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12
Declarations
12.1
Guidance and Manufacturer’s Declaration
Table 12 Guidance and Manufacturer’s Declaration of Electromagnetic Emissions
Guidance and Manufacturer’s Declaration of Electromagnetic Emissions
The x-ray detector is intended for use in the electromagnetic environment specified below. The installer,
x-ray system manufacturer, or user of the x-ray detector is responsible for the usage condition of the detector
to be within such environment.
x-ray system manufacturer, or user of the x-ray detector is responsible for the usage condition of the detector
to be within such environment.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF-emissions CISPR 11
Group 1
The x-ray detector uses RF energy only for its internal
function; therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment. Should any interference (EMC) be detected
with any other equipment, reposition the x-ray detector or
the other equipment away from each other.
function; therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment. Should any interference (EMC) be detected
with any other equipment, reposition the x-ray detector or
the other equipment away from each other.
RF-emissions CISPR 11
Class B
(wireless) Class
A (wired)
(wireless) Class
A (wired)
The X-Ray Detector is suitable for use in industrial and
clinical environments in the wired mode.
In the wireless mode the e x-ray detector is suitable for use
in all environments within Class B.
Should any interference (EMC) be detected with any other
equipment, reposition the x-ray detector or the other
equipment away from each other.
clinical environments in the wired mode.
In the wireless mode the e x-ray detector is suitable for use
in all environments within Class B.
Should any interference (EMC) be detected with any other
equipment, reposition the x-ray detector or the other
equipment away from each other.
Harmonic emissions
IEC 61000-3-2
IEC 61000-3-2
Class B
(wireless) Class
A (wired)
(wireless) Class
A (wired)
Voltage fluctuations/flicker
emissions IEC 61000-3-3
emissions IEC 61000-3-3
Complies
Table 13 Guidance and Manufacturer’s Declaration of Electromagnetic Immunity
Guidance and Manufacturer’s Declaration of Electromagnetic Immunity
The x-ray detector is intended for use in the electromagnetic environment specified below. The installer,
x-ray system manufacturer, or user of the x-ray detector is responsible for the usage condition of the detector
to be within such environment.
x-ray system manufacturer, or user of the x-ray detector is responsible for the usage condition of the detector
to be within such environment.
Immunity Test
IEC 60601 Test
Compliance
Electromagnetic Environment –
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
(ESD)
IEC 61000-4-2
Contact: 6 kV
Air: 8 kV
Air: 8 kV
Contact: 6 kV
Air: 8 kV
Air: 8 kV
Floors should be made of wood,
concrete, or ceramic tile. If floors are
covered with synthetic material, the
relative humidity should be at least 30%.
concrete, or ceramic tile. If floors are
covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast transients
(Burst) IEC 61000-4-4
(Burst) IEC 61000-4-4
0.5 kV (AC)
1kV (DC)
1kV (DC)
0.5 kV (AC)
1kV (DC)
1kV (DC)
Mains power quality should be that of a
typical commercial and/or hospital
environment.
typical commercial and/or hospital
environment.
Transients-Surges
IEC 61000-4-5
IEC 61000-4-5
1 kV / 2 kV
1 kV / 2 kV
Mains power quality should be that of a
typical commercial and/or hospital
environment.
typical commercial and/or hospital
environment.
Power frequency magnetic
field
IEC 61000-4-8
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 and/or
hospital environment.
be at levels characteristic of a typical
location in a typical commercial and/or
hospital environment.
Voltage dips and short
interruptions
IEC 61000-4-11
interruptions
IEC 61000-4-11
-95% / 10 ms
-60% / 100 ms
-30% / 500 ms
>-95% / 5000
ms
-60% / 100 ms
-30% / 500 ms
>-95% / 5000
ms
-95% / 10 ms
-60% / 100 ms
-30% / 500ms
>-95% / 5000
ms
-60% / 100 ms
-30% / 500ms
>-95% / 5000
ms
Mains power quality should be that of a
typical commercial or hospital
environment.
If the user of the x-ray detector requires
continued operation during power mains
interruptions, we recommend that the x-
ray detector be powered from an
uninterruptible power supply or battery.
typical commercial or hospital
environment.
If the user of the x-ray detector requires
continued operation during power mains
interruptions, we recommend that the x-
ray detector be powered from an
uninterruptible power supply or battery.