ResMed S9 AutoSet CS-A Technisches Handbuch

AutoSet™CS-A

ADAPTIVE SERVO-VENTILATOR

Information Guide

English

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

Indications for use

The S9 AutoSet CS-A 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 with reduced

left ventricular ejection fraction (LVEF ≤ 45%).

Positive airway pressure therapy may be contraindicated in some patients with the following pre-

existing 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 temporary

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

English 1

•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.

Problem/Possible cause Solution

No display

Power is not connected. Ensure the power cord 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 3 m air tubing ensure

that you have the correct air tubing selected via the menu.

Non-vented mask is used. Only use a vented mask.

Mask vents might be blocked. Check if you have sufficient venting. Unblock mask vents if

necessary.

EPAP may be set too low. Talk to your clinician about your settings.

Problem/Possible cause Solution

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.

SmartStart/Stop is disabled

because the High Leak or Low

Minute Ventilation alarm is

enabled.

Press Start/Stop to start therapy.

SmartStart/Stop is disabled. Talk to your clinician about enabling the SmartStart/Stop feature.

There is excessive leak. Adjust position of mask and headgear.

Connect the air tubing firmly at both ends.

Device does not stop when you remove your mask

SmartStart/Stop is disabled

because the High Leak or Low

Minute Ventilation alarm is

enabled.

Press Start/Stop to stop therapy.

SmartStart/Stop is disabled

because Confirm Stop is

enabled.

A message appears on the screen. To stop therapy, select Yes and

press the Push Dial.

SmartStart/Stop is disabled. Talk to your clinician about enabling the SmartStart/Stop feature.

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.

Incorrect mask setting being

used.

Check the selected mask type in the Setup menu. Change it if

necessary.

The patient is using a nasal

pillows mask with a set

pressure less than 6 cm H2O.

Disable SmartStart/Stop.

English 3

Problem/Possible cause Solution

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 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.

Humidity level setting is too

high, resulting in accumulation

of water in the air tubing.

Turn the humidity level setting down and empty the water from

the air tubing.

Displays 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.

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

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.

Alarms

If the system has not been properly assembled, the device will trigger an alarm. Check that the air

tubing has been properly attached to the device and mask (and humidifier if used).

Problem/Possible cause Solution

Alarm is activated and the LCD screen display disappears

Power failure.

Power cord is disconnected or

mains power switch is turned

off during therapy.

Remove your mask until power is restored.

Ensure the power cord is connected and the mains power switch

(if available) is on.

Displays message: High leak, please check system setup and all connections

There is excessive leak. Adjust position of mask and headgear.

Connect the air tubing firmly at both ends.

English 5

Problem/Possible cause Solution

Displays message: No tube, please check your tube is connected

Flow is high because air tubing

is not connected properly.

Note: The tube disconnection

check may not operate when an

antibacterial filter is used.

Connect the air tubing firmly at both ends.

Displays 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 message: No SpO2 data, check oxi sensor attachment to module/finger

Oximeter sensor is not attached

properly.

Ensure that the oximeter sensor is attached properly to the module

and the patient's finger.

Oximeter sensor might be

faulty.

If the message appears repeatedly but the oximeter is attached

properly to the module and the patient's finger, the oximeter

sensor might be faulty.

Contact your service provider or exchange the oximeter.

Displays message: Non-vented mask, use vented mask or unblock mask vents

Non-vented mask is used. Only use a vented mask.

Mask vents might be blocked. Check if you have sufficient venting. Unblock mask vents if

necessary.

A low EPAP in conjunction with

supplemental oxygen may result

in false triggering of this alarm

on a vented mask.

Talk to your clinician about your settings.

Displays message: No oximeter, check/connect oximeter adapter

Oximeter adapter is not

attached properly.

Ensure that the oximeter adapter is attached properly.

Problem/Possible cause Solution

Oximeter adapter might be

faulty.

If the message appears repeatedly but the oximeter adapter is

attached properly, the oximeter adapter might be faulty.

Contact your service provider.

Displays message: Check ResMed 30/90W Power Supply Unit

The power supply unit is being

covered by bedding.

The power supply unit is

overheated.

Make sure that the power supply unit is free from bedding, clothes

or other objects that could cover it.

Let the power supply unit cool down.

The DC plug is partially inserted

into the back of the device or

inserted too slowly.

Fully insert the DC plug.

Displays message: Alarm module fault, please contact service provider

General failure of the device

and/or the alarm module.

Therapy cannot be started again.

Contact your 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

English 7

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 2,591 m; air pressure range 1013 hPa to 738 hPa

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, Ingress protection IP21

AutoSet CS-A technical specifications

Mode pressure

ranges

CPAP mode

Set Pressure: 4–20 cm H2O

ASV and ASVAuto mode

EPAP: 4–15 cm H2O; PS: 0–20 cm H2O

Maximum single

fault pressure

Maximum single fault steady state pressure: 30 cm H

O—if pressure exceeded

for > 6 sec; 40 cm H2O—if pressure exceeded for >1 sec

Physical

Nominal dimensions (L x W x H): 153 mm x 172 mm x 86 mm

Weight: 1.04 kg

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

Alarm volume

settings

Low (nominal 56 dBA), Medium (nominal 68 dBA), High (nominal 80 dBA)

Supplemental

oxygen

Recommended maximum supplemental oxygen flow:

15 L/min (CPAP, ASV modes); 4 L/min (ASVAuto mode)

English 9

Air tubing technical specifications

Air tubing

Material

Length

Inner diameter

ClimateLine heated air tubing

Flexible plastic and electrical

components

2 m

15 mm

ClimateLine

MAX

heated air

tubing

Flexible plastic and electrical

components

1.9 m

19 mm

SlimLine air tubing

Flexible plastic

1.8 m

15 mm

Standard air tubing

Flexible plastic

2 m

19 mm

3 m air tubing

Flexible plastic

3 m

19 mm

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.

•The ClimateLine or ClimateLineMAX is designed only for use with the H5i.

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