Guidance and manufacture's declaration – electromagnetic immunity
The Examination Light ri-magic® HPLED is intended for use in the electromagnetic environment specified
below. The customer or the user of Examination Light ri-magic® HPLED should assure that it is used in such
an environment.
Immunity test IEC 60601 test level
Conducted RF
150 kHz to 80 MHz
IEC 61000-4-6
Outside ISM bands
Radiated RF
IEC 61000-4-3
26 MHz to 2.7 GHz
NOTE 1 At 26 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
The ISM (industrial, scientific and medical) bands between 150 kHz and 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
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2,7 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.
c
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
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the Examination Light ri-magic® HPLED is used exceeds the applicable RF
compliance level above, the Examination Light ri-magic® HPLED should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Examination Light ri-magic® HPLED.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
14
Compliance
level
3 V
rms
a
3 Vrms
3 V/m
3V/m
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the
Examination Light ri-magic® HPLED,
including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
26 MHz to 800 MHz
800 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 metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
a