VivaQuant Rhythm Express RX-1 User manual
DRAFTClinician’sUserManual
RhythmExpressTMModelRX‐1
ForResearchOnly.
ThisdeviceisnotclearedforsalebyFDA.
VivaQuant
4339NancyPlace,Suite100
St.Paul,MN55126
Tel.1‐866‐ECG‐TRUE(1‐866‐324‐8783)
Rx only CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE
ORDER OF A PHYSICIAN.
CAUTION: Carefully read all instructions prior to use. Observe all warnings and
precautions noted in these directions. Failure to do so may result in patient
complications.
Copyright 2018 VivaQuant. All rights reserved. No part of this manual may be reproduced, translated, transcribed, or
transmitted in any form or by any means manual, electronic, electromagnetic, chemical, or optical without the written
permission of VivaQuant.
One or more of the following patents may be applicable: US 8,632,465, US 8,478,389, US 8,433,395, US 9,050,007, U.S.
8,632,465, U.S. 8,543,195, U.S. 9,294,074, U.S. 9,314,181, and U.S. 9,339,202. Other US and foreign patents are pending.
ii
Contents
Manual Overview......................................................................................................................................................................4
Explanation of Symbols Used in this Manual...................................................................................................................4
Glossary...................................................................................................................................................................................5
Overview....................................................................................................................................................................................6
Device Description...............................................................................................................................................................6
Intended Use.........................................................................................................................................................................7
Contraindications..............................................................................................................................................................7
Indications for Use...............................................................................................................................................................7
Safety Information....................................................................................................................................................................8
Cautions and Warnings.......................................................................................................................................................8
Using the RX-1 to Monitor a Patient....................................................................................................................................10
Rhythm Express RX-1.......................................................................................................................................................10
Device Components...........................................................................................................................................................10
OverviewofRX‐1DeviceOperation.........................................................................................................................................11
Connecting to the Cellular Network and Signal Strength.............................................................................................11
Device Settings...................................................................................................................................................................12
Recording Symptoms........................................................................................................................................................14
BatteryChargingandStatus.................................................................................................................................................15
Notifications..........................................................................................................................................................................16
Preparing the RX-1 Device for a Recording...................................................................................................................16
Connecting the ECG Leads to the Patient.....................................................................................................................16
Initiating a Recording.........................................................................................................................................................18
Charging the Battery During a Recording Session.......................................................................................................19
Terminating a Recording...................................................................................................................................................20
Maintenance, Service, and Troubleshooting......................................................................................................................21
Storing the RX-1.................................................................................................................................................................21
Cleaning the RX-1..............................................................................................................................................................21
Service.................................................................................................................................................................................21
Disposal...............................................................................................................................................................................21
Troubleshooting..................................................................................................................................................................22
iii
Features and Specifications.................................................................................................................................................24
Rhythm ExpressTM Model RX-1 Features.......................................................................................................................24
ArrhythmiaDetection...........................................................................................................................................................24
Specifications......................................................................................................................................................................25
VivaQuantLimitedWarranty....................................................................................................................................................27
Obtaining Warranty Repairs.............................................................................................................................................27
Wireless Compliance.............................................................................................................................................................28
FCCRegulationsComplianceStatement...............................................................................................................................28
FederalCommunicationCommission(FCC)RadiationExposureStatement:.......................................................................28
FCCRFRadiationExposureStatement:................................................................................................................................28
RFSTATEMENT......................................................................................................................................................................29
PublicationInformation........................................................................................................................................................30
Chapter1:ManualOverview
4
1
Manual Overview
TheUserManualdescribeshowtosafelyoperatetheRhythmExpress
TM
RX‐1deviceinaccordancewithitsfunctionand
intendeduse.ThismanualisintendedsolelyasareferencefortheoperationoftheRX‐1device.
Thismanualisintendedforusebyclinicalprofessionals.Itisassumedthatthereaderhasaworkingknowledgeofmedical
terminologyandproceduresasrequiredformonitoringcardiacpatients.
Explanation of Symbols Used in this Manual
Symbol Meaning
Followinstructionsforuse
Caution!
IP64 Resistanttowateranddustingress(RX‐1)
IP21 Protectedfromcondensationandtouchbyobjectsgreater
than12mm(charger)
TypeBFAppliedPart.Avoidcontactbetweenconductive
partsofelectrodesandotherconductiveparts,including
earth.deviceisnotdefibrillatorproof
ChargerClassIIequipment,
Forindooruseonly(AC/DCadaptercharger)
Rxonly Caution:Federallawrestrictsthis devicetosalebyoronthe
orderofaphysician
Manufacturer:VivaQuant,
4339NancyPlace,Suite100,St.Paul,MN55126
Tel.1‐866‐ECG‐TRUE(1‐866‐324‐8783),
Web:www.vivaquant.com
ThisistheFCClogoindicatingcompliancewiththeFCCrules
forwirelessdevices.
