S7 Lightweight System Users Manual 2006

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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) 65 Milton Park Abingdon Oxfordshire OX14 4RX UK ResMed Offices Australia, Austria, Brazil, Finland, France, Germany, Hong Kong, Japan, Malaysia, Netherlands, New Zealand, Norway, Singapore, Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details). Protected by patents: US 4944310, US 5199424, US 5522382, US 6705315. Other patents pending. Protected by design registrations: AU 147283, AU 147335, AU 147336, CH 128.709, CH 128.710, CH 128.711, CH 128.712, DE 40201723, DE 40202007, DE 40202008, DE 40202020, ES 153514, ES 153515, ES 153516, ES 153518, ES 156135, ES 156136, FR 021395, FR 021396, FR 021397, FR 021407, GB 3001791, GB 3001819, GB 3001820, GB 3001821, JP 1164087, JP 1164265, JP 1164266, JP 1164267, SE 75598, SE 75599, SE 75600, SE 75715, US D467335, US D468011, US D476077, US D477868, US D487311, US D497203, US D503796. Other designs pending. HumidAire and S7 are trademarks of ResMed Ltd. HumidAire is registered in U.S. Patent and Trademark Office. © 2006 ResMed Ltd.

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INTRODUCTION... 1 DEFINITIONS USER/OWNER RESPONSIBILITY

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CONTENTS

CONTENTS

MEDICAL INFORMATION... 1 WHAT A RESMED S7™ LIGHTWEIGHT UNIT IS FOR TELL YOUR DOCTOR IF... WARNINGS CAUTIONS

1 1 2 3

THE RESMED S7 LIGHTWEIGHT SYSTEM... 5 RESMED S7 LIGHTWEIGHT COMPONENTS MASKS HUMIDIFIER

5 6 6

PREPARING FOR USE... 7 SETTING UP THE RESMED S7 LIGHTWEIGHT FEATURES OF THE RESMED S7 LIGHTWEIGHT

7 12

OPERATING INSTRUCTIONS... 15 STARTING TREATMENT STOPPING TREATMENT HELPFUL HINTS

15 15 16

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

17 17 17 18 18

TROUBLESHOOTING... 19 SYSTEM SPECIFICATIONS... 21 LIMITED WARRANTY... 27 INDEX... 29

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INTRODUCTION DEFINITIONS This manual contains special terms that appear in the text to draw your attention to specific and important information.

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INTRODUCTION

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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.

USER/OWNER RESPONSIBILITY The user or owner of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from: • operation which is not in accordance with the operating instructions supplied • maintenance or modifications carried out unless in accordance with authorised instructions and by authorised persons. Please read this manual carefully before use.

MEDICAL INFORMATION WHAT A RESMED S7™ LIGHTWEIGHT UNIT IS FOR The RESMED S7™ LIGHTWEIGHT system is intended for the treatment of adult patients with obstructive sleep apnoea (OSA).

TELL YOUR DOCTOR IF... You must tell your doctor, and CPAP (continuous positive airway pressure) therapy must not be used, if you have any of the following conditions: • pneumothorax or pneumomediastinum (air in the pleural cavity or mediastinum) • severe heart failure, low blood pressure or dehydration • surgery to the brain, middle or inner ear, pituitary gland, or sinuses • respiratory distress syndrome • middle ear infection or perforated ear drum • severe nosebleed.

