ResMed VPAP ST Bedienungsanleitung

Manufacturer: ResMed 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 Jubilee Ave Milton Park Abingdon Oxfordshire OX14 4RW UK. See www.resmed.com for other ResMed locations worldwide.

For patent information, see www.resmed.com/ip. S9, VPAP, AutoSet CS and H5i are trademarks of ResMed Ltd and S9 and VPAP are registered in U.S. Patent and Trademark Ofﬁce.

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

VPAP™ST

VPAP™S

AutoSet CS™

S9™Auto 25

POSITIVE AIRWAY PRESSURE DEVICES

User Guide

English

12 4

English

S9 VPAP ST indications for use

The S9 VPAP ST is intended to provide non-invasive ventilation for patients weighing more than 13 kg

with respiratory insufficiency or obstructive sleep apnoea (OSA). The S9 VPAP ST is intended for home

and hospital use.

S9 VPAP S indications for use

The S9 VPAP S is intended to provide non-invasive ventilation for patients weighing more than 13 kg

with respiratory insufficiency or obstructive sleep apnoea (OSA). The S9 VPAP S is intended for home

and hospital use.

S9 AutoSet CS 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.

S9 Auto 25 indications for use

The S9 Auto 25 is indicated for the treatment of obstructive sleep apnoea (OSA) in patients weighing

more than 30 kg. The S9 Auto 25 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 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.

English

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.

Setup

Refer to illustration A.

1. Connect the DC plug of the power supply unit to the rear of the device.

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 device 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.

English

Navigating the menus

Refer to illustration C.

In general, to navigate the menus:

1. Tu r n 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 .

Notes:

•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.

•If power is interrupted during treatment, the device automatically restarts therapy when power is

restored.

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 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 device 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.

English

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 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 or inserted too

slowly.

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.

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.

English

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.

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 or pediatric 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.

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.

Problem/Possible cause Solution

English

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.

Problem/Possible cause Solution

English

SD card

An SD card has been supplied to gather therapy data from your device and provide settings updates

from your clinician. When instructed to do so, disconnect the 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

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

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 (CPAP); 4 to 25 cm H2O (VAuto, ASV);

2 to 25 cm H2O (S, ST)

Maximum single fault steady state

pressure

30 cmH2O – if pressure exceeded for > 6 secs;

40 cmH2O – 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

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

Problem/Possible cause Solution

English

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)

90W DC/DC converter Nominal inputs 12V, 24V

Typical power consumption 70W

Maximum power consumption 110W

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 (VAuto or ASV mode); 15 L/min (S, ST or T mode)

Hypoallergenic air filter Non-woven acrylic and polypropylene fibers with

polypropylene carrier

Standard air filter Polyester fiber

SlimLineTM air tubing Flexible plastic, 1.8 m, 15 mm inner diameter

Standard air tubing Flexible plastic, 2 m, 19 mm inner diameter

English

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 or ClimateLine air tubing with

devices other than the S9 or H5i.

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

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