ResMed Stellar Series Clinical Manual

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Non-invasive/invasive ventilators

Clinical Guide

English

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Summary of Contents for ResMed Stellar Series

Page 1 Non-invasive/invasive ventilators Clinical Guide English...
Page 2 For full setup, see page 14. AC locking clip AC power cord Setting up for invasive use For full setup, see page 16. Catheter mount ResMed Leak Valve HMEF Bacterial/viral filter Air tubing AC power cord External humidifier AC locking clip...
Page 3 Stellar at a glance .......................... 11 Patient interface......................... 12 Humidification..........................12 Internal battery .......................... 12 ResMed USB stick ........................13 Use on an aircraft ........................13 Mobile use ..........................13 Remote Alarm ........................... 13 Setting up for noninvasive use ..................... 14 Attaching the H4i heated humidifier ....................
Page 4 Starting therapy ......................... 24 Stopping therapy........................24 Turning off the power ........................ 25 Working with alarms ........................25 Tailoring treatment setup options ....................27 Using mask-fit..........................28 Using the menus ........................... 29 Setup menu: Clinical Settings ..................... 30 Setup menu: Alarm Settings and Options ................... 31 Monitoring menu ..........................
Page 5 TiControl calculation guide......................60 EPAP/PEEP ..........................60 Trigger/cycle sensitivities ......................60 Troubleshooting ..........................61 Alarm troubleshooting ........................ 61 Other troubleshooting ........................ 64 Technical specifications ........................ 66 Displayed values ........................69 Measurement system and accuracy ................... 69 Altitude compensation ....................... 70 Pressure-flow table ........................
Page 6 (13 kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnoea. The device is for noninvasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.
Page 7 About Stellar therapy modes Stellar provides a number of therapy modes to suit a variety of ventilation requirements. Regardless of the mode, Stellar assists spontaneous breathing by providing two pressures in response to the patient flow or a preset fixed time.
Page 8 These therapy modes (excluding CPAP mode—where a single level of continuous pressure is delivered) are shown below. English...
Page 9 • 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.
Page 10 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.
Page 11 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.
Page 12 • 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 •...
Page 13 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 14 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. For some patients whose inspiratory effort or flow are weak and insufficient, Ti Min prevents the premature cycling to EPAP.
Page 15 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 optimise the patient's work of breathing, comfort and synchrony.
Page 16 Stellar at a glance 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 Stellar: •...
Page 17 As the battery degrades, the battery charge level indicator may lose accuracy. This will mean battery-related and system alarms may not activate as intended. ResMed recommends the battery be tested after two years to assess the remaining battery life. Testing and replacement of the internal battery should only be performed by an authorised service agent.
Page 18 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, refer to Data management (see page 56).
Page 19 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.
Page 20 Attaching the H4i heated humidifier The Stellar can be used with the H4i heated humidifier for noninvasive use when stationary. It will be automatically detected when the Stellar is turned on. A humidifier is recommended especially for patients experiencing: • nasal stuffiness/congestion •...
Page 21 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.
Page 22 With an external humidifier Without an external humidifier 10. If an external humidifier is not being used, you can connect the HMEF to the patient side of the ResMed Leak Valve. 11. Connect the catheter mount. ** The ResMed Leak Valve or the HMEF can be connected to standardised tracheostomy interfaces including connector pieces like catheter mounts.
Page 23 10 seconds. For part numbers of compatible oximeter accessories for this device, see the ventilation accessories on www.resmed.com/accessories. For information on how to use these accessories, refer to the user guide that comes with these accessories.
Page 24 Use only certified, clean oxygen sources. • 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 25 To add supplemental oxygen 1. Unlock the low flow oxygen inlet on the back of the device by pushing up on the locking clip. 2. Insert one end of the oxygen supply tubing into the oxygen connector port. The tubing automatically locks into place.
Page 26 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 27 1. Fit the bacterial/viral filter to the air outlet of the device. 2. Attach the air tubing to the other side of the filter. 3. Attach the mask system to the free end of the air tubing. 4. Perform the Learn Circuit function (refer to Setup menu: Options (see page 45)). From the Setup menu, select Options.
