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
i

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

used with the generator to help the paent manage
prescribed smulaon programs.
Indicaons for Use
This neurosmulaon system is indicated for spinal
column smulaon via epidural and intraspinal lead
access to the dorsal root ganglion as an aid in the
management of moderate to severe chronic intractable*
pain of the lower limbs in adult paents with complex
regional pain syndrome (CRPS) types I and II.**
*Study subjects from the ACCURATE clinical study had
failed to achieve adequate pain relief from at least two
prior pharmacologic treatments from at least two
dierent drug classes and connued their
pharmacologic therapy during the clinical study.
**Please note that in 1994, a consensus group of pain
medicine experts gathered by the Internaonal
Associaon for the Study of Pain (IASP) reviewed
diagnosc criteria and agreed to rename reex
sympathec dystrophy (RSD) and causalgia as complex
regional pain syndrome (CRPS) types I and II,
respecvely. CRPS II (causalgia) is dened as a painful
condion arising from damage to a nerve. Nerve
damage may result from traumac or surgical nerve
injury. Changes secondary to neuropathic pain seen in
CRPS I (RSD) may be present, but are not a diagnosc
requirement for CRPS II (causalgia).
7

Contraindicaons
This neurosmulaon system is contraindicated for
paents who are
▪Unable to operate the system▪
▪Poor surgical risks
▪
Paents who failed to receive eecve pain relief during
trial smulaon are contraindicated to proceed to the
permanent implant procedure.
MRI Safety Informaon
If you are using a trial system, you should not be
subjected to an MRI. The electromagnec eld
generated by an MRI may damage the device electronics
and induce voltage through the lead that could cause a
jolng or shocking sensaon.
If you are using a permanent system, you may be
implanted with the parts that make up a Magnec
Resonance (MR) Condional system, which allows you
to receive an MRI scan if all the requirements for the
implanted parts and for scanning are met. Scanning
under dierent condions may cause device
malfuncon, severe injury, or death. Contact your
physician before receiving an MRI scan to nd out if you
can undergo the procedure and to learn more about any
risks. Addionally, before receiving an MRI scan, inform
the healthcare professional that you are implanted with
a neurosmulaon system. If you do not have an MR
Condional system, you cannot receive an MRI.
8

Do not bring your paent controller into the scanner
magnet room. It can be aected by the MRI magnet,
may present a projecle hazard, and is MR Unsafe.
For more informaon about what you need to do to
prepare for an MRI scan, refer to “Using the MRI Mode
Feature” (page 40) in this guide.
Warnings
The following warnings apply to these components.
NOTE: For nontherapy-related warnings for the
NeuroSphere™ 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.
System Warnings
Pregnancy and nursing. Safety and eecveness of
neurosmulaon for use during pregnancy, nursing, the
unborn fetus, or delivery have not been established.
Pediatric use. Safety and eecveness of
neurosmulaon for pediatric use have not been
established.
Back pain. The safety and ecacy for the treatment of
paents who have back pain as the greatest region of
pain have not been evaluated.
Medical tests and procedures. Before undergoing
medical tests or procedures (such as therapeuc
radiaon or electrolysis), contact your physician to
determine if the procedure will cause you injury or
9

damage your neurosmulaon system. Specically, you
should be aware that medical devices such as
electrohydraulic lithotriptors, therapeuc X‑rays,
computerized tomography (CT) scans, cobalt machines,
and linear accelerators may cause damage to the
electronic circuitry of an implanted neurosmulaon
system. If using a trial system and radiaon therapy is
required, disconnect the trial generator from the leads
or extensions. Damage to the system may not be
immediately detectable.
Diathermy therapy. You cannot have any short-wave
diathermy, microwave diathermy, or therapeuc
ultrasound diathermy (all now referred to as diathermy)
on your body if you have any part of a neurosmulaon
system implanted. Energy from diathermy can be
transferred through the implanted system and can cause
ssue damage at the locaon of the implanted
electrodes, resulng in severe injury or death.
Diathermy is further prohibited because it may also
damage the neurosmulaon system components. This
damage could result in loss of therapy, requiring
addional surgery for system implantaon and
replacement. Injury or damage can occur during
diathermy treatment whether the neurosmulaon
system is turned on or o. You are advised to inform
your healthcare professional that you cannot be
exposed to diathermy treatment.
Electrosurgery devices. Electrosurgery devices may
harm you or damage your neurosmulaon system. If
you need to receive a procedure using an electrosurgery
device, place your IPG in Surgery Mode. Your physician
10

