ResMed Astral 100 Series User Manual Download Page 43

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Accessories

English

The Astral device can be used with different power sources:

•

Mains power

•

Astral External battery

•

Internal battery

•

External DC power supply (eg, car 12V power outlet)

•

ResMed Power Station II.

For information on power supplies and sources see the Technical Specifications.

Connecting to mains power

WARNING

Ensure that the power cord does not pose a tripping or choking hazard.

To connect to mains power:

Connect the DC plug of the supplied ResMed external power supply unit to the rear of the Astral

device.

Before connecting the power cord to the ResMed power supply unit, ensure the end of the

connector of the power cord is correctly aligned with the input socket on the power supply unit.

Plug the other end of the power cord into the power outlet.

Note:

The power cord is equipped with a push-pull locking connector. To remove, grasp the power cord housing and

gently pull the connector from the device. Do not twist its outer housing or pull on the cord.

Summary of Contents for Astral 100 Series

Page 1: ...User guide English ...

Page 2: ...g and unlocking the touch screen 15 Navigating the menus 15 Monitors menu 15 Setup menu 17 Alarms menu 17 Information menu 18 Device settings 18 Adjusting device settings 19 Programs 19 Manual Breath feature 20 Sigh Breath feature 20 Travelling with the Astral device 21 Assembling patient circuits 21 Circuit options 21 Fitting the circuit adapter 23 Connecting a single limb circuit with intentiona...

Page 3: ... and recharging 42 Connecting to an external DC power source 43 Astral Carry Bag 44 Alarms 45 Alarm priority 46 Viewing the active alarms 48 Muting alarms 48 Resetting alarms 49 Adjusting the alarm volume 49 Testing the alarm sounders and indicators 50 Testing the Remote Alarm 51 Power alarms 51 Detecting circuit disconnection and de cannulation 52 Astral Disconnection Alarm 53 Adjusting the Disco...

Page 4: ...ns 71 Guidance and manufacturer s declaration electromagnetic immunity 72 Recommended separation distances between portable and mobile RF communications equipment and the device 73 Symbols 74 Standards compliance 75 Training and support 75 Limited warranty 76 Appendix A Definitions 77 Ventilation settings definitions 77 Measured and calculated parameter definitions 79 ...

Page 5: ...d in this manual does not supersede instructions given by the prescribing physician Install and configure the Astral device in accordance with the instructions provided in this guide CAUTION In the US Federal law restricts this device to sale by or on the order of a physician Indications for use The Astral 100 150 provides continuous or intermittent ventilatory support for patients weighing more t...

Page 6: ...nnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction The Astral device is not intended to be operated by persons including children with reduced physical sensory or mental capabilities without adequate supervision by a person responsible for the patient s safety The Astral device is not intended to be operated by patients unles...

Page 7: ... the airflow for breathing produced by the device can be as much as 6ºC higher than the temperature of the room Caution should be exercised if the room temperature is warmer than 35ºC Do not expose the device to excessive force dropping or shaking A note advises of special product features Notes For assistance and reporting of issues associated with the Astral device contact your Health Care Provi...

Page 8: ...uble limb adapter Astral 150 only 2 Handle 3 Inspiratory port to patient Provides an outlet for pressurised air to be delivered to the patient via the patient circuit Includes FiO2 sensor on the Astral 150 The FiO2 sensor is an optional accessory on the Astral 100 4 Ethernet connector service use only 5 USB connector for download to ResScan and connection of approved accessories 6 Mini USB connect...

Page 9: ...face of the Astral device comprises several different features described in the following image Description 1 Touch screen 2 Power source indicators AC mains power supply DC external battery or car accessory adapter or RPSII Internal battery 3 Therapy on off indicator Device ready Constant green display when the device is turned on but not ventilating Device ventilating Flashes blue when the devic...

Page 10: ...larm Constant yellow Low priority alarm Touch screen The main method of interacting with the Astral device is via the touch screen The display on the touch screen changes according to the function being performed Description 1 Clinical mode access button Locked Unlocked 2 Manual breath button only shown if enabled 3 Information bar 4 Internal battery indicator 5 Lock touch screen button 6 Menu bar...

