ResMed AirFit F30i Full Face CPAP Mask User Guide
- June 5, 2024
- ResMed
Table of Contents
AirFit F30i Full Face CPAP Mask
User Guide
Thank you for choosing the AirFitTM F30i full face mask. This mask uses a cushion that seals under the nose and around the mouth, and a frame with a tube connection above the head. To breathe fresh air, this mask features vent holes in the cushion and elbow and valves in the frame.
An Elbow
B Frame
C Cushion
D Headgear
1 Vent hole (cushion)
2 Vent holes (elbow)
3 Side button| 4 Elbow ring
5 Anti-Asphyxia valve (inside the left and right of frame connector)
6Frame connector
7 Magnetic clip
8 Lower headgear strap
9 Upper headgear strap
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Intended Use
The AirFit F30i mask is intended to be used by patients weighing more than 66
lb (30 kg) who have been prescribed non-invasive positive airway pressure
(PAP) therapy such as CPAP or bi-level therapy. The mask is intended for
single patient re-use in the home and multi-patient re-use in the
hospital/institutional environment.
Contraindications
The use of masks with magnetic components is contraindicated in patients with
the following pre-existing conditions:
- a metallic hemostatic clip implanted in your head to repair an aneurysm
- metallic splinters in one or both eyes.
Before using your mask
Remove all packaging and inspect each mask component for visible
deterioration.
Fitting your mask
- Connect the air tubing from your device to the elbow.
- Squeeze the side buttons on the elbow and pull from the frame. Put the elbow and air tubing aside for now.
- Twist and pull both magnetic clips away from the frame connectors.
- Place the cushion under your nose and ensure it sits comfortably against your face. With the ResMed logo on the headgear facing up, pull the headgear and frame over your head.
- Bring the lower headgear straps under your ears and attach the magnetic clips to the frame connectors.
- Undo the fastening tabs on the upper headgear straps and pull evenly. Repeat with the lower headgear straps.
- Attach the elbow to the top of the frame. Your mask should now be positioned as shown.
Adjusting your mask
- With the device turned on and blowing air, adjust the position of the cushion for the most comfortable seal under your nose. Ensure that the cushion is not creased and the headgear is not twisted.
- To fix any mask leaks, adjust the upper or lower headgear straps. Adjust only enough for a comfortable seal and do not overtighten.
Sizing the mask
Use the fitting template to assist in selecting the right size cushion. If the
mask frame falls back over your head or sits too close to your ears, try a
smaller frame size. If the mask falls forward on your head or sits too close
to your eyes, try a bigger frame size.
Disassembling your mask for cleaning
If your mask is connected to a device, disconnect the device air tubing from
the mask elbow.
- Undo the fastening tabs on the upper headgear straps and pull from the frame. Keep the magnetic clips attached to the lower headgear straps.
- Squeeze the side buttons on the elbow and detach them from the frame.
- Grip the frame connector and lift to unclip from the cushion. Repeat on the other side.
Cleaning your mask
If there is any visible deterioration of a mask component (cracking, crazing,
tears etc.) the component should be discarded and replaced. Daily/After each
use: Cushion Weekly: Headgear, frame, and elbow 1. Soak the components in warm
water with a mild liquid detergent. 2. Hand wash the components with a soft
bristle brush. Pay particular
attention to the vent holes in both cushion and elbow. 3. Thoroughly rinse the
components under running water. 4. Leave the components to air dry out of
direct sunlight. If the mask components are not visibly clean, repeat the
cleaning steps. Make sure that the vent holes and anti-asphyxia valves are
clean and clear.
Reassembling your mask
- Align and insert the frame connector tab (a) into the cushion slot (b) and press down until it clicks. Repeat on the other side.
- Attach the elbow to the top of the frame until it clicks.
- With the ResMed logo facing outwards and up, insert the upper headgear straps into the frame from the inside and fold the fastening tabs over to secure.
Note: If the elbow ring detaches, re-insert it into the top of the frame.
WARNING
- Magnets are used in the lower headgear straps and the frame of the mask. Ensure the headgear and frame is kept at least 2″ (50 mm) away from any active medical implant (eg, pacemaker or defibrillator) to avoid possible effects from localized magnetic fields. The magnetic field strength is less than 400 mT.
- The mask contains safety features, exhaust vent holes, and anti-asphyxia valves, to enable normal breathing and exhaust exhaled breath. Occlusion of the exhaust vent holes or anti-asphyxia valves needs to be prevented to avoid having an adverse effect on the safety and quality of the therapy. Regularly inspect the vent holes and antiasphyxia valves to ensure they are kept clean, clear of blockages, and are not damaged.
- Only use compatible CPAP or bi-level therapy devices or accessories. The technical specifications of the mask are provided for healthcare professionals to determine compatible devices. Use in combination with incompatible medical devices can decrease the safety or alter the performance of the mask.
- The mask is not suitable for patients requiring life support ventilation.
- Regularly clean your mask and its components to maintain the quality of your mask and prevent the growth of germs that can adversely affect your health.
WARNING
- The mask must be used under qualified supervision for patients who are unable to remove the mask by themselves. The mask may not be suitable for those prone to aspiration.
- The mask should not be used unless the device is turned on. Once the mask is fitted, ensure the device is blowing air to reduce the risk of rebreathing exhaled air.
- Discontinue using or replacing this mask if the patient has ANY adverse reaction to the use of the mask. Consult your physician or sleep therapist.
