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ResMed Ventilation Hood 100 User's Manual

1. 3 Attach the H4i heated humidifier to the front of the Stellar If the H4i is not in use and if applicable connect the antibacterial filter firmly onto the air outlet of the device see Attaching an antibacterial filter on page 9 O 0 a 7 Note Other external humidifiers can be used for noninvasive setup ResMed recommends using a breathing system including antibacterial filter air tubings external humidifier with an impedance of maximum 2 cm H20 at 30 L min 5 cm H20 at 60 L min and 16 cm H20 at 120 L min Connect one end of the air tubing firmly onto the air outlet of the H4i Connect the mask system to the free end of the air tubing Select the mask type select Setup menu then Clinical Settings then Advanced Settings Perform Learn Circuit see Setup menu Options on page 16 Attaching the H4i heated humidifier for noninvasive use Use of the H4i heated humidifier may be recommended by your clinician For information on using the H4i see the H4i user guide WARNING e Always place the H4i on a level surface below the level of the patient to prevent the mask and tubing from filling with water e Make sure that the water chamber is empty and thoroughly dried before transporting the humidifier e The H4i heated humidifier is not intended for mobile use e Do not overfill the water chamber as during use this will cause water to spill into the air circuit Check the air circuit regularly for accumulated
2. Serial number LOT Batch code D Do not re use Use by date AN Keep away from sunlight Q Do not use if package is damaged Latex free Environmental information This device must be disposed of in accordance with the laws and regulations of the country in which disposal occurs The crossed out wheeled bin symbol A indicates that the product bearing this symbol may not be disposed of together with general household waste but instead requires separate disposal This requirement for separate disposal is based on the European Directive 2002 96 EC for electrical and electronic equipment and the European Directive 2006 66 EC for batteries You can hand in the product at a municipal collection point for example This reduces the impact on natural resources and prevents contamination of the environment through the release of hazardous substances Batteries containing more than 0 0005 percent of mercury by mass more than 0 002 percent of cadmium by mass or more than 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 Dispose of used alr filters and air tubings according to the directives in your country General warnings and cautions WARNINGS A warning alerts you to possible
3. e Masks with high resistance eg paediatric masks may cause the operation of the SmartStop feature to be restricted e When using with oxygen turn off oxygen flow before stopping therapy Turning off the power 1 Stop the therapy 2 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 power cord from the power socket English Working with alarms N WARNING This device is not intended to be used for vital signs monitoring If vital signs monitoring is required a dedicated device should be used for this purpose This device is fitted with alarms to alert you to changes that will affect your treatment Alarm message Alarm LED Alarm mute key Alarm messages are displayed along the top of the screen High priority alarms are displayed in red medium priority alarms in yellow and low priority alarms in light blue The Alarm LED lights red during high priority alarms and yellow during medium and low priority alarms The alarm volume can be set Low Medium or High From the Setup menu select Alarm Settings After the set value has been confirmed the alarm will sound and the alarm LED lights Alarm settings see Setup menu Alarm Settings Alarm Volume on page 16 You can mute an alarm by pressing Z once By pressing the Alarm mute key again the alarm sounds again When an alarm is muted the Alarm m
4. tell your doctor before using this device e pneumothorax or pneumomediastinum e pathologically low blood pressure particularly if associated with intravascular volume depletion e cerebrospinal fluid leak recent cranial surgery or trauma e severe bullous lung disease e dehydration The use of the Stellar or pulse oximetry including XPOD is contraindicated in an MRI environment English Adverse effects You should report unusual chest pain severe headache or increased breathlessness to your prescribing physician The following side effects may arise during the course of noninvasive ventilation with the device e drying of the nose mouth or throat e nosebleed e bloating e ear or sinus discomfort eye Irritation e skin rashes Introduction 1 Stellar at a glance N H4i connector plug and AC Air outlet connection Oxygen inlet Infrared connection for humidifier Air filter cover XPOD pulse oximeter connection DC power socket FiO sensor connection AC power socket Data port for USB stick Power on standby switch Remote alarm connection Data port for direct PC connection The Stellar comprises e Stellar device e Hypoallergenic air filter e AC power cord e Carry bag 2 m air tubing ResMed USB stick Low pressure oxygen connector The following optional components are compatible with Stellar e3mair tubing SlimLine air tubing Clear air tubing disposable e H4i heated humidifier
5. e Antibacterial filter e Heat moisture exchanger filter HMEF e ResMed XPOD oximeter Nonin pulse oximetry sensors FiO monitoring kit external cable T piece adapter e FiO monitoring sensor e Stellar Mobility bag e ResMed Leak Valve e Tubing wrap WARNING The Stellar 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 Patient interface Both masks and tracheostomy tubes can be used with Stellar To set the patient interface type go to the Setup menu select Clinical Settings then Advanced Settings For information on using masks see the mask manual For a full list of compatible masks for this device see the Mask Device Compatibility List on www resmed com on the Products page under Service amp Support If you do not have internet access please contact your ResMed representative Humidification A humidifier is recommended especially for patients experiencing dryness of the nose throat or mouth For information on using a humidifier as part of e noninvasive ventilation see Setting up for noninvasive use on page 4 e invasive ventilation see Setting up for invasive use on page 5 Internal battery I CAUTION x Over time the capacity of the internal battery will decreas
6. floor make sure the area is free from dust and clear of bedding clothes or other objects that could block the air inlets e When using a Heated Moisture Exchange Filter HMEF replace the HMEF regularly as specified in the instructions provided with the HMEF e The H4i is contraindicated for invasive use An external humidifier approved for invasive use is recommended according to EN ISO 8185 with an absolute humidity of gt 33 mg L e For optimal accuracy and synchrony perform Learn Circuit with a change of the circuit configuration in particular when adding or removing high impedance components eg antibacterial filter external humidifier water trap nasal pillow type mask or air tubing See Setup menu Options on page 16 Setting up for invasive use English A N dI 10 CAUTION When using a humidifier check the breathing system regularly for accumulated water Note When the mask type is set to Trach the Non Vented Mask alarm will be automatically enabled to alert you when the ResMed Leak Valve has no vent holes or when the vent holes are blocked Antibacterial filter Catheter mount Learn Circuit configuration ResMed Leak Valve AC power cord AC locking clip External Air tubing humidifier Connect the power cord Plug the free end of the power cord into a power outlet Connect the antibacterial filter firmly onto the air outlet of the device Connect the external humidifier to the othe
