Ameda Pearl Instrucciones De Uso página 26

TABLE 2
Guidance and declaration of manufacturer-electromagnetic immunity (For home healthcare environment)
The device is intended for use in the electromagnetic environment specified below. The customer or the user of
the device should assure that it is used in such an environment
IMMUNITY test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast
transients/bursts
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
26 | ENGLISH
IEC 60601 test level
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
±2 kV,
100kHz, for AC
power port
±0.5kV, ±1kV
(differential mode)
0% UT;
0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0% UT; 1 cycle and
70% UT;
25/30 cycles Single
phase: at 0°
0% UT; 250/300 cycle
30 A/m; 50Hz or 60Hz
Compliance level
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
±2 kV,
100kHz, for AC
power port
±0.5kV, ±1kV
(differential mode)
0% UT;
0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0% UT; 1 cycle and
70% UT;
25/30 cycles Single
phase: at 0°
0% UT; 250/300 cycle
30 A/m; 50Hz or 60Hz
Electromagnetic environment
-guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.