SoClean 2 Labelling Amendment in Canada

Please be notified of recent important change to the label and instructions for use applicable to
the SoClean 2 device (Medical Device Licence No. 100197) in Canada. SoClean 2 users should be aware of the following labelling changes, which were approved by Health Canada in June 2021:

• Running the SoClean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of
  microorganisms. Independent lab testing with SoClean 2 demonstrates that, when set at the 12-
  minute cycle time duration, it kills 99.9% of the following microorganisms comprised of the following bacteria: Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus epidermidis, and yeast: Candida albicans. Previous labelling did not specify to run SoClean 2 for a 12-minute cycle.
• SoClean 2 is not an Automated PAP disinfecting system but rather an Automated Supplemental PAP Maintenance Device.
• Users must follow the CPAP-manufacturer’s instructions for cleaning their PAP accessories. The
  SoClean 2 is intended for use as a supplement to that cleaning.

The SoClean 2 is intended for use with single-user, personal at-home-use PAP device accessories. This labeling amendment was made in consultation with Health Canada. Health Canada considers the re-labelling to be a recall, so we are notifying you of the action taken and to provide you with the following link to the updated label and instructions for use for the SoClean 2: SoClean2 CA IFU. This notice applies only to Canada.

No action is required in connection with the SoClean 2 device itself and it can continue to be used safely and effectively in accordance with the updated label and instructions for use linked above. All new orders and/or new customers will be provided with the new label/instructions for use.

Changing SoClean 2 From Factory Set 7-Minute To 12-Minute Cycle