Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic environ-
ment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humidi-
ty 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 for power
supply lines
±1 kV for input/
output lines
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Surge IEC
61000-4-5
±1 kV differen-
tial mode
±2 kV common
mode
±1 kV differen-
tial mode
±2 kV common
mode
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<5 % U
T
(>95
% dip in UT) for
0.5 cycle
40 % U
T
(60 %
dip in UT) for 5
cycles
70 % U
T
(30 %
dip in UT) for
25 cycles
<5 % U
T
(>95
% dip in UT) for
5 sec.
<5 % U
T
(>95
% dip in UT) for
0.5 cycle
40 % U
T
(60 %
dip in UT) for 5
cycles
70 % U
T
(30 %
dip in UT) for
25 cycles
<5 % U
T
(>95
% dip in UT) for
5 sec.
Mains power quality should
be that of a typical commer-
cial or hospital environment.
If the user of the device
requires continued operation
during power mains inter-
ruptions, it is recommended
that the device is powered
from an uninterruptible
power supply or a battery.
Power frequen-
cy (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commer-
cial or hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
EN-54 EN-55
English
English
Technical informationTechnical information
E E
7. Disposal
8. Electromagnetic compatibility (EMC)
Technical equipment and batteries do not belong in house-
hold waste. They must be disposed of at appropriate collec-
tion and disposal points.
The unit is an electrical medical product and is subject to special pre-
cautionary measures with regard to EMC which must be published in
the instructions for use.
Portable and mobile HF communications equipment can affect the unit.
Use of the unit in conjunction with non-approved accessories can af-
fect the unit negatively and alter the electromagnetic compatibility.
The unit should not be used directly adjacent to or between other elec-
trical equipment.
The unit satisfies the EMC requirements of the international standard
IEC60601-1-2. The requirements are satisfied under the conditions de-
scribed in the tables below.
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