Cardioline Walk Free User manual

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Rev.00–24/02/2022
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WalkFree
Usermanual

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WalkFree
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Manufacturer:
livetecIngenieurbueroGmbH
Marie‐Curie‐Str.8
79539Loerrach
GERMANY
[email protected]
www.livetec.de
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CARDIOLINE®isaregisteredtrademarkofCardiolineSpA.
Thispublicationmaynotbereproduced,inwholeorinpart,inanyformormanner,withoutpriorwrittenauthorisation
by:
CardiolineS.p.A.
ViaLinz,151‐38121Trento‐Italy
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WalkFree
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Contents
1.GENERALINFORMATION............................................................................................................................1
1.1.Importantadditionalinformation....................................................................................................1
2.SAFETYINFORMATION...............................................................................................................................2
2.1.Reccomendationsforusers..............................................................................................................5
2.2.Recommendationsforthepatientduringthetest..........................................................................6
2.2.1.Precautionsforthepatient,skinirritation.......................................................................................6
2.3.AnalysisSystems...............................................................................................................................7
3.ELECTROMAGNETICCOMPATIBILITY(EMC)..............................................................................................8
3.1.Guidanceandmanufacturer'sdeclaration–Electromagneticemissions.......................................8
3.2.Guidanceandmanufacturer'sdeclaration–Electromagneticimmunity.......................................9
4.SYMBOLSANDLABEL..................................................................................................................................12
4.1.Explanationofthesymbols..............................................................................................................12
4.2.Devicelabel......................................................................................................................................13
5.INTRODUCTION..........................................................................................................................................14
5.1.Purposeofthemanual.....................................................................................................................14
5.2.Recipients.........................................................................................................................................14
5.3.Intendeduse.....................................................................................................................................14
5.4.Descriptionofthedevice.................................................................................................................15
5.4.1.Generaloverview.............................................................................................................................17
5.4.2.Controlanddisplayelements...........................................................................................................18
6.PREPARATIONFORUSE..............................................................................................................................21
6.1.Switchingontherecorder................................................................................................................21
6.2.InstallationofDeviceWebManagerinitializationsoftware...........................................................21
7.EXECUTIONOFTHEEXAMINATION............................................................................................................22
7.1.Generalprocedure...........................................................................................................................22
7.2.Preparingthepatient’sskin.............................................................................................................22
7.3.Connectingthepatient.....................................................................................................................23
7.3.1.Suitableelectrodetypes...................................................................................................................24
7.3.2.Positioningoftheelectrodes...........................................................................................................24
7.4.InitialisationandstartofECGrecording..........................................................................................26
7.4.1.InitializationwithDeviceWebManager..........................................................................................26
7.5.Instructingthepatient......................................................................................................................26

