Emc Details - Enraf Nonius EN-DYNAMIC Manuel D'utilisation

EMC details

Medical electrical devices such as the EN-Dynamic are subject to special precautions with
regard to electromagnetic compatibility (EMC) and must be installed and commissioned in
accordance with the EMC advice given in the instructions for use.
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Use of accessories, probes and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm to any part of the EN-Dynamic,
including cables specified by the manufacturer. Otherwise degradation of the performance of
this equipment could result.
The EN-Dynamic should only be operated with the original power cable specified in the list of
contents delivered. Operating the device with any other power cable can lead to increased
emissions or reduced interference immunity of the device.
Guidance and manufacturer's declaration – electromagnetic immunity
The EN-Dynamic is intended for use in the electromagnetic environment specified below. The customer or the user of the
EN-Dynamic should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic  6 kV contact
discharge (ESD)  8 kV air
IEC 61000-4-2
Electrical fast  2 kV for power
transient/burst supply lines
IEC 61000-4-4  1 kV for input/output
lines
Surge  1 kV line(s) to line(s)
IEC 61000-4-5  2 kV line(s) to earth
Voltage dips, short <5 % U
interruptions and (>95 % dip in U
voltage variations for 0.5 cycle
on power supply 40 % U
input lines (60 % dip in U
IEC 61000-4-11 for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 sec
Power frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
Compliance level
 6 kV contact
 8 kV air
 1 kV for power
supply lines
not applicable
 1 kV line(s) to line(s)
 2 kV line(s) to earth
< 5% U
T T
) for 0.5 cycle
T
< 5% U
T T
) for 1 cycle
T
70% U
T T
) for 25 cycles
T
< 5% U
T T
) for 5 sec.
T
3 A/m
Page 23 of 26
Electromagnetic environment
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a
typical computer room.
Mains power quality should be that of a
typical computer room.
Mains power quality should be that of a
typical computer room. If the user of the
EN-Dynamic requires continued operation
during power mains interruptions, it is
recommended that the EN-Dynamic be
powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical computer room.
EN109-1412791-48 IFU
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