S8 Lightweight System User Manual May 2006

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D SETTING UP THE S8

INTEGRATED HUMIDIFIER

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S8 Lightweight™ System

A SYSTEM COMPONENTS

© 2005 ResMed Ltd.

ILLUSTRATIONS

Component of 338239/1

HumidAire 3i™

Carry handle LCD screen

Keypad

1

2

C OTHER ACCESSORIES

Air outlet

Connector plug

1 3m

Module

Air filter cover

DC input

Air inlet

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3 3

AC input

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© 2005 ResMed Ltd.

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© 2005 ResMed Ltd.

2m

© 2005 ResMed Ltd.

52 cm

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Page 2

H USING THE DATA CARD

© 2005 ResMed Ltd.

HUMIDAIRE 3i and S8 LIGHTWEIGHT

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I

BLANK MODULE Data communications port

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© 2005 ResMed Ltd.

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USING A HUMIDAIRE™

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0

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8

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8

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DATA CARD MODULE

1 Note: Some products not available in all regions

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© 2005 ResMed Ltd.

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© 2005 ResMed Ltd.

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S8 Lightweight™ System Reorder number: 338239/1 05 06

USER’S MANUAL English

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Manufactured by: ResMed Ltd 1 Elizabeth MacArthur Drive Bella Vista NSW 2153 Australia Tel: +61 (2) 8884 1000 or 1 800 658 189 (toll free) Fax: +61 (2) 8883 3114 Email: [email protected]

ResMed Offices: ResMed Corp 14040 Danielson Street Poway CA 92064-6857 USA Tel: +1 (858) 746-2400 or 1-800-424-0737 (toll free) Fax: +1 (858) 746-2900 Email: [email protected] ResMed (UK) Ltd 65 Milton Park Abingdon Oxfordshire OX14 4RX UK Tel: +44 (1235) 862 997 Fax: +44 (1235) 831 336 Email: [email protected] ResMed Asia Pacific Ltd 14040 Danielson Street Poway CA 92064-6857 USA Tel: +61 (2) 9886 5000 or 1 800 991 900 (toll free) Fax: +61 (2) 9889 1471 Email: [email protected] ResMed Austria Purtscherstraße 18, 9500 Villach Österreich Tel: +43 (4242) 430 830 Fax: +43 (4242) 430 830-4 Email: [email protected] ResMed BV Nieuwe Parklaan 86, 2587 BV Den Haag Nederland Tél: +31 (70) 358 6263 Fax: +31 (70) 358 4333 Email: [email protected] ResMed Finland Niittykatu 6 FIN 02200 Espoo Suomi Tel: +358 9 8676820 Fax: +358 9 86768222 Email: [email protected] ResMed GmbH & Co. KG Fraunhoferstraße 16 82152 Martinsried Deutschland Tel: +49 (0) 89 / 99 01 - 00 or +49 (0) 800 2 777 000 (gebürenfrei) Fax: +49 (0) 89 / 99 01 - 10 55 Email: [email protected] ResMed Hong Kong Ltd Room 1714 Miramar Tower 132-134 Nathan Road Tsim Sha Tsui Hong Kong Tel: +852 2366 0707 Fax: +852 2366 4546 Email: [email protected] ResMed Japan Nihonbashi Hisamatsu Bldg. 4F 2-28-1 Nihonbashi-Hamacho Chuo-Ku, Tokyo 103-0007 Japan Tel: +81 (3) 3662 5056 Fax: +81 (3) 3662 5040 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: +60 3 6201 7177 Fax: +60 3 6201 2177 Email: [email protected] ResMed NZ Ltd PO Box 51-048 Pakuranga Auckland New Zealand Tel: +0800 737 633 (NZ toll free) or +64 25 737 633 Fax: +0800 737 634 (NZ toll free) or +64 9 239 0193 Email: [email protected] ResMed SA Parc de la Bandonnière 2 rue Maurice Audibert 69800 Saint-Priest France Tel: +33 (0) 4 37 251 251 Fax: +33 (0) 4 37 251 260 Email: [email protected] ResMed Singapore Pte Ltd 238A Thomson Road # 12-03/04 Novena Square Tower A Singapore 307684 Tel: +65 6284 7177 Fax: +65 6284 7787 Email: [email protected] ResMed Spain SL C/ Arturo Soria, 245 28033 Madrid España Tel: +34 (93) 590 8154 Fax: +34 (93) 590 8153 Email: [email protected] ResMed Sweden AB Industrigatan 2 S-461 37 Trollhättan Sverige Tel: +46 520 420 110 Fax: +46 520 397 15 Email: [email protected] Labhardt AG Thannerstrasse 57 CH-4054 Basel Schweiz Tel: +41 (061) 307 9711 Fax: +41 (061) 307 9722 Email: [email protected] US DESIGNATED AGENT: ResMed Corp EU AUTHORIZED REPRESENTATIVE: ResMed (UK) Ltd www.resmed.com Protected by patents: US 4944310, US 5199424, US 5522382, US 6705315. Other patents pending. Design registrations pending. S8, S8 Lightweight, HumidAire, HumidAire 3i, Mirage, Mirage Activa, Mirage Vista, Ultra Mirage, Mirage Swift, and ResScan are trademarks of ResMed Ltd. Papillon is a trademark of MAP Medizin-Technologie GmbH. © ResMed Ltd 2005.

