ResMed S9 AutoSet Technical manual

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S9 AutoSet™& S9 Elite™
POSITIVE AIRWAY PRESSURE DEVICES
Information Guide
English
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 pre-
existing 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.
English

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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. Ensure the power cable is connected and the power
outlet (if available) is on.
The DC plug is partially inserted into the
back of the device.
Fully insert the DC plug.
Insufficient air delivered from the device
Ramp time is in use. Wait for air pressure to build up or change ramp time.
Air filter is dirty. Replace air filter.
Note: Replace the air filter every six months (or more
often if necessary).
Air tubing is not connected properly. Check air tubing.
Air tubing is blocked, pinched or
punctured.
Unblock or free the air tubing. Check the air tubing for
punctures.
Mask and headgear are not positioned
correctly.
Adjust position of mask and headgear.
Incorrect air tubing selected. 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.
Take a deep breath in and out through the mask.
There is excessive leak. Adjust position of mask and headgear.
Air tubing not connected properly. Connect firmly at both
ends.
SmartStart/Stop is disabled. Enable SmartStart/Stop.
Device does not stop when you remove your mask
SmartStart/Stop is disabled. Enable SmartStart/Stop.

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SmartStart/Stop is enabled but the device does not stop automatically when you remove your
mask
Incompatible mask system being used. Only use equipment recommended by ResMed.
The patient is using a nasal pillows mask
with a set pressure less than 7 cm H2O.
Disable SmartStart/Stop.
Pressure rises inappropriately
Talking, coughing or breathing in an
unusual manner.
Avoid talking with a nasal mask on, and breathe as
normally as possible.
Mask cushion is buzzing against the skin. Adjust the headgear.
Displays error message: High temperature fault, refer to user manual
Device has been left in a hot
environment.
Allow to cool before re-use. Disconnect the power cord
and then reconnect it to restart the device.
Air filter is blocked. Replace your air filter. Disconnect the power cord and
then reconnect it to restart the device.
Air tubing is blocked. Check your air tubing and remove any blockages.
Disconnect the power cord and then reconnect it to
restart the device.
Humidifier setting is too high, resulting in
accumulation of water in the air tubing.
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.
Fully insert the DC plug.
A non-ResMed power supply unit is
connected to the device.
Remove the power supply unit and replace with a
ResMed power supply unit.
The power supply unit is being covered
by bedding.
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.
Problem/Possible cause Solution

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Technical specifications
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.
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.
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, 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
Problem/Possible cause Solution

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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 (30VA)
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 Acrylic and polypropylene fibres in a polypropylene carrier
Standard air filter Polyester non-woven fibre
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 5356-1:2004

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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
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 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
S9 AutoSet/S9 Elite H5i
Blower
Mask
Tube
Inlet filter

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Symbols
The following symbols may appear on your S9, power supply unit, air tubing or packaging.
Caution; Read instructions before use; Protection against insertion of fingers and
against vertically dripping water; Not drip proof; Type BF equipment; Class II
equipment; Start/Stop; Manufacturer; European Authorised Representative;
Keep Dry; European RoHS; Batch code; Catalogue number; 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 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.
IP21
IP20

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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.
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.
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
90 days
•Batteries for use in ResMed internal and external battery systems 6 months
•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
1 year
•CPAP, bilevel and ventilation devices (including external power supply
units)
•Battery accessories
•Portable diagnostic/screening devices
2 years

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

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•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.
•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.

Global leaders in sleep and respiratory medicine www.resmed.com
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.
© 2017ResMed. 368892/22017-09