTS TABLE OF CONTENTS I I ntroduction ntroduction About this manual ....................6 Intended use......................6 Targetpopulation ....................7 Counterindications ....................8 Sideeffects ......................8 About Bora band® technology ................. 8 PresentationofBoraband PresentationofBoraband® Model BB-100 Model BB-100 .......................... - Page 4 Dataconsultation Dataconsultation ........................................24 24 Healthcareprofessionalsandstakeholders ............24 Patient ........................24 Cleaning Cleaning ..............................................24 24 Cleaning the case ....................24 CleaningtheBB100SandBB100SLfabricstrap ............. 24 Cleaninganddisinfectionbetweenpatients Cleaninganddisinfectionbetweenpatients ........................25 25 Disinfectingthecase....................25 BB100SfabricstrapandBB100SLfabricstrap ............25 Storage Storage ..............................................
- Page 5 TABLE OF FIGURES TABLE OF FIGURES Figure1:PresentationofBoraband® ..............9 Figure 2: Bora band® serial number ..............10 Figure 3: Pairing the Bora band® ................12 Figure 4: Fastening thefabricstrap ..............13 Figure5:Adjustingthelengthofthefabricstraponthewrist ......14 Figure6:WearingtheBoraband®onthewrist ............ 14 Figure 7: Adjustingthelengthofthefabricstraponthearm ....... 15 Figure 8: Wearing the Bora band®...
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Page 6: Ntroduction
Introduction Introduction About this manual ThismanualisauserguidefortheBoraband®ModelBB100wearabledevice,designedby Biosency. INSTRUCTIONS FOR USE PleasedonotusetheBoraband®wearabledevicewithoutfirstreadingandunderstanding alloftheinstructionscontainedwithin. PleasealwaysusetheBoraband®inaccordancewiththeinstructionscontainedwithin thismanual,whichincludeswheretolocateandplacetheoximeter.Failuretofollow theinstructionsinthismanualmayresultinmalfunctions,includinginaccuratereadings. TheBoraband®deviceshouldonlybeusedwiththeequipmentsuppliedbyBiosencyand theapplicationsdevelopedbyBiosencyoritspartners. Toensuresafeandoptimaluseofthedevice,pleasecarefullyreadtheprecautionsforuse markedwithan symbol. Created by Yudhi Restu Pebriyanto from the Noun Project Intended use Boraband®isawearabledeviceusedformeasuring(intermittentdatacollection),recording, processingandstoringphysiologicalparametersthatwilllaterbetransmittedtoaweb platformforremotereviewtosupportthefollow-upofthepatient’scare.Thereisnodisplay on Bora band®. Boraband®measures,recordsandprocesses: • functionaloxygensaturationofarterialhaemoglobin(%SpO • heartrate(HR),... -
Page 7: Flammable Substances
WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project MAGNETIC RESONANCE IMAGING DonotusetheBoraband®duringsurgeryorinamagneticresonanceimaging(MRI)setting. DEFIBRILLATION DonotusetheBoraband®duringdefibrillationproceduresasthisdeviceisnotshockproof (inaccordancewithIEC60601-1). ELECTROSURGERY Do not use the Bora band® during electrosurgery. FLAMMABLE SUBSTANCES Toavoidtheriskofexplosion,donotusetheBoraband®inthepresenceofflammable anaestheticsorotherflammablesubstances,orwithinoxygenornitrousoxide-enriched environments. COMPLEMENTARY DEVICE FOR PATIENT DIAGNOSIS Thisdeviceshouldbeusedinconjunctionwithothermethodsfortheassessmentof symptoms and clinical evidence. Targetpopulation Thedevice,whichisprescribedbyadoctor,isintendedtomeasurethecardio-respiratory parametersofpatientssufferingfromchronicrespiratorydisease.Thepatientsareadults... -
Page 8: Continuous Monitoring
Contraindications TheBoraband®doesnottriggeranalarmanddoesnotallowforcontinuousreadings. TheBoraband®isnotdesignedtocontinuouslymonitorpatientvitalsigns.TheBoraband® isnotintendedforuseinpatientswithlowperfusion. WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project ALARM Donotusethedevicewhenalarmsarerequired. CONTINUOUS MONITORING DonotusetheBoraband®forcontinuousmonitoringpurposes.TheBoraband® isintendedtoperiodicallyrecordphysiologicalparameters(SpO ,respiratoryrate, heartrate,temperature).Noalarmisprovidedtoallowcontinuousmonitoring. Sideeffects Skinirritation,superficialburnandtemporaryinjurymayoccur. Whennotusedasintended,adelayinpatientcaremayoccur. About Bora band® technology TheBoraband®pulseoximeterisacommunicationdevicedesignedtobewornonthewrist or armandacquirereal-timereadingsseveraltimesaday,whilemaintainingusercomfortat alltimes. The Bora band® has three sensors: • Aphotoplethysmography(PPG)sensor,formeasuringSpO and heart rate • A6-axisinertialmeasuringunit,tocountsteps,monitorphysicalactivityandmeasure... -
