ResMed AirFit N30i User manual

English 1
Disinfection guide Clinical use only
This guide is intended for multi-patient re-use of the AirFit N30i and AirFit P30i masks 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 - Alconox
Validated number of cycles
Thermal Disinfection - Manual
167°F (75°C) for 30 minutes
194-199°F (90-93°C) for 1 to 10 minutes
• AirFit N30i cushion 30
• AirFit P30i cushion 30
• Multi-hole vent 30
• Frame (SLM)230
• Elbow body / elbow clip / elbow ring 30
• Headgear 30
1 This mask may not be available in all regions. For full details regarding the correct use of this mask, 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.
2The frame of the Sleep Lab Mask (SLM) does not contain sleeves.
2
F
2
F
1
E
A
B
D
1
C
G
A Elbow body
B Elbow ring
C Headgear
D Frame (SLM)
E AirFit N30i nasal cushion
F AirFit P30i pillows cushion
G Elbow clip
1 Vent
2 Multi-hole vent (AirFit P30i only)

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
• Pull the elbow ring out of the frame.
• (AirFit P30i only) Peel the multi-hole vent from the AirFit P30i cushion
2. Cleaning
1. Make a solution of 1% (10 g/L) Alconox in water1at 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.
• AirFit N30i cushion / AirFit P30i cushion / elbow body 30 seconds brushing
• Elbow clip / elbow ring / multi-hole vent (AirFit P30i only) 10 seconds brushing
• Frame (SLM)2/ headgear 1 minute brushing
4. Rinse the components as follows under running water1at 68-140°F (20-60°C) directly contacting all surfaces.
• AirFit N30i cushion / AirFit P30i cushion / frame (SLM) / elbow body /
elbow clip / elbow ring / multi-hole vent (AirFit P30i only) 30-60 seconds rinsing
• Headgear 1 minute rinsing, while squeezing repeatedly
3. Inspection and drying
1. Inspect and if required, repeat washing 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
• 194-199°F (90-93°C) for 1 to 10 minutes
2. Squeeze the headgear to remove excess water.
3. Allow the mask 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 are 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. (AirFit P30i only) Align the tab in the AirFit P30i cushion with the notch in the multi-hole vent. Insert the multi-hole vent into the AirFit P30i cushion.
4. Reassemble the mask according to the instructions in the User Guide.
7. Packaging and storage For storage 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.
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 or disinfectants, always follow the manufacturer’s instructions. In the event of conflict, this guide takes precedence.
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/ip.© 2020 ResMed. 608492/3 2020-06
ResMed.com