BIOMET EBI Bone Healing System User manual

The Biomet®EBI Bone Healing System
Physician Manual and Package Insert
English Language
399JeffersonRoad,Parsippany,NJ07054
800.526.2579•www.biomet.com•1068220-00Rev.A•BNS231188L
©2013EBI,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.
oroneofitssubsidiariesunlessotherwiseindicated.†denotes a third party trademark. Velcro®is a registered
trademarkofVelcroIndustriesandVelcroUSAInc.RxOnly.PrescriptionOnly-SingleUseOnly-
NotforRe-saleorRe-Distribution-DoNotReuse

Contents
ImportantSafeguardsandContents ................................. Page 1
Biomet®EBI Bone Healing System...................................Page2
 Description....................................................................Page2
Electrical Requirements ................................................Page2
SystemComponents......................................................... Page 3
FullPrescribingInformation..............................................Page4
 IndicationsforUse........................................................Page4
 Contraindications ..........................................................Page4
 Warnings,Precautions,AdverseEffects.......................Page5
General Treatment Instructions.........................................Page6
OperatingInstructions....................................................... Page 8
 Step1:BatteryCharging............................................... Page 8
 Step2:PreparingtheSystemtoBeginTreatment....... Page 9
 Step3:TreatingandCharging...................................... Page 9
 Step4:RechargingtheBatteries ..................................Page10
 ControllerHolder........................................................... Page 11
 KeypadFunctions..........................................................Page12
Troubleshooting System Messages.............................. Page 13
 ComplianceDataSoftware............................................Page14
SFLXFlexibleTreatmentCoils...........................................Page17
SFLX-1,SFLX-2,SFLX-3,SFLX-4
andSFLX-5CoilApplication ............................................. Page 18
 ConformingtheSFLXTreatmentCoil........................... Page 19
 CastedandNoncastedApplications .............................Page20
CleaningInstructions ....................................................Page21
TreatmentCompletion.......................................................Page21
ReturningDefectiveProduct .............................................Page22
 EquipmentClassification...............................................Page22
Disposal/Recycling .................................................... Page22
 SymbolDescription.......................................................Page22
OrderingInformation.........................................................Page23
References.........................................................................Page23
Biomet®EBIBoneHealingSystemComponents..............Page24
ElectromagneticCompatibility...........................................Page25
FurtherInformation ...........................................................Page29
ReimbursementForm .......................................................Page30

1
Important Safeguards and Contents
Read All Instructions Before Using
Whenusingelectricalproducts,basicsafety
precautions should always be observed:
! WARNING:Toreducetheriskofelectricshock,
fireorpotentialinjuriespleaseadheretothe
following:
1. Donotuseyourbonehealingsystemwhile
bathing.
2. Donotplaceorstoreyourbonehealing
 systemwhereitcanfallorbepulledintoa
 tub,sinkoranypoolofliquid.
3. Donotimmerseordropyourbonehealing
 system’scontrolunit,treatmentcoil,AC
 WallAdapter,inanyliquid.
4. Donotreachforyourbonehealingsystem
 thathasfallenintoaliquid.Unplugfrom
the wall outlet immediately.
5. DonotpermittheACWallAdaptertobe
connected when wet.
6. NevertouchtheACWallAdaptercontacts
 whentheACWallAdapterispluggedinto
 anACWalloutlet.
7. DonotplacetheACWallAdapterinthe
 bedwithyouifyouaretreatingwhileyou
are sleeping.
8. Neveroperateyourbonehealingsystemif
it has a damaged link cable, cord or plug,
 ifitisnotworkingproperly,ifithasbeen
dropped and damaged, or immersed into
 anyliquid.ContactBiometimmediatelyfor
a replacement part(s).
9. Keep all electrical cords and cables away
 fromheatedsurfaces.
10. Keepallelectricalcordsandcablesaway
 fromchildren.
11. Neverinsertanyobjectintoanyopeningof
your bone healing system.
12. Donotplaceyourbonehealingsystem’s
control unit in prolonged heat or direct
 sunlight.(Normaloperatingtemperature
 rangeis5°Cto38°C,[41°Fto100°F],
 20-80%RHnon-condensing,normal
 storage/transporttemperatureis-15°Cto
 60°C[5°Fto140°F].)
13. Useyourbonehealingsystemonlyforits
intended use as prescribed by your
physician and described in this manual.
14. Nomodificationtothisdeviceisallowedfor
any reason whatsoever.
15. Routineuseofbonehealingsystemsfor
 over30yearshasdemonstratedthatany
known hazard associated with their use
 doesnotpresentanunreasonableriskof
 illnessorinjurywhencomparedtothe
 benefitoftheiruse.
16. Useofyourbonehealingsystemforthe
spine and skull has not been evaluated or
approved.
*NOTE: Please contact the Biomet Patient
SupportDepartmentinParsippany,NewJersey
betweenthehoursof8:30a.m.and5:30p.m.
EasternTimeat1.973.299.9300withany
questions or problems.
SAVE THESE INSTRUCTIONS
Contents – Biomet®EBI Bone Healing System
Controlunit/Controller
Connectorcables(0"and28")
Belt
ClipHolder
ACWallAdapter
UserManualandPackageInsert
Carryingcase
CAUTION:RxOnlyFederalLaw(U.S.A.)restricts
thisdevicetosalebyorontheorderofa
physician.ForPrescriptionUseOnly.Single
prescription.Singlepatientuse.Notforre-sale.
Please note: This system does not contain a
treatmentcoil.PleasecontactyourBiomet/
EBIrepresentativeforthespecificanatomically
correct treatment coil.
*NOTE:TheControlUnitmustnotbewornon
the coil.

