ResMed 248551-1, 2011-09 User Manual

Download

Stellar™ 100 Stellar

InvasIve and nonInvasIve

ventIlator

User Guide

English

™

150

Respiratory Care Solutions

Making quality of care easy

Respiratory Care Solutions

Making quality of care easy

Stellar™ 100 Stellar™ 150

User Guide

English

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Indications for use 1 Contraindications 1 Adverse effects 1

Stellar at a glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Patient interface 3 Humidification 3 Internal battery 3 ResMed USB stick 3 Use on an aircraft 3 Mobile use 4

Setting up for noninvasive use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Attaching the H4i heated humidifier for noninvasive use 5

Setting up for invasive use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Working with other optional accessories . . . . . . . . . . . . . . . . . . . . . . . 7

Attaching the pulse oximeter 7 Adding supplemental oxygen 7 Starting therapy using oxygen 8 Stopping therapy using oxygen 8 Using the FiO2 monitoring sensor 8 Attaching an antibacterial filter 9

Stellar basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

About the control panel 10 LCD screen 11

Starting therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Performing a functional test 11 Starting therapy 12 Stopping therapy 12 Turning off the power 13 Working with alarms 13 Tailoring treatment setup options 14 Using mask-fit 14

Using the menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Setup menu: Clinical Settings (Mask Type) 16 Setup menu: Alarm Settings (Alarm Volume) 16 Setup menu: Options 16 Setup menu: Configuration Menu 17

Info menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Event Summary 18 Used Hours 18 Device Information 18 Reminders 18

Data management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Daily 19 Weekly 20 Monthly 20 Replacing the air filter 20 Disinfection 20 Multipatient use 21 Servicing 21

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Alarm troubleshooting 21 Other troubleshooting 24

Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Guidance and manufacturer’s declaration – electromagnetic emissions and immunity 28 Symbols 30

General warnings and cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Introduction

Read the entire manual before using the device. This User Guide is for a non-clinician user, and does not contain all the information provided in the Clinical Guide.

Indications for use

The Stellar is intended to provide ventilation for non-dependent, spontaneously breathing adult and paediatric patients (13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnoea. The device is for noninvasive use, or invasive use with an uncuffed or deflated tracheostomy.

Users of the device include patients therapists and other clinical staff. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

Contraindications

The Stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. The Stellar is not a life support ventilator.

If you have any of the following conditions, tell your docto

• pneumothorax or pneumomediastinum

• pathologically low blood pressure, particularly if associated wi

depletion

• cerebrospinal fluid leak, recent

• severe bullous lung disease

• dehydration.

The use of the Stellar or pulse environment.

Adverse effects

You should report unusual chest pain, severe headache or increased breathlessness to your prescribing physician.

The following side effects may arise during the cou device:

• drying of the nose, mouth or throat

• nosebleed

• bloating

• ear or sinus discomfort

• eye irritation

• skin rashes.

and their caregivers, physicians, nurses, respiratory

r before using this device:

th intravascular volume

cranial surgery or trauma

oximetry (in

cluding XPOD) is contraindicated in an MRI

se of noninvasive ventilation with the

English

1Introduction

Stellar at a glance

Handle

H4i connector

plug and AC

connection

Infrared connection

for humidifier

XPOD pulse oximeter connection

Air outlet

FiO2 sensor connection

Data port for USB stick

Data port for direct PC connection

Oxygen inlet

Air filter cover

DC power socket

AC power socket

Power-on/standby switch

The Stellar comprises:

• Stellar device • Hypoallergenic air filter • AC power cord • Carry bag • 2 m

air tubing •

ResMed USB stick • Low pressure oxygen connector. The following optional components are compatible with S

• 3 m air tubing • SlimLine™ air tubing • Clear air tubing (disposable) • H4i™ heate

tellar:

d humidifier • Antibacterial filter • Heat moisture exchanger filter (HMEF) • ResMed XPOD oximeter • Nonin™ pulse oximetry sensors • FiO adapter) • FiO

monitoring sensor • Stellar Mobility bag • ResMed leak port • Tubing wrap.

monitoring kit (external cable, T-piece

WARNING

The Stellar should only be used with air tubing and accessories recommended by ResMed. Connection of other air tubing or accessories could result in injury or damage to the device.

ResMed regularly releases new products. Please check the catalogue of ventilation

cessories on our website at www.resmed.com.

Patient interface

Both masks and tracheostomy tubes can be used with Stellar. To set the patient interface type go to the Setup menu, select Clinical Settings, then Advanced Settings.

For information on using masks, see the for this device, see the Mask/Device Compatibility List on www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.

mask manual. For a full list of compatible masks

Humidification

A humidifier is recommended especially for patients experiencing dryness of the nose, throat or mouth. For information on using a humidifier as part of:

• noninvasive ventilation, see “Setting up for noninvasive use” on page 4.

• invasive ventilation, see “Setting up for invasive use” on page 5.

Internal battery

CAUTION

The internal battery must be replaced every two years from the manufacturing date of the Stellar. Replacement of the internal battery should only be performed by an authorised service agent.

Note: The battery duration depends on the state of c the condition and age of battery, the device settings and the patient circuit configuration.

In case of a mains power disruption, the device will operate using the inte there is no external battery connected to the device. The internal battery will operate for approximately two hours under normal conditions (see “Technical specifications” on page 26). The power status of the battery is displayed on top of th battery status regularly while operating device in time to mains power or alternatively to the external battery.

Additionally the Internal battery use alarm to clear the alarm.

To recharge the internal battery, connect the device to main hours to fully recharge the internal battery, however this can vary depending on environmental conditions and if the device is in use.

the device with the internal battery and connect the

will be d

harge, the environmental conditions,

rnal battery if

e LCD screen. Check the

isplayed. Press the Alarm mute button

s power. It can take

up to three

Storing

The internal battery has to be discharged and recharged every six months.

1 Remove the power cord while the Stellar is providing therapy and let the device operate

with the internal battery to a charge level of 50%.

2 Reconnect the power cord to the mains power while the device is operating. The internal

battery will be recharged.

Note: If the level of approximately 50% to increase the durability.

device is stored for a longer period the internal battery should be at the charge

ResMed USB stick

A ResMed USB stick may be used with the device either to help the clinician to monitor your treatment or to provide you with updated device settings. For more information, see “Data management” on page 19.

Use on an aircraft

ResMed confirms that the Stellar can be used during all phases of air travel without further testing or approval by the airline operator. See “Technical specifications” on page 26.

English

3Stellar at a glance

Mobile use

The Stellar Mobility bag allows the Stellar to be used in mobile situations, eg, in a wheelchair. For setup and correct use, see the Stellar Mobility Bag User Guide. For extended mobile use, the ResMed Power Station II external power supply unit can be used as an additional power source. Limitations apply to the use of oxygen with the Stellar Mobility Bag. For more information, contact your local ResMed representative.

Setting up for noninvasive use

WARNING

• The air filter cover protects the device in the event of accidental liquid spillage

onto the device. Ensure that the air filter and air filter cover are fitted at all times.

