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

SAFETY STANDARDS

REQUIREMENTS FOR ELECTROMAGNETIC COMPATIBILITY

This medical device requires particular precautionary measures to ensure electromagnetic compatibility, and shall be installed and
used in compliance with information provided in the accompanying documentation.
Manufacturer's guidelines and statement – Electromagnetic emissions
The lamp MAIA is designed to function in the electromagnetic environment specifi ed below. The client or user must ensure its use
Emission tests
RF Emission CISPR15
RF Emission CISPR15
Harmonic emission
Voltage fl uctuations/fl icker emission

ELECTROMAGNETIC IMMUNITY

Manufacturer's guidelines and statement – Electromagnetic immunity
The lamp MAIA is designed to function in the electromagnetic environment specifi ed below. The client or user must ensure its use
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 fi eld
IEC/EN61000-4-8
Conducted immunity
IEC/EN61000-4-6
Conducted immunity
IEC/EN61000-4-6
Note: Ut is the power-line voltage
Note 1: The highest frequency interval is applied at 80 MHz and 800Mhz.
Note 2: These guidelines might not apply to all situations. Electromagnetic propagation is infl uenced by absorption and refl ection
of structures, objects and persons.
a) ISN bands (industrial, scientifi c 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) Compliance levels in ISN bands between 150 kHz and 80 MHz and 80 MHz to 2.5 GHz present a decreasing probability of
portable transmission devices causing interference if inadvertantly taken to the patient area.
Therefore, an additional 10/3 factor has been incorporated into the formula used to calculate the distance between transmittors.
c) Field intensities for fi xed transmittors such as base stations for radiotelephones (mobiles and cordless) and cellular mobile radios
on land, CB user equipment, AM and FM transmittors and TV transmittors cannot be theoretically estimated with precision. To
establish an electromagnetic environment caused by fi xed RF transmittors, an electromagnetic investigation of the site should be
considered. If fi eld intensity measured at the site of use of the dental unit exceeds the aforementioned applicable compliance level,
normal function of the lamp should be monitored. If any abnormal performance is noticed, additional provisions such as a different
orientation or position of the lamp might be necessary.
d) The fi eld intensity in an interval of frequencies from 150 kHz to 80 MHz should be less than 3 V/m.
in the said environment.
Compliance
Compliant
Compliant
Class C
Compliant
in the said environment.
Compliance
± 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)
Electromagnetic environment - Guidelines
The lamp MAIA uses RF energy only for its internal function.
Therefore its RF emissions are very low and most likely do not
cause any interference in neighbouring electronic devices.
The lamp MAIA is fi t for use in all buildings, including domestic
ones and those directly connected to the public low voltage sup-
ply network that feeds buildings for domestic use.
Electromagnetic environment - Guidelines
The fl oor must be in wood, concrete or ceramic. If the fl oor is
covered with synthetic material, relative humidity should be at
least 30%.
The quality of supply network voltage should be typical of com-
mercial or hospital environments.
The quality of supply network voltage should be typical of com-
mercial or hospital environments.
The quality of supply network voltage should be typical of com-
mercial or hospital environments. If the user of the lamp MAIA
requires continuous use even without a supply network, use an
uninterruptible power supply.
Level of magnetic fi eld at the network frequency typical of com-
mercial or hospital environments.
Portable and mobile RF communication devices should not be
used near any part of the dental unit, including cables, unless
they comply with recommended distances calculated with the
applicable equation for transmittor frequency.
Recommended 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
P is the maximum nominal power issued by the transmittor in
Watts (W) depending on the manufacturer of the transmittor,
and d is the recommended distance in metres (m).
The intensity of the fi xed RF transmittor fi eld, as established in
an electromagnetic investigation of site a, could be less than the
compliance level of each frequency interval.
There can be interference near devices marked with the
following symbol:
15 15