SoClean 2 Labelling Amendment in Canada

Re-labelling & New Instructions For Your SoClean 2

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

• Running 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 for a 12-minute cycle.
• SoClean 2 is not an Automated PAP disinfecting system, rather an Automated Supplemental PAP
  Maintenance Device.
• Users must follow the CPAP-manufacturer’s instructions for cleaning their PAP accessories. SoClean 2 is intended for use as a supplement to that cleaning.

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 writing to notify you of the action taken and to provide you with the following link to the updated label and instructions for use for SoClean 2: SoClean2 CA IFU. This notice applies only within Canada.

No action is required in connection with 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 Your SoClean 2 From Factory Set 7-Minute Cycle To 12 Minute Cycle