System One REMstar Auto User Manual
Contents
1. PHILIPS REMstar Auto A Flex USER MANUAL RESPIRONICS 2010 Koninklijke Philips Electronics N V All rights reserved Table of Contents agf en 2 Importantia daneen alkeen eneen eerden 2 Warnings eenn ea E lederen 2 GaUtioN Sana R EE T RE SE 3 ContraindicatiOns E EE E E 3 SYMIDOM E E E EAE 3 System Contents asstat iei 4 System O T 4 ControliButtOns ernennen e etai E NEA EREE ANA 5 Available Therapi eSsnaressinians raia REN AE NE 5 Installinig the 6 Connecting the Breathing Circuit Where to Place the Device Supplying AC Power 6 NMavigating the Device SCreens snares randen eenander tende 7 Starting the Device erkens denten drieen enaar 7 Ramp Feature 8 Mask Fit rreraino re iias EE 8 Flex Screen Setup SCHESM E INFO Sere E 10 Device Alerts eiiie ran EASE A A TEN2. After the test normal therapy will start and the screen will either display a checkmark 4 or an X The shows that the leak found allows for optimal performance of the device The X shows that the leak may affect device performance however the device will remain functional and deliver therapy Note If you choose to try to improve your mask fit you can stop therapy adjust the fit of your mask and rerun the Mask Fit Check Please refer to the instructions that came with your mask and headgear for the proper fitting procedure Note Mask Fit Check is only available when the device is in Auto CPAP therapy mode Note If Split night is enabled Mask Fit Check will be disabled Flex Screen From the Home screen highlight Flex and press the wheel The following Flex screen will appear Back Flex Flex demo Flex Screen Note Flex shown above will display as the current Flex mode chosen by the provider e Flex The Flex comfort feature allows you to adjust the level of air pressure relief that you feel when you exhale during therapy Your home care provider can enable or disable this feature When your provider enables Flex a level will already be set for you on the device If this is not comfortable you can increase or decrease the setting The setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief If the provider has disabled this feature this setting will not d
3. Do not disassemble asa DC Power ol Class II Double Insulated Type BF Applied Part For Indoor Use Only IPX1 Drip Proof Equipment System Contents Your REMstar Auto A Flex system includes the following items Device Reusable gray foam filter User manual e Disposable ultra fine filter optional e Carrying case e Side cover panel Power cord and power supply Part 1058190 SD card e Flexible tubing 22 mm optional 15 mm tubing is also available e Humidifier optional Note If any of these items are missing contact your home care provider System Overview The REMstar Auto A Flex is a CPAP Continuous Positive Airway Pressure device designed for the treatment of Obstructive Sleep Apnea OSA It can deliver CPAP therapy or Auto CPAP therapy When prescribed for you the device provides several special features to help make your therapy more comfortable 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 You also have the option of not using the ramp feature at all Additionally the C Flex C Flex and A Flex comfort features provide you with pressure relief when you exhale during therapy Several accessories are also available for use with your REMstar Auto device Contact your home care provider to purchase any accessories not included with your system SD
4. A Flex device If you are traveling to a country with a line voltage different than the one you are currently using a different power cord or an international plug adaptor may be required to make your power cord compatible with the power outlets of the country to which you are traveling Contact your home care provider for additional information Airline Travel The REMstar Auto A Flex device is suitable for use on airlines when the device is operating from an AC or DC power source Note It is not suitable for airline use with any of the modems or humidifiers installed in the unit Cleaning the Device WARNING To avoid electrical shock always unplug the power cord from the wall outlet before cleaning the device DO NOT immerse the device in any fluids 1 Unplug the device and wipe the outside of the device with a cloth slightly dampened with water 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 Under normal usage you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months The white ultra fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty DO NOT clean the ultra fine filter CAUTION Dirty inlet filters may cause high operating temperatures that may affect device per
5. Card Accessory Slot Air Outlet Port Power Inlet Filter Area This figure illustrates some of the device features described in the following table Device FEATURE DESCRIPTION Air Outlet Port Connect the flexible tubing here conical 22 mm SD Card Accessory Slot If applicable insert the optional accessory SD card here SD Card Cover If applicable the optional accessories such as a Link Module or Modem can be installed here Refer to the instructions supplied with the accessory When not using an accessory this cover must be in place on the device Power Inlet Connect the power cord here Filter Area A reusable gray foam filter must be placed in the filter area to screen out normal household dust and pollens A white ultra fine filter can also be used for more complete filtration of very fine particles Side Cover If using a humidifier with the device this side cover can be easily removed with the release tab before attaching the humidifier Refer to the humidifier manual When not using a humidifier this cover must be in place on the device 4 User Manual Control Buttons _ LCD Display Screen Humidifier Icon amp Number Settings _ Control Wheel Push Button _ Ramp Button This figure shows the primary control buttons on the device described in the following table FEATURE DEscRIPTION Display Screen Shows therapy settings p
