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The complaint has been investigated and
resolved to the customer's satisfaction
Resolved
SoClean2 CPAP cleaner

L Jul 28, 2021
This review was posted by
a verified customer
Verified customer

On May 1, 2020, I purchased a SoClean 2 Deluxe Kit from Apria Direct (Order #[protected]) for a total of $342.00. I have been using the SoClean 2 CPAP Cleaner everyday, changing the filter and one-way check valve as necessary, to clean my ResMed Air Sense 10 CPAP machine. On my most recent visit to my doctor, Thomas Kilkenny [protected]), I was advised to stop using the SoClean 2 CPAP cleaner because that cleaning device was not FDA approved, and the residual ozone in the cpap machine, tubing, and mask could pose a health risk if the ozone gets into my lungs. Using ozone to clean my ResMed cpap machine also voids the warranty on that unit. The ozone that escapes while the SoClean 2 unit is operating also poses a health risk when used in a small bedroom. I have no choice but to listen to the advise of my doctor and to stop using the SoClean 2 CPAP Cleaner. I also purchased, and never used, two (2) SoClean Replacement Cartridge Filter Kits (valued @ $30.00 each). My complaint is that I purchased an expensive cleaning machine and accessories that I can no longer use.

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RESOLVED

The complaint has been investigated and resolved to the customer's satisfaction.

  • SoClean's response · Jul 28, 2021

    Good Day, Leonard,

    Thank you for reaching out to SoClean with your concerns. As the market leader in sleep equipment maintenance products, the health and safety of our patients is our number one priority.

    The SoClean 2 is designed to minimize ozone exposure in accordance with stringent requirements. When operated in a 125 square foot room with 8-foot ceilings, the average ambient ozone concentration in the room over the operating cycle is < 0.05 parts per million (PPM), which is in line with the FDA's requirements. When the cycle is complete, there is no ozone remaining as we utilize an activated carbon filter in order to effectively convert ozone back to room oxygen over the course of the two-hour rest period.

    It is also important to note that the SoClean 2 is registered with the FDA as a Class I medical device, which means the FDA considers it a low risk to the user. Class I medical devices are not required to be FDA approved, but we continue to work cooperatively with the FDA to ensure full compliance with all applicable requirements.

    Finally, we are aware that ResMed has raised concerns about the use of ozone devices with their AirSense 10 CPAP machine, but we stand by our product and have issued a warranty policy to cover AirSense 10 devices for a three-year period (one year beyond ResMed's warranty). Effective May 2020, SoClean will cover the costs of repair or replacement if a ResMed customer is no longer able to submit a warranty claim for increased noise due to use with a SoClean device. You can view the full details of this policy at www.soclean.com/service.

    If you have any further questions or concerns, please don't hesitate to reach out to us at [email protected] or [protected].

    Kind regards,

    Emily T.
    SoClean Customer Care

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