Page 11: ... Patient type Paediatric Circuit type Single limb with intentional leak Circuit type Single limb with expiratory valve Circuit type Double limb P1 A CV Program number and ventilation mode in use Multiple alarms are active simultaneously The highest priority active alarm is displayed first Message window Will display alarms or information Image above shows device in Standby Displayed when the devic...

Page 12: ...dal volume synchronisation and oximetry Setup menu Configure and view ventilation therapy and device settings Alarms menu Configure and view alarms including alarm volume Information summary menu View therapy statistics used hours events reminder and device information Bottom bar The Bottom bar changes with the function of the device It can display buttons to Stop or Start ventilation and Apply or...

Page 13: ...ar graph Peak inspiratory pressure is shown as a numerical value and watermark Spontaneously triggering and cycling is indicated by and The example below displays the pressure bar when a patient is spontaneously breathing Description 1 Peak inspiratory pressure PIP value 2 Spontaneous cycled breath marker indicates patient cycled breath 3 Peak inspiratory pressure marker 4 Current pressure 5 Posit...

Page 14: ...ies Damaged components should not be used 3 Check the patient circuit setup Check the integrity of the patient circuit device and provided accessories and that all connections are secure 4 Turn on the device and test alarms WARNING If no alarm sounds do not use the ventilator Press the power switch at the back of the device to turn on the device Check that the alarm sounds two test beeps and the L...

Page 15: ...ge 19 For information on powering the Astral device refer to Power see page 38 Powering off the device The Astral device can only be powered off when ventilation is stopped Removing AC power does not power off the device The device remains powered on internal battery Turning off the device must be done manually and must be performed before leaving the device disconnected from AC power for any exte...

Page 16: ...and accessibility The Big button can be used to start and stop ventilation as well as to mute alarms WARNING To prevent inadvertent alarm mute or reset do not leave the patient in contact with the device screen To enable Big Button mode 1 From the Main menu press Setup The Setup menu is displayed 2 Select the Patient Access tab from the Device Config menu ...

Page 17: ...ard Simply select the Home button from left hand corner of the Bottom bar Your screen will return to standard button size and the Home icon will be replaced by the Big Button icon To return to Big Button mode simply select the Big Button Icon from the bottom bar Note With the Big Button feature enabled your screen will return to Big Button mode once the screen locks after two minutes of inactivity...

Page 18: ...creen will return to Big button mode once the screen locks after two minutes of inactivity Starting and stopping ventilation Your clinician has set up one or more ventilation programs for your therapy If more than one program has been set up follow the directions given by your clinician for when and how each program should be used Note If using the device for the first time ResMed recommends perfo...

Page 19: ...Astral device has four menus accessible via the Menu bar Each menu is further broken down into various sub menus Monitors menu The Monitors menu allows you to view real time ventilation data and is comprised of three sub menus Waveforms Monitoring Trends Waveforms The Waveforms screen displays the last 15 seconds of patient airway pressure and flow in a graph The graph updates in real time Descrip...

Page 20: ... Trends screen The Trends screen shows the 5th and 95th percentile values as well as the median for the last 30 days for each of the following parameters Leak Minute ventilation Peak inspiratory pressure Tidal volume Respiratory rate Inspiratory time SpO2 Pulse rate FiO2 Alveolar ventilation Information is displayed as bar graphs with two graphs per screen Use the up and down scroll arrows to cycl...

Page 21: ... Data Transfer to transfer data between the device and a personal computer via a USB stick Device Config to change the device configuration Helpful hint Therapy and alarm settings can be viewed as read only in Patient mode ie with Clinical mode locked Alarms menu The Alarms menu displays the individual thresholds for each alarm to trigger Real time values are displayed between the upper and lower ...

Page 22: ...ts alert tones to on or off Default On Alarm Volume Sets the volume level of the alarm system Settings from 1 2 3 4 or 5 Default 3 Auto power off Automatically powers off the device after 15 minutes of inactivity Conditions The device is in Ventilation standby mode not ventilating is being powered by the Internal battery or an External battery and there are no active alarms Default On Display Brig...

Page 23: ...The current active selections are highlighted in orange To change settings simply select another of the available options The revised setting is highlighted in orange Programs Programs on the Astral device can be configured by your clinician to provide you with alternate treatment options For example a clinician can set up programs for sleeping versus daytime use or for use during exercise or phys...

