ResMed ELITE S8 User manual

RESMED
S8 Elite User’s Manual USA ML
1. ORACLE DESCRIPTION
S8 Elite User Mnl USA ML
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© ResMed Ltd. 2005
DOC NO 338116
REV 1
SPECIFICATION - PRINTED MATERIALS PAGE 1 of 200
Rev Change
Note
Date
Document
Drafted
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(Name)
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1 C12831 18-Apr-05 Suzanne Wood Sue Geercke or delegate
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www.myresmed.com Waking people up to sleep
Reorder number: 338116/1 05 05 USER’S MANUAL
English
Français
Español
Português
S8 Elite™System

1
S8 Elite™
ILLUSTRATIONS
ILLUSTRATIONS
FIGURAS
ILUSTRAÇÕES
Component of 338116/1
Partie de 338116/1
Componente de 338116/1
Componente de 338116/1
A
Keypad
Clavier
Teclado
Teclado
Carry handle
Poignée de transport
Asa para el transporte
Pega de transporte
Air filter cover / Couvercle
du logement du filtre à air /
Cubierta del filtro de aire /
Tampa do filtro de ar
Module
Module
Módulo
Módulo
DC input
Entrée CC
Entrada de CC
Entrada CC AC input
Entrée CA
Entrada de CA
Entrada CA
LCD screen
Écran LCD
Visor
Mostrador LCD Air outlet
Sortie d'air
Salida de aire
Saída de ar
SYSTEM COMPONENTS / COMPOSANTS DU SYSTÈME / COMPONENTES DEL
SISTEMA / COMPONENTES DO SISTEMA
Air inlet
Entrée d'air
Entrada de aire
Entrada de ar
6’6”/2 m
2
34 5
OTHER ACCESSORIES / AUTRES ACCESSOIRES / OTROS ACCESORIOS /
OUTROS ACESSÓRIOS
C
1
5
SETTING UP THE S8TM / INSTALLATION DE LA S8TM /
INSTALACIÓN DEL S8TM / MONTAGEM DO S8TM
D
2
3
4
BINTEGRATED HUMIDIFIER / HUMIDIFICATEUR INTEGRE /
HUMIDIFICADOR INTEGRADO / HUMIDIFICADOR INTEGRADO
32
9’10”/3 m
1
4
© 2005 ResMed Ltd.
© 2005 ResMed Ltd.
© 2005 ResMed Ltd.
© 2005 ResMed Ltd.
HumidAire 3i™
Note: Some products not available in all regions. Remarque : certains de ces produits ne sont pas disponibles dans tous les pays.
Nota: algunos productos no están disponibles en todas las regiones. Nota: alguns produtos não se encontram disponíveis em todas as regiões.

DATA CARD MODULE / MODULE DE CARTE DE DONNÉES /
MÓDULO TARJETA DE DATOS / MÓDULO DE CARTÕES DE DADOS
MÓDULO TARJETA DE DATOS
G
12
© 2005 ResMed Ltd.
HUSING THE DATA CARD / UTILISATION DE LA CARTE DE DONNÉES /
USO DE LA TARJETA DE DATOS / COMO USAR O CARTÃO DE DADOS
1
3
2
© 2005 ResMed Ltd.
Note: Some products not available in all regions. Remarque : certains de ces produits ne sont pas disponibles dans tous les pays.
Nota: algunos productos no están disponibles en todas las regiones. Nota: alguns produtos não se encontram disponíveis em todas as regiões.
HumidAire 3i
EHUMIDAIRE 3i AND S8 / HUMIDAIRE 3i ET S8 /
EL HUMIDAIRE 3i Y EL S8 / HUMIDAIRE 3i E S8
© 2005 ResMed Ltd.
BLANK MODULE / MODULE VIERGE / MÓDULO EN BLANCO /
MÓDULO EM BRANCO
F
12
© 2005 ResMed Ltd.
Data ccommunications
port / Port de
communication des
données / Puerto de
comunicación de
datos / Porta de
comunicação de
dados

ENGLISHESPAÑOLPORTUGUÊS FRANÇAIS
USER’SMANUAL 1
MANUAL DEL USUARIO 97
MANUEL UTILISATEUR 47
MANUAL DO UTILIZADOR 145
S8 Elite™ System

