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The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established. The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.

SoClean 3+ is an ozone-generating device used as an adjunct for bacterial reduction of certain compatible continuous positive airway pressure (CPAP) mask and hoses after performing the cleaning steps as recommended per the procedures of the original mask and hose manufacturer. To use the device, the CPAP Hose is disconnected from the CPAP machine and inserted into the Hose Port on the SoClean 3+. The other end of the CPAP Hose (near where the CPAP Masks attaches) is routed through the SoClean 3+ Hose Slot and the CPAP Mask is placed inside the SoClean 3+ Microbial Reduction Chamber. The lid of the SoClean 3+ is then closed, and a "Microbial Reduction Cycle" is initiated which generates and conveys humidified ozone through the CPAP Hose and CPAP Mask and into the SoClean 3+ Microbial Reduction Chamber. Prior to its exhaust, ozone generated from SoClean 3+ is converted to molecular oxygen via an Ozone Catalyst Filter located on the SoClean 3+ device. SoClean 3+ treatment is accomplished via a user-initiated and pre-programmed Microbial Reduction Cycle. During this cycle, SoClean 3+ produces ozone which is humidified in the SoClean 3+ Humidification Unit and conveyed through the CPAP Hose to the CPAP Mask and into the SoClean 3+ Microbial Reduction Chamber. A strong oxidant, ozone reduces bacteria on CPAP Mask and Hose surfaces by reacting with and damaging cell membranes and other biomolecules. SoClean 3+ can also perform a Fresh Air Cycle, where only the Air Pump and the Exhaust Fan operate for 5 minutes to move fresh air through the CPAP airway. Ozone is not generated during the Fresh Air Cycle. SoClean 3+ includes an Ultraviolet (UV) ozone sensor that monitors ozone concentrations, providing feedback to the Ozone Generator itself for ozone production adjustment and to the SoClean 3+ user via LED lights on the UI when measured ozone concentrations are above or below the prespecified 270 ± 15 ppm range.