Table of Contents
Advertisement
General Safety and Compliance Information
Safety Precautions
General Use Cautions and Warnings
United States Federal and State Regulations
IEC Regulations
Manufacturer's Responsibility
February 5, 2004
1-2
•
Observe all warnings and cautions in the procedures.
•
Follow all safety labels on the equipment.
CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician (or
properly licensed practitioner)
WARNING The DirectRay FFDM-S system includes no user serviceable parts. For service
assistance, contact the vendor who supplied the system.
DirectRay FFDM-S systems conform to the United States Code of Federal
Regulations, 21 CFR 1020.30 "Diagnostic X-Ray Systems and their major
components." However, additional state regulations may apply for X-ray products.
This may require notifying your state regulatory agency about your installation
and/or operator training and certification.
It is the responsibility of the user to contact the applicable state radiation control
agency to verify that your installation is in compliance with regulations in your
state governing installation and use of X-ray equipment.
Software used in the DirectRay FFDM-S system was developed using
IEC 60601-1-4 as a guide.
This equipment is sold with the understanding that Direct Radiography Corp., its
agents and representatives, do not accept any responsibility for overexposure of
patients or personnel to X-radiation.
Furthermore, Direct Radiography Corp. does not accept any responsibility for
overexposure of patients or personnel to X-radiation generated by this equipment
as a result of poor operating techniques or procedures.
Also, no responsibility is assumed for any unit that has not been serviced and
maintained in accordance with the technical service manual, or which has been
modified or tampered with in any way.
.
FFDM-S Service Manual
Advertisement
Table of Contents
Troubleshooting
