ResMed Stellar 150 Clinical Manual
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ResMed Stellar 150 Clinical Manual

Invasive and noninvasive ventilator
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See also: User Manual
Stellar™ 150
InvasIve and nonInvasIve
ventIlator
Clinical Guide
English
Respiratory Care Solutions
Making quality of care easy

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Summary of Contents for ResMed Stellar 150

  • Page 1 Stellar™ 150 InvasIve and nonInvasIve ventIlator Clinical Guide English Respiratory Care Solutions Making quality of care easy...
  • Page 2 Setting up for non-invasive use For full setup, see page 13. AC locking clip AC power cord Setting up for invasive use Catheter mount For full setup, see page 15. ResMed Leak Port Learn Circuit HMEF configuration Antibacterial filter Air tubing External humidifier...

  • Page 3: Table Of Contents

    Adverse effects About Stellar 150 therapy modes ............2...
  • Page 4 Info menu ................45 Event Summary General therapy information Apnea/Apnea Hypopnea Index...

  • Page 5: Introduction

    • 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...

  • Page 6: About Stellar 150 Therapy Modes

    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.
  • Page 7 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 Ti Min Ti Max One breath cycle Period of increased leak About Stellar 150 therapy modes...

  • Page 8: More About Ivaps

    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.
  • Page 9 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...
  • Page 10 iBR brings the patient back on target when back-up breaths are required Patient effort No Patient effort Patient effort 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.

  • Page 11: Ensuring Successful Ventilation With Stellar

    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 •...
  • Page 12 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).

  • Page 13: Ticontrol

    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...

  • Page 14: Rise/Fall Time

    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.

  • Page 15: Stellar 150 At A Glance

    • 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.

  • Page 16: Patient Interface

    50% to increase the durability. 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.

  • Page 17: Mobile Use

    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.

  • Page 18: Attaching The H4I Heated Humidifier

    Perform Learn Circuit (see “Setup menu: Options” on page 42). 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.

  • Page 19: Setting Up For Invasive Use

    Setting up for invasive use The Stellar 150 can be used invasively only with the ResMed leak port and an uncuffed or deflated cuff tracheostomy tube. WARNING Replace the HMEF regularly as specified in the instructions provided with the HMEF .

  • Page 20: Setting Up For Home Therapy

    ** The leak port or the HMEF can be connected to standardized tracheostomy interfaces including connector pieces like catheter mounts. The catheter mount and the external humidifier are not part of the ResMed component. Setting up for home therapy You may be required to set up a device for a patient to use at home. There are a number of...

  • Page 21: Working With Other Optional Accessories

    Working with other optional accessories Attaching a pulse oximeter WARNING Only use compatible NONIN finger pulse sensors. CAUTION Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: excessive ambient light, excessive motion, electrosurgical interference, blood flow restrictors (arterial catheters, blood pressure cuffs, infusing lines, etc.), moisture in the sensor, improperly applied sensor, incorrect sensor type, poor pulse quality, venous pulsations, anemia or low hemoglobin...

  • Page 22: Adding Supplemental Oxygen

    • oxygen does not accumulate within the device and create a risk of fire. ResMed 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).

  • Page 23: Using The Fio2 Monitoring Sensor

    Using the FiO monitoring sensor CAUTION Do not use the FiO monitoring sensor with the H4i humidifier. Preparing to use a new sensor Before use, leave the FiO monitoring sensor open to the air for 15 minutes. Attach a new FiO monitoring sensor (as shown below).

  • Page 24: Attaching An Antibacterial Filter

    Regularly check the filter for entry of moisture or other contaminants. The filter must be replaced according to the manufacturer‘s specifications. Note: ResMed recommends using a filter with a low impedance (less than 2 cm H O at 60 L/min, eg, PALL BB 50 filter).

  • Page 25: Stellar 150 Basics

    Stellar 150 basics About the control panel Mains power LED LCD screen On when operating on mains power. External power supply LED On when external battery is connected. Internal battery LED On when internal battery is in use. Flashes when device is turned off and battery is charging.

  • Page 26: Starting Therapy

    The LCD screen The LCD screen displays the menus, treatment screens and alarm status. Warm-up feature H4i Ramp time ResMed USB stick Program Mains power Therapy mode External power supply Internal battery Patient mode or Clinical mode Title bar Current screen/number of...

  • Page 27: Starting Therapy

    Check the H4i heated humidifier (if in use). Check that the warm-up feature is displayed on the Treatment screen. Start the warm-up 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 Warm-up humidifier humidifier prior to starting treatment.

  • Page 28: Turning Off The Power

    When using with oxygen, turn off oxygen flow when stopping therapy. • Turning off the power Stop the therapy. Press the power switch at the back of the device once and follow the instructions on the display. Note: To disconnect the device from the mains power pull out the mains plug from the power socket.

