User's Manual

SpinalModulation,Inc. PhysicianImplantManual

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29

parameters.

NOTE: Refer to the Trial Neurostimulator User Manual and Clinical Programmer User Manual

forspecificinstructionsontheprogrammingofthesedevices.

RemovingTrialLead–PercutaneousLeadTrial

WARNING:AlwaysremovetheTrialLeadsbeforeimplantingtheImplantLeads,asthere

isa riskofinfectio nthatmaycausedeathiftheleadsarenotremoved.Alwayspractice

propersterilepracticeswhenimplantingleadsandimplantableneurostimulator.

ToremovetheTrial Lead(s)fromapatient: 

1. DisconnecttheConnectorCableconnectionforeachTrialLead.

2. RemoveanysuturesoranchorsecuringeachTrialLeadtothepatient’sskin.

3. Slowlyapplylight tensiontoeachTrialLeadandverify thattheleadisretractingfromthe

patient.

4. PlacetheusedTrialLead(s)intoade signa te d “Biohazard”packageclearlylabeledwiththe

patient’sIDnumberandtheremovaldate.

5. Send Trial Lead(s) back to Spinal Modulation  for evaluation as instructed by clinical

personnel.

WARNING:Donot remove aTrialLead quickly, as thismay resultin lead breakage and

unintentionalleadfragmentsbeingleftinthepatient.

WARNING:Take proper precautions when handling removed Trial Lead components.

TreatallusedTrialLeadsanddeliverycomponentsasa“biohazard”.

WARNING:Donotreuseanydevice fromtheTrialLeadKitorTrialAccessoriesKit.

RemovingtheDeliverySystemComponents–ImplantLeadTrialOnly

TheseinstructionspertainonlyafterplacingImplantLeadduringthetrialprocedure.After

placingale adinitsfinalposition,usingthetechniquesdescribedabove,itshouldbesecured

usingale adanchortothesupraspinousligamentorfasciaandthenconnecte dtothe

externalizedleadextensions.

WARNING:Donotsuturedirectlyontothelead, asthereisariskofdamagingthelead. 

Failure to secure the lead may result in lead migration and uncomfortable motor

stimulationorpainfulstimulation.

PRECAUTION: Use extreme care when using sharp instruments or electrocautery around

theleadtoavoiddamagingthelead.

1. Leavingtheneedleinplace,preparethe anchorsitebymakinganapproximatelya3‐7cm