SUGGESTED MAINTENANCE AND
REPAIR
10.1. MAINTENANCE AND CLEANING
Clean the external surface using a damp cloth and non-corrosive non oil-based detergent and disinfect it using a non-aggressive medical
detergent. Do not spray detergent or disinfectant directly on the device. The spacer cone may be cleaned with cotton wool soaked with
surgical alcohol.
CAUTION
• Turn off and disconnect the device from the supply mains before carrying out cleaning operations.
• Do not spray products directly on the device. Apply the product on a clean cloth.
• Always use disposable protective covers for the applied parts.
• Do not use UV systems to disinfect the equipment, as exposed parts of the device can turn yellow or discolour.
• To avoid any potential hazard or danger to operators and patients, contact your authorized Acteon Technical Representative immedia-
tely if you experience any unusual operation, mechanical issues, or equipment malfunction
CAUTION
• To ensure both the patient’s and operator’s safety as well as preserving a high image quality, the device must always be well maintai-
ned as described in the accompanying documents. For other maintenance operations, refer to the installation and maintenance manual
and to the maintenance guide supplied.
• The RESPONSIBLE ORGANIZATION of the device is responsible for scheduling and having preventive maintenance carried out at least
every 12 (twelve) months, which consists of maintenance carried out by qualied, authorized authorized professional technicians. It is
the RESPONSIBLE ORGANIZATIONS’s responsibility to arrange for this service and to assure that the personnel performing this function
are fully qualied to service X-MIND unity x-ray equipment.
• The RESPONSIBLE ORGANIZATION must always carry out routine maintenance on a daily basis to ensure optimal device performance.
These checks must be performed to complete the installation of the X-MIND unity X-Ray System and as part of the recommended
maintenance as indicated in the accompanying documents. Failure to perform these checks may result in an installation that does not
comply with U.S. Radiation Performance Standards 21 CFR Subchapter J.
• The manufacturer shall not be held liable for damage or injuries caused by failure to carry out inspections and tests and by incomplete
maintenance.
• Repairs and replacements of any component must be carried out solely by authorized and highly qualied personnel and only using
genuine spare parts supplied by de Götzen® S.r.l. - ACTEON Group.
• Do not operate the unit if there is the threat of an earthquake. Following an earthquake, ensure that the unit is operating properly and
it’s mandatory to thoroughly check all functions and safety aspects before resuming use.
CAUTION
For Italy: Medical electrical equipment malfunctions resulting from incomplete or inadequate maintenance can cause serious adverse
events.
5
For Italy refer to Presidential Decree 14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and modied).
5
5 Recommendation No.9, April 2009 - Recommendation for the prevention of adverse events resulting from medical electrical equipment mal-
functions - Italian Ministry of Labour, Health and Welfare
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