• Make sure that all the air inlets at the rear of the d

vents at the masks or at the leak port are unobstructed. If you put the device on the floor, make sure the area is free from dust and clear of bedding, clothes or other objects that could block the air inlets.

• Hoses or tubes must be non-conductive and antistatic.

• Do not leave long lengths of the air tubing or the cable for the finger pulse sensor

arou

nd the top of your bed. It could twist around your head or neck while you are

sleeping.

CAUTION

• 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.

Notes:

• ResMed recommends using the AC power cord supplied with the

power cord is required, contact your ResMed Service Centre.

• Place the device on a flat surface near the head

evice and under the device and

unit. If a replacement

of the bed.

AC power cord

AC locking clip

1 Connect the power cord. 2 Plug the free end of the power cord into a power outlet. 3 Attach the H4i heated humidifier to the front of the Stellar.

If the H4i is not in use, and if applicable, conn outlet of the device (see “Attaching an antibacterial filter” on page 9).

ect the antibacterial filter firmly onto the air

4 Connect one end of the air tubing firmly onto the air outlet of the H4i. 5 Connect the mask system to the free end of the air tubing. 6 Select the mask type (select Setup menu, then Clinical Settings, then Advanced Settings). 7 Perform Learn Circuit (see “Setup menu: Options” on page 16).

Attaching the H4i heated humidifier for noninvasive use

Use of the H4i heated humidifier may be recommended by your clinician. For information on using the H4i, see the H4i user guide.

WARNING

• Always place the H4i on a level surface below the level of the patient to prevent

the mask and tubing from filling with water.

• Make sure that the water chamber is empty and thoroughly dried before

sporting the humidifier.

tran

• The H4i heated humidifier is not intended for mobile use.

• Do not overfill the water chamber, as during use this will cause water to spill into

e air circuit.

• For optimal accuracy and synchrony, perform Learn Circuit with a change of the

rcuit configuration, in particular when adding or removing high impedance components (eg, antibacterial filter, external humidifier, water trap, nasal pillow type mask or air tubing). See “Setup menu: Options” on page 16.

CAUTION

Check the air circuit for water condensation. Use a water trap or a tubing wrap if humidification is causing water condensation within the tube.

Notes:

• A humidifier increases resistance in the air

and

accuracy of display and delivered pressures. Therefore perform the Learn Circuit function (see “Setup menu: Options” on page 16). The device adjusts the airflow resistance.

• The heating feature of the H4i is disabled when the de

circuit and may affect triggering and cycling,

vice is not mains powered.

Setting up for invasive use

The Stellar can be used invasively only with the ResMed leak port and an uncuffed or deflated cuff tracheostomy tube.

WARNING

• When using a Heated Moisture Exchange Filter (HMEF), replace the HMEF

regularly as specified in the instructions provided with the HMEF.

• The H4i is contraindicated for invasive use. An external humidifier approved for

invasi

ve use is recommended according to EN ISO 8185 with an absolute

humidity of > 33 mg/L.

• For optimal accuracy and synchrony, perform Learn Circuit with a change of the

CAUTION

When using a humidifier check the breathing system regularly for accumulated water.

Note: W automatically enabled to alert you when the leak port has no vent holes or when the vent holes are blocked.

hen the mask type is set to Tr

a c h , the Non-Vented Mask alarm will be

English

5Setting up for invasive use

Leak Circuit configuration

Antibacterial filter

Catheter mount**

ResMed leak port

HMEF*

External humidifier*

AC power cord

AC locking clip

Air tubing

1 Connect the power cord. 2 Plug the free end of the power cord into a power outlet. 3 Connect the antibacterial filter firmly onto the air outlet of the device. 4

Connect the external humidifier to the other side of the antibacterial filter. *If not using an external humidifier, the HMEF can be connected to the leak port (at step 9).

5 Connect the air tubing to the external humidifier. 6 Connect the leak port to the air tubing. 7 Select the mask type Tr a c h (select Setup menu, then Clinical Settings, then Advanced

Settings).

8 Perform Learn Circuit (see “Setup menu: Options” on page 16). 9 If an external humidifier is not being used, you can connect the HMEF to the leak port if

necessary.

10 Connect the catheter mount.

** The leak port or the HMEF can be including connector pieces like catheter mounts.

The catheter mount and the external humidifier are not part of

connected to standardised tracheostomy interfaces

the ResMed component.

Working with other optional accessories

Attaching the pulse oximeter

Use of a pulse oximeter may be recommended by your clinician.

Contraindication

The pulse oximeter does not meet defibrillation-proof requirement per IEC 60601-1: 1990, clause 17.h.

1 Connect the plug of the finger pulse sensor to the plug of the pulse oximeter. 2 Connect the plug of the pulse oximeter at the rear of the device.

To view the oximetry values, from the Monitoring menu, select Monitoring.

Adding supplemental oxygen

Oxygen may be prescribed by your clinician.

Note: Up to 30 L/min at maximum oxygen pressure of 50 mbar (0.73 psi) can be added.

WARNING

• Oxygen flow must be turned off when the device is not operating, so that unused

oxygen does not accumulate within the device and create a risk of fire.

• Use only certified, clean oxygen sources.

• ResMed strongly recommends adding oxygen into Stellar’s oxygen inlet at the

rear of th a side port or at the mask, has potential to impair triggering and accuracy of therapy/monitoring and alarms (eg, High Leak alarm, Non-vented mask alarm). If used in this way, therapy and alarm operation must be verified each time oxygen flow is adjusted.

• O

presence o

• The breathing system and the oxygen s

distance of 2 m away from any sources of ignition (eg, electrical devices).

•

Oxygen must not be used while the device is being operated within the mobility bag.

e device. Entraining oxygen elsewhere, ie into the breathing system via

xygen supports combustion. Oxygen must not be used while smoking or in the

f an open flame. Only use oxygen supply in well-ventilated rooms.

ource must be kept at a minimum

English

7Working with other optional accessories

Press spring to release connection after use

Starting therapy using oxygen

1 Fit the oxygen connector to the oxygen inlet of the device. 2 Attach the other end of the oxygen supply tubing to the oxygen supply. 3 Press to start treatment. 4 Turn on oxygen.

Stopping therapy using oxygen

1 Turn off oxygen. 2 Press to stop treatment.

Using the FiO2 monitoring sensor

Use of the FiO2 monitoring sensor may be recommended by your clinician.

CAUTION

Do not use the FiO2 monitoring sensor with the H4i humidifier.

Preparing to use a new sensor

1 Before use, leave the FiO 2 Attach a new FiO

3 Perform the sensor calibration (see “Setup menu” on page 16).

Note: The FiO

monitoring sensor must be replaced every 12 months.

monitoring sensor open to the air for 15 minutes.

monitoring sensor (as shown below).

Oxygen supply

Connecting a sensor

1 Connect the air tubing to the T-piece adapter. 2 Connect the FiO

monitoring sensor to the T-piece adapter.

3 Connect the adapter to the air outlet of the device. 4 Connect one end of the cable to the FiO

monitoring sensor.

