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The DGSS™ is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children.

The DGSSTM is a single unit, designed to replace a traditional anesthetic gas scavenging (interface) assembly, located between the exhaust outlet of an anesthesia machine and the waste anesthetic gas disposal (WAGD) suction line in an operating room. Like prior technology, it provides a safe interface between anesthesia delivery systems and hospital-provided WAGD suction lines, The DGSS™ is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The DGSS™ incorporates the same safety systems as predicate devices, providing relief of excess positive pressure and excess negative pressure to the patient through the use of "pop-off" relief valves, in compliance with ASTM 1343-02 - Anesthetic Equipment - Scavenging Systems for Anesthetic Gases. Although the indications and intended use are identical with predicate devices, the DGSS™ replaces the manually-adjusted needle valve with an automatic mechanism regulating the flow in the WAGD suction line. This valve is controlled by a pressuresensing switch which closes the valve when negative pressure is sensed in the manifold. This serves to reduce the needless entrainment of room air into the WAGD system of the healthcare facility. This sensor-valve arrangement operates within the inlet pressure range of -0.5 to 3.5 cm H2O, as specified by ASTM 1343-02 The valve-sensor mechanism is electrically powered with low-voltage direct current to prevent any hazard of electrical or fire injury in compliance with IEC 60601-1. The valve is normally open, so that a failure of electrical power results in the unit reverting to function identically to the predicate device. Other failure modes operate identically with the predicate device. Although the electrical portion of the device section presents no hazard of spark or fire, additional protection is provided by physically separating the electrical system from the waste gas pathway. This isolates the electrical subsystem from exposure to any oxygen-enriched waste anesthetic gas. Although technologically more advanced and efficient than the predicate device, the DGSS™ presents no additional issues of safety or efficacy due to its design. Any failure of the new design feature converts the device to one identical to predicate technology. Due to this design, the DGSS™ is substantially equivalent to the predicate device.