Chapter1:ManualOverview
5
Emitsnon‐ionizingradiation
Directcurrent
Up/downarrowsusedtoscrollthroughmenu
RedPTEButtonusedtoenterrecordingmodeandPatient
TriggeredEvents
Glossary
Autotrigger:Theabilitytoautomaticallydetectanarrhythmia.
ECG(Electrocardiogram):Theheart’selectricalactivityrecordedfromelectrodesonthesurfaceofthebody.
EventRecorder:AsystemforcontinuousmonitoringoftheECG.Arrhythmiasaredetected,andthepatientcanreportthe
occurrenceofsymptoms.
MobileCardiacTelemetry:AsystemforcontinuousmonitoringoftheECG.Arrhythmiasaredetected,thepatientcan
reporttheoccurrenceofsymptoms,andheartrateismeasuredcontinuouslyforreportingtoaphysician.
Heartrate:Thenumberoftimestheheartbeatsinaminute,measuredinbeatsperminute.
Holtermonitor:AdevicewornbyapatientforrecordingcontinuousECG,typicallyfordiagnosingbrieftemporary
arrhythmias
Monitoringcenter:Themonitoringcenterisresponsibleforreviewingclinicaldatatransmissionsandreportingthemto
thephysician.
PatientTriggeredEvent(PTE):Occurswhenapatientreportstheoccurrenceofsymptomsbypressingthelargebuttonon
thekeyboardoftheRX‐1.
RoutineEvent:Anautodetectedeventthatmatchestheeventnotificationcriteriaestablishedbythephysicianfora
routineclinicalevent.ECGstripscorrespondingtotheseeventsaretransmittedtothemonitoringcenterduringscheduled
andadhocconnections.
WARNING:Indicatesapotentialhazardorunsafepracticewhich,ifnotavoided,couldresultindeathorseriousinjury.
CAUTION:Indicatesapotentialhazardorunsafepracticewhich,ifnotavoided,couldresultinminorpersonalinjuryor
damagetotheproductorproperty.
NOTE:Indicatesadditionalinformationortipstohelpyougetthemostoutofyourequipment.
UrgentEvent:Anautodetectedeventthatmatchestheeventnotificationcriteriaestablishedbythephysicianforan
urgentclinicalevent.Theseeventsareofhighclinicalsignificance.ECGstripscorrespondingtotheseeventsare
transmittedwithinafewminutesofonsetoftheevent.
Chapter2:Overview
6
2
Overview
ThischapterprovidesanoverviewoftheRhythmExpressRX‐1ECGMonitorandArrhythmiaDetector.Thefollowing
informationcanbefoundinthischapter:
Devicedescription
Intendeduse
Indicationsforuse
Device Description
RX‐1isaportablebattery‐poweredwearablerecorderforusebytrainedclinicalstafftocollectECGfrompatientsina
home,clinical,oroutpatientsettingforupto30consecutivedays.Thedevicecancapturepatientactivatedandauto‐
triggeredcardiaceventssuchasbradycardia,tachycardia,pause,andatrialfibrillationviaanon‐boardECGwaveform
analysisalgorithm.Thedevicecanautomaticallydeliverthedatawirelesslytoaserverusingabuilt‐inwirelesscellulardata
modemwhereitcanbereviewedbyaphysicianorotherqualifiedprofessional.Amedicalprofessionalcanadjustthe
devicenotificationcriteriaandautotriggeringparametersusingtheserverandsecurelycommunicatetheupdateddevice
notificationcriteriatothedeviceusingthecellularnetwork.Devicenotificationparametersincludearrhythmiadetection
thresholds,monitoringduration,andoperatingmode.
TheRX‐1consistsofamonitor,DIN40standardleadwires,andawallbatterycharger.TheRX‐1deviceisintendedtobe
usedonlywithleadwiressuppliedbyVivaQuant.HighqualityFDA‐clearedleadelectrodesdesignedforlong‐term
ambulatorymonitoringshouldbeused,suchas3M2259orequivalent.
RX‐1canrecordECGaseitheranEventRecorder(ER),MobileCardiacTelemetry(MCT)orWirelessHolter(WH)device.As
anEventRecorder,thedevicecontinuouslydetectsarrhythmiasandtransmitsthematapredeterminedinterval.Upon
feelingsymptoms,asdirectedbyaphysician,thepatientcanpresstheRedPatientTriggeredEvent(PTE)buttononthe
devicetomarkthetimesymptomsoccurred.Thedevicethenpromptsthepatienttoassignasymptomtypeandwill
immediatelyconnectwiththecellularnetwork.Onceasecureconnectionisestablishedonthecellularnetwork,thedevice
willtransmitanECGstripoverlappingthetimeatwhichtheredPTEbuttonwaspressed.Oncereceivedatamonitoring
centerorclinic,theECGcanbeevaluationbyaphysicianorothertrainedprofessionaltoaidindiagnosis.
