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Abbott NeuroSphere 3875 User Manual

Abbott NeuroSphere 3875
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NeuroSpherePaent
Controller
Dorsal Root Ganglion Neurosmulaon
Systems
Model 3875
User's Guide

Table of Contents

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Abbott NeuroSphere 3875 Specifications

General IconGeneral
BrandAbbott
ModelNeuroSphere 3875
CategoryController
LanguageEnglish

Summary

About This Guide

Symbols and Definitions

Definitions for symbols found on the product or product label, and instructions for finding more.

Terms Used in This Document

Prescription and Safety Information

Provides important prescription and safety information for the neurostimulation system.

Intended Use

Indications for Use

Specifies the system's indication for chronic intractable pain management.

Contraindications

Lists conditions under which the neurostimulation system is contraindicated for patients.

MRI Safety Information

Details safety precautions and requirements for MRI scans with the neurostimulation system.

Warnings

System Warnings

Covers warnings related to pregnancy, pediatric use, back pain, and medical procedures.

Diathermy therapy

Warns against using diathermy due to potential damage and injury.

Electrosurgery devices

Warns about electrosurgery devices and advises using Surgery Mode.

Implanted cardiac system

Discusses potential interactions between the neurostimulation system and implanted cardiac devices.

Emergency procedures

Advises designating a representative to notify medical personnel in emergencies.

Therapeutic radiation

Warns about potential damage to the system from therapeutic radiation.

Component manipulation

Advises against rubbing or pressing components through the skin.

Lead movement

Advises avoiding certain activities after implantation to prevent lead movement.

Operation of machines, equipment, and vehicles

Warns about operating dangerous equipment or vehicles if paresthesia occurs.

Additional Warnings Only Applicable to the Trial System

Advises informing healthcare providers and avoiding elective procedures with a trial system.

Additional Warnings Only Applicable to the Permanent System

Discusses safety concerns with defibrillators and RF/microwave ablation.

Device Warnings

Outlines warnings for device-specific issues like gases, interference, and modification.

Precautions

System Precautions

Covers system-specific precautions for patients regarding use and handling.

Device Precautions

Covers precautions related to handling, battery, and control of the device.

Product Description

About Your System

Describes the neurostimulation system and its primary components.

Overview of the Patient Controller

Details the patient controller device and its basic operational functions.

Items You Will Receive

Lists the items included with the patient controller.

Your Personal Identification Card

Explains the purpose and content of the medical identification card.

Directions for Use

Connecting to Your Generator

Guides on how to connect the patient controller app to the generator.

Overview of the Therapy Screen

Describes the elements and functions of the Therapy screen.

Starting and Stopping Stimulation

Explains how to start and stop stimulation using the patient controller app or the magnet.

Mode

Explains the different modes (Continuous, Intermittent, Sleep) and how to select them.

Using the Surgery Mode Feature

Provides information and instructions for using Surgery Mode.

Using the MRI Mode Feature

Explains how to use MRI Mode for patients with an MR Conditional system.

Viewing and Selecting a Program

Guides on how to view and select saved programs.

Adjusting Program Strength

Instructions on how to adjust stimulation strength.

System Information

Additional Patient Controller Information

Describes how to view additional patient controller information and export logs.

Maintaining the Generator and Patient Controller

Checking the Generator Battery Status

Instructions on how to view the generator battery status.

Checking the Patient Controller Battery Status

Guides on monitoring and recharging the patient controller's battery.

Caring for the Generator

Provides tips on how to care for the trial system generator.

Caring for the Patient Controller

Instructions on cleaning and caring for the patient controller.

Cybersecurity

Protecting Access to the Patient Controller

Advises on methods to prevent unauthorized access to the patient controller.

Wireless Security Measures

Details the security measures for wireless signals.

Guidelines for Secure Use

Provides guidelines for users to ensure secure operation.

Legal and Privacy Notice

Troubleshooting