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bioMetric SpinalPak Complete Manual

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Biomet® SpinalPak®
Non-invasive Spine Fusion
Stimulator System
Complete Manual
and Package Insert
1
Table of Contents
SYSTEM CONTENTS .....................................................................................................................1
IMPORTANT SAFEGUARDS .........................................................................................................2
BIOMET® SPINALPAK® NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM .........................3
• Description ............................................................................................................................3
• ElectricalRequirementsforBatteryPackandCharger .........................................................3
SYSTEM COMPONENTS ............................................................................................................3,4
FULL PRESCRIBING INFORMATION .............................................................................................5
• IndicationsforUse ................................................................................................................5
• Warnings,Precautions,AdverseEffects ...............................................................................5
DIRECTIONS FOR USE ..................................................................................................................6
• RecommendedUsage ...........................................................................................................6
OPERATING INSTRUCTIONS .....................................................................................................6,7
CHARGING THE BATTERY PACK ...............................................................................................7,8
BUTTON FUNCTIONS ....................................................................................................................9
LCD SYMBOL DESCRIPTION AND INSTRUCTIONS .....................................................................9
TREATMENT COMPLETION ........................................................................................................10
PATIENT COMPLIANCE MONITORING ......................................................................................10
ORDERING INFORMATION .........................................................................................................10
ELECTRODE INSTRUCTIONS FOR USE ......................................................................................10
SYMBOL DESCRIPTION ..............................................................................................................11
EQUIPMENT CLASSIFICATION ...................................................................................................11
CLEANING INSTRUCTIONS ........................................................................................................11
ELECTROMAGNETIC COMPATIBILITY .........................................................................12,13,14,15
PATIENT COUNSELING INFORMATION ......................................................................................16
STORAGE AND HANDLING ........................................................................................................16
DISPOSAL INSTRUCTIONS .......................................................................................................16
1
System Contents
• Electrodes-SoftTouch® - 72R
• Electrodes-SoftTouch® - LT-4500
• ChargerCradle
• RechargeableBatteryPacks(2)
• ElectrodeCovers
• Stimulator
• DeviceHolster
• LeadWires-20”LeadWireand48”LeadWire
• PatientManual
• CompleteManualandPackageInsert
• A/CAdaptor
2 3
Important Safeguards
READ ALL INSTRUCTIONS BEFORE USING
SAVE THESE INSTRUCTIONS
Whenusingelectricalproducts,basicsafetyprecautionsshouldalwaysbefollowed,including:
ATTENTION: To reduce the risk of electric shock, fire or injury:
 1. Donotusethisproductwhilebathing,showeringorswimming.
 2. Donotplaceorstorethisproductwhereitcanfallorbepulledintoatuborsink.
 3. Donotimmersethestimulator,batterychargerorthebatteryinwateroranyliquid.
 4. Donotreachforthisproductifithasfallenintowater.Unplugfromthewalloutletimmediately.
 5. Donotpermitthebatterychargertobeconnectedwhenwet.
6. Donottouchthebatterycontactswhenthebatterychargerispluggedintoanoutlet.
 7. Neveroperatethebatterychargerifithasadamagedpowercord,plugorifitisnotworking
properly.Donotuseifithasbeendroppedanddamaged,orimmersedintowater.Contact
Biometforreturninstructions.
 8. DonotattempttochargeanyothertypeofbatterypackintheBiomet®SpinalPak®Non-invasive
SpineFusionStimulatorSystembatterycharger.
 9. Keepallcordsawayfromheatedsurfaces
10.  Neverinsertanyforeignobjectintoanyopeningofthesystem.
11. Donotexposethestimulatororthebatterychargertoprolongedheatordirectsunlight.
(Normaloperatingtemperaturerangeis5°Cto38°C[41°Fto100°F],normalstorage/transport
temperatureis-15°Cto50°C[5°Fto122°F].
12. Usethisproductonlyforitsintendeduseasdescribedinthismanual.
13. TheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemhasnoinstallation,
periodicmaintenancerequirementsoruserserviceableparts.Ifanyofthereplacementpartsare
damagedtheymustbereplacedbyBiometinordertoavoidahazard.
