Seca ct330 - Manufacturers Declaration Regarding EMC

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5 Appendix
5
Instructions for Use
Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9
5.3 Manufacturer’s declaration regarding EMC
Electromagnetic compatibility according to DIN EN 60601-1-2:2022-01
Cable lengths of the patient leads and the USB cables
Patient leads:
gray: approx. 1050 mm (R, L, N, F), approx. 700 mm (C1 - C6)
Manufacturer's declaration
– electromagnetic emissions
Emission measurements
EMC standard / test method
Compliance
RF emissions
CISPR11
Group 1
RF emissions
CISPR11
Class B
Harmonics
IEC 61000-3-2
Not applicable
Voltage fluctuations/flickers
IEC 61000-3-3
Not applicable
Manufacturer’s declaration
– electromagnetic immunity
seca ct330/331 meets the test levels specified here.
Phenomenon
EMC standard / test method
IMMUNITY TEST LEVEL
Static electricity discharge (ESD)
IEC 61000
-4-2
± 8 kV contact discharge
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radio
-frequency electromagnetic fields
IEC 61000
-4-3
10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
Radiofrequency electromagnetic fields in the in the
immediate vicinity of wireless communication devices
IEC 61000
-4-3
Conforms to the standard, for the
immunity test level refer to the table on
the next page
Quick transient electric interference factors / bursts
IEC 61000
-4-4
± 2 kV
100 kHz Repetition frequency
Surges line against line
IEC 61000
-4-5
± 0.5 kV, ± 1 kV
Surges line against earth
IEC 61000-4-5
± 0.5 kV, ± 1 kV, ± 2 kV
Conducted disturbances, induced by high
-frequency
fields
IEC 61000
-4-6
3 V
0.15 MHz to 80 MHz
6 V in ISM frequency bands
between 0.15 MHz and 80 MHz
1)
80 % AM at 1 kHz
Power frequency magnetic fields
IEC 61000
-4-8
30 A/m
50 Hz
Voltage drops
IEC 61000-4-11
Not applicable
Voltage interruptions
IEC 61000-4-11
Not applicable
Magnetic fields in close proximity
IEC 61000-4-39
Not applicable
1) The ISM bands (EN: Industrial, Scientific and Medical, i.e., frequency bands used for industrial, scientific and medical
purposes) between 0.15 MHz and 80 MHz are 6.765 to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 MHz to 4
0.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz;
3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz
to 18.17 MHz; 21 MHz to 21.4 MHz; 24.89 MHz to 24.99 MHz; 2
8 MHz to 29.7 MHz and 50 MHz to 54.0 MHz.