nalu 12001-040 User manual

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

Nalu  Kit Instructions for Use PN: MA-000007 Rev J Page 2of 80
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


Nalu  Kit Instructions for Use PN: MA-000007 Rev J Page 6of 80
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

Nalu  Kit Instructions for Use PN: MA-000007 Rev J Page 8of 80
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

Nalu  Kit Instructions for Use PN: MA-000007 Rev J Page 10 of 80
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.