ELITONE CAD-1114 User manual

RegainControl
–
RegainConfidence
UserManual
Visitelitone.com/start/ foradditionalinformation
andvideosaboutgettingstartedwithELITONE.
 
®

2


 
OverviewofUserInterface.SeePage11forDetailedOperation
EitherButton
ON–TapOnce (fromoff) 
OFF–Hold2Seconds
Pause–TapOnce
(duringtreatment)
Treatment Light
SolidOrange
NoLight
BlinkingOrange
Contract
Relax
Paused
Intensity
Lights
TaptoDecreaseIntensity
GelPad
CablePort
Battery Light
Constant Green
BlinkingGreen
BlinkingRed
Constant Red
Charged
Charging
LowBattery
Error
TaptoIncreaseIntensity
USBChargingCablePort
(liftbluecover)

3
Overview
TheELITONE®Device(ELITONE)allowscomfortable,convenient,andnon‐invasivetreatmentofstressurinary
incontinencebydeliveringelectricalmusclestimulationtothepelvicfloormusclesandsurroundingtissues.This
manualprovidescomprehensiveinstructionregardinguseofthedevice.Pleasereaditthoroughlyandcontact
Elidahifyouhaveadditionalquestions.
Restoringcontinencecanoftenbeachievedthroughstrengtheningweakenedpelvicfloormusclesandcalming
overactivebladdermuscles.Electricalmusclestimulationisatherapythatdeliversasmallelectriccurrentto
thepelvicfloormuscles.Electricalmusclestimulationhasbeenusedformorethanfortyyears;however,itis
traditionallydeliveredthroughavaginalprobe.Elidahunderstandsthatwomenprefernon‐invasivetherapies
and has developed ELITONE as a discreet, wearable solution that allows at‐home treatment and doesn’t
interferewithwomen’sbusyschedules.
Becauseincontinenceoftengetsworsewithage,startingandcontinuingtreatmentisimportantforbothyour
currentandlongtermhealth.Wehopethatyoufindthetreatmenteffectiveandthatitallowsyoutogetback
toafullyactivelifestyle.
‐TheElidahTeam

4
Therapy
Typicaluseconsistsof20minutetreatmentsessions,4‐5timesperweek,duringwhichthepelvicfloormuscles
undergocomfortablecontractandrelaxcycles.After6‐12weeksofregularuse,incontinencesymptomsshould
reduce;however,everywoman’sbodyisdifferentandnoteveryonewillrespondtotreatmentinthesameway.
Consultyourhealthcareproviderregardingthebesttreatmentregimenforyou.Forbestresults,thesessions
should be spaced throughout the week and the intensity should beatthehighestlevelthatiscomfortably
tolerable.Intime,asyoubecomefamiliarwiththetreatment,youshouldstrivetoincreasetheintensitylevel.
Thepelvicfloormuscles,likeothermuscles,willatrophyifnotused.Aftercompleting6‐12weeksoftreatment,
somewomenbenefitfromoccasionalmaintenancesessionswithELITONE.
Indications,Contraindications,Warnings&Precautions
Indicationforuse:
ELITONEisanon‐implantedmusclestimulatordesignedtotreatstressurinaryincontinenceinwomen.Itapplies
stimulationtothepelvicfloormusclesandsurroundingtissues. 

5
Contraindications:
DoNOTuseifyouhave/are:
 Pregnantorattemptingtobecomepregnant.Thesafetyofelectronicmusclestimulatorsduringpregnancy
hasnotbeenestablished.
 Anelectronicimplant(e.g.cardiacpacemaker,implanteddefibrillator)orsufferfromheartproblems.
 Cancer,epilepsy,orcognitivedysfunction.
 Pelvicfloorsurgerywithinthelastsixweeks.
 Completedenervationofthepelvicfloor.
 Historyorsymptomsofurinaryretention,extra‐urethralincontinence,oroverflowincontinence.
 Conductiveintra‐uterinedevices(IUD/Coil)ormetalimplantsintheabdominalorpelvicarea,includingthe
hipandlumbarspine.
Warnings/Precautions/AdverseReactions/Notes:
 Readallinstructionspriortouse.Failuretofollowthesedirectionsmayresultinpersonaldiscomfortor
injury,ordamagetothedevice.
 Thelong‐termeffectsofchronicmusclestimulationareunknown.
 Thedeviceisintendedforindooruseonly.
 ExposureoftheControllertoliquidsmay resultinpersonal injuryordamagetothedevice.Donotuse
whilebathing,swimming,orotherwisesubmerged.