P
rotected by patents: AU 697652, EP 0661071, US 4944310, US 5199424, US 5522382, US 6240921, US 6705315. Other patents
p
ending.
Design registrations pending.
S
8, HumidAire, HumidAire 3i, AutoSet, S8 AutoSet Spirit, Mirage, Mirage Activa, Mirage Vista, Ultra Mirage, Mirage Swift, ResScan
a
nd SmartStart are trademarks of ResMed Ltd. HumidAire, HumidAire 3i, AutoSet, S8 AutoSet Spirit, Mirage, Mirage Activa,
M
irage Vista, Ultra Mirage, Mirage Swift and SmartStart are registered in US Patent and Trademark Office.
P
apillon is a trademark of MAP Medizin-Technologie GmbH.
©
ResMed Ltd 2005.
Manufactured by:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
Tel: [phone] or 1 800 658 189 (toll free) Fax: [phone] Email: rec[email protected]
Distributed by:
ResMed Corp 14040 Danielson Street Poway CA 92064-6857 USA
Tel: [phone] or 1-800-424-0737 (toll free) Fax: [phone] Email: [e-mail]
ResMed (UK) Limited 65 Milton Park Abingdon Oxfordshire OX14 4RX UK
Tel: [phone] Fax: [phone] Email: [e-mail]
ResMed Asia Pacific Ltd 97 Waterloo Road North Ryde NSW 2113 Australia
Tel: [phone] or 1 800 991 900 (toll free) Fax: [phone] Email: rec[email protected]
ResMed BV Nieuwe Parklaan 86, 2587 BV Den Haag Nederland
Tél: [phone] Fax: [phone] Email: [e-mail]
ResMed Finland Niittykatu 6 FIN 02200 Espoo Suomi
Puh: [phone] Faksi: [phone] Sähköposti: [email protected]i
ResMed Gmb H & Co. KG Fraunhoferstraße 16 82152 Martinsried Deutschland
Tel: +49 (0) 89 / 99 01 - 00 or [phone] (gebührenfrei) Fax: +49 (0) 89 / 99 01 - 10 55
Email: [e-mail]
ResMed Hong Kong Limited Room 1714, Miramar Tower 132-134 Nathan Road Tsim Sha Tsui Hong Kong
Tel: [phone] Fax: [phone] Email: [e-mail]
ResMed Japan Nihonbashi Hisamatsu Bldg. 4F, 2-28-1 Nihonbashi-Hamacho, Chuo-Ku, Tokyo 103-0007, Japan
Tel: [phone] Fax: [phone]
ResMed Malaysia Sdn Bhd Suite E-10-20, Plaza Mon’t Kiara No. 2 Jalan 1/70C Mon’t Kiara 50480 Kuala Lumpur Malaysia Tel: +6
0
3 6201 7177 Fax: [phone] Email: [e-mail]
ResMed NZ Ltd PO Box 51-048 Pakuranga Auckland New Zealand
Tel:[phone] Fax:[phone] Email: receptio[email protected].nz
ResMed SA Parc de la Bandonnière 2, rue Maurice Audibert 69800 Saint-Priest France
Tél: [phone] Fax: [phone] Email: r[email protected]
ResMed Singapore Pte Ltd 238A Thomson Road # 12-03/04 Novena Square Tower A Singapore 307684
Tel: [phone] Fax: [phone] Email: receptio[email protected]
ResMed Spain SL C/Arturo Soria, 245 28033 Madrid España
Tel: [phone] Fax: [phone] Email: [e-mail]
ResMed Sweden AB Industrigatan 2 S-461 37 Trollhättan Sverige
Tel: [phone] Fax: [phone] Email: receptio[email protected]
Labhardt AG Thannerstrasse 57 CH-4054 Basel Schweiz
Tel: [phone] Fax: [phone] Email: [e-mail]
US DESIGNATED AGENT: ResMed Corp
EU AUTHORIZED REPRESENTATIVE: ResMed (UK) Ltd
www.resmed.com

1
USER’S MANUAL
English
S8 Elite™System

2

3
ENGLISH
CONTENTS
CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
YOUR RESPONSIBILITY 5
MEDICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
ABOUT THE S8 ELITE 5
CONTRAINDICATIONS 5
WARNINGS 6
CAUTIONS 7
ADVERSE EFFECTS 7
THE S8 ELITE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
S8 ELITE 8
MASKS 8
HUMIDIFIER 9
RESSCAN DATA CARD MODULE 9
ACCESSORIES 9
HOW TO USE THE S8 ELITE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
SET UPTHE S8 ELITE 11
ASSEMBLE THE MASK 11
START TREATMENT 12
STOPPING TREATMENT 12
USING THE MASK-FITTING FEATURE 13
HOW TO ATTACH AHUMIDIFIER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
ATTACH AHUMIDAIRE 3IHUMIDIFIER 15
HOW TO USE THE KEYPAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
HOW TO CHANGE THE SETTINGS 17
HOW TO USE THE STANDARD MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
HOW TO USE THE DETAILED MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
SETTINGS MENU 21
RESULTS MENU 22
OPTIONS MENU 22
SERVICING MENU 22
MESSAGES ON THE S8 ELITE LCD 22
S8 MODULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
USING ABLANK MODULE 25
USING ARESSCAN DATA CARD MODULE 25
CLEANING AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

