ResMed
ResMed AirFit F20 and AirTouch Disinfection Guide June 2020
Disinfection Guide
5 Pages
Preview
Page 1
Disinfection and sterilization 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 sterilization of the mask in accordance with ISO17664.
AirFit F20 / AirTouch F20 mask component1
High level thermal disinfection
High level chemical disinfection
176°F (80°C)-10 min; 167°F (75°C)-30 min; 194°F (90°C)-1 min 200°F (93°C)-10 min
CIDEX™ OPA Ortho-phthalaldehyde 0.55%
Sterilization STERRAD™ 100S
Validated number of cycles2
STERRAD™ NX Standard or Advanced cycle
• AirFit F20 cushion
30
-
-
-
-
N/V4
• Elbow
-
-
-
30
• Frame
-
-
-
30
-
-
-
30
• AirTouch F20 cushion3
-
-
• Headgear
This mask may not be available in all regions. For full details regarding the correct use of this mask, 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 sterilization cycle after reassembly, the number of validated cycles must be halved. 3 The AirTouch F20 cushion is intended for single-patient reuse in both home and hospital/institutional environments and recommended to be replaced monthly. 4 Not validated. 1 2
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
1
Thermal disinfection procedures - Manual Disassembly
Disassemble the mask according to the instructions in the User Guide.
Cleaning
Alconox
Control III
AirFit F20 cushion : 1. Soak the component in 1% Alconox solution at 68-77°F (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 68-86°F (20-30°C) for 1 minute. 2. Soak the component in 1% Alconox solution at 101-104°F (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 66-68°F (19-20°C) for 1 minute. 6. Rinse the component under drinking quality water at 66-68°F (19-20°C). Headgear: 1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at 68-86°F (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 minutes 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 68-86°F (20-30°C) for 30 seconds. Repeat two more times with fresh water. 1
1 2
Elbow (manual): 1. Rinse the component under running drinking quality water at 59-77°F (15-25°C) for 1 minute. 2. Soak the component in 1.5-2% Alconox solution at 104-122°F (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 59-77°F (15-25°C) for 1 minute. 5. Rinse the component under running drinking quality water at 59-77°F (15-25°C) for 1 minute. 6. Shake the component to remove excess water. Elbow (ultrasonic bath): 1. Rinse and clean the component with a soft bristle brush under running drinking quality water at 68-86°F (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 68-86°F (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 68-86°F (20-30°C) for 1 minute. Repeat one more time.
AirFit F20 cushion1: 1. Make a solution of Control III by diluting with drinking quality water at 1.5-2%, ie, 15-20 g per liter, at 68-86°F (20-30°C), according to manufacturer’s instructions. 2. Soak the component in the solution for 10-15 minutes. 3. Whilst immersed in the solution, clean with a soft bristle brush. Pay particular attention to all crevices and cavities. 4. Rinse by shaking vigorously in 5 liters of drinking quality water. Repeat one more time.
Inspection / Drying
1. Inspect and if required, repeat washing until visually clean.2 2. Allow the mask components to air dry out of direct sunlight.
Disinfection
1. Using a hot water disinfection system, soak the disinfectable mask components using a temperature-time combination: • AirFit F20 cushion/elbow/frame: 167°F (75°C) for 30 minutes; 176°F (80°C) for 10 minutes; 194°F (90°C) for 1 minute; 200°F (93°C) for 10 minutes • Headgear: 167°F (75°C) for 30 minutes; 200°F (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 discoloration 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: -4°F to 140°F (-20°C to 60°C).
These instructions are not intended for use with the AirTouch F20 cushion. Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation. English
2
Chemical disinfection procedures - CIDEX OPA Disassembly
Disassemble the mask according to the instructions in the User Guide.
Cleaning
Alconox AirFit F20 cushion1: 1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at 68-77°F (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 2. Allow the mask components to air dry out of direct sunlight.
Disinfection
CIDEX OPA 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 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 discoloration 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: -4°F to 140°F (-20°C to 60°C).
These instructions are not intended for use with the AirTouch F20 cushion. Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation. 3 Failure to adequately rinse the component may result in toxic levels of residual CIDEX OPA. 1 2
English
3
Sterilization procedures - STERRAD Disassembly
Disassemble the mask according to the instructions in the User Guide.
Cleaning
Alconox AirFit F20 cushion1: 1. Make a solution of Alconox by diluting with drinking quality water at 1%, ie, 10 g per liter, at 68-77°F (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.
Inspection / Drying
1. Inspect and if required, repeat washing until visually clean.2 2. Allow the mask components to air dry out of direct sunlight.
Sterilization
STERRAD 1. Package the mask components prior to sterilization as described in the manufacturer’s instructions for the STERRAD Sterilization System with STERRAD chemical indicators. Note: The use of pouches is not recommended. 2. Sterilize the mask following the manufacturer’s instructions for the STERRAD Sterilization System: • STERRAD 100S • STERRAD NX (Standard or Advanced cycle) Notes: • Drying is achieved as part of the sterilization process. • Check STERRAD indicator strips to ensure machine has run correctly.
1 2
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 discoloration 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: -4°F to 140°F (-20°C to 60°C).
These instructions are not intended for use with the AirTouch F20 cushion. Failure to clean the mask component as indicated may result in inadequate disinfection and sterilisation.
English
4
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 sterilization.
•
When using detergents, disinfectants or sterilization agents, always follow the manufacturer’s instructions. In the event of conflict, this guide take precedence.
•
Do not iron the headgear as the material is heat sensitive and will be damaged.
ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
ResMed.com
See ResMed.com for other ResMed locations worldwide. AirFit and AirTouch 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. For patent and other intellectual property information, see ResMed.com/ip. © 2020 ResMed. 608451/5 2020-06