7. if the device is used on multiple patients e Ina mulitpatient use environment you must perform the following before the device is provided to a new patient Air filter and the antibacterial filter Mask Air tubing Device Humidifier Replace 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 Replace the air tubing Alternatively consult the air tubing instructions for cleaning and disinfection information Disinfect the Stellar as follows Use an anti bacterial cleaning disinfectant solution such as Mikrozid AF or CaviCide with a clean non dyed disposable cloth to clean and disinfect the exterior surfaces of the device Wipe all accessible surfaces of the device including the air outlet avoid liquid entering any openings In the device Follow the manufacturer s recommended cleaning instructions As instructions for humidifiers vary see the user guide for the humidifier in use For multipatient use environment use the H4i water chamber disposable in place of the H4i reusable water chamber Cleaning and maintenance English 27 Servicing N CAUTION Inspection and repair should only be performed by an authorised agent Under no circumstances should you attempt to open service or repair the device yourself This product should be inspe
8. is kinked or punctured There is a large impedance eg antibacterial filter in the air circuit Consult your clinician Take a deep breath in and out through the mask Adjust position of mask and headgear Replace plug s Connect firmly at both ends Straighten or replace tubing Perform the Learn Circuit function The device does not stop when you remove your mask SmartStart Stop is disabled Use of a full face mask or tracheostomy tube Incompatible accessories eg humidifier or mask system with high resistance being used High Leak Alarm or Low Min Vent alarms are set to ON Confirm Stop is enabled Consult your clinician SmartStart is disabled if Full face mask or Trach is selected as interface Use only equipment as recommended and supplied by ResMed Consult your clinician Consult your clinician High Leak Alarm is enabled but alarm does not activate when the mask is removed during treatment Incompatible air delivery system being used Pressure settings are too low for the air delivery components being used Learn Circuit failed e The circuit configuration is inappropriate as the impedance detected is too high e Too many components have been included or the impedance of accessories in use is above ResMed s recommendation eg type of filter external humidifier air tubing Use only equipment as recommended and supplied by ResMed Perform the Learn Circuit func
9. temperature conditions are within the specified operating range Check if the power cord is properly connected to the device if you want to run from mains power Press the Alarm mute button X to cancel the alarm Check if the AC power cord is properly connected to the device if you want to run from mains power Note The alarm will be cleared automatically after one minute Solution Remove the mask or the catheter mount from the tracheostomy tube until power is restored Ensure the power cord is connected and press the switch at the back of the device once Wait for air pressure to build up Replace air filter Straighten or replace tubing Connect the air tubing firmly at both ends Adjust position of mask and headgear Replace plug s See your clinician to adjust the pressure Perfom the Learn Circuit function Turn humidifier control down and empty the water from the air tubing Troubleshooting 25 26 Problem possible cause Treatment pressure seems high Pressure required for treatment may have changed There is a change in the impedance in the circuit configuration Solution Consult your clinician Perform the Learn Circuit function The device does not start when you breathe into the mask SmartStart Stop not on Breath is not deep enough to trigger SmartStart There is excessive leak Plug s missing from port s on mask Air tubing is not connected properly Air tubing
10. to start the Learn Circuit 6 Wait for the device to complete its automated tests lt 30 sec The results are displayed when complete If the circuit configuration has been successfully learnt displays If unsuccessful displays see Troubleshooting on page 22 os The device starts the calibration of the FiO monitoring sensor to measure the oxygen concentration of the breathable air 1 Press to start the FiO sensor calibration 2 Wait for the device to complete its calibration The results are displayed when complete Note Turn off the oxygen flow If Max Ramp Time has been set by the clinician you may select any value up to this time Options 0 min Max Ramp Time max 45 minutes 5 minutes increments Setup menu Configuration Menu Parameter Language Brightness Backlight Time format Date format Description Sets the display language Options Depending on regional configuration Sets the LCD backlight brightness Options 20 100 10 increments 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 Options On Auto Sets the time format Options 24 hrs 12 hrs Sets the date format Options dd mm yyyy mm dd yyyy To return to the Options screen press the Return button J Setup menu 17 Info menu i Event Summary Event s
11. water If you observe water has spilled into the air circuit clear the water and check that the water chamber is not overfilled When using the H4i at high pressures above 25 cm H 0 the use of a water trap will avoid water spillage back into the air circuit e For optimal accuracy and synchrony perform Learn Circuit with a change of the circuit configuration in particular when adding or removing high impedance components eg antibacterial filter external humidifier water trap nasal pillow type mask or air tubing See Setup menu Options on page 16 CAUTION Check the air circuit for water condensation Use a water trap or a tubing wrap if humidification is causing water condensation within the tube Notes e A humidifier increases resistance in the air circuit and may affect triggering and cycling and accuracy of display and delivered pressures Therefore perform the Learn Circuit function see Setup menu Options on page 16 The device adjusts the airflow resistance e The heating feature of the H4i is disabled when the device is not mains powered Setting up for invasive use The Stellar can be used invasively only with the ResMed Leak Valve or using an uncuffed or deflated cuff tracheostomy tube with the ResMed Leak Port 24976 WARNING Make sure that all the air inlets at the rear of the device and under the device and vents at the mask or at the ResMed Leak Valve are unobstructed If you put the device on the
12. 1 17 VP d 1 17 VP d 2 33 VP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 737 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Technical specifications 31 32 Symbols Follow instructions for use Class Il equipment Type BF applied part A Bell Remote Alarm IP31 Device is protected against solid foreign objects of 2 5 mm diameter and greater and vertically falling water drops A N Caution A General warning sign see H4i connector plug and AC connection on the device O Standby or preparatory state for a part of equipment O Connection for oxygen supply max 30 I min max 30 L min amp gt Data port CE CE labeling in accordance with EC directive 93 42 EEC class Il b AO Temperature limitation for storage and transport gt Handle with care DI Maximum humidity a Keep dry val Manufacturer i Upside REF Catalogue number Ne