5 Connect the other end of the cable to the rear of the device. 6 Start calibration (see “Setup menu: Options” on page 16). This should be repeated

periodically at the recommendation of your clinician.

Attaching an antibacterial filter

The use of an antibacterial filter may be recommended by your clinician. One antibacterial filter—product code 24966—can be purchased separately from ResMed.

Regularly check the filter for entry of moistu replaced according to the manufacturer‘s specifications.

Note: ResMed recommends using a filter with a lo 60 L/min, eg, PALL BB 50 filter).

WARNING

Do not use the antibacterial filter (product code 24966) with the H4i.

re or other contaminants. The filter must be

w impedance (less than 2 cm H2O at

English

1 Fit the antibacterial filter to the air outlet of the device. 2 Attach the air tubing to the other side of the filter. 3 Attach the mask system to the free end of the air tubing. 4 Perform the Learn Circuit function (see “Setup menu: Options” on page 16). From the

Setup menu, select Options. This enables introduced by the filters.

the device to compensate for the impedance

9Working with other optional accessories

Stellar basics

About the control panel

Mains Power LED

On when operating on mains power.

External power supply LED

On when external battery is connected.

Internal battery LED

On when internal battery is in use. Flashes when device is turned off and battery is charging.

LCD Screen

Monitoring menu

Setup menu

Alarm LED

Red or yellow during an alarm or during alarm testing.

Alarm mute button LED

On when is pressed.

Start/stop button

Key Function Start/Stop • Starts or stops treatment.

Alarm mute • During therapy: Press once to mute an alarm. Press a

Menu keys Press the appropriate menu button (Monitoring, Setup, Info)

Info menu

(rotate/

arts the

• Extended hold for at least three seco

Push dial

click)

Therapy LED

On during treatment. Flashes during maskfitting operation.

nds st

maskfitting feature.

second time to un-m

ute an alarm. If the problem is still present, the alarm will sound again after two minutes. See “Working with alarms” on page

13.

• In stand-by mode: Extended hold for at least three

seconds st

to enter and

the alarm LED and alarm buzzer test.

arts

scroll through the relevant menu.

Push dial Turning the dial allows you to scroll throug

change settings. Pushing the dial allows you to enter into a menu or confirm your choice.

h the m

enu and

LCD screen

The LCD screen displays the menus, monitoring screens and alarm status.

Warm-up feature H4i

ResMed USB stick

Mains power

External power supply

Internal battery

Title bar

Settings

Therapy status bar

Ramp time Program

Therapy mode

Patient mode or Clinical mode Current screen/number of

screens within the menu

Scroll bar

Starting therapy

Performing a functional test

Make sure your device is functioning properly each time before starting therapy. If any problems occur, see “Troubleshooting” on page 21. Please also check other

provided User Instructions for troubleshooting information.

1 Turn off the device by pressing the power switch at the back of the device. 2 Check condition of device and accessories.

Inspect the device and all the provided accessories. If there are any visible defects, the system should

3 Check the circuit configuration.

Check the integrity of the circuit configuration (dev to the setup descriptions in this User Guide and that all connections are secure.

4 Turn on the device and check alarms.

Press the power switch at the back of the device once to turn on the device. Check that the alarm sounds a test beep and the LEDs (visual indicator) for the alarm

and the Alarm mute button flash. The device is ready for use when the Treatment screen is displayed. If the display shows the Reminder page, follow the instructions, then press

to display the Tr

5 Check batteries.

Disconnect the device from the mains and external powered by the internal battery. Check that the Battery use alarm is displayed and the battery LED is on.

Note: If the charge state of the internal battery is too lo alarm occurs. See the Alarm troubleshooting section on page 21 for further information.

Reconnect the external battery (if in use) and check that the LED for the external power supply is lit. The External DC power use alarm will be displayed and the Alarm LED will light.

Reconnect the device to the mains.

6 Check H4i heated humidifier (if in use).

Check that the warm-up feature is displayed in the Tr feature. Check that the humidifier warm-up symbol is displayed on top of the screen.

not be used.

ice and provided accessories) according

eatment screen.

battery (if in use) so that the device is

w, or if the battery is empty, an

eatment screen. Start the warm-up

English

signal

11Starting therapy

Warm-up humidifier

You can use the warm-up feature to pre-heat the water in the humidifier prior to starting treatment. The humidifier will be detected when the device is turned on. The Treatment screen provides the option to start warming the humidifier. If the humidifier is heating, the related symbol is displayed at the top of the LCD screen.

For more information, see the H4i User Guide.

Note:

The H4i in heating mode can only be used

when the device is connected to mains supply.

automatically

7 Check the FiO

Start the FiO Options” on page 16). Follow the instructions on the display.

monitoring sensor (if in use).

sensor calibration. Select Setup menu, then Options (see “Setup menu:

8 Check pulse oximeter (if in use).

Attach the accessories according to the setup oximeter” on page 7). From the Monitoring menu page g that the values for SpO

and Heart rate are displayed.

descriptions (see “Attaching the pulse

o to the Monitoring screen. Check

9 Check oxygen connection (if in use).

Attach the accessories according to the setup oxygen” on page 7).

descriptions (see “Adding supplemental

Starting therapy

CAUTION

The Clinical mode is only for clinicians. If the device is operating in clinical mode

press the power switch to re-start the device in patient mode

1 Fit your patient interface (mask or catheter mount) as described in the user instructions. 2 Lie down and arrange the air tubing so that it is free to move if you turn in your sleep or

arrange the tubing so it is comfortable in your wheelchair.

3 To start treatment, press or if the SmartStart/Stop function is enabled, simply breathe

into your patient interface and treatment will begin.

Stopping therapy

You can stop therapy at any time, simply remove the patient interface and press to stop airflow or if SmartStart/Stop is enabled, simply remove the patient interf will stop automatically.

Notes:

• SmartStop may not work if Full face or Tr a c h is selected as mask type; the High Leak

alarm o

the Low Min Vent alarm is enabled; “Confirm Therapy Stop“ is enabled; or the

mask-fitting feature is running.

• When the device is stopped and operating in standby mode with an inte

humidifier connected, it will continue to blow air gently to assist cooling of the humidifier’s heater plate.

• Masks with high resistance (eg, paediatric masks) may cause the operation of the

artStop feature to be restricted.

• When using with oxygen, turn off oxygen flow before stopping therapy.

ace, and treatment

grated

Turning off the power

1 Stop the therapy. 2 Press the power switch at the back of the device once and follow the instructions on

the display.

Note: T

o disconnect the device from the mains po

power socket.

wer pull out the power cord from the

Working with alarms

WARNING

This device is not intended to be used for vital signs monitoring. If vital signs monitoring is required, a dedicated device should be used for this purpose.

This device is fitted with alarms

Alarm LED

Alarm mute key

Alarm messages are displayed along the top of the screen. High priority alarm displayed in red, medium priority alarms in yellow and low priority alarms in light blue. The Alarm LED lights red during high priority alarms and yellow during medium and low priority alarms.

