Creo Medical CROMA Instrucciones De Uso página 44

Specifications
Emissions
Conducted
Emissions:
Harmonics: EN61000-3-2 Class A
Voltage Fluctuations: EN61000-3-3 Clause 5b
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The Electrosurgical Generator is intended for use in the electromagnetic environment specified below. The
customer or the user of the Electrosurgical Generator should ensure that it is used in such an environment.
Emissions Test
RF Emissions
CISPR 11:
RF Emissions
CISPR 11:
Harmonic Emissions
IEC 61000-3-2:
Voltage Fluctuations
/ Flicker Emissions
IEC 61000-3-3:
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EN 55011, Level A Group 2 in non-treatment modes.
Blue Pedal Activation - Group 2 (deliberate generation in 5.8 GHz ISM band).
Exceeds EN 55011 Level A during RF (400 kHz) activation of the treatment output.
Exemption from compliance with EN55011 is in accordance with EN60601-2-2.
Compliance Electromagnetic Environment – Guidance
When not delivering treatment waveforms, the Electrosurgical
Group 1 (No
Generator uses RF energy only for its internal function. Therefore,
Treatment
its RF emissions are very low and are not likely to cause any
Delivery).
interference in nearby electronic equipment.
Compliance
Exempt (RF RF energy is delivered to the patient and may cause temporary
Treatment interference in nearby electronic equipment.
Delivery)
The Electrosurgical Generator uses microwave energy at 5.8 GHz for
Group 2
coagulating tissue. Therefore, its RF emissions are very low and are
(Microwave
not likely to cause any interference in nearby electronic equipment,
Treatment
except in devices operating at 5.8 GHz. Any such interference will
Delivery)
cease when treatment delivery is stopped.
Class A
The Electrosurgical Generator is suitable for use in
heath care facility environments – endoscopy suites and operating
Class A
theatres.
those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Complies
It is not suitable for use in domestic establishments and
professional