Page 9: PresentationOfBoraBand PresentationOfBoraBand® Model Bb-100 Model Bb-100
PresentationofBoraband PresentationofBoraband® ® Model BB-100 Model BB-100 Case andheartratesensorwindow Fabric strap Temperature sensor Button Micro-USB B Port Indicator light Figure1:PresentationofBoraband® VERSION 8.0 August 2024... -
Page 10: Standard Bora Band® Kit
Upondelivery,pleaseensurethatthefollowingpartsandelementsarepresent. Pleasecontactthecarrierimmediatelyifthepackageisdamaged. Kit equipment: Kit equipment: • 1Boraband®,connecteddevice,oximeterandheartandrespiratoryratesensor • 1BB100S,fabricstrap • 1BB100SL,fabricstrap • 1BB100DC,ACadaptorconformingtoIEC60601-1-1 • 1BB100UC,microUSBcable • 1BB100IFU,Usermanual(thisdocument) • 1BB100QUG,Quickuserguide(patient) Equipment TheBoraband®cannotbeusedwithelementsotherthanthosesuppliedbyBiosency. Model number Model number Description Description BB100DC ACadaptor,IEC60601-1-1compliant BB100UC Micro USB cable BB100S Fabric strap BB100SL Fabric strap... -
Page 11: BoraBand®DataFeedback BoraBand®DataFeedback
Bora band® ® datafeedback datafeedback ThedatastoredinBoraband®istransmittedviaamobileapplicationoradata feedbackterminal. Ifdatafeedbackisviaamobileapplication,themobileapplicationmustbeinstalledon aphoneortabletandBoraband®mustbepairedwithit. Theinstallationandpairingprocedurevariesdependingonthemobileapplicationused: • Boraconnectforhomeapplication • Boraconnect®application • Thapartnermobileapplication Ifthedatafeedbackissentviaadatatransmissionterminal,itisnotnecessarytopair Bora band®. Boraconnectforhome TheinstallationoftheapplicationandpairingofBoraband®arealreadydonebyyour healthcareproviderorbytheBiosencyteamsinceyouareusingaBorabox™,amobile phoneprovidedandconfiguredbeforehandbyBiosency. Bora connect® Installationoftheapplication Installationoftheapplication Theusershouldinstalltheapplicationontheirmobilephone(theuseoftheSamsungGalaxy A20ephoneisrecommended)oronatablet.TheappisavailableontheGooglePlayStore. TypeBoraconnect®inthestoresearchbar.Makesurethattheapplicationfoundisindeed publishedbyBIOSENCY.Followthestoreinstructionstoinstalltheapp. Inordertoensuretheapplicationworkscorrectly,themobilephoneonwhichBoraconnect® isinstalledmusthavethefollowingminimumtechnicalcharacteristics: • 1.4 GHz processor • RAM: 2GB • Resolution:360x640pixels • Bluetooth®:4.2(BLE) -
Page 12: MobileApplication
PairingoftheBoraband® PairingoftheBoraband® Boraband®mustthenbepairedwiththisphoneortablet.Todothis,thefirsttimeyouuse theapplication,youwillbeaskedtopairaBoraband®:fillintheserialnumberwhichisunder Boraband®asshowninFigure2:Boraband®Identificationnumber. Figure 3: Pair a Bora band® Inorderfordatatransfertotakeplace,makesurethatBoraband®isinthesameroomand closeto(lessthan10metres)thelaptoportablettowhichitisconnected. Dataaccessforpatient Dataaccessforpatient Itispossibletocheckthecorrectfunctioningoftheservicethankstothemobileapplication: itmustindicatethatBoraband®isconnected.Thismobileapplicationallowsyoutoconsult your physiological data. Formoreinformationontheinstallationanduseoftheapplication,refertotheBora connect® user manual. Partnermobileapplication Boraband®canbepairedwithmobileapplicationsdesignedbypartners.Pleasereferto theinstructionforuseoftheseapplicationsforasafecombinationwithBoraband®. Datafeedbackterminal Thedataterminalisinstalledbyyourselforyourhealthcareproviderinyourhome. Youdon’tneedtolinkBoraband®totheterminaltobeabletouploadyourdata. Formoreinformationoninstallingthedataterminal,pleaserefertotheusermanual. VERSION 8.0 August 2024... -
Page 13: Wearing The Bora Band Wearing The Bora Band
Wearing the Bora band Wearing the Bora band® ® AttachingtheBB100SandBB100SLfabricstrap Figure4showshowtoattachthefabricstrap to the Bora band® case. Figure4:Attachingthefabricstrap VERSION 8.0 August 2024... -
