Otivio FLOWOX 2.0 Manual De Uso página 69

Guidance and manufacturer's declaration – electromagnetic immunity
The Otivio AS FlowOx™ unit is intended for use in the electromagnetic environment below. The customer or the end user
of the FlowOx™ should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
61000-4-2
Electrical fast transient/burst
IEC61000-4-4
Surge
IEC 61000-4-5
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Rated power frequency magnetic field
IEC 61000-4-8
NOTE: Ut is the AC mains minimum and maximum rated input voltage
Guidance and manufacturer's declaration – electromagnetic emissions
The Otivio AS FlowOx™ unit is intended for use in the electromagnetic environment below. The customer or the end user
of the FlowOx™ should assure that it is used in such an environment.
Emissions tests
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC61000-3-3
FLOWOX™ 2,0 Patient IFU (610-00013) Rev 9
EMC SPECIFICATION
Compliance level
±8 kV contact
IEC
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
±2 kV for power supply lines
100 kHz repetition frequency
± 0,5 kV, ± 1 kV Line-to-line
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle
(250 periods for 50 Hz or 300 periods
for 60 Hz)
30 A/m
50 Hz or 60 Hz
Compliance
Group l
Class B
Class A
Complies
69
Electromagnetic environment
guidance
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
FlowOx™ requires continued
operation during power mains
interruptions, it is recommended that
the FlowOx™ be powered from an
uninterruptible power supply or a
battery.
Minimum distance between the The
Otivio AS FlowOx™ unit and sources of
power frequency magnetic field of at
least 15 cm
Electromagnetic environment
guidance
The FlowOx™ uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
The FlowOx™ is suitable for use in all
establishments, including domestic
establish- ments.
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