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WARNINGS CPAP therapy should be used with caution if you have any of the following conditions: • respiratory failure • cavities or cysts in the lung (called bullae, and usually due to emphysema), or previous history of pneumothorax • previous history of severe nosebleed • sinus infection. Tell your doctor if you have any of these conditions. Your doctor will advise you whether the likely benefits of CPAP therapy outweigh the expected risks. Special care should be exercised if you are dehydrated, or may become dehydrated, for example as a result of fluid restriction or diuretic therapy (including changes in therapy). Discontinue therapy and seek medical advice if, during therapy or when you start therapy each night, you feel faint or light-headed. The following are general warnings that pertain to your use of a RESMED S7 LIGHTWEIGHT unit. Specific warnings appear next to the relevant instructions in the manual. • This is NOT a life support device. It may stop operating with power failure or if a fault occurs in the unit. • The air flow for breathing produced by this device can be as much as 6oC (11oF) higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 32oC (90oF). • The RESMED S7 LIGHTWEIGHT unit should only be used with masks (and connectors)* recommended by ResMed, or by your physician or respiratory therapist. A mask should not be used unless the RESMED S7 LIGHTWEIGHT unit is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked. Explanation: The RESMED S7 LIGHTWEIGHT unit 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. The RESMED S7 LIGHTWEIGHT unit should only be connected to the components, humidifiers or accessories specified in this manual. Connection of other items may result in injury, or damage to the RESMED S7 LIGHTWEIGHT unit. • 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. • This device is not intended for use with supplemental oxygen. •

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

• •

Explosion hazard-do not use in the vicinity of flammable anaesthetics. Blocking the hose while in operation could lead to overheating of the device.

WARNINGS RELATED TO TREATMENT

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WARNING If you stop your CPAP treatment, your sleep apnoea will return. Always consult your clinician if you expect to be in a situation where you cannot use your RESMED S7 LIGHTWEIGHT unit. • If you are admitted to a hospital or prescribed any other form of medical treatment, always inform the medical staff that you are being treated with CPAP. It is also important to contact the clinician who is treating you for sleep apnoea. • If you experience an infection of the upper respiratory tract, middle ear or sinuses, contact your clinician before continuing your CPAP treatment. You may be advised to stop treatment until the infection has cleared. If you continue with treatment during an infection, be sure to clean your mask and tubing after every use. • •

MEDICAL INFORMATION

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CAUTIONS The following are general cautions. Specific cautions appear next to the relevant instructions in the manual. • Do not open the RESMED S7 LIGHTWEIGHT case. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorised service agent.

POSSIBLE SIDE EFFECTS The RESMED S7 LIGHTWEIGHT flow generator helps you have a good night’s sleep. However, you need to be aware of possible problems that may arise during CPAP treatment.

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WARNING Consult your clinician immediately if you experience any of the following symptoms during your CPAP treatment: • headache • middle ear or sinus discomfort • chest pain • dryness of the nose, mouth or throat • feeling bloated due to air swallowing • air continually leaking out of the mouth while sleeping • recurrence of any sleep apnoea symptoms while on CPAP. Skin irritation may occur from sensitivity to the mask materials or from excessively tight headgear straps. A correctly fitted mask and appropriately adjusted straps will often prevent skin irritation. If problems persist, contact your clinician for advice.

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THE RESMED S7 LIGHTWEIGHT SYSTEM RESMED S7 LIGHTWEIGHT COMPONENTS Please identify and familiarise yourself with the following components of the RESMED S7 LIGHTWEIGHT unit: ResMed S7 Lightweight unit Front view

THE RESMED S7 LIGHTWEIGHT SYSTEM

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Handle

LCD screen

Control panel

Air outlet Removable front cap

Air tubing, 2m (6ft6in)

Carry bag

Power cord

ACCESSORIES The following accessories may be purchased separately. RESMED S7 LIGHTWEIGHT ACCESSORIES

Air tubing, 3m (9ft10in)

HUMIDIFIER ACCESSORIES

(HUMIDAIRE and ResMed PASSOVER only)

Medium air tubing 52cm (21in) for humidifier connection

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MASKS You will also need a ResMed mask system (supplied separately). The following ResMed mask systems are recommended for use with the RESMED S7 LIGHTWEIGHT:

MIRAGE VISTA™ MASK

MIRAGE™ FULL FACE MASK SERIES 2

ULTRA MIRAGE™ MASK

MIRAGE™ MASK

MIRAGE™ FULL FACE MASK

PROTÉGÉ™ MASK (not available in all markets)

