bioMetric SpinalPak - System Components; DESCRIPTION; ELECTRICAL REQUIREMENTS FOR BATTERY AND CHARGER; STIMULATOR

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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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