10 Technical data
10.4 Labels on the unit
The main label of the unit is located on the vertical carriage next to the on/off power
switch. The unit is class I, type B and with IP20 protection.
10.5 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 re-orienting or relocating the device. Suggested actions according to
immunity of non-life-support equipment or system IEC 60601-1-2 ed.4
on page 111.
The device is suitablefor 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.
Table 1: Electromagnetic emissions IEC 60601-1-2 Ed4
OP 3D Pro is suitable for use in the specified electromagnetic environment. The purchaser or user
of OP 3D Pro should assure that it is used in an electromagnetic environment as described below:
Emissions Test
Compliance
Electromagnetic Environment
Radio-Frequency
Emissions CISPR11
Group 1
OP 3D Pro
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
OP 3D Pro
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 Pro
109