Stellar 150 Clinical Guide May 2012

Using the menus

Setting up for non-invasive use For full setup, see page 14.

2

MONITORING

3

Treatment

4

SETUP

INFO

Clinical Settings

Event Summary

5

1

Monitoring

Pressure / Flow AC locking clip AC power cord

For full setup, see page 16.

Catheter mount

Learn Circuit configuration

Leak

ResMed Leak Valve HMEF Antibacterial filter

Tidal Volume

10

5

1

Minute Ventilation

Tidal Volume

Options

For full Setup menu details, see: • Clinical Settings on page 34 • Alarm Settings on page 38 • Options on page 43

Respiratory Rate

I:E Ratio

Pressure Support Synchronisation

3

AHI

6 4 External humidifier AC power cord AC locking clip

Alarm Settings

Min Vent/Resp Rate or MV/Va (iVAPS Mode)

Setting up for invasive use

2

Leak

Air tubing

Accessing Clinical Mode

Oximetry SpO2

Used Hours

Device Information

Reminder

Respiratory Care Solutions

Making quality of care easy

Respiratory Care Solutions

Making quality of care easy

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Contents Introduction... 1 Indications for use Contraindications Adverse effects

1 1 1

About Stellar 150 therapy modes... 2 Common setting parameters More about iVAPS

2 4

Ensuring successful ventilation with Stellar... 7 Learn Circuit Vsync and mask selection TiControl Trigger/Cycle sensitivities Rise/Fall Time Pathology Defaults

7 7 9 9 10 10

Stellar 150 at a glance... 11 Patient interface Humidification Internal battery ResMed USB stick Use on an aircraft Mobile use Remote Alarm

12 12 12 13 13 13 13

Setting up for noninvasive use... 14 Attaching the H4i heated humidifier

15

Setting up for invasive use... 16 Setting up for home therapy... 17 Working with other optional accessories... 18 Attaching a pulse oximeter Adding supplemental oxygen Starting therapy using oxygen Stopping therapy using oxygen Using the FiO2 monitoring sensor Attaching an antibacterial filter

18 19 19 19 20 21

Stellar 150 basics... 22 About the control panel

22

Starting therapy... 23 Performing a functional test Starting therapy Stopping therapy Turning off the power Working with alarms Tailoring treatment setup options Programs Using mask-fit

23 24 25 25 25 26 27 27

Using the menus... 28 Monitoring menu... 31 Setup menu... 34 Accessing Clinical mode Setup menu: Clinical Settings Setup menu: Alarm Settings Testing the alarms Setup menu: Options

34 34 38 40 43

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Setup menu: Configuration Menu

44

Info menu... 46 Event Summary General therapy information Apnea/Apnea Hypopnea Index Used Hours Device information Reminders

46 46 47 47 47 48

Configuring iVAPS... 48 Using Learn Targets Manually setting iVAPS Assessing the clinical outcome

48 50 51

Data management... 52 Cleaning and maintenance... 53 Daily Weekly Monthly Replacing the air filter Multipatient use Servicing

53 53 53 54 55 55

Clinical titration guide... 56 Mouth leaks Setting TiControl EPAP/PEEP Trigger/cycle sensitivities

56 56 57 57

Troubleshooting... 58 Alarm troubleshooting Other troubleshooting

58 61

Technical specifications... 64 Guidance and manufacturer’s declaration – electromagnetic emissions and immunity Symbols

68 69

General warnings and cautions... 70 Limited warranty... 72

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Introduction Read the entire manual before using the device.

Indications for use The Stellar 150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb/13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea. 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.

CAUTION (USA ONLY) Federal law restricts this device to sale by or on the order of a physician.

Contraindications The Stellar 150 is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. The Stellar 150 is not a life support ventilator. The use of the device may be contraindicated in patients with: • pneumothorax or pneumomediastinum • pathologically low blood pressure, particularly if associated with intravascular volume depletion • cerebrospinal fluid leak, recent cranial surgery or trauma • severe bullous lung disease • dehydration. The use of the Stellar 150 or pulse oximetry (including XPOD) is contraindicated in an MRI environment.

