Federal Aviation Administration

Pulse oxygen systems deliver a pulse or bolus of oxygen during inhalation through a nasal cannula or oro-nasal mask. The design and function of pulse oxygen systems contains elements of continuous flow and diluter demand oxygen delivery systems. Continuous flow and diluter demand systems are defined by Federal Aviation Administration (FAA) regulation; however, these regulations do not define requirements for the certification of pulse oxygen systems. To provide data for potential certification actions, a physiological performance evaluation of an electronically operated pulse oxygen system manufactured by the Mountain High Company (MH) and a mechanical system manufactured by the Precise Flight Company (PF) was conducted in the Civil Aerospace Medical Institute’s research altitude chamber. Both the MH and PF systems were tested at 18,000 ft using nasal cannulas and oro-nasal masks for oxygen delivery and at 25,000 ft using only the oro-nasal masks as the delivery method. Sixteen subjects tested the MH system and 14 subjects tested the PF system. Pulse arterial oxygen saturation (SpO2) was determined via pulse oximeter. Heart rate and subjective observations were also used to assess system performance. Based on performance requirements for diluter demand oxygen systems, maintenance of an equivalent to 5,000 ft altitude breathing ambient air was established as the primary test criterion. The MH systems met the 5,000 ft criterion in all test conditions The PF system did not meet test criterion wit