Abbott St. Jude Medical Patient Controller 3875 User manual

St. Jude Medical™ Patient
Controller
For Spinal Cord Stimulation 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 Abbott group of companies.
‡ I
ndicates a third-party trademark, which is property of its respective owner.
Bluetooth® and the Bluetooth logo are registered trademarks of Bluetooth
SIG, Inc.
Pat.
http://www.abbott.com/patents
©
2020 Abbott. All Rights Reserved.

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Contents
About This Guide...................................................... 1
Symbols and Definitions ......................................1
Terms Used in This Document ............................ 6
Prescription and Safety Information ..........................7
Intended Use ......................................................7
Indications for Use .............................................. 7
Contraindications ................................................7
MRI Safety Information........................................8
Warnings............................................................. 9
Precautions....................................................... 13
Adverse Effects .................................................20
Product Description................................................ 21
About Your System............................................ 22
Overview of the Patient Controller ......................24
Items You Will Receive ......................................28
Your Personal Identification Card....................... 29
Directions for Use................................................... 30
Start-up Screen ................................................. 30
Overview of the Therapy Screen ........................31
Starting and Stopping Stimulation...................... 35
Mode ................................................................ 37
Using the Surgery Mode Feature .......................39
Using the MRI Mode Features...........................42
Viewing and Selecting a Program.......................47
Adjusting Program Strength...............................50
Adjusting Areas Strength ................................... 54
System Information ........................................... 56

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Maintaining the Generator and Patient Controller ....59
Checking the Generator Battery Status ..............59
Checking the Patient Controller Battery Status ...61
Caring for the Generator ....................................62
Caring for the Patient Controller.........................62
Troubleshooting......................................................63
Troubleshooting Messages for MRI Mode ..........75
Cybersecurity .........................................................77
Protecting Access to the Patient Controller..............77
Wireless Security Measures .................................... 77
Guidelines for Secure Use ......................................78
Technical Support ..................................................79
Appendix A: Downloading the Patient Controller
App ..................................................................... 80
Appendix B: Pairing the Patient Controller to the
Generator ............................................................82
Appendix C: Regulatory Statements ........................83
Statement of FCC Compliance ...........................83
Statement of Compliance With License-Exempt
RSS Standard (Canada) .................................. 84
Declaration of Conformity (Industry Canada)
Notice to Users of Radio and Television ..........85
Identification Information for Product
Registration ....................................................85
Product Classification Statement (CISPR 11,
Class B).......................................................... 86
Wireless Technology Information ....................... 86

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Radio Transmitter, Cables, Transducers ............88
Quality of Service for Wireless Technology ......... 89
Appendix D: Electromagnetic Compatibility
Guidelines ........................................................... 91
Radio Frequency Information .................................99

1
About This Guide
This guide explains how to use the St. Jude Medical™
Patient Controller application (Model 3875) with your
neurostimulation system. If you have any questions
about your system, contact Technical Support.
Symbols and Definitions
The following symbols may be used in this document
and on some of the products and packaging:
NOTE: For symbols and definitions for the
patient controller, refer to the user guide
available at support.apple.com/manuals for
the Apple‡ iOS‡ device you are using to run
the patient controller app; or, on the patient
controller Home screen, tap Settings >
General > About > Legal > Regulatory.

2
Table 1. Symbols and definitions
Symbol
Definition
Caution, consult accompanying documents
Consult this document for important safety-
related information (This symbol is blue
and white on the device.)
Consult instructions for use
Follow instructions for use on this website
Device contains a type BF applied part to
protect you from shock. The device is
internally powered and is intended for
continuous operation.
Magnetic Resonance (MR) Conditional, an
item with demonstrated safety in the MR
environment within the defined conditions.
At a minimum, address the conditions of
the static magnetic field, the switched
gradient magnetic field, and the
radiofrequency fields. Additional
conditions, including specific
configurations of the item, may be
required.