Adverse effects Patients should report unusual chest pain, severe headache or increased breathlessness. The following side effects may arise during the course of noninvasive ventilation with the device: • drying of the nose, mouth or throat • nosebleed • bloating • ear or sinus discomfort • eye irritation • skin rashes.

Introduction

1

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About Stellar 150 therapy modes Stellar provides a number of therapy modes to suit a variety of ventilation requirements. Regardless of the mode, Stellar 150 assists spontaneous breathing by providing two pressures in response to the patient flow or a preset fixed time.

Common setting parameters The inspiratory positive airway pressure (IPAP, or the sum of PEEP and Pressure Support/PS) assists inspiration. The lower expiratory positive airway pressure (EPAP or PEEP) eliminates exhaled air through the exhaust vent. This pressure also provides a stent to maintain an open upper airway, improves small airway recruitment and therefore oxygenation and may improve triggering in some patients with intrinsic PEEP. The difference of the two pressures-Pressure Support/PS-contributes to improved patient ventilation. One Breath Cycle

Pressure

Ti Max Ti Min IPAP Pressure Support EPAP / PEEP

Rise time

Fall time

0

Stellar provides the following modes: • CPAP mode-a fixed pressure is delivered. • S (Spontaneous) mode-the device senses the patient breath and triggers IPAP in

response to an increase in flow, and cycles into EPAP at the end of inspiration. The breath rate and the respiratory pattern will be determined by the patient. • ST (Spontaneous/Timed) or PS (Pressure Support) mode-the device augments any

breath initiated by the patient, but will also supply additional breaths should the patient breath rate fall below the clinician's set ’backup’ breath rate. • T (Timed) mode-the fixed breath rate and the fixed inspiration time set by the clinician are

supplied regardless of patient effort. • PAC (Pressure Assist Control)-the inspiration time is preset in the PAC mode. There is no

spontaneous/flow cycling. The inspiration can be triggered by the patient when respiratory rate is above a preset value, or time triggered breaths will be delivered at the backup breath rate. • iVAPS (intelligent Volume Assured Pressure Support)-designed to maintain a preset

target alveolar ventilation by monitoring delivered ventilation, adjusting the pressure support and providing an intelligent backup breath automatically. The iVAPS therapy mode is indicated for patients 66 lb (30 kg) and above.

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These therapy modes (excluding CPAP mode-where a single level of continuous pressure is delivered) are shown below. Very short breath (Restrictive lungs)

Long breath (Leak or obstructive lungs)

Inspiration Patient Effort

No breath effort

Expiration

Leak flow

IPAP S

Ti Min

Ti Max

Ti Min

Ti Max

EPAP

IPAP One breath cycle S/T EPAP

IPAP

T

One breath cycle Ti EPAP

IPAP One breath cycle PAC

Ti EPAP

iVAPS

One breath cycle

PS

Ti Min

Ti Max

PEEP

Machine initiates inspiratory phase increasing pressure up from EPAP/PEEP Inspiratory phase cycled down to EPAP/PEEP at Ti Max (S/ST mode) or Ti (PAC/T mode) Inspiratory phase sustained up to Ti Min Ti Min Ti Max Ti One breath cycle Period of increased leak

About Stellar 150 therapy modes

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More about iVAPS The iVAPS therapy mode is indicated for patients 66 lb (30 kg) and above. You may prefer some assurance that the patient's ventilatory needs will be maintained if their condition varies. A variety of ‘dual mode’ schemes exist, that aim to combine the benefits of pressure target and volume target, most of which can be categorized generically as volumeassured pressure support, or VAPS modes. With VAPS devices in general, the ventilatory assistance (pressure support) aims to automatically adjust to changes in patient condition over time, typically to maintain a target tidal volume.

