Perfect PFEPelvic Floor Exerciser

INSTRUCTIONS FOR USE

READ CAREFULLY BEFORE USE

1 Introduction 12 Isthisproductrightforyou? 13 Contraindications,WarningsandCautions 24 Controls and Display 75 LeadsAlarm 116 Programmes 117 Contents 148 Settingup 159 Preparingforyourtrainingsession 1710 Training 1911 Afteryourtrainingsession 2212 Cleaning 2313 FAQs 2314 AnalProbe 2515 BatteryRemovalandReplacement 2716 Helpline 2817 Troubleshooting 2818 ConsumablesandServicing 3119 PelvicFloorExercises 3220 Guarantee 3721 WEEE 3822 GeneralSpecifications 3923 Electromagneticinterference 42

CONTENTS

Section Page No.

1.INTRODUCTIONThe Perfect PFEisapoweredmusclestimulatorusedforstrengtheningthepelvicfloormuscles.Itsendsagentlestimulation(similartoyournaturalnerveimpulses)directtoyourpelvicfloormusclesthroughavaginalProbewithstainlesssteelelectrodes.Thesesignalsmakeyourpelvicfloormusclecontract.Ifyouhaveforgottenhowtocontractyourpelvicfloor,arehavingtroublegettingmuscleresponse,orsimplywanttobringbacktheconditionofyourpelvicfloormuscles,the Perfect PFE can work them for you to build up their strengthandhelpyoutodevelopyourownmusclecontrol.Itperfectlycomplementspelvicfloorexercises.The Perfect PFEisveryeasytouse,withfourclearlylabelledpre-settrainingprograms,afifthprogrammeforpelvicpainandsimplepushbuttoncontrol.

2.ISTHISPRODUCTRIGHTFORYOU?Therearethreetypesofincontinence:Stress,Urge and Mixed.

Stress IncontinenceIfyouleakurinewhenyoucough,sneeze,laugh,strainormakesuddenmovements,thisiscalledStressIncontinence.

Itisparticularlycommoninwomenwhohavehadanatural childbirth and occurs when the bladder neck and the other mechanisms that act to hold urine in the bladderarenotworkingproperly.Themostcommoncauseisaweakpelvicfloor.

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Urge Incontinence describesanover-activebladder.Apersonmayexperienceastrongandsuddenurgetogotothetoiletbutarenotalwaysabletoholdon,orhavetogosofrequentlythatitbecomesinconvenient.

Mixed Incontinence isacombinationofbothStressandUrgeIncontinence.

Chronic Pelvic Pain can be due to a number of causes suchas:Vulvodynia,SymphasisPubis,orInterstitialCystitis.LowfrequencystimulationencouragesthereleaseofEndorphins–yourbody’snaturalpainreliefmechanism–toreducepainwithoutsideeffects.

3.CONTRAINDICATIONS,WARNINGSANDCAUTIONSCONTRAINDICATIONS• Do not useifyouarepregnantorattemptingtobecomepregnant.It is not known whether electrical stimulation may affect foetal development.• Do not usewiththeoptionalself-adhesivepadsifyouhaveacardiacdemandpacemakerorimplanteddefibrillatororhaveaheartrhythmproblem.Stimulation in the direct vicinity of a pacemaker may affect some models. Stimulation on the front of the neck can affect your heart rate. Very strong stimulation across the chest may cause an extra heartbeat.

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• Do not useifyouhavesymptomsofactiveurinarytractinfection,vaginalinfections,orlocalizedlesions.Introducing the probe may irritate sensitive tissue. • Do not useifyouhavepoorsensationinthepelvicregion.You may not be able to control the intensity ofstimulation safely.• Do not useifyouhavecognitivedisabilities,i.e.;Alzheimer’sdiseaseordementia.• Do not use if you are unable to properly insert the vaginalprobe.If you have a severe prolapse, or any discomfort occurs when inserting the probe, consult your medical advisor before use.• You must be 6 weeks post pelvic surgery or vaginal childbirth to use this device. Stimulation may disrupt the healing process.

Inthismanual: A Warningisusedwhenfailuretofollowtheinstructionsmayresultinseriousinjuryordeath.

A Cautionisusedwhenfailuretofollowtheinstructionsmayresultinaminorormoderateinjury,ordamagetothedeviceorotherproperty.

Notesareusedtoprovideclarificationorrecommendation.

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WARNINGS: Warning:Thedeviceshouldnotbeusedwhile walking,driving,operatingmachinery,oranyotheractivityinwhichinvoluntarymusclecontractionmayputyouatriskofinjury.Warning:Ifyouhaveactivecancer,consultwith your clinician before use due to concerns forstimulationpotentiallyspreadingcancerouscells. Warning:Cautionshouldbeusedifyouhave suspected or diagnosed epilepsy as electrical stimulationmayaffectseizurethreshold. Warning: Cautionshouldbeusedifyouhavea bleedingdisorderasstimulationincreasesblood flowtothestimulatedregion.

CAUTIONS:Caution:ThePerfectPFEvaginalprobeisintendedforsinglepatientuseonly.DonotshareyourPerfectPFEprobewithanyoneelse.Impropertreatmentorcross-infectionmayoccur.Caution:Iftissueirritationoccurs,discontinuetreatmentimmediately.Askyourcareproviderforadvicebeforecontinuingfurthertreatmenttopreventinjury.Caution:Itisimportantthatthevaginalprobeiscleanedaftereachuse.Ineffectivecleaningmayleadtoirritationorinfection.

