ResMed S9 AutoSet Positive Airway Pressure Devices User Guide

S9 AutoSet Positive Airway Pressure Devices
User Guide

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.

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.

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.
Insufficient air delivered from the device
Ramp time is in use.
The 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 the air filter.
Note: Replace the air filter every six months (or more often if necessary).
Check air tubing.
Unblock or free the air tubing. Check the air tubing for punctures.
Adjust the position of the 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.
The device does not start when you breathe into the mask
The breath is not deep enough to trigger SmartStart/Stop.
There is an excessive leak.
SmartStart/Stop is disabled.| Take a deep breath in and out through the mask.
Adjust the position of the mask and headgear.
Air tubing is not connected properly. Connect firmly at both ends.
Enable SmartStart/Stop.
The 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
An incompatible mask system is being used. The patient is using a nasal pillow mask with a set pressure of 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.| Avoid talking with a nasal mask on, and breath as normally as possible.
Adjust the headgear.
Displays error message: High-temperature fault, refer to the user manual
The device has been left in a hot environment.
The air filter is blocked.
Air tubing is blocked.
The humidifier setting is too high, resulting in an accumulation of water in the air tubing.| Allow cooling 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 it 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 an excessive leak.| Adjust the position of the 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 the SD card  and contact the service, provider
SD card is not inserted correctly.
You may have removed the SD card before settings were copied to the  CPAP device.| Ensure that the SD card is inserted correctly.
Reinsert the SD card and wait for the home screen or the Settings to update 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.

Technical specifications

Pressure measurement tolerance
Flow measurement tolerance| ±0.5 cm H2O  ± 4% of the measured reading
±6 L/min or 10% of reading, whichever is greater, at 0 to
150 L/min positive flow
DECLARED DUAL -NUMBER NOISE EMISSION VALUES in accordance with ISO 4871:1996
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 1 15V, 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 1 15V, 400Hz
Typical power consumption 20W (30VA)
Maximum power consumption 36W (75VA)
Operating temperature|  to +35ºC
Note: The airflow 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| Acrylic and polypropylene fibers in a polypropylene carrier
Standard air filter| Polyester non-woven 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
ClimateLine
MAX™
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 5356-1:2004
Electromagnetic compatibility| The 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| ResMed confirms that the S9 AutoSet/Elite meets the Federal Aviation  Administration (FAA) requirements (RTCA/ DO-160,  section 21, category M) for all phases of air travel.
This applies to frequencies up to 400Hz nominal.
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 ClimateLine MAX have 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

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; Not drip-proof; IP20 Type BF  equipment; Class II equipment; Start/Stop; Manufacturer; European Authorised Representative; Keep Dry; European RoHS; LOT Batch code; REF Catalog number; NS Serial number; Direct current; Lock/unlock; Remove tub to fill; China pollution control logo 1; 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 the appropriate collection, reuse, and recycling systems available in your region. The use of this collection, reuse, and recycling system 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 the 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 authorized 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
ResMedPtyLtd(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……………………….90 days
• Accessories—excluding single-use devices
• Flex-type finger pulse sensors
• Humidifier water tubs
• Batteries for use in ResMed internal and external battery systems……………………………………………………………………………..6 months
• Clip-type finger pulse sensors…………………………………………………………………………………………………………………………………….. 1 year
• CPAP and bilevel device data modules
• Oximeters and CPAP and bilevel device oximeter adapters
• Humidifiers and humidifier cleanable water tubs
• Titration control devices
• CPAP, bi-level, and ventilation devices (including external power supply units)……………………………………………………………2 years
• 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 organization that has not been expressly authorized 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 products sold, or resold, outside the region of original purchase.
Warranty claims on defective products 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. The 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 is 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 connectors 1 ) 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 a 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 is 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 creates 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 is 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 authorized ResMed service agent.
• Do not use bleach, chlorine, alcohol, aromatic-based solutions, moisturizing 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.
• The airflow for breathing produced by the device can be as much as 6ºC higher than the temperature of the room. Caution should be exercised if the room temperature is warmer than 35ºC.
• Ensure that the device is protected against water if used outdoors. Enclose the device in the S9 travel bag for transport.

Manufacturer: ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.

See www.resmed.com for other ResMed locations worldwide.

For patent information, see www.resmed.com/ip.

S9, S9 AutoSet, S9 Elite, H5i, SlimLine, ClimateLine and SmartStart are trademarks of ResMed. S9, AutoSet, Slimline, ClimateLine and SmartStart are registered in U.S. Patient and Trademark Office.

© 2017 ResMed. 368892/2 2017-09

Global leaders in sleep and respiratory medicine
www.resmed.com

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Environmental policy - ResMed
• Legal disclaimers and intellectual property - ResMed

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