(a)As an EBT manufacturer, you must submit, for NHTSA approval, a quality assurance plan (QAP) for your EBT before ODAPC places the EBT on its Web page for “Approved Evidential Breath Measurement Devices.”
(1)Your QAP must specify the methods used to perform external calibration checks on the EBT, the tolerances within which the EBT is regarded as being in proper calibration, and the intervals at which these checks must be performed. In designating these intervals, your QAP must take into account factors like frequency of use, environmental conditions ( e.g., temperature, humidity, altitude) and type of operation ( e.g., stationary or mobile).
(2)Your QAP must also specify the inspection, maintenance, and calibration requirements and intervals for the EBT.
(b)As the manufacturer, you must include, with each EBT, instructions for its use and care consistent with the QAP.
(c)As the user of the EBT ( e.g., employer, service agent), you must do the following:
(1)You must follow the manufacturer's instructions (see paragraph (b) of this section), including performance of external calibration checks at the intervals the instructions specify.
(2)In conducting external calibration checks, you must use only calibration devices appearing on NHTSA's CPL for “Calibrating Units for Breath Alcohol Tests.”
(3)If an EBT fails an external check of calibration, you must take the EBT out of service. You may not use the EBT again for DOT alcohol testing until it is repaired and passes an external calibration check.
(4)You must maintain records of the inspection, maintenance, and calibration of EBTs as provided in § 40.333(a)(3).
(5)You must ensure that inspection, maintenance, and calibration of the EBT are performed by its manufacturer or a maintenance representative certified either by the manufacturer or by a state health agency or other appropriate state agency.