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Caution:NeverinsertorremovethevaginalprobeunlessthecontrolunitispoweredOFFasinsertionorremovalwhenstimulationisactivemaycausediscomfortortissueirritation.Caution: Do not use a silicone based lubricant on thestimulationcontactsoftheprobeasitmaydecreasetheeffectivenessofPerfectPFE’smusclestimulation.Caution:Strongelectromagneticfields(electrosurgery/microwavecookers/mobilephones)mayaffectthecorrectoperationofthisunit-seesection23.Ifitappearstobehaveunusually,moveitawayfromthesedevices.Caution: The stainless steel in the Probe electrodes containssomeNickel.ThiscouldcauseareactionifyouhaveaNickelallergy.Caution:Donotusethisdevicewithvaginalprobeorself-adhesiveelectrodesotherthanthoserecommendedbythemanufacturerinsection18.Electrodeswithsmallersurfaceareamaycausetissueirritation. Caution: PerfectPFEmayinterferewithpatient monitoring equipment with body-worn electrodepads. Caution:Simultaneousconnectiontohigh frequency surgical equipment may result in burnsanddamagetothestimulator.

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Caution: Notsuitableforchildrenunder5yearsofage.Longcord-riskofstrangulationininfants.

TOKEEPYOURDEVICEINGOODWORKINGORDER,OBSERVETHEFOLLOWINGADDITIONALCAUTIONS

Donotimmerseyourunitorvaginalprobeinwaterorplaceitclosetoexcessiveheatasthismaycauseittoceasetooperatecorrectly.

Donotattempttoopenuptheunit.Thismayaffectthecorrectoperationoftheunitandwillinvalidatetheguarantee.

Donotmixold,newordifferenttypesofbatteriesasthismayleadtobatteryleakageorlowbatteryindication.

KeeptheunitawayfromsourcesofhighmagneticfieldssuchasTV’S,microwaveovensandhi-fispeakers,asthesemayaffecttheLCDscreen.

Keepthedeviceawayfromafireplaceorradiantheater,astheheatmayaffectthedevice.

Keepthedeviceawayfromnebulizerorsteamkettle,asthemoisturemayaffectthedevice.

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4.CONTROLSANDDISPLAY

ON

OFF

Strength DOWN

Programme Type

Timer

Programme Duration(minutes)Keypad

Lock Strength (mA)

ProgrammeSelector

Strength UP

Keepthedeviceawayfromsunlight,aslong-termexposuretosunlightmayaffecttherubbercausingittobecomelesselasticandcrack.

Keepthedeviceawayfromlintanddust,aslong-termexposuretolintordustmayaffectthesocketsorcausethebatteryconnectortodevelopabadcontact.

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ON ButtonToswitchuniton:Press and hold down for at least 3 seconds.

One Touch Memory StartWhenswitchedontheunitwillautomaticallystart in the programme which was being used whenitwasswitchedoff.Thestrengthreturnsto50%ofthelevelthatwasbeingusedwhentheunitwasswitchedoff.To stop the increase in strength during start up,pressanykeyonce.

OFF ButtonToswitchunitoff:Press▼buttontoremovekeypadlock.PressandholdOFFbuttonforat least 3 secondsandtheunitwillswitchoff.NOTE:AlwayscheckunitisOFFbeforeapplyingorremovingprobeorpads.

Strength UP ButtonToincreasestrength:Pressandholddownuntilrequiredstrengthisachieved.Pressandreleasetoincreaseinsinglesteps.TheunitwillremainintheWORKpartofthecyclefor5secondswhileintensityisbeingadjusted.

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Strength DOWN ButtonTodecreasestrength:Holddownbuttonandstrengthwilldecreasesteadily.Pressandholdtorelease Keypad Lock.

Programme ButtonThe Perfect PFEhasfivepre-selectedprogrammes.WhenyouFIRSTswitchon,theunitautomaticallygoestoprogrammeSTRES.Nexttimeitisswitchedonitwilldefaulttotheprogrammelastused.Eachtimethe‘P’buttonispressedandreleasedtheprogrammechanges.Thescreenwillshowtheprogrammeselected.

Timer Button Theprogrammesdefaultto20minutesor C-Continuous.Tosetadifferenttime,setthestrengthtozero.Press‘T’andthe‘min’ displaywillflash.Adjustthetimeusingthe▲▼buttons:C,10,20,30,45,60,90Press‘T’againtoturnoffTimerselect.

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Usage MemoryThe Perfect PFE remembershowmanytimesithasbeenuse,andforhowlong.

Press‘T’and▼togetherfor3secondstodisplayusagememoryRepeattoreturntomainscreen.

Press‘T’ and OFF togetherfor3secondstoresetmemorytozero

LOW BATTERYAnemptybatterysymbolwillshowwhenyouneedtochangethebatteries.Theunitwillshutdownapproximately2minutesafterthis.

KEYPAD LOCK

Note: If you do not press any keys for 30 seconds the keypad will lock so that only the ▼ key will work. This is to avoid accidental changes in settings. To unlock, press and hold the ▼ key.

