ResMed Stellar 100, Stellar 150 User Manual

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Stellar™ 100 Stellar

InvasIve and nonInvasIve

ventIlators

User Guide

English

™

150

Respiratory Care Solutions

Making quality of care easy

Respiratory Care Solutions

Making quality of care easy

Contents

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 Remote Alarm 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 21 Multipatient use 21 Servicing 22

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Alarm troubleshooting 22 Other troubleshooting 25

Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Guidance and manufacturer’s declaration – electromagnetic emissions and immunity 29 Symbols 31

General warnings and cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

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 100/150 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 the use of the ResMed Leak Valve). 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 conditio

• pneumothorax or pneumomediastinum

• pathologically low blood pressure, particularly if associated w

depletion

• cerebrospinal fluid leak, recen

• severe bullous lung disease

• dehydration.

The use of the Stellar or pulse environment.

oximetry (including XPOD) is contraindicated in an MRI

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.

ns, tell your doctor before using this device:

ith intravascular volume

t cranial surgery or trauma

rse of noninvasive ventilation with the

English

1Introduction

Stellar at a glance

Handle

Infrared connection

for humidifier

Air outlet

H4i connector

plug and AC

connection

Oxygen inlet

Air filter cover

XPOD pulse oximeter connection

FiO2 sensor connection

Data port for USB stick

Data port for direct PC connection

DC power socket

AC power socket

Power on/standby switch

Remote alarm connection

The Stellar comprises:

• Stellar device • Hypoallergenic air filter • AC power cord • Carry bag ResMed USB stick • Low pressure oxygen connector.

The following optional components are com

• 3 m air tubing • SlimLine™ air tubing • Clear air tubing (disposable) • H4i™ heated humidifier • Antibacterial filter • Heat moisture exchanger filter (HMEF) • ResMed XPOD oximeter • Nonin™ pulse oximetry sensors • FiO adapter) • FiO

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 catalogu accessories on our website at www.resmed.com.

monitoring sensor • Stellar Mobility bag • ResMed Leak Valve • Tubing wrap.

patible with Stellar:

monitoring kit (external cable, T-piece

e of ventilation

• 2 m air tubing •

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 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.

the 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

Over time, the capacity of the internal battery will decrease. This depends on individual use and ambient conditions. As the battery degrades, it could lead to battery related alarms and or system errors. ResMed recommends the battery be tested after two years to assess the remaining battery life. Testing and replacement of the internal battery should only be performed by an authorised service agent.

Note: T

he battery duration depends on the state of charge, the environmental conditions,

the condition and age of battery, the device settings and the patient circuit configuration.

In case of a mains power disruption, the device will op there is no external battery connected to the device. The internal battery will operate for approximately two hours under normal conditions (see “Technical specificatio page 27). The power status of the battery is displayed on to battery status regularly while ope 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.

rating the device with the internal battery and connect the

will be displayed. Press the Alarm mute button

erate using the internal battery if

ns” on

p of the LCD screen. Check the

s power. It can take up to three

Maintenance

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

1 Remove the power cord while the Stellar is turned on (standy-by or in operation) and let

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

2 Reconnect the power cord to the mains power. The internal battery will be fully recharged.

Storing

If the device is stored for a longer period the internal battery should be at the charge level of approximately 50% to increase the durability.

Note: Chec to a charge level of 50%.

k the charge level every six months, if necessary recharge the internal battery

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 27.

English

3Stellar at a glance

Mobile use

AC locking clip

AC power cord

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.

Remote Alarm

The Remote Alarm may be used to transfer audible and visual alarms by a direct cable connection. For more information on using the Remote Alarm, see the Remote Alarm user guide.

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 th vents at the mask 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.

• Ho

ses or tubes must be non-conductive and antistatic. not leave long lengths of the air tubing or the cable for the finger pulse sensor

• Do around 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

power cord is required, contact your ResMed Service Centre.

• Place the device on a flat surface near th

e head of the bed.

e device and under the device and

the unit. If a replacement

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, outlet of the device (see “Attaching an antibacterial filter” on page 9).

connect the antibacterial filter firmly onto the air

Note: Other external humidifiers can be used for noninvasive setup. ResMed recommends using a breathing system (including antibacterial filter, air tubings, external humidifier) with an impedance of maximum 2 cm H and 16 cm H

O at 120 L/min.

