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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 (A TCC 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 AirFit P10 (mask), ResMed ClimateLine Air (tubing), and Slimline (tubing) for ResMed AirSense 10 CP AP 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 intended to reduce populations of bacteria on the surfaces of Continuous Positive Airway Pressure (CPAP) Masks and Hoses. SoClean 3+ treats CPAP Masks and Hoses while remaining disconnected from the CPAP machine.

SoClean 3+ treatment is accomplished via a user-initiated and pre-programmed Bacterial 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+ Bacterial Reduction Chamber. A strong oxidant, ozone reduces bacteria on CPAP Mask and Hose surfaces by reacting with and damaging cell membranes and other biomolecules.

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