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User manual DreamStation CPAP DreamStation CPAP Pro DreamStation Auto CPAP Table of Contents Intended Use........................................................................................................................................................... 1 Important................................................................................................................................................................. 1 Warnings .................................................................................................................................................................. 1 Cautions ................................................................................................................................................................... 2 Contraindications .................................................................................................................................................. 2 Symbol Key .............................................................................................................................................................. 3 System Contents .................................................................................................................................................... 3 How to Contact Philips Respironics ................................................................................................................. 3 System Overview ................................................................................................................................................... 4 Installing/Replacing the Air Filters ...................................................................................................................... 5 Where to Place the Device ................................................................................................................................. 6 Supplying AC Power to the Device.................................................................................................................... 6 Connecting the Breathing Circuit ...................................................................................................................... 7 Navigating the Device Screens............................................................................................................................ 8 Starting the Device ................................................................................................................................................ 8 Menu Navigation (Therapy ON) and Optional Humidification Settings ................................................... 9 Ramp Feature.......................................................................................................................................................... 9 Menu Navigation (Therapy OFF)......................................................................................................................10 Bluetooth® Wireless Technology.........................................................................................................................14 Check Mask Fit .....................................................................................................................................................15 Sleep Progress ......................................................................................................................................................15 Altitude Compensation ......................................................................................................................................15 Device Alerts ........................................................................................................................................................16 Troubleshooting ...................................................................................................................................................20 Accessories ...........................................................................................................................................................22 Traveling with the System ..................................................................................................................................23 Cleaning the Device ............................................................................................................................................24 Cleaning or Replacing the Filters .....................................................................................................................24 Cleaning the Tubing..............................................................................................................................................24 Service ....................................................................................................................................................................24 Additional Notices...............................................................................................................................................25 Specifications ........................................................................................................................................................26 Disposal..................................................................................................................................................................27 EMC Information .................................................................................................................................................27 Limited Warranty ................................................................................................................................... Back Page © 2015 Koninklijke Philips N.V. All rights reserved. Caution: U. S. federal law restricts this device to sale by or on the order of a physician. Intended Use The Philips Respironics DreamStation systems deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment. Important The device is to be used only on the instruction of a licensed physician. Your home care provider will make the correct pressure settings and device configurations including accessories according to your health care pro essional s prescription Several accessories are available to make your OSA treatment with the DreamStation system as convenient and comfortable as possi le To ensure that you receive the sa e e ective therapy prescri ed or you use only hilips espironics accessories Warnings A warning indicates the possibility of injury to the user or the operator. This manual serves as a re erence The instructions in this manual are not intended to supersede the health care pro essional s instructions regarding the use of the device. The operator should read and understand this entire manual e ore using the device This device is not intended or li e support The device should e used only ith mas s and connectors recommended y hilips espironics or ith those recommended y the health care professional or respiratory therapist. A mask should not be used unless the device is turned on and operating properly. The exhalation port(s) associated with the mask should never be blocked. Explanation of the Warning: The device is intended to e used ith special mas s or connectors that have e halation ports to allo continuous o o air out o the mas hen the device is turned on and unctioning properly ne air rom the device ushes the e haled air out through the mas e halation port Ho ever hen the device is not operating enough resh air ill not e provided through the mas and e haled air may e rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. you are using a ull ace mas (a mas covering oth your mouth and your nose) the mas must e e uipped ith a sa ety (entrainment) valve. hen using o ygen ith this system the o ygen supply must comply ith local regulations or medical o ygen O ygen supports com ustion O ygen should not e used hile smo ing or in the presence o an open ame hen using o ygen ith this system turn the device on e ore turning on the o ygen Turn the o ygen o e ore turning the device off. This will prevent oxygen accumulation in the device. Explanation of the Warning: hen the device is not in operation and the o ygen o is le t on o ygen delivered into the tu ing may accumulate ithin the device s enclosure O ygen accumulated in the device enclosure ill create a ris o fire hen using o ygen ith this system a hilips espironics ressure alve must e placed in line ith the patient circuit et een the device and the o ygen source The pressure valve helps prevent the ac o o o ygen rom the patient circuit into the device hen the unit is o ailure to use the pressure valve could result in a fire ha ard o not connect the device to an unregulated or high pressure o ygen source o not use the device in the presence o a amma le anaesthetic mi ture in com ination ith o ygen or air or in the presence of nitrous oxide. o not use the device near a source o to ic or harm ul vapors o not use this device i the room temperature is armer than ( ) the device is used at room temperatures armer than ( ) the temperature o the air o may e ceed ( ) This could cause irritation or in ury to your air ay o not operate the device in direct sunlight or near a heating appliance ecause these conditions can increase the temperature o the air