Guidance And Manufacturer's Declaration - Electromagnetic Immunity - DJO Donjoy IceMan CLEAR3 Instrucciones De Uso

ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES – RF EMISSIONS CLASS B (con't)
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Iceman is intended for use in the electromagnetic environment specified below. The
customer or the user of Iceman should assure that it is used in such an environment.
Immunity
Test
Conducted RF 150 kHz - 80
MHz at 3
Vrms
1 kHz 80%
IEC 61000-4-6
amplitude
modulated
Radiated RF Radiation
field strength
IEC 61000-4-3 of 3 V/m
from 80 -
2500 MHz
(80% AM 1
kHz)
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
a
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 Iceman is used exceeds
the applicable RF compliance level above, Iceman should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Cold Therapy Unit.
Over the frequency range
b
IEC 60601 Compliance
Test Level Level
150 kHz - 80
MHz at 3
Vrms
1 kHz 80%
amplitude
modulated
Radiation
field strength
of 3 V/m from
80 - 2500
MHz
(80% AM 1
kHz)
150 80
kHz to
Environment Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Cold Therapy Unit, including cables,
than the recommended separation
distance calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation
distance :
d = [3.5/V1]√P 150 KHz to 80 MHz
d = [3.5/E1]√P 80 MHz to 800 MHz
d = [7/E1]√P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manu-facturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
be less than the compliance level in
each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
MHz, field strengths should be less than [V1] V/m.
15
Electromagnetic
a
b
should