3
Table 1. Symbols and definitions
Symbol
Definition
Magnetic Resonance (MR) Unsafe, an item
poses unacceptable risks to the patient,
medical staff, or other persons within an
MR environment
Device contains a radio-frequency (RF)
transmitter, which may cause RF
interference with other devices near this
device.
Keep dry
Ingress protection rating 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 vertically dripping
water when the device is tilted at an angle
up to 15 degrees
Expiration date
Date of manufacture
Catalog number
Manufacturing facility

4
Table 1. Symbols and definitions
Symbol
Definition
Temperature limits for storage conditions
Humidity limits
Pressure limits
Manufacturer
Do not use if the product sterilization
barrier or its packaging is compromised
Contents quantity
Programmer
Accessories
Serial number
Batch code
Unique Device Identification
Prescription use only

5
Table 1. Symbols and definitions
Symbol
Definition
This product shall not be treated as
household waste. Instead it is the user’s
responsibility to return this product to
Abbott 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
Abbott Medical.
Authorized European representative
European conformity, affixed in
accordance with the relevant provisions of
AIMD directive 90/385/EEC. Hereby,
Abbott Medical declares that this device is
in compliance with the essential
requirements and other relevant provisions
of this directive.

6
Table 1. Symbols and definitions
Symbol
Definition
Australian Communications and Media
Authority (ACMA) and New Zealand Radio
Spectrum Management (RSM) Regulatory
Compliance Mark (RCM)
This equipment is certified for type
certification pursuant of Article 38-24 of
the Japan Radio Law
Terms Used in This Document
This section contains definitions of some of the terms
used in this document.
Magnetic Resonance (MR) Conditional system. A
group of implanted parts that allows a patient to
receive a magnetic resonance imaging (MRI) scan
safely if all the requirements for the implanted parts
and for scanning are met.
Perception. Perception strength is the value at which
stimulation is first felt.
Program. A combination of one or more subprograms
(areas).

7
Prescription and Safety Information
Read this section to gather important prescription and
safety information.
Intended Use
This neurostimulation system is designed to deliver
low-intensity electrical impulses to nerve structures.
The St. Jude Medical™ Patient Controller app is
intended to be used with the generator to help the
patient manage prescribed stimulation programs.
Indications for Use
This neurostimulation system is indicated as an aid in
the management of chronic, intractable pain of the
trunk and/or limbs, including unilateral or bilateral
pain associated with the following: failed back surgery
syndrome and intractable low back and leg pain.
Contraindications
This neurostimulation system is contraindicated for
patients who are unable to use the system.
Additionally, the permanent system is contraindicated
for patients who have failed to receive effective pain
relief during trial stimulation.

8
MRI Safety Information
If you are using a trial system, you should not be
subjected to an MRI. The electromagnetic field
generated by an MRI may damage the device
electronics and induce voltage through the lead that
could cause a jolting or shocking sensation.
If you are using a permanent system, you may be
implanted with the parts that make up a Magnetic
Resonance (MR) Conditional system, which allows
you to receive an MRI scan if all the requirements for
the implanted parts and for scanning are met.
Scanning under different conditions may cause device
malfunction, severe injury, or death. Contact your
physician before receiving an MRI scan to find out if
you can undergo the procedure and to learn more
about any risks. Additionally, before receiving an MRI
scan, inform the healthcare professional that you are
implanted with a neurostimulation system. If you do
not have an MR Conditional system, you cannot
receive an MRI.
Do not bring your patient controller into the scanner
magnet room. It can be affected by the MRI magnet,
may present a projectile hazard, and is MR Unsafe.
For more information about what you need to do to
prepare for an MRI scan, refer to "Using the MRI
Mode Features" (page 42) in this guide.

9
Warnings
The following warnings apply to these components.
NOTE: For nontherapy-related warnings
regarding the St. Jude Medical™ Patient
Controller, refer to the user guide available at
support.apple.com/manuals for the Apple‡
iOS‡ device you are using to run the patient
controller app.
System Warnings
Diathermy therapy. You cannot have any short-wave
diathermy, microwave diathermy, or therapeutic
ultrasound diathermy (all now referred to as
diathermy) on your body if you have any part of a
neurostimulation system implanted. Energy from
diathermy can be transferred through the implanted
system and can cause tissue damage at the location
of the implanted electrodes, resulting in severe injury
or death.
Diathermy is further prohibited because it may also
damage the neurostimulation system components.
This damage could result in loss of therapy, requiring
additional surgery for system implantation and
replacement. Injury or damage can occur during
diathermy treatment whether the neurostimulation
system is turned on or off. You are advised to inform
your healthcare professional that you cannot be
exposed to diathermy treatment.

