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1. LCD Internal Battery Empty The remaining battery charge is below Connect the device to mains power 15 The device can be powered by the Note In case of a total power failure the internal battery for maximum 2 minutes therapy settings will be stored and therapy will resume when the device is powered again LCD System Failure Component failure 1 Power off the device The device stops delivering air pressure 2 Power on the device again system failure 6 7 9 22 38 Therapy cannot be started system failure 21 The device internal temperature is too 1 Ensure that ambient temperature is low for the device to start deliver therapy above 5 C system failure 21 If the device has been stored below 5 C allow sufficient time for it to acclimatise 2 Poweroff the device 3 Power on the device again If the problem persists return the device for servicing Problem possible cause The self test of the device fails and therapy cannot be started system failure 21 Component failure system failure 8 25 LCD Over Pressure The device generates a pressure that Is greater than 59 cm H320 Treatment will be stopped LCD Blocked Tube Air path is blocked Action 1 Poweroff the device 2 Poweron the device again If the problem persists return the device for servicing 1 Power off the device 2 Power on the device again English 1 Power off the device 2 Check that the air
2. 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 6 6 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 To add supplemental oxygen 1 2 Unlock the low flow oxygen inlet on the back of the device by pushing up on the locking clip Insert one end of the oxygen supply tubing into the oxygen connector port The tubing automatically locks into place English Attach the other end of the oxygen supply tubing to the oxygen supply Start ventilation Turn on the oxygen source and adjust to the desired flow rate To remove supplemental oxygen Before you remove supplemental oxygen from the device ensure the oxygen supply has been turned off Unlock the low flow oxygen inlet on the back of the device by pushing up on the locking clip Remove the oxygen supply tubing from the oxygen connector por
3. and a disinfection solution eg Microzid Multipatient use A WARNING e An antibacterial filter is mandatory 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 sterilization instructions are available from the ResMed website www resmed com masks sterilization americas 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 23 Servicing N CAUTION Inspection and repair should only be performed by an authorized agent Under no
4. 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 d in 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 oo 34 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 0 1 2 5 mm diameter and greater and vertically falling water drops AN Caution A General warning sign see H4i connector plug and AC connection on the device ON STAND BY Standby or preparatory state for a part of equipment power switch O Connection for oxygen supply max 30 I min max 30 L min amp gt Data port C Canadian Standards Association A Temperature limitation for storage and transport gt Handle with care S Maximum humidity ai Keep dry sal Manufacturer tt Upside Catalogue number Serial num
5. dial set too high resulting in accumulation of water in the air tubing Treatment pressure seems high Pressure required for treatment may have changed Ensure the ambient temperature conditions are within the specified operating range English Check if the power cord is properly connected to the device if you want to run from mains power Press the Alarm mute button J 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 he 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 Consult your clinician Troubleshooting 27 28 Problem possible cause There is a change in the impedance in the circuit configuration Solution 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 i
6. from structures objects and people a 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 1 17 VP
7. of 3 dBA as measured according to ISO 17510 1 2007 gt 45 dBA lt 85 dBA at 3 3 1 m 3 steps low medium high 9 1 x 6 7 x 4 7 230 mm x 170 mm x 120 mm 4 6 lb 2 1 kg 0 9 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 24 V 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 6 6 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 6 6 2 m leak 0 respiratory rate 45 bom battery capacity 100 Flame retardant engineering thermoplastic Environmental conditions Electromagnetic compatibility Air filter Air tubing SlimLine air tubing IEC 60601 1 classifications Air travel requirements e Operating temperature 32 F 0 C to 95 F 35 C e Operating humidity 10 95 non condensing e Storage and transport temperature 4 F 20 C to 140 F 60 C 122 F 50 C e Storage and transport humidity 10 95 non condensing e Air pressure 680hPa to 1 100hPa Altitude 9 842 5 3 000 m NONIN XPOD Product
8. stored on the ResMed USB stick e Cancel Confirm the data transfer Cleaning and maintenance The cleaning and maintenance described in this section should be carried out regularly This also helps to prevent the risk of cross contamination Refer to the mask humidifier and other accessories user guide for detailed instructions for care and maintenance WARNING 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 e The mask system and air tubing are subject to normal wear and tear Inspect them regularly for damage CAUTION The device cannot be sterilized Daily Disconnect the air tubing from the device and humidifier if used and hang it in a clean dry place until next use 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 21 22 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 moisturizing 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 hardenin