14. Donotshortcircuit,overcharge,crush,mutilate,nailpenetrate,heat,reversethe+or-
terminalsordisassemblethebatterypack.Donotallowmetalobjectstocomeintocontactwith
thebatteryterminals.Theseandanyotherabusesofthebatterypackmaycauseseriousinjury
and/orburns.Toensureproperchargingandsafety,useonlythechargersuppliedwithyour
device.Keepthebatterypackdry.Thisbatterypackmustbedisposedofproperly.Disposal
informationcanbeobtainedbycontactingtheRechargeableBatteryRecyclingCorporation
(RBRC)at1-800-822-8837intheUS.
NOTE: Inside the United States call Biomet at 1-800-526-2579 or 1-973-299-9300 if calling from
outside the United States with any questions or problems.
2 3
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System
Caution: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician.
Rx Only.
2
Thisdeviceisnotintendedforre-saleorre-distribution.Singlepatientuse.
DESCRIPTION
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystem(Figure1)promoteshealing
byinducingalowelectricalcurrentatthefusionsite.Thetherapeuticsignalgeneratesalowenergy
electricalfieldbypassingaspecificcurrentbetweentheelectrodes.
ELECTRICAL REQUIREMENTS FOR BATTERY AND CHARGER
Charger
 Input:100-240VAC50/60Hz6W
 Output:12VDC500mA
 ForusewiththeBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystembatterypack
only(PN1067720).
Batteryrating:3.7VDC>800mAh
Donotusethebatterypacksuppliedwiththisunitinanyotherdevice.UseoftheBiomet®SpinalPak®
Non-invasiveSpineFusionStimulatorSystembatterypackinanyotherdevicemaycausedamageor
malfunctiontothebatterypackand/ordevice.
System Components
STIMULATOR
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemoperatesonarechargeablebatterypack,
whichallowsforambulatoryuse.Itincludesanaudibleandvisibleself-checkingalarmmechanismtoalertthe
patientifitisnotfunctioningproperly.TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystem
isdesignedtostorethepatient’sdailytherapeutictreatmentdatawhichmaybedownloadedandreadwiththe
patientcompliancesoftware(SeePatientComplianceMonitoringPage10).Patientsareencouragedtobringthe
stimulatortoeachfollow-upvisitwiththeprescribingphysiciantoreviewhowtheyareusingtheirstimulator.
Figure 1
4 5
System Components
BATTERY PACK AND BATTERY CHARGER
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemincludestworechargeablebatterypacks.
Uponreceipt,itisrecommendedthatthesecondbatterypackbeimmediatelyplacedintothechargercradleandfully
charged.Inthemeantimethefirstbatterypackmaybeusedtobeginyourtreatment.
Note: The first battery pack may not provide a 24-hour treatment initially. It is recommended that the patient keep one
battery pack in the battery charger cradle to assure that it is fully charged and ready, and the other inserted into the
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System. This will ensure continuous treatment prescribed by
the prescribing physician.
ThebatterychargerandcradlearedesignedtorechargetheBiomet®SpinalPak®Non-invasiveSpineFusionStimulator
Systembatterypacksonly.TwoLED(lightemittingdiode)lightsmonitorandindicatetheoperationalstatusofthebattery
charger.TheA/CPowerindicatorlightislocatedontheA/CAdaptor.Thechargingstatusindicatorlightislocatedonthe
chargercradle.ThefollowingtablelistsanddescribestheoperationalfunctionsoftheLEDlights:
Electrodes
Therearetwotypesofelectrodesthatarepackaged with the Biomet® SpinalPak® Non-invasiveSpine
FusionStimulatorSystemassembly:72RandLT-4500.The72Relectrodeshavegreenwritingontheir
packaging.TheLT-4500electrodeshaveblackwritingontheirpackaging. The72Relectrodeshavea
hydrogelthatisstickierthantheLT-4500electrodehydrogel.Thepatientcanusewhicheverelectrodes
bestsuittheirskintype.
