ResMed S8 Elite User Manual

S8 Elite™ System

USER’S MANUAL

English

338116-Eng/1 05 05

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 S8

TM

/ MONTAGEM DO S8

TM

D

2

3

4

B

INTEGRATED 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.

H

USING 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

E

HUMIDAIRE 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

1

2

© 2005 ResMed Ltd.

Data ccommunications
port

/ Port de
communication des
données / Puerto de
comunicación de
datos / Porta de
comunicação de
dados

CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

OUR RESPONSIBILITY 5

Y

MEDICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

BOUT THE S8 ELITE 5

A
C

ONTRAINDICATIONS 5

W

ARNINGS 6

C

AUTIONS 7

A

DVERSE EFFECTS 7

THE S8 ELITE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

LITE 8

S8 E
M

ASKS 8

H

UMIDIFIER 9

R

ESSCAN DATA CARD MODULE 9

A

CCESSORIES 9

HOW TO USE THE S8 ELITE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

ET UP THE S8 ELITE 11

S
A

SSEMBLE THE MASK 11

S

TART TREATMENT 12

S

TOPPING TREATMENT 12

U

SING THE MASK-FITTING FEATURE 13

ENGLISH

HOW TO ATTACH A HUMIDIFIER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

TTACH A HUMIDAIRE 3I HUMIDIFIER 15

A

HOW TO USE THE KEYPAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

OW TO CHANGE THE SETTINGS 17

H

HOW TO USE THE STANDARD MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

HOW TO USE THE DETAILED MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

ETTINGS MENU 21

S
R

ESULTS MENU 22

O

PTIONS MENU 22

S

ERVICING MENU 22

M

ESSAGES ON THE S8 ELITE LCD 22

S8 MODULES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

SING A BLANK MODULE 25

U
U

SING A RESSCAN DATA CARD MODULE 25

CLEANING AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

CONTENTS

3

AILY CLEANING 29

D
W

EEKLY CLEANING 29

P

ERIODIC CLEANING 29

R

EPLACING THE AIR FILTER 30

S

ERVICING 30

FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

SYSTEM SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

LITE (NO ACCESSORIES) 37

S8 E
A

CCESSORIES 37

A

LL DEVICES (WHERE APPLICABLE) 38

LIMITED WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

4

INTRODUCTION

!

Thank you for choosing the S8 ELITE™ flow generator. The S8 ELITE is a compact, all­in-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

ENGLISH

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

INTRODUCTION

5

• 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

• The S8 ELITE should only be used with masks (and connectors

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
connectors

*

S8 ELITE is intended to be used with special masks (or

) 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 H

of certain fault conditions, pressures up to 30 cm H

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

O are possible.

2

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.

*

) recommended by

O. In the unlikely event

2

S8 ELITE device.

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

6

• 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.

ENGLISH

MEDICAL INFORMATION

7

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 A of 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

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

8

S8 ELITE are:

• 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
humidifier (B-1).

S8 ELITE is compatible for use with the HUMIDAIRE 3i integrated heated

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 C of the illustration sheet.

Other accessories for use with the

• 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>.

S8 ELITE:

ENGLISH

THE S8 ELITE SYSTEM

9

10

HOW TO USE THE S8 ELITE

!

!

!

Please refer to the illustrations in section D of the illustration sheet.

SET UP THE S8 ELITE

1 Place 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.

2 Connect 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.

3 Connect 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.

ENGLISH

ASSEMBLE THE MASK

1 Assemble your mask system according to the mask user instructions.

2 Connect your mask system to the free end of the air tubing (D-3).

3 Check 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).

HOW TO USE THE S8 ELITE

11

START TREATMENT

!

!

1 Make 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.

2 Lie 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.

3 Alter 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).

4 Fit 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.

5 When ramping begins, the LCD will display the word "RAMPING", with the current

pressure indicated as dashes. Each dash is approximately equivalent to 2 cm H
example, 6 dashes represents approximately 12 cm H

O pressure.

2

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.

O. For

2

12

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.

USING THE MASK-FITTING FEATURE

MASK FIT:

*****

excelnt

mask-fit star rating

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:

1 Fit your mask as described in the mask user instructions.

2 Hold 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 H

0, whichever is greater.

2

ENGLISH

3 Adjust 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.

4 After 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).

HOW TO USE THE S8 ELITE

13

Table 1: Definitions of Mask-Fit Star Rating

Star rating Definition

***** Excellent

****- Very good

***-- Good

**--- Adjust mask

*---- Adjust mask

----- Adjust mask

14

HOW TO ATTACH A HUMIDIFIER

ATTACH A HUMIDAIRE 3i HUMIDIFIER

Please refer to the illustration in section E of the illustration sheet, and your HumidAire 3i
manual.

The

HUMIDAIRE 3

humidification. No other accessories are required for its use

Notes:

a. Make sure the water chamber of the HumidAire 3i is empty before you attach or

detach the humidifier.

b. Remove the connector plug on the S8 Elite before you attach the HumidAire 3i.

Reattach the connector plug firmly after you detach the humidifier.

STORING THE HUMIDAIRE 3

Store the HUMIDAIRE 3
not in use.

i

attaches to the front of the S8 ELITE to provide heated

.

i

i

in the larger, mesh-top pouch of the S8 ELITE carry bag when

ENGLISH

HOW TO ATTACH A HUMIDIFIER

15

HOW TO USE THE KEYPAD

LCD

screen

Left key

Up key

Right key

Start/Stop key

Down key

The control panel of the S8 ELITE includes an LCD screen and keypad for navigating
through the menus and delivering treatment.

