Section 1.0
MAN 06–0017H ZIEHM QUANTUM User’s Manual Page 16 of 220
1. Completing the records listed below,
2. Filing the original, and for
3. Forwarding copies to the indicated recipient.
Record When Required Recipient
Service log Whenever any service is
performed on the system
Original to Service files.
• Copy to Manufacturer for
DHR
FDA Form 2579,
Report Of Assembly
Diagnosis X-Ray
System
Whenever the system is
installed, or when any of the
following certified
components are replaced or
added:
• New system
• X-ray tube housing, high-
voltage generator
• Beam-limiting assembly
• Image receptor
• X-ray control unit
Original to Service files.
Copies to:
•FDA
• Manufacturer
• State
• Hospital
Must be filed within 15 days
Equipment
Locator Card
When system installation is
complete
Original to Service files.
• Copy to Manufacturer for
DHR