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1 2 | Cover Letter(s) | June 02 2018 / September 02 2018 | ||||||
1 2 | Cover Letter(s) | June 02 2018 / September 02 2018 | ||||||
1 2 | External Photos | June 02 2018 / September 02 2018 | ||||||
1 2 | ID Label/Location Info | June 02 2018 / September 02 2018 | ||||||
1 2 | Internal Photos | June 02 2018 / September 02 2018 | ||||||
1 2 | Cover Letter(s) | June 02 2018 / September 02 2018 | ||||||
1 2 | RF Exposure Info | June 02 2018 / September 02 2018 | ||||||
1 2 | Cover Letter(s) | / February 02 2018 | ||||||
1 2 | ID Label/Location Info | / February 02 2018 |
1 2 | Users Manual | Users Manual | 1.90 MiB | June 02 2018 / September 02 2018 |
BiosignsUnit HW9 Series Instructionsfor Use MedeiaInc. 80S.W.8thStreet,Suite2000 Miami,FL,33130,USA Version:1.0 Date:April20,2017 BiosignsUnitInstructionsforUse 1 CONTENTS Revisionsheet ................................................................................................................................................. 5 CopyrightNotice ......................................................................................................................................... 5 Disclaimer ........................................................................................................................................................ 5 Manufacturer .............................................................................................................................................. 5 Authorizedrepresentative .......................................................................................................................... 6 InstructionsforusePurpose ....................................................................................................................... 6 IntendedAudience ...................................................................................................................................... 6 Illustrations ...................................................................................................................................................... 6 TermsUsedinthisManual ......................................................................................................................... 6 Readinstructionsforuse ............................................................................................................................ 7 Intendeduse ................................................................................................................................................ 7 Intendedusers ............................................................................................................................................. 7 Physician`sResponsibility ................................................................................................................................ 7 Guidetosymbolsandmarkings ................................................................................................................. 8 Training ......................................................................................................................................................... 11 GeneralWarningsandcautions ............................................................................................................... 12 Precautionsandlimitations ...................................................................................................................... 15 Notes ..........................................................................................................................................................16 Userresponsibility ......................................................................................................................................... 16 Appliedstandards ..................................................................................................................................... 16 Accessories ................................................................................................................................................17 RadioFrequencyInterference .......................................................................................................... 17 PatientandOperationalSafety ................................................................................................................ 19 Selfcheck ...................................................................................................................................................19 Accessories ................................................................................................................................................19 LiabilityNotice ............................................................................................................................................... 19 TermsofWarranty ............................................................................................................................ 20 Copyright ....................................................................................................................................................... 20 GettingHelp .............................................................................................................................................. 21 Biosignsspecifications ............................................................................................................................ 22 Device ........................................................................................................................................................ 22 LCD ................................................................................................................................................. 22 ECG/Respiration .................................................................................................................................... 22 SPO2 ............................................................................................................................................... 22 Temperature .......................................................................................................................................... 23 WIFI ........................................................................................................................................................... 23 GSM/GPRS/GPS .............................................................................................................................. 23 USB ......................................................................................................................................................... 23 Endoflifestatement ............................................................................................................................. 23 Parts ................................................................................................................................................... 24 Biosignsunit ........................................................................................................................................... 24 BiosignsHW9Series .................................................................................................................... 25 Articlecodes.......................................................................................................................................25 Serialnumber .....................................................................................................................................25 ECGcable ....................................................................................................................................... 25 ECGelectrodes ...................................................................................................................................... 27 BiosignsUnitInstructionsforUse 2 Spo2sensor .................................................................................................................................... 27 USBcable ............................................................................................................................................... 27 PowerSupplyunit ................................................................................................................................. 28 PoucH ..................................................................................................................................................... 28 Accessories ............................................................................................................................................ 29 UsingtheDevice ....................................................................................................................................... 30 ConnectingtheECGcable ..................................................................................................................... 30 Connectingthecableto thepatient..................................................................................................... 30 Placementoftheelectrodes ......................................................................................................... 30 3leadECG .................................................................................................................................. 31 5leadECG .................................................................................................................................. 32 12leadECG ........................................................................................................................................ 33 Artifactduetopoor electrodeapplicatons .......................................................................................... 34 Remedy .............................................................................................................................................. 34 RecordingECGsofPacemakerPatients ........................................................................................ 35 ECGRecordingDuringDefibrillation ..................................................................................................... 36 ConnectingtheECGcableto thedevice .............................................................................................. 36 SpecificationsoftheECG ...................................................................................................................... 37 ECGfilters .............................................................................................................................................. 38 Responsetoirregularrhythm ............................................................................................................... 39 Aboutphotoplethysmography ................................................................................................................. 40 PulseVolumeRecording(PVR) WaveformInterpretation .................................................................. 40 PPGWaveforms ..................................................................................................................................... 40 OximetryTheory .................................................................................................................................... 40 Placingthespo2sensor ............................................................................................................................42 Choosingsensorsize .......................................................................................................................... 44 ChoosingtheSensorApplicationSite ............................................................................................... 45 Attachingthesensor .......................................................................................................................... 45 Cleaningthesensors ............................................................................................................................. 45 Compliance ............................................................................................................................................ 46 ConnectingtheSpO2cableto thedevice ............................................................................................ 46 Connectingthetemperaturesensor ........................................................................................................ 47 RespirationRate ........................................................................................................................................48 SpecificationsoftheRespirationRate.................................................................................................. 49 Usingthedevice ........................................................................................................................................ 51 Switchontheunit ................................................................................................................................. 51 ModesofOperation .............................................................................................................................. 52 USBmode .............................................................................................................................................. 52 WiFimode ................................................................................................................................................. 53 3Gmode ................................................................................................................................................ 54 Statusindicationsonthedisplay .......................................................................................................... 55 Generalstatementofservice ofoperation ............................................................................................. 55 Configurationandoperation ................................................................................................................ 56 Securityofwirelesssignals ................................................................................................................... 56 RFSAFETY ................................................................................................................................. 56 Buttonsonthedevicefrontpad ....................................................................................................... 57 Eventbutton ..............................................................................................................................................57 BiosignsUnitInstructionsforUse 3 BatteryinformationandRecharging thedevice ...................................................................................... 57 Chargingtimes ....................................................................................................................................... 58 Operationtime ......................................................................................................................................59 TechnicalSpecifications ............................................................................................................................60 DECLARATIONELECTROMAGNETICEMISSIONSANDIMMUNITY ................................................ 61 Maintenance ................................................................................................................................................. 63 EnvironmentalConditions .....................................................................................................................63 Calibration ................................................................................................................................................. 64 Avoidelectrostaticdischarge ................................................................................................................ 64 Sterilization,ShelfLifeandcleaning ......................................................................................................... 64 Inspectandcleanthemonitorandaccessories ........................................................................... 64 device ........................................................................................................................................................ 64 Cables ..................................................................................................................................................... 65 ECGLeadWire ............................................................................................................................... 65 CleaningandDisinfectingthe ECGElectrodes .....................................................................................65 SpO2Sensor ................................................................................................................................... 65 Disposal .................................................................................................................................................. 66 Warranty .................................................................................................................................................... 66 Serviceandsupport .......................................................................................................................... 67 MRISafetyInformation ............................................................................................................................. 68 FCCstatement ................................................................................................................................... 68 Regulatoryinformation ......................................................................................................................... 68 FCCInformationtoUser ............................................................................................................ 68 FCCRFexposureinformation ............................................................................................................68 FCCElectronicEmissionNotices ....................................................................................................... 69 FCCRadioFrequencyInterferencestatement .......................................................................... 69 BiosignsUnitInstructionsforUse 4 REVISIONSHEET ReleaseNo. Date RevisionDescription COPYRIGHTNOTICE Nopartofthispublicationmaybereproduced,transmitted,transcribed,storedina retrievalsystem,ortranslatedintoanylanguageorcomputerlanguage,inanyform,or byanymeans:electronic,mechanical,magnetic,optical,chemical,manual,orotherwise, withoutthepriorwrittenauthorizationfromMedeiaInc. DISCLAIMER This document may contain typographical errors or technical inaccuracies. Medeiadoesnotacceptanyliabilityfortheuseormisusewhetherdirectorindirectof theproducts,orfordamagesarisingoutoftheuseoforinabilitytousetheproducts. Usersmustacceptallresponsibilityforanyresultsobtainedbyorconcludedfromdata obtainedbytheproductsincludingsoftwarefromMedeiaInc. Allclinicalconclusionsanddecisionsthatarebasedontheuseofthisproductarethe responsibilityoftheuser. MANUFACTURER Manufacturercontact details:
MedeiaInc. 80S.W.8thStreet,Suite2000 Miami,FL,33130,USA Tel:+18004334609 E:info@medeia.com www.Biosigns.com BiosignsUnitInstructionsforUse 5 AUTHORIZEDREPRESENTATIVE YourlocalsupplieroftheBiosignsproductis:
INSTRUCTIONSFORUSEPURPOSE Thisinstructionforusecontainstheinstructionsnecessarytooperatethetelemetry monitoringsystem safelyandinaccordancewithitsfunctionandintendeduse. Observanceofthismanualisaprerequisiteforproperproductperformanceand correctoperationandensurespatientandoperators a f e t y . Thisinstructionforuseisanintegralpartoftheproduct.Itshouldalwaysbekeptclose totheequipmentsothatitcanbeobtainedconvenientlywhenneeded. INTENDEDAUDIENCE Thismanualisgearedforclinicalprofessionalswhoareexpectedtohaveaworking knowledgeofmedicalprocedures,practicesandterminologyasrequiredformonitoring of(critically)illpatients. ILLUSTRATIONS Allillustrationsinthismanualserveasexamplesonly.Theymaynotnecessarilyreflect your monitoringsetup or data displayed on yourtelemetry monitoringsystem. TERMSUSEDINTHISMANUAL WARNING CAUTION ATTENTION Identifiesanexceptionallyhazardoussituation.Ifyoufailtotakenote ofthisinformation,seriousirreversibleorfatalinjurymay result. Identifiesahazardoussituation.Ifyoufailtotakenoteofthis information,minortomoderateinjurymayr e s u l t . Indicatesthattheproductmayhavebeenoperatedincorrectly.Ifyou failtotakenoteofthisinformation,thedevicemaybedamagedor themeasuredresultsmaybe incorrect. NOTE Containsadditionalinformationonhowtousethisdevice. BiosignsUnitInstructionsforUse 6 READINSTRUCTIONSFORUSE InthismanualyouwilllearnhowtousetheBiosignsdeviceandhowtoconnectittoa patient.TousethedeviceyouwillneedtheBiosignsTelemonitoringSystem. Instructionson howto use thissoftwarearesupplied separately withthe software. PleasefollowtheinstructionsintheseInstructionsforUseastheywillassistyouin gettingthebestpossibleresultswiththeproduct.Mayyouhavefurtherquestions, remarksforthesupplierorinthecaseyouneedmoreassistance,pleasecontactthe manufactureroryourlocalrepresentative. Read this entire instructions for use carefully before using the Biosigns device. INTENDEDUSE TheBiosignsTelemonitoringSystemisawirelessambulatorymonitoringsystem intendedforusebyhealthcareprofessionalsforcontinuouscollectionofphysiological datainhomeandhealthcaresettings.Thisincludesthefollowingvitalsigns:
Electrocardiography(EGG),HeartRate,HeartRatevariability(RRinterval),Peripheral CapillaryOxygensaturation(SpO2),SkinTemperature,RespirationrateandBlood Pressure changes. Dataistransmittedwirelesslytoacentrallocationwhereitisstoredforanalysis.The BiosignssystemcanbeconfiguredbyAuthorizedPersonstonotifyhealthcare professionalswhenphysiologicaldatafallsoutsideselectedparameters. DatafromtheBiosignssystemisintendedtobeusedbyhealthcareprofessionalsas anaidtodiagnosisandtreatment.Itisnotintendedforuseoncriticalcarepatients. INTENDEDUSERS TheBiosignsTelemonitoringSystemisusedbytrainedoperatorswhoareusedtomonitor patientsvitalsignsandperformingremotediagnosticservices.Typicalusersarephysicians, nursesandtechniciansinvolvedin(tele)monitoringapplications. PHYSICIAN`SRESPONSIBILITY Biosignsisprovidedfortheexclusiveuseofqualifiedphysiciansorpersonnelunder theirdirectsupervision.Thenumericalandgraphicalresultsandanyinterpretation derivedfromarecordingmustbeexaminedwithrespecttothepatient`soverallclinical condition.Patientpreparationandthegeneralrecordeddataquality,whichcouldaffect thereportdataaccuracy,mustalsobetakenintoaccount.Itistheresponsibilityofthe physiciantomakethediagnosisortoobtainexpertopinionontheresults,andto institutecorrecttreatmentifindicated. BiosignsUnitInstructionsforUse 7 GUIDETOSYMBOLSANDMARKINGS MARKERS/SYMBOLS DESCRIPTION 0120 CEmarkedproductbynotifiedbody FDApending WARNING.Indicatesconditionsthatcouldleadtoillness, injury,ordeath. Caution.Inthismanual,indicatesconditionsthatcould damageequipmentorotherproperty. Caution.Ontheproduct,meansConsulttheaccompanying documentation. FollowInstructionsfor Use NoSpO2 Alarm SpO2connection port Temperatureconnectionport ECGconnectionport. PatientconnectionsareType B TypeCFappliedpart.Theunitdisplayingthissymbol containsanFtypeisolated(floating)patientpartprovidinga highdegreeofprotectionagainstshock,andissuitablefor useduringdefibrillation. BiosignsUnitInstructionsforUse 8 sk Nonionizingelectromagneticradiation.Thisdevice contains anapprovedRLANmodulefrequency2402to2480MHz. Nonionizingelectromagneticradiation.Thisdevicecontains an approved RLAN module frequency 5150 to 5825 MHz. Manufacturer location Manufacturerdate Serialnumber Batch code Europeancommunityrepresentative Altitude limit ThefollowingdefinitionoftheWEEElabelappliestoEU memberstatesonly.Thissymbolindicatesthatthisproduct shouldnotbetreatedashouseholdwaste.Byensuringthat thisproductisdisposedofcorrectly,youwillhelpprevent bringingpotentialnegativeconsequencestotheenvironment andhumanhealth.Formoredetailedinformationwithregard toreturningandrecyclingthisproduct,pleaseconsultthe distributorfromwhomyoupurchased it.
