Resmed Airtouch F20, Airfit F20 User Manual

Disinfection and sterilisation 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 sterilisation of the mask in accordance with ISO17664.

Cleaning

Alconox Neodisher

Alconox Aniosyme DD1 Gigazyme Alconox Alconox

AirFit F20 / AirTouch F20 mask component

Thermal disinfection Chemical disinfection Sterilisation

Manual AWD

CIDEX™ OPA Anioxyde 1000 Gigasept FF STERRAD™ 100S STERRAD™ NX

Validated number of

cycles

• AirFit F20 cushion 30

• AirTouch F20 cushion

• Standard elbow

™

• QuietAir

elbow

• Frame

• Headgear

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.

If a healthcare facility requires an additional disinfection or sterilisation cycle after reassembly, the number of validated cycles must be halved.

This component is intended for single patient reuse.

Neodisher MediZym or MediClean Forte.

Automatic Washer-Disinfector.

– – – – – – – –

– – – –

– – – – – – – –

– – –

A Standard elbow

B C

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

5 6 7

A+B+C Frame system

A+B+C+D Complete system

E QuietAir elbow

English 1

Thermal disinfection procedures - Manual

Disassembly

Cleaning

Inspection / Drying

Disinfection

Inspection

Reassembly

Packaging and storage

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

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).

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

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.

1. Inspect and if required, repeat washing until visually clean.

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

1. Using a hot water disinfection system, soak the disinfectable mask components using a temperature-time combination2:

• Cushion/standard elbow/frame: 75°C for 30 minutes; 80°C for 10 minutes; 90°C for 1 minute;

• Headgear:

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.

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.

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

Store in a dry, dust-free environment away from direct sunlight. Storage temperature: -20°C to 60°C.

93°C for 10 minutes

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.

6. 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.

English 2

Thermal disinfection procedures - AWD

Disassembly

AWD

Inspection

Reassembly

Packaging and storage

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

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

Neodisher MediZym Neodisher MediClean Forte

AirFit F20 cushion/standard elbow/frame/headgear:

Using an Automatic Washer Disinfector

Pre-clean 4 minutes tap water

Clean 0.5% Neodisher MediZym (enzymatic, Dr. Weigert) for 10 minutes at 45°C

Final rinse Deionised water for 3 minutes

Disinfection 93°C for 10 minutes

Drying 15 minutes

Reassemble the mask according to the instructions in the User Guide

Store in a dry, dust-free environment away from direct sunlight. Storage temperature: -20°C to 60°C.

, set the following machine settings:

AirFit F20 cushion/standard elbow/frame/headgear:

Using an Automatic Washer Disinfector1, set the following machine settings:

Pre-clean 4 minutes tap water

Clean 0.5% Neodisher MediClean forte (Dr. Weigert) for 10 minutes at 55°C

Neutralisation 0.1% Neodisher Z (Dr. Weigert) for 6 minutes

Final rinse Deionised water for 3 minutes

Disinfection 93°C for 10 minutes

Drying 15 minutes

English 3

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