20 Annex
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04) 77 / 85
Guidance and manufacturer´s declaration electromagentic immunity,
IEC 60601-1-2, 5.2.2.1, table 2
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment -
guidlines
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be made of wood
or concrete or covered with ce-
ramic tiles. If the floor is covered
with synthetic material, the rel-
ative humidity must be at least
30%.
Electrical Fast transient/bursts
IEC 61000-4-4
± 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.
Surge
IEC 6100-4-5
± 1 kV
kine(s) to line(s)
± 2 kV
line(s) to earth
± 1 kV
differential mode
± 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
τ
( > 95% dip in U
τ
)
for 0,5 cycle
40 % U
τ
( 60%
dip in U
τ
) for
5 cycles
70% U
τ
( 30% dip in U
τ
)
for 25 cycles
<5% U
τ
(> 95% dip in U
τ
)
for 5 s
< 5% U
τ
( > 95% dip in U
τ
)
for 0,5 cycle
40 % U
τ
( 60%
dip in U
τ
) for
5 cycles
70% U
τ
( 30% dip in U
τ
)
for 25 cycles
<5% U
τ
(> 95% dip in U
τ
)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Pentacam® AXL requires
continued operation during po-
wer mains interruptions, it is re-
commended that the
Pentacam® AXL be powered
from an uninterruptible power
supply or battery.
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 environ-
ment.
Note: U
τ
is the a.c. mains voltage prior to application of the test level.
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