9. 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 24 O 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 lt Setup menu 19 20 Info menu H Event Summary 05 09 2010 07 04 57pm IPAP changed from 30 0 cmH20 to 20 0 cmH20 07 04 23
10. 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 m W a eo treatment The humidifier will be automatically OA Treatment 18 detected when the device is turned on The Treatment screen provides the option to start 21 47 17 warming the humidifier If the humidifier is 110 P 09 04 2014 heating the related symbol is displayed at the top of the LCD screen ag sidia For more information see the H4i User Guide i n Note The H4i in heating mode can only be used when the device is connected to mains supply Lk 0 RR 0 Ti 0 0 Vt O MV 00 Check the FiO monitoring sensor if in use Start the FiO sensor calibration Select Setup menu then Options see Setup menu Options on page 18 Follow the instructions on the display Check pulse oximeter if in use Attach the accessories according to the setup descriptions see Attaching the pulse oximeter on page 8 From the Monitoring menu go to the Monitoring screen Check that the values for SpO and Heart rate are displayed Check oxygen connection if in use Attach the accessories according to the setup descriptions see Adding supplemental oxygen on page 8 Starting therapy To 14 Starting therapy CAUTION The Clinical mode amp is only for clinicians If the device is op
11. to be discharged and recharged every six months 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 21 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 30 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 II external power supply unit can be used as an additional power source Limitations apply to the use of oxygen with the Stellar Mobility Bag For more information contact your local ResMed repre
12. 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 authorized personnel are allowed to make Clinical setting changes Position the device ensuring the power cord can be easily removed from the power outlet General warnings and cautions English 35 36 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 the 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 i
13. tubing is connected properly 3 Power on the device again 4 Start Learn Circuit function Note 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 26 Problem possible cause Action LCD Low
14. 0 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 a Recommended separation distance o Conducted RF 3 Vrms d 1 17 VP a 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 p 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 reflection
15. BB 50 filter WARNING Do not use the antibacterial filter product code 24966 with the H4i 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 A O Na English Perform the Learn Circuit function see Setup menu Options on page 18 From the Setup menu select Options This enables the device to compensate for the impedance introduced by the filters Stellar basics About the control panel Mains Power LED On when operating on mains power LCD Screen External power supply LED On when external battery is connected Internal battery LED On when internal battery is in use Flashes when device is turned off and battery is W 15g Be 21 47 17 charging 09 04 2014 Alarm LED Red or yellow during an Z ORAO O e ao Et alarm or during alarm testing Alarm mute button LED On when is pressed Q N Start stop button RESMED Monitoring menu Setup menu Info menu Push dial rotate click Therapy LED On during treatment Flashes during mask fitting operation Stellar basics 11 Key Function Start Stop e Starts or stops treatment e 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 s
16. ResMed Stellar series Adult and paediatric ventilators V User Guide English Contents MACEOOUICTIOMN s seara aN ete Soe Ete oa GPM Ge EP ee eo Indications for use Contraindications Adverse effects Stellar ata GlaNiCe sine snc edscinedne ne dead a ee eh ee Patient interface Humidification Internal battery ResMed USB stick Use on an aircraft Mobile use Remote Alarm Setting up for noninvasive use 0 000 ee Attaching the H4i heated humidifier for noninvasive use Setting up for invasive USE 0 0 ee Using the Stellar device for the first time Working with other optional accessories _ BHPWWW W W Attaching the pulse oximeter Adding supplemental oxygen Using the FiO2 monitoring sensor Attaching an antibacterial filter Stelar DASICS sine et tick eee ee eae ee ee eee About the control panel LCD screen Stating THeELADY erer urtee cin cee en eee anaes Maas 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 neeet bee Beko eke Geeta dene ce SOMO MENU c c sti ae ees ol ee ee aod ll a i oa Setup menu Clinical Settings Mask Type Setup menu Alarm Settings Alarm Volume Setup menu Options Setup menu Configuration Menu ATOMIC acicien we ideedat conga bat te kee des Senaebes eens Event Summary Used H
