AtriCure COBRA Fusion Gebrauchsanweisung Seite 8

4. Connect the blue connector on one end of the 4-meter (12-foot) vacuum line to the vacuum canister.
Connect the male fitting of the 4-meter (12-foot) vacuum line to the three-way stopcock. Turn the
stopcock to the off position with the "Off" indicator pointed in the direction of the vacuum source.
5. If using the Introducer, insert the stylet into the curved tubing to straighten it and provide pushability for
advancement.
6. Advance the Introducer to the desired anatomical location. By withdrawing the stylet the Introducer
tubing will advance in a preformed curve. The tubing will curve opposite the axial dark stripe.
7. Remove the stylet and couple the proximal magnetic fitting of the Introducer tubing to the distal
magnetic fitting of the Probe. Ensure that the dark stripe of the Introducer tubing is oriented opposite
the open side of the suction stabilizer.
8. If using the Magnetic Retriever, advance toward the Introducer. Magnets at the distal end of the first
and second introducers will couple when in close proximity.
9. By pulling on the Retriever, the Introducer and connected Probe are brought into alignment with the
identified anatomical sites for pacing/recording. Once in place, the Introducer is detached from the
Probe. The accessory positioning devices can then be coupled to the distal end of the Probe to aid in
Probe placement.
10. The pacing/recording leads are located within the distal end of the suction chamber of the Probe. Turn
vacuum regulator on to -500 mmHg to affix device to tissue. Turn vacuum control stopcock on to
vacuum source. Push stabilizer against tissue to complete seal. Allow vacuum to build up prior to
activating device. Maintain manual pressure as required to ensure Probe/tissue contact.
11. Turn on the temporary external pacemaker. Refer to its IFU for appropriate settings and procedure.
12. The device will pace, sense, record, or stimulate when the auxiliary device is on, according to its
intended use.
13. Upon completion of procedure, disconnect Probe from pacing/recording adapter cable. Discard Probe
after use. The pacing adapter is reusable and should be cleaned and stored in accordance with
hospital procedures.
How Supplied
The Cobra Fusion™ System components are available in the COBRA Fusion 50 or 150 Ablation System,
the Magnetic Retriever System, and the Pacing/Recording Adapter Cable. Note: The Magnetic Retriever
System and Pacing Adapter Cable can be sold separately.
Contents
One (1) COBRA Fusion Ablation System
One (1) Instructions For Use
Complications
The following potential risks or discomforts may be associated with electrosurgical procedures. The
frequency and severity of these events can vary, and may necessitate additional medical intervention,
including surgery. Strict adherence to the forgoing instructions before use will help reduce the incidence of
complications.
Allergic reaction, Arrhythmias, Cardiac or respiratory arrest, Cardiac valve damage, Chest pain,
Damage to vessel intima or cardiac ultrastructures, Death, Embolus, Hematoma / ecchymosis,
Hemorrhage, Infarction, Infection, Perforation, Pericardial effusion, Pericarditis / pleuritis,
Pseudoaneurysm, Pulmonary edema, Sinus or AV node injury, Stroke, Tamponade, Thrombosis,
Vasovagal reaction.
Disposal
After use, dispose of product and packaging in accordance with hospital, administrative and/or local, state,
federal and international laws and regulations.
Warranty and Limitations
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