Performa
™
Professional Series
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EMC Details
Medical electrical devices such as the Performa
™
Professional Series
are subject to special precautions with regard to electromagnetic
compatibility (EMC) and must be installed and commissioned in
accordance with the EMC advice given in the instructions for use and
accompanying documents.
Portable and mobile RF communication systems (e.g. mobile phones)
may cause interference with the Performa
™
Professional Series.
The Performa
™
Professional Series should only be operated with the
original power cord specified in the list of contents delivered.
Operating the device with any other power cord can lead to
increased emissions or reduced interference immunity of the device.
Guidelines And Manufacturer’s Declaration – Electromagnetic Interference
The Performa
™
Professional Series device is intended for operation in an electromagnetic
environment as indicated below. The customer or user of the Performa
™
Professional Series
unit should ensure that it is operated in such an environment.
Interference Tests
Conformity
Electromagnetic Environment Guideline
RF emissions according
to CISPR 11
Group 1
The Performa
™
Professional Series
device uses RF energy solely for its
internal functioning. Its RF emission is
therefore very low and it is unlikely that
this will cause interference to
neighboring electronic Performa
™
Professional Series.
RF emissions according to
CISPR 11
Class A
The Performa
™
Combin8 Quattro device
is suitable for use in all establishments
other than domestic and those directly
connected to a low voltage power
supply network which supplies buildings
used for domestic purposes.
Harmonic emissions
according to IEC 61000-3-2
Class A
Voltage fluctuation emissions
and flicker according to IEC
61000-3-3
Conforms
The device should not be used when placed immediately next to
or stacked on top of other devices. If operation is necessary when
immediately next to or stacked on top of other devices, the device
should be monitored to ensure it is operating as intended in this
arrangement.
Guidance And Manufacturer’s Declaration – Electromagnetic Immunity
The Performa
™
Professional Series device is intended for use in the electromagnetic
environment specified below. The customer or the user of the Performa
™
Professional Series
device should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
to IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be
wood, concrete or
ceramic tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast tran-
sient / burst to IEC
61000-4-4
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 2 kV for power
supply lines
not applicable
Power Outlet quality
should be that of a
typical commercial or
hospital environment.
EMC Table