O at 30 L/min, 5 cm H2O at 60 L/min

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.

• M

ake sure that the water chamber is empty and thoroughly dried before

transporting the humidifier.

e H4i heated humidifier is not intended for mobile use.

• Th

• Do

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

the air circuit.

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

ircuit configuration, in particular when adding or removing high impedance

c 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 circuit and may affect triggering and cycling, 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 device is not mains powered.

English

Setting up for invasive use

The Stellar can be used invasively only with the ResMed Leak Valve.

WARNING

• Make sure that all the air inlets at the rear of the device and under the device and vents at the mask or at the ResMed Leak Valve 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.

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

larly as specified in the instructions provided with the HMEF.

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

vasive 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 c

ircuit 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.

5Setting up for invasive use

CAUTION

Antibacterial filter

External humidifier*

Air tubing

ResMed Leak Valve

Catheter mount**

HMEF*

AC locking clip

AC power cord

Learn Circuit configuration

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

Note: When the mask type is set to Tr a c h , the Non-Vented Mask alarm will be automatically enabled to alert you when the ResMed Leak Valve has no vent holes or when the vent holes are blocked.

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 ResMed Leak Valve (at step 9).

5 Connect the air tubing to the external humidifier. 6 Connect the ResMed Leak Valve to the air tubing. Position the ResMed Leak Valve so that

air from the vent holes does not blow directly onto the patient's chest.

WARNING

Always set up the ResMed Leak Valve in the breathing circuit with the arrows and the symbol p

7 Select the mask type Tr a c h (select Setup menu, then Clinical Settings, then Advanced

Settings).

ointing in the direction of air flow from the Stellar to the patient.

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 patient side

of the ResMed Leak Valve.

10 Connect the catheter mount.

** The ResMed Leak Valve or the HMEF can be con interfaces including connector pieces like catheter mounts.

The catheter mount and the external humidifier are not part o

nected to standardised tracheostomy

f 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 o

• R

• O

• Th

•

nly certified, clean oxygen sources.

esMed strongly recommends adding oxygen into Stellar’s oxygen inlet at the rear of the device. Entraining oxygen elsewhere, ie into the breathing system via 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.

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

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

e breathing system and the oxygen source must be kept at a minimum 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.

English

7Working with other optional accessories

Starting therapy using oxygen

Oxygen supply

Press spring to release connection after use

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).

he FiO2 monitoring sensor must be replaced every 12 months.

Note: T

monitoring sensor open to the air for 15 minutes.

monitoring sensor (as shown below).

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 m replaced according to the manufacturer‘s specifications.

esMed recommends using a filter with a low impedance (less than 2 cm H2O at

Note: R 60 L/min, eg, PALL BB 50 filter).

WARNING

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

oisture or other contaminants. The filter must be

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 introduced by the filters.

, select Options. This enables the device to compensate for the impedance

9Working with other optional accessories

Stellar basics

Mains Power LED

On when operating on mains power.

Internal battery LED

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

Alarm LED

Red or yellow during an alarm or during alarm testing.

Alarm mute button LED

On when is pressed.

Monitoring menu

Setup menu

Info menu

LCD Screen

Push dial

(rotate/

click)

Therapy LED

On during treatment. Flashes during maskfitting operation.

Start/stop button

External power supply LED

On when external battery is connected.

About the control panel

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)

Push dial Turning the dial allows you to scroll throug

• Extended hold for at least three seco

nds starts the

maskfitting feature.

second tim present, the alarm will sound again after two minutes. See “Working with

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

enter and scroll through the relevant menu.

change settings. Pushing the dial allows you to enter into a

e to un-mute an alarm. If the problem is still

alarms” on page 13.

arts the alarm LED and alarm buzzer test.

h the menu and

menu or confirm your choice.

LCD screen

Warm-up feature H4i

Program

Mains power

ResMed USB stick

Therapy status bar

Internal battery

Title bar

Therapy mode

Ramp time

Settings

External power supply

Current screen/number of screens within the menu

Scroll bar

Patient mode or Clinical mode

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

only.