17. Respiratory Rate High Respiratory Rate The respiratory rate level has dropped below or has exceeded 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 Apnea The device detects an apnea 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 LCD Keypad Failure One of the keys was held down for more than 10 seconds or got stuck Contact your clinician e Adjust the mask to minimize leak see Using mask fit on page 16 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 f the problem persists contact you
18. ber Batch code D Do not re use as Use by date EN 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 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 air filters and air tubings according to the directives in your country General warnings and cautions WARNINGS A warning alerts you to possible 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 e The device and the accessories are to be used for the specified intended use only 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 flu
19. circumstances should you attempt to open service or repair the device yourself This product should be inspected by an authorized ResMed service center 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 authorized ResMed service center 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
20. 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 32 Electro static fibre mesh with TPE frame structure Bacterial filtration efficiency of 99 540 on area weight 100g m Flexible plastic 6 6 2 m or 9 10 3 m length 0 9 22 mm diameter Flexible plastic 6 1 83 m length 0 6 15 mm diameter e Class II Clause 3 14 double insulation This adherence means the need for an protective earthing ie an earthed plug is not necessary e Type BF e Continuous operation 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 H20 or hPa Technical specifications English 31 Guidance and manufacturer s declaration electromagnetic emissions and immunity Medical Electrical Equipment needs special precautions regarding EMC an
21. d 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 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 device is int
22. e air circuit Check the air circuit regularly for accumulated 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 H30 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 18 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 18 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 e 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 R
23. e connected to standardized tracheostomy interfaces including connector pieces like catheter mounts The catheter mount and the external humidifier are not part of the ResMed component Setting up for invasive use 7 Using the Stellar device for the first time When using the Stellar device for the first time ensure that all components are in working CO ndition and perform a functional test see Performing a functional test on page 12 Alarms should also be checked by the physician when setting up a new patient See Clinical Guide 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 of 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
24. ended 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 IEC 6100
25. ent setup options English Setting Ramp Ramp time m Wt pegs 8 G Treatment wl 21 47 17 09 04 2014 oo iisetPrasraminy 0 0 cmH20 0 Ti 0 0 vt O MV 00 Programs Program o Wt 150a 5 A G Treatment fe wl 21 47 17 09 04 2014 ery Ee 0 0 Set Program 0 0 cmH20 Lk 0 RR 0 Ti 0 0 vt O MV 00 Ramp time is a feature that can be enabled by your clinician by setting a maximum ramp time Designed to make the beginning of treatment more comfortable ramp time is the period during which the pressure increases from a low start pressure to the treatment pressure See Setup menu Options on page 18 Programs can be configured by your clinician to provide you with multiple treatment options For example a clinician can set up programs for sleeping versus waking use or for use during exercise or physiotherapy Programs save different patient circuit configurations Learn Circuit result and therapy and alarm settings The Stellar comes with one active program Your clinician can configure two programs If your clinician has selected dual you can choose the program to use on the Treatment screen after stopping treatment If only a single program Is selected the option does not display Note Each program retains its own circuit configuration When switching between programs ensure you use the correct circuit breathing system as learned for that program If more
26. erating in clinical mode press the power switch C at the back to re start the device in patient mode A 1 Fit your patient interface mask or catheter mount as described in the user instructions 2 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 Contirm 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 e Masks with high resistance eg pediatric 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 2 Stop the therapy Press the power switch at the back of the device once and follow the instructions on the disp
