Device Description - Boston Scientific MAESTRO 4000 Manual De Instrucciones

WARNING:
Do not attempt to operate the Maestro 4000™ Cardiac Ablation System prior to reading
this entire Operator's Manual. All instructions should be understood, and followed carefully. For future
reference, keep this manual in a convenient, readily accessible place.
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

DEVICE DESCRIPTION

Maestro 4000 Cardiac Ablation System
The Maestro 4000 Cardiac Ablation System is a non-sterile product that supplies radiofrequency energy to
catheters during ablation procedures. The System is compatible with all BSC cardiac ablation catheters
including BSC open-irrigated catheters used in conjunction with the MetriQ™ Pump and MetriQ Irrigation
Tubing Set.
Note: Throughout this manual, the term "System" refers to the Maestro 4000 Cardiac Ablation System.
Maestro 4000 Controller
The Maestro 4000 Controller is an RF Generator specifically designed for cardiac ablation. It produces user-
selectable power-controlled or temperature-controlled RF power output in the range of 0 to 150 watts into a
nominal tissue impedance of 100 ohms. It delivers RF power via a monopolar method driving current between
a single active electrode at the tip of the ablation catheter and one or two dispersive pads applied on the skin.
When used with BSC open-irrigated catheters, the RF Generator communicates with the MetriQ Pump to
coordinate delivery of RF energy with irrigation flow to the catheter tip.
Note: Throughout this manual, the term RF Generator, or Generator, refers to the Maestro 4000 Controller.
Maestro 4000 Pod
The Pod, which is connected to the RF Generator, allows connection to all BSC catheters and provides
connections for dispersive pad(s) to complete the RF circuit. The Pod also connects to EP recording systems
and provides RF filtering to allow continuous electrogram recording during RF delivery. The Pod model varies
by operating territory and determines the maximum power setting allowed by the RF Generator.
Maestro 4000 Remote Control
The optional Remote allows the user to control the RF Generator with up to 75 feet between the user interface
and the sterile field.
Maestro Foot Switch
The optional Foot Switch provides hands-free control to start/stop RF delivery.
Dispersive Pads
A Dispersive Pad provides external patient contact to complete the RF circuit. It disperses current over a large
area to minimize damage due to heating of skin and underlying tissue. It is also known as the DIP (dispersive
indifferent pad), ground pad, or return pad.
2 Maestro 4000™ Cardiac Ablation System Operator's Manual, Global
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