3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Page 27
Appendix A
Guidance and manufacturer’s declaration – electromagnetic immunity
The Oxygen Assist Module is intended for use in the electromagnetic environment specified below. The customer or the
user of the Oxygen Assist Module should assure that it is used in such an environment.
IMMUNITY test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2, 4, 8, and 15 kV air
± 8 kV
± 2, 4, 8, and 15 kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
10 second wait time between discharges.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
100 kHz repetition rate
± 2 kV
± 1 kV
100 kHz repetition rate
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0.5, 1 and 2 kV Line(s) to
Ground
± 1 kV line(s) to Line(s)
± 0.5, 1, and 2 kV
± 1 kV
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 %
U
t
(>95 % dip in
U
t
)
for 0,5 cycle at phase angle
0°, 45°, 90°, 135°, 180°, 225°,
270°, and 315°
40 %
U
t
(60 % dip in
U
t
) for 5 cycles
70 %
U
t
(30 % dip in
U
t
) for 25 cycles
<5 %
U
t
(>95 % dip in
U
t
) for 5 s
Per Standard
Mains power quality should be that of a
typical commercial or hospital
environment.
If the user of the Oxygen Assist
Module requires continued operation
during power mains interruptions, it is
recommended that the Oxygen Assist
Module be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic
field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should
be
at levels characteristic of a typical
location
in a typical commercial or hospital
environment.
NOTE
U
t
is the a.c. mains voltage prior to application of the test level.