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7.6.Definitionofmanualeventmarkers................................................................................................26
7.7.Cyclicalfunctioncontrol...................................................................................................................27
7.8.StopECGrecordingandanalysisofECGrecording.........................................................................27
7.8.1.StopECGrecording..........................................................................................................................27
7.8.2.ReadouttheECGrecording/importintotheAnalysisSoftware.....................................................27
8.MAINTENANCEANDTROUBLESHOOTING.................................................................................................29
8.1.Cleaninganddisinfection.................................................................................................................29
8.2.Changeofelectrode.........................................................................................................................29
8.3.Batterychange.................................................................................................................................30
8.4.Self‐testing,internalsurveillanceandprotectionmeasures...........................................................32
8.4.1.Self‐testing........................................................................................................................................32
8.4.2.Internalmonitoringandsafeguardmeasures.................................................................................33
8.4.3.Electrodemonitoring.......................................................................................................................33
8.4.4.Cyclicalfunctioncontrolbytheuser................................................................................................33
8.5.Troubleshootingtable......................................................................................................................33
9.TECHNICALSPECIFICATIONS.......................................................................................................................35
9.1.Compatibleanalysissystem.............................................................................................................36
9.2.Classificationandstandards.............................................................................................................36
10.WARRANTY.................................................................................................................................................38
11.DISPOSAL....................................................................................................................................................39
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WalkFree
1.GENERALINFORMATION
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1
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1. GENERALINFORMATION
Thismanualisanintegralpartofthedeviceandshouldalwaysbeavailableassupportmaterialtotheclinical
practitionerortheoperator.Strictcompliancewiththeinformationcontainedinthismanualisanessential
prerequisiteforaproperandreliableuseofthedevice.
Havetheoperatorreadthemanualthoroughlyastheinformationrelatedtothedifferentchaptersisonly
describedonce.
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1.1. Importantadditionalinformation
Thismanualwaswrittenwiththeutmostcare.Shouldyoufindanydetailswhichdonotcorrespondtothose
containedinthismanual,pleaseinformCardiolineSpA,whowillproceedtocorrectsuchinconsistenciesas
soonaspossible.
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Theinformationcontainedinthismanualissubjecttochangewithoutnotice.
Allchangeswillbeincompliancewiththeregulationsgoverningthemanufacturingofmedicalequipment.
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Alltrademarksmentionedinthisdocumentarepropertyoftheirrespectiveowners.Theirprotectionis
guaranteed.
Nopartofthismanualmaybereprinted,translatedorreproducedwithoutthemanufacturer'swritten
authorisation.
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Thecoderelatingtothismanualisprovidedbelow.
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LanguageCode
ENGLISH36519200
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WalkFree
2.SAFETYINFORMATION
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2. SAFETYINFORMATION
Warnings
Thismanualprovidesimportantinformationonproperuseandsafetyofthedevice.Failuretocomply
withthedescribedoperatingprocedure,improperuseofthedevice,ignoringthespecificationsand
recommendationssupplied,maycauseseverephysicalinjuriestotheoperators,patientsand
bystanders,ormaydamagethedevice.
Nodevicemodificationispermitted.
Thedevicecapturesanddisplaysthedatathatreflectthephysiologicalconditionofthepatient;this
informationcanbeexaminedbyspecialistmedicalstaffandwillbeusefulinprovidinganaccurate
diagnosis.Inanyevent,thedatacannotbeusedastheonlymeanstomakeanaccuratediagnosisof
thepatient.
Theoperatorsforwhomthisdeviceisintendedmusthavetherequiredcompetenceregarding
medicalproceduresandthetreatmentofpatients.Theymustalsobesufficientlytrainedinusingthe
device.Havetheoperatorcarefullyreadandunderstandthecontentsoftheoperatormanualandthe
otherannexeddocumentsbeforeusingthedeviceforclinicalapplications.Inadequateknowledgeor
trainingcouldbeatagreaterriskforthephysicalsafetyofoperators,patientsandbystanders,or
coulddamagethedevice.Iftheoperatorsarenottrainedondeviceuse,itisrecommendedtocontact
CardiolineortheirAuthorisedDistributortoscheduleanadequatetrainingcourse.
Forambulantrecordings,patientsmustbeinstructedtohandleWalkFreebeforehand.Patientswho
areunabletooperateWalkFreeafterthoroughtraining(changeandapplicationofelectrodes,
batteries,e.g.disabledordementedpeople)shouldbeexcludedfromrecording,unlesstheycanrely
onthesupportofthirdpartieswhocanbeassignedtotheapplicationinyourusuallivingenvironment.
Forthecorrectoperationofthedeviceandforthesafetyoftheoperators,patientsandbystanders,
thedeviceandtheaccessoriesmustbeexclusivelyconnectedasoutlinedinthismanual.
Thesafetyofthepatientandoperatorisguaranteediftheaccessoriesthatmaycomeintodirect
contactwiththepatientcomplywithstandardsEN60601‐1andEN60601‐1‐11andEN60601‐2‐47.
Onlyusesparepartsandaccessoriessuppliedwiththedevice.
Theenclosureofthedeviceisclassifiedas“BF‐TypeAppliedPart”incompliancewithpar.4.6ofEN
standard60601‐1.Appliedpartreferstotheelectrodes.
Conductivepartsoftheelectrodesandassociatedconnectionsmustnotcomeintocontactwithother
conductiveparts,includinggroundlead.
Thisdeviceisdesignedtobeusedonlywiththeelectrodesspecifiedinthismanual.Strictlyfollowthe
correctclinicalprocedurestopreparetheskinbeforetheapplicationoftheelectrodesandmonitor
thepatientinordertoavoidanyirritation,inflammationorotherskinreactions.Theelectrodesare
designedforshort‐termandlong‐termapplicationsandmustbepromptlyremovedoncethetestis
complete.
TheECGelectrodesmaycauseskinirritation;checktheskinforanyirritationsorinflammations.
AlthoughtheelectrodesdefinedforWalkFreeareveryskin‐compatibleandcomplywithnormative
requirements(ENISO10993‐1),allergicskinreactions(e.g.redness,inflammationoritching)canbe
causedbytheadhesivelayeroftheelectrodesinpatients.Clarifypossibleskinallergieswiththe

