physician manual and package insert english language · 1. bassettcal,ncauloandjkort,“congenital...

The Biomet® EBI Bone Healing System

Physician Manual and Package Insert English Language

399JeffersonRoad,Parsippany,NJ07054800.526.2579•www.biomet.com•1068220-00Rev.A•BNS231188L

©2013EBI,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated.† denotes a third party trademark. Velcro® is a registered

trademarkofVelcroIndustriesandVelcroUSAInc.RxOnly.PrescriptionOnly-SingleUseOnly-NotforRe-saleorRe-Distribution-DoNotReuse

Contents

ImportantSafeguardsandContents ................................. Page 1Biomet® EBI Bone Healing System ...................................Page2 Description ....................................................................Page2 Electrical Requirements ................................................Page2SystemComponents ......................................................... Page 3FullPrescribingInformation ..............................................Page4 IndicationsforUse ........................................................Page4 Contraindications ..........................................................Page4 Warnings,Precautions,AdverseEffects .......................Page5General Treatment Instructions .........................................Page6OperatingInstructions ....................................................... Page 8 Step1:BatteryCharging ............................................... Page 8 Step2:PreparingtheSystemtoBeginTreatment ....... Page 9 Step3:TreatingandCharging ...................................... Page 9 Step4:RechargingtheBatteries ..................................Page10 ControllerHolder ........................................................... Page 11 KeypadFunctions ..........................................................Page12 Troubleshooting System Messages .............................. Page 13 ComplianceDataSoftware ............................................Page14SFLXFlexibleTreatmentCoils ...........................................Page17SFLX-1,SFLX-2,SFLX-3,SFLX-4andSFLX-5CoilApplication ............................................. Page 18 ConformingtheSFLXTreatmentCoil ........................... Page 19 CastedandNoncastedApplications .............................Page20 CleaningInstructions ....................................................Page21TreatmentCompletion .......................................................Page21ReturningDefectiveProduct .............................................Page22 EquipmentClassification ...............................................Page22 Disposal/Recycling .................................................... Page22 SymbolDescription.......................................................Page22OrderingInformation .........................................................Page23References .........................................................................Page23Biomet®EBIBoneHealingSystemComponents ..............Page24ElectromagneticCompatibility ...........................................Page25FurtherInformation ...........................................................Page29ReimbursementForm .......................................................Page30

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Important Safeguards and Contents

Read All Instructions Before UsingWhenusingelectricalproducts,basicsafetyprecautions should always be observed:

! WARNING:Toreducetheriskofelectricshock,fireorpotentialinjuriespleaseadheretothefollowing:1. Donotuseyourbonehealingsystemwhile bathing.2. Donotplaceorstoreyourbonehealing systemwhereitcanfallorbepulledintoa tub,sinkoranypoolofliquid.3. Donotimmerseordropyourbonehealing system’scontrolunit,treatmentcoil,AC WallAdapter,inanyliquid.4. Donotreachforyourbonehealingsystem thathasfallenintoaliquid.Unplugfrom the wall outlet immediately.5. DonotpermittheACWallAdaptertobe connected when wet. 6. NevertouchtheACWallAdaptercontacts whentheACWallAdapterispluggedinto anACWalloutlet.7. DonotplacetheACWallAdapterinthe bedwithyouifyouaretreatingwhileyou are sleeping.8. Neveroperateyourbonehealingsystemif it has a damaged link cable, cord or plug, ifitisnotworkingproperly,ifithasbeen dropped and damaged, or immersed into anyliquid.ContactBiometimmediatelyfor a replacement part(s).9. Keep all electrical cords and cables away fromheatedsurfaces.10. Keepallelectricalcordsandcablesaway fromchildren.11. Neverinsertanyobjectintoanyopeningof your bone healing system.12. Donotplaceyourbonehealingsystem’s control unit in prolonged heat or direct sunlight.(Normaloperatingtemperature rangeis5°Cto38°C,[41°Fto100°F], 20-80%RHnon-condensing,normal

storage/transporttemperatureis-15°Cto 60°C[5°Fto140°F].)13. Useyourbonehealingsystemonlyforits intended use as prescribed by your physician and described in this manual.14. Nomodificationtothisdeviceisallowedfor any reason whatsoever.15. Routineuseofbonehealingsystemsfor over30yearshasdemonstratedthatany known hazard associated with their use doesnotpresentanunreasonableriskof illnessorinjurywhencomparedtothe benefitoftheiruse.16. Useofyourbonehealingsystemforthe spine and skull has not been evaluated or approved.

*NOTE: Please contact the Biomet Patient SupportDepartmentinParsippany,NewJerseybetweenthehoursof8:30a.m.and5:30p.m.EasternTimeat1.973.299.9300withanyquestions or problems.

SAVE THESE INSTRUCTIONS

Contents – Biomet® EBI Bone Healing SystemControlunit/ControllerConnectorcables(0"and28")Belt ClipHolderACWallAdapterUserManualandPackageInsertCarryingcase

CAUTION:RxOnlyFederalLaw(U.S.A.)restrictsthisdevicetosalebyorontheorderofaphysician.ForPrescriptionUseOnly.Singleprescription.Singlepatientuse.Notforre-sale.

Please note: This system does not contain atreatmentcoil.PleasecontactyourBiomet/EBIrepresentativeforthespecificanatomicallycorrect treatment coil.

*NOTE:TheControlUnitmustnotbewornonthe coil.

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Biomet ® EBI Bone Healing System

SFLX Treatment Coil

DescriptionThe Biomet® EBI Bone Healing System promotes healing by inducing weak pulsing electricalcurrentsatthefracturenonunionsite. These signals are generated by a low energyelectromagneticfieldcreatedbypassingspecificcurrentpulsesthroughananatomicallyconfiguredtreatmentcoil.

Electrical Requirements of AC Wall Adapter Unit – USA/Americas Input:100–240V~50–60Hz0.3-0.8A Output:12V @2.0AMAX

DonotuseanyotherACwalladapterwiththeBiomet® EBI Bone Healing System.

Electrical RequirementsThe Biomet®EBIBoneHealingSystemControlunitisavailableinthefollowingconfiguration.

Americas• IncludesanACAdapterchargerwitha standard two prong plug

*NOTE: AnInternationalWallPlugBladeAdapterKitisavailableforpatientswhowillbetravelingoutsidetheUSandwishtocontinuetheir treatment while abroad.

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System Components

Control Unit – ControllerThe Biomet® EBI Bone Healing System control unit operates on a permanently installed lithium ion,rechargeablebatterywhichfacilitatesambulatory use. The control unit contains solid state electronics programmed to operate the SFLXfamilyofTreatmentCoils.Itincludesanaudibleandvisibleselfcheckingalarmmechanismtoalertthepatientiftheunitisnotfunctioningproperly.

*NOTE: The control unit can not be used with theFLX®familyofTreatmentCoilsusedwiththe EBI Bone Healing System®-Model2001.

The control unit is designed to store the patient’sdailytreatmentinformation.Patientsare recommended to bring the control unit and treatmentcoiltoeachfollow-upvisittoprovidethe opportunity to review their overall treatment complinace in how they are using their Biomet® EBI Bone Healing System.

*NOTE:Whilewalking,thepatientmaywearthecontrolunitcomfortablyonabeltorthewaistusingtheClipHolder.

Battery Charger/AC Wall Adapter1. TheACWallAdapterisdesignedto

recharge the permanently installed battery inside the control unit. (See step 3: Treating andCharging–page9)

2. Thecontrolunitallowsfortreatingwhilecharging.

DonotuseanyotherACWallAdapterwiththeBiomet® EBI Bone Healing System.