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 22. Please also check other

provided User Instructions for troub

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

should not be used.

system

3 Check the circuit configuration.

Check the integrity of the circuit configuration (de 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 Check that the alarm sounds a test beep and th

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 T

5 Check batteries.

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

f the charge state of the internal battery is too low, or if the battery is empty, an

Note: I alarm occurs. See the Alarm troubleshooting section on page 22 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.

other screens throughout the User Guide are examples

reatment screen.

leshooting information.

vice and provided accessories) according

to turn on the device.

e LEDs (visual indicator) for the alarm signal

s and external battery (if in use) so that the device is

English

11Starting therapy

6 Check H4i heated humidifier (if in use).

Warm-up humidifier

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

You can use the warm-up feature to pre-heat the water in the humidifier prior to starting treatment. The humidifier will b 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:

when the device is connected to mains supply.

reatment screen. Start the warm-up

e automatically

The H4i in heating mode can only be used

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 oximeter” on page 7). From the Monitoring me the values for SpO

and Heart rate are displayed.

the setup descriptions (see “Attaching the pulse

nu, go to the Monitoring screen. Check that

9 Check oxygen connection (if in use).

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

the setup 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 at the back 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 will stop automatically.

Notes:

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

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

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

• When using with oxygen, turn off oxygen flow b

if SmartStart/Stop is enabled, simply remove the patient interface, and treatment

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

alarm o mask-fitting feature is running.

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

SmartStop feature to be restricted.

efore stopping therapy.

an integrated

of the

Turning off the power

Alarm message

Alarm LED

Alarm mute key

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

the display.

o disconnect the device from the mains power pull out the power cord from the

Note: T power socket.

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 alarm

s to alert you to changes that will affect your treatment.

English

Alarm messages are displayed along 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. Fro 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 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.

the top of the screen. High priority alarms are

m the Setup menu, select Alarm

Volume)” on page 16.

mute key LED will light constantly.

13Starting therapy

Tailoring treatment setup options

Ramp time

Program

Setting Ramp

Ramp time is a feature that can be enabled by your clinician by set 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.

ting a maximum ramp

Programs

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

reatment 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 treatm

• The mask-fitting feature is d

O, whichever is greater.

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

ent immediately.

Using the menus

MONITORING

Monitoring

Pressure / Flow

Min Vent/Resp Rate

or MV/Va (iVAPS

Mode)

Leak

Tidal Volume

Treatment

Synchronisation

Oximetry

SETUP

Alarm Settings

Options

Clinical Settings

INFO

Leak

Minute Ventilation

Tidal Volume

Event Summary

SpO

Used Hours

Respiratory Rate

Device Information

Reminder

I:E Ratio

Pressure Support

AHI

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.

English

Note: iVAPS mode is only available in Stellar 150.

15Using the menus

Setup menu

Setup menu: Clinical Settings (Mask Type)

1 Press to display the Clinical Settings screen. 2 Use the push dial to scroll through the menu and change the Mask Type in the Advanced

Settings screen.

Mask type options: Nasal, Ultra, Pillow, Full Face, Trach, Pediatric.

Note: When Mask T automatically turns on.

For a full list of compatible masks for this device, see the Mask/Device Compatibility List

.resmed.com on the Products page under Service & Support. If you do not have

on www internet access, please contact your ResMed representative.

Setup menu: Alarm Settings (Alarm Volume)

1 Press to display the Alarm Settings screen. 2 Use the push dial to scroll through the menu and change the Alarm Volume to low,

medium or high.

ype is set to Tr ach or Full Face the Non-Vented Mask alarm

Setup menu: Options

1 Press to display the Options screen. 2 Use the push dial to scroll through the menu and change parameters (see descriptions

in the table below).

Parameter Description

Learn Circuit The device is calibrated according to your air tubing system.

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

2. Select the mask type.

3. Set up the air circuit including acces

Note: For invasive use, do not connect a catheter mount,

eostomy tube or HMEF, see “Setting up for invasive use”

trach 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 22).

FiO

Sensor

Calibration

Ramp 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.

Note: T

urn off the oxygen flow.

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

ments)

Setup menu: Configuration Menu

Parameter Description

Language Sets the display language.

Brightness Sets the LCD backlight brigh

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 w pressed again or an alarm occurs.

Options: On, Auto

Options: 24 hrs,12 hrs

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

ithout any actions and turns on again if any button is

sories and patient interface.

ucted and open to the air.

t, displays. If

sensor calibration.

clinician, you may select any

tness.