coming out of the device. ontact your health care pro essional i symptoms o sleep apnea recur you notice any une plained changes in the per ormance o this device i it is ma ing unusual or harsh sounds i it has een dropped or mishandled i ater is spilled into the enclosure or i the enclosure is ro en disconnect the po er cord and discontinue use ontact your home care provider epairs and ad ustments must e per ormed y hilips espironics authori ed service personnel only nauthori ed service could cause in ury invalidate the arranty or result in costly damage o not use any accessories detacha le parts and materials not recommended y hilips espironics ncompati le parts or accessories can result in degraded performance. se only approved ca les and accessories Misuse may a ect M per ormance and should e avoided The Health ndustry Manu acturers ssociation recommends that a minimum separation o si inches e maintained et een a ireless phone and a pacema er to avoid potential inter erence ith the pacema er The reamStation on oard Bluetooth communication should be considered a wireless phone in this regard. se only po er cords supplied y hilips espironics or this device se o po er cords not supplied y hilips espironics may cause overheating or damage to the device and may result in increased emissions or decreased immunity o the e uipment or system The device should not e used hile stac ed or in close appro imation to other non approved devices o not pull or stretch the tu ing This could result in circuit lea s User Manual 1 nspect the tu ing or damage or ear iscard and replace the tu ing as necessary eriodically inspect electrical cords and ca les or damage or signs o ear iscontinue use and replace i damaged To avoid electrical shoc al ays unplug the po er cord rom the all outlet e ore cleaning the device O NOT immerse the device in any uids the device is used y multiple persons (such as rental devices) a lo resistance main o acteria filter should e installed in line between the device and the circuit tubing to prevent contamination. e sure to route the po er cord to the outlet in a ay that ill prevent the cord rom eing tripped over or inter ered ith y chairs or other furniture. This device is activated hen the po er cord is connected or sa e operation hen using a humidifier the humidifier must al ays e positioned elo the reathing circuit connection at the mas The humidifier must e level or proper operation Note: lease see the imited arranty section o this manual or in ormation on arranty coverage Cautions A Caution indicates the possibility of damage to the device. Medical electrical e uipment needs special precautions regarding M and needs to e installed according to M in ormation ontact your home care provider regarding M installation in ormation Mo ile communications e uipment can a ect medical electrical e uipment ins o connectors mar ed ith the S arning sym ol shall not e touched and connections shall not e made ithout special precautions recautionary procedures include methods to prevent uild up o electrostatic charge (e g air conditioning humidification conductive oor coverings non synthetic clothing) discharging one s ody to the rame o the e uipment or system or to earth. It is recommended that all individuals that will handle this device understand these precautionary procedures at a minimum as part of their training. e ore operating the device ensure that the S card filter access door and the modem access door are oth closed henever any o the accessories such as the in Module or Modem are not installed e er to the instructions that came ith your accessory ondensation may damage the device this device has een e posed to either very hot or very cold temperatures allo it to ad ust to room temperature (operating temperature) e ore starting therapy o not operate the device outside o the operating temperature range sho n in the Specifications o not use e tension cords ith this device Ma e sure the filter area on the side o the device is not loc ed y edding curtains or other items ir must o reely around the device for the system to work properly. o not place the device directly onto carpet a ric or other amma le materials o not place the device in or on any container that can collect or hold ater properly installed undamaged hilips espironics lue pollen filter is re uired or proper operation To acco smo e may cause tar uild up ithin the device hich may result in the device mal unctioning irty inlet filters may cause high operating temperatures that may a ect device per ormance egularly e amine the inlet filters as needed for integrity and cleanliness. Never install a et filter into the device ou must ensure su ficient drying time or the cleaned filter l ays ensure that the po er cord securely fits into your therapy device prior to use ontact your home care provider or hilips espironics to determine i you have the appropriate cord or your specific therapy device hen po er is o tained rom a vehicle attery the device should not e used hile the vehicle s engine is running amage to the device may occur. Only use a hilips espironics o er ord and attery dapter a le se o any other system may cause damage to the device Contraindications hen assessing the relative ris s and enefits o using this e uipment the clinician should understand that this device can deliver pressures up to 20 cm H2O n the event o certain ault conditions a ma imum pressure o cm H2O is possible. Studies have sho n that the ollo ing pre e isting conditions may contraindicate the use o therapy or some patients ullous ung isease athologically o lood ressure ypassed pper ir ay neumothora neumocephalus has een reported in a patient using nasal ontinuous ositive ir ay ressure aution should e used hen prescri ing or suscepti le patients such as those ith cere ral spinal uid ( S ) lea s a normalities o the cri ri orm plate prior history o head trauma and or pneumocephalus ( hest ) The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear in ection Not or use ith patients hose upper air ays are ypassed ontact your health care pro essional i you have any uestions concerning your therapy 2 User Manual Symbol Key The ollo ing sym ols may appear on the device po er supply and accessories Symbol efinition onsult accompanying instructions or use. IP22 Symbol efinition or irline se omplies ith T section category M O o er Separate collection for electrical and electronic e uipment per irective o er Bluetooth® symbol rip roo uipment aution consult accompanying documents. S lass Type arning sym ol ( ou le nsulated) pplied art For Indoor Use Only. This device contains an RF transmitter. O imeter onnection Serial onnection Avoid ultraviolet radiation aution S ederal la restricts this device to sale by or on the order of a physician. Do not disassemble. System Contents our reamStation system may include the ollo ing items evice S card ser manual le i le tu ing arrying case eusa le lue pollen filter o er cord isposa le light lue ultra fine filter (optional) o er supply ( ) Humidifier (optional) Note: any o these items are missing contact your home care provider How to Contact Philips Respironics Should you e perience trou le ith this e uipment or re uire assistance setting up using or maintaining the device or accessories please contact your home care provider you need to contact hilips espironics directly call the hilips espironics ustomer Service department at or ou can also use the ollo ing address espironics nc Murry idge ane Murrysville User Manual 3 System Overview The reamStation is a ontinuous ositive ir ay ressure therapy device designed or the treatment o O structive Sleep pnea (OS ) The reamStation ro can also deliver chec therapy and the reamStation uto can also deliver hec and uto therapy our home care provider ill choose the appropriate pressure settings for you. hen prescri ed or you the device provides several special eatures to help ma e your therapy more com orta le The ramp function allows you to lower the pressure when you are trying to fall asleep. The air pressure will gradually increase until your prescription pressure is reached lso the le com ort eature provides you ith pressure relie when you exhale during therapy. Several accessories are also availa le or use ith your device ontact your home care provider to purchase any accessories not included with your system. This figure illustrates some of the device features, described in the following table. # Device Feature 1 Therapy On O 2 Ambient Light Sensor 3 utton amp utton oor S card ontrol oor ilter ccess ial ccessory ccess Humidifier onnector 10 Starts and stops the air o or therapy etects room light levels and ad usts rightness o Screen. isplay Activates the ramp feature during therapy. isplay Screen 6 Description This door li ts open or access to the S card and filter area This is the User Interface for the therapy device. Turn the dial to scroll between options on the screen. Press the dial to choose an option. This door lifts open for access to the (optional) accessories. Humidifier connects to the ac o the therapy device The humidifier pin connector will attach here. Air Outlet Port onnect the tu ing here Power Inlet onnect the po er cord here User Manual Installing/Replacing the Air Filters Caution: properly installed undamaged hilips espironics lue pollen filter is re uired or proper operation The device uses a lue pollen filter that is asha le and reusa le and a light