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Manafacture: ResMed File size: 347.66 kb File name: Language of manual:

Pay particular attention to all crevices and cavities. 3 Rinse 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 detergents Neodisher Medizyme (concentration at 2% for 30 minutes) and Alconox (diluted at 1%). Disinfection Using a certified hot water disinfection system, soak the disinfectable mask components using one of the temperature-time combinations listed in the following sections. European Standards Based on prEN ISO 15883-1, the mask has been tested at the following temperature-time combinations: • 70°C for 100 minutes • 75°C for 30 minutes • 80°C for 10 minutes • 90°C for 1 minute. Regional Requirements Due to specific regional requirements, the mask has also been tested for disinfection at the following temperature-time combination: • 93°C for 10 minutes. Testing by ResMed has shown that the mask components can withstand 15 cycles of thermal disinfection using the above temperature-time combinations. The device used for testing was Branson™ LTH 1828-24 hot water bath. 3 English 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 1 Disassemble the mask. 2 Clean 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. 3 Rinse 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 for a list of available replacement parts for each mask system. 4 Clinical Use Only The parts that cannot be disinfected or sterilized are listed in the following table. Masks/Pillows System Parts that cann...

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