Service Manual - Introduction
SERVICE MANUAL • X-MIND prime 3D • (19) • 11/2019 • NXMPEN080A
Note
The present manual is updated for the product it is sold with in order to
grant an adequate reference in performing diagnostics and repair
operations normally carried out by the service engineer.
The manual may not reflect changes to the product not impacting service
operations.
This manual provides the instructions for proper and safe installation and
maintenance of the appliance by technical personnel.
This manual is limited to the description of the radiographic equipment; the
instructions for the image acquisition, manipulation and processing are given in
the user manual supplied with the imaging software used with the X-MIND prime
3D unit.
Warning
•
The X-MIND prime 3D is an electro-medical device and it can be used
only under the supervision of a physician or of highly qualified
personnel, with the necessary knowledge on X-ray protection.
•
The device must be used in compliance with the procedures described,
and never be used for purposes different from those herewith
indicated.
•
The user is liable with regards to the legal fulfilment related to the
installation and the operation of the device.
•
Service engineers who install and maintain the device need knowledge
of radiation protection and must read the Service Manual prior to use
the X-ray equipment. They must be qualified and authorized by Acteon.
Note
For installation in USA, a report of assembly (Form FDA 2579) must be filled
out to certify that the medical equipment was assembled according to the
instructions provided by the manufacturer, and meets the requirements
of the applicable Federal standards contained in 21 CFR 1020.30 through
1020.33.
Reports must be filed with FDA's Center for Devices and Radiological
Health (CDRH) within 15 days of completion of the assembly. The report
must be filled in according to the methods provided in:
https://www.fda.gov/industry/fda-esubmitter/diagnostic-x-ray-reports-assembly
(remember to check the updated web address since this may change over
time)
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