ResMed C16389 User manual

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
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TEXT
Dimensions: A5 Portrait (210 H x 148 W)mm ± 2mm
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Art Work: As shown on following pages. If re-typeset, the same styles and sizes must
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3. RESMED QC INSPECTION
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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. 2006
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
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User Guide 1
Guía del Usuario 93
Guide Utilisateur 45
Manual do Usuário 141
VPAP Malibu™
EnglishFrançaisPortuguês Español
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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.
© 2006 ResMed Ltd.
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English
1
VPAP Malibu™
User Guide
English
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2
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
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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.
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4
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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.
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6
!
WARNING
•This is NOT a life support device. It may stop operating with power failure
or if a fault occurs in the unit.
•The air flow for breathing produced by this device can be as much as 11oF
(6oC) higher than the temperature of the room. Caution should be exercised if
the room temperature is warmer than 90oF (32oC).
•The VPAP Malibu unit should only be used with masks (and connectors)
recommended by ResMed, or by your physician or respiratory therapist. A
mask should not be used unless the VPAP Malibu unit is turned on and
operating properly. The vent hole or holes associated with the mask should
never be blocked.
Explanation: The VPAP Malibu unit is 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.
•The VPAP Malibu unit should only be connected to the components,
humidifiers, or accessories specified in this guide. Connection of other items
may result in injury, or damage to the VPAP Malibu unit.
•At low pressures, the flow through the exhalation ports of your mask may not
clear all exhaled gas from the tubing. Some rebreathing may occur.
•Explosion hazard—do not use in the vicinity of flammable anesthetics.
•If oxygen is used with this device, the oxygen flow must be turned off when
the device is not operating.
Explanation of the warning: When the device is not in operation and the
oxygen flow is left on, oxygen delivered into the ventilator tubing may
accumulate within the device enclosure. Oxygen accumulated in the device
enclosure will create a risk of fire. This warning applies to most types of flow
generators.
•Oxygen supports combustion. Oxygen should not be used while smoking or
in the presence of an open flame.
•Always ensure air flow is being generated by the device before the oxygen
supply is turned on.
•Always turn the oxygen supply off before stopping the air flow from the
device.
Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen
concentration will vary, depending on where the oxygen is introduced, pressure
settings, patient breathing pattern, mask selection, and leak rate. This applies to
most types of CPAP machines.
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7Medical Information
English
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 contact the clinician who is treating
you for sleep apnea.
•If you experience an infection of the upper respiratory tract, middle ear, or
sinuses, contact your clinician before continuing your CPAP or bilevel
treatment. You may be advised to stop treatment until the infection has
cleared. If you continue with treatment during an infection, be sure to clean
your mask and tubing after every use.
Cautions
The following are general cautions. Specific cautions appear next to the relevant
instructions in this guide.
!
CAUTION
•Do not open the VPAP Malibu case. There are no user serviceable parts
inside. Repairs and internal servicing should only be performed by an
authorized service agent.
Possible Side Effects
The VPAP Malibu flow generator is designed to help you have a good night’s
sleep. However, you need to be aware of possible problems that may arise
during CPAP or bilevel treatment.
!
WARNING
Consult your clinician immediately if you experience any of the following
symptoms during your CPAP or bilevel treatment:
•headache
•middle ear or sinus discomfort
•dryness of the nose, mouth, or throat
•feeling bloated due to air swallowing
•air continually leaking out of the mouth while sleeping
•recurrence of any sleep apnea symptoms while on CPAP or bilevel.
Skin irritation may occur from sensitivity to the mask materials or from
excessively tight headgear straps. A correctly fitted mask and appropriately
adjusted straps will often prevent skin irritation. If problems persist, contact your
clinician for advice.