English

17Setup menu

Info menu

Event Summary

Used Hours

Device Information

Event summary displays the summary of three types of events: ch 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 g compared to the data of the last 365 days.

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

t versions. Data on this screen may be

anges in settings, alarms and

raph and can be

Reminders

The Clinician uses the Reminders menu to alert you to specific events; for exam 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 when the device is powered on. You can clear a reminder message by selecting ‘Reset’, which clears the current reminder date to OFF, or displays the next preset Reminder date.

ple, 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 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 32).

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 simu

• If data transfer is not possible or faile

• Do not store files on the USB stick oth

application. Unknown files may be lost during data transfer.

d please read the troubleshooting section.

er than those created by the device or

ltaneously for data communication.

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 set

The settings will be transfered from the conne

• W

Settings of the device will be stored on th

• W

Settings and loggings of the device will be stored on the ResMed

• Cancel

tings

cted ResMed USB stick to the Stellar.

rite settings

e ResMed USB stick.

rite settings and loggings

3 Confirm the data transfer.

read from it to be

USB 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. If the device is visibly soiled, wipe the exterior surfaces of the device and the pulse oximeter (if used) with a damp cloth and mild detergent.

19Data management

CAUTION

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

• Do not use bleach, chlorine, alcohol or aro scented oils), moisturising or antibacterial soaps to clean the air tubing or the device on a daily basis (other than the approved cleaning agents Mikrozid CaviCide product. The use of cleaners and disinfecting solutions containing alcohol (other than the approved cleaning agents) is acceptable for periodic cleaning of the device, such as for cleaning between patients or especially for service periods, but not recommended for daily use.

). These solutions may cause hardening and reduce the life of the

matic-based solutions (including all

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. 5 If the device is visibly soiled, wipe the exterior surfaces of the device and the pulse

oximeter (if used) with a damp cloth and mild detergent.

Monthly

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

detergent.

2 Visually inspect 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.

AF or

Disinfection

Air filter cover

Air filter

Multipatient use

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 dam

disinfection solution (eg, Microzid).

p cloth and a

WARNING

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

• In a mulitpatient use environment, you must perform the following before the

vice is provided to a new patient:

Air filter and the antibacterial filter

Mask

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

Device Disinfect the Stellar as follows:

Humidifier As instructions for humidifiers v

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.

Use an anti-bacterial cleaning/disinf Mikrozid disposable cloth to clean and disinfect the exterior surfaces of the device. Wipe all accessible surfaces of the device, including the air outlet (avoid liquid entering any openings in the device). Follow the manufacturer’s recommended cleaning instructions.

the humidifier in use. For multipatient use environment, use the H4i water chamber (disposable) in place of the H4i reusable water chamber.

AF or CaviCide® with a clean non-dyed

ectant solution such as

ary, see the user guide for

English

21Cleaning and maintenance

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 R the date of manufacture, except for the internal battery which ResMed recommends be tested after two years to assess the battery life. 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.

esMed service centre five years from

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

in the event of a power loss.

• If multiple alarms are active simultaneously, the alarm

displayed first.

• If an alarm activates repeatedly,

Problem / possible cause Action LCD: Internal Battery Empty!

The remaining battery charge is below

5%. The device can be powered by the

1 internal battery for maximum 2 minutes.

LCD: System Failure!

Component failure. The device stops delivering air pressure

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

(sy cannot be started (system failure 21).

Component failure (system failure 8, 25). 1. Power-off the device.

LCD: Over Pressure!

The device generates a pressure greater than 59 cm H be stopped.

O. Treatment will

maintained when the device is powered down and

with the highest priority will be

discontinue use and return the device for servicing.

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.

1. Power-off the device.

2. Power-on the device again.

that is

1. Power-off the device.

2. Check that the air tubing is connected

properly

3. 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.

Problem / possible cause Action 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

treatment.

4. Re-start treatment.

LCD: High Temperature [1

The temperature inside the device is too

. Treatment may lead to stop.

high

LCD: High Pressure!

Therapy pressure exceeds pre-set alarm le

vel.

LCD: Low Pressure!

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

LCD: Circuit disconnected!

The air circuit is not connected p

LCD: Low Minute Ventilation!

Minute ventilation level has dropped

w the alarm setting level.

belo

LCD: Low Respiratory Rate!, High Respiratory Rate!

