CAUTION
ELECTRICAL SAFETY
• The x-ray system contains high voltage. It’s prohibited to inspect internal parts of the system.
• Never attempt to open the x-ray tube head.
• The covers on the X-MIND unity equipment must only be removed by qualied and authorized service personnel.
• The unit must be used only in environments that are in compliance with all the electrical safety standards set forth for medical environ-
ments.
• The unit is NOTwaterproof; it will therefore be necessary to make sure that no water or other liquids penetrate inside the equipment so
as to avoid short circuits or corrosion.
• Always disconnect the x-ray system from the power supply and wait for 2 minutes before commencing to clean or disinfect orperform any
maintenance operations.
• Do not connect the x-ray system to a multiple portable socket outlet (MPSO) or 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 combina-
tions – systems – shall comply with the safety requirements stated in the collateral standard IEC 60601-1-1 or the general 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.
• Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore res-
ponsible for the system to comply with the requirements. If in doubt, contact qualied medical technician or your local representative.
• It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the
equipment 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 dened in IEC 60601-1-1 and in IEC 60601-1, edition 3, clause 16.
• Based on the IEC 60601-1, the installation of the X-MIND unity wall version is a permanent type (xed). IT IS NOT ALLOWED TO connect
the equipment to the main supply using a plug.
• Do not touch the USB connector of the x-ray sensor and the patient at the same time.
• NEVER use the device without the presence of the lateral enclosure of the fork (example shown in the picture below) or without the
proper xing of the enclosure on the fork. In case if the Sopix/Sopix2 Inside is installed, the x-ray sensor support must also be present
and properly xed on the cover.
• The cone (Beam Limiting Device) is an APPLIED PART of the system and is classied type B.
• The Sopix/Sopix2 Inside Sensor (optional) is an APPLIED PART of the system and is classied type BF.
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