WhenoperatingasanMCTdevice,RX‐1functionsthesameasERmodewiththeadditionthattheRX‐1detectsthe
locationofeachheartbeatandtransmitstothemonitoringcenterforreportingtothephysicianasanaidindiagnosis.In
addition,whileinMCTmode,theserverprovidesforretrievalofanyECGstripduringtherecordingsession.When
operatingasaWHdevice,RX‐1functionsthesameasMCTmodeexceptthattheserverautomaticallyretrievesallECG
stripsrecordedbythedevice.
Whennotactivelymonitoringapatient,theRX‐1canbeplacedinStandbyModetosavebatterycharge.StandbyMode
essentiallyputsthedevicetosleeptopreservethebatteryandusesonlyabout1%ofremainingbatterycapacityforeach
weekthedeviceisinStandbyMode.ThedevicecanbechargedwheninStandbyMode.
Chapter2:Overview
7
Intended Use
TheRhythmExpressremotecardiacmonitoringsystemisintendedforusebypatientswhoeitherhaveorareatriskof
havingcardiacdiseaseandthosethatdemonstrateintermittentsymptomsindicativeofcardiacdiseaseandrequirecardiac
monitoringonacontinuingbasis.ThedevicecontinuouslyrecordsECGdataandupondetectionbyanECGanalysis
algorithmormanuallyinitiatedbythepatient,automaticallydeliverstherecordedcardiacactivitytotheserverwhereitis
presentedandcanbereviewedbyamedicalprofessional.
ThedatareceivedfromtheRhythmExpressdevicecanbeusedbyanotherdeviceforarrhythmiaanalysis,reportingand
signalmeasurements.TheRhythmExpressremotecardiacmonitoringsystemisnotintendedtosoundanyalarms.
Thedevicedoesnotdeliveranytherapy,administeranydrugs,provideinterpretiveordiagnosticstatementsorprovidefor
anylifesupport.
Contraindications
1. Patientsundertheageof18
2. Patientswithpotentiallylife‐threateningarrhythmiaswhorequireinpatientmonitoring.
3. Patientswhotheattendingphysicianthinksshouldbehospitalized.
Indications for Use
TheRX‐1ECGmonitorwitharrhythmiadetectionisintendedforuseinthefollowingindications:
Adultpatientswhohaveademonstratedneedforcardiacmonitoring.Thesemayincludebutarenotlimitedto
patientswhorequiremonitoringfor:a)non‐life‐threateningarrhythmiassuchassupraventriculartachycardias
(e.g.atrialfibrillation,atrialflutter,PACs,PSVT)andventricularectopy;b)evaluationofBradyarrhythmiasand
intermittentbundlebranchblock,includingaftercardiovascularsurgeryandmyocardialinfarction;andc)
arrhythmiasassociatedwithco‐morbidconditionssuchashypothyroidismorchroniclungdisease.
Patientswithsymptomsthatmaybeduetocardiacarrhythmias.Thesemayincludebutarenotlimitedto
symptomssuchas:a)dizzinessorlightheadedness;b)syncopeofunknownetiologyinwhicharrhythmiasare
suspectedorneedtobeexcluded;andc)dyspnea(shortnessofbreath).
Patientswithpalpitationswithorwithoutunknownarrhythmiastoobtaincorrelationofrhythmwithsymptoms.
Patientswhorequireoutpatientmonitoringofantiarrhythmictherapy:a)monitoringoftherapeuticandpotential
proarrhythmiceffects(e.g.QTprolongation)ofmembraneactivedrugs;andb)monitoringofeffectivedrugsto
controlventricularrateinvariousatrialarrhythmias(e.g.atrialfibrillation).
Patientsrecoveringfromcardiacsurgerywhoareindicatedforoutpatientarrhythmiamonitoring.
Patientswithdiagnosedsleepdisorderedbreathingincludingsleepapnea(obstructive,central)toevaluate
possiblenocturnalarrhythmias.
Patientsrequiringarrhythmiaevaluationofetiologyofstrokeortransientcerebralischemia,possiblysecondaryto
atrialfibrillation.
Comment [bp1]: Changesheremustbemade
everywhere.Theindicationsarepubliclyapproved
duringthe510(k).Theymustbeconsistentinall
labellingandrequirements.
Chapter3:SafetyInformation
8
3
Safety Information
ThischapterprovideswarningsandcautionsrelatingtouseoftheRX‐1device.Allpersonnelthatusethisdeviceshould
readandbefamiliarwiththecontentofthissectionpriortouse.
VivaQuantassertsthattheproductcoveredbythismanualissafe,reliable,andeffectiveprovidedthattheproductisused
inaccordancewiththeinstructionsforuse,asprovidedinthismanual.Observanceofallsafetymessageswillhelpprotect
theuserandthepatientagainstthosehazards.
