ResMed 248551-1, 2011-09 User Manual

Stellar™ 100 Stellar
InvasIve and nonInvasIve
ventIlator
User Guide
English
150
Respiratory Care Solutions
Making quality of care easy
Respiratory Care Solutions
Making quality of care easy
Stellar™ 100 Stellar™ 150
User Guide
English

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
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
i
Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Daily 19 Weekly 20 Monthly 20 Replacing the air filter 20 Disinfection 20 Multipatient use 21 Servicing 21
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Alarm troubleshooting 21 Other troubleshooting 24
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Guidance and manufacturer’s declaration – electromagnetic emissions and immunity 28 Symbols 30
General warnings and cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
ii

Introduction

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

Indications for use

The Stellar is intended to provide ventilation for non-dependent, spontaneously breathing adult and paediatric patients (13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnoea. The device is for noninvasive use, or invasive use with an uncuffed or deflated tracheostomy.
Users of the device include patients therapists and other clinical staff. Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.

Contraindications

The Stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. The Stellar is not a life support ventilator.
If you have any of the following conditions, tell your docto
pneumothorax or pneumomediastinum
pathologically low blood pressure, particularly if associated wi
depletion
cerebrospinal fluid leak, recent
severe bullous lung disease
dehydration.
The use of the Stellar or pulse environment.

Adverse effects

You should report unusual chest pain, severe headache or increased breathlessness to your prescribing physician.
The following side effects may arise during the cou device:
drying of the nose, mouth or throat
nosebleed
bloating
ear or sinus discomfort
eye irritation
skin rashes.
and their caregivers, physicians, nurses, respiratory
r before using this device:
th intravascular volume
cranial surgery or trauma
oximetry (in
cluding XPOD) is contraindicated in an MRI
se of noninvasive ventilation with the
r
English
1Introduction

Stellar at a glance

Handle

H4i connector
plug and AC
connection
Infrared connection
for humidifier
XPOD pulse oximeter connection
Air outlet
FiO2 sensor connection
Data port for USB stick
Data port for direct PC connection
Oxygen inlet
Air filter cover
DC power socket
AC power socket
Power-on/standby switch
The Stellar comprises:
• Stellar device • Hypoallergenic air filter • AC power cord • Carry bag • 2 m
air tubing •
ResMed USB stick • Low pressure oxygen connector. The following optional components are compatible with S
• 3 m air tubing • SlimLine™ air tubing • Clear air tubing (disposable) • H4i™ heate
tellar:
d humidifier • Antibacterial filter • Heat moisture exchanger filter (HMEF) • ResMed XPOD oximeter • Nonin™ pulse oximetry sensors • FiO adapter) • FiO
monitoring sensor • Stellar Mobility bag • ResMed leak port • Tubing wrap.
2
monitoring kit (external cable, T-piece
2
WARNING
The Stellar should only be used with air tubing and accessories recommended by ResMed. Connection of other air tubing or accessories could result in injury or damage to the device.
ResMed regularly releases new products. Please check the catalogue of ventilation
cessories on our website at www.resmed.com.
2
ac

Patient interface

Both masks and tracheostomy tubes can be used with Stellar. To set the patient interface type go to the Setup menu, select Clinical Settings, then Advanced Settings.
For information on using masks, see the for this device, see the Mask/Device Compatibility List on www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.
mask manual. For a full list of compatible masks

Humidification

A humidifier is recommended especially for patients experiencing dryness of the nose, throat or mouth. For information on using a humidifier as part of:
noninvasive ventilation, see “Setting up for noninvasive use” on page 4.
invasive ventilation, see “Setting up for invasive use” on page 5.

