Inova Labs Activox DUO2 - Manual (Page 31)

29
EMC INFORMATION
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided in the accompanying tables.
The Activox DUO2™ Stationary Base is intended for use in the electromagnetic
environment specified below. The customer or end user of the model
130-
001 should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity and
Emissions
Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level 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%.
+/- 2, 4, 8 kV
Air Direct
+/- 2, 4, 8 kV
Contact Direct
+/- 2, 4, 8 kV
Contact Indirect
+/- 2, 4, 8 kV
Air Direct
+/- 2, 4, 8 kV
Contact Direct
+/- 2, 4, 8 kV
Contact Indirect
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
3 A/m 3 A/m
Power Frequency
(50/60Hz)
Magnetic Field
IEC 61000-4-8
Mains power quality
should be that of a typical
commercial or hospital
environment.
+/-2 kV for
power
supply lines
+/-2 kV for
power
supply lines
Electrical Fast
Transient/Burst
IEC 61000-4-4
Mains power quality
should be that of a typical
commercial or hospital
environment.
± 0.5 kV, ± 1
kV differential
mode
± 0.5 kV, ± 1 kV,
± 2 kV common
mode
± 0.5 kV, ± 1 kV
differential mode
± 0.5 kV, ± 1 kV,
± 2 kV common
mode
Surge
IEC 61000-4-5
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of the
model REF 130-002 requires
continued operation during
power mains interruptions,
it is recommended that
the oxygen concentrator
be powered from an
uninterrupted power supply
or battery.
< 5% U
T
(>95% dip in U
T
)
for 0.5 cycle
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 seconds
< 5% U
T
(>95% dip in U
T
)
for 0.5 cycle
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 seconds
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11