Smarty Saver Plus - Page 41

SEMI-AUTOMATIC
41
Immunity test
Test level
IEC/EN 60601-1
Compliance level
Electromagnetic environment
Guidelines
Supply frequency
(magnetic field)
50/60 Hz
IEC 61000-4-8
3 A/m
80 A/m
Power frequency magnetic fields must be at levels
that do not exceed those of stations located in
typical heavy industry applications, power plants
and command rooms of high-voltage substations.
Note: U
T
is the alternating network current before the application of the test level
Conducted RF
3 Vrms
Not applicable
IEC 61000-4-6
from 150 kHz to 80 MHz
outside the ISM
a
bands
10 Vrms
from 150 kHz to 80 MHz
inside the ISM
a
bands
Not applicable
Radiated RF
IEC 61000-4-3
10 V/m
from 80 MHz to 2.5 GHz
10 V/m
The distance between portable and mobile RF
communication devices in use and any part of the AED,
including cables, must never be shorter than the
recommended separation distance calculated based on
the equation that applies to the transmitter's
frequency.
Recommended separation distance
Pd 2.1=
from 80 MHz to 800 MHz
Pd 3.2=
from 800 MHZ to 2.5 GHz
where P is the maximum output power of the
transmitter in watt (W) in accordance with the data
of the transmitter’s manufacturer and is the
recommended distance in metres (m)
b
.
The field strengths of fixed radiofrequency
transmitters, as determined by an investigation in
electromagnetic sites
c
, should be lower than the
compliance level in all frequency ranges
d
.
Interference may occur near devices marked with
this symbol.
NOTE 1
The higher frequency interval applies at 80 MHz and 800 MHz
NOTE 1
These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflected from
structures, objects and people
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; from 13.553 MHz
to 13.567 MHz; from 26.957 MHz to 27.283 MHz; and from 40.66 to 40.70 MHz.
b
The compliance levels in the ISM bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are there to reduce
the possibility of interference in case the portable and mobile communication devices are accidentally placed near the area
where the patient is. For this reason, an additional factor of 10/3 is added to the calculation of the recommended separation
distance for transmitters whose frequencies fall within these intervals.
c
It is not possible to predict with precision on a theoretical level the field strength of fixed transmitters, such as base stations for
radiotelephones (mobile/cordless telephones) and wireless phones, amateur radios, AM and FM transmitters, and TVs. In order
to assess the electromagnetic environment with fixed RF transmitters, please take into account the possibility of performing an
electromagnetic analysis of the site. If the field strength measured at the site where the AED is used exceeds the specific RF
compliance level as per above, it will be necessary to keep an eye on the AED, to check that it is working properly. If operating
anomalies are observed, it may be necessary to adopt corrective actions, for example by moving or turning the AED.
d
Other than the frequency interval between 150 kHz and 80 MHz, the field strengths must be lower than 1 V/m.