Abbott NeuroSphere 3875 User manual

NeuroSphere™ Paent
Controller
Dorsal Root Ganglion Neurosmulaon
Systems
Model 3875
User's Guide

CAUTION: Federal (USA) law restricts this device to sale
by or on the order of a physician.
™ Indicates a trademark of the Abbo group of
companies.
‡ Indicates a third-party trademark, which is property of
its respecve owner.
Bluetooth and Bluetooth logo are registered trademarks
of Bluetooth SIG, Inc.
Pat. hp://www.abbo.com/patents
© 2022 Abbo. All Rights Reserved.

Contents
About This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Terms Used in This Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Prescripon and Safety Informaon. . . . . . . . . . . . . . . . . . . . . 6
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Indicaons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
MRI Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Adverse Eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
About Your System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Overview of the Paent Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Items You Will Receive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Your Personal Idencaon Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Direcons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Connecng to Your Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Overview of the Therapy Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Starng and Stopping Smulaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Using the Surgery Mode Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Using the MRI Mode Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Viewing and Selecng a Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Adjusng Program Strength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
System Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Addional Paent Controller Informaon. . . . . . . . . . . . . . . 55
Maintaining the Generator and Paent Controller. . . . . . . . 56
Checking the Generator Baery Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
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Checking the Paent Controller Baery Status. . . . . . . . . . . . . . . . . . . . . . . 58
Caring for the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Caring for the Paent Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Cybersecurity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Protecng Access to the Paent Controller. . . . . . . . . . . . . . . . . . . . . . . . . . 60
Wireless Security Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Guidelines for Secure Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Legal and Privacy Noce. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Troubleshoong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Appendix A: Downloading the Paent Controller App. . . . . . 73
Appendix B: Pairing the Paent Controller to the Generator. . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Appendix C: Regulatory Statements. . . . . . . . . . . . . . . . . . . . 76
Statement of FCC Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Statement of Compliance With License-Exempt RSS Standard (Canada). . . 77
Declaraon of Conformity (Industry Canada) Noce to Users of Radio and
Television. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Idencaon Informaon for Product Registraon. . . . . . . . . . . . . . . . . . . . 78
Product Classicaon Statement (CISPR 11, Class B). . . . . . . . . . . . . . . . . . . 79
Wireless Technology Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Radio Transmier, Cables, Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Quality of Service for Wireless Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Appendix D: Electromagnec Compability Guidelines. . . . 84
Radio Frequency Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
ii

About This Guide
This guide explains how to use the NeuroSphere™
Paent Controller applicaon (Model 3875) with your
neurosmulaon system. If you have any quesons
about your system, contact Technical Support.
Symbols and Denions
The symbols below and harmonized symbols may be
found on the product or product label. For harmonized
symbols, refer to the Universal Symbols Glossary at
medical.abbo/manuals.
NOTE: For symbols and denions for the paent
controller, refer to the user guide available at
support.apple.com/manuals for the Apple‡ iOS‡ device
you are using to run the paent controller app; or, on
the paent controller Home screen, tap Sengs >
General > Legal & Regulatory.
Table 1. Symbols and denions
Symbol Denion
Cauon
Refer to instrucon manual/booklet
Consult instrucons for use
1

Table 1. Symbols and denions
Symbol Denion
Follow instrucons for use on this
website
Type BF Applied Part
MR Condional
NOTE: Magnec Resonance (MR)
Condional, an item with
demonstrated safety in the MR
environment within the dened
condions. At a minimum, address the
condions of the stac magnec eld,
the switched gradient magnec eld,
and the radiofrequency elds.
Addional condions, including specic
conguraons of the item, may be
required.
MR Unsafe
NOTE: Magnec Resonance (MR)
Unsafe, an item poses unacceptable
risks to the paent, medical sta, or
other persons within an MR
environment
Non-ionizing electromagnec radiaon
2

Table 1. Symbols and denions
Symbol Denion
Keep dry; keep away from rain
Ingress protecon rang for a device
that is protected from the intrusion of
solid foreign objects as small as
12.5 mm in diameter and is protected
from vercally dripping water when
the device is lted at an angle up to
15 degrees
Use-by date
Date of manufacture
Catalog number
NOTE: This symbol also refers to the
model number.
Manufacturing facility
Temperature limit
Humidity limitaon
3

Table 1. Symbols and denions
Symbol Denion
Atmospheric pressure limitaon
Manufacturer
Do not use if package is damaged
Packaging unit
Programmer
Accessories
Serial number
Batch code
Unique Device Idencaon
Prescripon use only
This product shall not be treated as
household waste. Instead it is the
user’s responsibility to return this
product to Abbo Medical for
reprocessing.
4

Table 1. Symbols and denions
Symbol Denion
By ensuring that this product is
disposed of properly, you will help
prevent potenal negave
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 informaon about how to
return this product for recycling, please
contact Abbo Medical.
Authorized representave in the
European Community
European conformity, axed in
accordance with the relevant
provisions of AIMD direcve 90/385/
EEC. Hereby, Abbo Medical declares
that this device is in compliance with
the essenal requirements and other
relevant provisions of this direcve.
Australian Communicaons and Media
Authority (ACMA) and New Zealand
Radio Spectrum Management (RSM)
Regulatory Compliance Mark (RCM)
5

Table 1. Symbols and denions
Symbol Denion
This equipment is cered for type
cercaon pursuant of Arcle 38‑24
of the Japan Radio Law
Terms Used in This Document
This secon contains denions of some of the terms
used in this document.
Magnec Resonance (MR) Condional system. A group
of implanted parts that allows a paent to receive a
magnec resonance imaging (MRI) scan safely if all the
requirements for the implanted parts and for scanning
are met.
Program. A combinaon of one or more subprograms
(areas).
Prescripon and Safety
Informaon
Read this secon to gather important prescripon and
safety informaon.
Intended Use
This neurosmulaon system is designed to deliver low-
intensity electrical impulses to nerve structures. The
NeuroSphere™ Paent Controller app is intended to be
6