19616-001 Rev. D
DiagnosticPRO
Edge
Film Digitizer Installation Guide
39
Guidance and
manufacturer’s declaration – electromagnetic immunity
Table 202
The DiagnosticPRO
Edge
Digitizer is intended for use in the electromagnetic environment specified below. The customer
or end user of the DiagnosticPRO
Edge
Digitizer 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 differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
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 % UT
(>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 sec
<5 % UT
(>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 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the DiagnosticPRO
Edge
Digitizer requires
continued operation during power mains
interruptions, it is recommended that the
DiagnosticPRO
Edge
Digitizer be powered from an
uninterruptible power supply or a battery
Power frequency
(50/60 Hz)
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 environment.
NOTE: U
T
is the A.C. mains voltage prior to application of the test level