*Forsystemproducts,thislabelmaybeattachedtothemain unit only. Separatebatteriesfromotherdisposablesforrecycling. USB notconnected:LEDis off/USB isconnected:LEDis on Onoffbutton Modeselection button BiosignsUnitInstructionsforUse 9 Modeconfirmationbuttonandeventbutton LCDdisplayonfrontpanelwithstartupscreen DeviceisinUSBmode WIFIDeviceisinWiFimodeandisconnectingtoWiFi network WiFiconnectionestablishedmessage IndicationthatdeviceissendingtoIPaddressofBiosigns ServerviaWiFiSSID.Flashingupwardsarrowindicates transmission GSMconnectionestablishedmessage Flashingupwardsarrowindicates transmission ConnectionwithBiosignsServerlost Batterystatusindicatorfullycharged,with80%powerlevel andchargerconnected symbol BiosignsUnitInstructionsforUse 10 ChargingwithUSBcableoncharger. WhenchargingonPC,themessageisSlowcharge, whenchargingonwallcharger,,themessageisFast charge. Deviceshutting down Temperatureandhumiditylimitation IngressProtectionmarking.Itclassifiesandratesthe degreeofprotectionprovidedagainstintrusion(bodyparts suchashandsandfingers),dust,accidentalcontact,and waterbymechanicalcasingsandelectricalenclosures. Federal(U.S.)Lawrestrictsthisdevicetosalebyoronthe orderofaphysician. Keepawayfromrain. Fragile,handlewith care. TRAINING Themanufacturerofferstrainingaftertheproductisdelivered.Thetrainingisprovided totrainedmedicalpersonnel(nurses,physicians,techniciansandotherswhoare generallyworkingwiththeproducttypeinclinicaland(para)medicalsettings).The durationofthetraininginaveragetakesthreehoursandislimitedtoinstructionsabout thewarnings,cautionsandlimitationsandonhowtousethedevicefortheintended use.Thetrainingcanbeprovidedatthelocationoftheuseroratthemanufacturers/
authorizedrepresentativesfacility. BiosignsUnitInstructionsforUse 11 GENERALWARNINGSANDCAUTIONS FamiliarizeyourselfwithallwarningsandcautionsbeforeusingtheBiosignsunit.Inaddition tothefollowing,otherwarningsandcautionsappearthroughoutthismanual. Warnings Caution possible damages Caution check manual Follow instructionsfor use MRunsafe Healthcareproviders,responsibleforusingBiosigns,mustbe trainedinthesystemandbeawareoftheinherentrisksof misinterpretationofthecollectedanddisplayedparameters. WARNING ReadtheseInstructionsforUsecarefullyandinitsentiretybeforeusing the product. WhenusingtheBiosignsTelemonitoringSystemalwaysfollowthe InstructionsforUse. Inthecaseyouhavequestionsaboutthisinstructionsforuseorthe BiosignsTelemonitoringSystemsoftware,pleasecontactyour supplier.ThecontactdetailscanbefoundintheseInstructionsforUse. Whenadditionalassistance,trainingorsupportisrequired,please contactthemanufacturerorthesupplierofyour product. Biosigns istobeoperatedbyqualifiedpersonnelonly. UseofBiosignsisrestrictedtomedicallytrainedstaff,suchasa physicianand/orregisterednurse. Safeandeffectiveuseofthisdevicerequirespropersetupand operationbytrainedpersonnel. BiosignsneedsspecialprecautionsregardingEMCandneedstobe installedandputintoserviceaccordingtotheEMCinformationprovided intheinstructionforuse. Thisequipmentneedstobeinstalledandputintoserviceinaccordance withtheinformationprovidedinthismanual. SafeinterconnectionbetweentheBiosignsunitandotherdevicesmust complywithapplicablemedicalsystemssafetystandardssuchasIEC 601011.Withincertaingovernmentaljurisdictions,allinterconnected accessoryequipmentmustbelabeledbyanapprovedtestinglaboratory. Afterinterconnectionwithaccessoryequipment,risk(leakage)current andgroundingrequirementsmustbe maintained. Donotconnectmorethanonepatienttoamonitor. Donotconnectmorethanonemonitortoapatient. It is allowed to use Biosigns on a patient when connected to the mainsorthepoweradaptor.However,werecommendtomakesure thatthemainsorpoweradaptorarenotusedinwetenvironment. DonotplaceBiosignsoraccessoriesinanypositionthatmightcauseitto fallonthepatient.DonotlifttheBiosignsbythepatientcable(s). BiosignsUnitInstructionsforUse 12 WARNING Aswithallmedicalequipment,carefullyroutethepatientcablingto reducethepossibilityofpatiententanglementorstrangulation. OnlyuseaccessoriesandsensorsprovidedandapprovedbyMedeia. Possiblepatientinjurycanresult. Misapplicationofapulseoximeterprobewithexcessivepressurefor prolongedperiodscaninducepressureinjury. Noalarmfor SpO2. Thesystemtransmitsdatathroughwirelessconnection.Riskofdataloss ispossible.Keepacloseeyeonthecriticalpatient. BiosignsunitusewirelessconnectionstotransmitdatatotheBiosigns TelemonitoringSystem.Themanufacturerhasnocontroloverthe availabilityofthisnetwork.BiosignsTelemonitoringSystemfeatures alertstoindicatewhentheconnectionbetweentheBiosignsunitandthe BiosignsTelemonitoringSystemisnotavailableandtheconnectionwith theBiosignsUnitcannotbeestablished. Westronglyrecommendyoutoalwaysusethisalertfeatureinthe softwaretoalertyouwhentheconnectionwiththedeviceislost. Biosignssendsrealtimedatatotheserver.Inoptimalsituationsthedelay ofdatatransmissionislessthanonesecond.Whentheconnection withthe wirelessconnectionispoor,thedelaymayincreasetouptoamaximumof 10seconds.Thereisnodatalossasthedeviceusesinternalbufferstostore datapackages,whicharesentwhentheconnectionimproves.Inthecasethe communicationisnotsufficienttosenddatafora10secondsperiod,the serverwillconsiderthisasconnectionlostandtheBiosigns TelemonitoringSystemshowthisinthesoftwareasaredcrossthroughthe patient display. TheBiosignsSystemsoftwareshowsthedelaybetweeneachBiosigns unitandthesoftware.Beawarethatthemaximumdelaybetweenthe timethedatawascollectedandwhenitisdisplayedinthesoftwarecan be10seconds. Biosignsunitisbatteryoperated.Whenthebatteryisdepletedtheunit cannotmeasureandtransmitdata.BiosignsTelemonitoringSystem featuresalertstoindicatewhentheleveloftheBiosignsunitisdepleted. Westronglyrecommendyoutoalwaysusethisalertfeatureinthe softwaretoindicatethatthebatteryisalmostdepleted.Inthiscasethe patientcanbeinformedtorechargethebatteryoftheunitbeforeitis fullydepleted. TheBiosignsunithasnotbeenevaluatedforsafetyandcompatibilityin theMRenvironment.Ithasnotbeentestedforheating,migration,or imageartifactintheMRenvironment.ThesafetyofBiosignsintheMR environmentisunknown.Riskofprojectileinjuryduethepresenceof ferromagneticmaterialsinthedevice;riskofburnstothepatientsduethe currentinducedbystrongelectromagneticfieldspresentinMR environment.Scanningapatientwhohasthisdevicemayresultinpatient injury. Donotoperatethisproductinthepresenceofflammableanestheticsor otherflammablesubstanceincombinationwithair,oxygenenriched environments,ornitrousoxide;explosioncanresult. Impedancepneumographymaynotoperateproperlywhenusedin conjunctionwithhighfrequencyjetventilationorhighfrequency oscillatoryventilation. BiosignsUnitInstructionsforUse 13 WARNING Electronicequipmentthatemitsstrongelectromagneticorradio frequencysignalscancauseelectricalinterferencewithECGmonitor operation.ThisinterferencemaydistortthedisplayedorrecordedECG signal,therebypreventingaccuraterhythmanalysis.Avoidoperatingthis devicenearequipmentofthis type. PortableandMobileRFCommunicationsequipmentcanaffectthe performanceofthe product. Thisproductcontainsnouserserviceablecomponents.Anyunauthorized changestotheproductinvalidateMedeiaswarrantyandalsoinvalidate allapplicableregulatorycertificationsandapprovals. DonotusethepulseoximeterasareplacementorsubstituteforECG basedarrhythmiaanalysis. Changes or modifications not expressly approved by Medeia Internationalcouldvoidthepurchasersauthoritytooperatethe equipment. DonotautoclavetheBiosignsunitoritsaccessories.Autoclave accessoriesonlyifthemanufacturer'sinstructionsclearlyapproveit.Many accessoriescanbeseverelydamagedby autoclaving. Healthcareproviders,responsibleforusingBiosignsTelemonitoringSystem, mustbetrainedinthesystemandbeawareoftheinherentrisksof misinterpretationofthecollectedanddisplayedparameters. BiosignsisnotintendedforSTmonitoring. Thefinaldecisionregardingthetreatmentofpatientslieswiththe prescribing physician. Mayyouhavefurtherquestionsorremarksforthesupplierorinthecaseyouneed moreassistance,pleasecontactthemanufactureroryourlocalrepresentative. BiosignsUnitInstructionsforUse 14 PRECAUTIONSANDLIMITATIONS CAUTION Do not connect other machines, devices, sensors or cables to Biosigns oritsaccessoriesunlessapprovedbyMedeia,becausedamageto Biosigns,themachines,devicesorcablesmayoccur.Usingotherparts mayalsoresultinincreasedemissionsordecreasaedimmunityofthe device. DonotusethepatientcabletomoveorlifttheBiosignsunit.Itmight causetheBiosignsunittofall,whichmightdamagetheBiosignsunitor injurethe patient. Riskofelectricalshock;donotattempttoserviceelectricalcomponents;refer servicingtoqualifiedpersonnel. DonotuseifanyofBiosignscomponentsisvisiblyopenedor damaged. DonotfloodBiosignscomponentswithexcessiveamountsoffluids. Ifliquidsentertheequipment,turnofftheBiosignsunitimmediately. Donotoperatethedeviceuntiltrainedpersonnelhaveinspectedthe interior. CheckallexternalpartsofBiosignspriortouse Whenconnectingauxiliaryequipmentapprovedby MedeiaInc., ensurethatthesummedleakagecurrentdoesnotexceedlocal standards. TheBiosignsshouldnotbeusednexttoorstackedwithotherequipmentand thatifnexttoorstackeduseisnecessary,theBiosignsshouldbeobservedto verifynormaloperationintheconfigurationinwhichitwillbeused. DonotopenthecoverorbackoftheBiosignsunit.Thereareno userserviceablecomponentsinsidethesystem.Doingsomayvoid equipmentwarranties. Authorizedservicepersonnelshoulddoallinternaltroubleshootingand repairorreplacementusingonlypartsandaccessoriesapprovedby MedeiaInc. Periodically check all connector cables and power receptacles for damage.Donotoperatetheequipmentiftheintegrityoftheseitemsis questionable. Peoplewhoare qualified andcompetent and have the rightknowledge aboutthelawsregardingtelemedicineshouldonlyusethisdevice. Thedevicehasnotbeentestedabove3000metersabovesea levelor airpressurelessthan850mBar. Wireless communications equipment,such ascellphones,should be kept atadistanceof3.3m,tonotinfluencethedevice. Donotusethe3GmodeorWiFimodewithpatientswhohavea pacemaker,to avoid any influenceof the device on the pacemaker. BiosignsUnitInstructionsforUse 15 NOTES Duetocontinuingproductinnovation,specificationsinthismanualaresubjectto changewithoutnotice.Theinformationinthismanualissubjecttochangewithout notice. Medeiashallnotbeliablefortechnicaloreditorialomissionsmadeherein,nor incidental or consequential damages resulting from the furnishing, for performance,oruseofthisguide. Allillustrationsinthismanualareprovidedasexamplesonly.Theymaynot necessarilyreflectyourmonitoringsetupordatadisplayedonyoursystem. Inthismanual,allnamesappearinginexamplesandillustrationsarefictitious. Theuseofanyrealpersonsnameispurelycoincidental. ThisdevicehasbeenvalidatedandtestedforcompliancewithISO806012 61:2011InternationalStandardforpulseoximetermonitors. USERRESPONSIBILITY Thisproductisdesignedtoperforminconformitywiththedescriptionthereofcontained inthismanualandaccompanyinglabelsandinserts,whenassembled,operated, maintainedandrepairedinaccordancewiththeinstructionsprovided.Adefective productshouldnotbeused. Partsthatarebroken,plainlyworn,missingorincomplete,distortedorcontaminated shouldbereplacedimmediately.Shouldanyrepairorreplacementbecomenecessary,we recommendthatservicebeperformedatthenearestapprovedservicecenter.Theuserof theproductshallhavethesoleresponsibilityforanymalfunction,whichresultsfrom improperuse,faultymaintenance,improperrepair,damageoralterationbyanyone other than MedeiaInc. ortheirauthorized service personnel. APPLIEDSTANDARDS EN606011(2006):Generalrequirementsforbasicsafetyandessential performance IEC60601122007:MedicalelectricalequipmentPart12:General requirementsforsafetyCollateralstandard:Electromagneticcompatibility Requirementsandtests IEC606012492011:MedicalelectricalequipmentPart249:Particular requirements for the safety of multifunction patient monitoring equipment IEC60601147:2012:Electrocardiographs ANSI/AAMIEC57:2012:Testingandreportingperformanceresultsofcardiac rhythmandSTsegmentmeasurementalgorithms ISO152231:2012:Graphicalsymbolsforuseinthelabelingofmedicaldevices IEC62366:2008MedicaldevicesApplicationofusabilityengineeringto