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INTRODUCTION... 1 YOUR RESPONSIBILITY

1

MEDICAL INFORMATION... 1 ABOUT THE S8 LIGHTWEIGHT™ CONTRAINDICATIONS WARNINGS CAUTIONS ADVERSE EFFECTS

CONTENTS

CONTENTS

1 1 2 3 3

THE S8 LIGHTWEIGHT SYSTEM... 5 S8 LIGHTWEIGHT MASKS HUMIDIFIERS RESSCAN DATA CARD MODULE ACCESSORIES

5 5 6 6 6

HOW TO USE THE S8 LIGHTWEIGHT... 7 SET UP THE S8 LIGHTWEIGHT ASSEMBLE THE MASK START TREATMENT STOP TREATMENT

7 7 7 8

HOW TO ATTACH A HUMIDIFIER... 9 ATTACH A HUMIDAIRE 3I HUMIDIFIER ATTACH A HUMIDAIRE HUMIDIFIER

9 9

HOW TO USE THE KEYPAD... 11 HOW TO CHANGE THE SETTINGS ON YOUR S8 LIGHTWEIGHT

12

S8 MODULES... 15 USING A BLANK MODULE USING A RESSCAN DATA CARD MODULE

15 15

CLEANING AND MAINTENANCE... 17 DAILY CLEANING WEEKLY CLEANING PERIODIC CLEANING REPLACING THE AIR FILTER SERVICING

17 17 17 18 18

FREQUENTLY ASKED QUESTIONS... 19 TROUBLESHOOTING... 21 SYSTEM SPECIFICATIONS... 23 iii

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S8 LIGHTWEIGHT ACCESSORIES

23 23

INDEX... 29

iv

INTRODUCTION Thank you for choosing the S8 LIGHTWEIGHT™ flow generator. The S8 LIGHTWEIGHT 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 LIGHTWEIGHT.

INTRODUCTION

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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 authorised instructions and by authorised persons. Please read this manual carefully before use. This manual contains special terms and icons that appear in the margins to draw your attention to specific and important information. • Warning alerts you to possible injury. • Caution explains special measures for the safe and effective use of the device. • Note is an informative or helpful note.

MEDICAL INFORMATION ABOUT THE S8 LIGHTWEIGHT™ The S8 LIGHTWEIGHT continuous positive airway pressure (CPAP) system is indicated for the treatment of obstructive sleep apnoea (OSA) in adult patients. The S8 LIGHTWEIGHT CPAP system is intended for home and hospital use.

CONTRAINDICATIONS The S8 LIGHTWEIGHT 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.

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WARNINGS Read the entire manual before using the S8 LIGHTWEIGHT. 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 LIGHTWEIGHT device. • The S8 LIGHTWEIGHT 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 LIGHTWEIGHT device is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked. Explanation: The S8 LIGHTWEIGHT 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 LIGHTWEIGHT can be set to deliver pressures up to 20 cm H2O. In the unlikely event of certain fault conditions, pressures up to 30 cm H2O are possible. • If oxygen is used with this device, the oxygen flow must be turned off when the device is not operating. If oxygen has been left on, turn off the flow generator, then wait 30 minutes before turning on the flow generatory again. 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. • •

*

2

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

Do not use the S8 LIGHTWEIGHT if there are obvious external defects or unexplained changes in performance. • Do not open the S8 LIGHTWEIGHT case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorised service agent. • Explosion hazard-do not use in the vicinity of flammable anaesthetics. •

CAUTIONS

MEDICAL INFORMATION

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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 6°C higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 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. It is not supplied with all models.) • If supplied, the Data Card module is designed for use with specific ResMed devices. • Only use the 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 CPAP device: • drying of the nose, mouth or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes • chest discomfort.

