Creo Medical CROMA Instrucciones De Uso página 9

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Safety Instructions
If liquid is spilled on the Electrosurgical Generator or the connectors, including the connectors
of the Interface Cable, Footswitch or Instruments, immediately cease operation, switch Elec-
trosurgical Generator off, and disconnect the Electrosurgical Generator at the wall socket. If
liquid is spilled on the Electrosurgical Generator or the connectors, including the connectors
of the Interface Cable, Footswitch, or Instruments, there is a risk of electrical shock to patient
or user and/or this may lead to unintended clinical effects with risk of injury or death to the
patient.
Do not activate the Electrosurgical Generator while the Instrument tip or connectors of the
Interface Cable are in unintentional contact with tissue; for example, if someone is touching
the tip of the Instrument or when the Instrument tip is not in direct view of the clinician.
To avoid or reduce the chance of unintended clinical effects during electrosurgery, please
ensure that:
• the patient cannot come into contact with grounded metal parts or parts with appreciable
capacitance to electrical ground such as operating table supports.
• all patient monitoring electrodes need to be placed as far as possible from electrosurgical
electrodes when electrosurgical and physiological equipment is used simultaneously on the
same patient.
• needle-type monitoring electrodes are not used.
• monitoring systems with high-frequency current limiting devices are used.
Activation of the Electrosurgical Generator will result in the delivery of energy that may cause
unintended tissue effects.
Use of radio frequency energy particularly when cutting tissue may result in neuromuscular
stimulation resulting in unintended movement of target tissue.
Do not use in oxygen-rich environments, in the presence of flammable gases (e.g. flammable
anesthetics or gastrointestinal gases) or in the presence of flammable liquids or other flam-
mable materials. Ensure that flammable liquids are not pooled.
The Instruments connected to the Electrosurgical Generator and the Electrosurgical Genera-
tor itself can be ignition sources. Using them in oxygen-rich environments or the presence of
flammable gases or liquids poses the risk of explosion or fire.
There is a risk of pooling of flammable solutions under the patient or in body depressions
such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas
should be mopped up before the Electrosurgical Generator is used.
During electrosurgery, smoke may be produced. Use of smoke-plume extraction is advised if
this occurs.
Do not open the cover of the Electrosurgical Generator or modify hardware or software in any
way. Servicing of the Electrosurgical Generator must only be performed by Creo Medical per-
sonnel or their designated representatives.
Proprietary & Confidential - Page 9 of 391 - Uncontrolled if Printed
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