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Electromagnetic Compatibility
The system is designed to be in compliance with IEC 60601-1-2, which contains electromagnetic
compatibility (EMC) requirements for medical electrical equipment. The limits for emissions and immunity
specified in this standard are designed to provide reasonable protection against harmful interference in a
typical medical installation.
The system complies with the applicable essential performance requirements specified in IEC 60601-1
and IEC 60601-2-18. Results of immunity testing show that the essential performance of the system is not
affected under the test conditions described in the following tables.
Electromagnetic immunity
Table 12.
Guidance and Manufacturer's Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should ensure that it is used in such an environment.
IMMUNITY TESTS
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
(Repetition
frequency 100
kHz)
Surge transient
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Operations & Maintenance Manual: Product Specifications
IEC 60601 TEST LEVEL
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips:
0% during 0.5 cycle
0% during 1 cycle
40% during 10/12 cycles
at 50/60 Hz
70% during 25/30 cycles
at 50/60 Hz
Voltage interruptions:
0% during 250/300 cycles
at 50/60 Hz
30 A/m; 50/60 Hz
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT –
LEVEL
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
In compliance
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that
In compliance
of a home healthcare or hospital
environment.
Mains power quality should be that
In compliance
of a home healthcare or hospital
environment.
Mains power quality should be that
of a home healthcare or hospital
environment. If the user of the
system requires continued operation
In compliance
during power mains interruptions, it
is recommended that the system be
powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields
should be at levels characteristic of a
In compliance
typical location in a home healthcare or
hospital environment.
GUIDANCE
33
0900-5165 REV-00
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