GE Portrait Hub01 User manual

Portrait™MobileMonitoringSolution
UserManual
Softwareversion1
Portrait™MobileMonitoringSolution
English
5815148-01
1stedition
©2021GeneralElectricCompany.
Allrightsreserved.

Theinformationinthismanualappliestothesoftwareversionandproductmodelsontherstpageofthemanual.Duetocontinuing
innovation,specicationsinthismanualaresubjecttochangewithoutnotice.
Fortechnicaldocumentationpurposes,theabbreviationGEisusedforthelegalentityname,GEMedicalSystemsInformationTechnologies,
Inc.,andGEHealthcareFinlandOy.
GE,GEMonogram,Edison,andPortraitaretrademarksofGeneralElectricCompany.
Allthirdpartytrademarksarethepropertyoftheirrespectiveowners.
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2021-06-10

Contents
1Legalmanufacturerinformation...............................................................13
Manufacturerinformation............................................................................13
2Standards......................................................................................................15
Standardscompliance..................................................................................15
IEC60601-1...................................................................................................15
SpO2standardscompliance.........................................................................16
Impedancerespirationstandardscompliance...........................................16
3Introductiontothismanual.......................................................................17
Manualintendeduse....................................................................................17
Intendedaudienceofthismanual...............................................................17
Trainingrequirements..................................................................................18
Manualconventions.....................................................................................18
Namingconventions.....................................................................................18
Illustrationsandnames................................................................................19
Orderingmanuals.........................................................................................19
Accessingmanualsonline............................................................................19
Accessingthirdpartysoftwarenotices.......................................................19
Productavailability.......................................................................................20
Trademarks...................................................................................................20
Thirdpartytrademarks...............................................................................20
Manufacturerresponsibility.........................................................................20
Relatedmanuals...........................................................................................20
4Safetyandintendeduse.............................................................................21
Safetymessagesignalwords.......................................................................21
Safetysymbols..............................................................................................21
Reportingofseriousincidents......................................................................22
Dangersafetymessages..............................................................................22
Warnings.......................................................................................................22
Systemwarnings.........................................................................................22
EMCwarnings..............................................................................................24
Operationwarnings....................................................................................25
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Debrillationwarnings................................................................................27
Alarmwarnings...........................................................................................27
Accessorieswarnings.................................................................................28
Batterywarnings.........................................................................................28
Carewarnings.............................................................................................28
Respirationwarnings..................................................................................29
SpO2warnings.............................................................................................29
Cautions.........................................................................................................30
Alarmcautions............................................................................................30
Systemcautions..........................................................................................30
Operationcautions.....................................................................................30
Disposalcautions........................................................................................31
Respirationcautions...................................................................................31
Intendedusestatements..............................................................................31
PortraitTMMobileMonitoringSolutionintendeduse.................................31
Equipmentmarkings.....................................................................................34
UniqueDeviceIdentier(UDI).....................................................................39
CEmarkingapplicationyear......................................................................39
5Systemdescription......................................................................................41
Shortdescriptionofthesystem...................................................................41
Clinicalbenets.............................................................................................41
Systemcomponents.....................................................................................42
CoreServicesoverview...............................................................................43
CentralViewerandalarmingunitoverview..............................................43
Hubandsensorsoverview.........................................................................45
Systeminstallationpointstonote................................................................50
6Graphicaluserinterface.............................................................................51
Userinterfaceindicators..............................................................................51
CentralViewer...............................................................................................53
MultiplePatientView...................................................................................53
SinglePatientView......................................................................................53
Hub.................................................................................................................55
Hubscreenelements..................................................................................55
Hublockedview..........................................................................................56
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Hubpasscodeview.....................................................................................58
Hubpatientlist............................................................................................58
Hubpatientdetails......................................................................................58
HubLIVEview..............................................................................................59
Hubdetailedview........................................................................................60
Hubmenu....................................................................................................61
7Managingpatientsandmonitoring..........................................................63
Admittingapatient.......................................................................................63
Editingpatientdemographics....................................................................64
PoweringontheHub....................................................................................65
UnlockingtheHubscreen............................................................................65
Selectingapatient........................................................................................66
Attachingmeasurementdevicestothepatient.........................................67
Pairingtherstsensor..................................................................................67
Pairinganothersensor.................................................................................68
Unpairingasensor........................................................................................69