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WalkFree
2.SAFETYINFORMATION
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patient.Contacttheelectrodemanufacturerformoredetailedinformation.Increasedskinirritation
isexpectedinpatientstreatedwithcortisonepreparations.
Topreventanyinfections,usethedisposablecomponents(e.g.theelectrodes)onlyonce.Toensure
safetyanduseefficiency,donotuseelectrodesaftertheirexpirationdate.
Thedeviceisintendedforexternaluseandisnotintendedfordirectcardiacapplication.
Thereisariskofexplosion.Donotusethedeviceinthepresenceofflammableanaesthetics.
Thereisnosafetyhazardifotherequipment,suchaspacemakersorotherstimulators,isused
simultaneouslywiththedeviceandifallthedevicesinvolvedareusedaccordingtotheirintended
purpose.
Thedeviceisnotdesignedforusewithhigh‐frequency(HF)surgicalequipment,anddoesnotprovide
anyprotectivemeansagainsthazardstothepatient.
Theoperationmaybeadverselyaffectedbythepresenceofstrongmagneticfieldssuchasthose
producedbyelectrosurgeryequipment.
Theuseofthedeviceisnotrecommendedinthepresenceofmedicaldiagnosticimagingequipment
suchastheMagneticResonanceImaging(MRI)orComputerisedAxialTomography(CAT)inthesame
environment.
Onlyusetherecommendedbatteries.Usingothertypesofbatteriesmaycausedangeroffireor
explosion.
Thelowbatterywarningisdesignedfortherecommendedbatteriesonly.Usingothertypesof
batteriesmayleadtoalackofindicationresultingindevicefailure.
WalkFreeisshower‐resistant,providedthebatterycoverisattachedtothedevice.
Nevertheless,itisrecommendedtoremoveWalkFreefromtheelectrode(fromthebody)before
showering.Donotspillliquidsoverthedevice.
Protectthedevicefrommoisture,dustordirt,especiallywhenthebatterycompartmentisopen.
Donotcleanthedevicebysubmersingitinliquid,autoclaving,orsteamcleaning.Thismaycause
seriousdamagetoequipmentorreduceitslifespan.Usingnon‐specificdetergents/disinfectants,
failuretocomplywiththerecommendedproceduresorcontactwithnon‐specificmaterialsmaycause
additionalriskstooperators,patientsorbystandersormaydamagethedevice.Donotsterilisethe
devicewithethyleneoxidegas(EO).RefertoSection8forinstructionsonpropercleaningand
disinfection.
Donotleavetheelectrodesunattendedinthepresenceofchildrenastheycouldcausesuffocationif
accidentallyswallowed.
Neverexposethedevicetoextremetemperatureanddonotleaveitindustybrackishorhumid
premises.
TheWalkFreedevicehasbeendesignedtobeconnectedtoaPConlyifithasalreadybeen
disconnectedfromthepatient.
MakesurethatifmultipleWalkFreeisusedinparalleltodifferentpatients,therecordeddatais
correctlyassignedtotherespectivepatients.






WalkFree
2.SAFETYINFORMATION


4



Attention
Thedeviceshouldbecleanedbeforeuse.Checktheconnectionsforanydamageorexcessivewear
beforeeachuse.
Electrodesmightloosenordetachduringuse,affectingsignalquality.Instructthepatientonthe
operationstobeperformedinthatcase.
Therearenouser‐serviceablepartsinsidethedevice.Thedevicecanonlybedismantledbyqualified
servicepersonnel.Anymalfunctioningordefectivedevicemustbeexcludedfromuseandbe
checked/repairedbyqualifiedservicepersonnelbeforebeingreused.
Thedevicedoesnotrequireanycalibrationorspecialinstrumentationforcorrectuseand
maintenance.
Whenitisrequiredtodisposeofthedevice,itscomponentsandaccessories(e.g.:batteries,electrodes
etc.)and/orpackagingmaterial,complywithlocalwastedisposalregulationsand2012/19/EU(WEEE).
Thedeviceusesstandardbatteries,thatneedtobereplacedbytheuser.Alwaysdisconnectthe
Patientbeforeopeningthebatterycompartmentpanel.
Donotexposethedeviceorbatteriestodirectsolarradiationandavoidthedirectproximityofheat
sources(microwaves,heatersorovens).
Intheeventofprolongedinactivity(morethan8h),removethebatteriesfromthedevice.
Thedeviceshouldnotbeoperatedinapotentiallyexplosiveenvironment.
WalkFreemustnotbesterilised.
PleaserefertotheinstructionsforcleaninganddisinfectioninChapter8.1aswellastheinstructions
fordisposalinChapter11.

