Implantable Pulse Generator; Leads; Therapy Disc; Trial System Description - nalu 12001-040 User Instructions For Use

A Nalu Neurostimulation System Clinician Programmer is used by your clinician or a Nalu representative under
a clinician's guidance to set up your stimulator and make adjustments later if needed.

Implantable Pulse Generator

The Nalu Implantable Pulse Generator is the implanted battery-free, microstimulator that receives power and
stimulation commands from the Therapy Disc. The service life of the Implantable Pulse Generator is 18 years.

Leads

Leads are surgical wires that connect to the Nalu Implantable Pulse Generator and transfer stimulation from
the implanted pulse generator to the target location.

Therapy Disc

The Therapy Disc is the externally worn transmitter module that powers and sends stimulation commands to
the Nalu Implantable Pulse Generator. The Therapy Disc is positioned externally over the implant using an
adhesive retention clip or textile belt and may be controlled using integrated buttons or via the Nalu Remote
Control application. The service life is 3 years for the Therapy Disc and Charger and 1 year for the Trial
Therapy Disc.
The term "Therapy Disc" is applicable to both the Trial Therapy Disc and the Therapy Disc unless otherwise
indicated in this document.

Trial System Description

The Trial Nalu Neurostimulation System is comprised of implanted leads, lead extensions, Electrode
Interfacing Cable and extension, and a Trial Therapy Disc for a trial period. The trial period is used to determine
whether spinal cord stimulation and the Nalu Neurostimulation System are appropriate for you.
Leads
Leads are surgical wires that transfer stimulation from the Trial Therapy Disc to the target location.

Trial Therapy Disc

The Trial Therapy Disc powers and sends signals to the implanted leads during the trial period.
Nalu User's Kit Instructions for Use PN: MA-000007 Rev J
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