Acelity ACTIV.A.C., User Manual

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CLINICIAN
70
Table 204
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ACTIV.A.C.™ 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 Intended Electromagnetic Environment
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150kHz to 80MHz
3V / m
80MHz to 2.5GHz
3Vrms
150kHz to 80MHz
6Vrms in ISM and
amateur radio bands
between 150kHZ and
80MHz
80% AM at 1kHz
10V / m
80MHz to 2.7GHz
80% AM at 1kHz
Portable and mobile RF communications equipment
should be used no closer to any part of the ACTIV.A.C.™
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 2.5GHz
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
b
.
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 ACTIV.A.C.™ 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 ACTIV.A.C.™ Therapy Unit.
b
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V / m .
Portable and mobile RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the ACTIV.A.C.™ Therapy Unit including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result. More precisely, the minimum
recommended separation distance should be calculated from the equation applicable to the frequency of the transmitter, as
noted in Table 206.
NOTE: This equipment (60601 3rd Edition device only) has been tested and found to comply with the limits for medical
devices to IEC 60601-1-2: 2014 4th edition. These limits and test levels are intended to provide reasonable safety with regard to
electromagnetic disturbances when the device is used in a typical medical installation.