(a) Contents. The manufacturer must include operating and storage instructions and a maintenance and service life plan with each new CPDM device sold. These documents must be clearly written.

(1) Operating and storage instructions must include:

(i) An explanation of how the CPDM works;

(ii) A schematic diagram of the CPDM;

(iii) Procedures for wearing and use of the CPDM;

(iv) A one page “quick start guide” that will enable a novice to start and operate the CPDM.

(v) Procedures for calibration of the CPDM;

(vi) Procedures for inspecting the operating condition of the CPDM;

(vii) Procedures and conditions for storage, including the identification of any storage conditions that would likely impair the effective functioning of the CPDM; and

(viii) Procedures and conditions of use, including identification of any conditions of use that would likely impair the effective functioning of the CPDM.

(2) The maintenance and service life plan must address:

(i) Conditions that should govern the removal from service of the CPDM; and

(ii) Procedures that a user or others should follow when inspecting, performing maintenance and calibration, and determining when the CPDM should be removed from service.

(b) Submission to NIOSH for approval. A copy of the instructions and plan under paragraph (a) of this section shall be submitted to NIOSH with the application for approval of the CPDM and if substantive changes are made to the approved device or approved instructions.