10
Operation of machines, equipment, and vehicles. If
you are using a therapy that generates paresthesia,
you should turn off stimulation before operating
motorized vehicles, such as automobiles, or
potentially dangerous machinery and equipment
because sudden stimulation changes may distract you
from properly operating them. However, current data
shows that most patients using BurstDR™ stimulation
therapy do not experience paresthesia. If you do not
feel paresthesia, sudden stimulation changes are less
likely to occur and distract you while operating
motorized vehicles, machinery, or equipment.
Implanted cardiac system. Be aware of the risk and
possible interaction between a neurostimulation
system and an implanted cardiac system, such as a
pacemaker or defibrillator. Electrical pulses from a
neurostimulation system may interact with the sensing
operation 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 neurostimulation
system, (1) maximize the distance between the
implanted systems; (2) verify that the
neurostimulation system is not interfering with the
functions 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
neurostimulation system settings that interfere with
the functions of the implantable cardiac system.

11
Electrosurgery devices. Electrosurgery devices may
harm you or damage your neurostimulation system. If
you need to receive a procedure using an
electrosurgery device, place your generator in Surgery
Mode. Your physician may only use bipolar
electrosurgery devices and they should keep the
device as far away from your neurostimulation system
as possible. Additionally, they must confirm the
neurostimulation system is functioning correctly after
your procedure.
Lead movement. Avoid bending, twisting, stretching,
and lifting objects over 2 kg (5 lb) for at least six
weeks after implantation. These activities may cause
lead movement, resulting in understimulation or
overstimulation. Excessive lead migration may require
reoperation to replace the leads.
Emergency procedures. Designate a representative
(family member or close friend) to notify any
emergency medical personnel of your implanted
neurostimulation system if emergency care is
required. You will receive an identification card to
carry that will inform emergency medical personnel of
your implanted system. Use caution when undergoing
any procedure that could include radiofrequency (RF)
or microwave ablation, defibrillation, or cardioversion.
Pediatric use. Safety and effectiveness of
neurostimulation for pediatric use have not been
established.

12
Pregnancy and nursing. Safety and effectiveness of
neurostimulation for use during pregnancy and
nursing have not been established.
Additional Warnings Only Applicable to the Trial
System
Routine medical procedures. If you are using a trial
system, inform your healthcare providers and avoid
elective medical procedures.
Additional Warnings Only Applicable to the
Permanent System
Cardioverter defibrillators. Neurostimulation systems
may adversely affect the programming of implanted
cardioverter defibrillators.
Device Warnings
Explosive or flammable gases. Do not use the device
in an environment where explosive or flammable gas
fumes or vapors are present. Operating the device
could cause it 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, including other active
implanted devices. Avoid placing equipment
components directly over other electronic devices. To
correct the effect of interference with other devices,
turn off the equipment or increase the distance
between the equipment and the device being
affected.

13
Device modification. This 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 Abbott Medical for
service.
Application modification. To prevent unintended
stimulation, do not modify the operating system in any
way.
Strangulation. The cords in this system pose a
strangulation risk. To avoid strangulation, be careful
when using cords and keep cords out of the reach of
children.
Precautions
The following precautions apply to these components.
NOTE: For nontherapy-related precautions for
the St. Jude Medical™ Patient Controller,
refer to the user guide available at
support.apple.com/manuals for the Apple‡
iOS‡ device you are using to run the patient
controller app.

14
System Precautions
Medical tests and procedures. Before undergoing
medical tests or procedures (such as therapeutic
radiation or electrolysis), contact your physician to
determine if the procedure will cause you injury or
damage your neurostimulation system. Specifically,
you should be aware that medical devices such as
electrohydraulic lithotriptors, therapeutic X rays,
computerized tomography (CT) scans, cobalt
machines, and linear accelerators may cause damage
to the electronic circuitry of an implanted
neurostimulation system. If using a trial system and
radiation therapy is required, disconnect the trial
generator from the leads or extensions. Damage to the
system may not be immediately detectable.
Component manipulation. Do not rub or press on
implanted components through the skin. This may
cause the leads to move leading to stimulation 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
infection.
High stimulation outputs. Stimulation at high outputs
may cause unpleasant sensations or motor
disturbances, or render you incapable of controlling
the stimulator. If unpleasant sensations occur, turn off
the device immediately.