ResMed S9 Series AutoSet CS Positive Airway Pressure Device User Guide

AutoSet CS ™
POSITIVE AIRWAY PRESSURE DEVICE
Information Guide

Please read the entire Information and Welcome Guides before using your device.

Indications for use

The S9 AutoSet CS is indicated to stabilise the ventilation of adult patients exhibiting central sleep apnoea (CSA), mixed sleep apnoea and periodic breathing, with or without obstructive sleep apnoea. It is intended for home and hospital use.

Contraindications

ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnoea.
Positive airway pressure therapy may be contraindicated in some patients with the following preexisting conditions:

• severe bullous lung disease
• pneumothorax or pneumomediastinum
• pathologically low blood pressure, particularly if associated with intravascular volume depletion
• 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  emporary discontinuation of treatment.
The following side effects may arise during the course of therapy with the device:

• 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 the device enclosure.

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 or inserted too slowly.| Fully insert the DC plug.
Insufficient air delivered from the AutoSet CS device
Ramp time is in use.| Wait for air pressure to build up or change ramp time.
Air filter is dirty.| Replace air filter.
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, Standard or 3m 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.
Problem/Possible cause| Solution
---|---
There is excessive leak.
Note: If Leak Alert is enabled, an audible alert is activated and a high leak message is displayed.| Adjust position of mask and headgear.
Air tubing not connected properly. Connect firmly at both ends.
SmartStart/Stop is disabled.
Note: SmartStart/Stop is not available if Leak Alert is enabled.| Enable SmartStart/Stop.
Device does not stop when you remove your mask

SmartStart/Stop is disabled.
Note: SmartStart/Stop is not available if Leak Alert is enabled.| Enable SmartStart/Stop.
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 inan 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.
Cushion seated incorrectly causing excessive leak.| Adjust headgear or re-fit cushion.
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. Disconnect the power cord and then reconnect it to restart the device.
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 SDcard before settings were copied to the 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 redisplayed.
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.

General technical specifications

Power supply| 90W power supply unit
Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use
Typical power consumption: 70W (80VA)
Maximum power consumption: 110W (120VA)
30W power supply unit
Input range: 100–240V, 50–60Hz, 115V, 400Hz nominal for aircraft use
Typical power consumption: 20W (40VA)
Maximum power consumption: 36W (75VA)
90W DC/DC converter
Nominal inputs: 12V, 24V
Typical power consumption: 70W
Maximum power consumption: 110W
---|---
Environmental conditions| Operating temperature: +5°C to +35°C
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 to 95% non-condensing
Operating altitude: Sea level to 2,591m
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: 10 to 95% non-condensing
Aircraft use| ResMed confirms that the device/s meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air travel.
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 this ResMed device can be found on  www.resmed.com, on the Products page under Service and Support. Click on the PDF file for your language.
IEC 60601-1 classification| Class II (double insulation), Type BF

AutoSet CS technical specifications

Pressure and flowstate| Operating pressure range (measured at the mask): 4–20 cm H2O (CPAP); 4–25 cm H2O (ASV)
Maximum single fault steady state pressure: 30 cm H2O – if pressure exceeded for > 6 sec; 40 cm H2O – if pressure exceeded for >1 sec
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
---|---
Mode reading| CPAP mode
Set Pressure: 4 to 20 cm H2O
ASV mode
EPAP: 4 to 15 cm H2O; Max PS: 8 to 16 cm H2O; Min PS: 3 to 6 cm H2O
Physical| Nominal dimensions (L x W x H): 153 mm x 140 mm x 86 mm
Weight: 835 g
Housing construction: Flame retardant engineering thermoplastic
Air outlet: 22 mm conical air outlet (complies with ISO 5356-1:2004)
Air filter| Hypoallergenic air filter: Acrylic and polypropylene fibers in a polypropylene carrier
Standard air filter: Polyester non-woven fiber
Sound
DECLARED DUAL NUMBER
NOISE EMISSION VALUES in
accordance with ISO 4871:1996| Pressure level (CPAP mode)
With SlimLine air tubing: 26 dBA with uncertainty of 2 dBA as measured according to EN ISO 17510-1:2009
With Standard air tubing: 27 dBA with uncertainty of 2 dBA as measured according to EN ISO 17510-1:2009
With either SlimLine or Standard air tubing and H5i: 28 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
Power level (CPAP mode)
With SlimLine air tubing: 34 dBA with uncertainty of 2 dBA as measured according to EN ISO 17510-1:2009
With Standard air tubing: 35 dBA with uncertainty of 2 dBA as measured according to EN ISO 17510-1:2009
With either SlimLine or Standard air tubing and H5i: 36 dBA with uncertainty of 2 dBA as measured according
to EN ISO 17510-1:2009
Supplemental oxygen| Recommended maximum supplemental oxygen flow: 15 L/min

Air tubing technical specifications

Heated air tubing temperature cut-out: ≤ 41°C

Notes:

• The manufacturer reserves the right to change these specifications without notice.
• The temperature and relative humidity settings displayed for Climate Control are not measured values.
• Check with your clinician/service provider before using the SlimLine air tubing with devices other than the S9 or H5i.
• The electrical connector end of the heated air tubing is only compatible with the H5i air outlet and should not be fitted to the device or mask.
• When using the SlimLine or ClimateLine above 20 cm H2O, the device optimum performance may not be reached if used with an antibacterial filter. The device performance must be checked prior to prescribing the SlimLine for use with an antibacterial filter.

