User's Guide - SJM

1 St. jude Medical Patient Controller For Spinal Cord Stimulation Systems Model 3875 User's Guide Unless otherwise noted, indicates that the name is a trademark 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. 2017 St. jude Medical, LLC. All Rights Reserved. i Contents About This Guide .. 1 Symbols and Definitions .. 1 Terms Used in This Document .. 7 Prescription and Safety Information .. 8 Intended Use .. 8 Indications for Use .. 8 Contraindications .. 8 MRI Safety Information .. 9 Warnings .. 10 Precautions .. 13 Adverse Effects .. 20 Product Description .. 21 About Your System .. 22 Overview of the Patient Controller .. 23 Items You Will Receive .. 26 Your Personal Identification Card .. 26 Directions for Use .. 27 Start-up Screen.

2 27 Overview of the Therapy Screen .. 28 Starting and Stopping Stimulation .. 32 Program Mode .. 34 Using the Surgery Mode Feature .. 36 Using the MRI Mode Features .. 38 Viewing and Selecting a Program .. 43 Adjusting Program Strength .. 46 Adjusting Areas Strength .. 50 System Information .. 53 ii Maintaining the Generator and Patient Controller .. 54 Checking the Generator Battery Status .. 54 Checking the Patient Controller Battery Status .. 56 Caring for the Generator .. 56 Caring for the Patient Controller .. 57 Protecting Access to the Patient Controller .. 57 Troubleshooting .. 58 Troubleshooting Messages for MRI Mode .. 70 Technical Support .. 72 Appendix A: Downloading the Patient Controller App .. 73 Appendix B: Pairing the Patient Controller to the 74 Appendix C: Regulatory Statements .. 75 Statement of FCC Compliance .. 75 Statement of Compliance With License-Exempt RSS Standard (Canada).

3 77 Declaration of Conformity (Industry Canada) Notice to Users of Radio and Television .. 77 Identification Information for Product Registration .. 78 Product Classification Statement (CISPR 11, Class B) .. 79 Wireless Technology Information .. 79 Radio Transmitter, Cables, Transducers .. 81 Quality of Service for Wireless Technology .. 82 iii Appendix D: Electromagnetic Compatibility Guidelines .. 84 Radio Frequency Information .. 93 Appendix E: CE Mark 94 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 ; or on the patient controller Home screen, tap Settings > General > About > Legal > Regulatory.

4 (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 3 Table 1. Symbols and definitions Symbol Definition Magnetic Resonance (MR) Conditional, an item with demonstrated safety in the MR environment within the defined conditions.

5 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. Keep the device dry Ingress protection rating for a device that is protected from the intrusion of solid foreign objects as small as mm in diameter and is protected from vertically dripping water when the device is tilted at an angle up to 15 degrees Single use only Expiration date 4 Table 1. Symbols and definitions Symbol Definition Date of manufacture Catalog number Manufacturing facility Manufacturer Do not use if the product sterilization barrier or its packaging is compromised Contents quantity Batch code 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 St.

6 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 6 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 7 Additional Symbols for Product Labels The following table shows additional symbols that may appear on the product labels for parts related to this kit.

7 Table 2. Additional symbols for product labels Symbol Description Patient Magnet Carrying Case, EPG Trial System Patient Manual and Magnet 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). 8 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.

8 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. 9 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.

9 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. 10 Warnings The following warnings apply to these components. NOTE: For non-therapy related warnings regarding the St. jude Medical Patient Controller, refer to the Apple manual available at 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.

10 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. Operation of machines, equipment, and vehicles. If you are using a therapy that generates paresthesia, 11 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.