SAEVO EVUS 8, Руководство пользователя

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Appendix B EMC Guidance and
Manufacturer’s Declaration
The EUT is classified as Group 1, Class A medical equipment according to CISPR 11.
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of
the EQUIPMENT should assure that it is used in such an environment.
The ultrasound system is suitable for use in a professional health care environment, not including areas where
there are sensitive equipment or sources of intense electromagnetic disturbances, such as the RF shielded
room of an imaging system magnetic resonance imaging, operating rooms near active AF surgical equipment,
electrophysiology laboratories, armored rooms or areas where short wave therapy equipment is used.
!
●
Do not use the system around strong electric filed, electromagnetic filed (e.g. MRI scan room) and mobile
wireless communication devices. Using the device in an improper environment may cause malfunction or
damage.
●
The compliance with EMC and EMI regulation can not be guaranteed by the use of modified cables or those
which do not comply with the same standards under what the equipment was validated.
●
The system must not be used adjacent or supported by other equipment. The recommendations of this manual
must be followed.
●
Do not use accessories, transducers, internal parts of components and other cables other than those previously
specified by the manufacturer. This may result in increased emission or decreased electromagnetic immunity
and 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 ultrasound system, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
● To maintain basic safety in relation to electromagnetic disturbances during the expected service life, always use
the system in the specified electromagnetic environment and follow the maintenance recommendation described
in this manual.
The following tables provide information on compliance of the equipment according to the standard EN 60601-1-
2:2015.
Emissions Test Compliance Electromagnetic Environment and Guidance
RF emissions
CISPR 11 Group 1 The equipment 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.
RF emissions
CISPR 11 Class A The equipment 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.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies