User's Manual

SpinalModulation,Inc. PhysicianImplantManual
42
AppendixB:TrialNeurostimulator
DeviceDescription
SeetheTrialNeurostimulatorManual for thefulldescription ofthe device.Theexternal Trial
Neurostimulator (TNS) provides energy and controls electrical signals delivered to the Leads.
TheTNSdeviceisintendedtobeconnectedtotheLeadsandwornbythesubjectforupto30
daysduringthestudy
period.ThedeviceisintendedtobeconnectedtotheSpinalModulation
Connector Cable.It is not compatible with other cables from other manufacturers.The
externalTNSdevicehasabeltclipthatcanbeusedorthesubjectmaychoosetouseaflexible,
elastic bandage to secure their
TNS device during the trial period.The patient should be
advisednottoallowtheTNStomakedirectcontactwithskin.
PackageContents
(1)TrialNeurostimulator
(1)TNSManual
DeviceSpecifications
Specifications Range StepSize DefaultValue
PulseAmplitude‐PA(µA)
(Dependingonmeasuredimpedance)
06000µA 25µA:02000µA
50µA:20006000µA
0µA
MaximumPulseAmplitude‐Max(µA)
ProgrammablebyPatient
SameasPA SameasPA 0µA
PulseWidthPW(µs) 40720µs 10µs 40µs
PulseFrequency‐PF(Hz) 4100Hz 2Hz 60Hz