Table 3
For NON-LIFE-SUPPORT MEDICAL-ELECTRICAL (ME) DEVICES and ME SYSTEMS: Manufacturer declaration and guidance – Electromagnetic immunity
Immunity test
IEC 60601 test level
Conducted RF
3 V
rms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m 80 MHz to 2.5 GHz
IEC 61000-4-3
10 V/m 80 MHz to 2.7 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 strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
Interference may occur in the vicinity 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 all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, 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 Thermoval baby is used, exceeds
the applicable RF compliance level above, the Thermoval baby should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Thermoval baby.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of
N/A
the device, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
3.5
d =
[
E
= 3 V/m
E
1
1
E
= 10 V/m
7
1
d =
[
E
1
a
should be less than the compliance level in each frequency range.
94
]
80 MHz to 800 MHz
]
800 MHz to 2.7 GHz
b