ResMed AirFit F30 User manual

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User guide
USER GUIDE

English 1
ENGLISH
A
QuietAir / standard elbow
3
Side buttons
B
Frame
4
Magnetic clips
C
Cushion
5
Upper headgear strap
D
Headgear
6
Lower headgear strap
1
Vent
7
Top headgear strap
2
Anti-Asphyxia Valve
Intended use
The AirFit F30 mask is intended to be used by patients weighing more
than 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.
Please read the entire guide before use.
QuietAir elbow
The QuietAir elbow is intended for single patient re-use in the home and
hospital/institutional environment.

2
Intended patient population/medical conditions
Obstructive pulmonary diseases (eg, Chronic Obstructive Pulmonary
Disease), restrictive pulmonary diseases (eg, diseases of the lung
parenchyma, diseases of the chest wall, neuromuscular diseases), central
respiratory regulation diseases, obstructive sleep apnoea (OSA) and
obesity hypoventilation syndrome (OHS).
Clinical benefits
The clinical benefit of vented masks is the provision of effective therapy
delivery from a therapy device to the patient.
Contraindications
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.
Use the fitting template to assist in selecting the right size cushion and
frame.

English 3
Fitting your mask
1. Twist and pull both magnetic clips away from the frame.
2. 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 over your head.
3. Bring the lower headgear straps under your ears and attach the
magnetic clips to the frame.
4. Undo the fastening tabs on the upper headgear straps and pull evenly.
Repeat with the lower headgear straps.
5. If the headgear is too close to the ear, adjust the top headgear strap
6. Connect the device air tubing to the elbow and attach the elbow to
the mask, ensuring that it clicks in place.

4
Adjusting your mask
•With the device turned on and blowing air, adjust the position of the
cushion for the most comfortable fit under your nose. Ensure that the
cushion is not creased and the headgear is not twisted.
•To fix any leaks at the upper or lower part of the mask, adjust the top,
upper or lower headgear straps. Adjust only enough for a comfortable
seal and do not overtighten.
Removing your mask
1. Twist and pull both magnetic clips away from the frame.
2. Pull the mask away from your face and back over your head.
Disassembling your mask for cleaning
If your mask is connected to a device, disconnect the device air tubing
from the mask elbow.
1. Undo the fastening tabs on the upper headgear straps and pull them
from the frame. Keep the magnetic clips attached to the lower
headgear straps.
2. Squeeze the side buttons on the elbow and detach from the frame.
3. Hold the top and bottom of the cushion and separate from the frame.
Cleaning your mask
After each use: Elbow, frame, cushion
Weekly: Headgear
1. Soak the components in warm water with a mild liquid detergent.
Ensure that there are no air bubbles while soaking.

English 5
2. Shake the components vigorously in the water for at least one minute
and hand wash with a soft bristle brush. Pay particular attention to all
connection areas, elbow vent holes and valves.
3. Thoroughly rinse the components under running water.
4. Squeeze the headgear to remove excess water. Leave the
components to air dry out of direct sunlight.
If the mask components are not visibly clean, repeat the cleaning steps.
Reassembling your mask
1. 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.
2. Hold the top and bottom of the cushion and attach to the frame.
3. Attach the elbow to the frame.
WARNING
•The mask must be used under qualified supervision for patients
who are unable to remove the mask by themselves. This mask is
not for use on patients with impaired laryngeal reflexes or other
conditions predisposing to aspiration in the event of regurgitation
or vomiting.
•To avoid affecting the safety and quality of therapy, the mask
vents must be kept clear to protect against rebreathing. Regularly
inspect the vents to ensure they are kept clean, undamaged and
clear of blockages.
•The mask contains specific safety features with the supplied
elbow (containing the valve and vent assembly) to ensure safe
and functional usage. Do not use the mask if these features are
damaged or missing.
•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 risk
of rebreathing exhaled air.
•Oxygen supports combustion and must only be used in well
ventilated rooms. Do not use oxygen while smoking or near an
open flame. Oxygen flow must be turned off when the device is
not operating.
•At a fixed rate of supplemental oxygen flow, the inhaled oxygen