MODULAR MASK

HUMIDIFIER A humidifier may be required if you are experiencing dryness of the nose, throat or mouth. The RESMED S7 LIGHTWEIGHT is compatible for use with the following humidifiers:

HUMIDAIRE 2i™ heated humidifier

HUMIDAIRE™ heated humidifier

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HUMIDAIRE 2iC passover humidifier (not available in all markets)

ResMed PASSOVER humidifier (not available in all markets)

WARNING Only the HumidAire 2i, HumidAire 2iC, HumidAire heated humidifier and the ResMed Passover are compatible for use with the ResMed S7 Lightweight. Please refer to “Warnings” on page 2. Note: ResMed regularly releases new products. Please check our website at <www.resmed.com>.

PREPARING FOR USE SETTING UP THE RESMED S7 LIGHTWEIGHT 1

Place the RESMED S7 LIGHTWEIGHT unit on a table near the head of your bed.

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CAUTION

PREPARING FOR USE

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Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord. Note: The ResMed S7 Lightweight unit may be placed 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. Connect the power cord to the socket at the rear of the flow generator. Plug the other end of the power cord into a power outlet.

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Make sure the power cord and plug are in good condition and the equipment is not damaged. • The air filter cover protects the device in the event of accidental liquid spillage onto the device. Ensure that the air filter and air filter cover are fitted at all times. •

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

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WARNING

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

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Connect your mask system to the free end of the air tubing.

The RESMED S7 LIGHTWEIGHT is now ready for use. To start treatment, see “Operating Instructions” on page 15.

HUMIDIFIER USE Notes • •

The ResMed S7 Lightweight has no humidifier setting options. The ResMed S7 Lightweight does not have the Warm-Up and cooling down features mentioned in the HumidAire 2i User’s Manual. When the HumidAire 2i is attached to the ResMed S7 Lightweight, you may begin therapy immediately.

HUMIDAIRE 2i™ The HUMIDAIRE 2i™ attaches to the front of the RESMED S7 LIGHTWEIGHT to provide heated humidification. No other accessories are required for its use. Please refer to the HumidAire 2i User’s Manual for details.

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HUMIDAIRE 2iC (not available in all markets) The HUMIDAIRE 2iC attaches to the front of a RESMED S7 LIGHTWEIGHT unit to provide passover humidification. No other accessories are required for its use. Please refer to the HumidAire 2iC User’s Manual for details.

PREPARING FOR USE

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HUMIDAIRE™ AND RESMED PASSOVER (not available in all markets) Medium size 52cm (21in) air tubing is a necessary accessory for connecting the RESMED S7 LIGHTWEIGHT unit to the HUMIDAIRE™ and ResMed PASSOVER humidifiers.

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Fill the HUMIDAIRE or PASSOVER with water as described in the humidifier manual.

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HumidAire Users Place the filled water chamber inside the HUMIDAIRE. Connect the medium 52cm (21in) air tubing to the left connector port, and the long air tubing 2m (6ft6in) or 3m (9ft10in) to the right connector port on the humidifier. Close the HUMIDAIRE lid. ResMed Passover Users Connect the medium 52cm (21in) air tubing to the left connector port, and the long air tubing 2m (6ft6in) or 3m (9ft10in) to the right connector port on the humidifier.

Medium (52cm) air tubing HumidAire

Long air tubing

Medium (52cm) air tubing

Long air tubing

ResMed Passover

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Place the RESMED S7 LIGHTWEIGHT on top of the HUMIDAIRE or PASSOVER. Do not place the RESMED S7 LIGHTWEIGHT unit underneath the humidifier. (This is to avoid water spilling into the unit.)

HumidAire

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HumidAire Users Connect the free end of the medium air tubing to the air outlet of the RESMED S7 LIGHTWEIGHT. ResMed Passover Users Connect the free end of the medium air tubing to the air outlet of the RESMED S7 LIGHTWEIGHT.

