10
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The CORE 500™ Digital Stethoscope is intended for use in the electromagnetic environment specified below. The user of the CORE 500™ Digital Stethoscope should ensure
that it is used in such an environment.
Immunity Test IEC 60601-1-2 Test
Level
Compliance
Level
Electromagnetic Environment –
Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
+/- 8 kV contact
+/- 15 kV
+/- 8 kV contact
+/- 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%.
Electrical Fast Transient/Burst
IEC 61000-4-4
± 2 kV
100 kHz repetition frequency
± 2 kV
100 kHz repetition frequency
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC 61000-4-5 +/- 1kV line(s) to line(s)
+/- 2 kV line(s) to earth
±1kV (0°, 90°, 180°, 270°) for AC Power Ports 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
Dips:
0 % of U
T
for 0,5 cycles
And phase angles of 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % of U
T
for 1 cycle
And phase angle of 0°
70 % of U
T
for 25/30 cycles and phase angle of 0°
Interruptions:
0 % of U
T
for 250/300 cycles
Dips:
0 % of U
T
for 0,5 cycles
And phase angles of 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % of U
T
for 1 cycle
And phase angle of 0°
70 % of U
T
for 25/30 cycles and phase angle of 0°
Interruptions:
0 % of U
T
for 250/300 cycles
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
(50/60 Hz)
magnetic field IEC 61000-4-8
30 A/m at 50Hz 30 A/m at 50Hz Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial magnetic field or
hospital environment.
NOTE 1: U
T
is the a.c. mains voltage prior to application of the test level.
NOTE 2: The device is nonfunctional during mains charging.