2
Biomet®EBI Bone Healing System
SFLX Treatment Coil
Description
The Biomet®EBI Bone Healing System
promotes healing by inducing weak pulsing
electricalcurrentsatthefracturenonunion
site. These signals are generated by a low
energyelectromagneticfieldcreatedbypassing
specificcurrentpulsesthroughananatomically
configuredtreatmentcoil.
Electrical Requirements of AC Wall Adapter
Unit – USA/Americas
 Input:100–240V~50–60Hz0.3-0.8A
 Output:12V @2.0AMAX
DonotuseanyotherACwalladapterwiththe
Biomet®EBI Bone Healing System.
Electrical Requirements
The Biomet®EBIBoneHealingSystemControl
unitisavailableinthefollowingconfiguration.
Americas
• IncludesanACAdapterchargerwitha
standard two prong plug
*NOTE: AnInternationalWallPlugBlade
AdapterKitisavailableforpatientswhowillbe
travelingoutsidetheUSandwishtocontinue
their treatment while abroad.

3
System Components
Control Unit – Controller
The Biomet®EBI Bone Healing System control
unit operates on a permanently installed lithium
ion,rechargeablebatterywhichfacilitates
ambulatory use. The control unit contains solid
state electronics programmed to operate the
SFLXfamilyofTreatmentCoils.Itincludes
anaudibleandvisibleselfcheckingalarm
mechanismtoalertthepatientiftheunitisnot
functioningproperly.
*NOTE: The control unit can not be used with
theFLX®familyofTreatmentCoilsusedwith
the EBI Bone Healing System®-Model2001.
The control unit is designed to store the
patient’sdailytreatmentinformation.Patients
are recommended to bring the control unit and
treatmentcoiltoeachfollow-upvisittoprovide
the opportunity to review their overall treatment
complinace in how they are using their Biomet®
EBI Bone Healing System.
*NOTE:Whilewalking,thepatientmaywearthe
controlunitcomfortablyonabeltorthewaist
usingtheClipHolder.
Battery Charger/AC Wall Adapter
1. TheACWallAdapterisdesignedto
recharge the permanently installed battery
inside the control unit. (See step 3: Treating
andCharging–page9)
2. Thecontrolunitallowsfortreatingwhile
charging.
DonotuseanyotherACWallAdapterwiththe
Biomet®EBI Bone Healing System.
Link Cable
The link cable connects the control unit to its
SFLXFlexibleTreatmentCoil.Thelinkcables
suppliedare“zero”and28"cables.Anoptional
linkcableisalsoavailableina48"length.For
a48"cable, call the Biomet Patient Support
Departmentat1.973.299.9300.Outsidethe
UnitedStatescontactyourlocalEBI/Biomet
Distributor.
SFLX Flexible Treatment Coil
TheSFLXFlexibleTreatmentCoilisanencased
wire 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.
Aspecificelectricalcurrentisdeliveredtothe
coil by the control unit. The coil then delivers
the therapeutic electromagnetic signal to the
fracturenonunionsite.
*NOTE: TheSFLXCoilisnotincludedwith
the system assembly and will be provided
separately by your Biomet sales representative.
*NOTE:TheControlUnitmustnotbeworn
on the coil.
Controller
Coil
Cable

4
Full Prescribing Information
ThemechanismofactionbehindthePEMF
technologyinvolvestheupregulationoffactors
thatmodulatenormalbonehealing.PEMF
increasesanumberoffactorssuchasTGF-
β1,BMP-2andBMP-4,whicharenormal
physiologicalregulatorsofthevariousstages
ofbonehealing,includingangiogenesis,
chondrogenesis and osteogenesis.
Intended User Profile
The EBI Bone Healing System®is intended to
treat adults who have been medically diagnosed
withafracturenonunionorfailedfusioninthe
appendicular system. It is also intended to treat
congenital pseudarthrosis in the appendicular
sytem in pediatric patients not skeletally
mature.
Indications for Use
The Biomet®EBI Bone Healing System
isindicatedforthetreatmentoffracture
nonunions,failedfusions,andcongenital
pseudarthrosisintheappendicularsystem.A
nonunion is considered to be established when
there are no visibly progressive signs
ofhealing.
Theoriginal1979PMAstudyincluded146
patientswithnonunionfractures.Thesedifficult
fractureswerecharacterizedasfollows:2.3
averagenumberofpriorsurgeriesandan
averageofthirty-sevenmonths(median
twentymonths)sinceoriginalinjury.These
patientswerefollowedforaminimumoffour
years(averagesevenyears)fromthedateof
treatment termination, with a success rate
of63.5%.Eventhoughlongtermfollow-up
requirements were not included in the original
studydesigns,afollow-uprateof82%was
achieved.Forty-three(43)oftheoriginal48
patients in the congenital pseudarthrosis study
wereclassifiedbyBassett1whodefinedthe
tibiallesionsasTypeI(n=6),TypeII(n=19)
and Type III (n=18), with Type III being the
most severe and recalcitrant to treatment. The
successrateforBassettTypeIlesionswas
66.7%,BassettTypeIIlesions57.9%and
BassettTypeIIIlesions22.2%.Thelongterm
posttreatmentfollow-upforthecongenital
pseudarthrosisstudypatientpopulation(n=48)
wastoskeletalmaturityortheageof18.The
studyhadan87.5%follow-uprate.
1. BassettCAL,NCauloandJKort,“Congenital
pseudarthrosisofthetibia:Treatmentwith
pulsingelectromagneticfields”.
ClinicalOrthop,154:136-149,1981.
Contraindications
A. Nonunionfracturesinwhichasynovial
pseudarthrosis(fluidfilledgap)exists.
B. Undercertainconditions,electromagnetic
stimulation could inhibit or impair the
functioningofcertainexternal,non-invasive
and/orimplanted,invasiveactivemedical
devicesinclusiveof“allactiveelectricaland
non-activeconductive/metallicimplants”
as well as “worn medical devices” due to
adverse events that may occur with other
activeelectricalimplants(e.g.,SpinalCord
stimulators,ImplantableCardioverter-
defibrillators,etc.)Theimpactoreffectof
pulsedelectromagneticfieldsgenerated
by a non invasive bone growth stimulator
onthefunctionofotheranatomical
stimulators, pain pumps, insulin pumps,
implanted spinal nerve stimulators and
similar active devices has not been
evaluated.

