ResMed AirFit F30 Bedienungsanleitung

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User guide

USER GUIDE

English 1

ENGLISH

QuietAir / standard elbow

Side buttons

Frame

Magnetic clips

Cushion

Upper headgear strap

Headgear

Lower headgear strap

Vent

Top headgear strap

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.

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.

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

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)

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

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.

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