Cautions and Warnings
WARNING:Wearthedeviceandlanyardunderashirtorothergarmenttoavoidbecomingentangledinyoursurroundings.
WARNING: DisconnectPatientleadsfromelectrodesbeforedefibrillation.ExposuretodefibrillationmaydamagetheRX‐1
deviceormayinterferewithoperationofthedefibrillator.
WARNING:RX‐1isnotintendedforuseasanemergencymedicalresponsesystem.
WARNING:Keepoutofreachofchildren.Thisdeviceincludesuseofsmallpartsandlongcordswhichcouldposeachoking
orstrangulationhazardtounattendedchildren.
CAUTION:Thisdevicecapturesandpresentsdatareflectingapatient’sphysiologicalconditionthat,whenreviewedbya
trainedmedicalprofessional,canbeusefulindeterminingadiagnosis.However,thedatashouldnotbeusedas
thesolemeansfordeterminingapatient’sdiagnosis.
CAUTION:TheRX‐1deviceisdesignedforusewithstandardelectrodes.Somepeoplearesensitivetothematerialsusedin
skinelectrodes.Ifareactionoccurs,removethedeviceandelectrodesfromthebody.
CAUTION:ThisdeviceisnotintendedforuseduringanMRI.
CAUTION:Useonlyspecifiedpartsandaccessoriestomaintainoperatorandpatientsafety.
CAUTION:TheRX‐1isdesignedtomeetorexceedrequirementsforelectromagneticcompatibility,however,some
environmentalelectricalinterferencemaycauseanartifactintheECG.ThequalityofECGsignalsmaybe
adverselyaffectedbyelectromagneticinterferencefromheavymachinery,electricblankets,andsimilar
apparatus,resultinginnon‐physiologicalwaveformswiththepotentialformisinterpretation.
CAUTION:DonotallowelectrodesorECGleadstocontactanelectricalpowersource.Contactcouldcauseelectrocutionof
thepatient.
CAUTION:Disconnecttheleadwiresfromtheelectrodespriortocharging.Althoughthechargerhasbeentestedtoassure
thatitmeetssafetystandards,failurecouldresultinelectricalshock.
Chapter3:SafetyInformation
9
CAUTION:Useonlythespecified,chargerforthisdevice(AC/DCadapter),aslistedinthesystemcomponentsofthis
manual.UsinganotherACadaptermaydamagethedeviceandmaycreateasafetyhazard.
CAUTION:Donotexposethedeviceorleadwirestoautoclavingorsteamcleaning,asdamagecouldresult.Recommended
cleaningprocedureistowipetheexteriorsurfaceswithaclothdampenedwithwarmwaterandmilddetergent
solutionandthendrywithaclean,softcloth.
CAUTION:Therearenouser‐serviceablepartsinside.Openingthecasewillvoidallwarrantiesandcouldresultin
permanentdamage.
CAUTION:TheRX‐1devicehasbeendesignedtotoleratenormaldropsandshocks.However,excessiveimpactandshocks
shouldbeavoidedtopreventdamagetothedevice.
CAUTION:TheRX‐1deviceusesaLithiumIonbattery.Thisbatterymaypresentafireorchemicalburnhazardif
mistreated.Donotdisassemble,heatabove70°C(160°F),orincinerate.Disposeofthedeviceinaccordance
withapplicablelocalregulations.
CAUTION:Theuserofthisproductisresponsibleforroutinemaintenance.Failuretodosomaycauseunduefailureand
possiblehealthhazards.
CAUTION:VivaQuantequipmentisidentifiedbytheUDI,Model,andserialnumberonthebackofthedevice.Takecare
nottodefacethesenumbers.
CAUTION:Thisequipmentisnotsuitableforuseinthepresenceofaflammableanestheticmixturewithair,oxygen,or
nitrousoxide.
CAUTION:Thisequipmentisresistanttowaterbutshouldnotbesubmergedinwater.Removedevicepriortoenteringa
poolorbathanddonotsubmergedeviceduringcleaningandmaintenanceprocedures.Submergingthedevice
inwatercouldresultindamage.
CAUTION:Thisequipmentshouldnotbeexposedtoenvironmentalconditionsoutsidethelistedspecifications.IftheRX‐1
isresultinachangeinperformancecontactcustomersupportat1‐866‐ECG‐TRUE(1‐866‐324‐8783).
Chapter4:UsingtheRX‐1toMonitoraPatient
10
4
Using the RX-1 to Monitor a Patient
ThischapterguidesyouthroughthestepsnecessarytopreparetheRX‐1foranewrecordingsession,completehookupof
thedevice,initiateamonitoringsession,andterminateamonitoringsession.
