User's Manual
5
INTRODUCTION
Your Patient Programmer is used to program your stimulator device, if required.This User Manual gives
detailed instructions on how to safely use your Patient Programmer and your stimulator device. It also
instructsyouonhowtorechargeyourPatientProgrammer.Seeyourdoctorifyouhaveanyquestions.
I
NDICATIONSFORUSE
TheSpinalModulationNeurostimulatorSystemwasdesignedtobeusedtomanageprolongedpainas
statedinthefollowingindicationstatement:
TheSpinalModulationneurostimulationsystemisindicatedasanaidinthemanagementofchronic,
intractable,neuropathicpainofthelowerlimbs‐includingunilateralorbilateralpain,associatedwith
the
followingconditions:radicularpain,peripheralneuropathies.
D
ESCRIPTION
TheClinicalandPatientProgrammersareusedtoconnecttothestimulatordevice.
– TheClinicalProgrammercontrolsthestimulatordevice.Only your doctorand/orSpinalModulation
clinicalpersonnelmayusetheClinicalProgrammer.
– The Patient Programmer allows you to
adjust the settings of the stimulator
device.Yourdoctor
specifiestherangeof
settings.ItalsoallowsyoutoturnOFFall
stimulation,ifrequired.
The Patient Programmer is a portable, handheld
device.Itis designed to be easytouse. Itcanbe
plugged into a power outlet or powered by an
internal, rechargeable battery. The Patient
Programmer
uses an internal magnet to connect
to the stimulator device. This allows the patient
tocontrolstimulationsettings.
W
ARNING
• DonotuseyourPatientProgrammerorthestimulatordeviceuntilyourdoctorhastrainedyou.
• DonotuseyourPatientProgrammeruntilyourdoctorhassetupyourstimulatordevice.
• Donotundergoanyelectivemagneticresonanceimaging(MRI)procedure.IfMRIisnecessary,your
physician
mustremoveanylead(s).YourdoctormustalsodisconnecttheTNSorINSdevice.Useof
MRIintheareaofthelead(s)maydislodge thelead(s)ordamagetheTNSorINS.Ifavoltageis
inducedthroughthelead,itmaycauseuncomfortable(“jolting”or“shocking”)levelsofstimulation.
• Donotundergoanydiathermy(highenergyheat)procedures.Diathermymaycausebodilyinjuryor
damagetothestimulatordevice.
• Donotremovethelead(s)orConnectorCableduringthetrialperiod.Aninfectionmayresult.
• Changes in body position can increase pain or cause uncomfortable stimulation.
Use the Patient
ProgrammertoadjuststimulationlevelsortoturnOFFstimulation,ifrequired.