ELITONE CAD-1114 Manuale utente
RegainControl
–
RegainConfidence
UserManual
Visitelitone.com/start/ foradditionalinformation
andvideosaboutgettingstartedwithELITONE.
®
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OverviewofUserInterface.SeePage11forDetailedOperation
EitherButton
ON–TapOnce
(fromoff)
OFF–Hold2Seconds
Pause–TapOnce
(duringtreatment)
Treatment Light
SolidOrange
NoLight
BlinkingOrange
Contract
Relax
Paused
Intensity
Lights
TaptoDecreaseIntensity
GelPad
CablePort
Battery Light
Constant Green
BlinkingGreen
BlinkingRed
Constant Red
Charged
Charging
LowBattery
Error
TaptoIncreaseIntensity
USBChargingCablePort
(liftbluecover)
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Overview
TheELITONE®Device(ELITONE)allowscomfortable,convenient,andnon‐invasivetreatmentofstressurinary
incontinencebydeliveringelectricalmusclestimulationtothepelvicfloormusclesandsurroundingtissues.This
manualprovidescomprehensiveinstructionregardinguseofthedevice.Pleasereaditthoroughlyandcontact
Elidahifyouhaveadditionalquestions.
Restoringcontinencecanoftenbeachievedthroughstrengtheningweakenedpelvicfloormusclesandcalming
overactivebladdermuscles.Electricalmusclestimulationisatherapythatdeliversasmallelectriccurrentto
thepelvicfloormuscles.Electricalmusclestimulationhasbeenusedformorethanfortyyears;however,itis
traditionallydeliveredthroughavaginalprobe.Elidahunderstandsthatwomenprefernon‐invasivetherapies
and has developed ELITONE as a discreet, wearable solution that allows at‐home treatment and doesn’t
interferewithwomen’sbusyschedules.
Becauseincontinenceoftengetsworsewithage,startingandcontinuingtreatmentisimportantforbothyour
currentandlongtermhealth.Wehopethatyoufindthetreatmenteffectiveandthatitallowsyoutogetback
toafullyactivelifestyle.
‐TheElidahTeam
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Therapy
Typicaluseconsistsof20minutetreatmentsessions,4‐5timesperweek,duringwhichthepelvicfloormuscles
undergocomfortablecontractandrelaxcycles.After6‐12weeksofregularuse,incontinencesymptomsshould
reduce;however,everywoman’sbodyisdifferentandnoteveryonewillrespondtotreatmentinthesameway.
Consultyourhealthcareproviderregardingthebesttreatmentregimenforyou.Forbestresults,thesessions
should be spaced throughout the week and the intensity should beatthehighestlevelthatiscomfortably
tolerable.Intime,asyoubecomefamiliarwiththetreatment,youshouldstrivetoincreasetheintensitylevel.
Thepelvicfloormuscles,likeothermuscles,willatrophyifnotused.Aftercompleting6‐12weeksoftreatment,
somewomenbenefitfromoccasionalmaintenancesessionswithELITONE.
Indications,Contraindications,Warnings&Precautions
Indicationforuse:
ELITONEisanon‐implantedmusclestimulatordesignedtotreatstressurinaryincontinenceinwomen.Itapplies
stimulationtothepelvicfloormusclesandsurroundingtissues.
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Contraindications:
DoNOTuseifyouhave/are:
Pregnantorattemptingtobecomepregnant.Thesafetyofelectronicmusclestimulatorsduringpregnancy
hasnotbeenestablished.
Anelectronicimplant(e.g.cardiacpacemaker,implanteddefibrillator)orsufferfromheartproblems.
Cancer,epilepsy,orcognitivedysfunction.
Pelvicfloorsurgerywithinthelastsixweeks.
Completedenervationofthepelvicfloor.
Historyorsymptomsofurinaryretention,extra‐urethralincontinence,oroverflowincontinence.
Conductiveintra‐uterinedevices(IUD/Coil)ormetalimplantsintheabdominalorpelvicarea,includingthe
hipandlumbarspine.
Warnings/Precautions/AdverseReactions/Notes:
Readallinstructionspriortouse.Failuretofollowthesedirectionsmayresultinpersonaldiscomfortor
injury,ordamagetothedevice.
Thelong‐termeffectsofchronicmusclestimulationareunknown.
Thedeviceisintendedforindooruseonly.
ExposureoftheControllertoliquidsmay resultinpersonal injuryordamagetothedevice.Donotuse
whilebathing,swimming,orotherwisesubmerged.
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Consultyourhealthcareproviderpriortouseifyouarefewerthansixweekspostpartumorfewerthan
threemonthspost‐caesareansection.
Ifatissueirritation,allergicreaction,orburnoccursbeneaththeGelPad,discontinueuseimmediatelyand
contactyourhealthcareprovider.Somereddeningoftheskin,lastingforseveralhours,mayoccurunder
normaluse.
Discontinuetreatmentandconsultahealthcareproviderifyoufeellight‐headedorfaintwhileusingthe
device.
Useofequipmentshouldbediscontinueduponsignsoftreatment‐relatedstressordiscomfort.
Thedeviceshouldnotbeusedwhiledriving,operatingmachinery,oranyotheractivityinwhichinvoluntary
musclecontractionmayputtheuseratrisk.