The alarm volume can be set Low, Medium or High. From Settings. After the set value has been confirmed, the alarm will sound and the alarm LED lights.

Alarm settings, see “Setup menu: Alarm Settings (Alarm Volume You can mute an alarm by pressing once. By pressing the Alarm mute key again, the

alarm sounds again. When an alarm is muted, the Alarm For a high or medium priority alarm, if after two minutes the problem is still present, the alarm will sound again. Any active low priority alarm will be permanently muted and the Internal Battery Use alarm will be cleared until the alarm condition is fulfilled again.

to alert you to changes that will affect your treatment.

Alarm message

s are

the Setup menu, select Alarm

)” on page 16.

mute key LED will light constantly.

English

13Starting therapy

Tailoring treatment setup options

Setting Ramp

Ramp time

Ramp time is a feature that can be enabled by your clinician by sett time. Designed to make the beginning of treatment more comfortable, ramp time is the period during which the pressure increases from a low start pressure to the treatment pressure. See “Setup menu: Options” on page 16.

ing a maximum ramp

Programs

Program

If the Clinician has selected both, ie, dual, you can choose the program to use on the

eatment screen. If only a single program is

selected, the option does not display.

Using mask-fit

You can use mask-fit to help you fit your mask properly. This feature delivers constant treatment pressure for a three-minute period, prior to starting treatment, during which you can check and adjust your mask-fit to minimise leaks. The mask-fit pressure is the set CPAP or EPAP pressure or 10 cm H

1 Put the mask on according to the mask user guide. 2 Hold down for at least three seconds until pressure delivery starts. 3

If necessary adjust the mask, mask cushion and headgear until you have a good mask fit. After three minutes treatment will begin. Mask-fit can be stopped at any time by pressing .

Notes:

• Press for at least three seconds during mask-fit to start the treatment imm

• The mask-fitting feature is di

O, whichever is greater.

sabled when the mask type Tr a c h is selected.

ediately.

Using the menus

The device has three menus (Monitoring, Setup, Info) accessed by the equivalent buttons on the right of the LCD screen. In each menu there are screens that display settings, device or therapy information.

MONITORING

Treatment

Monitoring

Pressure / Flow

Min Vent/Resp Rate

or MV/Va (iVAPS

Mode)

Leak

Tidal Volume

Synchronisation

Oximetry

SETUP

Clinical Settings

Alarm Settings

Options

INFO

Event Summary

Leak

Minute Ventilation

Tidal Volume

Respiratory Rate

I:E Ratio

Pressure Support

AHI

English

Note: iVAPS mode is only available in Stellar 150.

SpO

Used Hours

Device Information

Reminder

15Using the menus

Parameter Description

Learn Circuit The device is calibrated according to y

1. If in use, turn off the oxygen flow.

2. Select the mask type.

3. Set up the air circuit including access

Note: For invasive use, do not connect a catheter mount, tracheostomy tub on page 5).

4. Leave the air circuit unobstr

5. Press to start the Learn Circuit.

6. Wait for the device to complete its automated tests (<30 sec).

The results are displayed when complete. If the circuit configuration has been successfully learn unsuccessful, displays (see “Troubleshooting” on page 21).

Sensor

FiO

Calibration

amp Time If Max Ramp Time has been set by the

The device starts the calibration of the FiO2 monitoring sensor to measure the oxygen concentration of the breathable air.

1. Press to start the FiO

2. Wait for the device to complete its calibration. The results are displayed when complete.

urn off the oxygen flow.

Note: T

value up to this time. Options: 0 min-Max Ramp Time (max 45 minutes, 5 minutes increm

ents)

Setup menu: Configuration Menu

Parameter Description

Language Sets the display language.

Brightness Sets the LCD backlight bright

Backlight Enables the LCD and keypad backlight.

Time format Sets the time format.

Date format Sets the date format.

To return to the Options screen press the Return button

Options: Depending on regional configuration

Options: 20-100%, 10% increments

If the AUTO setting is selected the backlight turns dark after five minutes wi pressed again or an alarm occurs.

Options: On, Auto

Options: 24 hrs,12 hrs

Options: dd/mm/yyyy, mm/dd/yyyy

thout any actions and turns on again if any button is

our air tubing system.

ories and patient interface.

e or HMEF, see “Setting up for invasive use”

ucted and open to the

sensor calibration.

clinician, you may select any

ness.

air.

, displays. If

English

17Setup menu

Info menu

Event Summary

Used Hours

Device Information

Event summary displays the summary of three types of events: changes in se system events (eg, connection of ResMed USB stick). There are up to 200 events of each type, displayed in chronological order, with the most recent event displayed at the top by default.

Used Hours during the last seven days of treatment are displayed in a bar gr compared to the data of the last 365 days.

This screen shows the serial number (displayed as Device SN), software version and other component versions. Data on th requested for servicing or as part of problemsolving by a technician.

ttings, alarms and

aph and can be

is screen may be

Reminders

The Clinician uses the Reminders menu to alert you to specific events; for example replace the mask, when to replace the filter and so on. The reminder appears in yellow as the date approaches (within 10% of the reminder period). The reminder also displays on the startup screen. You can clear a reminder message by selecting ‘Reset’, which clears the current reminder date to OFF, or displays the next pre-set Reminder date.

, when to

Data management

There are two data ports at the rear of the device for connecting a USB stick (see “Stellar at a glance” on page 2). Therapy and device data can be stored on it or read from it to be used with ResMed software applications.

WARNING

Do not connect any device to the data ports other than specially designed devices recommended by ResMed. Connection of other devices could result in injury, or damage to the Stellar (see “General warnings and cautions” on page 30).

CAUTION

Do not disconnect the ResMed USB stick while data transfer is in progress. Otherwise loss of data or incorrect data may result. The download time depends on the data volume.

Notes:

• You cannot connect two ResMed USB sticks simultaneou

• If data transfer is not possible or failed please read the troubleshooting

• Do not store files on the USB stick other th

application. Unknown files may be lost during data transfer.

an those created by the device or

1 Plug the ResMed USB stick to one of the two USB connections on the rear side of the

device. The first dialogue for the USB data transfer is displayed automatically on the LCD. The device

checks if there is enough memory capacity on the USB stick and if readable data is available.

2 Select one of the available options

• Read sett

The settings will be transfered from the connected ResMed U

• Write settings

• Write settings and loggings

• Cancel

ings

ttings of the device will be stored on the ResMed U

ttings and loggings of the device will be stored on the ResMed USB stick.

3 Confirm the data transfer.

sly for data communication.

section.

SB stick to the Stellar.

SB stick.

English

Cleaning and maintenance

The cleaning and maintenance described in this section should be carried out regularly. This also helps to prevent the risk of cross contamination. Refer to the mask, humidifier and other accessories user guide for detailed instructions for care and maintenance.

WARNING

• Beware of electric shock. Do not immerse the device, pulse oximeter or power

cord in water. Turn off the device, unplug the power cord from the power socket and the device before cleaning and be sure that it is dry before reconnecting.

