430-15106-02_Rev J
Page 5 of 88
Indications
The ESTECH Cobra Fusion Ablation System is intended to ablate cardiac tissue during cardiac surgery
using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
The ESTECH Cobra Fusion Pacing/Recording Adapter Cable may be used for temporary cardiac pacing,
sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when
connected to a temporary external cardiac pacemaker or recording device.
Sterilization Method:
The sterilization method is EtO and provides sterility assurance level 10
-6
in
compliance with the obligatory requirements of ISO 11135.
Contraindications
Local or systemic infection
Do not apply suction over an artery, large vein or aneurismal tissue
Warnings
The device(s) should be used by physicians thoroughly trained in the techniques of invasive surgical
procedures and in the specific approach to be used.
The operator should keep the set temperature and power limit as low as possible to achieve the desired
end effect. This minimizes excessive thermal damage to tissue, potential for collateral damage to
adjacent tissue not intended for ablation, and potential for char, thrombus, or steam pop formation or
occurrence.
Recommended temperatures should not be exceeded.
Physicians should consider the use of intra-operative and post-operative anti-coagulation therapy to
prevent potential thromboemboli.
Ablation should be performed on the beating heart, with the heart at full or near full volume and normal or
near normal cardiac output, to prevent stasis of blood.
Care should be taken to assure that the Probe is not in contact with tissue other than that to be
coagulated to avoid inadvertent tissue damage.
Care should be taken when using the Probe in the proximity of vascular or nerve tissue to avoid
inadvertent tissue damage.
Care should be taken to thermally isolate the tissue to be ablated when anatomically possible to avoid
damage to unintended tissues or structures.
Following RF ablation, visual inspection of underlying tissues should be routinely performed to rule out the
presence of inadvertent tissue damage.
Care should be taken to ensure that the Probe is not in contact with other surgical instruments, staples or
other objects while coagulating. Inadvertent contact with objects while coagulating could lead to
conduction of RF energy or heat and unintentional ablation of tissues in contact with that object.
Care should be taken when positioning the Probe to prevent perforation or other damage to adjacent
tissue. Do not force the Introducer or Probe during advancement if snagged.
User should avoid twisting or extreme manipulation of the device to preclude inadvertent injury to
neighboring tissue (the correct orientation of the device should be ensured).
When using the push button magnetic decoupling feature, ensure that the distal end of the accessory
shafted device is directly facing the magnet to avoid applying the ejector rod to tissue.
Turn vacuum control stopcock open to atmosphere and off to vacuum source prior to removal of suction
attachment from tissue.
Care should be taken when positioning Suction Stabilizer to prevent perforation or other damage to
adjacent tissue during the application of a vacuum.
Take care not to occlude vacuum lumen or puncture the Suction Stabilizer as this may result in loss of
vacuum.
Do not exceed recommended vacuum limit. Excessive vacuum may cause bruising and/or hematoma.
Inadvertent application of vacuum or ablation over an artery may constrict or occlude the artery resulting
in infarction.
