English 3
Thermal disinfection procedures - Manual
Disassembly
Disassemble the mask according to the instructions in the User Guide. For the AirFit N20, magnetic clips must be removed from the lower headgear straps.
Cleaning
Alconox
AirFit N20 - Cushion / magnetic clips
AirFit N20 Classic - Cushion
1. Soak the component in a solution of Alconox diluted with drinking quality water at 1%, ie, 10 g per litre,
at 25-30°C, according to manufacturer’s instructions.
2. Whilst immersed in the solution, clean with a soft bristle brush for 1 minute. Pay particular attention to all
crevices and cavities.
3. Rinse by shaking vigorously in drinking quality water (five litres per component) for 1 minute. Repeat for
one more minute using fresh water.
4. Inspect and if required, repeat washing until visually clean.
2
5. Allow the components to air dry out of direct sunlight.
AirFit N20 - Frame / headgear
1. Soak the component in a solution of Alconox diluted with drinking quality water at 1%, ie, 10 g per litre,
at 20-30°C for 3 minutes, according to manufacturer’s instructions.
2. Whilst immersed in the solution, clean with a soft bristle brush for an additional 2 minutes. Pay particular
attention to all crevices and cavities.
3. Squeeze to remove excess solution.
4. Rinse by repeatedly squeezing under drinking quality water for 30 seconds at 20-30°C. Repeat two more
times. Squeeze to remove excess water.
5. Inspect and if required, repeat washing until visually clean.
2
6. Allow the components to air dry out of direct sunlight.
AirFit N20 - Elbow and short tube
1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per litre, at 45-55°C,
according to the manufacturer’s instructions.
2. Soak the component in the solution for 5 minutes. Rotate all connections three times around 360 degrees.
3. Whilst immersed in the solution, thoroughly clean with a test tube brush for an additional 1 minute. Pay
particular attention to all crevices and cavities.
4. Rinse by shaking vigorously in drinking quality water (five litres per component) at 25-30°C for 1 minute.
Repeat for one more minute using fresh water.
5. Rinse under fast-running drinking quality tap water (45-55°C) from one end of the component, for 20
seconds. Repeat the process from the other end of the component.
6. Inspect and if required, repeat washing until visually clean.
2
7. Allow the components to air dry out of direct sunlight.
Disinfection
AirFit N20 - Cushion / magnetic clips / elbow and short tube / frame / headgear
1. Using a certified hot water disinfection system, soak the disinfectable mask components using a temperature-time combination
1
, ensuring there are no air bubbles:
Cushion/magnetic clips/elbow and short tube (EN ISO 15883-1):
• 70°C for 100 minutes
• 75°C for 30 minutes
• 80°C for 10 minutes
• 90°C for 1 minute.
Frame/headgear:
• 93°C for 10 minutes.
2. On completion, remove the mask components from the hot water disinfection system.
3. Shake the components to remove excess water. For the frame and headgear, squeeze the components to remove excess water.
4. Allow the components to air dry out of direct sunlight.
Inspection
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 discolouration
of the silicone components may occur and is acceptable.
Reassembly
Reassemble the mask according to the instructions in the User Guide.
Packaging and storage
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature:
-20°C to 60°C.
1
Calculated and predicted from known thermal inactivation kinetics of vegetative micro-organisms subjected to thermal disinfection (EN ISO 15883-1) and they are inclusive of the time-temperature combination recommended by the APIC (Associations for Professionals in Infection Control and
Epidemiology) and RKI (Robert Koch Institute).
2
Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
