ResMed Stellar 150 Bedienungsanleitung

248369/5 2011-11

Stellar 150

CLINICAL

AMER ENG

Manufacturer: ResMed Germany Inc. Fraunhoferstr. 16 82152 Martinsried Germany

Distributed by: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.

ResMed Corp 9001 Spectrum Center Blvd. San Diego, CA 92123 USA.

ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK.

See www.resmed.com for other ResMed locations worldwide.

Protected by patents: AU 2002306200, AU 2002325399, AU 2003204620, AU 2004205275, AU 2004216918, AU 2005200987, AU 2006201573, AU

2009203204, AU 697652, AU 699726, AU 713679, AU 731800, AU 737302, AU 739753, AU 746101, AU7 56622, AU 757163, AU 759703, AU 773651,

AU 779072, CA 2235939, CA 2263126, CA 2266454, CA 2298547, CA 2298553, CN 20020814714.6, CN 200480006230.3, EP 0661071, EP 0858352,

EP 0929336, EP 0996358, EP 1005829, EP 1005830, EP 1132106, EP 1175239, EP 1277435, EP 1687052, JP 3558167, JP 3635097, JP 3638613, JP

3645470, JP 3683182, JP 3730089, JP 3902781, JP 4083154, JP 4597959, JP 4643724, JP 4158958, JP 4162118, NZ 541914, NZ 546457, NZ 563389,

NZ 567617, NZ 577484, US 6152129, US 6213119, US 6240921, US 6279569, US 6484719, US 6532957, US 6553992, US 6575163, US 6644312, US

6659101, US 6688307, US 6755193, US 6810876, US 6840240, US 6845773, US 6945248, US 7089937, US 7137389, US 7255103, US 7367337, US

7520279, US 7628151, US 7644713, US 7661428, US 8056559. Other patents pending. Protected by design registrations: CN 201030566594.5, EU

1768045

ResMed, SlimLine, SmartStart, Stellar and TiCONTROL are trademarks of ResMed Ltd. ResMed, SlimLine, SmartStart and Stellar are registered in

Stellar™ 150

InvasIve and nonInvasIve

ventIlator

Clinical Guide

English

Making quality of care easy

Respiratory Care Solutions

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

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

SpO2

Used Hours

Respiratory Rate

Device Information

Reminder

I:E Ratio

Pressure Support

AHI

510

Making quality of care easy

Respiratory Care Solutions

Making quality of care easy

Respiratory Care Solutions

For full Setup menu details, see:

• Clinical Settings on page 34

• Alarm Settings on page 37

• Options on page 42

Setting up for non-invasive use

345

AC locking clip

AC power cord

Setting up for invasive use

Learn Circuit

configuration

Antibacterial filter

HMEF

Catheter mount

ResMed Leak Port

Air tubing

External humidifier

AC locking clip

AC power cord

Using the menus

Accessing Clinical Mode

For full setup, see page 15.

For full setup, see page 13.

Contents

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

Indications for use 1

Contraindications 1

Adverse effects 1

About Stellar 150 therapy modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Common setting parameters 2

More about iVAPS 4

Ensuring successful ventilation with Stellar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Learn Circuit 7

Vsync and mask selection 7

TiControl 9

Trigger/Cycle sensitivities 9

Rise/Fall Time 10

Pathology Defaults 10

Stellar 150 at a glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Patient interface 12

Humidification 12

Internal battery 12

ResMed USB stick 12

Use on an aircraft 12

Mobile use 13

Setting up for noninvasive use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Attaching the H4i heated humidifier 14

Setting up for invasive use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Setting up for home therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Working with other optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Attaching a pulse oximeter 17

Adding supplemental oxygen 18

Starting therapy using oxygen 18

Stopping therapy using oxygen 18

Using the FiO2 monitoring sensor 19

Attaching an antibacterial filter 20

Stellar 150 basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

About the control panel 21

Starting therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Performing a functional test 22

Starting therapy 23

Stopping therapy 23

Turning off the power 24

Working with alarms 24

Tailoring treatment setup options 25

Programs 26

Using mask-fit 26

Using the menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Monitoring menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Setup menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Accessing Clinical mode 33

Setup menu: Clinical Settings 33

Setup menu: Alarm Settings 37

Testing the alarms 39

Setup menu: Options 42

Setup menu: Configuration Menu 43

248369r5.book Seite i Mittwoch, 16. November 2011 1:30 13

Info menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Event Summary 45

General therapy information 45

Apnea/Apnea Hypopnea Index 46

Used Hours 46

Device information 46

Reminders 47

Configuring iVAPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Using Learn Targets 47

Manually setting iVAPS 49

Assessing the clinical outcome 50

Data management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Daily 52

Weekly 52

Monthly 52

Replacing the air filter 53

Multipatient use 54

Servicing 54

Clinical titration guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Mouth leaks 55

Setting TiControl 55

EPAP/PEEP 56

Trigger/cycle sensitivities 56

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Alarm troubleshooting 57

Other troubleshooting 60

Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Guidance and manufacturer’s declaration – electromagnetic emissions and immunity 67

Symbols 68

General warnings and cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

248369r5.book Seite ii Mittwoch, 16. November 2011 1:30 13

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 an uncuffed or deflated tracheostomy.

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.

248369r5.book Seite 1 Mittwoch, 16. November 2011 1:30 13

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.

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.

Pressure

Support

Pressure

Ti Max

Ti Min

IPAP

EPAP /

PEEP Rise time

One Breath Cycle

Fall time

248369r5.book Seite 2 Mittwoch, 16. November 2011 1:30 13

About Stellar 150 therapy modes

These therapy modes (excluding CPAP mode—where a single level of continuous pressure is

delivered) are shown below.

IPAP

Inspiration

Patient

Effort

Leak flow

S/T

Expiration

EPAP

IPAP

EPAP

IPAP

EPAP

iVAPS

PEEP

PAC

IPAP

EPAP

Ti Min

One breath cycle

Ti Max

Ti Min Ti Max

Ti Max

Long breath

(Leak or obstructive lungs)

Very short breath

(Restrictive lungs) No breath effort

Machine initiates inspiratory phase increasing pressure up from EPAP/PEEP

Ti Max: inspiratory phase cycled down to EPAP/PEEP at Ti Max

Ti Min: inspiratory phase sustained up to Ti Min

One breath cycle

Period of increased leak

Ti Max

Ti Min

248369r5.book Seite 3 Mittwoch, 16. November 2011 1:30 13

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 volume-

assured 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 servo-

control 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 from 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 configurable limits.

The changing pressure support can vary from 0.7 cm H2O/sec to at 0.5 cm H2O/sec depending

on how close the patient is to the target alveolar ventilation. The change in pressure support

typically 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 47.

248369r5.book Seite 4 Mittwoch, 16. November 2011 1:30 13

About Stellar 150 therapy modes

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.

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/hypopnea), 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).

Anatomical Deadspace Estimation

iVAPS Deadspace

Estimation

Height (in)

Anatomical Deadspace Estimate (ml)

35 35 40 45 50 55 60 65 70 75 80

100

125

150

175

200

225

248369r5.book Seite 5 Mittwoch, 16. November 2011 1:30 13

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.

Time

Breaths perminute

Target patient rate

iVAPSintelligent back-up rate (iBR)Patient spontaneous rate

Patient effort No Patient effort Patient effort

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

248369r5.book Seite 6 Mittwoch, 16. November 2011 1:30 13

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