Page 24: ...more than one program has been set up follow the directions given by your clinician for when and how each program should be used Manual Breath feature Your clinician may have enabled the Manual Breath feature This feature allows a larger than normal breath to be delivered To deliver a manual breath press Sigh Breath feature Your clinician may have enabled the Sigh Breath feature This feature deliv...

Page 25: ...ge of circuits the device and accessories assembled together to suit individual patient needs The device uses interchangeable circuit adapters The following table may assist in selecting suitable circuits and settings for different patient types Tidal volume range Recommended patient type setting Suitable circuit diameters 50 mL to 300 mL Paediatric 10 mm 15 mm or 22 mm 300 mL Adult 15 mm or 22 mm...

Page 26: ...le limb circuit expiratory valve integrated into the adapter OR single limb circuit with intentional leak A Learn Circuit should be performed after any change of circuit Astral will provide accurate therapy as long as the Learn Circuit is completed Refer to Learn Circuit for further information WARNING When using a non invasive interface the measurement of patient exhaled gas volume may be affecte...

Page 27: ...s enhanced by ResMed s automatic leak management feature Vsync Vsync technology allows the device to estimate the patient respiratory flow and tidal volume in the presence of unintentional leak WARNING At low pressures the flow through the mask vents may be inadequate to clear all exhaled gases and some rebreathing may occur when using a single limb circuit with intentional leak Ensure the vent ho...

Page 28: ...priate and adjust the mask type setting on the Astral device Connecting a single limb circuit for invasive use CAUTION Always set up the ResMed Leak Valve in the breathing circuit with the arrows and the symbol pointing in the direction of air flow from the Astral device to the patient For invasive ventilation since the patient s upper respiratory system is bypassed by an artificial airway device ...

Page 29: ...lators To connect an Astral Quick Connect Single Limb Circuit with expiratory valve 1 Check the device is equipped with the single limb adapter otherwise change the adapter 2 Connect the air tubing to the inspiratory port on the device 3 Attach the Astral Quick Connect circuit to the single limb adapter on the device see diagram below 4 Attach any required circuit accessories eg humidifier or filt...

Page 30: ... single limb adapter 2 Connect the PEEP control line to the lower connector of the Astral device single limb adapter 3 Connect the air tubing to the inspiratory port of the device 4 Attach any required circuit accessories eg humidifier or filter 5 Select the circuit type and perform a Learn Circuit 6 Attach a patient interface eg mask to the connector on the pneumatic valve ...

Page 31: ...nt interface eg mask to the end of the air tubing Learn Circuit In order to support a wide range of circuit configurations and accessories the Astral device provides a Learn Circuit function to determine the characteristics of the circuit As part of the Learn Circuit functionality the Astral performs a device self test CAUTION To ensure optimum and accurate performance it is recommended that the L...

Page 32: ...nt interface disconnected from the patient connection port the Astral device will characterise the impedance of the inspiratory path With the patient connection port sealed the Astral device will characterise the total circuit compliance and then the impedance of the expiratory path A test result screen is displayed if any of the tests fail otherwise the Learn Circuit function has been successfull...

Page 33: ...connected and matches the selected circuit type 3 Check that the correct circuit adaptor is installed for the selected circuit type 4 Check the module the blue membrane and sensor are pressed all the way in and sit flush with the enclosure Accuracy of control and monitoring will be degraded Ensure that ventilation and alarms are effective before proceeding further Device Test Results Icon Descript...

Page 34: ...ce for servicing by an authorised ResMed Service Centre If you choose to proceed with ventilation FiO2 alarms will be disabled An alternate method for monitoring FiO2 is required Expiratory Flow Sensor Results Icon Description Expiratory flow sensor calibration has passed Expiratory flow sensor not tested or not installed Expiratory flow sensor calibration has failed Below are general steps to res...

Page 35: ... a range of accessories as follows Astral External Battery ResMed Power Station II Astral DC adapter ResMed Remote Alarm II Pulse Oximeter Optional accessories The Astral device can be used with a range of optional accessories as follows Astral Mobility Bag Astral SlimFit Mobility Bag ResMed Homecare Stand Astral Table Stand Aerogen nebuliser ResMed Connectivity Module RCM ResMed Connectivity Modu...

