Equipment Classification; Proper Use - AtriCure System Cart Manual Del Usuario

output power ranging from 12 Watts up to 30 Watts depending on the
operating mode.
AtriCure® Switch Matrix (ASB) is a reusable accessory interface module that
2.
allows simultaneous connection of AtriCure® Isolator™ Transpolar™ ablative
handpiece and pen devices to the ASU RF generator.
AtriCure® cryoICE BOX (ACM) is an electro-mechanical and pneumatic
3.
cryogenic surgical system that delivers a cryogenic energy source, namely
Nitrous Oxide, to create lines of ablation through cardiac tissue.
AtriCure® ORLab is a programmable diagnostic cardiac stimulator with
4.
electrocardiogram display tailored for use as a diagnostic tool during surgical
and RF ablation procedures.
a.
ORLab to produce paper copies of diagnostic read outs.
b.
and are not a part of the AtriCure® Basic Cart.
AtriCure® System Cart is a 450 mm wide cart with an onboard Isolation
5.
Transformer. The Isolation Transformer supplies power to the other subsystems
of AtriCure® System Cart.
No part of the AtriCure® System Cart or its accessories is intended to make contact the
patient, instead, pacing stimuli are delivered, and ECG signal recorded, via AtriCure®
Handpieces and 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® System Cart consisting of the Basic Cart, the Cryo Cart
Kit, and the 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.
4.0.

Proper Use

4.1. NOTE: The AtriCure® System Cart consists of the Basic Cart and is ONLY intended
to for use for the equipment in Table 2. A Cryo Cart Kit and an ORLab Cart Kit
are also available and are ONLY intended for use with the equipment listed in
Table 2.
4.2. NOTE: The cart should never be used to carry equipment other than what
is specified in this manual. The cart should not be operated on an incline
exceeding 10°. During operation and storage, the casters should be locked
NOTE: Lexmark MS310D printer is used in conjunction with the
NOTE: The handpiece and pen devices are separate components
4