Appendix A: Emc Information - Apex Medical iCH Prime Instruction Manual

English
English
Guidance and Manufacturer's Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment specified below. The user of this device should
make sure it is used in such an environment.
Emissions Test
Harmonic emissions
IEC61000-3-2
Voltage fluctuations /
Flicker emissions
IEC61000-3-3
Guidance and Manufacturer's Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The
user of this device should make sure it is used in such an environment.
Immunity Test
Electrostatic
Discharge(ESD)
IEC61000-4-2
Electrical fast transient/
burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC61000-4-11
Power frequency
(50/60Hz) magnetic
field
IEC61000-4-8
NOTE: U is the a.c. mains voltage prior to the application of the test level
T

Appendix A: EMC Information

Compliance
Class A The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network.
Complies
IEC60601
test level
±6kV contact ±6kV contact
±8kV air ±8kV air
±2kV for power ±2kV for power
supply line supply line
±1kV for input/out ±1kV for input/out
line line
± 1 kV line(s) to ± 1 kV line(s) to
line(s) line(s)
± 2 kV line(s) to
earth
<5 % UT(>95 % <5 % UT(>95 %
dip in UT)for 0,5 dip in UT) for 0,5
cycle cycle
40 % UT(60 % dip 40 % UT(60 % dip
in UT)for 5 cycles in UT) for 5 cycles
70 % UT(30 % dip 70 % UT(30 % dip
in UT)for 25 in UT) for 25
cycles cycles
<5 % UT(>95 % <5 % UT(>95 %
dip in UT)for 5 sec dip in UT) for 5
sec
3 A/m 3 A/m
Electromagnetic Environment-Guidance
Compliance 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. If the user of
this device requires continued operation during
power mains interruptions, it is recommended that
the device be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
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