EN
21
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Bone Growth Stimulator is intended for use in the electromagnetic environment
specified below. The customer or the user of the Bone Growth Stimulator should assure that
it is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3V
Portable and mobile RF communications
equipment should be used no closer to
any part of the Bone Growth Stimulator,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d =
[
3.5
]
√P 150 KHz to 80 MHz
V
1
d =
[
3.5
]
√P 80 MHz to 800 MHz
E
1
d =
[
7
]
√P 800 MHz to 2.5 GHz
E
1
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,
a
should be less than the
compliance level in each frequency
range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Radiated RF
IEC 61000-4-3
3V/m
80 MHz to
2.5 GHz
3 V/m
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 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 Bone Growth
Stimulator is used exceeds the applicable RF compliance level above, the Bone Growth
Stimulator should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Bone
Growth Stimulator.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
