St. Jude Medical Ampere Generator User Manual

© Copyright 2013
St. Jude Medical
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 services marks of St. Jude
Medical, Inc. and its related companies. © 2013 St. Jude
Medical, Inc. All Rights Reserved.
1
Ampere™ Generator
INSTRUCTIONS FOR USE
INTERNATIONAL EDITION
Software version 1.0
Rev. A 100081509-en
2013-08
St. Jude Medical
One St. Jude Medical Drive
St. Paul, MN 55117 USA
St. Jude Medical Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem Belgium
afcustomerservice@sjm.com
www.sjm.com
WARNING: The use of this device in conjunction with a radio frequency ablation
catheter, as a part of the diagnosis and treatment of cardiac arrhythmias,
may pose an increased risk of adverse events such as cardiac perforation,
myocardial infarction, air embolism, and hematoma requiring surgical
repair and/or blood transfusion.
651-756-6985 / 800-374-8038
651-647-9464 / 800-374-2505
EC REP
+32 2 774 68 11
+32 2 772 83 84
Australian Sponsor:
St. Jude Medical
Australia Pty Limited
17 Orion Rd.,
Lane Cove NSW 2066
AUSTRALIA
+61 2 9936 1200

St. Jude Medical Ampere Generator Specifications

General

Brand	St. Jude Medical
Model	Ampere Generator
Category	Medical Equipment
Language	English

Summary

Introduction

Precaution

Indications For Use

Intended for use with EP ablation catheters to create endocardial lesions for cardiac arrhythmias.

Contraindications

Device is contraindicated for patients with active systemic infection.

System Description

Overview

User Features

TempGuard™ Feature

Details the temperature control algorithm, including mode selection and response time.

Impedance Control

Covers impedance monitoring, limits, and delta impedance cutoff features.

Safety Features

Warnings, Precautions, and Adverse Reactions

Warnings

Lists critical safety warnings for patient and operator during ablation procedures.

Precautions

Display, Controls, and Connections

Front Panel Controls

Display Panel

Connection Icons

Rear Panel Connections

Technical Specifications

Power Specifications

Generator Output Specifications