may only use bipolar electrosurgery devices and they
should keep the device as far away from your
neurosmulaon system as possible. Addionally, they
must conrm the neurosmulaon system is funconing
correctly aer your procedure.
Implanted cardiac system. Be aware of the risk and
possible interacon between a neurosmulaon system
and an implanted cardiac system, such as a pacemaker
or debrillator. Electrical pulses from a neurosmulaon
system may interact with the sensing operaon of an
implanted cardiac system, causing the cardiac system to
respond inappropriately. To minimize or prevent the
implanted cardiac system from sensing the output of the
neurosmulaon system, (1) maximize the distance
between the implanted systems; (2) verify that the
neurosmulaon system is not interfering with the
funcons of the implanted cardiac system; and (3) avoid
programming either device in a unipolar mode (using
the device’s can as an anode) or using neurosmulaon
system sengs that interfere with the funcons of the
implantable cardiac system.
Other acve implantable devices. The eect of other
implanted devices, including deep brain smulators,
peripheral nerve smulators, implanted drug delivery
pumps, and cochlear implants on the neurosmulaon
system are unknown.
Emergency procedures. Designate a representave
(family member or close friend) to nofy any emergency
medical personnel of your implanted neurosmulaon
system if emergency care is required. You will receive an
idencaon card to carry that will inform emergency
11

medical personnel of your implanted system. Use
cauon when undergoing any procedure that could
include radiofrequency (RF) or microwave ablaon,
debrillaon, or cardioversion.
Therapeuc radiaon. Therapeuc radiaon may
damage the electronic circuitry of a neurosmulaon
system, although no tesng has been done and no
denite informaon on radiaon eects is available.
Sources of therapeuc radiaon include therapeuc
X‑rays, cobalt machines, and linear accelerators. If
radiaon therapy is required, either disconnect the EPG
from the leads or extensions or shield the area over the
implanted IPG with lead. Damage to the system may not
be immediately detectable.
Component manipulaon. Do not rub or press on
implanted components through the skin. This may cause
the leads to move leading to smulaon at the implant
site, IPG inversion leading to the inability to
communicate with the device, or skin erosion that can
lead to another surgical procedure or possible infecon.
Implantaon at vertebral levels above T10. The safety
and ecacy of implantaon of leads implanted above
the T10 vertebral level have not been evaluated.
Number of leads implanted. The safety and ecacy of
the implantaon of greater than four leads have not
been evaluated.
Lead movement. Avoid bending, twisng, stretching,
and liing objects over 2 kg (5 lb) for at least six weeks
aer implantaon. These acvies may cause lead
movement, resulng in undersmulaon or
12

oversmulaon. Excessive lead migraon may require
reoperaon to replace the leads.
Operaon of machines, equipment, and vehicles. If you
feel uncomfortable paresthesia during postural changes
do not operate potenally dangerous equipment such
as power tools, automobiles, or other motor vehicles.
Do not climb ladders or parcipate in acvies where
postural changes or abrupt movements could cause
oversmulaon (jolng sensaon) and cause you to fall
or lose control of equipment or vehicles or injure others.
Addional Warnings Only Applicable to the
Trial System
Roune medical procedures. If you are using a trial
system, inform your healthcare providers and avoid
elecve medical procedures.
Addional Warnings Only Applicable to the
Permanent System
External debrillators. Safety for use of external
debrillator discharges on a paent receiving
neurosmulaon has not been established. External
debrillaon can cause induced currents in the lead-
extension poron of the neurosmulaon system. Aer
debrillaon, conrm the neurosmulaon system is
sll working.
Cardioverter debrillators. Neurosmulaon systems
may adversely aect the programming of implanted
cardioverter debrillators.
Radiofrequency or microwave ablaon. Safety has not
been established for radiofrequency (RF) or microwave
13

