ResMed Adapt SV System User Manual

VPAP™Adapt SV

User Guide

English

Front Cover - User.qxp 05/04/2006 4:31 PM Page 1

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

26869/2

06 04

VPAP Adapt SV

User

USA ENG

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

Front Cover - User.qxp 05/04/2006 4:31 PM Page 2

VPAP™ Adapt SV

User Guide

English

Reorder number: 26869/2 06 04

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, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands,

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

Protected by patents: AU 691200, AU 697652, AU 702820, AU 709279, AU 724589, AU 730844, AU 731800, AU 736723, AU 734771, AU 750095, AU 750761, AU 756622, AU 761189, AU 2002306200, CA 2263126, EP 0661071, JP 3635097, JP 3737698, NZ 527088, US 4944310, US 5199424, US 5245995, US 5522382, US 5704345, US 6029665, US 6138675, US 6152129, US 6240921, US 6279569, US 6363933, US 6367474, US 6398739, US 6425395, US 6502572, US 6532959, US 6591834, US 6659101, US 6945248, US 6951217. Other patents pending. Protected by design registrations: AU 147283, AU 147335, AU 147336, AU 157903, AU 157904, AU 157905, CH

128.709, CH 128.710, CH 128.711, CN 200330123689.X, CN 200330123691.7, CN 200330123690.2, EP 000111190, DE 40202007, DE 40202008, DE 40201723, DE 40202020, ES 153514, ES 153515, ES 153516, ES 153518, FR 02 1407, GB 3001791, GB 3001819, GB 3001820, GB 3001821, JP 1164087, JP 1164265, JP 1164266, JP 1164267, SE 75598, SE 75599, SE 75600, SE 75715, US D467335, US D468011, US D476077, US D477868, US D493520, US D493884, US D497203, US D498527. Other designs pending.

Activa, HumidAire, Mirage, ResControl, ResLink, ResScan, Smart Data, SmartStart, Ultra Mirage, Vista, VPAP and VPAP Adapt SV are trademarks of ResMed Ltd. Activa, Humidaire, Mirage, SmartStart, Vista and VPAP are registered in U.S. Patent and Trademark Office. SmartMedia is a trademark of Toshiba.

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

VPAP™ Adapt SV 1 User/owner responsibility 1 Definitions 1 Medical Information 1

Intended Use 1 Contraindications 1

Warnings 2 Cautions 2

Quick Setup Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

VPAP Adapt SV System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

VPAP Adapt SV Components 7

Masks 8

Assembling the VPAP Adapt SV System 9 Humidifiers 11

Connecting a Humidifier 11 HumidAire 2i™ 12 HumidAire™ 13

ResLink™ 15 Anti-bacterial Filter 15 Using DC Power to Run the VPAP Adapt SV 16 Supplemental Oxygen 16

Using the VPAP Adapt SV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Starting Treatment 17 Stopping Treatment 17 Standby Mode 17 Control Panel Functions 18 Adjusting Settings 19 Menus 21

Settings Menu 22 Results Menu 23 Options Menu 24 Servicing Menu 25

Treatment Screens 25

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Low Mask Pressure Alarm 27 Power Fail Alarm 28 High Pressure Alarm 28 High Leak Alarm 28 Insufficient Pressure Support Alarm 29 Flow Blocked Alarm 29

iContents

Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Daily 31 Weekly 31 Periodically 32 Air Filter 33

Hypoallergenic Air Filter 33

Servicing 33

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Introduction

VPAP™ Adapt SV

The VPAP™ Adapt SV flow generator has been designed to be reliable, comfortable and easy to use. You can observe your treatment and make adjustments to settings using a keypad and LCD screen.

CAUTION

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

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 manual carefully before use.

Definitions

WARNING

Heading alerts you to possible injury.

CAUTION

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

Medical Information

Intended Use

The VPAP Adapt SV system is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing. This device is intended for use in the hospital or home.

Contraindications

The VPAP Adapt SV is not a life support ventilator and may stop operating with power failure or in the unlikely event of certain fault conditions.

Before using the VPAP Adapt SV tell your doctor if you have any of the following conditions:

• hypotension or significant intravascular volume depletion

• acute sinusitis or otitis media

• epistaxis (severe nose bleeds) causing a risk of pulmonary aspiration

• conditions predisposing to a risk of vomiting into mask

1Introduction

• impaired ability to clear secretions

• pneumothorax or pneumomediastinum

• recent cranial trauma or surgery

• chronic hypoventilation.

