ResMed S9 Series 36015 AutoSet and Elite Positive Airway Pressure Devices User Guide

ResMed S9 Series 36015 AutoSet and Elite Positive Airway Pressure Device

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.

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 until the parameter you require is displayed in blue.
2. Press . The selection is highlighted in orange.
3. Turn until you see the setting that you require.
4. Press 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.

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.

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 pressure 30 cm H2O

• 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

• 90W power supply unit Input range 100–240V, 50–60Hz, Nominal for aircraft use 115V, 400Hz Typical power consumption 70W (80VA) Maximum power consumption 110W (120VA)

• 30W power supply unit Input range 100–240V, 50–60Hz, Nominal for aircraft use 115V, 400Hz Typical power consumption 20W (40VA) Maximum power consumption 36W (75VA)

• Operating temperature +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.

• Operating humidity 10–95% non-condensing

• Operating altitude Sea level to 2,591 m

• Storage and transport temperature -20ºC to +60ºC

• Storage and transport humidity 10–95% non-condensing

• Housing construction Flame retardant engineering thermoplastic

• Supplemental oxygen Recommended maximum supplemental oxygen flow: 4 L/min

• Hypoallergenic air filter Non-woven acrylic and polypropylene fibers with polypropylene carrier

• Standard air filter Polyester fiber

• SlimLine™ air tubing Flexible plastic, 1.8 m, 15 mm inner diameter

• Standard air tubing Flexible plastic, 2 m, 19 mm inner diameter

• ClimateLine™ heated air tubing Flexible plastic and electrical components, 2 m, 15 mm inner diameter

• ClimateLineMAX™ heated air tubing Flexible plastic and electrical components, 1.9 m, 19 mm inner diameter

• Air outlet The 22 mm conical air outlet complies with ISO 5356-1

• Electromagnetic compatibility 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.

• Aircraft use 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.

• IEC 60601-1 classification 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

Symbols which appear on these devices

The following symbols may appear on your S9, power supply unit, air tubing or packaging.

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.

Limited warranty

ResMed Pty 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.

• 90 Days Warranty
  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

• 6 months
  Batteries for use in ResMed internal and external battery systems 6 months

• 1 year
  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

• 2 years
  CPAP, bilevel and ventilation devices (including external power supply units)
  Battery accessories
  Portable diagnostic/screening devices

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 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

• 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.

• 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

• 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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