Human Design Medical Z1 CPAP System User Manual page 13

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
Electrostatic ±6 kV contact
discharge (ESD) ±8 kV air
IEC 61000-4-2
Electrical fast ±2 kV for power
transient/burst supply lines
IEC 61000-4-4 ±1 kV for input/
output lines
Surge ±1 kV line(s) to
line(s)
IEC 61000-4-5
±2 kV line(s) to
earth
Voltage dips, short <5 % UT
interruptions and
(>95 % dip in
voltage variations
UT) for 0 . 5 cycle
on power supply
40% UT
input lines
(60% dip in UT)
IEC 61000-4-11
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95 % dip in
UT) for 5 sec
Power frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the a . c . mains voltage prior to application of the test level .
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Compliance level Electromagnetic
environment – guidance
±6 kV contact Floors should be wood,
concrete or ceramic tile .
±8 kV air
If floors are covered with
synthetic material, the
relative humidity should be
at least 30% .
±2 kV for power Mains power quality
supply lines should be that of a typical
±1 kV for input/ commercial or hospital
output lines environment .
±1 kV line(s) to Mains power quality
line(s) should be that of a typical
commercial or hospital
±2 kV line(s) to
environment .
earth
<5 % UT Mains power quality
should be that of a typical
(>95 % dip in
commercial or hospital
UT) for 0 . 5 cycle
environment, If the user
40% UT
of the Z1 Auto System
requires continued
(60% dip in UT)
operation during power
for 5 cycles
mains interruptions, it is
70% UT
recommended that the Z1
(30% dip in UT)
Auto System be powered
for 25 cycles
from an uninterruptible
power supply or a battery .
<5% UT
(>95 % dip in
UT) for 5 sec
3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment .
Guidance and manufacturer's declaration — electromagnetic immunity
The Z1 Auto System is intended for use in the electromagnetic environment specified below . The
customer or the user of the Z1 Auto System should assure that it is used in such an environment .
Immunity test IEC 60601 test level Compliance level Electromagnetic environment —
Conducted RF
3 Vrms 3V
IEC61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
3V/m
IEC 61000-4-3
80 MHz to 2 . 5 GHz
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies .
NOTE 2: 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 Z1 CPAP
System is used exceeds the applicable RF compliance level above, the Z1 CPAP System should be observed to verify normal operation . If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Z1 CPAP System .
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m .
guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Z1 Auto System, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter .
Recommended separation distance
d =1.2 √P
d =1.2 √P 80 MHz to 800 MHz
d =2.3 √P 80 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 the
following symbol:
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