Nalu Medical Nalu Neurostimulation System User manual

Nalu™ Medical, Inc.
Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
NALU™ NEUROSTIMULATION SYSTEM
USER INSTRUCTIONS FOR USE

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 2 of 44
EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE
Refer to the appropriate product for symbols that apply.
Symbol
Title
Explanation
Standard
Reference
Manufacturer
Medical device manufacturer, as
defined in EU Directive 93/42/EEC
ISO 15223-1
5.1.1
Date of manufacture
Date when the medical device was
manufactured.
ISO 15223-1
5.1.3
Use-by date
Date after which the medical device
is not to be used.
ISO 15223-1
5.1.4
Batch code
Manufacturer’s batch code so that
the batch or lot can be identified.
ISO 15223-1
5.1.5
Catalogue number
Manufacturer’s catalogue number so
that the medical device can be
identified.
ISO 15223-1
5.1.6
Do not use if package is
damaged
Medical device should not be used if
the package has been damaged or
opened.
ISO 15223-1
5.2.8
Keep away from sunlight
A medical device that needs
protection from light sources.
ISO 15223-1
5.3.2
Keep dry
A medical device that needs to be
protected from moisture.
ISO 15223-1
5.3.4
Temperature limit
The temperature limits to which the
medical device can be safely
exposed.
ISO 15223-1
5.3.7
Humidity limitation
Indicates the range of humidity to
which the device can be safely
exposed
ISO 15223-1
5.3.8
Atmospheric pressure
limitation
Indicates the range of atmospheric
pressure to which the device can be
safely exposed
ISO 15223-1
5.3.9
Do not re-use
A medical device that is intended for
one use, or for use on a single
patient during a single procedure.
ISO 15223-1
5.4.2
Consult instructions for use
Indicates the need for the user to
consult the instructions for use.
ISO 15223-1
5.4.3
Refer to instruction
manual/booklet.
Indicates the instruction
manual/booklet must be read. (This
symbol is blue and white on the
device label)
ISO 7010:2011
M002
Caution
User to consult the instructions for
use for important cautionary
information such as warnings and
precautions that cannot, for a variety
of reasons, be presented on the
medical device itself.
ISO 15223-1
5.4.4

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 3 of 44
MR Conditional
Medical device demonstrated safety
in the MR environment within defined
conditions.
ASTM F2503-13
Fig. 6
MR Unsafe
Medical device poses unacceptable
risks to the patient, medical staff or
other persons within the MR
environment.
ASTM F2503-13
Fig. 9
Radio Transmitter
Device contains a radio-frequency
(RF) transmitter, which may cause
RF interference with other devices
near this device
IEC 60601-1-2:2007
5.1.1
Prescription use only
Caution: Law prohibits dispensing
without prescription
21 CFR 801.109
N/A
Quantity
Indicates the total number of
products provided in a package.
N/A
N/A
Serial Number
Manufacturer’s serial number so that
a specific medical device can be
identified.
ISO 15223-1
5.1.7
Best Before
This device is best used before this
date.
N/A
N/A
Authorized Representative
in the European Community
Authorized representative in the
European Community
ISO 15223-1
5.1.2
Protected against electric
shock
Device contains a type BF applied
part to protect you from shock. The
device is internally powered and is
intended for continuous operation
IEC 60417
5333
Protected against access to
certain hazardous parts
Protected against solid objects over
12.5mm (e.g., a finger) and protected
against falling drops of water, if the
case is disposed at any angle up to
15 degrees from vertical
IEC 60529
N/A
Protected from dust and
temporary immersion in
water
Protected from dust and against
effects of immersion in water up to
1m depth for 30 mins
IEC 60529
N/A
FCC
This symbol indicates that this
equipment has been tested and
found to comply with the limits for a
Class B digital device, pursuant to
part 15 of the FCC Rules.
47 CFR 2.926
N/A
Do not throw in the trash
This product shall not be treated as
household waste. Instead it is the
user’s responsibility to return this
product to Nalu Medical for
reprocessing.
By ensuring that this product is
disposed of properly, you will help
prevent potential negative
consequences for the environment
and human health, which could be
caused by inappropriate waste
handling of this product. The
recycling of materials will help to
conserve natural resources.
For more information about how to
return this product for recycling,
please contact Nalu Medical.
BS EN 50419 Marking of
Electrical and Electronic
Equipment in Accordance
with Article 11(2) of
Directive 2002/96/EC
(WEEE)
Fig. 1
IP22

