Opera FLO Instructions Manual page 15

Declaration – electromagnetic emissions and immunity –
for EQUIPMENT and SYSTEMS that are use in the professional healthcare facility
environment or in the home healthcare environment
The Air Pump declaration – electromagnetic immunity
The Air Pump system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Air Pump system should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Conducted RF 3 Vrms ; 6 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m ; 10V/m
IEC 61000-4-3 80 MHz – 2.7 GHz
80%
27 V/m 385 MHz
Proximity fields
28 V/m 450 MHz
from RF wireless
9 V/m 710 MHz
Communications
745 MHz
equipment
780 MHz
IEC 61000-4-3
28 V/m 810 MHz
870 MHz
930 MHz
28 V/m 1720 MHz 28 V/m
1845 MHz
1970 MHz
28 V/m 2450 MHz 28 V/m
9 V/m 5240 MHz 9 V/m
5500 MHz
5785 MHz
The Air Pump system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Air Pump system should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic
±8 kV contact
discharge (ESD)
±2 kV , ±4 kV , ±8 kV , ±15 kV
IEC 61000-4-2
air
Electrical fast ±2 kV for power supply lines
transient/burst ±1 kV for input/output lines
IEC 61000-4-4
Surge ±0.5 kV
IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode
Voltage dips, 0 % ; 0 , 5 cycle
U
T
o o o
short At 0 , 45 , 90
o o
interruptions and 225 , 270 and 315
voltage 0 % ; 1 cycle
U
T
variations on and
power supply 70 % ; 25/30 cycle
U
T
input lines Single phase: at 0
IEC 61000-4-11
Power frequency
(50/60 Hz)
30 A/m
magnetic field
IEC 61000-4-8
Compliance level
3 Vrms ; 6 Vrms
Portable and mobile RF communications equipment should be
150 kHz to 80 MHz
used no closer to any part of the EQUIPMENT or SYSTEM
3 V/m ; 10V/m
including cables, than the recommended separation distance
80 MHz – 2.7 GHz
calculated from the equation applicable to the frequency of the
80%
transmitter.
27 V/m 385 MHz
Interference may occur in the vicinity of equipment marked
28 V/m 450 MHz
with the following symbol.
9 V/m 710 MHz
745 MHz
780 MHz
28 V/m 810 MHz
870 MHz
930 MHz
1720 MHz
1845 MHz
1970 MHz
2450 MHz
5240 MHz
5500 MHz
5785 MHz
Declaration – electromagnetic immunity
Compliance level
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV
air
±2 kV for power supply lines
±0.5 kV
±1 kV differential mode
±2 kV common mode
0 % ; 0 , 5 cycle
U
T
o o o o o
, 135 , 180 , At 0 , 45 , 90 , 135
o o o
225 , 270 and 315
0 % ; 1 cycle
U
T
and
70 % ; 25/30 cycle
U
T
o
Single phase: at 0
30 A/m
Electromagnetic environment - guidance
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
o o
, 180 , typical commercial or hospital environment.
o
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended that
the EQUIPMENT or SYSTEM be powered
o
from an uninterruptible power supply or a
battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
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