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Boston Scientific EPT-1000 XP User Manual

Boston Scientific EPT-1000 XP
77 pages
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EPT-1000 XP
TM
Cardiac Ablation System
Aflutter IDE 110V
Operator’s Manual
CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
EP Technologies, Inc.
2710 Orchard Parkway
San Jose, CA 95134
Phone: 408.895.3500 P/N 13754-901 EAW Ver AA 6/01

Table of Contents

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Boston Scientific EPT-1000 XP Specifications

General IconGeneral
BrandBoston Scientific
ModelEPT-1000 XP
CategoryMedical Equipment
LanguageEnglish

Summary

Preface

Manual Conventions

Naming conventions used in the operator's manual for system components and catheters.

General Information

Overview of the manual's content and importance of reading it before operation.

System Description

System Features

Lists the functionalities and capabilities of the EPT-1000 XP™ Cardiac Ablation System.

Safety Features

Details the built-in safety mechanisms and automatic shutoff conditions for the system.

Control Modes

Explains the two operating modes: Power Control and Temperature Control.

Indications and Contraindications

Indications for Use

Specifies the medical conditions for which the system is indicated.

Contraindications

Lists conditions or patient types for which the system should not be used.

Warnings, Precautions, and Adverse Reactions

Warnings

Critical safety warnings regarding operation, radiation, pacemakers, and catheter placement.

Precautions

Guidelines to follow to prevent patient injury, equipment damage, and ensure proper use.

Potential Adverse Reactions

Lists possible complications and adverse events that may occur during or after ablation.

Unpacking the Controller

Unpacking Procedure

Details the system components included in the shipping carton and the unpacking procedure.

Repackaging the Controller

Instructions for repacking the controller for service or transfer.

Controls and Displays

Front Panel Layout

Describes the location and function of controls and displays on the system's front panel.

Control Panel Indicators and Buttons

Explains control mode indicators (LEDs), control button, and related displays.

Power and Temperature Controls

Describes the POWER and TEMPERATURE panels and their associated buttons.

Impedance, Time, and Counter Displays

Explains IMPEDANCE, TIME, and COUNTER displays and their functions.

Calibration and RF Power Controls

Details CALIBRATION button, RF POWER CONTROL button, and their functions.

System Connectors and Displays

Describes Isolated Patient Connector and MAINS power display.

Rear Panel Interface

Describes rear panel ports including analog outputs, volume, serial, auxiliary, and ground stud.

Analog Output Ports

Details RF POWER, IMPEDANCE, and TEMPERATURE analog output ports.

Ancillary Controls and Ports

Describes volume control, serial port, auxiliary outlet, and ground stud.

Accessories

Footswitch

Describes the functionality and usage of the footswitch.

High Power Automatic Personality Module (XP APM)

Details the features and connections of the XP APM.

Operational Sequence

System Setup and Connections

Instructions for initial installation, connecting APM, catheter, DIP electrodes, and footswitch.

Connecting APM and Peripherals

Instructions for connecting APM to recording equipment, catheter, and DIP electrodes.

Footswitch Connection and Controller Power-On

Connecting the footswitch and turning on the controller.

READY Mode Operation

Describes the system's state after successful self-test, ready for parameter setting.

Control Mode and Parameter Selection

How to select control modes, RF power output, and temperature setpoints.

Temperature and Time Control Settings

How to select desired temperature and set RF power delivery duration.

Clearing Counter and Audio Adjustment

How to reset the counter and adjust audio volume.

Turning the RF Power Delivery ON

RF Power Delivery Displays

Explains readings on TEMPERATURE, IMPEDANCE, TIME, COUNTER, and CONTROL displays during operation.

Addressing Operational Issues

Steps to correct high impedance and interpret display readings during interruption.

Directions for Use

Catheter Insertion and Manipulation

Instructions for inserting and manipulating the Steerable Ablation Catheter.

Turning RF Power Delivery OFF

How to stop RF power delivery.

Causes of RF Power Delivery Interruption

Lists reasons for interruption of RF power delivery.

Interruption Display Readings

How displays indicate interruption and readiness for next delivery.

Service and Maintenance

Cleaning and Disinfecting

Procedures for cleaning and disinfecting the controller and accessories.

Replacing the Fuses

Instructions for replacing the main fuse in the controller.

Auxiliary Power Outlet Fuses

Instructions for replacing fuses for the auxiliary power outlet.

Product Specifications

General System Specifications

Lists general specs for power, footswitch, APM dimensions, connectors, and filters.

System Power and Footswitch Specs

Specifications for line power, auxiliary power, and footswitch cable.

XP APM and Controller Specs

Specifications for XP APM connectors, filters, power outputs, and impedance.

Controller Dimensions and Time Settings

Specs for controller dimensions, time, counter, and leakage.

Calibration Mode Analog Outputs

Specifications for analog outputs during calibration mode.

Environmental Specifications

Storage Conditions

Environmental specifications for storing the system.

Operating Conditions

Environmental specifications for operating the system.

Power Delivery

Error Codes

Limited Warranty and Disclaimer

Limited Warranties

Details the manufacturer's warranty for the instrument.

Disclaimer and Exclusion of Other Warranties

Excludes implied warranties of merchantability and fitness.

Limitation of Liability for Damages

Limits the buyer's recourse for damages.

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