  • Page 29: Tailoring Treatment Setup Options

    Fixed alarms User adjustable alarms High priority alarms: High priority alarms: Circuit disconnected—when leak exceeds Non-Vented Mask • • 105 L/min (1.75 L/sec) for at least 15 sec Medium priority alarms: Over pressure • Low Min Vent • Blocked tube •...

  • Page 30: Programs

    Ramp time IPAP EPAP Start pressure Time Ramp time Programs Up to two sets of therapy settings, ie, Programs, can be Program saved for convenient retrieval. They are stored while in the Clinical Settings menu. If both, ie, dual, is selected, the patient can choose the program to use on the Treatment screen.

  • Page 31: Using The Menus

    Using the menus 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. The menu structure is the same in Patient and Clinical modes. Differences mainly exist in the settings that will be described in the following pages.
  • Page 32 Setup menu: Clinical Settings SETUP MENU Clinical Settings Advanced Settings CPAP Mode Mode CPAP Advanced Mask CPAP Settings 8 cm H 2 O Type S Mode Mode IPAP Ti Min Ti Max Trigger Pathology 10 cm H 2 O EPAP Advanced Cycle Rise...
  • Page 33 Setup menu: Alarm Settings and Options SETUP MENU Alarm Settings Set all alarms off? Low Min Vent High Leak Non-Vented Mask High Pressure Low Pressure High Resp Rate Low Resp Rate Low SpO High FiO Alarm Low FiO Alarm Apnoea Alarm Alarm Volume Options Configuration Menu...

  • Page 34: Monitoring Menu

    Monitoring menu Screen 1: Treatment 1 Pressure bar graph with the set pressure limits and measured pressure. 2 Machine breath indicators: Machine cycled breath: Ti Min: the inspiratory phase is sustained up to Ti Min. • Ti Max: the inspiratory phase is cycled down to •...
  • Page 35 Screen 2: Monitoring Pressure bargraph with the set pressure limits. The following therapy parameters are displayed: Leak, Vt, RR, Ti (refer to Therapy status bar in Treatment screen). • Alveolar Ventilation (Va): minute volume without deadspace (Unit: L), • displayed in iVAPS mode. Inspiration to expiration ratio per breath (I:E).
  • Page 36 Screen 7: Synchronisation Diagram of the measured inspiration phases of the last 20 breaths. The last 20 breaths of measured inspiration time (sec). The height of the bar indicates the inspiration time. In S/ST modes, Ti Min/Ti Max thresholds are shown as Min/Max.

  • Page 37: Setup Menu

    Setup menu The Setup menu allows you to view and change therapy, alarm and device settings. Accessing Clinical mode CAUTION For home treatment the device must be set to Patient mode • Only trained and authorized personnel must make changes to clinical settings. •...
  • Page 38 Factory default settings and parameter ranges Parameter Mode Default Description      Pathology Normal Disease-specific preset setting values to facilitate efficient commencement of therapy (see page 10). Note: If the default pathology settings have been changed, the button is marked with an asterisk. Options: Obstructive, restrictive, normal, obesity hypoventilation ...
  • Page 39 Parameter Mode Default Description  Respiratory 10 bpm Sets the fixed number of breaths per minute Rate (bpm). The patient cannot spontaneous trigger the machine in this mode. Options: 5–60 bpm, 1 bpm increments  Target 15 bpm The rate input to the iVAPS algorithm. This should Patient Rate be set at the patient’s actual respiratory rate.
  • Page 40 Advanced Settings - Factory default settings and parameter ranges Parameter Mode Default Description  Min PS 2 cm H Minimum pressure support in iVAPS mode. Options: 0-20 cm H O (Min PS always below Max PS); 0.2 cm H O increment ...

  • Page 41: Setup Menu: Alarm Settings

    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.
  • Page 42 Alarm Setting Default Description Non-Vented Mask This alarm activates within 30 sec of therapy being delivered with a non-vented interface attached or a vented mask with occluded vents. Note: When the mask type is set to Full Face or Trach the Non-Vented Mask alarm will be enabled automatically to ensure the circuit configuration has an intentional leak.

  • Page 43: Testing The Alarms

    Alarm Setting Default Description Apnea On, 20 s Sets the maximum apnea time. Activates when there is no inspiration (either patient or machine triggered) detected from the previous beginning of inspiration. Two consecutive inspirations (either patient or machine triggered) resets the Apnea alarm.
  • Page 44 Alarm Testing interval High Respiratory Rate 1. On the Setup, Clinical Settings menu, set Mode to ST and Each new patient. Backup Rate to 30 bpm. 2. On the Setup, Alarm Settings menu, set All alarms off to Yes. 3. Now set High Resp Rate Alarm Setting to 10 bpm, and change the alarm to be On.
  • Page 45 Alarm Testing interval Non-Vented Mask 1. With the device set up to deliver therapy using the patient‘s mask When considered and circuit, start therapy. necessary by the 2. Block the mask’s vent holes. clinician. The alarm should sound within 30 sec. Blocked Tube 1.

