Acelity PREVENA INCISION Manual De Instrucciones página 22

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
3 Vrms
150 kHz
Conducted RF
to
IEC 61000-4-6 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
1
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To asses 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.
2 Over the frequency range 150kHz, field strengths should be less than [V1] V / m.
22
Compliance Level
Portable and mobile RF communications equipment
should be used no closer to any part of the Prevena™
recommended separation distance calculated from
the equation application to the frequency of the
Not Applicable
3 V / m
80 MHz
to
2.5 GHz
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
determined by an electromagnetic site survey
should be less than the compliance level in each
Interference may occur in the vicinity of equipment
Electromagnetic Environment Guidance
125 Therapy Unit, including cables, than the
transmitter.
Recommended separation distance
Battery Operated Device
3.5
d = [ ]
P
80 MHz to 800 MHz
E1
7
d = [ ]
P
800 MHz to 2.5 GHz
E1
distance in metres (m)
Field strengths from fixed RF transmitters, as
frequency range
marked with the following symbol:
,
1
.
2