Movingapatienttoanewbed....................................................................69
UsingtheHubpouch....................................................................................69
UnassigningthepatientfromtheHub........................................................70
ShuttingdowntheHub.................................................................................70
Dischargingapatient...................................................................................71
8Batterymanagement..................................................................................73
Safetyprecautions........................................................................................73
Connectinganddisconnectingsensorbatteries........................................73
LEDindicatorsonsensorbatteries..............................................................73
LEDindicatorsonthecharger......................................................................75
AboutHubandsensorbatteries..................................................................75
Chargingbatteries........................................................................................76
Charginganemptysensorbattery............................................................77
CheckingtheHubbatterystatus.................................................................77
Checkingthestatusofasensorbattery......................................................78
Changingasensorbattery...........................................................................78
Aboutthelithium-ionbattery.......................................................................79
Batteryrecycling...........................................................................................79
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9Hubandmodes............................................................................................81
Aboutmodes.................................................................................................81
Selectingtheusemode................................................................................81
10Alarms...........................................................................................................83
Safetyprecautions........................................................................................83
Alarmconditions...........................................................................................83
Alarmprioritylevels......................................................................................83
Activealarms.................................................................................................83
Alarmsignalsanduserposition...................................................................84
Visualalarmindicators.................................................................................84
Aboutalarmmessages...............................................................................85
Auditoryalarmindicators.............................................................................85
AlarmsettingsontheCentralViewer..........................................................85
Adjustingalarmlimitsettings.....................................................................85
AdjustingalarmvolumeontheCentralViewer.........................................86
AdjustingalarmvolumeontheHub............................................................86
Alarmacknowledgement.............................................................................87
Acknowledgingalarms...............................................................................87
Reactivatingalarms....................................................................................88
Checkingalarmfunction..............................................................................88
Alarmsduringpowercycle...........................................................................88
Alarmlogs......................................................................................................89
11Parameterlteringandsignalquality......................................................91
Parameterltering........................................................................................91
Signalqualityindicator(SQI).........................................................................91
12Impedancerespiration................................................................................93
Safetyprecautions........................................................................................93
PortraitTMWearableRespirationRateSensor(PortraitRRP-RR01)
intendeduse..................................................................................................93
PortraitTMRRElectrodePatch(PortraitRRP01)intendeduse.....................93
Respirationmeasurementlimitations..........................................................94
Respirationmeasurementdescription........................................................94
Respirationmeasurementpracticalities......................................................95
Respirationpointstonote............................................................................95
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Respirationmeasurementsetup..................................................................96
Preparingthepatient'selectrodesites......................................................96
Startingtherespirationmeasurement......................................................96
Checkingtherespirationmeasurement....................................................98
Removingrespirationelectrodes.................................................................98
Troubleshootingthemeasurement.............................................................98
13Pulseoximetryandpulserate....................................................................99
Safetyprecautions........................................................................................99
PortraitTMWearablePulseOximetrySensorP-SA01(PortraitSpO2
P-SA01)intendeduse....................................................................................99
PortraitTMWearablePulseOximetrySensor(PortraitSpO2P-SP01)
intendeduse..................................................................................................99
PortraitTMWearablePulseOximetrySensor(PortraitSpO2P-W01,
PortraitSpO2P-SE01)intendeduse...........................................................100
SpO2andpulseratemeasurementlimitations.........................................100
SpO2measurementdescription.................................................................100
SpO₂measurementquality........................................................................101
SpO2andpulseratemeasurementinterference....................................101
SpO2waveformquality.............................................................................101
SpO2andpulseratemeasurementpracticalities.....................................102
SpO2andpulseratepointstonote............................................................102
SpO2andpulseratemeasurementsetup.................................................103
PreparingtheSpO2andpulserateconnection.......................................103
StartingtheSpO2andpulseratemeasurement.....................................103
CheckingtheSpO2andpulseratemeasurement...................................105
Troubleshootingthemeasurement...........................................................106
SpO2functionaltesters.............................................................................106
14Trends..........................................................................................................107
AbouttrendsontheCentralViewer...........................................................107
ViewingtrendsontheCentralViewer.......................................................107
UsingthetrendcursorontheCentralViewer...........................................108
AbouttrendsontheHub............................................................................109
ViewingtrendsontheHub.........................................................................109
UsingthetrendcursorontheHub............................................................110
15Cleaning,disinfection,andcare..............................................................113
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Safetyprecautions......................................................................................113
Cleaning,disinfection,andcareoverview.................................................113
Visualinspection,cleaning,anddisinfectionfrequency...........................113
Cleaning.......................................................................................................114
Generalcleaninginstructions...................................................................114
Cleaningpointstonote.............................................................................114
Permitteddetergents................................................................................114
CleaningprocedurefortheHub...............................................................115
