Berlin Heart EXCOR Pediatric VAD, Manual, Page: 244 / 250

Chapter 17 EMC tables
Immunity
test IEC 60601
test level Compliance
level Electromagnetic environment ­
guidance
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.
Tab. 17-3 Electromagnetic immunity - part 2
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 2.5 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/
3has 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 Ikus is used exceeds the applicable RF compliance level above,
the Ikus should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating
the Ikus.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
10V/m.
17.5 Recommended separation distances between portable
and mobile RF communications equipment and the Ikus
The Ikus is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Ikus can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the Ikus as
recommended below, according to the output power of the communications
equipment.
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