• The mask system and air tubing are subject to normal wear and tear. Inspect

them regularly for damage.

CAUTION

The device cannot be sterilised.

Daily

Disconnect the air tubing from the device (and humidifier, if used) and hang it in a clean, dry place until next use.

CAUTION

Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack.

19Data management

Weekly

1 Remove the air tubing from the device and the patient interface. 2 Wash the air tubing in warm water using mild detergent. 3 Rinse thoroughly, hang and allow to dry. 4 Reconnect the air tubing to the air outlet and patient interface.

CAUTION

Do not use bleach, chlorine, alcohol or aromatic-based solutions (including all scented oils), moisturising or antibacterial soaps to clean the air tubing or the device. These solutions may cause hardening and reduce the life of the product.

Monthly

1 Wipe the exterior of the device and the pulse oximeter (if used) with a damp cloth and mild

detergent.

2 Check the air filter to check if it is blocked by dirt or contains holes.

Replacing the air filter

Replace the air filter every six months (or more often if necessary).

WARNING

Do not wash the air filter. The air filter is not washable or reusable

1 Remove the air filter cover from the back of the device. 2 Remove and discard the old air filter. 3 Insert a new air filter. 4 Refit the air filter cover.

Air filter

Air filter cover

Disinfection

Disinfection of your device helps to prevent the risk of cross contamination. Disinfect the exterior of the device, and especially the air outlet, with a damp cloth an

disinfection solution (eg, Microzid).

d a

Multipatient use

WARNING

An antibacterial filter is mandatory if the device is used on multiple patients.

In a mulitpatient use environment, you must perform the following befo provided to a new patient:

Air filter and the antiba

cterial filter

Mask

Air tubing Replace the air tubing. Alternatively, consult the air tubing

Device Disinfect the Stellar as follows:

Humidifier As instructions for humidifiers va

Replace.

Reprocess; Cleaning, disinfection and sterilisation instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have Internet access, please contact your ResMed representative.

instructions for cleaning and disinfection information.

1. Apply undiluted mikrozid clean non-dyed disposable cloth.

2. Wipe all surfaces of the device, including the avoid liquid entering any openings in the device.

3. Leave the disinfectant to work for five minutes.

4. Wipe residual disinfectant from the de dry non-dyed disposable cloth.

the humidifier in use.

AF or CaviCide® liquid to a

ry, see the user guide for

re the device is

vice w

Servicing

CAUTION

Inspection and repair should only be performed by an authorised agent. Under no circumstances should you attempt to open, service or repair the device yourself.

This product should be inspected by an authorised Re the date of manufacture, except for the internal battery which must be replaced every two years from the manufacturing date of the device. Prior to this, the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed. Applicable ResMed warranty details are provided with the device at the time of original supply. Of course, as with all electrical devices, if any irregularity becomes apparent, you should exercise caution and have the device inspected by an authorised ResMed service centre.

sMed service centre five years from

air outle

ith a clean,

English

Troubleshooting

If there is a problem, try the following suggestions. If a problem cannot be solved, contact ResMed.

Alarm troubleshooting

The most common reason for an alarm to sound is because the system has not been properly assembled. Check that the air tubing has been properly attached to the device and patient interface (and humidifier if used).

Notes:

• The alarm log and alarm settings are m

in the event of a power loss.

• If multiple alarms are active simultaneously, the alarm with the h

displayed first.

• If an alarm activates repeatedly, discontinue use and return the device for servicin

aintained when the device is powered down and

ighest priority will be

21Troubleshooting

Problem / possible cause Action

LCD: Internal Battery Empty!

The remaining battery charge is below

The device can be powered by the

15%. internal battery for maximum 2 minutes.

Connect the device to mains power.

Note:

In case of a total power failure, the therapy settings will be stored and therapy will resume when the device is powered again.

LCD: System Failure!

Component failure. The device stops delivering air pressure (sys

tem failure 6, 7, 9, 22, 38). Therapy

1. Power-off the device.

2. Power-on the device again.

cannot be started (system failure 21). Component failure (system failure 8, 25). 1. Power-off the device.

2. Power-on the device again.

LCD: Over Pressure!

The device generates a pressure greater than 60 cm H be stopped.

O. Treatment will

that is

1. Power-off the device.

2. Check that the air tubing is connected

properly. Power-on the device again.

4. Start Learn Circuit function.

Note: If the alarm activates repeatedly

internal components may be defective. Discontinue use and return the device for servicing.

LCD: Blocked Tube!

Air path is blocked. 1. Check the air path for any blockages.

2. Remove the blockages.

3. If the alarm is n

ot cleared

, stop

treatment.

4. Re-start treatment.

LCD: High Temperature [10, 11, 12, 13]!

The temperature inside the device is too

. T

reatment may lead to stop.

high

Ensure the ambient temperature is within the specified operating range. If the problem persists within the specified operating conditions please return the device for servicing. Contact your clinician.

LCD: High Pressure!

Therapy pressure exceeds pre-set alarm lev

el.

1. Stop treatment.

2. Re-start treatment. If the problem persists cont

act y

our

clinician.

LCD: Low Pressure!

The air tubing is not connected properly. 1. Check the air circuit integrity and

nnect.

reco

If the alarm doesn‘t get cleared, stop treatment. Re-start treatment.

Problem / possible cause Action

LCD: Circuit disconnected!

The air tubing is not connected properly to the humidifier or the device.

. Check that the air tubing is connected

properly to the humidifier or the device.

2. If the alarm is n

treatment.

3. Re-start treatment.

LCD: Low Minute Ventilation!

Minute ventilation level has dropped

the alarm setting level.

belo

Contact your clinician.

LCD: Low Respiratory Rate!, High Respiratory Rate!

The respiratory rate level has dropped

or has exceeded the alarm setting

below

Contact your clinician.

level.

LCD: High Leak!

High mask leak for more than 20 seconds.

• Adjust the mask to minimise leak (see

“Using mask-fit” on page 14).

• Check the air circuit integrity and

reconnect.

• If the p

roblem persists c

clinician.

LCD: Non-Vented Mask!

• Connection of a non-vented mask.

• Mask vents may be blocked.

• ResMed leak port is missing or vent

blocked.

• Ensure the mask has vents.

• Ensure the mask vents are not

block

ed.

• Ensure the leak port is installed and

that the ve

nt is not blocked.

• Ensure oxygen (if in use) has only been

connected at the rear of the de

• If the problem persists c

clinician.

LCD: Apnoea!

The device detects an apnoea that has ex

ceeded the pre-set alarm level.

• Breathe normally to disable the alarm.

• If the problem persists c

clinician.

LCD: Internal Battery Low!

The internal battery capacity is below

Connect the device to mains power.

30%.

LCD: Low SpO

has dropped below pre-set alarm

SpO

level.

• Check the attachment of the sensor.

• If the problem persists c

clinician.

LCD: SpO

The finger sensor is not connected properly or delivers f

finger sensor failure!

aulty values.

Check if the finger sensor is attached properly to the finger and connection to the pulse oximeter.

LCD: Xpod oximeter disconnected!

