Compliance FAQ & Links
Keep your Panoramic Corporation™ device in complaince with both the FDA and STATE by perfroming routine maintenance. In addition to compliance, most costly repairs are a result of falilure to maintain the device. Many components in the machine are designed to work within a certain specification, and require attention as described by the manufacturer.
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From your equipment User Manual:
"Panoramic has an extensive network of independent installation and service organizations throughout the U.S. and Canada to install and service our products. The Independent Representatives have been specifically trained by our organization in the service and installation of Panoramic products. We strongly recommend that you use one of our Independent Representatives to service Panoramic products. To the extent you use third parties other than Independent Representatives to service Panoramic products, we cannot accept responsibility or liability for any work performed by those third parties and any resulting damages or liability attributable thereto. In no event shall Panoramic be liable to you or any other third party for any direct, indirect, punitive, incidental, consequential or special damages or lost profits arising from, relating to or connected with, the installation of or repair of a Panoramic product by someone other than an Independent Representative."
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What is FDA Compliance?
The FDA requires manufactures to establish a schedule of maintenance that will ensure a device is operating within compliance. Compliance boils down to operation within the manufacturer's operational specifications. The FDA considers that ALL devices of this type are to ALWAYS be maintained within the specifications. This is typically accomplished through a Preventive Maintenance Inspection {PM) set on a schedule determined by the manufacturer.
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What is California State Compliance?
California State requires the user of the equipment shall "provide sufficient maintenance" to the equipment to bring into compliance with the FDA , and appropriate records of such are kept.
California Code of Regulations (CCR), title 17, section § 30305:
https://govt.westlaw.com/calregs/Document/I9FEA72525A4F4D9B8DC1DBD2C51FC423
California Code of Regulations (CCR), title 17, section §30319.20:
https://govt.westlaw.com/calregs/Document/IE45D6F50D60611DE88AEDDE29ED1DC0A
Radiation Safety and Protection Program Requirement Guidance
https://www.cdph.ca.gov/Programs/CEH/DRSEM/CDPH%20Document%20Library/RHB/X-ray/RHB-Guide-RadProtectionProgram.pdf
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What is Manufacturer Compliance?
According to the manual provided with your equipment, "Panoramic Corporation™ strongly recommends a preventive maintenance be performed on your equipment at least every two years."
PC-1000 User Manual, Appendix "C"
http://pancorp.com/images/files/upload/1329941048PMC6000_Rev_D.pdf
PC-3000 User Manual, Appendix "C"
http://pancorp.com/images/files/upload/1345464689UMF20000_Rev_A_-_PC-3000_User_Manual.pdf
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PC-4000 User Manual, pg 24
http://pancorp.com/images/files/upload/1345464701UMD20000_Rev_B_-_PC-4000_User_Manual.pdf
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Encompass CCD User Manual, Section 15.3
http://pancorp.com/images/files/upload/Encompass-CCD-Users_Manual-English-Rev32.pdf
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Encompass CdTe User Manual, Section 16.3
http://pancorp.com/images/files/upload/Encompass-CdTe-Users_Manual-English-Rev26.pdf