Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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Introduction
This user manual gives detailed instructions on how to use your Nalu™ Neurostimulation System. It includes
instructions for both the Permanently Implanted System and the Trial System.
Indications for Use
Spinal Cord Stimulation (SCS)
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a
multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral
pain.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before
recommendation for a permanent (long term) device.
Peripheral Nerve Stimulation (PNS)
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral
nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary
approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before
recommendation for a permanent (long term) device.
Permanently Implanted System Description
The Permanently Implanted Nalu Neurostimulation System is comprised of wirelessly powered Implantable Pulse
Generator, lead(s), anchor(s) and a Therapy Disc. The Nalu Implantable Pulse Generator and lead(s) are designed
to be implanted and configured by qualified medical professionals. The Therapy Disc is designed to be worn when
stimulation is needed. Stimulation programs can be selected and adjusted from the Therapy Disc or a remote-
control application.
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 10 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.
