Guidelines And Manufacturer's Declaration - Electromagnetic Immunity For The Nebusteam Inhaler - Fahl NEBUSTEAM Mode D'emploi

12.0 INSTRUCTIONS WITH REGARD TO EMC
12.2 GUIDELINES AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY
FOR THE NEBUSTEAM
Der NEBUSTEAM INHALER is intended for operation in the electromagnetic environment specified below. The customer or user
®
of the NEBUSTEAM INHALER should ensure that the device is used in such an environment.
®
Electromagnetic
immunity tests
Electrostatic discharge
(ESD) as per IEC 61000-
4-2
Fast transient electric
disturbances/bursts as per
IEC 61000-4-4
Surge voltages as per IEC
61000-4-5
Voltage dips, short inter-
ruptions and variations of
the power supply voltage
as per IEC 61000-4-11
Magnetic field at the supply
frequency (50/60 Hz)
as per IEC 61000-4-8
NOTE U is the alternating mains power supply voltage before application of the test levels.
T
• Medical electrical devices are subject to special precautions with regard to EMC and must be installed in accordance with the
EMC instructions specified below.
• Portable and mobile HF communication equipment can influence medical electrical devices.
• The use of accessories, transducers or cables other than those specified can lead to increased emission or a reduced electro-
magnetic immunity of the device or system.
INHALER
®
IEC 60601- test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for power supply
lines
± 1 kV for input and output
lines
± 1 kV common mode
voltage
± 2 kV series mode voltage
< 5 % U
T
(> 95 % dip of U for
T
0.5 cycle)
40 % U
T
(60% dip of U for 5 cycles)
T
70 % U
T
(30% dip of U for 25 cy-
T
cles)
< 5 % U
T
(> 95 % dip of U for 5 s)
T
3 A/m
Accordance level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for power supply
lines
± 1 kV common mode
voltage
< 5 % U
T
(> 95 % dip of U for
T
0.5 cycle)
40 % U
T
(60% dip of U for 5 cycles)
T
70 % U
T
(30% dip of U for 25 cy-
T
cles)
< 5 % UT
(> 95 % dip of U for 5 s)
T
30 A/m
51
Electromagnetic environment -
guidelines
Floors should be made of wood or con-
crete or tiled with ceramic tiles. If the floor
is covered with synthetic material, the re-
lative air humidity must be at least 30 %.
The quality of the supply voltage should
be equivalent to that of a typical home or
hospital environment.
The quality of the supply voltage should
be equivalent to that of a typical home or
hospital environment.
The quality of the supply
should be equivalent to that of a typi-
cal home or hospital environment. If the
NEBUSTEAM INHALER user requires
®
continued functions even when the power
supply is interrupted, it is recommended
to power the NEBUSTEAM
from an uninterruptible power supply or a
battery.
Magnetic fields at the mains power sup-
ply frequency should be equivalent to the
typical values found in the business and
hospital environment.
EN
voltage
INHALER
®