The respiratory rate level has dropped

w or has exceeded the alarm setting

belo level.

LCD: High Leak!

High mask leak for more than 20 seconds.

0, 11, 12, 23]!

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.

1. Stop treatment.

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

reco

nnect.

2. If the alarm doesn‘t get cleared, stop

ent.

treatm

3. Re-start treatment.

roperly. 1. Check the air circuit integrity and

reconnect.

2. If the alarm is n

treatment.

3. Re-start treatment.

Contact your clinician.

• Adjust the mask to minimise leak (see

“Using mask-fit” on page 14).

• Check the air circuit integrity and

reco

nnect.

If the problem persists contact your

•

clinician.

ot cleared, stop

act your

ot cleared, stop

English

23Troubleshooting

Problem / possible cause Action LCD: Non-Vented Mask!

• Connection of a non-vented mask.

• Mask vents may be blocked.

• ResMed Leak Valve is missin

g or vent

is blocked.

• Ensure the mask has vents.

• Ensure the mask vents are not

bloc

ked.

• Ensure the ResMed Leak Valve is

alled and that the vent is not

inst blocked.

• Ensure oxygen (if in use) has only been

connected

• If the problem persists co

at the rear of the device.

ntact your

clinician.

LCD: Apnoea!

The device detects an apnoea that has e

xceeded the pre-set alarm level.

• Breathe normally to disable the alarm.

• If the problem persists co

ntact your

clinician.

LCD: Internal Battery Low!

The internal battery capacity is below 30%.

LCD: Low SpO

has dropped below pre-set alarm

SpO

level.

Connect the device to mains power.

• Check the attachment of the sensor.

• If the problem persists co

ntact your

clinician.

LCD: SpO

The finger sensor is not connected properly or deliv

finger sensor failure!

ers faulty 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

perly to the device.

pro

LCD: Low FiO

has dropped below the pre-set

FiO

alarm level.

Level!

• Perform FiO2 sensor calibration.

• If the problem persists co

ntact your

clinician.

LCD: High FiO

has exceeded the pre-set alarm

FiO

level.

Level!

• Perform FiO2 sensor calibration.

• If the problem persists co

ntact your

clinician.

LCD: Keypad Failure!

One of the keys was held down for more

0 seconds or got stuck.

than 1

Remove any blockages from the keypad.

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

The temperature inside the device is high

Ensure 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

connected to the de

vice if you want to run from mains power. Press the Alarm mute button to cancel the alarm.

Problem / possible cause Action LCD: External DC Power Use!

The device is powered by an external

tery.

bat

Other troubleshooting

Problem / possible cause Solution No display

Power failure. The device stops delivering air pressure.

Power not connected or device is not

itched 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

rectly.

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

sk.

Pressure required for treatment may

ve changed.

ha There is a large impedance (eg,

antibacterial filter) in the air circuit. Humidifier control dial set too high,

ulting in accumulation of water in the

res air tubing.

Treatment pressure seems high

Pressure required for treatment may

ve changed.

ha There is a change in the impedance in the

circuit configuration.

The device does not start when

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

artStart.

Sm 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.

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 autom

atically after one minute.

Remove the mask or the catheter mount from the trac 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).

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.

you breathe into the mask

Take a deep breath in and out through the mask.

heostomy tube until power

English

25Troubleshooting

Problem / possible cause Solution

There is a large impedance (eg,

Perform the Learn Circuit function.

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

ask system) with high resistance

or m

SmartStart is disabled if Full face mask or Trach is selected as interface.

Use only equipment as recommended and su

pplied by ResMed.

being used. High Leak Alarm or Low Min Vent alarms

e set to ON.

“Confirm

Stop” is enabled. Consult your clinician.

Consult your clinician.

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

removed during treatment

Incompatible air delivery system being

use Pressure settings are too lo

w for the air

delivery components being used.

Use only equipment as recommended and supplied by ResMed.

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

Learn Circuit failed

• The circuit configuration is ropriate as the impedance

inapp detected is too high.

• Too many components have been

included or the

impedance of

Review the components included in the circuit configuration

and adjust as appropriate, then rerun Learn Circuit (see “Setup menu” on page 16).

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

The delivered airflow is not humid/heated

although the H4i humidifier is

in use

The humidifier is not properly at

tached. Correctly attach the humidifier.