Page 28 Function Menu keys Press the appropriate menu button (Monitoring, Setup, Info) to enter and scroll through the relevant menu. Push dial Turning the dial allows you to scroll through the menu and change settings. Pushing the dial allows you to enter into a menu or confirm your choice. LCD screen The LCD screen displays the menus, treatment screens and alarm status.
Page 29 SmartStart function is enabled instruct the patient to breathe into the patient interface and treatment will begin. Note: When the ResMed Leak Valve is used, check that the anti-asphyxia valve (membrane) within the ResMed Leak Valve stays closed during the entire breathing cycle. Increase the EPAP if necessary.
Page 30 Alternatively if the Ramp Down feature is enabled, turn the push dial and select Ramp Down on the Treatment screen. When the device has ramped down, remove the patient interface (refer to Ramp Down (see page 28)). Notes: • SmartStop may not work if Full face or Trach is selected as mask type; the High Leak alarm or the Low Min Vent alarm is enabled;...
Page 31 Time: MIN, Fall Time: MIN, Ti: 2.0 sec, Respiratory Rate: 10 bpm, Test lung configuration: R = hPa (L/s)-1 ± 10%, C = 50 mL (hPa)-1 ± 5%, with H4i, bacterial/viral filter, 2m air tubing, ResMed leak valve. Fixed alarms...
Page 32 Resetting alarms When the Alarm mute key is pressed during therapy for at least three seconds, the following alarm messages and the audible alarm will be temporarily cleared: • • High Pressure High Breath Rate • • Low Pressure Low Breath Rate •...
Page 33 Ramp Down If difficulties are experienced in taking off the ventilation, the patient can use the Ramp Down feature. This feature reduces the treatment pressure to Start EPAP/PEEP over five minutes. After five minutes the therapy stops. The patient can enable the Ramp Down feature when it is selected in the Options menu. Notes: •...
Page 34 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.
Page 35 Setup menu: Clinical Settings Note: When the Option Multi Program is set to dual, the setting Program is displayed in the Clinical Settings menu. Refer to Setup menu: Clinical Settings (see page 35).
Page 36 Setup menu: Alarm Settings and Options English...
Page 37 Monitoring menu Screen 1: Treatment 1. Pressure bar graph with the set pressure limits and measured pressure. 2. Machine breath indicators: Machine cycled breath: the inspiratory phase is sustained up to Ti Min. the inspiratory phase is cycled down to EPAP/PEEP at Ti Max (S/ST mode) or Ti (PAC/T mode).
Page 38 Screen 2: Monitoring 1. Pressure bargraph with the set pressure limits. 2. 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.
Page 39 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 40 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 authorised personnel must make changes to clinical settings. To activate Clinical mode , hold down simultaneously for at least...
Page 41 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 Program...
Page 42 Parameter Mode Default Description   2.0 sec Sets the inspiratory time. Options: 0.2–-**4 sec or 2/3 of one breath cycle defined by Respiratory or Backup Rate; 0.1 sec increments Backup  10 bpm Sets the breaths per minute (bpm). ...
Page 43 Advanced Settings - Factory default settings and parameter ranges Parameter Mode Default Description Min PS 4 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 Max PS ...
Page 44 When the Mask Type is set to Full Face the Non-Vented Mask alarm automatically turns on. For a full list of compatible masks for this device, see the Mask/Device Compatibility List on www.resmed.com/downloads/devices. If you do not have internet access, please contact your ResMed representative. Min EPAP ...
Page 45 Setup menu: Alarm Settings The following alarms that can be set in while in Clinical mode. Alarm Setting Default Description Set all alarms off? Sets all user selectable alarms off. Note: When the mask type is set to Trach the Non-Vented Mask alarm will stay ON.
Page 46 Alarm Setting Default Description Low Respiratory Rate Sets the minimum allowed respiratory rate. Activates when the measured respiratory rate remains below the set level for four breath cycles. Note: This alarm is not enabled in T mode. Range: On, Off, 5–30 bpm, 1 bpm increments Low SpO Sets the minimum allowed SpO value.
Page 47 Testing the alarms When the device is turned on, the Alarm LED and the Alarm mute key LED will flash, and the alarm will sound to confirm that the alarm is working. If required, you can test the alarm manually by holding down the Alarm mute button for at least three seconds when therapy is not running and no alarm is active.