medicaldevices ISO80601261:2001:Particularrequirementsforbasicsafetyandessential performanceofpulseoximeterequipment IEC806012592008Particularrequirementsforthebasicsafetyandessential performanceofscreeningthermographsforhumanfebrile temperature BiosignsUnitInstructionsforUse 16 screening EN124704:2000Part4Performanceofelectricalthermometersfor continuousmeasurement IEC62304:2006:Medicaldevicesoftware.Softwarelifecycleprocesses. IEC60601111:2010:Medicalelectricalequipment.Generalrequirementsforbasic safetyandessentialperformance.Collateralstandard.Requirementsformedical electricalequipmentandmedicalelectricalsystemsusedinthehomehealthcare environment. ACCESSORIES MedeiaonlyacceptswarrantyclaimsifMedeiaapprovedaccessoriesand replacementpartsareused.Useofaccessoriesotherthanthoserecommendedby MedeiaInc.maycompromiseproductperformance. RADIOFREQUENCYINTERFERENCE Thisproductemitsradiofrequencyenergy,buttheradiatedoutputpowerofthisdevice isfarbelowtheFCCradiofrequencyexposurelimits.Nevertheless,thedeviceshouldbe usedinsuchamannerthatthepotentialforhumancontactwiththeantennaduring normaloperationis minimized. BiosignsUnitInstructionsforUse 17 CAUTION Exposuretoradiofrequencyradiation. Wirelesscommunicationsequipmentsuchaswireless home networkdevices,mobilephones,cordlesstelephonesandtheir basestations,walkietalkiescanaffectthisequipmentandshould be kept at least a distance d away from the equipment. ThedistancediscalculatedbyMedeiafromthe800MHzto 2,5GHzcolumnofTable5orTable6ofIEC6060112:2007,as appropriate. Thedeviceshouldnotbeusedadjacentto,orstacked with, otherequipment. Ifadjacentorstackeduseisnecessary,thedeviceshouldbeobservedtoverify normaloperationintheconfigurationinwhichitwillbeused. Electrostaticdischarges(ESD)maycauseartifactsinthesignalfrom the device.Avoidconditionswhereelectrostaticchargecanbuildupbecause oflowhumidityandfrictionagainstcarpets,clothingandsheetsmadefrom artificialfibers. Theuseofaccessories,sensors,andcablesotherthanthoselistedin this manualmayresultinincreasedemissionand/ordecreasedimmunityofthis device. Otherequipmentmayinterferewiththissystem,evenif thatequipment complieswithCISPRemission requirements. Refertothetablesbelowinthissectionforspecificinformationregarding theBiosignscompliancetothestandardIEC60601 RadioFrequency(RF)interferencebetweenBiosigns and anyexistingRF transmittingorreceivingequipmentattheinstallationsite,including electrosurgicalequipment,incloseproximitytothecardiographshouldbe evaluatedbeforetheequipmentisoperatedastheymayseriously degradeperformance. BiosignsissusceptibletointerferencefromRFenergy sources(lowered RFimmunity)whichexceedtheIEC6060112limits,suchaspowerline bursts,othermedicaldevices,cellularproducts,informationtechnology equipmentandradio/televisiontransmission.ToreduceEMCinterference Biosignsshallbeseparatedfromtheemittingsourceasmuchaspossible. Ifassistanceisneeded,callyourlocalMedeiaInc.servicerepresentative AphysicianshouldevaluateartifactontheECGcaused byelectromagnetic interferenceorphysicianauthorizedpersonneltodetermineifitwill negativelyimpactpatientdiagnosisortreatment.Like allelectronic devices,Biosignsissusceptibletoelectrostaticdischarge(ESD). Electrostaticdischargetypicallyoccurswhenelectrostaticenergyis transferredtothepatient,theelectrodes,ortoBiosigns. ESD may result in ECG artefact that may appear as narrow spikes on the cardiographdisplayorontheprintedreport.WhenESDoccurs,theECG interpretationwithBiosignsmaybeinconsistentwiththephysicians interpretation.MedeiaInc.assumesnoliabilityforfailuresresultingfromRF interferencebetweenMedeiaInc.s medicalelectronicsandanyradio frequencygeneratingequipmentwhentheselevelsexceedthoseestablished byapplicablestandards. U.S.Federallawrestrictsthisdevicefrombeingsoldbyoronthe recommendationofaphysician. BiosignsUnitInstructionsforUse 18 PATIENTANDOPERATIONALSAFETY Anysystemcomponents(e.g.treadmill,personalcomputer,ergo meter) thatrequiretobeconnectedtoanoutletsocketshalluseonlygrounded powercords(threewirepowercordswithgroundedplugs).Alsomake sure the outlet acceptsthe plug and is grounded. Neveradaptagroundedplugtofitanungroundedoutletbyremovingthe CAUTION groundprongorground clip. Multipleportableoutletsocketsshallnotbeplacedonthefloor. Multipleportableoutletsocketsorextensioncordshallnotbeconnected tothesystem. Donotconnectitems,whicharenotpartofthesystem. The use ofmultiple (non)medicalelectricalequipmentconnectedtothe samepatientmayposeasafetyhazardduetothesummationofleakage currentsfromeachinstrument.Anycombinationof(non)medical electricalequipmentshouldbeevaluatedbylocalsafetypersonnelbefore putinto service. Multipleportableoutletsocketsusewithoutanisolation transformeris disapprovedunlesscasualaccessforadditionalequipmentisimpededor prevented. Biosignsisolatesallconnectionstothepatientfromelectricalgroundandallother conductivecircuitsintheBiosignsunit.Thisreducesthepossibilityofhazardous currents passing from Biosigns through the patients heart to ground. SELFCHECK BoththeBiosignsTelemonitoringSoftwareandtheBiosignsUnithaveautocalibration builtin.Duringbootingthesoftware,itwillchecktheoriginalfileformatoftheprogram. When the software is not considered "original" it will automatically reset to the preuse installation setting. ACCESSORIES UseofaccessoriesotherthanthoserecommendedbyMedeiaInc.maycompromise productperformance.MedeiaInc.canonlyacceptwarrantyifyouuseMedeiaInc. approvedaccessoriesandreplacementparts. LIABILITYNOTICE FailuretofollowtheconditionssetforthinthisdocumentshallabsolveMedeiaInc. fromanyresponsibilityforthesafety,reliability,andperformanceoftheequipment. Eachoperatormustreadthismanualinfullbeforeusingthesystem.Onlyauthorized personnelmaycarryoutassembly,modification,orrepairsofthesystem.Electrical wiringmustcomplywithlocalstandards.Equipmentmustbeusedinaccordancewith itsintendeduse. BiosignsUnitInstructionsforUse 19 TERMSOFWARRANTY MedeiaInc.("MEDEIA")warrantsthatitsproductsarefreefromdefectsinmaterialand workmanship.Subjecttotheconditionsandlimitationssetforthbelow,MEDEIAwill,at itsoption,eitherrepairorreplaceanypartofitsproduct(s)thatprovedefectiveby reasonofimproperworkmanshipormaterials.Repairedorreplacementparts/products willbeprovidedbyMEDEIAonanexchangebasis.Thiswarrantydoesnotcoverany damagetothisproductthatresultsfromaccident,abuse,misuse,naturalorpersonal disaster,oranyunauthorizeddisassembly,repair,ormodification.Biosignsunitssold byMEDEIAarewarrantedfor12months.Allaccessories,supplies,anddisposablesare warrantedforninetydays.Thiswarrantycoversonlyrepairorreplacementofdefective MEDEIAproducts,asprovidedabove.MEDEIAisnotliablefor,anddoesnotcoverunder warranty,anycostsassociatedwithpatientcare,servicing,and/ortheinstallationof MEDEIAproducts.MEDEIAwillnotdiscontinuesupportofitsproducts,norobsoleteits products,aslongastherearecomponentmaterialsandproductsavailableinthe marketplaceandreasonablecustomerdemandfortheproducts.Theforegoingisthe completewarrantyforMedeiaproductsandsupersedesallotherwarrantiesand representations,whetheroralorwritten.Exceptasexpresslysetforthabove,noother warrantiesaremadewithrespecttoMedeiaproductsandMedeiaexpresslydisclaimsall warrantiesnotstatedherein,including,totheextentpermittedbyapplicable,any impliedwarrantyofmerchantabilityorfitnessforaparticularpurpose.Innoeventwill MedeiabeliabletothepurchaserortotheuserofaMedeiaproductforanydamages, expenses,lostrevenues,lostsavings,lostprofits,oranyotherincidentalor consequentialdamagesarisingfromthepurchase,useorinabilitytousetheMedeia product, even if Medeia has been advised of the possibility of such damages. COPYRIGHT Allrightsreserved.Nopartsofthisworkmaybereproducedinanyformorbyany meansgraphic,electronic,ormechanical,includingphotocopying,recording,taping,or informationstorageandretrievalsystemswithoutthewrittenpermissionofMedeia Inc.. Productsthatarereferredtointhisdocumentmaybeeithertrademarksand/or registeredtrademarksoftherespectiveowners.Thepublisherandtheauthormakeno claimtothesetrademarks.Whileeveryprecautionhasbeentakeninthepreparationof thisdocument,thepublisherandtheauthorassumenoresponsibilityforerrorsor omissions,orfordamagesresultingfromtheuseofinformationcontainedinthis documentorfromtheuseofprogramsandsourcecodethatmayaccompanyit.Inno eventshallthepublisherandtheauthorbeliableforanylossofprofitoranyother commercialdamagecausedorallegedtohavebeencauseddirectlyorindirectlybythis document. MedeiaInc. 80S.W.8thStreet,Suite2000 Miami,FL,33130,USA T:+18004334609/F:+18004334609 www.Biosigns.com BiosignsUnitInstructionsforUse 20 GETTINGHELP Togethelpwitheithertechnicaloruseri s s u e s :
1. CallMedeiaHelpDeskat+18004334609MondayFriday8AM5PMCET,or 2. Youlocalrepresentative/supplier. BiosignsUnitInstructionsforUse 21 DYNAVISIONSPECIFICATIONS DEVICE Dimensions:
Weight:
Power:
Capacity:
Operationtime:
Memory:
Controls:
Power consumption:
Charger:
Measuringduringcharging:Yes,onUSBpowerconnector Eventbutton:
Defibrillationprotection:
118x65x33 mm
+/260gram Internalbattery(3.7V) 4,500mAh 22hours3G/30hoursWi Fi 4GBembeddedmicroSDcard RuggedizedFoilwithintegratedbuttons 200mAh(WiFi)300mAh(3G) USB charger Yes Yes LCD Pixels:
Dimensions:
Display mode:
Displaycolor:
ECG/RESPIRATION Leads:
ECGcable:
Connector:
4008001.000Hz R peak analysis:
RRintervals:
Heartrate:
Accuracy:
128x64pixels 34.50x23.00x1.45mm Passivematrix(1.3) MonochromeWhite Color 3,5or10lead wires Regular&ECGflatcable SubDtypewithtemperatureintertemperatureinterface200 Yes,automatically Yes,automatically 30250 bpm
+/2bpm(basedonQRSdetectionaccuracyof 99.2%) Respirationprinciple:
electrodes:
Impedancedynamicrange:20ohms Respiration rate range:
ImpedancepneumographySensing Autoselectedbydevice(RA/LA/LL) 3to150breaths/min(technical range) 3120breaths/min(softwarelimitation) ECGsignal 5 seconds Respiration source (RR):
Resolution:
SPO2 DisplayRange(SpO2):
Accuracy Range (SpO2):
Type:
SpO2Accuracy:
0%100%
70%to100%
Infrared:910nanometers@1.2 mWnominal Red:660nanometers@0.8mWnominal
+/2digits(nomotionforcombinationofsensorwith device) BiosignsUnitInstructionsforUse 22 SpO2Accuracy(Arms)70%to100%:
BiosignsUnitInstructionsforUse 23 TEMPERATURE Type:
Samplerate:
Accuracy:
WIFI Type:
Frequency:
Encryption:
Certificates:
Antenna:
WPA2PSK:
GSM/GPRS/GPS Operationfrequency:
Certificates:
Antenna:
SIMcard:
GPS:
USB Type:
STS400(SmithsMedical) 1kHz
+/0.4C 2.4GHzIEEE802.11b/gtransceiver 2.402to2.480MHz WEB128bit/WPAPSK/WPA2PSK/None FCC/CE/ICSandRoHScompliant Builtin WiFiAlliancecertified UMTS:80085090019002100MHz Quad:9001800MHz R&TTE/FCC/GCF/PTCRB/UL/IC/CE,RoHSandWEEE compliant Builtin LocalSIMcardtobeinstalledbymanufacturer GPSand GLONASS 2.0 Note:thedeviceisclassifiedasnotwaterproof.TheIPclassificationisIP22. Note:Donotusethedeviceinwetenvironmentsuchasrain,bathrooms,showersand otherareaswherewatercouldreachthedevice. ENDOFLIFESTATEMENT ThelifeexpectancyoftheBiosignsunithasbeendeterminedtobefive(5)years. BiosignsUnitInstructionsforUse 24 PARTS Inthissectionyouwillfindallthepartsthatcomewithyoupackage.Yourproductis deliveredinacartonboxwithindicationofthe content. Coverofthecartonbox Insideofthecartonbox BIOSIGNSUNIT TheBiosignsunitisasmall,portable,batterypoweredandlightweightdevice,which canbewornonabelt.Itisattachedtothepatientbycablesandskinelectrodes. BiosignsUnitInstructionsforUse 25 Devicepicture BacksideSticker BIOSIGNSHW9 SERIES Biosignsisdeliveredin3variants,dependingonthefeaturesthatareactivatedinthe unit:
ARTICLECODES HW9GSLP:BiosignsunitwithECGand3G HW9SLCD:BiosignsunitwithECG,SpO2,WiFiandLCD display HW9SGLCD:BiosignsunitwithECG,SpO2,WiFi,3G,GPSandLCDdisplay Note: each unit can be used with a temperature sensor for temperature monitoring. SERIAL NUMBER
(1) DV
(2) XxY
(3) XxB
(4) xxxx Theserialnumberindicatesthetypeofdevice(1),themanufacturingyear(2),thebatch number(3)andthedevicenumbermanufacturedwithinthatbatch(4). ECG CABLE TheECG cablesare regularcableswithspecialconnectionplug to connecttothe device. Note:BiosignsdoesnotworkwithothercablesthantheonessuppliedtoyoubyMedeia!
