Synapse Biomedical TransAeris Manuel De L'utilisateur page 83

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The TransAeris stimulator is intended for use in the electromagnetic environment specified below. The
customer or the user of the TransAeris stimulator should assure that it is used in such an environment.
IEC 60601
Immunity Test Test Level
Conducted RF 3 Vrms
150 kHz to 80 MHz
IEC 61000-4-6
outside ISM bands
10 Vrms
150 kHz to 80 MHz
in ISM bands
Radiated RF 10 V/m
80 MHz to
IEC 61000-4-3
2,5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz
a
to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5
b
GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae
used in calculating the recommended separation distance for transmitters in these frequency ranges.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
c
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the TransAeris stimulator is used exceeds the applicable RF compliance level
above, the TransAeris stimulator should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the TransAeris stimulator.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
d
Compliance
Level
3 Vrms
a
10 Vrms
a
10 V/m
Electromagnetic Environment
– Guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the TransAeris stimulator,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 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 metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compliance
c
level in each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
b
d
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