CEFLA RX DC - USA INSTALLATION CHECKLIST

65
cod. 97050989 rev. 00
RX DC - 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 ll out and review the manufacturer’s INSTALLATION CHECKLIST (document number 97050989 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 (dened 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 ll 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; e-mail: service@ceadental.com). Please also keep a copy for yourself.
Done Step Description
Installation/service Manual
Reference (97071214)
1 Positioning the x-ray unit’s structure Section 4.1
2 Installing the double pantograph arm Section 4.5
3 Installing the RX DC Plus generator Section 4.6/4.7
4 Installing the collimator Section 4.8
5 Balancing the double pantograph arm Section 4.9
6 Adjusting the double pantograph arm end-stops Section 4.10
7 Wall-mounted plate wiring connections Section 4.11
8 Completion of wall-mounting plate and holder for hand-held Section 4.12
9 Turning on the unit Section 6.1
10 Setting the operating mode ( 21CFR 1020.30(a)(2)) Section 7.2
11 Calibrating the X-ray head Section 7.4
12 ll out and distribute the Report of Assembly, using the Form FDA 2579
Date: __________________ Printed name __________________________ Installer Signature ____________________________
Customer (stamp or complete data)
Assembler information
Serial Number
Company name ___________________________________________________
Street address ____________________________________________________
City ___________________________________ State __________________
Zip code ______________ Telephone number __________________________
FAC SIMILE
with "ball end socket joint" generator
GB
INSTALLATION
RX DC X-RAY UNIT
15. RX DC WITH "BALL END SOCKET JOINT" / WITH STANDARD JOINT - 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
ll out and review the manufacturer’s
INSTALLATION CHECKLIST (document
number 97050989, supplied with the device
or available on "extranetmedical.cea.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
(dened 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 ll
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 Sta󰀨 - 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@ceadental.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,
- ll 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,
- ll 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).