5
C. UseoftheBiomet®EBI Bone Healing
System on pregnant patients has not been
 evaluated;therefore,itisnotrecommended
in these cases.
D. TheBiomet®EBI Bone Healing System has
notbeentestedforsafetyorbeenevaluated
forheatingintheMRenvironment.The
effectsofMRIproceduresandscansusing
MR systems has not been determined
orestablished:therefore,MRIscansand
proceduresshouldnotbeperformedon
patients until the device system has been
completely removed.
 MRUnsafe-NotforMRIUse
Warnings
A. Thelongtermeffectsofexposureto
lowlevelmagneticfieldsarenotknown.
Routineuseofthebonehealingsystem
devicesforover30yearshasindicatedno
known risks.
B. Duringthetreatmentofpatientswithopen
epiphyses, when the epiphysis is in the
pulsingfield,physiciansareadvisedthat
the epiphyseal growth plates should
bemonitoredforpossibleeffects.
C. UseoftheBiomet®EBI Bone Healing
Systemforthespineandskullhavenot
been evaluated.
D. Toreducetheriskofpotentialinjury:
 1. AVOIDtouchingtheACWallAdapter
contactswhentheACWallAdapteris
pluggedintoanACoutlet.
 2. DONOTchargethebatteryinbedif
treating while sleeping.
E. The control unit is electrically live when
connectedwiththeACWallAdapterand
pluggedintoanoutlet.Toreducetheriskof
seriousinjurybyelectricshockpatientsare
advised:
 1. DONOTpermittheACAdaptertobe
connected when wet.
 2. DONOTimmersethecontrolunit,
treatmentcoil,ortheACWallAdapter
in any liquid.
Precautions
Thefollowingconditionsmaycompromisea
successfultreatmentoutcome.
A. Nonunionfractureswithgapsinexcess
 of1.0cm.
B. Presenceoffixationdevicesor
instrumentationmadefrommagnetic
materials.
Please note: Most presently used internal
orexternalfixationdevicesareconstructed
of316LS.S.,titaniumalloys,andcobalt-
chromiumalloyswhicharenon-magneticand,
therefore,compatiblewiththeBiomet®EBI
Bone Healing System.
Adverse Effects
Based upon an historical adverse event report re-
viewcomposedofMedicalDeviceReports–MDRs
identifiedwithintheFDAManufacturerandUser
FacilityDatabaseforsimilar,relevantdevices,the
probabilityofexperiencinganadverseeventwhen
usingaBoneHealingSystemisextremelyunlikely,
orlessthan1%(.0133%).
The database, although imprecise is intended to
provideandpresentageneralsummaryofproduct-
specificeventdatathatmanufacturers,userfacilities
anddistributorsprovidetotheFDAbasedupon
relevantproductcodesforsimilardevices.
The original EBI Bone Healing System was approved
andintroducedin1979.Sincethen,over600,000
systemshavebeenmarketed.Thesafeandeffec-
tiveuseofnon-invasivebonegrowthstimulation
devices over this time has clearly established their
therapeuticbenefitofuse.Inaddition,allknown
hazardsassociatedwiththeuseofBoneHealing
Systemsdonotpresentanunreasonableriskof
illnessorinjurywhencomparedtotheirtherapeutic
benefitandcanbetypicallyaddressedbyeither
modifyingorterminatingtreatment.

