Disinfection and sterilisation guide Clinical use only
This guide is intended for multipatient use of the AirFit™ F20 / AirTouch™ F20 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.
Cleaning
Alconox Neodisher
4
Alconox Aniosyme DD1 Gigazyme Alconox Alconox
AirFit F20 / AirTouch F20
mask component
1
Thermal disinfection Chemical disinfection Sterilisation
Manual AWD
5
CIDEX™ OPA Anioxyde 1000 Gigasept FF STERRAD™ 100S STERRAD™ NX
Validated number of
cycles
• AirFit F20 cushion 30
• AirTouch F20 cushion
3
• Standard elbow
™
3
• QuietAir
elbow
• Frame
• Headgear
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 Product Guide on 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
This component is intended for single patient reuse.
4
Neodisher MediZym or MediClean Forte.
5
Automatic Washer-Disinfector.
– – – – – – – –
– – – –
– – – – – – – –
– – –
– – –
A Standard elbow
E
A
B C
D
1 Valve (AAV)
2 Vent
3 Side buttons
4 Swivel
1
B Frame
C Cushion
2
D Headgear
5 Magnetic clips
6 Lower headgear straps
7 Upper headgear straps
3
5 6 7
4
A+B+C Frame system
A+B+C+D Complete system
E QuietAir elbow
2
30
30
30
English 1
Thermal disinfection procedures - Manual
Disassembly
Cleaning
Inspection / Drying
Disinfection
Inspection
Reassembly
Packaging and storage
1
Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
2
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).
Disassemble the mask according to the instructions in the User Guide.
Alconox
AirFit F20 cushion:
1. Soak the component in 1% Alconox solution at 20-25°C for 1 minute.
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 5 liters of drinking quality water. Repeat one more time.
Frame:
1. Rinse the component under running drinking quality water at 20-30°C for 1 minute.
2. Soak the component in 1% Alconox solution at 38.5-40°C for 5 minutes. Ensure no air bubbles are present
and all surfaces come in contact with the solution.
3. Whilst immersed in the solution, shake vigorously for another 5 minutes while squeezing the fabric of the
arms.
4. Clean with a soft bristle brush for another minute. Pay particular attention to all crevices and interfaces.
5. Rinse the component by agitating in 5 liters of drinking quality water at 19-20°C for 1 minute.
6. Rinse the component under drinking quality water at 19-20°C.
Headgear:
1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at 20-30°C,
according to the manufacturer’s instructions.
2. Soak the component in the solution for 3 minutes.
3. Thoroughly clean the mask component with a soft bristle brush for 2 minute while continuing to soak it in
the solution. Pay particular attention to all crevices and cavities.
4. Squeeze the component to remove excess solution.
5. Rinse the component by repeatedly squeezing it under running drinking quality water at 20-30°C for 30
seconds. Repeat two more times with fresh water.
1. Inspect and if required, repeat washing until visually clean.
2. Allow the mask components to air dry out of direct sunlight.
1. Using a hot water disinfection system, soak the disinfectable mask components using a temperature-time combination2:
• Cushion/standard elbow/frame: 75°C for 30 minutes; 80°C for 10 minutes; 90°C for 1 minute;
• Headgear:
2. On completion, remove the mask components from the hot water disinfection system. For the frame and headgear, squeeze the component to remove excess water.
3. Allow the mask components to air dry out of direct sunlight.
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.
Reassemble the mask according to the instructions in the User Guide.
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature: -20°C to 60°C.
93°C for 10 minutes
1
93°C for 10 minutes
Standard elbow (manual):
1. Rinse the component under running drinking quality water at 15-25°C for 1 minute.
2. Soak the component in 1.5-2% Alconox solution at 40-50°C for 5 minutes. Ensure no air bubbles are
present and all surfaces come in contact with the solution.
3. Whilst immersed in the solution, shake vigorously for another 3 minutes. Brush the component for another
minute. Pay particular attention to swivel and vents.
4. Rinse the component by vigorously agitating in 5 liters of drinking quality water at 15-25°C for 1 minute.
5. Rinse the component under running drinking quality water at 15-25°C for 1 minute.
6. Shake the component to remove excess water.
Standard elbow (ultrasonic bath):
1. Rinse and clean the component with a soft bristle brush under running drinking quality water at 20-30°C for
1 minute. Pay particular attention to all crevices, cavities and rotate moveable parts.
2. Fill two-thirds of an ultrasonic cleaner with 1% Alconox solution at 20-30°C and sonicate for 20 minutes.
Ensure the component is fully immersed in the solution. Use a basket/tray to prevent contact between the
component and the tank.
3. Rinse the component by agitating vigorously in 5 liters of drinking quality water at 20-30°C for 1 minute.
Repeat one more time.
English 2
Thermal disinfection procedures - AWD
Disassembly
AWD
Inspection
Reassembly
Packaging and storage
1
Validated using an EN ISO 15883-compliant AWD model: Miele & Cie, KG, Guterson, Type G 7836 CD
Disassemble the mask according to the instructions in the User Guide.
