Electromagnetic Compatibility - DTF medical PURENEB CLASSIC AEROLIGHT Gebrauchsanweisung

Essential performance features: Supplies pressure to convert drugs into an aerosol.
Applied part: Mouth piece or mask.
NOTE: The CE compliance certificate and the technical specifications can be provided upon request.
Identification:
Each compressor has a batch identification that indicates the year of manufacture.
Each accessory is also identified by a given batch number. For more information, refer to the user instructions
for the nebulizer.
Electromedical units require special precautions with regard to EMC and must be set up and turned on in
accordance with the EMC information provided in this manual.
WARNING: Avoid using this unit near to or stacked on other units as this may cause a malfunction. If such use
is necessary, this unit and the other units should be monitored to make sure they are operating normally.
WARNING: Using accessories, transducers and cables other than the ones specified or supplied by the
manufacturer of this unit may cause an increase in electromagnetic emissions or a decrease in the immunity
of this unit and cause improper operation.
WARNING: Portable RF communication units (including peripherals such as aerial cables and external aerials)
should not be used within 30 cm (12 inches) of any part of the AEROLIGHT, including cables specified by the
manufacturer. Otherwise, performance of these units may be impaired.
WARNING: If the unit malfunctions due to electromagnetic interferences, the performance of the unit may be
impaired and this may result in delayed patient care.
Wireless communication units such as wireless home networking devices, mobile phones, cordless phones
and their bases, and walkie-talkies can affect the unit. Keep them at least 0.5 m away from the unit.
Harmonic emissions (IEC 61000-3-2)
Voltage fluctuations/Flicker (IEC 61000-3-3)
Immunity testing
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Electrical Fast Transient/Burst
(IEC 61000-4-4)
Transient overvoltage
(IEC 61000-4-5)
Voltage dips, brief outages and
voltage variations on power supply
input lines
(IEC 61000-4-11)
Voltage outages
(IEC 61000-4-11)
Magnetic field at the frequency of
the electricity grid (50/60 Hz)
(IEC 61000-4-8)
RF interference
(IEC 61000-4-3)

11. Electromagnetic compatibility

Guidelines and manufacturer's declaration – electromagnetic emissions
Emission test
RF emissions (CISPR 11)
RF emissions (CISPR 11)
Guidelines and manufacturer's declaration – Electromagnetic immunity
Test level (IEC 60601-1-2)
± 8 kV through direct contact
± 15kV in the air
± 2kV for electrical power lines
± 1kV for input/output lines
± 1kV phase-to-phase
± 2kV phase-to-earth
0% U
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
and 70% U
Single phase: at 0°
0% UT: 250/300 cycles
80MHz to 2.7GHz
385 MHz at 27 V/m
450MHz at 28V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930MHz at 28V/m
1720, 1845, 1970MHz at 28V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m
; 0.5 cycle
T
315°
0% U ; 1 cycle
T
; 25/30 cycles
T
30A/m
10 V/m
22
Compliance
Group 1
Class B
Class A
Compliant
Compliance Level
± 8kV
± 15kV
± 2kV
± 1kV
± 1kV phase-to-phase
± 2kV phase-to-earth
0% U ; 0.5 cycle
T
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0% U ; 1 cycle
T
and 70% U ; 25/30 cycles
T
Single phase: at 0°
0% UT: 250/300 cycles
30A/m
10 V/m
80MHz to 2.7GHz
385 MHz at 27 V/m
450MHz at 28V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930MHz at 28V/m
1720, 1845, 1970MHz at 28V/m
2450 MHz at 28 V/m
5240, 5500, 5785 MHz at 9 V/m