ResMed AutoSet S9 Series Bedienungsanleitung

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

Trademark Ofﬁce.

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

User Guide

English

S9™Series

AutoSet™& Elite™

POSITIVE AIRWAY PRESSURE DEVICES

12 4

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.

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.

English

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.

English

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.

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.

English

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.

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.

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

7cmH

2O.

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.

Problem/Possible cause Solution

English

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.

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.

Problem/Possible cause Solution

English

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

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

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

Problem/Possible cause Solution

English

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

English

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 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

S9 AutoSet/ S9 Elite H5i

Blower

Mask

Tube

Inlet filter

English

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; 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;

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.

IP21

IP20

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