ResMed Positive AirwAy Pressure Device S8 Elite II Bedienungsanleitung

English

S8 Series II

S8 AutoSet Spirit™ II

S8 Elite™ II

POSITIVE AIRWAY PRESSURE DEVICES

User Guide

English

ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA

ResMed (UK) Ltd (EU Authorized Representative) 96 Milton Park Abingdon Oxfordshire OX14 4RY UK

ResMed Offices Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Malaysia, Mexico,

Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa, 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, AU

2002231456, CN 02804930.6, EP 0651971, EP 0661071, EP 0920845, EP 0934723, EP 1028769, EP 1126893, EP 1502618, EP 1144036, JP 3580776, JP

3778797, NZ 504595, US 5199424, US 5245995, US 5522382, US 5704345, US 6138675, US 6240921, US 6363933, US 6367474, US 6425395, US

6502572, US 6591834, US 6705315, US 6745768, US 6817361, US 6988498, US 7040317, US 7100608. 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, EU 269436, EU 815071, HK

0412901.9, JP 1257662, JP 1257663, JP 1266956, JP 1266957, JP 1267270, JP 1267271, NZ 405614, NZ 406923, NZ 406924, NZ 406925, NZ 406926, NZ

406927, NZ 406928, US D544598, US D553228, US D557406, US D557407, US D560795, US D561891, US D565160. Others pending.

S8, S8 AutoSet, S8 Elite and SmartStart are trademarks of ResMed Ltd and AutoSet and HumidAire are registered in U.S. Patent and

Trademark Office.

Contents

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

Contraindications 1

Adverse Effects 1

Parts of the S8 Series II system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Masks 2

Humidifiers 2

ResScan Data Card 2

Using the S8 Series II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Setting Up 3

How to Use the Control Panel 4

Selecting the Mask Type 4

Using the Mask-fitting Feature 5

Starting Treatment 5

Stopping Treatment 6

Changing the Settings on your S8 II Device . . . . . . . . . . . . . . . . . 6

The Standard Menu 6

The Detailed Menu 7

Messages on the S8 Series II LCD . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Using the Data Card to Collect Data . . . . . . . . . . . . . . . . . . . . . . . . 8

Copying Data onto the Data Card 8

Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Daily 9

Weekly 9

Monthly 9

Replacing the Air Filter 10

Servicing 10

Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

1Introduction

English

Introduction

S8 AutoSet Spirit II

The S8 AutoSet Spirit II self-adjusting sleep apnea 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 system is intended for home and hospital use.

S8 Elite II

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

treatment of obstructive sleep apnoea (OSA) in adult patients. The S8 Elite II CPAP

system is intended for home and hospital use.

Contraindications

Your S8 Series II is not a life-support device and may stop operating during power

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

on continuous therapy.

Positive airway pressure therapy may be contraindicated in some patients with the

following pre-existing conditions:

•severe bullous lung disease

•pneumothorax

•pathologically low blood pressure

•dehydration

•cerebrospinal fluid leak, recent cranial surgery, or trauma.

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 CPAP device:

•drying of the nose, mouth, or throat

•nosebleed

•bloating

•ear or sinus discomfort

•eye irritation

•skin rashes

•chest discomfort.

Parts of the S8 Series II system

Your S8 Series II device comprises:

•S8 Series II device

•Power cord

•Premium carry bag

•2 m air tubing.

Optional components include:

•Integrated humidifier

•Front cap

•3 m air tubing

•DC-12 converter

•ResMed Tubing Wrap.

Masks

A list of masks (and their settings) compatible with these devices can be found on

www.resmed.com, on the Products page under Service and Support.

Humidifiers

A list of humidifiers compatible with ResMed devices can be found on

www.resmed.com, on the Products page under Service and Support.

ResScan Data Card

The ResScan Data Card may be used with the S8 Series II either to help your clinician

monitor your treatment or provide you with updates to your device settings.

