User's Manual
5
Introduction
The Clinical Programmer (MN0700) is part of the Spinal Modulation Neurostimulator System.It is
intended to be used by the clinical investigator or a Spinal Modulation representative to query and
program the Neurostimulator (NS), to retrieve data from the NS and to allow for adjustment of the
patient’stherapy.ThisUser
Manual givesdetailedinstructionsonhowto usetheClinical Programmer
safely,howtorechargeitandhowtouseittosetupthepatient’spainmanagementtherapy.
IndicationsforUse
The Spinal Modulation Neurostimulator System is indicated as an aid in the management of chronic,
intractable,neuropathicpainofthelowerlimbs‐includingunilateralorbilateralpain,associatedwiththe
followingconditions:radicularpain,peripheralneuropathies.
Description
Patients who are indicated for Spinal Modulation’s Implantable Neurostimulator System (INS) system
willfirstundergoatrialperiodusinganexternalTrialNeurostimulatorSystem(TNS)connectedtoleads
placedwithinthe epidural space nearthedorsalrootganglion(DRG).Up to fourleadsmay be placed
andconnectedtotheNeurostimulator.
Althoughtheleadsandstimulatorhardwareuseddiffer,theprogrammerhardwareandinstructionsfor
programmingtheTNSandINSdevicesarethesame.
NOTE: In this manual the general abbreviation “NS” is used for information which applies to both
TNSandINS.Inallothercasesthespecificabbreviations“TNS”
or“INS”areused.
For specific description of the TNS and INS system components and implant procedures, refer to the
relevantlabeling.
TwoprogrammersareavailabletointeractwiththeNSdevice.
1. The Clinical Programmer described in this user manual is used to program the stimulation
parameters for the NS,
as determined by the investigator.The NS delivers the programme d
stimulationparameters(energy)totheimplantedLeads.
2. ThePatientProgrammerallowsthepatientto adjustthestimulationsettingsoftheNSdevices
withinlimitspresetbytheinvestigator.ThePatientProgrammeralsoallowsthepatienttoturn
stimulation off,
if necessary. For further information and instructions related to the patient
programmer,refertotherespectiveusermanual.