DHS 157.67(1)(b)1.1. Is approved in the sealed source and device registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the sealed source and device registry, but must be used in accordance with radiation safety conditions and limitations described in the sealed source and device registry. DHS 157.67(1)(b)2.2. In research in accordance with an active investigational device exemption application accepted by the FDA and provided the requirements of s. DHS 157.61 (6) are met. DHS 157.67(2)(2) Surveys of patients and human research subjects treated with a remote afterloader unit. DHS 157.67(2)(a)(a) Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source has been removed from the patient or human research subject and returned to the safe shielded position. DHS 157.67(3)(3) Installation, maintenance, adjustment and repair. DHS 157.67(3)(a)(a) A person shall be specifically licensed by the department, NRC or another agreement state to install, maintain, adjust or repair a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source driving unit used to move the source or other electronic or mechanical component that could expose the source, reduce the shielding around the source or compromise the radiation safety of the unit or the source. DHS 157.67(3)(b)(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the department, NRC or another agreement state may install, replace, relocate or remove a sealed source or source contained in other remote afterloader units, teletherapy units or gamma stereotactic units. DHS 157.67(3)(c)(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the department, NRC or another agreement state, or an authorized medical physicist, shall install, replace, relocate or remove a sealed source contained in the unit. DHS 157.67(3)(d)(d) A licensee shall retain a record of the installation, maintenance, adjustment and repair done on remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units under s. DHS 157.71 (19). DHS 157.67(4)(4) Safety procedures and instructions for remote afterloader, teletherapy and gamma stereotactic radiosurgery units. DHS 157.67(4)(a)1.1. Secure the unit, console, console keys and the treatment room when unattended or not in use. DHS 157.67(4)(a)2.2. Permit only individuals approved by the authorized user, radiation safety officer or authorized medical physicist to be present in the treatment room during treatment with the source. DHS 157.67(4)(a)3.3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable. DHS 157.67(4)(a)4.4. Develop, implement and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position or remove the patient or human research subject from the radiation field with controls from outside the treatment room. The procedure shall include all the following: DHS 157.67(4)(a)4.a.a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions. DHS 157.67(4)(a)4.b.b. The process for restricting access to and posting signs in the proximity of the treatment area to minimize the risk of inadvertent exposure. DHS 157.67(4)(a)4.c.c. The names and telephone numbers of the authorized users, the authorized medical physicist and the radiation safety officer to be contacted if the unit or console operates abnormally. DHS 157.67(4)(b)(b) A copy of the procedures required by par. (a) 4. shall be physically located at the unit console. DHS 157.67(4)(c)(c) A licensee shall post instructions at the unit console to inform the operator of both of the following: DHS 157.67(4)(c)2.2. The names and telephone numbers of the authorized users, the authorized medical physicist and the radiation safety officer to be contacted if the unit or console operates abnormally. DHS 157.67(4)(d)(d) A licensee shall provide operational and safety instruction, initially and at least annually, at intervals not to exceed 13 months, to all persons who operate the unit, as appropriate to the person’s assigned duties, in all of the following: DHS 157.67(4)(e)(e) A licensee shall ensure that operators, authorized medical physicists and authorized users participate in drills of the emergency procedures, initially and at least annually, at intervals not to exceed 13 months, thereafter. DHS 157.67(4)(g)(g) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.