Guidance And Manufacturer's Declaration - Electromagnetic Emissions - Mectron Piezosurgery Flex Gebrauchs- Und Wartungsanleitung

8.1 Electromagnetic Compatibility IEC/EN 60601-1-2
WARNING: Contraindications.
Interference with other devices. The
PIEZOSURGERY® flex device complies with
the standard IEC 60601-1-2. However, it may
interfere with other devices in its vicinity.
Install PIEZOSURGERY® flex at safety distance
from life-support systems. If adjacent or
stacked use of the device is necessary,
normal operation of the equipment and
PIEZOSURGERY® flex, in the configuration
in which they will be used, should be verified
prior their use.
WARNING: Portable and mobile radio
communication devices may influence the
correct functioning of the device.
8.1.1 Guidance and Manufacturer's Declaration - Electromagnetic
Emissions
PIEZOSURGERY® flex is intended for use in the electromagnetic environment specified
below. The customer or user of PIEZOSURGERY® flex should ensure that it is used in such an
environment.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
TECHNICAL SPECIFICATIoNS
WARNING: Contraindications.
Interference from other devices. An
electro-surgical knife or other electro-
surgical units placed in the vicinity of the
PIEZOSURGERY® flex device may interfere
with its correct functioning.
WARNING: The device requires specific
EMC precautions and must be installed
and commissioned according to the EMC
information provided in this chapter.
WARNING: The use of cables and
accessories not supplied by Mectron might
negatively affect the EMC performances.
Compliance Electromagnetic Environment Guidance
PIEZOSURGERY® flex only uses RF energy
for internal function. Therefore, its FR
Group 1 emissions are very low and are not likely
to cause any interference with nearby
electronic equipment.
Class B
PIEZOSURGERY® flex is suitable for use
in all establishments, including domestic
Class A establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
Compliant
for domestic purposes.
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