The pulse oximeter is disconnected.

Check if the pulse oximeter is connected properly to the device.

ot cleared

, stop

ontact your

vice.

ontact your

English

23Troubleshooting

Problem / possible cause Action

LCD: Low FiO2 Level!

has dropped below the pre-set

FiO

alarm level.

• Perform FiO

• If the problem persists cont

sensor calibration.

act your

clinician.

LCD: High FiO

has exceeded the pre-set alarm

FiO

level.

Level!

• Perform FiO

• If the problem persists cont

sensor calibration.

act your

clinician.

LCD: Keypad Failure!

One of the keys was held down for more than 1

0 seconds

or got stuck.

Remove any blockages from the keypad.

LCD: Attention High Temp [42, 43, 44, 45]!

The temperature inside the device is high.

sure the ambient temperature conditions are within the specified operating range.

LCD: Internal Battery Use!

The device is using the internal battery. Check if the power cord is properly

vice if y

connected to the de

ou want to run from mains power. Press the Alarm mute button to cancel the alarm.

LCD: External DC Power Use!

The device is powered by an external batt

ery.

Check if the AC power cord is properly connected to the device if you want to run from mains power.

Note: The alarm will be cleared automa

tically after one minute.

Other troubleshooting

Problem / possible cause Solution

No display

Power failure. The device stops delivering air pressure.

Power not connected or device is not switc

hed on.

Treatment pressure seems low

Ramp time is in use. Wait for air pressure to build up. Air filter is dirty. Replace air filter. Air tubing is kinked or punctured. Straighten or replace tubing. Air tubing is not connected properly. Connect the air tubing firmly at both

Mask and headgear not positioned

ectly.

cor Plug(s) missing from access port(s) on

mask

Remove the mask or the catheter mount from the trache

ostomy tube until power

is restored. Ensure the power cord is connected and

press the switch at the back of the device once.

ends. Adjust position of mask and headgear.

Replace plug(s).

Problem / possible cause Solution

Pressure required for treatment may have changed.

There is a large impedance (eg, antibacterial filter) in the air circuit.

Humidifier control dial set too high,

lting in accumulation of water in the

resu air tubing.

Treatment pressure seems high

Pressure required for treatment may

e changed.

ha There is a change in the impedance in the

circuit configurations.

The device does not start when y

SmartStart/Stop not on. Consult your clinician. Breath is not deep enough to trigger

tStart.

Smar There is excessive leak. Adjust position of mask and headgear. Plug(s) missing from port(s) on mask. Replace plug(s). Air tubing is not connected properly. Connect firmly at both ends. Air tubing is kinked or punctured. Straighten or replace tubing. There is a large impedance (eg,

antibacterial filter) in the air circuit.

The device does not stop when you remove your mask

SmartStart/Stop is disabled. Consult your clinician. Use of a full face mask or tracheostomy

ube.

t Incompatible accessories (eg, humidifier

sk system) with high resistance

or ma being used.

High Leak Alarm or Low Min Vent alarms are se

t to ON.

“Confirm Stop” is enabled. Consult y

High Leak Alarm is enabled, but alarm does not activate when the mask is remo

Incompatible air delivery system being used

Pressure settings are too low f delivery components being used.

Learn Circuit failed

• The circuit configuration is

• Too many components have been

ved during treatment

or the air

opriate as the impedance

inappr detected is too high.

included or the impedan accessories in use is above ResMed’s recommendation, eg, type of filter, external humidifier, air tubing.

ce of

See your clinician to adjust the pressure.

Perfom the Learn circuit function.

Turn humidifier control down and empty the water from the air tubing.

Consult your clinician.

Perform the Learn Circuit function.

ou breathe into the mask

Take a deep breath in and out through the mask.

Perform the Learn circuit function.

artStart is disabled if Full face mask or

Sm Trach is selected as interface.

Use only equipment as recommended and su

pplied by ResMed.

Consult your clinician.

our clinician.

Use only e and supplied by ResMed.

Perform the Learn circuit function to adjust the therapy pressure according to your air tubing system.

Review the components included in the circuit configuration and adjust as appropriate, “Setup menu” on page 16

quipment as recommended

un Learn Circuit (see

then rer

English

25Troubleshooting

Problem / possible cause Solution

The delivered airflow is not humid/heated although the H4i humidifier is in use

The humidifier is not properly at

ached. Correctly attach the humidifier.

The humidifier does not heat. The device is currently powered by

ery use or not connected to the

batt mains.

The humidifier does not work. Return the device and the humidifier for

icing.

serv

The water chamber is empty. Fill the water chamber of the humidifier.

USB stick is not readable or writeable

The USB stick contains unreadable data, does not hav

e enough space available, is

Consult your clinician.

not compatible with the device. USB stick is defective. Replace the USB stick after consulting

our clinician.

sensor calibration failure

sensor is not attached properly. For the correct attachment of the FiO2

FiO

sensor, see “Using the FiO2 monitoring sensor” on page 8.

FiO

sensor is used or defective. If the lifetime of the FiO2 sensor has

exceeded one year please replace the FiO

sensor and start calibration again.

LCD: is displayed in the header

Battery is not charging.

•

Ensure the ambient temperature conditions are within the specified operating range. If the problem persists within the specified operating conditions please return the device for servicing.

• Power-off the device. Power-on the

device again.

Technical specifications

Operating pressure ra

Maximum single fault

essure

pr Breathing resistance

under s

ingle fault

Maximum flow > 200 L/min at 20 cm H Flow accuracy ± 6 L/min or 20% measured value, whichever is greater

• IPAP: 2 cm H

• PS: 0 cm H

• EPAP: 2 cm H

• CPAP: 4 cm H

• Min PS: 0 cm H

• Max PS: 0 cm H

Note: iVAPS mode is only available in Stellar 150.

60 cm H2O (in all modes)

2 cm H2O at 30 L/min;

7. 2 c m H

Test condition: T mode, IPAP: 40 cm H 2 cm H Respiratory Rate: 10 bpm, with ResMed calibration cap.

O to 40 cm H2O (in S, ST, T, PAC mode)

O to 38 cm H2O (in S, ST, T, PAC mode)

O to 25 cm H2O (in S, ST, T, iVAPS, PAC

mode)

O to 20 cm H2O (in CPAP mode only)

O to 20 cm H2O (in iVAPS mode)

O to 30 cm H2O (in iVAPS mode)

O at 60 L/min

O, EPAP:

O, Rise Time: MIN, Fall Time: MIN, Ti: 4.0 sec,

Therapy pressure tolerance

IPAP: ± 0.5 cm H2O ± 10% of set pressure (end of inspiration) EPAP/PEEP: ± 0.5 cm H CPAP: ± 0.5 cm H Test condition: T mode, IPAP: 40 cm H

O, Rise Time: MIN, Fall Time: MIN, Ti: 4.0 sec,

Respiratory Rate: 10 bpm, with ResMed calibration cap.

O ± 4% of set pressure

O ± 10% of set pressure

O, EPAP: 2 cm

Sound pressure level 29 dBA as measured according to ISO 17510 – 1:2002.

