ResMed AirFit N20 and N20 Classic Disinfection and Sterilisation Guide Sept 2017

Thermal disinfection procedures - Manual Disassembly

Disassemble the mask according to the instructions in the User Guide. Magnetic clips must be removed from the lower headgear straps.

Cleaning

Alconox Cushion/magnetic clips: 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. 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 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.

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

1. Using a certified hot water disinfection system, soak the disinfectable mask components using a temperature-time combination1, 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 • 93°C for 10 minutes. 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. 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.

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. 1

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Thermal disinfection procedures - AWD

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Disassembly

Disassemble the mask according to the instructions in the User Guide. Magnetic clips must be removed from the lower headgear straps.

AWD

Neodisher MediZym

Neodisher MediClean

Cushion/magnetic clips/elbow and short tube/frame/headgear: Using an Automatic Washer Disinfector1, set the following machine settings:

Cushion/magnetic clips/elbow and short tube/frame/headgear: Using an Automatic Washer Disinfector1, set the following machine settings:

• Pre-clean

4 minutes tap water

• Pre-clean

4 minutes tap water

• Clean

0.5% Neodisher MediZym (enzymatic, Dr. Weigert) for 10 minutes at 45°C

• Clean

0.5% Neodisher MediClean forte (Dr. Weigert) for 10 minutes at 55°C

• Neutralisation

–

• Neutralisation

0.1% Neodisher Z (Dr. Weigert) for 6 minutes

• Final rinse

Deionised water for 3 minutes

• Final rinse

Deionised water for 3 minutes

• Disinfection

93°C for 10 minutes (hot water)

• Disinfection

93°C for 10 minutes

• Drying

15 minutes

• Drying

15 minutes

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.

Validated using an EN ISO 15883-compliant AWD model: Miele & Cie, KG, Guterson, Type G 7836 CD

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Chemical disinfection procedures Disassembly

Disassemble the mask according to the instructions in the User Guide. Magnetic clips must be removed from the lower headgear straps.

Cleaning

Alconox

Aniosyme DD1

Gigazyme

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.1 5. Allow the component to air dry out of direct sunlight.

Cushion/magnetic clips/elbow and short tube/frame/headgear: 1. Rinse each individual component with cold running tap water for 1 minute. 2. Soak the components in a solution of Aniosyme DD1 diluted at 0.5% with drinking quality water at 20°C for 8 minutes. Ensure the components are fully immersed in the solution ensuring there are no air bubbles. 3. Whilst immersed in the solution, clean the inside and outside of the components with a soft bristle brush for the specified number of minutes. Pay particular attention to the crevices and cavities.

Cushion/magnetic clips/elbow and short tube/headgear: 1. Rinse each individual component with cold running tap water for 1 minute. 2. Soak the components in a solution of Gigazyme diluted at 1% with drinking quality water at 23°C for 8 minutes. Ensure the components are fully immersed in the solution ensuring there are no air bubbles. 3. Whilst immersed in the solution, clean the inside and outside of the components with a soft bristle brush for the specified number of minutes. Pay particular attention to the crevices and cavities.

• Cushion • Magnetic clips • Elbow and short tube* • Frame • Headgear

2 minutes 30 seconds 1 minute 1 minute 2 minutes

*Use a tube/small bottle brush. 4. Rinse the components in 5 litres of drinking quality water at 20-30°C for 1 minute. 5. Rinse both internal and external parts of the components under fast running tap water at 20-30°C for another minute. 6. Inspect and if required, repeat washing until visually clean.1 7. Allow the components to air dry out of direct sunlight.

Disinfection

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• Cushion • Magnetic clips • Elbow and short tube* • Frame • Headgear

1 minute 30 seconds 1 minute 1 minute 2 minutes

*Use a tube/small bottle brush. 4. Rinse the components in 5 litres of drinking quality water at 20-30°C for 1 minute. 5. Rinse both internal and external parts of the components under fast running tap water at 20-30°C for another minute. 6. Inspect and if required, repeat washing until visually clean.1 7. Allow the components to air dry out of direct sunlight.

