ResMed AirFit N10 Bedienungsanleitung

ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and not to be used in any unauthorised way.

ResMed Ltd 2014.

DOC NO 628053

PAGE 1 of 70

SPECIFICATION – PRINTED MATERIALS REV 2

Rev Change

Note

Date

document

drafted

Document prepared by

(Name)

Document Checked by

(Name)

1 C35447 12 Dec 13 Dina Elenbaas Alison Besley or delegate (refer to change note)

2 C36440 23 Apr 13 Dina Elenbaas Alison Besley or delegate (refer to change note)

AirFit N10 / AirFit N10 for Her User Guide EUR2 Multi

1. ORACLE DESCRIPTION

AIRFIT N10 UG EUR2 ML

2. TRANSLATION DESCRIPTION

Refer to the Change History on the English source listed for summary of changes in each version.

Rev English source This translation replaces…

2 628050r5 n/a

1 628050r1 n/a (initial release)

3. PRINT DETAILS

Print according to master spec R001-7370

4. RESMED QC INSPECTION

For general sampling and inspection requirements, refer to AWI203-002 Appendix A, Printed or

Unprinted Materials and Labels, Criteria 1, 2, 3, 4, 5, 6, 8 and 9

Additional requirement

a) None

5. FOR ALL OTHER REQUIREMENTS, REFER TO RESMED SUPPLIER MANUAL AQP119.

6. LOW RESOLUTION VERSION

Low resolution versions suitable for web publishing or other distribution can be found in Objective

under the same file name contained within the Objective folder “files for web upload”.

ResMed Confidential Proprietary Information, not to be reproduced or made available to third parties

without prior consent from ResMed and not to be used in any unauthorised way.

ResMed Ltd 2014.

DOC NO 628053

PAGE 2 of 70

SPECIFICATION – PRINTED MATERIALS REV 2

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N10

AirFit

Nasal Mask

User guide

English | Svenska

Dansk | Norsk

Suomi | Eesti

628053 Enmore User Guide_Eur 2.indb 1 30/04/2014 9:32:50 AM

Fitting /Tillpassning / Tilpasning / Tilpasning /

Sovittaminen / Paigaldamine

1 21

3 4

5 6 7

628053 Enmore User Guide_Eur 2.indb 2 30/04/2014 9:33:04 AM

Removal / Borttagning / Aftagning / Avtaking /

Pois ottaminen / Eemaldamine

1 21

Disassembly / Demontering / Adskillelse / Demontering /

Purkaminen / Osadeks lahtivõtmine

1 21 3

628053 Enmore User Guide_Eur 2.indb 3 30/04/2014 9:33:14 AM

Reassembly / Montering / Samling / Montering /

Kokoaminen / Uuesti kokkupanek

1 21

628053 Enmore User Guide_Eur 2.indb 4 30/04/2014 9:33:24 AM

English 1

ENGLISH

Nasal Mask

Thank you for choosing the AirFit N10. This document provides the user

instructions for the AirFit N10 and AirFit N10 for Her masks referred to

collectively as AirFit N10 throughout this manual. AirFit N10 has blue

headgear while AirFit N10 for Her has pink headgear.

Using this guide

Please read the entire guide before use. When following instructions,

refer to the images at the front and back of the guide.

Intended Use

The AirFit N10 channels airflow noninvasively to a patient from a positive

airway pressure (PAP) device such as a continuous positive airway

pressure (CPAP) or bilevel device.

The AirFit N10 is:

to be used by patients (> 30 kg) for whom positive airway pressure

has been prescribed

intended for single-patient re-use in the home environment and

multipatient re-use in the hospital/institutional environment.

WARNING

Magnets used in this mask are within ICNIRP guidelines for general

public use. Some active medical implants—such as a pacemaker or

defibrillator—may be affected by localised magnetic fields. The

magnetic clips in this mask should be kept at least 50 mm away from

any active medical implant.

Contraindications

Use of the AirFit N10 may be contraindicated in some 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 following a penetrating eye

injury.

GENERAL WARNINGS

The vent holes must be kept clear.

The mask should only be used with CPAP or bilevel devices

recommended by a physician or respiratory therapist.

The mask should not be used unless the device is turned on. Once

the mask is fitted, ensure the device is blowing air. Explanation:

CPAP and bilevel devices are intended to be used with special

masks (or connectors) which have vent holes to allow continuous

flow of air out of the mask. When the device is turned on and

functioning properly, new air from the device flushes the exhaled

air out through the mask vent holes. However, when the device is

not operating, insufficient fresh air will be provided through the

mask, and the exhaled air may be rebreathed. Rebreathing of

exhaled air for longer than several minutes can, in some

circumstances, lead to suffocation. This applies to most models of

CPAP or bilevel devices.

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 3

The technical specifications of the mask are provided for your

clinician to check that they are compatible with the CPAP or

bilevel 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 bilevel device

function.

Discontinue using this mask if you have ANY adverse reaction to

the use of the mask, 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.

As with all masks, some rebreathing may occur at low CPAP

pressures.

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

settings and operational information.

Remove all packaging before using the mask.

Using your mask

When using your mask with ResMed CPAP or bilevel devices that have

mask setting options, refer to the Technical specifications section in this

user guide for mask selection options.

For a full list of compatible devices for this mask, see the Mask/Device

Compatibility List on www.resmed.com on the Products page under

Service & Support. If you do not have internet access, please contact

your ResMed representative.

Fitting

1. With the grey side of the headgear facing outward and with both

lower headgear straps released, align the bottom of the cushion

opening with the bottom of your nose.

2. Place the mask over your nose. Hold the mask against your face and

pull the headgear over your head.

Headgear check:

Ensure the label on the headgear faces outwards when the

headgear is put on.

3. Bring the lower straps below your ears. Attach the magnet clip to the

outside of the frame.

4. Undo the fastening tabs on the upper headgear straps. Adjust the

straps evenly until the mask sits comfortably just under the nose.

Reattach the fastening tabs to the upper headgear straps.

5. Undo the fastening tabs on the lower headgear straps. Adjust the

straps evenly until the mask is stable. Reattach the fastening tabs.

6. Connect the free end of the short tube assembly to the device air

tubing. Turn on your device so that it is blowing air.

7. Adjust the cushion and headgear until the mask sits comfortably on

your nose and is not creased or twisted.

Notes:

The upper straps are the key adjustments for seal and comfort.

Ensure they are not overtightened.

The lower straps are used to keep the cushion in the right position.

They do not need to be tightened much for the mask to fit

comfortably.

Removing your mask

1. Remove one or both magnets from the frame by twisting the lower

headgear strap and clip away.

2. Pull the mask away from your face and back over your head.

Disassembly

1. Undo the fastening tabs on the upper headgear straps. Pull the straps

out of the frame.

2. Squeeze and pull the cushion away from the frame.

3. If the soft sleeves are fitted, remove them by pulling them off of the

frame.

Reassembly

1. Attach the cushion to the frame by inserting the top and bottom clips

into the correct slots on the frame.

2. To fit the optional soft sleeves, pull them over the upper arms of the

frame.

3. With the ResMed logo facing out, thread the top headgear straps into

the frame slots from the inside out. Fold the strap over to secure.

4. To reattach the magnet clips to the headgear, thread the lower

headgear straps into the slots with the clips facing down. Fold the

strap over to secure.

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