Rhythm Express RX-1
TheRX‐1isasmall,battery‐powereddevicethatistypicallywornonawaistband,alanyard,oronapatient’sbeltinacell‐
phone‐typepouch(notprovidedbyVivaQuant).
RX-1 Device
Device Components
Feature Description
ECG lead wires These 4 leads conduct the signal from the electrodes on the
patient’s skin to the device. Use only the electrodes provided by
VivaQuant. RX-1 may not meet the required performance if other
leads are used.
Display The LCD display provides the user with feedback on device
operation.
Menu selection
buttons up down
Arrow control
Used to move cursor on the display to select symptoms after
pressing PTE button. These buttons can also be used in
combination with the PTE button to control operation in some cases.
Patient Triggered
Event (Red PTE)
button
Used to mark the location of a patient triggered event while
recording. It is also used to control operation of the device when
operating in certain modes.
USB connector Used to connect a battery charger.
Chapter4:UsingtheRX‐1toMonitoraPatient
11
OverviewofRX‐1DeviceOperation
Thedeviceacquiresatwo‐channelECG,continuouslyevaluatestheincomingsignalstoremovenoise,anddetects
bradycardia(brady),tachycardia(tachy),pause,andatrialfibrillation(AF)usinganon‐boardembeddedalgorithm.RX‐1
canalsomarkpatienttriggeredeventsandoffersthepatienttheabilitytoselectfromamenuofcommonsymptomstoaid
inassessmentofsymptom‐rhythmcorrelation.RX‐1usesstandardDIN40ECGleadwirestoconnecttostandard
commerciallyavailableskinelectrodestosensethepatient’sECG.AcellularmodemembeddedwithintheRX‐1isusedto
establishasecurecommunicationslinktoaserverthatisaccessiblefromamonitoringcenterorclinic.Auto‐andpatient‐
triggeredECGarrhythmiastripsarecommunicatedtotheserverforviewingandincorporationintoareportbyamedical
professional.
Connecting to the Cellular Network and Signal Strength
Tomaximizecybersecurity,allcommunicationswiththeserverareoriginatedbythedevice.Thedeviceattemptsto
communicatewiththeserveruponthefollowingconditions:(Notethatforaconnectiontobeestablished,cellularservice
mustbeavailable.Ifnocellserviceisavailable,thedevicewillretryuntilaconnectionisestablished.)
Expiration of the server connection interval timer. This timer, built into the device, causes the device to attempt a
connection at regular intervals (i.e. every 30 minutes). Wheneverthedeviceconnects,allrhythminformationis
transferredtotheserver.
Uponapatienttriggeredevent.Whenthedeviceisactivelyrecording,andthepatientpressestheRedPTEbutton(for
5seconds)onthedevice,thedevicemarksthetimeofbuttonpressandinitiatescommunicationwiththeservervia
thecellularmodem.
Whenthedevicedetectsanarrhythmiameetingurgentcriteria,itattemptstoestablishacommunicationlinkwiththe
servertoavoidthepotentialdelayofwaitingforexpirationoftheserverconnectionintervaltimer.Autodetectionof
anarrhythmiathatmeetsurgentcriteria.Urgentcriteriaaredeterminedbyaphysicianand are selected forclinical
import.Forexample,aphysicianmayhaveselectedaroutinetachycardiathresholdtobe140bpmbutselectedurgent
tachycardiathresholdtobe180bpm.
AconnectioncanbemanuallyinitiatedbypressingtheredPTEbuttonformorethan5secondsifthedeviceisin
Standby,Charging,orRecording.Ifthedevicejustconnected,ortriedandfailedtoconnect,thedevicewillwaitabout
1minutebeforeattemptingtoconnect.
Whenthedeviceisconnectedorattemptingtoconnecttotheserver,thecloudiconappearsonthedisplay.Thecellular
signaliconisupdatedwhenthemodemfirstconnectstothetowerandcontinuestodisplaysignalstrengthuntil
disconnected.Whenthedeviceisnotconnected,thecellsignalstrengthiconisnotupdatedandthecloudicondisappears.
Chapter4:UsingtheRX‐1toMonitoraPatient
12
Device Notification Criteria
Tosetupthedevicepriortothestartofarecordingsession,monitoringcenterorclinicstaffarerequiredtoselectcriteria
forarrhythmiadetectionandotherusefulinformationontheportal.Thisinformationisthencommunicatedtothedevice
viathewirelesscellularlinkonthenextconnection.Table1belowshowsselectablecriteria.
Table 1. Device notification criteria.