lue ultra fine filter that is disposa le The reusa le lue filter screens out normal household dust and pollens hile the light lue ultra fine filter provides more complete filtration o very fine particles The reusa le lue filter must e in place at all times hen the device is operating The ultra fine filter is recommended or people ho are sensitive to to acco smo e or other small particles The reusa le lue filter is supplied ith the device disposa le light lue ultra fine filter may also e included your filter is not already installed hen you receive your device you must at least install the reusa le filter e ore using the device. This device has an automatic air filter reminder very days the device ill display a message reminding you to chec your filters and replace them as directed Note: This message is a reminder only The device does not detect the per ormance o the filters nor does it recogni e hen a filter has een cleaned or replaced i t up on the filter access door and s ing open replacing pull out the old filter assem ly applica le place a clean reusa le lue pollen filter ( ) on top o a ne filter ( ) and firmly snap them together optional disposa le light lue ultra fine lace the ne filter assem ly ac in the side o the therapy device S ing the door closed User Manual Where to Place the Device lace the device on a firm at sur ace some here ithin easy reach o here you ill use it at a level lo er than your sleeping position Ma e sure the device is a ay rom any heating or cooling e uipment (e g orced air vents radiators air conditioners) Note: hen positioning the device ma e sure that the po er ca le is accessi le ecause removing po er is the only way to turn off the device. Caution: Ma e sure the filter area on the side o the device is not loc ed y edding curtains or other items ir must o reely around the device or the system to or properly Caution: o not place the device directly onto carpet a ric or other amma le materials Caution: Do not place the device in or on any container that can collect or hold water. Supplying AC Power to the Device omplete the ollo ing steps to operate the device using po er lug the soc et end o the po er cord (included) into the po er supply (also included) lug the pronged end o the po er cord into an electrical outlet that is not controlled y a all s itch lug the po er supply cord s connector into the po er inlet on the side o the device eri y that the plug at the side o the device at the po er supply and at the electrical outlet are ully inserted This ill help to ensure that a secure relia le electrical connection has een made Note: the ollo ing ncorrect o er Supply icon appears on the screen please repeat step Important: To remove po er disconnect the po er supply cord rom the electrical outlet Warning: Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace if damaged. Caution: Do not use extension cords with this device. 6 User Manual Connecting the Breathing Circuit To use the system you ill need the ollo ing accessories in order to assem le the recommended reathing circuit hilips espironics inter ace (nasal mas or ull ace mas ) ith integrated e halation port or hilips espironics inter ace ith a separate e halation device (such as the hisper S ivel ) hilips espironics e i le tu ing m( t) hilips espironics headgear ( or the mas ) To connect your reathing circuit to the device complete the ollo ing steps onnect the e i le tu ing to the air outlet on the ac o the therapy device ine up the connector ( ) at the top of the heated tube to the top of the air outlet port on the back of the device. 2. Press the tubing into place over the air outlet port until the tabs on the side of the tube click into place in the slots on the sides of the outlet port. Note: you are using a standard tu e (not sho n) instead o a heated tu e simply slide the tu ing over the air outlet port on the therapy device. Note: re uired connect a acteria filter to the device air outlet and then connect the e i le tu ing to the outlet o the acteria filter hen using the acteria filter the device per ormance may e a ected Ho ever the device will remain functional and deliver therapy. onnect the tu ing to the mas or proper placement and positioning re er to the instructions that came ith your mask. Warning: Do not pull or stretch the tubing.This could result in circuit leaks. Warning: Inspect the tubing for damage or wear. Discard and replace the tubing as necessary. ttach the headgear to the mas i necessary e er to the instructions that came ith your headgear Warning: you are using a ull ace mas (a mas covering oth your mouth and your nose) the mas must e e uipped with a safety (entrainment) valve. Warning: the device is used y multiple persons (such as rental devices) a lo resistance main o acteria filter should e installed in line et een the device and the circuit tu ing to prevent contamination User Manual Navigating the Device Screens The ser nter ace ( ) on this device allo s you to ad ust the device settings and vie in ormation a out your therapy. The UI is comprised of the display screen and the control dial. Rotate the control dial in either direction to scroll through the menu options on the display screen. Note: The display is not a touch screen.You must use the control dial to navigate the device menu. To ad ust a setting 1. Rotate the control dial to your desired menu option. 2. Press the control dial to select that setting. 3. Rotate the control dial to change the setting. ress the control dial again to save the change Note: The rotate dial icon on any screen indicates to rotate the dial to perform an action. The click dial icon on any screen indicates to press the dial to perform an action. Note: Pressing the dial when the down arrow appears on any screen ill ta e you to a su menu ith more menu options. Pressing the dial when the up arrow appears on any su menu ill return you ac to the main menu. Note: The screens shown throughout this manual are examples for reference only. Actual screens may vary based upon device model and provider settings. Starting the Device nsure po er is supplied to the device The first screen to display ill e the hilips espironics logo ollo ed y the device model screen and then the Home screen Home Screen The first time the device is po ered on a pop up ill prompt you to set the time on the device The de ault setting is reen ich Mean Time ut you may ad ust the time in minute increments to match your local time one you choose to s ip this initial time setting the time can al ays e ad usted under the My Setup menu Note: This time setting is not displayed as a clock function on the device. It is only used to align your therapy data or your rovider s data reports 2. Put on your mask assembly. Refer to the instructions supplied with the mask. 3. Press the Therapy button ( ) on top o the device to turn on air o and egin therapy The current delivered pressure will display on the screen. Ma e sure that no air is lea ing rom your mas necessary ad ust the mas and headgear until the air lea stops See the instructions provided with your mask for more information. Note: small amount o mas lea is normal and accepta le orrect large mas lea s or eye irritation rom an air leak as soon as possible. you are using the device in a ed ith a head oard try placing the tu ing over the head oard This may reduce tension on the mask. 6. Press the Therapy button again to turn off therapy. Note: uring therapy it there is a mains interruption (i e po er loss) the device ill return to the Home screen once power is restored.You may resume therapy as needed. User Manual Menu Navigation (Therapy ON) and Optional Humidification Settings hile the device is delivering therapy you can ad ust Tu e Temperature or Humidifier Settings otate the control dial to choose either setting. Press and rotate the dial to change the setting. Note: you are using the Humidifier ithout the Heated Tu e simply ust rotate the control dial to change the Humidifier setting Therapy Pressure Screen # Feature Description 1 Therapy Pressure Displays the current delivered pressure. 