Neodisher MediZym Neodisher MediClean Forte
AirFit F20 cushion/standard elbow/frame/headgear:
Using an Automatic Washer Disinfector
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
Drying 15 minutes
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.
Reassemble the mask according to the instructions in the User Guide
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature: -20°C to 60°C.
1
, set the following machine settings:
AirFit F20 cushion/standard elbow/frame/headgear:
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
English 3
Chemical disinfection procedures - CIDEX OPA
Disassembly
Cleaning
Disassemble the mask according to the instructions in the User Guide.
Alconox
AirFit F20 cushion:
1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at (20-25°C, according to manufacturer’s instructions.
2. Soak the component in the solution.
3. Whilst immersed in the solution, clean with a soft bristle brush for 1 minute. Pay particular attention to all crevices and cavities.
4. Rinse by shaking vigorously in 5 liters of drinking quality water. Repeat one more time using fresh water.
Inspection/Drying
1. Inspect and if required, repeat washing until visually clean.
2. Allow the mask components to air dry out of direct sunlight.
Disinfection
CIDEX OPA
AirFit F20 cushion:
1. Fully immerse and soak the disinfectable mask components for 12 minutes in a commercially available solution according to the manufacturer’s instructions:
• ortho-phthalaldehyde 0.55% (eg, CIDEX OPA) at room temperature of 68-77°F (20-25°C).
2. Rinse the mask components 3 times in 5 liters of drinking quality water at 68-86°F (20-30°C) for 1 minute
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
Packaging and storage
Reassemble the mask according to the instructions in the User Guide.
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.
1
2
.
English 4
Chemical disinfection procedures - Anioxyde 1000
Disassembly
Cleaning
Inspection/Drying
Disinfection
Inspection
Reassembly
Packaging and storage
1
Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
Disassemble the mask according to the instructions in the User Guide.
Aniosyme DD1
Manual – AirFit F20 cushion/frame/headgear:
1. Rinse each individual component with drinking quality tap water for 1 minute.
2. Soak the components in a solution of Aniosyme DD1 diluted at 0.5% with drinking quality water at 15-20°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.
1. Inspect and if required, repeat washing until visually clean.
2. Allow the components to air dry out of direct sunlight.
Anioxyde 1000
AirFit F20 cushion/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 and there are no air bubbles.
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.
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.
Reassemble the mask according to the instructions in the User Guide.
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature: -20°C to 60°C.
1
English 5
Chemical disinfection procedures - Gigasept FF
Disassembly
Cleaning
Inspection/Drying
Disinfection
Inspection
Reassembly
Packaging and storage
1
Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
Disassemble the mask according to the instructions in the User Guide.
Gigazyme
Sonication – Standard 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.
Manual – AirFit F20 cushion/frame/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 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.
1. Inspect and if required, repeat washing until visually clean.
2. Allow the components to air dry out of direct sunlight.
Gigasept FF
AirFit F20 Cushion/standard elbow/frame/headgear:
1. Make a solution of Gigasept FF diluted at 5% with drinking quality cold water with a solution temperature of 15-25°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. For the frame, squeeze the fabric to release any air bubbles.
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.
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.
Reassemble the mask according to the instructions in the User Guide.
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature: -20°C to 60°C.
Manual – Standard 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 for 5
minutes. Ensure that the components are 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.
1
English 6
Sterilisation procedures - STERRAD
Disassembly
Cleaning
Inspection / Drying
Sterilisation
Inspection
Reassembly
Packaging and storage
1
Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
Disassemble the mask according to the instructions in the User Guide.
Alconox
AirFit F20 cushion:
1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at 20-25°C, according to manufacturer’s instructions.
2. Soak the component in the solution for 1 minute.
3. Whilst immersed in the solution, clean with a soft bristle brush for 1 minute. Pay particular attention to all crevices and cavities.
4. Rinse by shaking vigorously in 5 liters of drinking quality water. Repeat one more time.
1. Inspect and if required, repeat washing until visually clean.
2. Allow the mask components to air dry out of direct sunlight.
STERRAD
AirFit F20 cushion:
1. Package the mask components prior to sterilisation as described in the manufacturer’s instructions for the STERRAD Sterilisation System with STERRAD chemical indicators.
Note: The use of pouches is not recommended.
2. Sterilise the component 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.
• Check STERRAD indicator strips to ensure machine has run correctly.
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.
Reassemble the mask according to the instructions in the User Guide.
Store in a dry, dust-free environment away from direct sunlight.
Storage temperature: -20°C to 60°C.
1
English 7
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 or
safety 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. In case of conflict, this guide takes precedence.
• 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
ResMed.com
See ResMed.com for other ResMed locations worldwide. AirFit, AirTouch and QuietAir are trademarks and/or registered trademarks 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. For patent and other intellectual property information, see ResMed.com/ip. © 2017 ResMed Ltd. 608434/4 2017-11
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