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101
MAGNAMED TECNOLOGIA MÉDICA S/A
11.17.3 Radiated Immunity
Immunity Test
Test Level
ABNT NBR IEC 60601
Conformity
Electromagnetic environment - Guidelines
Distance removal recommended
Portable and mobile RF communications
equipment should not be used near any part
of the system, including cables, with a
separation distance than recommended,
calculated from the equation applicable to the
frequency of the transmitter.
RF conduced
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz out
of band ISM
(a)
(?)1 Vrms (V1)
D = 3.5/V
1
√P
10 Vrms
150 kHz to 80 MHz out
of band ISM
(a)
(?)1 Vrms (V2)
D = 12/V
2
√P
RF radiated
IEC 61000-4-6
10 V/m
(?)10 V/m (E1) D = 12/E
1
√P 80 MHz to 800 MHz
80 MHz to 2,5 GHz D= 23/E
1
√P 800 MHz to 2,5 GHz
Where P is the maximum output power of the
transmitter in watts (W) according to the
manufacturer's transmitter, and D is the
recommended spacing distance in meters
(m) (b).
The field intensity established by the RF
transmitter, as determined by an
electromagnetic site inspection (c) should be
less than the compliance level in each
frequency range
(d)
.
(a)
The bands ISM (industrial, scientific and medical) between 150 kHz to 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 the ISM bands between 150 kHz and 80 MHz and 80 MHz to 2.5 GHz frequency band is intended to reduce the
likelihood of mobile and portable communications equipment causing interference if inadvertently brought into the patient's environment.
For this reason, an additional factor of 10/3 is used in the recommended separation distance calculation for transmitters in these frequency
bands.
(c)
Field strengths from fixed transmitters, such as base stations, telephone (cellular / wireless) land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, consider an electromagnetic inspection of the site. If the measured field strength in the location where the system
is used exceeds the RF compliance level above apply, the system should be observed to see whether the operation is normal. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or system replacement.
(d)
Above 150 kHz to 80 MHz frequency range, the field strength should be less than [V1] V / m.