Guidance And Manufacturer's Declaration - Electromagnetic Immunity - OxyGo NEXT Manual Del Usuario

Guidance and Manufacturer's Declaration - Electromagnetic Immunity:

The Concentrator is intended for use in the electromagnetic environment specified below. The user of the
Concentrator should make sure it is used in such an environment.
Immunity Test IEC 60601
Test Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz
to 80 MHz
6Vrms at various
bands per standard
Radiated RF 10V/m
IEC 61000-4-3 80 MHz
to 6.0 GHz
Electrostatic ± 8 kV contact
discharge (ESD)
IEC 61000-4-2 ± 15 kV air
Electrical fast ± 2 kV for power
transient/burst supply lines
EC 61000-4-4 ± 1 kV for input/
output lines
Surge ± 1 kV line(s) to line(s)
IEC 61000-4-5 ± 2 kV line(s) to earth
Voltage 0% U
dips, short 0 °, 45 °, 90 °, 135 °,
interruptions 180 °, 225 °, 270 °, and
and voltage 315 °.
variations on
power supply 0% U
input lines
70% U
IEC 61000-4-11
0% U
cycle
Power 30 A/m
frequency
(50/60 Hz)
magnetic
field
IEC 61000-4-8
25
Compliance
Level
3 Vrms
6Vrms at various
bands per standard
10V/m
± 8 kV contact
± 15 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
for 0.5 cycle at 0% U
T
0 °, 45 °, 90 °, 135 °,
180 °, 225 °, 270 °, and
315 °.
for 1 cycle 0% U
T
for 25/30 cycle 70% U
T
for 200/300 0% U
T
cycle
30 A/m
Electromagnetic
Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d=1.2√P 150 kHz to 80 MHz
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency rangeb.
As a condition observed to ensure compliance
with current FCC RF exposure guidelines,
maintain at least 6 cm separation distance
between the antenna and the user's body at all
times.
Interference may occur in the vicinity of
equipment marked with the following symbol:
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. Inbed 6cm
distance info somewhere
for 0.5 cycle at Mains power quality should be that of a typical
T
commercial or hospital environment. If the user
of the [ME EQUIPMENT or ME SYSTEM] requires
continued operation during power mains
interruptions, it is recommended that the
for 1 cycle [ME EQUIPMENT or ME SYSTEM] be powered
T
from an uninterrupted power supply or a battery.
for 25/30 cycle
T
for 200/300
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical hospital or home environment.