ResMed AirFit N30 Bedienungsanleitung

User guide

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USER GUIDE

English 1

ENGLISH

Split-band headgear

End cap

Cushion

Stabilizer

QuietAir™ / standard frame

QuietAir vent

Buckle

Vent

Buttonhole

Mask tubing

Intended Use

The AirFit N30 nasal cradle 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.

QuietAir frame

The QuietAir frame is intended for single patient re-use in the home and

hospital/institutional environment.

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).

Fitting your mask

1. While holding the cushion away from your nose, make sure that the

cushion size, left (L) and right (R) indicators are facing towards you.

Place the cushion under your nose.

English 3

2. Pull the headgear bands over your head by holding the bottom band

and stretching it around the back of your head. The top band should sit

comfortably on the crown of your head.

3. Briefly pull your mask away from your nose and place it back to

ensure that the cushion fits comfortably.

Adjusting your mask

•To achieve a comfortable fit, adjust the split bands by spreading them

apart to loosen or draw them closer together to tighten.

•To fix any mask leak, adjust the headgear by pulling the headgear

through the buckle. Adjust only enough for a comfortable seal and do

not overtighten. You may need to adjust the headgear as it stretches

over time.

Your mask is now fitted and ready to use. While lying down and the

device is running, a light breeze should be felt near the venting area

around the tube connection. To inspect the vent, place a finger close to

the connection area and feel for air. Do not allow the venting area to

become blocked.

Removing your mask

To take off your mask system, pull the mask

and headgear by the split-band up and over your

head.

Disassembling your mask for cleaning

1. Firmly pinch one side of the cushion and pull away from the frame.

2. Unhook the headgear from the stabiliser by pulling on the end cap to

reveal the buttonhole.

3. Slide the headgear off the end of the stabiliser.

Cleaning your mask

After each use: Cushion

Weekly: Headgear and frame

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.

3. Thoroughly rinse the components under running water.

4. Shake the frame to remove any excess water from the vent. 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 is clean and clear.

English 5

Reassembling your mask

1. With the gray side of the headgear facing out, insert each end of the

headgear band over the stabilisers through the buttonholes.

2. Secure the headgear by pulling the buttonholes over the ends of the

stabilisers.

3. Holding the mask frame, stretch the headgear lightly to ensure it is

securely attached. Ensure that the headgear band is not twisted.

4. Align the notch in the cushion to the tab on the mask frame. Firmly

push one side of the cushion onto the frame, then repeat on the other

side. Push down all the edges of the cushion onto the frame to ensure

that the edges are completely flat.

WARNING

•Remove all packaging before using the mask

•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

•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 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 to prevent the growth of germs that can

adversely affect your health.

•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 risk

of rebreathing exhaled air.

•Discontinue using or replace this mask if the patient has ANY

adverse reaction to the use of the mask. Consult your physician or

sleep therapist.

•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.

English 7

WARNING

•Refer to your CPAP or bilevel device manual for details on

settings and operational information.

•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

•Using a mask may cause tooth, gum or jaw soreness or aggravate

an existing dental condition. If symptoms occur, consult your

physician or dentist.

•As with all masks, some rebreathing may occur at low pressures.

•The mask is not intended to be used simultaneously with

nebulizer medications that are in the air path of the mask/tube.

CAUTION

•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.

•When fitting the mask, do not overtighten the headgear as this

may lead to skin redness or sores around the mask cushion.

•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.

•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 device, these

should be reported to ResMed and the competent authority in your

country.

Technical specifications

Mask setting options: For AirSense: Select 'Pillows'.

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: 4 to 20 cm H20

Resistance: Drop in pressure measured (nominal)

at 50 L/min: 0.4 cm H2O

at 100 L/min: 1.7 cm H2O

Sound: Declared dual-number noise emission values in accordance with ISO4871:1996

and ISO3744:2010. The A-weighted sound power level and the A-weighted pressure level

at a distance of 1 m, with uncertainly of 3 dBA, are shown.

Power level (with QuietAir Frame): 25 dBA

Pressure level (with QuietAir frame): 18 dBA

Power level (with standard frame): 28 dBA

Pressure level (with standard frame): 21 dBA

Environmental conditions

Operating temperature: 5°C to 40°C

Operating humidity: 15% to 95% RH non-condensing

Storage and transport temperature: -20°C to +60°C

Storage and transport humidity: up to 95% RH 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 ‘Caution’ 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.

English 9

Disposal

This product and 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. Reprocessing instructions are

available on ResMed.com/downloads/masks.

Symbols

The following symbols may appear on your product or packaging:

Nasal cradle mask

Device setting - Pillows

QuietAir vent

Size - small

Size - medium

Size - small wide

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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