Notes
Anappropriatepreparationofthepatientisimportantinordertoguaranteeaproperapplicationof
theECGelectrodesandthecorrectoperationofthedevice.
WalkFreeissuitableforuseinchildrenwithabodyweightlessthan10kg.
ForchildrenuseelectrodesthataresuitableforHolter/Long‐TimeECGrecordingsonchildren.
AsdefinedbytheEN60601‐1andEN60601‐2‐47safetystandards,thedeviceisclassifiedasfollows:
EquipmentwithIPprotectionrating(MEInternalpowersupply).
BF‐typeappliedparts.
Ordinaryequipment.
Notsuitableforuseinthepresenceofflammableanaesthetics.
Continuousoperation
TheaccuracyofsignalsrecordedwiththedevicecomplieswithENstandard60601‐2‐47.
ThedevicebelongstoClassIIaincompliancewithDirective93/42/EECandsubsequentamendments.


WalkFree
2.SAFETYINFORMATION


5



ThedevicehasIP54Bprotectionratingagainsttheingressofsolidparticlesandwater.
Inordertopreventdamagetothedeviceduringtransportationandstorage(whenstillinitsoriginal
packaging),complywiththefollowingenvironmentalconditions:

Ambienttemperature................... ‐25ºC÷70ºC
Relativehumidity.......................... 15%÷90%(non‐condensing)
Atmosphericpressure................... 700÷1060mbar

Thedeviceisintendedforuseinhospitalsordoctor'sofficesandshouldcomplywiththefollowing
environmentalrequirements:

Ambienttemperature................... 5ºC÷40ºC
Relativehumidity.......................... 15%÷90%(non‐condensing)
Atmosphericpressure................... 700÷1060mbar
NOTE:Avoidsuddenchangesintemperatureorhumidity.
2.1. Recommendationsforusers
WhencommissioningandoperatingtheWalkFreeHolterrecordersystem,pleasenotethefollowing
information:
NotetheusagerecommendationsforapplyingtheWalkFreerecorder(Chapter7).
Clean(saveifnecessary)anddrytheareawheretheelectrodesareplacedcarefully.
Donotuseelectrodeswhosepackagingisopenformorethan5days(considerthemanufacturer’s
recommendation).
Forplannedlong‐termshots(>=24h):Useonlynewbatteries.
Payattentiontothecorrectconnectionoftherecordertotheelectrodes.
Placetheelectrodescarefully.
Checktheadhesiveresistanceoftheelectrodesseveraltimesaday.
Checkthecontactoftherecordertotheelectrodesseveraltimesaday(byraisingtherecorderatthe
corners).
Whenusingradio‐basedphones(e.g.mobilephone/smartphone/tabletPC/DECTphone/radio),a
distancefromtheWalkFreerecorderofatleast30cmshouldberespected.Thedevicesmustnotbe
storedontheWalkFreerecorder.Thisappliesinprincipletootherelectricallyoperateddevices(e.g.
hairdryer,shaver,computer,WLAN,etc.)



WalkFree
2.SAFETYINFORMATION
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
6
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2.2. Recommendationsforthepatientduringthetest
ThedevicehasbeendesignedforperformingoutpatientECGtests(Holter)normallylasting24or48hours.
TheWalkFreemodelisabletoperformmultiplerecordingsupto9daysintotal.
ClinicalpracticerequiresthePatienttowearorcarrythedeviceinsideoroutsidethehospital,inindoor
premisesaswellasoutdoors.Itisthereforeespeciallyimportantforthepatienttobesufficientlyinstructed
abouttheoperationsheisallowedtoperformandtherelatedrisks.

Inparticularthefollowingwarningsmustbeexplainedtothepatient:
Theadhesiveresistanceoftheelectrodesshouldbecheckedbythepatientsseveraltimesaday.
Theelectrodesshouldbechangedatleastevery2days,inhotweatherorbadadhesivecontact
every24hours.
Thecontactoftherecordertotheelectrodesshouldbecheckedregularlyandseveraltimesaday
(bycarefullyliftingtherecorderatthecontactstotheelectrode).
Directcontacts/impactswith/totheWalkFreeshouldbeavoidedasfaraspossible.
Thepatientshouldsleepasfaraspossibleinsupineposition.
Thepatientshouldavoidstrongphysicalactivitysuchasjoggingorsportsingeneralorstrenuous
physicalworkunlesstheseactivitiesareinstructedbyadoctor.Thisservestoimprovethesignal
quality(e.g.avoidingshocksandshocks).
Ifpossible,notightclothingshouldbeworninthechestarea.
Attention
TheWalkFreeisshower‐resistant,providedthebatterycoverisattachedtothedevice.
Nevertheless,itisrecommendedtoremoveWalkFreefromtheelectrode(fromthebody)before
showering.Donotspillliquidsoverthedevice.
Protectthedevicefrommoisture,dustordirt,especiallywhenthebatterycompartmentisopen.
2.2.1. Precautionsforthepatient,skinirritation
TheWalkFreeissuitableforuseonchildrenunder10kg.
AlthoughtheelectrodesdefinedforWalkFreeareveryskin‐compatibleandcomplywiththe
normativerequirements(ISO10993‐1‐5‐10:2018),longerrecordsmaycauseskinirritation
(itching,redness).
Inthesecases,stoptheECGrecordandcontactyourdoctorimmediately.
Increasedskinirritationisexpectedinpatientstreatedwithcortisonepreparations.Youshouldalsodovery
carefullyherewhengluingandremovingtheelectrodesfromtheskinsurface.Forbodycareforlong‐term
recordings,especiallyforapplications>24hours,thefollowinginstructionsshouldbetakenintoaccountfor
dailypersonalcare(bothinpatientandoutpatient).