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 4 of 44
TABLE OF CONTENTS
Introduction ............................................................................................................................................ 6!
Indications for Use ................................................................................................................................. 6!
Permanently Implanted System Description ......................................................................................... 6!
Implantable Pulse Generator ............................................................................................................. 6!
Leads ................................................................................................................................................. 6!
Therapy Disc ...................................................................................................................................... 6!
Trial System Description ........................................................................................................................ 6!
Leads ................................................................................................................................................. 7!
Trial Therapy Disc .............................................................................................................................. 7!
Lead Extension .................................................................................................................................. 7!
Electrode Interfacing Cable ................................................................................................................ 7!
System Accessories .............................................................................................................................. 7!
Adhesive Clip ..................................................................................................................................... 7!
Relief Belt ........................................................................................................................................... 7!
Limb Cuff ............................................................................................................................................ 7!
Remote Control .................................................................................................................................. 7!
Charger .............................................................................................................................................. 7!
Safety Information .................................................................................................................................. 7!
Contraindications ................................................................................................................................... 7!
Warnings ............................................................................................................................................... 8!
Precautions .......................................................................................................................................... 11!
Adverse Event Summary ..................................................................................................................... 13!
Therapy Disc ......................................................................................................................................... 16!
Description ........................................................................................................................................... 16!
Therapy Disc Features ........................................................................................................................ 16!
Powering ON the Therapy Disc ........................................................................................................... 17!
Connecting the Therapy Disc with the Nalu Implantable Pulse Generator ......................................... 17!
Connecting the Trial Therapy Disc (For the Trial System Only) .......................................................... 17!
Increasing Stimulation from the Therapy Disc ................................................................................. 18!
Decreasing Stimulation from the Therapy Disc ................................................................................ 18!
Changing the Stimulation Program from the Therapy Disc .............................................................. 18!
Low Battery Mode on the Therapy Disc ........................................................................................... 18!
Powering OFF the Therapy Disc ......................................................................................................... 18!
Adhesive Clip ........................................................................................................................................ 20!
Description ........................................................................................................................................... 20!
Preparing Your Skin ............................................................................................................................ 20!
Applying the Clip ................................................................................................................................. 20!
Placing the Therapy Disc into the Adhesive Clip ................................................................................. 21!

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Removing Therapy Disc ...................................................................................................................... 21!
Adhesive Wear Time ........................................................................................................................... 21!
Removing the Clip ............................................................................................................................... 21!
Relief Belt .............................................................................................................................................. 22!
Description ........................................................................................................................................... 22!
Placing the Therapy Disc in the Relief Belt Pocket ............................................................................. 22!
Removing the Therapy Disc from the Relief Belt Pocket .................................................................... 22!
Wearing the Relief Belt ........................................................................................................................ 22!
Removing the Relief Belt ..................................................................................................................... 22!
Belt Care .............................................................................................................................................. 22!
LIMB CUFF INSTRUCTIONS FOR USE ............................................................................................... 23!
Charger .................................................................................................................................................. 24!
Description ........................................................................................................................................... 24!
Powering Up the Charger .................................................................................................................... 24!
Charging the Therapy Disc .................................................................................................................. 24!
Removing the Therapy Disc ................................................................................................................ 24!
Powering Down the Charger ............................................................................................................... 25!
Troubleshooting ................................................................................................................................... 25!
Safety and Technical Checks .............................................................................................................. 26!
Cleaning Your Device ........................................................................................................................... 26!
Cleaning the Therapy Disc .................................................................................................................. 26!
Cleaning the Trial Therapy Disc .......................................................................................................... 26!
Therapy Disc, Charger, and Clip Disposal ......................................................................................... 26!
Environmental Conditions for Storage and Operation ..................................................................... 27!
Therapy Disc ....................................................................................................................................... 27!
Therapy Disc Charger ......................................................................................................................... 27!
Adhesive Clip ....................................................................................................................................... 27!
Identification Card ................................................................................................................................ 27!
When to Call Your Clinician ................................................................................................................. 27!
Kit Contents .......................................................................................................................................... 28!
Device Specifications ........................................................................................................................... 29!
Radiofrequency (RF) and Wireless Data Parameters ...................................................................... 32!
Quality of Service for Wireless Technology ..................................................................................... 32!
Troubleshooting for Wireless and Coexistence Issues .................................................................... 33!
Statement of FCC Compliance ........................................................................................................ 33!
Magnetic Resonance Imaging (MRI) Safety information (SCS) ........................................................ 35!
Magnetic Resonance Imaging (MRI) Safety information (PNS) ........................................................ 41!
Contact Information .............................................................................................................................. 44!