UseonlywithELITONEGelPads.
UseonlywithELITONEGelPadCable.Usewithothercablescould result in increased electromagnetic
emissionsordecreasedelectromagneticimmunityandresultinimproperoperation.
TheGelPadisforsinglepersonuse.ReuseoftheGelPadbyanotherusercouldcausecross‐infectionof
skindisease.
OnlyapplytheGelPadasinstructed.ApplyingtheGelPadtoorinproximityofthechest,neck,head,face,
oreyescouldresultinseriousinjury.
DonotpoweronthedevicepriortoapplyingtheGelPadandconnectingittotheController.
OnlyapplytheGelPadtonormal,intact,clean,healthyskin.
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DonotplacetheGelPadoverorinproximitytocancerouslesions, open wounds,rashes, recentscars,
swollen,redinfectedorinflamedtissue,orskinthatissusceptibletoacne,thrombosisorothervascular
problems.
UsecautionifGelPadapplicationarealacksnormalsensation.
ReplacetheGelPadifitnolongersticksfirmlytotheskin.
DonotuseGelPadsortheGelPadCableiftheyhavevisibledamage.
DonotconnecttheGelPadsorGelPadCabletootherobjects.
Donotmodifyorattempttorepairthisdevice.
Donottouchthegel,metalstuds,orsnapswithyourfingerswhiletheControllerison.
Donotusemorethanonceperdayoratanintensitythatexceedsyourcomfortlevel.Treatmentshould
notcauseunduediscomfortormusclefatigue.
TurntheControlleroffbeforeremovingGelPad.
Keepdeviceoutofreachofchildrenandpets.ELITONEisforusebyadultsonly.
Donotattempttousethedevicewhileitischargingorconnectedtothechargingcable.
Donotusetheproductwhilesleeping.
Usethetoiletbeforestartingatreatmentsession.
Bestresultsmaybeachievedbyremoving/trimminghairfromtheapplicationsite.
Donotusethedevicewithanyotherproductwhichdeliverselectricalcurrenttothebody(e.g.muscle
stimulators,highfrequencysurgicalequipment)asthiscouldresultinburnsorotherinjury.
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Donotapplystimulationinthepresenceofelectronicmonitoringequipment(e.g.cardiacmonitors,ECG
alarms),whichmaynotoperateproperlywhenthedeviceisinuse.
Donotuseincloseproximity(e.g.1meter)toshortwaveormicrowavetherapyequipment,asthismay
produceinstabilityintheController’soutput.
Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones,basestations,andwalkie‐talkiescanaffectthisdevice.SeetheEMCInformationsectionof
thisUserManualforadditionalinformation.
Consultyourhealthcareproviderbeforeusingthedeviceif:
o Youhaveanyseriousillnessorinjurynotmentionedinthisguide.
o Youhaveanunderlyingneurologicalcondition(e.g.MultipleSclerosisorParkinson’sdisease).
o Youhaveatendencytohemorrhage,followingacutetraumaorfracture.
o Youtakeinsulinfordiabetes.
o Yousufferfrommuscleorjointproblems,includingpelvicpainoraparavaginaldefect.
o Yousufferwithsuspectedordiagnosedheartdisease.
o You underwent a recent surgical procedure and where muscle contraction may disrupt the healing
process.
o Youhaveanydoubtaboutusingthedevice.
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What’sintheBox
1.Controller(EC‐1003)
TheControllergeneratesatreatmentsignalthatissent
into your body, causing your muscles to contract and
relax. It includes intensity adjustment buttons, a user
display, a rechargeable battery, and connection points
fortheGelPadCableandChargingCable.
2.GelPad(EE‐1002,PackagedSeparately)
The patented GelPad lightly adheres to the skin and
allowsthetreatmentsignaltocomfortablypassthrough
yourmuscles.TheGelPadisthin,flexibleandshapedto
fityouranatomy.Ifstoredproperlyitcanbeworn
multipletimesbythesameuser.
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3.GelPadCable(EC‐1005,alsocalledPatientCable)
ThisreusablecableconnectstheGelPadtotheController.ItislongenoughtoallowtheControllertobeworn
atyourwaistorinyourpocket.
4.USBChargingCable(EA‐1007)
ThiscableisusedtorechargetheControllerbattery.ThesmallendofthecableisamicroUSB‐Bconnector,
whichfitsintothesideoftheController.TheotherendisaUSBTypeAconnector,whichfitsintoastandard5
voltUSBjack.
5.StorageCase(EA‐1004,Accessory)
ThecollapsiblecaseprovidesanelegantandconvenientwaytostoretheController,BeltClip,cables,andtear‐
offQuickReferenceGuide.Pullthesideflapsoutwardtokeepthecaseopen.
6.UserManual
ThisUserManualprovidescomprehensiveinstructionsregardingtheuseandmaintenanceofthedevice.Please
read it thoroughly. The tear‐off Quick Reference Guide within the box (not shown) provides abbreviated
instructionondeviceoperation.
BeltClip(EA‐1008,Accessory,Notvisible,attachedtoController)
TheremovableBeltClipallowseasyattachmenttoclothing.
Indice