2 d usta le Tu e Temperature Setting 3 d usta le Humidifier Setting ou can change this setting rom to Only displays hen optional heated tube is connected. ou can change this setting rom to Only displays hen humidifier is attached epending on setup certain ena led therapy eatures ill display here. na led eatures Ramp Feature The device is e uipped ith an optional ramp eature that your home care provider can ena le or disa le This feature reduces the air pressure when you are trying to fall asleep and then gradually increases (ramps) the pressure until your prescription setting is reached allo ing you to all asleep more com orta ly ramp is ena led on your device a ter you turn on the air o press the amp ( ) button on the top of the device. You can use the Ramp button as often as you wish during the night. hen you clic the ramp utton the Therapy screen ill change to re ect the amp pressure and the green circle ill re ect the gradual increase in pressure Ramp Pressure Screen Your device has two ramp modes.Your Provider will select the one that is most appropriate for you. The standard ramp mode increases pressure at a steady rate lternately the Smart amp mode maintains a constant lo er pressure until the device detects that you re uire more pressure User Manual Menu Navigation (Therapy OFF) rom the Home screen you can scroll et een the ollo ing our options My Info Preheat My Provider My Setup My Info: This menu provides summary statistics of your therapy use. Preheat: This unction lets you arm up your humidifier or minutes e ore starting a therapy session My Provider: This menu contains information that your provider may direct you to read to them so they can better assist you over the phone. My Setup: This menu contains com ort settings that you can ad ust as needed My Info: hen you select My n o you ill e a le to vie the ollo ing screens ou cannot change settings in the n o menu These screens are only for reference.Your home care provider may periodically ask you for this information. Icon AHI Text Therapy Hours This screen displays the amount of time the user is actually receiving therapy on the device for the most recent 1 day time frame. It also displays the average amount o time the patient is actually receiving therapy over the last days and 30 days. AHI This screen displays the nightly Apnea/Hypopnea indices (AHI) value for the most recent 1 day time frame. It also displays the average of these individual nightly H values over a day and a day time rame This screen only displays i your home care provider has ena led it Only availa le on ro and uto devices. Mas Periodic Breathing 10 Description it Periodic reathing isplays the value minus arge ea arge ea is the percentage o time that the mask leak was so high that it is no longer possible for the device to identify respiratory events with statistical accuracy. Displays the value for the most recent day as ell as the values over last days and days This screen only displays i your home care provider has ena led it Only availa le on ro and uto devices Displays the percentage of time that the user experienced periodic breathing. isplays the value or the most recent day time rame as ell as values or the last days and days you o serve a large increase in the percent o time in periodic reathing indicated her contact your home care provider or assistance This screen only displays if your home care provider has enabled it. Only available on ro and uto devices User Manual Preheat: Preheat On Screen Preheat Off Screen hen using a humidifier the device can preheat the ater tan or up to minutes prior to starting therapy n order to activate the preheat mode the lo er must e o and a humidifier must e attached hen reheat is selected you ill e a le to turn the control dial to choose et een on or o ress the control dial again to ma e your selection uring the minute preheat you ill still e a le to use the control dial to select other menu options from the Home screen. Note: This screen only displays hen a humidifier is attached My Provider: hen you select My rovider you ill e a le to vie the ollo ing screens ou cannot change settings in the Provider menu. These screens are only for reference.Your home care provider may periodically ask you for this information. Icon Text Device Info Description This screen displays your therapy device in ormation serial num er model and software version. rovider ontact This screen will display the contact information for your provider if it has been Info uploaded to your device. hone n This screen displays the total therapy hours or the device the total lo er hours the total num er o days used hen the sessions ere greater than hours and a compliance chec num er used y your home care provider to validate that the data provided by you is the data taken from this screen. ompliance This screen displays your start date the total num er o days used hen the sessions ere greater than hours and a chec code num er used y your home care provider. VIC90 A-TRIAL User Manual This isual nspection hec screen ill display a chec code num er created rom in ormation gathered over the most recent day period This digit num er ill display as xxx.xxxx.xxxx.xxxx. Your home care provider may periodically ask you for this information. Trial uto Trial mode is availa le this screen displays Days: xx/xx (where xx/xx is the number of accumulated trial days / number of selected trial days). Available on the ro uto i ro and i uto models 11 Icon Text 90% Pressure ressure Description This screen displays the nightly value o ressure or the most recent day time rame t also displays the average o these individual nightly values o ressure over a day and a day time rame vaila le on the uto model Upload llo s user to initiate a modem call hen an optional ellular Modem or i i ccessory is installed ter the modem upload has finished the screen ill either display a green chec mar ith the te t ompleted to indicate a success ul upload or a red ith the te t ailed to indicate an unsuccess ul upload the upload ails initiate an upload a second time or contact your home care provider if the issue persists. This screen is locked if modem is off. Performance hec our device is e uipped ith a sel diagnostic tool called er ormance hec This tool can evaluate your device for certain errors. It also allows you to share ey device settings ith your home care provider se er ormance hec hen directed to by your home care provider. t conclusion o the scan the screen displays a green chec mar i no issue is detected device displays a red please contact your home care provider or assistance. My Setup: hen you select My Setup you ill e a le to vie the ollo ing screens ou can change the settings in the Setup menu. These screens will only display if they are available and enabled on your device. Icon 12 Text Description Ramp This displays the ramp starting pressure. You can increase or decrease the ramp starting pressure in cm H2O increments. Flex This allo s you to ad ust the level o air pressure relie that you eel hen you exhale during therapy. Your home care provider can enable or disable this eature hen your provider ena les le a level ill already e set or you on the device. You can increase or decrease the setting from 1 to 3. The setting of provides a small amount o pressure relie ith higher num ers providing additional relief. Note: If a lock icon is displayed on this screen it indicates that your provider has locked this setting and you cannot change it. Humidification This displays the Humidification Mode eing used ou can choose et een i ed or daptive Humidification a heated tu e is eing used the device ill automatically s itch to Heated Tu e Humidification Mode loc sym ol ill appear next to the mode setting indicating that so long as the heated tube is attached to the device this mode cannot e changed Ho ever the heater plate and tu e temperature settings can still e ad usted on the device Therapy screen as normal. User Manual Icon Text Mas Type This setting allo s you to ad ust the level o air pressure relie ased on the specific hilips espironics mas ach hilips espironics mas may have a “System One resistance control setting ontact your home care provider i you cannot find this resistance setting or your mas Note: If a lock icon is displayed on this screen it indicates that your provider has locked this setting and you cannot change it. Tube Type This setting allo s you to select the correct si e diameter tu ing that you are using with the device. You can choose either (22) for the Philips Respironics 22 mm tu ing or ( ) or the hilips espironics mm tu ing hen using Heated Tu ing the device ill automatically change this setting to the appropriate tu ing type ( H) and you ill not e a le to change it Note: Tu ing is identified on the cu ith the tu ing identifier sym ol or H Note: If a lock icon is displayed on this screen it indicates that your provider has locked this setting and you cannot change it. Language This feature allows you to choose which language to display on the interface. You can choose nglish or Spanish hec Mas Modem luetooth Time User Manual Description it This eature allo s you to chec the fit o your mas prior to starting therapy This is done by measuring the amount of leak. llo s you to turn modem o temporarily or turn it ac on hen modem is turned o it ill automatically turn on again a ter days Only displays hen modem is installed. llo s you to turn luetooth o and on ith a compati le luetooth device lso it allo s you to clear the pairing llo s you to ad ust the time The de ault setting is reen ich Mean Time ut you may ad ust the time in minute increments to match your local time one Note: This time setting is not displayed as a clock function on the device. It is only used to align your therapy data or your rovider s data reports 13 Bluetooth Wireless Technology Your device has Bluetooth wireless technology. You can pair the therapy device to a mobile device that has the reamMapper app installed reamMapper is a mo ile and e ased system designed to help O structive Sleep Apnea (OSA) patients enhance their sleep therapy experience. Pairing to your Bluetooth enabled Mobile Device Note: You can only pair your therapy device to one mobile device at any given time. Note: Pairing works best when your therapy device and mobile device are in the same room. Follow the steps below to manually pair to your mobile phone or tablet. To pair to your mo ile device first ensure that the Bluetooth setting is turned ON on your mo ile device your mo ile device s instruction manual or more in ormation 2. If you need to select from a list of available Bluetooth devices the therapy device ill appear as T ( ill e the last our digits o the serial num er listed on your therapy device) hen your therapy device is po ered up ut