Link CableThe link cable connects the control unit to its SFLXFlexibleTreatmentCoil.Thelinkcablessuppliedare“zero”and28"cables.Anoptional

linkcableisalsoavailableina48"length.Fora48" cable, call the Biomet Patient Support Departmentat1.973.299.9300.OutsidetheUnitedStatescontactyourlocalEBI/BiometDistributor.

SFLX Flexible Treatment CoilTheSFLXFlexibleTreatmentCoilisanencasedwire coil that may be incorporated into a cast, over a cast or brace, or when a cast is not utilized, may be applied directly onto the skin. Aspecificelectricalcurrentisdeliveredtothecoil by the control unit. The coil then delivers the therapeutic electromagnetic signal to the fracturenonunionsite.

*NOTE: TheSFLXCoilisnotincludedwiththe system assembly and will be provided separately by your Biomet sales representative.

*NOTE:TheControlUnitmustnotbeworn on the coil.

Controller

Coil

Cable

4

Full Prescribing Information

ThemechanismofactionbehindthePEMFtechnologyinvolvestheupregulationoffactorsthatmodulatenormalbonehealing.PEMFincreasesanumberoffactorssuchasTGF-β1,BMP-2andBMP-4,whicharenormalphysiologicalregulatorsofthevariousstagesofbonehealing,includingangiogenesis,chondrogenesis and osteogenesis.

Intended User ProfileThe EBI Bone Healing System® is intended to treat adults who have been medically diagnosed withafracturenonunionorfailedfusionintheappendicular system. It is also intended to treat congenital pseudarthrosis in the appendicular sytem in pediatric patients not skeletally mature. Indications for UseThe Biomet® EBI Bone Healing System isindicatedforthetreatmentoffracturenonunions,failedfusions,andcongenitalpseudarthrosisintheappendicularsystem.Anonunion is considered to be established when there are no visibly progressive signs ofhealing.

Theoriginal1979PMAstudyincluded146patientswithnonunionfractures.Thesedifficultfractureswerecharacterizedasfollows:2.3averagenumberofpriorsurgeriesandanaverageofthirty-sevenmonths(mediantwentymonths)sinceoriginalinjury.Thesepatientswerefollowedforaminimumoffouryears(averagesevenyears)fromthedateoftreatment termination, with a success rate of63.5%.Eventhoughlongtermfollow-uprequirements were not included in the original studydesigns,afollow-uprateof82%wasachieved.Forty-three(43)oftheoriginal48patients in the congenital pseudarthrosis study wereclassifiedbyBassett1whodefinedthetibiallesionsasTypeI(n=6),TypeII(n=19)and Type III (n=18), with Type III being the

most severe and recalcitrant to treatment. The successrateforBassettTypeIlesionswas66.7%,BassettTypeIIlesions57.9%andBassettTypeIIIlesions22.2%.Thelongtermposttreatmentfollow-upforthecongenitalpseudarthrosisstudypatientpopulation(n=48)wastoskeletalmaturityortheageof18.Thestudyhadan87.5%follow-uprate.

1. BassettCAL,NCauloandJKort,“Congenital

pseudarthrosisofthetibia:Treatmentwith

pulsingelectromagneticfields”.

ClinicalOrthop,154:136-149,1981.

ContraindicationsA. Nonunionfracturesinwhichasynovialpseudarthrosis(fluidfilledgap)exists.

B. Undercertainconditions,electromagneticstimulation could inhibit or impair the functioningofcertainexternal,non-invasiveand/orimplanted,invasiveactivemedicaldevicesinclusiveof“allactiveelectricalandnon-activeconductive/metallicimplants”as well as “worn medical devices” due to adverse events that may occur with other activeelectricalimplants(e.g.,SpinalCordstimulators,ImplantableCardioverter-defibrillators,etc.)Theimpactoreffectofpulsedelectromagneticfieldsgeneratedby a non invasive bone growth stimulator onthefunctionofotheranatomicalstimulators, pain pumps, insulin pumps, implanted spinal nerve stimulators and similar active devices has not been evaluated.

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C. UseoftheBiomet® EBI Bone Healing System on pregnant patients has not been

evaluated;therefore,itisnotrecommended in these cases.

D. TheBiomet® EBI Bone Healing System has notbeentestedforsafetyorbeenevaluatedforheatingintheMRenvironment.TheeffectsofMRIproceduresandscansusingMR systems has not been determined orestablished:therefore,MRIscansandproceduresshouldnotbeperformedonpatients until the device system has been completely removed.

MRUnsafe-NotforMRIUse

WarningsA. Thelongtermeffectsofexposuretolowlevelmagneticfieldsarenotknown.Routineuseofthebonehealingsystemdevicesforover30yearshasindicatedno known risks.

B. Duringthetreatmentofpatientswithopenepiphyses, when the epiphysis is in the pulsingfield,physiciansareadvisedthatthe epiphyseal growth plates should bemonitoredforpossibleeffects.

C. UseoftheBiomet® EBI Bone Healing Systemforthespineandskullhavenotbeen evaluated.

D. Toreducetheriskofpotentialinjury: 1. AVOIDtouchingtheACWallAdapter

contactswhentheACWallAdapterispluggedintoanACoutlet.

2. DONOTchargethebatteryinbediftreating while sleeping.

E. The control unit is electrically live when connectedwiththeACWallAdapterandpluggedintoanoutlet.Toreducetheriskofseriousinjurybyelectricshockpatientsare

advised: 1. DONOTpermittheACAdaptertobe

connected when wet. 2. DONOTimmersethecontrolunit,

treatmentcoil,ortheACWallAdapterin any liquid.

PrecautionsThefollowingconditionsmaycompromiseasuccessfultreatmentoutcome.A. Nonunionfractureswithgapsinexcess of1.0cm.B. Presenceoffixationdevicesorinstrumentationmadefrommagneticmaterials.

Please note: Most presently used internal orexternalfixationdevicesareconstructedof316LS.S.,titaniumalloys,andcobalt-chromiumalloyswhicharenon-magneticand,therefore,compatiblewiththeBiomet® EBI Bone Healing System.

Adverse EffectsBased upon an historical adverse event report re-viewcomposedofMedicalDeviceReports–MDRsidentifiedwithintheFDAManufacturerandUserFacilityDatabaseforsimilar,relevantdevices,theprobabilityofexperiencinganadverseeventwhenusingaBoneHealingSystemisextremelyunlikely,orlessthan1%(.0133%).The database, although imprecise is intended to provideandpresentageneralsummaryofproduct-specificeventdatathatmanufacturers,userfacilitiesanddistributorsprovidetotheFDAbaseduponrelevantproductcodesforsimilardevices.The original EBI Bone Healing System was approved andintroducedin1979.Sincethen,over600,000systemshavebeenmarketed.Thesafeandeffec-tiveuseofnon-invasivebonegrowthstimulationdevices over this time has clearly established their therapeuticbenefitofuse.Inaddition,allknownhazardsassociatedwiththeuseofBoneHealingSystemsdonotpresentanunreasonableriskofillnessorinjurywhencomparedtotheirtherapeuticbenefitandcanbetypicallyaddressedbyeithermodifyingorterminatingtreatment.

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General Treatment Instructions

Recommended UsageThe recommended daily treatment dosage is normally10hoursperday.

Althoughthedevicewasshowntobeeffectiveattreatmenttimesbetween3to10hoursperday,areviewoftheclinicaldatahasshownthathealingmay occur earlier when treatment is achieved at therecommended10hoursperday.

Compliancewiththerecommendedten (10)hoursperdaytreatmentisveryimportant.Areviewoftheclinicaldatademonstratesthatlessthantherecommendeduseofthisdevicepossibly results in an increase in the time to healyourfracture.Ifyouareunabletotreatforten continuous hours, it is recommended that you break up the total treatment time into more thanonesession.PleaserefertothefollowingGeneral Treatment Instructions.

