Instructions for use DIAGNOcam 2170 U
9 Information concerning the electromagnetic compatibility according to EN IEC 60601-1-2 | 9.3 Immunity to elec-
tromagnetic interference
34 / 38
Interference im-
munity tests
EN 60601 test level Compliance level
Electromagnetic environment
- Guidelines
Wire-based HF inter-
ference according to
EN 61000-4-6
Wireless HF interfer-
ence according to EN
61000-4-3
3 V
eff
150 kHz to 80 MHz
outside the ISM
bands
a
3 V/m
80 MHz to 2.5 GHz
3 V
eff
3 V/m
Handheld and mobile wireless
devices should not be used at a
shorter distance from the DIA-
GNOcam 2170 U including cables
than the recommended safe
clearance calculated using the
appropriate equation for the
emission frequency.
Recommended safe distance:
d = 1.17
P
d= 1.17
P
for 80 MHz to 800
MHz
d= 2.33
P
for 800 MHz to 2.5
GHz
where P is the maximal nominal
power of the transmitter in watts
(W) as specified by the transmit-
ter manufacturer and d is the re-
commended safe clearance in
metres (m).
b
The field strength of stationary
wireless radio transmitters as
measured locally
c
should be
lower than the conformance level
at all frequencies.
d
Interference is possible in the vi-
cinity of devices bearing the fol-
lowing icon.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not be applicable in every case. The propagation
of electromagnetic waves is subject to absorption and reflection by buildings,
objects, and people.
a
The ISM frequency bands (for industrial, scientific, and medical applications)
between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz, and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80
MHz and in the frequency range from 80 MHz to 2.5 GHz are intended to re-
duce the probability of mobile/handheld communications facilities causing inter-
ference when they are inadvertently introduced into the patient area. For this
reason, the additional factor of 10/3 is applied in the calculation of the recom-
mended safe clearances in these ranges of frequencies.
c
The field strength of stationary transmitters, such as, e.g. base stations of mo-
bile phones and mobile terrestrial radio devices, amateur radio stations, AM and
FM radio and television transmitters, cannot be determined exactly based on
theoretical considerations. A site study should be considered to determine the
electromagnetic environment in terms of stationary transmitters. If the meas-
ured field strength at the site, at which the DIAGNOcam 2170 U is used, ex-
ceeds the compliance levels shown above, the DIAGNOcam 2170 U should be
monitored to demonstrate proper function. If any uncommon performance
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