Vyaire PulmoLife Instrucciones De Uso página 15

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Pulmolife is intended for use in the electromagnetic environment specified
below. The customer or the user of the Pulmolife should assure that it is used
in such an environment.
Immunity
Test
Electrostatic
discharge
(ESD)
IEC 61000-4-
2
Electrical fast
transient/burst
IEC 61000-4-
4
Surge
IEC 61000-4-
5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-
8
English
IEC 60601
test level
Contact:
± 8 kV
Air:
±2 kV, ± 4
kV, ± 8 kV,
± 15 kV
± 2 kV
100 kHz
repetition
frequency for
power supply
lines
± 0,5 kV, ±
1 kV, ± 2 kV
0 % U ; 0,5
T
cycle
At 0°, 45°,
90°, 135°,
180°, 225°,
270° and
315°
0 % U ; 1
T
cycle
and
70 % U ;
T
25/30 cycles
Single phase:
at 0°
and
0 % U ;
T
250/300
cycle
30 A/m
50 & 60 Hz
Compliance
Level
Contact:
± 8 kV
Air:
±2 kV, ± 4
kV, ± 8 kV,
± 15 kV
Not
Applicable
Not
Applicable
Not
Applicable
30 A/m
50 & 60 Hz
Electromagnetic
Environment -
Guidance
Floors should be wood,
concrete or ceramic
tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the device
requires
continued operation
during power main
interruptions, it is
recommended that the
device be powered
from an uninterruptible
power supply or a
battery.
If incorrect operation
occurs, it may be
necessary to position
the device further
from sources of power
frequency magnetic
fields or to install
magnetic shielding.
The power frequency
magnetic field should
be measured in the
intended installation
location to assure that
11