6. EATE 12 Troubleshooting 15 ACCESSORIES E E E EE 16 Traveling With theSystEmMi sree enen ER EERS 17 Cleaning the Device Cleaning or Replacing the Filters 2 2 17 Cleaning the trente arend 17 SOPVICE san sons vensinaainsenerae 17 Le N eE EAE E 18 DIS jef EN 20 How to Contact nst hensen 20 Limited Warranty User Manual CAUTION U S federal law restricts this device to sale by or on the order of a physician Intended Use The Respironics REMstar Auto A Flex system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg 66 Ibs 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 The system can deliver CPAP therapy or Auto CPAP therapy For enhanced pressure relief in CPAP mode the device can also deliver C Flex or C Flex For enhanced pressure relief in Auto mode the device can deliver C Flex or A Flex Your home care provider will make the correct pressure settings according to your health care professional s prescription When set in the Auto CPAP therapy the system will monitor your breathing as you sleep and automatically ad
7. of a high priority sound which is a continuous two beep pattern indicated in the following table e e Additionally the backlights on the buttons will provide a high priority flashing pattern consisting of a continuous bright to off two flash pattern indicated in the following table as 00 00 Medium Priority These alerts require prompt operator response The alert signal consists of a medium priority sound which is a continuous one beep pattern indicated in the following table as Additionally the backlights on the buttons will provide a medium priority flashing pattern consisting of a continuous bright to dim one flash pattern indicated in the following table as 0 Alert Summary Table The following table summarizes the alerts ALERT Service Required AUDIBLE INDICATOR VISUAL INDICATOR 00 99 Screen displays Service required indicating that service is required Device ACTION The device enters the Safe state in which the device power remains on but the airflow is disabled POSSIBLE Cause Device failure PATIENT ACTION Press either the wheel or ramp button to silence the alert Remove the power supply cord from the device to remove power Plug the cord back into the device s power inlet to restore power If the alert continues to occur contact your home care provider Mask Alert 6 Alert present until The breathing Tu
8. the device performance may be affected However the device will remain functional and deliver therapy 2 Connect the tubing to the mask Refer to the instructions that came with your mask 3 Attach the headgear to the mask if necessary Refer to the instructions that came with your headgear Where to Place the Device Place the device on a firm flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position Make sure the filter area on the back of the device is not blocked by bedding curtains or other items Air must flow freely around the device for the system to work properly Make sure the device is away from any heating or cooling equipment e g forced air vents radiators air conditioners CAUTION Do not place the device directly onto carpet fabric or other flammable materials CAUTION Do not place the device in or on any container that can collect or hold water Supplying AC Power to the Device CAUTION Condensation may damage the device If this device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Do not operate the device outside of the operating temperature range shown in the Specifications WARNING Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture WARNING This device is
9. the pressure valve could result in a fire hazard Do not connect the device to an unregulated or high pressure oxygen source Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide Do not use the device near a source of toxic or harmful vapors Do not use this device if the room temperature is warmer than 35 95 F If the device is used at room temperatures warmer than 35 C 95 F the temperature of the airflow may exceed 43 C 109 F This could cause irritation or injury to your airway Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device e Contact your health care professional if symptoms of sleep apnea recur e If you notice any unexplained changes in the performance of this device if it is making unusual or harsh sounds if it has been dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken disconnect the power cord and discontinue use Contact your home care provider e Repairs and adjustments must be performed by Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage e Periodically inspect electrical cords and cables for damage or signs of wear Discontinue use and replace if damaged To a
10. two 2 years from the date of sale by Respironics Inc to the dealer If the product fails to perform in accordance with the product specifications Respironics Inc will 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 reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics or authorized distributors Respironics Inc disclaims all liability for economic loss loss of profits overhead or consequential damages which 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 consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including any warranty of merc
11. activated when the power cord is connected 6 User Manual IMPORTANT If you are using your device with a humidifier refer to the instructions included with your humidifier for details on how to power the device and humidifier Complete the following steps to operate the device using AC power 1 Plug the socket end of the AC power cord included into the power supply also included 2 Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch 3 Plug the power supply cord s connector into the power inlet on the back of the device 4 Ensure that all connections are secure IMPORTANT To remove AC power disconnect the power supply cord from 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 Navigating the Device Screens Turn the wheel to toggle between options and settings on the screen Press the wheel to choose an option or setting that is highlighted If you choose Back on any screen it will take you back to the previous screen Note The screens shown throughout this manual are examples only Actual screens may vary slightly Examples are for reference only Starting the Device 1 Supply power to the device 2 The Home screen will appear shown below Therapy Flex Home Screen Note Flex shown above will displ
