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User Guide - Medical Dynamics, Inc.

1. Alarms This device is fitted with alarms to alert you to changes that will affect your treatment 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 Alarm display The alarm LED lights during an alarm or the alarm test Additionally an alarm message is shown on top of the LCD High priority alarms are displayed in red medium priority alarms in yellow and low priority alarms in turquoise For further information about alarms see Troubleshooting on page 15 Your clinician has the option to set and to turn on or turn off the alarms Press the settings menu key and switch to the alarm page to view the current settings Alarm message re wl 22 30 00 N Alarm LED i lct Eae nl C Alarm mute key ik_a rR_ 10 Ti_ 20 vt soo mv 5 0 l 0 z 5 Muting alarms You can mute an alarm by pressing the Alarm Mute key once When an alarm is muted the LED of the alarm mute key will light constantly Pressing this key a second time will un mute the alarm and the LED of the alarm mute key will go out In case of a high or medium priority alarm the alarm will sound again after two minutes if the problem is still present The alarm LED will remain on until the problem is solved The top of the LCD will display the alarm message as long as the problem is present except if the alarm mute key was pressed when a lo
2. Notes The manufacturer reserves the right to change these specifications without notice e Pressure may be displayed in cm H5O or hPa Further clinical information is available through your authorised ResMed service centre Guidance and manufacturer s declaration electromagnetic emissions and immunity Medical Electrical Equipment needs special precautions regarding 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 fon including domestic establishments and those directly Harmonic Emissions Class A connected to the public low voltage network that EC 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 f adjacent
3. Consult your clinician Use of a full face mask or tracheotomy tube SmartStop does not work with a full face mask or tracheotomy tube Incompatible humidifier or mask system being used Use only equipment as recommended and supplied by ResMed Leak Alarm or Low Minute Ventilation Alarm is set to ON Consult your clinician Confirm Stop is enabled Consult your clinician Leak Alarm is enabled but alarm does not activate when the mask is removed during treatment Incompatible air delivery system being used Use only equipment as recommended and supplied by ResMed Pressure settings are too low for the air delivery components being used Perform the Learn circuit function to adjust the mask pressure according to your air tubing system The delivered airflow is not heated although the H4i humidifier is in use The humidifier is not properly attached Correctly attach humidifier The humidifier does not heat The device is currently powered by battery The humidifier does not work Return your device and the humidifier for servicing Data storage device is not readable or writeable The data storage device contains unreadable data does not have enough space available or is not compatible with the device Consult your clinician LCD 4 is displayed on top of the LCD Battery is not charging Ensure the ambient temperature con
4. 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles lt 5 Ut gt 95 dip in lt 12 V gt 95 dip in 240V for 0 5 cycle 96 V 60 dip in 240 V for 5 cycles 168 V 30 dip in 240 V for 25 cycles lt 12 V gt 95 dip in Mains power quality should be that of a typical commercial or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power source English 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 rom the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 10 V m 3 V m d 0 35 VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 0 70 VP 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fi
5. be connected to the data communication port Do not connect any other device to the data communication ports Connecting other devices could result in injury or damage to the Stellar 100 see General warnings and cautions on page 22 l CAUTION z 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 Note Unknown files can get lost during data transfer English Turning off the device 1 Turn off the oxygen flow if used 2 Check that the device is in standby mode no ventilation 3 Press the power switch O 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 Optional device settings The optional device settings are available from the Options menu and the Configuration submenu Function Description Settings Learn Circuit The device is calibrated according to The function is enabled by your air tubing system pressing the Push dial Before performing the Learn circuit function set up the circuit including accessories and patient interface except catheter mount and HMEF for invasive use The circuit must be unobstructed and left open to the air while performing the Learn circuit function Notes The Learn circuit function has to be performed with every change of the circuit configuration e Turn of
