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St. Jude Medical 3875 User Manual

St. Jude Medical 3875
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St. Jude Medicalâ„¢ Patient
Controller
For Deep Brain Stimulation Systems
Model 3875
User's Guide

Table of Contents

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St. Jude Medical 3875 Specifications

General IconGeneral
BrandSt. Jude Medical
Model3875
CategoryController
LanguageEnglish

Summary

Prescription and Safety Information

System Warnings

MRI Safety Warning

Warns against performing MRI scans with an implanted neurostimulator or lead.

High Stimulation Output Risks

Warns about risks of brain tissue damage from high stimulation settings and charge density.

Depression and Suicide Risk

Addresses reported risks of depression, suicidal ideations, and suicide associated with DBS therapy.

Device Components and Electrosurgery Risks

Warns about non-approved components and risks from electrosurgery devices.

RF and Microwave Ablation Caution

Advises caution with radiofrequency or microwave ablation due to unestablished safety.

Interaction with Implanted Cardiac Devices

Discusses interaction risks between neurostimulation and implanted cardiac systems like pacemakers.

Device Warnings

Flammable Gases and Interference Warnings

Warns against flammable gases and potential interference with other devices.

General Precautions

Electromagnetic Interference (EMI)

Explains EMI sources and their potential effects on the neurostimulation system.

Electrical Medical Treatment Precautions

Details specific precautions to take during electrical medical treatments.

Ultrasonic and Lithotripsy Risks

Warns about potential damage from high-output ultrasonics, lithotripsy, and ultrasonic scanning.

External Defibrillator and Therapeutic Radiation Safety

Discusses safety of external defibrillators and therapeutic radiation effects.

Adverse Effects

Possible Surgical Complications

Lists potential surgical complications like intracranial hemorrhage, infection, and pain.

Deep Brain Stimulation Complications

Details system-related complications such as lead issues, IPG failure, and infections.

Stimulation-Related Complications

Describes complications related to stimulation, including motor, sensory, and cognitive impairments.

Directions for Use

Program Mode

Starting and Stopping Stimulation

Magnet Usage for Stimulation Control

Provides step-by-step instructions for using the magnet to start or stop stimulation.

Program Mode Details

Using the Surgery Mode Feature

Viewing and Selecting a Program

Adjusting Stimulation Strength

Troubleshooting Common Issues

Technical Support Information

Appendix A: Downloading the Patient Controller App

Appendix B: Pairing Controller to Generator

Troubleshooting Wireless Issues

Appendix D: EMC Guidelines