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Doc. HD40-0007-02 En-Eu L-4
Guidance and manufacturer’s declaration — electromagnetic immunity
The
Z1
CPAP System is intended for use in the electromagnetic environment specified below. The
customer or the user of the
Z1
CPAP System should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic envi-
ronment - 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/out-
put lines
±2 kV for power
supply lines
±1 kV for input/out-
put lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to earth
±1 kV line(s) to
line(s)
±2 kV line(s) to earth
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 % U
T
(>95 % dip in U
T
) for
0,5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<5% U
T
(>95 % dip in U
T
) for
5 sec
<5 % U
T
(>95 % dip in U
T
) for
0,5 cycle
40% U
T
(60% dip in U
T
) for
5 cycles
70% U
T
(30% dip in U
T
) for
25 cycles
<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
Z1
CPAP System
requires continued oper-
ation during power mains
interruptions, it is recom-
mended that the
Z1
CPAP
System be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency mag-
netic fields should be
at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.