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AcuCam® Concept® IV FWT User Manual
Guidance and Manufacturer's Declaration - electromagnetic immunity -for all equipment and
systems (see 6.8.3.201 a) 6)).
The AcuCam® Concept® IV FWT intraoral camera system is intended for use in the
electromagnetic environment specified below. The customer or user of the Concept IV FWT
camera system must ensure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
Note: U
is the a.c. mains voltage prior to application of the test level.
T
7-2
IEC 60601
Compliance Level
Test Level
±6 kV contact
±2, 4 & 6 kV contact
±8 kV air
±2, 4 & 8 kV air
±2 kV for power
±0.5, 1 & 2 kV for
supply lines
power supply lines
±1 kV for input/output
±1 kV for
lines
input/output lines
±1 kV differential mode
±0.5 & 1 kV
differential mode
±2 kV common mode
±0.5, 1 & 2 kV
common mode
<5% U
<5% U
T
(>95% dip in U
)
(>95% dip in U
T
for 0.5 cycle
for 0.5 cycle
40% U
40% U
T
(60% dip in U
)
(60% dip in U
T
for 5 cycles
for 5 cycles
70% U
70% U
T
(30% dip in U
)
(30% dip in U
T
for 25 cycles
for 25 cycles
<5% U
<5% U
T
(>95% dip in U
)
(>95% dip in U
T
for 5 sec
for 5 sec
3A/m
3A/m
Electromagnetic
Environment – Guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with syn-
thetic material, the relative
humidity should be at least
30%.
Mains power quality should
be that of a typical commer-
cial or hospital environ-
ment.
Mains power quality should
be that of a typical commer-
cial or hospital environ-
ment.
Mains power quality should
T
be that of a typical commer-
)
T
cial or hospital environ-
ment. If the user of the
Concept IV FWT camera sys-
T
tem requires continued
)
T
operation during power
mains interruptions, it is
recommended that the
T
Concept IV FWT camera sys-
)
tem be powered from an
T
uninterruptible power sup-
ply or a battery.
T
)
T
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical com-
mercial or hospital environ-
ment.
032-0161-EN Rev 5
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