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5.LEADSALARM The Perfect PFE monitorstheconnectionandthecontactbetweenyouandtheprobe,orthepads.If either of these goes outside of a standard range while thestrengthisabove20,theunitwillflash“LEADS”,bleepthreetimes,andreturnthestrengthtozero.Checktheleadandifnecessary,lubricatetheprobewithawaterbasedpersonallubricatinggel.Pleaseseesection17formoretroubleshootingtips.

6.PROGRAMMESThe Perfect PFEhasfivepresetprogrammes.Oneforeachtypeofincontinence(‘Stress’,‘Mixed’and‘Urge’),onefortoningofthepelvicfloormuscles(‘Tone’),andoneforchronicpelvicpain(‘Pain’).

STRESSINCONTINENCE:Shownonthescreenas:“STRES”.

TheSTRESSincontinenceprogrammestrengthensthemusclesofthepelvicfloorusinggentlestimulation.Oncethesemusclesarestrongertheyarebetterable to resist urinary leakage caused by

externalpressurebeingappliedtothebladdersuchaswithacough,sneezeorphysicalexertion.

Note: Do not use a silicone based lubricant on the stimulation contacts of the probe as it may decrease the effectiveness of the Perfect PFE’s stimulation.

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Thestimulationcausesthemusclestocontractandwork.Thisbuildstheirstrength.Likeotherfitnesstraining,successfultreatmentrequiresstimulationonceadayforonetothreemonths.Improvementstartsbecomingapparentafteraboutfourweeks.Ithelpstokeeparecord of leakage problems so that you can measure this improvement.

Thesensationislikeastrongdrawinginofthemusclesofthevagina,pullingupthepelvicfloor.Yournaturalreactionwillbetopullyourmusclesinandup,andthisexercisesandstrengthensthem.

URGEINCONTINENCE:Shownonthescreenas:“URGE”.TheURGEprogrammeworksinadifferentwaytotheSTRESSprogram.Thegentlecontinuousstimulationsoothesthebladder(detrusor)muscle,reducingitsinvoluntarycontractions.Thispreventstheunwantedandunexpectedemptyingofthebladder.Successfultreatmentrequiresstimulationonceadayandimprovementscansometimesbeseeninaslittleastwoweeks.Thesensationisasofter,vibrating,stimulation.Neverthelesswhentheprogrammefinishesandyourpelvicfloor

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relaxes,itwillbecomeapparenthowmuchyourpelvicfloorhasbeenexercised.

MIXEDINCONTINENCE:Shownonthescreenas:“MIXED”. ThisprogramissuitableifyouaresufferingfrombothStressandUrgeincontinence.ItisacombinationoftheSTRESandURGEprograms.

Thefirst10minutesusestheURGEprogramtoreducesensitivity,theninthesecond10minutes,theSTRESprogramexercisesthepelvicfloormuscles.Youmay need to increase the strength in order tofeelthemusclecontractionwhentheSTRESprogramstarts.

TONE:Shownonthescreenas:“TONE”.

Havingrestoredyourpelvicfloormusclestoanexcellentconditionyouwillwanttokeepthemtonedandstrong.Regularuseofthisprogramme,abouttwiceaweek,willensurethatyourmusclesremainfit

andtoned.TheTONEprogrammemayalsobeusedasanalternativetreatmentforSTRES.ThesensationwhenusingtheToneprogrammeisamixtureofastrongdrawinginofthemusclesandthenreleasing.

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Astrongandfitpelvicfloormusclemayincreasesexualhealthandenjoyment.

PAIN: Shownonthescreenas:“PAIN”. The PAIN programme can be used to alleviatechronicpelvicpainfrommany causes.AswithallTENS,itdoesnottreat theunderlyingconditionandyoushouldobtain a professional diagnosis of the cause before startinguse.Itgivesaconstantsoothingtinglingsensation.UsewiththeLibertyLoopvaginalelectrodeforatleast40minutestwoorthreetimesaweek.Setthestrengthashighasyoucanwhileremainingcomfortable.

7.PACKCONTENTS•“PerfectPFE”continencestimulator•LibertyLoopvaginalprobe(X-VPL)•ConnectingLeadwires(L-CPT)•2x1.5vAAbatteries•Instructionbooklet• Transit pouch

 

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8.SETTINGUPPreparing your Perfect PFEforuseisverysimple.

1)Insertbatteries

i)Removebeltclipby sliding down

ii)Removebatterycoverbypulling on tag

iii)Insertbatteries

Ensurethatthebatteriesareinsertedtherightwayasshowninbatterycompartmentandthattheribbonisbehindthem.

2)Pressandholdthe‘ON’buttonforatleastthree seconds.Thedisplayshouldappear.

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3)Inserttheleadwireplugintothebaseoftheunit.

4)ConnecttheleadfromthebaseoftheunittotheleadintheProbe.

5)YourPerfect PFEisnowreadyforuse.

6)Youcanswitchthecontrolunitoffatanytimebypressingandholdingthe“OFF”button.The“OFF”buttonisthebottomleftbuttononthecontrolunitkeypad.

Caution: Ensure the control unit is switched OFF by holding down the OFF button before use.

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9.PREPARINGFORYOURTRAININGSESSION

1)BeforeusingyourPerfect PFE Pelvic Floor Muscle Stimulator you will need to visitthebathroomandyoumaywanttolubricate the Probe with a water-based personallubricatinggelorwater,althoughthisisn'talwaysnecessary.

2)Chooseacomfortableposition,suchasleaning back or lying down on your bed withyourkneesraised.3)InserttheProbeintothevagina,inthesamewayasyouwouldatampon,untilonlytheplasticrimatthebaseoftheProbeisvisible.

