Sutter CURIS 36 0 00-01, Instructions For Use Manual

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CURIS
®
Instructions for Use
18
7 Safety measures
7.1 General information
RF devices are high-frequency generators that generate high voltages and currents for their
intended application. To avoid danger for the patient, operating personnel, or third parties, the
device must always be used carefully and strict compliance with the operating and safety
instructions is required!
Ensure that disinfectants are fully removed or evaporated before using the device.
A medical device record must be maintained according to the operator ordinance.
A defect in an RF device can cause an unwanted increase in the output power. In order to prevent
this, a protective circuit against overdosing is integrated into the CURIS
®
.
7.2 Patient positioning
For monopolar applications, the electric current supplied to the patient by the RF device via the
active electrode can return to the device in two ways to close the electric circuit. The regular path
leads through the neutral electrode, which conducts the current from the patient to the device over
a large area and therefore without the heating effect that occurs on the active electrode. The
second path is an unwanted bypass that can form when the patient is in contact with conductive
components that are connected to ground potential. These are all large-scale metal components
such as the frames of treatment tables, operating tables, chairs with metal frames and the
housings of electrical equipment supplied by the mains network. The patient must not have any
contact with grounded metal components, otherwise there is a risk of point burns at the contact
points. Especially the patient’s limbs should not be in contact with metal fixtures.
If the patient is lying on an operating table or treatment table with a metal frame, high-frequency
insulation to the metallic surface must be ensured by a sufficient number of pads (drapes). If
moisture, perspiration, and the like is expected during the operation, wetting of the pads serving
as high-frequency insulation must be prevented with waterproof film where applicable.
The accumulation of fluids under the patient must be prevented under all circumstances. Additional
dry cloth layers must be used as needed.
The RF current flowing through the body must reach the neutral electrode along the shortest
possible path. Ensure that the current does not leave the body and re-enter it in a different place
on the way to the neutral electrode, for example in case of contact between the hand and thigh or
elbow and torso. This current bypass causes a risk of burns at such contact points. Therefore, areas
with high levels of perspiration, limbs in contact with the trunk, or skin to skin contact should be
kept dry with layers of drapes (arm/torso, leg/leg, mammae).
Ensure that the aforementioned insulation requirements are also met when the patient is shifted
to a different position during the operation!
7.3 Application of the neutral electrode and high-frequency current
Electrodes and cables must be applied carefully. Here the following must be observed
in particular: