AirFit P30i - Respiratory ventilator ResMed - Free user manual and instructions

Product type	Nasal pillow mask (Pillows) for respiratory ventilation
Intended use	Non-invasive positive pressure treatment (CPAP or bi-level) for patients >30 kg
Target populations	COPD, restrictive syndromes, central respiratory disorders, OSA, obesity-hypoventilation syndrome
Device compatibility	AirSense, AirCurve, S9; pressure range 4 to 25 cmH₂O
Ventilation ports	QuietAir (silent) and Standard; never obstruct
Sound level (QuietAir)	Acoustic power 21 dBA, acoustic pressure 14 dBA
Sound level (Standard)	Acoustic power 24 dBA, acoustic pressure 17 dBA
Flow resistance	At 50 L/min: 0.4 cmH₂O; at 100 L/min: 1.5 cmH₂O
Ventilation flow	From 20 L/min to 70 L/min depending on pressure (4 to 24 cmH₂O)
Main components	Cushion with pillows, rigid frame, headgear, elbow with ring, ventilation ports
Materials	Latex-free (natural rubber latex)
Maintenance	Manual cleaning with mild detergent; cushion after each use, headgear/frame/elbow weekly
Safety - rebreathing	Do not obstruct ports; wear only when device is on
Safety - oxygen	Turn off oxygen supply when device is off; do not smoke
Service life	Varies with use; regular inspection and replacement if deterioration
Ambient conditions	Operation: 5°C to 40°C, 15-95% RH; storage: -20°C to 60°C
Available sizes	Cushions: small, medium, large; rigid frame: standard and small
Warranty	In accordance with European directive 1999/44/EC

Frequently Asked Questions - AirFit P30i ResMed

How to properly adjust the AirFit P30i mask?

Place the rigid frame and headgear on top of your head, then position the pillows under your nose. Tighten or loosen the headgear until the cushion sits comfortably. Adjust the rigid frame forward or backward for optimal comfort.

How often should I clean the mask?

Clean the cushion after each use. The headgear, rigid frame, and elbow should be cleaned weekly. Use warm water and a mild liquid detergent, rinse thoroughly, and let dry away from direct sunlight.

Why should the ventilation ports never be obstructed?

The ventilation ports prevent rebreathing of carbon dioxide. Obstructing them can compromise treatment safety and effectiveness. Inspect them regularly to ensure they are clean and clear.

Is the AirFit P30i mask compatible with all CPAP devices?

It is compatible with ResMed AirSense, AirCurve, and S9 devices. For a complete list, visit ResMed.com/downloads/masks. The SmartStop function may not work properly with some devices.

What should I do if I feel discomfort or skin irritation?

Do not overtighten the headgear to avoid redness and irritation. If an adverse reaction occurs, stop using the mask and consult your doctor or sleep specialist.

Can I use nebulizers with this mask?

No, this mask is not intended for use with nebulized medications in the air circuit. This could damage the mask or compromise safety.

How to reassemble the mask after cleaning?

Connect the elbow to the rigid frame until it clicks. Insert the headgear strap into the frame and fold the tabs. Finally, insert the frame ends into the cushion, aligning the arrows.

What are the visual criteria for inspecting the mask?

Check for cracks, splits, or tears on all components. If you notice any deterioration, replace the affected part.

Can the mask be used with supplemental oxygen?

Yes, but take precautions: turn off the oxygen supply when the device is off to avoid fire risk. Use in a well-ventilated area and do not smoke nearby.

How to choose the correct cushion and rigid frame size?

Use the provided template to determine cushion size (small, medium, large) and rigid frame size (standard or small). The standard frame fits if the mask is too close to the eyes, the small one if it is too close to the ears.

USER MANUAL AirFit P30i ResMed

English Deutsch Français Italiano Nederlands Svenska Norsk Suomi Dansk Español Português Česky Polski العربية

Device Setting

Pillows

QuietAir

Nasal cradle mask

Nasal pillows mask

A Elbow

B Elbow ring

C Headgear

D Frame

E P30i pillows cushion

F N30i nasal cushion

1 Vent

2 QuietAir vent

3 Standard vent

4 Sleeve

5 Side buttons

Note: These masks may not be available in all countries.

Intended use

The AirFit N30i and AirFit P30i masks are 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 masks are 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.

Clinical benefits

The clinical benefit of vented masks is the provision of effective therapy delivery from a therapy device to the patient.

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).

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.

Fitting your mask

Illustration of a person applying a bandage to another person's mouth, showing anatomical positioning (no text or symbols)

1. Pull the frame and headgear over your head until the elbow is positioned on top and the headgear is behind your head.
2. Place the cushion under your nose. For the AirFit P30i mask, align the pillows into your nostrils.
3. Tighten or loosen the headgear until the cushion fits comfortably under your nose.
4. Squeeze the side buttons on the elbow and detach from the frame. Connect the air tubing from your device to the elbow, then reattach to the frame.

Adjusting your mask

• When using the mask, air will flow out of the vents in the cushion and elbow. If air leaks from the side or top of the cushion, adjust the mask fitting to improve the seal.
• You can position the top of the frame forward or backwards over your head until the mask feels comfortable.

Sizing the mask frame

graph LR
    A["Standard frame"] --> B["Small frame"]
    C["Standard frame"] --> D["Standard frame"]

If the mask frame falls back over your head or sits too close to your ears, try a small frame size. If the mask falls forward on your head or sits too close to your eyes, try a standard frame size.

Disassembling your mask for cleaning

If your mask is connected to a device, disconnect the device air tubing from the mask elbow.

1. Pull the cushion from the frame.
2. Undo the fastening tabs on the headgear strap and pull it from the frame.
3. Squeeze the side buttons on the elbow and detach from the frame.

Note: The QuietAir or standard vent can be removed to allow inspection of the vent holes.

Cleaning your mask

After each use: Cushion

Weekly: Headgear, frame and elbow

1. Soak the components in warm water with a mild liquid detergent. Ensure that there are no air bubbles while soaking.
2. Hand wash the components with a soft bristle brush. Pay particular attention to the vent holes.
3. Thoroughly rinse the components under running water.
4. For the frame sleeves, squeeze with a clean towel to remove excess water. Shake the QuietAir or standard vent to remove any 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. Connect the elbow into the top of the frame until it clicks.
2. Insert the headgear strap into the frame and fold the fastening tabs backwards.
3. Insert the ends of the frame into the cushion, ensuring that the arrows on the cushion and frame are aligned.

Note: If the elbow ring detaches, re-insert into the top of the frame.

Removing/inserting the QuietAir/standard vent

1. To remove the vent, gently pull the cushion away and slide the vent out.

2. To insert the vent, align the tab (a) on the cushion with the notch (b) on the vent, and then gently pull the cushion over the vent.

WARNING

• The mask is not suitable for patients requiring life support ventilation.
- 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 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.
- Regularly clean your mask to maintain the quality of your mask and to prevent the growth of germs that can adversely affect your health.
- 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.
- Only use compatible CPAP or bi-level therapy devices. The technical specifications of the mask are provided for healthcare professionals to determine compatible devices. Use with incompatible devices may affect the performance or safety of the mask.
- Discontinue using the mask if you have ANY adverse reaction and 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.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the CPAP or bilevel device is not operating, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire.
• Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. Only use oxygen in well ventilated rooms.
• At a fixed rate of supplemental oxygen flow, the inhaled oxygen 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 bilevel devices.

CAUTION

• Remove all packaging before using the mask.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
• When fitting the mask, do not overtighten the headgear as this may lead to skin redness or sores around the mask cushion.
• 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.
• As with all masks, some rebreathing may occur at low pressures.
• Always follow cleaning instructions and only use a mild liquid detergent. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours. Do not use a dish washer or washing machine to clean the mask.
• Do not iron the headgear as the material is heat sensitive and will be damaged.

