Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11
Class B The X-ray unit is suitable for
use in all establishments,
including domestic
establishments and those
directly connected to the public
low-voltage power supply
network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic immunity
The Planmeca Viso X-ray unit is intended for use in the electromagnetic environment specified
below. The customer or the user of the X-ray unit should assure that it is used in such an
environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic
environment- 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/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 61000-4-5
±1 kV line to line
±2 kV line to earth
±1 kV line to line
±2 kV line 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
s
<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
s
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the X-ray
unit requires continued
operation during power
mains interruptions, it is
recommended that the
X-ray unit be powered
from an uninterruptible
power supply.
1 General and technical data
28 Planmeca Viso Technical manual