iVAPS offers the comfort and synchrony of pressure support, but with the assurance offered by a volume target. iVAPS has the following advantages over traditional VAPS schemes: • iVAPS is a unique combination for a servo-controlled ventilator, in that iVAPS has the goal of regulating alveolar ventilation to a prescribed target, and iVAPS has a rapid but gentle servocontrol response. iVAPS is tuned to be fast enough to avoid blood-gas derangement associated with most breathing challenges, including during sleep, but is gentle enough to avoid disruption. • iVAPS has an intelligent Backup Rate (iBR) which aims to keep ‘out of the way’ while the

patient is breathing, yet during sustained apnea will mimic the patient's own breath rate. This contributes to iVAPS’ ability to maintain its ventilation target and so stabilize blood gases even during sleep. • iVAPS has ResMed’s robust leak compensation feature (Vsync), a product of ResMed’s long

experience in noninvasive ventilation. This promotes synchrony and comfort even during significant leak. Pressure support is adjusted continuously during the inspiration phase breath to breath, aiming to maintain target alveolar ventilation. If ventilation falls, pressure support is increased until the target is reached. Conversely, if alveolar ventilation rises above target, pressure support falls. The range of pressure support adjustment is constrained within Min PS and Max PS. The rate of increase in pressure support can reach up to 0.7 cm H2O/sec. The breath to breath changes in pressure support depend on the breath rate and how far the patient is from the target alveolar ventilation. Typically the change in pressure support does not exceed 3 cm H2O per breath. iVAPS provides benefits across a range of situations. For example, it can benefit patients with a progressive lung condition, because the ventilation target can be maintained despite degradation of lung mechanics or muscle function. Similarly, iVAPS offers advantage in nocturnal hypoventilation. iVAPS, by providing pressure support when required, is more comfortable and better tolerated. Some key concepts important to clinical understanding of iVAPS operation are discussed below, ahead of guidance on the iVAPS setup procedure on Stellar 150. See “Configuring iVAPS” on page 48. 4

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Target alveolar ventilation iVAPS targets alveolar ventilation. Alveolar ventilation was chosen because it is at the level of the alveoli that gas exchange occurs. Total ventilation includes the ventilation devoted to the conducting airways, whereas alveolar ventilation best represents the useful portion of ventilation that reaches the alveoli. Alveolar ventilation cannot be measured directly, so iVAPS estimates it using a height approximated value of anatomical deadspace as shown in the graph below. Anatomic deadspace is the amount of breath that remains in the conducting airways, which does not reach alveoli and does not contribute to gas exchange. Its contribution is proportional to breath rate. By using alveolar ventilation as a servo-ventilation target, as opposed to tidal volume or total ventilation, the effect of respiratory rate change on effective ventilation is negated. Anatomical Deadspace Estimation 225

Anatomical Deadspace Estimate (ml)

200

iVAPS Deadspace Estimation

175

150

125

100

75

50

25 35

35

40

45

50

55

60

65

70

75

80

Height (in)

Adapted from Hart MC et al. Journal Applied Physiology.18(3), p519-522. 1963

Target Patient Rate iVAPS has a novel approach to providing a backup rate. Instead of mandating a fixed backup rate, iVAPS’ intelligent Backup Rate (iBR) will shift automatically between two limits, according to the context. The benefit of this approach is improved synchrony, while maximizing iVAPS’ ability to maintain the target ventilation, at minimal pressure support. • During sustained apnea, the iBR will adopt a pre-configured Target Patient Rate. This Target Patient Rate defines the upper boundary for iBR. You set the Target Patient Rate to match the patient’s average spontaneous rate (unlike a traditional backup rate). • During spontaneous ventilation, the iBR adjusts to remain well in the background, at 2/3rd of

the Target Patient Rate. This ‘background’ backup rate gives the patient maximum opportunity to spontaneously trigger. • When spontaneous triggering ceases (eg, at the onset of an apnea), the iBR adjusts from its

background frequency to its Target Patient Rate. It will adjust quickest typically (within 4-5 breaths) when ventilation is below the target ventilation. • A single spontaneous triggered breath resets the iBR to its background rate (2/3rds of Target

Patient Rate).

