Ameda Mya Joy - Page 25

27
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 IEC 60601 test
level
Compliance level Electromagnetic
environment
-guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 8 kV
contact
±2 kV,±4 kV,
±8 kV,
±15 kV air
± 8 kV
contact
±2 kV,±4 kV,
±8 kV,
±15 kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30 %.
Electrostatic

61000-4-4
± 2 kV ,
100kHz, for AC power
port
± 2 kV ,
100kHz, for AC power
port
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±0.5kV, ±1kV
(differential mode)
±0.5kV, ±1kV
(differential mode)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0 % UT;
0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225
, 270° and 315°
0 % UT; 1 cycle and
70 % UT;

phase: at 0°
0 % UT;

0 % UT;
0,5 cycle
At 0°, 45°, 90°,
°135°, 180°, 225°
, 270° and 315°
0 % UT; 1 cycle and
70 % UT;

phase: at 0°
0 % UT;

Mains power quality
should be that of a
typical commercial or
hospital environment.
Power frequency

magnetic field
IEC 61000-4-8
  Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical comme- rcial or
hospital environment.