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Defines system purpose, approved medical uses, and patient conditions for which it is not recommended.
Details safety precautions and requirements for MRI scans with the system.
Lists crucial warnings related to the neurostimulation system's use and potential risks.
Provides guidelines and precautions for using electrosurgery with the system.
Covers interference from other devices and safety precautions for gases.
Advises on handling, modification restrictions, and case damage for the device.
Lists general precautions for system use, including clinician training and patient selection.
Details precautions related to lead implantation, spacing, and potential heating.
Lists sources of EMI and how to avoid them to protect the system.
Explains potential interference from common electronic devices like mobile phones.
Advises patients on avoiding actions causing lead movement and stresses patient training.
Covers sterilization methods, storage, and component handling requirements.
Warns about potential damage from medical devices like lithotripsy and radiation.
Discusses interference from security devices and wireless use restrictions.
Provides guidance and restrictions for diving and hyperbaric chambers.
Lists risks associated with using the neurostimulation system, beyond surgical risks.
Outlines the main components of the neurostimulation system.
Details software upgrade capabilities and compatibility with other leads.
Lists the items included in the generator kit.
Describes ways to identify the generator, including model number and radiopaque tag.
Instructions for pre-surgical setup, communication, and generator activation.
Outlines the suggested procedure for creating the generator implant pocket.
Provides guidelines for connecting leads or extensions to the generator header.
Details visual indicators and testing to confirm correct lead/extension insertion.
Instructions on tightening setscrews and inserting port plugs for secure connections.
Details generator pocket depth and stabilization within the pocket.
Instructions for checking lead positioning and performing intraoperative testing.
Final steps for closing the incision and ensuring surgery mode is off.
Steps for turning off stimulation, opening the site, and removing leads.
Procedures for returning explanted components for proper disposal.
Explains how to check battery status and interpret alerts.
Provides contact phone numbers for technical questions and support.
Details recommended storage and excursion temperature conditions for components.
Lists the materials used for generator kit components that contact tissue.
Details physical specifications like height, weight, and volume of the generator.
Lists operating parameters like pulse width, frequency, and amplitude for the generator.
Lists compatible adapters and extensions for connecting non-Abbott leads.
Lists the generator model and its associated accessories.
Lists the charging system and its accessories.
Lists programmers, controllers, and their accessories.
Lists various types of leads and extensions available for the system.
Lists accessories for leads and extensions.
Lists adapters and extensions for connecting compatible leads and extensions.
Details battery longevity, charging requirements, and ERI alerts.
Lists the nominal stimulation settings for BurstDR™ programs.
Provides guidelines for disposing of battery-powered devices according to EU directives.
Details the FCC compliance statement for the device and potential interference.
Information regarding product identifiers for registration purposes.
Summarizes technical details of the Bluetooth® Low Energy implementation in the device.
Describes the quality of service for wireless communication and factors affecting it.
Details the security measures implemented for wireless communication.
Provides steps to resolve issues with wireless communication between devices.
Explains common symbols found on the product or label, including MR conditional and safety symbols.
The Eterna™ Implantable Pulse Generator (IPG), Model 32400, is a rechargeable electronic device designed to deliver low-intensity electrical impulses to nerve structures for therapeutic stimulation. It is intended for use with compatible leads and extensions as an aid in managing chronic, intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome and intractable low back and leg pain.
The IPG delivers constant-current electrical stimulation through leads connected to electrodes near selected nerve fibers. It supports both single and multiple programs, with each program capable of stimulating single or multiple anatomical areas. The generator communicates wirelessly with a clinician programmer and a patient controller using Bluetooth® wireless technology. It receives radio frequency energy from an external charger to recharge its internal lithium-ion battery. The patient magnet can be used to turn the generator on and off if this functionality is enabled by the physician.
General| Brand | Abbott |
|---|---|
| Model | Eterna 32400 |
| Category | Pulse Generator |
| Language | English |
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