Clinical Use Only
Option 3: STERRAD Sterilization System
Note: The Ultra Mirage™ II Nasal Mask is not validated for the STERRAD Sterilization System.
Pre-sterilization
1Disassemble the mask.
2Clean the individual parts of the mask with a soft bristle brush for one minute while soaking them in detergent (eg, Alconox). Pay particular attention to all crevices and cavities.
3Rinse the components twice by agitating them vigorously in drinking quality water and allow them to air dry out of direct sunlight.
ResMed has tested the detergent Alconox (diluted at 1%).
Sterilization
Sterilize the sterilizable mask components as described in the manufacturer’s instructions for the STERRAD Sterilization System (eg, Sterrad 100S or Sterrad NX).
Testing by ResMed has shown that the mask components can withstand 15 cycles of the STERRAD 100S Sterilization System, when using the tray method.
Note: The use of pouches is not recommended.
Inspection after Disinfection/Sterilization
Perform a visual inspection of each mask component. If any visible deterioration of a mask component is apparent (cracking, crazing, tears etc), the mask component should be discarded and replaced. Slight discoloration of the silicone components may occur and is acceptable.
Note: If a healthcare facility requires an additional disinfection or sterilization process after reassembly, the number of validated cycles is halved.
Parts not Validated for Multipatient Use
Some parts of the masks have not been validated for multipatient use. These parts need to be replaced with new parts when using between patients. Please check the Components Card on the website www.resmed.com for a list of available replacement parts for each mask system.
4