Creo Medical CROMA Instrucciones De Uso página 11

Safety Instructions
The Electrosurgical Generator contains no user serviceable parts. To avoid risk of electric
shock and equipment malfunction do not remove any cover.
Modification or opening of the Generator by unqualified persons may result in electrical
shock and will breach warranty of the Generator.
Microwave energy should not be applied to persons wearing metallic jewelry or clothing con-
taining metallic material. Hearing aids should be removed. Patients with implanted electronic
devices and/or electrodes should be excluded from treatment with microwaves and from
areas where the microwave equipment is operated. For patients with cardiac pacemakers or
other active implants, a possible hazard exists due to interference with the action of the pace-
maker, or the pacemaker may be damaged, and when in doubt, approved qualified advice
should be obtained.
Caution: Disconnecting the Instrument from the Interface Cable while microwave or radiofre-
quency power is delivered poses the risk of burns when touching the connector of the Inter-
face Cable. Avoid touching the connectors of the Interface Cable at all times.
Cybersecurity
The Electrosurgical Generator is a table-top, non-network connected, mains powered medical
device. It has means for hard-wired connection to an external computer for the purpose of
installing new firmware by Creo Medical service team.
Keep the device in a location with controlled access between uses to prevent tampering.
Prior to use, inspect packaging and device for signs of tampering to pay attention to the Pro-
gramming Port (item 12 in figure below).
Do not use the Electrosurgical Generator and contact customer support if there are signs of
tampering, or for technical assistance.
Proprietary & Confidential - Page 11 of 391 - Uncontrolled if Printed
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