ResMed AirFit F20 Magnetic Full Face Mask Installation Guide

**ResMed AirFit F20 Magnetic Full Face Mask Installation Guide

**

Disinfection and sterilisation guide Clinical use only

WARNING
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.

This guide is intended for multipatient use of the AirFit™ F20 / AirFit F20 NV / AirTouch™ F20 ResMed / AirFit F20 Non Magnetic 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. The processor is responsible for ensuring that reprocessing is completed in accordance with ResMed’s validated procedures.

STERRAD™ NX

• Air Fit  F20 cushion

| | | | | | | | | 30

• Air Touch F 20 cushion

3

| –| –| –| –| –| –| –| –| –

• Standard elbow

| | | | –| –| | –| –| 30

• Non-vented elbow

| | –| | –| –| –| –| –| 30
•  QuietAir™ elbow3| –| –| –| –| –| –| –| –| –

• Frame

| | | | –| | | –| –| 30

• AirFit F20 Non Magnetic frame3

| –| –| –| –| –| –| –| –| –

• Headgear

| | | | –| | | –| –| 30
•  AirFit F20 Non Magnetic headgear3| –| –| –| –| –| –| –| –| –

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. Replace with new parts between patients.
4. Automatic Washer- Disinfection.
5. This sterilisation procedure is an alternative to the disinfection procedure for reprocessing

A Standard 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
E : QuietAir elbow
F : Non-vented elbow

Thermal disinfection procedures – Manual

1. Disassembly| Disassemble the mask according to the instructions in the User Guide.
---|---
2. Cleaning| 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.

| 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.
5. 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.

Non-Vented elbow (manual):

1. Soak the component in 1% Alconox solution at 30-55°C for 5 to 10 minutes. Ensure there are no air bubbles.
2. After the soaking time, while keeping the component in the solution, clean the inside and outside with a soft bristle brush for 30 seconds. Pay particular attention to the crevices and cavities. 3. Rinse the component under running water (≤60°C) directly contacting all surfaces for 30-60 seconds.

3. Inspection / Drying|

1. Using a hot water disinfection system, soak the disinfectable mask components using a temperature-time combination2 :
   • Cushion/standard elbow/non-vented elbow/frame: 75°C for 30 minutes; 80°C for 10 minutes; 90°C for 1 minute; 93°C for 10 minutes
   • Headgear: 93°C for 10 minutes.
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.

5. 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.
6. Reassembly| Reassemble the mask according to the instructions in the User Guide.
                                                                       7. 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 sterilization.
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).

Thermal disinfection procedures – AWD

1. Disassembly| Disassemble the mask according to the instructions in the User Guide.
---|---
2. AWD| Isherwood Medium| Isherwood Media Clean forte
Air Fit F20 cushion/standard elbow/frame/headgear:Using an Automatic Washer Disinfect or 1, set the following machine settings:| Air Fit F 20 cushion/standard elbow/frame/headgear:                        Non-vented elbow:Using an Automatic Washer Disinfect or 1, set the following machine

1. Soak the mask components in a 5 liter rinse bath of cold tap water 2 for settings:                   1 minute. Ensure there are no air bubbles on the components.2. Rinse each component under cold running tap water 2 for 30 seconds 3. Transfer the components into an ISO 15883 series compliant washer- disinfection.
   3. Inspection| 1. Inspect and if required, repeat all steps in Section [2. AWD] step until visually clean3.2. 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.
   4. Reassembly| Reassemble the mask according to the instructions in the User Guide
   5. Packaging and storage| Store in a dry, dust-free environment away from direct sunlight.Storage temperature: -20°C to 60°C.

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

3. Drinking quality water

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

Chemical disinfection procedures – CIDEX OPA

Disassembly| Disassemble the mask according to the instructions in the User Guide.
---|---
Cleaning| 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 disinfect able mask components for 12 minutes in a commercially available solution according to the manufacturer’s instructions:
   • or tho-formaldehyde 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 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 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: -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.

Chemical disinfection procedures – Anioxyde 1000

Disassembly| Disassemble the mask according to the instructions in the User Guide.
---|---
Cleaning| 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.

Inspection/Drying| 1.  Inspect and if required, repeat washing until visually clean.12.  Allow the components to air dry out of direct sunlight.
Disinfection| 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.
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 sterilization.

Chemical disinfection procedures – Gigasept FF

Disassembly| Disassemble the mask according to the instructions in the User Guide.
---|---
Cleaning

Inspection/Drying

| 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 – 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.

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 titres 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
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.

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 sterilization.

Sterilization procedures – STERRAD

Disassembly| Disassemble the mask according to the instructions in the User Guide.
---|---
Cleaning| 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.

Inspection / Drying|

1. Inspect and if required, repeat washing until visually clean.1
2. Allow the mask components to air dry out of direct sunlight.

Sterilisation| 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

   • 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.

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 sterilization.

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

Manufacturer

ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia

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. © 2023 ResMed. 608434/7 2023-11

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Legal disclaimers and intellectual property - ResMed

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