smartheart 01-508 Manual De Instrucciones página 29

ELECTROMAGNETIC COMPATIBILITY
Guidance and manufacture's declaration - electromagnetic immunity
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
IEC 61000-4-2
Electrical fast transient/
burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interuptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2
For all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level
±8 kV contact
±15 kV air
power supply lines: ±2 kV
input/output lines: ±1 kV
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV 100
kHz repetition frequency
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 ; 300 cycle
30 A/m
50Hz/60Hz
Compliance level
±8 kV contact Floors should be wood, oncrete or ceramic
±15kV air tile. If floors are covered with synthetic
material, the relative humidity should be
at least 30%.
power supply lines: Mains power quality should be that of a
±2 kV typical commercial or hospital environment.
line(s) to line(s): ±1 kV Mains power quality should be that of a
100 kHz repetition typical commercial or hospital environment.
frequency
Mains power quality should be
0% UT ; 0.5 cycle
At 0°, 45°, 90°, 135°, that of a typical commercial or
180°,225°,270° and hospital environment.
315°
0% UT ; 1 cycle
and
70% UT ; 25/30 cycles
Single phase: at 0°
0% UT ;300 cycle
30 A/m Power frequency magnetic fields should
50Hz/60Hz be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Electromagnetic environment
guidance
ENGLISH • 29