HumidAire

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ResMed Passover

Connect the mask system to the free end of the long air tubing. The final assembly should look like this:

HumidAire

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ResMed Passover

ResMed Passover

HumidAire Users Plug the HUMIDAIRE power cord into a power outlet and turn the power on.

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Connect the power cord to the socket at the rear of the RESMED S7 LIGHTWEIGHT. Plug the other end of the power cord into a power outlet and turn the power on.

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WARNING Make sure that the power cord and plug are in good condition and the equipment is not damaged.

PREPARING FOR USE

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The RESMED S7 LIGHTWEIGHT is now ready for use with the HUMIDAIRE or ResMed PASSOVER.

ALTITUDE COMPENSATION Changes in altitude will affect the pressure delivered by the RESMED S7 LIGHTWEIGHT. The device has a feature which compensates for these changes in altitude. As you move or travel with the RESMED S7 LIGHTWEIGHT to areas of different altitudes, you will need to adjust the altitude compensation setting in the device. To change the altitude compensation setting, see “Using the Menus” on page 12. There are three altitude settings to choose from: Altitude Settings 0–2000ft

(0–610m)

2001–4000ft

(611–1219m)

4001–7000ft

(1220–2134m)

For example, if you are at an altitude of 3107ft (947m), your altitude compensation setting would be 2001–4000ft (611–1219m), as 3107ft (947m) falls within that range. Note: If you are above 7000ft (2134m), consider consulting your clinician.

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FEATURES OF THE RESMED S7 LIGHTWEIGHT LCD SCREEN AND KEYPAD The control panel of the RESMED S7 LIGHTWEIGHT includes an LCD screen and keypad.

LCD screen Left key

Right key

Up/down key

top

rt/S

Sta

Front Key

The RESMED S7 LIGHTWEIGHT keypad has the following keys: Key

Function

Front

• Starts or stops treatment top

rt/S

Sta

Up/Down

• Allows you to scroll through the ResMed S7 LIGHTWEIGHT menus and setting options.

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.

To assist you in adjusting the RESMED S7 LIGHTWEIGHT the keypad is equipped with a backlight. The keypad is backlit with power-up of the unit. Under normal operation, the keypad remains illuminated to indicate that the device is ON.

USING THE MENUS The ResMed S7 LIGHTWEIGHT unit provides a set of functions which are arranged in menus. Via the LCD screen, the menus allow you to view and change the settings for a particular function. You can access the menus when the Ramp screen is displayed. After the Welcome Screen appears and device self-checks are complete, the Ramp screen appears. In the Ramp screen, you can immediately set a ramp time. Ramp time is the period during which the pressure increases from a low comfortable pressure to

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the prescribed treatment pressure. Ramp time can be altered in 5 minute increments (from 0min to a maximum ramp time set by your clinician) by using the Up/Down key. See Figure 1 for a summary of the RESMED S7 LIGHTWEIGHT menus. • To access the RESMED S7 LIGHTWEIGHT menus: Press the Left key (menu) while the Ramp screen is displayed. •

To scroll through items within a menu: Press the Up/Down key

•

To change a setting option for a function: 1. Press the Left key (change) 2. Press the Up/Down key until the desired setting option appears. 3. Press the Left key (apply) to select the setting option.

•

To exit without changing options: Press the Right key (cancel)

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To exit out of a menu or submenu: Press the Right key (exit)

RAMP:

10min

menu

PREPARING FOR USE

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ResMed S7 Lightweight Ramp screen

ALT: 0-2000ft

change

exit

USED HRS: 8888

exit

Figure 1: ResMed S7 Lightweight Menu Series

MENU FUNCTIONS The RESMED S7 LIGHTWEIGHT menu functions are summarised in Table 1 with a brief description of what each function does and the available setting options. To access these functions see “Using the Menus” on page 12.