About Stellar 150 therapy modes

5

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iBR brings the patient back on target when back-up breaths are required

Breaths per minute

Patient effort

No Patient effort

Patient effort

15

10

Time Target patient rate

Patient spontaneous rate

iVAPS intelligent back-up rate (iBR)

Min/Max PS The default settings for maximum and minimum pressure support are normally adequate, but you may wish to alter them in some patients. Min PS and Max PS define the range of pressure support adjustment available to the iVAPS algorithm as it regulates alveolar ventilation. It is recommended that Max PS be set high enough to allow the alveolar ventilation target to be met, while exercising clinical judgement over considerations such as patient comfort and tolerance, lung mechanics, age, mask seal, etc. It is recommended that Min PS is left at the level set when learning the patient’s ventilation target unless the patient finds this too little for comfort.

6

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Ensuring successful ventilation with Stellar Successful ventilation, whether using a mask or tracheostomy tube, relies on improving gas exchange and reducing the work of breathing for the patient. Maintaining patient-device synchrony and managing leak is critical to achieving this. A good device should help this by: • monitoring and compensating for leak • accurately sensing the start and end of a patient’s inspiratory effort for triggering and cycling • responding quickly to reach and maintain the set pressure • offering flexibility of settings to accommodate pathological variations in the patient’s

respiratory timing/pattern. Stellar effectively provides this capability through: • Learn Circuit-method to calculate circuit impedance so that pressure can be controlled and estimated at the patient’s airway • Vsync- an automatic algorithm to compensate for unintentional leak • Mask selection-a correct selection indicates to Stellar how much leak through the mask

vent or ResMed Leak Valve can be expected as the therapy pressure varies • Mask fit-ensures an optimal seal for the patient interface to avoid unintentional leak • TiControl-offers control over the inspiratory time limits between which the patient can

spontaneously cycle • Trigger/Cycle sensitivities-five sensitivities for triggering and cycling offer flexibility to

personalize therapy and accommodate a range of patient conditions • Rise/Fall Time-adjustable duration for transitions to both inspiration and expiration offer

opportunity for maximal comfort • Pathology Defaults-offer a choice of disease-specific preset setting values to facilitate a

quick and sensible starting point to therapy.

Learn Circuit The Learn Circuit procedure permits optimal therapy and monitoring accuracy, by measuring and storing the breathing system impedance up to and including the vent. This allows the device to accurately estimate the therapy pressure. For more information on performing a Learn Circuit, see “Setup menu: Options” on page 43.

Vsync and mask selection Stellar’s unique leak management combines Vsync and Mask Selection to monitor leak ie, unintentional mask leak and vent leak, and effectively compensate for its potentially detrimental effect on therapy. It is important for a device to monitor the patient’s respiratory flow, which provides information about lung ventilation and timing of the patient’s effort. Using the respiratory flow signal, the device is able to trigger and cycle breaths that synchronize closely with the patient’s effort. Leak flow, both unintentional and from the mask/inline vent, adds to the Total Flow measured by the device’s flow sensor and obscures the true Respiratory Flow. Without leak compensation, this would cause asynchronous triggering and cycling, as well as inaccurate data monitoring which may impact clinical decision-making. Stellar is able to extract the patient’s Respiratory Flow from the Total Flow. It uses information from Mask Selection to accommodate for mask/in-line Vent Leak, and Vsync to compensate for Unintentional Leak. That is: Estimated Respiratory Flow = Total Flow – (Vent Leak + Unintentional Leak)

Ensuring successful ventilation with Stellar

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Unintentional leak

Mask vent leak Patient respiratory flow Total flow

Unintentional leak may arise due to factors such as poor mask fit, mask movement during sleep, and fast therapy pressure transitions. When an unintentional leak is introduced (see below graph), synchrony between the device and the patient is disrupted. The increased flow from a leak can be interpreted as patient inhalation and cause the ventilator to trigger from EPAP to IPAP out of time with the patient’s actual effort (A). Vsync responds rapidly to correct the disruption and restore synchrony within 2-6 breaths (B) depending on the patient’s respiratory rate and the size of the leak. Unintentional leak introduced Period of asynchrony Therapy pressure Patient effort

A

B

Total flow Estimated patient respiratory flow Unintentional leak

Unintentional leak flow varies with changes to therapy pressure or the size of the leak opening. Vsync calculates changing leak by: • monitoring average pressure and flow • assuming that on average volume delivered to the patient is equal to volume exhaled by the patient • using this information to continuously estimate the size of the leak opening as it changes • calculating the air flowing through the opening, knowing its size and the therapy pressure.