Below are general warnings and cautions. Further specific warnings, cautions and notes appear next to the relevant instructions in the manual.

Warnings

• The VPAP Adapt SV is NOT a life support ventilator.

• The entire manual should be read before using the VPAP Adapt SV.

• Advice contained in this manual should not supersede instructions given by

the prescribing physician.

• The VPAP Adapt SV should be used with masks and accessories

recommended by ResMed or the prescribing physician. Use of incorrect masks and accessories may adversely affect the function of the VPAP Adapt SV.

• The VPAP Adapt SV is designed for use with masks that allow exhaled gases

to be flushed out through vent holes. Exhaled gases will be rebreathed if the mask is worn with the machine turned off, or the vent holes are occluded. If this occurs over prolonged periods, suffocation may occur.

• In the event of power failure or machine malfunction, remove the mask.

• The air flow for breathing produced by this device can be as much as 11

(6oC ) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 90oF (32oC).

• The VPAP Adapt SV can be set to deliver pressures up to 20 cm H

O. In the

unlikely event of certain fault conditions, pressures of up to 40 cm H2O for less than one second are possible.

• The VPAP Adapt SV is not suitable for use in the vicinity of flammable

anesthetics.

• If oxygen is used with the VPAP Adapt SV, the oxygen flow should be

stopped when the device is not operating. If oxygen flow continues when the device is not operating, oxygen may accumulate within the device and create a risk of fire.

• Do not use the VPAP Adapt SV if there are obvious external defects or

unexplained changes in performance.

• Do not open the VPAP Adapt SV case. There are no user serviceable parts

inside. Repairs and internal servicing should only be performed by an authorized ser vice agent.

Cautions

You should report unusual chest pain, severe headache or increased breathlessness to your physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment.

The following side effects may arise during a course of therapy with the VPAP Adapt SV:

• drying of the nose, mouth, or throat

• bloating

• ear or sinus discomfort

• eye irritation

• skin rashes

• chest discomfort.

3Introduction

Quick Setup Guide

1 Attach the air tubing and pressure sensor tube to the VPAP Adapt SV and mask

(page 9).

Attach a humidifier if required (page 11).

Switch on the VPAP Adapt SV. Make sure the mask is unblocked.

Select the mask setting (page 22).

Perform the Air Circuit Learn function (page 22) at first-time use, or if you are

adding or removing a component of the system (eg, a humidifier or anti-bacterial filter).

Fit the mask and commence breathing into it. The SmartStart™ function should

trigger treatment to commence within the first couple of breaths. If not, press the Start/Stop key once to commence treatment (page 17).

Note: You can observe treatment progress (eg, mask leak) via the Treatment screens (page 25).

Remove your mask to stop treatment. If SmartStop is enabled, treatment will

stop automatically. If the SmartStop function has been disabled, press the Start/Stop key once.

5Quick Setup Guide

VPAP Adapt SV System

VPAP Adapt SV Components

The VPAP Adapt SV flow generator is supplied with air tubing and a power cord. Masks are supplied separately, as you and your clinician have to decide which

mask is best for you. Masks that can be used with VPAP Adapt SV are listed on page 8.

Some people experience dryness of the nose, mouth and throat while using the VPAP Adapt SV system, especially during winter. Others may experience sneezing and/or a runny or blocked nose during the first few weeks of VPAP treatment. In many cases, these symptoms of nasal irritation can be resolved with a humidifier. See page 11 to connect a humidifier to the VPAP Adapt SV.

LCD screen

Control panel

Carry handle

Removable front cover

Air tubing connector

Figure 1: VPAP Adapt SV flow generator

Pressure sensor tube connector

The control panel allows you to adjust settings on the flow generator, and the LCD screen displays information about your treatment. See “Control Panel Functions” on page 18.

ResLink attachment point

Air filter

Powe r cord

Figure 2: Rear of VPAP Adapt SV

See page 15 to connect a ResLink™. See page 33 to replace the air filter.