ablaon in paents who have an implanted
neurosmulaon system. Induced electrical currents
may cause heang, especially at the lead electrode site,
resulng in ssue damage.
Ultrasonic scanning equipment. The use of ultrasonic
scanning equipment may cause mechanical damage to
an implanted neurosmulaon system if used directly
over the implanted system.
Scuba diving and hyperbaric chambers. Avoid scuba
diving and entering hyperbaric chambers above
1.5 atmospheres absolute (ATA) because these acvies
might damage your neurosmulaon system.
Device Warnings
Explosive or ammable gases. Do not use an EPG or
paent controller in an environment where explosive or
ammable gas fumes or vapors are present, including
hyperbaric chambers. Operang these devices could
cause them to ignite, causing severe burns, injury, or
death.
Interference with other devices. This equipment can
radiate radiofrequency (RF) energy that may interfere
with other electronic devices. Avoid placing equipment
components directly over other electronic devices. To
correct the eect of interference with other devices,
turn o the equipment or increase the distance
between the equipment and the device being aected.
Device modicaon. The equipment is not serviceable
by the customer. To prevent injury or damage to the
system, do not modify the equipment. If needed, return
the equipment to Abbo Medical for service.
14

Keep the device dry. Your EPG and paent controller
devices are not waterproof. Keep them dry to avoid
damage. Do not use your device when engaging in
acvies that might cause it to get wet, such as
swimming or bathing.
Applicaon modicaon. To prevent unintended
smulaon, do not modify the operang system or
applicaon in any way.
Strangulaon. The cords in this system pose a
strangulaon risk. To avoid strangulaon, be careful
when using cords and keep cords out of the reach of
children.
Precauons
The following precauons apply to these components.
NOTE: For nontherapy-related precauons for the
NeuroSphere™ 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.
System Precauons
Physician instrucons. Always follow the programs and
therapy instrucons established for you by your
physician. If you do not, the therapy may be less
eecve in providing pain relief.
Paent training. Do not use your neurosmulaon
system unl an authorized clinician has trained you how
to control smulaon and safely use the system.
15

Device components. The use of components not
approved for use by Abbo Medical may result in
damage to the system and increased risk of injury.
Infecon. Follow proper infecon control procedures
and avoid showering and touching the bandages.
High smulaon outputs. Smulaon at high outputs
may cause unpleasant sensaons or motor
disturbances, or render you incapable of controlling the
smulator. If unpleasant sensaons occur, turn o the
device immediately.
Postural changes. Changes in posture or abrupt
movements can change the level of smulaon and
potenally cause unpleasant sensaons. Turn
smulaon o or lower the smulaon strength before
stretching, liing your arms over your head, or
exercising. If unpleasant sensaons occur, turn o
smulaon.
Smulaon eecveness. The long-term eecveness
of dorsal root ganglion (DRG) smulaon has not been
documented, and not all paents realize the long-term
benets from DRG smulaon. Smulaon eecveness
has been established for one year.
Electromagnec interference (EMI). Some equipment in
home, work, medical, and public environments can
generate electromagnec disturbances that are strong
enough to interfere with the operaon of a
neurosmulaon system or damage system
components. Avoid geng too close to these types of
sources of electromagnec disturbance, which include
the following examples: commercial electrical
equipment (such as arc welders and inducon furnaces),
16