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Operations & Maintenance Manual: Product Specications
0900-5165 REV-00
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
specied 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 specied in IEC 60601-1
and IEC 60601-2-18. Results of immunity testing show that the essential performance of the system is not
aected 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 specied below. The customer or the
user of the system should ensure that it is used in such an environment.
IMMUNITY TESTS IEC 60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT –
GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
In compliance
Floors should be wood, concrete, or
ceramic tile. If oors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
(Repetition
frequency 100
kHz)
± 2 kV for power
supply lines
± 1 kV for input/
output lines
In compliance
Mains power quality should be that
of a home healthcare or hospital
environment.
Surge transient
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
In compliance
Mains power quality should be that
of a home healthcare or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
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
In compliance
Mains power quality should be that
of a home healthcare or hospital
environment. If the user of the
system requires continued operation
during power mains interruptions, it
is recommended that the system be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m; 50/60 Hz In compliance
Power frequency magnetic elds
should be at levels characteristic of a
typical location in a home healthcare or
hospital environment.