Page 14: AdjustingTheLengthOfTheFabricStrapOnTheWrist
Adjustingthelengthofthefabricstraponthewrist AdjustthesizeofthefabricstrapasillustratedinFigure5below. • Undothefabricstrap’sVelcrofasteningandadjusttothesizeofyourwrist,thensimply secure back in place. • Toensureoptimalcomfortandreadingaccuracy,makesuretheBoraband®fitssnugly onyourwrist(neithertootightnortooloose). Figure5:Adjustingthelengthofthefabricstraponthewrist PositioningtheBoraband®onthewrist TheBoraband®iswornonthebackoftheforearm,slightlybelowthewristbone,as illustratedbelowinFigure6.Thisplacementensuresoptimalcomfortandreadingaccuracy. TheBoraband®canbewornontheleftorrightwrist. Figure6:WearingtheBoraband®onthewrist VERSION 8.0 August 2024... -
Page 15: AdjustingTheLengthOfTheFabricStrapOnTheArm
Adjustingthelengthofthefabricstraponthearm AdjustthesizeofthefabricstrapasillustratedinFigure7below. • Undothefabricstrap’sVelcrofasteningandadjusttothesizeofyourarm,thensimply secure back in place. • Toensureoptimalcomfortandreadingaccuracy,makesuretheBoraband®fitssnugly onyourarm(neithertootightnortooloose). Figure7:Adjustingthelengthofthefabricstraponthearm PositioningtheBoraband®onthearm TheBoraband®iswornontheupperarm,slightlyabovetheelbow,asshownbelowin Figure8.AvoidwearingtheBoraband®onthebiceps. Thisplacementensuresoptimalcomfortandreadingaccuracy. TheBoraband®canbewornontheleftorrightarm. Figure 8: Wearing the Bora band® on the arm VERSION 8.0 August 2024... - Page 16 WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project ALLERGIES Thisdeviceshouldnotbeusedbypeoplewithknownallergiestothefabricstrapmaterial (polyamide)orcase(Polycarbonate/ABS-SEBS). SKIN SENSITIVITY Monitortheskincontactareacloselytoensurenosensitivityoccurs.Ifirritationoccurs, checkthecleanlinessofthesensor,andcleanthedeviceifnecessary.Shouldtheproblem persist,pleasecontactasalesrepresentative. FASTENING TOO TIGHT Donotovertightenthedevice.Fasteningthedevicetootightlycancausediscomfort. FACTORS THAT MAY NEGATIVELY EFFECT DEVICE PERFORMANCE: FASTENING INCORRECT Thedevicemustbetightenoughsothatitdoesnotslideontheskinbutshouldnotcause anycompressionmarks.Tootightortoolooseafasteningcannegativelyaffectthedevice’s performance. FACTORS THAT MAY NEGATIVELY AFFECT THE PERFORMANCE OF THE PULSE OXIMETER: SIGNIFICANT TATTOOS OR EXCESS HAIR Donotplacethisdeviceonatattoooranareawithsignificanthairgrowth.Atatooand...
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Page 17: Removing The Bora Band® FromTheWrist
Removing the Bora band® fromthewrist Torelease,undotheVelcrofasteningsonbothsidesofthefabricstrap(asshowninFigure9). Figure 9: Removing the Bora band® fromthewrist RemovingtheBoraband®fromthearm Torelease,undotheVelcrofasteningsonbothsidesofthefabricstrap(asshowninFigure10). Figure10:RemovingtheBoraband®fromthearm OperatingtheBoraband OperatingtheBoraband® ® StartingtheBoraband® Makesurethatthedeviceisnotconnectedtothemains,thenstartitbypressing thebutton(3).Theindicatorlight(4)flashesgreen,indicatingthatBoraband®isstartingup, thenremainssteadyfor3seconds,indicatingthatBoraband®hasswitchedon. What you need to do What you need to do What you see What you see Meaning Meaning Pressbutton(3) Bora band®... -
Page 18: Troubleshooting
4 Indicator light 3Button Figure11:SwitchingonBoraband® Onceswitchedon,theBoraband®automaticallycollectsandrecordsreadingsforoxygen saturation(SpO2)levels,heartrate,respiratoryrate,skintemperature,numberofsteps andactivity. Inordertobeasdiscreetaspossible,theBoraband®indicatorlight(4)goesoutonceithas started up. WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project TROUBLESHOOTING TROUBLESHOOTING Ifthedevicedoesnotperformasexpected,refertotheTroubleshootingsectionor discontinueuseandcontactasalesrepresentative. PRECAUTIONS PRECAUTIONS Created by Yudhi Restu Pebriyanto from the Noun Project EXPOSURE TO LIQUIDS Donotsubmergethedeviceinwateroranyotherliquidsolutionasthiswillcause permanent damage. -
Page 19: TurningOffTheBoraBand