12. an be SD card full checked in the Status menu Remove SD card and replace SD Card Remove single beep 0 Alert present for SD card has No action needed Screen displays 30 seconds or until been removed SD card user acknowledges removed SD Card Data single beep Screen displays Alert present until n a Only displayed immediately after Activity Data activity Do user acknowledges therapy is turned off when data is not remove card or data activity complete transferring to the card User Manual 13 AUDIBLE VISUAL Device AcTION POSSIBLE PATIENT ACTION INDICATOR INDICATOR CAUSE SD Card Corrupt e o gt 0 Alert present until A problem Choose yes to reformat Screen displays action is taken exists with the the card Screen displays Corrupt card SD card The Reformatting do not remove inserted reformat data may be card card corrupted If you choose no the alert will disappear and the card will not be reformatted Note Any information on the card will be lost when reformatted Contact your home care provider with any questions SD Card Remove ee Alert present until Device cannot Remove SD card and reinsert and Reinsert Screen displays action is taken read the If the alert continues to occur SD card error SD card A replace with another card or remove and problem may contact your home care provider reinse
13. atient data and other messages The startup screen is shown temporarily when the unit is first powered Humidifier Icon This Icon lights up when the optional humidifier is attached and heat is being applied The humidifier number settings are only visible when the humidifier is attached and therapy is active Please refer to the humidifier user manual for more information Control Wheel Push Button Turn the wheel to toggle between options on the screen Press the wheel to choose an option Primary function is to turn airflow on off Ramp Button When the airflow is on this button allows you to activate or restart the ramp function When the airflow is off this button allows you to activate the Mask Fit Check This button lights up when therapy is active or during specific alerts Available Therapies The REMstar Auto A Flex device delivers the following therapies User Manual CPAP Delivers Continuous Positive Airway Pressure CPAP maintains a constant level of pressure throughout the breathing cycle CPAP with C Flex Delivers CPAP therapy with pressure relief upon exhalation to improve patient comfort based on patient needs CPAP with C Flex Delivers CPAP therapy with pressure relief taking place at the end of inhalation and at the start of exhalation to improve patient comfort based on patient needs Auto CPAP Delivers CPAP therapy while automatically adjusting the pressure level to meet the pa
14. ay as the current Flex mode chosen by the provider Note The SD card icon will display next to Info if the SD card is inserted 3 Put on your mask assembly Note If you are having trouble with your mask refer to the instructions supplied with the mask 4 Turn the wheel to toggle between the four options Highlight Therapy Press the wheel to turn on the airflow and begin therapy The Therapy screen will appear which will show the current pressure setting being delivered example shown below 11 0 cm H20 a Therapy Screen Note The SD card icon will display in the lower left corner if the SD card is inserted Note If the Ramp feature is on the Ramp icon will display in the lower right corner 5 Make sure that no air is leaking from your mask into your eyes If necessary adjust the mask and headgear until the air leak stops See the instructions provided with your mask for more information Note A small amount of mask leak is normal and acceptable Correct large mask leaks or eye irritation from an air leak as soon as possible 6 If you are using the device in a bed with a headboard try placing the tubing over the headboard This may reduce tension on the mask 7 Press the wheel again to turn off therapy and return to the Home screen User Manual 7 Ramp Feature The device is equipped with an optional ramp feature that your home care provider can enable or disable This feature reduces the air pressure when you a
15. crements Pressure Stability Static Dynamic Dynamic lt 10 cm H O 2 10 0 to 20 cm H O Device 0 5 cm H O lt 0 5 cm H O lt 1 0 cm H O Device w Humidifier 0 5 cm H O lt 0 5 cm H O lt 1 0 cm H O 18 User Manual Maximum Flow Rate typical User Manual Test pressures cm H O 4 0 8 0 12 0 16 0 20 0 22 mm Measured pressure at the patient 3 6 7 5 11 0 15 0 19 0 tubing connection port Average flow at the patient 84 1 135 2 154 5 146 9 128 7 connection port l min 15 mm Measured pressure at the patient 3 8 7 0 11 0 15 0 19 0 tubing connection port cm H O Average flow at the patient 85 1 120 7 121 6 119 3 119 2 connection port l min 19 Disposal Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Dispose of this device in accordance with local regulations How to Contact Respironics To have your device serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 or 1 724 387 4000 You can also use the following address Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 20 User Manual Limited Warranty Respironics Inc warrants that the system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of
16. e or decrease this setting If your provider has disabled Flex you will not see this setting Note This same setting is also available under the Flex screen e SYSTEM ONE humidification System One humidity control maintains a consistent mask humidity by monitoring and adjusting for changes in room temperature and room humidity You can enable or disable this feature If the System One humidity control has been disabled the classic style of basic temperature controlled heated humidification will be used This will only display if the humidifier is attached e Humidifier This setting allows you to choose the desired humidity setting 0 1 2 3 4 or 5 If the System One humidity control has been disabled the classic style of basic temperature controlled heated humidification will be used and the display will show 0 C1 C2 C3 C4 or C5 for these settings This will only display if the humidifier is attached Please refer to the humidifier manual if using a humidifier e Ramp Start This displays the ramp starting pressure You can increase or decrease the ramp starting pressure in 0 5 cm H O increments This is only available if Ramp time has been set to gt 0 and auto min or CPAP pressure gt 4 cm H O This will not display if your provider enabled Split night on your device Tubing Type This setting allows you to select the correct size diameter tubing that you are using with the device You can choose either 22 for any Respiron
