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EMV-Herstellererklärung ·
Dichiarazione CEM del fabbricante · CEM – Déclaration du fabricant
Medical electrical equipment such as the SonoOne are subject to special precautions with regard to EMC (electromagnetic compatibility) and must be installed
and commissioned in accordance with the EMC information contained in the user manual or the accompanying documents.
Portable and mobile RF communications equipment (e.g. mobile phones) can affect electrical medical equipment.
SonoOne may only be operated with the original parts specified in the list of parts and accessories included within the scope of delivery. The operation of the
device with other parts may result in increased emissions or in the device's decreased interference immunity.
Guidelines and Manufacturer's Declaration - Electromagnetic Emissions
The SonoOne device is intended for use in the electromagnetic environment specified below. The customer or the user of the SonoOne must
ensure that it is operated in such an environment.
Emissions measurements
RF emissions in accordance with CISPR 11
RF emissions in accordance with CISPR 11
Emissions of harmonics in accordance with IEC
61000-3-2
Emissions of voltage fluctuations /
flickers in accordance with IEC 61000-3-3
Table 201 according to EN 60601-1-2: 2006-10
The device must not be used in direct proximity to or stacked directly on top of another similar device. If operation near to or stacked on top of another device is
unavoidable, the device should be monitored to verify its proper operation within this setup.
Guidelines and manufacturer's declaration - electromagnetic immunity
The SonoOne device is intended for use in an electromagnetic environment, as specified below. The customer or the user of the SonoOne device should
ensure that it is used in such an environment.
Immunity tests
Electrostatic discharge (ESD) in
accordance with IEC 61000-4-2
Electrical fast transient / burst in
accordance with IEC 61000-4-4
Surges in accordance with IEC
6100-4-5
Voltage dips, short-term interruptions
and voltage variations in accordance
with
Magnetic field of the supply frequency
(50/60 Hz) in accordance with IEC
61000-4-8
Note: UT is the mains AC voltage before application of the test level
Manufacturer's EMC Declaration
Compliance
Group 1
Class A
Category A
Compliant
IEC 60601 - Test Level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
± 1 kV for input and output
cables
± 1 kVdifferential mode
± 2 kVcommon mode
< 5% UT
(> 95% dip in UTfor ½ period)
40% UT
(60% dip in UTfor 5 periods)
70% UT
(30% dip in UTfor 25 periods)
< 5% UT
(> 95% dip in UTfor 5
seconds)
3 A/m
Compliance level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for mains cables
Not applicable
± 1 kVdifferential mode
± 2 kVcommon mode
< 5% UT
(> 95% dip in UT for ½ period)
40% UT
(60% dip in UT for 5 periods)
70% UT
(30% dip in UT for 25 periods)
< 5% UT
(> 95% dip in UT for 5
seconds)
3 A/m
Electromagnetic environment - guidelines
The SonoOne device uses RF energy solely for its
internal functioning. It RF emission is therefore
very low and it is unlikely that this will cause
interference to neighbouring electronic Rehab-series
The SonoOne device is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Electromagnetic environment - Guidelines
Floors should be made from wood, concrete or
ceramic tiles. If floors are covered with synthetic
material, the relative humidity must be at least 30%.
The supply voltage quality must correspond to that
of a typical commercial or hospital environment.
Not applicable The supply voltage quality must
correspond to that of a typical commercial or
hospital environment.
The supply voltage quality must correspond to that
of a typical commercial or hospital environment.
If the user of the SonoOne requires continued
operation, even in the case of interruptions in the
power supply, it is recommended that the SonoOne-
be powered from an uninterruptible power supply
or a battery.
Magnetic fields at mains frequency should have
the typical values found in a business or hospital
environment.
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