estech COBRA 604-4810B Instrucciones De Uso página 9

430-11902-02 Rev N
•
The risk of igniting flammable gases or other materials is inherent in
the application of RF power. Precautions must be taken to restrict
flammable materials from the surgery site.
•
Electromagnetic interference (EMI) produced by the ESU during the
delivery of RF power may adversely affect the performance of other
equipment.
•
DIP Electrodes should be reliably attached with their entire area to
the patient's body and as close to the operating field as possible.
•
Skin-to-skin contact (for example, between the arms and the body of
the patient) should be avoided, for example by insertion of dry gauze.
•
When the System and physiological monitoring equipment are used
simultaneously on the same patient, monitoring electrodes should be
placed as far as possible from the Electrosurgical Probe. Needle
monitoring electrodes are not recommended. In any case,
monitoring systems incorporating high frequency current limiting
devices are recommended.
•
The Instrument Cable to the Electrosurgical Probe should be
positioned in such a way that contact with the patient or other leads
is avoided.
•
Failure of the ESU could result in unintended increase of output
power.
•
Pacemakers and implantable cardioverter/defibrillators can be
adversely affected by RF signals. Refer to the manufacturer's
Directions for Use.
•
Regularly evaluate and inspect re-usable cables and accessories.
•
AtriCure relies on the physician to determine, assess and
communicate to the individual patient all foreseeable risks of the
electrosurgical procedure.
POTENTIAL ADVERSE REACTIONS:
The following adverse events are possible:
•
Excessive thermal damage to tissue
•
Collateral damage to adjacent tissue not intended for coagulation.
• Wrapping the accessory cord or return electrode cords around metal
objects. This may induce current that could lead to shocks, fires or
injury to patient or surgical team.
•
The potential for alternate site burns. To avoid this, do one or more of
the following:
o
Position the return electrode to provide direct current route
between the surgical site and the return electrode which avoids
skin-to-skin contact areas.
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