Parameter Description
Mode SelectseitherWH,MCT, orERastheoperatingmodeforrecording
Timezone Selectsthetimezonewherethepatientresides
Tachycardiaratethreshold–urgentevent Specifiesheartratethresholdnecessarytotriggeranurgentevent
Tachycardiaratethreshold
–
routineevent Specifiesheartratethresholdnecessarytotriggeraroutineevent
TachycardiaNumberofbeats Thenumberofbeatsinaconsecutiverunabovethetachycardia
ratethresholdrequiredtotriggerdetectionofatachycardiaevent
Bradycardiaratethreshold
–
urgentevent Specifiesheartratethresholdnecessarytotriggeranurgentevent
Bradycardiaratethreshold
–
routineevent Specifiesheartratethresholdnecessarytotriggeraroutineevent
BradycardiaNumberofbeats Thenumberofconsecutivebeatsthatmustfallbelowthe
bradycardiaratethresholdtotriggeranevent.
Pausethreshold
–
urgentevent Specifiesminimumpausedurationnecessarytotriggeranurgent
event
Pauseeventthreshold–routineevent Specifiesminimumpausedurationnecessarytotriggeraroutine
event
Atrialfibrillationevent–urgent Whenchecked,anAFeventof4minutesormoreindurationwill
triggerurgentnotification
Audiblenotification Whencheckedaudiblenotificationswillbeenabled
Recordingduration Specifiestherecordingdurationinhours
Hookupmodeenable Ifhookupmodeisenabled,thedevicescrollsthepatient’sECGon
thedisplaypriortoenteringrecordingmode.Ifnotenabled,the
devicedirectlyentersrecordingmode.Ifthedeviceissenttothe
patientforhookup,thismodeshouldbedisabled.
NOTE:WesuggestthatHookupbedisabledunlessaclinicianispresentduringhookup.
TheRX‐1includesthreebuttons;aRedPTEbutton,andtwosmallerupdownarrowbuttons,asshowninError!Reference
sourcenotfound.above.Thefunctionofthesethreebuttonsdependsuponthecurrentoperatingstateofthedevice,as
indicatedinthetablebelow.Notethatinthescreenimagesinthetable,theword“Connected”willonlyappearwhenthe
deviceisconnectedtotheserverviatheInternet.
Chapter4:UsingtheRX‐1toMonitoraPatient
13
Table 2. Actions provided by PTE button vs. Operating State.
ShownonDisplay ActionTaken Result
PressPTEformore
than5seconds
DevicetransitionstoReady,provided
thatthedevicesolidstatedrivehasbeen
erasedandthedevicehasbeen
configuredforthenextpatienttobe
monitored.
PressPTEformore
than5seconds
Devicetransitionsdirectlytorecording
mode,providedthattheremaining
batterycapacityisatleast3barsand
Hookupmodeisdisabled.
PressPTEformore
than5seconds
DevicetransitionstoHookupmode(if
enabled)anddisplaysanECGtracefor
eachchannel.IfPTEisnotpressedfor60
seconds,thedevicestartsrecordingECG.
PressPTEformore
than5seconds
DevicetransitionstoRecordingmode
andstartsrecordingECG.
PressPTEfor1‐‐
2seconds
DisplayssymptomiconforShortof
Breath.IfPTEispressedagainwhilethis
iconisdisplayed,HeartPoundingis
selectedattheclassificationofthe
patientsymptom.
PressPTEtotagthis
patienttriggered
eventwithShortof
Breathasthe
patientsymptom
PressUpArrowtoselectOtheras
symptom.PressDownArrowtoselect
heartpounding(palpitations)as
symptom.
PressPTEtotagthis
patienttriggered
eventwithheart
poundingasthe
patientsymptom
PressUpArrowtoselectShortof Breath
assymptom.PressDownArrowtoselect
Dizzyassymptom.
PressPTEtotagthis
patienttriggered
eventwithDizzyas
patientsymptom
PressUpArrowtoselectHeartPounding
assymptom.PressDownArrowtoselect
ChestPainassymptom.
PressPTEtotagthis
patienttriggered
eventwithChest
Painasthepatient
symptom
PressUpArrowtoselectDizzyas
symptom.PressDownArrowtoselect
Otherassymptom.Otherindicatesthat
thepatientisexperiencingsomething
otherthanisdescribedinothericons.
Chapter4:UsingtheRX‐1toMonitoraPatient
14
PressPTEtotagthis
patienttriggered
eventwithOtheras
thesymptom
PressUpArrowtoselectChestPainas
symptom.PressDownArrowtoselect
ShortofBreathassymptom.
NOTE:WesuggestthatHookupbedisabledunlessaclinicianispresentduringhookup.
Recording Symptoms
1.Whenaphysicianrequestedsymptomisexperienced,pressandholdtheRedPTEbuttononthedevicefor1‐2seconds.
2.Oneofthesymptomiconsshownbelowwillappearonthedisplay.
3.TheUporDownArrowbuttonscannowbepressedtostepthroughthepossibleselections.
4.Oncethesymptomthatbestdescribeswhatthepatientisfeelingisdisplayed,presstheRedPTEbuttonagain.Thiswill
capturethesymptomforlaterviewingbyamedicalprofessional.
