CEFLA NewTom GO 2D, Technical Manual

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EN
NewTom GO 2D/3D
- TECHNICAL MANUAL
TROUBLESHOOTING
7. INSTALLATION CHECK LIST (FOR USA ONLY)
It is the responsibility of the Assemblers or Installers to report the installation to the manufacturer within 15 days of the
date of installation.
Upon completion of an installation, please
fill out and review the manufacturer’s
INSTALLATION CHECKLIST (document
number 97050897, PDF file available on
the CD ROM supplied with the device or on
extranetdentale.cefla.it
) in its entirety. Return
a copy, along with the original manufacturer’s
INSTALLATION AND TEST REPORT
(document number 97011067) to CEFLA
North America, Inc. 6125 Harris Technology
Blvd. Charlotte, NC 28269 USA.
It is the responsibility of the Assemblers
(defined as “any person engaged in the
business of assembling, replacing, or installing
one or more components into a diagnostic
x-ray system or subsystem”) to fill out and
distribute the “Report of assembly”, using
the Form FDA 2579, upon completion of an
installation and within 15 days of the date of
installation. For more guidance, please refer
to FDA document number 1751 “Guidance for
Industry and Food and Drug Administration
Staff - Assembler’s Guide to Diagnostic X-Ray
Equipment”.
Please send a photocopy of the Form
FDA 2579 to the manufacturer along with
the INSTALLATION CHECKLIST and the
INSTALLATION AND TEST REPORT:
fax 704-631-4608 or
e-mail: service@cefladental.com.
Please also keep a copy for yourself.
In the event of a technical maintenance, if components bearing a serial number are replaced, an authorized technician
must:
• repeat all the steps prescribed by the installation checklist,
• fill out a new installation report bearing the new serial number of the replaced component,
• send the the new installation report and installation checklist to the manufacturer,
• fill out and distribute the Report of Assembly, using the Form FDA 2579 - for a list of exceptions to reporting
requirements, please refer to 21CFR 1020.30(d)(2).