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

tery use or not connected to the

bat mains.

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

ser

vicing.

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 ha

ve enough space available, is

Consult your clinician.

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

our clinician.

FiO

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

Problem / possible cause Solution

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

LCD: is displayed in the header.

Battery is not charging.

Technical specifications

exceeded one year please replace the FiO

sensor and start calibration again.

•

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 son the

device again.

English

Operating pressure ra

nge

Maximum single fault p

ressure

Maximum breathing

esistance under single

r fault

Maximum flow > 200 L/min at 20 cm H

• IPAP: 2 cm H2O to 40 cm H2O (in S, ST, T, PAC mode)

• PS: 0 cm H

• EPAP: 2 cm H

mode)

• CPAP: 4 cm H

• Min PS: 0 cm H

• Max PS: 0 cm H

Note: iVAPS mode is only available in Stellar 150.

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

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

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)

60 cm H2O (in all modes)

O at 30 L/min;

2 cm H

7. 2 c m H

O at 60 L/min

Flow accuracy ± 5 L/min or 20% measured value, whichever is greater

O, EPAP: 2 cm

Therapy pressure to

lerance

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. 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

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

32 dBA with uncertainty of 3 dBA as measured according to ISO 1

7510 – 1:2007.

Alarm Volume Range

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

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 & R

espiratory Equipment - Conical

Connectors

Pressure measurement Internally mounted pressure transducer Flow measurement Internally mounted flow transducer

27Technical specifications

Power supply AC 100–240V, 50–60Hz, 2.2 A, max. 65 W External DC Power

ply (isolated)

Sup

24 V, 3 A

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

below).

Patient type: home chronic; pressure: IPAP/EPAP 15/5 cm

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

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

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

Housing construction Flame retardant engineering therm Environmental

ditions

con

• Operating temperature: 0°C to 35°C

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

oplastic

• Storage and transport temperature: -20°C to 60°C (+50°C*)

• Storage and transport humidity: 10%–95% noncond

ensing

• Air pressure: 680hPa to 1,100hPa; Altitude: 3,000 m

*NONIN XPOD

Electromagnetic compatib

ility

Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, comm

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

ctromagnetic

emissions and immunity” on page 29.

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

IEC 60601-1

sifications

clas

Flexible plastic, 1.83 m length (15 mm diameter)

• 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 F

ederal 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 Stellar meets RTCA/ DO-160 requirements.

This device is not suitable for use in the p

resence of a flammable anesthetic mixture.

Notes:

• The manufacturer reserves the right to chan

• Pressure may be displayed in cm H

ge these specifications without notice.

O or hPa.

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.

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 device 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

000-4-5

Voltage dips, sho

rt 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

IEC606 01-1-2 test level

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV for input/output

ines

±1 kV differential mode

±2 kV common mode

<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

Class A

Complies

Compliance level Electromagnetic environment –guidance

±6 kV contact ±8 kV air

±2 kV

±1 kV

±1 kV differential mode

±2 kV common mod

< 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

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.

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 co

mmercial or hospital environment.

Mains power quality should be that of a typical

mmercial or hospital environment.

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.

English

29Technical specifications

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:

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

rom 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 3 V/m.

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 user 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.

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms

3 V/m

d = 1.17 √P

d = 1.17 √P 80 MHz to 800 MHz d = 2.33 √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:

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 = 1.17 √P

800 MHz to 2.5 GHz d = 2.33 √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1. 17 1. 17 2.33

10 3.70 3.70 7. 3 7

100 11.7 0 11. 70 23.30

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

- 20 °C

+ 60 °C

- 4 °F

+ 140 °F

LATEX

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

Bell (Remote Alarm);

IP31 Device is protected against solid foreign objects of 2.5 mm

diameter and greater and vertically falling water drops; Caution; General warning

sign (see H4i connector plug and AC conn

state for a part of equipment; Connection for oxygen supply;

min); Data port; CE labeling in accordance with EC di

ection on the device); Standby or preparatory

max 30 l/min

(max 30 L/

rective 93/42/EEC, class II b;

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

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-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 prod may not be disposed of together with general ho

usehold waste, but instead requires

uct bearing this symbol

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

y mass, more than 0.002 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,

please 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.

