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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 cannot be disinfected or sterilized • Mirage Vista™ Nasal Mask • Mirage Activa™ Nasal Mask • Mirage Kidsta™ Nasal Mask Swivel, short tubing • Mirage Swift™ Nasal Pillows System • Mirage Swift™ II Nasal Pillows System Short tube assembly • Mirage™ Full Face Mask Series 2 • Ultra Mirage™ Full Face Mask Valve membrane • Non-vented Ultra Mirage™ Nasal Mask • Non-vented Ultra Mirage™ Full Face Mask • Ultra Mirage™ II Nasal Mask • Non-vented Mirage™ Full Face Mask Series 2 None Note: Parts that cannot be disinfected or sterilized should be replaced when using between patients. Note: Different disinfectants and detergents are available in each country. For this reason, ResMed has identified alternatives as examples and has validated the disinfectants and detergents listed in this guide. 5 English Clinical Use Only 6 Nur zur klinischen Behandlung ResMed Desinfektion/Sterilisation der Maske oder des Nasenpolstersystems bei einem Patientenwechsel Diese Hinweise zur Desinfektion/Sterilisation wurden für Masken- oder Nasen...

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