  • Page 46: Setup Menu: Options

    Setup menu: Options The optional device settings are available from the Options menu and its Configuration submenu. Parameter Default Description Learn Circuit 1. If in use, turn off the oxygen flow. 2. Select the mask type. 3. Set up the air circuit including accessories and patient interface. Note: For invasive use, do not connect a catheter mount, tracheostomy tube or HMEF).

  • Page 47: Setup Menu: Configuration Menu

    Parameter Default Description Start EPAP or 4.0 cm H Sets the pressure at the beginning of the ramp time in bilevel Start PEEP modes (S, ST/PS, T, iVAPS, PAC). Options: 3 cm H O–EPAP , 0.2 cm H O increments Max Ramp Maximum setting for Ramp Time.
  • Page 48 Parameter Default Description Flow Unit L/min Selection of the display units for flow. Options: L/min, L/sec Therapy LED Enables or disables the therapy LED. If enabled, the blue therapy LED in the Start/Stop button is lit while the device is delivering therapy. Options: On, Off Confirm Stop This feature helps to avoid anyone inadvertently stopping therapy.

  • Page 49: Info Menu

    Info menu The Info menu provides event summary, therapy results, device information and reminders. Stellar 150 stores usage and summary data up to 365 treatment sessions. The stored data can be accessed in the Info menu or using ResScan. Event Summary Event summary displays the summary of three types of events: changes in settings, alarms and system events (eg, data erased, connection of ResMed USB stick).

  • Page 50: Apnea/Apnea Hypopnea Index

    Apnea/Apnea Hypopnea Index This screen displays the apneas and hypopneas measured per hour for one day. The daily index values will be displayed for a period of seven days and can be compared to data from the last 365 days. An apnea is scored when flow decreased by more than 75% of baseline (ie, to 25% or below from the baseline) for more than 10 seconds.

  • Page 51: Reminders

    Reminders You can use the Reminders menu to alert the patient to specific events; for example, when to replace their mask, when to replace the filter and so on. Using ResScan, you can select which Reminder message to show when and its recurrence frequency (Off, 1–24 months). The reminder appears in yellow as the date approaches (within 10% of the reminder period).
  • Page 52 Enter the patient Height (approximate or arm span). Connect the patient. Select Learn Targets. The device has to be in Standby to commence the Learn Targets procedure. Turn on oxygen if in use. Configure primary therapy controls. Enter the preliminary EPAP or PEEP (see page 56). It is recommended that you start at 4–6 cm H O which most patients can tolerate.

  • Page 53: Manually Setting Ivaps

    Refine EPAP/PEEP to suit the type of therapy required. For more information, see “Assessing the clinical outcome” on page 50. Manually setting iVAPS While the Learn Targets procedure offers the best means of obtaining an initial ventilation estimate, iVAPS also allows manual entry of its target, using an entered minute ventilation, spontaneous rate, and patient height.

  • Page 54: Assessing The Clinical Outcome

    50. Assessing the clinical outcome If the patient sleeps well on the Stellar 150 and SpO , if available, shows adequate oxygen saturation throughout the night, this can be a good indication of successful therapy.

  • Page 55: Data Management

    For more information, see the PC application’s manual. There are two data ports at the rear of the device for connecting a USB stick (see “Stellar 150 at a glance” on page 11). Therapy and device data can be stored on it or read from it.

  • Page 56: Cleaning And Maintenance

    The mask system and air tubing are subject to normal wear and tear. Inspect them • regularly for damage. CAUTION The Stellar 150 cannot be sterilized. Daily Disconnect the air tubing from the device (and humidifier, if used) and hang it in a clean, dry place until next use.

  • Page 57: Replacing The Air Filter

    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. Remove the air filter cover at the back of the device. Remove and discard the old air filter.

  • Page 58: Multipatient Use

    This product should be inspected by an authorized ResMed service centre five years from the date of manufacture, except for the internal battery which must be replaced every two years from the manufacturing date of the device.

  • Page 59: Clinical Titration Guide

    Full face masks cover both the nose and mouth, preventing mouth leaks, and are available from ResMed. Contact your supplier for more details or see www.resmed.com. ResScan detailed data also provides a visual representation of leak.

  • Page 60: Epap/Peep

    TiControl calculation guide The following table is a guide to selecting the Ti Max and Ti Min values that best correspond to the patient's respiratory rate (ideally while using the ventilator at rest). Patient breaths I:E = 1:2 I:E = 1:1 I:E = 1:3 per min 60 ÷...