LCD SCREEN

The LCD screen displays the menus and treatment screens.

The LCD backlight turns off after two minutes of inactivity. It turns back on when you
press a key.

KEYPAD KEYS

The S8 ELITE keypad has the following keys:

16

Key Function

Start/Stop • Starts or stops treatment.

• Extended hold (for at least three seconds) starts the mask­fitting feature.

Up • Allows you to scroll through the S8 Elite menus and

submenus, and increase the setting options.

Down • Allows you to scroll through the S8 Elite menus and

submenus, and decrease the setting options.

Left • Performs the function indicated by the guiding text displayed

Right • Performs the function indicated by the guiding text displayed

When the

S8 device is in standby mode all keys remain lit. During therapy, the keypad

backlight turns off after two minutes of inactivity and the Start/Stop key dims.

above it on the LCD screen. Guiding text includes menu,
change, and apply.

above it on the LCD screen. Guiding text includes exit and

.

cancel

HOW TO CHANGE THE SETTINGS

You can change settings on the S8 ELITE by using the keypad and LCD. When the

S8 ELITE is in standby mode you can display a series of screens (a menu) on the LCD

screen in order to view and change the settings for a particular function.
Your clinician will preset the menu to either a standard view or a detailed view.
See “How to Use the Standard Menu” on page 18 and “How to Use the Detailed

Menu” on page 20 for more information.

HOW TO ENTER THE MENU SCREENS

When the S8 ELITE standby (RAMP) screen is displayed you will see the word “menu”
in the left-hand corner. To select an

HOW TO SCROLL THROUGH THE MENU

When you are in the menu, scroll through items by pressing the Up or Down keys.

HOW TO CHANGE A SETTING OPTION

When you have scrolled to the item you require:

1. Press the Left key (Change).

2. Press the Up or Down keys until you see the setting option that you require.

3. Press the Left key (Apply) to select the setting option.

If you wish to exit without changing the option, press the Right key (Cancel).

HOW TO EXIT OUT OF A MENU

Press the Right key (Exit). This will take you back to the standby (RAMP) screen.

HOW TO EXIT OUT OF AN ITEM WITHIN THE MENU

Press the Right key (Exit).

S8 ELITE menu, press the Left key.

ENGLISH

HOW TO CHANGE THE RAMP TIME

During ramp time, the pressure increases from a low pressure to the prescribed
treatment pressure. You can set the ramp time in 5-minute intervals, from 0 minutes
(OFF) up to a maximum ramp time set by your clinician.

The standby screen displays the current ramp time in the right-hand corner. To change
the ramp time, press the Up or Down key until the desired ramp time appears.

Once a ramp time is selected, begin therapy by pressing the Start/Stop key.

HOW TO USE THE KEYPAD

17

HOW TO USE THE STANDARD MENU

Figure 1 shows the standard menu.

WELCOME
>>>>>>

RAMP: 10min
menu

EPR SETTING: 1

change exit

USED HRS: 08000

exit

USAGE: 1000/1068

exit

MASK: ULTRA
change exit

SW: SX3960200
exit

Figure 1 : Standard menu screen

You enter the standard menu from the standby (RAMP) screen, by pressing the Left
(Menu) key.

HOW TO CHANGE THE EXPIRATORY PRESSURE RELIEF SETTING

Note: EPR may not be available in all regions.

Your clinician may have set up your device to deliver expiratory pressure relief (EPR).
This can be used to help ease any discomfort you may experience when breathing out
during treatment. There are four settings:

• OFF (no EPR)

• 1 (lowest EPR)

• 2

• 3 (highest EPR).

The EPR SETTING screen only appears if your clinician has enabled access to EPR
settings. To change the EPR setting, select Change (Left key). Press the Up or Down

keys until you see the setting that you require.

HOW TO SELECT THE MASK TYPE

Scroll to MASK and select Change (Left key). Press the Up or Down keys until you
see the mask type that you require.

18

The following table shows the setting that should be selected for each mask type.

Table 2: Settings for mask types

Settings Mask

ULTRA Ultra Mirage Nasal Mask

MIR FULL Mirage Full Face Mask

ACTIVA Mirage Activa Nasal Mask

SWIFT Mirage Swift Nasal Pillows System

MIRAGE Mirage Nasal Mask

STANDARD Mirage Vista Nasal Mask

Mirage Full Face Mask Series 2
Ultra Mirage Full Face Mask
ResMed Hospital Full Face Mask

Modular Nasal Mask
Papillon

OTHER VIEWABLE INFORMATION

You can also view the total number of hours of treatment (USED HRS): the number
of sessions for which the

S8 ELITE was used in a usage period (USAGE); and the current

software version (SW).

ENGLISH

HOW TO USE THE STANDARD MENU

19

HOW TO USE THE DETAILED MENU

Figure 2 shows the detailed menu.

WELCOME
>>>>>>

RAMP: 10 min



menu

SETTINGS
enter



RESULTS

enter exit

exit

EPR SETTING: 1
change



MASK: ULTRA
change



TUBE LENGTH: 2m
change



HUMID: NONE
change



SMARTSTART: ON
change



LEAK ALERT: OFF
change



USED HRS: 08000

exit

USAGE: 1000/1068

exit

exit

exit

exit

exit

exit

exit

20

OPTIONS

enter exit

LANG: ENGLISH

change exit

SERVICING

enter exit

SN: 12345678912

exit

PCB: 123456789123

4567 exit
SW: SX3960200

exit

Figure 2 : Detailed menu screens

You enter the detailed menu from the standby (RAMP) screen, by pressing the Left
(Menu) key. The SETTINGS menu screen is displayed.