- The mask is not intended to be used simultaneously with nebulizer medications that are in the air path of the mask/tube.
- If there is any visible deterioration of a mask component (cracking, crazing, tears, etc.) the component should be discarded and replaced.
CAUTION
- Always follow cleaning instructions and only use a mild liquid detergent. Some cleaning products may damage the mask, its parts, and its function, or leave harmful residual vapors. Do not use a dishwasher or washing machine to clean the mask.
- When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
- As with all masks, some rebreathing may occur at low pressures.
- Using a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
- Do not iron the headgear as the material is heat sensitive and will be damaged.
Technical specifications
Mask setting options: For AirSense, AirCurve, or S9: Select ‘Full Face’.
Compatible devices: For a full list of compatible devices for this mask, see
the Mask/Device Compatibility List at
ResMed.com/downloads/masks.
SmartStop may not operate effectively when using this mask with some CPAP or
bi-level devices.
Therapy pressure: 4 to 30 cm H20 Pressure-flow curve
Resistance with Anti-Asphyxia Valve closed to atmosphere Drop in pressure
measured (nominal) at 50 L/min: 0.2 cm H2O Drop in pressure measured (nominal)
at 100 L/min: 1.0 cm H2O
Resistance with Anti Asphyxia Valve open to atmosphere Inspiration at 50
L/min: 0.2 cm H2O Expiration at 50 L/min: 0.4 cm H2O
Anti-Asphyxia Valve open-to-atmosphere pressure: <4 cm H2O
Anti-Asphyxia Valve closed-to-atmosphere pressure: <4 cm H2O
Sound: Declared dual-number noise emission values in accordance with
ISO4871:1996 and ISO3744:2010.
A-weighted sound power level is 25 dBA, with the uncertainty of 3 dBA.
A weighted pressure level at a distance of 1 m is 18 dBA, with uncertainty of
3 dBA.
Environmental conditions Operating temperature: 41°F to 104°F (5°C to 40°C)
Operating humidity: 15% to 95% RH non-condensing
Storage and transport temperature: -4°F to 140°F (-20°C to +60°C)
Storage and transport humidity: up to 95% RH non-condensing
International Commission on Non-Ionizing Radiation Protection (ICNIRP)
The magnets used in this mask are within ICNIRP guidelines for general public
use.
Service life: The service life of the mask system is dependent on the
intensity of usage, maintenance, and environmental conditions in which the
mask is used or stored. As this mask system and its components are modular in
nature, it is recommended that the user maintain and inspect it on a regular
basis, and replace the mask system or any components if deemed necessary or
according to the instructions in the `Cleaning your mask’ section of this
guide. Accessories: Soft sleeves are available as an accessory,
Storage
Ensure that the mask is thoroughly clean and dry before storing it for any length of time. Store the mask in a dry place out of direct sunlight.
Disposal
This mask does not contain any hazardous substances and may be disposed of
with your normal household refuse.
Reprocessing the mask between patients
Only Sleep Lab Mask (SLM) variants of the mask system are intended for multi-
patient reuse. When used between patients, these masks must be reprocessed
according to instructions available on ResMed.com/downloads/masks.
Symbols
The following symbols may appear on your product or packaging:
Full face mask|
---|---
Device setting- Full face|
Small frame|
Standard frame|
Large frame|
Cushion size – small| S
Cushion size – medium| M
Cushion size – small wide| SW
Cushion size – wide| W
Caution, consult accompanying documents.|
Prescription-only (In the US, Federal law restricts these devices to sale by
or on the order of a physician.) See the symbols glossary at
ResMed.com/symbols.|
Limited warranty
ResMed Pty Ltd (hereafter ‘ResMed’) warrants that your ResMed mask system
(including mask frame, cushion, headgear and tubing) shall be free from
defects in material and workmanship from the date of purchase for the period
of 90 days or in the case of disposable masks the maximum use period. This
warranty is only available to the initial consumer. It is not transferable. If
the product fails under conditions of normal use, ResMed will repair or
replace, at its option, the defective product or any of its components. This
limited warranty does not cover:
a) any damage caused as a result of improper use, abuse, modification or
alteration of the product;
b) repairs carried out by any service organization that has not been expressly
authorized by ResMed to perform such repairs; and
c) any damage or contamination due to cigarette, pipe, cigar or other smoke.
Warranty is void on products sold, or resold, outside the region of original
purchase. Warranty claims on defective products must be made by the initial
consumer at the point of purchase. This warranty replaces all other expressed
or implied warranties, including any implied warranty of merchantability or
fitness for a particular purpose. Some regions or states do not allow
limitations on how long an implied warranty lasts, so the above limitation may
not apply to you. ResMed shall not be responsible for any incidental or
consequential damages claimed to have resulted from the sale, installation or
use of any ResMed product. Some regions or states do not allow the exclusion
or limitation of incidental or consequential damages, so the above limitation
may not apply to you. This warranty gives you specific legal rights, and you
may also have other rights which vary from region to region. For further
information on your warranty rights, contact your local ResMed dealer or
ResMed office.
ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia
See ResMed.com for other ResMed locations worldwide.
AirFit, AirSense, AirCurve and S9 are trademarks and/or registered trademarks
of the ResMed family of companies. For patent and other intellectual property
information, see ResMed.com/ip. © 2020 ResMed.
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