Electrode Covers
Theelectrodecoversarewaterresistantandareintendedtoenhanceelectrodesecuritytotheskin,if
needed,orforshoweringwiththeelectrodesattached,ifdesired.
Device Holster
Thedeviceholsterisdesigned to securely holdtheBiomet®SpinalPak® Non-invasive Spine Fusion
StimulatorSysteminplace.Ithasacliponthebackwhichallowsthepatienttowearthedeviceon
theirwaistbandorbelt.
Lead Wires
TwodifferentlengthleadwiresareincludedwiththeBiomet®SpinalPak®Non-invasiveSpineFusion
StimulatorSystem.Thepatientshouldchoosetheleadwirethatbestaccommodatestheirneedsfor
wheretheywouldliketowearthecontrolunit.
Following are possible error conditions and possible resolutions.
Status A/C Power
Indicator Light
Charging Status Indicator
Light on Cradle
Nobatterypackinserted
(idle)onA/Cpowered
batterycharger
Solidgreen Off
Batterypackinchargingstate Solidgreen Solidorange
Fullychargedbatterypack Solidgreen Solidgreen
A/Cpowerdeficiency Off Off
Error Solidgreen Off
Error Conditions (flashes orange) Possible Resolutions
Batterypacknotproperlyconnected
tothecharger
Removeandre-installthebatterypackto
ensureacompleteconnectiontothecharger
Batterytemperatureistooloworhigh Normaloperatingtemperatureis
5°Cto38°C[41°F-100°F]
Batteryvoltageistoolow CallBiometforanewbatterypack
4 5
Full Prescribing Information
INDICATIONS FOR USE
TheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemisanoninvasivespinefusion
stimulatorindicatedasanadjunctelectricaltreatmenttoprimarylumbarspinalfusionsurgeryforone
ortwolevels.
WARNINGS
Cardiac pacemakers or cardioverters may be adversely affected by the Biomet® SpinalPak®
Non-invasiveSpineFusionStimulatorSystem.Theconcomitantuseofthedeviceandapacemakeror
cardiovertermustbeassessedonanindividualbasis,suchaswithanelectrocardiogram,priortouse.
Thepatientshouldbereferredtoacardiologistformonitoringofpacemakerfunctionwhilewearing
theactiveBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemdevice.Ifthereareany
observableadversechangesinthepacemakerrhythmoroutput,thedeviceshouldnotbeused.
ThesafetyandeffectivenessoftheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystem
inpregnantwomenhavenotbeenstudied,andtheeffectsofthedeviceonthemotherorthedeveloping
fetusareunknown.Apatientwhoiseitherpregnantorisintendingtobecomepregnantshouldbe
referredtoherdoctorpriortotreatmentwiththedevice.
PRECAUTIONS
ThesafetyandeffectivenessoftheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystem
in individuals with the following conditions have not been studied, and therefore the safety and
effectivenessofthedeviceintheseindividualsareunknown:
– spondylitis,infection,Paget’sdisease
– cancer,diabetesmellitus,renaldisease
– traumaofthelumbarspine
– osteoporosis.
Applytheelectrodesaftertheskinhasbeencleanedanddried.Iferythemadevelopsattheelectrode
sites, the electrodes should be relocated adjacent to the original sites. If the reaction does not
resolveafter48hoursafterrelocatingtheelectrodes,thepatientshouldbeinstructedtoconsultwith
thephysician.
Donot submerge or exposethe Biomet® SpinalPak® Non-invasiveSpineFusion Stimulator System
to water. The patient must be instructed to remove the stimulator during bathing, showering
orswimming.
Compliance with the treatment schedule, daily battery pack changes, and replacing the electrodes
(1to7days)asneededareessentialforproperdevicefunction.Thissystemshouldonlybeusedwith
componentsandreplacementpartssuppliedbyBiomet.Othercomponents,partsandaccessoriesmay
notbecompatible,andmaydamagethedevice.Ifanycomponentdoesnotfunctionproperly,contact
Biomet.Noattemptshouldbemadetomodifyorrepairthedevice.
