ResMed AirFit F30i Disinfection Guide Oct 2019

Thermal disinfection procedures - Manual 1. Disassemble the mask according to the instructions in the User Guide. 2. Additionally:

1. Disassembly

• Firmly pull the elbow clip away from the elbow body. (Fig a.) • Pull the elbow ring out of the frame. (Fig b.) • Firmly slide the frame magnetic clip from the frame connector. Repeat on the other side. (Fig c.) 1. Make a solution of a mild alkaline, anionic detergent and water1 as per manufacturer’s instructions. ResMed has validated the following:

2. Cleaning

• Alconox 1% concentration (10 g/L) 30-55°C 2. Soak all mask components for 5 to 10 minutes. Ensure there are no air bubbles. 3. After the soaking time, while keeping the components in the solution, clean the inside and outside with a soft bristle brush as follows. Pay particular attention to the crevices and cavities. • Elbow body 30 seconds brushing • Elbow clip / elbow ring / frame magnetic clips 10 seconds brushing 1 minute brushing • Cushion / frame2 / headgear 4. Rinse the components as follows under running water1 (≤60°C) directly contacting all surfaces. • Cushion / frame / frame magnetic clips / elbow body / elbow clip / elbow ring • Headgear

3. Inspection and drying

30-60 seconds rinsing 1 minute rinsing, while squeezing repeatedly

1. Inspect and if required, repeat all steps in section [2. Cleaning] until visually clean.3 2. Squeeze the headgear to remove excess water. 3. Allow the components to air dry out of direct sunlight.4 1. Soak the mask components in a hot water1 bath using one of the following temperature-time combinations:

4. Disinfection

• 75°C for 30 minutes • 80°C for 10 minutes • 90-93°C for 1 to 10 minutes. 2. Squeeze the headgear to remove excess water. 3. Allow the 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

1. Push the elbow clip onto the elbow body until it clicks into place. 2. Insert the elbow ring into the top of the frame. 3. Firmly slide the frame magnetic clip onto the frame connector. Repeat on the other side. 4. Reassemble the mask according to the instructions in the User Guide.

7. Storage and transportation For storage and transportation details, check the User Guide. For all cleaning, rinsing and disinfection steps, use drinking quality water. Where local regulations impose water quality requirements for medical device reprocessing, these requirements shall be met. A soft bristle tube/bottle brush is required to clean the inside of the frame. 3 Failure to clean the mask component as indicated may result in inadequate disinfection. 4 Drying is not required if thermal disinfection is continued immediately. 1 2

English

2

Thermal disinfection procedures - Washer-Disinfector 1. Disassemble the mask according to the instructions in the User Guide. 2. Additionally: • Firmly pull the elbow clip away from the elbow body. (Fig a.) • Pull the elbow ring out of the frame. (Fig b.) • Firmly slide the frame magnetic clip from the frame connector. Repeat on the other side. (Fig c.)

1. Disassembly

1. Soak the mask components in a 5 litre rinse bath of cold tap water1 for 1 minute. Ensure there are no air bubbles on the components. 2. Rinse each component under cold running tap water1 for 30 seconds. Ensure internal surfaces are flushed. 3. Transfer the components into an ISO 15883 series compliant washer-disinfector. Components should be orientated to ensure effective drainage. 4. Set the washer-disinfector using the following settings:

2. Washer-Disinfector

Phase/Stage

Recirculation time (minutes)

Temperature (°C)

Detergent

Pre-wash Wash Neutralisation Final Rinse Thermal Disinfection

4 10 6 3 5-10

Cold 43-60 43-60 43-60 90-93

– 2-10 mL/L (0.2-1%) Neodisher Mediclean Forte 1-2 mL/L (0.1-0.2%) Neodisher Z – –

3. Inspection and drying

1. Inspect and if required, repeat all steps in section [2. Washer-Disinfector] until visually clean2. 2. Squeeze the headgear to remove excess water. 3. Allow the components to air dry out of direct sunlight.

4. 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.

5. Reassembly

1. Push the elbow clip onto the elbow body until it clicks into place. 2. Insert the elbow ring into the top of the frame. 3. Firmly slide the frame magnetic clip onto the frame connector. Repeat on the other side. 4. Reassemble the mask according to the instructions in the User Guide.

6. Storage and transportation For storage and transportation details, check the User Guide. 1 2

For all cleaning, rinsing and disinfection steps, use drinking quality water. Where local regulations impose water quality requirements for medical device reprocessing, these requirements shall be met. Failure to clean the mask component as indicated may result in inadequate disinfection.

GENERAL WARNINGS AND CAUTIONS •

Always follow cleaning and disinfection instructions. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours. Any deviations from the procedures listed in this guide, including exceeding the specified number of maximum cycles, can have an adverse effect on the mask and consequently the safety or the quality of therapy.

•

Mask components should not be subjected to autoclave or ethylene-oxide gas sterilisation.

•

When using detergents, disinfectants or equipment, always follow the manufacturer’s instructions. In the event of conflict, this guide takes precedence.

•

Always follow safe operating practices, including the use of appropriate personal protective equipment (PPE), as required. Refer to the manufacturer’s safety instructions for more details.

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

ResMed.com

See ResMed.com for other ResMed locations worldwide. AirFit is a trademark and/or registered trademark of the ResMed family of companies. Alconox is a trademark of Alconox Inc. Neodisher is a trademark of Chemische Fabric Dr Weigert. For patent and other intellectual property information, see ResMed.com/ip. © 2019 ResMed Pty Ltd. 608619/1 2019-10

English

3