9 Technical data
9.6
Electromagnetic Compatibility (EMC) tables
NOTICE!
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed according to EMC information.
IEC60601-1-2 ed4 testing has verified that electromagnetic interference stimulus has no effect to
safety critical functionality of the device. This includes the patient positioning and other imaging pre-
conditions, imaging program value selection from the GUI, imaging process, image transfer to the
workstation and the image quality.
If abnormal performance is observed, such as degradation of essential performance in form of
reduction of line pair resolution, additional measures may be necessary, such as reorienting or
relocating the device. Suggested actions according to
RF immunity of non-life-support equipment or
on page 103.
The device is suitable for use in both at professional healthcare (hospitals/large clinics) facility
environment and home healthcare (clinics in domestic establishments and those directly connected to
the public low-voltage power supply) environment.
Exceptions for professional healthcare facility environment : Not to be used or installed near active HF
SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging,
where the intensity of EM DISTURBANCES is high.
Electromagnetic emissions IEC 60601-1-2 Ed4
PCX-1 is suitable for use in the specified electromagnetic environment. The purchaser or user of PCX-1 should assure that it is
used in an electromagnetic environment as described below:
Emissions Test
Compliance
Electromagnetic Environment
Radio-Frequency Emissions
CISPR11
Group 1
PCX-1
uses RF energy only for its internal function. Therefore, the RF
emission is very low and not likely to cause any interference in nearby
electronic equipment.
Radio-Frequency Emissions
CISPR11
Class B
Harmonic emissions
IEC61000-3-2
IEC61000-3-2
Class A
Voltage fluctuations/ flicker
emissions
IEC61000-3-3
Complies
PCX-1
is suitable for use in both at professional healthcare (hospitals/
large clinics) facility environment and home healthcare (clinics in
domestic establishments and those directly connected to the public
low-voltage power supply) environment.
Exceptions for professional healthcare facility environment : Not to
be used or installed near active HF SURGICAL EQUIPMENT and the RF
shielded room of an ME SYSTEM for magnetic resonance imaging, where
the intensity of EM DISTURBANCES is high.
ORTHOPANTOMOGRAPH
™
OP 3D
101
