AtriCure nContact EPi-Sense Mode D'emploi page 5

IFU for EPi-Sense Guided Coagulation System with VisiTrax
®
Glossary of Terms
Electrocoagulation Surgical procedures in which high-frequency electric current is used
to coagulate tissues.
Coagulation
The metal conductor in the coagulation device used to transmit
Electrode
radiofrequency energy to tissue.
Sensing Electrodes
Metal conductors between the coagulation electrode used to sense
cardiac voltages from the heart.
Commonly referred to as the "return electrode" or "patient electrode"
Indifferent,
or "ground pad." Large surface area indifferent ground pad used to
Dispersive
Electrode complete the circuit of the electrical current. Usually placed on the
patient's back or thigh, the indifferent, dispersive electrode is
connected to the generator at the Indifferent Connector.
Abbreviations
RF Radiofrequency
VAC Vacuum
Symbols
Manufacturer
VAC Vacuum
OC Open Circuit
Equipotential
Indifferent, Dispersive
Electrode
Caution: Electrical Shock
Hazard
W Watts

Time
Follow instructions for
use
Lot Number
Use-By Date
Not made with Natural
Rubber Latex or Dry
Natural Rubber
Do Not Resterilize
Caution: Federal law
(US) restricts this device
to sale by or on the order
of a physician.
Non-pyrogenic
Manufacturer:
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
Customer Serice:
1-866-349-2342 (toll free)
1-513-755-4100 (phone)
Customer Service
LIMITED WARRANTY
AtriCure warrants that reasonable care has been used in the design and
manufacture of this instrument. This warranty is in lieu of and excludes all other
warranties not expressly set forth herein, whether expressed or implied by operation
of law or otherwise, including, but not limited to, any implied warranties of
merchantability or fitness for a particular use. AtriCure's sole obligation under this
warranty is limited to the repair or replacement of this instrument. AtriCure neither
assumes, nor authorizes any other person to assume for it, any other or additional
liability or responsibility in connection with this instrument.
Handling, storage, cleaning and sterilization of this instrument as well as other
factors relating to the patient, diagnosis, treatment, surgical procedures, and other
matters beyond AtriCure's control directly affect the instrument and the result
obtained from its use. AtriCure assumes no liability with respect to instruments
deliberately mis-used or those reused, reprocessed or re-sterilized and makes no
warranties expressed or implied, including but not limited to merchantability or
fitness for intended use, with respect to such mis-used or reused instruments.
AtriCure shall not be liable for any incidental or consequential loss, damage, or
expense directly or indirectly arising from the deliberate mis-use or re-use of this
instrument.
DISCLAIMER
Users assume responsibility for approving the acceptable condition of this
product before it is used, and for ensuring that the product is only used in the
manner described in these instructions for use, including, but not limited to,
ensuring that the product is not re-used.
Under no circumstances will AtriCure, Inc. be responsible for any incidental,
special or consequential loss, damage, or expense, which is the result of the
deliberate misuse or re-use of this product, including any loss, damage, or
expense which is related to personal injury or damage to property.
®
IFU Instructions for Use
LBL Label
Catalog Number
RF Radiofrequency
Perfusion
Footswitch Connection
Caution
Defibrillation Proof Type CF
Applied Part
Ω
Ohms
s Seconds
Non-ionizing Radiation
Sterile by gamma irradiation
Single Use Only
CE Mark and
Identification number
of Notified body
Do Not Use if Package is
Damaged
Waste Electrical and Electronic
Equipment
Authorized European
Representative:
AtriCure Europe B.V.
De Entrée 260
1101 EE Amsterdam
The Netherlands
+31 20 7005560
ear@atricure.com
English
LBL-1819-EU Rev. G
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