ResMed S8 Elite II Bedienungsanleitung

S8 Elite™ II System

User Guide

English

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 Authorised

Representative) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK • ResMed Offices Australia, Austria, Brazil, China,

Finland, France, Germany, Hong Kong, India, Japan, Malaysia, Netherlands, New Zealand, Norway, Singapore, Spain,

Sweden, Switzerland, UK, USA (see www.resmed.com for contact details).

Protected by patents: AU 697652, EP 0661071, US 4944310, US 5199424, US 5522382, US 6240921, US 6705315.

Other patents pending.

Protected by design registrations: AU 302180, AU 302181, AU 302182, AU 302183, AU 302184, AU 302185, AU 302186,

CN 200430121212.2, CN 200430121213.7, CN 200430121211.8, CN 200430121214.1, CN 200430121215.6, CN

200430121216.0, CN 200430121217.5, EP 269436, HK 0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP

1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924, NZ 406926, NZ 406927. Others pending.

S8, S8 Elite, Mirage, HumidAire, HumidAire 3i, ResScan, Mirage Vista, Ultra Mirage, Mirage Activa, Mirage Swift,

Mirage Liberty, Mirage Quattro, Papillon and SmartStart are trademarks of ResMed Ltd and HumidAire is

registered in U.S. Patent and Trademark Office.

S8 Elite™II System

ILLUSTRATIONSComponent of 338425/1

Keypad

Carry handle

Air filter cover

Module

DC input

AC input

LCD screen

Air outlet

SYSTEM COMPONENTS

Air inlet

2 m

34 5

OTHER ACCESSORIES

SETTING UPTHE S8TM

BINTEGRATED HUMIDIFIER

3 m

HumidAire 3i™

Note: Some products not available in all regions.

338425 Illustrations.qxp 21/08/2007 1:03 PM Page 1

DATA CARD MODULE

HUSINGTHE DATA CARD

Note: Some products not available in all regions.

HumidAire 3i

EHUMIDAIRE 3i AND S8

BLANK MODULE

DDaattaa

ccoommmmuunniiccaattiioonnss

ppoorrtt

338425 Illustrations.qxp 21/08/2007 1:03 PM Page 2

iContents

Contents

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

Your Responsibility 1

Medical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

About the S8 Elite II 2

Contraindications 2

Warnings 2

Cautions 3

Adverse Effects 4

The S8 Elite II System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

S8 Elite II 5

Masks 5

Humidifier 6

ResScan Data Card Module 6

Accessories 6

How to Use the S8 Elite II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Set Up the S8 Elite II 7

Assemble the Mask 7

Start Treatment 8

Stopping Treatment 8

Using the Mask-Fitting Feature 9

How to Attach a Humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Attach a HumidAire 3i Humidifier 11

How to use the Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

How to Change the Settings 13

How to Use the Standard Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

How to Use the Detailed Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Settings Menu 17

Results Menu 18

Options Menu 18

Servicing Menu 18

Messages on the S8 Elite II LCD 18

S8 Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Using a Blank Module 20

Using a ResScan Data Card Module 20

Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Daily Cleaning 23

Weekly Cleaning 23

Periodic Cleaning 23

iiContents

Replacing the Air Filter 24

Servicing 24

Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

S8 Elite II (no Accessories) 31

Accessories 32

All Devices (where applicable) 32

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

1Introduction

Introduction

Thank you for choosing the S8 Elite™ II flow generator. The S8 Elite II is a

compact, all-in-one package with an inbuilt power supply and the option of

integrated data management and humidification.

This user manual contains the information you need for the correct use of your

S8 Elite II.

Your Responsibility

The owner or user 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

authorised instructions and by authorised persons.

Please read this manual carefully before use.

This manual 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.

2Medical Information

Medical Information

About the S8 Elite II

The S8 Elite II continuous positive airway pressure (CPAP) system is indicated

for the treatment of obstructive sleep apnoea (OSA) in adult patients.

The S8 Elite II CPAP system is intended for home and hospital use.

Contraindications

The S8 Elite II is not a life support device and may stop operating during power

failure or certain fault conditions. It should not be used by patients who are

dependent on continuous therapy.

Positive airway pressure therapy may be contraindicated in some patients with

the following pre-existing conditions:

•severe bullous lung disease

•pneumothorax

•pathologically low blood pressure

•dehydration

•cerebrospinal fluid leak, recent cranial surgery or trauma.

Warnings

•The entire manual should be read before using the S8 Elite II.

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

the prescribing physician.

•A patient should not connect a device to the data communication port unless

instructed to do so by their health care provider or physician. Only ResMed

products are designed to be connected to the data communication port.

Connecting other devices could result in injury, or damage to the S8 Elite II

device.

•The S8 Elite II should be used with masks (and connectors)1recommended

by ResMed, or by a physician or respiratory therapist. A mask should not be

used unless the S8 Elite II device is turned on and operating properly. The

vent hole or holes associated with the mask should never be blocked.

Explanation: The S8 Elite II is intended to be used with special masks (or

connectors)1which 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

1 Ports may be incorporated into the mask or in connectors that are near the mask.

3Medical Information

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 devices.

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

•The S8 Elite II can be set to deliver pressures up to 20 cm H2O. In the

unlikely event of certain fault conditions, pressures up to 30 cm H2O are

possible.

•If oxygen is used with this device, the oxygen flow must be turned off when

the device is not operating. If oxygen has been left on while the device is not

operating, disconnect the oxygen and wait 30 minutes before turning on the

device.

Explanation: When the CPAP device is not in operation and the oxygen flow

is left on, oxygen delivered into the air delivery tubing may accumulate within

the CPAP machine enclosure and create a risk of fire. This applies to most

types of CPAP machines.

•Oxygen supports combustion. Oxygen should not be used while you are

smoking or in the presence of an open flame.

•Always ensure airflow is being generated by the device before the oxygen

supply is turned on.

•Always turn the oxygen supply off before stopping the airflow 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, the

pressure settings, patient breathing pattern, mask selection and leak rate.

•Do not use the S8 Elite II if there are obvious external defects or unexplained

changes in performance.

•Do not open the S8 Elite II case. There are no user serviceable parts inside.

Repairs and internal servicing should only be performed by an authorised

service agent.

•Explosion hazard—do not use in the vicinity of flammable anesthetics.

Cautions

•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.

•The airflow for breathing produced by this device can be as much as 6°C

higher than the temperature of the room. Caution should be exercised if the

room temperature is warmer than 32°C.

•When AC mains power (100–240V AC) is not available, always use a ResMed

DC-12 converter. (The DC-12 converter is available as an optional accessory.)

•If supplied, the ResScan™ Data Card module is designed for use with

specific ResMed devices.

•Only use the ResScan Data Card module (if supplied) as specified in this

manual.

4Medical Information

Note: The above are general warnings and cautions. Specific warnings, cautions

and notes appear with the relevant instructions in the manual.

Adverse Effects

Patients should report unusual chest pain, severe headache or increased

breathlessness to their prescribing physician. An acute upper respiratory tract

infection may require temporary discontinuation of treatment.

The following side effects may arise during the course of therapy with the S8

device:

•drying of the nose, mouth or throat

•nosebleed

•bloating

•ear or sinus discomfort

•eye irritation

•skin rashes

•chest discomfort.

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