CIDEX OPA

Anioxyde 1000

Gigasept FF

Cushion: 1. Fully immerse and soak the component in CIDEX OPA at 20-25°C for 12 minutes according to the manufacturer’s instructions and agitate to ensure there no air bubbles. 2. Rinse the component in drinking quality water (7.5 litres per component) at 20-30°C for 1 minute.2 3. Repeat the process by using fresh water two more times. 4. Allow the component to air dry out of direct sunlight.

Cushion/magnetic clips/elbow and short tube/frame/ headgear: 1. Activate the solution according to the manufacturer’s instructions. Use Anioxyde 1000 at room temperature. 2. Soak the components in the activated solution for 5 minutes. Ensure the components are fully immersed in the solution. 3. Rinse the components in 5 litres of drinking quality water at 20-30°C for 1 minute. 4. Rinse both internal and external parts of the components under fast running tap water at 20-30°C for another minute. 5. Allow the components to air dry out of direct sunlight.

Cushion/magnetic clips/elbow and short tube/headgear: 1. Make a solution of Gigasept FF diluted at 5% with drinking quality cold water with a solution temperature of 20°C. 2. Soak the components in the activated solution for 5 minutes. Ensure the components are fully immersed in the solution. 3. Rinse the components in 5 litres of drinking quality water at 20-30°C for 1 minute. 4. Rinse both internal and external parts of the components under fast running tap water at 20-30°C for another minute. 5. 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.

Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation. Failure to adequately rinse the component may result in toxic levels of residual CIDEX OPA.

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Sterilisation procedures Disassembly

Disassemble the mask according to the instructions in the User Guide. Magnetic clips must be removed from the lower headgear straps.

Cleaning

Alconox Cushion: 1. Soak the component in a solution of Alconox diluted with drinking quality water at 1%, ie, 10 g per litre, at 20-25°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 mask). Repeat for one more minute using fresh water. 4. Inspect and if required, repeat washing until visually clean.1 5. Allow the components to air dry out of direct sunlight. 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 mask component in the solution for 5 minutes. Rotate all connections three times around 360 degrees. 3. Whilst in the solution, thoroughly clean the component with a test tube brush for an additional 1 minute. Pay particular attention to all crevices and cavities. 4. Rinse the component by agitating it vigorously in drinking quality water, 5 litres per component at 25-30°C for 1 minute. Repeat the process by using fresh water for another 1 minute. 5. Rinse the component 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.1 7. Allow the components to air dry out of direct sunlight.

Sterlisation

STERRAD 100S

STERRAD NX

Cushion: 1. Package the component prior to sterilisation as described in the manufacturer’s instructions for the STERRAD Sterilisation System. ResMed masks have been validated using the tray method. Note: The use of pouches is not recommended. 2. Sterilise the component following the manufacturer’s instructions:

Cushion/elbow and short tube: 1. Package the component prior to sterilisation as described in the manufacturer’s instructions for the STERRAD Sterilisation System. ResMed masks have been validated using the tray method. Note: The use of pouches is not recommended. 2. Sterilise the component following the manufacturer’s instructions:

• STERRAD 100S

Short cycle (boosters not required)

Notes: Drying is achieved as part of the sterilisation process.

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• STERRAD NX

Standard or Advanced cycle

Notes: Drying is achieved as part of the sterilisation process.

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.

Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.

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GENERAL WARNINGS AND CAUTIONS •

ResMed cannot give any assurance that deviations from the procedures listed in this guide (eg, exceeding the number of reprocessing cycles), and their effect on the performance of the product, will be acceptable.

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Mask components should not be subjected to autoclave or ethylene-oxide gas sterilisation.

•

When using detergents, disinfectants or sterilisation agents, always follow the manufacturer’s instructions.

•

Do not iron the headgear as the material is heat sensitive and will be damaged

ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

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DISTRIBUTED BY ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA ResMed (UK) Ltd 96 Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK

See www.resmed.com for other ResMed locations worldwide. For patent and other intellectual property information, see www.resmed.com/ip. AirFit is a trademark and/or registered trademark of the ResMed family of companies. CIDEX and STERRAD are trademarks of Johnson & Johnson. Alconox is a trademark of Alconox Inc. Neodisher MediZym and Neodisher MediClean are trademarks of Chemische Fabric Dr Weigert. Aniosyme and Anioxyde are trademarks of Laboratoires Anios. Gigasept and Gigazyme are trademarks of Schülke & Mayr. © 2017 ResMed Ltd. 608464/2 2017-01