General Treatment InstructionsTreatment should not be suspended until healing occurs or until such time as the prescribing physician recommendsdiscontinuationofthedevice.The Biomet® EBI Bone Healing System is programmedtodeliveramaximumof270therapeutic treatment periods. Biometrecommends a therapeutic treatment period of10hoursperday.Atherapeutictreatmentperiodisdefinedasa10hourtreatmentsession accomplished either continuously or discontinuouslyinsegmentstotaling10hours.

• Unsegmented Continuous Treatment Period: Patient wears the device with coil in place for 10 consecutive hours without interruption

•Segmented Discontinuous Treatment Period (Example): Patient treats with coil in place for four hours, turns the device off and does not push the RESET button. Patient then turns the device on within the next 12 hours and only

completes the remaining six hours of treatment for that therapeutic treatment period.

•Shortened Segmented:A treatment period of less than 10 hours may be achieved by pushing the reset button prior to the completion of the 10-hour period. Once the device has been reset, the system software will reset the controller to start a new treatment period.

•Shortened Segment Treatment Period (Example): Patient completes eight hours of treatment with coil in place and then turns device off. Less than 12 hours later, the patient turns device on and pushes RESET button. Patient received eight hours of treatment and controller is set to treat for a full 10 hours. Patient compliance usage log is credited with eight hours. Allhourstreatedwillbeelectronicallyrecordedand stored within the controller. Patients unable to treat on consecutive days will be able to treat non-consecutivelywithin400daysafterthefirstone-hourtreatmentperiod.Ifthedeviceisnotusedfora12hourperiod,thetreatmentclock will automatically reset and be ready to deliverthenext10hourtherapeutictreatmentperiodwhennextturnedon.

•Non-consecutive treatment period (Example): On Monday, the patient treats for seven hours and turns the device off. Patient does not treat on Tuesday. Wednesday, patient turns controller on. System will be ready to treat for a full 10 hours, not the remaining three from Monday’s period. Device usage log will record a seven hour treatment and a day of no treatment.

Themaximumrecommendedtherapeutictreatmentperiodisninemonths(approximately270days).

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*Note:•Thecontrolunitshouldbeturnedoffwhenfinishedwiththetreatmentsession•Whenreadytoresumetreating,turnthecontrol unit on. The display will indicate thetreatment time that has been completed and keepstrackofthecumulativetreatmenttimefor the day•Ifthepatientdoesnotfinishtenhoursinthatday, then use the RESET button to return the time to zero

Forconvenience,thedailytreatmenttimeisdisplayed continuously in hours and minutes. Aftertenhoursoftreatment,thedisplaywillread“10:00”,andbeepthree(3)times,andthenshutoffautomatically.

ATTENTION: This is a single patient use device, donotreuse.ForPrescriptionUseOnly.TheBiomet® EBI Bone Healing System is a durable therapeuticelectricaldeviceintendedforsinglepatient use only under a prescription. Treatment at home or in another appropriate or similar setting is acceptable. The device cannot be reprocessed,refurbished,disinfected,resold,sterilized, etc. with the intent to be used by anotherpatientorfortreatmentotherthaninitially prescribed.

This device has been designed to reduce the riskofpotentialreusebyautomaticallyceasingtofunctioninaccordancewiththeGeneralTreatmentInstructionsspecifiedanddefinedwithin.

Recommended Concurrent Fracture Treatment The Biomet® EBI Bone Healing System works bestwhenmotionofthefracturesiteisminimizedornonexistent.Thisimmobilizationis achieved by applying a well molded plaster or syntheticcastatthebeginningoftreatment

(togetherwithinitialnon-weightbearingifitistreatingthelowerextremity.)

• Ankle/Tarsals/Metatarsals:shortlegcast or rigid internalfixation

• Tibia:stableinternalorexternalfixation, or long leg cast (short leg cast with rigid fixation)

• Shoulder/Clavicle:braceorabductionsplint, internalfixation,orfigureeightimmobilization

• Humerus:stableinternalfixationand/or adequate immobilization with controlled rotation

• Scaphoid/Wrist:stableinternalfixationor long arm cast with thumb spira (short arm castwithrigidfixation)

• Carpals/Metacarpals/Phalanges:cast, internal,orexternalfixation

Operating Instructions

BeforeusingtheBiomet® EBI Bone Healing Systemforthefirsttime,thepermanentlyinstalled battery housed within the control unit mustbefullycharged.

Step 1: Battery ChargingThe Biomet® EBI Bone Healing System operatesonalithiumionbattery.Beforetreating with the system,thepatientmustfullychargethebattery.Atroomtemperatures,(24°C[75°F])chargingmaytakeuptothreeandone-halfhours.

ControllerA. PlugtheACAdapterintoanACwalloutlet.

B. ConnecttheACWallAdaptertotheController.TheorangelightonthesideoftheControllerwillilluminatewhileincharging mode.

C. UnplugtheACWallAdapterfromthewall outletanddisconnectitfromtheController, afterchargingiscomplete.

*NOTE:Duringbatterycharging,itisnormalforthecontrollertoexhibitamoderateincreaseinoperatingtemperature.Oncethebatteryisatfullcapacity,batterychargingautomatically stops and the controller will return to an ambient state.

*NOTE:Forbatterychargingandrecharging incountriesoutsidetheUSAwithdifferentpower grid requirements, the plug blades should be replaced on the charger adapter to conformtolocalpowergridrequirements.

Battery Safety Warning

CAUTION: The Biomet® EBI Bone Healing System control unit contains a permanently installed Lithium Ion battery and cannot be replaced by a service technician. You must readandfollowthesesafetyinstructionsandwarningsinconjunctionwiththeImportantsafeguardsprovidedwithinthismanualbeforeusing or charging the battery within your control unit.

•Donotattempttoopenthecontrolunittoaccess the battery or its internal electronic componentsforanyreason.Nounauthorizedmodificationofthecontrolunitisallowed.•Neverattempttochange,adjustorreversethebattery’spolarityconnectionsforanyreason.•Donotalloworpermitthecontrolunitoritspermanently installed battery to be physically mishandled, abused, crushed, mutilated or penetratedbyanymetalobjectsuchasanail.•Neveralloworpermitanymetalobjecttotouch or contact the permanently installed battery’s terminals. •Neverstorethecontrolunitorchargethe batteryinextremetemperatures.•Neverchargethebatteryunattended.•Alwayskeepthecontrolunitawayfromchildren.

Anyabuseormisusetothecontrolunitoritspermanently installed battery may result in seri-ouspersonalinjuryand/orpropertydamage.

Biomet®isnotliableforanysuchabuse, misuse or resulting damage.

Toensurepropercharging,ONLYUSEtheACWallAdaptersuppliedwithyourdevicesystemandfollowthespecificoperatinginstructionsprovided within this manual.Alwayskeepthecontrolunitanditsperma-nently installed battery dry.Whenalltreatmenthasbeencompleted,thecontrol unit and permanently installed battery

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9

Battery Safety Warning (continued)

MUSTBEdisposedofproperly.IntheUSA,disposalinformationmaybeobtainedbycontacting the Rechargeable Battery Recycling Corporation Hotline (RBRC)at1-800-822-8837.PleasecontactlocalrecyclingauthoritiesforproperdisposalinformationandinstructionsifoutsidetheUSA.Neverdisposeinnormalhouseholdwasteorrefuse.

Normalchargingtemperaturerangeis50°F(10°C)to+95°F(35°C).

Step 2: Preparing the System to Begin TreatmentThe Biomet® EBI Bone Healing System includes twolinkcables:“zero”lengthand28".Thecableexitingthecontrolleris41/2"long.AllSFLX TreatmentCoilshavean8"cable.Hence,useofthe“zero”lengthlinkcablewouldseparatethestimulatorcontrollerfromthetreatmentcoilbyapproximately14".Useofthe28"linkcablewouldseparatethecontrollerandtreatmentcoilbyapproximately41".Alinkcableof48"isavailablefromBiometasareplacementpart.(Seeorderinginformationpage24.)The48"and28"linkcablescannotbeusedwiththeSFLX5treatmentcoil.