6
 Consultyourhealthcareproviderpriortouseifyouarefewerthansixweekspostpartumorfewerthan
threemonthspost‐caesareansection.
 Ifatissueirritation,allergicreaction,orburnoccursbeneaththeGelPad,discontinueuseimmediatelyand
contactyourhealthcareprovider.Somereddeningoftheskin,lastingforseveralhours,mayoccurunder
normaluse.
 Discontinuetreatmentandconsultahealthcareproviderifyoufeellight‐headedorfaintwhileusingthe
device.
 Useofequipmentshouldbediscontinueduponsignsoftreatment‐relatedstressordiscomfort.
 Thedeviceshouldnotbeusedwhiledriving,operatingmachinery,oranyotheractivityinwhichinvoluntary
musclecontractionmayputtheuseratrisk.
 UseonlywithELITONEGelPads.
 UseonlywithELITONEGelPadCable.Usewithothercablescould result in increased electromagnetic
emissionsordecreasedelectromagneticimmunityandresultinimproperoperation.
 TheGelPadisforsinglepersonuse.ReuseoftheGelPadbyanotherusercouldcausecross‐infectionof
skindisease.
 OnlyapplytheGelPadasinstructed.ApplyingtheGelPadtoorinproximityofthechest,neck,head,face,
oreyescouldresultinseriousinjury.
 DonotpoweronthedevicepriortoapplyingtheGelPadandconnectingittotheController.
 OnlyapplytheGelPadtonormal,intact,clean,healthyskin.

7
 DonotplacetheGelPadoverorinproximitytocancerouslesions, open wounds,rashes, recentscars,
swollen,redinfectedorinflamedtissue,orskinthatissusceptibletoacne,thrombosisorothervascular
problems.
 UsecautionifGelPadapplicationarealacksnormalsensation.
 ReplacetheGelPadifitnolongersticksfirmlytotheskin.
 DonotuseGelPadsortheGelPadCableiftheyhavevisibledamage.
 DonotconnecttheGelPadsorGelPadCabletootherobjects.
 Donotmodifyorattempttorepairthisdevice.
 Donottouchthegel,metalstuds,orsnapswithyourfingerswhiletheControllerison.
 Donotusemorethanonceperdayoratanintensitythatexceedsyourcomfortlevel.Treatmentshould
notcauseunduediscomfortormusclefatigue.
 TurntheControlleroffbeforeremovingGelPad.
 Keepdeviceoutofreachofchildrenandpets.ELITONEisforusebyadultsonly.
 Donotattempttousethedevicewhileitischargingorconnectedtothechargingcable.
 Donotusetheproductwhilesleeping.
 Usethetoiletbeforestartingatreatmentsession.
 Bestresultsmaybeachievedbyremoving/trimminghairfromtheapplicationsite.
 Donotusethedevicewithanyotherproductwhichdeliverselectricalcurrenttothebody(e.g.muscle
stimulators,highfrequencysurgicalequipment)asthiscouldresultinburnsorotherinjury.

8
 Donotapplystimulationinthepresenceofelectronicmonitoringequipment(e.g.cardiacmonitors,ECG
alarms),whichmaynotoperateproperlywhenthedeviceisinuse.
 Donotuseincloseproximity(e.g.1meter)toshortwaveormicrowavetherapyequipment,asthismay
produceinstabilityintheController’soutput.
 Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones,basestations,andwalkie‐talkiescanaffectthisdevice.SeetheEMCInformationsectionof
thisUserManualforadditionalinformation.
 Consultyourhealthcareproviderbeforeusingthedeviceif:
o Youhaveanyseriousillnessorinjurynotmentionedinthisguide.
o Youhaveanunderlyingneurologicalcondition(e.g.MultipleSclerosisorParkinson’sdisease).
o Youhaveatendencytohemorrhage,followingacutetraumaorfracture.
o Youtakeinsulinfordiabetes.
o Yousufferfrommuscleorjointproblems,includingpelvicpainoraparavaginaldefect.
o Yousufferwithsuspectedordiagnosedheartdisease.
o You underwent a recent surgical procedure and where muscle contraction may disrupt the healing
process.
o Youhaveanydoubtaboutusingthedevice.