17. ent was experiencing periodic breathing This screen displays the average of these individual nightly values of periodic breathing over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display If you see a large increase in the percent of time in periodic breathing indicated here contact your home care provider for assistance This screen only displays if your home care provider has enabled it 90 Pressure During any given night the device recognizes the 90 Pressure achieved by the Auto Algorithm 90 Pressure is defined as the pressure at which the device spent 90 of the session time at or below For example if the device recognized airflow for 10 hours and 9 hours were spent at or below 11 cm H O and 1 hour was spent above 11 cm H O then the 90 Pressure would be 11 cm H O This screen displays the average of these individual nightly values of 90 Pressure over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display This screen only displays if the device was set to Auto CPAP therapy User Manual 11 Device Alerts e High Priority These alerts require immediate operator response The alert signal consists
18. exceeded 4 hours over a 7 day and 30 day time frame e Large leak During any given night the device recognizes the percentage of time the patient was experiencing what it deemed to be a large leak Large leak is defined as the level of leak that is so large it is no longer possible to determine respiratory events with statistical accuracy This screen displays the average of these individual nightly values of percentage of time in large leak over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display If you see a large increase in the percent of time in large leak indicated here contact your home care provider for assistance This screen only displays if your home care provider has enabled it device accumulates individual Apnea Hypopnea indices for each session the patient used the device This screen displays the average of these individual nightly AHI values over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display This screen only displays if your home care provider has enabled it e Periodic Breathing During any given night the device recognizes the percentage of time the pati
19. formance Regularly examine the inlet filters as needed for integrity and cleanliness 1 If the device is operating stop the airflow Disconnect the device from the power source 2 Remove the filter s from the enclosure by gently squeezing the filter in the center and pulling it away from the device 3 Examine the filter s for cleanliness and integrity 4 Wash the gray foam filter in warm water with a mild detergent Rinse thoroughly to remove all detergent residue Allow the filter to air dry completely before reinstalling it If the foam filter is torn replace it Only Respironics supplied filters should be used as replacement filters 5 If the white ultra fine filter is dirty or torn replace it 6 Reinstall the filters inserting the white ultra fine filter first if applicable CAUTION Never install a wet filter into the device You must ensure sufficient drying time for the cleaned filter Cleaning the Tubing Clean the tubing before first use and daily Disconnect the flexible tubing from the device Gently wash the tubing in a solution of warm water and a mild detergent Rinse thoroughly Air dry Service The device does not require routine servicing WARNING If you notice any unexplained changes in the performance of this device if it is making unusual or harsh sounds if it has been dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken disconnect the power cord and discontinue use Co
20. ge to the device Contraindications When assessing the relative risks and benefits of using this equipment the clinician should understand that this device can deliver pressures up to 20 cm H O In the event of certain fault conditions a maximum pressure of 30 cm H O is possible Studies have shown that the following pre existing conditions may contraindicate the use of CPAP therapy for some patients Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Pneumothorax Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure Caution should be used when prescribing CPAP for susceptible patients such as those with cerebral spinal fluid CSF leaks abnormalities of the cribriform plate prior history of head trauma and or pneumocephalus Chest 1989 96 1425 1426 The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection Not for use with patients whose upper airways are bypassed Contact your health care professional if you have any questions concerning your therapy Symbol Key The following symbols may appear on the device and power supply SYMBOL DEFINITION SYMBOL DEFINITION For Airline Use Complies with RTCA DO 160F Nef Separate collection for electrical and electronic section 21 category M equipment EC Directive 2002 96 EC User Manual 18 Consult accompanying instructions for use
21. hantability or fitness for the particular purpose are limited to two years Some states do not allow 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 which vary from 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 1 724 387 4000 Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA PHILIPS REF 1058156 1057243 R04 JR 9 21 2010 EN DOM
22. his feature with your home care provider to see if they will change your prescription If your provider has enabled Ramp but the feature still does not work check the CPAP setting on your Active Display screen If CPAP is set to the minimum setting 4 0 cm H O or the starting pressure is the same as the prescribed pressure the Ramp feature will not work Make sure that the ramp time setting is gt 0 The airflow is much warmer than usual The air filters may be dirty The device may be operating in direct sunlight or near a heater Clean or replace the air filters The temperature of the air may vary somewhat based on your room temperature Make sure that the device is properly ventilated Keep the device away from bedding or curtains that could block the flow of air around the device Make sure the device is away from direct sunlight and heating equipment If using the humidifier with the device check the humidifier settings Refer to the humidifier instructions to make sure the humidifier is working properly If the problem continues contact your home care provider high or too low The airflow pressure feels too The Tubing type setting may be incorrect Make sure the Tubing type setting 22 or 15 matches the tubing that you are using Respironics 22 mm tubing or the optional Respironics 15 mm tubing If you do not see the Tubing type setting in the setup menu you must use the Respironics 22