27. esMed Leak Valve are unobstructed If you put the device on the floor make sure the area is free from dust and clear of bedding clothes or other objects that could block the air inlets 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 a Learn Circuit when a new circuit is used or with a change of the circuit configuration in particular when adding or Setting up for invasive use English 5 A NO 0l removing high impedance components eg antibacterial filter external humidifier water trap or different type of air tubing Do not connect patient interfaces prior to performing the Learn Circuit Patient interfaces include any components placed after the ResMed Leak Valve eg HMEF catheter mount tracheostomy tube See Setup menu Options on page 18 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 ResMed Leak Valve CUN AC power cord AC l
28. 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 Progl ST olti oo vt i olti ool vt o mv 0 0 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 rol A m g Options 3 3 a Configuration Menu Learn Circuit Language English 0 0 RR o Ti 0 0 vt 0 0 RR o Ti 0 0 vt o Parameter Learn Circuit FiO Sensor Calibration Ramp Time Description The device is calibrated according to your air tubing system 1 Ensure that the therapy is turned off before performing a Learn Circuit 2 If in use turn off the oxygen flow Select the mask type 4 Set up the air circuit including accessories and patient interface English w Note When performing a Learn Circuit for invasive use do not connect a catheter mount tracheostomy tube or HMEF see Setting up for invasive use on page 5 5 Leave the air circuit unobstructed and open to the air Press to start the Learn Circuit 7 Wait for the device to complete its automated
29. g and reduce the life of the product The use of cleaners and disinfecting solutions containing alcohol other than 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 Ifthe 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 A OO Na 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 English 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
30. he capacity of the internal battery will decrease 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 authorized 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 30 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
31. ir tubing Use only equipment as recommended and supplied by ResMed Perform the Learn Circuit function 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 18 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 The humidifier does not work The water chamber is empty Correctly attach the humidifier The device is currently powered by battery use or not connected to the mains Return the device and the humidifier for Servicing Fill the water chamber of the humidifier Problem possible cause Solution USB stick is not readable or writeable 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 10 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 a
32. ive Bella Vista NSW 2153 Australia manuracrunen FrQunhoferstr 16 ResMed Corp 9001 Spectrum Center Blvd San Diego CA 92123 USA 82152 Martinsried Germany 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 and TICONTROL are trademarks of ResMed Ltd ResMed SlimLine SmartStart and Stellar are registered in U S Patent and Trademark Office 2014 ResMed Ltd 248722 1 2014 06 ResMed com
33. l the provided accessories If there are any visible defects the system should not be used 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 English 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 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 24 for further information Reconnect the external 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 Check H4i heated humidifier if in use Check that the warm up feature is displayed in the Treatment screen Start
34. lay Note To disconnect the device from the mains power pull out the power cord from the power socket Working with alarms 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 ailrr 10 Ti 20 vt soolmv 5 0 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 18 You can mute an alarm by pressing X once By pressing the Alarm mute key again the alarm sounds again When an alarm is muted the Alarm mute 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 Tailoring treatm
35. mbient temperature conditions are within the specified operating range If the problem persists within the specified operating conditions please return the device for servicing e Power off the device Power on the device again Troubleshooting English 29 30 Operating pressure range Maximum single fault pressure Maximum breathing resistance under single fault Maximum flow Flow accuracy 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 Technical specifications IPAP 3 cm H320 to 40 cm H50 in S ST T PAC mode e PS 0 cm H320 to 37 cm H30 in S ST T PAC mode e EPAP 3 cm H320 to 25cm H 0 in S ST T iVAPS PAC mode e CPAP 4 cm H20 to 20 cm H20 in CPAP mode only e Min PS 0 cm H20 to 20 cm H320 in iVAPS mode e Max PS 0 cm H20 to 30 cm H20 in iVAPS mode Note iVAPS mode is only available in Stellar 150 60 cm H30 in all modes 2 cm H320 at 30 L min 7 2 cm H20 at 60 L min gt 200 L min at 20 cm H20 5 L min or 20 measured value whichever is greater IPAP 0 5 cm H20 10 of set pressure end of inspiration EPAP PEEP 0 5 cm H20 4 of set pressure CPAP 0 5 cm H20 10 of set pressure 29 dBA as measured according to ISO 17510 1 2002 32 dBA with uncertainty
36. ng disposable e H4i heated humidifier Antibacterial filter e Heat moisture exchanger filter HMEF e ResMed XPOD oximeter Nonin pulse oximetry sensors FiO monitoring kit external cable T piece adapter FiO monitoring sensor Stellar Mobility bag e ResMed Leak Valve Tubing wrap l 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 m Over time t
