(1) All manufacturers/vendors of breath analysis instruments, associated equipment, and supplies are required to submit such breath analysis instrumentation, associated equipment, or supplies to the division for formal state approval prior to introduction into the state of Montana.

(2) A record of all breath analysis instruments which have met the approval criteria established by the division shall be kept on file at the division.

(3) A record of all associated equipment and supplies which have met approval criteria established by the division shall be kept on file at the division.

(4) The division reserves the right to withdraw approval status of any breath analysis instrument, associated equipment, or supply, or the manufacturer's/vendor's approval to market said product, if the manufacturer/vendor fails to comply with the provisions set forth in the approval criteria or regulations pertaining to the manufacturer's/vendor's responsibilities to the state of Montana.

(5) Manufacturers/vendors of breath analysis instrumentation, equipment, and/or supplies must comply with the following regulations:

(a) All manufacturers/vendors must have a completed and signed application on file with the division.

(b) All manufacturers/vendors must provide technical manuals, schematics, and other material necessary for operation, preventative maintenance, and repair of the breath analysis instruments and associated equipment.

(c) The manufacturer/vendor shall provide at least two breath analysis instruments for the approval process. The manufacturer/vendor shall provide at least two (or more at the request of the division) associated equipment devices for the approval process.

(d) The manufacturer/vendor shall send at least one representative knowledgeable in the technology and electronic configurations of the breath analysis instrument and capable of providing training for the personnel in the breath analysis section of the division. The manufacturer/vendor shall, if requested to do so, send at least one representative knowledgeable in the technology and electronic configurations of the associated equipment.

(e) The manufacturer/vendor must provide all information concerning any modification, change, or upgrade to an approved breath analysis instrument or approved associated equipment within six months of that modification, change or upgrade. The division will evaluate such modifications, changes, or updates and determine if such modification, change, or update necessitates reapproval of the breath analysis instrument.

(f) Failure to comply with these or any subsequent manufacturer/vendor related regulations may negate the manufacturers approval to market additional breath analysis instrumentation, associated equipment accessories, and/or supplies in the state of Montana.

(6) The division shall have the duty to select the primary breath analysis instrument for use in the state of Montana. Selection shall be based on, but not limited to, performance of the breath analysis instrumentation in each segment of the state approval process, breath analysis instrumentation field history, legal history, manufacturer's/vendor's support capability, and references of other users.

(7) Breath samples of deep lung air shall be analyzed using only the breath analysis instrumentation approved under this rule. Breath analyses will be performed according to an operational checklist for the breath analysis instrument being used.

(8) All results of a breath analysis shall be reported as grams of alcohol by weight per 210 liters of deep lung breath (G/210L). All test results will be reported on a form approved by the division. Copies of all test results will be sent to the division on a monthly schedule. Failure to file a copy of the report with the division does not invalidate the test results, if the report is on file at the testing location.