Cardinal Health ALLY TO GO NPWT Patient User Manual page 32

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Immunity test IEC 60601 test level
Conducted RF 3Vrms
IEC 61000-4-6 150kHz to 80MHz outside
ISM bands
10Vrms
150kHz to 80MHz
in ISM bands
Radiated RF 10V/m
IEC 61000-4-3 80MHz to 2.5GHz
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 structures, objects and people.
a The ISM (industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz; 13.553MHz to 13.567MHz; 26.957MHz to 27.283 MHz;
and 40.66MHz to 40.70MHz.
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range 80MHz to 2.5GHz are intended to decrease the likelihood
b
that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
c
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 ALLY TO GO™ is used exceeds the applicable RF
compliance level above, the ALLY TO GO™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the ALLY TO GO™.
Over the frequency range 150kHz to 80MHz, field strengths should be less than [V
d
The ALLY TO GO™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the ALLY TO GO™ should assure that it is used in such an environment.
Compliance level
[V ] 3V
1
a
a
[E ] 3 V/m
1
Electromagnetic environment –
guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
ALLY TO GO™, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 3.5 P
V
1
d = 12 P
V
2
d = 12 P
E
1
d = 23 P
E
1
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
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
c
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
] V/m.
1
80MHz to 800MHz
800MHz to 2.5GHz
b
d
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