the lo er is o initiate pairing rom your mo ile device your mo ile device is in range one o the ollo ing t o steps ill apply • Your mobile device has Bluetooth Secure Simple Pairing (SSP) The ollo ing icon ill pop up on your therapy device screen ith a digit num er and air e er to This num er is a si digit pass ey generated during SS eri y that the si digit SS pass ey is the same on oth the mo ile device and therapy device otate the ontrol ial et een yes or no and then press the ontrol ial to choose no is selected or the pop up screen times out a ter seconds the device ill re ect the pair re uest yes is selected the therapy device ill ac no ledge the si digit SS pass ey the mo ile device also ac no ledges the re uest the t o ill no e paired and ready to connect using reamMapper • Your Bluetooth enabled mobile device does not support Bluetooth SSP our mo ile device ill prompt you to enter a pin code nter on your mo ile device The following icon ill pop up on your therapy device screen ith the num er and air otate the ontrol ial et een yes or no and then press the ontrol ial to choose no is selected or the pop up screen times out a ter seconds the device ill re ect the pair re uest yes is selected the therapy device ill ac no ledge the pass ey the mo ile device also ac no ledges the re uest the t o ill no e paired and ready to connect using reamMapper Note: o NOT select yes on the pop up screen unless you are currently trying to pair your devices This ill ensure that only your mobile device connects to your therapy device. User Manual Check Mask Fit The optional chec mas fit eature can e ena led or disa led y your home care provider This eature allo s you to chec the fit o your mas prior to starting therapy This is done y measuring the amount o lea ut on your mas assem ly e er to your mas instructions i needed Navigate to the hec Mas it screen under My Setup and press the control dial to initiate the check. The device ill deliver a test pressure hile the screen counts do n seconds green ar indicates good fit hile a red ar indicates improvement is needed ter the test normal therapy ill start and the screen ill either display a green chec mar or a red The green chec mar indicates that the lea ound allo s or optimal per ormance o the device The red indicates that the lea may a ect device per ormance ho ever the device ill remain functional and deliver therapy. Check Mask Fit Screen Note: you choose to try to improve your mas fit you can stop therapy ad ust the fit o your mas and rerun the chec mas fit lease re er to the instructions that came ith your mas and headgear or the proper fitting procedure. Sleep Progress our device provides summary in ormation a out your therapy use each time the therapy is turned o The first screen displays your Three Night Summary t sho s your nightly usage or the last sleep sessions (measured in hour periods ending at noon each day) The most recent session is displayed in the right hand ar la eled ith the num er o hours slept green ar indicates that you slept more than hours and a yello ar indicates less than hours of use. The second screen sho s the total num er o hour nights that you have slept in the last days t provides a goal o sleeping at least hours per night or o the last nights There ore the goal is good nights o use This screen provides a simple ay to trac your progress The screen ill stop displaying hen you reach the goal or a ter the first days o use has passed hichever comes first Three Night Summary Screen Altitude Compensation This device automatically compensates or altitude up to User Manual Goal Progress Screen eet No manual ad ustment is necessary Device Alerts evice alerts are pop ups that sho up on the screen There are types o alerts descri ed here • Status: These alerts are ust the pop up screen • Notification: These alerts consist o the pop up screen in addition to a lin ing o er on top o the device • Alert 1: These alerts consist o the pop up screen a lin ing o er and an audi le eep hen displayed This alert will not occur during therapy. • Alert 2: These alerts consist o the pop up screen a lin ing o er and an audi le eep hen displayed This alert can occur during therapy. • Safe State: These alerts consist o the pop up screen a lin ing o er and a repeating audi le eep Note: Status alerts automatically time out after 30 seconds and their pop up screens disappear. All other alerts must be acknowledged to clear. Alert Summary Table: The ollo ing ta le summari es the alerts Alert Icon Type Description ossi le ause Action ata ctivity o not remove SD card. Status SD card read/write underway. n/a No action needed hange ccepted Status onfirms acceptance n/a of prescription change or device upgrade. No action needed Start Pressure Incremented to xx.x Status Displays when Start mode is enabled and device is increasing therapy pressure setting for the next session. n/a No action needed O imetry ood onnection (icon only) Status Displays on the therapy screen when the blower is on and 3 seconds of good connection is detected. Appears at the beginning of therapy. This screen will not display again i the finger probe is removed and reapplied unless therapy is stopped and restarted. n/a No action needed Status Prompts to accept or decline pairing to a luetooth compati le device. This device can e identified y the digits displayed. n/a Rotate control dial to accept pairing ( es) or decline (No) then press control dial to confirm selection air es No 16 User Manual Alert Icon Type Description ossi le ause Action S ard Removed. Notification or Alert 2 Indicates SD card has been removed from therapy device and not reinserted before the start of the current therapy session. O imetry ood Study (icon only) Notification Notifies that user has n/a a achieved at least hours of therapy and oximetry use. Appears at the end of therapy. ress ontrol ial to acknowledge and clear the message. S ard rror Remove and Reinsert Notification SD card error detected Device cannot read the SD card. A problem may exist with the SD card or it as e ected during a riting activity or it was inserted incorrectly. Remove SD card and reinsert. If alert continues to occur replace with another card or contact your provider. S Notification SD card is full. SD card is full. Remove SD card and replace with a new card or contact your provider for a new SD card. Notification Message rom your Provider. n/a ress ontrol ial to acknowledge and clear the message. hange e ected Alert 1 A prescription or settings change was re ected hange missing or incorrect. ontact your provider. Humidification rror ontact support if the problem persists. Status Humidifier error (only Humidifier heater hen humidifier is plate error or present) humidifier not properly connected to therapy device ard ull atient Message (Refer to section) User Manual SD card was not einsert S card or reinserted into device. click to clear alert. Turn off device and disconnect from power. Detach the humidifier visually check that electrical contacts are clear then reconnect humidifier and power cord. If alert continues contact your provider. Alert Icon Type Description ossi le ause Action Heated Tube rror ontact support if the problem persists. Status Heated tube error (only when heated tube is present) Heated tube may be overheated or damaged. Turn off device. Detach heated tube rom humidifier make sure that tube is not covered or o structed and then reattach to humidifier alert continues contact your provider. The attached power supply does not support humidification Alert 2 Indicates that the attached power supply is not capable of supporting humidification or heated tube. Incorrect power supply. Switch to a Philips Respironics DreamStation power supply that is capable of supporting humidification Or operate therapy device without humidifier Service e uired Safe State Indicates an error which enters device into Sa e State This allows power to remain on ut air o is disabled. Device error. ress ontrol ial to silence alert. Disconnect device from power. Reattach power cord to restore power. If the alert continues to occur contact your home care provider. Incorrect Power Supply Notification Indicates an incompatible power supply is attached. Incompatible power supply or po er cord is not fully inserted into device s po er inlet. onfirm po er cord is fully inserted into device s po er inlet onfirm a compati le Philips Respironics power supply is attached. Switch to compatible power supply if needed. Notification Low voltage. Incompatible power supply is attached. onfirm a compati le Philips Respironics power supply is attached. Switch to compatible power supply if needed. If attery is eing used ensure battery is ade uately charged o oltage User Manual Alert Icon Type Description ossi le ause Automatic Off Status Inlet blocked. hec filter Notification loc ed air ay loc age at device inlet. hec device air inlet is not obstructed. hec air filter(s) are installed properly and are clean replace i needed. o ea hec Mas and Tu e Notification loc ed air ay loc age at tu e or mask. hec tu e is not crushed or folded such that air o is restricted hec mask is attached properly and without any obstruction. n/a This alert can be cleared by pressing the ontrol ial Otherwise it will time out after 60 seconds. hec Mas it n/a Loading Language and Rebooting usy Sleep rogress User Manual n/a Displayed when The mask has been therapy ends due to removed. automatic