EKOM invent DK50 DI, User Manual

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ELECTROMAGNETIC COMPATIBILITY DECLARATION
NP-DK50 DI-15_08-2020 29
Guidance and manufacturer's declaration - electromagnetic immunity
Pursuant to IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
The equipment is intended for use in the electromagnetic environment specified below. The customer or the
user of the equipment should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air ±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply
lines
±1 kV for
input/output lines ±2 kV
100 kHz repetition
frequency
Applied to mains
connection
Mains power quality should be
that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode ±1 kV L-N
±2 kV L-PE; N-PE
Applied to mains
connection
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
short interruption,
and voltage
variations on
power
supply
input lines IEC
60601-4-11 U
T
=0%, 0,5 cycle
(at 0, 45, 90, 135,
180, 225, 270 and
315°)
U
T
=0%, 1 cycle
U
T
=70% 25/30
cycles (at 0°)
U
T
=0%, 250/300
cycles
U
T
=>95%, 0,5 cycle
(at 0, 45, 90, 135, 180,
225, 270 and 315°)
U
T
=>95%, 1 cycle
U
T
=70% (30% dipp U
T
),
25(50Hz)/30(60Hz)
cycles (at 0°)
U
T
=>95%,
250(50Hz)/300(60Hz)
cycle
Mains power quality should be
that of a typical commercial or hospital
environment.
The device stops and restarts
automatically at each dip. In this case
does not occur unacceptable pressure
drop.
Power frequency
(50/60 Hz)
IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment
NOTE: U
T
is the A.C. mains voltage prior to application of the test level.