6. 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 Internal battery The internal battery of your device has to be discharged and recharged every six months 1 Remove the power cord while the Stellar 100 is providing therapy and let the device operate with the internal battery to a charge level of 50 2 Reconnect the power cord to the mains power while the device is operating The internal battery will be recharged CAUTION The internal battery must be replaced after two years Replacement of the internal battery should only be performed by an authorised agent Under no circumstances should you attempt to replace the internal battery yourself Maintenance reminder Your device informs you about the following maintenance events that are set by your clinician Replace mask call provider replace filter service due custom reminder If an event occurs it will be shown on the Reminder screen right after the device is turned on Once the maintenance issue has been dealt with you have to confirm this to reset the reminder date Servicing This product should be inspected by an authorised ResMed service centre five years from the date of manufacture 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 Ap
7. the catalogue of ventilation accessories on our website at www resmed com Setting up the device Setting up the device for non invasive use AC locking clip AC power cord Note For stationary use place the device on a flat surface near the head of your bed WARNING 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 Make sure that all the air inlets at the rear of the device and under the device and vents at the masks or at the leak port 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 Use only ResMed air tubing with this device Different types of air tubing may alter the pressure you receive and reduce the effectiveness of your treatment Do not use conductive or antistatic hoses or tubes 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 e 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 Note ResMed recommends using the AC power cord supplied with the unit If a replacement power cord is reguired
8. 652 AU 699726 AU 713679 AU 731800 AU 756622 AU 2002306200 AU 2005200987 CA 2235939 CA 2263126 EP 0661071 EP 0858352 EP 0929336 JP 3635097 JP 3638613 JP 4083154 US 6152129 US 6213119 US 6240921 US 6279569 US 6659101 US 6945248 US 7661428 Other patents pending ResMed SmartStart TICONTROL Stellar SlimLine and Vsync are trademarks of ResMed Ltd ResMed and SmartStart are registered in U S Patent and Trademark Office 2011 ResMed Ltd 0 N Ci Global leaders in sleep and respiratory medicine www resmed com
9. CD screen Stellar Push dial rotate click Therapy LED Start stop button LEDs Therapy LED blue on during treatment and flashes during mask fitting operation The therapy LED can be disabled by the clinician Alarm LED red yellow on during an alarm condition or during alarm testing Power supply LEDs green on when operating correctly Internal Battery when the internal battery is in use the yellow light LED is on The LED flashes when the device is turned off and the battery is charging Alarm mute LED yellow on when the alarm mute button is pressed LCD screen The LCD screen displays the menus monitoring screens and alarm status To assist you in adjusting the device the keypad and LCD are equipped with a backlight The LCD backlight indicates when the device is turned on when you press a key or an alarm occurs The LCD backlight may be set to be on continually see Optional device settings on page 11 If the backlight is set to Auto and no actions are performed for five minutes the backlight dims Warm up feature H4i ResMed USB stick Ramp time Program Mains power DC voltage m Therapy mode Internal battery ma 77 15 Cy Es m ia a inical mode Title bar Current screen number of ad EE faa ay a Y Therapy status bar MEET TT Only available when an external power supply unit is connected Operating functions Settings Key Functio
10. LL L eee Guidance and manufacturer s declaration electromagnetic emissions and immunity Symbols General warnings and cautions LL Yu Limited warranty ee eyn Reed do y gg Y Ty Rood Blea ene By wo O OO O PG Be WW Introduction Indications for use The Stellar 100 is intended to provide ventilation for non dependent spontaneously breathing adult and pediatric patients 13kg and above with respiratory insufficiency or respiratory failure with or without obstructive sleep apnoea The device is for non invasive use or invasive use with an uncuffed or deflated tracheostomy Users of the device include patients and their caregivers physicians nurses respiratory therapists and other clinical staff Operation of the device includes both stationary such as in hospital or home or mobile such as wheelchair usage Contraindications The Stellar 100 is contraindicated in patients who are unable to endure more than brief interruptions in ventilation The Stellar 100 is not a life support ventilator f you have any of the following conditions tell your doctor before using this device pneumothorax or pneumomediastinum e pathologically low blood pressure particularly if associated with intravascular volume depletion e cerebrospinal fluid leak recent cranial surgery or trauma severe bullous lung disease e dehydration Adverse effects You should report unusual chest pain severe headache or increased breathl
