Directives and manufacturer‘s declaration - Electromagnetic immunity
The EliteVue instrument is intended for use in the electromagnetic environment specified below.
The custo-
mer or user of the EliteVue should ensure that it is used in such an environment.
Immunity testing
IEC 60601 test
level
Compliance
Electromagnetic environment -
Instructions
Electrostatic
discharge (ESD)
IEC 61000-4-2
Con: ± 8 kV
Air: ± 2,4,8,15 kV
Con: ± 8 kV
Air: ± 2,4,8,15 kV
Floors should be wood, concrete or
ceramic tile.
If the floor is covered with synthetic
material, the relative humidity must be
at least 30%.
Fast transient elec-
trical disturbances/
bursts
IEC 61000-4-4
5/50 ns, 100 kHz,
±2 kV
Not applicable
The quality of the supply voltage should
be that of a typical business or hospital
environment.
Surge voltage
IEC 61000-4-5
±0.5 kV voltage
Phase-to-phase
conductor
±2 kV voltage
Line-to-earth
±0.5 kV voltage
outer conductor
outer conductor
±2 kV voltage outer
conductor ground
Not applicable
The quality of the
supply voltage should be that of a typical
business or hospital environment.
IEC 61000-4-11
Voltage dips, short-
term interruptions
and
fluctuations in
the supply voltage
pursuant to
IEC61000-4-11
<
0% UT 0.5 period
at 0.45, 90, 135, 180,
225, 270 and 315
degrees
0% UT 1 period
and 70% UT 25/30
periods
Single phase: at 0
degrees (50/60 Hz)
Not applicable
The quality of the supply voltage should
be that of a typical business or hospital
environment.
Magnetic field with
efficiency-rated
frequencies IEC
61000-4-8
30A/m
50/60 Hz
30A/m
50/60 Hz
Mains frequency magnetic fields should
be at a level characteristic of a typical
location in a typical commercial hospital
environment.
NOTE UT is the AC source. Mains voltage before the application of the test level.
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