off function. Action Put your mask back on confirm good fit and turn air o on to resume therapy. Status Displayed when hec Mas it function is enabled rom atient Menu Status Displayed when a new n/a language is selected from the menu. No action needed Times out when complete. Status Displayed when the device is temporarily inaccessible due to data communication. n/a No action needed Status Displays last 3 nights hourly use on first screen and nights o use on second screen. n/a ress ontrol ial to acknowledge and clear each screen. Otherwise message times out after 30 seconds. Troubleshooting our device is e uipped ith a sel diagnostic tool call er ormance hec This tool can evaluate your device or certain errors t also allo s you to share ey device settings ith your rovider se er ormance hec hen directed y your provider The table below lists some of the problems you may experience with your device and possible solutions to those problems. Problem hy t Happened hat To o Nothing happens when you apply power to the device. The backlights on the buttons do not light. There s no po er at the outlet or the device is unplugged. you are using po er chec the outlet and veri y that the device is properly plugged in Ma e sure there is po er availa le at the outlet Ma e sure the power cord is connected correctly to the power supply and the power supply cord is securely connected to the device s po er inlet the pro lem continues to occur contact your home care provider eturn oth the device and po er supply to your provider so they can determine i the pro lem is ith the device or po er supply. you are using po er ma e sure your po er cord and attery adaptor ca le connections are secure hec your attery t may need recharged or replaced the pro lem persists chec the cord s use ollo ing the instructions supplied ith your cord The use may need to e replaced the pro lem still occurs contact your home care provider The air o does not turn on. There may be a problem with the blower. Ma e sure the device is po ered correctly Ma e sure the Home screen appears on the user inter ace ress the Therapy utton on top o the device to start air o the air o does not turn on there may e a pro lem ith your device ontact your home care provider for assistance. The device s display is erratic. The device has been dropped or mishandled or the device is in an area with high lectromagnetic nter erence ( M ) emissions. nplug the device eapply po er to the device the pro lem continues relocate the device to an area ith lo er M emissions (a ay rom electronic e uipment such as cellular phones cordless phones computers T s electronic games hair dryers etc ) the pro lem still occurs contact your home care provider or assistance. The Ramp feature does not work when you press the Ramp button. Your home care provider did not prescribe Ramp or you or your therapy pressure is already set to the minimum setting. amp has not een prescri ed or you discuss this eature ith your home care provider to see if they will change your prescription. your provider has ena led amp ut the eature still does not or chec the current pressure setting on the Therapy screen. If the therapy pressure is set to the minimum setting ( cm H2O) or the amp starting pressure is the same as the therapy pressure the amp eature ill not or Ma e sure that the ramp time setting is >0. The air o is much warmer than usual. The air filters may be dirty. The device may be operating in direct sunlight or near a heater. lean or replace the air filters The temperature of the air may vary somewhat based on your room temperature. Ma e sure that the device is properly ventilated eep the device a ay rom edding or curtains that could loc the o o air around the device Ma e sure the device is a ay rom direct sunlight and heating e uipment using the humidifier ith the device chec the humidifier settings e er to the humidifier instructions to ma e sure the humidifier is or ing properly the pro lem continues contact your home care provider The air o pressure feels too high or too low. The Tubing type setting may be incorrect. Ma e sure the Tu ing type setting ( or ) matches the tu ing that you are using ( hilips espironics or mm tu ing) you are using the Heated Tu ing this setting ill e H and you cannot change it. 20 User Manual Problem hy t Happened hat To o Tube Temperature is turned on in Setup screen but Heated Tubing is not warm. Incorrect power supply is being used. Ma e sure the po er supply is eing used or a compati le attery or cable is being used. m having di ficulty ad usting the heated humidifier setting or the heated tube temperature setting. The blower is not turned on or the humidifier or heated tube is not fully connected. The humidifier setting and tu e temperature settings can only e ad usted rom the Therapy ON display screen onfirm that the lo er is turned on and that the settings are visi le on the right side o the screen then ad ust to desired com ort the lo er is on ut the humidifier settings are not displayed on the Therapy ON screen then unplug the device onfirm that the humidifier and or heated tu e electrical contacts are not o structed or damaged Then reconnect the humidifier and or heated tu e and reconnect the device s po er supply Turn the lo er on i the settings are still not visi le contact your provider or assistance The water in the water chamber runs out before morning. ater cham er was not full at start o session Mas leak is excessively high. The ambient conditions are very dry/cool. nder most conditions a ull ater cham er should last or a typical sleep session Ho ever many actors impact ater consumption including the am ient temperature and humidity in your edroom your humidifier or heated tu e settings the level o mas lea and the duration o your sleep session irst ma e sure that the ater cham er is filled to the ma imum fill line at the start o your sleep session hec that your mas is fitted properly and ad ust as needed to reduce mas lea to normal levels ou may use the hec Mas it unction to evaluate your mas fit lso confirm that the device humidifier humidifier seals and tube are connected properly and not leaking. You may also choose to lo er your humidifier and or heated tu e settings or change the humidification mode rom i ed to daptive humidification mode to increase the time that your humidifier ater ill last I hear a leak or whistling sound coming from my therapy device or humidifier (not related to mask leak). The therapy device air inlet may be obstructed. The humidifier or tube is not fully connected. The humidifier seals are not fully seated or are missing. hec therapy device air inlet is not o structed and filters are clean and properly inserted onfirm that the device humidifier and tu e are connected properly and not lea ing onfirm that the humidifier lid seal and dry o seal are present and properly seated i needed gently press around the perimeter o the seals to reseat them. I accidentally spilled water into my humidifier asin The water chamber has been filled eyond the ma imum fill line small amount o ater spilled in the asin o the humidifier ill not harm your device small spill in the humidifier ill evaporate under normal humidifier use Ho ever too much ater in the humidifier asin could spill over the humidifier lid hinge and might damage your furniture. isconnect po er rom the device emove the ater cham er pour out any e cess ater until the ater level is at or elo the ma imum fill line and set the cham er aside Separate the humidifier rom the therapy device and pour out the spilled ater Once the heater plate has cooled ipe the inside o the humidifier ith a paper to el or so t cloth needed dry the underside o the humidifier and confirm that your ta le top is dry econnect the humidifier and po er supply and reinstall the water chamber. User Manual 21 Accessories There are several accessories availa le or your reamStation system such as a Humidifier ellular Modem i i ccessory or a in Module ontact your home care provider or additional in ormation on the availa le accessories hen using optional accessories al ays ollo the instructions enclosed ith the accessories Caution: ins o connectors should not e touched onnections should not e made to these connectors unless S precautionary procedures are used recautionary procedures include methods to prevent uild up o electrostatic charge (e g air conditioning humidification conductive oor coverings non synthetic clothing) discharging one s ody to the rame o the e uipment or system or to earth or a large metal o ect and onding onesel y means o a rist strap to the e uipment or system or to earth Adding a Humidifier with or without Heated Tubing ou can use the heated humidifier and the heated tu e ith your device They are availa le rom your home care provider humidifier may reduce nasal dryness and irritation y adding moisture to the air o Warning: or sa e operation the humidifier must al ays e positioned elo the reathing circuit connection at the mas The humidifier must e level or proper operation Note: e er to the humidifier s instructions or complete setup in ormation Using the SD Card The DreamStation system comes with an SD card inserted in the SD card slot on the side of the device to record information for the home care provider. Your home care provider may ask you to periodically remove the SD card and send it to them for evaluation. Using the DreamStation Link Module The in Module is a le to receive o imetry data and trans er it to the therapy device or home use or in a la oratory setting or use in a la oratory setting the in Module also includes an S (or ) port to allo remote control of the DreamStation Sleep Therapy Device by a personal computer. Note: lease consult the instructions that accompany the in Module or installation and removal Note: There are no SpO2 alarms available. Note: Oximetry data is not displayed. To clean the module remove the module rom the therapy device ipe the outside o the device ith a cloth slightly dampened with water and a mild detergent. Let the device dry completely before reinstalling into the therapy device. Dispose of the module following the same disposal instructions for your therapy device. Warnings: you notice any une plained changes in the per ormance o this device i it has een dropped or mishandled i ater is spilled into the enclosure or i the enclosure is ro en discontinue use ontact your home care provider. epairs and ad ustments must e per ormed y hilips espironics authori ed service personnel only nauthori ed service could cause in ury invalidate the arranty or result in costly damage o not use any accessories detacha le parts and materials not recommended y hilips espironics Incompatible parts or accessories can result in degraded performance. 