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4

THE S8 LIGHTWEIGHT SYSTEM The S8 LIGHTWEIGHT device is part of a system that consists of six elements: • S8 LIGHTWEIGHT flow generator • Mask • Humidifier • Data management products • Premium noise guard (front cap) • Accessories.

THE S8 LIGHTWEIGHT SYSTEM

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S8 LIGHTWEIGHT 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 LIGHTWEIGHT to the AC (mains) power. CARRY BAG (A-4) The S8 LIGHTWEIGHT carry bag contains two pouches: one for storing the S8 device, the other for storing the HUMIDAIRE 3i™. When storing the HUMIDAIRE 3i, always put it in the larger, mesh pouch. AIR TUBING The 2 m air tubing (A-5) connects the S8 LIGHTWEIGHT to your mask . You will need medium 52 cm air tubing (see C-3) to connect the S8 LIGHTWEIGHT to the HUMIDAIRE™ humidifier.

MASKS You will also need a ResMed mask system (supplied separately). The ResMed mask systems that are recommended for use with the S8 LIGHTWEIGHT 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.

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FULL FACE MASKS • • •

!

MIRAGE™ FULL FACE MASK MIRAGE™ FULL FACE MASK SERIES 2 ULTRA MIRAGE™ FULL FACE MASK.

WARNING ResMed mask systems are compatible for use with the S8 Lightweight. Please refer to “Warnings” on page 2.

HUMIDIFIERS A humidifier may be required if you are experiencing dryness of the nose, throat or mouth. The S8 LIGHTWEIGHT is compatible for use with: • HUMIDAIRE 3i integrated heated humidifier (Figure B on the illustrations sheet) • HUMIDAIRE heated humidifier (Figure I on the illustrations sheet).

RESSCAN DATA CARD MODULE The RESSCAN™ Data Card module and RESSCAN Data Card (C-1) may be used with the S8 LIGHTWEIGHT 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 15 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 S8 LIGHTWEIGHT: • Premium noise guard (front cap): standard with S8 LIGHTWEIGHT (C-2) • Air tubing 3 m (C-3) • Medium air tubing 52 cm for HUMIDAIRE connection (C-4) • DC-12 converter (C-5) • Blank module (C-6). Note: ResMed regularly releases new products. Please check our website at <www.resmed.com>.

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HOW TO USE THE S8 LIGHTWEIGHT Please refer to the illustrations in section D of the illustration sheet.

SET UP THE S8 LIGHTWEIGHT 1

Place the S8 LIGHTWEIGHT on a table near the head of your bed.

!

2

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 Lightweight 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.

HOW TO USE THE S8 LIGHTWEIGHT

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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.

! 3

WARNING Make sure the power cord and plug are in good condition and the equipment is not damaged. 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 hose 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 1.5 m away from, or at least 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 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). The S8 LIGHTWEIGHT is now ready for use (D-4).

START TREATMENT 1

Make sure the power is on. The product name 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.

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!

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 13).

4

To start treatment, press the Start/Stop key.

5

Fit your mask as described in the mask user instructions.

! 6

WARNING A mask should not be used unless the S8 Lightweight device is turned on and operating properly. 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 H2O. For example, 6 dashes represents approximately 12 cm H2O pressure.

STOP TREATMENT To stop treatment at any time, remove your mask and press the Start/Stop key.

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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 3i attaches to the front of the S8 LIGHTWEIGHT to provide heated humidification. No other accessories are required for its use. Notes:

HOW TO ATTACH A HUMIDIFIER

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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 Lightweight (see section A of the illustrations sheet) before you attach the HumidAire 3i. Reattach the connector plug firmly after you detach the HumidAire 3i. STORING THE HUMIDAIRE 3i Store the HUMIDAIRE 3i in the larger, mesh-top pouch of the S8 LIGHTWEIGHT carry bag when not in use.

ATTACH A HUMIDAIRE HUMIDIFIER Please refer to the illustrations in section I of the illustration sheet. To connect your S8 LIGHTWEIGHT to a HUMIDAIRE humidifier you need medium sized (52 cm) air tubing.

1

Fill the HUMIDAIRE water chamber and place inside the HUMIDAIRE. Connect the medium (52 cm) and long (2 m) air tubing (I-1), and close the humidifier lid.

2

Place the S8 LIGHTWEIGHT on top of the HUMIDAIRE (I-2) and connect the free end of the medium air tubing to the air outlet (I-3). Note: To avoid water spilling into the S8 LIGHTWEIGHT, do not put it underneath the humidifier.

