10 Electromagnetic Compatibility (EMC) DIN EN 60601-1-2
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201000401000 / Rev 04
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ECG system is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer
or user to ensure that the ECG system is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance
Level
Conducted RF to
EN 61000-4-6
Radiated RF to
EN 61000-4-3
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.7 GHz
3 V
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the ECG system, including cables, than
the recommended separation distance calcu-
lated from the equation applicable to the fre-
quency of the transmitter.
Recommended separation distance:
d = 1.2 √P
d = 1.2 √P for 80 MHz to 800 MHz d = 2.3 √P
for 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the 1-channel transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation dis-
tance in meters (m).
Field strengths from fixed RF transmitters, as
determined 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 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 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
ECG system is used exceeds the applicable RF compliance level above, the ECG system should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ECG system.
(b) Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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