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USER MANUAL • Owandy-RX AC • 02/2020 • NXACEN160A
User Manual – Owandy-RX AC
CAUTION
MECHANICAL RISK
Before removing the tubehead from the positioning arm, RELEASE THE SPRING.
The sudden opening of the joint may cause damage to people and/or things.
Check that the installation of the unit complies with the mechanical specifi cations of the support (walls, ceiling, etc..) where it is installed.
Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualifi ed and authorized service personnel.
The Owandy-RX AC must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.
CAUTION
ELECTRIC SAFETY
The radiographic system contains high voltage. It is prohibited to inspect internal parts of the system.
Never attempt to open the X-ray tubehead.
The covers on the Owandy-RX AC radiographic system must only be removed by qualifi ed and authorized service personnel.
The unit must be used only in environments that are in compliance with all electrical safety standards set forth for medical environments.
To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth.
The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other liquids
penetrate inside in order to avoid short circuits or corrosion.
Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning cleaning and disinfecting operations.
Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to any type of extension cord.
External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g.
IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations – systems – shall
comply with the safety requirements stated in the standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient support.
It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the equip-
ment located inside the patient environment. In particular such a Separation Device is required when a network or data connection is made.
The requirements on the Separation Device is defi ned in IEC 60601-1, edition 3, clause 16.
For the wall version of Owandy-RX AC:
based on the IEC 60601-1, the installation is a permanent type (fi xed). IT IS NOT ALLOWED TO connect the equipment to the main supply using
a plug.
The cone (beam limiting device) is an APPLIED PART of the system and it is classifi ed as type B.
