KCI PREVENA PLUS, Instructions For Use Manual

Page: 34 / 500

34
Table 204
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The PREVENA PLUS™ 125 Therapy Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the unit should assure it is used in such an environment.
Immunity Test IEC 60601
Test Level Compliance Level Electromagnetic Environment Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150kHz to 80 MHz
6Vrms in ISM and
amateur radio bands
between 150 kHz
and 80 MHz
80% AM at 1kHz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
3Vrms
150kHz to 80 MHz
6Vrms in ISM and
amateur radio bands
between 150 kHz and
80 MHz
80% AM at 1kHz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1kHz
Portable and mobile RF communications
equipment should be used no closer
to any part of the PREVENA PLUS™ 125
Therapy Unit, 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 = 0.35√P 80MHz to 800 MHz
d = 0.7√P 800MHz to 2.7GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended minimum
separation distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey
a
, should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1: At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from objects, structures 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 PREVENA PLUS™ 125 Therapy Unit
is used exceeds the applicable RF compliance level above, the 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 PLUS™ 125 Therapy Unit.