Acutus Medical Qubic Force, Техническое руководство

Страница: 7 / 52

5
Safety during Use
The following tests were performed according to IEC 60601-1-2: 2014:
Section of
IEC 60601-
1-2:2014
Test Test level
7.1 EN 55011 (CISPR 11)
Conducted
interference
emissions
• Group 1
• Class A
EN 55011 (CISPR 11)
Radiated emissions
8.9 IEC 61000-4-2
Electrostatic
discharge (ESD)
• ±8 kV contact discharge
• ±15 kV air discharge
8.9 / 8.10 IEC 61000-4-3
Electromagnetic
fields
• Modulation: 1 kHz
• 3 V/m, 80 MHz – 2.7 GHz
• Limits for RF communication
equipment per Table 9 in IEC
60601-1-2 (9-28 V/m)
8.9 IEC 61000-4-4
Transient conducted
surge voltages (EFT,
bursts)
• ± 2kV mains supply
• ± 1kV signal line
IEC 61000-4-5
Surge voltage waves
on supply lines
• ± 2 kV common mode
• ± 1 kV common mode
IEC 61000-4-6
Conducted
radio- frequency
interference
• Modulation: 1 kHz
• 3 V
• 6 V in ISM bands
IEC 61000-4-8
Power frequency
magnetic fields
• 30 A/m
• 50/60 Hz
IEC 61000-4-11
Voltage fluctuations
and interruptions in
supply voltage