3

Assemble your mask system and connect it to the free end of the long air tubing (I-4).

4

Plug the HUMIDAIRE power cord into a power outlet. Connect the S8 LIGHTWEIGHT power cord to the socket at the rear of the S8 LIGHTWEIGHT and plug the other end into a power outlet. Please refer to the HumidAire User’s Manual for further details.

!

WARNING Make sure that the power cord and plug are in good condition and the equipment is not damaged. The S8 LIGHTWEIGHT is now ready for use with the HUMIDAIRE.

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HOW TO USE THE KEYPAD The control panel of the S8 LIGHTWEIGHT includes an LCD screen and keypad for navigating through the menus and delivering treatment.

HOW TO USE THE KEYPAD

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LCD screen Up key Right key

Left key Down key

Start/Stop key

LCD SCREEN The LCD screen displays the menus and treatment screens.

KEYPAD KEYS The S8 LIGHTWEIGHT keypad has the following keys: Key

Function

Start/Stop

• Starts or stops treatment.

Up

• Allows you to increase settings options and scroll through the S8 LIGHTWEIGHT menu.

Down

• Allows you to decrease settings options and scroll through the S8 LIGHTWEIGHT menu.

Left

• Performs the function indicated by the guiding text displayed above it on the LCD screen. Guiding text includes menu, change and apply.

Right

• Performs the function indicated by the guiding text displayed above it on the LCD screen. Guiding text includes exit and cancel.

BACKLIGHTS 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

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on when you press a key. Once the Start/Stop key has been pressed to start treatment, the LCD backlight stays on for two minutes. The keypad backlight is always on while the S8 LIGHTWEIGHT is on.

HOW TO CHANGE THE SETTINGS ON YOUR S8 LIGHTWEIGHT You can change settings (such as Ramp Time, Altitude) on the S8 LIGHTWEIGHT by using the keypad and LCD. When the S8 LIGHTWEIGHT 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. S8 LIGHTWEIGHT

MENU S8PATIENT CLASSIC

S8 RAMP CLASSIC 10min Menu

ALT: Change

0-610m Exit

USED HRS:

960 Exit

USAGE:

120/180 Exit

LANG: Change

ENGLISH Exit

SW: SX123456789 Exit

Use the menu screens to change the ramp time, altitude compensation and language. You can also view details about the usage and software version of your S8 LIGHTWEIGHT.

HOW TO ENTER THE MENU SCREENS When the S8 LIGHTWEIGHT standby screen is displayed you will see the word ‘Menu’ in the left-hand corner. To select the S8 LIGHTWEIGHT menu, press the Left key. 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).

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HOW TO EXIT OUT OF A MENU Press the Right key (Exit). This will take you back to the Patient Menu screen. HOW TO EXIT OUT OF AN ITEM WITHIN THE MENU Press the Right key (Exit).

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. 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 H2O. For example, six dashes represents approximately 12 cm H2O pressure.

HOW TO USE THE KEYPAD

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HOW TO CHANGE THE ALTITUDE SETTING If you move or travel with your S8 LIGHTWEIGHT to areas of different altitude, you will need to adjust the altitude compensation setting. Changes in altitude will affect the pressure delivered by the S8 LIGHTWEIGHT. You can use the Altitude setting (ALT) to specify the altitude range at which you are using your S8 LIGHTWEIGHT. Select the S8 LIGHTWEIGHT menu by pressing the Left key in the standby (RAMP) screen. Scroll to ALT and select Change (Left key). Press the Up or Down keys until you see the setting option that you require. There are four altitude settings to choose from: • 0–609 m • 610–1219 m • 1220–1828 m • 1829–2591m. For example, if you are at an altitude of 947 m, your altitude compensation setting would be 610–1219 m, as 947 m falls within that range. Press the Left key (Apply) to select the correct setting.

HOW TO CHANGE THE LANGUAGE SETTING To display menus and messages in a different language, select the S8 LIGHTWEIGHT menu by pressing the Left key in the standby (Ramp) screen. Scroll to LANG and select Change (Left key). Press the Up or Down keys until you see the language that you require.

OTHER VIEWABLE INFORMATION You can also view the total number of hours of treatment (USED HRS); the number of sessions that the S8 LIGHTWEIGHT was used in a usage period (USAGE); and the current software version installed on your unit (SW). Access to all of these screens is provided via the menu. See “How to enter the menu screens” on page 12.

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