System Description; Equipment Classification - AtriCure P000880 Manual Del Usuario

AtriCure, Inc.
3.0

System Description

The System Cart supports medical equipment used in procedures for the treatment of
arrhythmias in cardiothoracic theatres and hospital electrophysiological laboratories.
The complete system is comprised of five sub-systems:
1. AtriCure Ablation Sensing Unit (ASU) produces and delivers RF energy, in a bipolar
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mode, at a frequency of approximately 460 kHz, with a maximum output power ranging
from 12 Watts up to 30 Watts depending on the operating mode.
2. AtriCure Switch Matrix (ASB) is a reusable accessory interface module that allows
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simultaneous connection of AtriCure
pen devices to the ASU RF generator.
3. AtriCure ® cryoICE BOX (ACM) is an electro-mechanical and pneumatic cryogenic
surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to create
lines of ablation through cardiac tissue.
4. AtriCure ® ORLab is a programmable diagnostic cardiac stimulator with
electrocardiogram display tailored for use as a diagnostic tool during surgical and RF
ablation procedures.
a. NOTE: Lexmark MS310D printer is used in conjunction with the ORLab to
produce paper copies of diagnostic read outs.
b. NOTE: The handpiece and pen devices are separate components and are not a
part of the AtriCure
5. AtriCure ® System Cart is a 450 mm wide cart with an onboard Isolation Transformer.
The Isolation Transformer supplies power to the other subsystems of AtriCure
Cart.
No part of the AtriCure
instead, pacing stimuli are delivered, and ECG signal recorded, via AtriCure
approved third party products, which may include transvenous endocardial electrode catheters
or epicardial mapping.
Indications for Use: The AtriCure System Cart is intended to be used as an accessory to the
AtriCure Bipolar System, AtriCure Cryo Module System, and ORLab.
3.1

Equipment Classification

3.1.1 The AtriCure ®
ORLab Cart Kit are categorized as: Class 1 Equipment; Type CF Applied Part; IPX0; rated for
115-230 VAC 50-60 Hz; and 1800 VA.
Basic Cart.
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® System Cart or its accessories is intended to make contact the patient,
System Cart consisting of the Basic Cart, the Cryo Cart Kit, and the
® Isolator™ Transpolar™ ablative handpiece and
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P000880.J
® System
Handpieces and
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