Air
Life
®
nCPAP Driver Service Manual
2008, Cardinal Health
Page 78 of 81
Table 3: Guidance and Manufacturer's Declaration—Electromagnetic Immunity
The Air
Life
®
nCPAP System Driver is intended for use in the electromagnetic environment
specified below. The customer or user of the Air
Life
®
nCPAP System Driver should assure
that it is used in such an environment.
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic
Environment—Guidance
IEC 61000-4-2
Electro-Static
Discharge (ESD)
±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 %.
IEC 61000-4-4
Electrical Fast
Transient, Burst
(EFT) (Note 2)
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
IEC 61000-4-5
Power Line Surge
(Note 2)
±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
IEC 61000-4-8
Power Frequency
Magnetic Field
(50/60 Hz)
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.
<5 %
U
T
(Note 1)
(>95 % dip in UT)
for 0.5 cycle
<5 %
U
T
(>95 % dip in
U
T)
for 0.5 cycle
40 %
U
T
(60 % dip in
U
T)
for 5 cycles
40 %
U
T
(60 % dip in
U
T)
for 5 cycles
70 %
U
T
(30 % dip in
U
T)
for 25 cycles
70 %
U
T
(30 % dip in
U
T)
for 25 cycles
IEC 61000-4-11
Voltage Dips,
Short
Interruptions, and
Voltage Variations
(Note 2)
<5 %
U
T
(>95 % dip in
U
T)
for 5 sec
<5 %
U
T
(>95 % dip in
U
T)
for 5 sec
Mains power quality should
be that of a typical
commercial or hospital
environment.
If the user of the Air
Life
®
nCPAP System Driver
requires continued operation
during power mains
interruptions, it is
recommended that the
Air
Life
®
nCPAP System
Driver be powered from a
non-interruptible power
supply or a battery.
Note 1—
U
T is the AC mains voltage prior to application of the test level.
Note 2—Performed with an Input Voltage of 120 V AC only.
