Effective Date: 12/30/92
Title: Section 16.61 - Therapy equipment operating at potentials of 60 kV and below

16.61 Therapy equipment operating at potentials of 60 kVp and below. (a) Equipment. All provisions of subdivision (a) of section 16.60 shall apply except that the leakage five centimeters from the surface of the tube housing shall not exceed 0.1 roentgen per hour.

(b) Conditions for operation of equipment.

(1) The output of the X-ray generator shall be calibrated prior to the use of the apparatus for treating humans. Calibration shall be performed by a person qualified pursuant to subdivision (f) of section 16.122 of this Part and experienced in the calibration of such units. The method of calibration used shall ensure accurate delivery of the prescribed dose under all conditions of use. Calibrations shall be made at least annually. Recalibration, however, shall be made after each tube replacement and after any changes or replacements in the generating apparatus which could change the x-ray ouput.

(2) If the tube must be hand-held during irradiation, the operator shall wear protective gloves and a protective apron of no less than 0.5 mm lead equivalent.

(3) The operator shall be able to observe and communicate with the patient during irradiation.

(4) Equipment having an output of more than 1,000 roentgens per minute at any accessible place shall not be left unattended without the power being shut off at the main disconnect switch in addition to the control panel switch.

(5) When operating equipment constructed with beryllium or other low filtration windows the operator shall insure that the useful beam is blocked at all times except when actually being used.

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