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electromagnetic immunity from this equipment and result in improper operation.
•
Portable RF communication equipment (including peripherals such as antenna cables
and external antennas) shall not be used within 30 cm of any part of the Fleximag Max,
including cables specified by Magnamed. Failure to do so may cause performance
degradation.
•
If essential performance is requested or degraded due to electromagnetic disturbances,
the ventilator may stop ventilating. In this case, the operator shall provide manual
ventilation.
10.24.1 Guidelines and manufacturer's declaration -
Electromagnetic emissions
The Fleximag Max is intended for use in the electromagnetic environment specified below. It is recommended
that the customer or user of Fleximag Max ensure that it is used in such an environment.
Emissions Testing
Compliance
Electromagnetic environment - guidelines
RF emissions
CISPR 11
Group 1
Fleximag Max uses RF energy only for its internal functions.
Therefore, RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
The Fleximag Max 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 for domestic purposes, as long as the following
warning is respected:
Warning: This equipment / system is intended for use by
healthcare professionals only. This equipment / system may
cause radio interference or may impair the operation of
nearby equipment. It may be necessary to take measures
such as reorienting or relocating the Fleximag Max or
shielding the site.
Harmonic emissions
IEC 61000-3-2
Class A
EF voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
10.24.2 Guidelines and manufacturer's declaration -
Electromagnetic immunity
The Fleximag Max is intended for use in the electromagnetic environment specified below. It is recommended
that the purchaser or user of Fleximag Max ensure that it is used in such an environment.
Immunity Test
IEC-60601 Test Level
Level of Compliance
Electromagnetic environment - guidelines
IEC
61000-4-2
-
Electrostatic discharge
(ESD)
± 8 kV per contact
± 15 kV through the air
± 8 kV per contact
± 15 kV through the air
Floors should be made of wood, concrete or
ceramic. If the floors are covered with
synthetic material, the relative humidity should
be at least 30%.