Page 48 2. Start therapy. configuration 3. Disconnect the tube from the mask or the ResMed leak valve and check the and/or device settings. alarm activation. The alarm activates when leak exceeds 105 L/min (1.75 L/sec) for at least 15 seconds.
Page 49 Alarm Testing interval Non-Vented Mask 1. With the device set up to deliver therapy using the patient's mask and circuit, When considered start therapy. necessary by the clinician. 2. Block the mask's vent holes. The alarm should sound within 30 sec. Blocked Tube 1.
Page 50 Setup menu: Options The optional device settings are available from the Options menu and its Configuration submenu. Parameter Default Description Learn Circuit 1. Ensure that the therapy is turned off before performing a Learn Circuit. 2. If in use, turn off the oxygen flow. 3.
Page 51 Parameter Default Description Start CPAP 4.0 cm H O Sets the pressure at the beginning of the Ramp Time in CPAP mode. When Ramp Down is on, the treatment pressure reduces to this pressure setting. Options: 4 cm H O–CPAP, 0.2 cm H O increments Start EPAP or 4.0 cm H...
Page 52 Setup menu: Configuration Menu Parameter Default Description Language English Sets the display language. Options: Depending on regional configuration Brightness Sets the LCD backlight brightness. Options: 20-100%, 10% increments Backlight Auto Enables the LCD and keypad backlight. If the AUTO setting is selected the backlight turns dark after five minutes without any actions and turns on again if any button is pressed again or an alarm occurs.
Page 53 Parameter Default Description Pressure Naming IPAP/EPAP Choose the terminology type used through the screens displays. Options: PS/PEEP, IPAP/EPAP Multi Program single You have the option to define two different programs for therapy and alarm settings. Each therapy program saves the results of the Learn Circuit (circuit impedance).
Page 54 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). There are up to 200 events of each type, displayed in chronological order, with the most recent event displayed at the top by default.
Page 55 Apnoea/Apnoea Hypopnoea Index This screen displays the apnoeas and hypopnoeas 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 apnoea 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 56 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).
Page 57 Configuring iVAPS There are two ways in which you can configure iVAPS mode: • using Learn Targets—which learns the patient's breathing pattern and calculates the targets automatically; or • directly entering the targets. Using Learn Targets Learn Targets monitors the patient's resting ventilation, with the goal of learning the patient's Target Alveolar Ventilation and Target Patient Rate in preparation for iVAPS mode.
Page 58 View data. The Learn Targets screen displays a blank graph on which up to 15 min of live data (monitored Alveolar Ventilation (Va) and Respiratory Rate (RR) will be plotted as time passes. The values are calculated from the median within a 5 min range. You can select the 5 min portion that best represents stable Va and RR, by using the dial to highlight the 5 min of interest.
Page 59 5. Select Target Va calculator. Enter the patient's Height. Enter the patient's spontaneous breath rate. Enter a previously measured Minute Ventilation (MV) or Tidal Volume (Vt). Note: Press Monitoring or Info key to scroll through the related pages (eg, Breath Rate, MV, Vt) if necessary.
Page 60 Assessing the clinical outcome If the patient sleeps well on the Stellar and SpO , if available, shows adequate oxygen saturation throughout the night, this can be a good indication of successful therapy. ResScan may assist you assessing the therapy outcome. A close look at the Detail graph in statistics is useful to evaluate the quality of treatment.
Page 61 Data management Apart from the data available to view directly on the device, you can view and update data via ResMed's applications that assist with compliance management. These are ResScan and EasyCare Tx. When using ResScan, you can view therapy data as well as change settings on the device. To transfer data between the device and a PC, you can use the ResMed USB Stick.
Page 62 Cleaning and maintenance The cleaning and maintenance described in this section should be carried out regularly. This also helps to prevent the risk of cross contamination. Refer to the mask, humidifier and other accessories user guide for detailed instructions for care and maintenance. WARNING •...
Page 63 Mask Reprocess; Cleaning, disinfection and sterilisation instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have Internet access, please contact your ResMed representative. Air tubing Replace the air tubing. Alternatively, consult the air tubing instructions for cleaning and disinfection information.
