Resmed Airfit f30i User manual

Full face mask

English 1

Disinfection guide Clinical use only

This guide is intended for multi-patient re-use of the AirFit™F30i 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.

Mask component1

Cleaning - Mild alkaline, anionic detergent

eg, Alconox

Validated number of cycles

Thermal Disinfection

167°F (75°C) for 30 minutes OR

194-199°F (90-93°C) for 1 to 10 minutes

• Cushion 30

• Frame / frame magnetic clips 30

• Elbow body / elbow clip / elbow ring 30

• Headgear230

• Soft wraps3– –

1 May 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.

2Headgear includes headgear magnetic clips.

3Not intended for multi-patient re-use.

A Elbow body

1 Elbow clip

2 Elbow ring

B Frame

3 Frame connector

4 Frame magnetic clip

C Cushion

D Headgear

Additional disassembly

a b c

English 2

Thermal disinfection procedure

1. Disassembly

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.)

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) 86-131°F (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

• Cushion / frame2/ headgear 1 minute brushing

4. Rinse the components as follows under running water1at 68-140°F (20-60°C) directly contacting all surfaces.

• Cushion / frame / frame magnetic clips /

elbow body / elbow clip / elbow ring 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.3

2. Squeeze the headgear to remove excess water.

3. Allow the mask components to air dry out of direct sunlight.4

4. Disinfection

1. Soak the mask components in a hot water1bath using one of the following temperature-time combinations. Ensure there are no air bubbles.

• 167°F (75°C) for 30 minutes OR

• 194-199°F (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 discoloration 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.

1For all cleaning, rinsing and disinfection steps, use drinking quality water.

2A soft bristle tube/bottle brush is required to clean the inside of the frame.

3Failure to clean the mask component as indicated may result in inadequate disinfection.

4Drying is not required if thermal disinfection is continued immediately.

ResMed Pty Ltd

1 Elizabeth Macarthur Drive

Bella Vista NSW 2153 Australia

See ResMed.com for other ResMed locations worldwide. AirFit is a trademark of the ResMed family of companies. Alconox is a trademark of Alconox Inc. For patent and other intellectual property information, see

ResMed.com

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 sterilization.

• 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.

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