ResMed
AirFit F20 Face Mask ResMed Disinfection and Sterilisation Guide
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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 Manual
Chemical disinfection
Sterilisation
CIDEX OPA
STERRAD
Automatic Washer Disinfector (AWD)
™
Validated number of cycles2
™
100S
NX
• Cushion
30
• Headgear
–
–
–
30
• Elbow
–
–
–
30
–
–
–
30
–
• Frame 1 2
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. If a healthcare facility requires an additional disinfection or sterilisation cycle after reassembly, the number of validated cycles must be halved.
B
A
D
C
1 2
3 4
5 6
7
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 English
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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.
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 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 Disinfector3, set the following machine settings:
Cushion/headgear/elbow/frame: Using an Automatic Washer Disinfector3, 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
Final rinse
Deionised water for 3 minutes
Neutralisation
0.1% Neodisher Z (Dr. Weigert) for 6 minutes
Disinfection
93°C for 10 minutes (hot water)
Final rinse
Deionised water for 3 minutes
Drying
15 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.
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. 3 Validated using the AWD model: Miele & Cie, KG, Guterson, Type G 7836 CD 1
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Chemical disinfection procedures 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. 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).1 3. Allow the mask components to air dry out of direct sunlight.
1
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 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.
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 no 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.
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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.
•
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
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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. © 2016 ResMed Ltd. 608434/2 2016-12