13. C 61000 4 11 lt 5 Ut gt 95 dip in lt 12 V gt 95 dip in Ut for 5 sec 240 V for 5 sec Power 3 A m 3 A m Power frequency magnetic fields should be at frequency levels characteristic of a typical location in a 50 60 Hz typical commercial or hospital environment magnetic field IEC 61000 4 8 Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter T Recommended separation distance DI Conducted RF 3 Vrms d 1 17 VP G IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m d 1 17 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 33 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol in NOTE 1 Ut is the AC mains voltage prior to application of the test level NOTE 2 At 80 MHz and 800 MHz the higher frequency range applies NOTE 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflec
14. E vwt olmv oo Mask type options Nasal Ultra Pillow Full Face Trach Pediatric Note When Mask Type is set to Trach or 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 on the Products page under Service amp Support If you do not have internet access please contact your ResMed representative Setup menu Alarm Settings Alarm Volume 1 Press to display the Alarm Settings screen 2 Use the push dial to scroll through the menu and change the Alarm Volume to low medium or high F AlarmSettings im FRA olmv 00 fi o ti nol vt olmv oo Setup menu Options 1 Press to display the Options screen 2 Use the push dial to scroll through the menu and change parameters see descriptions in the table below nol vt ik 3 0 RR olmi olmv oo nal RR oli nol vt o mv 0 0 16 Parameter Learn Circuit FiO Sensor Calibration Ramp Time Description The device is calibrated according to your air tubing system 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 English Note For invasive use do not connect a catheter mount tracheostomy tube or HMEF see Setting up for invasive use on page 5 Leave the air circuit unobstructed and open to the air Press
15. H20 whichever is greater 1 Put the mask on according to the mask user guide Hold down i for at least three seconds until pressure delivery starts 3 If necessary adjust the mask mask cushion and headgear until you have a good mask fit After three minutes treatment will begin Mask fit can be stopped at any time by pressing Notes e Press for at least three seconds during mask fit to start the treatment immediately e The mask fitting feature is disabled when the mask type Trach is selected e Availability of this feature is country dependent 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 INFO A MA MONITORING SETUP Pressure Flow Min Vent Resp Rate or MV Va IVAPS Mode Event Summary Leak Minute Ventilation Alarm Settings Tidal Volume Respiratory Rate E Ratio Tidal Volume Pressure Support AHI SpO2 Used Hours Device Information Reminder Note IVAPS mode is only available in Stellar 150 Using the menus English 15 Setup menu Setup menu Clinical Settings Mask Type 1 Press to display the Clinical Settings screen 2 Usethepushdial to scroll through the menu and change the Mask Type in the Advanced Settings screen ra et lik ool oln oolvt olmv oo aoler oln
16. RESMED Stellar 100 Stellar 150 INVASIVE AND NONINVASIVE VENTILATORS User Guide English Respiratory Care Solutions Making quality of care easy _ Respiratory Care Solutions Making quality of care easy RESMED Stellar 100 Stellar 150 User Guide English Contents INTFOOUGHON scesi Caleb ULISSE Indications for use Contraindications Adverse effects otellaratia glance psoriasi Patient interface Humidification Internal battery ResMed USB stick Use on an aircraft Mobile use Remote Alarm Setting up for noninvasive use 0 Attaching the H4i heated humidifier for noninvasive use Setting up for invasive USE 0 0 eee Working with other optional accessories BPA WWW VW Attaching the pulse oximeter Adding supplemental oxygen Starting therapy using oxygen Stopping therapy using oxygen Using the FiO2 monitoring sensor Attaching an antibacterial filter Selar Das CS orale aaa li iaia About the control panel LCD screen otartingitherapy i e see sro eee aaa Performing a functional test Starting therapy Stopping therapy Turning off the power Working with alarms Tailoring treatment setup options Using mask fit Using the menus 0 00 cee SEUEN aceon Ses RL ASILI Setup menu Clinical Settings Mask Type Setup menu Alarm Settings Alarm Volume Setup menu Options Setup menu Configuration Menu Info Menu Event Summary Us
17. arding EMC and needs to be installed and put into service according to EMC information provided in this document 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 Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments l a including domestic establishments and those directly Harmonic Emissions Class A connected to the public low voltage network that IEC 61000 3 2 supplies buildings used for domestic purposes Voltage Fluctuations Flicker Complies Emissions IEC 61000 3 3 Warnings 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 normal operation in the configuration in which it will be used The use of accessories eg humidifiers other than those specified in this manual is not recommended They may result in increased emissions or decreased immunity of the device Guidance and manufacturer s declaration electromagnetic immunity The de
18. art stop button ResMen Key Function Start Stop Starts or stops treatment Extended hold for at least three seconds starts the mask fitting feature Alarm mute e During therapy Press once to mute an alarm Press a second time to un mute an alarm If the problem is still present the alarm will sound again after two minutes DX See Working with alarms on page 13 e In stand by mode Extended hold for at least three seconds starts the alarm LED and alarm buzzer test Menu keys Press the appropriate menu button Monitoring Setup Info to enter and scroll through the relevant menu A p 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 monitoring screens and alarm status Values on this LCD screen and other screens throughout the User Guide are examples only Warm up feature H4i ResMed USB stick Ramp time Mains power Program External power supply E Therapy mode Internal battery dims lly 150 tai riers or Clinical mode r __ el n a a Title ba IESI Options YEE Current screen number of e ET a ia eae _ Therapy status bar Me I olti oolvte olmv oo Starting therapy Performing a functional test Make sure your device is functioning properly each time before starting therapy If any problems occur see Trouble
19. ation can be provided on the packaging see also symbols on page 32 e At low pressures the flow through the mask vent holes may be inadequate to clear all exhaled gas and some rebreathing may occur The device may not be exposed to excessive force e f the device should fall accidentally on the ground please contact your authorised service agent 1 Ports may be incorporated into the mask or in connectors that are near the mask 2 During partial below rated minimum voltage or total power failure therapy pressures will not be delivered When power is restored operation can proceed with no change to settings General warnings and cautions English 33 34 Pay attention to leaks and other unusual sounds If there is a problem contact an authorised service agent Do not replace any parts in the breathing circuit while the device is in operation Stop operation before changing parts Notes A note advises to special product features The above are general warnings and cautions Further specific warnings cautions and notes appear next to the relevant instructions in the user guide Only trained and authorised personnel are allowed to make clinical setting changes Position the device ensuring the power cord can be easily removed from the power outlet Limited warranty ResMed Ltd hereafter ResMed warrants that your ResMed product shall be free from defects in material and workmanship from the date of purchase for t