Cleaningprocedurefortherespirationsensor.......................................117
CleaningprocedurefortheSpO2sensors...............................................119
Cleaningprocedureforsensorbatteries.................................................122
Cleaningprocedureforthecharger.........................................................124
Cleaningprocedureforthealarmingunit...............................................125
Disinfection..................................................................................................126
Disinfectionpointstonote........................................................................126
Permitteddisinfectants.............................................................................127
Disinfectionprocedure..............................................................................127
Care..............................................................................................................128
Careschedules..........................................................................................128
16Periodicmaintenance...............................................................................129
Dailychecks.................................................................................................129
Preventivemaintenance.............................................................................129
Aboutserviceandmaintenanceduringmonitoring.................................129
17Troubleshooting.........................................................................................131
TroubleshootingtheCentralViewer..........................................................131
TroubleshootingtheHub............................................................................132
Troubleshootingtherespirationmeasurement........................................134
TroubleshootingtheSpO2andpulseratemeasurements.......................135
18Alarmmessages.........................................................................................137
Alarmsrelatedtotherespirationratemeasurement...............................137
AlarmsrelatedtotheSpO2andpulseratemeasurement.......................139
Alarmsrelatedtodeviceissues..................................................................142
19Technicalspecications............................................................................145
Design,environmental,andphysicalspecications.................................145
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FCCinformation..........................................................................................145
RadioEquipmentDirective(RED)information...........................................146
ISEDinformation.........................................................................................146
RFexposureinformation............................................................................146
Technicalspecications,Hub.....................................................................147
Technicalspecications,charger...............................................................147
Technicalspecications,sensors...............................................................148
Technicalspecications,sensorbatteries.................................................148
Technicalspecications,alarmingunit.....................................................149
Minimumrequirements,CentralViewer....................................................149
Technicalspecications,EHLPlatform......................................................150
20Alarmspecications..................................................................................151
Auditoryalarmvolume,IECtones..............................................................151
Audioalarmsoundtolerances...................................................................151
IECalarmtonesoundpatterns..................................................................152
Auditoryinformationsignalcharacteristics..............................................152
Alarmdelayspecications.........................................................................152
Alarmdelayspecicationsforimpedancerespirationalarms...............153
AlarmdelayspecicationsforSpO2andPRalarms...............................154
Alarmdelayspecicationsfortechnicalissues......................................154
21Parameterspecications..........................................................................157
SpO2displayedsaturationvalues..............................................................157
SpO₂summaryofclinicalstudiesusedtoestablishaccuracy
claims...........................................................................................................157
AccuracyofPortraitTMsensortechnology...............................................157
SpO2testmethodsusedtoestablishaccuracyclaimsduring
motion........................................................................................................157
SpO2testmethodsusedtoestablishaccuracyclaimsduringlow
perfusion....................................................................................................158
SpO2testmethodsusedtoestablishpulserateaccuracy.....................158
SpO2performancespecications..............................................................158
SpO₂supplementalanalysisgraphs..........................................................159
AdditionalaccuracyinformationforPortraitTMsensors.........................159
Impedancerespirationperformancespecications.................................163
22Abbreviations.............................................................................................165
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Listofabbreviations....................................................................................165
ASkillschecklist............................................................................................167
Safety...........................................................................................................167
Systemintroduction....................................................................................168
Graphicaluserinterface.............................................................................168
Conguration..............................................................................................169
Managingpatientsandmonitoring...........................................................169
Batterymanagement.................................................................................170
Hubmodes..................................................................................................170
Alarms..........................................................................................................171
Parameterlteringandsignalquality.......................................................171
Impedancerespiration...............................................................................171
Pulseoximetryandpulserate....................................................................172
Trends..........................................................................................................172
Cleaning,disinfection,andcare.................................................................173
BQuickworkowoverview..........................................................................175
Quickworkowinstructions.......................................................................175
CDefaultsettingsandconguration.........................................................177
Aboutcongurationsettings......................................................................177
CongUIPatientdefaultprolesconguration........................................177
DCompatibledevices...................................................................................183
Hub(HUB01)compatibility.........................................................................183
SpO2sensor(SpO2P-SA01,P-SP01)compatibility....................................183
SpO2sensor(P-SE01)compatibility............................................................184
SpO2sensor(P-W01)compatibility............................................................184
Respirationratesensor(P-RR01)compatibility.........................................184
Sensorbattery(SBT01)compatibility.........................................................185
Bedsidecharger(BCH01)compatibility.....................................................185
Alarmingunit(CAU01)compatibility..........................................................185
Mountscompatibility..................................................................................185
ESuppliesandaccessories..........................................................................187
Listofsuppliesandaccessories.................................................................187
FElectromagneticcompatibility.................................................................189
IEC60601-1-2..............................................................................................189
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