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P073GUI001 - e-Celsius Medical Connect System User Manual.4 - EN
Guidelines and manufacturer's declaration of conformity regarding electromagnetic immunity
The e-Celsius® Medical System is intended for use in the magnetic and electromagnetic environment
described in the table below. The user and installer should ensure compliance with the electromagnetic
environment.
Immunity test Standards
Test level according
to IEC 60601
Level of compliance
Electromagnetic environ-
ment Remarks
Electrostatic
discharge (ESD)
EN 61000-4-2
±8kV to contact ±15kV
to air
±8kV to contact
±15kV to air
Professional health care facility
environment.
We were able to observe during
the indirect discharges
at +15KV at the level of the
power supply, a break on
the USB connector of this
one. This breakage does not
induce any degradation of the
essential performances and
the basic safety of the device
is not altered.
Rapid electrical tran-
sients in bursts
NF EN 61000-4-4
± 2 kV for power supply
lines
± 2 kV for power supply
lines
± 1 kV for signal ports
Environment of a professional
health care facility.
Shock waves NF EN 61000-4-5
± 1 kV in differential
mode
± 2 kV in common
mode
± 1 kV in differential
mode
± 2 kV in common mode
Environment of a professional
health care facility.
Magnetic eld at the
assigned industrial
frequency
NF EN 61000-4-8 30 A/m 30 A/m
Environment of a professional
health care facility.
Tension dips NF EN 61000-4-11
0% UT
for 0.5 cycles
A 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315
0% UT
for 1 cycle
and 70% UT
for 25 cycles at 50 Hz
For 30 cycles at 60 Hz
Single-phase: at
0
0% UT
for 0.5 cycles
A 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315
0% UT
for 1 cycle
and 70% UT
for 25 cycles at 50 Hz
For 30 cycles at 60 Hz
Single-phase: at 0
Environment of a professional
health care facility.
Voltage interruptions NF EN 61000-4-11
0% UT;
for 250 cycles at 50 Hz
for 300 cycles at 60 Hz
0% UT;
for 250 cycles at 50 Hz
for 300 cycles at 60 Hz
Environment of a professional
health care facility.
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