WalkFree
2.SAFETYINFORMATION


7



Cleaningwithoutshower/bathroom
Ifpossible,savetheareaaroundWalkFreefromcleaningwithoutashower/bathifpossible.Forsuchcleaning,
WalkFreedoesnotneedtoberemovedfromtheelectrode.
Showers
TheWalkFreeisshower‐resistant,providedthebatterycoverisattachedtothedevice.
Nevertheless,itisrecommendedtoremoveWalkFreefromtheelectrode(fromthebody)before
showering.
Whenshowering,theelectrodescanremainonthebody.
Aftershowering,drytheelectrodecarefullyandwaitafewminutesuntiltheelectrodeiscompletely
driedbeforereconnectingtheWalkFreetotheelectrode.
Bathing/swimming
RemoveWalkFreefromtheelectrode(fromthebody)beforebathingorswimming.Alsoremovethe
electrodefromthebody.
Afterthebath,applytheWalkFreetothebodyagainaccordingtotheinstructionsinChapter7.
Drytheskincarefullybeforestickingthenewelectrodeontothebody.
Alwaysglueanewelectrodetothesameplaceasthepredecessorelectrode.
Instructionsonremoving/applyingWalkFreefromtheelectrodeandchangingtheelectrodecanbe
foundinPar.0
2.3. AnalysisSystems
TheWalkFree:
doesnotprovideintegratedanalysisordiagnosticfunctions;
doesnotincludemonitoring,detection,signalingordisplayoflife‐threateningarrhythmiasorchanges
inmorphology.

Itisthereforenotsuitableforapplicationsthatrequireatleastoneofthesefunctionalities.
Allanalysisfunctionscanonlybeperformedviaappropriatecompatibleanalysissystem.
TherecordedECGdataoftheWalkFreearenotsuitablefortheanalysisofamplitudechanges(e.g.changeof
amplitudeintheSTsegment).
TherecordedECGdatamustnotbeusedformorphologicalECGinterpretationtoderivediagnosesfor
amplitude‐specificheartdisease(e.g.ischemicheartdisease,repolarizationanomalies).

ATTENTION:
Notethatthecomputersusedinthecompatibleanalysissystems(Par.9.1)mustmeetthenormative
requirementsofEN60601‐1,oratleastthenormativerequirementsforinformationtechnologyequipment,in
ordertoensurethereadoutoftherecordedECGdataviatheUSBcable
ReadingouttheECGrecordingsmayonlyhappenifthedevicehasnoconnectiontothepatient(viatheECG
electrodecontacts).

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WalkFree
3.ELECTROMAGNETICCOMPATIBILITY(EMC)
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
8

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3. ELECTROMAGNETICCOMPATIBILITY(EMC)
TheWalkFreeisintendedforoperationintheelectromagneticenvironmentofmedicalcarefacilities
(ProfessionalHealthcare)andindomesticenvironments.ThecustomerortheuserofWalkFreeshouldensure
thattheoperationtakesplaceinanelectromagneticenvironmentthatcomplieswiththefollowing
requirements.

Warnings
ThemanufacturershallguaranteecomplianceofthedevicewiththeEMCrequirementsonlywhen
thespecifiedaccessoriesareused.Theuseofotheraccessoriesmayresultinincreasedemissionof
electromagneticinterferenceorreducedstrengthagainstelectromagneticinterference.
PortableandmobileRFcommunicationdevices(includingtheiraccessoriessuchasantennacables
andexternalantennas)shouldbeatleast30cm(12inches)distancefromallpartsoftheWalkFree
includingconnectedelectrodes.Non‐compliancecanleadtoareductionintheperformance
characteristicsofthedevice.
Theapparatusshallnotbeplaceddirectlynexttoorstackedwithotherequipment.Ifsuchan
arrangementisneverthelessnecessary,theapparatusmustbeobservedinordertoverifyitsintended
operationinthisarrangement.

