11.17.4 ELECTROMAGNETIC IMMUNITY, HANDHELD RADIOFREQUENCY EQUIPMENT
The medical device is designed for use in the magnetic and electromagnetic environment described in the table below. The
user and/or installer must ensure conformity of the electromagnetic environment.
Immunity test CEI EN 60601 test level Compliance level Electromagnetic environment guidance
Handheld and mobile RF communication equipment must be used no closer to any part of the medical device, including
cables than the recommended separation distance, calculated according to the equation corresponding to the frequency
of the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Recommended separation distance
d = 1,2 √P
Radiated RF
IEC 61000-4-3
10 V/m
80MHz to 2.5GHz
3 V/m
d = 1,2 √P 80 MHz - 800 MHz
d = 2,3 √P 800 MHz - 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W)according to
the transmitter manufacturer and “d” is the
recommended separation distance in meters (m).
Field strength from xed RF transmitters as determined by an electromagnetic site survey
a
must be below the compliance
level corresponding to each frequency range.
b
Interference can occur in the proximity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz the higher frequency range applies.
Note 2: These guidelines may not apply in every situation. Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
(a) Field strength from xed RF transmitters, such as base stations for radio (cellular/wireless) telephones and land mobile
radios, amateur radio, AM and FM radio and TV broadcast cannot be predicted with accuracy on a theoretical basis. To assess
the electromagnetic environment created by xed RF transmitters, an electromagnetic site survey should be considered. If
the measured eld strength in the place where the equipment is used exceeds the corresponding RF compliance level (see
above), it is important to ensure regular equipment operation. In the event of abnormal operation, additional measures may
be required, such as redirecting or relocating the product.
(b) Over the frequency range between 150 kHz and 80 MHz, the eld strength must be below 10
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