23. ics 22 mm tubing or 15 for the optional Respironics 15 mm tubing WARNING If you are using the optional Respironics 15 mm tubing the device tubing type setting must be set to 15 If your device does not have the tubing type setting you must use the Respironics 22 mm tubing SYSTEM ONE resistance lt This setting allows you to adjust the level of air pressure relief based on the specific Respironics mask Each Respironics mask may have a System One resistance control setting Contact your home care provider if you cannot find this resistance setting for your mask If your provider has locked the resistance setting into place you can view the setting but cannot change it and the screen will display a lock symbol If your provider has disabled resistance you will not see this setting User Manual 9 e Auto on You can enable this feature if you want the device to automatically turn the airflow on whenever you apply the interface mask to your airway You can also disable this feature e Auto off You can enable this feature if you want the device to automatically turn the airflow off whenever you remove the interface mask from your airway You can also disable this feature e Mask alert You can enable or disable the mask alert setting If this feature is enabled the mask alert will appear on the display screen when a significant mask leak is detected and an audible alert will sound Refer to the Device Alerts section fo
24. isplay Note This same setting is also available under the Setup screen 8 User Manual e Flex demo The Flex setting allows you to set the Flex level prior to beginning therapy The Flex demo setting allows you to try out the different Flex settings in real time After a period of time of inactivity the device will stop therapy and will use the last Flex demo setting as the new Flex setting for your device When therapy is again started from the Home screen the device will operate using the new Flex setting Setup Screen From the Home screen highlight Setup and press the wheel The following Setup screen will appear The user can change settings in the Setup menu Back Flex 1 2 3 SYSTEM ONE humidification on off Humidifier 012345 Ramp start 4 0 auto min or CPAP pres Tubing type 15 22 SYSTEM ONE resistance X1 X2 X3 X4 X5 Auto on on off Auto off on off Mask alert on off Humidifier LED Backlight on off Language EN ES Back Setup Screen Note The screen will only show 4 lines at a time As you rotate the wheel to toggle over different options the screen will slide up and down accordingly If the text is too long to completely fit on the screen it will scroll horizontally across the screen when highlighted e Flex This displays the Flex level set by your home care provider Your home care provider will either enable or disable Flex If Flex is enabled and the setting is not comfortable you can increas
25. just the pressure to meet your needs When in CPAP therapy the system will deliver a continuous set pressure during the night Several accessories are available to make your OSA treatment with the REMstar Auto A Flex system as convenient and comfortable as possible To ensure that you receive the safe effective therapy prescribed for you use only Respironics accessories Warnings A warning indicates the possibility of injury to the user or the operator e This manual serves as a reference The instructions in this manual are not intended to supersede the health care professional s instructions regarding the use of the device The operator should read and understand this entire manual before using the device e This device is not intended for life support The device should be used only with masks and connectors recommended by Respironics or with those recommended by 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 be used with special masks or connectors that have exhalation ports 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 exhalation port However when the device is not operating enough fresh air wi
26. ll not be provided through the mask and exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation e Ifyou are using a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve If you are using the optional Respironics 15 mm tubing the device tubing type setting must be set to 15 If your device does not have the tubing type setting you must use the Respironics 22 mm tubing e When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame When using oxygen with this system turn the device on before turning on the oxygen Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device Explanation of the Warning When the device is not in operation and the oxygen flow is left on oxygen delivered into the tubing may accumulate within the device s enclosure Oxygen accumulated in the device enclosure will create a risk of fire e When using oxygen with this system a Respironics Pressure Valve must be placed in line with the patient circuit between the device and the oxygen source The pressure valve helps prevent the backflow of oxygen from the patient circuit into the device when the unit is off Failure to use
27. mm tubing User Manual 15 Accessories There are several accessories available for your REMstar Auto A Flex system such as a humidifier or a modem Contact your home care provider for additional information on the available accessories When using optional accessories always follow the instructions enclosed with the accessories CAUTION Pins of connectors should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic charge e g air conditioning humidification conductive floor coverings non synthetic clothing discharging one s body to the frame of the equipment or system or to earth or a large metal object and bonding oneself by means of a wrist strap to the equipment or system or to earth Adding a Humidifier You can use the Heated humidifier or the Passover humidifier with your device They are available from your home care provider A humidifier may reduce nasal dryness and irritation by adding moisture to the airflow WARNING For safe operation the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device The humidifier must be level for proper operation Note Refer to the humidifier s instructions for complete setup information Using the SD Card The REMstar Auto A Flex system comes with an SD card inserted in the SD card slot