20. battery if in use and check that the LED for the external power supply is lit The External DC power use alarm will be displayed and the Alarm LED will light Reconnect the device to the mains Starting therapy 11 6 Check H4i heated humidifier if in use Check that the warm up feature is displayed in the Treatment screen Start the warm up feature Check that the humidifier warm up symbol is displayed on top of the screen Warm up humidifier You can use the warm up feature to pre heat the water in the humidifier prior to starting quos LT o gt Dele treatment The humidifier will be automatically detected when the device is turned on The Treatment screen provides the option to start n n warming the humidifier If the humidifier is al 22 30 00 heating the related symbol is displayed at the 21 07 2010 top of the LCD screen Tre Warm up the humidifier For more information see the H4i User Guide Note The H4i in heating mode can only be used when the device is connected to mains supply olen iol ti zo ve soo mw n 7 Check the FiO monitoring sensor if in use Start the FiO sensor calibration Select Setup menu then Options see Setup menu Options on page 16 Follow the instructions on the display 8 Check pulse oximeter if in use Attach the accessories according to the setup descriptions see Attaching the pulse oximeter on page 7 From the Monitoring menu go to th
21. by the internal battery for maximum 2 minutes LCD System Failure Component failure The device stops delivering air pressure system failure 6 7 9 22 38 Therapy cannot be started system failure 21 The device internal temperature is too low for the device to start deliver therapy system failure 21 The self test of the device fails and therapy cannot be started system failure 21 Connect the device to mains power Note In case of a total power failure the therapy settings will be stored and therapy will resume when the device is powered again 1 Poweroff the device 2 Poweron the device again 1 Ensure that ambient temperature is above 5 C If the device has been stored below 5 C allow sufficient time for it to acclimatise 2 Poweroff the device 3 Poweron the device again If the problem persists return the device for servicing 1 Poweroff the device 2 Poweron the device again If the problem persists return the device for servicing Problem possible cause Component failure system failure 8 25 LCD Over Pressure The device generates a pressure that is greater than 59 cm H30 Treatment will be stopped LCD Blocked Tube Air path is blocked Action 1 Poweroff the device 2 Poweron the device again 1 Poweroff the device 2 Check that the air tubing is connected properly 3 Poweron the device again 4 Start Learn Circuit function English Not
22. cted 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 Applicable ResMed warranty details are provided with the device at the time of original supply Of course as with all electrical devices if any irregularity becomes apparent you should exercise caution and have the device inspected by an authorised ResMed service centre Troubleshooting If there is a problem try the following suggestions If a 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 Notes e The alarm log and alarm settings are maintained when the device is powered down and in the event of a power loss e If multiple alarms are active simultaneously the alarm with the highest priority will be displayed first e Ifan alarm activates repeatedly discontinue use and return the device for servicing Problem possible cause Action LCD Internal Battery Empty 22 The remaining battery charge is below 15 The device can be powered
23. d TICONTROL are trademarks of ResMed Ltd ResMed SlimLine SmartStart and Stellar are registered in U S Patent and Trademark Office 2014 ResMed Ltd N SS Global leaders in sleep and respiratory medicine www resmed com
24. d the alarm setting level LCD High Leak High mask leak for more than 20 seconds LCD Non Vented Mask e Connection of a non vented mask e Mask vents may be blocked e ResMed Leak Valve is missing or vent is blocked LCD Apnoea The device detects an apnoea that has exceeded the pre set alarm level LCD Internal Battery Low The internal battery capacity is below 30 LCD Low SpO SpO gt has dropped below pre set alarm level LCD SpO finger sensor failure The finger sensor is not connected properly or delivers faulty values LCD Xpod oximeter disconnected The pulse oximeter is disconnected LCD Low FiO Level FiO has dropped below the pre set alarm level LCD High FiO Level FiO has exceeded the pre set alarm level Contact your clinician e Adjust the mask to minimise leak see Using mask fit on page 14 e Check the air circuit integrity and reconnect e f the problem persists contact your clinician e Ensure the mask has vents e Ensure the mask vents are not blocked e Ensure the ResMed Leak Valve is installed and that the vent is not blocked e Ensure oxygen if in use has only been connected at the rear of the device e fthe problem persists contact your clinician Breathe normally to disable the alarm e fthe problem persists contact your clinician Connect the device to mains power e Check the attachment of the sensor e fthe problem
25. e If the alarm activates repeatedly internal components may be defective Discontinue use and return the device for servicing 1 Check the air path for any blockages 2 Remove the blockages 3 If the alarm is not cleared stop treatment 4 Re start treatment LCD High Temperature 10 11 12 23 The temperature inside the device is too high Treatment may lead to stop LCD High Pressure Therapy pressure exceeds pre set alarm level LCD Low Pressure The air tubing is not connected properly LCD Circuit disconnected The air circuit is not connected properly LCD Low Minute Ventilation Minute ventilation level has dropped below the alarm setting level Ensure the ambient temperature is within the specified operating range If the problem persists within the specified operating conditions please return the device for servicing Contact your clinician 1 Stop treatment 2 Re start treatment If the problem persists contact your clinician 1 Check the air circuit integrity and reconnect 2 If the alarm doesn t get cleared stop treatment 3 Re start treatment 1 Check the air circuit integrity and reconnect 2 If the alarm is not cleared stop treatment 3 Re start treatment Contact your clinician Troubleshooting 25 24 Problem possible cause Action LCD Low Respiratory Rate High Respiratory Rate The respiratory rate level has dropped below or has exceede
26. e This depends on individual use and ambient conditions As the battery degrades it could lead to battery related alarms and or system errors ResMed recommends the battery be tested after two years to assess the remaining battery life Testing and replacement of the internal battery should only be performed by an authorised service agent Note The battery duration depends on the state of charge the environmental conditions the condition and age of battery the device settings and the patient circuit configuration In case of a mains power disruption the device will operate using the internal battery if there is no external battery connected to the device The internal battery will operate for approximately two hours under normal conditions see Technical specifications on page 27 The power status of the battery is displayed on top of the LCD screen Check the battery status regularly while operating the device with the internal battery and connect the device in time to mains power or alternatively to the external battery Additionally the Internal battery use alarm will be displayed Press the Alarm mute button to clear the alarm To recharge the internal battery connect the device to mains power It can take up to three hours to fully recharge the internal battery however this can vary depending on environmental conditions and if the device is in use Maintenance The internal battery has to be discharged and recharged every six mon