Note:Anothersymptommaynotberecordedfor3minutes.
Ifnoneofthesymptomsmatchwhatyouareexperiencing,select“Other.”Ifnosymptomisselectedwithin30seconds,
thescreenwillreturntoshowthatitisrecording,andnosymptomwillberecorded.
AfterpressingtheRedPTEbuttontorecordasymptom,theShortofbreath
iconappears.TheUpandDownarrowkeyswillskipbetweeniconstoallow
selectionofthesymptomiconthatmatchesthepatientssymptom.
Chapter4:UsingtheRX‐1toMonitoraPatient
15
BatteryChargingandStatus
Batterystatusisprovidedonthedisplayinmostoperatingmodes.
Batterydisplays
(numberofbars)
BatteryCharge
5 Fullycharged
4 75‐95%
3 50‐75%
2 20‐50%
1 5‐20%
0 Lessthan5%
remaining
Oncethebatteryicondisplays0bars,thedeviceallowsforonecommunicationattemptwiththeservertoindicatethat
thebatteryisneartheendofitslifethenthedevicewillstopacquiringdata.Itisrecommendedthatthedevicebe
connectedtoachargeroncethedevicedisplays1baronthebatteryicon.Fullchargewillbereachedinapproximately2
hours.BatterylifeforMCTmodeisabout14days.
Remove leads from electrodes then plug RX-1 into charger.
Caution:Disconnecttheleadwiresfromthepatientelectrodesbeforecharging.Useonlythechargerprovidedwiththe
devicetochargethebattery.
Chapter4:UsingtheRX‐1toMonitoraPatient
16
Notifications
TheRhythmExpressTMRX‐1deviceprovidesstatusinformationtotheserveroneachconnection.Theservercanprovide
alertsandnotificationinformationtothemonitoringcenterstaffastobatterystatus,qualityoftheECGsignal,and
whetheraleadisdisconnected.TheRX‐1canalsoprovideanaudiblenotificationdirectlytothepatient,whenconfigured
bytheserver.Theaudiblenotificationwillbeepwhenanyofthefollowingconditionsaremet:
BothECGleadsaredisconnectedformorethan30minutes.
ThedevicehasdetectedanUrgentArrhythmia Eventandhasbeenunabletoconnectwiththeserverwithin15
minutesofonsetoftheevent.
Thedevicehasbeenunabletoconnectwiththeserverformorethan4hours.
Thebatteryisnearlydepletedandneedstobechargedimmediately.
Preparing the RX-1 Device for a Recording
Preparingadeviceforanewpatientinvolvesthefollowingtasks:
PresstheredPTEbuttonforatleast5secondsuntilthedisplayshowseitherStandbyorReady.Ifthedevicewas
preparedforthenextpatient,thedisplaywillshowReady.Ifnot,itwillshowStandby.
Confirmthatthebatteryischargedtoatleast1baronthebatteryicon.Ifthebatteryisnotchargedtoatleast3
bars,anewrecordingsessioncannotbeinitiated.
IfthedisplayshowsStandby,usetheservertoselectdevicenotificationsettings.Oncethesettingsareenteredon
theserver,presstheredPTEbuttonfor5secondstoinitiateaconnectionwiththeserver.Oncethesettingshave
beendownloadedtothedevice,Readywillappearonthedisplay.
NOTE:Westronglysuggestthatallleadwiresbeconnectedtothedevicebyaclinician.Leadsaredesignedtobedifficult
toremoveandmayrequiretheuseofatool(e.g.pliersorforceps).
Connecting the ECG Leads to the Patient
ThequalityoftheECGsignaldependsonthecontactbetweentheelectrodeandthepatient’sskin.Werecommendthe
useofelectrodes3M2259orAmbuBlueSensorVLC,designedforlong‐termambulatorymonitoring.
UseonlytheECGleadsprovidedbyVivaQuant,plugtheECGleadsintothedeviceaccordingtothelabelnexttothe
connectorsasshownbelow.
ThecolorofeachleadwirepluggedintothefourconnectorsontheRX‐1shouldbeasfollows:
RL - - - - Green LA - - - - Black
RA - - - - White LL - - - - Red
RX-1 ECG lead wire connection locations.
Comment [HS2]: Thishasbeenchangedtoone
barcoarrect?
Chapter4:UsingtheRX‐1toMonitoraPatient
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Chapter4:UsingtheRX‐1toMonitoraPatient
18
Preparationofthepatient’sskinisimportanttoobtainagoodqualityECGrecording.Itisbesttorefertoyourelectrode
manufacturerforinstructionsonproperskinpreparationtechniques.However,thefollowingpointscanassistinobtaining
goodqualityECGrecordings:
Identifythelocationsoftheelectrodes.Foratwo‐leadrecording,usethelocationshowninthefigurebelow.Placing
electrodesoverbonestructureswillreduceartifactandnoise.