9
What’sintheBox
1.Controller(EC‐1003)
TheControllergeneratesatreatmentsignalthatissent
into your body, causing your muscles to contract and
relax.  It includes intensity adjustment buttons, a user
display, a rechargeable battery, and connection points
fortheGelPadCableandChargingCable.
2.GelPad(EE‐1002,PackagedSeparately)
The patented GelPad lightly adheres to the skin and
allowsthetreatmentsignaltocomfortablypassthrough
yourmuscles.TheGelPadisthin,flexibleandshapedto
fityouranatomy.Ifstoredproperlyitcanbeworn
multipletimesbythesameuser.

10
3.GelPadCable(EC‐1005,alsocalledPatientCable)
ThisreusablecableconnectstheGelPadtotheController.ItislongenoughtoallowtheControllertobeworn
atyourwaistorinyourpocket.
4.USBChargingCable(EA‐1007)
ThiscableisusedtorechargetheControllerbattery.ThesmallendofthecableisamicroUSB‐Bconnector,
whichfitsintothesideoftheController.TheotherendisaUSBTypeAconnector,whichfitsintoastandard5
voltUSBjack.
5.StorageCase(EA‐1004,Accessory)
ThecollapsiblecaseprovidesanelegantandconvenientwaytostoretheController,BeltClip,cables,andtear‐
offQuickReferenceGuide.Pullthesideflapsoutwardtokeepthecaseopen.
6.UserManual
ThisUserManualprovidescomprehensiveinstructionsregardingtheuseandmaintenanceofthedevice.Please
read it thoroughly.   The tear‐off Quick Reference Guide within the box (not shown) provides abbreviated
instructionondeviceoperation.
BeltClip(EA‐1008,Accessory,Notvisible,attachedtoController)
TheremovableBeltClipallowseasyattachmenttoclothing.

11
ControllerUserInterfaceOverview

 
EitherButton
ON–TapOnce (fromoff) 
OFF–Hold2Seconds
Pause–TapOnce
(duringtreatment)
TreatmentLight
SolidOrange
NoLight
BlinkingOrange
Contract
Relax
Paused
Intensity
Lights
TaptoDecreaseIntensity
Patient
CablePort
BatteryLight
Constant Green
BlinkingGreen
BlinkingRed
Constant Red
Charged
Charging
LowBattery
Error
TaptoIncreaseIntensity
USBChargingCablePort
(liftbluecover)

12
Operation
1. EnsureBatteryisCharged
Press either button to check the battery status.  If
batteryoutlineblinksredordoesnotlight,chargethe
batterypriortouse.Lifttheblueflapandconnectthe
USBChargingCabletothesideofControllerandaUSB
powersupply.Thebatterylightwillblinkgreenwhile
chargingandturnsolidgreenwhenfullycharged.The
devicecannotbeusedwhenthebatteryisloworwhile
charging.RemovetheUSBChargingCablepriortouse.
The fully charged device can deliver at least two
treatment sessions, depending on the selected
intensity level and frequency of use.  See Technical
Specifications for information regarding appropriate
useofUSBpowersupplies.
2. ConnectGelPadCabletoGelPad
WithControllerturnedoff,snaptheGelPadCabletothe
GelPad.
SnapGelPad Cable
to GelPad
PeelLiner
fromGelPad
Constant Green
–
FullyCharged
BlinkingGreen–Charging
BlinkingRed
–
LowBattery

13
3. PositiontheGelPad
Peelthelinerfromgelsurfaceandsaveforlateruse.Placethestickygelsurfaceonskinasshowninthe
figures.Thetopportionshouldbelowonthepubicbonearea.Firmlypressandensurethatallfoursticky
regionsareadheredtotheskin.Note:initially,youmayneedtoreadjusttounderstandthebestplacement
forstrongestcontractionsonyourbody.WearingunderwearovertheGelPadmayhelpkeepitadheredto
theskin.