37. ocking clip External 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 other 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 Press the power switch on the back to turn on the device Select the mask type Trach select Setup menu then Clinical Settings then Advanced Settings Perform a Learn Circuit see Setup menu Options on page 18 according to the following setup illustrations With an external humidifier Antibacterial filter ResMed Leak Valve English External Humidifier Without an external humidifier Antibacterial filter ResMed Leak Valve Air tubing 10 If an external humidifier is not being used you can connect the HMEF to the patient side of the ResMed Leak Valve 11 Connect the catheter mount Catheter mount HMEF The ResMed Leak Valve or the HMEF can b
38. 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 No modification of this equipment is allowed CAUTIONS A caution explains special measures for the safe and effective use of the device When using accessories read the manufacturer s User Manual For consumables important information can be provided on the packaging see also symbols on page 34 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 If the device should fall accidentally on the ground please contact your authorized service agent Pay attention to leaks and other unusual sounds If there is a problem contact an authorized 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
39. or 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 e eye Irritation e skin rashes Introduction 1 Stellar at a glance mane z H4i connector plug and AC Air outlet connection Oxygen inlet Infrared connection for humidifier Air filter cover ON STAND BY XPOD pulse oximeter connection DC power socket FiO sensor connection Data port for USB stick Remote alarm connection AC power socket Power on standby switch Data port for direct PC connection The Stellar comprises e Stellar device Hypoallergenic air filter e AC power cord Carry bag 6 6 2 m air tubing ResMed USB stick Low pressure oxygen connector The following optional components are compatible with Stellar e 9 10 3 m air tubing SlimLine air tubing Clear air tubi
40. ours Device Information Reminders Data management 0 0 0 cee Cleaning and maintenance Daily Weekly Monthly Replacing the air filter Disinfection Multipatient use Servicing IFOUDIGSHOOUNG 25 20 bt bwieine ee but erie rede ee eee ans Alarm troubleshooting Other troubleshooting Technical specifications Guidance and manufacturer s declaration electromagnetic emissions and immunity Symbols General warnings and cautions Limited warranty 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 is intended to provide ventilation for non dependent spontaneously breathing adult and pediatric patients 30 Ib 13 kg and above with respiratory insufficiency or respiratory failure with or without obstructive sleep apnea The device is for noninvasive use or invasive use with 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 N CAUTION USA ONLY Federal law restricts this device to sale by or on the order of a physician 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 tell your doct
41. pm Therapy mode changed from T to ST pm Internal Batter rm cleared 07 01 57pm Internal Batter y Use Alarm activated 04 09 2010 10 54 08pm Data erased Used Hours I j Week Avg 08 17h _ Min 01 00 h Ma 09 00 h Used hours Hours 420 15 h Event summary displays the summary of three types of events changes in settings alarms and 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 Used Hours during the last seven days of treatment are displayed in a bar graph and can be compared to the data of the last 365 days 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 a
42. r clinician e Breathe normally to disable the alarm e f the problem persists contact your clinician Connect the device to mains power e Check the attachment of the sensor e f the problem 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 f the problem persists contact your clinician e Perform FiO sensor calibration e f the problem persists contact your clinician Remove any blockages from the keypad Problem possible cause Action 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
43. s excessive leak Plug s missing from port s on mask Air tubing is not connected properly Air tubing 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 a
44. sentative Remote Alarm The Remote Alarm 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 N WARNING 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 Hoses or tubes must be nonconductive 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 CAUTION Be careful not to place the device where it can be bumped or where someone is likely to trip over the power cord 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 Center Place the device on a flat surface near the head of the bed Mea AC power cord AC locking clip Connect the power cord Plug the free end of the power cord into a power outlet A
45. shes 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 Inthe 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 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 Do not use the device if there are obvious external defects unexplained changes in performance Only use original and approved ResMed accessories and parts 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 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 Additional equipment connected to medical electrical equipment must comply with the respective IEC