4)EnsurethattheProbeisalignedsothatthecontactplates are to the sides and the longer sides of the positioningendrimarevertical.

Caution: Ensure the control unit is switched OFF by holding down the OFF button.

Caution: Do not use a silicone based lubricant on the stimulation contacts as it may decresase theeffectiveness of Perfect PFE’s muscle stimulation.

Contact PlatePositioning End Rim

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5)TheLibertyLoopprobehasapointerattachmentwhichenablesyoutovisuallymonitorthesuccesfullnessofyourpelvicfloorcontractions(theprobecanbeusedwithoutthepointer). •Whenperformed correctly, the pointerwillmovedownwards.•Whenperformed incorrectly, the pointer willmoveupwards. Thepointerdemonstratesthestrengthanddurationofeachcontraction,whethercausedbystimulationorperformedmanually.Forexample,weakcontractionsaredefinedbylittleornomovementinthepointer. Assemblethepointerandattachtotheprobeasfollows:

6)IfusingoptionalpadsforUrge,placethepadseithersideofthespine,aslowaspossibleonthebuttocks.

1 2 3

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10.TRAININGSESSION

1)Pressandholdthe“ON”buttononthecontrolunitforat least 3 secondstoswitchthecontroluniton.

2)Whenswitchedon,in‘STRES’and‘TONE’programmestheunitwillgothroughanexerciseprogramfor4-5seconds,followedbyarestperiodof8-10seconds.

Thestrengthdisplayonthecontrolunitwillreduceto‘0’andflashduringtherestperiod.

3)Thecontrolunitwillautomaticallyselectthe‘STRES’programthefirsttimeitisswitchedon.Afterthatitwillautomaticallyselecttheprogramyouwereusingthelasttimeitwasswitchedoff.

4)Youcanselectfromthefivepresetprogrammes.Detailsinsection6willhelpyouidentifythebestprogramtosuityou.

To change between the programmes press the ‘programme’button,whichislabelled‘P’,inthecentreofthecontrolunitkeypad.

Caution: If tissue irritation occurs, discontinue treatment immediately. Ask your care provider for advice before continuing further treatment to prevent injury.

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5)Withtherequiredprogrammeselectedyoucannowadjusttheintensityofthemusclestimulationbypressingthestrengthup‘▲’button,onthetoprightofthekeypadorthestrengthdown‘▼’button,onthebottomrightofthekeypad,untilyoureachacomfortablelevel.

6) The strength required depends on the programmes you areusing.

Atlowerstrengthsettings,youmaynotfeelanysensationatall,thisdependsverymuchontheindividualandanypre-existingphysicalconditions,soslowlyincreasetheintensitybyrepeatedlypressingthe‘▲’buttonuntilyoubegintofeelthemusclesaroundyourvaginacontract.ForSTRESandTONEprogrammesthemuscleMUSTcontractinordertogiveabenefit.Increasethestrengthashighasiscomfortable,andthentakeitbackdownonestep.The‘URGE’and‘PAIN’programmesworkdifferently.Thereisnoneedtohaveacontraction.Thestrengthshouldbecomfortable,butalwaysremainnoticeable.Youmayneedtoincreaseitoverthecourseofthetreatment.

7)Ifthesensationbecomesuncomfortable,reducetheintensityusingthe‘▼’button.

8)Ifyouexperiencecramping,switchtheunitoffuntilthesymptomsgoawaythencontinuethesessionwiththe

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intensitysetatalowerlevel.The Perfect PFEcausesasensationwhichfeelslikeastrongdrawinginofthevaginaandpullingupofthepelvicfloor.Yournaturalreactionwillbetopullinandupwithyourmuscles.Thisexercisesandstrengthensthem.ForbestresultsintheSTRESSandMIXEDprogrammestrytocontractthepelvicfloormusclesalongwiththePerfect PFE,andtosustainthecontractionintotherestinterval.Ifpossible,linkthecontractiontoyourbreathinginordertogetintoagentlerhythm.

9)TheLCDdisplayshowsthestrengthyouareusing.Youshouldaimtoincreasethisoveranumberofdays.Butrememberthereisnohurry,soonlyincreasethestrengthofthestimulationasandwhenyouarecomfortableandreadytoprogress.

10)Thelengthofeachsessionisautomaticallysetto20minutes.The length of each session for muscle strengthening will also depend on your ability to contract and your resistancetofatigue.Becarefulnottooveruseearlyon,astheresultingachesmaynotbefeltuntilthenextday.

Caution: Session times longer than 20 minutes should only be used in URGE and PAIN programmes, or with advice from a medical professional.

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Ifyouexperiencecramping,youcanreducethesessiontimeto10minutesandalsoreducetheintensity.Tosetadifferenttime,setthestrengthtozero.Pressthetimerbutton‘T’andthe‘min’displaywillflash.Adjustthetimeusingthe‘▲’ or ‘▼’buttons.Press‘T’againtoturnoffTimerselect.

11.AFTERYOURTRAININGSESSIONWhenthetimerreacheszero,yoursessioniscompleteandtheunitturnsoff.

1)CheckthatthecontrolunitisOFF.Ifitisnot,holddowntheOFFbuttontoswitchoffthenremovetheprobefromyourvaginabyholdingthepositioningendrimandgentlypullingoutwards.Becarefulnottopullthewireasthismaydamageit. Ifyouareusingthepointer,detachthisfirstbeforeremovingtheprobe.

