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European Standards - ResMed Nasal Mask Mirage Activa Supplementary Manual

Resmed masks disinfection/sterilization guide

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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
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 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
water bath.
Clinical Use Only
3
Medizyme or
LTH 1828-24 hot

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