11. Your local representative N Medical Dynamics RESMED EONO 366 624 3952 TODAY www thinkMDI net Stellar 100 INVASIVE AND NONINVASIVE VENTILATOR User Guide English ResMed Ventilation Solutions Making quality of care easy ResMed Ventilation Solutions Making quality of care easy RESMED Stellar 100 User Guide English Contents Introduction Indications for use Contraindications Adverse effects The Stellar 100 system 00 0 0 Setting up the device LLY ene Setting up the device for non invasive use Attaching the H4i heated humidifier for non invasive use Setting up the device for invasive use Attaching the pulse oximeter Adding supplemental oxygen Attaching antibacterial filters Using the device when mobile Using an external power supply unit Using the Stellar 100 arrn sro senet r rasg t a E AAN EAEE ARY Control panel LCD screen Operating functions Functional test Starting therapy Therapy settings Using mask fit Stopping therapy Using the internal battery Use of the ResMed USB stick Turning off the device Optional device settings Alarms Alarm display Muting alarms Setting the alarm volume Testing the alarm Cleaning and maintenance LLL LL ua Daily Weekly Monthly Replacing the air filter Disinfection Internal battery Maintenance reminder Servicing Troubleshooting ey en anes ro Wa gn O yn yd Technical specifications
12. ange Press the Push dial The setting will be marked in orange Change a setting Rotate the Push dial to change the setting value Confirm setting change Press the Push dial within three seconds or setting change times out Functional test Make sure your device is functioning properly each time before starting therapy 1 Check that the device is turned off Check condition of device and accessories Inspect the device and all the provided accessories eg air tubing mask humidifier antibacterial filter oximetry oxygen supply ResMed leak port catheter mount If there are any visible defects the system should not be used 3 Check the patient circuit setup Check the integrity of your patient circuit 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 test 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 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 the Monitoring menu button 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 an
13. ar 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 CAUTION Do not hang the air tubing in direct sunlight as the tubing may harden over time and eventually crack Weekly 1 2 3 4 Remove the air tubing from the device and the patient interface Wash the air tubing in warm water using mild detergent Rinse thoroughly hang and allow to dry Reconnect the air tubing to the air outlet and patient interface CAUTION 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 These solutions may cause hardening and reduce the life of the product Cleaning and maintenance 13 Monthly 1 Wipe the exterior of the device and the pulse oximeter if used with a damp cloth and mild detergent 2 Check the air filter to check if it is blocked by dirt or contains holes Replacing the air filter Replace the air filter every six months or more often if necessary Remove the air filter cover from the back of the device Remove and discard the old air filter Insert a new air filter khwWRN Refit the air filter cover l WARNING Do not wash the air filter The air filter is not washable or reusable Disinfection Disinfection of your device helps to
14. arm The respiratory rate level has dropped Contact your clinician below or has exceeded the alarm setting level LCD A High Leak Alarm High mask leak for more than 20 Adjust the mask to minimise leak see seconds Using mask fit on page 10 LCD A Non Vented Mask Alarm Note The non vented mask alarm activates within 30 seconds of using therapy with a non vented mask or invasive ventilation without a leak port for exhalation e Connection of a non vented mask e Ensure your mask has an expiratory e Mask expiratory flow port vent may flow port vent be blocked Ensure your mask expiratory flow e ResMed leak port is missing or flow ports vents are not blocked ports vent are blocked e Ensure the leak port is installed and that the flow ports vent are not blocked e Contact your clinician LCD A Apnoea Alarm The device detects an apnoea Breathe normally to disable the alarm LCD JA Internal Battery Low Alarm The voltage capacity of the internal Connect the device to mains power battery is below 30 LCD A Low SpO Alarm The oxygen saturation of the blood is too Contact your clinician low LCD A SpO finger sensor failure Xpod oximeter disconnected Alarm The finger sensor or the pulse oximeter is Check if the finger sensor or the XPOD is not connected properly or delivers faulty attached properly to the finger and values c
15. attery 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 To recharge the internal battery connect the Stellar 100 to mains power It will take approximately three hours to fully recharge the internal battery however this can vary depending on environmental conditions and if the device is in use Note The battery duration depends on the state of charge the environmental conditions the Stellar 100 settings and the patient circuit setup Use of the ResMed USB stick A ResMed USB stick may be used with the Stellar 100 either to help your clinician to monitor your treatment or to provide you with updates to your device settings You can connect one ResMed USB stick to one of the data communication ports at the rear of the device The Stellar 100 checks the USB stick and opens a dialogue for the data transfer The various operations are described in the following table Function Description Read settings The settings will be transfered from the connected ResMed USB stick to the Stellar 100 Write settings Write The settings or the settings and loggings of the settings and loggings Stellar 100 will be saved on the connected ResMed USB stick Function Description Cancel Data transfer will be cancelled You can also disconnect the ResMed USB stick to Cancel the action WARNING Only the ResMed USB stick is designed to