14
4. ConnectGelPadCabletoController
ConnectthecylindricalendoftheGelPadCabletothe
bottomoftheController.
5. BeginTreatmentSession/TurnON
 Turn device on by tapping either button.  The solid
greenlightindicatesthatthedeviceison.
 Keeptappingtheincrease[+]anddecrease[‐]buttons
to adjust the intensity level until you feel strong
tolerablemusclecontractions.Thereare35intensity
levels.
 Thebluelightchangeswithevery5intensitylevels.
Thefirstlight correspondstolevels 0‐4,thesecond
lighttolevels5‐9,andsoon.
 After 4 seconds without further adjustment the
devicebeginscyclesof6secondsofstimulation(solid
orangetreatmentlighton),followedby6secondsof
rest(orangetreatmentlightoff).
Decrease
Intensity

5x
35Levels
Increase
Intensity

5x

15
 [Optional]SecuretheControllertounderwearorclothingusingthe
BeltClipandresumenormalactivity.Note:somewomenfeel
strongercontractionsiftheysitdownduetotheelectrodebeing
pressedagainstthebody.
6. PauseorAdjustTreatment
 Duringtreatmenttapeither[+]or[‐]topausetreatment.The
orangetreatmentlightwillblink.
 Tap[+]or[‐]againtoresumetreatmentand/oradjustintensity.For
comfort,thetreatmentautomaticallyresumesatalowerintensity.
 Thedevicewillturnoffafter30secondsinpausemodeifno
additionalbuttonsarepressed.
7. FinishTreatment/TurnOFF
 Thedevicewillautomaticallyturnoffafterthe20minute
treatmentsession.Threeshortburstssignaltheendof
treatment.
 Alternately,turnoffthedevicebyholdingeither[+]or[‐]fortwo
seconds.Thiswillendthetreatment.
Adjust Treat
Pause
Ta
p
Ta
p

Wait
Constant Orange
–
Contract
Off–Relax
BlinkingOrange‐Paused
Beltclip
Facesout

16
 DisconnecttheGelPadCable.
 GentlypeeloffGelPad.
 PlacetheGelPadonthecorrectsideoftheliner
andresealitinthestoragebagtopreventitfrom
dryingout.
 StoreControllerandcablesinthestoragecase.
FrequentlyAskedQuestions
Q: Whatdoesthetherapyfeellike?
A: WomenreportatinglingsensationwheretheGelPadcontactstheskin.Internallyyouwillfeeltightening,
andpossiblyaraisingofthepelvicfloormuscles.YoucontroltheintensitywiththeController,sosetittoa
tolerablelevel.Thetreatmentshouldneverbepainful(see“Troubleshooting”).
Q: ShouldtreatmentfeellikeKegelexercises?
A: SomewomenreportsimilaritiestoKegelexercises,butnotalldo.Togetastrongmusclecontractiontry
movingtheGelPadslightlyforwardorbackward.Alsotrysittingduringtreatment,whichforcestheGelPad
intomoredirectcontactwiththeskin.
PullFlaps
Outward

17
Q: ShouldIdoKegelexercisesatthesametime?
A: SomestudiesreportthatperformingKegelexerciseswhilereceivingmusclestimulationprovidesbenefits,
butdoingsoisnotarequirement.
Q: DoIneedtoshave?
A: ThegelusedintheGelPadisdesignedforcomfortableremovalinthepresenceofsomepubichair.Ifyou
believetheGelPadisnotmakingfullcontactwithyourskin,trimmingsomehairmayimproveperformance
(see“Troubleshooting”).
Q: HowmanytimescanIreusetheGelPadandhowwillIknowwhentoreplaceit?
A: IfstoredinthesealablepouchtheGelPadshouldlast3treatments.ReplacetheGelPadifyounoticea
reduction in adhesiveness or the intensity of muscle contraction, or for cleanliness (see “Caring for the
Product”).
Q: CanIuseELITONEwhileonmyperiod?
A: Youmayusethedevicewithatampon,oryoumaywanttowaituntilalighterflowday.
Q: CanIusethiswhileusingotherelectronicdeviceslikeamobilephone?
A: You can operate common electronic devices like phones and computerswhilewearingELITONE.See
“Indications,Contraindications,Warnings&Precautions”forspecificuselimitations.