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8
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9The VPAP Malibu System
English
The VPAP Malibu System
Please identify and familiarize yourself with the following components of the
VPAP Malibu system:
Mask
You will also need a ResMed mask system (supplied separately). The following
ResMed mask systems are recommended for use with the VPAP Malibu:
Nasal Masks
•Meridian™ Nasal Mask
•Mirage Vista™ Nasal Mask
•Ultra Mirage™ Nasal Mask
•Ultra Mirage II Nasal Mask.
Nasal Pillow System
•Mirage Swift™ Nasal Pillows System.
Full Face Masks
•Ultra Mirage Full Face Mask.
Notes:
•ResMed devices have been designed and manufactured to provide optimum
performance using ResMed vented mask systems. Other mask systems
may be used, however performance and data outputs may be affected.
VPAP Malibu Unit
LCD
Air outlet
Control
Front View
Power
Filter
AC power
Rear View
screen
panel
switch
sockets
Auxiliary
port
Serial
communications
port
cover
Air tubing
Carry bag
Removable
front cap
6’6" (2 m)
Power cord Power cord clip
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10
•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.
Please refer to the relevant clinician’s guide for details.
!
WARNING
Only the HumidAire 2i is compatible for use with the VPAP Malibu. Please
refer to Warnings on page 6.
Accessories
The following accessories are available for use with the VPAP Malibu:
VPAP Malibu Accessories
•Hypoallergenic air filter (not shown)
Note: ResMed recommends the following tubing products for use with the
VPAP Malibu: 3 m air tubing, gray (PN: 14980); 2 m air tubing, gray
(PN: 14948); disposable air tubing, clear (PN: 14912).
HumidAire 2i™ heated humidifier
DC-24/30 Converter
Air tubing 9’9" (3 m)
Antibacterial air filter
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11The VPAP Malibu System
English
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 applies to most types of CPAP machines.
!
WARNING
•If oxygen is used with this device, the oxygen flow must be turned off
when the device is not operating.
Explanation: When the device is not in operation, and the oxygen flow is
left on, oxygen delivered into the ventilator tubing may accumulate
within the device enclosure and create a risk of fire.
•Always begin VPAP Malibu therapy before the oxygen supply is turned
on.
•Always turn the oxygen supply off before stopping VPAP Malibu
therapy.
•Oxygen supports combustion. Oxygen should not be used while
smoking or in the presence of an open flame.
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12
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13Preparing for Use
English
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 least 5’ (1.5 m) away from, or at least 8’ (2.5 m) above
the patient. It must also comply with IEC 60950 or equivalent.
Note: The air filter cover protects the device in the event of accidental liquid
spillage onto the device. Ensure that the air filter and air filter cover are fitted at
all times.
1Place the VPAP Malibu unit on a flat surface near the head of your bed. If the unit
is placed on the floor, ensure that the area is free from dust and clear of bedding,
clothes, or any other objects that could block the air inlet.
!
CAUTION
Be careful not to place the device where it can be bumped or where
someone is likely to trip over the power cord.
2Connect the power cord:
There are two sockets at the rear of the flow generator—the top one for an AC
(standard mains electricity) and the lower one for a DC power cord (see “Using
DC Power to Run the VPAP Malibu” on page 25). ResMed recommends using
the AC power cord supplied with the unit.
The customized ResMed power cord can be held in place with the locking clips.
To insert the locking clip, pinch the free ends together and fit the pins into the
holes on both sides of the socket. Insert the power cord into the socket. Push
the locking clip down so that the groove holds the power cord in place. Plug one
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14
end of the power cord into the power socket at the rear of the unit, and the other
end into a power outlet.
!
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.
3Connect one end of the air tubing firmly onto the air outlet of the unit.
!
WARNING
Only ResMed air tubing should be used with your flow generator. A
different type of air tubing may alter the pressure you actually receive
reducing the effectiveness of your treatment.
4Assemble your mask system according to the mask user instructions.
AC power switch
Locking clip
AC power cord
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15Preparing for Use
English
5Connect your mask system to the free end of the air tubing.
The VPAP Malibu is now ready for use. To start treatment, see “Operating
Instructions” on page 21.
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