FHIT TEC_FHIT_M Rev.1 11/2016
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6. POTENZIALE ELETTROMAGNETICO
The device is biult in observance of CEI EN 60601-1-2 (Electromedical device, collateral standard: Electromagnetic compatibility) and has
an immunity and emission degree that not create warning interferences with device with the same standard. ATTENTION: It could happen
interferences with electrical device that not have the immunity and emission not compliant to the CEI EN 60601 -1 -2 standard; in that
case do not use the device at the same time of LABAT MED device; if the device is in a impasse situation caused from this interferences,
switch off the device and switched on again.
With sudden change in voltage presence, it is possible that the micro-motor has a timely velocity decrease that not compromise the device
security and performance, the event duration is limitated at the sudden change in voltage duration.
Guide and manufacturer declaration
– electromagnetic emissions
The device was developed to operate in an electromagnetic environment as specified below. Device
buyer or user must guarantee that it is used in this environment.
Emission test
Conformity
Electromagnetic environment - guide
RF Emission
CISPR 11
Group 1
The device uses
RF power only for it’s
internal use. Its RF emission are low and not
do interference with other electric devices in
its proximity
RF Emission
CISPR 11
Class B
The device is suitable for the use in all the
environment, including at home and in those
directly connected to low voltage public
electricity supply such as the one provded to
households.
Armonic emission
IEC 61000-3-2
Class A
Potential difference/flicker flutuation
emission
IEC 61000-3-3
Compliant
Guide and manufacturer declaration
– electromagnetic immunity
The device has to operate in the electromagnetic einvironment below specified. Devie customer or user
must guarantee that the device is used in this environment.
Immunity test
Test level IEC 60601
Conformity level
Electromagnetic
einvironment - guide
Electrostatic charge
(ESD)
IEC 61000-4-2
Contact ± 6kV
In air ± 8kV
± 6kV
± 8kV
The floor must be wood,
concrete or ceramic tile. If
the floors are artificial
material, relaticity umidity
must be at least 30%.
± 2kV for mains supply
± 1Kv for enter/exit line
± 2 kV
±1 kV
Main supply tension must be
same as the commercial or
hospital environment
Overvoltage
(Surge)
IEC 61000-4-5
± 1kV between the
phase
± 2kV between phase
and ground
± 1kV
± 2kV
Main supply tension must be
same as the commercial or
hospital environment
Sudden change in
tension, brief
interruption and
tension change on the
mains supply enter
line.
<5 % U
T
(>95% hole U
T
for 0.5
cycle)
<5% U
T
0.5 cycle (10mS)
40% U
T
5 cycle (100 mS)
Main supply tension must be
same as the commercial or
hospital environment.
If the device user require a
uninterrupted employment
during the mains supply
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