OT Bioelettronica Sessantaquattro+ User Manual page 44

Portable bioelectrical signal amplifier
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Manufacturer's declaration and guidelines – electromagnetic immunity – casing door
Phenomenon
Electrostatic discharges
Radiated RF EM fields
Radiated RF EM fields and
proximity wireless fields
Electrical fast transient and bursts
Surges
Conducted disturbances induced by
RF fields
Voltage variation and dips
Rated power-frequency magnetic
fields
a)
The tests at 15 kV weren't exceeded, the device stops functioning and enters an unknown state.
TAB. 11.2: Tests carried out and passed for compliance with current regulations on electromagnetic immunity.
EMC reference standard or
test method
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
IEC 61000-4-11
IEC 61000-4-8
44
Sessantaquattro+ User Manual v.2.0 – March 2023
Immunity test levels -
Professional healthcare environment
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV in air
3 V/m 80 MHz – 2.7 GHz 80% AM a 1 kHz
28 V/m 450 MHz, 810 MHz - 2.45 GHz at
217 Hz
27 V/m 385 MHz at 18 Hz
9 V/m 710 MHz – 780 MHz, 5.24 GHz –
5.785 GHz at 217 Hz
+/- 2 kV at 100 kHz on power supply
+/- 1 kV at 5 kHz on power supply
500 V and 1 kV line to line
500 V, 1 kV and 2 kV line to ground
3 V RMS outside ISM band 80% AM at 1 kHz
6 V RMS in ISM band 80% AM at 1 kHz
V supply: 100 V AC, 240 V AC and 230 V AC
with DIP pattern: 0V – 10ms; 0V – 20ms;
0.7 Un – 500ms; 0V – 5s
Testing on power supply
30 A/m - 50 Hz
a)

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