P000463.F
Page 3 of 39
1.
Getting Started
This manual and the equipment it describes are for use only by qualified medical professionals
trained in the particular technique and surgical procedure to be performed.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Please read all information carefully. Failure to properly follow the instructions may lead to
serious surgical consequences.
Important: This manual is designed to provide instructions for use of the AtriCure Ablation and
Sensing Unit (ASU) with the AtriCure Bipolar Handpiece (Isolator
clamp, Isolator
Transpolar
pen, or CoolRail
linear pen
) and AtriCure Accessory Devices (ASB1, ASB
3)
. It is not a reference to surgical technique.
The AtriCure
ASU produces and delivers RF energy, in a bipolar mode, at a frequency of
approximately 460 kHz, with a maximum output power ranging from 22.8 Watts up to 28.5 Watts
for the Isolator
clamps, 12.0 Watts up to 30.0 Watts for the Isolator
Transpolar
pen or
CoolRail
linear pen devices depending on the mode of operation The AtriCure
ASU is
capable of producing a maximum output power of 32.5 Watts under a 100 Ohm load, although no
current AtriCure
Bipolar Handpiece uses power above 30 Watts. The operating mode is a
function of the handpieces or pen and is set by the ASU. The AtriCure ASU is designed to operate
only with an AtriCure Bipolar Handpiece, AtriCure Isolator Pen, or AtriCure CoolRail
linear
pen. The Footswitch is the input device used to activate RF energy delivery. Please refer to the
handpiece and pen Instructions for Use for complete description of the indications and use of these
devises.
For the user’s convenience, the AtriCure Ablation and Sensing Unit will be referred to in this
User’s Manual as the “ASU”. The AtriCure Bipolar Handpiece will be referred in this User’s
Manual as the “Handpiece”.
This User’s Manual provides a description of the ASU, its controls, displays, indicators, tones
and a sequence for its operation with the Handpiece. This User’s Manual also supplies other
information of importance to the user. This manual is intended as a User’s Manual only. Do
not operate the ASU before thoroughly reading this manual.