Patientsshouldbeabletousethedeviceinaccordancewiththeinstructionsforuse.If a patient cannot
comply with these instructions for any reason, use of the device is not recommended.
ADVERSE EVENTS
Duringamulti-center clinical study of349patients treated with thedevice fortheindication listed
above,skinirritationwasthemostcommonadverseeffectassociatedwiththeuseofthedevice.It
occurredin9patients(2.6%ofthetrialpopulation):4patientstreatedwiththeactivedeviceand5
patientstreatedwiththeplacebodevice.
6 7
Directions for Use
RECOMMENDED USAGE
The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System is designed to deliver 270
daysofcontinuoustherapeutictreatmentfor24hoursperday.Therecommendeddailytherapeutic
treatmentiscontinuousfor24hours.
OPERATING INSTRUCTIONS
TheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemhasbeenspecificallydesigned
tobeconvenienttouse,comfortabletowear,andsafetooperate.Patientsshouldbeginusingthe
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System immediately after reading the
instructionsforuseandhavingreceivedinstructionsfromtheirprescribingphysician.
To begin treatment - Electrode Placement
• Cleananddrytheskinwheretheelectrodeswillbeplaced.Trimming(notshaving)bodyhairfrom
theelectrodeapplicationareaisoftenhelpful.
• Note: To ensure electrode placement and adhesion, you may use one of the provided electrode
retainer patches. Place one electrode
twoto three inches tothe left of the
area of the surgery and a second
electrode two to three inches to the
rightoftheareaofthesurgerysothat
the electrodes are four to six inches
apart. See Figure 2.Dependingonthe
patient’sabilitytomoveaftersurgery,
it may be helpful for the patient to
ask another person to assist them
inplacing theelectrodes. Seeinstructions for use on Page 10. The patient shouldconsult their
prescribingphysicianorBiometiftheyhaveanyquestionsorconcernsregardingproperelectrode
placement.Iftheirskinbecomesabnormallyredattheelectrodesites,theelectrodesshouldbe
moved adjacent to the original sites. If the redness does not go away after 48 hours with the
electrodesremoved,thepatientshouldcontacttheirprescribingphysician.
Tips:
Loose electrodes–Confirmthatbothelectrodesareincompletecontactwithclean,dryskin.See
instructionsontheelectrodepacket.
Incomplete circuit/disconnection –Checkallconnectionpoints,confirmingasnugfit.
Broken electrode lead wire–Ifalarmingcontinues
afterconfirmingconnection,attachanewelectrode
leadwire.
To begin treatment - Lead Wires
• Thepatientisprovidedwithtwostimulatorleadwire
lengthswiththeBiomet®SpinalPak®Non-invasive
SpineFusionStimulatorSystem.Thepatientshould
selectthelengthofthestimulatorleadwireinorder
to provide both convenience and comfort when
wearingthestimulatorduringtreatment.
• Insertthestimulatorleadwiremaleconnectioninto
eachfemaleelectrodeleadwireconnection.
• Inserttheleadwireplugintotheopeningatthetopofthestimulator.See Figure 3.
Figure 2
Figure 3
6 7
Operating Instructions
Both battery packs provided with the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
Systemarechargedpriortobeingpackagedanddistributed.UponreceiptoftheBiomet®SpinalPak®
Non-invasive Spine Fusion Stimulator System, it is recommended that the second battery pack be
immediatelyplacedintothechargercradleandcompletelycharged.Inthemeantime,thefirstbattery
packmaybeusedtobeginyourtreatmentimmediately.Note: The first battery pack may not provide
a complete 24-hour treatment initially.
STEP 1:
Following the arrows, insert the charged battery pack
(1,2)intotheBiomet®SpinalPak® Non-invasiveSpineFusion
Stimulator System (Figure 4). The LED light on top of the
device will blink, indicating power. Each symbol will be
indicatedonthedisplayandthealarmwillflashandbeepif
theelectrodesarenotproperlyapplied.Tosilencetheaudio
alarmpressthebuttonbelowthedisplay.
