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EMC information
The device satisfies the EMC requirements of the international standard IEC
60601-1-2.The requirements are satisfied under the conditions described in the
table below.The device is an electrical medical product and is subject to special
precautionary measures with regard to EMC which must be published in the
instructions for use.Portable and mobile HF communications equipment can
affect the device.Use of the unit in conjunction with non-approved accessories
can affect the device negatively and alter the electromagnetic compatibility.
The device should not be used directly adjacent to or between other electrical
equipment.
Table 1
Guidance and manufacturers
declaration - electromagnetic emission
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.
Emissions test
Compliance
RF emission
Group 1,
CISPR 11
RF emission
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage fluctuations/ flicker
Not applicable
emissions IEC 61000-3-3
62
Electromagnetic environment -guidance
The device uses RF energy only for its
internal function. Therefore, its emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.
The device is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Table 2
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
IEC 60601 test
IMMUNITY test
level
Electrostatic
± 8 kV contact
discharge (ESD)
±2 kV,±4 kV, ±8 kV,
±15 kV air
IEC 61000-4-2
± 2 kV for power
supply lines
Electrostatic
100 kHz repetition
transient/burst
frequency
IEC 61000-4-4
± 1 kV for input/
output lines
± 0.5 kV ± 1 kV
Surge IEC 61000-
differential mode
4-5
line-line
0%UT
(100 % dip in UT)
for 0.5 cycle at
0(。), 45(。) 90(。),
135(。),180(。),
225(。), 270(。).and.
Voltage dips,
315(。)
short interruptions
0%UT
and voltage
(100 % dip in UT)
variations on
for 1 cycle at 0(。)
power supply
70%UT
in-put lines IEC
(30 % dip in UT)
61000-4-11
for 25/30 cycles at
0(。)
0%UT
(100 % dip in UT)
for 250/300 cycles at
0(。)
Power frequency
(50/60 Hz)
30 A/m; 50Hz
magnetic field IEC
61000-4-8
NOTE: UT is the a. c. mains voltage prior to application of the test level.
Compliance
Electromagnetic
level
environment -guidance
Floors should be wood,
concrete or ceramic tile.
± 8 kV contact
If floors are covered with
±2 kV,±4 kV, ±8
synthetic material, the
kV, ±15 kV air
relative humidity should be
at least 30%.
N/A
N/A
N/A
N/A
N/A
N/A
Power frequency magnetic
fields should be at levels
characteristic of a typical
30 A/m; 50Hz
location in a typical
commercial or hospital
environment.
ES
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