6
General Treatment Instructions
Recommended Usage
The recommended daily treatment dosage is
normally10hoursperday.
Althoughthedevicewasshowntobeeffectiveat
treatmenttimesbetween3to10hoursperday,a
reviewoftheclinicaldatahasshownthathealing
may occur earlier when treatment is achieved at
therecommended10hoursperday.
Compliancewiththerecommendedten (10)
hoursperdaytreatmentisveryimportant.A
reviewoftheclinicaldatademonstratesthat
lessthantherecommendeduseofthisdevice
possibly results in an increase in the time to
healyourfracture.Ifyouareunabletotreatfor
ten continuous hours, it is recommended that
you break up the total treatment time into more
thanonesession.Pleaserefertothefollowing
General Treatment Instructions.
General Treatment Instructions
Treatment should not be suspended until
healing occurs or until such time as the
prescribing physician recommends
discontinuationofthedevice.
The Biomet®EBI Bone Healing System is
programmedtodeliveramaximumof270
therapeutic treatment periods. Biomet
recommends a therapeutic treatment period
of10hoursperday.Atherapeutictreatment
periodisdefinedasa10hourtreatment
session accomplished either continuously or
discontinuouslyinsegmentstotaling10hours.
• 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.
Allhourstreatedwillbeelectronicallyrecorded
and stored within the controller. Patients unable
to treat on consecutive days will be able to treat
non-consecutivelywithin400daysafterthe
firstone-hourtreatmentperiod.Ifthedevice
isnotusedfora12hourperiod,thetreatment
clock will automatically reset and be ready to
deliverthenext10hourtherapeutictreatment
periodwhennextturnedon.
•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.
Themaximumrecommendedtherapeutic
treatmentperiodisninemonths(approximately
270days).

7
*Note:
•Thecontrolunitshouldbeturnedoffwhen
finishedwiththetreatmentsession
•Whenreadytoresumetreating,turnthe
control unit on. The display will indicate the
treatment time that has been completed and
keepstrackofthecumulativetreatmenttimefor
the day
•Ifthepatientdoesnotfinishtenhoursinthat
day, then use the RESET button to return the
time to zero
Forconvenience,thedailytreatmenttimeis
displayed continuously in hours and minutes.
Aftertenhoursoftreatment,thedisplaywill
read“10:00”,andbeepthree(3)times,and
thenshutoffautomatically.
ATTENTION: This is a single patient use device,
donotreuse.ForPrescriptionUseOnly.The
Biomet®EBI Bone Healing System is a durable
therapeuticelectricaldeviceintendedforsingle
patient 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
anotherpatientorfortreatmentotherthan
initially prescribed.
This device has been designed to reduce the
riskofpotentialreusebyautomaticallyceasing
tofunctioninaccordancewiththeGeneral
TreatmentInstructionsspecifiedanddefined
within.
Recommended Concurrent Fracture
Treatment
The Biomet®EBI Bone Healing System works
bestwhenmotionofthefracturesiteis
minimizedornonexistent.Thisimmobilization
is achieved by applying a well molded plaster or
syntheticcastatthebeginningoftreatment
(togetherwithinitialnon-weightbearingifitis
treatingthelowerextremity.)
• Ankle/Tarsals/Metatarsals:shortlegcast
or rigid internalfixation
• Tibia:stableinternalorexternalfixation,
or long leg cast (short leg cast with rigid
 fixation)
• Shoulder/Clavicle:braceorabductionsplint,
 internalfixation,orfigureeightimmobilization
• Humerus:stableinternalfixationand/or
adequate immobilization with controlled
rotation
• Scaphoid/Wrist:stableinternalfixationor
long arm cast with thumb spira (short arm
 castwithrigidfixation)
• Carpals/Metacarpals/Phalanges:cast,
 internal,orexternalfixation

Operating Instructions
BeforeusingtheBiomet®EBI Bone Healing
Systemforthefirsttime,thepermanently
installed battery housed within the control unit
mustbefullycharged.
Step 1: Battery Charging
The Biomet®EBI Bone Healing System
operatesonalithiumionbattery.Before
treating with the system,thepatientmustfully
chargethebattery.Atroomtemperatures,
(24°C[75°F])chargingmaytakeuptothree
andone-halfhours.
Controller
A. PlugtheACAdapterintoanACwalloutlet.
B. ConnecttheACWallAdaptertothe
Controller.Theorangelightontheside
oftheControllerwillilluminatewhilein
charging mode.
C.
UnplugtheACWallAdapterfromthewall
 outletanddisconnectitfromtheController,
 afterchargingiscomplete.
*NOTE:Duringbatterycharging,itisnormal
forthecontrollertoexhibitamoderate
increaseinoperatingtemperature.Oncethe
batteryisatfullcapacity,batterycharging
automatically stops and the controller will
return to an ambient state.
*NOTE:Forbatterychargingandrecharging
incountriesoutsidetheUSAwithdifferent
power grid requirements, the plug blades
should be replaced on the charger adapter to
conformtolocalpowergridrequirements.
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
readandfollowthesesafetyinstructionsand
warningsinconjunctionwiththeImportant
safeguardsprovidedwithinthismanualbefore
using or charging the battery within your
control unit.
•Donotattempttoopenthecontrolunitto
access the battery or its internal electronic
componentsforanyreason.Nounauthorized
modificationofthecontrolunitisallowed.
•Neverattempttochange,adjustorreversethe
battery’spolarityconnectionsforanyreason.
•Donotalloworpermitthecontrolunitorits
permanently installed battery to be physically
mishandled, abused, crushed, mutilated or
penetratedbyanymetalobjectsuchasanail.
•Neveralloworpermitanymetalobjectto
touch or contact the permanently installed
battery’s terminals.
•Neverstorethecontrolunitorchargethe
batteryinextremetemperatures.
•Neverchargethebatteryunattended.
•
Alwayskeepthecontrolunitawayfromchildren.
Anyabuseormisusetothecontrolunitorits
permanently installed battery may result in seri-
ouspersonalinjuryand/orpropertydamage.
Biomet®isnotliableforanysuchabuse,
misuse or resulting damage.
Toensurepropercharging,ONLYUSEtheAC
WallAdaptersuppliedwithyourdevicesystem
andfollowthespecificoperatinginstructions
provided within this manual.
Alwayskeepthecontrolunitanditsperma-
nently installed battery dry.
Whenalltreatmenthasbeencompleted,the
control unit and permanently installed battery
8