  • Page 61: Troubleshooting

    Troubleshooting If there is a problem, try the following suggestions. If the 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).
  • Page 62 • • Mask vents may be blocked. Ensure the mask vents are not blocked. • • ResMed leak port is missing or vent is Ensure the leak port is installed and that the • • blocked. vent is not blocked.
  • Page 63 Problem/Possible cause Action LCD: Low SpO2! has dropped below pre-set alarm level. Check the attachment of the sensor. • Reassess the patient to ensure adequate • therapy. LCD: SpO2 finger sensor failure! The finger sensor is not connected properly or Check if the finger sensor is attached properly to delivers faulty values.

  • Page 64: Other Troubleshooting

    Incompatible accessories (eg, humidifier or mask Use only equipment as recommended and system) with high resistance being used. supplied by ResMed. High Leak or Low Min Vent alarms are set to On. SmartStop is disabled when High Leak or Low Min Vent alarms are is set to On.
  • Page 65 Connect the USB stick to a PC and delete data that is not needed. Reconnect the USB stick to the Stellar 150 then retry writing data to the USB stick. USB stick is not compliant with USB 2.0 or write Use only equipment as recommended and protected.
  • Page 66 Problem/Possible cause Action sensor calibration failure sensor is not attached properly. For the correct attachment of the FiO sensor see “Using the FiO2 monitoring sensor” on page 19. sensor is used or defective. If the lifetime of the FiO sensor has exceeded one year please replace the FiO sensor and start calibration again.

  • Page 67: Technical Specifications

    Technical specifications Operating pressure range IPAP: 3 cm H O to 40 cm H O (in S, ST, T, PAC mode) • PS: 0 cm H O to 37 cm H O (in S, ST, T, PAC mode) • EPAP/PEEP: 3 cm H O to 25 cm H O (in S, ST, T, iVAPS, PAC •...
  • Page 68 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 150 meets RTCA/DO-160 requirements. This device is not suitable for use in the presence of a flammable anesthetic mixture.
  • Page 69 3 Results may be inaccurate in the presence of leak and supplemental oxygen > 10 L/min. If necessary for therapy, use external monitoring. 4 Results may be inaccurate if the tidal volume is below 50 mL. Pressure-flow table Stellar 150 with 6’ 6” (2 m) standard tube Flow (L/min) Technical specifications...
  • Page 70 measurement concentration measurement at EPAP/IPAP 5/10 cm H O (blue curve), 5/20 cm H O (red curve) and 5/30 cm H O (green curve), R/C 5/20, respiratory rate 20 bpm, full face mask. Full Face Leak = 0L/min MV: ~2.5 L/min MV: ~8.2 L/min MV: ~12.3 L/min supply (L/min)

  • Page 71: Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity

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

  • Page 72: 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.

  • Page 73: General Warnings And Cautions

    Do not use the device if there are obvious external defects, unexplained changes in • performance. Only use original and approved ResMed accessories and parts. • The use of an antibacterial filter is obligatory in situations in which cross contamination is •...
  • Page 74 CAUTIONS A caution explains special measures for the safe and effective use of the device. When using accessories, read the manufacturer’s User Manual. For consumables, important • information can be provided on the packaging. For more information, see “Symbols” on page 68.

  • Page 75: Limited Warranty

    • This warranty is only available to the initial consumer. It is not transferable. If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components. This limited warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product;...
  • Page 77 Index Language 43 LCD screen 22 Leak 30 Aircraft Learn Circuit 7 Use on 12 Alarm Messages 24 Mute 21 Mask fit 26 Troubleshooting 57 Mask Type 37 Volume 24 Max PS 6 Alarms Medium priority alarms 25 Fixed 25 Menu High priority 25 Info 45...
  • Page 78 SmartStart/Stop 42 ST (Spontaneous/Timed) mode 2 Start/Stop 21 Supplemental oxygen 18 T (Timed) mode 2 Target alveolar ventilation 5 Target Patient Rate 5 Target Va 35 Calculator 35 Therapy Start 23 Stop 23 Therapy modes 34 Therapy status bar 30 Ti 34 Ti Max 36 Ti Min 36...
  • Page 79 Using the menus SETUP MONITORING INFO Treatment Clinical Settings Event Summary Monitoring Leak Pressure / Flow Alarm Settings Minute Ventilation Min Vent/Resp Rate Tidal Volume or MV/Va (iVAPS Mode) Respiratory Rate Options Leak For full Setup menu details, see: • Clinical Settings on page 34 I:E Ratio Tidal Volume • Alarm Settings on page 37...
  • Page 80 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 U.S. Patent and Trademark Office. © 2011 ResMed Ltd Global leaders in sleep and respiratory medicine www.resmed.com...

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