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However, it is necessary to thoroughly wash the headgear before using between patients. The cleaning procedure is detailed in the User Guide. • The mask must be disassembled and cleaned prior to disinfection or sterilization. The mask must also be inspected after disinfection/sterilization. See the section "Inspection after Disinfection/Sterilization" for inspection details. * References to mask/s in this guide refer to ResMed masks and nasal pillows system. 1 English Clinical Use Only After disassembly, thoroughly disinfect or sterilize the mask components by following the procedure for one of these methods: • Chemical Disinfection • Thermal Disinfection • STERRAD™ Sterilization. Option 1: Chemical Disinfection Pre-disinfection 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, Aniosyme™ DDI or Alconox™). Pay particular attention to all crevices and cavities. 3 Rinse the components twice by agitating them vigorously in drinking quality water (5 litres per mask) and allow them to air dry out of direct sunlight. ResMed has tested the detergents Aniosyme DDI (diluted at 0.5% for 15 minutes) and Alconox (diluted at 1 %). Disinfection 1 Soak the disinfectable mask components in a commercially available solution of peracetic acid 0.15% (eg, Anioxyde™1000), ortho-phthalaldehyde 0.55% (eg, CIDEX™ OPA) or glutaraldehyde 3.4% (eg, CIDEX Plus™). 2 Rinse the mask components in drinking quality water (5 litres per mask) and allow them to air dry out of direct sunlight. Testing by ResMed has shown that the mask components can withstand 15 cycles using solutions of peracetic acid (0.15% Anioxyde 1000 for 30 minutes), ortho-phthalaldehyde (0.55% CIDEX OPA for 20 minutes) or glutaraldehyde (3.4% CIDEX Plus for 20 minutes). Note: If using the detergents and disinfectants listed above, the following combinations should be followed: • Detergent Aniosyme DDI with Anioxyde 1000 as the disinfectant OR • Detergent Alconox with disinfectant CIDEX OPA or CIDEX Plus. 2 Clinical Use Only Option 2: Thermal Disinfection Pre-disinfection 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, Neodisher™ Medizyme or 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 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 minute...

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