BiosignsUnitInstructionsforUse 26 Therearethreecablesavailable:
1) ECGcablewithregular3leadwireECGsnaps 2) ECGcablewithregular5leadwireECGsnaps 3) ECGcablewith10leadwirecrocodilesnaps(regularECGsnapsbeusedaswell) 3leadwireECGcable
(RA/LA/LL)and(R/L/F)
*Note:withthe3leadECGcable,onlyleadIisavailableformonitoring.TheFactsastheRight LegDrive(RL)identicaltoa5leador12leadECGconfiguration. 5leadwireECGcable
(RA/LA/RL/LL/C)and (R/L/F/N/C) 10leadwireECGcable
(LA/RA/RL/LL/V1V6)and(L/R/F/N/C1C6) BiosignsUnitInstructionsforUse 27 ECG ELECTRODES BiosignsworkswithstandardECGadhesiveelectrodes.However,wedorecommend youtousehighqualityelectrodesastheygreatlydeterminethequalityofyour measurement.Interrupted skin contact results in poor quality ECG signals. SPO2 SENSOR Biosignsisdesignedformonitoringthephotoplethysmogram(PPG)andarterialoxygen saturationlevelandworkswiththefollowingNoninbrand sensors:
8000SS 8000 SM 8000SL Note:donotuseothersensorsthantheonessuppliedtoyoubyMedeiaInc. Note:forseparateinstructionsoftheNoninsensors,refertoAnnexItothis instructionsforuse USBCABLE SpO2fingerclip sensor TheUSBcableisusedtochangetheconfigurationofthedevicetothedifferentuser modes.TheUSBcableisalsousedtomonitorthepatientwiththecomputerandto download data from the internalmemory card to the PC. DVUSB(USBcablewithmicroUSB connector) ConnectionportforUSBcable BiosignsUnitInstructionsforUse 28 TheUSBcablehasamicroUSBplugononesideandaregularUSBplugontheother side.TheregularUSBplugisconnectedtothePCorachargerandthemicroUSBplugis connectedtothedevice. POWERSUPPLYUNIT TheBiosignsunithasanintegratedrechargeablelithiumpolymerbattery.Recharching thebatteryisdoneusingaUSBpowersupply.Biosignsisdeliveredwithapower supply,whichisidentifiedasDVPSU.Thischargerhasbeentestedincombinationwith theBiosignsunitforpatientsafetyandelectromagneticcompatibility.Also,this chargerallowsforfastchargingtheBiosignsunitasitisrecognisedbythedevice. DVPSUwall charger DVPSU label BiosignsUnitInstructionsforUse 29 ACCESSORIES Please check with your supplier for more details about available accessories. BiosignsUnitInstructionsforUse 30 USINGTHEDEVICE CONNECTINGTHEECGCABLE WARNING CAUTION DonotuseothercablesthantheonessuppliedbyMedeiaasthis maydamagethedeviceorcauseinjurytothepatientortheuserof the product. Do not misuse the cable and the snaps as damage to the cable might occur.ThiswillinfluencetheECGsignal quality. CONNECTINGTHECABLETOTHE PATIENT ThequalityoftheECGsignalhighlydependsonthecontactwiththeskin.Tooptimize results,preparetheskinbeforeyouplacetheECGadhesiveelectrodes.Theproper techniqueistoremovehairfromtheplacewheretheelectrodeshavetobeplaced.Avoid skinlesioninthecaseyouhavetoshavethearea.Cleantheareawithalcoholandmake sure that the skinis completelydry before placing theECG adhesive electrodes. ThenattachtheECGadhesiveelectrodestothesnapsoftheECGcable. Attachthecoloredsnapsofthecabletothestickerelectrodes.Removethebackfoilof theelectrodesandattachthemtotheskin.Placementoftheelectrodesdependsonthe leadconfiguration.Youcanchoosebetween3,5and12leadECG. Note:placementoftheelectrodesotherthannormalmakesthatthemorphologyof theECGsignalchanges. Note:werecommendyoutoplacetheelectrodesoverbonestructures.Avoid placementoftheelectrodesoverlargemusclesorfattytissuebecausethesewillcause artefactsandnoiseintheECGsignal(seeArtifactduetopoorelectrodeapplicatons sectionformoredetails). Note:alwaystapethesnapandtheelectrodetotheskintoavoidmovementofthe ECGsnap,leadsandtrunkcableasthiscreatesnoiseontheECGsignal. PLACEMENTOFTHE ELECTRODES InordertomakegooddiagnosisbasedontheECGsignalsrecordedwithBiosignsitis importanttoplacetheECGelectrodesandtheECGcablethecorrectway. Otherwiseaphysicianwillnotbeableinterpretthecollectedsignals.Properplacement forthe3availablecablesisshownintheimagesbelow.Notethatplacementoverbone structuresresultsinthebestpossiblesignalquality. BiosignsUnitInstructionsforUse 31 3LEAD ECG 3lead ECG RA LA LL RA=right shoulder LA=leftshoulderLL
=leftthoraxorhip BiosignsUnitInstructionsforUse 31 5LEAD ECG 5lead ECG LA RA C1 RL LL RA=Rightfrontsideoftheshoulder LA=Leftfrontsideoftheshoulder LL=Lefthip RL=Right hip C1=Rightofthe sternum BiosignsUnitInstructionsforUse 32 12LEAD ECG 12lead ECG RA=Rightfrontsideoftheshoulder LA=Leftfrontsideoftheshoulder LL=Lefthip RL=Right hip C1=Rightofthesternum C2=Leftofthesternum C3=BetweenC2andC4 C4=Underleftnipple C5=BetweenC4andC6 C6=Leftsideofthoraxinlinewithaxilla BiosignsUnitInstructionsforUse 33 ARTIFACTDUETOPOORELECTRODEAPPLICATONS The Biosigns unit is equipped with stateoftheart electronic utilities that ensure artifactfreerecordings.Amongthesearetheautomaticbaselineadjustmentandtheanti driftsystem(cubicspline) (ADS). Atthebeginningoftherecordingtheautomaticbaselineadjustmentalgorithmverifies theincomingsignalandadjuststhebaselinepositionaccordingly. Duringtherecording,theantidriftsystem(cubicspline)continuouslychecksthe baselinepositionandreturnsittothenormallevel,ifrequired(seeSampleRecording figure). FortheManualMode,theantidriftsystem(cubicspline)canbeenabledanddisabled fromthesetupmenu. Whenelectrodesarenotproperlyapplied,thesemeasuresmaynotfullycompensatefor artifact.Highpolarizationvoltagesinducedbyelectrodesappliedwithoutconductivegelmay causetheamplifiertooverrange,sothatastraightlinewillberecordedinsteadoftheECG(see figure).Inthissituationthedevicewillautomaticallyblockandreturnthebaselinetoitsnormal position.Abaselineisthenrecordedforapproximately1second.Itispossibletoblockthe amplifiersmanuallybydisconnectingtheRelectrode. REMEDY Applytheelectrodesaccordingto instructions. Donotapplytheelectrodesontopof clothing. Useacontactagent(e.g.moistenedelectrodepaper,electrodecream,spray, etc.). Waitapproximately10secondsbeforeinitiatingarecording.Afterthe10second period,theautomaticfunctionsareenabledandthepolarizationvoltageshave stabilized,providedtheelectrodesareproperlyapplied.Incaseofimproper electrodeapplication,anerrormessagewillappearonthedisplay(RL,LL,LA,LL,V1 toV6). BiosignsUnitInstructionsforUse 34 RECORDINGECGSOFPACEMAKERPATIENTS Duetotheslowdisplayspeed,itisnotpossibletodisplaypacerpulsesdirectlyonthe ECGrecording.Forthisreason,therecorderreducesthepulseamplitudeandexpands thepulsewidth,sothatthepacerpulseiseasiertoidentify.TheBiosignsrecordsthe pulsewiththecorrectpolarity,withawidthof5msandwiththesameamplitudeinall leads(dependingonthepolarityofthepacerpulseinleadsIandII,thepacerpulsein leadIIImaybesuppressed)Theamplitudeofthereversecurrentinthefigurebelow showsanECGrecordingwithpacerpulses. BiosignsUnitInstructionsforUse 35 WARNING Incorrectheartrate:ifseveraladverseconditionsexistatonce, thepossibilitythatthepacerpulsesareinterpreted(and counted)asQRScomplexesshouldbeconsidered.Atthesame time,however,QRScomplexesmightbesuppressedincertain situations.Therefore,pacemakerpatientsshouldalwaysbe watched closely. Pacemaker patients: as Biosigns uses builtin radios to transmitECGdataandvitalsignstoacentralstationwenot recommendtousethedeviceonpatientswithapacemaker. ECGRECORDINGDURING DEFIBRILLATION ThepatientsignalinputisdefibrillationproofsoitisnotnecessarytoremovetheECG electrodesbeforedefibrillatingthepatient.However,whenusingstainlesssteelorsilver electrodes,thedefibrillatordischargecurrentmaycausecompletepolarizationatthe electrode/skininterface.ThisconditionmaypreventECGsignalacquisitionforseveral minutes.Withsilver/silverchlorideelectrodes,thiswillnothappen. Whenusingotherelectrodes,disconnectthepatientcablefromtherecorderwhile defibrillatingthe patient. WARNING EquipmentdamageForreasonsofpatientsafety,useonlythe originalMedeiapatientcable.Beforeconnectingthecabletothe device,checkitforsignsofmechanicaldamage.Donotusea damagedcable. Patient hazard, delayed ECG displays Use silver/silver chloride electrodesforECGsignalacquisition,ifthepatientmayhaveto bedefibrillated. ShockhazardDuringdefibrillation,donottouchthepatient,the electrodesorthe leadwires. Note:Observethedefibrillatorsafety information. CONNECTINGTHEECGCABLETOTHE DEVICE TheECGcablehasaplug.InserttheplugintheportatthetopsideofBiosigns.Onthe frontsideofthedeviceyouwillfindtheindicatorsforthecorrectport.Theplugisalarge flat SubD type of plug that corresponds with the ECG port onthe device. Note:Theplugfitsinonedirectiononly!