18
Q: CanIuseELITONEifIhaveametalimplant?
A: See“Indications,Contraindications,Warnings&Precautions”andconsultyourhealthcareproviderbefore
usingELITONE.
Q: HowsoonafterchildbirthcanIuseELITONE?
A: See“Indications,Contraindications,Warnings&Precautions”andconsultyourhealthcareprovider.
Q: Mymusclesaretired/weakafteruse.Isthisnormal?
A: Yes.Aswithanyexercise,yourmusclesmaybeweak/tiredforadayafteruse,andyoumayleakmore
immediatelyafterwards.IfyouarenewtoELITONEwerecommendstartinguseatarelativelylowlevelof
musclecontraction.Then,asyoubecomefamiliarwiththetreatment,increasethetreatmentintensity.We
alsorecommendspacingapartyourtreatmentsthroughouttheweektoallowadequaterecoverytime.
Q: Myskinisnumbafteruse.Isthisnormal?
A: Somenumbingoftheapplicationsiteisnormal.Ifnumbnesspersistsconsultyourhealthcareprovider.
Q: CanIadjusttheintensitymid‐treatment?
A: Yes,increasingordecreasingtheintensityisatyourcontrol,butatnotimeshouldthedevicecausepain.
Somewomenreportminornumbingattheapplicationsiteafterafewminutesandthatthisallowsthemto
increasetheintensityduringtreatment.

19
Q: IfIusethedevicemoreoftenwillIgetbetterfaster?
A: Typical treatment regimens consists of a single 20 minute session, 4‐5 times per week.  More use may
providefasterimprovement,butoverusemayfatiguethepelvicfloormusclesandreducethetreatment
benefits.Consultyourhealthcareproviderbeforeaddingadditionaltreatmentsessionsorincreasingthe
treatmentlength.
Q: Whyistheresuchawiderangeinrecommendedtreatmentduration(6‐12weeks)?
A: Howquicklyyourespondtothetreatment,andthereforehowlongyoushouldcontinue,dependsonfactors
including your symptom severity, the treatment intensity (higher is better), your compliance with the
recommended4‐5sessionsperweek,andyourphysiology.

Q: Myskinisredafteruse.Isthisnormal?
A: Somerednessattheapplicationsiteisnormalduetoincreasedbloodflow.Theskinshouldreturntonormal
appearanceafter1‐2hours.Ifrednesspersistsconsultyourhealthcareprovider.
Q: Doesonesizefitall?
A: TheGelPadisdesignedtofitawiderangeofbodytypes.PositioningthetopoftheGelPadlowonthepubic
bonemattersmorethanpositioningthebackpartinaspecificlocation.


20
Q: Ifeelatighteninginmybutt/anus.Isthisnormal?
A: Some tightening in thebutt/anus is normal.  More important isthat youare feeling musclecontraction
aroundtheurethra.Ifnot,shifttheGelPadforward.
Q: DoesELITONEstimulatetheclitoris?
A: No.TheGelPadisnotdesignedtocontacttheclitorisandshouldnotprovideclitoralstimulation.

Q: WhatisthetwosecondofpulsingIfeelattheendofeach6secondsofstimulation?
A: Thatpartofthestimulationisintendedtorelaxthebladderandmaytreaturgeincontinencesymptoms.

Q: HowisthisdifferentfromageneraluseTENSorelectricalstimulationdevice?
A:TheELITONEGelPadisspecificallydesignedtoalloweasyandaccurateplacementthattargetsthepelvic
floormusclesthroughasingleelectrode.Also,theControlleroutputsa“modulated”stimulationthat
allowsstimulationtocomfortablypassthroughtheskinandeffectivelycontractthepelvicfloormuscles.

Seeelitone.com/faqs/forresponsestoadditionalquestions