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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.

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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.
Lead Extension
The lead extension adds additional length to a lead to connect to the Electrode Interfacing Cable, as needed, for
connection to the Trial Therapy Disc.
Electrode Interfacing Cable
The Electrode Interfacing Cable connects the leads or the lead extensions with the Trial Therapy Disc during the
user’s Nalu Neurostimulation System trial period.
System Accessories
Adhesive Clip
The adhesive clip holds the Therapy Disc in place over the Implantable Pulse Generator location.
Relief Belt
The relief belt holds the Therapy Disc in place over the Implantable Pulse Generator location.
Limb Cuff
The limb cuff holds the Therapy Disc in place over the Implantable Pulse Generator location.
Remote Control
The Nalu Remote Control Application is an application that runs on Android and IOS platforms and can be optionally
used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.
Charger
The Nalu charger recharges the batteries inside both the Therapy Discs.
SAFETY INFORMATION
Contraindications
Users contraindicated for this therapy are those who:
• Are unable to operate the system
• Have failed trial stimulation by failing to receive effective pain relief
• Are poor surgical risks
• Are pregnant
Exposure to shortwave, microwave, or ultrasound diathermy – Diathermy should not be operated within the
vicinity of a patient implanted with a Nalu Neurostimulation System or when wearing a Therapy Disc. The energy
from diathermy can be transferred through the stimulator and cause tissue damage, resulting in severe injury.
Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy – Patients
who regularly work in environments with elevated levels of non-ionizing radiation should not be implanted with the
device. The energy in high-level areas can be transferred through the device and cause tissue damage, resulting
in severe injury. Examples of environments having high level non-ionizing radiation include the following:
• Radio or cell phone transmission stations
• Facilities using radiofrequency heat sealers or induction heaters

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• Electric power infrastructure controlled environments (i.e. step down transformers or high voltage power
lines)
Implanted Cardiac or Other Neurostimulation Systems—Patients who have implanted cardiac or other
neurostimulation systems should not use the Nalu Neurostimulation System. Electrical pulses from the Nalu
Neurostimulation System may interact with the sensing operation of an implanted cardiac or neurostimulation
system, causing the system to respond inappropriately.
Warnings
Electromagnetic Interference (EMI)—EMI is a field of energy generated by equipment found in the home, work,
medical, or public environments. Very strong EMI can interfere with the System. The device includes features that
provide protection from EMI. Most electrical device and magnets encountered in a normal day will not affect the
operation of the System, however, strong sources of EMI could result in the following:!
• Serious user injury resulting from heating of the implanted device and damage to surrounding tissue.
• System damage resulting in a loss of, or change in, symptom control that might require additional surgery.
• Operational changes to the Therapy Disc. This may cause the external device to turn on, turn off, or reset
to factory settings. If this occurs, the Therapy Disc needs to be reprogrammed.
• Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation.
Some users have described a jolting or shocking sensation. Although the unexpected change in stimulation
may feel uncomfortable, it will not damage the device or cause direct injury to the user. In rare cases, as a
result of the unexpected changes in stimulation, users have fallen down and been injured.
If you suspect that your Nalu Neurostimulation System is being affected by EMI, then you should:
• For the Therapy Disc – Remove or Turn Off
• For the Trial Therapy Disc – Disconnect and/or Turn Off Stimulation
• Immediately move away from the equipment or object.
Electromagnetic Equipment/ Environments—Avoidance of high electromagnetic equipment radiators or
environments is highly encouraged. Examples of equipment and/or environments include the following:
• High-power amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private
recreation, communication, and wireless experimentation.
• Electric arc welding or resistance welding equipment used for melting and joining metals or plastics.
• Industrial electric induction furnace/heater or electric arc furnace/heater used for melting metals and
plastics.
• High-voltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside
the fenced area).
• Microwave transmitters identified by fenced areas, restricted access signs, and caution signs (safe if outside
the fenced area).
• Television, cell phone and radio towers identified by fenced areas, restricted access signs, and caution
signs (safe if outside the fenced area).
• Linear power amplifiers used for increasing the power output of radio transmitters, wireless communication
applications, audio equipment or other electronic equipment.
• Radio telemetry equipment used for tracking location of vehicles, equipment or animals.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

