Guidance And Manufacturer's Declaration- Electromagnetic Immunity - Apex iX Sense CPAP System Manual De Instrucciones

iX Sense / English

Guidance and Manufacturer's Declaration- Electromagnetic Immunity:

iX series is intended for use in the electromagnetic environment specified below. The user of this device
should make sure it is used in such an environment.
Immunity Test Levels
Basic EMC
Professional
standard
healthcare
facility environment
Electrostatic
±8 kV contact
Discharge (ESD)
± 2, 4, 8, 15 kV air
IEC61000-4-2
Electrical fast
±2 kV, 100 kHz for power supply line
transient/ burst
±1 kV, 100 kHz for input/output line
IEC61000-4-4
± 0.5, 1 kV (line to line)
Surge
± 0.5, 1, 2 kV (line to earth)
IEC61000-4-5
Voltage dips,
short Voltage Dips:
interruptions i) 100% reduction for 0.5 period,
and voltage ii) 100% reduction for 1 period,
variations on iii) 30% reduction for 25/30 period,
power supply Voltage Interruptions:
input lines 100% reduction for 250/300 period
IEC61000-4-11
Power
frequency
(50/60Hz) 30 A/m
magnetic field
IEC61000-4-8
3 Vrms
0,15 MHz – 80 MHz
Conducted RF 6 Vrms in ISM bands
IEC 61000-4-6 between 0,15 MHz and
80 MHz
80 % AM at 1 kHz
Compliance
HOME HEALTHCARE
Levels
ENVIRONMENT
±8 kV contact
± 2, 4, 8, 15 kV
air
±2 kV, 100 kHz
for power
supply line
±1 kV, 100 kHz
for
input/output
line
± 0.5, 1 kV
(line to line)
100 Vac & 240
Vac input
30 A/m 30 A/m
3 Vrms
3 Vrms 0,15 MHz – 80
0,15 MHz – 80 MHz MHz
6 Vrms in ISM and 6 Vrms in ISM
amateur radio bands
bands between between 0,15
0,15 MHz and 80 MHz MHz and 80
80 % AM at 1 kHz MHz 80 % AM
at 1 kHz
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 atypical commercial or
hospital environment
Mains power quality should be
that of atypical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of this device requires
continued operation during
power mains interruptions, it is
recommended that the device
be powered 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.
Portable and mobile RF
communications equipment
should be used no closer to any
part of this device, including
cables, than there commended
separation distance calculated
from the equation applicable to
the frequency of the
transmitter.
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