ResMed S8 AutoSet Spirit II Bedienungsanleitung

RESMED

S8 AutoSet Spirit II Clinical Guide ROW English

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DOC NO 338356

REV 1

SPECIFICATION - PRINTED MATERIALS PAGE 1 of 62

Rev Change

Note

Date Document created by

(Name)

Document checked by

(Name)

1 C17928 17/07/2007 Alison Besley Andrew Cheung or delegate

(see change note)

S8 AutoSet Spirit™ II System

Clinical 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 691200, AU 697652, AU 709279, AU 724589, AU 730844, AU 736723, AU 750095, AU

750761, AU 764761, AU 779327, CN 02804930.6, EP 0651971, EP 0661071, EP 0920845, EP 0934723, EP 1028769, EP

1126893, EP 1502618, JP 3580776, JP 3778797, NZ 504595, US 4944310, US 5199424, US 5245995, US 5522382, US

5704345, US 6029665, US 6138675, US 6240921, US 6363933, US 6367474, US 6398739, US 6425395, US 6502572,

US 6591834, US 6635021, US 6705315, US 6745768, US 6817361, US 6988498, US 7004908, US 7040317, US

7100608, US 7141021. 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 AutoSet Spirit, HumidAire, HumidAire 3i and SmartStart are trademarks of ResMed Ltd and AutoSet and HumidAire

are registered in U.S. Patent and Trademark Office.

S8 AutoSet Spirit™ II System

ILLUSTRATIONS

Component of 338356/1

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 UP THE S8™

BINTEGRATED HUMIDIFIER

3 m

HumidAire 3i™

Note: Some products not available in all regions

338356 illos.qxp 17/07/2007 1:47 PM Page 1

DATA CARD MODULE

HUSING THE DATA CARD

Note: Some products not available in all regions

HumidAire 3i

EHUMIDAIRE 3i AND S8

BLANK MODULE

Data

communications

port

USING AN ADAPTER

338356 illos.qxp 17/07/2007 1:47 PM Page 2

iContents

Contents

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

User/Owner Responsibility 1

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

Indications for Use 2

Contraindications 2

Warnings 2

Cautions 3

Adverse Effects 4

The S8 AutoSet Spirit II System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

S8 AutoSet Spirit II 5

Masks 5

Humidifiers 6

Data Management Products 6

Accessories 6

Operating Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Principles of Operation 7

System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

SmartStart 11

Delivering Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Using the Mask Fitting Feature 13

Using Humidifiers 14

Navigating the S8 AutoSet Spirit II Menus . . . . . . . . . . . . . . . . . 15

S8 AutoSet Spirit II Keypad and LCD 15

S8 AutoSet Spirit II Menus 17

Data Management Using the Menus . . . . . . . . . . . . . . . . . . . . . . 29

Clinical Menu Results 29

Interpreting Data in the Clinical Menu 32

Smart Data in the Patient Menu 33

S8 Data Management Products . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Using a Blank Module 34

Using the ResScan Data Card Module 34

Patient Management of the Data Card 35

Transmitting Data with the Data Card 37

S8 Adapters 38

Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Daily Cleaning 40

Weekly Cleaning 40

Periodic Cleaning 40

iiContents

Replacing the Air Filter 41

Servicing 41

Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

S8 AutoSet Spirit II (without Accessories) 51

Accessories 52

All Devices (where applicable) 52

Symbols which appear on the device 53

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

1Introduction

Introduction

The ResMed S8 AutoSet Spirit™ II system is designed to provide continuous

positive airway pressure (CPAP) therapy to patients with obstructive sleep

apnoea (OSA). Patients with OSA experience recurrent obstruction of their upper

airway (apnoeas) due to relaxation of the tongue and soft palate while they sleep.

Common symptoms are associated with poor sleep quality and may include

excessive daytime sleepiness and tiredness, as well as diminished concentration

and memory loss.

The S8 AutoSet Spirit II device has two therapeutic modes. When set to AutoSet

mode, the device self-adjusts the pressure delivered according to the state of the

patient’s airway. In CPAP mode, the device delivers a fixed treatment pressure.

In both modes, pressure delivered is within the range 4 to 20 cm H2O.

Data storage and processing capabilities of the S8 AutoSet Spirit II system

facilitate patient management. The system provides summary data for a variety

of time intervals, which can be viewed via the LCD menus. The patient’s usage

hours, treatment pressure, mask leak, apnoea + hypopnoea index (AHI), apnoea

index (AI) and hypopnoea index (HI) are displayed in the Results section of the

clinical menu. At your discretion, the patient may view mask fit, treatment

pressure and usage hours for the last session. This patient feature is called Smart

Data™.

You can download the data stored in the S8 AutoSet Spirit II and review it in a

PC-based software program. You can download the data directly via cable. You

can also access the data remotely, using a ResScan™ Data Card. A patient’s

therapy and reminder settings can also be updated using the software. Patient

data can be accessed and S8™ device settings updated either via direct cable

connection to the S8 AutoSet Spirit II or remotely, via a Data Card.

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

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

Indications for Use

The S8 AutoSet Spirit II self-adjusting sleep apnoea system is indicated for the

treatment of obstructive sleep apnoea (OSA) in adult patients. The S8 AutoSet

Spirit II self-adjusting sleep apnoea system has two treatment modes: AutoSet

and fixed-pressure CPAP.

The S8 AutoSet Spirit II flow generator is intended for home and hospital use.

Contraindications

The S8 AutoSet Spirit II is not a life support device and may stop operating with

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 AutoSet Spirit 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 AutoSet

Spirit II device.

•The S8 AutoSet Spirit II should be used with masks (and connectors*)

recommended by ResMed, or by a physician or respiratory therapist. A mask

should not be used unless the S8 AutoSet Spirit II device is turned on and

operating properly. The vent hole or holes associated with the mask should

never be blocked.

Explanation: The S8 AutoSet Spirit II is intended to be used with special

masks (or connectors*) which have vent holes to allow continuous flow of air

out of the mask.

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

3Medical Information

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 devices.

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

•The S8 AutoSet Spirit 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 and leak rate.

•Do not use the S8 AutoSet Spirit II if there are obvious external defects or

unexplained changes in performance.

•Do not open the S8 AutoSet Spirit 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 anaesthetics.

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 air flow for breathing produced by this device can be as much as 6ºC

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

room temperature is warmer than 32ºC.

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

and notes appear with the relevant instructions in the manual.

4Medical Information

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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