BiosignsUnitInstructionsforUse 36 ECGconnectorontopof device InsertECGcableandalwaystightenthe2 screwstoavoidthecablefromdetachingthe devicewhenin use Note:donotforce(!)theplugintotheport.Damagetotheplugand/orthedevicemay occur. SPECIFICATIONSOFTHEECG ThespecificationsoftheECGareprovidedinthetablebelow. ECGAmplifier Samplingfrequency Digitalresolution Dynamicrange Max.Electrode potential 300mVDC Timeconstant Frequency response Inputimpedance LineFrequency Filter LowPass HighPass Patient Leakage Current Patient Input Common Mode Rejection LeadsOffIndicators Simultaneous,synchronousregistrationofall8 active electrodesignals(=12standardleads) 100/200/400/800/1.000Hz 5V 10mVAC
>3.2s 0.05to150Hz(3 dB)
>10MOhms Distortionfreesuppressionofsuperimposed50or60 Hzsinusoidalinterferences. 50or 150Hz 0.05Hzor3.5Hz
<10 A Fullyfloatingandisolated,defibrillationprotected. 80dB (minimum) 100dB(with filter) Connectionstatusforeachleadisshownon"Recording ECG"screen BiosignsUnitInstructionsforUse 37 Gain/Sensitivity 5mm/mV BiosignsUnitInstructionsforUse 38 SweepSpeed InputRange A/DConversion EMGFilter Twaveamplitude(aT) HeartRateRange HeartRate averaging HeartRateResolution HeartRateAccuracy HeartRateandQRS detectionstabilization period Responsetimeof heart ratemetertochangein heartrate Isolation ECGFILTERS 12.5,25,50mm/sec
+/10mV 16bit 35Hz(3dB)/25Hz(3dB) RejectsTwaves=1.2*Rwave 30250 1beat 1bpm
+/2bpm 20s HRchangefrom80to120bpm:9to12seconds HRchangefrom80to40bpm:9to13seconds Isolatedfromgroundrelatedcircuitsby>4kVrms,6kV peak Biosigns can be configured with 3 ECG filter settings. These are configured in the Biosigns Telemonitoring Software and cannot be changed in the device but the operatorofthedevice.Theavailablefiltersare:
Filter Notchfilter Highpassfilter Lowpassfilter Specifications 60Hz Comments ForUSA mains 50Hz 0,05Hz 3,5Hz 50Hz 150Hz ForEuropemains This setting does notalter the ECG trace and is the recommendedsettingfordiagnostic ECG ThissettingdoesaltertheECGtraceandisthe recommendedsettingforambulatorypatientsas itfiltersournoisecausedbymovement Thissettingisrecommendedforambulatory patients Thissettingisrecommendedforrestingpatients Note:Thesoftwareautomaticallyforcesthelowpassfilterto50Hzwhentheselected sampleratefortheECGisselectedtobe100HztoavoidaliasingoftheECGsignal. Note:theaccuracyoftheQRSheartbeatdetectionwasvalidatedagainsttheMIT database,AHAdatabaseandtheNSTdatabase.Theaverageaccuracyofthebeat detectionisfoundtobe99,2%. Note:ThesensitivityoftheQRSdetectionisvalidforpersonswithanormalQRS complex. BiosignsUnitInstructionsforUse 39 RESPONSETOIRREGULARRHYTHM 1. Ventricularbigeminy:theBiosignscountsbothlargeandsmallQRS complexestodisplayarateof80bpm. 2. Slowalternatingventricularbigeminy:theBiosignscountsbothlargeand smallQRScomplexestodisplayarateof60bpm. 3. Rapidalternatingventricularbigeminy:theBiosignscountsallQRS complexestodisplayarateof120bpm. 4. Bidirectionalsystoles:theBiosignscountsallQRScomplexestodisplayarateof 90bpm. BiosignsUnitInstructionsforUse 40 ABOUTPHOTOPLETHYSMOGRAPHY PULSEVOLUMERECORDING(PVR)WAVEFORM INTERPRETATION:
PVRservesasaqualitativeaidintheassessmentofperipheralhemodynamics.Normal plethysmographicwaveformsresemblethearterialpressurepulse.ThenormalPVR waveform(shownbelow)hasasharpsystolicupstroke,andasomewhatnarrowpeak. Afterpeaking,thewaveformdropsquicklyduringdiastolewithitsslopebowingin towardthebaseline.Normalwaveformsusuallyhaveadicroticnotchbetweenthepeak andbaseline.However,thedicroticnotchmaybecomelessnoticeablewithvasodilation ormaybecomemorepronouncedduringvasoconstriction. Distaltoanarterialocclusion,thewaveformbecomesmoreroundedwithamore gradualupslope,andthedownslopemaybowawayfromthebaseline.Amplitudeof theabnormalwaveform(shownbelow)isusuallydiminished,butthisconditionisnot sufficientfordiagnosisbecauseamplitudeisinfluencedbyadditionalfactorssuchas bloodpressure,arrhythmia,vasomotortone,andlimbposition. Again,notethatthewaveformcontourmaybealteredduringvasodilationor vasoconstriction. PVRwaveformsaregivenaRecommendationofClassIIintheACC/AHAP.A.D. Guidelines(Hirsch,2005). PPGWAVEFORMS:
PPGwaveformsaremadeavailableasanaidforobtainingsystolicpressures.PPG waveformcontourinterpretationissimilartotheinterpretationofPVRwaveforms. However,becausethePPGwaveformisobtainedatadigit,distortionofthePPG contourduetovasoconstrictionorvasodilationismorecommon. OXIMETRYTHEORY Thepulseoximetershinesredandinfraredlightthroughthetissueanddetectsthe fluctuatingsignalscausedbyarterialbloodpulses.Theratio ofthefluctuationofthered BiosignsUnitInstructionsforUse 41 and infrared light signals received determines the oxygen saturation content. Conditionssuchassteadyvenousbloodflow,skinthickness,fingernailthickness,etc.,do notaffectthesaturationreadingbecausetheyareconstantanddonotcause fluctuations. Thefunction,f,dependsonthephysicalpropertiesoftheLEDsproducingthelight. These physical properties are fixed by the manufacturing material and processes. Notethatthepulseoximeterreadingsdonotdependupontheabsolutelightintensity, ratheruponthefluctuationsinlightintensity. Characteristicssuchasthickskinorskinpigmentationwillaffecttheminandmax proportionally,thustheratiomin/maxdoesnotchange.However,iftoolittlelightpasses through,thepulseoximeterwillnotdisplayvalues.Pulseoximetersusetwodifferent wavelengthsoflight(redandinfrared),providingtheabilitytodetermineonecomponentof blood.Thepulseoximeteriscalibratedtocloselyapproximatefunctionaloxygensaturation values.Thesevalueswillcloselyapproximatelaboratoryinstrumentfractionalsaturation valuesifthedysfunctionalhemoglobinsaturationlevelsarenegligible. Insummary,becausethepulseoximeterperformsallcomputationsfromtheinternal softwareand thereare no criticalparts todrift,no recalibrationis needed. Ifthedysfunctionalhemoglobiniscarboxyhemoglobinormethemoglobin,thedifference betweentheoxygensaturationvaluedisplayedbythepulseoximeterandtheoxygen saturationvaluesdeterminedbythelaboratoryinstrumentwillbegreaterasthe dysfunctionalhemoglobinlevelsriseapproximatelyinaccordancewiththefollowing formulas,where:
SpO2=950determinedandnumericallydisplayedoxygensaturationinpercent O2Hb=Fractionaloxyhemoglobinsaturationinpercent COHb=Carboxyhemoglobinsaturationinpercent MetHb=Methemoglobinsaturationinpercent SaO2=Functionaloxygensaturationinpercent BiosignsUnitInstructionsforUse 41 PLACINGTHESPO2SENSOR WARNING SevereanemiamaycauseerroneousSpO2readings. InterferingSubstances:SpO2isafunctionalcalculationofarterial oxygensaturation.Carboxyhemoglobinandmethemoglobinmay erroneouslyincreaseSpO2readings.Thelevelofincreaseis approximatelyequaltotheamountofcarboxyhemoglobinand/or methemoglobinpresent.Dyes,oranysubstancecontainingdyes,that changeusualbloodpigmentationmaycauseerroneousreadings. Donotconnect/useotherthanprovidedSpO2sensorwiththat equipment,readingsmaybeinaccurate.SpO2probesaredesignedfor usewiththatspecificequipmentonly. Oxygensaturationmeasurementsusingpulseoximetryarehighly dependentonproperplacementofthesensorandpatientconditions. Patientconditionssuchasshiveringandsmokeinhalationmayresultin erroneousoxygensaturationreadings.Ifpulseoximetrymeasurements aresuspect,verifythereadingusinganotherclinicallyaccepted measurementmethod,suchasarterialbloodgasmeasurementsona cooximeter. Tissuedamagecanbecausedbyincorrectapplicationoruseofa sensor
(e.g.,wrappingthesensortootightly,applyingsupplementaltape, failingtoperiodicallyinspectthesensorsite,leavingasensorontoolong inoneplace).RefertotheDirectionsforUseprovidedwith eachsensor forspecificinstructionsonapplicationanduse,andfordescription, warnings,cautions,andspecifications. Sensorsexposedtoambientlightwhilenotappliedtoapatientcan exhibitseminormalsaturationreadings.Besurethesensorissecurely placedonthepatientandcheckitsapplicationoftentoensureaccurate readings. ThepulseoximetrychannelmustNOTbeusedasanapneamonitor. Thepulseoximetryoptioncanbeusedduringdefibrillation,butthe Inaccuratemeasurementsmaybecausedbyvenouspulsations. readingsmaybeinaccurateforashort time. Averysuddenandsubstantialchangeinpulseratecanresultinerroneous pulseratereadings.Besuretovalidatethepatientdataandpatient condition before interventionor change in patient care. InterferingSubstances:Carboxyhemoglobinmayerroneouslyincrease readings;thelevelofincreaseisapproximatelyequaltotheamountof carboxyhemoglobinpresent.Methemoglobinmayalsocauseerroneous readings.Dyes,oranysubstancescontainingdyes,thatchangeusual arterialpigmentationmaycauseerroneous readings Thepulseoximetrysystemmightmisinterpretmotionasgoodpulse quality.Minimizefingermotionorchangethetypeofsensorbeingused. Donotfastenthepulseoximetertootightlyaroundthewrist.Inaccurate readingsandpatientdiscomfortcouldresult. Biosignsunitandsensorhasnotbeenclinicallyvalidatedformotion accuracyandduringLowPerfusion.BiosignsSpO2isnotintended foruseduringmotionandduringLowPerfusion. BiosignsUnitInstructionsforUse 42 WARNING Biosignsunitandsensorhasbeenvalidatedfornomotionaccuracy inhumanbloodstudiesonhealthyadultmaleandfemalevolunteerswith lighttodarkskinpigmentationininducedhypoxiastudies intherangeof 70100%SpO2againstalaboratoryOximeterandECGmonitor.1%was addedtoaccountforthepropertiesoffetalhemoglobin.Thisvariation equalsplusorminusonestandarddeviation,which encompasses 68% of the population. DonotexposetheBiosignstoexcessivemoisturesuchasdirect exposuretorain.ExcessivemoisturecancausetheBiosignsto performinaccuratelyorfail. BecausePULSEOXIMETEREQUIPMENTmeasurementsarestatistically distributed,onlyabouttwothirdsofPULSEOXIMETEREQUIPMENT measurementscanbeexpectedtofallwithinArmsofthevalue measuredbyaCOOXIMETER.WhenaPULSEOXIMETERMONITORis suitableforusewithavarietyofPULSEOXIMETERPROBES,SpO2 ACCURACYinformationshallbemadeavailableforeachtypeofPULSE OXIMETER PROBE. Topreventthesensorfromfallingoffsecurethewiretothedigitwith medical tape. CAUTION Donot use adamaged sensor.Ifthe sensoris damaged in any way, discontinueuseimmediatelyandreplacethesensor. Topreventimproperperformanceand/orpatient injury,verify the sensor and pulse oximeter compatibility before use. Factorsthatmaydegradepulseoximeterperformanceincludethe following:
infusionlines improperlyappliedsensor o excessiveambient light o excessivemotion o electrosurgicalinterference o arterialcatheter o bloodpressure cuffs o o moistureinthesensor o o carboxyhemoglobin o methemoglobin o artificialnails o o poorpulse quality o venouspulsations o anemiaor low o hemoglobinconcentrations o cardiovascular dyes o sensornotatheart level o dysfunctional hemoglobin o incorrectsensortype fingernailpolish Each SpO2 sensor is designed for application to a specific site on the patientwithinacertainsizerange.Toobtainoptimalperformance,use anappropriatesensorandapplyitasdescribedinthesensors directionsforuse. BiosignsUnitInstructionsforUse 43 CAUTION Ifexcessive ambientlightispresent,coverthe sensorsitewith opaque materialtoblockthelight.Failuretodosomayresultininaccurate measurements.Lightsourcesthatcanaffectperformanceinclude surgicallights(especiallythosewithaxenonlightsource),bilirubinlamps, fluorescentlights,infraredheatinglamps,anddirectsunlight. Ifnoninvasivebloodpressure(NIBP)willbemonitoredwhileusing SpO2,placetheNIBPcuffonadifferentlimbthantheSpO2sensorto helpreduceunnecessarySpO2alerts.Foroptimalmeasurements, avoidplacingtheSpO2sensoronthesamelimbasanarterialcatheter orintravascularline. Lossofpulsesignalcanoccurifthesensoristootight,thereisexcessive ambientlight,anNIBPcuffisinflatedonthesamelimbasthesensor, thereisarterialocclusionproximaltothesensor,thepatientisin cardiacarrestorshock,orthepatienthashypotension,severe vasoconstriction,severeanemia,or hypothermia Thechoiceforthetypeofsensordependsontheapplicationforuse.FornormalSpO2 testingathomeorinthehospitalwerecommendtouseareusablesensor.Forthe longtermSpO2monitoringorsleepstudywerecommendtousedisposablesticker sensorstoavoidthesensortoloosecontactwiththeskin. CHOOSINGSENSOR SIZE FORSOFT SENSOR Softsensorsizerecommendationsarebasedondigitheight(thickness).Thedigitheight
(H) ismeasuredasshowninthefigure below. Fordigitheightfrom7.5mm(0.3in)to12.5mm(0.5in),sizesmallshouldbe selected(8000SS). Fordigitheightfrom10.0mm(0.4in)to19.0mm(0.75in),sizemediumshouldbe selected(8000SM). Fordigitheightfrom12.5mm(0.5in)to25.5mm(1.0in),sizelargeshouldbe selected(8000SL). FORFLEX SENSOR Flexsensorsizeisdeterminedfromthepatients weight. Forapatientwhoweighs220kg(4.444lbs),sizeinfantshouldbeselected. Forapatientwhoweighsover20kg(44lbs),sizeadultshouldbeselected. BiosignsUnitInstructionsforUse 44 CHOOSINGTHESENSORAPPLICATION SITE Thepreferredapplicationsiteforpatientsover20kgistheleftindexfinger.However, otherfingersortoesmaybeusedwherethetissuethicknessisbetween5and21 millimeters.Othersitesmaynotgiveacceptableresultsbecauseofinadequatelight transmissionorperfusion. ATTACHINGTHESENSOR 1. Inserttheselecteddigit(refertothesizingrecommendationsabove)intothe sensorasillustratedinFigures1and2.Thepatientsdigitmustreachtheendofthe sensor. 2. Directthecablealongthepatientsfinger/toe,paralleltothearm/leg.(Optional:
Securethesensorcableasneeded.) 3. Connectthesensorcabletothepulseoximeterortothepatientcable. 4. Verify proper operation as described in the pulse oximeter operators manual. Note:Propersensorplacementiscriticalforgoodperformance.Ifthesensorisnot positioned properly, light may bypass the tissue and result in SpO2 inaccuracies. Werecommendtheplacementofthefingertipsensorasdepicted below. Slidesensoroverindex finger Wireoverthehand CLEANINGTHESENSORS Makesurethesensoris placedcomfortableforthe patient. CAUTION Cleanthesensorbeforeapplyingittoanew patient. Unplugthesensorfromthepulseoximeterbefore cleaning. Donotsterilize,autoclaveorimmersethesensorinliquidof any kind. Do not pour or spray any liquids onto the sensor. Do notuse caustic or abrasive cleaning agents on the sensor.Do notusecleaningagentscontainingammoniumchloride.Useof these chemicals may shortenthelife ofthe product. Do not misuse the cable and the snaps as damage to the cable might occur.ThiswillinfluencetheECGsignal quality. BiosignsUnitInstructionsforUse 45 1. Tocleanthesensor,wipeallpatientcontactsurfaceswithasoftclothdampened withamilddetergent,isopropylalcohol,ora10%bleach/90%watersolution
(householdbleach[containinglessthan10%sodiumhypochlorite]). Referencesensorinfigurebelow;
2. Allowthesensortodrythoroughlybeforereusing. COMPLIANCE ThisproductcomplieswithISO109931. Notmadewithnaturalrubberlatex. CONNECTINGTHESPO2CABLETOTHEDEVICE TheSpO2cablecanbeconnectedtotheBiosignsunitusingtheplasticplugatthe endofthecable.OnthetopsideofthedeviceyoucanfindtheportfortheSpO2 cable. SpO2connectionportwith whitearrow marker SpO2sensorconnectorwith whitearrowmarker SpO2connectorinserted inthedevice Thereisawhitearrowindicatorontheplugthatcorrespondswithawhitearrow indicatorontheconnectoronthedevice.Theplugonlyfitsinonedirection. Notes Ifinsertingtheplugdoesnotgosmoothly,neverforcetheplugdamagetothe plugand/orthedevicemayoccur. BiosignsUnitInstructionsforUse 46 ConnecttheSpO2cabletothedesignatedconnectionportatthetopsideofthe BiosignsUnitInstructionsforUse 47 Biosigns. SpO2sensorscanbepurchasedatMedeiaInc.orfromyourlocalBiosigns representative. Ifpatientmovementinterfereswithmeasurements,considerthefollowing possible solutions:
o Be sure the sensor is secure and properly applied. o Useanewsensorwithfreshadhesivebacking. o Selectadifferenttypeof sensor. o Movethesensortoalessactivesit CONNECTINGTHETEMPERATURESENSOR WARNING Applicationanduseofmetaljacketedtemperatureprobesthatcome incontactwithconductiveobjectsorclinicalpersonnelduring electrocauterymaycauseburnsatthepatientprobe/electrode contactpoints. Donottouchconductivetemperaturesensorsduringdefibrillationor cautery. UseonlytemperatureprobeslistedbyMedeia.Otherprobesmay produceincorrecttemperaturereadings. BiosignsunitworkswiththedisposableSTS400sensorofSmithsMedical. TheSTS400sensorsshouldpreferablybeplacedintheleftaxillarycavityoron thesternum. BiosignsUnitInstructionsforUse 48 A B PlacementofTemperaturesensor Onthesternum(A) Intheleftaxillarycavity(B) ThesensorcanbeconnectedtotheBiosignsunitusingthetemperatureconnection cableasdisplayedbelow.Thiscableisinsertedinthephonejackportatthebottomside oftheBiosignsunit. Connectedtemperaturecable RESPIRATIONRATE Biosignsisintendedtodetecttherespiratoryeffort,derivingthesignalbymeasuring theACimpedancebetweenselectedterminalsofECGelectrodes.Thismethodiscalled impedancepneumography.Impedancepneumographyisacommonlyusedtechnique BiosignsUnitInstructionsforUse 49 tomonitorapersonsrespirationrate,orbreathingrate.Itis BiosignsUnitInstructionsforUse 50 implemented by using two electrodes. The objective of this technique is to measure changes in the electrical impedance of the persons thorax caused by respiration or breathing. ArrangementofElectrodesforImpedancePneumography Inthismethod,ahighfrequencyaccurrentisinjectedintothetissuethroughthedrive electrodes(seeRef.1).Theaccurrentcausesapotentialdifferencetodevelopacross anytwopointsbetweenthedriveelectrodes.Thispotentialdifferenceisrelatedtothe resistivityofthetissuebetweenthevoltagesensingorreceiveelectrodes.The equivalentresistanceisdefinedastheratioofthevoltagedifferencebetweenthetwo receiveelectrodesandthecurrentthatflowsthroughthetissue.ThenormalECG electrodesareusedforthismethod. WARNING Impedancepneumographydetectsrespiratoryeffortviachangesin chestvolume.Artifactduetopatientmotion,orelectrocauteryusemay causerespirationtogoundetected.AlwaysmonitorSpO2whenusing impedancepneumographytomonitorrespiratoryfunction. DontplacetheBiosignsunitincloseproximitytoanother respirationmonitorbecausetheImpedancepneumography measurementfrequenciesmayinterferewithoneanother. Becausepacemakerpulsesinsomeinstancesmaybefalselycounted asbreaths,impedancepneumographyisnotrecommendedforuseon paced patients. Motionartifactcancauseincorrectbreathrateorheartratereadings. Minimizepatientmotionwheneverpossible. Ifadisconnectedleadisintoocloseproximitytootherelectrical devices,itmaycausefalserespirationrates. SPECIFICATIONSOFTHERESPIRATIONRATE Sweepspeed:
Amplituderange:
Sensingelectrodes:
3.13,6.25,12.5mm/s:userselectable 1x,2x,4x,8x,16x Autoselectedbydevice Impedancedynamicrange:
20 ohms Signalbandwidthafterdetection:
0.06Hz(singlepole)to3.2Hz(2pole) Breath detectionthreshold140milliohmsor2xCVA, whicheverisgreater BiosignsUnitInstructionsforUse 51 Respirationraterange Adult:
3to150breaths/min(technical range) 3120breaths/min(softwarelimitation) Respirationrate source (RR):
ECGimpedancesignal Resolution:
5 seconds Cardiovascularartifactrejection(CVA):
PresenceofCVAisdetectedautomatically. BreathswillbepickedinthepresenceofCVA unlesstheBreathRateiswithin5%ofthe HeartRateorasubmultipleoftheheartrate. Motionartifactrejection:
Obstructiveapnea:
Not rejected Notdetected Notes:
Impedancepneumographyisnotrecommendedforusewithhighfrequency ventilation. SincerespirationrateisderivedfromthesameleadsastheECGchannel,the devicedetermineswhichsignalsarecardiovascularartifactandwhichsignalsare resultsofrespiratoryeffort.Ifthebreathrateiswithinfivepercentoftheheart rateoramultipleorsubmultipleoftheheartrate,themonitormayignore breaths. WhenmonitoringrespirationrateitishighlyrecommendedthatyouuseSpO2 monitoringasabackupmonitoringmethod. ItisrecommendedthatBiosignsrespiratorymeasurementsnotbemadeinclose proximitytoelectricallyradiatedequipment.WhenBiosignsisoperatedperEN 6060112(radiatedRFimmunity3V/m),fieldstrengthsabove2V/mmaycause erroneousmeasurementsatvariousfrequencies. Biosignscountsasbreathsrespiratoryeffortsthatarelargerthantwotimes backgroundcardiovascularartifact. Severeartifactandinterference(suchasdefibrillationinterference)cancausethe waveform to move offthe display forafewseconds beforeit is restored. BiosignsUnitInstructionsforUse 52 USINGTHEDEVICE SWITCHONTHE UNIT Afteryouconnectthepatienttothedevice,switchitonbypressingtheOn/Offbutton foronesecond. ThedevicewillstartandtheLCDdisplaywillshowtheBiosignsTelemonitoringSystem logo. On/off button Startup screen Toswitchtheunitoff,keeptheon/offbuttonpressedfor3secondsuntilthedevice showsthemessageTurnoffinProgress. On/off button Turnoffscreen BiosignsUnitInstructionsforUse 51 MODESOF OPERATION Thedevicehas3modesofoperation,whicharedescribedinthenextsections.Each modecanonlybeconfiguredusingtheBiosignsTelemonitoringSystemsoftware. Please refer to that manual for more detailed information. USB MODE ToplacethedeviceinUSBmode,switchofftheBiosignsunitandconnectittothePC usingtheUSBcable.Whenthecableisconnected,switchtheBiosignsunitonandit willshowtheUSBconnectionmessageonthescreen. PCrecogniseddevice DeviceisinUSBmode WhenthedeviceswitchedonwhenconnectingittothePC,itwillnotbeplacedinUSB modebutinchargingmode.Thescreenwillshowthemessagebelow. WhenchargingviaPC,themessageisSlow charge WhenthedeviceisconnectedtotheUSBportsofthecomputerwheretheBiosigns softwareisinstalled,thefollowingfeaturesareavailable;
Configurationofthemodesofthedevice:withthesoftwareitispossibleto configurethedevicefortheoperationalmode.FortheWIFImodeandthe3G mode,thenetworksettingscanbeconfigured.Whenthedeviceisconfiguredvia USB it needs to be restarted forthe new settings to take place. Configurationofthesensorsusedwiththedevice:thedevicecanbeusedfor differentconfigurationswithECG,SpO2andTemperature.Thisconfigurationis doneviathesoftwareonthe PC. MonitoringoftherealtimevitalsignsandECGofthepatient:thedevicecanbe usedforrealtimemonitoringwhenthepatientisconnectedtothedevice.Inthis case,the data is received via the USB cable connection. Downloadingdatafromtheinternalmemoryofthedevice:thedevicerecordsthe dataduringoperation.ViathesoftwareonthePC,thedataontheinternalmemory cardcanbe(partially)downloadedtothePCandaddedto(onemore)patient recordsforreview,reportingandstorage. BiosignsUnitInstructionsforUse 52 Chargingtheinternalbatteryofthedevice:assoonastheUSBispluggedinthe unit,itwillpowertheunitandchargetheinternalbattery.Thedevicecanbe chargedwithalaptop,PC,phonecharger,carchargerandothermeansthat providechargingpower.Withthedifferentchargingsources,thetimeofthe chargingprocessisdifferent(seerechargingthedevicesectionintheinstructions foruse). WIFI MODE WARNING Sometimestheconnectionwiththeservercanbeinterrupted.Inthat casethedevicewillshowthemessagethattheserverconnectionis dropped.TheBiosignsTelemonitoringSystemsoftwarewillshow the samemessagetoindicatethatmonitoringthepatientisnotavailable. Inthismode,theBiosignsunitcommunicatesviaalocalWiFinetwork.Inorderforthe devicetoconnecttothenetwork,itneedstobeconfiguredwiththeappropriate settings.ThisisdoneusingtheBiosignsTelemonitoringSystemsoftware.For instructions,pleaserefertothespecificusermanual. ThedeviceisdesignedtoautomaticallyconnecttothepredefinedWiFinetwork. Therefore,theoperationislimitedtoswitchingontheunitandwaitingforittoconnect. Duringtheconnectionprocess,thedisplayshowsthemessageWiFimoduleon.The WiFiradioindicatorflashesuntilitisconnectedtotheWiFinetwork.Theunitdisplay thenindicatesWiFiconnectionestablished. ThebarsoftheWiFistatusindicatordisplaythesignalstrength.Themorebars,the moreradiostrengthavailable.TherangeofreceptionoftheWiFisignalmaybe affectedbyequipmentusedinthedirectvincinityoftheBiosignsunitorWiFi router.EnsurethatwhenusingtheWiFimodethereissufficientcoverageofthe networktoadequatelymonitorthepatient. AssoonastheBiosignsserverisreceivingthedatafromthedevice,thedisplayshows themessageJoinedWiFinetworkandanupwardsflashingarrowshowsactive transmissionofdatatotheBiosignsTelemonitoringSystemsoftware. Note:Biosignsunitwillautomaticallytrytoreconnecttotheserverwithaoneminute interval. BiosignsUnitInstructionsforUse 53 WiFi connection established message. Indicationthat deviceissendingto IPaddressofBiosigns ServerviaWiFiSSID. Flashingupwardsarrow indicates transmission. Connectionwith BiosignsServerlost. WIFIDeviceisinWiFi modeandis connectingtoWiFi network Now,monitoringbytheremoteworkstationisavailable. Sometimestheconnectionwiththeservercanbeinterruped.Inthat casethedevicewillshowthemessagethattheserverconnectionis dropped.TheBiosignsTelemonitoringSystemsoftwarewillshowthe samemessagetoindicatethatmonitoringthepatientisnotavailable. 3G MODE WARNING Inthismode,theBiosignsunitcommunicatesviathecellularnetwork.Inorderforthe devicetoconnecttothecellularnetwork,itneedstobeconfiguredwiththeappropriate settings.ThisisdoneusingtheBiosignsTelemonitoringSystemsoftware. For instructions, please refer to the specific user manual. Whenthedeviceisin3Gmode,thedeviceconnectstothelocalcellphonenetwork.During theconnectionprocess,thedisplayshowsthemessageGSMmoduleon.TheGSMradio indicatorwillflashuntilitisconnectedtothe3Gnetwork.Thenthe3Gradioindicatortells youGSMconnectionestablished. Thebarsofthe3Gstatusindicatordisplaysthesignalstrength.Themorebars,themore radiostrengthavailable.Pleasenotethatalthoughthecoverageofthe3Gnetworkmay begreatinmanyplaces,sometimesitcanbeverypoor.Inplaceslikethebasements, buildingswithmetalrastersinthewindowsorsunblockingwindowfoils,theconnection maybepoororevennotexisting.Inthatcasethedevicecannotconnecttothecellular networkandmonitoringisnotavailable. Whentheserverisreceivingthedatafromthedevice,thedisplayshowsanupwards flashingarrow. BiosignsUnitInstructionsforUse 54 Deviceisin3Gmode andisconnectingto cellularnetwork GSM connection established message Indicationthat deviceissendingto IPaddressofBiosigns ServerviaGSM network.Flashing upwards arrowindicates transmission Connectionwith BiosignsServerlost Now,monitoringbytheremoteworkstationisavailable. Note:Biosignsunitwillautomaticallytrytoreconnecttotheserverwithaoneminute interval. STATUSINDICATIONSONTHE DISPLAY Thedisplaymayshowthefollowingstatusindicationsafterturningiton:
USBmode:indicatesthe deviceisconnectedto theUSBportofthePC USBconnection established:indicatesthat theUSBcommunication betweenthedeviceand thePCisstarted USB WiFi GSM WiFimoduleon:
indicatesthedeviceisin WiFi mode GSMmoduleon:
indicatesthedeviceisin GSM mode Battery Batteryindicator:is alwaysdisplayedand showsthelevelofthe batteryin5 steps. WiFiconnection established:indicatesthat thedeviceisconnectedto theWiFi network GSMconnection established:indicatesthat thedeviceisconnectedto theGSM network Flashingbatteryindicator meansthatthebatteryis almostempty Wifijoinedto****:indicates thatthedeviceis connectedtoaWiFi network Open209.126.110.91+WiFi symbol:indicatesthatdata transmissionbetweenthe deviceandtheBiosigns Serveris active Open209.126.110.91+
