St. Jude Medical 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.
Unless otherwise noted, ™ indicates that the name is a trademar
k of, or
licensed to, St.
Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL
and the nine
-squares symbol are trademarks and service marks of St. Jude
Medical, LLC and its related companies.
Pat.
http://patents.sjm.com
©
2017 St. Jude Medical, LLC. All Rights Reserved.
i
Contents
About This Guide......................................................1
Symbols and Definitions ......................................1
Terms Used in This Document ............................6
Prescription and Safety Information ..........................6
Intended Use ......................................................6
Indications for Use ..............................................7
Contraindications ................................................7
Warnings.............................................................8
Precautions.......................................................14
Adverse Effects .................................................22
Patient Expectations ..........................................27
Product Description................................................29
About Your System............................................30
Overview of the Patient Controller ......................31
Items You Will Receive ......................................34
Your Personal Identification Card.......................34
Directions for Use...................................................35
Start-up Screen .................................................35
Overview of the Therapy Screen ........................36
Starting and Stopping Stimulation......................40
Program Mode ..................................................42
Using the Surgery Mode Feature .......................43
Viewing and Selecting a Program.......................47
Adjusting Strength.............................................50
System Information ...........................................52
Maintaining the Generator and Patient Controller ....54
Checking the Generator Battery Status ..............54
ii
Checking the Patient Controller Battery Status ...55
Caring for the Patient Controller.........................55
Protecting Access to the Patient Controller.........56
Troubleshooting......................................................56
Technical Support ..................................................68
Appendix A: Downloading the Patient Controller
App .....................................................................68
Appendix B: Pairing the Patient Controller to the
Generator.............................................................70
Appendix C: Regulatory Statements ........................71
Statement of FCC Compliance ...........................71
Statement of Compliance With License-Exempt
RSS Standard (Canada) ..................................72
Declaration of Conformity (Industry Canada)
Notice to Users of Radio and Television ..........73
Identification Information for Product
Registration ....................................................73
Product Classification Statement (CISPR 11,
Class B)..........................................................73
Wireless Technology Information .......................74
Radio Transmitter, Cables, Transducers ............75
Quality of Service for Wireless Technology .........76
Appendix D: Electromagnetic Compatibility
Guidelines............................................................79
Radio Frequency Information ............................89
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 Apple™
manual available at
http://www.apple.com/support/ipodtouch/; or
on the patient controller Home screen, tap
Settings > General > About > Legal >
Regulatory. (Apple™ is a trademark of Apple
Inc.)
Table 1. Symbols and definitions
Symbol
Definition
Caution, consult accompanying
documents
2
Table 1. Symbols and definitions
Symbol
Definition
Consult this document for important
safety-related information (This
symbol is blue and white on the
device.)
Consult instructions for use
Device contains a type BF applied
part to protect you from shock. The
device is internally powered and is
intended for continuous operation.
Device contains a radio-frequency
(RF) transmitter, which may cause RF
interference with other devices near
this device.
Magnetic Resonance (MR) Unsafe,
an item poses unacceptable risks to
the patient, medical staff, or other
persons within an MR environment
Expiration date
Date of manufacture
Catalog number
3
Table 1. Symbols and definitions
Symbol
Definition
Manufacturing facility
Manufacturer
Do not use if the product sterilization
barrier or its packaging is
compromised
Contents quantity
Batch code
Prescription use only
4
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 St. Jude 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 St. Jude Medical.
Authorized European representative
Australian Sponsor
5
Table 1. Symbols and definitions
Symbol
Definition
European conformity, affixed in
accordance with the relevant
provisions of AIMD directive
90/385/EEC. Hereby, St. Jude
Medical declares that this device is in
compliance with the essential
requirements and other relevant
provisions of this directive.
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
6
Terms Used in This Document
This section contains definitions of some of the terms
used in this document.
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.
Prescription and Safety Information
Read this section to gather important prescription and
safety information.
Intended Use
The St. Jude Medical™ neurostimulation system is
designed to deliver electrical stimulation to targets in
the brain. The St. Jude Medical™ Patient Controller
app is intended to be used as part of the system to
help the patient manage prescribed stimulation
programs.
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