Resmed Airfit n30 User manual

English 1

Disinfection guide Clinical use only

This guide is intended for multi-patient use of the AirFit™N30 nasal 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.

Mask component1

Cleaning

Validated number of cycles

Mild Alkaline, Anionic Detergent e.g. Alconox Neodisher Mediclean Forte

Thermal Disinfection

Manual Washer-Disinfector

• Cushion 30

• Standard frame 30

• QuietAir™ frame2– – –

• Split-band headgear 30

1May not be available in all regions. For full details regarding the correct use of this mask, please refer to the User Guide. For a list of available replacement parts, check the Product Guide on ResMed.com

2Not intended for multi-patient re-use.

A Split-band headgear

1 Buckle

2 Buttonhole

3 End cap

B Cushion

C QuietAir™ / Standard frame

4 Stabiliser

5 QuietAir vent

6 Vent

7 Mask tubing

English 2

Thermal disinfection procedure

1. Disassembly Disassemble the mask according to the instructions in the User Guide.

2. Cleaning

1. Make a solution of a mild alkaline, anionic detergent and water1as per manufacturer’s instructions. ResMed has validated the following:

• 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.

• Cushion / frame / headgear 1 minute brushing

4. Rinse the components as follows under running water1(≤60°C) directly contacting all surfaces.

• Cushion / frame 30-60 seconds rinsing

• Headgear 1 minute rinsing, while squeezing repeatedly

3. Inspection and drying

1. Inspect and if required, repeat all steps in section [2. Cleaning] until visually clean.2

2. Squeeze the headgear to remove excess water.

3. Allow the components to air dry out of direct sunlight.3

4. Disinfection

1. Soak the mask components in a hot water1bath using one of the following temperature-time combinations:

• 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 Reassemble the mask according to the instructions in the User Guide.

7. Storage and transportation For storage and transportation details, check the User Guide.

1For all cleaning, rinsing and disinfection steps, use drinking quality water. Where local regulation impose water quality requirements for medical device reprocessing, these requirements must be met.

2Failure to clean the mask component as indicated may result in inadequate disinfection.

3Drying is not required if thermal disinfection is continued immediately.

English 3

Thermal disinfection procedures - Washer-Disinfector

1. Disassembly Disassemble the mask according to the instructions in the User Guide.

2. Washer-Disinfector1

1. Soak the mask components in a 5 litre rinse bath of cold tap water1for 1 minute. Ensure there are no air bubbles on the components.

2. Rinse each component under cold running tap water1for 30 seconds. Ensure internal surfaces are ﬂushed.

3. Transfer the components into an ISO 15883 series compliant washer-disinfector. For the standard frame component, place on a spray nozzle3to facilitate water ﬂow through the mask tubing. Components should be

orientated to ensure effective drainage.

4. Set the washer-disinfector using the following settings:

Phase/Stage Recirculation time (minutes) Temperature (°C) Detergent

Pre-wash 4 Cold –

Wash 10 43-60 2-10 mL/L (0.2-1%) Neodisher Mediclean Forte

Neutralisation 6 43-60 1-2 mL/L (0.1-0.2%) Neodisher Z

Final Rinse 3 43-60 –

Thermal Disinfection 5-10 90-93 –

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 Reassemble the mask according to the instructions in the User Guide.

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

1For 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.

2Failure to clean the mask component as indicated may result in inadequate disinfection.

3Use a washer-disinfector load carrier/rack containing spray/injector nozzles.

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

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