bioMetric SpinalPak Complete Manual

Brand: bioMetric

Model: SpinalPak

Type: Complete Manual

Biomet® SpinalPak®

Non-invasive Spine Fusion

Stimulator System

Complete Manual

and Package Insert

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

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.

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SpineFusionStimulatorSystem

isdesignedtostorethepatient’sdailytherapeutictreatmentdatawhichmaybedownloadedandreadwiththe

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recommendedthatthesecondbatterypackbeimmediatelyplacedintothechargercradleandfully

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.

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

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

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

oroneofitssubsidiariesunlessotherwiseindicated.RxOnly.

bioMetric SpinalPak Complete Manual

Brand: bioMetric

Model: SpinalPak

Type: Complete Manual

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bioMetric SpinalPak Complete Manual

bioMetric SpinalPak Complete Manual

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