Minnesota Department of Health Radiation Control, X-ray Unit 625 North Robert Street PO Box 64975 St. Paul, Minnesota 55164-0975 Phone: (651) 201-4545 Fax: (651) 201-4606 Email: [email protected] NOTIFICATION OF TEMPORARY X-RAY EQUIPMENT USE IN MINNESOTA (use a separate sheet for requested information when necessary) 1. Company Name and Address: 2. Company Contact Name, Phone and Email: 3. Site of Temporary Usage/Facility Name: 4. Onsite Contact Name, Phone and Email Address: 5. Facility’s Minnesota Registration Number: 6. Date(s) of Temporary Usage: 7. Service Provider Name and Minnesota Registration Number: 8. Location(s) of equipment use: 9. Manufacturer: 11. Console Serial Number: 13. X-ray Equipment Type: Portable Radiographic X-RAY EQUIPMENT INFORMATION 10. Model Number: 12. Tube Serial Number: Computed Tomography (CT) C-arm Industrial Other 14. Federal 2579 Form Reference Number submitted to MDH: 15. I certify that the information is accurate and complete. Sign and date. Sign: _____________________________________________________ Date: ___________________ Revised 10.15 INSTRUCTIONS FOR COMPLETING THE NOTIFICATION FOR TEMPORARY X-RAY EQUIPMENT USE Mobile x-ray units, c-arm fluoroscopic units, and industrial x-ray fluorescent analyzer units are x-ray units that are routinely used in Minnesota on a temporary basis. The manufacturers, distributors, or individuals who provide x-ray equipment for temporary use and the individual registrant each have responsibilities for compliance with Minnesota X-ray Rule Chapter 4732. The Temporary Use form is not intended for companies registered with other states wishing to perform x-ray services within the state of Minnesota on a temporary basis. Companies registered with other states must submit a “Notification for Temporary X-ray Equipment Use” to MDH. Provide the following information for each respective item. 1. The name and address of the company providing the x-ray equipment for temporary use in the State of Minnesota. 2. Provide the name, phone number, and email address for a company contact providing the temporary x-ray equipment. 3. The name and address of facility where x-ray equipment is to be used temporarily. 4. The name, phone number, and email address of an onsite contact at the facility. 5. The Minnesota x-ray facility registration number. 6. The dates of temporary use at this location. 7. The name and Minnesota Registration number of the individual installing and ensuring the x-ray equipment is functioning properly prior to temporary use. 8. Information as to where the x-ray equipment will be used within the facility (ED, OR, room number, etc.). 9. The manufacturer of the x-ray equipment. 10. The model number of the x-ray equipment. 11. The console serial number of the x-ray equipment. 12. The x-ray tube serial number of the x-ray equipment. 13. Check the appropriate box for the type of x-ray equipment to be used temporarily. Provide a brief explanation if “Other” is checked. 14. The preprinted reference number on the federal 2579 form or include the form with this notification, when required by the FDA. 15. This form must be signed and dated by an authorized company representative. Responsibilities of the Manufacturers, Distributors or Individuals That Provide X-ray Equipment for Temporary Use Manufacturers, distributors or individuals that provide x-ray equipment for temporary use must notify MDH within three working days prior to the day of temporary use per Minnesota Rules, Chapter 4732.0250, http://www.health.state.mn.us/divs/eh/radiation/xray/rules/index.html#0200. • Notification must be done through the temporary notification form or equivalent form. • Manufacturers, distributors and sellers must ensure the x-ray equipment delivered for temporary use meets the Code of Federal Regulations Title 21, Performance Standards for Ionizing Radiation Emitting Products, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1020, and the requirements of Minnesota Rules, Chapter 4732 when placed in operation. • Manufacturers, distributors or individuals that provide x-ray equipment for temporary use must perform an install calibration according to Minnesota Rules, Chapter 4732.0280, if the x-ray equipment is maintained at one location for greater than 30 days. See registrant responsibilities for registration, Minnesota Rules, Chapter 4732.0220. Responsibilities of the Registrant It is the registrant’s responsibility to comply with all applicable Minnesota Rules, Chapter 4732, http://www.health.state.mn.us/divs/eh/radiation/xray/rules/index.html, when x-ray equipment is received for temporary use including ensuring that: • The facility receiving the x-ray equipment must be registered with MDH, Minnesota Rules, Chapter 4732.0200. • Staff are qualified to use the x-ray equipment, Minnesota Statute 144.121, https://www.revisor.mn.gov/statutes/?id=144.121. • Staff are properly trained in the use of the x-ray equipment. o Training requirements of Minnesota Rules, Chapter 4732.0510 and the following applicable x-ray equipment specific training: Specific training requirements for fluoroscopic x-ray equipment per Minnesota Rules, Chapter 4732.0825 Specific training requirements for computed tomography (CT) x-ray equipment, per Minnesota Rules, Chapter 4732.0860 Specific training requirements for industrial x-ray equipment: XRF and bomb detection units, Minnesota Rules, Chapter 4732.1000 Manufacturing, gauges and cabinets, Minnesota Rules, Chapter 4732.1040 Industrial Radiography, Minnesota Rules, Chapter 4732.1060 • The x-ray equipment has documentation verifying it is working within manufacturer’s specifications upon receipt. • The locations where the x-ray equipment will be used are adequately shielded, Minnesota Rules, Chapter 4732.0220. • The registrant must notify MDH of the temporary use within three working days prior to use. • Registrants who wish to use temporary x-ray equipment for greater than 30 days: o Must register the x-ray equipment with MDH, Minnesota Rules, Chapter 4732.0220 o Must have an install calibration performed according to Minnesota Rules, Chapter 4732.1100, subpart 2 • If you have questions regarding the temporary use of x-ray equipment in the state of Minnesota, contact Craig Verke at [email protected] or by phone at (651) 201-4533.
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