9
Battery Safety Warning (continued)
MUSTBEdisposedofproperly.IntheUSA,
disposalinformationmaybeobtainedby
contacting the Rechargeable Battery Recycling
Corporation Hotline (RBRC)at1-800-822-8837.
Pleasecontactlocalrecyclingauthoritiesfor
properdisposalinformationandinstructionsif
outsidetheUSA.
Neverdisposeinnormalhouseholdwasteorrefuse.
Normalchargingtemperaturerangeis50°F
(10°C)to+95°F(35°C).
Step 2: Preparing the System to Begin Treatment
The Biomet®EBI Bone Healing System includes
twolinkcables:“zero”lengthand28".The
cableexitingthecontrolleris41/2"long.All
SFLXTreatmentCoilshavean8"cable.Hence,
useofthe“zero”lengthlinkcablewould
separatethestimulatorcontrollerfromthe
treatmentcoilbyapproximately14".Useof
the28"linkcablewouldseparatethecontroller
andtreatmentcoilbyapproximately41".A
linkcableof48"isavailablefromBiometasa
replacementpart.(Seeorderinginformation
page24.)The48"and28"linkcablescannotbe
usedwiththeSFLX5treatmentcoil.
*NOTE: The Biomet®EBI Bone Healing System
isnotcompatiblewiththeFLX®Coilsusedwith
the EBI Bone Healing System®–Model2001.
Afterconfirmingthatthelinkcableisproperly
connected to the controller, connect the other
endofthelinkcabletotheSFLXFlexible
TreatmentCoil.Thisconnectionallowsforsimple
quick disconnect and reconnect by the patient.
Next,positiontheSFLXFlexibleTreatment
Coiloverthefracturenonunionsite.Theentire
fracturenonunionsiteshouldbecentered
withinthecoiltreatmentwindow.During
treatment,thepositionofthetreatmentcoil
mayshiftduetopatientactivity.Thetreatment
coilmustbeadjustedandcenteredasrequired
tocoverthefracturenonunionsite.
Step 3: Treating and Charging
Patients may treat with the system while
rechargingthebattery.Whenthepatienttreats
and 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.FollowinstructionsStep1,(Page8)-
Controller
*NOTE:Iftreatingwhilethecontrollerunitis
connectedtotheACAdapter,thedisplaywill
read,“TREATING00:00BATTERYCHARGING”.
Oncethepatienthascompletedthetreatment,
theyshouldturnthecontrolleroff,andleave
itconnectedtotheACAdaptertocontinue
chargingthebattery,untiltheLEDchanges
fromorangetogreen.
TREATING00:00
BATTERYCHARGING

10
Operating Instructions (Continued)
Step 4: Recharging the Battery
The average daily treatment time supplied by
the battery in the controller will vary according
tothesizeofSFLXTreatmentCoilbeingused.
Thecontrollerwilldeliveraminimumof10
hoursofunsegmentedcontinuoustreatment
foralltreatmentcoilsexcepttheSFLX-4and
SFLX-5TreatmentCoils.Thecontrollerwill
deliver a minimum seven hour unsegmented
continuoustreatmentwiththeSFLX-4
TreatmentCoilandathreehourminimum
unsegmented continuous treatment with the
SFLX-5TreatmentCoil.Atroomtemperatures,
(24°C[75°F])chargingmaytakeuptothree
andone-halfhours.
Aftercompletingadailytreatmentsession,
patientsshoulddothefollowing:
A.Turnthecontrolleroff.
B.FollowinstructionsA-Cfrom
 Step1.Controller(Page8)
C.Itisnotnecessarytodisconnectthe
controllerfromtheACAdapterchargeronce
fullycharged.Thecontrollercanremain
pluggedintotheACWallAdapteruntilthe
patient’snexttreatmentsession.
*NOTE: The controller’s permanently installed
batterycannotbeovercharged.Ifthecontroller
ispluggedintotheACAdapterandthebattery
isfullycharged,thechargerwillterminatethe
rechargingprocessearly.Duringthecharging
processtheLEDadjacenttotheplugwillremain
orange and once the charging is complete
theLEDwillturngreen.Therefore,donotbe
concernedifthebatteryisinadvertentlycharged
more than once.
When the Controller Needs Recharging
1. The display will read “Recharge Battery”;
“Treatment Halted” and emit three audible
beeps.Oncebeepingstops,theController
willautomaticallyshutOFF.
Afterdailytreatment,turnthecontrollerOFF
and recharge as described in step 1: Battery
Charging.(Seepage8).
*NOTE:Anexcessivelylowbatterywillresultin
noLCDdisplay.
Ifyouareexperiencingchargingdifficulties,
pleaseverifythatallelectricalconnectionsare
established. Then try charging the controller
again.Ifyouarestillexperiencingdifficulties,
contactBiomet.Foracompletelistingof
contactinformation,refertopage29.
RECHARGEBATTERY
TREATMENTHALTED

