ED01_REV01-2021 IFU OB500_ENG
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15.
INFORMATION ON EMC ELECTROMAGNETIC COMPATIBILITY
The OB500 suction unit does not create interference for other medical devices performing clinical tests and treatments in the same
area. The unit does not need to be connected to other equipment for its operation and has an internal power supply.
15.1.
RISKS OF MUTUAL INTERFERENCE WITH OTHER DEVICES
Medical electrical equipment requires special precautions with regard to electromagnetic compatibility. For this reason, they must
be installed and/or operated in accordance with the information specified in the accompanying documents (in this case in the tables
below). Portable and mobile radio communication devices may affect the operation of the medical device. Electromedical equipment
and systems should not be used in close proximity to, adjacent to or on top of other electrical or radio communication equipment. If
such use is necessary and unavoidable, special precautions must be taken to ensure that the medical electrical device operates
correctly in its intended configuration (e.g. by constantly and visually checking for faults or failures). The following tables provide
electromagnetic compatibility (EMC) information relevant to this medical electrical unit. Full functionality of the unit is considered
an "essential service" for the purposes of electromagnetic immunity. The OB500 suction unit is a CISPR 11 Group 1 electromedical
unit and complies with Class B requirements.
15.2.
METHODS TO PREVENT ELECTROMAGNETIC INTERFERENCE
When there may be interference between the medical device and other electrical equipment in the vicinity, try to change the
operating position or remove the sources generating the interference (mobile phones, radio transceivers, mobile antennas). Try to
move to another location (if possible) or switch off all non-essential equipment in the vicinity (including electrical appliances) and
follow the instructions below.
15.3.
GUIDELINES AND MANUFACTURER'S DECLARATIONS - ELECTROMAGNETIC EMISSIONS
The OB500 vacuum unit is intended for use in the electromagnetic environment specified below. The customer or the operator of
the OB500 suction unit must ensure that it is used in such an environment.
Emission test
Limit
Guide - electromagnetic environment
Conducted emissions
CISPR 11, Group 1,
Class B
OB500 secretarial suction units (all variants) use RF
energy only for its internal function. Therefore, its RF
emissions are very low and are unlikely to cause any
interference in nearby electronic equipment.
Radiated emissions
CISPR 11, Group 1,
Class B
Harmonic current emission
IEC 61000-3-2, Class A
OB500 suction units (all variants) are connected
directly to the public low-voltage power supply
network that supplies buildings used for domestic
purposes. For domestic sanitary environments only.
Voltage fluctuations/flicker emission
IEC 61000-3-3
IEC 61000-3-3
15.4.
GUIDELINES AND MANUFACTURER'S DECLARATIONS - ELECTROMAGNETIC IMMUNITY
The OB500 vacuum unit is intended for use in the electromagnetic environment specified below. The customer or the operator of
the OB500 suction unit must ensure that it is used in such an environment.
Immunity tests
Compliance level
Guide - electromagnetic environment
Electrostatic discharges
(IEC 61000-4-2)
Discharge contact: ±8 kV contact
Air discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Floors should be made of wood, concrete or
ceramic tiles. If floors are covered with
synthetic material, the relative humidity
must be at least 30%.
Portable and mobile RF communications
equipment should not be used near any
part of the device, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