Page 36: ...UTION Make sure that the water tub is empty and thoroughly dried before transporting the humidifier To attach a humidifier to a patient circuit 1 Connect a length of air tubing to the inspiratory port on the device 2 Connect the other end of the air tubing to the inlet port on the humidifier 3 Connect the patient circuit to the outlet port on the humidifier The image below shows proper use of a hu...

Page 37: ...aces prior to performing the Learn Circuit Patient interfaces include any components placed after the single circuit s expiratory valve or exhalation port or double limb circuit s Y piece eg HMEF catheter mount mask tracheostomy tube Attaching an antibacterial filter WARNING Regularly check the antibacterial filter and expiratory valve for signs of moisture or other contaminants particularly durin...

Page 38: ...evice is to be used on multiple patients The expiratory module internal antibacterial filter expiratory flow sensor and blue membrane come into contact with exhaled gases but do not form part of the inspiratory pathway Adding supplemental oxygen Oxygen may be prescribed by your clinician The Astral device is designed to be compatible with levels of supplemental oxygen up to 30 L min At a fixed rat...

Page 39: ...tal oxygen using the integrated FiO2 sensor and alarms To monitor the fraction of inspired oxygen use an external O2 monitor compliant with ISO 80601 2 55 Sampling should be taken from the connection to the patient interface When operating Astral in its mobility bag do not add more than 6 L min of supplemental oxygen Astral is not designed for use with heliox nitric oxide or anaesthetic gases Do n...

Page 40: ...particularly during nebulisation or humidification Failure to do so could result in increased breathing system resistance and or inaccuracies in expired gas measurement Only operate the nebuliser when the device is ventilating If ventilation is stopped switch off the nebuliser Use of a gas jet nebuliser may affect ventilator accuracy Monitor the patient and compensate for the gas volume introduced...

Page 41: ...ons anaemia or low haemoglobin concentrations cardiogreen or other intravascular dyes carboxyhaemoglobin methaemoglobin dysfunctional haemoglobin artificial nails or fingernail polish or a sensor not at heart level To connect the pulse oximeter 1 Connect the plug of the finger pulse sensor to the plug of the pulse oximeter 2 Connect the plug of the pulse oximeter to the SpO2 pulse oximeter connect...

Page 42: ...e Remote Alarm II to the Astral device 1 Connect one end of the alarm cable to the 3 pin input connector on the remote alarm 2 Connect the other end to the 5 pin output connector located at the rear of the Astral device CAUTION To remove the cable pull firmly on the connector Do not twist Power WARNING Beware of electrocution Do not immerse the device power supply or power cord in water Make sure ...

Page 43: ...hazard To connect to mains power 1 Connect the DC plug of the supplied ResMed external power supply unit to the rear of the Astral device 2 Before connecting the power cord to the ResMed power supply unit ensure the end of the connector of the power cord is correctly aligned with the input socket on the power supply unit 3 Plug the other end of the power cord into the power outlet Note The power c...

Page 44: ...rmation bar of the Astral interface this may take a couple of minutes The total will be the sum of the Astral internal battery plus either one or two external batteries Under normal operating conditions the ventilator will display Total system state of charge as a percentage when in ventilation standby mode or connected to mains power The battery percentage is an average of all batteries connected...

Page 45: ...ternal battery as its power source you are notified by the Internal battery use alarm and with the internal battery power source indicator The internal battery operates for approximately eight hours under typical conditions During ventilation alarms will alert the user to a low battery condition During standby no alarms will be announced The user should regularly check the battery status WARNING W...

Page 46: ...rge level is displayed When the internal battery is in use during ventilation the remaining usage is displayed as estimated by current operating conditions When the internal battery is charging the charge battery symbol and percentage charged is displayed For more information on the expected operating time of the internal battery see the Technical Specifications Battery run time The internal batte...

Page 47: ...evice has been stored outside the operating temperature range an alarm message Power fault No charging may appear You can still continue using the device however if the alarm persists for more than 2 hours the battery may need replacement Connecting to an external DC power source CAUTION When using a car auxiliary adapter start the car before plugging in the device s DC adapter If the external DC ...