11
Battery Indicator Display
Thecapacityofthebatteryisdisplayedduring
thecourseoftreatment.Fourbarsindicates
afullchargewiththreebarsindicating
approximately75%charge.
California Perchlorate Label
The controller contains a permanently installed
back up battery mounted on the printed circuit
boardthatcontainsverysmallamountsof
perchlorate.Californialawrequiresthefollowing
label:“PerchlorateMaterial–specialhandling
may apply. See www.dtsc.ca.gov/hazardous-
waste/perchlorate.” There is no special handling
required by patients.
Avoid Potentially Explosive Atmospheres
Areaswithpotentiallyexplosiveatmospheres
areoften,butnotalways,postedandcan
includefuelingareas,suchasbelowdecks
onboats,fuelorchemicaltransferorstor-
agefacilities,orareaswheretheaircontains
chemicals or particles, such as grain dust, or
metal powders.
Whenthepatientisinsuchanarea,turnoff
your controller and do not charge the battery.
In such areas, sparks can occur and cause an
explosionorfire.
Controller Clip Holder
• Thecontrollermaybewornonabeltina
clip holder that is included in the system,
 orintheoptionalextremityband.Theholder
will securely hold the controller during
normal treatment.
• Toinsertthecontrollerintotheclipholder,
 alignthefrontofthecontrollerthatfeatures
 thereset/backlightbuttonfacingawayfrom
 theclipholder.Aligntheslotsonthe
 controllerunitwiththepairofmatchingtabs
on the clip holder. Press the controller into
the holder until the tab engages.
 Anaudibleclickshouldbeheard,thus
securing the controller to the holder.
• Adjustclipholderplacementtomaximize
 patientcomfortandavoidpossibleimpacts
 withfurniture,etc.
Keep the Bone Healing System and its
accessoriesawayfromsmallchildren
These devices are not toys and may be
hazardoustochildren.ForExample:
• Achokinghazardmayexistforsmall
detachable parts
• Improperusecouldresultinexposuretoa
 treatmentsignalforwhichtherisksof
 exposuretochildrenhavenotbeen
established
Driving Precautions
Theuseofanoninvasivebonehealingsystem
while driving may cause or contribute to
potentially hazardous distractions. Patient
shoulddiscontinueusewhiledrivingifthis
occurs.

12
Operating Instructions (Continued)
Keypad Functions
On/Off Button
EachtimetheON/OFFbuttonispressed,
an audible beep will be heard. To turn the
controlleron,presstheon/offbuttononetime.
Pressingthisbuttonasecondtimeforatleast
onesecondwillturnthecontrolleroff.Every
time the controller is turned on, the display will
indicatethefollowingsequence:
1.“RECOMMENDEDUSE10HOURSPER
DAY”fortheBiomet®EBI Bone
Healing System.
2.“PATIENTUSAGE”;“AVGHR/DAY00:00”-
This is the daily treatment average since the
patient’s treatment started.
3.“PATIENTUSAGE”;“DAYSUSED000”-
 Thisisthetotalnumberofdaysof
treatment.
4.“PATIENTUSAGE”;“DAYSUNUSED000”-
Thisisthetotalnumberofdayswhenthere
was no treatment.
5.“TREATING00:00”;“BATTERY ”-
Thisisthecumulativenumberofhours
oftreatmentinthepresentorprevious
treatment session, provided that the reset
button has not been pressed (see RESET
BUTTON).
6.PressingtheRESETbuttonwillresultin
thedisplayreading“RESETTING...”forap-
proximatelythreeseconds.Thedisplaywill
then return to display as indicated in number
fiveabove.
1.
2.
3.
4.
5.
6.
RECOMMENDEDUSE
10HOURSPERDAY
PATIENTUSAGE
AVGHR/DAY00:00
PATIENTUSAGE
DAYSUSED000
PATIENTUSAGE
DAYSUNUSED000
TREATING0:00
BATTERY
RESETTING...
RESET and Display Backlight Button – Located
on the Body of the Controller
The controller is designed with a backlight
functiontoenhancethevisibilityoftheLCD
displayindimlighting.Whenpressedbriefly,
thedisplay’sbacklightwillturnonfor5
seconds. The system is designed with a reset
functiontoallowthedailytimertobereset
tozero.Shouldthepatientnotfinishtheten
hoursoftreatmentinoneday,he/shepresses
theRESET/Backlightbuttonfortwo(2)beeps
and the daily timer will go back to zero in
preparationforthenexttreatmentsession.The
treatment time will be retained on the display
unlesstheRESETbuttonisdepressedfortwo
audible beeps.

