Requirements For Electromagnetic Compatibility; Electromagnetic Immunity - Faro ALYA Mode D'emploi

SAFETY rEGULATIOnS

rEQUIrEMEnTS FOr ELEcTrOMAGnETIc cOMPATIBILITY

this medical device requires particular precautionary measures to ensure electromagnetic compatibility, and must be installed and
used in compliance with the information provided in the accompanying documentation.
Manufacturer's guide and declaration – Electromagnetic emissions
The ALYA lamp is made to function in the electromagnetic environment specified below. The client or user should make sure that it is
Emission tests
RF Emission CISPR15
RF Emission CISPR15
Harmonic emission
RF Emission
CISPR11 / EN 55011

ELEcTrOMAGnETIc IMMUnITY

Manufacturer's guide and declaration – Electromagnetic immunity
The ALYA lamp is made to function in the electromagnetic environment specified below. The client or user should make sure that it is
Immunity test
Electrostatic discharge (ESD)
IEC/EN61000-4-2
Electrical fast transient/burst
IEC/EN61000-4-4
Surge
IEC/EN61000-4-5
Voltage dips, short interruption
and voltage variation
IEC/EN61000-4-11
Power frequency magnetic field
IEC/EN61000-4-8
Conducted immunity
IEC/EN61000-4-6
Conducted immunity
IEC/EN61000-4-6
Note: Ut is the value of the voltage.
Note 1: At 80 MHz and 800 Mhz the higher frequency interval is applied.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is influenced by the absorption and reflection
of structures, objects and people.
a) The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
b) The levels of conformity of the ISM bands between 150 kHz and 80 MHz and in the bands 80 MHz to 2.5 GHz are indicative.
The probability of a portable transmitter causing interference if accidentally brought in the range of a patient decreases depending
on environment conditions. This is why an additional factor of 10/3 has been incorporated into the formula used to calculate the
separation distance from transmitters.
c) Field intensities for fixed transmitters like base stations for radio-telephones (cellular and cordless phones) and terrestrial tran-
smitters, amateur radio stations, AM and FM radio transmitters and TV transmitters cannot be predicted theoretically and precisely.
To establish an electromagnetic environment caused by fixed RF transmitters, an electromagnetic investigation of the site should be
done. If the intensity of the field measured in the area of use of the dental unit is higher than the applicable level of conformity de-
scribed above, it is necessary to monitor the lamp to check that it functions properly. If abnormal performance is detected, additional
measures could prove necessary, such as a different orientation or position of the lamp.
d) The field intensity in an interval of frequencies from 150 kHz to 80 MHz should be less than 3 V/m.
effectively used in this environment.
Conformity
Yes
Yes
Class C
Yes
effectively used in this environment.
Conformity
± 6kV contact
± 8kV air
± 2kV power supply
± 1kV for input/output lines
± 1kV differential mode
± 2kV common mode
< 5% Ut for 0,5 cycle
40% Ut for 05 cycle
70% Ut for 25 cycle
<5% Ut for 5 sec.
3A/m
3Vrms 150kHz to 80MHz
(for non life-supporting
equipment)
3Vrms 80MHz to 2.5GHz
(for non life-supporting
equipment)
Guide – Electromagnetic environment
The ALYA lamp uses RF energy only for internal functioning.
Therefore, its RF emissions are very low and probably do not
cause any interference with other nearby electronic equipment.
The ALYA lamp is suitable for use in all buildings, including do-
mestic buildings and those connected directly to the low voltage
public electricity mains that power domestic buildings.
The ALYA lamp is not suitable for interconnections with other
devices (ceiling model).
Guide – Electromagnetic environment
Flooring must be in wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%.
The quality of network voltage should be equivalent to that of a
typical commercial or hospital environment.
The quality of network voltage should be equivalent to that of a
typical commercial or hospital environment.
The quality of network voltage should be equivalent to that of
a typical commercial or hospital environment. If the user of the
ALYA lamp requires continuative use, also when electrical po-
wer is not present, it is advisable to have a UPS (uninterrupted
power supply).
Level of the magnetic field at the typical power main frequency
of a commercial or hospital environment.
Portable and mobile RF communication devices should not be
used near any part of the dental unit, including cables, except
for when they comply with the recommended separation di-
stances calculated by the equation applicable for the transmitter
frequency.
Recommended separation distances:
d = 1,2√P
d = 1,2√P from 80 Mhz to 800 MHz
d = 2,3√P from 800 MHz to 2,5 GHz
Where P is the maximum nominal power emitted from the tran-
smitter in Watts (W), according to the transmitter manufacturer,
and d is the recommended separation distance in metres (m).
The intensity of the fixed RF transmitter field, as determined
in an electromagnetic study of the site a, could be less than the
level of conformity of each frequency interval.
Interference could be experienced in proximity to devices bea-
ring the following symbol:
13 13