28. ng the white disposable filter simply insert the gray foam filter into the filter area Connecting the Breathing Circuit To use the system you will need the following accessories in order to assemble the recommended circuit e Respironics interface nasal mask or full face mask with integrated exhalation port or Respironics interface with a separate exhalation device such as the Whisper Swivel II WARNING If you are using a full face mask a mask covering both your mouth and your nose the mask must be equipped with a safety entrainment valve e Respironics 22 mm flexible tubing 1 83 m 6 ft optional Respironics 15 mm tubing for compatible devices e Respironics headgear for the mask WARNING If the device is used by multiple persons such as rental devices a low resistance main flow bacteria filter should be installed in line between the device and the circuit tubing to prevent contamination To connect your breathing circuit to the device complete the following steps 1 Connect the flexible tubing to the air outlet on the side of the device WARNING If you are using the optional Respironics 15 mm tubing the device tubing type setting must be set to 15 If your device does not have the tubing type setting you must use the Respironics 22 mm tubing Note If required connect a bacteria filter to the device air outlet and then connect the flexible tubing to the outlet of the bacteria filter Note When using the bacteria filter
29. ntact your home care provider User Manual 17 Specifications Environmental Operating Temperature 5 to 35 C 41 to 95 F Storage Temperature 20 to 60 4 to 140 F Relative Humidity operating amp storage 15 to 95 non condensing Atmospheric Pressure 101 to 77 kPa 0 2286 m 0 7500 ft Physical Dimensions 18 x 14 10 7 Lx 5 5 W x 4 H Weight Device with power supply Approximately 1 53 kg 3 37 Ibs Standards Compliance This device is designed to conform to the following standards IEC 60601 1 General Requirements for Safety of Medical Electrical Equipment EN ISO 17510 1 Sleep Apnea Breathing Therapy Devices EN 60601 1 2 Electromagnetic Compatibility RTCA DO 160F section 21 category M Emission of Radio Frequency Energy IEC 60601 1 Classification Type of Protection Against Electric Shock Class Il Equipment Degree of Protection Against Electric Shock Type BF Applied Part Degree of Protection against Ingress of Water device amp AC power supply Drip Proof IPX1 Mode of Operation Continuous Electrical AC Power Consumption 100 240 VAC 50 60 Hz 2 1 A DC Power Consumption 12 VDC 5 0 A Fuses There are no user replaceable fuses Noise Sound Pressure Level lt 30 dB A This measurement applies to the therapy device with or without the optional Humidifier Sound Power Level lt 38 dB A Pressure Accuracy Pressure Increments 4 0 to 20 0 cm H O in 0 5 cm H O in
30. on the back 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 Note If the SD card is inserted the device the SD card icon f will display next to Info on the Home screen and it will also display in the lower left corner of the Therapy screen Note The SD card does not need to be installed for the device to work properly The SD card records device usage information for your home care provider You can refer to the Device Alerts section in this manual for more information on the SD card Contact your provider if you have any questions about the SD card Adding Supplemental Oxygen Oxygen may be added at the mask connection Please note the warnings listed below when using oxygen with the device WARNINGS e When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen e Oxygen supports combustion Oxygen should not be used while smoking or the presence of an open flame When using oxygen with this system a Respironics Pressure Valve must be placed in line with the patient circuit between the device and the oxygen source The pressure valve helps prevent the backflow of oxygen from the patient circuit into the device when the unit is off Failure to use the pressure valve could result in a fire hazard Note Refer to the pressure valve s instructions for complete se
31. pply to your provider so they can determine if the problem is with the device or power supply If you are using DC power make sure your DC power cord and battery adaptor cable connections are secure Check your battery It may need recharged or replaced If the problem persists check the DC cord s fuse following the instructions supplied with your DC cord The fuse may need to be replaced If the problem still occurs contact your home care provider Make sure the device is powered correctly Make sure Therapy is highlighted when pressing the control wheel to start airflow If the airflow does not turn on there may be a problem with your device Contact 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 Electromagnetic Interference EMI emissions Unplug the device Reapply power to the device If the problem continues relocate the device to an area with lower EMI emissions away from electronic equipment such as cellular phones cordless phones computers TVs electronic games hair dryers etc If the problem still occurs contact your home care provider for assistance The Ramp feature does not button work when you press the Ramp Your home care provider did not prescribe Ramp for you or your CPAP pressure is already set to the minimum setting If Ramp has not been prescribed for you discuss t
32. r more information about the mask alert e Humidifier LED Backlight Ramp Backlight You can enable or disable the LED backlight for the humidifier number settings and Ramp button on the device Note If the humidifier is not attached this feature will display as Ramp Backlight and control the LED backlight for the Ramp button only Note If the Humidifier LED Backlight is enabled or disabled the humidifier icon will always remains on if humidifier is attached and heat is being applied but will dim after 30 seconds of inactivity e Language This feature allows you to choose which language to display on the interface You can choose English EN or Spanish ES Info Screen From the Home screen highlight Info and press the wheel The following Info screen will appear The user cannot change settings in the Info menu Note These screens are only for reference Your home care provider may periodically ask you for this information Compliance VIC Therapy hours Days gt 4 Large leak AHI Periodic breathing 90 pressure Back Info Screen Note The screen will only show 4 lines at a time As you rotate the wheel to toggle over different options the screen will slide up and down accordingly e Status This displays information sent from a peripheral SD card modem mall etc If two peripherals are attached two lines will appear with corresponding icons Note This will not display if no peripherals are being