SETTINGS MENU

Select Enter (Left key) on the Settings menu to access the options in this menu.

HOW TO CHANGE THE EXPIRATORY PRESSURE RELIEF SETTING

Note: EPR may not be available in all regions.

Your clinician may have set up your device to deliver expiratory pressure relief (EPR).
This can be used to help ease any discomfort you may experience when breathing out
during treatment. There are four settings:

• OFF (no EPR)

• 1 (lowest EPR)

• 2

• 3 (highest EPR).

If you have access and want to change the EPR setting, scroll to EPR SETTING and
select Change (Left key). Press the Up or Down keys until you see the setting that

you require.

HOW TO SELECT THE MASK TYPE

Scroll to MASK and select Change (Left key). Press the Up or Down keys until you
see the mask type that you require.

The following table shows the setting that should be selected for each mask type.

Table 3: Settings for mask types

Settings Mask

ULTRA Ultra Mirage Nasal Mask

MIR FULL Mirage Full Face Mask

Mirage Full Face Mask Series 2
Ultra Mirage Full Face Mask
ResMed Hospital Full Face Mask

ENGLISH

ACTIVA Mirage Activa Nasal Mask

SWIFT Mirage Swift Nasal Pillows System

MIRAGE Mirage Nasal Mask

STANDARD Mirage Vista Nasal Mask

Modular Nasal Mask
Papillon

HOW TO CHANGE THE TUBE LENGTH

Scroll to TUBE LENGTH and select Change (Left key). Press the Up or Down keys
until you see the tube length that you require.

HOW TO ADD A HUMIDIFIER OR FRONT CAP

Scroll to HUMID and select Change (Left key). Press the Up or Down keys until you
see the setting that you require. You can use the device with or without a front cap.

HOW TO USE THE DETAILED MENU

21

OW TO CHANGE THE SMARTSTART SETTING

H

SmartStart enables your device to start automatically when you breathe into the mask.
Scroll to SMARTSTART and select Change (Left key). Press the Up or Down keys

to change the option to ON or OFF.

HOW TO CHANGE THE LEAK ALERT SETTING

Leak alert indicates when a high mask leak is present.
Scroll to LEAK ALERT and select Change (Left key). Press the Up or Down keys to

change the option to ON or OFF.

RESULTS MENU

Select Enter (Left key) on the Results menu to access the options in this menu.

Note: Your clinician may have customized your device to display Smart Data. Contact
your clinician for further details about Smart Data.

VIEWING USAGE INFORMATION

You can view the total number of hours of treatment (USED HRS) and the number
of sessions for which the

S8 ELITE was used in a usage period (USAGE).

OPTIONS MENU

Select Enter (Left key) on the Options menu to access the options in this menu.

HOW TO CHANGE THE LANGUAGE SETTING

Scroll to LANG and select Change (Left key). Press the Up or Down keys until you
see the language that you require.

22

SERVICING MENU

Select Enter (Left key) on the Servicing menu to access the options in this menu.
You can view the current software version installed on your unit (SW); the serial

number of the printed circuit board in your device (PCB); and the serial number of the
device (SN).

MESSAGES ON THE S8 ELITE LCD

Your clinician may have set your S8 ELITE to remind you about important events, such
as when to replace your mask, when to insert your Data Card (if your device is Data
Card enabled), and so on.

The reminder message is displayed on the LCD, and is visible if the device is not
delivering therapy. The backlight on the LCD flashes when a message is displayed.

Your clinician can set any of the following reminders on your LCD:

Message Description Action

INSERT CARD May appear if your

REPLACE
MASK

CALL
PROVIDER

REPLACE
FILTER

SERVICE DUE May appear as a

Customized
messages

device is Data Card
enabled.

May appear when
your mask is due
for replacement.

May appear as a
reminder to contact
your clinician; for
example to discuss
how your therapy is
going.

May appear as a
reminder to replace
the air filter on your
device.

reminder to return
your device for
service.

Your clinician may
also set reminders
for other reasons;
for example to
return equipment
or to call a
particular person or
number.

Insert your Data Card (see Section H of the
illustrations sheet), and follow any instructions
that your clinician has given you. When you
have done this, the message will disappear
from the LCD. Pressing the Left (Ok) key will
also remove the message.

Press the Left (Ok) key to remove the message
from your LCD, and replace your mask with a
new one.

Press the Left (Ok) key to remove the message
from your LCD, and contact your clinician.

Press the Left (Ok) key to remove the message
from your LCD, and replace the air filter.

Press the Left (Ok) key to remove the message
from your LCD.

Press the Left (Ok) key to remove the message
from your LCD.

ENGLISH

HOW TO USE THE DETAILED MENU

23

24

S8 MODULES

Note: Do not remove modules while power is connected to the S8 Elite.

Your

S8 ELITE will have one of two modules fitted to the back: a blank module or a

RESSCAN Data Card module.

USING A BLANK MODULE

Please refer to the illustrations in section F of the illustration sheet.

The blank module is a protective cover on your
remove or attach the module, for example to use another module.