16. ce of maximum 2 cm H20 at 30 L min 5 cm H20 at 60 L min and 16 cm H30 at 120 L min 1 WARNING a The HMEF has to be replaced regularly as specified in the manufacturer s instructions of use The H4i is contraindicated for invasive use An external humidifier approved for invasive use is recommended according to EN ISO 8185 AC locking clip AC power cord Attaching the pulse oximeter t ti Use of a pulse oximeter may be recommended by your clinician Contraindication The pulse oximeter does not meet defibrillation proof requirement per IEC 60601 1 1990 clause 17 h 1 Adding supplemental oxygen Note Up to 30 L min at maximum oxygen pressure of 50 mbar can be added 2 mp m Oxygen supply Press spring to release connection after use Attach oxygen only to the specified oxygen connection of the device N WARNING Use only certified clean oxygen sources 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 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 patient circuit and the oxygen source must be kept at a minimum distance of 2 m away from any sources of ignition eg electrical devices Attaching antibacterial filters The use of an antibacterial filter may be recomm
17. contact your ResMed service centre Attaching the H4i heated humidifier for non invasive use The H4i heated humidifier attaches to the front of the Stellar 100 to provide heated humidification The device automatically detects the presence of the humidifier A humidifier is recommended at all times when stationary except when mobile especially for patients experiencing dryness of the nose throat or mouth For information on using the H4i see your humidifier user guide WARNING Always place the H4i on a level surface below the level of the user to prevent the mask and tubing from filling with water Make sure that the water chamber is empty and thoroughly dried before transporting the humidifier The H4i heated humidifier is not intended for mobile use Setting up the device English 3 Notes Effective humidification can be achieved up to 25 cm H30 The H4i is disabled when the device is not AC powered A tubing wrap can help if high humidification is causing water condensation within the tube Setting up the device for invasive use ResMed leak port ilter External humidifier HMEF Catheter mount Air tubing Le W When using this setup select the mask type Trach in the Advanced settings of the Clinical settings menu A heat moisture exchange filter HMEF can be connected in place of an external humidifier ResMed recommends using a circuit system with an impedan
18. d 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 for further information Reconnect the external battery if in use and check that the LED for the DC 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 6 Check 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 7 Check oximeter if in use Attach the accessories according to the setup descriptions see Attaching the pulse oximeter on page 4 and go to the Monitoring page in the Monitoring menu Check that the values for SpO and Heart rate are displayed 8 Check oxygen connection if in use If any problems occur please read the troubleshooting section in this User Guide Please also check other provided User Instructions of your accessories for troubleshooting information Starting therapy 1 2 3 Turn on your device Fit your patient interface mask or catheter mount as described in the user instructions 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 To start treatment press or if the SmartStart Stop function is enabled simp
19. device too high Treatment will be stopped 2 Check that the air tubing is connected properly 3 Turn on the device again 4 Re start treatment LCD A Blocked Tube Alarm Airpath is blocked 1 Check the airpath for any blockages 2 Remove the blockages 3 Stop treatment 4 Re start treatment LCD A High Temperature X Alarm The temperature inside the device is too Therapy could be stopped automatically high Ensure the ambient temperature conditions are within the specified operating range If the problem persists within the specified operating conditions please return the device for servicing LCD A High Pressure Alarm Mask pressure exceeds alarm setting 1 Stop treatment level 2 Re start treatment LCD A Low Pressure Alarm e Mask pressure has dropped below the 1 Check that the air tubing is connected alarm setting level properly e Mask is removed while SmartStop has 2 Stop treatment been disabled 3 Re start treatment Troubleshooting 15 16 Problem possible cause Solution LCD JA Circuit disconnected Alarm The air tubing is not connected properly 1 Check that the air tubing is connected to the humidifier or the device properly to the humidifier or the device 2 Re start treatment LCD A Low Minute Ventilation Alarm Minute ventilation level has dropped Contact your clinician below the alarm setting level LCD A Low Respiratory Rate High Respiratory Rate Al
