Zephyr MATRx Plus, Инструкция по эксплуатации

Страница: 18 / 21

18
Essential Performance
The prevention of excessive mandibular motion is considered Essential Performance of the MATRx plus
device� Excessive mandibular motion is mitigated by design�
EMC Standards and Testing
TABLE 1: EMC TEST LIMITS
Manufacturer Declaration for Emissions
Phenomenon Basic EMC Standard Immunity Test Level
Electrostatic Discharge IEC 61000-4-2 +/-8kV contact, +/ 2,4,6,8, 15kV air
Radiated RF EM fields IEC 61000-4-3 10V/m, 80MHz-2.7GHz, 80% AM at 1kHz
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
As per Clause 8.10 of IEC 60601-1-2, see Table 2:
Proximity Field Parameters
EFT/Bursts IEC 61000-4-4 +/-2kV, AC mains, +/-1kV, I/O ports
Surges Line-Line IEC 61000-4-5 ± 0.5 kV, ±1 kV
Surges Line-Ground IEC 61000-4-5 ± 0.5 kV, ±1 kV, ±2 kV
Rated power frequency magnetic fields IEC 61000-4-8 30A/m, 50 and 60Hz
Conducted disturbances
induced by RF fields
IEC 61000-4-6 6V in ISM + Amateur bands, 3V (0.1580MHz)
Voltage Dips IEC 61000-4-11
0 % UT; 0.5 cycle, @ 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
Voltage Interruptions IEC 61000-4-11 Interrupt >95% drop, 5s
Radiated Disturbance
FCC 47 CFR Part 15, Subpart
B, CISPR 11, Group 1, Class B
Conducted Disturbance CISPR 11, Group 1, Class B
RF Emissions
IEC 61000-3-2 Harmonics,
IEC 61000-3-3 Flicker