*NOTE: The Biomet® EBI Bone Healing System isnotcompatiblewiththeFLX®Coilsusedwiththe EBI Bone Healing System®–Model2001.

Afterconfirmingthatthelinkcableisproperlyconnected to the controller, connect the other endofthelinkcabletotheSFLXFlexibleTreatmentCoil.Thisconnectionallowsforsimplequick disconnect and reconnect by the patient.

Next,positiontheSFLXFlexibleTreatmentCoiloverthefracturenonunionsite.Theentirefracturenonunionsiteshouldbecenteredwithinthecoiltreatmentwindow.Duringtreatment,thepositionofthetreatmentcoilmayshiftduetopatientactivity.Thetreatmentcoilmustbeadjustedandcenteredasrequiredtocoverthefracturenonunionsite.

Step 3: Treating and ChargingPatients may treat with the system while rechargingthebattery.Whenthepatienttreatsand charges at the same time, the treatment time and charging message will be displayed.

To treat and charge, patients should:

1. Turn the control unit on.

2.FollowinstructionsStep1,(Page8)-Controller

*NOTE:IftreatingwhilethecontrollerunitisconnectedtotheACAdapter,thedisplaywillread,“TREATING00:00BATTERYCHARGING”.Oncethepatienthascompletedthetreatment,theyshouldturnthecontrolleroff,andleaveitconnectedtotheACAdaptertocontinuechargingthebattery,untiltheLEDchangesfromorangetogreen.

TREATING00:00 BATTERYCHARGING

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Operating Instructions (Continued)

Step 4: Recharging the BatteryThe average daily treatment time supplied by the battery in the controller will vary according tothesizeofSFLXTreatmentCoilbeingused.Thecontrollerwilldeliveraminimumof10hoursofunsegmentedcontinuoustreatment foralltreatmentcoilsexcepttheSFLX-4andSFLX-5TreatmentCoils.Thecontrollerwilldeliver a minimum seven hour unsegmented continuoustreatmentwiththeSFLX-4TreatmentCoilandathreehourminimumunsegmented continuous treatment with the SFLX-5TreatmentCoil.Atroomtemperatures,(24°C[75°F])chargingmaytakeuptothreeandone-halfhours.

Aftercompletingadailytreatmentsession,patientsshoulddothefollowing:

A.Turnthecontrolleroff.

B. FollowinstructionsA-Cfrom Step1.Controller(Page8)

C. ItisnotnecessarytodisconnectthecontrollerfromtheACAdapterchargeroncefullycharged.ThecontrollercanremainpluggedintotheACWallAdapteruntilthepatient’snexttreatmentsession.

*NOTE: The controller’s permanently installed batterycannotbeovercharged.IfthecontrollerispluggedintotheACAdapterandthebatteryisfullycharged,thechargerwillterminatetherechargingprocessearly.DuringthechargingprocesstheLEDadjacenttotheplugwillremainorange and once the charging is complete theLEDwillturngreen.Therefore,donotbeconcernedifthebatteryisinadvertentlychargedmore than once.

When the Controller Needs Recharging 1. The display will read “Recharge Battery”;

“Treatment Halted” and emit three audible beeps.Oncebeepingstops,theControllerwillautomaticallyshutOFF.

Afterdailytreatment,turnthecontrollerOFFand recharge as described in step 1: Battery Charging.(Seepage8).

*NOTE:AnexcessivelylowbatterywillresultinnoLCDdisplay.Ifyouareexperiencingchargingdifficulties,pleaseverifythatallelectricalconnectionsareestablished. Then try charging the controller again.Ifyouarestillexperiencingdifficulties,contactBiomet.Foracompletelistingofcontactinformation,refertopage29.

RECHARGEBATTERYTREATMENTHALTED

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Battery Indicator DisplayThecapacityofthebatteryisdisplayedduringthecourseoftreatment.Fourbarsindicatesafullchargewiththreebarsindicatingapproximately75%charge.

California Perchlorate LabelThe controller contains a permanently installed back up battery mounted on the printed circuit boardthatcontainsverysmallamountsofperchlorate.Californialawrequiresthefollowinglabel:“PerchlorateMaterial–specialhandlingmay apply. See www.dtsc.ca.gov/hazardous-waste/perchlorate.” There is no special handling required by patients.

Avoid Potentially Explosive AtmospheresAreaswithpotentiallyexplosiveatmospheresareoften,butnotalways,postedandcanincludefuelingareas,suchasbelowdecksonboats,fuelorchemicaltransferorstor-agefacilities,orareaswheretheaircontainschemicals or particles, such as grain dust, or metal powders.

Whenthepatientisinsuchanarea,turnoffyour controller and do not charge the battery. In such areas, sparks can occur and cause an explosionorfire.

Controller Clip Holder

• Thecontrollermaybewornonabeltina clip holder that is included in the system, orintheoptionalextremityband.Theholder will securely hold the controller during normal treatment.

• Toinsertthecontrollerintotheclipholder, alignthefrontofthecontrollerthatfeatures thereset/backlightbuttonfacingawayfrom theclipholder.Aligntheslotsonthe controllerunitwiththepairofmatchingtabs on the clip holder. Press the controller into the holder until the tab engages.

Anaudibleclickshouldbeheard,thus securing the controller to the holder.

• Adjustclipholderplacementtomaximize patientcomfortandavoidpossibleimpacts withfurniture,etc.

Keep the Bone Healing System and its accessoriesawayfromsmallchildren

These devices are not toys and may be hazardoustochildren.ForExample:

• Achokinghazardmayexistforsmall detachable parts

• Improperusecouldresultinexposuretoa treatmentsignalforwhichtherisksof exposuretochildrenhavenotbeen established

Driving Precautions

Theuseofanoninvasivebonehealingsystemwhile driving may cause or contribute to potentially hazardous distractions. Patient shoulddiscontinueusewhiledrivingifthisoccurs.

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Keypad Functions

On/Off Button

EachtimetheON/OFFbuttonispressed,an audible beep will be heard. To turn the controlleron,presstheon/offbuttononetime.Pressingthisbuttonasecondtimeforatleastonesecondwillturnthecontrolleroff.Everytime the controller is turned on, the display will indicatethefollowingsequence:

1.“RECOMMENDEDUSE10HOURSPERDAY”fortheBiomet® EBI Bone

Healing System.

2.“PATIENTUSAGE”;“AVGHR/DAY00:00”-This is the daily treatment average since the patient’s treatment started.

3.“PATIENTUSAGE”;“DAYSUSED000”- Thisisthetotalnumberofdaysof treatment.

4.“PATIENTUSAGE”;“DAYSUNUSED000”-Thisisthetotalnumberofdayswhentherewas no treatment.

5.“TREATING00:00”;“BATTERY ”-Thisisthecumulativenumberofhoursoftreatmentinthepresentorprevioustreatment session, provided that the reset button has not been pressed (see RESET BUTTON).

6.PressingtheRESETbuttonwillresultinthedisplayreading“RESETTING...”forap-proximatelythreeseconds.Thedisplaywillthen return to display as indicated in number fiveabove.

1.

2.

3.

4.

5.

6.

RECOMMENDEDUSE10HOURSPERDAY

PATIENTUSAGEAVGHR/DAY00:00

PATIENTUSAGEDAYSUSED000

PATIENTUSAGEDAYSUNUSED000

TREATING0:00BATTERY

RESETTING...