20. ditions are within the specified operating range Turn off the device Turn on the device again If the problem persists within the specified operating conditions please return the device for servicing Technical specifications Operating pressure range e IPAP 2 cm H20 to 40 cm H20 e EPAP 2 cm H20 to 25 cm H20 e CPAP 4 cm H20 to 20 cm H20 Maximum single fault pressure English 60 cm H20 Breathing resistance under single fault 2 cm HO at 30 L min 72 cm H20 at 60 L min Mask pressure tolerance 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 Mask flow tolerance 6 L min or 20 whichever is greater Maximum flow gt 200 L min at 20 cm H20 Sound pressure level lt 30 dB A Dimensions L x W x H 230 mm x 170 mm x 120 mm Weight 2 1 kg Air outlet 22 mm taper compatible with ISO 5356 1 2004 Anaesthetic amp Respiratory Equipment Conical Connectors Pressure measurement Internally mounted pressure transducer Flow measurement Internally mounted flow transducer Power supply AC 100 240V 50 60Hz 2 2 A max 65 W External DC Power Supply 24V3A Internal Battery Lithium lon battery 14 4 V 1 6 Ah 23 Wh Battery run time 2 hours measured at IPAP15 cm H20 EPAP 5 cm H30 nasal mask 2 m air tubing no leak 20 bpm Housing cons
21. ended by your clinician Antibacterial filters can be purchased separately from ResMed Regularly check the filter for entry of moisture or other contaminants The filter must be changed according to the manufacturer s specifications Always perform the Learn circuit function when changing filter types see Optional device settings on page 11 N CAUTION Do not use the antibacterial filter with the H4i heated humidifier Using the device when mobile The mobility bag is intended for mobile use of the Stellar 100 It protects the device against dust and water For longer mobile use power the device using the ResMed Power Station II Setting up the device English 5 external power supply unit or other DC power supply that meets the required voltage and current specifications For setup and correct use please read the User Guide of the mobility bag Using an external power supply unit You can operate the Stellar 100 with the ResMed Power Station II The ResMed Power Station ll is an external lithium ion battery that allows operation of the Stellar 100 where mains power is not available and can also provide a power back up in case of an unexpected disruption of the mains supply For setup and correct use please read the ResMed Power Station ll User Guide Using the Stellar 100 Control panel Mains power External power Monitoring menu supply Internal battery Setup menu Alarm Info menu Alarm mute button L
22. essness to your prescribing physician The following side effects may arise during the course of non invasive ventilation with the device e drying of the nose mouth or throat nosebleed bloating ear or sinus discomfort e eye irritation e skin rashes Introduction English 1 The Stellar 100 system Handle Oxygen inlet LCD screen Control panel Air filter cover 6 tg a Oximetry connection Air outlet Oxygen sensor connection Infrared connection for humidifier Data communication ports DC power socket AC connection for H4i humidifier AC power socket Power on stand by switch The Stellar 100 comprises the following elements e Stellar 100 device Hypoallergenic air filter e AC power cord Carry bag 2 m air tubing ResMed USB stick e Low pressure oxygen connector The following optional accessories have been validated for use with the Stellar 100 e 3 m air tubing SlimLine air tubing Clear air tubing H4i heated humidifier Antibacterial filter e ResMed XPOD oximeter e Nonin pulse oximetry sensors e Mobility bag ResMed leak port e Tubing wrap Heat moisture exchanger filter WARNING The Stellar 100 should 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
23. f the oxygen flow SmartStart If SmartStart Stop is enabled by your ON OFF Stop clinician the device will start automatically when you start breathing and will stop automatically when you take your mask off 2 Ramp Time Pressure will be slowly increased to 0 Max ramp time max full operating pressure during the 45 minutes ramp time Using the Stellar 100 11 12 Function Description Settings Language Selects the menu language Depends on regional configuration Brightness Setting of the LCD backlight 20 100 brightness Backlight Enables or disables the LCD backlight ON AUTO If the AUTO setting is selected the backlight turns off after five minutes without any actions and turns on again if any button is pressed again or an alarm occurs Time Setting of the time Hours minutes seconds Date Setting of the date Day month year Time format Setting of the time format 24 h 12 h Date format Setting of the date format dd mm yyyy mm dd yyyy To return to the Options screen press the Return button J 1 If you select Full Face or Trach as the mask type SmartStop is automatically disabled 2 SmartStop is automatically disabled when the Leak or Low minute ventilation alarm is set to ON because if either of these conditions occur SmartStop will stop treatment before the alarm signal is activated 3 Only displayed on the Configuration menu