32 dBA with uncertainty of 3 dBA as measured according

Alarm Volume Range

to ISO 1751 > 45 dBA - < 85 dBA at 1 meter (3 steps: low, medium, high)

0 – 1:2007.

Dimensions (L x W x H) 230 mm x 170 mm x 120 mm Weight 2.1 kg Air outlet 22 mm taper, compatible with ISO 5356-1:2004

Anaesthetic & Re

spiratory Equipment - Conical

Connectors

Pressure measurement Internally mounted pressure transducer Flow measurement Internally mounted flow transducer Power supply AC 100–240V, 50–60Hz, 2.2 A, max. 65 W External DC Power

24 V, 3 A

Supply Internal Battery Lithium-Ion battery, 14.4 V, 1.6 Ah, 23 Wh

Operating hours: 2 h with a new battery under normal conditions (see belo

w). Patient type: home chronic; pressure: IPAP/EPAP 15/5 cm H

O; mask type: Ultra Mirage; air tubing: 2 m; leak:

0; respiratory rate: 20 bpm; battery capacity: 100% Patient type: hospital acute; pressure: IPAP/EPAP 20/5 cm H

O; mask type: Ultra Mirage; air tubing: 2 m; leak:

0; respiratory rate: 45 bpm; battery capacity: 100%

Housing construction Flame retardant engineering thermoplastic

vironmental

En condition

• Operating temperature: 0°C to 35°C

• Operating humidity: 10%–95% non-condensing

• Storage and transport temperature: -20°C to 60°C

(+50°C*)

• Storage and transport humidity: 10%–95% non-

cond

ensing

ir pressure: 1,100hPa to 680hPa; Altitude: 3,500 m

• A *NONIN XPOD

Electromagnetic compatibility

roduct complies with all applicable electromagnetic

compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial, and

light industry environments. For further details see “Guidance and manufacturer’s declaration – elec

tromagnetic

emissions and immunity” on page 28.

Air filter

Electro static fibre mesh with TPE frame structure. Bacterial filtration efficiency of 99.540% on area weight 100g/m².

Air tubing Flexible plastic, 2 m or 3 m length (22 mm diameter)

SlimLine air tubing

Flexible plastic, 1.83 m length (15 mm diameter)

English

27Technical specifications

IEC 60601-1 classif

ications

• Class II (Clause 3.14—double insulation). This

adherence means the need for an protective earthing (ie, an earthed plug) is not necessary.

• Type BF

• Continuous operation

Air travel requirements Medical-Portable Electronic Devices (M-PED) that meet

the Federal A

viation 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 Stellar meets RTCA/ DO-160 requirements.

This device is not suitable for use in the p

esence of a flammable anesthetic mixture.

Notes:

• The manufacturer reserves the right to change these specification

• Pressure may be displayed in cm H

O or hPa.

s without notice.

Guidance and manufacturer’s declaration – electromagnetic emissions and immunity

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document.

Guidance and manufacturer’s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR11 Group 1 The device uses RF energy only for its internal function.

RF emissions CISPR 11 Class B The device is suitable for use in all establishments,

Harmonic Emissions IEC 61000-3-2

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

Warnings: The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may result in increased emissions or decreased immunity of the device.

Class A

Complies

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

including domestic establishments and those directly connected to the public low-voltage network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the

vice should assure that it is used in such an environment.

Immunity test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

IEC606 01-1-2 tes t lev

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

Compliance level Electromagnetic environment –guidance

±6 kV contact ±8 kV air

±2 kV

±1 kV

±1 kV differential mode

±2 kV common mode

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Powe r frequency (50/60 Hz) magnetic field IEC 61000-4-8

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTE 1: Ut is the AC mains voltage prior to application of the test level. NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection

om structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

<5% Ut (>95% dip in Ut) for 0.5 cycle

40% Ut (60% dip in Ut) for 5 cycles

70% Ut (30% dip in Ut) for 25 cycles

<5% Ut (>95% dip in Ut) for 5 sec

3 A/m 3 A/m Power frequency magnetic fields should be at

3 Vrms 150 kHz to 80 MHz

10 V /m 80 MHz to 2.5 GHz

< 12 V (>95% dip in 240V) for 0.5 cycle

96 V (60% dip in 240 V) for 5 cycles

168 V (30% dip in 240 V) for 25 cycles

<12 V (>95% dip in 240 V) for 5 sec

3 Vrms

3 V/m

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power source.

levels characteristic of a typical location in a typical commercial or hospital environment.

Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

d = 1.17 √P

d = 0.35 √P 80 MHz to 800 MHz d = 0.70 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

English

Recommended separation distances between portable and mobile RF communications equipment and the device

The device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the us

er of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m)

Rated maximum output power of transmitter (W)

150 kHz to 80 MHz d = 1.17 √P

80 MHz to 800 MHz d = 0.35 √P

800 MHz to 2.5 GHz d = 0.7 √P

0.01 0.17 0.04 0.07

0.1 0.37 0.11 0.22

1 1. 17 0.35 0.7

29Technical specifications

10 3.69 1. 11 2.21

100 11.7 0 3.50 7. 0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Symbols

Follow instructions for use; Class II equipment; Type BF equipment;

IP31 Device is protected against solid foreign objects of 2.5 mm diameter and greater and

vertically falling water drops; Caution; Standby or preparatory state for a part of

equipment; Connection for oxygen supply;

port; CE labeling in accordance with EC directive

+ 60 °C + 140 °

- 20 °C

Temperature limitation for storage and transport; Handle with care; Maximum

- 4 °F

max 30 l/min

(max 30 L/min); Data

93/42/EEC, class II b;

humidity; Keep dry; Manufacturer; Upside; Catalogue number;

Serial number;

away from sunlight; Do not use if package is damaged;

Batch code; Do not re-use; Use by date; Keep

LATEX

Latex-free

Environmental information This device must be disposed of in accordance with the laws and regulations of the country in which disposal occurs.

The crossed-out wheeled bin symbol indicates that the product bearing this symbol may not b

e disposed of together with general househo

ld waste, but instead requires separate disposal. This requirement for separate disposal is based on the European Directive 2002/96/EC for electrical and electronic equipment, and the European Directive 2006/66/EC for batteries. You can hand in the product at a municipal collection point, for example. This reduces the impact on natural resources and prevents contamination of the environment through the release of hazardous substances.

Batteries containing more than 0.0005 percent of mercury b

mass, more than 0.002

y percent of cadmium by mass or more than 0.004 percent of lead by mass are marked below the crossed-bin symbol with the chemical symbols (Hg, Cd, Pb) of the metals for which the limit is exceeded.

For further information regarding product disposal, pl

ease contact your local ResMed office

or your specialist distributor, or visit our website at www.resmed.com. Dispose of used air filters and air tubings according to the directives in

your country.

General warnings and cautions

WARNINGS

A warning alerts you to possible injury.

• Read the entire manual before using the device.

• This device should only be used with air t

ResMed or the prescribing clinician. Use of incorrect air tubing and accessories may affect the functioning of this device.