27. e Monitoring screen Check that the values for SpO and Heart rate are displayed 9 Check oxygen connection if in use Attach the accessories according to the setup descriptions see Adding supplemental oxygen on page 7 Starting therapy A CAUTION The Clinical mode amp is only for clinicians If the device is operating in clinical mode press the power switch 0 at the back to re start the device in patient mode A Fit your patient interface mask or catheter mount as described in the user instructions N Lie down and arrange the air tubing so that it is free to move if you turn in your sleep or arrange the tubing so it is comfortable in your wheelchair 3 To start treatment press or if the SmartStart Stop function is enabled simply breathe into your patient interface and treatment will begin Stopping therapy You can stop therapy at any time simply remove the patient interface and press to stop airflow or if SmartStart Stop is enabled simply remove the patient interface and treatment will stop automatically Notes e 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 Confirm Therapy Stop is enabled or the mask fitting feature is running e When the device is stopped and operating in standby mode with an integrated humidifier connected it will continue to blow air gently to assist cooling of the humidifier s heater plate
28. ed Hours Device Information Reminders Datamanagement oh aridi perla Cleaning and maintenance Daily Weekly Monthly Replacing the air filter Disinfection Multipatient use Servicing IFOUDISSNOOHNG tcc ca5ecdtecatevbsueetsncesanecathdeckeaws Alarm troubleshooting Other troubleshooting Technical specifications x ssa Oe ghee Geek we eee nak Guidance and manufacturer s declaration electromagnetic emissions and immunity Symbols General warnings and cautions 0 0 0 0 eee eee LIMICCO WarronbVi 2 a5 otar cued woos teas oor neat Bote tot fe Ge bed Introduction Read the entire manual before using the device This User Guide is for a non clinician user and does not contain all the information provided in the Clinical Guide Indications for use The Stellar 100 150 is intended to provide ventilation for non dependent spontaneously breathing adult and paediatric patients 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 Contraindications The Stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation The Stellar is not a life support ventilator If you have any of the following conditions
29. f the device To view the oximetry values from the Monitoring menu select Monitoring Adding supplemental oxygen Oxygen may be prescribed by your clinician Note Up to 30 L min at maximum oxygen pressure of 50 mbar 0 73 psi can be added Ww ARNING Oxygen flow must be turned off when the device is not operating so that unused oxygen does not accumulate within the device and create a risk of fire 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 If used in this way therapy and alarm operation must be verified each time oxygen flow is adjusted Oxygen supports combustion Oxygen must not be used while smoking or in the presence of an open flame Only use oxygen supply in well ventilated rooms The breathing system and the oxygen source must be kept at a minimum distance of 2 m away from any sources of ignition eg electrical devices Oxygen must not be used while the device is being operated within the mobility bag Working with other optional accessories English 7 Oxygen supply i 2 J Press spring to release connection after use Starting therapy using oxygen 1 Fit the oxygen connector to the oxygen inlet
30. han the approved cleaning agents is acceptable for periodic cleaning of the device such as for cleaning between patients or especially for service periods but not recommended for daily use Weekly 1 Remove the air tubing from the device and the patient interface 2 Wash the air tubing in warm water using mild detergent 3 Rinse thoroughly hang and allow to dry 4 Reconnect the air tubing to the air outlet and patient interface 5 If the device is visibly soiled wipe the exterior surfaces of the device and the pulse oximeter if used with a damp cloth and mild detergent Monthly 1 Wipe the exterior of the device and the pulse oximeter if used with a damp cloth and mild detergent 2 Visually inspect the air filter to check if it is blocked by dirt or contains holes Replacing the air filter fd O NO 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 from the back of the device Remove and discard the old air filter Insert a new air filter Refit the air filter cover Air filter Air filter cover Disinfection Disinfection of your device helps to prevent the risk of cross contamination Disinfect the exterior of the device and especially the air outlet with a damp cloth and a disinfection solution eg Microzid Multipatient use A WARNING e An antibacterial filter is mandatory
31. he period specified below Mask systems including mask frame cushion headgear 90 days and tubing excluding single use devices Accessories excluding single use devices Flex type finger pulse sensors Humidifier water tubs Batteries for use in ResMed internal and external battery 6 months systems Clip type finger pulse sensors 1 year CPAP and bilevel device data modules Oximeters and CPAP and bilevel device oximeter adapters Humidifiers and humidifier cleanable water tubs Titration control devices CPAP bilevel and ventilation devices including external 2 years power supply units Battery accessories Portable diagnostic screening devices 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 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 the region of original purchase Warranty claims on defective product must be made by the initia
32. hin the specified operating conditions please return the device for servicing e Power off the device Power son the device again Technical specifications Operating pressure e IPAP 2 cm H20 to 40 cm H20 in S ST T PAC mode range e PS 0 cm H320 to 38 cm H30 in S ST T PAC mode e EPAP 2 cm H20 to 25 cm H 0 in S ST T IVAPS PAC mode e CPAP 4 cm H320 to 20 cm H320 in CPAP mode only e Min PS 0 cm H20 to 20 cm H20 in IVAPS mode e Max PS 0 cm H320 to 30 cm H20 in IVAPS mode Note IVAPS mode is only available in Stellar 150 Maximum single fault 60 cm H30 in all modes pressure Maximum breathing 2 cm H20 at 30 L min resistance under single 7 2 cm H20 at 60 L min fault Maximum flow gt 200 L min at 20 cm H20 Flow accuracy 5 L min or 20 measured value whichever is greater Test condition T mode IPAP 40 cm H20 EPAP 2 cm H20 Rise Time MIN Fall Time MIN Ti 4 0 sec Respiratory Rate 10 bom with ResMed calibration cap Technical specifications 27 28 Therapy pressure tolerance Sound pressure level Alarm Volume Range Dimensions L x W x H Weight Air outlet Pressure measurement Flow measurement Power supply External DC Power Supply isolated Internal Battery Housing construction Environmental conditions Electromagnetic compatibility Air filter Air tubing SlimLine air tubing IPAP 0 5 cm H20 10 of set pressure end of inspiration EPAP PEEP 0 5 c