If the light does not blink, which indicates that the battery
packisnotcharged,changethebatterypack
(SeeChargingtheBatteryPackbelow).
STEP 2:
Attach electrodes as per instructions on
Page10, andas per“To Begin Treatment -
ElectrodePlacement”sectiononpage6.
Charging the Battery Pack
Chargethebatterypackatroomtemperature(24°C(75°F)).Chargingmayrequiretwotothreehours.
Chargingmayvaryinwarmerorcoldertemperatures.
STEP 1:
Plugthebatterypackchargerandcradleintoawalloutlet(Figure5).AgreenlightontheA/Cadaptor
willilluminateindicatingpower(Figure6).
Figure 4
Figure 5 Figure 6
8 9
STEP 2: CHANGING BATTERY PACKS
Eachday,preferablyatthesametimetoensuretreatment
is continued without interruption, patients should do
thefollowing:
A. Depressthelatch(1)onthebatterydoorandslide
downthebatterydooronthebackofthestimulator
(2)andremovethedepletedbatterypack(Figure7).
B. Followingthearrows,placethedepletedbatterypack
into the battery charger cradle (1, 2) for charging
(Figure8).Asolidorangelightonthechargercradle
willilluminate,indicating the batteryischarging. If
nolightappearsonthechargingcradleanerroris
indicated. If this occurs, try removing the battery
packfromthechargercradleandreinsertingit.Ifthe
orangelightdoesnotappearcontactBiomet.
C. Once the charger cradle’s orange light turns off
and a solid green light appears, the battery pack
is fully charged. Remove the battery pack (1, 2)
from the battery charger cradle with a gentle lift
on the battery tab (Figure 9) and place the fully
charged battery pack into the Biomet® SpinalPak®
Non-invasive Spine Fusion Stimulator System in
order to commence treatment.
D. Thereshouldalwaysbeonebatterypackinthecharger
andonebatterypackinstalledinthestimulatoratall
times,ensuringafullychargedbatterypackevery24
hoursasrecommended.
NOTE: Do not be concerned if the battery packs are inadvertently charged more than once or kept on
the charger cradle for a long period of time. The battery packs cannot be overcharged. If the battery
pack is in the battery pack charger and the battery pack is fully charged, the charger will terminate
the recharging process. The charger cradle will indicate termination of charging when the orange
light is not illuminated. Additional replacement battery packs are available by contacting Biomet.
Figure 7
Figure 8
Figure 9
8 9
Button Functions
ALARM ON/OFF BUTTON
The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System is activated as soon as a
chargedbatterypackisinserted.ThebuttonlocatedbelowtheLCDdisplayenablesordisablesthe
audiblealarm.Duringanalarmcondition,depressingthebuttonquickly(0.5seconds)willtemporarily
disabletheaudiblealarm.Depressingthebuttonforalongerperiodoftime(3seconds)willtoggle
theaudiblealarmbetweenenabledanddisabled.Patientsshouldbeadvisedtoleavetheaudiblealarm
enabledasfrequentlyaspossibleinordertoassurethefullyprescribedtreatment.Aspeakersymbol
willbeindicatedontheLCDdisplaywhenthealarmisenabled.
Thealarmdefaultstoaudiblealarm.Pressthebuttonbelowthedisplayonthefrontofthestimulator
tosilencethealarm.Aftersilenced,thelightwillcontinuetoflashandthedisplaywillindicatethe
alarmcondition.
Symbol Condition Instructions
  Treating Continueuse.
  Audiblealarm Ifbeeping,depressthebutton
  brieflytosilencethealarm.Depressthe
  buttonapproximately3secondsto
  engageordisengagetheaudiblealarm.
  Lowbatterycharge Insertachargedbatterypack.
  Disconnection Confirmthateachelectrodeisproperly
  appliedontheskin.Seetheelectrode
  pouchforinstructions.Confirmthatthe
  leadwireisattachedproperly.Replace
  theleadwireifnecessary.
  Systemerror Errorinthestimulator–
  ContactBiometforassistance.