2)Washandthoroughlydrytheprobeandreturnittothestoragepouch.

3)ThePerfect PFEpelvicfloorstimulatorwillnotonlyimproveyourpelvicfloormusclesbutalsohelpyoutorecognisethecorrectsensationyouneedtofeelwhendoingyourKegelexercises(explainedinsection19).

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12.CLEANING

Followingeachuse,cleantheprobewitheitheranalcohol-freeantibacterialwipe or by washing in warm soapy water,rinseanddrythoroughly.DoNOTimmersetheprobeinwater. Clean the case of the unit and the lead wire inthesamewayatleastonceaweek.

13.FREQUENTLYASKEDQUESTIONS

HOWHIGHSHOULDISETTHESTRENGTH?

The Perfect PFEstimulatesthepelvicfloormuscles.Thesensationislikeastrongdrawinginofthemusclesofthevaginaandapullingupofthepelvicfloor.ThemuscleMUSTcontractinordertogiveabenefit.Increasethestrength as high as is comfortable and then take it back downonestep.Thelevelrequiredvarieswidelybetweenusers–evenuptothefullpoweroftheunit.

Clean after every use

MON

TUES

WEDS

THURS

FRI

SAT

SUN

Warning: ThePerfectPFEprobeisintendedforsinglepatientuseonly.DonotshareyourPerfectPFEprobewithanyoneelseascross-infectionmayoccur.

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NOTE: AtfirstitisadvisablenottousethePerfect PFEattoohighastrength,orfortoolong.Aslongasyoucanfeelthecontraction,it

isworking.Youcanbuildupslowlyoveranumberofdays.Withthefirstfewsessionsthemusclesmayachethenextday-thesamereactionyouwouldgetwithanyunaccustomedexercise.Withthepelvicfloor,thisgivesa‘cramping’feeling.Ifthishappens,stopusingyour Perfect PFEuntiltheachinggoesaway,thenstartagainusingalowerstrengthandthe10minutetreatmenttime.Asthepelvicfloorbeginstoimprove,itwillbepossibletomaintainthestimulationforlonger.

SHOULDITRYTOEXERCISEALONGWITHTHEPERFECTPFE?

Forbestresultstrytocontractyourpelvicfloormusclesalong with the Perfect PFEandtosustainthecontractionintotherestinterval.Ifpossible,linkthecontractiontoyourbreathinginordertogetintoagentlerhythm.

OncethepelvicfloorhasbeenstrengthenedusingthePerfect PFE,continuetoexercisethepelvicfloormuscles.Thepelvicfloorneedstobeworkedandreactsverywelltosuchexercises.

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14.ANALPROBEAnanalprobe(X-APorX-PR13)canbepurchasedasanaccessory.Theseprobescanbeusedforfaecalincontinenceinbothmalesandfemales.

Conditions that may be treatedTheseanalprobesmaybeusedtotreatUrinaryandFaecalIncontinenceinasimilarwaytothevaginalprobe.Becausethestimulationcannotberestrictedtoonemusclegroup,andthemucosaltissuehasdifferentelectricalcharacteristics,analstimulationislesscomfortablethanvaginal.Youshouldconsultyourphysicianbeforestartingtreatment.

Faecal IncontinenceFaecalincontinencecanbetheresultofweakenedorpoorlyfunctioninganalsphinctermusclesordamagetothenervescontrollingthem.Thepurposeisto re-educate the anal sphincter and other muscles of the pelvicfloortocontract.Thetreatmentsaimtoprogresstowardsgraduatedactiveexercises,inordertoimprovepelvicfloormusclestrengthandenduranceandtoregainfunction.YoumaybenefitfromthePerfect PFE if you eitherhavenoactiveanalsphinctercontraction,oraweakorpoorlysustainedcontraction.

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UsetheSTRESSorTONEprogrammes.Intensity should be as strong as possible without being painful.Whenpossible,trytocontractthemusclesatthesametimeasthePerfect PFE.

Post Prostatectomy Urinary IncontinenceElectricalstimulationhasbeenfoundtohelpurinaryincontinenceinmenafterradicalprostatectomyinsometrials.

Usethesameprogrammesasforvaginalstimulation.IncreaseintensityinStress,Mixed,orToneprogrammestothehighesttolerable.

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15.BATTERYREMOVALANDREPLACEMENT

Whenthebatteriesarerunninglow,alowbattery indicator will show on the screen and it is importanttochangethebatteriesassoonaspossible. Open as shown in section 8.Toremovebatteriespullgently on the ribbon that goes around the back of the batteries.

Battery type:ONLYuseeither1.5vAAalkalinebatteriesorNiMHAArechargeablebatteries.DONOTmixbatteriesofdifferenttypes. CAUTION:NEVERattempttorechargeanalkaline battery-there is a risk of explosion.

Storage Removebatteriesfromyourmachineiftheunitisunlikelytobeusedforalongperiod.Sometypesofbatterymayleakcorrosivefluid.If battery leakage occurs and comes in contact with the skin or eyes, wash thoroughly with plenty of water.

Battery LifeBatteriesshouldlastabout48hoursatfullpower.Unusedbatterieshaveanominalshelflifeof3years,butwillusuallylastlongerthanthis.

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Caution: Keep batteries out of the reach of small children.

