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.

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 ................................................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