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OPERATOR’S MANUAL • Owandy-RX DC • 02/2020 • NXDCEN160A
Operator’s manual – Owandy-RX DC
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 maintained as
described in the accompanying documents. For other maintenance operations, refer to the installation and maintenance manual.
• 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 qualifi ed, 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 qualifi ed to service
Owandy-RX DC 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 Owandy-RX DCX-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 mainte-
nance.
• Repairs and replacements of any component must be carried out solely by authorized and highly qualifi ed personnel and only using genuine
spare parts supplied by de Götzen® S.r.l.
• Do not operate the unit if there is the threat of an earthquake. Following an earthquake, ensure that the unit is operating properly. It’s mandatory
to thoroughly check all functions and safety aspects before resuming use.