Disposal of batteriesAlwaysdisposeofbatteriessafely.Do not throw batteries onto a fire. Risk of explosion.

16.HELPLINEAhelplineisavailable,MondaytoFriday,8:30am-5.00pm.Call:01372723434/Overseas:+44(0)1372723434OrEmail:ask@tenscare.co.uk

17.TROUBLESHOOTINGIftheunitdoesnotwork:

• No display-changebatteriesandensurethattheyareinsertedcorrectly.Checkbatterysprings.

• Controls won’t work-IfLOCKisshownondisplay,pressandholdthe▼button.-IfnoLOCKisshowing,removeandreplacethebatteries.

• No sensation and LEADS alarm showingCheckleadandprobeconnection:--Dampenyourhandwithwaterandalittletablesalt.SqueezetheprobefirmlyandcarefullyincreasestrengthuntilyoucanfeelsomethingorLEADSalarmshows.

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-Ifyoucan’tfeelanything,eitherleadorunitisfaulty.-Ifyoucanfeelsomethingonyourhand,andtheLEADSalarmdoesnotshow,thenthereisnothingwrongwiththeunitorlead.

Theelectricalconductivityofthevaginavarieswidely.TheLEADSdetectioncircuitintheproductisthereasasafetyfeature.Itensuresthatrapidchangesinconnectioncannotcauseveryuncomfortablerapidchangesinstimulation.Unfortunatelythismeansthatsomeusers,whofalloutsideofthegeneralrange,mayexperienceunwantedLEADSalarms.

Ifthishappenstoincludeyou,youcantry:-

i)Usingawater–basedlubricant,whichwillimproveconduction

ii)Crossingyourlegsandsqueezingtoincreasepressureontheprobe,whichshouldimprovetheconnection.Ifthisenablesyoutousetheunit,youshouldfindthatinafewweeksofstimulationthecontactimproves.Ifitdoesnot,thenwearesorrytosaythattheunitwillnotworkforyou.

Caution: Do not use a silicone based lubricant on the stimulation contacts of the probe as it may descrease the effectiveness of the Perfect PFE’s muscle stimulation.

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iii)Theprobesuppliedwiththeunithasa28mmdiameter.Anoptional,larger32mmprobe,partnumberX-VPM,isavailable(seesection18).

• No sensation and no LEADS alarm-IfyouhavetriedthetestaboveandDOhavesensationwhentheprobeisinyourhand,thenyoumayhavereducedsensitivityduetopreviouslydamagedordesensitizedpudendalnerves(thiscanhappeninchildbirthorsomesurgicalprocedures).Seesection3.

• No sensation on one side -Thecurrentflowsfromonesideoftheprobetoother,soitisnotpossibletohaveoneside“notworking”.However,thestrengthofthesensationdependsonhowclosetothenervethecurrentflows,andalsoinwhichdirectionitflowsrelativetothenerve.Youcantryslightlyadjustingthepositionontheprobe,orexchangingtheconnectionofthewiresintheprobe.

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18.CONSUMABLESANDSERVICINGPARTNUMBER(REF):X-VPL LibertyLoopVaginalProbe(32mmdia.)X-VP LibertyVaginalprobe(28mmdia.)X-VPM LibertyPlusVaginalProbe(32mmdia.)X-VPG GoldVaginalProbe(26mmdia.)L-CPT Replacementlead,1.25mlengthX-AP Analprobe(25mmdia.)X-PR13 Smalldiameteranalprobe(19.6mmdia.)E-CM5050 Self-adhesiveelectrodepads(50x50mm)K-GO GoGelPersonalWater-basedLubricant

NOTE: Youshouldonlyusetheprobesuppliedwiththeunitorthereplacementsaboveasperformancemayvarywithotherelectrodes.

NOTE:DoNOTusesiliconebasedorhybrid(mixedwaterandsilicone)lubricants.

These consumables can be purchased either from your supplierorbycontactingTensCareon01372 72 34 34 or by going online to www.tenscare.co.uk

Please ensure that you order the correct part number.

Forservicing,pleasecallTensCareon01372 72 34 34 to discusstheproblem.

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If your unit needs to be returned please send it to The Service Department, TensCare Ltd, 9, Blenheim Road, Epsom, Surrey, KT19 9BE, UK. Pleaseensurethatyouencloseyourname,addressandcontact telephone number so that you can be contacted andinformedaboutanyproblemandanycostsinvolved.

Therearenouser-serviceablepartsandnocalibrationisrequired.Partlistsanddiagramsareavailableonrequest.

19.PELVICFLOOREXERCISES

19.1.WHATISYOURPELVICFLOOR?Thepelvicfloorisagroupofmusclesformingabroadslingrunningfromfronttobackandtheyformthefloorofyourpelvis.

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Whoshoulddopelvicfloorexercises?Allwomenneedtodopelvicfloorexercisesthroughouttheirlives.

Pelvicfloormusclesmaybecomeweak:• following childbirth•throughalackofexercise• as a result of the menopause•followingpelvicsurgery,forexampleahysterectomy(removalofyourwomb),orbladderrepair• by straining to open your bowels•bybeingoverweight•havingachroniccough.Pelvicfloorexercisescanhelpstrengthenyourmusclessothattheycangiveyourorganssupportagain.Thiswillimproveyourbladder/bowelcontrolandcanimproveorstopanyleakage.

