S9 Series AutoSet and Elite User Guide Oct 2012

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S9 AutoSet indications for use The S9 AutoSet self-adjusting system is indicated for the treatment of obstructive sleep apnoea (OSA) in patients weighing more than 30 kg. The S9 AutoSet self-adjusting system is intended for home and hospital use.

S9 Elite indications for use The S9 Elite CPAP system is indicated for the treatment of obstructive sleep apnoea (OSA) in patients weighing more than 30 kg. The S9 Elite CPAP system is intended for home and hospital use.

Contraindications Positive airway pressure therapy may be contraindicated in some patients with the following preexisting 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 these devices: • drying of the nose, mouth, or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes.

Masks and humidifiers Recommended masks and humidifiers are available on www.resmed.com on the Products page under Service & Support. For information on using your mask or humidifier, refer to the manual supplied with your mask or humidifier.

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Setup Refer to illustration A. 1. Connect the DC plug of the power supply unit to the rear of the S9. 2. Connect the power cord to the power supply unit. 3. Plug the other end of the power cord into the power outlet. 4. Connect one end of the air tubing firmly onto the air outlet. 5. Connect the assembled mask system to the free end of the air tubing.

Control panel Refer to illustration B. The control panel of your S9 devices includes the following items: 1. Start/Stop button: Starts or stops treatment 2. Home menu 3. LCD screen 4. Info menu*: Allows you to view your sleep statistics 5. Setup menu*: Allows you to make changes to settings 6. Push dial: Turning the dial allows you to scroll through the menu and change settings. Pushing the dial allows you to enter into a menu and confirm your choice. *The Info and Setup menus are disabled if S9 Essentials has been enabled by your clinician.

Navigating the menus Refer to illustration C. In general, to navigate the menus: 1. Turn 2. Press 3. Turn 4. Press

until the parameter you require is displayed in blue. . The selection is highlighted in orange. until you see the setting that you require. to confirm your choice. The screen returns to blue.

Getting started 1. Make sure the power is connected. 2. Adjust the ramp time if required. 3. Fit your mask as described in your mask user guide. 4. To start therapy, simply breathe into the mask and/or press . 5. Lie down and arrange the air tubing so that it is free to move if you turn in your sleep. 6. To stop treatment at any time, remove your mask and/or press . Note: If your clinician has enabled SmartStart your device will start automatically when you breathe into the mask and stop automatically when you remove the mask. 2 English

Cleaning and maintenance Daily: Remove the air tubing by pulling on the finger grips on the cuff. Hang it in a clean, dry place until next use. Notes: • Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack. • Do not wash the air tubing in a washing machine or dishwasher. Weekly: 1. Remove the air tubing from the S9 device and the mask. 2. Wash the air tubing in warm water using mild detergent. 3. Rinse thoroughly, hang, and allow to dry. 4. Before next use, reconnect the air tubing to the air outlet and mask. Monthly: 1. Wipe the exterior of the S9 with a damp cloth and mild detergent. 2. Check the air filter for holes and blockage by dirt or dust. Replace the air filter if necessary. Replacing the air filter: Replace the air filter every six months (or more often if necessary). 1. Remove the air filter cover from the back of the S9 device. 2. Remove and discard the old air filter. 3. Insert a new ResMed air filter ensuring that it is sitting flat in the air filter cover. 4. Replace the air filter cover. Notes: • Ensure the air filter and air filter cover are fitted at all times. • Do not wash the air filter. The air filter is not washable or reusable.

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 these devices. Problem/Possible cause

Solution

No display Power is not connected. The DC plug is partially inserted into the back of the device.

Ensure the power cable is connected and the power outlet (if available) is on. Fully insert the DC plug.

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Problem/Possible cause

Solution

Insufficient air delivered from the device Ramp time is in use. Air filter is dirty. Air tubing is not connected properly. Air tubing is blocked, pinched or punctured. Mask and headgear are not positioned correctly. Incorrect air tubing selected.