33. ilter must be replaced according to the manufacturer s specifications Note ResMed recommends using a filter with a low impedance less than 2 cm H20 at 60 L min eg PALL BB 50 filter WARNING Do not use the antibacterial filter product code 24966 with the H4i A f Sa vie ca J SL nl g ve 2 fi 1 ty Ms Le hy ae My a 2 k Fit the antibacterial filter to the air outlet of the device Attach the air tubing to the other side of the filter Attach the mask system to the free end of the air tubing Perform the Learn Circuit function see Setup menu Options on page 16 From the Setup menu select Options This enables the device to compensate for the impedance introduced by the filters Working with other optional accessories English 9 10 Stellar 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 Monitoring menu use Flashes when device Is WG Treatment turned off and battery is gt IN DINLAN charging x 22 30 00 Setup menu i 21 07 2010 IS aes Alarm LED Info menu Red or yellow during an alarm or during alarm testing Push dial rotate Alarm mute button LED click On when SY is pressed Therapy LED On during treatment Flashes during mask fitting operation St
34. ing 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 e Beware of electric shock Do not immerse the device pulse oximeter or power cord in water Turn off the device unplug the power cord from the power socket and the device before cleaning and be sure that it is dry before reconnecting The mask system and air tubing are subject to normal wear and tear Inspect them regularly for damage CAUTION The device cannot be sterilised Daily Disconnect the air tubing from the device and humidifier if used and hang it in a clean dry place until next use If the device is visibly soiled wipe the exterior surfaces of the device and the pulse oximeter if used with a damp cloth and mild detergent Data management 19 20 CAUTION e Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack e Do not use bleach chlorine alcohol or aromatic based solutions including all scented oils moisturising or antibacterial soaps to clean the air tubing or the device on a daily basis other than the approved cleaning agents Mikrozid AF or CaviCide These solutions may cause hardening and reduce the life of the product The use of cleaners and disinfecting solutions containing alcohol other t
35. injury e Read the entire manual before using the device e This device should only be used with air tubing and accessories recommended by ResMed or the prescribing clinician Use of incorrect air tubing and accessories May affect the functioning of this device The device and the accessories are to be used for the specified intended use only e The device must only be used with masks and connectors recommended by ResMed or by a Clinician or respiratory therapist A mask should not be used unless the device is turned on and operating properly The vent hole or holes associated with the mask should never be blocked Explanation The Stellar is intended to be used with special masks or connectors which have vent holes to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask vent holes However when the device is not operating insufficient fresh air will be provided through the mask and the exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation This applies to most Positive Airway Pressure devices e In the event of power failure or machine malfunction remove the mask or the catheter mount from the tracheostomy tube e Explosion hazard do not use in the vicinity of flammable anesthetics Do not use the device if there are obvious exter
36. l consumer at the point of purchase This warranty replaces all other expressed or implied warranties including any implied warranty of merchantability or fitness for a particular purpose Some regions or states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale installation or use of any ResMed product Some regions or states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from region to region For further information on your warranty rights contact your local ResMed dealer or ResMed office R001 325 2 09 09 Limited warranty English 35 _ Respiratory Care Solutions Making quality of care easy 248716 1 2014 02 Stellar 100 Stellar 150 tal 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 Jubilee Ave Milton Park Abingdon Oxfordshire 0X14 4RW UK See www resmed com for other ResMed locations worldwide For patent information see www resmed com ip ResMed SlimLine SmartStart Stellar an
37. m H20 4 of set pressure CPAP 0 5 cm H20 10 of set pressure Test condition T mode IPAP 40 cm H20 EPAP 2 cm H50 Rise Time MIN Fall Time MIN Ti 4 0 sec Respiratory Rate 10 bpm with ResMed calibration cap 29 dBA as measured according to ISO 17510 1 2002 32 dBA with uncertainty of 3 dBA as measured according to ISO 17510 1 2007 gt 45 dBA lt 85 dBA at 1 meter 3 steps low medium high 230 mm x 170 mm x 120 mm 2 1 kg 22 mm taper compatible with ISO 5356 1 2004 Anaesthetic amp Respiratory Equipment Conical Connectors Internally mounted pressure transducer Internally mounted flow transducer AC 100 240V 50 60Hz 2 2 A max 65 W 24V 3A Lithium lon battery 14 4 V 1 6 Ah 23 Wh Operating hours 2 h with a new battery under normal conditions see below Patient type home chronic pressure IPAP EPAP 15 5 cm H20 mask type Ultra Mirage air tubing 2 m leak 0 respiratory rate 20 bpm battery capacity 100 Patient type hospital acute pressure IPAP EPAP 20 5 cm H20 mask type Ultra Mirage air tubing 2 m leak 0 respiratory rate 45 bpm battery capacity 100 Flame retardant engineering thermoplastic e Operating temperature 0 C to 35 C e Operating humidity 10 95 non condensing Storage and transport temperature 20 C to 60 C 50 C e Storage and transport humidity 10 95 non condensing e Air pressure 680hPa to 1 100hPa Altitude 3 000 m NONIN XPOD P
38. nal defects unexplained changes in performance e Only use orignal and approved ResMed accessories and parts e Use only accessories from the original package If the packaging is damaged the respective product must not be used and should be disposed along with the packaging e Before using the device and the accessories for the first time ensure that all components are In a proper condition and that their operational safety is guaranteed If there are any defects the system should not be used e Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards eg IEC 60950 for data processing equipment Furthermore all configurations shall comply with the requirements for medical electrical systems see IEC 60601 1 1 or clause 16 of the 3Ed of IEC 60601 1 respectively Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems Attention is drawn to the fact that local laws take priority over the above mentioned requirements If in doubt consult your local representative or the technical service department e No modification of this equipment is allowed CAUTIONS A caution explains special measures for the safe and effective use of the device e When using accessories read the manufacturer s User Manual For consumables important inform
39. of the device 2 Attach the other end of the oxygen supply tubing to the oxygen supply 3 Press to start treatment 4 Turn on oxygen Stopping therapy using oxygen 1 Turn off oxygen 2 Press to stop treatment Using the FiO monitoring sensor Use of the FiO monitoring sensor may be recommended by your clinician N CAUTION Do not use the FiO monitoring sensor with the H4i humidifier Preparing to use a new sensor 1 Before use leave the FiO monitoring sensor open to the air for 15 minutes 2 Attach a new FiO monitoring sensor as shown below 3 Perform the sensor calibration see Setup menu on page 16 Note The FiO monitoring sensor must be replaced every 12 months Connecting a sensor 1 Oo oh W N Connect the air tubing to the T piece adapter Connect the FiO monitoring sensor to the T piece adapter Connect the adapter to the air outlet of the device Connect one end of the cable to the FiO monitoring sensor Connect the other end of the cable to the rear of the device Start calibration see Setup menu Options on page 16 This should be repeated periodically at the recommendation of your clinician Attaching an antibacterial filter fd 0O NO The use of an antibacterial filter may be recommended by your clinician One antibacterial filter product code 24966 can be purchased separately from ResMed Regularly check the filter for entry of moisture or other contaminants The f