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TiControl TiControl™ allows the clinician to set minimum and maximum inspiratory time limits. Ti Min and Ti Max can be set to either side of the patient's ideal spontaneous inspiratory time, ensuring adequate time for gas exchange and offering a ’window of opportunity’ to cycle into EPAP. Ti Max Ti Min

Cycle Window

Patient flow

Pressure

For some patients whose inspiratory effort or flow are weak and insufficient, Ti Min prevents the premature cycling to EPAP. Premature cycling to EPAP can result in insufficiently supported breaths. When breath detection becomes difficult due to excessive leak or inhibited exhalation effort or flow, Ti Max effectively prevents prolonged inspiration. See “Setting TiControl” on page 56.

Trigger/Cycle sensitivities Under normal conditions, the device triggers (initiates IPAP) and cycles (terminates IPAP and changes to EPAP) as it senses the change in patient flow. Patient breath detection is enhanced by the device’s automatic leak management feature-Vsync. In addition, the device has five adjustable trigger/cycle sensitivities to optimize the sensing level according to patient conditions. For more information, see “Trigger/cycle sensitivities” on page 57. For characteristic data, see “Technical specifications” on page 64. Adjustable Trigger Sensitivity

Adjustable Cycle Sensitivity

Very High Medium

Very Low Medium Very High Patient Flow

Very Low Patient Flow

Ensuring successful ventilation with Stellar

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Rise/Fall Time Rise Time sets the time taken for the device to reach the set inspiratory pressure after triggering. The greater the Rise Time value, the longer it takes for pressure to increase from EPAP to IPAP. A controllable Rise Time allows the clinician to optimize the patient’s work of breathing, comfort and synchrony. Fall Time sets the time taken for the device to reach the set expiratory pressure after cycling. The greater the Fall Time value, the longer it takes for pressure to decrease from IPAP to EPAP. Adjustable Fall Time may in certain patients improve breathing comfort and synchrony. For more information, see “Advanced Settings - Factory default settings and parameter ranges” on page 37.

Pathology Defaults

Setting

S ST T PAC iVAPS

The Pathology Defaults offer a choice of disease-specific preset setting values to facilitate efficient commencement of therapy. You can select from four sets of respiratory system mechanics. Before use you will need to review the set parameters on the Clinical Settings screen. Obstructive lung disease

Restrictive lung disease

Obesity Hypoventilation Syndrome

Normal lung mechanics

IPAP [cm H2O]

   

13

11

15

11

EPAP or PEEP [cm H2O]

    

5

5

7

5

PS [cm H2O]

   

8

6

8

6

Rise Time [ms]*

    

150

300

300

200

Fall Time [ms]*

    

200

200

200

200

Trigger sensitivity

 

 

Medium

Medium

Medium

Medium

Cycle sensitivity

 



High

Low

Medium

Medium

Min PS [cm H2O]



4

4

4

2

Max PS [cm H2O]



20

20

18

20

Ti Min [sec]

 



0.3

0.5

0.5

0.5

Ti Max [sec]

 



1.0

1.5

1.5

1.5

*The Rise/Fall Time milliseconds scale is an approximate only.

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Stellar 150 at a glance Handle

Oxygen inlet H4i connector plug and AC connection

Air outlet Air filter cover

Infrared connection for H4i humidifier

XPOD pulse oximeter connection FiO2 sensor connection Data port for USB stick

DC power socket AC power socket Power on/stand-by switch

Remote alarm connection Data port for direct PC connection

The Stellar 150 comprises: • Stellar 150 device • Hypoallergenic air filter • AC Power cord • Carry bag • 6’ 6” (2 m) air tubing • ResMed USB stick • Low pressure oxygen connector. The following optional components are compatible with Stellar 150: • 9’ 10” (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 • FiO2 monitoring kit (external cable, T-piece adapter) • FiO2 monitoring sensor • Stellar Mobility bag • ResMed Leak Valve • Tubing wrap.

WARNING The Stellar 150 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 accessories on our website at www.resmed.com. Stellar 150 at a glance

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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 mask manual. For a full list of compatible masks 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.

