This document specifies requirements for thebasic safetyandessential performanceof anoxygen
concentratorin combination with itsaccessories, hereafter referred to asME equipment, intended to
increase the oxygen concentration of gas intended to be delivered to a singlepatient. Suchoxygen
concentratorsare typically intended for use in thehome healthcare environmentby a singlepatientin
various environments including any private and public transportation as well as in commercial aircraft.All current amendments available at time of purchase are included with the purchase of this document.