Mode Of Action And Intended Use; General Information About The Mode Of Action Of Electrosurgery - Sutter Curis Gebrauchsanweisung

2 Mode of action and intended use

2.1 General information about the mode of action of electrosurgery

Electrosurgery is a surgical method that uses electric current to achieve surgical effects. To prevent
this current from causing nerve stimulation (electric shocks), alternate current with a sufficiently
high frequency (approximately 4 MHz with this device) is used so that nerve stimulation no longer
occurs (Nernst equation). Since the frequency is in the range of radio waves, one also speaks of
"radio frequency surgery" (RF surgery).
If the current is supplied to the surgical area by an electrode and conducted away from the body
again outside the surgical area using a large-scale electrode with no electrosurgical effect, one
speaks of monopolar application. The electrode in the surgical area is called the active electrode,
the current return electrode is called the neutral electrode. If on the other hand the current is
conducted away from the body and back to the device by an electrode directly within the surgical
area – which is usually symmetrical to the supply electrode – then one speaks of bipolar
application.
When RF surgery and monitoring screens are used simultaneously on a patient, only
monitoring electrodes with supply cables that contain protective resistors or RF inductors
may be used. Needle electrodes for monitoring may not be used. Do not use the active
surgery electrode in the vicinity of the ECG electrodes (minimum distance 15 cm)!
Compliance with the following general rules is required for RF surgery applications:
Always work with the lowest RF output setting for the desired surgical effect. On the other
hand, note that setting the output too low can also constitute a risk, for instance because
a first cut is not made due to excessively low output so that local coagulation results
where it is not desirable or even dangerous.
NOTE
An inadequate effect with the usual setting may for instance be due to poor application
of the neutral electrode, poor contact in plug connections, cables broken underneath
the insulation, or encrusted electrodes. This needs to be checked and defective
components must be replaced.
After repositioning the patient, the electrodes and cables must be checked to verify they
are correctly applied.
The use of ignitable anesthetics, nitrous oxide (N
use of RF devices may generate sparks on the active electrode. Combustible substances
used as cleaning agents, disinfectants, or solvents must evaporate before the
application of RF surgery. There is a risk that combustible liquids may accumulate under
the patient or in body recesses such as the navel or body cavities such as the vagina.
Wipe up liquid that has accumulated in these areas before using the RF device. There is
a risk that endogenous gases may ignite. Materials saturated with oxygen such as cotton
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CURIS Instructions for Use
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O), and oxygen should be avoided. The
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