To remove the blank module, pull it off the back of the
communications port (F-1).

To attach the blank module, push the blank module onto the data communications
port, until the module clicks into place (F-2).

Note: To protect the data communications port, always ensure there is a module
attached to the back of the device.

USING A RESSCAN DATA CARD MODULE

Please refer to the illustrations in section G of the illustration sheet.

The

RESSCAN Data Card module is an accessory to the S8 ELITE. Use a RESSCAN

Card with the Data Card module to collect data and update settings in the
The module and card give your clinician convenient access to data about your
treatment, and can provide you with new device settings from your clinician without
your having to leave home.

S8 ELITE. At times, you may wish to

S8 ELITE to show the data

Data

S8 ELITE.

ENGLISH

ATTACHING THE MODULE

To attach the Data Card module, push it onto the data communications port at the
back of your

S8 ELITE until it clicks into place (G-1).

REMOVING THE MODULE

To remove the Data Card module, pull it off the back of the S8 ELITE (G-2).

Note: To protect the data communications port, always ensure there is a module
attached to the device.

USING THE DATA CARD TO COLLECT DATA

Please refer to the illustrations in section H of the illustration sheet.

If your clinician needs to review your treatment, they will ask you to use the Data Card
to copy data from your
be provided in a convenient mailback envelope.

Data that is copied to a Data Card is still stored and available on the
It takes up to 30 seconds to copy data onto the Data Card.

S8 ELITE, and to return the card to them. The Data Card will

S8 ELITE.

S8 MODULES

25

NSERT THE DATA CARD

1 I

•

Switch on the S8 ELITE and wait until you see the standby (RAMP) screen.

• Hold the Data Card with the arrow facing up, and insert it into the slot in the

Data Card module (H-1).

• Push the card in smoothly until it stops moving (H-2) and messages start

appearing on the LCD.

2 COPY DATA ONTO THE DATA CARD

Data copying starts automatically when the Data Card is inserted into the Data

•

Card module.

• The “Card Inserted Please Wait” message is displayed on the S8 ELITE LCD

while data is being copied. Copying takes up to 30 seconds.

• The “Copy Complete Remove Card” message is displayed on the LCD when

copying has finished.

• Remove the Data Card from the Data Card module.

3 REMOVE THE DATA CARD

Grip the end of the Data Card and pull it out of the Data Card module (H-3).

4 STORE THE DATA CARD

Your Data Card should be stored in its mailback envelope when not in use.

5 MAIL THE DATA CARD TO YOUR CLINICIAN

A bubble mailer envelope is provided to ensure safe transportation of the Data Card.
When mailing the Data Card to your clinician:

1. Insert the Data Card into the pocket provided on the mailback envelope. Fold up
the mailback envelope.

2. Place the mailback envelope containing the Data Card in the bubble mailer
envelope and seal it.

3. Make sure that your clinician’s name and address details are on the bubble mailer
envelope, and mail it back immediately.

26

USING THE DATA CARD TO UPDATE SETTINGS

If your clinician has provided a Data Card with new device settings:

• With the device in standby (Ramp) mode, insert the Data Card into the slot on

the Data Card module. Updating will start automatically.

• The “Card Inserted Please Wait” message is displayed on the LCD while updating

is in progress. Updating takes up to 30 seconds.

• The “Settings Success Remove Card” message is displayed on the LCD if the

settings were updated successfully.

Note: This message only appears once. If you re-insert the Data Card after you have
updated your settings, this message is not displayed.

• Remove the Data Card from the Data Card module.

• Store the Data Card in its mailback envelope when not in use.

!

WARNING

If your clinician has told you to use this Data Card to update the settings on your
device and the “Settings Success” message does not appear, contact your clinician
immediately.

ENGLISH

S8 MODULES

27

28

CLEANING AND MAINTENANCE

!

You should regularly carry out the cleaning and maintenance described in this section.
Refer to your mask manual for detailed instructions.

DAILY CLEANING

MASK

Clean the mask according to the instructions supplied with the mask.

AIR TUBING

Disconnect the air tubing from the S8 ELITE (and humidifier, if used) and hang the
tubing and mask in a clean, dry place until next use.

HUMIDIFIER

If you are using a humidifier, remove it from the S8 ELITE and clean it according to the
instructions in the humidifier user’s manual.

WEEKLY CLEANING

1. Remove the air tubing from the S8 ELITE and the mask.

2. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang,
and allow to dry.

3. Before next use, assemble the mask and headgear according to the user
instructions.

4. Reconnect the air tubing to the air outlet and mask.

PERIODIC CLEANING

1. Clean the exterior of the S8 ELITE with a damp cloth and mild liquid soap.

2. Check the air filter for blockage or holes (see “Replacing the Air Filter” on
page 30).

ENGLISH

WARNING

• Beware of electric shock. Do not immerse the unit or power cord in water.

Always unplug the unit before cleaning and be sure it is dry before plugging back
in.

• The mask system and air tubing are subject to normal wear and tear. Inspect

them regularly for damage.

CLEANING AND MAINTENANCE

29

REPLACING THE AIR FILTER

!

!

Air filter cover

To replace the air filter:

1. Remove the air filter cover at the back of the

2. Remove and discard the old air filter.

3. Insert a new filter with the blue tinted side facing out from the device.

4. Replace the air filter cover.

Inspect the air filter every month to check if it is b locked by dirt or contain s holes. With
normal use of an
often if your device is in a dusty environment).