3G symbol:indicatesthatdata transmissionbetweenthe deviceandtheBiosigns Charging indicator:
indicatesthatthedeviceis connectedtoapower sourceandisbeing charged GENERALSTATEMENTOFSERVICEOFOPERATION Biosignsisatelemedicinesolution.Thismeansthatitrequirestransmissionofdata viathebuiltinWiFiorcellularmodem. Itshouldbecleartotheuserthattheconnectionqualityisimportantforthe performanceofthedevice.Thedevicehastheabilitytoworkwithchangingbandwidths asitbuffersthedatatocopewithchangingsignalstrengths.Thedevicerequiresa bandwidthof20Kb/sectosenddatatothecentralserver.Thedeviceusesinternal bufferstocopewithfluctuationsofbandwidth.Thesebuffersensurethatthereareno datalossesorlatencyissues.Whenthebandwidthfallsbelow20KB/sec,thedeviceis notabletosenditsdatatotheWiFiorcellularnetwork.Ifthisconditionremainsfor BiosignsUnitInstructionsforUse 55 morethan10seconds,thesoftwareconsidersthedevicetobeofflineanddisplays thatthedeviceisnotmonitoredbyaredcrossthroughthepatientnameinthe software. CONFIGURATIONAND OPERATION Biosignssendsrealtimedatatotheserver.Inoptimalsituationsthedelayofdata transmissionislessthanonesecond.Whentheconnectionwiththewirelessconnection ispoor,thedelaymayincreasetouptoamaximumof10seconds.Thereisnodata lossasthedeviceusesinternalbufferstostoredatapackages,whicharesendwhen theconnectionimproves.Inthecasethecommunicationisnotsufficienttosenddata fora10secondsperiod,theserverwillconsiderthisasconnectionlostandthe BiosignsTelemonitoringSystemshowthisinthesoftwareasaredcrossthroughthe patientdisplayandthedatapackageswillbestoredintheBiosigns. SECURITYOFWIRELESS SIGNALS Medeiadeliversahighendtelemonitoringsolutionallowinghealthcareproviders to remotely monitor vitalsigns and other (para) medical data. TocomplywiththePrivacyRuleandSecurityRuleoftheUSHealthInsurancePortability andAccountabilityAct(HIPAA)fortheprocessingofpersonaldatatheBiosignsprovides thePhysicalSafeguardsasrequiredby45CFR164.310andthetechnicalsafeguardsas requiredby45CFR164.312. Howeverthesafeguards,mentionedinthe45CFR164.310and312,needtobe implementedandactivateDbythehealthcare providers. Anoverviewofthesecurity:
TheWebsiteportalSoftwareusesahttpsconnectionandisusernameand password protected WiFiWPA2PSKpasswordprotected The3GcommunicationisdonebyaAPNconnectionwiththecellularnetwork and directly to the Linux servers IP address via one data port ThedatatransmissionoftheBiosignshasnodirectlinktothepatient references name. RF SAFETY ThisdevicehasbeenevaluatedinaccordancewiththeFCCbulletin56Hazardsof radiofrequencyandelectromagneticfieldsandBulletin65Humanexposuretoradio frequencyandelectromagneticfields. Combine(GSMandWiFi)SpecificAbsorptionRate (SAR). TheSARisavaluethatcorrespondstotherelativeamountofRFenergyabsorbedin theheadofauserofawirelesshandset.TheFCClimitforpublicexposurefrom cellulartelephonesisanSARlevelof1.6wattsperkilogram(1.6W/kg).Specific AbsorptionRate(SAR)forWirelessPhonesandDevicesareavailableatOETBulletin 65SupplementC.ThedeviceSARiswithintheFCClimit BiosignsUnitInstructionsforUse 56 BUTTONS ON THE DEVICE FRONT PAD Thedeviceisoperatedwiththe3buttonsonthefrontpad.Thesebuttonshave indicatorsfortheiroperationaltasks. Onoffbutton:
Keepthebuttonpressedforonesecondtostartthedevice. Keepthebuttonpressedfor3secondstostopthedevice. Modeselectionbutton:
PressthebuttontoselecttheUSB,WiFior3Gmode.Thedisplay showstheselectedmode.Pressbutton3toconfirmthemodeof choice. Modeconfirmation button:
Pressthebuttontoconfirmtheselectedmode. To create an event, keep the button pressed for 3 seconds. EVENTBUTTON Tocreateamanualevent,keepbutton3pressedfor3seconds.Thiscreatesanevent intheBiosignsTelemonitoringSystem.Theremoteoperatorcanseethatthebutton onthedevicewaspressed. To create an event, keep the button pressed for 3 seconds. BATTERYINFORMATIONANDRECHARGINGTHEDEVICE WhenthebatteryindicatorontheLCDdisplayflashes,thebatteryisalmostdepleted andshouldberecharged. Batterystatusindicatorwith Chargerconnected 80%power level symbol Tochargethebattery,connectthedevicetothepowersupplyunitandthemains,using theUSBconnectioncable.InserttheUSBcableintheportwiththeUSBindication. Note:ThepowersupplyunitdeliveredtoyoubyMedeiacomplieswiththeapplicable standardsandhasbeentestedincombinationwiththe Biosigns BiosignsUnitInstructionsforUse 57 device.Thesuppliedchargerisrecognisedbythedeviceandallowsfastcharging procedure.Thereforewehighlyrecommendyoutonotuseotherchargerswithyour device. DVPSUwall charger Connectionportfor USB cable DVUSB(USBcable withmicroUSB connector) WhentheUSBcableisconnectedtothedeviceandapowersource,theLEDwiththe batterysymbolonthefrontpadwillbelid. Chargingindicatoronthefrontpad Also,theLCDdisplaywillindicatethedeviceischarging. Whenthechargingprocessiscompleted,theLEDwillbeoffandtheLCDwillstop showingtheSlowchargeorFastcharge message. WhenchargingwithaPC ororlaptop,themessage isSlow charge Whenchargingwith the suppliedmains charger, themessageis Fast charge Note: Charging the battery takes around 4.59 hours, depending on the charger used. CHARGINGTIMES Chargingtimeswillvarybutingeneralthetablebelowmaybeusedasreference:
Charger Timetofullycharge PCorlaptopcharger(0.5A) 9hours Wallcharger (1A) 4.5 hours BiosignsUnitInstructionsforUse 58 OPERATIONTIME Thedevicecanbeusedontheinternalbattery.Thetimebetweenchargesisshownin thetable below. Modeofoperation Autonomyofdevicewithsinglecharge USB WiFi GSM/3G Unlimited 30hours 22hours BiosignsUnitInstructionsforUse 59 TECHNICALSPECIFICATIONS General technical data Temperature range Operation Storage Transport USB communication. Power Supply Voltage 10C to +40C (50 to 104F)
-40C to +70C (-40 to 158F)
-40C to +70C (-40 to 158F) 5V DC from the Computer/Notebook USB port. Biosigns USB communication power consumption not more than: 5V DC/200mA DC. FRIWO FW7721W Friwo Geratebau GmbH Von-Liebig-St 11 D-48346 Ostbevern, Germany. Type: Medical Grade Supply Rated Mains Supply Voltage:
Input: 100-240V~, 50/60Hz, 200 mA Output: +5. VDC Protection Class II Max clock frequency: < 1 MHz Standard: EN 60601-1-2:2007 3000m
, 1500 mA 50kPa to 106kPa 30%- 70% non-condensing 5% - 95% non-condensing 5% - 95% non-condensing Class llb Setup location, maximum height above mean sea level Atmospheric Pressure Air humidity Operation Storage Transport Medical device in accordance with Directive 93/42/EEC EN 60601-1:
Insulated device, protection class II Electric medical device, Defibrillator-proof Type CF Degree of protection against harmful ingress of water Ordinary Equipment(enclosed equipment without Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Method(s) of sterilization or disinfection recommended by the manufacturer protection against ingress of water) Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Not applicable 60 Biocompatibility The parts of the product described in this operator manual, including all accessories, that come in contact with the patient during the intended use, fulfill the biocompatibility requirements of the applicable standards ISO 10993. If you have questions in this matter, please contact Medeia. DECLARATIONELECTROMAGNETICEMISSIONSAND IMMUNITY Guidance and Manufacturers declaration-electromagnetic immunity The Biosigns is intended for use in the electromagnetic environment specified below IEC 60601-1-2 Test Level Immunity Test RF Common mode/
Conducted Susceptibility IEC 61000-4-6 Radiated RF Electromagnetic Field IEC 61000-4-3 20 Vrms 150 kHz to 80 MHz 20 V/m 80 MHz to 2,5 GHz Electromagnetic Environment -
guidance Portable and mobile RF communications Equipment should be used no closer to any part of the Biosigns, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d =1,2 P d =1,2 P 80 MHz to 800 MHz d =2,4 P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Compliance Level 20 Vrms 20 V/m 61 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Biosigns Unit Instructions for Use 62 a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Biosigns is used exceeds the applicable RF compliance level above, the Biosigns should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Biosigns. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. EXAMPLE 1 As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m. EXAMPLE 2 As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d = 0,5 m at an IMMUNITY LEVEL of 20 V/m. Guidance and manufacturers declaration electromagnetic emissions Biosigns is intended for use in the electromagnetic environment specified below Emissions test RF emissions CISPR 11 Compliance Electromagnetic environment guidance Group 1 Biosigns uses RF energy for communication. Its RF emissions are low and are not likely to cause any interference in nearby electronic equipment. RF Emissions CISPR 11 Class B Biosigns is suitable for use in all establishments, including domestic. Guidance and manufacturers declaration electromagnetic immunity Biosigns is intended for use in the electromagnetic environment specified below IEC 60601-1-2 test level 6 kV contact 6/8 kV air 2 kV for power supply lines 1 kV for input/output lines 300 A/m Immunity test Electrostatic discharge (ESD) Electrical fast transient/burst Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 Compliance level B B 2 kV for power supply lines 1 kV for input/output lines 300 A/m Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 15 %. Mains power quality should be that of a typical commercial or hospital environment. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 62 Recommended separation distances between portable and mobile RF communications equipment and is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W 0,01 0,1 1 10 100 Separation distance according to frequency of transmitter m 150 kHz to 80 MHz outside ISM bands d=[3,5/V1] P 80 MHz to 800 MHz d=[3,5/3] P 800 MHz to 2,5 GHz d=[7/3] P 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 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. MAINTENANCE TheBiosignsdeviceandaccessoriesshouldbestoredinaclean,dryplace.Handlethe Biosignsdevicewithcareandprotectitagainstmechanicalshocks,dirtandliquids.The deviceisnotwaterprooforsplashproof. ENVIRONMENTAL CONDITIONS Temperature Charge:
0Cto+45C Discharge:20Cto+50C Operation:+10C to+40C Storage:40C to +70C
(32F to113F)
(4Fto 122 F)
(50F to 104 F)
(40Fto158F) RelativeHumidity Operation:
30%70%(noncondensing) Storage:
5%95%(noncondensing) 63 Pressure Withstandsatmosphericpressuresfrom700hPato1060hPa 64 CALIBRATION The Biosigns device is factory calibrated. No further calibration is needed. AVOIDELECTROSTATIC DISCHARGE Whenhumidityintheworkingenvironmentdecreases,thehumanbodyandother insulatorscanbecomechargedwithstaticelectricityduetofriction.Toprevent unwantedelectrostaticdischarge(ESD),followthesestandard guidelines:
Maintaintherecommendedhumidityof40%to60%intheworkenvironment. Dissipateelectrostaticchargebeforeperformingroutineoperator maintenance. STERILIZATION,SHELFLIFEANDCLEANING Thedeviceandtheaccessoriesarenotprovidedsterile,notintendedtobesterilizedor providedwithashelflife.Assuch,theseaspectsarenotapplicableforthesubmission. However,thedeviceandsomeoftheaccessoriesareintendedtobereusedand instructionsforreprocessingareincludedintheusermanual.Thereprocessing instructionsprovidedinthenextsections. INSPECTANDCLEANTHEMONITORANDACCESSORIES CAUTION Do not autoclave the Biosigns or its accessories. Do not immersethemonitorinliquidwhencleaning.Donotimmerse accessoriesinliquidwhencleaningunlesstheaccessory manufacturerscleaninginstructionsexplicitlyinstructyoutodo so. Beforecleaning,thoroughlyinspecttheBiosignsandallaccessoriesforanysignsof damage, cracks, or improper mechanical function of keypads, switches, connectors, andprinterpaperdoor.Whilegentlybendingandflexingcablesandtubing,inspectfor damage,cracks,cuts,abrasions,extremewear,exposedwiresorbentconnectors. Confirmconnectorssecurelyengage.Reportdamageorimproperfunctiontoyour servicedepartment. DEVICE PleasemakesurethatyoucleantheBiosignsdeviceaftereachuseonapatientand beforeusingitonanewpatient.Avoidingcrosscontaminationhastobetaken seriously.Thedeviceandthecablescanbecleanedusingamilddetergentsolution.Do notsubmergeorrinsetheproductorpartsanddonotallowanyliquidstoenterany openingonthedevice.Allowtheunittodrythoroughlybeforeuse. 65 CABLES AllcablesusedwithBiosignsarereusable.Cleanthecableswithamoistclothusinga hospitalgradecleaner. DisconnectthecablefromtheBiosignsunitbeforecleaningordisinfectingit. Whendisconnectingthecable,besuretopullontheconnector,notonthecable. Cleanthecablebyrubbingitdownwithaclothmoistenedwithsoapwater.Usea disinfectantfordisinfection.Donotimmersethecableinl iq u i d . Donotimmersethecablesinliquidandavoidcontractofthecleaningsolution withthe connectors. ECGLEAD WIRE Disconnectcable.Wipeplasticpartswithaclothmoistenedinlukewarmwaterwith alcoholfreeneutralsoap.Alwayswipetowardsthepatientconnectors/ECGclips. Proceedcarefullyastonotdamagethecablethroughexcessivestretching, bendingorkinkingofthewires. Removethecleaningagentwipingthecablewithaclothmoistenedinwater. Wipeorairdrybeforeuse. Removeadhesiveresiduesonlywiththealcoholslistedbelow.Neveruseother organicsolvents(i.e.acetoneortoluolwilldamagethecableja cket)!