Note: For any serious incidents that occur in relation to this product, these should be reported to ResMed and the competent authority in your country.

Technical specifications

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.

Pressure-flow curve:

AirFit N30i

AirFit P30i

Mask setting options:

For AirSense, AirCurve or S9	Pillows	Pillows
Therapy Pressure:	4 to 25 cm H_2O	4 to 25 cm H_2O
Resistance: Drop in pressure measured (nominal)
at 50 L/min	0.5 cm H_2O	0.4 cm H_2O
at 100 L/min	1.7 cm H_2O	1.5 cm H_2O

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996 and ISO3744:2010. A-weighted sound power level and A-weighted sound pressure level at a distance of 1 m, with uncertainty of 3 dBA, are shown

Sound power level (QuietAir vent)	21 dBA	21 dBA
Sound pressure level (QuietAir vent)	14 dBA	14 dBA
Sound power level (Standard vent)	25 dBA	24 dBA
Sound pressure level (Standard vent)	18 dBA	17 dBA

Environmental conditions:

Operating temperature: 5°C to 40°C

Operating humidity: 15% to 95% non-condensing

Storage and transport temperature: -20^ to +60^

Storage and transport humidity: up to 95% non-condensing

Service life: The service life of the 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 packaging do not contain any hazardous substances and may be disposed of with your normal household refuse.

Reprocessing the mask between patients

This mask should be reprocessed when used 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.

Symbols

The following symbols may appear on your product or packaging:

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.

A Kniestück

B Kniestückring

C Kopfband

Illustration of a hand using a tool to lift a cylindrical object, with an arrow indicating upward motion (no text or symbols)

Taille de la bulle - petite-large

Illustration of a person applying a bandage to another person's mouth, showing anatomical positioning (no text or symbols)

Illustration of a person using a medical device to adjust head and neck (no text or symbols present)

Illustration of a person applying a toothed instrument to their mouth, showing a finger placement (no text or symbols present)

Neussteunmasker

QuietAir-ventilatiegedeelte

Formaat kussentje - klein

Illustration of a person applying a bandage to another person's mouth, showing anatomical positioning (no text or symbols)

Illustration of a person applying a bandage to another person's neck area, showing anatomical positioning (no text or symbols)

Apparatinnstilling – puter

2 QuietAir-poistoilma-aukko

3 Vakiopoistoilma-aukko

4 Sivukappale

5 Sivupainikkeet

Illustration of a person applying a bandage to another person's mouth, showing anatomical positioning (no text or symbols)

Kurve over trykflow:

AirFit N30i
AirFit P30i

Maskens indstillingsmuligheder:
Til AirSense, AirCurve eller S9	Puder	Puder
Behandlingstryk:	4 til 25 cm H_2O	4 til 25 cm H_2O
Modstand: Målt trykfald (nominelt)
ved 50 l/min.	0,5 cm H_2O	0,4 cm H_2O
ved 100 l/min.	1,7 cm H_2O	1,5 cm H_2O

Illustration of a hand holding a small mechanical component above a cylindrical object, with an arrow indicating upward motion (no text or symbols)

Illustration of a person applying a medical or cosmetic device to another person's mouth (no text or symbols visible)

Illustration of a person applying a medical or cosmetic device to another person's neck (no text or symbols visible)

Illustration of a person applying a nasal swab or cuff to another person's neck (no text or symbols present)

Illustration showing two-step finger manipulation technique (no text or symbols)

Illustration of a hand holding a small mechanical component above a cylindrical object, with an arrow indicating upward motion (no text or symbols)

Illustration of a person applying a nasal palpure to another person's mouth, showing anatomical positioning (no text or symbols)

Illustration of hands holding a device with bidirectional arrows indicating movement (no text or symbols)

Illustration showing two-step finger manipulation technique (no text or symbols)

Illustration of a hand pouring liquid into a pipe fitting (no text or symbols)

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. 638270/1 2020-12