Selectaleadwirelengthtocomfortablyreachfromtheelectrodelocationtothedevice.Useawhiteleadfortheright
arm(RA)electrode,ablackleadfortheleftarm(LA)electrode,redleadfortheleftleg(LL)electrode,andgreenfor
thedrivenrightleg(DRL)electrode.
Ateachelectrodelocation,shavehairifnecessary.
Usingthe3M2259electrode,usetheabrasivepatchonthebackoftheECGelectrodetomildlyabradetheskinatthe
locationofeachelectrodebygentlyrubbingtheabrasivepatchovertheareathreeorfourtimes.Ifyouareusinga
differentelectrode,followthemanufacturer’srecommendationsforskinpreparation.
AttachtheECGleadsnaptoeachelectrodeandattachtheelectrodetotheskin.Iftheelectrodeismistakenlyattached
tothewronglocation,useanewelectrodetocorrectthemistake.Reusinganelectrodecanresultinpoorquality
signals.
Note:Makeashortloopintheleadwireneareachelectrodeandtapethelooptotheskin.Thiswillpreventthelead
wirefromtuggingontheelectrodeduringmovementandcanimprovetherecordingquality.
ECG lead placement.
Initiating a Recording
IfHookupModeisenabled:WhenthedisplayshowsReady,presstheredPTEbuttonfor5seconds.IftheECG
electrodesandleadwiresareconnected,thepatient’sECGwillscrollacrossthedisplay.Onceconfirmedthatthe
electrodesareconnectedcorrectly,presstheredPTEbuttonagainfor5secondstostartrecording.IftheredPTE
buttonisnotpressedwithin120seconds,thedevicewillautomaticallystartrecording.
IfHookupModeisdisabled:WhenthedisplayshowsReady,presstheredPTEbuttonfor5secondstostartrecording.
Chapter4:UsingtheRX‐1toMonitoraPatient
19
Charging the Battery During a Recording Session
Werecommendchargingthebatterywhenthechargeindicatorshowsonly1barofcharge.Innormaloperation,charging
thebatteryshouldonlyberequiredaboutonceperweek.
Tochargethebattery,
1. DisconnecttheECGleadwiresnapsfromtheskinelectrodes,leavingtheleadwirespluggedintothedevice
Disconnect the ECG lead wire snaps from the skin electrodes
2. PlugtheUSBcablefromthechargerintotheRX‐1connector.
Note:Useonlythechargerprovidedwiththedeviceforcharging.Whenthedeviceischarging,alightningboltwillappear
insidethebatteryiconeveryfewseconds.
Battery charging
When the battery is fully charged, 5 bars will appear in the battery icon. The device will reach full charge in
approximately 2 hours. To maximize the diagnostic utility of RX‐1,reconnectthedeviceassoonaschargingis
complete.
WerecommendreplacingtheelectrodesatthistimebyfollowingtheinstructionsinConnectingtheECGLeadsto
thePatient.
Forcomfort,repositionthelocationofeachelectrodeslightlytoavoidplacingitatthesamelocation.
UseonlytheECGleadsprovidedbyVivaQuantandfollowtheinstructionsintheabovesection,NOTE:Westrongly
suggestthatallleadwiresbeconnectedtothedevicebyaclinician.Leadsaredesignedtobedifficulttoremove
andmayrequiretheuseofatool(e.g.pliersorforceps).
Connecting the ECG Leads to the Patient
NOTE:Westronglysuggestthatallleadwiresbeconnectedto
thedevicebyaclinician.Leadsaredesignedtobedifficulttoremoveandmayrequiretheuseofatool(e.g.pliers
orforceps).
Connecting the ECG Leads to the Patient
,andthecolor‐codinginthefigureabove.
Caution:DisconnecttheECGleadwiresfromtheelectrodespriortocharging.Althoughthechargerhasbeentestedto
assurethatitmeetssafetystandards,failurecouldresultinelectricalshock.
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Caution:Useonlythespecified,chargerforthisdevice(AC/DCadapter),aslistedinthesystemcomponentsofthis
manual.UsinganotherACadaptermaydamagethedeviceandmaycreateasafetyhazard.
Terminating a Recording
Therecordingisautomaticallyterminateduponexpirationoftherecordingdurationtimersetwhenconfiguredbythe
server..Alternately,therecordingcanbeterminatedviaacommandfromthemonitoringcenterprovideduponphysician
orders.Upontermination,thedevicewillautomaticallytransmitremainingpatientdataonthenextconnectionwiththe
server.
When the recording is complete, the RX-1 will transition from Recording Mode (left
above) to Standby. Remove the electrodes and device and return it to the
monitoring center or clinic, as directed.
Time to recharge the battery. Battery fully charged.
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