Magnamed Fleximag, Руководство по эксплуатации

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MAGNAMED TECNOLOGIA MÉDICA S/A
11.17.1 Manufacturer declaration
– Electromagnetics emissions
The system is intended for use in an electromagnetic environment specified below and therefore, it is
recommended that the client or user of the system ensures that it is used in such an environment.
Emission Test Compatibility Directive for Electromagnetic Environment
RF Emissions
ABNT NBR IEC CISPR 11 Group 1 The system uses RF energy only for its internal functions.
However, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF Emissions
ABNT NBR IEC CISPR 11 Class B The system can emit electromagnetic energy to perform its
functions intended. electronic equipment nearby may be
affected. It is suitable for use in all establishments including
domestic establishments and those
directly connected to the public power grid
low voltage
Harmonics emissions
IEC 61000-3-2 Class A
Emissions due to voltage fluctuation
/ flicker
IEC 61000-3-3 Compliant
11.17.2 Manufacturer declaration
– Electromagnetic immunity
The system is intended for use in an electromagnetic environment specified below and therefore, it is
recommended that the client or user of the system ensures that it is used in such an environment.
Immunity Test
Test level IEC 60601-
1-2,
Compliance Policy to electromagnetic environment
IEC 61000-4-2 -
Electrostatic discharge
(ESD) ± 6 kV by contact
± 8 kV by air
± 6 kV by contact
± 8 kV by air
Floors should be wood, concrete or ceramic.
If floors are covered with synthetic material,
the relative humidity should be at least 30%
IEC 61000-4-4
–
Electrical fast transient /
pulse train (“Burst”)
± 2 kV on supply lines
±1 kV the input / output
lines ± 2 kV on supply lines
±1 kV the input / output
lines Quality power supply should be that of a
typical commercial or hospital environment.
IEC 61000-4-5 -
Outbreaks
± 1 kV lines(s) to
lines(s)
±2 kV lines(s) to earth ± 1 kV lines(s) to
lines(s)
±2 kV lines(s) to earth Quality power supply should be that of a
typical commercial or hospital environment.
IEC 61000-4-11
–
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
< 5% U
T
(> 95% of voltage
drop in U
T
) for 0,5 cycle
40% U
T
(60% of voltage
drop in U
T
) for 5 cycles
70% U
T
(30% of voltage
drop in U
T
) for 25 cycles
< 5% U
T
(> 95% of voltage
drop in U
T
) for 5 seconds.
< 5% U
T
(> 95% of voltage
drop in U
T
) for 0,5 cycle
40% U
T
(60% of voltage
drop in U
T
) for 5 cycles
70% U
T
(30% of voltage
drop in U
T
) for 25 cycles
< 5% U
T
(> 95% of voltage
drop in U
T
) for 5 seconds.
Quality power supply should be that of a
typical commercial or hospital environment.
Magnetic field of power
frequency (50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m Magnetic fields in the frequency of the supply
should be at levels characteristic of a typical
location in a typical commercial or hospital
environment
Note: U
T
is the voltage a.c. before application of the test level.