  Stimulatoris StimulatorwillnottreatuntilUSB
  connectedto cableisdisconnected
a PC
Endofoperation/ ContactBiomet
  TreatmentCompletion
LCD Symbol Descriptions and Instructions
10 11
Treatment Completion
Therapeutictreatmentshouldnotbesuspendeduntilfusionoccursoruntilsuchtime
asadeterminationismadebytheprescribingphysician.Thedeviceisprogrammedto
deliver 270 continuous days of therapeutic treatment and automatically discontinues
operationafterthe270days.
Patient Compliance Monitoring
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemcontainsembeddedsoftware
whichallows the display of patientspecific history dataincluding usageand therapeutic treatment
times.Thisdatamaybedownloadedtoapersonalcomputerforviewing,storageand/orprintoutvia
theuseofBiometComplianceDataDownloadSoftware.PleasecallyourlocalBiometrepresentative
toobtainmoreinformation.
Ordering Information
Toordersupplies,contactBiomet.Seepage2“ImportantSafeguards”forcontactinformation.
The following information is necessary to expedite any inquiry:
• Patientname
• Physicianname
• Addresstosendreplacementparts(patienthome,MDoffice,etc.)
Electrode Instructions for Use
Donotopenouterpacketuntilreadytouse.
1) Tearopenpacket.
2) Removeelectrodefromclearplasticbackingliner.
3) Wetfingerwithtapwaterandmoistenentiregelarea.
4) Placeelectrodeonskin.
5) Connectelectrodetoelectrodelead.
Renewal
1) Withcontinuoususe,electrodesmaydryout.
2) Torenew,wetfingerwithtapwaterandmoistenentiregelarea.
3) Reapplyelectrodetoskin.
Storeinacoolplace
10 11
 Attentionseeinstructions
 AlternatingCurrent
 DirectCurrent
 TypeB
 Storage/Transport
 temperaturelimits
Class II
 NonSterile
 Manufacturer
 WEEE
 SinglePatientUse
 PrescriptionOnly
 Warning:Theconcomitant
 useofthestimulatoranda
 pacemakerorcardioverter
 mustbeassessedbya
 cardiologistonan
 individualbasiswithan
 Electrocardiogram(EKG).
 Caution:Thesafetyof
 thisdeviceusedduring
 pregnancyandnursing
inhumanshasnot
beenestablished.
Symbol Description
Equipment Classification
• Stimulator-Internallypoweredbyrechargeablebatteries
• Charger-ClassII,TypeB
• OrdinaryEquipmentwithoutprotectionagainstingressofwater
• Equipmentnotsuitableforuseinpresenceofflammableanestheticmixturewithairoroxygen
 ornitrousoxide.
• Modeofoperation-continuous
Cleaning Instructions
UseadampclothforcleaninganypartoftheBiomet®SpinalPak®Non-invasiveSpineFusion
StimulatorSystem.Donotusecleaningproductsordetergents.
2
Rx only
12 13
RFemissions
CISPR 11
Electromagnetic Compatibility
A. Theuseofaccessories,cablesorreplacementpartsotherthanthosesuppliedbyBiometmay
resultinincreasedemissionsordecreasedimmunityoftheequipmentorsystem.
B. Thisequipmentshouldnotbeusedadjacenttoorstackeduponotherequipment.
C. PortableandmobileRFcommunicationsequipmentcanadverselyaffecttheoperationof
MedicalElectricalEquipment.
D. Intheeventthisequipmentinterfereswiththeoperationofotherequipment,orexperiences
interferencefromotherequipment,tocontinuetreatment,itwillbenecessarytomovethe
Biomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemawayfromthesourceofthe
interferenceasindicatedinTable4.
Guidance and manufacturer’s declaration -
electromagnetic emissions
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemisintendedforuseinthe
electromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet®SpinalPak®
Non-invasiveSpineFusionStimulatorSystemshouldassurethatitisusedinsuchanenvironment.