6
WARNING
concentration varies, depending on the pressure settings, patient
breathing pattern, mask, point of application and leak rate. This
warning applies to most types of CPAP or bi-level devices.
•The technical specifications of the mask are provided for your
clinician or respiratory therapist to check that they are compatible
with the CPAP or bi-level device. If used outside specification or if
used with incompatible devices, the seal and comfort of the mask
may not be effective, optimum therapy may not be achieved, and
leak, or variation in the rate of leak, may affect the CPAP or bi-
level device function.
•Discontinue using the mask if you have ANY adverse reaction and
consult your physician or sleep therapist.
•Using a mask may cause tooth, gum or jaw soreness or aggravate
an existing dental condition. If symptoms occur, consult your
physician or dentist.
•The F30 line of full face CPAP masks are not intended to be used
simultaneously with nebuliser medications that are in the air path
of the mask/tube.
•Magnets are used in the lower headgear straps and the frame of
the mask. Ensure the headgear and frame is kept at least 50 mm
away from any medical implant (eg, pacemaker, defibrillator,
magnetic cerebrospinal fluid (CSF) shunt valve, cochlear implants
etc) to avoid possible effects from localised magnetic fields. The
magnetic field strength is less than 400 mT.
•Avoid connecting flexible PVC products (eg, PVC tubing) directly
to any part of the mask. Flexible PVC contains elements that can
be detrimental to the materials of the mask, and may cause the
components to crack or break.
•Regularly clean your mask to maintain the quality of your mask
and to prevent the growth of germs that can adversely affect your
health.
•Always follow cleaning instructions. Some cleaning products may
damage the mask, its parts and their function, or leave harmful
residual vapours.

English 7
CAUTION
•Remove all packaging before using 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.
•Visual criteria for product inspection: If there is any visible
deterioration of a mask component (cracking, crazing, tears etc.),
the component should be discarded and replaced.
Note: For any serious incidents that occur in relation to this device, these
should be reported to ResMed and the competent authority in your
country.
Technical specifications
Mask setting options
For AirSense or AirCurve: 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.
Pressure-flow curve:
Pressure
(cm H2O)
Flow
(L/min)
3
19
10
37
20
54
30
69
Therapy pressure: 3 to 30 cm H2O
Resistance with Anti- Asphyxia Valve closed to atmosphere
Drop in pressure measured (nominal) at 50 L/min: 0.3 cm H2O
Drop in pressure measured (nominal) at 100 L/min: 0.7 cm H2O
Inspiratory and expiratory resistance with Anti Asphyxia Valve open to
atmosphere
Inspiration at 50 L/min: 0.6 cm H2O
Expiration at 50 L/min: 0.8 cm H2O
Anti Asphyxia Valve open-to-atmosphere pressure: ≤3 cm H2O
Anti Asphyxia Valve closed-to-atmosphere pressure: ≤3 cm H2O

8
Sound: Declared dual-number noise emission values in accordance with ISO4871 and
ISO3744. The A-weighted sound power level and A-weighted sound pressure level of the
mask at a distance of 1 m, with uncertainty of 3 dBA, are shown.
Power level (with QuietAir elbow): 21 dBA
Pressure level (with QuietAir elbow): 14 dBA
Power level (with standard elbow): 31 dBA
Pressure level (with standard elbow): 23 dBA
Environmental conditions
Operating temperature: 5°C to 40°C
Operating humidity: 15% to 95% non-condensing
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% non-condensing
Gross dimensions
Mask fully assembled (H x W x D)
110 mm x 116 mm x 102 mm
International Commission on Non-Ionising Radiation Protection (ICNIRP)
Magnets used in this mask are within ICNIRP guidelines for general public use.
Service life
The service life of the AirFit F30 mask system is dependent on the intensity of usage,
maintenance, and environmental conditions to 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 ‘Visual criteria for product inspection’
in the ‘Warning’ section of this guide.
Note: The manufacturer reserves the right to change these
specifications without notice.
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 and its packaging do not contain any hazardous substances and may be
disposed of with your normal household refuse.
Reprocessing the mask between patients
Reprocess this mask when using between patients. Cleaning, disinfection and sterilisation
instructions are available on ResMed.com/downloads/masks. If you do not have internet
access, please contact your ResMed representative.

English 9
Symbols
The following symbols may appear on your product or packaging:
Full face mask Device setting - Full face
Cushion size - small Cushion size - medium
Medical device Importer
Not made with natural rubber
latex
See symbols glossary at ResMed.com/symbols.
Consumer Warranty
ResMed acknowledges all consumer rights granted under the EU
Directive 1999/44/EC and the respective national laws within the EU for
products sold within the European Union.