Maquet HCU 40, Instructions For Use Manual

Page: 144 / 148

| 144 | 12 Applied Standards | HCU 40 |
Instructions for Use | 1.0 | EN | 01
Copyright Maquet Cardiopulmonary GmbH
Immunity test IEC 60601 test
level Compliance level Electromagnetic environment –
guidance
Electrostatic dis­
charge (ESD)
IEC 61000­4­2 ±6 kV contact ±6 kV contact Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humid­
ity should be at least 30%.
±8 kV air ±8 kV air
Electrical fast
transient/burst
IEC 61000­4­4 ±2 kV for power
supply lines ±2 kV for power
supply lines Mains power quality should be that of
a typical commercial or hospital envi­
ronment.
±1 kV for input/
output lines ±1 kV for input/out­
put lines
Surges
IEC 61000­4­5 ±1 kV differential
mode ±1 kV differential
mode Mains power quality should be that of
a typical commercial or hospital envi­
ronment.
±2 kV common
mode ±2 kV common
mode
Voltage dips,
short interrup­
tions and volt­
age variations
on power supply
input lines
IEC 61000­4­11 < 5% U
T
for ½ cy­
cle (> 95% dip)
< 5% U
T
for ½ cycle
(> 95% dip)
Mains power quality should be that of
a typical commercial or hospital envi­
ronment.
Thanks to its built­in battery, the de­
vice continues to operate during power
mains interruptions. It therefore does
not need to be powered from an unin­
terruptible power supply or external
battery.
40% U
T
for 5 cy­
cles (60% dip)
40% U
T
for 5 cycles
(60% dip)
70% U
T
for 25 cy­
cles (30% dip)
70% U
T
for 25 cy­
cles (30% dip)
< 5% U
T
for 5 s
(> 95% dip)
< 5% U
T
for 5 s
(> 95% dip)
Magnetic field
with a power fre­
quency
(50/60 Hz) as
per
IEC 61000­4­8 3 A/m 3 A/m The strength of power­frequency mag­
netic fields should correspond to that
of a typical commercial or hospital en­
vironment.
Note: U
T
is the AC supply voltage prior to application of the test level.
Portable and mobile RF communica­
tions equipment should be used no
closer to any part of the device, includ­
ing cables, than the recommended
separation distance calculated from
the equation applicable to the fre­
quency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000­4­6 3 V
eff
150 kHz to
80 MHz
10 V
eff
d = 0.35 √P
Radiated RF
IEC 61000­4­3 3↓V/m 80 MHz to
2.5 GHz 10 V/m d = 0.35 √P 80 MHz to 800 MHz
d = 0.7 √P 800 MHz to 2.5 GHz