RESET and Display Backlight Button – Located on the Body of the ControllerThe controller is designed with a backlight functiontoenhancethevisibilityoftheLCDdisplayindimlighting.Whenpressedbriefly,thedisplay’sbacklightwillturnonfor5seconds. The system is designed with a reset functiontoallowthedailytimertoberesettozero.Shouldthepatientnotfinishthetenhoursoftreatmentinoneday,he/shepressestheRESET/Backlightbuttonfortwo(2)beepsand the daily timer will go back to zero in preparationforthenexttreatmentsession.Thetreatment time will be retained on the display unlesstheRESETbuttonisdepressedfortwoaudible beeps.

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Toavoidtheaccidentalresetofthedailytime,theRESETfunctionhasathreeseconddelay.Whenpressedformorethanonesecond,thecontrollerwill beep. To clear the time back to zero, continue holding the button until a second beep is heard (approximatelythreeseconds).ReleasetheRESET/Backlightbutton.Thiswillclearthetimebackto0:00.

Followingcompletionofyourdailytreatment,youshoulddothefollowing:

1.Makesurethecontrollerisoff.Ifyouhavecompleted10hours,theunitwillautomaticallyshutoff.Withlessthan10hoursoftreatment,youwillneedtomanuallyturnthecontrolleroff.

2.InserttheACAdapterchargerintothecontrollertorechargethebatteryforyournexttreatment(seeStep1:BATTERYCHARGINGpage8).

The Biomet® EBI Bone Healing System may be used at home or at work. Your patient’s scheduleandlifestylewilldeterminethebesttimeforusingthesystem.Manypeoplefinditconvenient to treat while they are sleeping.

Troubleshooting System MessagesAllowuptooneminuteforthedisplaymessagetochange,aftertakingcorrectiveaction.

• “RECHARGE BATTERY TREATMENT HALTED”Ifthismessageappears,the battery needs to be recharged. This message will only appear during a treatment session. In order to recharge the battery and continuetreatment,connecttheACWallAdapterandturnthecontrolleron.RefertoStep4:(Page10)“RECHARGINGTHEBATTERY”

“Check Connectors See Manual”This message, accompanied by audible beeps, appears when the controller is not properly connectedtotheSFLXTreatmentCoilwhenthe controller is turned on. The controller will turnitselfoff.Besuretocheckallelectricalconnections between the controller, link cable andtreatmentcoil.Whenthecontrolleristurned back on and the message continues, check all cable connections again. Ifyouneedassistance,youshouldcall1.973.299.9300and ask to speak to a Patient Support Representative.OutsidetheUnitedStatescontactyoulocalEBI/BiometDistributor.

”Check Coil See Manual”This message, accompanied by three to fouraudiblebeeps,appearswhentheSFLX TreatmentCoilisdisconnected,damaged,orinappropriatelyflexed.Themessagewillstay on the display until the controller turns itselfoff.Ifyouneedassistance,youshouldcall1.973.299.9300andasktospeaktoaPatientSupportRepresentative.OutsidetheUnitedStatescontactyourlocalEBI/BiometDistributor.

RECHARGEBATTERYTREATMENTHALTED

CHECKCOILSEEMANUAL

CHECKCONNECTORSSEEMANUAL

14


“Cannot Treat Call Biomet 1.973.299.9300”This message, accompanied by three audible beeps, appears when there is a hardware problem within the controller. The message “CANNOTTREAT”willappearandalternatewith“CALLBIOMET1-973-299-9300”.Ifthe patient needs assistance, they should call1.973.299.9300andasktospeaktoaPatientSupportRepresentative.OutsidetheUnitedStatescontactyourlocalEBI/BiometDistributor.

“System Endpoint Call Biomet”, Whenthecontroller’sinternaltimerreaches400daysofoperationfromthefirstonehourtreatmentor270therapeutictreatments,thetreatmentsignalislockedoff.Thecontroller’sLCDdisplaywillread“SYSTEMENDPOINTCALLBIOMET”Thismessagewillappeareverytimethecontrolleristurnedon.Atthispoint, the system should be discarded. It is recommended that the patient contact the prescribing physician indicating that they have reached this point in their treatment. See page 22forDisposalInstructions.

CANNOTTREAT

CALLBIOMET1-973-299-9300

Alternates with

SYSTEMENDPOINTCALLBIOMET

Compliance Data Software Introduction(Physician Use Only)This bone healing system contains embedded softwareandfirmwarewhichallowsthedisplayofpatient-specifichistorydataincludingusageandtherapeutictreatmenttimeviauseofBiometComplianceDataDownloadSoftware.

TheComplianceDataDownloadSoftwareisclassifiedasamedicaldevicedatasystem(MDDS).Itsprimaryfunctionistheelectronicretrieval,transfer,display,andstorageofdevicegenerated-specificpatienthistorydata,withoutalteringthefunctionorparametersoftheconnecteddevice.ThissoftwareisonlyintendedtobeusedandinterfacewiththefollowingBiometdevices:

• Biomet® EBI Bone Healing System

• Biomet® SpinalPak®Non-invasiveSpine FusionStimulatorSystem

• Biomet®OrthoPak®Non-invasiveBone Growth Stimulator System

ThesoftwareisavailableasadownloadableexecutablefiletoBiometrepresentativesonlythrough a secure web portal.

Patient Usage Reports (Physician Use Only)TheComplianceDataDownloadSoftwarewilldownloadandtransferdevice-specificpatienthistorydataviaaUSBcablefromtheattacheddevicetoapersonalcomputer(PC)anddisplay itonthePC’smonitor.Itcanthengeneratearead-onlyreport,inAdobePDFformat,whichcan be saved or printed. The device does not record a patient name or diagnosis. The analysisofthedownloadedpatienthistorydatamust be limited to the prescribing physician.

Theprintout/displayincludes,amongother

15

information,daysused,averagehoursperday,daysun-usedanddayslapsed.Totaltreatmenttimeisdisplayedalongwithagraphofthenumberoftreatmentsessionsrecordedatspecifictreatmentdurationhourintervals.

Careshouldbetakennottomanipulatedatainany way.

Biomet recommends patients bring their controllertoeachfollow-upvisitsothataccumulated compliance data can be accessed, downloaded and reviewed by their prescribing physician at that time.

In the event patient data reveals a compliance deviation with the prescribed treatment regimen, the prescribing physician may discuss treatment options or alternatives including an evaluation regarding ongoing compliance in the patient’s overall prescribed therapeutic treatment regimen.Set-Up (Physician Use Only)Beforestarting:1)ObtainaUSBcableforcompliancedownloadforpatienthistorydatatransfer(yourBiometrepresentative has this).

2)Call/ContactyourlocalBiometrepresentativetoarrangedownloadoftheComplianceDataDownloadSoftware.

ConnecttheUSBAccessorycableforcompliancedownload(PN1067725-00)tothedevice’sUSBportlocatedonthesideofthecontrollertotheleftofthepowerbutton.ConnecttheUSBcabletoanopenUSBportonaPC.Turnonthedevice.OpentheComplianceDataDownloadSoftwareonthePC,andanintroductoryscreenwillappear.Followtheinstructions.

TroubleshootingIfconnectionorprintingproblemsoccur,please check all connection cables or your network administrator. Please call Biomet (page 29)shouldanyadditionalproblemsarise.

