Owandy Radiology i-max touch 3D, User Manual

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User Manual
– Safety information
NIMXEN020I
Owandy Radiology SAS
12
3.3 Information about Electromagnetic Compatibility
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the accompanying documents.
Portable and mobile RF communications equipment can affect medical electrical equipment.
The equipment can be installed both in professional buildings (e.g. hospitals or clinics) and in
residential buildings. Residential buildings, according to IEC 60601-1-2 4th edition, are intended
to be connected to dedicated power supply system (normally fed by separation transformers).
For the purpose of EMC environment classification according to IEC 60601-1-2 4th edition, both
installations are classified as "Professional healthcare facility environment".
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment, even if it is usually permanently installed in X-Ray shield
locations, might not offer adequate protection to radio-frequency communication services. If
abnormal performance is observed, such as degradation of essential performance in the form of
lack of accuracy of exposure parameters and lack of reproducibility of exposure parameter,
additional measures may be necessary, such as re-orienting or relocating the device.
Warning
The use of cables other than:
•
Ethernet cable CAT.5E L=5 m - code 5007090100
•
Ethernet cable CAT.5E L=10 m - code 5007090300
with the exception those sold by the manufacturer of the equipment or system as
replacement parts for internal components, may result in increased emission or
decreased immunity of the equipment or system.
Warning
I-MAX 3D should not be used adjacent to or stacked with other equipment; if adjacent
use is necessary, I-MAX 3D has to be observed to verify if it operates in a normal way.
Interference may occur in the vicinity of equipment marked with the symbol
Warning
Portable and mobile RF communications equipment should be used no closer to any
part of I-MAX 3D, including cables. Minimum distance 30 cm.