Humidifier performance
The following settings have been tested at 22°C ambient temperature:

a. AH – Absolute Humidity in mg/L.
b. BTPS – Body Temperature Pressure Saturated.

1. Inlet filter
2. Blower
3. Air tubing
4. Mask

Flow (maximum) at set pressures

The following are measured at the end of the specified air tubing:

Pressure, cm H2O| AutoSet CS and Standard air tubing, L/min| AutoSet CS, Hsi
and Standard air
tubing, L/min| AutoSet CS and SlimLine air tubing, L/min| AutoSet CS, Hsi and
ClimateLine heated air tubing, L/min
---|---|---|---|---
4| 200| 170| 195| 170
8| 200| 170| 190| 170
12| 200| 170| 184| 170
16| 200| 170| 175| 170
20| 190| 170| 168| 161
25| 180| 161| 144| 125

Displayed values

b

| 1 L/min
Tidal volume| 0-4000 mL| ±10%| 1 mL
Respiratory rate| 0-50 BPM| ±1 BPMc| 1 BPM
Minute ventilation| 0-30 Umin| ±10%| 0.1 L/min
Ti Avg| 0-4.0 sec| ±10%| 0.2 sec

1. Results may be inaccurate in the presence of leaks or supplemental oxygen.
2. The displayed values are estimates. They are provided for trending purposes
3. Results may be inaccurate if the tidal volume is below 50 mL.

Maximum static pressure variation at a cm H2O according to EN ISO 17510-1:2009

Without H5i| Standard air tubing| SlimLine air tubing
9.89 cm H2O to 9.97 cm H2O| 9.76 cm H2O to 9.87 cm H2O
With Hsi| 9.82 cm H2O to 9.98 cm H2O| 9.78 cm H2O to 9.88 cm H2O
Maximum dynamic pressure variation according to EN ISO 17510-1:2009

Pressure (cm H20)

|

10 BPM

|

15 BPM

|

20 BPM

AutoSet CS and Standard air tubing without H5i / AutoSet CS and Standard air tubing with H5i

4

| 0.18 / 0.18| 0.30 / 0.30| 0.51 /0.51

8

| 0.21 / 0.20| 0.26 / 0.24| 0.38 / 0.36

12

| 0.21 /0.20| 0.26 / 0.23| 0.34 / 0.31

16

| 0.22 / 0.21| 0.27 / 0.26| 0.36 / 0.33

20

| 0.23 / 0.22| 0.26 / 0.28| 0.38 / 0.35

25

| 0.30 / 0.31| 0.54 / 0.50| 0.74 / 0.71

Pressure (cm H20)

| 10 BPM| is BPM| 20 BPM
AutoSet CS and SlimLine air tubing without H5i / AutoSet CS and SlimLine air tubing with H5i

4

| 0.22 / 0.20| 0.28 / 0.29| 0.47 / 0.53

8

| 0.23 / 0.19| 0.32 / 0.29| 0.41 /0.42

12

| 0.22 / 0.21| 0.35 / 0.29| 0.41 /0.45

16

| 0.22 / 0.23| 0.41 / 0.33| 0.44 / 0.50

20

| 0.24 / 0.27| 0.37 / 0.34| 0.48 / 0.50

25

| 031/031| 050/054| 0.78/0.84

Symbols

The following symbols may appear on your product 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 RoHS; Batch code; Catalogue number; ****Serial number; Direct current;    Lock/unlock; China pollution control logo 1; China pollution control logo 2; ; European Authorised Representative; Keep Dry;

Environmental information

WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic equipment. This device 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 AutoSet CS device is intended to provide safe and reliable operation when operated in accordance with the instructions provided by ResMed. ResMed recommends that the AutoSet CS device 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.

• 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

| 90 days
Product| Warranty period
---|---

• 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

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

• 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.

Manufacturer: ResMed Pty 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.
For patent information, see www.resmed.com/ip.
S9, H5i, ClimateLine, SlimLine, SmartStart and AutoSet CS are trademarks of ResMed Pty Ltd and S9, ClimateLine, SlimLine and SmartStart are registered in U.S. Patent and Trademark Office.
© 2015 ResMed. 3681041/1 2015-08

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

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