nalu 12001-040 User manual

Nalu  Kit Instructions for Use PN: MA-000007 Rev J Page 1of 80
NEUROSTIMULATION SYSTEM
USER INSTRUCTIONS FOR USE

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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

that the batch or lot can be
identified.
ISO 15223-1
5.1.5
Catalogue number

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

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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

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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

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

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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.

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


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TABLE OF CONTENTS
Introduction................................................................................................................................................10
Indications for Use.....................................................................................................................................10
Permanently Implanted System Description..............................................................................................10
Implantable Pulse Generator.................................................................................................................11
Leads.....................................................................................................................................................11
Therapy Disc .........................................................................................................................................11
Trial System Description............................................................................................................................11
Leads.....................................................................................................................................................11
Trial Therapy Disc .................................................................................................................................11
Lead Extension......................................................................................................................................12
Electrode Interfacing Cable ...................................................................................................................12
System Accessories..................................................................................................................................12
Adhesive Clip.........................................................................................................................................12
Relief Belt..............................................................................................................................................12
Limb Cuff...............................................................................................................................................12
Remote Control .....................................................................................................................................12
Charger..................................................................................................................................................12
Safety Information....................................................................................................................................... 13
Contraindications.......................................................................................................................................13
Warnings ...................................................................................................................................................14
Precautions................................................................................................................................................20
Adverse Event Summary ............................................................................................................................24

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Therapy Disc................................................................................................................................................27
Description.................................................................................................................................................27
Therapy Disc Features ..............................................................................................................................27
Powering ON the Therapy Disc.................................................................................................................28
Connecting the Therapy Disc with the Nalu Implantable Pulse Generator ................................................29
Connecting the Trial Therapy Disc (For the Trial System Only).................................................................30
Increasing Stimulation from the Therapy Disc.......................................................................................30
Decreasing Stimulation from the Therapy Disc......................................................................................30
Changing the Stimulation Program from the Therapy Disc....................................................................31
Low Battery Mode on the Therapy Disc.................................................................................................31
Powering OFF the Therapy Disc ...............................................................................................................32
Adhesive Clip...............................................................................................................................................35
Description.................................................................................................................................................35
Preparing Your Skin ..................................................................................................................................35
Applying the Clip........................................................................................................................................36
Placing the Therapy Disc into the Adhesive Clip.......................................................................................37
Removing Therapy Disc ............................................................................................................................37
Adhesive Wear Time.................................................................................................................................37
Removing the Clip.....................................................................................................................................38
Relief Belt..................................................................................................................................................... 38
Description.................................................................................................................................................38
Placing the Therapy Disc in the Relief Belt Pocket....................................................................................38
Removing the Therapy Disc from the Relief Belt Pocket...........................................................................39

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Wearing the Relief Belt..............................................................................................................................39
Removing the Relief Belt...........................................................................................................................39
Belt Care ...................................................................................................................................................39
LIMB CUFF INSTRUCTIONS FOR USE.......................................................................................................40
Charger.........................................................................................................................................................42
Description.................................................................................................................................................42
Powering Up the Charger..........................................................................................................................43
Charging the Therapy Disc........................................................................................................................43
Removing the Therapy Disc ......................................................................................................................43
Powering Down the Charger......................................................................................................................43
Troubleshooting..........................................................................................................................................44
Safety and Technical Checks..................................................................................................................... 46
Cleaning Your Device..................................................................................................................................46
Cleaning the Therapy Disc ........................................................................................................................46
Cleaning the Trial Therapy Disc ................................................................................................................46
Therapy Disc, Charger, and Clip Disposal ................................................................................................47
Environmental Conditions for Storage and Operation.............................................................................47
Therapy Disc .............................................................................................................................................47
Therapy Disc Charger ...............................................................................................................................47
Adhesive Clip.............................................................................................................................................47
Identification Card....................................................................................................................................... 48
When to Call Your Clinician........................................................................................................................48
Kit Contents.................................................................................................................................................49

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Device Specifications..................................................................................................................................51
Radiofrequency (RF) and Wireless Data Parameters............................................................................56
Quality of Service for Wireless Technology...........................................................................................57
Troubleshooting for Wireless and Coexistence Issues..........................................................................58
Statement of FCC Compliance..............................................................................................................59
Magnetic Resonance Imaging (MRI) Safety information (SCS) ...............................................................63
Magnetic Resonance Imaging (MRI) Safety information (PNS) ...............................................................75
Contact Information ....................................................................................................................................80

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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.

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A Nalu Neurostimulation System Clinician Programmer is used by your clinician or a Nalu representative under
 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 isused 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.

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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 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.

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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
•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.

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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.

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•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.
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


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
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.

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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
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 theNalu Neurostimulation System and do notapply 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:
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.

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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)

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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.
•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

Nalu  Kit Instructions for Use PN: MA-000007 Rev J Page 20 of 80
•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: