Texas Register, Volume 32, Number 23, Pages 3077-3422, June 8, 2007 Page: 3,163
3077-3422 p. ; 28 cm.View a full description of this periodical.
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(i) treatment table retraction mechanism, using
backup battery power or hydraulic backups with the unit "off;"
(ii) helmet microswitches;
(iii) emergency timing circuits; and
(iv) stereotactic frames and localizing devices (trun-
nions); and
(B) determination of the following:
(i) the output for one typical set of operating con-
ditions measured with the dosimetry system described in subsection
(iii)(2) of this section;
(ii) the difference between the measurement made in
clause (i) of this subparagraph and the anticipated output, expressed as
a percentage of the anticipated output, (i.e., the value obtained at last
full calibration corrected mathematically for physical decay);
(iii) sealed source output against computer calcula-
tion;
(iv) timer accuracy and linearity over the range of
use;
(v) "on-off" error; and
(vi) trunnion centricity.
(5) To satisfy the requirements of paragraphs (1)(B) and
(C) of this subsection, spot checks shall assure proper operation of the
following:
(A) electrical interlocks at each gamma stereotactic ra-
diosurgery room entrance;
(B) sealed source exposure indicator lights on the
gamma stereotactic radiosurgery unit, on the control console, and in
the facility;
(C) viewing and intercom systems;
(D) timer termination;
(E) radiation monitors used to indicate room exposures;
and
(F) emergency "off" buttons.
(6) The licensee shall arrange for prompt repair of any sys-
tem identified in paragraph (4) of this subsection that is not operating
properly.
(7) If the results of the checks required in paragraph (5)
of this subsection indicate the malfunction of any system, the licensee
shall lock the control console in the "off" position and not use the unit
except as may be necessary to repair, replace, or check the malfunc-
tioning system.
(8) The licensee shall retain a record of each check required
by paragraphs (4) and (5) of this subsection in accordance with subsec-
tion (www) of this section for inspection by the agency. The record
shall include the following:
(A) date of the spot check;
(B) manufacturer's name, and model and serial number
for the gamma stereotactic radiosurgery unit and the instrument used
to measure the output of the unit;
(C) an assessment of timer linearity and accuracy;
(D) the calculated "on-off" error;
(E) a determination of trunnion centricity;(F) the difference between the anticipated output and
the measured output;
(G) an assessment of sealed source output against com-
puter calculations;
(H) notations indicating the operability of radiation
monitors, helmet microswitches, emergency timing circuits, emer-
gency "off" buttons, electrical interlocks, sealed source exposure
indicator lights, viewing and intercom systems, timer termination,
treatment table retraction mechanism, and stereotactic frames and
localizing devices (trunnions);
(I) the name of the individual who performed the peri-
odic spot check; and
(J) the signature of an authorized medical physicist who
reviewed the record of the spot check.
(ppp) Additional technical requirements for mobile remote af-
terloader units.
(1) A licensee providing mobile remote afterloader service
shall do the following:
(A) check survey instruments before medical use at
each address of use or on each day of use, whichever is more frequent;
and
(B) account for all sealed sources before departure from
a client's address of use.
(2) In addition to the periodic spot checks required by sub-
section (nnn) of this section, a licensee authorized to use remote after-
loaders for medical use shall perform checks on each remote afterloader
unit before use at each address of use. At a minimum, checks shall be
made to verify the operation of the following:
(A) electrical interlocks on treatment area access
points;
(B) sealed source exposure indicator lights on the re-
mote afterloader unit, on the control console, and in the facility;
(C) viewing and intercom systems;
(D) applicators, sealed source transfer tubes, and trans-
fer tube-applicator interfaces;
(E) radiation monitors used to indicate room exposures;
(F) sealed source positioning (accuracy); and
(G) radiation monitors used to indicate whether the
sealed source has returned to a safe shielded position.
(3) In addition to the requirements for checks in paragraph
(2) of this subsection, the licensee shall ensure overall proper opera-
tion of the remote afterloader unit by conducting a simulated cycle of
treatment before use at each address of use.
(4) If the results of the checks required in paragraph (2)
of this subsection indicate the malfunction of any system, the licensee
shall lock the control console in the "off" position and not use the unit
except as may be necessary to repair, replace, or check the malfunc-
tioning system.
(5) The licensee shall maintain a record for inspection by
the agency, in accordance with subsection (www) of this section, of
each check required by subparagraph (B) of this paragraph. The record
shall include the following:
(A) date of the check;PROPOSED RULES June 8, 2007 32 TexReg 3163
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Texas. Secretary of State. Texas Register, Volume 32, Number 23, Pages 3077-3422, June 8, 2007, periodical, June 8, 2007; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth97400/m1/86/: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.