English

31Technical specifications

General warnings and cautions

WARNINGS

A warning alerts you to possible injury.

• Read the entire manual before using the device.

• T

his device should only be used with air tubing and accessories recommended by ResMed or the prescribing clinician. Use of incorrect air tubing and accessories may affect the functioning of this device.

• T

he device and the accessories are to be used for the specified intended use only.

he device must only be used with masks (and connectors1) recommended by

• T ResMed, or by a clinician or r the device is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked.

Explanation:

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 failure2 or machine malfunction, remove the mask or the catheter mount from the trac

• Explosion hazard – do not use in the vicinit

• Do no

performance.

• Only use orignal and appro Use only accessories from the original package. If the packaging is damaged, the

•

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.

• No modification of this equipment is allowed.

The Stellar is intended to be used with special masks (or connectors1)

t use the device if there are obvious external defects, unexplained changes in

CAUTIONS

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

• When

• At

• T

•

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

using accessories, read the manufacturer’s User Manual. For consumables

important information can be provided on the packaging, see also symbols on page 31.

low pressures, the flow through the mask vent holes may be inadequate to clear all

exhaled gas, and some rebreathing may occur.

he device may not be exposed to excessive force. If the device should fall accidentally on the ground, please contact your authorised service agent.

authorised service agent.

espiratory therapist. A mask should not be used unless

heostomy tube.

y of flammable anesthetics.

ved ResMed accessories and parts.

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

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

Notes:

A note advises to special product features.

• The above are general warnings and cautions. notes appear next to the relevant instructions in the user guide.

• Only trained and authorised personn

• Position the device ensuring the powe

outlet.

el are allowed to make clinical setting changes.

Further specific warnings, cautions and

r cord can be easily removed from the power

English

33General 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 and tubing)—excluding single-use devices

• Accessories—excluding single-use devices

• Flex-type finger pulse sensors

• Humidifier water tubs

• Batteries for use in ResMed internal and e

systems

• Clip-type finger pulse sensors

• CPAP and bilevel device data modules

• Oximeters and CPAP and bilevel de

• Humidifiers and humidifier cleanable w

• Titration control

• CPAP, bile

power supply units)

• Battery accessories

• Portable diagnostic/screening devices

This warranty is only available to the initial If the product fails under cond

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

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, pip 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

purchase. This warranty replaces all other expressed

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 regio ResMed dealer or ResMed office.

devices

vel and ventilation devices (including external

itions of normal use, ResMed will repair or replace, at its

product must be made by the initial consumer at the point of

n. For further information on your warranty rights, contact your local

vice oximeter adapters

n, headgear

xternal battery

ater tubs

consumer. It is not transferable.

sed as a result of improper use,

e, cigar or other smoke; and d) any

or implied warranties, including any implied

90 days

6 months

1 year

2 years

ages claimed to

R001-325/2 09 09

Respiratory Care Solutions

Making quality of care easy

248578-Eng/1 2012-06

Stellar 100 Stellar 150

USER

EUR1

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.

For patent information, see www.resmed.com/ip ResMed, SlimLine, SmartStart, Stellar, and TiCONTROL are trademarks of ResMed Ltd. ResMed, SlimLine, SmartStart and Stellar are registered in U.S. Patent and Trademark Office. © 2012 ResMed Ltd

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

ResMed Stellar 100, Stellar 150 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Introduction

Indications for use

Contraindications

Adverse effects

Stellar at a glance

Patient interface

Humidification

Internal battery

ResMed USB stick

Use on an aircraft

Mobile use

Remote Alarm

Setting up for noninvasive use

Attaching the H4i heated humidifier for noninvasive use

Setting up for invasive use

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

Attaching an antibacterial filter

Stellar basics

About the control panel

LCD screen

Starting therapy

Performing a functional test

Starting therapy

Stopping therapy

Turning off the power

Working with alarms

Tailoring treatment setup options

Using mask-fit

Using the menus

Setup menu

Setup menu: Clinical Settings (Mask Type)

Setup menu: Alarm Settings (Alarm Volume)

Setup menu: Options

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

Servicing

Troubleshooting

Alarm troubleshooting

Other troubleshooting

Technical specifications

Guidance and manufacturer’s declaration – electromagnetic emissions and immunity

Symbols

General warnings and cautions

Limited warranty