Carry handle

Screen

Keypad

Air outlet DC

Data Card

slot

3Using the S8 Series II

English

Using the S8 Series II

Setting Up

1Connect the power cord to the socket at the rear of the S8 Series II device.

2Plug the other end of the power cord into the power outlet.

3Connect one end of the air tubing firmly onto the air outlet.

4Connect the assembled mask system to the free end of air tubing.

For information on assembling your mask, see your mask manual.

WARNING

•Make sure the power cord and plug are in good condition and the

equipment is not damaged.

•Only ResMed air tubing should be used with the device. A different type

of air tubing may alter the pressure you actually receive, reducing the

effectiveness of your treatment.

•Blocking the hose and/or air inlet of the device while in operation could

lead to overheating of the device.

CAUTION

•Be careful not to place the device where it can be bumped or where

someone is likely to trip over the power cord.

•If you put the device on the floor, make sure the area is free from dust

and clear of bedding, clothes or other objects that could block the air

inlet.

•Make sure the area around the device is dry and clean.

How to Use the Control Panel

The control panel of the S8 Series II includes an LCD screen which displays the

menus and treatment screens as well as a keypad for navigating through the

menus and delivering treatment.

The S8 Series II keypad has the following keys:

The keypad and LCD are equipped with backlights that come on when the device

is powered. The LCD backlight turns off after two minutes of inactivity, and

comes back on when you press a key. The keypad backlight is always on while

the S8 Series II is on.

Selecting the Mask Type

To ensure your device functions as intended with your selected mask, you need to

select the mask type that you are using.

1With the RAMP or SETTLING screen displayed, press . (In CPAP mode, the

standby screen displays RAMP. In AutoSet mode (S8 AutoSet Spirit II only) the

standby screen displays SETTLING.)

2Press until MASK is displayed.

3Press to change the setting.

Key Function

Start/Stop Starts or stops treatment.

Up Allows you to increase settings options and scroll through

the S8 Series II menu.

Down Allows you to decrease settings options and scroll through

the S8 Series II menu.

Left Performs the function indicated by the guiding text

displayed above it on the LCD screen (eg, change).

Right Performs the function indicated by the guiding text

displayed above it on the LCD screen (eg, exit).

LCD screen

Start/Stop key

Keypad

5Using the S8 Series II

English

4Press or until you see the setting that you require.

5Press to apply.

Using the Mask-fitting Feature

You can use the S8 Series II 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 minimise leaks.

Note: Make sure that the mask setting on the MASK screen is the same as the mask

you are using.

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

2With the RAMP or SETTLING screens displayed, hold down for at least

three seconds until air pressure delivery starts.

Your device will ramp to the mask-fit pressure and will remain at this pressure

for three minutes.

The following displays on the LCD screen indicating that the mask-fitting feature

is operating, where: ***** is an excellent fit;****- is a very good fit; ***-- is a

good fit; while **---, *---- and ----- each require you to adjust your mask.

3Adjust your mask, mask cushion and headgear until you have a secure and

comfortable fit.

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 for at least

three seconds to start treatment immediately.

If you press for less than three seconds, the unit will return to standby

mode (the RAMP or SETTLING screen).

Starting Treatment

1Make sure the power is on.

The product name is displayed briefly on the screen, then the standby screen

displays RAMP (or SETTLING). 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.

3Alter the ramp or settling time if required.

MASK FIT: *****

excelnt

4To start treatment, press .

5Fit your mask as described in the mask user instructions.

WARNING

A mask should not be used unless the S8 Series II device is powered and

operating properly.

Stopping Treatment

To stop treatment at any time, remove your mask and press .

If your clinician has enabled SmartStart, simply remove your mask and treatment will

end.

Changing the Settings on your S8 II Device

You can change settings (such as Ramp Time, EPR Level) on S8 II devices by using the

keypad and LCD. When the device 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.