Page 48: ...ing Remote Alarm and oximeter the USB Stick 2 Place the Astral device carefully into the Carry Bag ensuring the handle is at the top and the screen faces the printed image on the bag 3 Secure the Astral device in place by using the Velcro strap To ensure the most secure position thread the Velcro strap through the handle and attach 4 Place the Power Supply unit and any heavy components in the side...

Page 49: ... the Astral device provides both audible and visual alerts without delay Indicator Description 1 Alarm display Displays either the alarm message for the highest priority active alarm or the last alarm not yet reset Press the Alarm display for further alarm information Certain conditions may result in multiple alarms indicates that there are multiple active alarms Press when displayed to view all a...

Page 50: ...rm display Alarm priority Alarms are classified into relative priority high medium and low according to the severity and urgency of the alarm condition Respond to all alarms An immediate response is required for high priority alarms Alarm priority Alarm bar Audible alert High Red flashing light 10 beeps every 5 seconds Medium Yellow flashing light 3 beeps every 15 seconds Low Yellow steady 2 beeps...

Page 51: ...stopped Low SpO2 High SpO2 Low FiO2 High FiO2 NV mask Vent not started incorrect adapter Critically low battery Incorrect circuit attached Safety reset complete Battery inoperable High pressure Low PEEP High PEEP Low pulse rate High pulse rate Device overheating Pressure line disconnected Last self test failed Flow sensor not calibrated No SpO2 monitoring No FiO2 monitoring Internal battery degrad...

Page 52: ...e audible alert on the Astral device for a two minute period The Alarm display and Alarm bar continue to display the alarm as usual If after two minutes the alarm condition is still present the audible alert will sound again You can also use the Alarm Mute in advance to pre silence alarms that you expect to occur This can be helpful during suctioning procedures or when intending to disconnect the ...

Page 53: ...ause of the alarm Resolving the alarm will automatically clear the display To reset the displayed active alarm 1 Press to mute the alarm The button illuminates and flashes 2 Press again to reset the alarm The alarm message is removed from the Alarm display It is also cleared from the Active alarms screen Note You can carry out this procedure with the Active alarms screen open if you want visibilit...

Page 54: ... alarm sounders and indicators To confirm the alarm will sound as intended regularly test the alarm The Astral device incorporates two alarm sounders During an alarm condition both sounders are operated in parallel To confirm the correct operation of each sounder regularly perform the Alarm test function During this test each sounder will be operated separately and in sequence To test the alarm so...

Page 55: ...the battery if the battery life is low If a second Remote Alarm is connected the second Remote Alarm will also sound Power alarms CAUTION Data cannot be saved while there is a Critically low battery or Battery inoperable alarm Program selections made while these alarms are active may be lost if the device is restarted Recording of ventilation data and alarms is suspended Alarm Activates when Low b...

Page 56: ...ctiveness of the alarm after any of these changes are made CAUTION Alarms should be configured and tested to ensure that circuit disconnection and de cannulation is detected We recommend configuring and testing multiple alarms and testing disconnection at the ventilator and at the cannula Independent monitoring can be used as an alternative The following table provides the most appropriate alarms ...

Page 57: ...ree of disconnection that it takes to activate the alarm 3 Turn the Disconnection Alarm On Off Note The Disconnection Alarm default setting is On To test the Disconnection Alarm These steps should be performed prior to connecting patient to the ventilator 1 Attach all components of the patient circuit including interface a test cannula should be used in the case of a tracheostomy 2 Start ventilati...

Page 58: ...B connector on completion of transfer If data was being transferred at the time a message in the Information bar alerts you to a failed transfer WARNING Only connect devices specially designed and recommended by ResMed to the data communication ports Connecting other devices could result in patient injury or damage to the Astral device To transfer data 1 From the Settings menu select Patient Data ...

Page 59: ...nce Weekly 1 Inspect the condition of the circuit adapter for entry of moisture or contaminants Replace as necessary 2 Test the alarm sounders refer to Testing the alarm sounders see page 50 Helpful hint For information on removing and replacing the circuit adapter refer to Fitting the circuit adapter see page 22 Monthly 1 Inspect the condition of the air filter and check whether it is blocked by ...