S8 ELITE, the air filter needs to be replaced every six months (or more

S8 ELITE.

WARNING

• Do not wash the air filter. The air filter is not washable or reusable.

• The air filter cover protects the device in the event of accidental liquid spillage

onto the device. Ensure the air filter and air filter cover are fitted at all times.

SERVICING

CAUTION

• Do not attempt to open the S8 Elite case. There are no user serviceable parts

inside.

• Inspection and repair should only be performed by an authorized agent. Under

no circumstances should you attempt to service or repair the flow generator
yourself.

This product (
5 years from the date of manufacture. Prior to this, the device is intended to provide
safe and reliable operation provided that it is operated and maintained in accordance
with the instructions provided by ResMed. Applicable ResMed warranty details are
provided with the device at the time of original supply. Of course, as with all electrical
devices, if any irregularity becomes apparent, you should exercise caution and have the
device inspected by an authorized ResMed service center.

If you feel that your flow generator is not performing properly, see “Troubleshooting”
on page 33.

S8 ELITE) should be inspected by an authorized ResMed service center

30

FREQUENTLY ASKED QUESTIONS

HOW WILL IT FEEL WHEN I AM BREATHING WITH THE S8 ELITE?

When you first use your S8 ELITE, you may feel uncomfortable breathing against the
airflow. This is normal. You will continue to breathe normally while you sleep. Take
time to adjust to this new sensation.

WHAT DO I DO WHEN I WANT TO GET UP IN THE NIGHT?

If you need to get up during the night, remove your mask and stop therapy. Always
remember to restart therapy and put your mask on when you return to bed.

WHAT DO I DO IF I FEEL AIR LEAKING OUT OF THE MASK?

The flow generator delivers the most effective treatment when the mask is well fitted
and comfortable. Treatment can be affected by leaks, so it is important to eliminate
any leaks that may arise. For example, try repositioning the mask and adjusting the
straps.

If you are using a nasal mask, try to keep your mouth closed during treatment. Air leaks
from your mouth can decrease the effectiveness of your treatment. If mouth leaks are
a problem, a full face mask or chin strap may help. Contact your clinician or equipment
supplier for further details.

If you are using a full face mask and you have problems trying to get a comfortable
mask fit, contact your sleep clinic or equipment supplier. You may benefit from a
different size or style of mask.

You can also use the mask-fitting feature to help you fit your mask properly. See “Using
the Mask-Fitting Feature” on page 13.

ANYTHING SPECIAL I SHOULD DO BEFORE PUTTING THE MASK ON?

Before wearing your mask, wash your face to remove excess facial oils. This will allow
a better fit and prolong the life of the mask cushion.

Do not use moisturizer when wearing a mask.

MY MOUTH FEELS DRY DURING TREATMENT—WHAT CAN I DO?

You may experience dryness of the nose, mouth, and/or throat during the course of
treatment, especially during winter. In many cases, a humidifier may resolve this
discomfort. Contact your clinician for advice.

MY NOSE IS IRRITATED DURING TREATMENT—WHAT CAN I DO?

You may experience sneezing and/or a runny or blocked nose during the first few
weeks of treatment. In many cases, nasal irritation can be resolved with a humidifier.
Consult your clinician or equipment supplier for advice.

CAN I TRAVEL WITH THE S8 ELITE?

ENGLISH

INTERNATIONAL USE

Your S8 ELITE flow generator has an internal power supply that enables it to operate
in other countries. It will operate on power supplies of 100–240V and 50/60Hz. No
special adjustment is necessary, but you may need a plug adapter for the power outlet.

FREQUENTLY ASKED QUESTIONS

31

ALTITUDE CHANGES

!

Your S8 ELITE automatically adjusts to changes in altitude up to 8500’ (2591 m).

ON AN AIRCRAFT

Please consult the medical services department of your carrier if you intend to use your

S8 ELITE on an aircraft. The S8 ELITE complies with US FCC Part 15, Class B

requirements if no external data cables are used.

Note: Do not use your

S8 ELITE while the aircraft is taking off or landing.

CAN I USE MY S8 ELITE IF MAINS (AC) POWER IS NOT AVAILABLE?

You must use a ResMed DC-12 converter to connect the S8 ELITE to a 12V or 24V
DC power source. Contact your equipment supplier or ResMed for details.

WARNING

The device should not be connected to both AC and DC power sources
simultaneously.

32

TROUBLESHOOTING

If there is a problem, try the following suggestions. If the problem cannot be solved,
contact your equipment supplier or ResMed. Do not attempt to open the device.

Problem Possible Cause Solution

No display. Power not connected. Ensure the appropriate power

cord is connected to your S8 Elite
and the power switch (if
available) is on.

Insufficient air
delivered from
S8 Elite.

S8 Elite does not start
when you breathe into
the mask.

Ramp time is in use. Wait for air pressure to build up

Air filter is dirty. Replace air filter.

Air tubing is kinked or
punctured.

Air tubing not connected
properly.

Mask and headgear not
positioned correctly.

Cap(s) missing from access
port(s) on mask.

Pressure required for treatment
may have changed.

Power cord not connected
properly.

Power outlet may be faulty. Try another power outlet.

SmartStart not on. Enable SmartStart.

Leak Alert has been enabled;
SmartStart has automatically
been disabled.

Use of a Mirage or Ultra Mirage
Full Face Mask.

Breath is not deep enough to
trigger SmartStart.

or change ramp time.

Straighten or replace tubing.