FACTORS THAT MAY NEGATIVELY EFFECT PULSE OXIMETER READINGS Thisdeviceisintendedtodeterminetheamountofoxygen-carryinghaemoglobinin theblood.Somefactorsmaynegativelyaffecttheoximeter’sperformanceorreading accuracy. These include: • Movement • Moisture in the sensor • Electrosurgicalinterference • Restrictedbloodcirculation(arterialcatheters,bloodpressurecuffs,infusiontubing,etc.) • Anaemiaorlowhaemoglobinlevels • Weakened pulse rate • Indocyanine green or other intravascular dyes • Carboxyhaemoglobin • Methaemoglobin • Dysfunctionalhaemoglobin • Venouspulsations • Residueonthesensorwindow(5) -
Page 20: IncorrectOperation
4 Indicator light 3Button Figure12:TurningofftheBoraband® Malfunction Intheeventofmalfunction: • Stop using the device immediately. • Trytoidentifyoreliminatethecauseusingthisdocument(refertotheTroubleshooting section). • Ifitisnotpossibletoidentifyoreliminatethecauseusingthisdocument,turnoff thedeviceandcallasalesrepresentative. Chargingthebattery Lowbatteryindicator Lowbatteryindicator TheindicatorlightflashesORANGEwhenthebatteryislow(lessthan20%batterylife remaining). What you see What you see Meaning Meaning What you need to do What you need to do Charge the device as Thebatteryislow describedbelow... -
Page 21: Charging The Device
Device charging Tochargethedevice,proceedasexplainedinthefigurebelow. 2/Connectoneendofthemicro-USB 1/Taketheitemsoutofthepackaging cabletothepoweradapter 3/ConnecttheotherendofthemicroUSB 4/Connecttothepowersupply cable to the USB port on Bora band®. Make sure you place the cable the right wayroundinrelationtoBoraband®port. Figure13:Chargingthebattery VERSION 8.0 August 2024... -
Page 22: Battery Charging
Charging the Bora band® takes approximately 2 hours. TheautonomyoftheBoraband®batteryismorethan3days. NOTE: NOTE: 1.Ifyouarechargingthedeviceforthefirsttime,orafteralongperiodofstorage (over6months),besuretochargeitforatleast2hours. 2.Thisproductshouldnotbeusedinanenvironmentwhichmaycauseelectromagnetic interference. 3.Duringcharging,thereadingfunctionsaredisabledasasafetyprecaution. WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project BATTERY CHARGING Beforechargingthedevice,checkthatthemicro-USBcableisnotdamaged.Useonly themicro-USBcablesuppliedbyBiosency.Ifthemicro-USBcableisfaulty,contactasales representative. BATTERY CHARGING Donotwearthedevicewhilecharging. CHARGER UseonlytheBB100DCACadaptersuppliedbyBiosency.Theuseofanunauthorisedcharger maycauseanelectricshock.IftheACadapterisdamaged,contactasalesrepresentative. BATTERY Thebatterymayleakorexplodeifnotusedordisposedofinaccordancewithregulations. Donotremovethebattery. VERSION 8.0 August 2024... -
Page 23: MeaningsOfIndicatorLights
Indicatorlightsignification Inordertobeasdiscreetaspossible,theBoraband®indicatorlightgoesoutonceithas startedup.TheBoraband®indicatorlightwillbeoffmostofthetime. AsolidGREENlightindicatesthatthedeviceisoperatingcorrectly AflashingGREENlightindicatesthatthedeviceisbeingswitchedon AsolidBLUElightindicatesthatthedeviceisinstallingasoftwareupdateor transmittingorreceivingdataviaaBluetoothconnection AflashingORANGElightindicatesthatthedevicebatteryislow. AsolidREDlightindicatesthatthedeviceisfaulty. AflashingWHITElightindicatesthatthedeviceisbeingcharged UpdatingtheBoraband UpdatingtheBoraband® ® software software TheBoraband®updatesautomaticallywhenitisswitchedon;duringtheupdate, theindicatorlightwillbeblue.BecarefulnottoturnofftheBoraband®whentheblue indicator light is on. What you see What you see Meaning Meaning What you need to do What you need to do The device is installing Donotswitchoff ®... -
Page 24: Data Transmission Data Transmission
Dataaccessforhealthprofessionnals Dataaccessforhealthprofessionnals Boraband®isdesignedtoworkwithamobileapplicationoradatafeedbackterminal. Themobileapplication,onceinstalledonamobilephoneoratablet,andconnected toyourBoraband®,allowsyoutosenddatatohealthcareprofessionals.Pleasereferto theapplication’susermanualforinstallationanduse. Onceinstalled,thedatatransmissionterminalcanbeusedtotransmitdatatohealthcare professionals.Pleaserefertotheapplication’susermanualforinstallationanduse. Toenablecommunicationtotakeplace,makesurethatBoraband®isinthesameroomand incloseproximity(lessthan10metres)tothemobileapplicationordatafeedbackterminal. What you see What you see Meaning Meaning What you need to do What you need to do The device sends or Donotswitchoff Fixed BLUE light ® receives data the Bora band Dataconsultation Dataconsultation Actorsandhealthprofessionals... -