• The device and the accessories are to be use

ubing and accessories recommended by

d for the specified intended use only.

• The device must only be used with masks (and connectors

ResMed, or by a clinician or respiratory ther

apist. A mask should not be used unless

) recommended by

the device is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked.

Explanation:

The Stellar is intended to be used with special masks (or connectors1) 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 Positive Airway Pressure devices.

• In the event of power failure

catheter mount from the tracheo

• Explosion hazard – do not use in the vicinity

• Do not use the device if there are obvious e

or machine malfunction, remove the mask or the

stomy tube.

of flammable anesthetics. xternal defects, unexplained changes in

performance.

• Only use orignal and approv

Use only accessories from the original package. If the packaging is damaged, the

•

ed ResMed accessories and parts.

respective product must not be used, and should be disposed along with the packaging.

• Before using the device and the accessories for the first time, ensure that all

components are in a proper condition and that their operational safety is guaranteed. If there are any defects, the system should not be used.

•

Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (eg, IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical service department.

CAUTIONS

A caution explains special measures for the safe and effective use of the device.

• When using accessories, read the manufact

important information can be provided on the packaging, see also symbols on page 30.

• At low pressures, the flow through the mask v

exhaled gas, and some rebreathing may occur.

• The device may not be exposed to excessive force.

•

If the device should fall accidentally on the ground, please contact your authorised service agent.

• Pay attention to leaks and other unusual sounds. If there is a problem, contact an

authorised service agent.

Notes:

A note advises to special product features.

• The above are general warnings and cautions. Furth

notes appear next to the relevant instructions in the user guide.

• Only trained and authorised personnel are allowed

urer’s User Manual. For consumables

ent holes may be inadequate to clear all

er specific warnings, cautions and

to make clinical setting changes.

English

1 Ports may be incorporated into the mask or in connectors that are near the mask. 2 During partial (below rated minimum voltage) or total power failure, therapy pressures will not be

red. When power is restored, operation can be proceeded with no change to settings.

delive

31General warnings and cautions

Limited warranty

ResMed 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.

Product Warranty period

• Mask systems (including mask frame, cushio

ubing)—excluding single-use devices

and t

• Accessories—excluding single-use devices

• Flex-type finger pulse sensors

• Humidifier water tubs

• Batteries for use in ResMed internal and ex

systems

• Clip-type finger pulse sensors

• CPAP and bilevel device data modules

• Oximeters and CPAP and bilevel device o

• Humidifiers and humidifier cleanable wa

• Titration control de

• CPAP, bilevel and ventilation devi

power supply units)

• Battery accessories

• Portable diagnostic/screening devices

This warranty is only available to the initial consum If the product fails under conditions of n

option, the defective product or any of its components. This limited warranty does not cover: a) any damage caus

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 sm 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

purchase. This warranty replaces all other expressed or implie

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 dam 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 furt ResMed dealer or ResMed office.

vices

ces (including external

ormal use, ResMed will repair or replace, at its

must be made by the initial consumer at the point of

her information on your warranty rights, contact your local

n, headgear

ternal battery

ximeter adapters

ter tubs

er. It is not transferable.

ed as a result of improper use,

d warranties, including any implied

90 days

6 months

1 year

2 years

oke; and d) any

ges claimed to

R001-325/2 09 09

248551/1 2011-09

Stellar 100 Stellar 150

USER

A PAC

Manufacturer: ResMed Germany Inc. Fraunhoferstr. 16 82152 Martinsried Germany Distributed by: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.

ResMed Corp 9001 Spectrum Center Blvd. 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.

Protected by patents: AU 2002306200, AU 2002325399, AU 2003204620, AU 2004205275, AU 2004216918, AU 2005200987, AU 2006201573, AU 697652, AU 699726, AU 713679, AU 731800, AU 737302, AU 739753, AU 746101, AU 756622, AU 757163, AU 759703, AU 773651, AU 779072, CA 2235939, CA 2263126, CA 2266454, CA 2298547, CA 2298553, CN 20020814714.6, CN 200480006230.3, EP 0661071, EP 0858352, EP 0929336, EP 0996358, EP 1005829, EP 1005830, EP 1132106, EP 1175239, EP 1277435, EP 1687052, JP 3558167, JP 3635097, JP 3638613, JP 3645470, JP 3683182, JP 3730089, JP 3902781, JP 4083154, JP 4597959, JP 4643724, JP 4158958, JP 4162118, NZ 541914, NZ 546457, NZ 563389, NZ 567617, NZ 577484, US 6152129, US 6213119, US 6240921, US 6279569, US 6484719, US 6532957, US 6553992, US 6575163, US 6644312, US 6659101, US 6688307, US 6755193, US 6810876, US 6840240, US 6845773, US 6945248, US 7089937, US 7137389, US 7255103, US 7367337, US 7520279, US 7628151, US 7644713, US 7661428. Other patents pending. Protected by design registrations: EU 1768045 ResMed, SmartStart, TiCONTROL, SlimLine, and Stellar are trademarks of ResMed Ltd. ResMed, SmartStart and Stellar are registered in U.S. Patent and Trademark Office. © 2011 ResMed Ltd

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

ResMed 248551-1, 2011-09 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

Introduction

Indications for use

Contraindications

Adverse effects

Stellar at a glance

Handle

Patient interface

Humidification

Internal battery

ResMed USB stick

Use on an aircraft

Mobile use

Setting up for noninvasive use

AC locking clip

Attaching the H4i heated humidifier for noninvasive use

Setting up for invasive use

Antibacterial filter

Working with other optional accessories

Attaching the pulse oximeter

Adding supplemental oxygen

Starting therapy using oxygen

Stopping therapy using oxygen

Using the FiO2 monitoring sensor

Oxygen supply

Attaching an antibacterial filter

Stellar basics

About the control panel

Mains Power LED

On when operating on mains power.

LCD screen

Warm-up feature H4i

Starting therapy

Performing a functional test

Warm-up humidifier

Starting therapy

Stopping therapy

• When using with oxygen, turn off oxygen flow before stopping therapy.

Turning off the power

Working with alarms

Alarm message

Tailoring treatment setup options

Ramp time

Program

Using mask-fit

Using the menus

1. If in use, turn off the oxygen flow.

2. Select the mask type.

5. Press to start the Learn Circuit.

2. Wait for the device to complete its calibration. The results are displayed when complete.

Setup menu: Configuration Menu

Info menu

Event Summary

Used Hours

Device Information

Reminders

Data management

Cleaning and maintenance

Daily

Weekly

Monthly

Replacing the air filter

Disinfection

Multipatient use

3. Leave the disinfectant to work for five minutes.

Servicing

Troubleshooting

Alarm troubleshooting

1. Power-off the device.

2. Power-on the device again.

cannot be started (system failure 21). Component failure (system failure 8, 25). 1. Power-off the device.

2. Power-on the device again.

1. Power-off the device.

4. Start Learn Circuit function.

Air path is blocked. 1. Check the air path for any blockages.

2. Remove the blockages.