Check air tubing.

Adjust position of mask and
headgear.

Replace cap(s).

See your clinician to adjust the
pressure.

Connect power cord firmly at
both ends.

Disable Leak Alert to enable
SmartStart.

SmartStart does not work with a
full face mask as the anti­asphyxia valve will not allow
sufficiently high pressure on
exhalation.

Take a deep breath in and out
through the mask.

ENGLISH

TROUBLESHOOTING

33

Problem Possible Cause Solution

There is excessive leak. Adjust position of mask and

headgear.

Caps may be missing from ports
on mask. Replace them.

Air tubing not connected
properly. Connect firmly at both
ends.

Air tubing kinked or punctured.
Straighten or replace.

S8 Elite unit does not
stop when you remove
your mask.

SmartStart is enabled
but the flow generator
does not stop
automatically when
you remove your
mask.

SmartStart/Stop is disabled. Enable SmartStart/Stop.

Incompatible humidifier or mask
system being used.

Use only equipment as
recommended and supplied by
ResMed.

34

Display error message:

Check tube!!
Key if done

Display error message:

SYSTEM ERROR
Call service!

Display error message:

High leak in
last session

The air tubing is loose or
blocked.

Component failure. Return your S8 Elite for servicing.

You have experienced
excessively high leak levels
during the night.

Check that the air tubing is
connected securely to your mask
and the air outlet on the front of
the S8 Elite.
When you have checked the air
tubing, press the Start/Stop key to
restart the device.
If this does not clear the message,
disconnect the power cord and
then reconnect it to restart the
device.

Check that your air tubing is
connected properly and that your
mask does not leak excessively.
Use the mask-fitting feature to
help you to fit your mask
properly.
If this message appears again,
contact your clinician.

Problem Possible Cause Solution

Display error message:

HIGH LEAK!!!
Adjust Mask

Display error message:
Exxxx (where xxxx
defines an error)

The following message
is displayed on the
LCD after you try to
update settings using
the Data Card:

Card Error
Remove Card

The following message
is displayed on the
LCD after you try to
copy data to a Data
Card:

Card Error
Remove Card

The following message
is displayed on the
LCD after you try to
update the settings
using the Data Card:

Settings Invalid
Remove Card

You have experienced
excessively high leak levels for
more than 20 seconds.

Component failure. Return your S8 Elite for servicing.

The Data Card is not inserted
correctly.

The Data Card is only partly
inserted.

You may have removed the Data
Card before settings were copied
to the S8 Elite.

The card is not a ResScan Data
Card.

The Data Card is not inserted
correctly.

The card is not a ResScan Data
Card.

You may have removed the Data
Card before data was copied to
it.

The identification details on the
Data Card do not match the
details on your device.

Check that your air tubing is
connected properly and that your
mask does not leak excessively.
Use the mask-fitting feature to
help you to fit your mask
properly.
If this message appears again,
contact your clinician.

Ensure that the Data Card is
inserted with the arrow facing up
and pointing towards the device.
Ensure that the device is switched
on and in standby mode before
you insert the Data Card.

Ensure that the Data Card is
inserted into the slot on the Data
Card module as far as it will go.

Reinsert the Data Card and wait
for the Settings Success
Remove Card message to
appear on the LCD.

Only use a ResScan Data Card.

Ensure that the Data Card is
inserted with the arrow facing up
and pointing toward the device.

Use a ResScan Data Card, as
specified in this manual.

Reinsert the Data Card and wait
for the Copy Complete
Remove Card message to
appear on the LCD.

Contact your clinician
immediately.

ENGLISH

TROUBLESHOOTING

35

Problem Possible Cause Solution

The following message
is displayed on the
LCD after you try to
update the settings
using the Data Card:

Settings Error
Remove Card

The following message
is NOT displayed on
the LCD after you try
to update the settings
using the Data Card:

Settings Success
Remove Card

There is a data error on the Data
Card.

The settings were not updated. Contact your clinician

Contact your clinician
immediately.

immediately.

36

SYSTEM SPECIFICATIONS

S8 ELITE (NO ACCESSORIES)

Perfor mance: Operating pressure range: 4 to 20 cm H2O
Dimensions (H x W x D): 4.4” x 6.5” x 5.7” (112 mm x 164 mm x 145 mm)
Weigh t: 2.9 lb (1.3 kg)

Power Supply

• Input range for S8 ELITE with HUMIDAIRE 3i: 100–240 V, 50/60 Hz; 110 V, 400 Hz;

2.5 A <140 VA (110 W) (maximum power consumption). Instantaneous peak
power consumption <340 VA.

• Refer to the DC-12 converter instructions for DC ratings. Only use the ResMed

DC-12 converter for DC input.