13
Toavoidtheaccidentalresetofthedailytime,the
RESETfunctionhasathreeseconddelay.When
pressedformorethanonesecond,thecontroller
will beep. To clear the time back to zero, continue
holding the button until a second beep is heard
(approximatelythreeseconds).Releasethe
RESET/Backlightbutton.Thiswillclearthetime
backto0:00.
Followingcompletionofyourdailytreatment,
youshoulddothefollowing:
1.Makesurethecontrollerisoff.Ifyou
havecompleted10hours,theunitwill
automaticallyshutoff.Withlessthan10
hoursoftreatment,youwillneedtomanually
turnthecontrolleroff.
2.InserttheACAdapterchargerintothe
controllertorechargethebatteryforyour
nexttreatment(seeStep1:BATTERY
CHARGINGpage8).
The Biomet®EBI Bone Healing System may
be used at home or at work. Your patient’s
scheduleandlifestylewilldeterminethebest
timeforusingthesystem.Manypeoplefindit
convenient to treat while they are sleeping.
Troubleshooting System Messages
Allowuptooneminuteforthedisplaymessage
tochange,aftertakingcorrectiveaction.
• “RECHARGE BATTERY TREATMENT
HALTED”Ifthismessageappears,the
battery needs to be recharged. This message
will only appear during a treatment session.
In order to recharge the battery and
 continuetreatment,connecttheACWall
Adapterandturnthecontrolleron.Refer
toStep4:(Page10)“RECHARGINGTHE
BATTERY”
“Check Connectors See Manual”
This message, accompanied by audible beeps,
appears when the controller is not properly
connectedtotheSFLXTreatmentCoilwhen
the controller is turned on. The controller will
turnitselfoff.Besuretocheckallelectrical
connections between the controller, link cable
andtreatmentcoil.Whenthecontrolleris
turned back on and the message continues,
check all cable connections again. Ifyouneed
assistance,youshouldcall1.973.299.9300
and ask to speak to a Patient Support
Representative.OutsidetheUnitedStates
contactyoulocalEBI/BiometDistributor.
”Check Coil See Manual”
This message, accompanied by three to
fouraudiblebeeps,appearswhentheSFLX
TreatmentCoilisdisconnected,damaged,
orinappropriatelyflexed.Themessagewill
stay on the display until the controller turns
itselfoff.Ifyouneedassistance,youshould
call1.973.299.9300andasktospeaktoa
PatientSupportRepresentative.Outsidethe
UnitedStatescontactyourlocalEBI/Biomet
Distributor.
RECHARGEBATTERY
TREATMENTHALTED
CHECKCOIL
SEEMANUAL
CHECKCONNECTORS
SEEMANUAL

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
“CANNOTTREAT”willappearandalternate
with“CALLBIOMET1-973-299-9300”.If
the patient needs assistance, they should
call1.973.299.9300andasktospeaktoa
PatientSupportRepresentative.Outsidethe
UnitedStatescontactyourlocalEBI/Biomet
Distributor.
“System Endpoint Call Biomet”,
Whenthecontroller’sinternaltimerreaches
400daysofoperationfromthefirstonehour
treatmentor270therapeutictreatments,the
treatmentsignalislockedoff.Thecontroller’s
LCDdisplaywillread“SYSTEMENDPOINT
CALLBIOMET”Thismessagewillappear
everytimethecontrolleristurnedon.Atthis
point, 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
22forDisposalInstructions.
CANNOTTREAT
CALLBIOMET
1-973-299-9300
Alternates with
SYSTEMENDPOINT
CALLBIOMET
Compliance Data Software Introduction
(Physician Use Only)
This bone healing system contains embedded
softwareandfirmwarewhichallowsthedisplay
ofpatient-specifichistorydataincludingusage
andtherapeutictreatmenttimeviauseof
BiometComplianceDataDownloadSoftware.
TheComplianceDataDownloadSoftwareis
classifiedasamedicaldevicedatasystem
(MDDS).Itsprimaryfunctionistheelectronic
retrieval,transfer,display,andstorageof
devicegenerated-specificpatienthistorydata,
withoutalteringthefunctionorparametersof
theconnecteddevice.Thissoftwareisonly
intendedtobeusedandinterfacewiththe
followingBiometdevices:
• Biomet®EBI Bone Healing System
• Biomet®SpinalPak®Non-invasiveSpine
 FusionStimulatorSystem
• Biomet®OrthoPak®Non-invasiveBone
Growth Stimulator System
Thesoftwareisavailableasadownloadable
executablefiletoBiometrepresentativesonly
through a secure web portal.
Patient Usage Reports (Physician Use Only)
TheComplianceDataDownloadSoftwarewill
downloadandtransferdevice-specificpatient
historydataviaaUSBcablefromtheattached
devicetoapersonalcomputer(PC)anddisplay
itonthePC’smonitor.Itcanthengeneratea
read-onlyreport,inAdobePDFformat,which
can be saved or printed. The device does
not record a patient name or diagnosis. The
analysisofthedownloadedpatienthistorydata
must be limited to the prescribing physician.
Theprintout/displayincludes,amongother

15
information,daysused,averagehoursperday,
daysun-usedanddayslapsed.Totaltreatment
timeisdisplayedalongwithagraphofthe
numberoftreatmentsessionsrecordedat
specifictreatmentdurationhourintervals.
Careshouldbetakennottomanipulatedatain
any way.
Biomet recommends patients bring their
controllertoeachfollow-upvisitsothat
accumulated 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)
Beforestarting:
1)ObtainaUSBcableforcompliancedownload
forpatienthistorydatatransfer(yourBiomet
representative has this).
2)Call/ContactyourlocalBiometrepresentative
toarrangedownloadoftheComplianceData
DownloadSoftware.
ConnecttheUSBAccessorycablefor
compliancedownload(PN1067725-00)to
thedevice’sUSBportlocatedonthesideof
thecontrollertotheleftofthepowerbutton.
ConnecttheUSBcabletoanopenUSBporton
aPC.Turnonthedevice.OpentheCompliance
DataDownloadSoftwareonthePC,andan
introductoryscreenwillappear.Followthe
instructions.
Troubleshooting
Ifconnectionorprintingproblemsoccur,
please check all connection cables or your
network administrator. Please call Biomet (page
29)shouldanyadditionalproblemsarise.
Warnings
TheComplianceDataDownloadSoftwaremust
only be run on a personal computer operated
byorundertheguidanceandsupervisionofa
Biometsalesrepresentative.Thissoftware
isonlyintendedtobeusedwiththefollowing
Biomet devices:
• Biomet®EBI Bone Healing System
• Biomet®SpinalPak®Non-invasiveSpine
 FusionStimulator
•Biomet®OrthoPak®Non-invasiveBone
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
00-1 1-2 2-3 3-4 4-5 5-6 6-7
7777
14 14
12 11 10 9
7-8 8-9 9-10
Treatment Hours
NumberOfSessions
Sample

