AtriCure CSK-2000 Gebrauchsanweisung

RF Cable:
Instructions for Use
AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA
1-866-349-2342
1-513-755-4100
For Use only with the nContact Coagulation System
INDICATIONS:
For use only with nContact Generator, Coagulation Device, and Sensing Cable.
CONTENTS:
CSK-2000 RF Cable Kit contains:
1ea CS-2000 RF extension cable in sterile packaging
1ea Instructions for Use (IFU) Brochure.
INSTRUCTIONS:
CSK-2000
1. Inspect package and cable for damage. If either cable or package is damaged, discard without using.
2. Remove cable from sterile package.
3. Connect BLUE end of cable to BLUE port on nContact Coagulation Device
4. Connect BLACK end of cable to
a. BLACK port on nContact Generator or
b. BLACK port on the sensing cable
5. Follow instructions for use of generator, coagulation device, and sensing cable.
6. To disconnect cable, grasp by connector cover and pull back. Do NOT pull on wire.
7. Discard after use following local governing ordinances and recycling plans for disposal or recycling
of device components.
WARNING: Devices are sterile in unopened, undamaged outer package. For single use ONLY.
Do NOT resterilize. Do NOT reuse. If opened and unused, discard immediately.
CAUTION: Cables to surgical electrodes should be positioned to prevent contact with patient or
other leads
WARNINGS:
For information concerning all warnings, precautions, and troubleshooting see nContact Coagulation
System Radiofrequency (RF) Generator Unit Model CS-3000 Operators Manual.
ENGLISH
2797
CSK-2000
AtriCure Europe B.V.
De Entree 260
1101 EE Amsterdam
EC REP
The Netherlands
+31 20 7005560
ear@atricure.com
EXPLANATION OF SYMBOLS FROM PACKAGE LABEL:
Caution
Sterilized Using Irradiation
STERILE R
2
Single Use Only
Use by Date
Caution: Federal (US) law
restricts this device to sale by or
on the order of a physician or
other licensed practitioner.
Do not resterilize
85%
%
Storage Humidty Range
30%
Waste Electrical Electonic
Equipment
NOMENCLATURE:
RF=Radiofrequency LT=Label
WARRANTY AND DISCLAIMER INFORMATION:
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.
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.
2021/04 IFU-0023.A
Lot Number
LOT
Catalog Number
REF
CE Mark and Identification
2797 number of Notified Body
Authorized Representative in
EC REP
the European Community
Follow instructions for use
Manufacturer
Do Not Use if Package is
Damaged
60°C
(140°F)
Storage Temperature Range
-29°C
(-20°F)
1