Magneticandelectricfieldsorionizingradiationcaninfluencethefunctionofthedevice.Therefore,donot
operateWalkFreeneardevicesthatproducelargeelectromagneticfieldsorionizingradiation,suchasRF
chirurgic,X‐ray,magneticresonancetherapyordiathermydevices.

Undertheinfluenceofincreasedelectromagneticinterference,datarecordingcanbetemporarilydisturbed
orinterrupted.Thishasnoinfluenceonthevalidityoftheexistingrecordeddataanditssubsequentanalysis.

IncompliancewiththeEMCandelectromagneticenvironmentguidelineslistedinthisusermanual,no
restrictionofperformancecharacteristicsovertheentirelifeofthemedicaldeviceistobeexpected.

3.1. Guidanceandmanufacturer'sdeclaration–Electromagnetic
emissions
TheWalkFreeisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeroruser
oftheWalkFreemustensurethedeviceisusedinsuchasenvironment.



WalkFree
3.ELECTROMAGNETICCOMPATIBILITY(EMC)


9



InterferencemeassurementComplianceElectromagneticenvironment‐Guide
HFemissions(CISPR11)Group1
TheWalkFreeusesRFenergyexclusivelyforitsinternal
function.Therefore,itsRFemissionisverylowanditis
unlikelythatadjacentelectronicdeviceswillbedisturbed.
HFemissions(CISPR11)ClassB
WalkFreeissuitableforuseinallfacilities,includingthosein
theresidentialareaandthosedirectlyconnectedtothepublic
utilitynetwork,whichalsosuppliesbuildingsusedfor
residentialpurposes.
Transmissionsofharmonics
(IEC61000‐3‐2)
Notapplicable
(<75W)
Transmissionsofvoltage
fluctuations/flickertoIEC61000‐
3‐3
Notapplicable
(<75W)

3.2. Guidanceandmanufacturer'sdeclaration–Electromagnetic
immunity
TheWalkFreeisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeroruser
oftheWalkFreemustensurethedeviceisusedinsuchasenvironment.
Manufacturer’sdeclarationonelectromagneticimmunity

ImmunitytestsTestlevel
IEC60601‐1‐2:2014
ConformitylevelElectromagneticenvironment‐
Guidelines
Electrostaticdischarge
(ESD)
(IEC61000‐4‐2)
±8kVcontact
discharge
±2kV,±4kV,±8kV,
±15kVairdischarge
±8kVcontact
discharge
±2kV,±4kV,±8kV,
±15kVairdischarge
Floorsshouldbemadeofwoodor
concreteorwithceramictiles.Ifthe
floorisfittedwithsyntheticmaterial,
therelativehumidityshallbeatleast
30%.
Magneticfieldat
frequenciesof50/60Hz
(IEC61000‐4‐8)
150Hz(EN60601‐2‐47)
30A/m
50Hzor60Hz
30A/m
50Hzor60Hz
Magneticfieldsatthemains
frequencyshouldcorrespondtothe
typicalvaluesfoundinabusinessor
hospitalenvironment.WalkFree
doesnotcontainmagnetically
sensitivecomponentsorcircuit
elements.


WalkFree
3.ELECTROMAGNETICCOMPATIBILITY(EMC)


10



ConductedRF
disturbances
(IEC61000‐4‐6)





IrradiatedRF
disturbances
(IEC61000‐4‐3)
3Veff
0,15‐80MHz
6VeffinISMbands
between0,15and80
MHz
80%AMat1kHz

3V/m
80MHz–2,7GHz
80%AMat1kHz
Notapplicable







3V/m
80MHz–2,7GHz
80%AMat1kHz
Portableandmobileradiosshouldbe
usedatnodistancefromWalkFree,
includinglines,thanthe
recommendedprotectiondistanceof
30cm:

Supportforthemanagementofthe
EMenvironmentandmanagementof
medicaldevicesforEMC,including
evaluationoftheEMenvironment,
investigationandreportingofEMI
problemsandlocationselection,is
providedbytheAAMITIR18
guideline.