Patient Usage Report
Device: Biomet®EBI Bone Healing System
Demonstration mode – Invalid Data
17
SFLX Treatment Coils
Depth of Penetration Specifications for SFLXTreatment Coils
SFLX 1, 2, 3, 4, 5, and Coilette Treatment Coils Tolerances
SFLXCoil M/L Flexion Depth of Vertical Anatomical
Penetration
Fracture Length Location(s)
SFLXMiniCoilette Minimum 2.5cm 2.5cm 1.5cm 
 Maximum 3.5cm 2cm 1.5cm
 SFLXCoilette Flat N/A 2.75cm 4cm
  Elliptical N/A 3.5cm 4cm
  Saddle N/A 3.5cm 2cm
 SFLXXL Flat N/A 3.5cm 6cm
 Coilette Elliptical 5cm 4.25cm 4cm
  Saddle 7.5cm 5.5cm 4cm
SFLX1 Minimum 9cm 6.5cm 7cm
  Maximum 13cm 5.5cm 6cm
 SFLX2 Minimum 8cm 8cm 10cm
  Maximum 11cm 7cm 10cm
 SFLX2-1 Minimum 10cm 5cm 16cm
 (Elliptical) Maximum 12cm 4.5cm 14cm
 SFLX 2-1 Minimum 8cm 8cm 10cm
 (Saddle) Maximum 11cm 7cm 10cm
 SFLX2-4 Minimum 8cm 8cm 10cm
  Maximum 11cm 7cm 10cm
 SFLX3 Minimum 5cm 7cm 7cm
  Maximum 9cm 5.5cm 6cm
 SFLX4 Minimum 9.25cm 10cm 12cm
  Maximum 14.5cm 8cm 8cm
 SFLX4-1 Minimum 9.25cm 10cm 12cm
 (Saddle) Maximum 14.5cm 8cm 8cm
 SFLX4-1 Minimum 12cm 6cm 22cm
 (Elliptical) Maximum 14cm 6cm 18cm
 SFLX4-4 Minimum 9.25cm 10cm 12cm
  Maximum 14.5cm 8cm 8cm
 SFLX5 Minimum 13cm 12cm 10cm
  Maximum 20cm 10cm 10cm
phalanges
clavicle, metatarsals,
scaphoid, distal
radius, cuboid, medial
lateral malleolus
foot,hand,small
bones
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,distaltibia/fibula
midshaftfemur,tibia,
fibula,humerus
tibia,fibula,humerus,
radius, ulna
tibia,fibula,humerus,
radius, ulna
ankle
femur(proximalor
midshaft)

18
*NOTE: The Biomet®EBI Bone Healing
System does not include a treatment coil. The
prescribing physician and Biomet representative
willselectthetreatmentcoilsuitableforthe
particularpartofthepatient’sanatomytobe
treated.Ifinitiallytreatingwithacasttreatment
coil can be interchanged in the event a cast is
removed.ContactyourBiometRepresentative
forasuitablereplacement.The48"and28"
linkcablescannotbeusedwiththeSFLX-5
TreatmentCoil.
AllSFLXCoil–Anatomicalplacement
instructionsandFlexionGaugesareincluded
with the coil.
Specialtytreatmentcoilsareforapplications
where the standard straps may not be adequate
to secure the treatment coil. Each specialty
SFLXTreatmentCoilfeaturesone(1)snap
atallfourcornersofthecoilandcomes
pre-assembledtofittherightsideofthebody,
but the same snaps and straps may be easily
switchedforleftsideapplications.
Application Instructions for the SFLX-1, SFLX-2, SFLX-3, SFLX-4 and SFLX-5 Treatment Coils
Appliesto:
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,DistalTibia/Fibula
 SFLX-4 1068235 MidshaftFemur,Tibia/Fibula,Humerus
 SFLX-5 1068224 Femur–ProximalorMidShaft
*NOTE:Givencertainanatomiclocations,treatmentcoilsmayhaveatendencytomigrateawayfrom
theintendedtreatmentarea.Oftenthismovementisassociatedwithpatientactivity,mobilityorthe
underlyingsurfacethetreatmentcoilrestson(skin,shirt,cast,etc.).Thetreatmentcoilstrap(s)may
beloosenedandthetreatmentcoilmustbeadjustedandcenteredasrequiredtocoverthefracture
nonunionsite.Tightenthestrapsagaintofinishthecorrection.
*Anatomiclocationsaresuggestedbasedontreatmentcoilsizeandconfiguration.Theselectionof
asuitabletreatmentcoilisindividualtoeachpatientandshouldtakeintoaccountfactorssuchas
activitylevel,presenceofacast,patientbodymassindex(BMI),etc.
SFLX Treatment Coils (Continued)