Wait for air pressure to build up or change ramp time. Replace air filter. Check air tubing. Unblock or free the air tubing. Check the air tubing for punctures. Adjust position of mask and headgear. If you are using the SlimLine or Standard air tubing ensure that you have the correct air tubing selected via the menu.

Device does not start when you breathe into the mask Breath is not deep enough to trigger SmartStart/Stop. There is excessive leak.

SmartStart/Stop is disabled.

Take a deep breath in and out through the mask. Adjust position of mask and headgear. Air tubing not connected properly. Connect firmly at both ends. Enable SmartStart/Stop.

Device does not stop when you remove your mask SmartStart/Stop is disabled.

Enable SmartStart/Stop.

SmartStart/Stop is enabled but the device does not stop automatically when you remove your mask Incompatible mask system being used. The patient is using a nasal pillows mask with a set pressure less than 7 cm H2O.

Only use equipment recommended by ResMed. Disable SmartStart/Stop.

Pressure rises inappropriately Talking, coughing or breathing in an unusual manner. Mask cushion is buzzing against the skin.

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Avoid talking with a nasal mask on, and breathe as normally as possible. Adjust the headgear.

Problem/Possible cause

Solution

Displays error message: High temperature fault, refer to user manual Device has been left in a hot environment. Air filter is blocked. Air tubing is blocked.

Humidifier setting is too high, resulting in accumulation of water in the air tubing.

Allow to cool before re-use. Disconnect the power cord and then reconnect it to restart the device. Replace your air filter. Disconnect the power cord and then reconnect it to restart the device. Check your air tubing and remove any blockages. Disconnect the power cord and then reconnect it to restart the device. Turn the humidifier setting down and empty the water from the air tubing.

Displays error message: Check ResMed 30/90W Power Supply Unit and fully insert the connector

The DC plug is partially inserted into the back of the device or inserted too slowly. A non-ResMed power supply unit is connected to the device. The power supply unit is being covered by bedding.

Fully insert the DC plug.

Remove the power supply unit and replace with a ResMed power supply unit. Make sure that the power supply unit is free from bedding, clothes or other objects that could cover it.

Displays error message: Tube blocked, please check your tube Air tubing is blocked.

Check your air tubing and remove any blockages.

Displays error message: High leak, please check system setup and all connections There is excessive leak.

Adjust position of mask and headgear. Air tubing is not connected properly. Connect firmly at both ends.

The following message is displayed on the LCD after you try to update settings or copy data to the SD card: Card error, please remove SD card and contact service provider SD card is not inserted correctly.

Ensure that the SD card is inserted correctly.

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Problem/Possible cause

Solution

You may have removed the SD card before settings were copied to the CPAP device.

Reinsert the SD card and wait for the home screen or the Settings updated successfully, press any key message to appear on the LCD. Note: This message only appears once. If you re-insert the SD card after you have updated your settings, the message will not be re-displayed.

The following message is NOT displayed on the LCD after you try to update the settings using the SD card: Settings updated successfully, press any key The settings were not updated.

Contact your clinician/service provider immediately.

SD card An SD card has been supplied to gather therapy data from your S9 device and provide settings updates from your clinician. When instructed to do so, disconnect the S9 device from the power outlet, remove your SD card, insert it in the protective folder and send it to your clinician. For more information on removing and inserting your card refer to the S9 SD Card Protective Folder provided with your device. Please retain the S9 SD Card Protective Folder for future use.

Technical specifications Operating pressure range 4 to 20 cm H2O Maximum single fault steady state 30 cm H2O pressure Pressure measurement tolerance ±0.5 cm H2O ± 4% of the measured reading Flow measurement tolerance ±6 L/min or 10% of reading, whichever is greater DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871: Sound pressure level 24 dBA as measured according to ISO 17510-1:2002 26 dBA with uncertainty of 2 dBA as measured according to EN ISO 17510-1:2009 Sound power level 34 dBA with uncertainty of 2 dBA as measured according to EN ISO 17510-1:2009 Nominal dimensions (L x W x H) 153 mm x 140 mm x 86 mm Weight 835 g

