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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
Содержание Dena 650
Страница 1: ...User Manual Dena Electrocardiograph DENA 650 Linux AADAT Co D00912 7...
Страница 3: ......
Страница 11: ......
Страница 12: ...Chapter 1 Introduction 1 1 Introduction...
Страница 25: ...Chapter 1 Introduction 14...
Страница 26: ...Chapter 2 System settings 15 2 System settings...
Страница 38: ...Chapter 3 Patient information 27 3 Patient information...
Страница 41: ...Chapter 3 Patient information 30...
Страница 42: ...Chapter 4 Patient preparation 31 4 Patient preparation...
Страница 47: ...Chapter 4 Patient preparation 36 Lead Placement Diagram Figure 4 4 Lead placement digram...
Страница 48: ...Chapter 5 Recording Operation 37 5 Recording Operation...
Страница 52: ...Chapter 6 ECG analysis and measurement 41 6 ECG analysis and measurement...
Страница 58: ...Chapter 7 Data management 47 7 Data management...
Страница 64: ...Chapter 8 Care and Cleaning 53 8 Care and Cleaning...
Страница 71: ...Chapter 8 Care and Cleaning 60...
Страница 72: ...Chapter 9 Troubleshooting and Error messages 61 9 Troubleshooting and Error messages...
Страница 77: ...Chapter 9 Troubleshooting and Error messages 66...
Страница 78: ...Chapter 10 Technical specification 67 10 Technical specification...
Страница 81: ...Chapter 10 Technical specification 70...
Страница 82: ...Appendix 1 Accessories 71 Appendix 1 Accessories...
Страница 84: ...Appendix 2 System parameters 73 Appendix 2 system parameters...
Страница 87: ...Appendix 2 System parameters 76...
Страница 88: ...Appendix 3 Electromagnetic compliance EMC 77 Appendix 3 Electro magnetic compliance...
Страница 93: ...Appendix 3 Electromagnetic compliance EMC 82...
Страница 94: ...Appendix 4 The GLASGOW program 83 Appendix 4 The GLASGOW program...
Страница 101: ......