Guidelines And Manufacturer's Declaration; Nebufirst ® Inhaler - Fahl NEBUFIRST Mode D'emploi

12.0 INSTRUCTIONS WITH REGARD TO EMC
EN
The NEBUFIRST
®
with other devices. If the device has to be operated close to or stacked with other devices, the device should be observed in
order to verify its proper use when used in this arrangement.
12.2 GUIDELINES AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY
FOR THE NEBUFIRST
Der NEBUFIRST
®
of the NEBUFIRST
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
INHALER must not be used in an arrangement where it is placed directly next to other devices or stacked
INHALER
®
INHALER is intended for operation in the electromagnetic environment specified below. The customer or user
INHALER should ensure that the device is used in such an environment.
®
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
T
0.5 cycle)
40 % U
T
(60 % dip of U for 5 cy-
T
cles)
70 % U
T
(30 % dip of U for 25 cy-
T
cles)
< 5 % U
T
(> 95 % dip of U
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
for (> 95 % dip of U
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
T
for 5 s)
30 A/m
42
Electromagnetic environment -
guidelines
Floors should be made of wood or
concrete or tiled with ceramic tiles. If the
floor is covered with synthetic material,
the relative 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 voltage should
for be equivalent to that of a typical home or
hospital environment. If the
NEBUFIRST INHALER user requires
®
continued functions even when the
power supply is interrupted, it is recom-
mended to power the NEBUFIRST
INHALER from an uninterruptible power
supply or a battery.
for 5 s)
Magnetic fields at the mains power sup-
ply frequency should be equivalent to the
typical values found in the business and
hospital environment.
®