40. persists contact your clinician Check if the finger sensor is attached properly to the finger and connection to the pulse oximeter Check if the pulse oximeter is connected properly to the device e Perform FiO sensor calibration e lf the problem persists contact your clinician e Perform FiO sensor calibration e f the problem persists contact your clinician Problem possible cause LCD Keypad Failure One of the keys was held down for more than 10 seconds or got stuck LCD Attention High Temp 42 43 44 45 The temperature inside the device is high LCD Internal Battery Use The device is using the internal battery LCD External DC Power Use The device is powered by an external battery Other troubleshooting Problem possible cause No display Power failure The device stops delivering air pressure Power not connected or device is not switched on Treatment pressure seems low Ramp time is in use Air filter is dirty Air tubing is kinked or punctured Air tubing is not connected properly Mask and headgear not positioned correctly Plug s missing from access port s on mask Pressure required for treatment may have changed There is a large impedance eg antibacterial filter in the air circuit Humidifier control dial set too high resulting in accumulation of water in the air tubing Action Remove any blockages from the keypad English Ensure the ambient
41. r side of the antibacterial filter If not using an external humidifier the HMEF can be connected to the ResMed Leak Valve at step 9 Connect the air tubing to the external humidifier Connect the ResMed Leak Valve to the air tubing Position the ResMed Leak Valve so that air from the vent holes does not blow directly onto the patient s chest WARNING Always set up the ResMed Leak Valve in the breathing circuit with the arrows and the symbol f pointing in the direction of air flow from the Stellar to the patient Select the mask type Trach select Setup menu then Clinical Settings then Advanced Settings Perform Learn Circuit see Setup menu Options on page 16 If an external humidifier is not being used you can connect the HMEF to the patient side of the ResMed Leak Valve Connect the catheter mount The ResMed Leak Valve or the HMEF can be connected to standardised tracheostomy interfaces including connector pieces like catheter mounts The catheter mount and the external humidifier are not part of the ResMed component Working with other optional accessories Attaching the pulse oximeter Use of a pulse oximeter may be recommended by your clinician Contraindication Th e pulse oximeter does not meet defibrillation proof requirement per IEC 60601 1 1990 clause 17 h Connect the plug of the finger pulse sensor to the plug of the pulse oximeter Connect the plug of the pulse oximeter at the rear o
42. re applications WARNING Do not connect any device to the data ports other than specially designed devices recommended by ResMed Connection of other devices could result in injury or damage to the Stellar see General warnings and cautions on page 33 CAUTION Do not disconnect the ResMed USB stick while data transfer is in progress Otherwise loss of data or incorrect data may result The download time depends on the data volume Notes You cannot connect two ResMed USB sticks simultaneously for data communication e f data transfer is not possible or failed please read the troubleshooting section Do not store files on the USB stick other than those created by the device or application Unknown files may be lost during data transfer English Plug the ResMed USB stick to one of the two USB connections on the rear side of the device The first dialogue for the USB data transfer is displayed automatically on the LCD The device checks if there is enough memory capacity on the USB stick and if readable data is available Select one of the available options e Read settings The settings will be transfered from the connected ResMed USB stick to the Stellar e Write settings Settings of the device will be stored on the ResMed USB stick e Write settings and loggings Settings and loggings of the device will be stored on the ResMed USB stick e Cancel Confirm the data transfer Cleaning and maintenance The clean
43. rm may be used to transfer audible and visual alarms by a direct cable connection For more information on using the Remote Alarm see the Remote Alarm user guide Setting up for noninvasive use I WARNING z e The air filter cover protects the device in the event of accidental liquid spillage onto the device Ensure that the air filter and air filter cover are fitted at all times e Make sure that all the air inlets at the rear of the device and under the device and vents at the mask are unobstructed If you put the device on the floor make sure the area is free from dust and clear of bedding clothes or other objects that could block the air inlets e Hoses or tubes must be non conductive and antistatic Do not leave long lengths of the air tubing or the cable for the finger pulse sensor around the top of your bed It could twist around your head or neck while you are sleeping I CAUTION e Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord e Make sure the area around the device is dry and clean Notes e ResMed recommends using the AC power cord supplied with the unit If a replacement power cord is required contact your ResMed Service Centre e Place the device on a flat surface near the head of the bed 2 ad F i ha 3 d we ZITTI AC power cord AC locking clip 1 Connect the power cord Plug the free end of the power cord into a power outlet
44. roduct complies with all applicable electromagnetic compatibility requirements EMC according to IEC60601 1 2 for residential commercial and light industry environments For further details see Guidance and manufacturer s declaration electromagnetic emissions and immunity on page 30 Electro static fibre mesh with TPE frame structure Bacterial filtration efficiency of 99 540 on area weight 100g m2 Flexible plastic 2 m or 3 m length 22 mm diameter Flexible plastic 1 83 m length 15 mm diameter IEC 60601 1 e Class Il Clause 3 14 double insulation This classifications adherence means the need for an protective earthing ie an earthed plug is not necessary e Type BF e Continuous operation Air travel requirements 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 This device is not suitable for use in the presence of a flammable anesthetic mixture Notes e The manufacturer reserves the right to change these specifications without notice e Pressure may be displayed in cm H30 or hPa Technical specifications English 29 Guidance and manufacturer s declaration electromagnetic emissions and immunity Medical Electrical Equipment needs special precautions reg