4
DAILY CLEANING 29
WEEKLY CLEANING 29
PERIODIC CLEANING 29
REPLACING THE AIR FILTER 30
SERVICING 30
FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SYSTEM SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
S8 ELITE (NO ACCESSORIES) 37
ACCESSORIES 37
ALL DEVICES (WHERE APPLICABLE) 38
LIMITED WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

ENGLISH
5
INTRODUCTION
INTRODUCTION
Thank you for choosing the S8 ELITE™ flow generator. The S8 ELITE 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.
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 authorized
instructions and by authorized 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.
MEDICAL INFORMATION
ABOUT THE S8 ELITE
The S8 ELITE continuous positive airway pressure (CPAP) system is indicated for the
treatment of obstructive sleep apnea (OSA) in adult patients.
The S8 ELITE CPAP system is intended for home and hospital use.
!
CAUTION
In the US, Federal law restricts this device to sale by or on the order of a physician.
CONTRAINDICATIONS
The S8 ELITE 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

6
•dehydration
•cerebrospinal fluid leak, recent cranial surgery, or trauma.
WARNINGS
•The entire manual should be read before using the S8 ELITE.
•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 device.
•The S8 ELITE should only 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 ELITE device is turned on and operating properly. The vent hole or
holes associated with the mask should never be blocked.
Explanation: The S8 ELITE 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 devices.
•In the event of power failure or machine malfunction, remove the mask.
•The S8 ELITE 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.
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.
* Ports may be incorporated into the mask or in connectors that are near the mask.

ENGLISH
7
MEDICAL INFORMATION
•Do not use the S8 ELITE if there are obvious external defects or unexplained
changes in performance.
•Do not open the S8 ELITE case. There are no user serviceable parts inside. Repairs
and internal servicing should only be performed by an authorized 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 11°F (6°C)
higher than the temperature of the room. Caution should be exercised if the room
temperature is warmer than 90°F (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.
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.

8
THE S8 ELITE SYSTEM
The S8 ELITE device is part of a system that consists of five elements:
•S8 ELITE flow generator
•Mask
•Humidifier
•Data management products
•Accessories.
S8 ELITE
Please refer to the illustrations in section Aof the illustration sheet.
FRONT VIEW (A-1)
Shows the keypad and LCD screen, and the air outlet.
REAR VIEW (A-2)
Shows where the module attaches, and the location of the air filter and power sockets.
POWER CORD (A-3)
Power cord to attach the S8 ELITE to the AC (mains) power.
CARRY BAG (A-4)
The S8 ELITE carry bag contains two pouches: one for storing the S8 device, the other
for storing the integrated humidifier. When storing the humidifier, always put it in the
larger, mesh pouch.
AIR TUBING (A-5)
The 6‘6” (2 m) air tubing connects the S8 ELITE to your mask.
MASKS
You will also need a ResMed mask system (supplied separately).
The ResMed mask systems that are recommended for use with the S8 ELITE are:
NASAL MASKS
•MODULAR NASAL MASK
•MIRAGE VISTA™ NASAL MASK
•ULTRA MIRAGE™ NASAL MASK
•MIRAGE™ NASAL MASK
•MIRAGE ACTIVA™ NASAL MASK
•PAPILLON™.
NASAL PILLOWS SYSTEMS
•MIRAGE SWIFT™ NASAL PILLOWS SYSTEM.
FULL FACE MASKS
•MIRAGE™ FULL FACE MASK
•MIRAGE™ FULL FACE MASK SERIES 2
•ULTRA MIRAGE™ FULL FACE MASK

ENGLISH
9
THE S8 ELITE SYSTEM
•RESMED HOSPITAL FULL FACE MASK.
Note: Not all masks are available in all regions.
!
WARNING
Only ResMed mask systems are compatible for use with the S8 Elite. Please refer
to “Warnings” on page 6.
HUMIDIFIER
Please refer to the illustration in section B of the illustration sheet.
A humidifier may be required if you are experiencing dryness of the nose, throat, or
mouth. The S8 ELITE is compatible for use with the HUMIDAIRE 3i integrated heated
humidifier (B-1).
RESSCAN DATA CARD MODULE
The RESSCAN™Data Card module and RESSCAN Data Card (C-1) may be used with
the S8 ELITE either to help your clinician to monitor your treatment or to provide you
with updates to your device settings. See “Using a ResScan Data Card Module” on
page 25 for information about how to use the Data Card module and Data Card.
ACCESSORIES
Please refer to the illustrations in section Cof the illustration sheet.
Other accessories for use with the S8 ELITE:
•Front cap (not available in all regions) (C-2)
•Air tubing 9‘10” (3 m) (C-3)
•DC-12 converter (C-4)
•Blank module (C-5).
Note: ResMed regularly releases new products. Please check our website at
<www.myresmed.com>.