WarningsTheComplianceDataDownloadSoftwaremustonly be run on a personal computer operated byorundertheguidanceandsupervisionofaBiometsalesrepresentative.Thissoftware isonlyintendedtobeusedwiththefollowingBiomet devices:

• Biomet® EBI Bone Healing System

• Biomet® SpinalPak®Non-invasiveSpine FusionStimulator

• Biomet®OrthoPak®Non-invasiveBone Growth Stimulator System

16


Patient Usage Report

Device: Biomet® EBI Bone Healing System

Serial Number: 0002 Days Lapsed: 1

Days Used: 78 Days Unused: 21

Avg Hours / Day: 4:13 Avg Hours / Session: 6:22

Total Treatment Time: 417 Hours Treatment Period: 123 Days

Demonstration mode – Invalid Data

Frequency of Treatment Dose

20

18

16

14

12

10

8

6

4

2

0 0-1 1-2 2-3 3-4 4-5 5-6 6-7

7 7 7 7

14 14

1211

109

7-8 8-9 9-10

Treatment Hours

NumberOfSessions

Sample

Patient Usage Report

Device: Biomet® EBI Bone Healing System

Demonstration mode – Invalid Data

17

SFLX Treatment Coils

Depth of Penetration Specifications for SFLX Treatment Coils

SFLX 1, 2, 3, 4, 5, and Coilette Treatment Coils Tolerances

SFLX Coil M/L Flexion Depth of Vertical Anatomical

Penetration Fracture Length Location(s)

SFLXMiniCoilette Minimum 2.5cm 2.5cm 1.5cm

Maximum 3.5cm 2cm 1.5cm

SFLXCoilette Flat N/A 2.75cm 4cm

Elliptical N/A 3.5cm 4cm

Saddle N/A 3.5cm 2cm

SFLXXL Flat N/A 3.5cm 6cm

Coilette Elliptical 5cm 4.25cm 4cm

Saddle 7.5cm 5.5cm 4cm

SFLX1 Minimum 9cm 6.5cm 7cm

Maximum 13cm 5.5cm 6cm

SFLX2 Minimum 8cm 8cm 10cm

Maximum 11cm 7cm 10cm

SFLX2-1 Minimum 10cm 5cm 16cm

(Elliptical) Maximum 12cm 4.5cm 14cm

SFLX 2-1 Minimum 8cm 8cm 10cm

(Saddle) Maximum 11cm 7cm 10cm




Maximum 9cm 5.5cm 6cm

SFLX4 Minimum 9.25cm 10cm 12cm

Maximum 14.5cm 8cm 8cm

SFLX4-1 Minimum 9.25cm 10cm 12cm

(Saddle) Maximum 14.5cm 8cm 8cm


(Elliptical) Maximum 14cm 6cm 18cm

SFLX4-4 Minimum 9.25cm 10cm 12cm

Maximum 14.5cm 8cm 8cm



phalanges

clavicle, metatarsals, scaphoid, distal radius, cuboid, medial lateral malleolus

foot,hand,smallbones

metatarsals, scaphoid, metacarpals, radius, ulna

humerus,tibia,fibula,radius, ulna

tibia,fibula,radius,ulna, humerus

tibia,fibula,radius,ulna, humerus

ankle

radius, ulna, metatar-sals,distaltibia/fibula

midshaftfemur,tibia,fibula,humerus

tibia,fibula,humerus,radius, ulna

tibia,fibula,humerus,radius, ulna

ankle

femur(proximalormidshaft)

18

*NOTE: The Biomet® EBI Bone Healing System does not include a treatment coil. The prescribing physician and Biomet representative willselectthetreatmentcoilsuitablefortheparticularpartofthepatient’sanatomytobetreated.Ifinitiallytreatingwithacasttreatmentcoil can be interchanged in the event a cast is removed.ContactyourBiometRepresentativeforasuitablereplacement.The48"and28"linkcablescannotbeusedwiththeSFLX-5TreatmentCoil.

AllSFLXCoil–Anatomicalplacement instructionsandFlexionGaugesareincludedwith the coil.

Specialtytreatmentcoilsareforapplicationswhere the standard straps may not be adequate to secure the treatment coil. Each specialty SFLXTreatmentCoilfeaturesone(1)snap atallfourcornersofthecoilandcomes pre-assembledtofittherightsideofthebody,but the same snaps and straps may be easily switchedforleftsideapplications.

Application Instructions for the SFLX-1, SFLX-2, SFLX-3, SFLX-4 and SFLX-5 Treatment Coils

Appliesto:

Description Treatment Coil # Suggested Placement*

SFLX-1 1068225 Metatarsals,Radius,Ulna,Scaphoid,Metacarpals

SFLX-2 1068226 Humerus,Tibia,Fibula,Radius,Ulna

SFLX-3 1068229 Radius,Ulna,Metatarsals,DistalTibia/Fibula

SFLX-4 1068235 MidshaftFemur,Tibia/Fibula,Humerus

SFLX-5 1068224 Femur–ProximalorMidShaft

*NOTE:Givencertainanatomiclocations,treatmentcoilsmayhaveatendencytomigrateawayfromtheintendedtreatmentarea.Oftenthismovementisassociatedwithpatientactivity,mobilityortheunderlyingsurfacethetreatmentcoilrestson(skin,shirt,cast,etc.).Thetreatmentcoilstrap(s)maybeloosenedandthetreatmentcoilmustbeadjustedandcenteredasrequiredtocoverthefracturenonunionsite.Tightenthestrapsagaintofinishthecorrection.

*Anatomiclocationsaresuggestedbasedontreatmentcoilsizeandconfiguration.Theselectionofasuitabletreatmentcoilisindividualtoeachpatientandshouldtakeintoaccountfactorssuchasactivitylevel,presenceofacast,patientbodymassindex(BMI),etc.

SFLX Treatment Coils (Continued)

19

Conforming the SFLX Treatment CoilTheSFLXTreatmentCoilisconformablesoitmaybeshapeddirectlytothesurfaceanatomyofthefracturenonunionsitebeingtreated.The coil is also rigid enough to retain its shape onceconformed.Thecoil’slightweight,low,flatprofilemakesthetreatmentcoileasytoapplyandcomfortableforthepatienttowear.The treatment coil is designed to be bent in one direction (single plane, see illustration) only. It should not be twisted or kinked.

SFLX Treatment Coil ApplicationsItisimperativethattheentirefracturenonunionsitereceiveatherapeuticpulsingfield.Thisis accomplished by placing the treatment coil overthefracturenonunionsite.Ensurethattheentire site is centered within the treatment coil window/fieldofcoverage.

TheSFLXTreatmentCoilischosenbytheprescribing physician and Biomet representative basedupontheanatomicallocationofthefracturenonunion,theverticallengthofthefracturenonunion,thefieldofcoveragerequiredtotreatthefracturenonunionandthephysicalsizeofthepatient.

*NOTE: Included with each treatment coil are anatomicalspecificplacementinstructionsandaFlexionGaugeformeasuringthetolerancesofthecoil.ThecoilshouldnotbeflexedbeyondtheFlexRangeofthegauge(theareaindicatedby green color).

Flexion Gauge Instructions for SFLX-1, SFLX-2, SFLX-3, SFLX-4 and SFLX-5 Treatment CoilsInordertoensureproperfitandefficacioustreatmenttheFlexionGaugeshouldbeemployedtocheckforthepropershape.

1) Placethetreatmentcoilatthefracturenonunionsiteandshapeforbestfit.TheTreatmentCoilshouldbebentonlyinonedirection.Donotkinkortwistthecoil.

2) Removetheshapedtreatmentcoilandplace edge closest to the connector cable intotheslot/notchontherighthandsideoftheFlexionGaugemarkedwithagreentriangle. The opposite treatment coil edge shouldfallwithinthegreenzoneintheareamarked“FLEXIONRANGE”.EachFlexionGaugehasachartoftreatmentcoiltoleranceswithdepthofpenetrationdata.

3) Ifthetreatmentcoiledgedoesnotfallwithin the green zone contact your Biomet representativeforasuitablereplacementand assistance.

*NOTE:Duringtreatment,thepositionofthetreatmentcoilmayshiftduetopatientactivity.The treatment coil strap(s) may be loosened andthecoiladjustedandcenteredasrequiredtocoverthefracturenonunionsite.Tightenthestrapsagaintofinishthecorrection.