24. irty Replace air filter Air tubing is kinked or punctured Straighten or replace tubing Air tubing is not connected properly Check air tubing connection Mask and headgear not positioned Adjust position of mask and headgear correctly Plug s missing from access port s on Replace plug s mask Pressure required for treatment may See your clinician to adjust the pressure have changed There is a large impedance eg Perfom the Learn circuit function antibacterial filter in the air circuit Humidifier control dial set too high Turn humidifier control down and empty resulting in accumulation of water in the the water from the air tubing air tubing The device does not start when you breathe into the patient interface SmartStart Stop not on Consult your clinician Breath is not deep enough to trigger Take a deep breath in and out through the SmartStart patient interface There is excessive leak Adjust position of mask and headgear Plug s may be missing from access Replace plug s port s on mask Air tubing is not connected properly Connect firmly at both ends Air tubing is kinked or punctured Straighten or replace Troubleshooting 17 18 Problem possible cause Solution There is a large impedance eg antibacterial filter in the air circuit Perform the Learn circuit function The device does not stop when you remove your mask SmartStart Stop is disabled
25. ly breathe into your patient interface and treatment will begin CAUTION The Clinical mode is only for clinicians If the device is operating in clinical mode press the power switch to re start the device in patient mode A Note If the circuit configuration has changed ensure that the Learn circuit function is performed before fitting your patient interface see Optional device settings on page 11 Therapy settings Setting the mask type For information on using masks see your mask user guide For the latest available masks see www resmed com To set the mask type go to the Settings menu Clinical settings Advanced settings WARNING Perform the Learn circuit function before the first use and each time any changes are made to the circuit You must also check the correct setting of the patient interface Failing to perform these actions may mean that under certain set pressures and combinations of air delivery components that alarms eg Leak alarm fail to activate Note When the mask type is set to Trach or Full Face the Non vented mask alarm is enabled Change settings in Treatment screen 1 The treatment screen is displayed when the device is turned on Depending on your configuration and settings the functions set ramp warm up humidifier or set program may be available explanations see below To change a setting proceed as follows From your treatment screen turn till the req
26. manship from the date of purchase for the period specified below Product Warranty period e Mask systems including mask frame cushion headgear 90 days and tubing excluding single use devices e Accessories excluding single use devices e Flextype finger pulse sensors Humidifier water tubs Batteries for use in ResMed internal and external battery 6 months systems e Clip type finger pulse sensors 1 year e CPAP and bilevel device data modules e Oximeters and CPAP and bilevel device oximeter adapters e Humidifiers and humidifier cleanable water tubs e Titration control devices e CPAP bilevel and ventilation devices including external 2 years power supply units e Battery accessories e 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
27. n Start Stop Starts or stops treatment i Extended hold for at least three seconds starts the mask fitting feature Alarm mute During therapy Press once to mute an alarm Press a e second time to un mute an alarm If the problem is still present the alarm will sound again after two minutes Xx See Muting 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 al K The Monitoring menu comprises the following screens A oe treatment monitoring of treatment settings pressure flow minute ventilation target alveolar ventilation leak tidal volume synchronisation oximetry optional On the Treatment screen you have several settings see Therapy settings on page 9 In the Setup menu you will find the therapy and alarm settings of the Stellar 100 In the options sub menu you can change device settings see Optional device settings on page 11 The Info menu allows you to view the following screens Therapy statistics used hours events during device operation reminder and device information Using the Stellar 100 English 7 Key Function Push dial The Push dial acts as an enter select button Change between settings Rotate the Push dial The selected button is marked dark blue Enabling a setting for ch
28. onnection to the pulse oximeter respectively the device is proper LCD A Pressure too high for H4i Alarm The device delivers an over pressure with H4i cannot be used for treatment connected H4i humidifier pressures exceeding 25 cm H O Contact your Clinician LCD A Keypad Failure Alarm One of the keys was held down for more 1 Stop treatment than 10 seconds or got stuck 2 Re start treatment Problem possible cause Solution LCD A Attention High Temp X Alarm The temperature inside the device is Ensure the ambient temperature high conditions are within the specified operating range If the alarm remains enabled stop treatment then re start treatment If the problem persists within the specified operating conditions please return the device for servicing English LCD JA Internal Battery Use Alarm The device is using the internal battery Check if the power cord is properly connected to the device and the power socket LCD A External DC Power Use Alarm The device loses accidental or Check if the power cord is properly intentional mains power and switches to connected to the device external DC power No display Power not connected Ensure the power cord is connected and press the switch at the back of the device once Treatment pressure seems low Ramp time is in use Wait for air pressure to build up Air filter is d
