User's Manual

SpinalModulation,Inc. PhysicianImplantManual
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19
• When inserting the lead/sheath assembly through the needle into the epidural space,
tightentheleadstabilizertopreventleadmigrationoutofthesheath.Failuretodoso
maycauseharmtothepatientsuchasdamagetothedura.
• Donotbendthe sheathwithout theleadinsidethesheath,asthiswillpermanentlykink
itandmakeitdifficulttodeploythelead.
• Donot use surgical instrumentsto handle thelead.The force of the instruments may
damagetheleadorleadstylet.
• Donotbend,kinkorusesurgicalinstrumentsonthestylet,asthismaydamageit.Use
carewhenreinsertingastylet.Toomuchpressureonthestyletcoulddamagethelead,
resultinginintermittentorlossofstimulation.
• Donotovermanipulatethesheathandleadsystemasthismayresultin
traumawithin
theepiduralspace.
• Donotusesalineorotherionicfluidsatornearanyoftheelectricalconnections,asthis
couldresultinshortcircuits.
• Do notplace sutures directly around the lead body since the suturesmay damage the
lead.
• Beforeopeningany sterile
package,verifythekitmodelnumber,thatthekitiswithinits
expiration(use‐by)dateandthatthepackaginghasnotbeendamagedorcompromised
in any way.If the packaging has been compromised or the device is beyond its
expirationdate,donotusethedeviceasitmaybecompromisedandcouldcauseharm
tothepatient.
• Carefully inspect the lead (in the sterile field) for damage after removing it from the
sterilepackage.Damagetotheleadbodycancauseimproperfunctionandstimulation
orstimulationtoareasotherthantheintendedtarget.
• Iftheoperatingfieldisbloody,wipegloves,lead,stylet,andsheath,beforehandlingthe
lead.Failuretodosomayresultindifficultydeliveringthelead.
• Theleads,accessories,andneurostimulatorareonlycompatiblewiththeSpinal
Modulationcomponents.Useofothermanufacturer’scomponentsmayresultin
unexpecteddeviceperformanceandincreasedriskofinjurytothepatient.
SelectionofNeurostimulatorTrialAppr oach
Therearetwosuggestedapproachesforaneurostimulationtrial:
A. PercutaneousLeadTrial‐AtrialisdoneusingaTrialLeadwhichexitstheskinattheneedle
entry site and which is completely removed after the trial period. In a second procedure,
thesystemisimplanted,includingtheImplantLeads.
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