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
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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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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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Operating Instructions (Continued)
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
Operating Instructions (Continued)
“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
Operating Instructions (Continued)
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
SFLX2-4 Minimum 8cm 8cm 10cm
Maximum 11cm 7cm 10cm
SFLX3 Minimum 5cm 7cm 7cm
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
SFLX4-1 Minimum 12cm 6cm 22cm
(Elliptical) Maximum 14cm 6cm 18cm
SFLX4-4 Minimum 9.25cm 10cm 12cm
Maximum 14.5cm 8cm 8cm
SFLX5 Minimum 13cm 12cm 10cm
Maximum 20cm 10cm 10cm
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
The Biomet®EBIBoneHealingSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet® EBI Bone Healing System should assure that it is used in such an environment.
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
The Biomet®EBIBoneHealingSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet® EBI Bone Healing System should assure that it is used in such an environment.
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:
33
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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