7VPAP Adapt SV System

Proximal cuff

Tube clip

Pressure sensor tube

Luer connector

Connect this end to the mask

Figure 3: Air tubing fully assembled

Air tubing

Connect this end to the flow generator

All necessary air tubing components are packed with the VPAP Adapt SV:

• a 6’6" (2 m) length of air tubing

• a pressure sensor tube (to measure pressure at the mask) with Luer

connectors

• tube clips (to hold the pressure sensor tube onto the air tubing)

• a proximal cuff (a special connector that attaches the pressure sensor tube

into the main air tubing so that you only need to make one attachment to the

mask). The air tubing is supplied with the Proximal cuff connected. Attach the tube clips evenly along the air tubing. Press the pressure sensor tube into the tube clips, and screw the Luer connectors together at the Proximal cuff. Make sure the pressure sensor tube is not kinked, obstructed or twisted.

Note: ResMed recommends the following tubing products for use with the VPAP Adapt SV: replacement air hose (only) PN14968; replacement air delivery system (hose, sensor line, clips, proximal cuff) PN26923.

Masks

The following mask systems (supplied separately) are recommended for use with the VPAP Adapt SV system. Please refer to the table on page 22 to set up your mask correctly for use with the VPAP Adapt SV.

Ultra Mirage™ Full Face Mask

Mirage™ Full Face Mask Series 2

Mirage Vista™

Mirage Activa™

Ultra Mirage™

Your clinician can explain the features of the masks available and will discuss the mask that best suits your needs.

Assembling the VPAP Adapt SV System

Complete the following steps to assemble the VPAP Adapt SV system. Make sure the area around the unit is clean (dust free) and clear of bedding, clothes and any other potential blockages.

To add a humidifier see page 11.

WARNING

Use only the air tubing system supplied with the VPAP Adapt SV system.

Connect 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 Adapt SV” on page 16). 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 end of the power cord into the power socket at the rear of the unit, and the other end into a power outlet.

Power switch

AC locking clip

AC power cord

Plug the free end of the power cord into a power outlet.

CAUTIONS

• Do not connect both AC and DC power cords to the VPAP Adapt SV at

the same time.

• Be careful not to place the device where it can be bumped or where

someone is likely to trip over the power cord.

WARNING

Make sure the power cord and plug are in good condition and the equipment is not damaged.

9VPAP Adapt SV System

Connect air tubing

Connect the air tube firmly onto the air outlet at the front of the unit.

Air tubing connector

Pressure sensor tube connector

Figure 4: Front view of VPAP Adapt SV

To attach the pressure sensor tube to the unit, screw the Luer connector onto the socket on the side of the unit.

Figure 5: Twisting the Luer lock connectors together

WARNING

Use care when handling the air tubing. Be particularly careful when attaching the Luer connector to the VPAP Adapt SV. If you kink or excessively twist the sensor tube it may affect the protection offered by the mask pressure alarm system.

Attach the mask to the air tubing.

The mask system should already be assembled. If not, please refer to the user instructions supplied with the mask.

Connect the mask system to the free end of the air tubing.

Proximal cuff

Figure 6: Assembling the VPAP Adapt SV system

Humidifiers

A humidifier may be required if you are experiencing dryness of the nose, throat, or mouth. The following ResMed humidifiers are compatible with the

VPAP Adapt SV:

HumidAire™

heated humidifier

Humidifier accessory (HumidAire only)

Medium air tubing

Figure 7: Humidifiers compatible with the VPAP Adapt SV

When using a humidifier, stop the by removing the mask to trigger the VPAP Adapt SV this could result in condensation in the motor.

Please refer to the relevant humidifier user manual for detailed instructions and warnings.

off at the power switch or the power source while it is running, as

HumidAire 2i™

heated humidifier

21" (52 cm)

VPAP Adapt SV

SmartStop

by using the Start/Stop key or

function. Do not switch the

CAUTIONS

• Be very careful not to allow water to enter the VPAP Adapt SV as this

could affect therapy and/or damage the device.

• Do not tip the humidifier while it is connected to the VPAP Adapt SV. If

water enters the VPAP Adapt SV device, turn off the main power switch

at the back of the unit and unplug it from the power outlet. Return the

unit to your equipment supplier for checking.

Connecting a Humidifier

Note: After connecting or removing a humidifier, always perform the Air Circuit Learn function (see page 22).

WARNING

When using a humidifier, position it so that it is lower than your head will be during sleep, and at the same level or lower than the VPAP Adapt SV.

11VPAP Adapt SV System

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