22 User Manual Adding Supplemental Oxygen Oxygen can be added to the patient circuit. Please note the warnings listed below when using oxygen with the device. Warnings: hen using o ygen ith this system the o ygen supply must comply ith local regulations or medical o ygen O ygen supports com ustion O ygen should not e used hile smo ing or in the presence o an open ame hen using o ygen ith this system a hilips espironics ressure alve must e placed in line ith the patient circuit et een the device and the o ygen source The pressure valve helps prevent the ac o o o ygen rom the patient circuit into the device hen the unit is o ailure to use the pressure valve could result in a fire ha ard Note: e er to the pressure valves instructions or complete setup in ormation hen using o ygen ith this system turn the device on e ore turning on the o ygen Turn the o ygen o before turning the device off. This will prevent oxygen accumulation in the device. o not connect the device to an unregulated or high pressure o ygen source Supplying DC Power to the Device hilips espironics po er cord can e used to operate this device in a stationary recreational vehicle oat or motor home n addition a hilips espironics attery adapter ca le hen used ith a po er cord allo s the device to e operated rom a ree standing attery Caution: l ays ensure that the po er cord securely fits into your therapy device prior to use ontact your home care provider or hilips espironics to determine i you have the appropriate cord or your specific therapy device Caution: hen po er is o tained rom a vehicle attery the device should not e used hile the vehicle s engine is running. Damage to the device may occur. Caution: Only use a hilips espironics o er ord and attery dapter a le se o any other system may cause damage to the device. e er to the instructions supplied ith the po er cord and adapter ca le or in ormation on ho to operate the device using po er Traveling with the System hen traveling the carrying case is or carry on luggage only The carrying case ill not protect the system i it is put through checked baggage. traveling ith the optional humidifier do not travel ith ater in the ater tan or your convenience at security stations there is a note on the ottom o the device stating that it is medical e uipment and is suita le or airline use t may e help ul to ring this manual along ith you to help security personnel understand the DreamStation device. you are traveling to a country ith a line voltage di erent than the one you are currently using a di erent po er cord or an international plug adaptor may e re uired to ma e your po er cord compati le ith the po er outlets o the country to hich you are traveling ontact your home care provider or additional in ormation Airline Travel The device is suita le or use on airlines hen the device is operating rom an or po er source Note: t is not suita le or airline use ith any o the modems or humidifiers installed in the unit User Manual 23 Cleaning the Device Warning: To avoid electrical shoc al ays unplug the po er cord rom the all outlet e ore cleaning the device O NOT immerse the device in any uids nplug the device and ipe the outside o the device ith a cloth slightly dampened ith ater and a mild detergent. Let the device dry completely before plugging in the power cord. 2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts. Cleaning or Replacing the Filters nder normal usage you should clean the reusa le lue pollen filter at least once every t o ee s and replace it ith a ne one every si months The light lue ultra fine filter is disposa le and should e replaced a ter nights o use or sooner i it appears dirty O NOT clean the ultra fine filter Caution: irty inlet filters may cause high operating temperatures that may a ect device per ormance egularly e amine the inlet filters as needed or integrity and cleanliness This device has an automatic air filter reminder very days the device ill display a message reminding you to chec your filters and replace them as directed Note: This message is a reminder only The device does not detect the per ormance o the filters nor does it recogni e hen a filter has een cleaned or replaced the device is operating stop the air o isconnect the device rom the po er source emove the filter(s) rom the device e er to the nstalling eplacing the ir ilters section o this manual amine the filter(s) or cleanliness and integrity To clean the reusa le lue pollen filter first detach the light lue ultra fine filter i applica le and set aside or dispose o as needed Then ta e the reusa le filter to the sin turn it upside do n and run arm tap ater through the hite filter media to rinse a ay any de ris Ne t lightly sha e the filter to remove as much ater as possi le llo the filter to air dry completely e ore reinstalling it the reusa le lue pollen filter is torn replace it (Only hilips espironics supplied filters should e used as replacement filters ) the light lue ultra fine filter is dirty or torn replace it einstall the filters e er to the nstalling eplacing the ir ilters section o this manual Caution: Never install a et filter into the device ou must ensure su ficient drying time or the cleaned filter Cleaning the Tubing lean the e i le tu ing e ore first use and daily isconnect the e i le tu ing rom the device or the or mm e i le tu ing gently ash the tu ing in a solution o arm ater and a mild detergent inse thoroughly. Air dry. Inspect the tubing for damage or wear. Discard and replace if necessary. Note: e er to the humidifier manual or the instructions on ho to clean the heated tu e Service The device does not re uire routine servicing Warning: you notice any une plained changes in the per ormance o this device i it is ma ing unusual or harsh sounds i it has een dropped or mishandled i ater is spilled into the enclosure or i the enclosure is ro en disconnect the po er cord and discontinue use ontact your home care provider User Manual Additional Notices Notice: The Bluetooth® ord mar and logos are registered trademar s o ned y luetooth S nc and any use of such marks by Philips Respironics is under license. Other trademarks and trade names are those of their respective owners. Notice: The DreamStation Therapy Device transmits data between the therapy device and a mobile device ut it does not store any o your personal data This connection et een the therapy device and a mobile device is encrypted. Notice: This device contains a certified Bluetooth radio module (located on the main board). Only the co location o this Bluetooth radio ith the radio transceivers o the reamStation ccessory and ellular Modem has een approved and is permitted i i or compliance ith e posure guidelines a minimum distance o cm et een the i i ccessory or the ellular Modem and the user s ody should e maintained during operation o one of those accessories together with the DreamStation. Notice: THO Notice: THO is the o the certified Bluetooth module contained in this device. Notice: se o non original manu acturer approved accessories may violate your local guidelines and should be avoided. Notice: This device complies ith part o the ules Operation is su ect to the ollo ing t o conditions ( ) This device may not cause harm ul inter erence and ( ) this device must accept any inter erence received including inter erence that may cause undesired operation e posure This e uipment has een tested and ound to comply ith the limits or a lass digital device pursuant to art o the ules These limits are designed to provide reasona le protection against harm ul inter erence in a residential installation This e uipment generates uses and can radiate radio re uency energy and i not installed and used in accordance ith the instructions may cause harm ul inter erence to radio communications Ho ever there is no guarantee that inter erence ill not occur in a particular installation this e uipment does cause harm ul inter erence to radio T reception or other devices hich can e determined y turning the e uipment on and o the user is encouraged to try to correct the inter erence y one or more o the ollo ing measures eorient