KCI V.A.C.Via v.a.c.therapy Negative Pressure Wound Therapy System, Инструкция по эксплуатации

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18
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The V .A.C.Via
™
Therapy Unit is intended for use in an electromagnetic environment specified below. The customer or user of the V .A.C.Via
™
should
assure that 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
150K - 80 MHz
3 v/m
80 MHz - 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the V
.A.C.Via ™ Therapy Unit,
including cables, than the recommended separation distance
calculated from the equation application to the frequency of
the transmitter.
Recommended Separation Distance
d = (1.17) x sqrt(p)
d = (1.17) x sqrt(p) 80 MHz to 800 MHz
d = (2.34) x sqrt(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 manufacturer and is
the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey (see note a) should be less than the
compliance level in each frequency range (see note b).
Interference may occur in the vicinity of equipment marked with
the following symbol:
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.
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 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 [ME EQUIPMENT OR ME
SYSTEM] is used exceeds the applicable RF compliance level above, the V
.A.C.Via
™
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 V .A.C.Via
™
Therapy Unit.
b) Over the frequency range 150kHz to 80 MHz,, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the V.A.C.Via™ Therapy
Unit
The V .A.C.Via ™ Therapy Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of theV .A.C.Via
™
can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the V .A.C.Via
™
Therapy Unit as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.17 x sqrt (p)
80 MHz to 800 MHz
d=1.17 x sqrt (p)
800 MHz to 2.5 GHz
d=2.34 x sqrt (p)
0.01 0.1 0.1 0.2
0.1 0.4 0.4 0.7
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 11.7 11.7 23.4
For transmitters rated at a maximum output power not listed above, the recommended separate distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1, At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2, These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from surfaces, objects
and people.
Accessories, transducers, and cables other than those specified, with the exception of transducers and
cables sold by the manufacturer of the medical electrical equipment as replacement parts for internal
components, may result in increased emissions or decreased immunity of the medical equipment and
model or part number.
The V
.A.C.Via ™ Therapy Unit should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, the V .A.C.Via
™
Therapy Unit should be observed to verify
normal operation in the configuration in which it will be used.