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Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the Nalu Neurostimulation System. Otherwise,
performance degradation of the equipment might occur.
Machinery or Heavy Equipment—Machinery and heavy equipment (including vehicles) should not be operated
while using the Nalu Neurostimulation System. Malfunction of the System could result in the loss of body control,
body function, or a feeling that could render the user incapable of controlling the equipment.
Theft Detectors and Metal Screening Devices – Certain types of antitheft devices, such as those used at the
entrances/exits of department stores, libraries, and other public establishments, and/or airport security screening
devices may affect stimulation. If you are sensitive to low stimulation thresholds, you may experience a momentary
increase in perceived stimulation, which has been described as “uncomfortable” or “jolting”. Use caution when
approaching such a device and request assistance to bypass the device. If you must proceed through the device,
remove the Therapy Disc and proceed with caution, but be sure to move through the detector quickly.
Temperature Rise During Stimulation – During prolonged use of Therapy Disc the temperature of the device may
rise by 1°C above ambient temperature. If the Therapy Disc becomes uncomfortable remove the device from the
clip and discontinue use.
When you are considering additional medical tests or treatments, please share the following
Warnings with your clinician.
Active Implantable or Body-Worn Medical Devices—Safety has not been established for users who use the Nalu
Neurostimulation System with other active implantable or body-worn medical devices. Malfunction and/or damage
could occur to either system that could result in harm to the user or other people nearby
Magnetic Resonance Imaging (MRI)—MR Unsafe – For the Nalu Neurostimulation System, the only components
that are allowed into the MRI system room are the 40 cm Lead (Model 12001-040), the Nalu Anchor (Model 13001)
and the Nalu Implantable Pulse Generators (Model 11001-040, 11002-040, 11003-002, 11004-002).
All other components (i.e., the external component and programmer) are not permitted in the MRI system
room.
Magnetic resonance imaging (MRI) – MR Conditional – Prior to conducting or recommending an MRI
examination on a patient with the Nalu Neurostimulation System, it is important to read and understand the entire
section entitled, “MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION” in the Table of Contents,
which pertains to performing an MRI examination safely in a patient.
These instructions apply only to the Nalu Neurostimulation System and do not apply to other products. If
you have any questions, please contact Nalu Medical or visit Nalu’s website <www.nalumed.com>.
The only Nalu Medical components that are labeled and approved as MR Conditional are the Lead (Model
12001-040), the Nalu Anchor (Model 13001) and the Nalu Implantable Pulse Generators (Model 11001-040,
11002-040, 11003-002, 11004-002). All other components are MR Unsafe.
Computed Tomography (CT) Scanning—Safety has not been established for CT scanning of users with a Nalu
Neurostimulation System. X-rays from the scan could cause unintended shocks or malfunctions of the System, and
may not be immediately detectable.
1. The CT operator should use CT scout views to determine if implanted medical devices are present and
their location relative to the programmed scan range. For CT procedures in which the device is in or
immediately adjacent to the programmed scan range, the operator should:

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a. Remove the Therapy Disc from the CT scan range.
b. Minimize X-ray exposure to the implanted device by:
c. Using the lowest possible X-ray tube current consistent with obtaining the required image quality.
d. Making sure that the X-ray beam is not placed over the Nalu Implantable Pulse Generator for more
than a few seconds.
2. After CT scanning directly over the implanted device:
a. Place the Therapy Disc on body/connect the Trial Therapy Disc and turn on stimulation.
b. Check for proper stimulation, and that indicator lights are operating as expected.
c. Shut off the Therapy Disc if it is suspected that the device is not functioning properly.
Radiofrequency (RF) Ablation—Safety has not been established for RF ablation in users with the device. RF
ablation may result in heating and tissue damage. Do not use RF ablation anywhere near the device. If RF ablation
is used, ensure that ablation is not performed over or near the device.
Medical Devices/Therapies— The following medical therapies or procedures may turn stimulation off or may cause
permanent damage to the Nalu Implantable Pulse Generator particularly if used in close proximity to the device:
• Lithotripsy
• Electrocautery. Do not use monopolar cautery
• External defibrillation
• Radiation therapy
• Ultrasonic scanning
• High-output ultrasound
• Bone growth stimulators
• Dental Drills and Ultrasonic Probes
• Electrolysis
• Laser Procedures
• Radiation Therapy
• TENS (transcutaneous electrical nerve stimulation)
If the user is required by medical necessity to undergo any of the above therapies or procedures, the procedural
guidelines below must be followed. Ultimately, however, the device may need to be explanted as a result of
associated failure.
• Turn off stimulation of the Nalu Implantable Pulse Generator before the procedure or therapy.
• All equipment, including ground plates and paddles, must be used as far away from the Implantable Pulse
Generator as possible.
• Bipolar electrocautery is recommended. Do not use monopolar electrocautery.
• Every effort should be taken to keep fields, including current, radiation, or high-output ultrasonic beams,
away from the Implantable Pulse Generator.
• If radiation therapy is required, the area over the Nalu Implantable Pulse Generator should be shielded with
Lead.
• Equipment should be set to the lowest energy setting clinically indicated.

