Acelity PREVENA INCISION Manual De Uso página 32

Guidance and manufacturer's declaration - electromagnetic immunity
The PREVENA™ 125 Therapy Unit is intended for use in an electromagnetic environment specified
below. The customer or user of the PREVENA™ 125 Therapy Unit should assure that it is used in such an
environment.
Immunity IEC 60601
Test Test Level
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
1
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 PREVENA™ 125 Therapy Unit is used exceeds the applicable RF compliance level above, the
PREVENA™ 125 Therapy Unit should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the PREVENA™ 125
Therapy Unit.
Over the frequency range 150kHz, field strengths should be less than 3 V/m.
2
Compliance Level
Portable and mobile RF communications equipment
Not Applicable
PREVENA™ 125 Therapy Unit than the recommended
separation distance calculated from the equation
10 V/m
80 MHz to
2.7 GHz
80% AM at 1 kHz
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
Interference may occur in the vicinity of equipment
32
Electromagnetic Environment Guidance
should be used no closer to any part of the
application to the frequency of the transmitter.
Recommended separation distance
d = 0.35 P
80 MHz to 800 MHz
d = 0.7 P
800 MHz to 2.5 GHz
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
frequency range
marked with the following symbol:
1 ,
2 .