Disturbancesarepossiblein
theenvironmentofdevices
carryingthisimagesign.
NearfieldofwirelessRF
communicationdevices
385MHz–5,7GHz
9‐28V/m

385MHz–5,7GHz
9‐28V/m

Note1:At80MHzand800MHzthehigherfrequencyrangeapplies.
Note2:Theseguidelinesmaynotbeapplicableinallcases.Thepropagationofelectromagneticquantitiesisinfluenced
byabsorptionsandreflectionsofbuildings,objectsandhumans.
Note3:Table9ofIEC6100‐2‐1:2014givesalltestfrequenciesandimmunitylevelsforwirelessRFcommunication
devices.Informationisalsoprovidedtocalculatetheminimumprotectiondistancesdependingonthepower,
frequencybandandimmunitylevel.

ImmunityinthenearfieldofwirelessRFcommunicationdevices(IEC60601‐1‐2:2014,Table9)

Test
FrequencyBand1)
Service1)Modulation2)
Maximum
powerDistanceImmunity testlevel
Conformity
level
MHzMHzWmeter(V/m)(V/m)
385380‐390TETRA400Pulsmodulation2)
18Hz1,80,32727
450430‐470GMRS460,
FRS460
FM3)
±5kHzdeviation
1kHzsinus
20,32828
710
745
780
704‐787LTEBand13,
17
Pulsmodulation2)
217Hz0,20,399
810
870
930
800‐960
GSM800/900,
TETRA800,
iDEN820,
CDMA850,
LTEBand5
Pulsmodulation2)
18Hz20,32828


WalkFree
3.ELECTROMAGNETICCOMPATIBILITY(EMC)


11



1720
1845
1970
1700‐1900
GSM1800;
CDMA1900;
GSM1900;
DECT;
LTEBand1,3,
4,25;UMTS
Pulsmodulation2)
217Hz20,32828
24502400‐2570
Bluetooth,WLAN
802.11b/g/n,
RFID2450,
LTEBand7
Pulsmodulation2)
217Hz20,32828
5240
5500
5785
5100‐5800WLAN802.11a/nPulsmodulation2)
217Hz0,20,399
Note:Inordertoachievetheimmunitytestlevel,thedistancebetweenthetransmittingantennaandtheWalkFree
canbeshortenedto1mifnecessary.Thetestdistanceof1mispermittedinaccordancewithIEC61000‐4‐3.
1)Forsomeservicesonlytheuplinkfrequenciesareincluded.
2)Thecarrierismodulatedwitharectangularsignalwithatouchratioof50%.
3)Alternativelytofrequencymodulation,a50%pulsemodulationat18Hzcanbeused.Sincethisdoesnotcorrespond
tothecurrentmodulation;thiswouldbetheworstcase.




WalkFree
4.SYMBOLSANDLABEL


12



4. SYMBOLSANDLABEL
4.1. Explanationofthesymbols
SymbolDescription

CEmarking.ThedevicecomplieswiththerequirementsoftheEuropeanCouncilDirective93/42/EEC
formedicalequipmentfollowedbyNotifiedBody0633.

Manufacturerinformation.

JJJJ
Dateofproduction.Indicationoftheyearinwhichthedevicewasmanufactured.

Distributorinformation.
IP54BIPdegreeofprotectionagainstwater.

ClassificationoftheapplicationpartaccordingtoIEC60601‐1.Defibrillation‐protected
applicationpartoftypeBF.

Specialwastethatmaynotbedisposedofinnormalhouseholdwaste.Mustbedisposed
ofinanenvironmentallyfriendlymannerinaccordancewithlocalrules.

Instructionsforuse.


Deviceincludesradiotransmitter(Bluetoothmodule).

Serialnumber.

Batteryoperation.
SizeofbatteryAAAA.

<10kg
SuitableforECGrecordingsinchildrenwithabodyweightoflessthan10kg.


WalkFree
4.SYMBOLSANDLABEL


13




TemperaturerangeStorageandtransport.

Arearelativehumiditystorageandtransport.

AmbientairpressureStorageandtransport.

Keepitdry.

Avoiddirectsunlight.

Top.

Recycling.

