Abbott St.Jude Medical Patient Controller 3875 User manual

St. Jude Medical™ Patient
Controller
For Deep Brain 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.
‡ Ind
icates 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.

i
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 ................................................8
MRI Safety Information........................................8
Warnings............................................................. 9
Precautions....................................................... 15
Adverse Effects .................................................24
Patient Expectations .......................................... 28
Product Description................................................ 30
About Your System............................................ 31
Overview of the Patient Controller ......................33
Items You Will Receive ......................................37
Your Personal Identification Card....................... 38
Directions for Use................................................... 39
Start-up Screen ................................................. 39
Overview of the Therapy Screen ........................40
Starting and Stopping Stimulation...................... 44
Mode ................................................................ 46
Using the Surgery Mode Feature .......................48
Using the MRI Mode Features...........................51
Viewing and Selecting a Program.......................56
Adjusting Strength.............................................59
System Information ........................................... 62

ii
Maintaining the Generator and Patient Controller ....65
Checking the Generator Battery Status ..............65
Checking the Patient Controller Battery Status ...66
Caring for the Patient Controller.........................67
Troubleshooting...................................................... 67
Troubleshooting Messages for MRI Mode ..........78
Cybersecurity .........................................................81
Protecting Access to the Patient Controller.........81
Wireless Security Measures ...............................81
Guidelines for Secure Use .................................82
Technical Support ..................................................83
Appendix A: Downloading the Patient Controller
App ..................................................................... 84
Appendix B: Pairing the Patient Controller to the
Generator ............................................................86
Appendix C: Regulatory Statements ........................87
Statement of FCC Compliance ...........................87
Statement of Compliance With License-Exempt
RSS Standard (Canada) .................................. 88
Declaration of Conformity (Industry Canada)
Notice to Users of Radio and Television ..........89
Identification Information for Product
Registration ....................................................89
Product Classification Statement (CISPR 11,
Class B).......................................................... 89
Wireless Technology Information ....................... 90
Radio Transmitter, Cables, Transducers ............91
Quality of Service for Wireless Technology .........92

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.
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

2
Table 1. Symbols and definitions
Symbol
Definition
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.
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.

3
Table 1. Symbols and definitions
Symbol
Definition
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
Temperature limits for storage conditions
Humidity limits
Pressure limits
Manufacturer

4
Table 1. Symbols and definitions
Symbol
Definition
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 e
nsuring 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.
Program. A combination of stimulation parameters
that are set to get a desired therapeutic effect.
Stimulation parameter. A setting that is part of a
complete program.