Page 25: CleaningAndDisinfectionBetweenPatients CleaningAndDisinfectionBetweenPatients
Created by Yudhi Restu Pebriyanto from the Noun Project CLEANING TheBoraband®shouldonlybecleanedwiththeproductsspecifiedinthismanual. Usingdifferentproductscoulddamagethedevice. CLEANING - MULTI-USAGE FOR DIFFERENT PATIENTS IftheBoraband®isusedsuccessivelybydifferentpatients,thestrapmustbechangedand the Bora band® case should be cleaned as directed by Biosency. PRECAUTIONS PRECAUTIONS Created by Yudhi Restu Pebriyanto from the Noun Project STERILISATION Donotsteriliseusingautoclaves,irradiation,gas,ethyleneoxideoranyothermethod. This could seriously damage the device. -
Page 26: Troubleshooting
Afaultmayhave Indicator light goes 2. Charge the Iftheindicatorlight occurred. outwhenIpress device. doesnotcomeonafter thebutton. 5minutes,contactyour salesrepresentative. Whentoconsultahealthcareprofessional Whentoconsultahealthcareprofessional Ifyouhaveanynewsymptoms,orifyoursymptomsworsen,pleasecontactyourdoctor. Warranty and Support Warranty and Support Aspartofitssalesorrentalcontract,Biosencyofferscustomersatwo-yearwarrantyfor theBoraband®-ModelBB100.Thisiseffectivefromthedateofpurchaseorfortheduration oftherentalcontract.Inaccordancewiththiswarranty,Biosencywillrepairorreplaceany faultyBoraband®-BB100modelfreeofcharge,providedithasbeenreportedtoBiosency bythecustomerwithdetailsofthedevice’sserialnumber.ForanydefectiveBoraband® -ModelBB100deliveredtothecustomer,thiswarrantyisthesoleandexclusiveremedy available,whetherthatbeaspartofacontract,aclaimforredressorrequiredbylaw. VERSION 8.0 August 2024... -
Page 27: Warranty Exclusions
Thiswarrantydoesnotincludethecostofsendingthedevicetoberepairedorreplaced byBiosency.Biosencyisliableforthereshipmentofareplacementdevice.Biosencyreserves therighttochargearepairfee(withguarantee)shouldthedevicenotbefoundtobefaulty. NoreturnedproductwillbeacceptedwithoutawrittenagreementfromBiosencyorareturn merchandiseauthorisation(RMA)number.ThisnumberwillbeprovidedbyBiosency. Anyworkcarriedoutbeyondtheremitofthewarrantymustbecarriedoutinaccordance withBiosency’sstandardrates(ineffectatthetimeofdeliverytoBiosency). Warranty exclusions TheBoraband®,ModelBB100,isaprecisionelectronicinstrumentwhichshouldonly berepairedbyauthorisedpersonnel.Consequently,shouldtherebeanysignorproofthat aBoraband®,ModelBB100,hasbeenopenedorrepairedbypeopleoutsideofBiosency, thewarrantywillbedeemednullandvoid.Thesameappliestoanyalterationsorimproper useoftheBoraband®ModelBB100. Thewarrantydoesnotcoverindirectdamagesofanykind. Warranty disclaimer/exclusivity Thewarrantiessetforthinthismanualareexclusiveandnootherwarranty,whether statutory,written,oralorimplied,shallapply. Incidents AnyseriousincidentwhichoccursinconnectionwiththeBoracare®solutionshouldbe reportedtothemanufacturerandtothecompetentauthorityofthecountryinwhich thepatientresides. WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project WARRANTY Openingthecasemaydamagethedeviceandvoidthewarranty. MODIFICATIONS / REPAIRS / WARRANTY Nomodificationofthedeviceispermitted,otherwiseitsperformancemaybecompromised.... -
Page 28: Disposal
PRECAUTIONS PRECAUTIONS Created by Yudhi Restu Pebriyanto from the Noun Project CALIBRATION CALIBRATION Theadvancedcircuitdesignrequiresnocalibrationormaintenance. AfunctionaltestcannotbeusedtoassesstheaccuracyoftheBoraband®. Disposal PRECAUTIONS PRECAUTIONS Created by Yudhi Restu Pebriyanto from the Noun Project RECYCLING Whendisposingoforrecyclingfabricstraps,pleasefollowlocal,regional,andnational guidelinesaswellasanycurrentrecyclinginstructionsinforce. WEEE DIRECTIVE InaccordancewithEuropeandirective2002/96/EConWasteElectricalandElectronic Equipment(WEEE),pleasedonotthrowthisproductintounsortedhouseholdwaste. ThisdevicecontainsWEEEmaterials;pleasecontactthedistributortoreturnorrecycleit. Cybersecurity Cybersecurity Thischapterprovidesasetofprecautionsandwarningstoguardagainstcybersecurityrisks. Toensuretheconfidentiality,integrityandsecurityofyourpersonaldata,westronglyadvise youtoreadtheinformationbelow. Forfurtherinformation,pleaseconsultthispagedescribingthesecuritymanagementofour platform: https://doc.bora-connect.com/security-description-BC/en... -