Internal battery

CAUTION
The internal battery must be replaced every two years from the manufacturing date of the Stellar. Replacement of the internal battery should only be performed by an authorised service agent.
Note: The battery duration depends on the state of c the condition and age of battery, the device settings and the patient circuit configuration.
In case of a mains power disruption, the device will operate using the inte there is no external battery connected to the device. The internal battery will operate for approximately two hours under normal conditions (see “Technical specifications” on page 26). The power status of the battery is displayed on top of th battery status regularly while operating device in time to mains power or alternatively to the external battery.
Additionally the Internal battery use alarm to clear the alarm.
To recharge the internal battery, connect the device to main hours to fully recharge the internal battery, however this can vary depending on environmental conditions and if the device is in use.
the device with the internal battery and connect the
will be d
harge, the environmental conditions,
rnal battery if
e LCD screen. Check the
isplayed. Press the Alarm mute button
s power. It can take
up to three
Storing
The internal battery has to be discharged and recharged every six months.
1 Remove the power cord while the Stellar is providing therapy and let the device operate
with the internal battery to a charge level of 50%.
2 Reconnect the power cord to the mains power while the device is operating. The internal
battery will be recharged.
Note: If the level of approximately 50% to increase the durability.
device is stored for a longer period the internal battery should be at the charge

ResMed USB stick

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

Use on an aircraft

ResMed confirms that the Stellar can be used during all phases of air travel without further testing or approval by the airline operator. See “Technical specifications” on page 26.
English
3Stellar at a glance

Mobile use

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

Setting up for noninvasive use

WARNING
The air filter cover protects the device in the event of accidental liquid spillage
onto the device. Ensure that the air filter and air filter cover are fitted at all times.
Make sure that all the air inlets at the rear of the d
vents at the masks or at the leak port are unobstructed. If you put the device on the floor, make sure the area is free from dust and clear of bedding, clothes or other objects that could block the air inlets.
Hoses or tubes must be non-conductive and antistatic.
Do not leave long lengths of the air tubing or the cable for the finger pulse sensor
arou
nd the top of your bed. It could twist around your head or neck while you are
sleeping.
CAUTION
Be careful not to place the device where it can be bumped or where someone is
likely to trip over the power cord.
Make sure the area around the device is dry and clean.
Notes:
ResMed recommends using the AC power cord supplied with the
power cord is required, contact your ResMed Service Centre.
Place the device on a flat surface near the head
2
evice and under the device and
unit. If a replacement
of the bed.
3
4
5
1
AC power cord

AC locking clip

1 Connect the power cord. 2 Plug the free end of the power cord into a power outlet. 3 Attach the H4i heated humidifier to the front of the Stellar.
If the H4i is not in use, and if applicable, conn outlet of the device (see “Attaching an antibacterial filter” on page 9).
ect the antibacterial filter firmly onto the air
4 Connect one end of the air tubing firmly onto the air outlet of the H4i. 5 Connect the mask system to the free end of the air tubing. 6 Select the mask type (select Setup menu, then Clinical Settings, then Advanced Settings). 7 Perform Learn Circuit (see “Setup menu: Options” on page 16).
4

Attaching the H4i heated humidifier for noninvasive use

Use of the H4i heated humidifier may be recommended by your clinician. For information on using the H4i, see the H4i user guide.
WARNING
Always place the H4i on a level surface below the level of the patient to prevent
the mask and tubing from filling with water.
Make sure that the water chamber is empty and thoroughly dried before
sporting the humidifier.
tran
The H4i heated humidifier is not intended for mobile use.
Do not overfill the water chamber, as during use this will cause water to spill into
th
e air circuit.
For optimal accuracy and synchrony, perform Learn Circuit with a change of the
ci
rcuit configuration, in particular when adding or removing high impedance components (eg, antibacterial filter, external humidifier, water trap, nasal pillow type mask or air tubing). See “Setup menu: Options” on page 16.
CAUTION
Check the air circuit for water condensation. Use a water trap or a tubing wrap if humidification is causing water condensation within the tube.
Notes:
A humidifier increases resistance in the air
and
accuracy of display and delivered pressures. Therefore perform the Learn Circuit function (see “Setup menu: Options” on page 16). The device adjusts the airflow resistance.
The heating feature of the H4i is disabled when the de
circuit and may affect triggering and cycling,
vice is not mains powered.

