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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:
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:
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.
Refer to illustration A.
Refer to illustration B.
The control panel of your S9 devices includes the following items:
*The Info and Setup menus are disabled if S9 Essentials has been enabled by your clinician.
In general, to navigate the menus:
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.
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:
Weekly:
Monthly:
Replace the air filter every six months (or more often if necessary).
Notes:
Problem/Possible cause | Solution |
No display
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Insufficient air delivered from the device
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Device does not start when you breathe into the mask
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Device does not stop when you remove your mask
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SmartStart/Stop is enabled but the device does not stop automatically when you remove your mask
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Pressure rises inappropriately
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Displays error message: High temperature fault, refer to user manual
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Displays error message: Check ResMed 30/90W Power Supply Unit and fully insert the connector
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Displays error message: Tube blocked, please check your tube
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Displays error message: High leak, please check system setup and all connections
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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
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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
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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.
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:
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;
Type BF equipment;
Class II equipment;
Start/Stop;
Manufacturer;
European Authorised Representative;
European RoHS;
Batch Code;
Catalogue number;
Serial number;
Direct current;
Lock/unlock;
Remove tub to fill;
Keep Dry;
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 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.
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.
Product | Warranty period |
| 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 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.
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.
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.
Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.
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