Emissionstest Compliance Electromagneticenvironment-guidance
Group 1
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulator
SystemusesRFenergyonlyforitsinternalfunction.Therefore,
itsRFemissionsareverylowandnotlikelytocauseany
interferenceinnearbyelectronicequipment.
RFemissions
CISPR 11
Class B
TheBiomet®SpinalPak®Non-invasiveSpineFusionStimulator
Systemissuitableforuseinallestablishments,including
domesticestablishmentsandthosedirectlyconnectedtothe
publiclow-voltagepowersupplynetworkthatsupplies
buildingsusedfordomesticpurposes.
Harmonic
emissions
IEC 61000-3-2
Notapplicable
Voltage
fluctuations/
flickeremissions
IEC 61000-3-3
Notapplicable
Table 1
12 13
Guidance and manufacturers declaration - electromagnetic immunity
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemisintendedforuseinthe
electromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet®SpinalPak®
Non-invasiveSpineFusionStimulatorSystemshouldassurethatitisusedinsuchanenvironment.
Immunitytest IEC 60601
testlevel
Electromagneticenvironment-
guidance
Electrostatic
discharge(ESD)
IEC 610004-2
± 6 kV contact
±8kVair
Floorsshouldbewood,concreteor
ceramictile.Iffloorsarecoveredwith
syntheticmaterial,therelativehumidity
shouldbeatleast30%.
Electricalfast
transient/burst
IEC 61000-4-4
NotApplicable
Surge
IEC 61000-4-5
Notapplicable
Voltagedips,short
interruptionsand
voltagevariations
onpowersupply
inputlines
IEC 61000-4-11
Notapplicable
Powerfrequency
(50/60Hz)
magneticfield
IEC 61000-4-8
Notapplicable
Compliancelevel
Group 1
Class B
Notapplicable
Notapplicable
Notapplicable
Table 2
14 15
Guidance and manufacturers declaration - electromagnetic immunity
TheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemisintendedforuseinthe
electromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheBiomet®SpinalPak®
Non-invasiveSpineFusionStimulatorSystemshouldassurethatitisusedinsuchanenvironment.
Immunitytest IEC 60601
testlevel
Electromagneticenvironment-
guidance
Conducted RF
IEC 61000-4-6 NotApplicable
NOTE1. At80MHzand800MHz,thehigherfrequencyapplies.
NOTE2. Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionand
 reflectionfromstructures,objects,andpeople.
 aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthe
locationinwhichtheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemisusedexceeds
the applicable RF compliance level, the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
Systemdeviceshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,
additional measures may be necessary, such as reorienting or relocating the Biomet® SpinalPak®
Non-invasiveSpineFusionStimulatorSystem.
 bOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan1V/m.
Compliancelevel
NotApplicable
RadiatedRF
IEC 61000-4-3
3V/m
80MHzto2.5
GHz
1V/m PortableandmobileRFcommunicationsequipment
shouldbeusednoclosertoanypartoftheBiomet®
SpinalPak®Non-invasiveSpineFusionStimulatorSystem,
includingcables,thantherecommendedseparation
distancecalculatedfromtheequationapplicabletothe
frequencyofthetransmitter.
Recommendedseparationdistance
d=3.5√P80MHzto800MHz
d=7√P800MHzto2.5GHz
wherePisthemaximumpoweroutputratingofthe
transmitterinwatts(W)accordingtothetransmitter
manufactureranddistherecommendedseparation
distanceinmeters(m).
FieldstrengthsfromfixedRFtransmitters,as
determinedbyanelectromagneticsitesurvey,ashouldbe
lessthanthecompliancelevelineachfrequencyrange.b
Interferencemayoccurinthevicinityofequipment
markedwiththefollowingsymbol:
Table 3
14 15
Recommended separation distances between portable and
mobile RF communications equipment and the Biomet®
SpinalPak® Non-invasive Spine Fusion Stimulator System
TheBiomet®SpinalPak® Non-invasiveSpineFusionStimulatorSystemisintendedforuseinan
electromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.Thecustomerortheuser
oftheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemcanhelppreventelectromagnetic
interferencebymaintainingaminimumdistancebetweenportableandmobilecommunicationsequipment
(transmitters)andtheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystem as recommended
below,accordingtothemaximumpoweroutputofthecommunicationsequipment.
