ResMed AirFit F20 User manual

English 1
Disinfection and sterilisation guide Clinical use only
This guide is intended for multipatient use of the AirFit™F20/ AirFit™F20 for Her ResMed full face mask in a sleep lab, clinic or hospital. If you use the mask as a single user in the home, refer to the User Guide for
cleaning instructions. This guide describes ResMed’s recommended and validated procedures for cleaning, disinfection and sterilisation of the mask in accordance with ISO17664.
AirFit F20 / AirFit F20 for Her
mask component1
Thermal disinfection Chemical disinfection Sterilisation Validated number of
cycles2
Manual AWD3CIDEX™OPA Gigasept FF STERRAD™ 100S STERRAD™ NX
• Cushion 30
• Headgear – – – 30
• Elbow – – – 30
• Frame – – – – 30
1 This mask may not be available in all regions. For full details regarding the correct use of these masks, please refer to the specific User Guide. For a list of available replacement parts for each mask system, check the Components Card on www.resmed.com.
2 If a healthcare facility requires an additional disinfection or sterilisation cycle after reassembly, the number of validated cycles must be halved.
3 Automatic Washer-Disinfector
A Elbow
1 Valve (AAV)
2 Vent
3 Side buttons
4 Swivel
B Frame
C Cushion
D Headgear
5 Magnetic clips
6 Lower headgear straps
7 Upper headgear straps
A+B+C Frame system
A+B+C+D Complete system
A
1
2
3
4
B C
5 6 7
D

English 2
Thermal disinfection procedures - Manual
Disassembly Disassemble the mask according to the instructions in the User Guide.
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 component). Repeat for one more time
using fresh water.
4. Inspect and if required, repeat washing until visually clean.2
5. Allow the mask components to air dry out of direct sunlight.
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, 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 for two
more times. Squeeze to remove excess water.
5. Inspect and if required, repeat washing until visually clean.2
6. Allow the mask components to air dry out of direct sunlight.
Elbow (Manual):
1. Rinse the component under fast flowing drinking quality cold tap water for 1 minute. Pay particular
attention to all crevices and rotate movable parts.
2. Soak the component for 5 minutes in a solution of Alconox diluted with drinking quality water at 1.5-2%
and at 40-50°C. Ensure the component is fully immersed in the solution and there are no air bubbles.
3. Whilst immersed in the solution, agitate the component vigorously for another 3 minutes, then brush the
outside of the component for another minute. Pay particular attention to the swivel and vents.
4. Rinse by shaking vigorously in 5 litres of tap water for a minimum of 1 minute. Repeat for one more time
under a fast flowing water for another minute. Shake the component to remove excess water.
5. Allow the mask components to air dry out of direct sunlight.
Elbow (Manual-Ultrasonic bath):
1. Rinse and clean the component with a soft bristle brush for 1 minute under fast flowing drinking quality
cold tap water at 20-30°C. Pay particular attention to all crevices and rotate movable parts.
2. Sonicate the component for 20 minutes in an Ultrasonic cleaner filled two-thirds of Alconox solution
diluted with drinking quality water at 1% and at 20-30°C. Ensure the component is fully immersed in the
solution and there are no air bubbles. Use a basket/tray/rack to prevent contact between the component
and the tank.
3. Rinse by shaking vigorously in 5 litres of tap water at 20-30°C for a minimum of 1 minute. Repeat for one
more time.
4. Allow the mask 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:
Cushion (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.
Headgear/elbow:
• 93°C for 10 minutes.
2. On completion, remove the mask components from the hot water disinfection system.
3. Allow the mask 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.

English 3
Thermal disinfection procedures - AWD
Disassembly Disassemble the mask according to the instructions in the User Guide.
AWD Neodisher MediZym Neodisher MediClean
Cushion/headgear/elbow/frame:
Using an Automatic Washer Disinfector1, set the following machine settings:
Pre-clean 4 minutes tap water
Clean 0.5% Neodisher MediZym (enzymatic, Dr. Weigert) for 10 minutes at 45°C
Final rinse Deionised water for 3 minutes
Disinfection 93°C for 10 minutes (hot water)
Drying 15 minutes
Cushion/headgear/elbow/frame:
Using an Automatic Washer Disinfector1, set the following machine settings:
Pre-clean 4 minutes tap water
Clean 0.5% Neodisher MediClean forte (Dr. Weigert) for 10 minutes at 55°C
Neutralisation 0.1% Neodisher Z (Dr. Weigert) for 6 minutes
Final rinse Deionised water for 3 minutes
Disinfection 93°C for 10 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.
1 Validated using the AWD model: Miele & Cie, KG, Guterson, Type G 7836 CD

English 4
Chemical disinfection procedures - CIDEX OPA
Disassembly Disassemble the mask according to the instructions in the User Guide.
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 (5 litres per component). Repeat for one more time using fresh water.
4. Inspect and if required, repeat washing until visually clean.1
5. Allow the mask components to air dry out of direct sunlight.
Disinfection CIDEX OPA
1. Fully immerse and soak the disinfectable mask component in CIDEX OPA for 12 minutes according to the manufacturer’s instructions:
2. Rinse three times by shaking vigorously in drinking quality water (5 litres per component).2
3. Allow the mask 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 Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
2 Failure to adequately rinse the component may result in toxic levels of residual CIDEX OPA.

English 5
Chemical disinfection procedures - Gigasept FF
Disassembly Disassemble the mask according to the instructions in the User Guide.
Cleaning Gigazyme
Sonication – Elbow:
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.
3. Sonicate the components in ultrasonic bath filled with cleaning solution for 20 minutes. Ensure that the
components are fully immersed in the solution and there are no air bubbles. Follow the ultrasonic bath
manufacturer’s instructions.
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.
Manual – Elbow:
1. Rinse the component with drinking quality tap water for 1 minute.
2. Soak the component in a solution of Gigazyme diluted at 1% with drinking quality water at 23°C for 5
minutes. Ensure that the component is fully immersed in the solution and there are no air bubbles.
3. While immersed in the solution, agitate the component vigorously for another 3 minutes and brush the
outside only for 1 minute. Pay particular attention to the swivel and vents.
4. Rinse the component by agitating vigorously in 5 litres of drinking quality water at 20-30°C for 1 minute.
5. Rinse both internal and external parts of the component 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 component to air dry out of direct sunlight.
Manual – Cushion/headgear/frame:
1. Rinse each individual component with drinking quality 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 that the components are fully immersed in the solution and 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 1 minute
• Frame 1 minute
• Headgear 2 minutes
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 component 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 Gigasept FF
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 solution for 15 minutes. Ensure that the components are fully immersed in the solution and there are no air bubbles.
3. Rinse the components in 5 litres of drinking quality water thoroughly for 1 minute.
4. Rinse both internal and external parts of the components with drinking quality water 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.
1 Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.

English 6
Sterilisation procedures - STERRAD
Disassembly Disassemble the mask according to the instructions in the User Guide.
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 time using fresh water.
4. Inspect and if required, repeat washing until visually clean.
5. Allow the mask components to air dry out of direct sunlight.
Sterlisation STERRAD
1. Package the mask components 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 mask following the manufacturer’s instructions for the STERRAD Sterilisation System:
• STERRAD 100S Short or Long cycle
• STERRAD NX Standard or Advanced cycle
Notes:
• Drying is achieved as part of the sterilisation process.
• Boosters are not required.
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.

ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia
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. Gigasept and Gigazyme are trademarks of Schülke & Mayr.
© 2017 ResMed Ltd. 608434/3 2017-01
ResMed.com
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.
• 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