ResMed Stellar 100, Stellar 150 User Manual

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).

+ 28 hidden pages