45. shooting on page 22 Please also check other provided User Instructions for troubleshooting information English Settings TSE Learn cirwuil 1 Turn off the device by pressing the power switch 0 at the back of the device Check condition of device and accessories Inspect the device and all the provided accessories If there are any visible defects the system should not be used 3 Check the circuit configuration Check the integrity of the circuit configuration device and provided accessories according to the setup descriptions in this User Guide and that all connections are secure 4 Turn on the device and check alarms Press the power switch at the back of the device once to turn on the device Check that the alarm sounds a test beep and the LEDs visual indicator for the alarm signal and the Alarm mute button flash The device is ready for use when the Treatment screen is displayed If the display shows the Reminder page follow the instructions then press to display the Treatment screen 5 Check batteries Disconnect the device from the mains and external battery if in use so that the device is powered by the internal battery Check that the Battery use alarm is displayed and the battery LED Is on Note If the charge state of the internal battery is too low or if the battery is empty an alarm occurs See the Alarm troubleshooting section on page 22 for further information Reconnect the external
46. ths 1 Remove the power cord while the Stellar is turned on stand by or in operation and let the device operate with the internal battery to a charge level of 50 2 Reconnect the power cord to the mains power The internal battery will be fully recharged Storing If the device is stored for a longer period the internal battery should be at the charge level of approximately 50 to increase the durability Note Check the charge level every six months if necessary recharge the internal battery to a charge level of 50 ResMed USB stick A ResMed USB stick may be used with the device either to help the clinician to monitor your treatment or to provide you with updated device settings For more information see Data management on page 19 Use on an aircraft ResMed confirms that the Stellar can be used during all phases of air travel without further testing or approval by the airline operator See Technical specifications on page 27 Stellar at a glance English Mobile use The Stellar Mobility bag allows the Stellar to be used in mobile situations eg in a wheelchair For setup and correct use see the Stellar Mobility Bag User Guide For extended mobile use the ResMed Power Station Il external power supply unit can be used as an additional power source Limitations apply to the use of oxygen with the Stellar Mobility Bag For more information contact your local ResMed representative Remote Alarm The Remote Ala
47. tion from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an environment 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 Separation distance according to frequency of transmitter m Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz power of transmitter W d
48. tion to adjust the therapy pressure according to your air tubing system Review the components included in the circuit configuration and adjust as appropriate then rerun Learn Circuit see Setup menu on page 16 The delivered airflow is not humid heated although the H4i humidifier is in use The humidifier is not properly attached The humidifier does not heat Correctly attach the humidifier The device is currently powered by battery use or not connected to the mains Problem possible cause Solution The humidifier does not work Return the device and the humidifier for servicing The water chamber is empty Fill the water chamber of the humidifier USB stick is not readable or writeable English The USB stick contains unreadable data Consult your clinician does not have enough space available is not compatible with the device USB stick is defective Replace the USB stick after consulting your clinician FiO sensor calibration failure FiO sensor is not attached properly For the correct attachment of the FiO sensor see Using the FiO2 monitoring sensor on page 8 FiO 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 LCD is displayed in the header Battery is not charging e Ensure the ambient temperature conditions are within the specified operating range If the problem persists wit
49. ummary displays the summary of three Pi eae types of events changes in settings alarms and I Event Summary iji system events eg 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 05 09 2010 n cin Dar 04 09 2000 ie hens Used Hours Used Hours during the last seven days of sl treatment are displayed in a bar graph and can be compared to the data of the last 365 days bi ks wg 1 17 01 00 E F io Us ve PIT This screen shows the serial number displayed as Device SN software version and other component versions Data on this screen may be requested for servicing or as part of problem solving by a technician The Clinician uses the Reminders menu to alert you to specific events for example when to replace the mask when to replace the filter and so on The reminder appears in yellow as the date approaches within 10 of the reminder period The reminder also displays when the device is powered on You can clear a reminder message by selecting Reset which clears the current reminder date to OFF or displays the next pre set Reminder date Data management 3 There are two data ports at the rear of the device for connecting a USB stick see Stellar at a glance on page 2 Therapy and device data can be stored on it or read from it to be used with ResMed softwa
50. ute key LED will light constantly For a high or medium priority alarm if after two minutes the problem is still present the alarm will sound again Any active low priority alarm will be permanently muted and the Internal Battery Use alarm will be cleared until the alarm condition is fulfilled again Starting therapy 13 14 Tailoring treatment setup options Setting Ramp Ramp time Ramp time is a feature that can be enabled by your clinician by setting a maximum ramp 100 M i 1500 Foe time Designed to make the beginning of treatment more comfortable ramp time is the period during which the pressure ie 22 30 00 increases from a low start pressure to the treatment pressure See Setup menu 21 07 2010 Options on page 16 Setramp olrr i1o0 Ti 20 vt soo mv 5 0 40 I 4 0 emH20 Program If the Clinician has selected both ie dual you can choose the program to use on the duo NI sga a A Treatment screen If only a single program is selected the option does not display wi 22 30 00 21 07 2010 rr uni YY CENA Set Program 4 0 emH20 Lk olrr i10 Ti 20o vt soo mv 5 0 Using mask fit You can use mask fit to help you fit your mask properly This feature delivers constant treatment pressure for a three minute period prior to starting treatment during which you can check and adjust your mask fit to minimise leaks The mask fit pressure is the set CPAP or EPAP pressure or 10 cm
51. vice 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 IEC60601 1 2 test Immunity test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile discharge ESD 8 kV air 8 kV air If floors are covered with synthetic material the IEC 61000 4 2 relative humidity should be at least 30 Electrical fast 2 kV for power Mains power quality should be that of a typical transient burst supply lines commercial or hospital environment IEC 61000 4 4 1 kV for input output lines Surge IEC 1 kV differential 1 kV differential Mains power quality should be that of a typical 61000 4 5 mode mode commercial or hospital environment 2 kV common mode 2 kV common mode Voltage dips lt 5 Ut gt 95 dipin lt 12 V gt 95 dip in Mains power quality should be that of a typical short Ut for 0 5 cycle 240V for 0 5 cycle commercial or hospital environment interruptions 40 Ut 60 dip in 96 V 60 dip in If the user of the device requires continued and voltage 240 V for 5 cycles operation during power mains interruptions it is Ut for 5 cycles variations on recommended that the device be powered from power supply 70 Ut 30 dip in 168 V 30 dip in an uninterruptible power source input lines Ut for 25 cycles 240 V for 25 cycles IE

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