Actual power consumption will vary, depending on factors such as the use of
accessories, height above sea level, and ambient temperature. Power consumption
values for typical treatment conditions (using a breathing machine set to 0.5 L and
15 breaths/min with 6’6” (2 m) air tubing, and an
following table

ULTRA MIRAGE mask) are given in the

ENGLISH

Device

S8 Elite 5 18 7.6

Pressure
(cm H2O)

10 23 11.6

15 30 15.9

20 39 20.7

Power
(VA)

Power
(W)

Power outlet for HumidAire 3i

Outlet range: 100–240V, 50/60Hz; 110V, 400Hz; 2.0A

Air Filter: Two-layered, powder-bonded, polyester non-woven fiber
Air Tubing: Flexible plastic, 6’6” (2 m)

Air Outlet: The 22 mm conical air outlet complies with EN 1281-1
IEC 60601-1 Classifications: Class II (double insulation), Type CF
Noise level: Radiated sound pressure is measured at <30 dBA at 10 cm H

1 m (3’3.37”) according to ISO17510

ACCESSORIES

DATA CARD

Dimensions (L x W x D): 2.56” x 0.87” x 0.03” (65.04 mm x 22.15 mm x 0.85 mm)

O and

2

SYSTEM SPECIFICATIONS

37

DATA CARD MODULE

Dimensions (H x W x D): 1.95” x 1.66” x 0.47” (49.7 mm x 42.2 mm x 12 mm)

ALL DEVICES (WHERE APPLICABLE)

Housing Construction: Flame retardant engineering thermoplastic

Environmental Conditions

Operating Temperature: +41°F to +104°F (+5°C to +40°C)
Operating Humidity: 10%–95% non-condensing
Storage and Transport Temperature: -4°F to +140°F (-20°C to +60°C)
Storage and Transport Humidity: 10%–95% non-condensing
Operating Altitude: sea level to 8500’ (2591 m)

Electromagnetic Compatibility

Product complies with all applicable electromagnetic compatibility requirements
(EMC) according to IEC60601-1-2, for residential, commercial, and light industry
environments. For further details, see “Guidance and Manufacturer’s Declaration ­Electromagnetic Emissions and Immunity” on page 39.

Note: The manufacturer reserves the right to change these specifications without notice.

SYMBOLS WHICH APPEAR ON THE DEVICE

Attention, consult accompanying documents

Type CF equipment

38

Class II equipment

Drip proof

Dangerous voltage

Start/Stop and Mask-fit

GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC

MISSIONS AND IMMUNITY

E

Guidance and manufacturer’s declaration—electromagnetic emissions

The S8 series of devices is intended for use in the electromagnetic environment specified below. The
customer or the user of the S8 device should assure that the device is used in such an environment.

Emissions test Compliance

RF emissions CISPR11 Group 1 The S8 device uses RF energy only for its

RF emissions CISPR 11 with serial
adapter

RF emissions CISPR 11 with USB
adapter

Harmonic Emissions
IEC 61000-3-2

Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3

* Class B for all system configurations except when a PC is attached to the S8 device via a serial adapter,
in which case the system is Class A compliant. Class A is suitable for use in all establishments other than
domestic and those directly connected to a low voltage power supply network which supplies buildings
used for domestic purposes.

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put
into service according to EMC information provided in this document.

Warnings: The S8 device should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the S8 device should be observed to verify normal operation in
the configuration in which it will be used.

The use of accessories (eg humidifiers) other than those specified in this manual is not recommended.
They may result in increased emissions or decreased immunity of the S8 device.

Class B* The S8 device is suitable for use in all

Class B

Class A

Complies

Electromagnetic environment—
guidance

internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.

establishments, including domestic
establishments and those directly
connected to the public low-voltage
network that supplies buildings used for
domestic purposes.

ENGLISH

SYSTEM SPECIFICATIONS

39

Guidance and manufacturer’s declaration—electromagnetic immunity

The S8 series of devices is intended for use in the electromagnetic environment specified below. The
customer or the user of the S8 device should assure that the device is used in such an environment.

Immunity test

Electrostatic
discharge (ESD)
IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

Vol ta ge dips, sh or t
interruptions and
voltage variations on
power supply input
lines.
IEC 61000-4-11

Power freque ncy
(50/60 Hz)
magnetic field
IEC 61000-4-8

NOTE: Ut is the AC mains voltage prior to application of the test level.

IEC60601-1-2
test level

±6 kV contact

±8 kV air

±2 kV for power
supply lines

±1 kV for input/
output lines

±1 kV differential
mode

±2 kV common
mode

<5% Ut
(>95% dip in Ut)
for 0.5 cycle

40% Ut
(60% dip in Ut)
for 5 cycles

70% Ut
(30% dip in Ut)
for 25 cycles

<5% Ut
(>95%dip in Ut)
for 5 sec

3 A/m 3 A/m Power frequency magnetic

Compliance level

±6 kV contact

±8 kV air

±2 kV

Not Applicable

±1 kV differential
mode

±2 kV common
mode

< 12V
(>95% dip in 240V)
for 0.5 cycle

96V
(60% dip in 240V)
for 5 cycles

168V
(30% dip in 240V)
for 25 cycles

<12V
(>95%dip in 240V)
for 5 sec

Electromagnetic
environment—guidance

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.

Mains power quality should
be that of a typical
commercial or hospital
environment.

Mains power quality should
be that of a typical
commercial or hospital
environment.

Mains power quality should
be that of a typical
commercial or hospital
environment.
If the user of the S8 device
requires continued operation
during power mains
interruptions, it is
recommended that the S8
device be powered from an
uninterruptible power
source.

fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

40

Guidance and manufacturer’s declaration—electromagnetic immunity

The S8 series of devices is intended for use in the electromagnetic environment specified below. The customer or
the user of the S8 device should assure that the device is used in such an environment.

Immunity test

Conducted RF
IEC 61000-4-6

IEC60601-1-2
test level

3 Vrms
150 kHz to 80 MHz

Compliance
level

3 Vrms d = 1.17 √P

Electromagnetic environment—guidance

Portable and mobile RF communications
equipment should be used no closer to any part
of the S8 device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.