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 11 of 44
• Instruct users to confirm Implantable Pulse Generator functionality following treatment by turning on the
Implantable Pulse Generator and gradually increasing stimulation to the desired level.
• Damage from these procedures to the Nalu Neurostimulation System may not be detected immediately.
Psychotherapeutic Procedures—Safety has not been established for psychotherapeutic procedures using
equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic
stimulation) in users who have spinal cord stimulators. Induced electrical currents can cause heating that may result
in tissue damage.
Other Medical Procedures—EMI from the following medical procedures is unlikely to affect the device:
• Diagnostic x-rays or fluoroscopy
• Magnetoencephalography (MEG)
• Positron emission tomography (PET) scans
• Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist wraps, elbow wraps)
Painful Stimulation—If the user experiences painful stimulation do the following:
For Therapy Disc – Remove or decrease the stimulation amplitude
For Trial Therapy Disc – Disconnect or decrease the stimulation amplitude
Contact your clinician if this continues to occur.
Strangulation— Entanglement in the Therapy Disc Charger cable, Electrode Interfacing Cable, or Relief Belt may
cause a fall or strangulation.
Tampering - Do not modify or tamper with any component of the Nalu Neurostimulation System. Tampering with
the device could result in harm. If the device is not working properly, contact your clinician for help.
Precautions
Clinician Training – If you have a Nalu Neurostimulation System, please inform your regular clinician or specialist.
Your clinician should visit www.nalumed.com for more information about the system prior to any medical
procedures.
Clinician Instructions– Always follow the programs and therapy instructions established by your clinician. Failure
to do so may cause the therapy to be less effective in providing pain relief.
Post-Operative— During the two weeks following surgery, it is important to use extreme care so that appropriate
healing will secure the implanted components and close the surgical incisions:
a. Do not lift objects of more than five pounds.
b. Do not engage in rigorous physical activity such as twisting, bending, or climbing.
c. If new Leads were implanted, do not raise your arms above your head.
Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond
two weeks, contact your clinician.
If you notice excessive redness around the wound areas during this time, contact your clinician to check for infection
and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this
period.
Be sure to consult your clinician before making lifestyle changes due to decreases in pain.

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 12 of 44
Medical Tests and Procedures – Before undergoing medical tests or procedures, contact your clinician to
determine if the procedure will cause damage to the user or to the System.
When you are considering additional medical treatments, please share the following Precautions with your
clinician.
The following precautions should be followed to properly use and care for your Therapy Disc and/or Trial
Therapy Disc:
Use the Therapy Disc as Directed – Use the Therapy Disc only as explained your clinician or as discussed in the
User Manual. Using the Therapy Disc in any other manner could result in harm. Do not use any equipment or
accessories that are not supplied with the Therapy Disc.
Use of Another User’s Therapy Disc - Use of another user’s Therapy Disc will not deliver therapy. The therapy
programmed is a unique prescription for each user and their specific Nalu Implantable Pulse Generator.
Handle the Therapy Disc with Care – The Therapy Disc is a sensitive electronic device. Avoid dropping the device
onto hard surfaces. Keep the Therapy Disc out of the reach of children, pests and pets.
Keep the Trial Therapy Disc Dry – The Trial Therapy Disc is not waterproof. Keep the Trial Therapy Disc dry to
avoid damage.
Avoid extended immersion with the Therapy Disc – The Therapy Disc can get wet within certain limits. It is not
recommended that the Therapy Disc be used during water activities. Upon shipment, the Therapy Disc is rated IP67
(protected from total dust ingress, protected from immersion between 15 centimeters and 1 meter in depth for 30
minutes) and over time with normal wear and use, the Therapy Disc may become more susceptible to damage by
immersion.
Clean the Therapy Disc – When needed, clean the outside of the Therapy Disc with a damp cloth to prevent dust
and dirt.
Storage Temperatures – The Nalu Neurostimulation System should be kept
within the storage temperatures listed on product packaging. Exceeding the
storage temperature can affect the performance of the device.
Random Component Failure – Although unlikely, a failure of the Nalu
Neurostimulation System is possible due to random component failure. If any
part of your Neurostimulation System stops working or changes how it works,
remove the Therapy Disc and contact your Nalu representative.
Unexpected Changes in Stimulation – Electromagnetic interference, changes
in posture, and other activities can cause a perceived increase in stimulation.
Some users have described this as a jolting or shocking sensation. Before engaging in potentially unsafe activities
you should do the following:
1. For Therapy Disc – Remove or Turn Off
2. For Trial Therapy Disc – Disconnect and/or Turn Off Stimulation
Discuss these activities with your clinician.
Airline Policies - Follow airline policies for use of medical spinal cord stimulation systems and electronic equipment
during flights. Refer all questions to airline personnel. Carry your ID card with you at all times.
Flammable or Explosive Environments – Do not use the Therapy Disc in flammable or explosive environments.
Using the Therapy Disc in one of these environments could result in harm.
Activities Requiring Excessive Twisting or Stretching – Avoid activities that could potentially put stress on the
device. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can cause
your stimulator to fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, and additional
medical procedures.