19.2.HOWTOPERFORMPELVICFLOOREXERCISESOnce your Perfect PFEhashelpedyoutodevelopcontrolofyourPelvicFloormusclesandbuiltmusclestrength,youshouldmakePelvicFloor(sometimescalledKegel)Exercisespartofyourdailylife.

Kegelexercisesareintendedtohelpstrengthenthepelvicfloormuscles.

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Thepelvicfloormuscleshelptosupportandkeepthebladder,uterusandbowelinplace,buttheycanbeweakenedbythestressesandstrainsofpregnancy,childbirthandthenaturalprogressionofageing,soitisimportanttoexercisethesemusclestokeepthemstrong.

1)Kegelexercisescanbedoneatanytimeandareverydiscreetsoyoucandothemalmostanywhere;lyinginbed,sittingatthecomputerorwaitingforabus.Itisagoodideatotryanddeveloparoutinewhichyoucanrepeateachday.

2)Firstofall,itisimportanttofindyourpelvicfloormusclesandfeelthemworking.Sohereareacoupleoftechniqueswhichmighthelp:

Tryinsertingoneortwofingersintoyourvaginaandthensqueezingthesurroundingmuscles,liftingupandtowardsyourbellybutton–asqueezingandliftingsensation.

Anotherwayistotryandstoptheflowofurineduringurination.Ifyouaresuccessfulthenyouknowyouareexercisingthecorrectmuscles.Thesetechniquesarejusttohelpyouconfirmthatyouareusingthecorrectmuscles.Itisimportanttohaveanemptybladderbeforestartingtheexercises.

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3)Trytoremembertheliftingandsqueezingsensationandwhenyouarereadytrytorecreatetheexercises,justusingthemusclesyouidentifiedearlier;don'ttensethemusclesinyourlegs,stomachorbuttocksandremembertobreathenormally.

4)Aimtoholdeachsqueezeor'contraction'forbetweenthreeandfiveseconds,thenreleaseandrelax.Youshouldfeela‘lettinggo’ofthemuscles.Restforfivesecondsandthenrepeat.

5)Tryanddoabouttensqueezesinthisway.

6)Repeatthewholeprocessthreeorfourtimesaday.

7)Overaperiodoftimetrytoincreasethemusclecontractionsuptoabouttenseconds,butremembertorestinbetweeneachsqueezeforlongerperiods.Itisimportanttoaimforqualitycontractions,notquantity,soafewgoodhardsqueezesarebetterthanaseriesofweakones.Donotworryifyoufindholdingfor3secondsdifficultatfirst.Justsqueezeforaslongasyoufeelcomfortable.Themoreexerciseyoudo,thestrongerthemuscleswillbecomeandthelongeryouwillbeabletosqueeze.

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8)YoucanalsouseyourPerfectPFEpelvicfloorstimulatorinconjunctionwithKegelexercises,whichwillgiveyouabetterunderstandingofhowtheyworkandhowtogetthegreatestbenefitfromthem.

UsethepointerasanindicationofhowwellyouareperformingtheKegelexercises.

• Whenperformedcorrectly,thepointerwillmove downwards.• Whenperformedincorrectly,thepointerwillmove upwards.

How can I tell if it’s working?

Everytwoweeks,testthestrengthofyourpelvicfloorbystoppingtheflowofurinemid-stream.Thiswillfeelsimilartotheexercisesaboveandusesthesamemuscles.Youmaynotbeabletocompletelystoptheflowofurinetobeginwith,butyoumaynoticethatyouareabletoslowtheflowdown.Thisisyourbaselineassessment.Graduallyovertheweeksyoushouldnoticeanimprovement.Itisimportantthatyoudonotdothistest more than once a fortnight as it may cause problems withyourbladder.Thisisjustatesttoseehowyouareprogressing.

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Do not expect instant results!

Ittakestimeforexercisetomakemusclesstronger.Youareunlikelytonoticeanyimprovementforseveralweeks-sostickatit!Youwillneedtoexerciseregularlyfor at least three months before the muscles regain their strength.Youneedtodotheseexercisesfortherestofyourlife.Ifyoustopexercising,yourproblemswillreturn.

20.GUARANTEE

YourPerfect PFE is guaranteed for two years from the dateofpurchase.IfafaultdevelopscontactyourdealerorTensCare.

Theguaranteedoesnotcoverprobe,pads(optionalextra),batteries,orthemonoleadwire.

PleasenotethattheGuaranteeisinvalidatedif:i)incorrectbatterieshavebeenfittedii)iftheunithasbeenimmersedinwater,maltreatedortamperedwith.

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21.DISPOSALOFWASTEELECTRICALANDELECTRONICPRODUCTS(WEEE)

OneoftheprovisionsoftheEuropeanDirective2002/96/CEisthatanythingelectricalorelectronicshouldnotbetreatedasdomesticwasteandsimplythrownaway.ToremindyouofthisDirectiveallaffectedproductsarenowbeingmarkedwithacrossed-outwheeliebinsymbol,asdepictedbelow.

TocomplywiththeDirectiveyoucanreturnyouroldelectrotherapyunittousfordisposal.

Simplyprintapostage-paidPACKETPOSTRETURNSlabelfrom our website www.tenscare.co.ukattachthistoanenvelopeorpaddedbagwiththeunitenclosed,andpostitbacktous.

