24
s
Regulatory Statements
11.1 Electromagnetic Compatibility
The Hailie
™
sensor does not perform any clinical
function where loss or degradation would result in
unacceptable risk.
Emissions / Immunity Test
and Standard
Compliance Level
Conducted and Radiated
EMICISPR 11
Group 1 Class B
Electrostatic Discharge
IEC 61000-4-2
± 8 kV contact,
± 2/4/8/15 kV air
Radiated RF EM Fields
IEC 61000-4-3
10 V/m: 80 - 2700 MHz
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
9 V/m: 710, 745, 780,
5240, 5500, 5785 MHz
27 V/m: 385 MHz
28 V/m: 450, 810,
870, 930, 1720, 1845,
1970, 2450 MHz
Power frequency
magnetic fields
IEC 61000-4-8
30 A/m
Voltage dips and
Interruptions
IEC 61000-4-11
0 % UT : 0.5 cycle
0 % UT : 1 cycle
70 % UT : 25/30
cycles
0 % UT : 250/300
cycles