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90W power supply unit

30W power supply unit

Operating temperature

Operating humidity Operating altitude Storage and transport temperature Storage and transport humidity Housing construction Supplemental oxygen Hypoallergenic air filter Standard air filter SlimLine™ air tubing Standard air tubing ClimateLine™ heated air tubing ClimateLineMAX™ heated air tubing Air outlet

Input range 100–240V, 50–60Hz, Nominal for aircraft use 115V, 400Hz Typical power consumption 70W (80VA) Maximum power consumption 110W (120VA) Input range 100–240V, 50–60Hz, Nominal for aircraft use 115V, 400Hz Typical power consumption 20W (40VA) Maximum power consumption 36W (75VA) +5ºC to +35ºC Note: The air flow for breathing produced by this therapy device can be higher than the temperature of the room. Under extreme ambient temperature conditions (40ºC) the device remains safe. 10–95% non-condensing Sea level to 2,591 m -20ºC to +60ºC 10–95% non-condensing Flame retardant engineering thermoplastic Recommended maximum supplemental oxygen flow: 4 L/min Non-woven acrylic and polypropylene fibers with polypropylene carrier Polyester fiber Flexible plastic, 1.8 m, 15 mm inner diameter Flexible plastic, 2 m, 19 mm inner diameter Flexible plastic and electrical components, 2 m, 15 mm inner diameter Flexible plastic and electrical components, 1.9 m, 19 mm inner diameter The 22 mm conical air outlet complies with ISO 5356-1

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Electromagnetic compatibility

Aircraft use

IEC 60601-1 classification

Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial, and light industry environments. It is recommended that mobile communication devices are kept at least 1 m away from the device. Information regarding the electromagnetic emissions and immunity of these ResMed devices can be found on www.resmed.com, on the Products page under Service and Support. Click on the PDF file for your language. Medical-Portable Electronic Devices (M-PED) that meet the Federal Aviation Administration (FAA) requirements of RTCA/DO-160 can be used during all phases of air travel without further testing or approval by the airline operator. ResMed confirms that the S9 meets RTCA/DO-160 requirements. Class II (double insulation), Type BF

Notes: • The manufacturer reserves the right to change these specifications without notice. • The temperature and relative humidity settings displayed for ClimateLine or ClimateLineMAX are not measured values. • Check with your clinician/service provider before using the SlimLine air tubing with devices other than the S9.

Pneumatic flow path S9 AutoSet/ S9 Elite

H5i

Blower Mask Inlet filter Tube

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Symbols which appear on these devices The following symbols may appear on your S9, power supply unit, air tubing or packaging. Caution;

Read instructions before use; IP21 Protection against insertion of fingers and

against vertically dripping water; IP20 Not drip proof; equipment;

Start/Stop;

European RoHS; current; control logo 1;

Manufacturer; Batch Code;

Lock/unlock;

Type BF equipment;

Class II

European Authorised Representative; Catalogue number;

Remove tub to fill;

Serial number; Keep Dry;

Direct

China pollution

China pollution control logo 2;

Environmental information WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic equipment. These devices should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region. The use of these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment. If you need information on these disposal systems, please contact your local waste administration. The crossed-bin symbol invites you to use these disposal systems. If you require information on collection and disposal of your ResMed device please contact your ResMed office, local distributor or go to www.resmed.com/environment.

Servicing The S9 device is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed. ResMed recommends that the S9 be inspected and serviced by an authorised ResMed Service Centre if there is any sign of wear or concern with device function. Otherwise, service and inspection of the devices generally should not be required during the five year design life of the device.