Setting up for invasive use

The Stellar can be used invasively only with the ResMed leak port and an uncuffed or deflated cuff tracheostomy tube.
WARNING
When using a Heated Moisture Exchange Filter (HMEF), replace the HMEF
regularly as specified in the instructions provided with the HMEF.
The H4i is contraindicated for invasive use. An external humidifier approved for
invasi
ve use is recommended according to EN ISO 8185 with an absolute
humidity of > 33 mg/L.
For optimal accuracy and synchrony, perform Learn Circuit with a change of the
ci
rcuit configuration, in particular when adding or removing high impedance components (eg, antibacterial filter, external humidifier, water trap, nasal pillow type mask or air tubing). See “Setup menu: Options” on page 16.
CAUTION
When using a humidifier check the breathing system regularly for accumulated water.
Note: W automatically enabled to alert you when the leak port has no vent holes or when the vent holes are blocked.
hen the mask type is set to Tr
a c h , the Non-Vented Mask alarm will be
English
5Setting up for invasive use
Leak Circuit configuration
2

Antibacterial filter

Catheter mount**
ResMed leak port
HMEF*
1
5
3
6
4
External humidifier*
AC power cord
AC locking clip
Air tubing
1 Connect the power cord. 2 Plug the free end of the power cord into a power outlet. 3 Connect the antibacterial filter firmly onto the air outlet of the device. 4
Connect the external humidifier to the other side of the antibacterial filter. *If not using an external humidifier, the HMEF can be connected to the leak port (at step 9).
5 Connect the air tubing to the external humidifier. 6 Connect the leak port to the air tubing. 7 Select the mask type Tr a c h (select Setup menu, then Clinical Settings, then Advanced
Settings).
8 Perform Learn Circuit (see “Setup menu: Options” on page 16). 9 If an external humidifier is not being used, you can connect the HMEF to the leak port if
necessary.
10 Connect the catheter mount.
** The leak port or the HMEF can be including connector pieces like catheter mounts.
The catheter mount and the external humidifier are not part of
connected to standardised tracheostomy interfaces
the ResMed component.
10
6

Working with other optional accessories

Attaching the pulse oximeter

1
2
Use of a pulse oximeter may be recommended by your clinician.
Contraindication
The pulse oximeter does not meet defibrillation-proof requirement per IEC 60601-1: 1990, clause 17.h.
1 Connect the plug of the finger pulse sensor to the plug of the pulse oximeter. 2 Connect the plug of the pulse oximeter at the rear of the device.
To view the oximetry values, from the Monitoring menu, select Monitoring.

Adding supplemental oxygen

Oxygen may be prescribed by your clinician.
Note: Up to 30 L/min at maximum oxygen pressure of 50 mbar (0.73 psi) can be added.
WARNING
Oxygen flow must be turned off when the device is not operating, so that unused
oxygen does not accumulate within the device and create a risk of fire.
Use only certified, clean oxygen sources.
ResMed strongly recommends adding oxygen into Stellar’s oxygen inlet at the
rear of th a side port or at the mask, has potential to impair triggering and accuracy of therapy/monitoring and alarms (eg, High Leak alarm, Non-vented mask alarm). If used in this way, therapy and alarm operation must be verified each time oxygen flow is adjusted.
O
presence o
The breathing system and the oxygen s
distance of 2 m away from any sources of ignition (eg, electrical devices).
Oxygen must not be used while the device is being operated within the mobility bag.
e device. Entraining oxygen elsewhere, ie into the breathing system via
xygen supports combustion. Oxygen must not be used while smoking or in the
f an open flame. Only use oxygen supply in well-ventilated rooms.
ource must be kept at a minimum
English
7Working with other optional accessories
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