
19
Manufacturer standards and declaration - Electromagnetic Immunity - Equipment which doesn’t give
SUPPORT FOR LIFE [IEC 60601-1-2 / 2007 – subcl. 6.8
Therapy Plus is designated to be used in electromagnetic environment specified below. Therapy Plus’ customer or user shall
ensure it will be used in such environment.
Immunity test
ABNT NBR IEC
60601 test level
Compliance
level
Electromagnetic Environment - Standard
RF Conducted
IEC 61000-4-6
RF Radiated
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communication equipment can’t
be used close to any part of Therapy Plus, including ca-
bles, recommending a safe distance calculated from
equation applicable to transmitter frequency.
Recommended distance:
D = 10.10 m
D = 10.10 m
(80 MHz to 800 MHz)
D = 20.20 m
800 MHz to 2.5 GHz
Where P is maximum nominal transmitter output power in
watts (W), according to the transmitter manufacturer and
D is the distance recommended in meters (m).
It’s recommended the intensity of the field established by
RF transmitter, as determined by an electromagnetic in-
spection on site
a
, be lower than compliance level of each
frequency range
b
.
It may clash the equipment marked with the symbol:
Note 1:
In 80 MHz and 800 MHz, the highest frequency range is applied.
Note 2:
These standards can’t be applied at all situations. Electromagnetic propagation is affected by absorption and
reflection of structures, objects and people.
a
Field intensities established by fixed transmitters, such as base radio stations, telephone (mobile/wireless) and terrestrial
trunked radio, amateur radios, AM and FM radio transmission and TV transmitters can’t be predicted theoretically and
precisely. To evaluate electromagnetic environment due to fixed RF transmitters, an electromagnetic inspection on site is
recommended. If measurement of field intensity on site where Therapy Plus is used surpasses the compliance level used
above, Therapy Plus should be inspected to check whether operation is normal. If an abnormal performance is checked,
additional procedures can be required, such as Therapy Plus reorientation or replacement.
b
If the frequency range is higher than from 150 kHz up to 80 MHz, the field intensity should be lower than 3 V/m.
Table 3: Information regarding compliance to the requirements for electromagnetic immunity for
equipment which doesn’t aim LIFE-SUPPORT based on Table 204 – 60601-1-2, 2007.
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