Page 29: Internet Connection
WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project IT RISK AstheBoraband®devicereliesonBluetoothtechnology,itisinherentlyexposed todenial-of-service(DoS)attacksthatmaypreventitfromoperatingnormally. Thisdoesnotaffectthesecurityofyourdata,butitmaypreventitfrombeingtransmitted correctly.Ifyoususpectanything,contactasalesrepresentativeimmediately. RECOMMENDATIONS RECOMMENDATIONS Created by Yudhi Restu Pebriyanto from the Noun Project INTERNET CONNECTION WiththeBoracare®solution,useanInternetconnectionsecuredbyaminimumWPA2-type encryptionprotocol.Thiswillensurethesecurityandconfidentialityofyourdata. YOURPHONE’SOPERATINGSYSTEMVERSION Makesureyoualwayshavethelatestversionoftheoperatingsystem(OS)installedon yourphonebeforeusingtheBoracare®solution.HavingthelatestversionoftheOSisvery important,particularlybecauseitallowsyoutotakeadvantageofthelatestsecuritypatches foryoursmartphone. THEFT / DAMAGE DonotleavetheBoraband®deviceunattended.Amaliciousthirdpartycouldcompromise theintegrity,securityand/orconfidentialityofyourdatabyphysicallyaccessing the device case. -
Page 30: TechnicalInformation TechnicalInformation
Technicalinformation Technicalinformation Specifications Performanceatrest Performancewhenmeasuringatthearmorwristisasfollows: Oxygensaturationaccuracy ±3%(70%to100%SpO Heart rate accuracy ±3bpm(from35bpmto240bpm) Respiratory rate accuracy ±3cpm(from10cpmto50cpm) Skin temperature accuracy ±0.2°C(from25°Cto43°C) Measurementwavelengthandoutput power Red ..........660nmat0.35mW/cm2maximumonaverage Infrared ......... 940 nm at 1.37mW/cm2 maximum on average Green ..........530nmat1.6mW/cm2maximumonaverage Reading accuracy: Reading accuracy: andheartrateaccuracytestsareperformedininducedhypoxiastudieswithfair todarkskinned,nonsmoking,healthysubjectsofbothsexes,aged18yearsandover. Thearterialhaemoglobinsaturation(SpO... -
Page 31: EquipmentResponseTime
The precision indicated is the average root mean square error A .Twothirdsof measurementsmadebythedevicewillhaveanerrorlessthantheA TheBlandandAltmanplot(i.e.(SpO - SaO )versusSaO )areavailableatbiosency.com/ clinique/#Vc. Equipmentresponsetime Equipment delay Equipment delay Delaytime Delaytime DisplaytimedelayonBoraconnect® The data measured by the Bora band® ModelBB100istimestampedand transmittedviaBLUETOOTH®tothemobile applicationordatafeedbackterminal. The Bora connect® display takes into accountthetimestampformeasurements.... -
Page 32: PhysicalCharacteristics
Physicalcharacteristics Case dimensions Case dimensions 42 mm x 40.2 mm x 13.7 mm (lengthxwidthxheight) (lengthxwidthxheight) Weight Weight Case Case 19.8 g Case and device Case and device 25.1 g Materials Materials Case Case Polycarbonate/ABS – SEBS Device Device Polyamide CaseIPrating CaseIPrating IP64 Protectedfromtotaldustingress... -
Page 33: Compliance
PRECAUTIONS PRECAUTIONS Created by Yudhi Restu Pebriyanto from the Noun Project Pleaserespecttheenvironmentaloperatingconditions,inparticularthetemperature. Shouldthedevicebeexposedtoenvironmentalconditionsotherthanthosespecifiedin the“EnvironmentalConditions”section,patientsshouldwait15minutesbeforewearingit. Conformity Biocompatibility Biocompatibility ISO 10993-1 ISO 10993-5 ISO 10993-10 IEC60601-1-2 IEC60601-1-11 ETSI EN 301 489-1 ETSI EN 301 489-17 Electricalsafety Electricalsafety IEC60601-1 IEC60601-1-6 IEC60601-1-11 ISO80601-2-61 IEC60529-1 RF RF ETSI EN 300 328 EN62479... -
Page 34: Wireless Transmission
Wireless transmission Bluetoothconformity BLUETOOTH® LOW ENERGY 4.2 and 5.0 Operatingfrequency 2.4 to 2.483 GHz Outputpower <10dBm Operatingrange 10 m range indoors Networktopology Point to point Operation Slave Antenna type Internal Modulationtechnique Frequencyshiftmodulation Frequency-hopping spread spectrum modulation Bandwidth 1MHz,2MHz Operatingprinciples Pulseoximetryisanon-invasivemethodthatdiffuseslight(redandinfrared)through irrigatingtissuesanddetectssignalfluctuationsduetoarterialbloodpulses.Well-oxygenated bloodisbrightred,whilepoorlyoxygenatedbloodisdarkred.Thepulseoximeterdetermines thefunctionaloxygensaturationofarterialhaemoglobin(SpO... - Page 35 Benefits Benefits Population Population Source Source Results Results Acceptation COPD,OSAS eMEUSE clinical trial 84%(95%Confidence ofthe Interval:[75%-93%]) rehabilitation ofpatientstakinga training personalized physical training in pulmonary Quality rehabilitationwithBora care®solutiondidnotquit ofLife the program improvement Patient COPD,OSAS eMEUSE clinical trial 95%ofpatients(95% reassurance CI:[91%-99%])were reassured by the Bora care® solution.