33. re trying to fall asleep and then gradually increases ramps the pressure until your prescription setting is reached allowing you to fall asleep more comfortably If ramp is enabled on your device after you turn on the airflow press the RAMP 22 button on the top of the device You can use the RAMP button as often as you wish during the night Note If the Ramp feature is the Ramp icon add will display in the lower right corner of the Therapy screen Note If the Ramp feature is disabled and airflow is on nothing will happen when you press the RAMP button Note If the airflow is off and you press the RAMP button the mask fit check feature will start if it is enabled by your provider Note If in Auto mode there is no ramp at minimum pressure when starting Ramp would only be useful if you wake in the middle of the night Mask Fit Check Feature If available on your device the optional mask fit check feature can be enabled or disabled by your home care provider This feature allows you to check the fit of your mask prior to starting therapy This is done by measuring the amount of leak Put on your mask assembly If mask fit check is enabled before you turn on the airflow press the RAMP 222 button on the top of the device Airflow will start and the mask fit check screen will appear shown below Mask fit checking 40 Mask Fit Check The device will deliver a test pressure while the screen will count down 40 seconds
34. rn off airflow Check your Screen displays action is taken circuit is breathing circuit connections Mask alert disconnected and reconnect the tubing if it has or there is a come loose Make sure your large air leak mask is on properly before you restart the airflow If the alert continues to occur contact your home care provider to have your mask checked You may need a mask refitting Auto Off single beep Screen displays The airflow shuts The mask has Put your mask back on and turn Auto off off and the device been removed the airflow on to resume therapy enters the Standby state approximately 45 60 seconds after detection Alert present for 30 seconds or until user acknowledges Humidifier Alert none Q Only displayed when Humidifier Alert is present for 12 minutes or Humidifier LED both the humidifier failure until the condition is fixed Turn icon will flash and therapy is on off airflow and reconnect the humidifier to the device according 66 to the humidifier instructions AAA If the alert continues to occur contact your home care provider 12 User Manual ALERT AUDIBLE VISUAL Device AcTION POSSIBLE PATIENT ACTION INDICATOR INDICATOR Cause Patient Reminder single beep Screen displays Only displayed when Message from Your home care provider may message from the therapy transitions the provider set a patient reminder scheduled provider from on to off to pop up at a par
35. rt exist with the SD card or it is inserted incorrectly Modem Making Call single beep Modem will Alert present for 30 Refer to If modem is making call while display its own seconds after call modem therapy is active alert for call icon on the device sequence or until instruction sequence is not displayed Refer to modem user acknowledges manual instruction manual Modem Unsuccessful single beep 0 Alert present for Refer to No action needed Call Modem will 30 seconds or until modem display its own user acknowledges instruction icon on the device manual Refer to modem instruction manual 14 User Manual Troubleshooting The table below lists some of the problems you may experience with your device and possible solutions to those problems PROBLEM Nothing happens when you not light apply power to the device The backlights on the buttons do The airflow does not turn on Why IT HAPPENED There s no power at the outlet or the device is unplugged There may be a problem with the blower What To Do If you are using AC power check the outlet and verify that the device is properly plugged in Make sure there is power available at the outlet Make sure the AC power cord is connected correctly to the power supply and the power supply cord is securely connected to the device s power inlet If the problem continues to occur contact your home care provider Return both the device and power su
36. t or system or to earth Before operating the device ensure that the SD card cover is replaced whenever any of the accessories such as the Link Module or Modem are not installed Refer to the instructions that came with your accessory Condensation may damage the device If this device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Do not operate the device outside of the operating temperature range shown in the Specifications Do not use extension cords with this device Do not place the device directly onto carpet fabric or other flammable materials Do not place the device in or on any container that can collect or hold water A properly installed undamaged reusable foam inlet filter is required for proper operation Tobacco smoke may cause tar build up within the device which may result in the device malfunctioning Dirty inlet filters may cause high operating temperatures that may affect device performance Regularly examine the inlet filters as needed for integrity and cleanliness Never install a wet filter into the device You must ensure sufficient drying time for the cleaned filter When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the device may occur Only use a Respironics DC Power Cord and Battery Adapter Cable Use of any other system may cause dama
