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Abbott 3599 User Manual

Abbott 3599
60 pages
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Abbo Medical External Pulse Generator
Spinal Cord Smulaon Systems
Model 3599
Clinician's Manual

Table of Contents

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Abbott 3599 Specifications

General IconGeneral
BrandAbbott
Model3599
CategoryPortable Generator
LanguageEnglish

Summary

Prescription and Safety Information

Intended Use

Defines the external trial system's purpose and maximum duration of 30 days.

Indications for Use

Refers to a separate data sheet for specific indications.

Contraindications

Lists patient conditions where the neurostimulation system should not be used.

Warnings

Details critical safety warnings for diathermy, gases, electrosurgery, cardiac systems, and MRI.

Precautions

General Precautions

Covers essential clinician training and appropriate patient selection criteria.

Handling and Implementation Precautions

Outlines precautions for single use, liquid exposure, care, and component damage.

Environmental Precautions

Addresses precautions for hospital, home, and occupational environments, including EMI and wireless restrictions.

Adverse Effects

Stimulation-Related Effects

Lists potential risks like unpleasant sensations, lead migration, and CSF leakage.

Device and Patient Response Effects

Details additional risks such as pain, seroma, allergic response, and battery failure.

Product Description

EPG and EPG Header Features

Illustrates and labels the key physical features of the EPG and EPG header.

Getting Started

Package Contents

Lists the specific items included in the EPG and EPG header kits.

EPG Procedure Overview

Step-by-Step Procedure

Provides a high-level summary of the EPG setup and use process.

Replacing EPG Batteries

Battery Replacement Steps

Detailed instructions for removing and inserting CR2450 batteries into the EPG.

Checking EPG Battery Status

Monitoring Battery Levels

Explains how to monitor the EPG's battery levels via the clinician programmer app.

Setting Up EPG Communication

Establishing Wireless Connection

Guides on establishing wireless communication between the EPG and its controllers.

EPG Indicator Light

Understanding Indicator States

Describes the meaning of the EPG's various indicator light states.

Stimulation Control

Starting and Stopping Stimulation

Instructions for initiating and terminating stimulation using the app or magnet.

EPG Usage Guidelines

General Usage

Provides general guidance on EPG operation and system compatibility.

Compatibility Guidelines

Compatible Components

Lists trial cable and leads that are compatible with the EPG.

Connecting the Multilead Trial Cable

Connecting to EPG

Steps for connecting the multilead trial cable to the EPG stimulator port.

Disconnecting from EPG

Procedure for safely removing the multilead trial cable from the EPG.

Securing Leads and EPG

Securing Leads or Extensions

Recommended methods for securing leads and bandaging the lead entry site.

Securing EPG to Patient

Instructions for placing the EPG into its pouch and securing it to the patient.

EPG Header Connections

Connecting Header to EPG

How to attach the EPG header to the EPG body securely.

Connecting Leads to Header

Steps for connecting leads or extensions to the EPG header ports.

EPG Maintenance

Programming the EPG

Guidance on programming the system using the clinician programmer app.

Caring for and Handling the EPG

Tips and precautions for maintaining the EPG's condition and avoiding damage.

EPG Cleaning and Storage

Cleaning the EPG

Methods for cleaning the EPG using approved materials.

Storing and Transporting the EPG

Guidelines for proper storage and safe transportation of the EPG.

Service and Support

Technical Support

Contact information for technical assistance.

Ordering Information

Information on ordering replacement parts and accessories.

Product Specifications

EPG and Header Specifications

Details physical specifications like height, width, thickness, weight, and volume.

Operating Parameters

EPG Operating Parameters

Lists pulse width, frequency, amplitude, and stimulation output ranges.

Regulatory Statements

Disposal Guidelines

Guidance on proper disposal of battery-powered devices.

FCC Compliance

Statement on compliance with FCC rules for digital devices.

Canadian Compliance and Identification

RSS Standard (Canada)

Compliance statement for Canadian radio standards.

Interference-Causing Equipment Standard (Canada)

Compliance with Canadian ISM device standards.

Product Registration Information

Details of product identifiers for registration.

Product Classification and Wireless Info

Product Classification Statement

Classification as Class B equipment for domestic environments.

Bluetooth Wireless Technology

Summarizes technical details of the Bluetooth Low Energy implementation.

Radio Transmitter and Cables

Radio Transmitter Parameters

Details frequency, bandwidth, and channel information for the radio transmitter.

Wireless Technology Quality of Service

Quality of Service (QoS)

Describes communication quality requirements for Bluetooth LE technology.

Wireless Security and Troubleshooting

Wireless Security Measures

Explains how wireless signals are secured and authenticated.

Troubleshooting Wireless Issues

Provides steps to resolve wireless communication problems.

Electromagnetic Compatibility

EMC Guidelines

Provides guidance on EMC and essential performance for medical equipment.

Electromagnetic Emissions Guidance

RF Emissions Guidance

Details compliance and guidance for RF emissions in various environments.

Electromagnetic Immunity Guidance

Immunity Test Levels

Lists immunity test levels and compliance for ESD, transients, surges, and power frequency magnetic fields.

Radiated RF Immunity

Radiated RF Test Levels

Details radiated RF immunity test levels and recommended separation distances.

Proximity Fields Guidance

Proximity Field Test Levels

Lists test levels and recommended separation distances for proximity fields.

Radio Frequency Information

RF Compliance Standards

Details RF compliance standards for USA, Canada, and Europe.

Symbols and Definitions

General and Device Symbols

Explains common and device-specific symbols.

Manufacturing, Product, and Compliance Symbols

Defines symbols related to manufacturing, product ID, and compliance.

Certification Marks

Explains marks related to NRTL certification and Australian/New Zealand compliance.