- Page 36 Benefits Benefits Population Population Source Source Results Results COPD DACRE clinical trial Respiratory rate Brinchault,G.,etal. correlateswith "Évolutiondessignes readmission(0.607, vitauxenvieréellede p-value=0.010). patientsBPCO:facteurs Heart rate correlates préventifsd’une withreadmission Preventionof réadmissionaprèsune (0.416,p-value=0.097) readmissionafter hospitalisationpour hospital discharge exacerbationsévère– étudecliniqueenvie réelleDACRE." Revue des Maladies Respiratoires Actualités15.1 (2023):70.
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Page 37: Manufacturer'sDeclarations Manufacturer'sDeclarations
Manufacturer’sdeclarations Manufacturer’sdeclarations Alltheinformationgivenbelowistakenfromstandardrequirementstowhichmanufacturers ofelectromedicaldevicesmustadheretoinaccordancewithstandardIEC60601-1-2. Themedicaldevicecomplieswithapplicableelectromagneticcompatibilitystandards. However,theusershouldensurethatpossibleelectromagneticinterferencedoesnotcreate anadditionalrisk,e.g.,radiofrequencytransmittersorotherelectronicdevices. Inthischapteryouwillfindallthenecessaryinformationtoensuretheeffectiveinstallation andcommissioningofyourmedicaldeviceintermsofelectromagneticcompatibility. TheuseofaccessoriesotherthanthosespecifiedorsoldbyBiosencyasreplacementparts, mayresultinanincreaseinemissionsoradecreaseinthemedicaldevice’simmunity. Themedicaldevicemustnotbeusednearorplacedontopofanotherdevice.Ifthiscannot beavoided,pleasecheckitscorrectfunctioningbeforeuse(inaccordancewiththeconditions ofuse). Theuserorinstallerofthemedicaldevicecanhelppreventelectromagneticinterferenceby maintainingaminimalseparationdistance,whichwillbedependentonthemaximumradio frequencypowerofthetransmittingequipment.DonotuseanyportableRFcommunications device(includingperipheralssuchasantennacablesorexternalantennas)within30cmof theBoraband®,includingcablesspecifiedbythemanufacturer.Otherwise,theperformance ofthesedevicesmaybeimpaired. WARNINGS WARNINGS Created by Yudhi Restu Pebriyanto from the Noun Project ELECTROMAGNETIC INTERFERENCE ThisequipmentcomplieswiththeinternationalIEC60601-1-2standardrelatingto theelectromagneticcompatibilityofmedicalelectricalequipmentand/orsystems. Thisstandardisdesignedtoprovidereasonableprotectionagainstharmfulinterference wheninstalledinatypicalmedicalsetting.However,giventheproliferationof radiofrequencywavestransmittedbyequipmentandotherparasiticsourcesinhealthcare settingsandotherenvironments,itispossiblethathighlevelsofinterference,caused bycloseproximityorpowerfromasource,couldnegativelyimpacttheoperationof thedevice.Medicalelectricaldevicesrequirespecialprecautionsregardingelectromagnetic... - Page 38 PortableRFcommunicationdevices(includingperipheralssuchasantennacablesandexternal antennas)shouldnotbeusedwithin30cmoftheBoraband®,includingcablesspecifiedby themanufacturer.Otherwise,theperformanceofthesedevicesmaybeimpaired. Table1:Electromagneticemissions Table1:Electromagneticemissions Emission test Conformity Electromagneticenvironment- notes Thismedicaldeviceisintendedforuseintheelectromagneticenvironmentdescribedin thistable.Theuserandinstallershouldthereforeensurethatthemedicaldeviceisusedin such an environment. Electromagneticradiation Group 1 The medical device uses disturbance RFenergyforitsinternal (Radiatedemissions)(CISPR11) functioning. Nearby electronic equipment maybeaffected. Interferencevoltageatthesupply Class B Thisdeviceissuitableforuse terminals inallestablishments,including (Conductedemissions)(CISPR11) domesticestablishmentsand those directly connected to publiclow-voltagesystems supplyingbuildingsfor domesticuse.