29. 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 R001 325 2 09 09 ResMed Ventilation Solutions Making quality of care easy 248446 Eng 2 2011 02 Stellar 100 USER EUR1 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 Milton Park Abingdon Oxfordshire 0X14 4RY UK See www resmed com for other ResMed locations worldwide Protected by patents AU 697
30. 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 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 2 kV 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 1 kV 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 short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ut gt 95 dip in Ut for
31. ossed 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 air filters and air tubings according to the directives in your country General warnings and cautions N 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 Stellar 100 and the accessories are to be used for the specified intended use only The Stellar 100 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 Stellar 100 is turned on and operating properly The vent hole or holes associated with the mask should never be blocked Explanation The Stellar 100 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
32. plicable 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 l CAUTION J 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 14 Troubleshooting If there is a problem try the following suggestion s If a problem cannot be solved contact your eguipment supplier or ResMed Do not attempt to open the device Problem possible cause Solution E n LCD turns off The device stops delivering air pressure gt Power failure Remove the mask or the catheter mount Lu from the tracheotomy tube until power is restored LCD A Internal Battery Empty Alarm The voltage capacity is below 15 The Connect the device to mains power device is powered by the internal battery Note In case of a total power failure the for maximum 2 minutes current settings will be stored and restored when the device is powered again LCD A System Failure X Alarm The device could stop delivering air pressure Component failure 1 Turn off the device 2 Turn on the device again 3 Re start treatment LCD Over Pressure Alarm The device generates a pressure that is 1 Turn off the
33. ssure delivery starts 3 If necessary adjust your mask mask cushion and headgear until you have a good mask fit You can end mask fit at any time by pressing After three minutes treatment will begin Notes Press for at least three seconds during mask fit to start the treatment immediately The treatment screen will be displayed The mask fitting feature is disabled when the mask type Trach is selected Stopping therapy To stop treatment at any time remove your patient interface and press or if the SmartStart Stop function is enabled simply remove your mask Notes The SmartStop function is disabled if the mask type Full Face Trach or special alarms have been set by your clinician The function is also disabled if the mask fitting feature is running When the device is stopped and operating in standby mode with integrated humidifier it will continue to blow air gently to assist cooling of the heater plate e Masks with high resistance eg pediatric masks may cause the operation of the SmartStop feature to be restricted Using the internal battery In case of a mains 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 19 The power status of the battery is displayed on top of the LCD screen Check the b
34. ted 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 eguipment transmitters and the device as recommended below according to the maximum output power of the communications eguipment Separation distance according to freguency 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 d 0 35 VP d 0 7 VP 0 01 0 17 0 04 0 07 0 1 0 37 0 11 0 22 1 1 17 0 35 0 7 Technical specifications 21 10 3 69 1 11 2 21 100 11 70 3 50 7 0 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 Symbols o Follow instructions for use Class II equipment Type BF equipment IP31 Device is protected against solid foreign objects of 2 5 mm diameter and grea
35. ter and vertically falling water drops A Caution Standby or preparatory state for a part of equipment O Connection for oxygen supply max 30 I min max 30 L min es Data communication port E CE labeling in accordance with EC directive 93 42 EEC class II b A Temperature limitation for storage and transport bd Handle with care amp Maximum a Keep dry ual Manufacturer tt Upside Catalogue number Serial number Batch code Q Do not re use z Use by date AN Keep away from sunlight S Do not use if package is damaged Ce Latex free Environmental information This device must be disposed of in accordance with the laws and regulations of the country in which disposal occurs humidity The crossed out wheeled bin symbol yr indicates that the product bearing this symbol may not be disposed of together with general household waste but instead reguires separate disposal This reguirement for separate disposal is based on the European Directive 2002 96 EC for electrical and electronic eguipment 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 cr
