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Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
1) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, 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 transmit-
ters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the medical device is used exceeds the
applicable RF compliance level above, the medical device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the medical device.
2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances from mobile high-
frequency communication equipment
The medical device is intended for use in an electromagnetic envi-
ronment in which radiated RF disturbances are controlled. The
customer or the user of the medical device can help prevent elec-
Rated maximum output
power of transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres (m) can
be determined using the equation applicable to the frequency of
the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Supplement Scio Four modules
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d = [ 3.5
]
P
3
0.1
0.4
1.2
3.8
12
Compliance level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the medical device, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = [ 3.5
3 V
3
d = [ 3.5
3
3 V/m
d = [ 7
3
where P is the maximum output power rat-
ing 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
1)
survey
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
tromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment
(transmitters) and the medical device as recommended below,
according to the maximum output power of the communications
equipment.
m
80 MHz to 800 MHz
d = [ 3.5
]
P
3
0.1
0.4
1.2
3.8
12
English
]
P
80 MHz to 800 MHz
]
P
]
P
800 MHz to 2.5 GHz
,should be less than the compliance
2)
800 MHz to 2.5 GHz
d = [ 7
]
P
3
0.2
0.7
2.3
7.4
23
17
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