Rated maximum
output power of
transmitter
W
Separation distance (meters)
according to frequency of transmitter
150kHzto80
MHz
d = 3.5 √ P
80MHzto800
MHz
d = 3.5 √ P
800MHzto2.5
GHz
d = 7 √ P
0.01 .35 .35 .7
0.1 1.1 1.1 2.21
1 3.5 3.5 7
10 11.06 11.06 22.13
100 35 35 70
 Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparation
 distancedinmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthe
 transmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)according
 tothetransmittermanufacturer.
 NOTE1.At80MHzand800MHz,theseparationdistanceforthehigherfrequencyapplies.
 NOTE2.Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationis
 affectedbyabsorptionandreflectionfromstructures,objects,andpeople.
Table 4
16 17
Patient Counseling Information
ThepatientshouldbethoroughlyinstructedonhowtoproperlyuseandcarefortheBiomet®SpinalPak®
Non-invasiveSpineFusionStimulatorSystemandreceivethePatientManual,whichprovidesdetailed
instructions.Asummaryofthekeypointsinthepatientlabelingisprovidedbelow.
Compliance- Thepatientshouldbeinstructedthatcompliancewithdeviceuseandcareiscritical
toassuretheproperfunctionofthedeviceandeffectivetreatment.
Battery Pack- The patient should be instructed to insert a fully charged battery pack into the
stimulatorevery24hours.
Electrodes- The patient should be instructed to replace the electrodes when needed, and
to clean the electrode sites thoroughly with soap and water prior to applying
theelectrodes.
Skin Irritation - Thepatientshouldbeinstructedtoexaminetheskinforirritationwhenreplacing
theelectrodes.Ifirritationispresent,thepatientshouldbeinstructedtorelocatethe
electrodesadjacenttotheoriginalsites.Thepatientshouldbeevaluatedperiodically
toassesstheskinforsensitivity.
Alarms- See LCD Symbol Descriptions and Instructions (page 9). The patient should be
instructedtokeeptheaudiblealarmsystemengagedasoftenaspractical,andto
engagethealarmsystemifithasbeendisengagedassoonaspractical.
Bathing- The patient should be instructed to disconnect the stimulator during bathing,
showering or swimming. It should be reconnected as soon as practical
followingtheseactivities. The patientshouldalso be instructedtoeitherremove
the electrodes, or to cover the electrodes with the protective retainer patches,
duringshowering.
Storage and Handling
TheBiomet®SpinalPak®Non-invasiveSpineFusionStimulatorSystemshouldbestoredinacooland
dryplace.Thedevicecomponentsshouldbehandledwithcare.Damagemayoccurifthedeviceis
inappropriatelyhandledorabused.
Disposal Instructions
When treatment has concluded as determined by the prescribing physician (see page 10), Biomet
requests that the patient disposes of the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
Systemaccordingtolocalstatutesandregulations.
16 17
Notes:
OPTIONS
Theindustry’smostcomprehensiveoptions:
• PEMF,CCandDC
• Anatomyspecificcoils
• Wear-timechoice
EVIDENCE
• Backedbyprovenscience
• Multiplescientificpapers
• Theproofisinthepatient
EXPERIENCE
Recognizedasanindustry
pioneerwithEBIlineage,Biomet
hashelpedoveronemillionpeople
Tolearnmoreaboutthisproduct,
contactyourlocalBiometSalesRepresentativetoday.
PN#1067795-00Rev.D
Biomet® SpinalPak® Non-invasive
Spine Fusion Stimulator System
Complete Manual and Package Insert
399JeffersonRoad•Parsippany,NJ07054
800.526.2579•www.biomet.com•BNS231002L11/13
©2013EBI,LLC.AlltrademarksarethepropertyofBiomet,Inc.
oroneofitssubsidiariesunlessotherwiseindicated.RxOnly.
/