20

Noncasted Applications:1. PositiontheSFLXTreatmentCoiloverthefracturenonunionsite.Theentirefracturenonunion site should be centered within the treatmentcoilwindow/fieldofinfluence.

2. AttachandsecuretheSFLXTreatmentCoilaroundtheextremitywiththeVelcro† strap or the garment to give the patient a snug yet comfortablefit.

*NOTE:Toallowflexibilityinanatomiccoverageand positioning, the treatment coils are availableinmultiplesizesandconfigurations.ItisrecommendedthatthecenteroftheTreatmentCoilbepositionedoverthefracturenonunion site.

*NOTE:Duringtreatment,thepositionofthetreatmentcoilmayshiftduetonormalpatientactivity.Ifthisoccurs,thetreatmentcoilstrap(s) may be loosened to allow the coil to be adjustedandcenteredasrequiredtocoverthefracturenonunionsite.Tightenthestrapsagain tofinishtheadjustment.

Casted Applications:1. Applyonetotworollsofcastingmaterial

(synthetic or plaster) in the usual manner, andallowittoset.CentertheSFLX TreatmentCoiloverthefracturenonunionsite,confirmingcorrectplacementwithanX-rayifnecessary.

2. IncorporatetheSFLXTreatmentCoilintothecastwithanadditionalwrapofcastingmaterial.

3. Position the connector mounting assembly neartheSFLXTreatmentCoilandincorporate it into the cast with additional cast material.

*NOTE:Ifpatientcompliancewiththesystemisnot a concern, the treatment coil may be placed ontopofacastorbrace.Besuretomarkthe treatment coil placement with an indelible markerforeasyrefittingbythepatient.

Casted and Noncasted Applications

21

Cleaning Instructions Treatment Completion

Biomet® EBI Bone Healing SystemThecontrollerandACWallAdaptercanbecleaned by wiping with a damp cloth and mild soap.Donotimmerseinwaterorusesolventsor other cleaning agents. DO NOT MACHINE WASH OR DRY

SFLX Treatment CoilsSFLXcoilsarenotsterile.Cleanwithmildsoapandwaterbywipingwithadampcloth.Donotimmerse in any liquid.

*NOTE: Please make sure the controller is disconnectedfromtheACWallOutletbeforecleaning.

Biomet ® EBI Bone Healing SystemThemaximumrecommendedtherapeutictreatmentperiodisninemonths(approximately270days).

WhentheControlUnitreachessystemendpoint,thesignalislocked.“SYSTEMENDPOINTCALLBIOMET”willappearontheLCDdisplay.ThedisplaywillthenturnOFF.ThismessagewillappeareverytimetheControlUnitisturnedON.Atthispoint,thesystemshouldbedisposedofinanenvironmentallysafemanner.(SeeDisposal/Recyclingonpage22).

*NOTE:Iftheprescribingphysicianfeelsthattreatment with the Biomet® Bone Healing SystemisstillnecessaryaftertheSystemEndpoint has been reached, please contact Biometforinstructionsandproceduretoreplacetheexpiredcontroller.

22

Equipment Classification

• Biomet® EBI Bone Healing System ClassII TypeBF

• Ordinaryequipmentwithoutprotection againstingressofwater

• Equipmentnotsuitableforusein presenceofflammableanaesthetic mixturewithairorwithoxygenorwith nitrousoxide

• Modeofoperation–continuous

Disposal/RecyclingThecontrolunit,ACWalladapter,linkcables,SFLXTreatmentCoilareregulatedandshouldbeproperlydisposedoforrecycledaccordingto local statutes and regulations. Please contact yourlocalrecyclingcenterforinstructionsandprocedurestosafelydisposeoftheBiomet® EBI Bone Healing System.

WARNING:Neverdisposeofcontrolunitinafirebecauseitcontainsapermanentlyinstalledbatterywhichcouldexplode.

Warning Note TypeBFEquipment

DirectCurrent

AlternatingCurrent

Attention–SeeInstructions

Non-ionizingRadiation

ClassII

SinglePatientUse/SinglePrescription

WEEE–Donotdisposeofthis device with household waste

ChargeBattery

Reset

Backlight

On/Off

RxOnly PrescriptionOnly

Manufacturer

Notforusebypatientswhoare pregnant or becoming pregnant

Notrecommendedforpatientswith certain types ofpacemakersor implantabledefibrillators

Temperaturerangeforstorageand transportation

LithiumIonBattery–Recycleincompliance with local laws

The Biomet® EBI Bone Healing SystemhasnotbeentestedforsafetyorbeenevaluatedforheatingintheMR environment.

Symbol Description

2

!*

Symbol Description

23

Ordering Information References

To order replacement treatment coils or related components contact your Biomet representative orcalltheBiometPatientSupportDepartmentdirectlyat1.973.299.9300,8:30a.m.to5:30p.m.EasternTimeMondaythroughFriday.OutsidetheUnitedStatescontactyourlocalEBI/BiometDistributor.

The Following Information is Necessary to Expedite Any Requests:

• Patientname

• PrescribingPhysicianname

• Wheretosendreplacementitems (patienthome,MDoffice,etc.)

• Availablecomponentparts:(Seepage24)

C.A.L.Bassett,RobertJ.Pawluk,andA.A.Pilla.“AugmentationandBoneRepairbyInductivelyCoupledElectromagneticFields”.Science 184:575-577,1974.

C.A.L.Bassett,S.N.Mitchell,L.Norton,N.CauloandS.R.Gaston.“ElectromagneticRepairsofNon-Unions.ElectricalandMagneticControlofMusculoskeletalGrowthandRepair”.C.T.Brighton,ed.,Grune and Stratton,NewYork,1979.

C.A.L.Bassett,S.N.Mitchell,andS.R.Gaston.“TreatmentofUnunitedTibialDiaphysealFracturesWithPulsingElectromagneticFields”.Journal of Bone and Joint Surgery Vol.63-A,No.4,pp.511-523,April,1981.

C.A.L.Bassett,S.N.Mitchell,andS.R.Gaston.“PulsingElectromagneticFieldTreatmentinUnunitedFracturesandFailedarthrodeses”.Journal of the American Medical Association Vol.247,No.5,pp.623-628,February5,1982.

C.A.L.Bassett,PulsingElectromagneticFields:“ANewMethodtoModifyCellBehaviorinCalcifiedandNon-CalcifiedTissue”.Calcified Tissue,Int.Vol.34,No.1:1-8,1982.

24

Biomet ® EBI Bone Healing System Components

Replacements and Components

Catalog # Description

1068234 ControllerAssembly–USA

1068233 ControllerOnlyRP

1068208 ClipHolderRP

1068209 ExtremityBand

1068222 BeltStrapRP

1068315 ACWallAdapterRP–USA

1068225 SFLX1Coil

1068226 SFLX2Coil

1068227 SFLX2-1Coil

1068228 SFLX 2-4Coil

1068229 SFLX3Coil

1068235 SFLX4Coil

1068236 SFLX4-1Coil

1068237 SFLX4-4Coil

1068224 SFLX5Coil

1068238 SFLX-Coilette

1068239 SFLX-MiniCoilette

1068240 SFLX-XLCoilette

1068210 Cable“Zero”InchRP

1068215 Cable28" RP

1068223 Cable48"

1068313 BlackVelcro†StrappingFor SFLXTreatmentCoilette

1068314 BlackVelcro†StrappingFor SFLXTreatmentCoilette– ClavicleApplication

1068317 InternationalWallPlugBlade AdapterKit

RP = Replacement Part

Accessories

Catalog # Description

1067725-00 USBCableForCompliance Download

25

Electromagnetic Compatibility

• Theuseofaccessoriesandcablesother than those supplied may result in increased emissions or decreased immunity oftheequipmentorsystem

• Thisequipmentshouldnotbeusedadjacent to or stacked upon other equipment

• PortableandmobileRFcommunications equipmentcanadverselyaffecttheoperation ofMedicalElectricalEquipment

• Intheeventthisequipmentinterfereswith theoperationofotherequipment,or experiencesinterferencefromother equipment, to continue treatment it will be necessary to move the Biomet® EBI Bone HealingSystemawayfromthesource oftheinterferenceasindicatedintable4

The Biomet® EBI Bone Healing System must emit electromagnetic energy in order to performitsintendedfunction.Nearbyelectronicequipmentmaybeaffected.