or relocate the receiving antenna (on the radio T or other device) ncrease the separation et een the e uipment and receiver onnect the e uipment into an outlet on a circuit di erent rom that to hich the receiver is connected. onsult the dealer o the device or help Notice: User Manual ny changes or modifications made to the device that are not e pressly approved y espironics may void the user s authority to operate the e uipment Specifications Environmental Operating Temperature to ( to ) Storage Temperature to ( to ) elative Humidity (operating storage) to (non condensing) tmospheric ressure to a( m t) Physical imensions cm ( eight ( evice ith po er supply) H) g( ppro imately l s) Service Life The e pected service li e o the reamStation Therapy evice and in Module is years Standards Compliance This device is designed to con orm to the ollo ing standards eneral e uirements or asic Sa ety and ssential er ormance o Medical lectrical SO Sleep pnea reathing Therapy uipment N lectromagnetic ompati ility T O section category M mission o adio re uency nergy uipment IEC 60601-1 Classification Type o rotection gainst lectric Shoc lass egree o rotection gainst lectric Shoc Type egree o rotection against ngress o ater evice rip roo in Module rip roo po er supply rip roo Mode o Operation ontinuous uipment pplied art Electrical o er onsumption ( ith po er supply) Note: o er supply is part o the medical electrical e uipment o er onsumption uses There are no user replacea le uses H Radio Specifications Operating re uency ange Ma imum Output o er Modulation MH d m S S S Intake Port Filters ollen ilter olyester ficient micron si e ltra fine ilter lended Synthetic i er ficient micron si e Declared Dual-Number Noise Emissions Values n accordance ith SO The eighted sound pressure level is evice d ( ) ith and uncertainty o d ( ) evice ith Humidifier d ( ) ith and uncertainty o d ( ) The eighted sound po er level is evice d ( ) ith an uncertainty o d ( ) evice ith Humidifier d ( ) ith an uncertainty o d ( ) Note: alues determined according to noise test code given in SO standards SO and SO 26 using the asic User Manual Pressure Accuracy ressure ncrements to cm H2O (in cm H2O increments) Ma imum static pressure accuracy according to SO Pressure Static Accuracy cm H2O 10 cm H2O Static pressure accuracy has a measurement uncertainty of 1.20% Ma imum dynamic pressure variation according to SO Pressure < 10 cm H2O 10 BPM 15 BPM ± 0.3 cm H2O 20 BPM cm H2O ± 0.6 cm H2O cm H2O cm H2O ≥ 10.0 to 20 cm H2O Dynamic pressure accuracy has a measurement uncertainty of 2.10% cm H2O Note: ll tests ere per ormed mm heated tu e ith and ithout humidifier and ith oth mm standard tu e and Maximum Flow Rate (typical) Test pressures (cm H2O) 4.0 22 mm tubing 8.0 16.0 20.0 Measured pressure at the patient connection port (cm H2O) Average flow at the patient connection port (l/min) 15 mm tubing (heated or non heated) 12.0 160.0 Measured pressure at the patient connection port (cm H2O) Average flow at the patient connection port (l/min) Disposal Separate collection or electrical and electronic e uipment per accordance with local regulations. irective ispose o this device in EMC Information our unit has een designed to meet M standards throughout its Service i e ithout additional maintenance There is al ays an opportunity to relocate your DreamStation Therapy Device within an environment that contains other devices with their own un no n M ehavior you elieve your unit is a ected y locating it closer to another device simply separate the devices to remove the condition. Pressure and Flow Accuracy The reamStation Therapy evice is designed to per orm ithin the pressure and o rate accuracies specified in the user manual you suspect that the pressure and or o rate accuracy is a ected y M inter erence remove po er and relocate the device to another area. If performance continues to be affected discontinue use and contact your home care provider. SpO2 and Pulse Rate Accuracy The DreamStation Therapy Device is designed to capture the SpO2 and ulse ate o imetry data ithin the accuracy specification descri ed in the sensor manu acture s instructions or use hen hours o success ul o imetry data have een achieved the device indicates this to the user y displaying O imetry ood Study you suspect that your unit is a ected y M inter erence remove power and relocate the device to another area. If performance continues to be affected discontinue use and contact your home care provider. User Manual uidance and Manu acturer s eclaration lectromagnetic missions This device is intended or use in the electromagnetic environment specified elo The user o this device should ma e sure it is used in such an environment missions Test ompliance RF emissions S Group 1 RF emissions S lass Harmonic emissions lass uidance The device uses energy only or its internal unction There ore its emissions are very low and are not likely to cause any interference in nearby electronic e uipment The device is suita le or use in all esta lishments including domestic esta lishments and those directly connected to the pu lic lo voltage po er supply net or oltage uctuations lic er emissions omplies mission o T O ategory M adio re uency nergy Section lectromagnetic nvironment This device is suitable for use onboard commercial airplanes inside passenger cabin. uidance and Manu acturer s eclaration lectromagnetic mmunity This device is intended or use in the electromagnetic environment specified elo The user o this device should ma e sure it is used in such an environment Immunity Test lectrostatic Test evel ischarge ( S ) contact lectrical ast Transient urst Surge oltage dips short interruptions and voltage variations on power supply input lines ompliance evel contact air or po er supply lines or supply mains or input output lines or input output lines di erential mode di erential mode common mode or common mode ( T cycle at increments dip in T) for degree ( T cycle at increments ( T seconds NOT T H ) dip in ) for 30 A/m Mains po er uality should e that o a typical home or hospital environment. Mains po er uality should e that o a typical home or hospital environment. dip in T) for degree (30% dip in UT) for T seconds ( T seconds T 30 A/m uidance loors should e ood concrete or ceramic tile oors are covered ith synthetic material the relative humidity should be at least 30%. air (30% dip in UT) for T seconds o er re uency ( magnetic field lectromagnetic nvironment dip in Mains po er uality should e that o a typical home or hospital environment. If the user of the device re uires continued operation during po er mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery. ) for T o er re uency magnetic fields should e at levels characteristic of a typical location in a typical hospital or home environment. is the a.c. mains voltage prior to application of the test level. uidance and Manu acturer s eclaration lectromagnetic mmunity This device is intended or use in the electromagnetic environment specified elo The user o this device should ma e sure it is used in such an environment Immunity Test onducted Test evel rms H to MH rms mateur adio ands et een and MH Radiated RF m MH to SM H ompliance evel rms H to MH rms mateur adio ands et een and MH SM H lectromagnetic nvironment uidance orta le and mo ile communications e uipment should e used no closer to any part o the device including ca les than the recommended 30 cm separation distance. nter erence may occur in the vicinity o e uipment mar ed ith the ollo ing sym ol m H User Manual Limited Warranty Respironics, Inc. warrants that the system shall be free from defects of workmanship and materials and will perform in accordance ith the product specifications or a period o t o ( ) years rom the date o sale y espironics nc to the dealer the product ails to per orm in accordance ith the product specifications espironics nc ill repair or replace – at its option – the defective material or part. Respironics, Inc. will pay customary freight charges from Respironics, Inc. to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration, water ingress, and other defects not related to material or workmanship. The Respironics, Inc. Service department shall examine any devices returned for service, and Respironics, Inc. reserves the right to charge an evaluation fee for any returned device as to which no problem is found after investigation by Respironics, Inc. Service. This warranty is non-transferable by unauthorized distributors of Respironics, Inc. products and Respironics, Inc. reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics, Inc. or authorized distributors. espironics nc disclaims all lia ility or economic loss loss o profits overhead or conse uential damages hich may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion or limitation of incidental or conse uential damages so the a ove limitation or e clusion may not apply to you This warranty is given in lieu of all other express warranties. In addition, any implied warranties – including any arranty o merchanta ility or fitness or the particular purpose are limited to t o years Some states do not allo limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights and you may also have other rights hich vary rom state to state To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contact Respironics, Inc. at: 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668-8550 1120830 EN-DOM