10

ENGLISH
11
HOW TO USE THE S8 ELITE
HOW TO USE THE S8 ELITE
Please refer to the illustrations in section Dof the illustration sheet.
SET UPTHE S8 ELITE
1Place the S8 ELITE on a table near the head of your bed.
!
CAUTION
Be careful not to place the device where it can be bumped or where someone is
likely to trip over the power cord.
Note: You can also place your S8 Elite on the floor beside or underneath your bed. Ensure
that the area is free from dust and clear of bedding, clothes, or any other objects that could
block the air inlet.
2Connect the power cord to the socket at the rear of the flow generator (D-1). Plug
the other end of the power cord into the power outlet.
!
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 (D-2).
!
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.
•Blocking the air inlet or tubing while in operation could lead to overheating of
the device.
•In the clinical environment any personal computer that is used with your CPAP
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 the relevant test standard. For personal
computers the international standard is IEC 60950 or equivalent.
ASSEMBLE THE MASK
1Assemble your mask system according to the mask user instructions.
2Connect your mask system to the free end of the air tubing (D-3).
3Check that the mask setting on the MASK screen is the one recommended for the
mask you are using (see the table in “How to Select the Mask Type” on page 18).
The S8 ELITE is now ready for use (D-4).

12
START TREATMENT
1Make sure the power is on.
A welcome message is displayed briefly on the LCD screen, then the standby (Ramp)
screen appears. The key and LCD backlights also turn on.
2Lie down and arrange the air tubing so that it is free to move if you turn in your sleep.
!
CAUTION
•Do not leave long lengths of air tubing around the top of your bed. They could
twist around your head or neck while you are sleeping.
•Make sure the area around the flow generator is dry and clean. It should also be
clear of bedding, clothes, and other potential blockages.
3Alter the ramp time if required (see “How to Change the Ramp Time” on page 17).
To start treatment, press the Start/Stop key, unless your clinician has set up your
device to start delivering therapy automatically. If so, your device will start when you
breathe into your mask (see “SmartStart” for details).
4Fit your mask as described in the mask user instructions.
!
WARNING
A mask should not be used unless the S8 Elite device is powered and operating
properly.
5When ramping begins, the LCD will display the word "RAMPING", with the current
pressure indicated as dashes. Each dash is approximately equivalent to 2 cm H2O. For
example, 6 dashes represents approximately 12 cm H2O pressure.
SMARTSTART™
The S8 ELITE has a function called SmartStart™that your clinician can enable. If
SmartStart is enabled, your device will start automatically when you breathe into your
mask, and will stop automatically when you take your mask off. This means you do not
have to press the Start/Stop key to begin or end treatment.
Note: Do not use SmartStart when using a mask with an anti-asphyxia valve, such as the
Mirage Full Face Mask.
STOPPING TREATMENT
To stop treatment at any time, remove your mask and press the Start/Stop key
or
if your clinician has enabled SmartStart, simply remove your mask and treatment will
end.

ENGLISH
13
HOW TO USE THE S8 ELITE
USING THE MASK-FITTING FEATURE
You can use the S8 ELITE mask-fitting feature to help you fit your mask properly. This
feature delivers air pressure for a three-minute period, prior to starting treatment,
during which you can check and adjust your mask fit to minimize leaks.
Note: Make sure that the mask setting on the MASK screen is the same as the mask you
are using.
To use the mask-fitting feature:
1Fit your mask as described in the mask user instructions.
2Hold down the Start/Stop key for at least three seconds until air pressure delivery
starts.
The following display will appear on the LCD screen indicating that the mask-fitting
feature is operating. Your S8 device will ramp to the mask-fit pressure and will remain
at this pressure for three minutes.
The LCD also displays a mask-fit star rating. See Table 1 on page 14.
Note: The mask-fit star rating display disappears after three minutes.
The mask-fitting feature can only be started from the RAMP screen.
The mask-fit pressure is the set treatment pressure or 10 cm H20, whichever is greater.
3Adjust your mask, mask cushion, and headgear until you have a secure and comfortable
fit.
Once you have a secure and comfortable fit, check your mask-fit star rating on the
LCD screen. Table 1 explains the mask-fit star ratings.
Note: If there is another person nearby to check your mask-fit star rating, you can adjust
your mask, mask cushion, and headgear while lying down.
4After three minutes, the pressure reverts to the set pressure and treatment will begin.
•If you do not wish to wait three minutes, hold down the Start/Stop key for at
least three seconds to start treatment immediately.
•If you press the Start/Stop key for less than three seconds, the unit will return
to standby mode (the RAMP screen is displayed).
MASK FIT: *****
excelnt
mask-fit star rating

14
Table 1: Definitions of Mask-Fit Star Rating
Star rating Definition
***** Excellent
****- Very good
***-- Good
**--- Adjust mask
*---- Adjust mask
----- Adjust mask