User's Manual

SpinalModulation,Inc. PhysicianImplantManual

39
6. GentlyremovetheleadfromtheINSheader;thencleananddryallconnectionsonthe
lead,ensuringtheyarefreefromfluidandtissue.
PRECAUTION:If resistance is met while removing leads from the  epidural  space, do not
use excessive  force to extract.Always perform removal with the patient conscious and
abletogivefeedback.
WARNING: Do not remo ve a 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leadcomponents.Treatall
usedleadsanddeliverycomponentsasa“biohazard”.
7. Ifyouneedtoreplacealead,performthefollowingactions:
a. Makeanincisionabovethelocationofthesutureanchor.
b. Carefullycutthesuturesfromthesutureanchor.
c. Slidethe leadoutoftheepiduralspaceslowly.
8. TocompletetheINSreplacementprocedure,see“ConnectingtheLeadtotheINS”.
9. Tocompleteleadplacement,see“PlacingaLead”.
DisposingofanExplantedDevice
AllexplantedINSsshouldbereturnedtoSpinalModulationforproperdisposal.Todisposeof
anexplanteddevice,followthesesteps:
WARNING:Donot crush,puncture, or burntheINS becauseit mayexplode or catch on
fire.
1. Decontaminatetheexplanteddevice.
2. Placeitinacontainerwithabiohazardlabel.
3. Includeacompleted“ReturnedProductForm.”(OneispackagedwitheachnewINS)
4. Returntheexplanted
deviceto:
SpinalModulation
1135O’BrienDrive
MenloPark,CA94025
U.S.A.