Uponreceiptwewillsendyourolddeviceforcomponentsrecoveryandrecyclingtohelptoconservetheworld’sresourcesandminimizeanyadverseeffectsontheenvironment.

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22.GENERALSPECIFICATIONMaxIntensity: 50Vzerotopeak Constantvoltageover470-1500Ohm Constantcurrentover160-470OhmChannels: SingleWaveform: AsymmetricalrectangularMaxPulseenergy: Totaloutputlimitedto25uCperpulsePower: 2xAAAlkalineOR2xAANiMHBatterylife: Atleast15hoursat50mA300uS0HzAdjustableTimer: 10,20,3045,60,90min Defaultsto20min Pausebutton“T”keywhenrunningOutputplug: FullyshieldedWeight: 75gmwithoutbatteriesDimensions: 120x60x20mmSafetyClassification: Internalpowersource.TypeBF: Designedforcontinuoususe.IP22 EnvironmentalSpecifications:Operating:

Storage:

Contactduration:Atleast10minutesNB:Theelectricalspecificationsarenominalandsubjecttovariationfromthelistedvaluesduetonormalproductiontolerances.

Temperaturerange:5to40C

Humidity:15to93%RH

Atmosphericpressure700hPato1060hPa

Temperaturerange:-25to+70C

Humidity:93%RHnon-condensing

Atmosphericpressure700hPato1060hPa

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Symbols Used Attention!PleasefollowtheinstructionsintheUserManual.

TYPEBFEQUIPMENT:Equipmentprovidingadegreeofprotectionagainstelectricshock,withisolatedappliedpart.Indicatesthatthisdevicehasconductivecontactwiththeenduser.

Thissymbolontheunitmeans“RefertoInstructionManual”.

TemperatureLimitation:indicatesthetemperaturelimitstowhichthemedicaldevicecanbesafetyexposed. LotNumber:indicatesthemanufacturer’sbatchcodesothatthebatchorlotcanbeidentified.

HumidityLimitation:indicatesthehumiditylimitstowhichthemedicaldevicecanbesafelyexposed.

SerialNumber:indicatesthemanufacturer’sserialnumbersothataspecificmedicaldevicecanbeidentified.

Donotdisposeinhouseholdwaste.

CatalogNumber:indicatesthemanufacturer’scatalognumbersothatthedevicecanbeidentified.

Thismedicaldeviceisnotwaterresistantandshouldbeprotectedfromliquids.

LOT

S/N

REF

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IP22

AtmosphericPressure:indicatestheatmosphericlimitstowhichthemedicaldevicecanbesafelyexposed.

Date of Manufacture: indicates the date which themedicaldevicewasmanufactured.Thisisincludedwithintheserialnumberfoundonthedevice(usuallyinthebatterycompartment),eitheras“E/Year/Number”(YY/123456)or“E/Month/Year/Number”(MM/YY/123456).

Thismedicaldeviceisindicatedforhomeuse.

The first number 2: Protectedagainstaccesstohazardous partswithafinger,andthejointedtestfingerof12mmø,80mmlength,shallhaveadequateclearancefromhazardousparts,andprotectedagainstsolidforeignobjectsof12.5mmøandgreater.The second number 2:Protectedagainstverticallyfallingwaterdropswhenenclosureistiltedupto15˚.Verticallyfallingdropsshallhavenoharmfuleffectswhentheenclosureistiltedatanyangleupto15˚oneithersideofthevertical.

Expected Service Life •Themachinewilloftenlastformorethan5years,butisguaranteedfor2years.Accessories(leadwire,probeandbatteries)arenotcoveredbytheguarantee.•Leadlifedependsgreatlyonuse.Alwayshandletheleadwirewithcare.•Replacetheprobeeverysixmonthstoensurehygiene.•Optionalelectrodepadsshouldlast12-20applications,dependingonskinconditionandhumidity.•AAAlkalineBatteriesshouldlastabout18hourscontinuoususe.

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Storage life •Storagelifeofanunopenedpackofself-adhesiveelectrodesis2years.Thismaybeaffectedbyveryhightemperaturesorverylowhumidity.•Storagelifeofbatteriesis3years.•Theunitandprobehavenofixedshelflife.

PROGRAM SETTINGSProg Hz Pulse

Width (µS)

Ramp Up & Down (Sec)

Plateau (Sec)

Off (Sec)

Default Duration (Min)

STRES 50 300 1 5 10 20TONE 35 250 2 3 6 20MIXED 10/50 200/300 20URGE 10 200 Continuous ConstantPAIN 4 200 Continuous Constant

23.ELECTROMAGNETICINTERFERENCE

Wireless communications equipment such as wireless homenetwork devices, mobile phones, cordless telephones andtheir base stations, walkie-talkies can affect this equipmentandshouldbekeptatleastadistanced=3,3mawayfromtheequipment.

(Note. As indicated in Table 6 of IEC 60601-1-2:2007 forMEEQUIPMENT,atypicalcellphonewithamaximumoutputpowerof2Wyieldsd=3,3matanIMMUNITYLEVELof3V/m).

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NOTES:

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Distributedby:

Manufacturedby:

TensCareLtd,9BlenheimRoad,

LongmeadBusinessPark,Epsom,Surrey,KT199BE,UKTel:+44(0)1372723434Fax:+44(0)1372745434Email:ask@tenscare.co.ukWeb:www.tenscare.co.uk

Pub Ref: I-PPFE-UK Rev 1.1 11/15