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Limited warranty ResMed Ltd (hereafter ’ResMed’) warrants that your ResMed product shall be free from defects in material and workmanship from the date of purchase for the period specified below. Product

Warranty period

• Mask systems (including mask frame, cushion, headgear and tubing) – excluding single-use devices • Accessories – excluding single-use devices • Flex-type finger pulse sensors • Humidifier water tubs • Batteries for use in ResMed internal and external battery systems • Clip-type finger pulse sensors • CPAP and bilevel device data modules • Oximeters and CPAP and bilevel device oximeter adapters • Humidifiers and humidifier cleanable water tubs • Titration control devices • CPAP, bilevel and ventilation devices (including external power supply units) • Battery accessories • Portable diagnostic/screening devices

90 days

6 months 1 year

2 years

This warranty is only available to the initial consumer. It is not transferable. 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 organisation that has not been expressly authorised by ResMed to perform such repairs; c) any damage or contamination due to cigarette, pipe, cigar or other smoke; and d) any damage caused by water being spilled on or into an electronic device. Warranty is void on product sold, or resold, outside the region of original purchase. Warranty claims on defective product must be made by the initial consumer at the point of purchase. This warranty replaces all other expressed 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 resulted from the sale, installation or use of any ResMed product. Some regions or states do not allow the

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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.

WARNINGS • • • •

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Read the entire manual before using the device. Use the device only as directed by your physician or healthcare provider. Use the device only for the intended use as described in this manual. Advice contained in this manual should not supersede instructions given by the prescribing physician. If you notice any unexplained changes in the performance of the device, if it is making unusual or harsh sounds, if the device or the power supply are dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, discontinue use and contact your ResMed Service Center. Beware of electrocution. Do not immerse the device, humidifier, power supply or power cord in water. In the event of a spill, disconnect the device from the power supply and let the parts dry. Always unplug the device before cleaning and make sure that all parts are dry before plugging in the device. Explosion hazard-do not use in the vicinity of flammable anesthetics. Make sure the power cord and plug are in good condition and the equipment is not damaged. Keep the power cord away from hot surfaces. The device should only be used with masks (and connectors1) recommended by ResMed, or by a physician or respiratory therapist. A mask should not be used unless the device is turned on. Once the mask is fitted, ensure that the device is blowing air. The vent hole or holes associated with the mask should never be blocked Explanation: The device 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 or bilevel devices.

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

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• • • • • • • • •

Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. Always ensure that the device is turned on and airflow generated before the oxygen supply is turned on. Always turn the oxygen supply off before the device is turned off, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire. 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. Do not use electrically conductive or antistatic air tubings. Do not use the air tubing if there are any visible signs of damage. Only ResMed air tubing and accessories should be used with the device. A different type of air tubing or accessory may alter the pressure you actually receive, reducing the effectiveness of the treatment. Only use the ResMed 90W or 30W power supply unit. Use the 90W power supply unit to power the system comprising the device, H5i, air tubing, DC/DC converter and battery pack. The 30W power supply unit is designed to power the device only and recommended for traveling. Only ResMed products are designed to be connected to the module connector port. Connecting other devices could damage the device. Blocking the air tubing and/or air inlet of the device while in operation could lead to overheating of the device.

CAUTIONS • • • • • •

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Do not open the device enclosure. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorised ResMed service agent. Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturising or antibacterial soaps or scented oils to clean the device, humidifier or air tubing. These solutions may cause damage and reduce the life of these products. Incorrect system setup may result in incorrect mask pressure reading. Ensure the system is correctly set up. Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord. Make sure the area around the device is dry and clean and clear of bedding, clothes or other objects that could block the air inlet or cover the power supply unit. Ensure that the device is protected against water if used outdoors. Enclose the device in the S9 travel bag for transport.

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S9™ Series AutoSet™ & Elite™ POSITIVE AIRWAY PRESSURE DEVICEs

User Guide English • Deutsch • Français • Italiano • Español • Português • Nederlands • Ελληνικά • Polski • Magyar • Pусский • Türkçe • Česky • Slovensky 5

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Manufacturer: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributed by: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA. ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK. See www.resmed.com for other ResMed locations worldwide.

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For patent information, see www.resmed.com/ip. S9, S9 AutoSet, S9 Elite, ClimateLine, SlimLine and SmartStart are trademarks of ResMed Ltd. S9, AutoSet, ClimateLine, SlimLine and SmartStart are registered in U.S. Patient and Trademark Office. © 2012 ResMed Ltd. 368873/1 2012-10

Global leaders in sleep and respiratory medicine

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www.resmed.com