ResMed C16389 Bedienungsanleitung

RESMED

VPAP Malibu User Guide USA Multilingual

1. ORACLE DESCRIPTION

VPAP Malibu User Gd USA ML

2. DETAILS

Cover

Dimensions: Trimmed to A5 Portrait (210 H x 148 W ± 2 mm)

Style: Covers printed one side only. Inside cover is blank.

Stock: 250gsm Chorus Silk

Colour of printing: 4 colour process

TEXT

Dimensions: A5 Portrait (210 H x 148 W)mm ± 2mm

Style: Printed double-sided, bound and trimmed to make A5 portrait sized booklet.

80 gsm offset.

Colour of printing: Black.

Art Work: As shown on following pages. If re-typeset, the same styles and sizes must

be maintained.

Manufacturer: Small quantities may be printed in-house and large quantities externally.

3. RESMED QC INSPECTION

Refer to AU10006 - Printed Materials/Labels/CDs/Videos Section 19.1

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.

DOC NO 268106

REV 1

SPECIFICATION - PRINTED MATERIALS PAGE 1 of 195

Rev Change

Note

Date Document Prepared by Document Checked by

(Name)

1 C16389 24 Nov 06 Roberto Fermin Andrew Cheung or delegate

(refer to Change Note)

VPAP Malibu™

User Guide

English • Français • Español • Português

Front Cover - User.qxp 30/11/2006 3:43 PM Page 1

Global leaders in sleep and respiratory medicine www.myresmed.com

268106/1 06 12

VPAP Malibu

User

AMER ML

Bleed this panel onto spine (if applicable) but NOT onto Front Cover

268106

Front Cover - User.qxp 30/11/2006 3:43 PM Page 2

User Guide 1

Guía del Usuario 93

Guide Utilisateur 45

Manual do Usuário 141

VPAP Malibu™

EnglishFrançaisPortuguês Español

268106r1.book Page iii Thursday, November 30, 2006 2:35 PM

ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA

ResMed (UK) Ltd (EU Authorized Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK

ResMed Offices Australia, Austria, Brazil, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands,

New Zealand, Norway, Singapore, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details).

Protected by patents: AU 691200, AU 697652, AU 699726, AU 702820, AU 709279, AU 713679, AU 724589, AU 764761,

EP 0651971, EP 0661071, EP 0858352, EP 0920845, EP 0927538, EP 0934723, JP 3638613, US 4944310, US 5199424,

US 5245995, US 5522382, US 5704345, US 6029665, US 6138675, US 6213119, US 6363933, US 6398739, US

6591834, US 6635021, US 6675797, US 6705315, US 6745768, US 6770037, US 6935337, US 7004908. Other patents

pending.

Protected by design registrations: AU 147283, AU 147336, CH 128709, CH 128710, DE 40202007.3, DE 40202020.0, ES

153514, ES 153515, FR 021396, FR 021397, GB 3001791, GB 3001819, JP 1164087, JP 1164265, SE 75599, SE 75600, US

D467335, US D468011. Others pending.

Humidaire, Meridian, Mirage, Mirage Swift, Mirage Vista, SmartStart, ResLink, Ultra Mirage, VPAP and VPAP Malibu are

trademarks of ResMed Ltd. Humidaire, Mirage, SmartStart, Vista and VPAP are registered in U.S. Patent and Trademark

Office. SmartMedia is a registered trademark of Toshiba.

268106r1.book Page iv Thursday, November 30, 2006 2:35 PM

English

VPAP Malibu™

User Guide

English

268106r1.book Page 1 Thursday, November 30, 2006 2:35 PM

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Definitions 3

User/Owner Responsibility 3

Medical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

What the VPAP™ Malibu Is Intended For 5

Tell Your Doctor If... 5

Warnings 5

Cautions 7

The VPAP Malibu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Mask 9

Supplemental Oxygen 11

Preparing for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Setting Up the VPAP Malibu 13

Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Starting Treatment 21

Stopping Treatment 23

Using the Mask-Fitting Feature 24

Using DC Power to Run the VPAP Malibu 25

Helpful Hints 25

Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Daily 27

Weekly 27

Periodically 27

Replacing the Air Filter 28

Replacing the Antibacterial Filter 28

Servicing 28

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

268106r1.book Page 2 Thursday, November 30, 2006 2:35 PM

3Introduction

English

Introduction

Definitions

This guide contains special terms and icons that appear in the margins to draw

your attention to specific and important information.

WARNING

Alerts you to possible injury.

CAUTION

Explains special measures for the safe and effective use of the device.

Note: Is an informative or helpful note.

User/Owner Responsibility

The user or owner of this system shall have sole responsibility and liability for any

injury to persons or damage to property resulting from:

•operation which is not in accordance with the operating instructions supplied

•maintenance or modifications carried out unless in accordance with

authorized instructions and by authorized persons.

Please read this guide carefully before use.

268106r1.book Page 3 Thursday, November 30, 2006 2:35 PM

268106r1.book Page 4 Thursday, November 30, 2006 2:35 PM

5Medical Information

English

Medical Information

What the VPAP Malibu™ Is Intended For

The VPAP Malibu is indicated for the treatment of adult patients with obstructive

sleep apnea (OSA). It is intended for use in the hospital and home.

CAUTION (USA ONLY)

Federal law restricts this device to sale by or on the order of a physician.

Tell Your Doctor If...

You must tell your doctor if you have any of the following conditions, and CPAP

(continuous positive airway pressure) or bilevel therapy must not be used:

•pneumothorax or pneumomediastinum

•severe heart failure, low blood pressure, or dehydration

•surgery to the brain, middle or inner ear, pituitary gland, or sinuses

•respiratory distress syndrome

•middle ear infection or perforated ear drum

•severe nosebleed.

Warnings

CPAP or bilevel therapy should be used with caution if you have any of the

following conditions:

•respiratory failure

•cavities or cysts in the lung, or previous history of pneumothorax

•previous history of severe nosebleed

•sinus infection.

Tell your doctor if you have any of these conditions. Your doctor will advise you

whether the likely benefits of CPAP or bilevel therapy outweigh the expected

risks.

Special care should be exercised if you are dehydrated, or may become

dehydrated, for example as a result of fluid restriction or diuretic therapy

(including changes in therapy).

Discontinue therapy and seek medical advice if, during therapy or when you start

therapy each night, you feel faint or light-headed.

The following are general warnings that pertain to your use of a VPAP Malibu

unit. Specific warnings appear next to the relevant instructions in this guide.

268106r1.book Page 5 Thursday, November 30, 2006 2:35 PM

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