Abbott NeuroSphere 3875 Manuale utente
NeuroSphere™ Paent
Controller
Dorsal Root Ganglion Neurosmulaon
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 respecve owner.
Bluetooth and Bluetooth logo are registered trademarks
of Bluetooth SIG, Inc.
Pat. hp://www.abbo.com/patents
© 2022 Abbo. All Rights Reserved.
Contents
About This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Terms Used in This Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Prescripon and Safety Informaon. . . . . . . . . . . . . . . . . . . . . 6
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Indicaons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
MRI Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Adverse Eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
About Your System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Overview of the Paent Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Items You Will Receive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Your Personal Idencaon Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Direcons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Connecng to Your Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Overview of the Therapy Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Starng and Stopping Smulaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Using the Surgery Mode Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Using the MRI Mode Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Viewing and Selecng a Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Adjusng Program Strength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
System Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Addional Paent Controller Informaon. . . . . . . . . . . . . . . 55
Maintaining the Generator and Paent Controller. . . . . . . . 56
Checking the Generator Baery Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
i
Checking the Paent Controller Baery Status. . . . . . . . . . . . . . . . . . . . . . . 58
Caring for the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Caring for the Paent Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Cybersecurity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Protecng Access to the Paent Controller. . . . . . . . . . . . . . . . . . . . . . . . . . 60
Wireless Security Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Guidelines for Secure Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Legal and Privacy Noce. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Troubleshoong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Appendix A: Downloading the Paent Controller App. . . . . . 73
Appendix B: Pairing the Paent 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
Declaraon of Conformity (Industry Canada) Noce to Users of Radio and
Television. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Idencaon Informaon for Product Registraon. . . . . . . . . . . . . . . . . . . . 78
Product Classicaon Statement (CISPR 11, Class B). . . . . . . . . . . . . . . . . . . 79
Wireless Technology Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Radio Transmier, Cables, Transducers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Quality of Service for Wireless Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Appendix D: Electromagnec Compability Guidelines. . . . 84
Radio Frequency Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
ii
About This Guide
This guide explains how to use the NeuroSphere™
Paent Controller applicaon (Model 3875) with your
neurosmulaon system. If you have any quesons
about your system, contact Technical Support.
Symbols and Denions
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 denions for the paent
controller, refer to the user guide available at
support.apple.com/manuals for the Apple‡ iOS‡ device
you are using to run the paent controller app; or, on
the paent controller Home screen, tap Sengs >
General > Legal & Regulatory.
Table 1. Symbols and denions
Symbol Denion
Cauon
Refer to instrucon manual/booklet
Consult instrucons for use
1
Table 1. Symbols and denions
Symbol Denion
Follow instrucons for use on this
website
Type BF Applied Part
MR Condional
NOTE: Magnec Resonance (MR)
Condional, an item with
demonstrated safety in the MR
environment within the dened
condions. At a minimum, address the
condions of the stac magnec eld,
the switched gradient magnec eld,
and the radiofrequency elds.
Addional condions, including specic
conguraons of the item, may be
required.
MR Unsafe
NOTE: Magnec Resonance (MR)
Unsafe, an item poses unacceptable
risks to the paent, medical sta, or
other persons within an MR
environment
Non-ionizing electromagnec radiaon
2
Table 1. Symbols and denions
Symbol Denion
Keep dry; keep away from rain
Ingress protecon rang 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 vercally 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 limitaon
3
Table 1. Symbols and denions
Symbol Denion
Atmospheric pressure limitaon
Manufacturer
Do not use if package is damaged
Packaging unit
Programmer
Accessories
Serial number
Batch code
Unique Device Idencaon
Prescripon 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 denions
Symbol Denion
By ensuring that this product is
disposed of properly, you will help
prevent potenal negave
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 informaon about how to
return this product for recycling, please
contact Abbo Medical.
Authorized representave in the
European Community
European conformity, axed in
accordance with the relevant
provisions of AIMD direcve 90/385/
EEC. Hereby, Abbo Medical declares
that this device is in compliance with
the essenal requirements and other
relevant provisions of this direcve.
Australian Communicaons and Media
Authority (ACMA) and New Zealand
Radio Spectrum Management (RSM)
Regulatory Compliance Mark (RCM)
5
Table 1. Symbols and denions
Symbol Denion
This equipment is cered for type
cercaon pursuant of Arcle 38‑24
of the Japan Radio Law
Terms Used in This Document
This secon contains denions of some of the terms
used in this document.
Magnec Resonance (MR) Condional system. A group
of implanted parts that allows a paent to receive a
magnec resonance imaging (MRI) scan safely if all the
requirements for the implanted parts and for scanning
are met.
Program. A combinaon of one or more subprograms
(areas).
Prescripon and Safety
Informaon
Read this secon to gather important prescripon and
safety informaon.
Intended Use
This neurosmulaon system is designed to deliver low-
intensity electrical impulses to nerve structures. The
NeuroSphere™ Paent Controller app is intended to be
6
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