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Scuba Diving or Hyperbaric Chambers – Do not dive below 13 meters (45 feet) of water or enter hyperbaric
chambers above 1.48 atmospheres absolute (ATA) with the Nalu Implantable Pulse Generator. These conditions
can damage the device. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with the
clinician. Do not dive or enter hyperbaric chambers with the Therapy Disc.
Remote Control Interference– If interference is suspected during use of the remote control, confirm that the
Bluetooth data transmission is operating properly. If the Nalu Remote Control application is not connecting to the
Therapy Disc:
a. Terminate the current stimulation program and shut down the Nalu Remote Control application.
b. Check for sources of Bluetooth interference in the surrounding area.
c. Remove or turn off the source of interference.
d. Re-establish the Bluetooth link with the Therapy Disc through pairing.
Reopen the Nalu Remote Control application and resume the therapy.
Adverse Environments – Any user with a Nalu Neurostimulation System should seek medical guidance before
entering environments which could adversely affect the operation of the Nalu Neurostimulation System, including
areas protected by a warning against entry by users.
ADVERSE EVENT SUMMARY
Below is a list of side effects that may occur during surgery and/or during standard spinal cord
stimulation:
• Undesirable changes in stimulation sensation and/or location with or without user movement.
• Persistent post-surgical pain at hardware implantation sites.
• Seroma or hematoma at surgery sites.
• Spinal cord injury and or compression with subsequent neurological deficits - permanent or temporary.
• Stroke.
• Lead migration, causing the electrodes to move from the intended location.
• Implantable Pulse Generator migration, which may or may not require surgical intervention.
• Fracture of the lead(s) or failure of other system components, which may result in the loss of stimulation or
untoward stimulation induced dysesthesias.
• Allergic or rejection reaction to the anesthesia, implanted components, or external components.
• Reaction to the selected antibiotics or to the Nalu device including: rash, diarrhea, abdominal pain,
nausea/vomiting, dizziness, headaches, hypersensitivity (allergic) reactions
• Undesirable skin problems such as infection, irritation, blistering, tearing or allergic reactions that may occur
during the use of any wearable component of the Nalu Neurostimulation System.
• Skin irritation, including redness, itchiness, and bumpiness
• Infection at implant site that may or may not require hospitalization and require treatment with antibiotic therapy
or surgical intervention
• Cerebral spinal fluid (CSF) leak inclusive of those requiring active medical intervention.
• Inadequate pain relief or increase in pain following system implantation
• Wound complications that may require medical intervention inclusive of surgical management.
• Thromboembolic events requiring medical intervention; inclusive of deep vein thrombosis and pulmonary
embolism.
• Death and/or catastrophic neurological complications.
• Anesthetic complications - e.g. nausea, urinary retention.
• Headache.
• Bleeding.

