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RESMED
Proprietary Information, not to be reproduced or made available to third parties
DOC NO
268106
without prior consent from ResMed and not to be used in any unauthorised way.
© ResMed Ltd. 2006 REV 1
PAGE 1 of 195
SPECIFICATION - PRINTED MATERIALS
Rev Change Date Document Prepared by Document Checked by
Note (Name)
Andrew Cheung or delegate
1 C16389 24 Nov 06
Roberto Fermin
(refer to Change Note)
VPAP Malibu User Guide USA Multilingual
1. ORACLE DESCRIPTION
VPAP Malibu User Gd USA ML
2.
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Front Cover - User.qxp 30/11/2006 3:43 PM Page 1 VPAP Malibu™ User Guide English • Français • Español • Português
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Front Cover - User.qxp 30/11/2006 3:43 PM Page 2 Bleed this panel onto spine (if applicable) but NOT onto Front Cover 268106/1 06 12 VPAP Malibu User AMER ML 268106 Global leaders in sleep and respiratory medicine www.myresmed.com
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268106r1.book Page iii Thursday, November 30, 2006 2:35 PM VPAP Malibu™ User Guide 1 Guide Utilisateur 45 Guía del Usuario 93 Manual do Usuário 141 Português Español Français English
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268106r1.book Page iv 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,
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268106r1.book Page 1 Thursday, November 30, 2006 2:35 PM VPAP Malibu™ User Guide English 1 English
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268106r1.book Page 2 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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268106r1.book Page 3 Thursday, November 30, 2006 2:35 PM 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 inju
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268106r1.book Page 4 Thursday, November 30, 2006 2:35 PM 4
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268106r1.book Page 5 Thursday, November 30, 2006 2:35 PM 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 p
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268106r1.book Page 6 Thursday, November 30, 2006 2:35 PM WARNING ! • This is NOT a life support device. It may stop operating with power failure or if a fault occurs in the unit. o • The air flow for breathing produced by this device can be as much as 11 F o (6 C) higher than the temperature of the room. Caution should be exercised if o o the room temperature is warmer than 90 F (32 C). • The VPAP Malibu unit should only be used with masks (and connectors) recommended by ResMed, or by you
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268106r1.book Page 7 Thursday, November 30, 2006 2:35 PM Warnings Related to Treatment WARNING ! • If you stop your CPAP or bilevel treatment, your sleep apnea will return immediately. • Always consult your clinician if you expect to be in a situation where you cannot use your VPAP Malibu unit. • If you are admitted to a hospital or prescribed any other form of medical treatment, always inform the medical staff that you are being treated with CPAP or bilevel. It is also important to conta
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268106r1.book Page 8 Thursday, November 30, 2006 2:35 PM 8
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268106r1.book Page 9 Thursday, November 30, 2006 2:35 PM The VPAP Malibu System Please identify and familiarize yourself with the following components of the VPAP Malibu system: VPAP Malibu Unit Front View Rear View LCD Filter screen cover Control panel AC power switch Power Removable sockets front cap Serial Auxiliary Air outlet communications port port Carry bag Air tubing Power cord Power cord clip 6’6" (2 m) Mask You will also need a ResMed mask system (supplied separately). The followi
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268106r1.book Page 10 Thursday, November 30, 2006 2:35 PM • In VSet mode, only ResMed masks are compatible for use with the VPAP Malibu. • Your clinician needs to set up your VPAP Malibu for use with your particular mask. Humidifier A humidifier may be required if you are experiencing dryness of the nose, throat, or mouth. The VPAP Malibu is compatible for use with the following humidifier. HumidAire 2i™ heated humidifier Please refer to the relevant clinician’s guide for details. WARNIN
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268106r1.book Page 11 Thursday, November 30, 2006 2:35 PM Supplemental Oxygen The VPAP Malibu is designed to be compatible with the use of low flow oxygen therapy provided from an external source and supplied at a fixed rate of up to 15 L/min (S mode, CPAP mode) or 5 L/min (VSet mode). At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary,depending on the pressure settings, patient breathing pattern,mask selection,and the leak rate. This warning app
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268106r1.book Page 12 Thursday, November 30, 2006 2:35 PM 12
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268106r1.book Page 13 Thursday, November 30, 2006 2:35 PM Preparing for Use Setting Up the VPAP Malibu WARNING ! • Do not connect any device (other than the ResLink™ module) to the auxiliary port. Although your health care provider may connect specially designed devices to the auxiliary port of the VPAP Malibu unit, connection of other devices could result in injury to persons, or damage to the unit. • In the clinical environment any PC that is used with the VPAP Malibu system must be at
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268106r1.book Page 14 Thursday, November 30, 2006 2:35 PM end of the power cord into the power socket at the rear of the unit, and the other end into a power outlet. AC power switch Locking clip AC power cord CAUTION ! Do not connect both AC and DC power cords to the VPAP Malibu at the same time. WARNING ! Make sure the power cord and plug are in good condition and the equipment is not damaged. Connect one end of the air tubing firmly onto the air outlet of the unit. 3 WARNING ! Only ResMe
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268106r1.book Page 15 Thursday, November 30, 2006 2:35 PM Connect your mask system to the free end of the air tubing. 5 The VPAP Malibu is now ready for use. To start treatment, see “Operating Instructions” on page 21. Preparing for Use 15 English
