ResMed Positive Airway Pressure Device VPAP IV ST - Manual (Page 21)

18
Guidance and manufacturer’s declaration – electromagnetic immunity
The VPAP device is intended for use in the electromagnetic environment specified below. The customer or the user of the VPAP
device should assure that the device is used in such an environment.
Immunity test
IEC60601-1-2 test
level
Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2 ±6 kV contact
±8 kV air ±6 kV contact
±8 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%.
Electrical fast
transient/burst
IEC 61000-4-4 ±2 kV for power
supply lines
±1 kV for input/
output lines ±2 kV
Not Applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5 ±1 kV differential
mode
±2 kV common
mode ±1 kV differential
mode
±2 kV common
mode 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% Ut (>95% dip in
Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95%dip in
Ut) for 5 sec < 12V (>95% dip in
240V) for 0.5 cycle
96V (60% dip in
240V) for 5 cycles
168V (30% dip in
240V) for 25 cycles
<12V (>95%dip in
240V) for 5 sec Mains power quality should be that of a typical
commercial or hospital environment.
If the user of the VPAP device requires continued
operation during power mains interruptions, it is
recommended that the VPAP device be powered from
an uninterruptible power source.
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
3 Vrms
10 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the VPAP
device, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.17
√P
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with this symbol
.
NOTE 1: Ut is the AC mains voltage prior to application of the test level.
NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the VPAP device is used exceeds the applicable RF compliance level above, the VPAP device
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the VPAP device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.