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 14 of 44
• Excessive fibrotic reaction to device leading to pain and/or new pain symptoms.
• Unexpected stimulation effects including but not limited to: chest wall stimulation, muscle stimulation, tremor,
dyskinesia, superficial pain, cramping, light-headedness and metallic taste.
• Weakness.
• Numbness.
• Clumsiness.
• Tissue damage.
• Nerve damage.
• Paralysis.
• Swelling.
• Sensory loss.
• Discomfort during the treatment.
• Skin erosion around the Nalu Implantable system or at the site of the Nalu wearable devices.
• Battery failure
• Lead breakage requiring replacement of the Lead.
• Electromagnetic interference causing a change in System performance.
• Loss of therapeutic effect despite a functioning system.
• Hardware malfunction requiring replacement of the neurostimulator components.
• Pain from a non-injurious stimulus to the skin (allodynia).
• An exaggerated sense of pain (hyperesthesia).
• Change in stimulation that are possibly related to tissue changes around the electrodes, shifts in electrode
position, loose electrical connections, and lead or extension fractures which have been described by some
users as uncomfortable stimulation (a jolting or shocking sensation).
• Formation of reactive tissue in the epidural space around the lead can result in delayed spinal cord compression
and paralysis, requiring surgical intervention. Time to onset can range from days to many years after implant.
• Arrhythmia.
• Cardiac arrest.
• Intracranial hypotension.
• Fracture of the lead(s) or failure of other system components.
• Loss of therapy or unpleasant paraesthesia.
Adverse effects of stimulation are usually mild and go away when stimulation is turned off. Contact your clinician
immediately if you experience any problems. There may be changes in the level of pain control over time.
Notice: In the event of any serious incident that has occurred in relation to the Nalu Neurostimulation System, the
user should report the incident to Nalu Medical at +1.800.618.3402 or visit www.nalumed.com.

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 15 of 44

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 16 of 44
THERAPY DISC
Description
The Therapy Disc is a part of the Nalu Neurostimulation System that wirelessly powers and sends stimulation
commands to the Nalu Implantable Pulse Generator. The Therapy Disc is positioned over the implant using an
Adhesive Retention Clip or Relief Belt and may be controlled using integrated buttons or via a remote-control
application (see Nalu Remote Control Application Instructions for Use for details). Battery life is optimal when the
Therapy Disc is placed directly over the implant. You are provided with two Therapy Discs in the initial Nalu User’s
Kit, one to be used while the other is charging.
The Trial Therapy Disc has a wired connection to the lead or lead extension to provide stimulation during the trial
period.
Therapy Disc Features
Therapy Disc
Trial Therapy Disc
ON/OFF Program
• Turns Therapy Disc on/off
• Changes stimulation
programs
Down Button
• Decrease Stimulation
• Dismisses and reactivates alerts
Up Button
• Increase Stimulation
LED (white, blue, green, orange)
• Indicates Therapy Disc status
Buzzer
• Indicates Therapy Disc
status
Micro HDMI
Connector

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 17 of 44
Powering ON the Therapy Disc
1. Press and release the ON / OFF Program button.
2. Listen and watch.
3. The buzzer will beep and the white LED will blink to indicate battery level.
# white blinks/ beeps
Battery Level
4
Fully charged
3
¾ charged
2
½ charged
1
¼ charged
Orange
Discharged (low battery mode)
4. Following the white LED blinks, the green LED will blink to indicate the most recently used program. The
number of green LED blinks corresponds to the current program.
Connecting the Therapy Disc with the Nalu Implantable Pulse Generator
1. Place the Therapy Disc over the implant.
2. Three (3) short beeps will sound when the Therapy Disc connects to the implant.
NOTE: The Therapy Disc starts stimulation at the most recently used program and stimulation level.
NOTE: If the Therapy Disc becomes disconnected from the implanted Pulse Generator after having
been connected, the Therapy Disc will beep once every second.
3. To dismiss the alert, press and hold the Up or Down button.
4. To reactivate the alert, press and hold the Up or Down button.
Connecting the Trial Therapy Disc (For the Trial
System Only)
1. Plug the micro HDMI adapter into the micro HDMI port on the
Trial Therapy Disc as shown in Figure 1.
2. Three (3) short beeps will sound when the Trial Therapy Disc
connects to the lead.
Figure 1: Connect Trial Therapy Disc
to Electrode Interfacing Cable

