Please be notified of a recent important change to the label and instructions for use applicable to
the SoClean 2 device (Medical Device License 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 hominins, Staphylococcus epidermidis, and yeast: Candida albicans. The previous labelling did not specify running 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 labelling 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 providing 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
- Ensure SoClean 2 is plugged in
- Open mask chamber lid
- Press "hourglass" button twice (2 times) until the number 7 is visible in the lower left of the LCD screen
- Press "+" button until the LCD screen shows the number 12 in the lower left corner
- Press "hourglass" button again if you wish to change the auto-start time