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ManualsBrandsSpinal Modulation ManualsElectronicsImplantable Neurostimulator
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SpinalModulation,Inc. PhysicianImplantManual
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TheINSispackagedinasealedinnertraywithinasealedoutertray.
ImplantLeads/TrialLeads/LeadExtension
The Lead Kits contain theLeads and the individual deliverydevices that are required fortheir
placement.
CAUTION:ThetemporarilyplacedTrialLeadsareintendedforuseforupto30days.
• Implant/TrialLeads:TheLeadsaredesignedforpercutaneousintroductionintothebody
using a special needle and a set of custom delivery tools provided in their respective kits.
Each Lead is fitted with four cylindrical electrodes spaced at equal intervals which are
intended to provide stimulation at the target dorsal root ganglion (DRG).Each Lead is
packaged with a Complex Curved Stylet inserted into the Lead and the Lead is pre‐loaded
intoa22cmSmallCurveDeliverySheathforthephysician’sconvenience.
• Lead Extension:The Lead Extension consists of a silicone port header that accepts the
Spinal ModulationTrial Lead and Implant Lead.It is intended to extend the length of the
leadandprovide a connectionbetweenthelead and theConnector Cable ortheleadand
the Implantable Neurostimulator System.The Lead Extension is intended for chronic
implantationasacomponentoftheAxium™NeurostimulatorSystem.
ConnectorCableKit
TheConnectorCableconnectstheLeadsorLeadExtensiontotheexternalTNS.
• ConnectorCable:TheConnectorCableispackagedseparatelyfromtheLeadandLead
ExtensionKit.TheConnectorCableincludesaconnectorand2extensioncablesforuse
asneeded.
• LeadIdentifiers:TheLeadIdentifiersaresmallbentwiresthatcanbeinsertedintothe
proximalstyletlumenintheleadsandareindividuallycoloredtoidentifytheleads.
LeadAccessories
• Small/BigCurveDeliverySheath:TheDeliverySheathsareintendedtoallowpassageof
the lead percutaneously into the epidural space.The labeled length of the sheath is the
distance from the hub to the pre‐shaped tip and the length of the curve at the tip is
approximately
2mmfortheSmallCurveandapproximately8mmfortheBigCurve.
• Complex Curved Stylet:The Complex Curved Stylet is intended to assist in steering and
positioning the lead within the epidural space.The Complex Curved Stylet has been pre‐
insertedintotheLeadforthephysician’sconvenience.

• 14G Delivery Needles:The Delivery Needle is intended to access the epidural space,
providingaconduitforlead,guidewireanddeliverysheathplacement.
• Guidewire:The Guidewire is intended to verify that the needle is in the epidural space
afterusingalossofresistancetechnique.