Mich. Admin. Code R. 333.5396 - Hand-held portable dental x-ray systems
Rule 396.
(1)
As used in this section, "handheld dental X-ray system" or "system" means an
X-ray system that is used to take radiographs, is designed to be handheld
during its operation, and is portable.
(2) A handheld dental X-ray system that meets
the requirements described in this section may be used for routine dental
radiography in a dental office or a situation in which it is impractical to
transfer a patient to a radiation machine that is stationary.
(3) X-ray equipment designed to be hand-held
must meet the requirements of
R
333.5373, excluding subrules (9) and (13).
(4) The x-ray tube housing for tubes designed
to be hand-held must be constructed so that the leakage radiation measured in
air at a distance 5 centimeters from a point on the external surface does not
exceed 0.02 mGy (2 milliroentgens) in 1 hour when operated under conditions of
maximum radiation output permitted by the design or operating characteristics
of the radiation machine.
(5)
Operation of a hand-held portable x-ray system must meet the requirements of
R
333.5376, excluding subrules (3) and (6).
(6) A person shall not use a handheld dental
X-ray system to perform dental radiography unless the machine is registered
with the department under department rules for registration of radiation
machines and the system, the personnel operating the system, and the facility
in which the system is used meet all of the following requirements:
(a) The system has been approved for human
use by the United States Food and Drug Administration and is used in a manner
consistent with that approval.
(b)
The system has a backscatter shield that meets all of the following
requirements:
(i) The shield is composed of a
leaded polymer or a lead-equivalent substance that has a substantially
equivalent protective capacity.
(ii) The shield has at least 0.5 millimeters
of lead or lead-equivalent shielding, as determined by the
department.
(iii) The shield is
permanently affixed to the system.
(c) The system is calibrated by its
manufacturer before its first use and is recalibrated at least every 24 months
after the date of the last calibration.
(d) When not in use, the system is stored in
a manner that restricts access to the system, such as by storing the system in
a locked area of the facility.
(e)
Each individual who operates the system is an individual who is authorized to
operate a dental radiography machine pursuant to rules promulgated under part
166 of the act, MCL 333.16601 to 333.16659.
(f) An individual operating the system is not
required to wear a lead apron or other personal monitoring equipment while
operating the system if it is determined that the use of the system is in
compliance with part 381 of the Michigan occupational safety and health
administration general industry safety and health standards,
R
325.60601a to R 325.60618, or equivalent federal
occupational safety and health standards; part 33 of the Michigan occupational
safety and health administration general industry safety and health standard,
R
408.13301 to
R 408.13395g, or equivalent
federal occupational safety and health standards;
R
333.5057; and
R
333.5063 to
R 333.5065. However, upon request, a
registrant shall make a lead apron or other personal monitoring equipment
available to an individual who operates the system.
(g) The system is not used if the backscatter
shield described in subdivision (b) of this subrule is broken, missing, or
malfunctioning.
(7) An
operator shall complete the training program supplied by the manufacturer and
approved by the department before using the x-ray unit. Records of the training
shall be maintained on file for examination by the department.
Notes
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