MEDIANA
HEART
ON
AED A16
Automated External Defibrillator
57
57
Table 7. Electromagnetic Immunity (IEC60601-1-2) (continued)
Immunity
Test
IEC60601
test level
Compliance
Level
Electromagnetic
environment guidance
The AED is intended for use in the electromagnetic environment specified below. The
customer or the user of the AED should assure that it is used in such an environment.
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.7 GHz
(80 % AM at 1 kHz)
According to
IEC60601-1-2:2014
10V/m, 20 V/m
80 MHz to 2.5 GHz
(80 % AM at 1 kHz)
(According to
IEC60601-2-
4:2010)
10 V/m
10V/m, 20V/m
Potable and mobile RF
communications equipment
should be used no closer to any
part of the AED including cables,
than the recommended separation
distance calculated from the
equation appropriate to the
frequency of the transmitter.
Recommend separation
distance
d
= 0.4 √
P
80 MHz to 800 MHz
d
= 0.7 √
P
800 MHz to 2.5 GHz
d
= 0.2 √
P
80 MHz to 800 MHz
d
= 0.4 √
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
d
is
the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters as deter-mined 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: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: 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 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 AED is used exceeds the applicable RF compliance level
above, the AED should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the
AED.
b
Over the frequency range 80 MHz to 2.5 GHz, field strengths should be less than 10 V/m
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the AED. (IEC60601-1-2)
Note: According to the revised IEC60601-1-2:2014, there is no distinction between
Life-Supporting device and not Life-Supporting device; all device shall ensure
basic safety and essential performance.