Page 60: ...tory module internal antibacterial filter expiratory flow sensor and blue membrane come into contact with exhaled gases but do not form part of the inspiratory pathway Replacing the air filter Inspect the condition of the air filter and check whether it is blocked by dirt or dust With normal use the air filter needs to be replaced every six months or more often in a dusty environment CAUTION Do no...

Page 61: ...ervice interval Conducted by Instructions Every six months Personnel who have been trained in the use of Astral Replacement of the air filter replace earlier if dirty Replacement of Single or Double limb circuit adapters if used Two years Qualified technician Two year Preventative maintenance Replacement of the internal battery and FiO2 sensor if fitted 35 000 hours Qualified technician Pneumatic ...

Page 62: ... Battery 1 with new external battery Battery 2 fault Check battery connections If problem persists replace External Battery 2 with a new external battery Battery Inoperable 1 If the device has been stored in extreme temperatures wait until the device returns to room temperature 2 If the device has been stored for long periods of time the battery may have discharged Connect to mains power 3 If alar...

Page 63: ...rn Circuit High pressure 1 Check the patient s status and airway 2 Inspect the circuit for obstruction 3 Perform a Learn Circuit High Pulse Rate Check the patient s status High Resp Rate 1 Check the patient s status 2 Perform a Learn Circuit High SpO2 Check the patient s status High Vte 1 Check the patient s status 2 Inspect the expiratory valve If necessary replace the expiratory valve 3 Perform ...

Page 64: ...status Low SpO2 Check the patient s status Low Vte 1 Check the patient s status and airway 2 Inspect the circuit and the expiratory valve for obstruction or leaks 3 Perform a Learn Circuit Low Vti 1 Check the patient s status and airway 2 Inspect the circuit for obstruction 3 Perform a Learn Circuit No FiO2 monitoring Perform a Learn Circuit to calibrate the oxygen sensor No SpO2 monitoring 1 Chec...

Page 65: ...nect the device to AC mains 3 Check the battery charge level of the internal and external if applicable battery The total power failure alarm can only be silenced by connecting the device to AC mains power Using internal battery Confirm operation on internal battery is intended or restore external power If intending to use external power 1 Check the power cable connection between the mains or batt...

Page 66: ...al pressure line are connected to the single limb adapter correctly Refer to Connecting a single limb circuit with expiratory valve for further information 2 Check that the single limb circuit adapter is firmly inserted and adapter cover is installed correctly Refer to Fitting the circuit adapter see page 22 for further information Double limb 1 Check that the double limb circuit adapter is firmly...

Page 67: ... persists contact your clinician or an authorised Service Centre 206 Hardware fault detected Contact an authorised Service Centre 303 Unable to calibrate oxygen sensor 1 Check that supplemental oxygen is not added during the Learn Circuit 2 Repeat Learn Circuit If the problem persists contact an authorised Service Centre 404 405 406 Hardware fault detected Contact an authorised Service Centre 409 ...

Page 68: ...nt end is not blocked 3 If using humidification ensure that the humidifier tub is not overfilled 4 Follow the on screen instructions carefully circuit should not be blocked during step 2 circuit should be completely blocked during step 3 If the problem persists contact your clinician or an authorised Service Centre 506 512 Hardware fault detected Contact an authorised Service Centre 600 Unable to ...

Page 69: ...d by device 1 Remove and reinsert the USB stick 2 Use a new USB stick 3 Remove the AC or external DC power supply the restart the Astral by switching it off then on 4 Reformat your USB stick Note that any data currently saved on the USB will be lost Learn Circuit failed If the Learn Circuit fails and a warning message appears on the top of the Learn Circuit results page try the following 1 Check t...

Page 70: ...le fault Paediatric circuit Inspiration 2 2 hPa at 15 L min 5 3 hPa at 30 L min Expiration 2 4 hPa at 15 L min 5 0 hPa at 30 L min Adult circuit Inspiration 5 7 hPa at 30 L min 8 3 hPa at 60 L min Expiration 4 2 hPa at 30 L min 6 2 hPa at 60 L min Maximum flow 220 L min Inspiratory trigger nominal characteristics Inspiratory trigger occurs when patient flow exceeds trigger setting Double limb with...

