User's Manual

SpinalModulation,Inc. PhysicianImplantManual
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40
AppendixA:TrialLeadKit/ImplantLeadKit
HowSupplied
The components of the Spinal Modulation Trial Lead Kit and Implant Lead Kit are provided
sterile in adouble pouch assembly and are intended for single use only.Do not re sterilize or
reuseanydevicesfromthe LeadKits,foranyreason,becauseofriskofinfectiontothesubject
and
malfunctionofthedevices.
PRECAUTION:Do not resterilize the Lead Kits or any other sterile components as it will
createariskofinfectionormalfunctionofthedevice.
StorageTemperature‐Storethe Trial LeadKit and LeadAccessories Kit between14°F ( ‐10°C)
and 122°F (50°C).Temperatures outside this range may damage the components.If a
temperaturedeviationhasoccurred,donotusetheproduct.
Sterilization‐The Trial Lead Kit, Connector Cable, and all Lead Kit Accessories have been 
sterilizedusingethyleneoxide(EO)gas.
PackageContents
(1)Trial/ImplantLead50cm/90cm
(1)22cmSmallCurveDeliverySheath
(1)22cmBigCurveDeliverySheath
(1)Guidewire
(1)ComplexCurveStylet
(1)4.5”14GaugeNeedle
(2)SoftTissueAnchors
(1)PhysicianImplantManual