CLEANINGANDDISINFECTINGTHEECGELECTRODES Inadditiontotheinformationgiveninthismanual,observetheinstructionsforuseof the respective electrode types. Discard disposable adhesive electrodes immediately after use to prevent that they are reused. SPO2 SENSOR CAUTION Donotspray,pour,orspillanyliquidonthe Biosigns, their accessories,switchesoropenings. Cleaningoximetryequipmentisjustasimportantasproperuse.Forsurfacecleaning anddisinfectingtheBiosignsunitandreusableSpO2sensorswerecommendthe followingprocedures:
TurnofftheBiosignsbeforecleaning Wipeexposedsurfaceswithasoftclothorapadmoistenedwithamild detergentsolutionormedicalalcohol(70%isopropylalcohols o l u t i o n ) CleanyourBiosignswheneveryouseeanytypeofsoil,dirtorobstructioninit Cleantheinsideoftheelasticthimbleandthetwoopticalelementsinsidewitha 66 cottonswaborequivalentmoistenedwithamilddetergentsolutionormedical alcohol(70%isopropylalcoholsolution) Ensurethatnodirtorbloodisontheopticalcomponentsinsidetheelastic thimble SpO2Sensorscanbecleanedanddisinfectedwithsamesolutions.Letthesensordry beforeusingitagain.TherubberinsideoftheSpO2sensorbelongstomedical rubber,whichhasnotoxinandnoharmfultotheskinofhumanbeing. ItisrecommendedthattheBiosignsshouldbekeptinadryenvironment anytime.Awetambientmightaffectitslifetimeandevenmightdamagethe oximeter DISPOSAL Followlocalgoverningordinancesandrecyclinginstructionsregardingdisposalor recyclingofthisdeviceandaccessories. AccordingtotheregulationinEuropeonWasteofElectricaland ElectronicEquipment(WEEE)thecomponentslabeledwiththis symbolmaynotbedisposedofasunsortedmunicipalwaste.The componentsshallbecollectedseparatelyandreturnedtothe appropriatecollectionsystemavailable. Pleasecontactyourdistributorregardingtakebackorrecyclingof thecomponents WARRANTY YourBiosignsunitcomeswitha12monthswarrantyperiod.Thesensorshavea90 dayswarranty.Forwarrantyclaimscontactthemanufactureroryourlocal representativeforfurtherinstructions.Pleasenotethatonlycleanedanddisinfected partswillbeservicesorrepaired.Makesurethatyouonlyshipproductsandpartsthat areproperlycleaned.Yourwarrantycardcanbefoundinthepackagingofyourdevice. 67 SERVICEANDSUPPORT TheCustomerServicestaffatMedeiaencouragesyoutocontactthemforproduct assistance. Ifyouhavequestionspleasesendthembyemailtosupport@Biosigns.comor+1800 4334609forapromptr e s p o n s e . Medeiamakesnoclaimthatitsproductstreatorheal.Medeiasproductsaredesigned tomeasureandmonitorphysiologicalchange.Professionalsshouldworkwithinthe scopeoftheirlicensesand/orcertificationswheninterpretingorapplyingdataderived fromMedeiasproducts. YourBiosignsunitdoesnotneedcalibration.Werecommendyoutoreplacethe internalbatteryeverytwoyearsasthebatterypowerandoperationtimedecreases afterthisperiod.ContactMedeiaoryoursupplierforchangingoutthebattery. Note:Theoperatorofthisdeviceshouldreadandgainathoroughunderstandingof thismanualbeforeuse. Note:donotopenthedeviceorreplacepartsyourselfasdamagetothedevicecould occur. 68 MRISAFETYINFORMATION TheBiosignsunithasnotbeenevaluatedforsafetyandcompatibilityintheMR environment.Ithasnotbeentestedforheating,migration,orimageartifactintheMR environment.ThesafetyofBiosignsintheMRenvironmentisunknown.Riskof projectileinjuryduethepresenceofferromagneticmaterialsinthedevice;riskofburns tothepatientsduethecurrentinducedbystrongelectromagneticfieldspresentinMR environment.Scanningapatientwhohasthisdevicemayresultinpatientinjury. FCCSTATEMENT ThelabelatthebacksideoftheproducthastheFCClogoandFCCregistrationnumber. FortheBiosignsproduct,theindicationisshownbelow:
2ANW8HW9 FCClogo FCCregistrationnumber REGULATORYINFORMATION FCCINFORMATIONTO USER Thisproductdoesnotcontainanyuserserviceablecomponentsandistobeusedwith approvedantennasonly.Anyproductchangesormodificationswillinvalidateall applicableregulatorycertificationsand approvals. FCCRFEXPOSURE INFORMATION ThisdevicemeetstheU.S.Governmentsrequirementsforexposuretoradiofrequency electromagneticfields.Thisdevicecontainsaradiotransmitterandreceiver.Thisdevice isdesignedandmanufacturednottoexceedtheemissionlimitsforexposuretoradio frequency(RF)energyassetbytheFCCoftheU.S. Government. 69 ThisdevicehasbeentestedforbodywornoperationandmeetstheFCCRFexposure guidelines. FCCELECTRONICEMISSIONNOTICES Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowing twoconditions:
1. Thisdevicemaynotcauseharmfulinterference 2. Thisdevicemustacceptanyinterferencereceived,includinginterferencethat maycauseundesired operation. FCCRADIOFREQUENCYINTERFERENCE STATEMENT ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaclassBdigital device,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovide reasonableprotectionagainstharmfulinterferencewhentheequipmentisoperatedin acommercialenvironment.Thisequipmentgenerates,usesandcanradiateradio frequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions,may causeharmfulinterferencetoradiocommunications.Operationofthisequipmentina residentialareamaycauseharmfulinterference,inwhichcasetheuserwillberequired tocorrecttheinterferenceatitsownexpense. Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,which canbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotry tocorrecttheinterferencebyoneormoreofthefollowingmeasures:
Reorientorrelocatethereceiving antenna Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhich Increasetheseparationbetweentheequipmentand receiver thereceiverisconnected Consultthe dealer oran experienced radio/TV technician forhelp LASTPAGEOFINSTRUCTIONSFORUSE 70
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-02-09 | 1852.4 ~ 1907.6 | PCB - PCS Licensed Transmitter | Class II permissive change or modification of presently authorized equipment |
2 | 2018-02-02 | 1852.4 ~ 1907.6 | PCB - PCS Licensed Transmitter | Change in identification of presently authorized equipment. Original FCC ID: QIPEHS6 Grant Date: 07/31/2013 |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2018-02-09
|
||||
1 2 |
2018-02-02
|
|||||
1 2 | Applicant's complete, legal business name |
Medeia Inc.
|
||||
1 2 | FCC Registration Number (FRN) |
0026893883
|
||||
1 2 | Physical Address |
80 S.W. 8th Street, Suite 2000
|
||||
1 2 |
Miami, Florida 33130
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@ckc.com
|
||||
1 2 | TCB Scope |
B1: Commercial mobile radio services equipment in the following 47 CFR Parts 20, 22 (cellular), 24,25 (below 3 GHz) & 27
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2ANW8
|
||||
1 2 | Equipment Product Code |
HW9
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
S******** D******
|
||||
1 2 | Title |
President
|
||||
1 2 | Telephone Number |
800 4********
|
||||
1 2 | Fax Number |
800 4********
|
||||
1 2 |
d******@medeia.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | 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 2 | No | |||||
1 2 | 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?: | No | ||||
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 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | PCB - PCS Licensed Transmitter | ||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | GSM/GPRS/ EDGE/UMTS/HSPA Module | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Single Modular Approval | |||||
1 2 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 | Change in identification of presently authorized equipment. Original FCC ID: QIPEHS6 Grant Date: 07/31/2013 | |||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 | 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 2 | Grant Comments | C2PC for host specific RF exposure evaluation. Output power listed is conducted This device contains functions that are not operational in U.S. Territories. This filing is only applicable for US operations. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operated in conjunction with any antenna or transmitter, except in accordance with FCC multi- transmitter product procedures This device is to be used in mobile or fixed applications only. For mobile and fixed operating configurations the antenna gain, including cable loss, must not exceed 1.2 dBd at 850 MHz, 2.5 dBi at 1900 MHz for satisfying RF exposure compliance. Under no conditions may an antenna gain be used that would exceed the ERP and EIRP power limits as specified in Part 22H and 24E. The final product operating with this transmitter must include operating instructions and antenna installation instructions, for end-users and installers to satisfy RF exposure compliance requirements. OEM integrators must insure that the end user has no manual instructions to remove or install this module. The Grantee is responsible for providing the documentation required for modular use Approved for portable RF exposure conditions with module FCC ID: Z64-CC3100MODR1. Highest reported SAR values: Body: 1.45 W/kg(Cellular) 0.35 W/kg (WiFi) | ||||
1 2 | Output power listed is conducted This device contains functions that are not operational in U.S. Territories. This filing is only applicable for US operations. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operated in conjunction with any antenna or transmitter, except in accordance with FCC multi- transmitter product procedures This device is to be used in mobile or fixed applications only. For mobile and fixed operating configurations the antenna gain, including cable loss, must not exceed 1.2 dBd at 850 MHz, 2.5 dBi at 1900 MHz for satisfying RF exposure compliance. Under no conditions may an antenna gain be used that would exceed the ERP and EIRP power limits as specified in Part 22H and 24E. The final product operating with this transmitter must include operating instructions and antenna installation instructions, for end-users and installers to satisfy RF exposure compliance requirements. OEM integrators must insure that the end user has no manual instructions to remove or install this module. The Grantee is responsible for providing the documentation required for modular use | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | 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 2 | Firm Name |
CETECOM GmbH
|
||||
1 2 | Name |
N**** J****
|
||||
1 2 | Telephone Number |
+49 2********
|
||||
1 2 | Fax Number |
+49 2********
|
||||
1 2 |
n******@cetecom.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 22H | 824.2 | 848.8 | 1.86 | 0.02 ppm | 247KGXW | ||||||||||||||||||||||||||||||||||
1 | 2 | 22H | 824.2 | 848.8 | 1 | 0.02 ppm | 247KG7W | ||||||||||||||||||||||||||||||||||
1 | 3 | 22H | 824.4 | 848.6 | 0.5 | 0.01 ppm | 4M07F9W | ||||||||||||||||||||||||||||||||||
1 | 4 | 24E | 1850.2 | 1909.8 | 0.95 | 0.03 ppm | 247KGXW | ||||||||||||||||||||||||||||||||||
1 | 5 | 24E | 1850.2 | 1909.8 | 0.76 | 0.02 ppm | 247KG7W | ||||||||||||||||||||||||||||||||||
1 | 6 | 24E | 1852.4 | 1907.6 | 0.48 | 0.01 ppm | 4M06F9W | ||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 22H | 824.2 | 848.8 | 1.86 | 0.02 ppm | 247KGXW | ||||||||||||||||||||||||||||||||||
2 | 2 | 22H | 824.2 | 848.8 | 1 | 0.02 ppm | 245KG7W | ||||||||||||||||||||||||||||||||||
2 | 3 | 22H | 824.4 | 848.6 | 0.5 | 0.02 ppm | 4M07F9W | ||||||||||||||||||||||||||||||||||
2 | 4 | 24E | 1850.2 | 1909.8 | 0.95 | 0.02 ppm | 247KGXW | ||||||||||||||||||||||||||||||||||
2 | 5 | 24E | 1850.2 | 1909.8 | 0.76 | 0.02 ppm | 247KG7W | ||||||||||||||||||||||||||||||||||
2 | 6 | 24E | 1852.4 | 1907.6 | 0.48 | 0.02 ppm | 4M06F9W |
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