SETTINGS MENU The Settings Menu allows you to view and change certain operating features of the RESMED S7 LIGHTWEIGHT unit.

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Table 1: Settings Menu Functions

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Function

Function Description

Setting Options

Altitude (Compensation)

Sets the altitude compensation range.

0–2000ft (0–610m), 2001–4000ft (611–1219m), 4001–7000ft (1220–2134m)

Used hours

Displays the total number of treatment hours.

(View only)

OPERATING INSTRUCTIONS STARTING TREATMENT The RESMED S7 LIGHTWEIGHT unit should be assembled beside your bed with the air tubing and mask system connected. See “Setting Up The ResMed S7 Lightweight” on page 7.

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OPERATING INSTRUCTIONS

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Turn the main power switch at the back of the unit to on (I).

When the RESMED S7 LIGHTWEIGHT is turned on, the software version is displayed on the LCD screen. The Ramp screen then appears.

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Fit your mask as described in the mask user instructions.

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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. It 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. •

To start treatment, press the Front key. If a ramp time is selected, the LCD will display the word RAMPING with set pressure indicated as dashes. At the end of the ramping period the LCD will display CPAP. After starting treatment, the LCD will look similar to one of the screens below. CPAP

RAMPING

––––––

–––

The dashes represent the set pressure, where each dash is approximately equivalent to 2 cmH2O pressure. For example, 6 dashes represents approximately 12 cmH2O pressure.

STOPPING TREATMENT To stop treatment at any time, remove your mask and press the Front key.

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HELPFUL HINTS STARTING OUT FIRST USE When you first use your RESMED S7 LIGHTWEIGHT unit, you may feel uncomfortable breathing against the air flow. This is normal. You will continue to breathe normally while you sleep. Take time to adjust to this new sensation. Taking a few deep breaths may help. GETTING UP If you need to get up during the night, remove your mask and turn the flow generator off. Always remember to put your mask on and turn your flow generator on when you return to bed. MOUTH LEAKS If 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. MASK FITTING 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. If 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. 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.

NASAL IRRITATION DRYNESS 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. RUNNY OR BLOCKED NOSE 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 clinican for advice.

TRAVELLING WITH THE RESMED S7 LIGHTWEIGHT INTERNATIONAL USE Your RESMED S7 LIGHTWEIGHT flow generator has an internal power adapter 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.

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CLEANING AND MAINTENANCE You should regularly carry out the cleaning and maintenance described in this section.

DAILY 1. Disconnect the air tubing and hang it in a clean, dry place until next use. Do not hang the air tubing in direct sunlight as it may harden and crack over time. 2. Clean the mask according to the mask user instructions. 3. If you are using a humidifier, clean it according to the instructions in the manual.

CLEANING AND MAINTENANCE

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WEEKLY 1. Remove the air tubing from the RESMED S7 LIGHTWEIGHT unit and the mask. 2. Wash the mask system according to the instructions supplied with it. 3. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang and allow to dry. 4. Before next use, assemble the mask and headgear according to the mask user instructions. 5. Reconnect the air tubing to the air outlet and mask.

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CAUTION Do not use bleach, chlorine-, alcohol- or aromatic-based solutions (including all scented oils), moisturising or antibacterial soaps to clean the cushion, mask, air tubing or the ResMed S7 Lightweight. These solutions may cause hardening and reduce the life of the product. • Do not wash or dry the mask frame at a temperature above 80oC (176oF). Exposure to higher temperatures may reduce the life of the product. • Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack. •

PERIODICALLY 1. The mask and air tubing are subject to normal wear and tear. Inspect them regularly for damage. 2. Clean the exterior of the flow generator with a damp cloth and mild detergent. 3. Inspect the air filter to check if it is blocked by dirt or contains holes. See “Replacing the Air Filter” on page 18.

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WARNING Beware of electric shock. Do not immerse the flow generator or power cord in water. Always unplug the flow generator before cleaning and be sure that it is dry before reconnecting.

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