46. t Working with other optional accessories 9 Using the FiO monitoring sensor Use of the FiO monitoring sensor may be recommended by your clinician CAUTION Do not use the FiO monitoring sensor with the H4i humidifier Preparing to use a new sensor 1 2 3 Before use leave the FiO monitoring sensor open to the air for 15 minutes Attach a new FiO monitoring sensor as shown below Perform the sensor calibration see Setup menu on page 18 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 18 This should be repeated periodically at the recommendation of your clinician Attaching an antibacterial filter 10 The use of an antibacterial filter may be recommended by your clinician One antibacterial tilter product code 24966 can be purchased separately from ResMed Regularly check the filter for entry of moisture or other contaminants The filter must be replaced according to the manufacturer s specifications Note ResMed recommends using a filter with a low impedance less than 2 cmH 0 at 60 L min eg PALL
47. t a glance on page 2 Therapy and device data can be stored on it or read from it to be used with ResMed software 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 34 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 e 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 e 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 dialog 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
48. than one program has been set up follow the directions given by your clinician for when and how each program should be used Ramp Down If you experience difficulties in taking off the ventilation you can use the Ramp Down feature This feature reduces the treatment pressure over five minutes You can enable the Ramp Down feature when it is selected by the physician in the Options menu Starting therapy 15 16 Ramp Down mom o Smo Q G Treatment g 21 47 54 09 04 2014 B _ ee Eu Ramp Down 0 0 9 0cmH20 0 RR ToT 1 0 vt SOO MV 1 0 Notes e Therapy can be stopped at any time by pressing the therapy start stop button including during the Ramp Down time e During the Ramp Down time the low pressure alarm is not active e This feature is not available in all countries 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 minimize leaks The mask fit pressure is the set CPAP or EPAP pressure or 10 cm H20 whichever is greater Put the mask on according to the mask user guide Hold down for at least three seconds until pressure delivery starts 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 b
49. till present the alarm will sound again after two minutes LX See Working with alarms on page 14 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 i 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 Therapy mode Internal battery 100 m ZA Ww 15 Cg a Patient mode sj or Title b a Clinical mode amp poe Current screen number of screens within the menu Settings Scroll bar Therapy status bar MAET i re Cina o mMv 00 Starting therapy Performing a functional test Make sure your device is functioning properly each time before starting therapy If any problems occur see Troubleshooting on page 24 Please also check other provided User Instructions for troubleshooting information 12 Turn off the device by pressing the power switch at the back of the device Check condition of device and accessories Inspect the device and al
50. ts 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 Warranty is void on product sold or resold outside the region of original purchase Warranty claims on defective product must be made by the initial 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 RO01 325 2 09 09 ResMed MANUFACTURER DISTRIBUTED BY ResMed Germany Inc ResMed Ltd 1 Elizabeth Macarthur Dr
51. ttach 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 10 GCG A 8 Note Other external humidifiers can be used for noninvasive setup ResMed recommends using a breathing system including antibacterial filter air tubings external humiditier with an impedance of maximum 2 cm H30 at 30 L min 5 cm H320 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 Press the power switch on the back to turn on the device Select the mask type select Setup menu then Clinical Settings then Advanced Settings Perform Learn Circuit see Setup menu Options on page 18 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 th
52. y 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 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 M M MONITORING SETUP Pressure Flow Min Vent Resp Rate or MV Va IVAPS Mode Event Summary Leak Minute Ventilation Alarm Settings Tidal Volume Respiratory Rate I E Ratio Tidal Volume Pressure Support AHI SpO Used Hours Device Information Reminder Note i VAPS mode is only available in Stellar 150 Using the menus English 17 18 Setup menu Setup menu Clinical Settings Mask Type 1 Press to display the Clinical Settings screen 2 Use the push dial to scroll through the menu and change the Mask Type in the Advanced Settings screen wg i w A 3 AdvancedSettings Clinical Settings Pathology Normal l cea el e ao l 3 Lk 0 0 RR olti o0 0 vt o mv 0 0 Lk 0 0 RR olti o 0 vt o mv 0 0 v 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

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