This equipment generates, uses and can radiate radio frequency (RF) energy. This equipment may cause electromagnetic interference if
it is not installed and used in accordance with the manual.This device has been tested for Medical Products in accordance with
EN-60601-1-2:2015 and has been determined to comply with acceptable limits. These limits indicate that the device provides an acceptab-
le level of protection against electromagnetic interference (EMC) if the device is used as specified in the manual.This device may be
affected by portable and mobile RF communication devices. This equipment must not be stored together with other equipment.See the
following tables for more information about this device and EMC.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
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
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
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
ELECTROMAGNETIC COMPATIBILITY (EMC) DECLARATION
Emission test
Compliance
Electromagnetic environment – guidance
Emissions RF
CISPR 11
Group 1
The device uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic
equipment.
Emissions RF
CISPR 11
Class B
The device is suitable for use in all establishments including domestic and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
used fordomestic purposes.
IEC 61000-3-2
Class A
Voltage fluctuations/
flickeremissions
IEC 61000-3-3
Complies
Immunity test
IEC 60601 Testlevel
Electromagnetic environment – guidance
Electrostatic
discharges
IEC 61000-4-2
± 8 kV contact
±2 kV, ±4 kV,
±8 kV,±15 kV air
± 8 kV contact
±2 kV, ±4 kV,
±8 kV,±15 kV air
Compliancelevel
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30
Conduced RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
150kHz to
80MHz:
3Vrms
6 Vrms (in
ISM and amateur
radio bands)
80% Am at 1kHz
10V/m
80% Am at 1kHz
150kHz to
80MHz:
3Vrms
6 Vrms (in
ISM and amateur
radio bands)
80% Am at 1kHz
10V/m
80% Am at 1kHz
Portable and mobile RF communications equipmentshould be used no
closer to any part ofthe device including cables, than the
recommendedseparation distance calculated from theequation applicable
to the frequency the transmitter.Recommended separation distance:
d= 0.35√
d= 1.2√ 80 MHz ile 800 MHz
d= 1.2√ 800 MHz ile 2.7 GHz
d= 2.3√
Where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended
separation distance in metres (m). Field strengths from fixed RF
transmitters, asdetermined by an electromagnetic site survey, should be
less than the compliance level in each frequency range.Interference may
occur in the vicinity of equipment marked with the following symbol:
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Not: UT is the a.c. mains voltage prior to application of the test level.
30
A
/m
50Hz/60Hz
30
A
/m
50Hz/60Hz
Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital
environment.
Electrical fast
transient/burst
IEC 61000-4-4
Power supplylines: ±2 kV
Input/output lines:±1 kV
100 kHz repetitionfrequency
Power supplylines: ±2 kV
Input/output lines:±1 kV
100 kHz repetitionfrequency
Mains power quality should be that of a typical commercial or hospital
environment.
Surges
Line-to-line
IEC 61000-4-5
± 0,5 kV, ± 1 kV
± 0,5 kV, ± 1 kV
Surges
Line-to-ground
IEC 61000-4-5
± 0,5 kV, ± 1 kV,
± 2 kV
± 0,5 kV, ± 1 kV,
± 2 kV
Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
0% UT;0.5 cycle
0º, 45 º, 90 º, 135 º,
180 º,225 º, 270 º and 315 º
0% UT;0.5 cycle
0º, 45 º, 90 º, 135 º,
180 º,225 º, 270 º and 315 º
0% UT; 1 cycle and 70%
UT;25/30 cycle
Single phase: 0º
0% UT; 1 cycle and 70%
UT;25/30 cycle
Single phase: 0º
0% UT;250/300 cycle
0% UT;250/300 cycle
Mains power quality should be that of a typical commercial or hospital
environment.
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Summary of Contents for UN300 A
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