ResMed S8 AutoSet Spirit II User manual

RESMED
S8 AutoSet Spirit II Clinical Guide ROW English
CD\Web only — not for printing
ResMed Confidential 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. 2007
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.
© 2007 ResMed Ltd. 338356/1 07 07

1
S8 AutoSet Spirit™ II System
ILLUSTRATIONS
Component of 338356/1
A
Keypad
Carry
handle
Air filter
cover
Module
DC input
AC input
LCD
screen
Air outlet
SYSTEM COMPONENTS
Air inlet
2 m
2
34 5
OTHER ACCESSORIES
C
1
8
SETTING UP THE S8™
D
2
3
4
BINTEGRATED HUMIDIFIER
65
3 m
1
7
© 2007 ResMed Ltd.
© 2007 ResMed Ltd.
© 2007 ResMed Ltd.
© 2007 ResMed Ltd.
HumidAire 3i™
1
Note: Some products not available in all regions
3
4
2
338356 illos.qxp 17/07/2007 1:47 PM Page 1

DATA CARD MODULE
G
12
© 2007 ResMed Ltd.
HUSING THE DATA CARD
1
3
2
© 2007 ResMed Ltd.
Note: Some products not available in all regions
HumidAire 3i
EHUMIDAIRE 3i AND S8
© 2007 ResMed Ltd.
1
BLANK MODULE
F
12
© 2007 ResMed Ltd.
Data
communications
port
USING AN ADAPTER
I
12
3
© 2007 ResMed Ltd.
a
a
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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.