- Page 39 Table2:Magneticandelectromagneticimmunity Table2:Magneticandelectromagneticimmunity Immunity test Immunity test Test level according Test level according Levelofconformity Levelofconformity Electro- Electro- toIEC60601 toIEC60601 magnetic magnetic environment - environment - notes notes Thismedicaldeviceisintendedforuseinthemagneticandelectromagneticenvironmentdescribed inthistable.Theuserandinstallershouldthereforeensurethatthemedicaldeviceisusedinsuch an environment. Electrostaticdischarge(ESD) ± 8 kV contact discharge ± 8 kV contact discharge (IEC61000-4-2) ±...
- Page 40 Table3:Manufacturer’sdeclarationsandnotes-electromagneticimmunity Table3:Manufacturer’sdeclarationsandnotes-electromagneticimmunity Immunity test Immunity test IECtestlevel60601 IECtestlevel60601 Levelofconformity Levelofconformity Electromagnetic Electromagnetic environment - environment - notes notes Thismedicaldeviceisintendedforuseinthemagneticandelectromagneticenvironmentdescribedin thetablebelow.Theuserandinstallershouldensurethecomplianceoftheelectromagneticenvironment. WARNING:PortableRFcommunicationsdevices(includingperipheralssuchasantennacablesand externalantennas)shouldnotbeusedwithin30cm(12inches)oftheBoraband®ModelBB100, includingcablesspecifiedbythemanufacturer.Otherwise,theperformanceofthesedevicesmay be impaired. Conducted Home health care Disturbances, 150kHZ to 80MHz 150 kHz to 80 MHz environment. Induced by RF Fields 80%AMat (IEC61000-4-6) 1 kHz...
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Page 41: Copyrights And Trademarks Copyrights And Trademarks
Copyrights and Trademarks Copyrights and Trademarks TheBLUETOOTH®brandandlogosareregisteredtrademarksofBluetoothSIG,Inc.Bora band®andBoraconnect®areregisteredtrademarksofBiosencyinFranceandEurope. Symbols Symbols This chapter describes the symbols that are used on the product or its packaging. Pleaseconsulttheuserguidebeforeusingthedevice. Type BF applied part. No alarm triggered. Non-ionisingelectromagneticradiation.IncludesRadiofrequency (RF)transmitters.Theequipmentcontainsradiotransmitters. Interferencemayoccurinthevicinityofequipmentmarked withthissymbol. CEmarkindicatingcompliancewithcurrentmedicaldevices regulations. Notifiedbody:BSINL. IP64 IP64 Protectedfromtotaldustingress. -
Page 42: ManufacturerContactInformation ManufacturerContactInformation
Uniquedeviceidentifier. Productreference. The box should be recycled. BLUETOOTH® logo. Required temperature. Minimumandmaximumtemperature(°C). Humidity rate limit. Maximumandminimumhumidity(%relativehumidity,without condensation). Store in a dry place. Donotuseifthepackagingisdamaged. Manufactureranddateofmanufacture. NameandaddressoftheregisteredbranchoftheSwiss representative. 3.7VDCdirectvoltagepowersupply Manufacturercontactinformation Manufacturercontactinformation Biosency 13RueClaudeChappe-BâtAOxygène 35510CessonSévigné France support@biosency.com VERSION 8.0 August 2024... - Page 43 VERSION 8.0 August 2024...
- Page 44 You have access to an electronic version ofthismanualusingthisQRcode. VERSION 8.0 August 2024...
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