Recommended separation distance

ENGLISH

Radiated RF
IEC 61000-4-3

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the S8 device is used exceeds
the applicable RF compliance level above, the S8 device should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
S8 device.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

10 V/m
80 MHz to 2.5 GHz

10 V/m d = 0.35 √P 80 MHz to 800 MHz

d = 0.70 √P 800 MHz to 2.5 GHz

where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:

b

a

SYSTEM SPECIFICATIONS

41

Recommended separation distances between portable and mobile RF communications
equipment and the S8 series of devices

The S8 series of devices is intended for use in an environment in which radiated RF disturbances are controlled.
The customer or the user of the S8 device can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the S8 device
as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

m

Rated maximum output

power of transmitter

W

0.01 0.17 0.04 0.07

0.1 0.37 0.11 0.22

1 1.17 0.35 0.7

10 3.69 1.11 2.21

100 11.70 3.50 7

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

150 kHz to 80 MHz

d = 1.17 √P

80 MHz to 800 MHz

d = 0.35 √P

800 MHz to 2.5 GHz

d = 0.7 √P

42

LIMITED WARRANTY

R001-307/1 05 02

ResMed warrants that your ResMed product shall be free from defects in material and
workmanship for the period specified below from the date of purchase by the initial
consumer. This warranty is not transferable.

Product Warranty Period

ResMed humidifiers, ResControl™, ResLink™ 1 Year

ResMed flow generators 2 Years

ENGLISH

Accessories, mask systems (including mask frame, cushion,
headgear and tubing). Excludes single-use devices.

90 Days

Note: Some models are not available in all regions.

If the product fails under conditions of normal use, ResMed will repair or replace, at its
option, the defective product or any of its components. This Limited Warranty does
not cover:
a) any damage caused as a result of improper use, abuse, modification or alteration of
the product;
b) repairs carried out by any service organization that has not been expressly
authorized by ResMed to perform such repairs;
c) any damage or contamination due to cigarette, pipe, cigar or other smoke;
d) any damage caused by water being spilled on or into a flow generator.

To make a warranty claim, the initial consumer must return the defective product to
the point of purchase, freight prepaid.

This warranty is in lieu of all other express or implied warranties, including any implied
warranty of merchantability or fitness for a particular purpose. Some regions or states
do not allow limitations on how long an implied warranty lasts, so the above limitation
may not apply to you.

ResMed shall not be responsible for any incidental or consequential damages claimed
to have occurred as a result of the sale, installation or use of any ResMed product.
Some regions or states do not allow the exclusion or limitation of incidental or
consequential damages, so the above limitation may not apply to you. This warranty
gives you specific legal rights, and you may also have other rights which vary from
region to region.

For further information on your warranty rights, contact your local ResMed dealer
or ResMed office.

LIMITED WARRANTY

43

44

INDEX

A

accessories 9

air filter

8, 33

replacing

air pressure
air tubing

cleaning

connect to air outlet

kinked

positioning

aircraft
airflow

breathing with 31

B

blank module

C

carry bag
cleaning

daily 29

periodic

weekly

contraindications

D

daily cleaning
Data Card

copying data

dimensions

inserting

mailback envelope

removing

Data Card module

dimensions

data management products
DC-12 converter
detailed menu
down key
dryness

mouth, nose, or throat 31

E

EPR setting
error messages
expiratory pressure relief

30
33

8

29

11

33

12

32

25

8

29

29

5

29

25, 35

26

37

26

26

26

9, 25

38

32

20

16

18, 21

34

18, 21

25

F

frequently asked questions
front cap
front cap (muffler)

H

headgear position
HumidAire 3i

humidifiers

I

international use

K

keypad

L

language setting
LCD

leak alert setting
left key

M

mailback envelope
mask

Mask screen
mask settings
mask types
mask-fit

21

9

33

9

attaching
storage

alleviating dryness 31

cleaning
HumidAire 3i
type

15

8, 15

29

9

21

31

8

key functions

16

22

8, 12, 16

error messages
messages

35

22

22

16

26

air leak

31

attaching
cleaning
mask type
port
position
preparing to use
removing
types

11

29

18, 21

33

33

31

31

8, 9

13

19, 21

19, 21

13

star rating

14

31

ENGLISH

INDEX

45

medical information 5

menu

detailed 20

standard

menu screens

access

change

exit

scrolling

modules

attaching

blank

Data Card

N

nasal irritation

O

Options Menu 22

18

17

17

17

17

17

8

25

25

31

serial number
Servicing Menu
setting up
Settings Menu
SmartStart
SmartStart setting
SN

22

software version
software version number
standard menu
standby screen
start/stop key
stopping treatment
SW

22

system specifications

T

troubleshooting
tube length setting

22

22

11

21

12

22

19, 22

18
12

16

12

37

33

21

22

P

PCB

serial number 22

periodic cleaning
power cord

connecting

power sockets
power sources
power supply
printed circuit board

R

ramp time
reminders

call provider

customized messages

insert card

replace air filter

replace mask

service due

ResScan Data Card module
Results Menu
right key

S

S8 Elite

S8 modules

16

servicing

setup

11

start treatment

travelling with

29

8, 33

11

8

32

37

22

12, 17, 33

23

23

23

23

23

23

23

22

30

12

31

25

U

up key 16

usage details
use on aircraft
used

hours 19, 22

number of sessions

W

weekly cleaning 29

19

32

19, 22

9

46