4.2. Devicelabel









WalkFree
5.INTRODUCTION


14



5. INTRODUCTION
5.1. Purposeofthemanual
ThismanualreferstodevicesWalkFree.
Themanualrepresentsaguideforexecutionofthefollowingoperations:
Reasonableuseofthedeviceanduseofthefunctionkeys.
Preparationofthedeviceforuse(Section6)
Executionofatest(Section7).
Maintenanceandtroubleshooting(Section8).
5.2. Recipients
Thismanualisintendedforprofessionalhealthcareoperators.Theyarethereforepresumedtohavespecific
knowledgeofmedicalproceduresandterminology,asrequiredbyclinicalpractice.
It’sresponsibilityofthephysician,oroftheauthorizedpersonnelthatpreparesthepatienttoinformthe
patientabouthowtousethedevice,theoperationsheisallowedtoperformandtherelatedrisks(Par.2).
5.3. Intendeduse
WalkFreeisanECGHolterrecorderintendedforcontinuousmeasurementanddigitalstorageofECGsignals
duringthepatient’sdailyactivitiesaspartofalong‐term/HolterECG.Therecordeddataareusedtodiagnose
cardiacarrhythmias.
Therecordeddata,storeintheinternalmemoryofthedevice,isdownloadedfromWalkFreetoaPCina
medicalfacilityandevaluatedwithasuitableHolter‐EKGanalysissoftware.Therecordeddataaretransferred
tothePCthroughaUSBconnection.AdoctorevaluatesthenormalandabnormalECGdataforfurther
therapeuticmeasures.
Thedeviceisindicatedforuseinaclinicalsetting:hospitals,clinicsandoutpatientfacilitiesofanysize.Itis
alsosuitedforhomeuse.
ThedeviceisindicatedforcontinuouslyrecordingtheECGsignal.
Thedeviceisnotindicatedforuseasphysiologicalmonitoringofvitalsigns.
Thedevicemustnotbeusedontheopenheart.
Thedeviceisnotintendedastheonlymeansfordeterminingthediagnosis.
Thedeviceisindicatedforuseonadultandpaediatricpatients.
Thedeviceisindicatedforusebyaphysicianortrainedpersonnelactingonbehalfofanauthorised
physician.


WalkFree
5.INTRODUCTION


15



5.4. Descriptionofthedevice
TheWalkFreeisamedicaldeviceforlong‐termHolterECGdatarecordingwiththefollowingfeatures:
Nocablesnecessary.
Highwearingcomfortforthepatient.
Loweffortforcleaninganddisinfection.
Easyapplicationorremovaloftheadhesiveelectrode(s)viathreepushbuttons.
ContinuousrecordingofthreeECGsignalsupto9dayswithoutchangingthebattery.
Recordingofusual24h–48hHolterECGs.
Supportforeventmarkingbythepatient(e.g.incaseofsymptomsormedication).
SecureandsimpledatadownloadviatheintegratedUSBinterface.
Bluetoothinterfaceforpatient‐specificinitialisationofthedevice.
SupportofstandardizedECGdataformatssuchasMIT,ISHNE,EDF+.

Byusingdecentralisedsingle‐useelectrodesinconjunctionwithstate‐of‐the‐arthardwareandsoftware
technology,WalkFreeenablespermanentrecordingoflong‐termECGswellover24hwithveryhighsignal
qualityandatthesametimemaximumpatientcomfort.
Byeliminatingpreviouslycommoncablesandduetotheintegratedintelligence,WalkFreerequiresalmost
nooperationstepsandthusenables(especiallyforambulantapplicationswithelderlypatients)ECG
recordingswithoutaffectingpatientsintheirusuallivingenvironmentandqualityoflife.
Forthefirsttime,thisenablespracticable,efficient,andsafe“roundtheclock”long‐termECGrecordings.
Bysimplychangingthesingle‐useelectrodes,WalkFreecanbeusedasalong‐termrecorderforECG
recordingsupto9days.
Advantagesforthecardiologist
Simplestconfiguration,commissioningandapplication.
Securerecordingsbycable‐freetechnology;alsooverlongperiodsoftime(noloosecables,noloose
adhesiveelectrodes,andnobadelectrodecontacts).
ModularconceptenablesECGrecordingsovertheoreticallyunlimitedperiodsoftime.
Highsignalqualitybyeliminatingthecablesandderivationofthevectorsonthesmallestarea(low‐
artefact,low‐interferenceECGrecordings).
Lowpatientinstructioneffortforambulantrecordings.
Benefitsforthepatient
Noimpairmentofqualityoflifeandhabits.Afterashortwearingperiod,youdon'tnoticetheWalk
Freeanymore.
Simplestoperation/handlingbypatientsevenduringlongerrecordingperiods(onlynecessaryto
changetheelectrodes).



WalkFree
5.INTRODUCTION
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16
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Thedeviceincludes:
1. Recordermodule(WalkFree).
Itincludestheelectronicsformeasuringandstoringthe3ECGleads.

2. BatteriesAAAAsize.
Itisadisposablepartandmustbechangedaftereachexamination.

example
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3. Decentralisedsingleelectrodes.
Usingthreedecentralisedsingle‐useECGadhesiveelectrodestherecordermodulemeasuresand
calculatestheleads.Theelectrodesarealsoadisposablepart.

example
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4. PCinitialisationsoftware(DeviceWebManager)providedviaalinkwheredownloadit.
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5. PCmicroUSBcable
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