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 18 of 44
Increasing Stimulation from the Therapy Disc
1. Press and release the Up button.
2. The green LED will blink after each button press.
Maximum Stimulation: When at the maximum level of stimulation, further attempts to increase
stimulation will cause the buzzer to beep twice and the orange LED to blink twice.
Decreasing Stimulation from the Therapy Disc
1. Press and release the Down button.
2. The green LED will blink after each button press.
Minimum Stimulation: When at the minimum level of stimulation, further attempts to reduce stimulation
will cause the buzzer to beep twice and the orange LED to blink twice.
Changing the Stimulation Program from the Therapy Disc
1. Press and release the ON / OFF Program button.
2. The green LED will blink after the button press. The selected program will be indicated by the number of
LED blinks. For example, if Program 4 is selected, the green LED will blink four (4) times.
NOTE: The Therapy Disc cycles through the programs in order. When the last program is
reached, the next program will be Program 1.
NOTE: The maximum number of programs the Therapy Disc can hold is 8.
Low Battery Mode on the Therapy Disc
1. When the device is in low battery mode, the orange LED will blink slowly and the buzzer will beep slowly
seven (7) times every minute.
2. To dismiss the low battery indication, press and hold the Up or Down button. The white LED will remain lit
while the button is held down.
3. To reactivate the low battery indication, press and hold the Up or Down button. The white LED will remain
lit while the button is held down.
NOTE: Low battery mode disables stimulation, and disables program change and amplitude
change buttons.
Powering OFF the Therapy Disc
1. The buzzer will beep once every second when the Therapy Disc is disconnected from the implant after
having been connected.
2. Press and hold the ON / OFF Program button.
3. The white LED will blink while the Therapy Disc shuts down completely. The white LED will stop blinking
after the Therapy Disc has powered off.

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 19 of 44
Below is a table with button actions and the meaning of the corresponding LED or buzzer sound.
Action
LED indication
Buzzer indication
Meaning
Press ON / OFF
Program Button to
Power On
4 white blinks
4 beeps
Battery fully charged.
3 white blinks
3 beeps
Battery ¾ charged.
2 white blinks
2 beep
Battery ½ charged.
1 white blink
1 beep
Battery ¼ charged.
Slow orange blinks.
7 slow beeps per
minute.
Battery discharged (low
battery mode).
Place Device Over
Implant
3 short beeps.
Device is connected to
implant.
3 long beeps.
Device connection failed.
Short Press on the
Up Button
1 green blink per press.
Stimulation increased.
2 short orange blinks.
2 short beeps.
Maximum stimulation level
reached.
Long Press on the
Up Button
Dismiss/ reactivate alert.
Short Press on the
Down Button
1 green blink per press.
Stimulation decreased.
2 short orange blinks.
2 short beeps.
Minimum stimulation level
reached.
Long Press on the
Down Button
Dismiss/ reactivate alert.
Short Press on the
ON / OFF Program
Button When the
Device is On
(#)* green blinks
Program (#)* selected.
*(#) indicates the program
number. For example,
Program 3 would have
three green blinks.
Orange blinks every
second.
Beeps every
second.
No communication with
the implant.
Long Press on the
ON / OFF Program
Button to Power Off
White LED blinks for one
second, and then stops
blinking.
Device is off.
Below is a table with Therapy Disc button actions and timing.
Therapy Disc Action
Time
Short Press on Any Button
Press for less than one (1) second.
Long Press on Any Button
Press for more than one (1)
second.
Therapy Disc Response
Time
Short Beeps / Blinks
Last for 0.1 seconds when the
device is turned ON or OFF.
Long Beeps
Last for 0.5 seconds when the
device is turned ON or OFF.
Slow Beeps / Blinks
Occur every 1.5 seconds.

Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C Page 20 of 44
ADHESIVE CLIP
Figure 2: Clip
Figure 3: Clip (Back)
Figure 4: Clip and Therapy Disc
Description
The single-use Adhesive Clip is designed to hold the Therapy Disc on the body using a skin friendly adhesive. The
Adhesive Clip is placed over the implant and the Therapy Disc is inserted into the clip. The Adhesive Clip is not
intended to be reused.
Your user kit contains the H100 Adhesive Clips (34005-002). If you experience moderate to severe skin reactions
from the H100 Adhesive Clip, switch to the H300 Adhesive Clip (34005-003). If the H100 Adhesive Clip is not sticky
enough, switch to the H200 Adhesive Clip (34005-001) for easier clip removals.
Preparing Your Skin
1. Make sure your skin is clean and dry.
2. If necessary, trim hair with scissors or small beard trimmer. Do not shave since this can lead to irritation.
3. If desired, commercially available skin barrier wipes and sprays may be used to prep the skin.
Applying the Clip
1. Remove the adhesive liner, as shown in Figure 5.
2. Grasp the clip between your thumb and finger and place your index
finger through the center hole. The clip should be held, as shown in
Figure 6.
Figure 5 Remove Liner
Figure 6 Clip Orientation