The Biomet® EBI Bone Healing System is suitableforuseinallestablishments,includingdomestic establishments and those directly connectedtothepubliclow-voltagepowersupply network that supplies buildings used fordomesticpurposes.

Group 1 RFEmissionsCISPR11

RFEmissionsCISPR11

Harmonic EmissionsIEC61000-3-2

VoltageFluctuations/FlickerEmissionsIEC61000-3-3

ClassB

NotApplicable

NotApplicable

Emissions Test Compliance Electromagnetic Environment - Guidance

The Biomet®EBIBoneHealingSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet® EBI Bone Healing System should assure that it is used in such an environment.

Guidance and Manufactures Declaration – Electromagnetic Emissions

Table 1

26

Electromagnetic Compatibility (Continued)

Floorsshouldbewood,concreteorceramictile.Iffloorsarecovered with synthetic material, the relative humidity should be atleast30%.

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocation in a typical commercialor hospital environment.

Mains power quality should be thatofatypicalcommercialorhospital environment.

Mains power quality should be thatofatypicalcommercialorhospital environment.

Mains power quality should be thatofatypicalcommercialor hospital environment. IftheuseroftheBiomet® EBI Bone Healing System requires continued operation during power mains interruptions, it isrecommended that the Biomet® EBI Bone Healing Systembepoweredfromanuninterruptible power supply(UPS).

±6kVcontact± 8 kV air

3A/m

±2kVforpowersupplylines

±1kVforinput/outputlines

±1kVfordifferentialmode±2kVforcommonmode

<5%UT(>95%dipinUT)for0.5cycle

40%UT(60%dipinUT)for5cycles

70%UT(30%dipinUT)for25cycles

<5%UT(>95%dipinUT)for5sec

ElectrostaticDischarge(ESD)IEC610004-2

ElectricalFastTransient/BurstIEC610004-4

Powerfrequency(50/60Hz)magneticfield

SurgeIEC610004-5

Voltage dips, shortinterruptions andvoltage variationson power supplyinput linesIEC61000-4-11

Immunity Test IEC 60601 Test Level Compliance Level


Guidance and Manufactures Declaration – Electromagnetic Immunity

Table 2

Electromagnetic Environment - Guidance

PortableandmobileRFcommunicationsequipment should be used no closer toanypartoftheBiomet® EBI Bone Healing System, including cables, than the recommended separation distance calculatedfromtheequationapplicabletothefrequencyofthetransmitter.Recommended Separation Distanced=3.5√Pd=3.5√P80MHzto800MHzd=7√P800MHzto2.5GHzWherePisthemaximumpoweroutputratingofthetransmitterinwatts(W)accordingtothetransmittermanufactureranddistherecommendedseparation distance in meters (m).FieldstrengthsfromfixedRFtransmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequencyrange.bInterferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

3 Vrms

3V/m

80MHzto2.5GHz

ConductedRF

IEC61000-4-6

Radiated-4-6

IEC61000-4-3

1 Vrms

1V/m

Immunity Test IEC 60601 Test Level Compliance Level


NOTE1.At80MHzand800MHz,thehigherfrequencyapplies.NOTE2.Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedby

absorptionandreflectionfromstructures,objects,andpeople.

a.Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcast

cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due tofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheBiomet®EBIBoneHealingSystemisusedexceedstheapplicableRFcompliancelevel,theBiomet®EBIBoneHealingSystemshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,such as reorienting or relocating the Biomet® EBI Bone Healing System.

b.Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan1V/m.

Guidance and Manufactures Declaration – Electromagnetic Immunity

Table 3

Electromagnetic Environment - Guidance

27

28

Electromagnetic Compatibility (Continued)

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistance(d)inmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

NOTE1.At80MHzand800MHz,theseparationdistanceforthehigherfrequencyapplies.

NOTE2.Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objects,andpeople

Rated Maximum OutputPower of Transmitter

W

150 kHz to 80 MHz 80 MHz to 800 MHz 150 MHz to 2.5 GHz

d=3.5√P d=3.5√P

.35 .35

d=7√P

.01

1.1 1.1

.7

.1

3.5 3.5

2.21

1

11.06 11.06

7

10

35 35 70

22.13

100

Separation Distance (Meters) According to Frequency of Transmitter

The Biomet®EBIBoneHealingSystemisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheBiomet® EBI Bone HealingSystemcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetween portable and mobile communications equipment (transmitters) and the Biomet® EBIBoneHealingSystemasrecommendedbelow,accordingtothemaximumpoweroutputofthecommunications equipment.

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Biomet® EBI Bone Healing System

Table 4

29

Further Information

Biomet

399JeffersonRoad

Parsippany,NewJersey07054

1.973.299.9300

Ifyouareapatientandneedtocontact

Biomet,pleaseusethefollowingnumbers:

Ordering Replacements

• PatientServicesDepartment

• 1.973.299.9300

Returns/Defective Products/

Troubleshooting

• QualityAssuranceDepartment

• 1.973.299.9300

Questions About Your Bill

• PatientAdvocacyDepartment

• Phone:1.888.236.3652(USAonly)

• e-mail:[email protected]

30

Reimbursement Form

CPT Code 20974 Electrical Stimulation to Aid Bone Healing: Non-Invasive (Non-Operative)

FromaCPTperspective,anadditionalevaluationandmanagementservice(E/M-officevisitcode)isgenerallynotpayable;unless

• thephysicianisprovidingasignificant,separatelyidentifiableE/Mservicebeyond the noninvasive electrical bone stimulation; or,

• beyondtheusualpostoperativecareassociated with the procedure(s) performed;and,

• thephysicianisprovidingandmeetingthe three, key components (e.g., history, examinationandmedicaldecisionmaking).

Oncetheseadditionalrequirementsaremet,thentheappropriatelevelofE/Mservicewiththemodifier-25amended,maybereportedinadditiontoCPTcode20974.

CPT20974isexemptfromtheuseofmodifier-51(multipleprocedures)forservicesperformedonthesamedayoratthesamesession by the same provider.

Reimbursement Coding NoteCPT 20974 - Electrical Stimulation to Aid Bone Healing (Non-Invasive)

(CPTCode20974isconsideredtobeaminor procedurewithaglobalday“000”designation)

ABiometStimulatorhasbeenapplied asfollows:

Patient________________________________

Fracture/FusionSite______________________

Physician______________________________

Date__________________________________

Physician Management of Biomet Stimulators are generally recognized under CPT code 20974. This code encompasses services associated with the initial patient evaluation for stimulation, application and follow-up assessment related to the treatment system. (Global period for primary procedure remains the same.)

PleasenotethatfromaCPTperspective,officevisits(E&M-EvaluationandManagementCodes)aregenerallynotpayablewhenprovidedonthesamedayofserviceas20974.

31

Notes:

32

Notes:

To learn more about this product,

contact your local Biomet Sales Representative today.

Biomet® EBI Bone Healing SystemPhysician Manual and Package Insert English Language

OPTIONSThe industry’s most comprehensive options:

• PEMF,CCandDC

• Anatomyspecificcoils

• Wear-timechoice

EVIDENCE• Backedbyprovenscience

• Multiplescientificpapers

EXPERIENCERecognized as an industry

pioneer with EBI lineage, Biomet

has helped over one million people

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©2013EBI,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated.† denotes a third party trademark. Velcro® is a registered

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