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 14. • invasive ventilation, see “Setting up for invasive use” on page 16.

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 authorized service agent. Note: The 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 operate using the internal battery if 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 64). The power status of the battery is displayed on top of the LCD screen. Check the battery status regularly while operating the device with the internal battery and connect the device in time to mains power or alternatively to the external battery. Additionally the Internal battery use alarm will be displayed. Press the Alarm mute button to clear the alarm. To recharge the internal battery, connect the device to mains power. It can take up to three hours to fully recharge the internal battery, however this can vary depending on environmental conditions and if the device is in use. The internal battery has to be discharged and recharged every six months.

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

1

Remove the power cord while the Stellar 150 is turned on (stand-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: Check the charge level every six months, if necessary recharge the internal battery to a charge level of 50%.

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ResMed USB stick A ResMed USB stick may be used with the device either to help you to monitor the patient‘s treatment, to provide the patient with updated device settings or to transfer settings from one device to another. For more information, see “Data management” on page 52.

Use on an aircraft ResMed confirms that the Stellar 150 can be used during all phases of air travel without further testing or approval by the airline operator. See “Technical specifications” on page 64.

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.

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.

Stellar 150 at a glance

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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 device and under the device and 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. • 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

around the top of the bed. It could twist around the patient‘s head or neck while 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 unit. If a replacement

power cord is required, contact your ResMed Service Centre. • Place the device on a flat surface near the head of the bed.

2

3

4

5

1

AC locking clip AC power cord

14

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 150. If the H4i is not in use, and if applicable, connect the antibacterial filter firmly onto the air outlet of the device (see “Attaching an antibacterial filter” on page 21). 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 H2O at 30 L/min, 5 cm H2O at 60 L/min and 16 cm H2O at 120 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.

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6

Select the mask type (select Setup menu, then Clinical Settings, then Advanced Settings).

7

Perform Learn Circuit (see “Setup menu: Options” on page 43).

Attaching the H4i heated humidifier The Stellar 150 can be used with the H4i heated humidifier for noninvasive use when stationary. It will be automatically detected when the Stellar 150 is turned on. A humidifier is recommended especially for patients experiencing: • nasal stuffiness/congestion • rhinnorhea following the use of mask ventilation • dryness of the nose, throat or mouth • patients with thick secretions (eg, cystic fibrosis, bronchiectasis, etc) • patients using oxygen.

Humidification may be required for patients who experience nasal and upper airway dryness as a consequence of the high flow of air being directed through the nasal and oral passages. It may also be required in those individuals who have tenacious secretions. Mouth leaks occurring during the use of positive pressure therapy can significantly increase nasal resistance. This increase in nasal resistance associated with mouth leaks may be prevented by fully humidifying the inspired air. In most cases, using heated humidification is the most effective way to decrease nasal resistance. 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 transporting

the humidifier. • The H4i humidifier is not intended for mobile use. • 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 circuit

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 43.

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 43). The device adjusts the airflow resistance. • The heating feature of the H4i is disabled when the device is not mains powered.

Setting up for noninvasive use

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Setting up for invasive use The Stellar 150 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. • 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

invasive use is recommended according to EN ISO 8185 with an absolute humidity of > 33 mg/L and a maximum flow within the technical specifications of Stellar 150. • For optimal accuracy and synchrony, perform Learn Circuit with a change of the circuit

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 43.

CAUTION When using a humidifier, use a water trap and check the air circuit regularly for accumulated water. Notes: • When the mask type is set to Trach, the Non-Vented Mask alarm will be automatically

enabled to alert the user when the ResMed Leak Valve has no vent holes or when the vent holes are blocked. • ResMed recommends using a breathing system (including antibacterial filter, air tubings, external humidifier and ResMed Leak Valve) with an impedance of maximum 2 cm H2O at 30 L/min, 5 cm H2O at 60 L/min and 16 cm H2O at 120 L/min. Catheter mount** Learn Circuit configuration

ResMed Leak Valve HMEF*

2 Antibacterial filter

10

5

1 3

6 4 Air tubing External humidifier* AC power cord AC locking clip

16

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.