37. ticular time to Alert present for remind you to replace your mask 6 minutes or until change your filters etc Check user acknowledges your mask a new may be available Call your provider is the default message The provider may change the message Instant Message single beep Home care Only displayed when Message from Your home care provider may provider will therapy is off the provider send an instant message Contact supply text to be your home care provider with any displayed questions SD Card Prescription single beep Screen displays Alert present for n a Card status can be checked in Accepted SD card inserted 30 seconds or until Status menu prescription user acknowledges accepted SD Card Prescription single beep 0 Alert present for Prescription Contact your home care provider Rejected Screen displays 30 seconds or until missing or for correct prescription SD card inserted user acknowledges incorrect prescription rejected SD Card Inserted e o Alert present until SD card Alert is present until card is Incorrectly Screen displays action is taken inserted removed Remove SD card and SD card inserted incorrectly reinsert correctly If the alert incorrectly continues to occur contact your home care provider SD Card Full 6 o Alert present until SD card is full Alert is present until card is Screen displays action is taken removed Card status c
38. tient s needs Auto CPAP with C Flex Delivers Auto CPAP therapy with pressure relief upon exhalation to improve patient comfort based on patient needs Auto CPAP with A Flex Delivers Auto CPAP therapy with pressure relief taking place at the end of inhalation and at the start of exhalation to improve patient comfort based on patient needs Installing the Air Filters CAUTION A properly installed undamaged gray foam filter is required for proper operation The device uses a gray foam filter that is washable and reusable and a white ultra fine filter that is disposable The reusable filter screens out normal household dust and pollens while the ultra fine filter provides more complete filtration of very fine particles The gray reusable filter must be in place at all times when the device is operating The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles The reusable gray foam filter is supplied with the device A disposable ultra fine filter may also be included If your filter is not already installed when you receive your device you must at least install the reusable gray foam filter before using the device To install the filter s 1 If you are using the white disposable ultra fine filter insert it into the filter area first mesh side facing in towards the device 2 Insert the required gray foam filter into the filter area after the ultra fine filter Note If you are not usi
39. tup information e When using oxygen with this system turn the device on before turning on the oxygen Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device Do not connect the device to an unregulated or high pressure oxygen source Supplying DC Power to the Device The Respironics DC Power Cord can be used to operate this device in a stationary recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable when used with the DC Power Cord enables the device to be operated from a 12 VDC free standing battery CAUTION When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the device may occur CAUTION Only use a Respironics DC Power Cord and Battery Adapter Cable Use of any other system may cause damage to the device Refer to the instructions supplied with the DC Power Cord and adapter cable for information on how to operate the device using DC power 16 User Manual Traveling with the System When traveling the carrying case is for carry on luggage only The carrying case will not protect the system if it is put through checked baggage For your convenience at security stations there is a note on the bottom of the device stating that it is medical equipment and is suitable for airline use It may be helpful to bring this manual along with you to help security personnel understand the REMstar Auto
40. used Phone in This screen displays the total therapy hours for the device the total blower hours and the total number of days used when the sessions were greater than 4 hours since the device was last reset by the home care provider This screen also displays a compliance check number used by your home care provider to validate that the data provided by you is the data taken from this screen This setting only appears if your provider has enabled this feature e Compliance VIC Visual Inspection Check This screen displays the start day and the total number of days used when the sessions were greater than 4 hours This screen also displays a check code number used by your home care provider to validate that the data provided by you is the data taken from this screen This setting only appears if your provider has enabled this feature e Therapy hours The device is capable of recognizing the difference between the time the patient is actually receiving therapy and the time when the blower is simply running This screen displays the average amount of time the patient is actually receiving therapy on the device over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display 10 User Manual e Days gt 4 This screen displays the cumulative number of device therapy sessions that
41. void electrical shock always unplug the power cord from the wall outlet before cleaning the device DO NOT immerse the device in any fluids If the device is used by multiple persons such as rental devices a low resistance main flow bacteria filter should be installed in line between the device and the circuit tubing to prevent contamination sure to route the power cord to the outlet a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture e This device is activated when the power cord is connected e For safe operation when using a humidifier the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device The humidifier must be level for proper operation 2 User Manual Note Please see the Limited Warranty section of this manual for information on warranty coverage Cautions A Caution indicates the possibility of damage to the device Pins of connectors should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic charge e g air conditioning humidification conductive floor coverings non synthetic clothing discharging one s body to the frame of the equipment or system or to earth or a large metal object and bonding oneself by means of a wrist strap to the equipmen
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