Electromagnetic Emissions; Electromagnetic Immunity - Satelec Acteon I-Surge Manual De Uso

The use of accessories other than those specified or sold by BY DENTAL and/or SATELEC as replacement parts
may have the consequence of increasing the emissions or decreasing the immunity of the I-SURGE.
 To avoid possible risks of electromagnetic interferences do not use other electro-medical
instruments of similar nature near I-SURGE. The unit complies with the current normative
electromagnetic radiation law.
 This device has been tested and found to comply with the emissions requirements of IEC
60601-1-2. These requirements provide reasonable protection against harmful
electromagnetic interference in a typical medical installation. However, high levels of radio-
frequency (RF) emissions from electrical devices, such as cellular phones, may disrupt the
performance of this device. To mitigate disruptive electromagnetic interference, position
this device away from RF transmitters and other sources of electromagnetic energy.
 Risks from electromagnetic fields: The functions of implanted systems (such as
pacemakers) can be influenced by electromagnetic fields. Patients and users must inquire
about implanted systems before using the motors and check the use. Do not bring the
motors close to the systems. Take suitable emergency precautions and immediately react to
any changes in health.

12.1 ELECTROMAGNETIC EMISSIONS

I-SURGE is intended for use in the electromagnetic environment specified below. The I-SURGE should only be
used in such an environment.
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuation/
flicker emissions
IEC 61000-3-3

12.2 ELECTROMAGNETIC IMMUNITY

I-SURGE is intended for use in the electromagnetic environment specified below. The I-SURGE should only be
used in such an environment.
Immunity test
Electrostatic 6kV contact
discharge
8kV air
(ESD) EN61000-4-2
Group 1 I-SURGE uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic
equipment.
Class B
I-SURGE is suitable for use in all establishment including domestic establishments
Class A
Conforms
and those directly connected to the public low-voltage power supply.
Conforms
Test level Compliance level
IEC 60601-1-2
6kV
8kV
Electromagnetic environment - guidance
Floor should be wood, concrete or ceramic tile. If
floor are covered with synthetic material, the
relative humidity should be at least 30%
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