The Standard Menu

Your clinician will have enabled a standard menu on your S8 Series II device. The figure

below shows the standard menu in each mode.

Toenter the standard menu from the standby (RAMP or SETTLING) screen,

press .

Note: The AutoSet menu is available on the S8 AutoSet Spirit II only.

S8 CLASSICRAMP: 10min

S8 CLASSIC

WELCOME

>>>>>>

S8 CLASSICSETTLING: 10min

S8 CLASSIC

WELCOME

>>>>>>

EPR LEVEL: 1

change exit

CPAP AUTOSET

MASK: ULTRA

change exit

exit

SW: SX4800100

USED HRS: 08000

exit

USAGE: 1000/1068

exit

MASK: ULTRA

change exit

exit

SW: SX4800100

USED HRS: 08000

exit

USAGE: 1000/1068

exit

EPR LEVEL: 1

change exit

* Only displayed if access set by clinician.

7Changing the Settings on your S8 II Device

English

The Detailed Menu

Your clinician may have enabled a detailed menu on your S8 Series II device. The figure

below shows the detailed menu in each mode.

Toenter the detailed menu from the standby (RAMP or SETTLING) screen, press .

Note: The AutoSet menu is available on the S8 AutoSet Spirit II only.

RAMP: 10min

WELCOME

>>>>>>

SETTINGS

enter exit

SETTLING: 10min

WELCOME

>>>>>>

EPR LEVEL: 1

change exit

MASK: ULTRA

change exit

TUBE LENGTH: 2m

change exit

HUMID: NONE

change exit

SMARTSTART: ON

change exit

LEAK ALERT: OFF

change exit

CPAP AUTOSET

MASK: ULTRA

change exit

TUBE LENGTH: 2m

change exit

HUMID: NONE

change exit

SMARTSTART: ON

change exit

LEAK ALERT: OFF

change exit

AUTOSETCPAP

USED HRS: 08000

exit

USAGE: 1000/1068

exit

RESULTS

enter exit

SERVICING

enter exit

OPTIONS

enter exit

LANG: ENGLISH

change exit

SN: 12345678912

exit

PCB: 123456789123

4567 exit

SW: SX4800100

exit

SMART DATA

enter exit

SMART DATA

enter exit

AUTO APPEAR: OFF

change cancel

EPR LEVEL: 1

change exit

* Only displayed if access set by clinician.

Messages on the S8 Series II LCD

Your clinician may have set your S8 Series II device 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:

Using the Data Card to Collect Data

If your clinician needs to review your treatment, they will ask you to use the Data Card

to copy data from your S8 Series II, and to return the card to them.

Copying Data onto the Data Card

1Switch on the S8 Series II and wait until you see the standby (Ramp or Settling)

screen.

2Hold the Data Card with the arrow facing up and insert it into the Data Card slot

until it stops. Data copying starts automatically.

The “Card Inserted Please Wait” message is displayed on the S8 Series II LCD

while data is being copied. Copying takes approximately five seconds.

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

copying has finished.

Message Description Action

INSERT

CARD

May appear if your device is

Data Card enabled.

Insert your Data Card and follow any

instructions that your clinician has given you.

When you have done this, the message will

disappear from the LCD. Pressing (Ok)

will also remove the message.

REPLACE

MASK

May appear when your mask

is due for replacement.

Press (Ok) to remove the message

from your LCD, and replace your mask with a

new one.

CALL

PROVIDER

May appear as a reminder to

contact your clinician, eg, to

discuss how your therapy is

going.

Press (Ok) to remove the message

from your LCD, and contact your clinician.

REPLACE

FILTER

May appear as a reminder to

replace the air filter on your

device.

Press (Ok) to remove the message

from your LCD, and replace the air filter.

SERVICE

DUE

May appear as a reminder to

return your device for service.

Press (Ok) to remove the message

from your LCD, and contact your clinician.

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