ResMed Masks and Nasal Masks Disinfection and Sterilization Guide July 2018

Mask1

Replace these parts with new parts between patients

Swift FX Nano / Swift FX Nano for Her

None

AirFit N10 / AirFit N10 for Her

None

High level thermal disinfection ISO 15883-1 158°F (70°C)-100 min; 167°F (75°C)-30 min 176°F (80°C)-10 min; 194°F (90°C)-1 min

High level chemical disinfection

Sterilization

CIDEX™ OPA Orthophthalaldehyde 0.55%

STERRAD™

CIDEX™ Plus Glutaraldehyde 3.4%

Validated number of cycles2

100S

NX

5

5

20 20

Nasal pillows systems Swift FX / Swift FX for Her / Swift FX Bella / Swift FX Bella Gray

None

5

5

20

Swift LT

None

5

5

20

Swift LT for Her/ Swift LT-F

None

5

5

20

Mirage Swift II

None

AirFit P10 / AirFit P10 for Her

Headgear clip

AirFit P10 for AirMini

Mask frame, headgear clip

15

4

20 8

8

8

20

Not all masks are 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 Components Card on www.resmed.com. 2 If a healthcare facility requires an additional disinfection or sterilization cycle after reassembly, the number of validated cycles must be halved. 3 Alternative disassembly available. See “Disassembling the masks before cleaning”. 4 Short tube assembly validated to 158ºF (70ºC). 5 Short tube assembly cannot be treated via STERRAD sterilization. 6 Cushion cannot be treated via STERRAD sterilization. 7 Some components cannot be treated. Alternative cleaning must be used. See “Cleaning other components”. 8 Mask cushions are the only components validated for disinfection and sterilization. 1

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Validated disinfection and sterilization procedures In the procedures below, only one of the following three disinfection or sterilization procedures needs to be performed.

High level thermal disinfection Disassembly

High level chemical disinfection

Sterilization

Disassemble the mask according to the instructions in the User Guide. 1. Thoroughly clean the separated mask components (excluding headgear) with a soft bristle brush for one minute while soaking them in the detergent Alconox™ (diluted at 1%) according to the manufacturer’s instructions. Pay particular attention to all crevices and cavities.

Cleaning and drying

2. Inspect each component and if required, repeat washing until visually clean. 3. Rinse the components twice by agitating them vigorously in drinking quality water (five litres per mask). 4. Allow the mask components to air dry out of direct sunlight.

Pre-disinfection and drying

Not validated.

Disinfection or sterilization and drying

1. Using a certified hot water disinfection system, soak the disinfectable mask components using a temperature-time combination1: ISO 15883-1: • 158°F (70°C) for 100 minutes • 167°F (75°C) for 30 minutes • 176°F (80°C) for 10 minutes • 194°F (90°C) for 1 minute. 2. On completion, remove the mask components from the hot water disinfection system. 3. Allow the mask components to air dry out of direct sunlight.

1. Fully immerse and soak the disinfectable mask components in a commercially available solution according to the manufacturer’s instructions: • ortho-phthalaldehyde 0.55% (eg, CIDEX OPA) for 20 minutes or • glutaraldehyde 3.4% (eg, CIDEX Plus) for 20 minutes. 2. Rinse the mask components in drinking quality water (five litres per mask). 3. Allow the mask components to air dry out of direct sunlight.

1. Package the mask components prior to sterilization as described in the manufacturer’s instructions for the STERRAD Sterilization System. ResMed masks have been validated using the tray method. Note: The use of pouches is not recommended. 2. Sterilize the mask following the manufacturer’s instructions for the STERRAD Sterilization System. Note: Drying is achieved as part of the sterilization process.

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: -4°F to 140°F (-20°C to 60°C).

Calculated and predicted from known thermal inactivation kinetics of vegetative micro-organisms subjected to thermal disinfection (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).

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Disassembling the masks before cleaning

Cleaning other components

These instructions apply only to:

These instructions apply only to:

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Mirage Quattro

•

AirFit N10 / AirFit N10 for Her – Soft sleeves

•

Mirage Micro

•

AirFit F10 / AirFit F10 for Her – Frame, Soft sleeves

•

Mirage Activa LT

•

Quattro Air / Quattro Air for Her / Quattro Air NV – Frame

•

Mirage SoftGel.

•

Quattro FX / Quattro FX for Her – Spring frame, Soft sleeves

•

Quattro FX NV - Spring frame, Soft sleeves

•

Mirage FX / Mirage FX for Her – Frame.

As an alternate to the disassembly instructions shown in the relevant user guide for removing the forehead support and dial from the mask frame, you can disassemble these components as follows: 1.

Unscrew the dial so that the forehead support protrudes about halfway from the mask frame.

2. Firmly push the forehead support against the mask frame until the dial clicks and detaches from the mask frame.

The component does not require disinfection and should not be washed in disinfection chemicals. Thoroughly washing the component between patients is acceptable. 1.

Handwash the component in warm 86°F (30°C) water using mild soap.

2. Rinse well and allow it to air dry out of direct sunlight.

3. Fully unscrew and remove the dial, then pull forehead support out of the mask frame.

GENERAL WARNINGS AND CAUTIONS

Cleaning the headgear The headgear does not require disinfection and should not be washed in disinfection chemicals. Thoroughly washing the headgear between patients is acceptable. 1.

Handwash the headgear in warm 86°F (30°C) water using mild soap.

2. Rinse well and allow it to air dry out of direct sunlight.

ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

ResMed.com

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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 of the product, will be acceptable.

•

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

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When using detergents, disinfectants or sterilization agents, always follow the manufacturer’s instructions.

•

Do not iron the headgear as the material is heat sensitive and will be damaged.

See www.resmed.com for other ResMed locations worldwide. For patent information, see www.resmed.com/ip. AirFit, Mirage, Mirage Activa, Mirage Kidsta, Mirage Micro, Mirage Swift, Swift, Mirage Vista, Mirage Quattro, Quattro, Mirage Liberty and Ultra Mirage are trademarks of ResMed Ltd and AirFit, Mirage, Activa, Kidsta, Mirage Quattro, Quattro, Swift and Vista are Registered in U.S. Patent and Trademark Office. CIDEX and STERRAD are trademarks of Johnson & Johnson. © 2018 ResMed Ltd. 608400/4 2018-07