36. 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 In the event of power failure or machine malfunction no air pressure will be delivered Remove the mask or the catheter mount from the tracheotomy tube Explosion hazard do not use in the vicinity of flammable anesthetics Only use orignal 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 Stellar 100 and the accessories ensure that all components are in a proper condition and that their operational safety is guaranteed Do not use the system if there are obvious external defects or unexplained changes in performance 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 dra
37. truction Flame retardant engineering thermoplastic Air filter Electro static fibre mesh with TPE frame structure Environmental conditions e Operating temperature 0 C to 35 C Operating humidity 10 95 non condensing e Storage and transport temperature 20 C to 60 C 50 C Storage and transport humidity 10 95 non condensing Air pressure 1 100hPa to 680hPa Altitude 3 500 m NONIN XPOD Air tubing Flexible plastic 2 m or 3 m length 22 mm diameter SlimLine air tubing Flexible plastic 1 83 m length 15 mm diameter Electromagnetic compatibility Product 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 20 Technical specifications 19 IEC 60601 1 Class II double insulation type BF continuous operation classifications Aircraft use Product complies with RTCA DO 160 section 21 requirements Consult the medical services department of your carrier if you intend to use your device on an aircraft Note You should not use the Stellar 100 while the aircraft is taking off or landing This device is not suitable for use in the presence of a flammable anesthetic mixture with air or nitrous oxide entrained in the device airpath
38. uired setting is displayed in dark blue 2 Press 8 The selection is highlighted in orange 3 Turn amp until the setting you require is displayed 4 Press within three seconds to confirm your choice or setting change times out Ramp time 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 Program Your clinician can set two programs with the therapy and alarm settings appropriate to your therapy and set the program availability on the treatment screen Using the humidifier warm up function The H4i heated humidifier will be automatically detected when the device is turned on The treatment screen will give you the option to start warming up the humidifier prior to starting treatment If the humidifier is heating the related symbol is displayed at the top of the LCD screen Note The H4i can only be used when the device is connected to mains supply Using the Stellar 100 English Using mask fit You can use mask fit to help you fit your mask properly This feature delivers treatment pressure for a three minute period prior to starting treatment during which you can check and adjust your mask fit to minimise leaks 1 Fit your mask as described in the mask user guide 2 Hold down for at least three seconds until air pre
39. w priority alarm occured If a high or medium priority alarm occured and the alarm mute key was pressed the alarm mute symbol will be displayed on the LCD When the alarm mute key is pressed during therapy for at least three seconds specific alarm messages and the audible alarm will be temporarily reset English Setting the alarm volume To set the alarm volume select the Settings menu then Alarm settings The alarm volume can be set to low medium or high After the set value has been confirmed the alarm will sound and the alarm LED lights Testing the alarm When the device is turned on the alarm LED and the alarm mute key LED will flash and the alarm will beep to confirm that the alarm is working If reguired you can test the alarm manually by holding down the alarm mute button for at least three seconds when therapy is not running Cleaning and maintenance Ihe cleaning and maintenance described in this section should be carried out regularly This also helps to prevent the risk of cross contamination Refer to your mask humidifier and other accessories user guide for detailed instructions for care and maintenance WARNING Beware of electric shock Do not immerse the device pulse oximeter if used 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 we
40. wn 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 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 22 At low pressures the flow through the exhalation ports of your mask may not clear all exhaled gas from the tubing 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 ResMed service Notes A note advises to special product features 1 2 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 Ports may be incorporated into the mask or in connectors that are near the mask During partial below rated minimum voltage or total power failure therapy pressures will not be delivered When power is restored operation can be proceeded with no change to settings General warnings and cautions English 23 24 Limited warranty ResMed Ltd hereafter ResMed warrants that your ResMed product shall be free from defects in material and work
41. xed 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 G 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 freguency range applies NOTE 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 4 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 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Recommended separation distances between portable and mobile RF communications eguipment and the device The device is intended for use in an environment in which radia

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