Page 71: ...f All other parameters remain at default settings Housing construction Flame retardant engineering thermoplastic Environmental conditions Operating temperature 0 C to 40 C Charging temperature 5 C to 35 C Operating humidity 5 to 93 non condensing Storage and transport temperature 25 C to 70 C for up to 24 hours Storage and transport temperature 20 C to 50 C for greater than 24 hours Note Storing t...

Page 72: ...irline operator ResMed confirms that the Astral meets the Federal Aviation Administration FAA requirements RTCA DO 160 section 21 category M for all phases of air travel IATA classification for internal battery UN 3481 Lithium Ion batteries contained in equipment Automotive use Product complies with ISO 16750 2 Road Vehicles Environmental Conditions and Testing for Electrical and Electronic Equipm...

Page 73: ...ternational ventilator standard indicates that Paediatric patient type is intended to be used for a patient receiving less than 300 mL however Astral permits adjustment of Vt setting parameter up to 500 mL for cases where Vt is set such that it compensates for leak in the breathing circuit WARNING ResMed does not recommend 500 mL as the upper limit for the pediatric tidal volume use however clinic...

Page 74: ...Technical specifications 70 Pneumatic flow path ...

Page 75: ...twork that supplies buildings used for domestic purposes Harmonic Emissions IEC 61000 3 2 with or without specified accessories Class A Voltage Fluctuations Flicker Emissions IEC 61000 3 3 with or without specified accessories Complies WARNING The device should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device should be observed to verify no...

Page 76: ... hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power source The internal battery will provide backup power of eight hours Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical ...

Page 77: ...ment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separati...

Page 78: ...rent Direct current Battery Alarm Mute Reset Audio Pause Oxygen supply inlet connector Connector for control line of external expiratory valve Connector for the breathing pressure measuring line Expiratory Connector From Patient Inspiratory Connector To Patient USB connector Ethernet connector Remote Alarm connector Remote Alarm Test button Environmental information This device should be disposed ...

Page 79: ...al electrical systems IEC 60601 1 11 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10651 2 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2 Home...

Page 80: ...s a result of improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs c any damage or contamination due to cigarette pipe cigar or other smoke and d any damage caused by water being spilled on or into an electronic device Warranty is void on product sold or resold outside...

Page 81: ...n Time Ti or Peak Inspiratory Flow PIF is used to configure volume controlled breaths Interface type Invasive mask or mouthpiece Interval Sigh interval sets the period between sigh breaths IPAP Inspiratory Positive Airway Pressure IPAP sets the pressure to be delivered to the patient during inspiration Magnitude Magnitude sets the size of the manual or sigh breath delivered relative to the size of...

Page 82: ... Time Rise time sets the time taken for the ventilator to reach inspiratory pressure for pressure controlled breaths Safety Vt Safety tidal volume sets the target minimum tidal volume Vt for each ventilator delivered breath Sigh Alert Sigh alert sets whether the ventilator gives a single beep just prior to delivery of a sigh breath Sigh Breath Sigh Breath sets whether a magnified breath a sigh bre...

Page 83: ...e product of the respiratory rate and inspired tidal volume averaged over the last eight breaths The measured MVi is displayed as a monitored parameter during ventilation Pressure Pressure is the current airway pressure of the patient as measured at the patient port The measured Pressure is displayed as a monitored parameter during ventilation PEEP End expiratory pressure PEEP is the airway pressu...

Page 84: ...lculated and displayed for volume controlled breaths on the settings screens when the Inspiratory Phase Duration Option is set to PIF Va Alveolar Minute Ventilation Va is calculated by Tidal Volume Deadspace x Resp Rate The measured Va is shown as a monitored parameter during ventilation Vte Expiratory Tidal Volume Vte is the volume expired during the last breath The measured Vte is displayed as a...

Page 85: ... Abingdon Oxfordshire OX14 4RW UK See www resmed com for other ResMed locations worldwide Astral is a trademark and or registered trademark of the ResMed family of companies For patent and other intellectual property information see www resmed com ip CaviCide is a trademark of Metrex Mikrozid is a trademark of Schülke Mayr Velcro is a trademark of Velcro Industries B V 2017 ResMed Ltd 278257 1 201...

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