Recommended Separation Distance - KCI CelluTome Système de prélèvement de cellules épidermiques Manuel D'utilisation

Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The CelluTome™ Epidermal Harvesting System is intended for use in the electromagnetic environment
specified below. The customer or the user of the CelluTome™ Epidermal Harvesting System should assure
that it is used in such an environment.
IMMUNITY Test
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
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 CelluTome™ Epidermal Harvesting System is used exceeds the applicable RF compliance level above,
the CelluTome™ Epidermal Harvesting System should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the
CelluTome™ Epidermal Harvesting System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
IEC 60601 Compliance Level
Test Level
3 V
3 V/m
Electromagnetic Environment -
Portable and mobile RF
communications equipment should
be used no closer to any part of the
CelluTome™ Epidermal Harvesting
System, including cables, than the

recommended separation distance

calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance
d = 1.2√P
d = 1.2√P
d = 2.3√P
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,
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
23
Guidance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
a should be
b