Saadat Dena 650, User Manual

Page: 92 / 101

Appendix 3: Electromagnetic compliance (EMC)
81
Guidance and manufacturer's declaration – electromagnetic immunity
The DENA 650 electrocardiograph is intended for use in the electromagnetic environment specified below.
The customer or the user of the DENA 650 electrocardiograph should assures that it is used in such an
environment.
Immunity test Port Compliance level
Electromagnetic
environment –
guidance
Conducted RF IEC 61000-4-6
Input a.c. power 3 V
0,15 MHz – 80 MHz
6 V
in ISM bands between 0,15 and 80
MHz
80 % AM at 1 kHz
Electrocardiograph
coupling
Signal input/output
parts
Radiated RF IEC 61000-4-3 ENCLOSURE 3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Proximity fields from RF
wireless communications
equipment IEC 61000-4-3
ENCLOSURE
Refer to the following table (table 9
of EN 60601-1-2: 2015)
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test
frequency
(MHz)
) a
d n a B
(MHz)
) a
Service
) b
lation du Mo
Max
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
385 380-
390
TETRA
400
) b
tion a odul m ulse P
18 Hz
1.8
0.3
27
450 430-
470
GMRS
460, FRS 460
FM C)
±5 KHz deviation
1 KHz sine
2 0.3
28
710
704-
787
LTE Band
13, 17
) b
tion a odul m ulse P
217 Hz
0.2 0.3
9
745
780
810
800-
960
GSM800/900, TETRA
800, iDEN 820,
CDMA850, LTE
Band 5
) b
tion a odul m ulse P
18 Hz
2 0.3
28
870
930
1720 1700-
1990
GSM
1800; CDMA
1900; GSM
1900; DECT; LTE
Band
1, 3, 4 25; UMTS
) b
tion a odul m ulse P
217 Hz
2 0.3
28
1845
1970