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.
A licensee shall provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions shall include instruction in—
The procedures identified in paragraph (a)(4) of this section; and
The operating procedures for the unit.
A licensee shall retain a copy of the procedures required by paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with § 35.2610.
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