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Verfügbare Sprachen
Verfügbare Sprachen
To meet the EMC (electromagnetic compatibility) requirements and prevent any dangerous situations, the IEC60601-1-2 standard was implemented. The standard
defines the device resistance to electromagnetic interference and the maximum electromagnetic emissions level for medical devices. This device conforms to the
IEC60601-1-2 standard for resistance and emission level.
Guidelines and declarations concerning electromagnetic emissions
This device is intended for use in the below-mentioned electromagnetic environment.
The user should use the device solely in that environment.
Emissivity testing
Radio frequency emissions CISPR 11
Radio frequency emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flickering IEC 61000-3-3
Guidelines and declarations concerning electromagnetic immunity
This device is intended for use in the below-mentioned electromagnetic environment.
The user should use the device solely in that environment.
Immunity testing
IEC 60601 test level
Static discharge (ESD)
±8 kV by touch,
IEC 61000-4-2
±2 kV, ±4 kV, ±8 kV, ±15
kV by air,
Transient state and
±2 kV for feeders, ±1 kV for
pulses IEC 61000-4-4
output / input lines
Discharge IEC
±0.5 ±1 kV between the lines
61000-4-5
±0.5 kV ±1 kV ±2 kV line to
the base
Voltage drops, short
<5% UT (>95% UT voltage drop)
breaks and changes of
for one half of the cycle
the supply voltage in
feeders IEC 61000-
<5% UT (>95% UT voltage drop)
4-11
for one cycle
70% UT (30% UT voltage drop)
for 25 cycles
<5% UT (>95% UT voltage drop)
for 5/6 seconds
Conformity
Electromagnetic environment — guidelines
Group 1
The nebulizer generates radio frequency energy solely as a result of its internal
functions. RF emission is negligible and there is little probability that it will cause
any interference with any electronic devices near the device.
B class
The nebulizer may be used in all facilities, including residential premises and premises
connected directly to the LV grid providing power to residential premises.
A class
Conforming
Conformity level
±8 kV by touch,
±2 kV, ±4 kV, ±8 kV, ±15
kV by air,
±2 kV for feeders
±0.5 ±1 kV between the lines
<5% UT (>95% UT voltage drop)
for one half of the cycle
<5% UT (>95% UT voltage drop)
for one cycle
70% UT (30% UT voltage drop)
for 25 cycles
<5% UT (>95% UT voltage drop)
for 5/6 seconds
Electromagnetic environment — guidelines
The floor should be made from wood, concrete or covered with
ceramic tiles. If the floor is covered with a synthetic material,
relative humidity should be at least 30%.
The quality of the service line should correspond to the level of the
standard commercial or hospital environment.
The quality of the service line should correspond to the level of the
standard commercial or hospital environment.
The quality of the service line should correspond to the level of the
standard commercial or hospital environment. If continuous power
supply is required for any power outage from the service line, it is
recommended that an UPS or battery is used.
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