Page 64 This product should be inspected by an authorised ResMed service centre five years from the date of manufacture, except for the internal battery which ResMed recommends be tested after two years to assess the battery life. Prior to this, the device is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed.
Page 65 1. Observe the patient's inspiration time and spontaneous respiratory rate. (The measured Ti and I:E ratio on the Monitoring and Synchronisation screen may help.) 2. Adjust the Ti Min in accordance with the measured Ti (see table below). Check that the patient doesn't feel that the inspiratory time is too long.
Page 66 For characteristic data, refer to Technical specifications (see page 66). 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 67 Problem / possible cause Action LCD: Over Pressure! 1. Power-off the device. The device generates a pressure that is greater than 59 cm H O. Treatment will be 2. Check that the air tubing is connected properly. stopped. 3. Power-on the device again. 4.
Page 68 Ensure the mask vents are not blocked. • • ResMed Leak Valve is missing or vent is Ensure the ResMed Leak Valve is installed and that the vent is blocked. not blocked. • Ensure oxygen (if in use) has only been connected at the rear of the device.
Page 69 When the remaining battery capacity is low, it can affect the battery charge level indication and lead to power failure without activating Low or Empty battery alarms. ResMed recommends the battery be tested after two years to assess the remaining battery life (refer to Internal battery (see page 12)).
Page 70 Use of a full face mask or tracheostomy tube. SmartStart is disabled if Full Face or Trach is selected as interface. Use only equipment as recommended and supplied by ResMed. Incompatible accessories (eg, humidifier or mask system) with high resistance being used.
Page 71 Test condition: T mode, IPAP: 40 cm H O, EPAP: 2 cm H O, Rise Time: MIN, Fall Time: MIN, Ti: 4.0 sec, Respiratory Rate: 10 bpm, with ResMed calibration cap. Flow accuracy ± 5 L/min or 20% measured value, whichever is greater...
Page 72 Inspiratory trigger (nominal) The minimum flow required to initiate IPAP by ASL5000 simulator characteristics with chronically weak efforts (R20, C20, BPM20): For Very High setting: 2.4 L/min • For High setting: 4.2 L/min • For Medium setting: 6.0 L/min • For Low setting: 10.2 L/min •...
Page 73 IEC 60601-1-2:2014, for residential, commercial and light industry environments. It is recommended that mobile communication devices are kept at least 0.3 m away from the device. Information regarding the electromagnetic emissions and immunity of this ResMed device can be found in www.resmed.com/downloads/devices. Potential impact of electromagnetic...
Page 74 Medical-Portable Electronic Devices (M-PED) that meet the Federal 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 meets RTCA/DO- 160 requirements.
Page 75 Altitude compensation The Stellar device measures and displays flow-based quantities assuming the air is at standard temperature, pressure and ambient humidity (STPH). The air flow reaching the patient airways expands due to altitude, body temperature and humidity. The following correction factor should be applied to compensate for these effects and convert those values to BTPS (Body Temperature, Pressure, Saturated).
Page 76 FiO2 measurement concentration measurement at EPAP/IPAP 5/10 cm H2O (blue curve), 5/20 cm H O (red curve) and 5/30 cm O (green curve), R/C 5/20, respiratory rate 20 bpm, full face mask. Pneumatic flow path English...
Page 77 0.004 percent of lead by mass are marked below the crossed- bin symbol with the chemical 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 78 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 a bacterial/viral filter is obligatory in situations in which cross contamination is possible.
Page 79 Position the device ensuring the power cord can be easily removed from the power outlet. • Any serious incident that has occurred in relation to this device should be reported to ResMed and to the competent authority in your country.
Page 80 This warranty is only available to the initial consumer. It is not transferable. During the warranty period, 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.
Page 81 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 35 I:E Ratio Tidal Volume •...
Page 82 See ResMed.com for other ResMed locations worldwide. H4i, Stellar, SlimLine, SmartStart, and TiControl are trademarks and/or registered trademarks of the ResMed family of companies. Nonin is a trademark of Nonin Medical, Inc. Actichlor is a trademark of Ecolab US Inc. Mikrozid is a trademark of Schülke &...

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