System One ASV user manual
Contents
1. User Manual 13 ALARM PRIORITY AUDIBLE VISUAL INDICATORS Device ACTION User ACTION INDICATOR Low High ee Red flashing button Operates This could be caused by an excessive Pressure Low Pressure leak or blockage or a device Alarm or the following symbol malfunction Press the Alarm Silence cm Indicator button to silence the alarm H20 Remove your mask Check for the following dirty inlet filters blocked air intake excessive leak in the patient circuit If the alarm continues contact your home care provider High High ee Red flashing button Operates This may be caused by a malfunctioning Pressure High Pressure If the alarm device Press the Alarm Silence Indicator or the following symbol continues for button to silence the alarm Remove A cm 10 seconds the your mask Remove power from the alarm escalates device Restore power If the alarm to a Device continues contact your home care Inoperative alarm provider for service Apnea High ee Red flashing button Operates This alarm is generated when an apnea Apnea event occurs during therapy Press or the following symbol the Alarm Silence Indicator button to A A silence the alarm Report the alarm to your home care provider Continue using your device Low Minute High Red flashing button Operates This alarm occurs when the calculated Ventilation Low Minute Vent minute ventilation is le2. 7 Monitor PRESSUFE Scree Ti gt 8 Ramp Feature 8 5 Rn 9 Setup Scheen u n ne nes seines 9 Info SONCEM ea een 11 Device Alerts naeh 12 Troubleshooting lt ssscivssscoassssstsssccusecssonsesescapeassecszonsaucoussasausescssegngsaitbgaaunsssevntassobenaasedeodatudead edigostseadoonduscobsgestacadoebeie 16 E A T E A A 17 Mave ling withithie Sy Sterns o EEE EE renee EO 18 Home carcass tas cases 18 arte lenen E A E O 18 Specifications nnee tte eere len 19 DiS Te NR 20 How to Contact Respiromics u 20 Limited teenaa Back Page User Manual Intended Use The BiPAP autoSV Advanced System One device is intended to provide mask applied non invasive ventilatory support to adult patients gt 30 kg for the primary treatment of obstructive sleep disordered breathing with secondary Central Sleep Apnea or Cheyne Stokes Respiration CSR The device may be used in the hospital or home Warnings A warning indicates the possibility of injury to the user or the operator 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
3. 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 or entrainment valve 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 or entrainment valve However when the device is not operating enough fresh air will not be provided through the mask and exhaled air may be rebreathed 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 the pressure valve could result in a fire hazard 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 devic
4. 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 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 The BiPAP autoSV Advanced System One device can deliver pressures up to 25 cm H O In the unlikely event of certain fault conditions pressures of up to 35 cm H O are possible The data obtained when using an Oximetry module accessory is not considered to be diagnostic and is not to be used in the diagnosis of a patient s condition 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 e 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 Before operating the device ensure that the SD card cover is replaced whenever
5. BIPAP autoSV Advanced System One PHILIPS USER MANUAL RESPIRONICS 2010 Koninklijke Philips Electronics N V All rights reserved Table of Contents Intended eenn ded 2 VVARMINBS eten eenen 2 Eautlons tante tendeert ralen bet eee lade 2 Contraindications sn sve teens serena std nn rel ee aen vaker 3 Patient Preca tionssea s nn eek ea 3 ae E 3 System 5 2 lt 4 System A AA E 4 5 Available Therapy Reatures nesten tement 5 Installing the Air Filters ae Re 6 Connecting the Breathing Circuit me a dan 6 Where to Place the DEVIC scuisccisdssscssivesscccssedseessevestsnta causes acashusansessseostiessbsasuseovansisdsssdbsiseveteusetescsstblaresnusecebiate 6 Supplying AC Power to the Device isssscsssssecvacssscsiesaccsacseadecssstbeansscasssstscssutesnatuvsnsesdteustbusavescsanstesscusbusssdessedbcien 6 Navigating the Device Screens c essiscsissssscsosontassovsnsscossssasassadsedscisctecosossustovensstavobeanbal ei iii 7
6. exists with the SD card The data may or the following symbol be corrupted Press the Alarm Silence fed Indicator button to silence the alarm I Contact your home care provider with any questions SD Card Low Solid yellow button Operates This alarm occurs when the SD card is Full SD card full full Press the Alarm Silence Indicator or the following symbol button to silence the alarm Remove the A SD card and replace it SD Card Low Solid yellow button Operates This alarm occurs when the device Remove and Reinsert SD Card cannot read the SD card The card may Reinsert or the following symbol be inserted incorrectly Remove the SD 1 0 card and reinsert If the alert continues to occur replace the SD card or contact your home care provider SD Card Low Solid yellow button Operates This message occurs when the Prescription SD card inserted prescription is missing or incorrect Rejected prescription rejected Contact your home care provider for or the following symbol the correct prescription SD Card Info SD card inserted Operates This info message will be present for 30 Prescription prescription accepted seconds or until the user acknowledges Accepted or the following symbol it No action needed Ry SD Card Info SD card removed Operates This message occurs when the SD Removed or the following symbol card is removed from the device It is User Manual present for 30 seconds or
7. 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 merchantability 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 righ
8. Inspiratory Positive Airway Pressure when you inhale and a lower pressure known as EPAP Expiratory Positive Airway Pressure when you exhale The higher pressure makes it easier for you to inhale and the lower pressure makes it easier for you to exhale When prescribed the device can also provide features to help make your therapy more comfortable The ramp function allows you to lower the pressure when trying to fall asleep The air pressure will gradually increase until the prescription pressure is reached Additionally the Bi Flex comfort feature provides increased pressure relief during the expiratory phase of breathing Several accessories are also available for use with the device Contact your home care provider to purchase any accessories not included with your system SD Card Accessory Slot SD Card Cover Air Outlet Port Tab Power Inlet Filter Area Side Cover This figure illustrates some of the device features described in the following table Device FEATURE DESCRIPTION Air Outlet Port conical 22 mm Connect the flexible tubing here 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 he
9. LED Backlight on off 1 a Language DE FR IT ES BR 0 mS DE FR IT ES BR 0 Back lt lt Setup Screen Text Mode Setup Screen Icon Mode Note The screen will only show a few 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 Bi Flex FLEX The 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 lock or disable this feature When your provider enables Bi 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 display If the provider has locked this feature a lock symbol will display next to the setting and you will not be able to change the setting Note This same setting is also available under the Flex Rise time screen User Manual 9 e Rise time _ The Rise time comfort feature is the time it takes for the device to change from EPAP to IPAP If Rise time is prescribed for you you can adjust the Rise time from 0 to 3 to find the setting that provides you wit
10. 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 BE This feature allows you to choose which language to display on the interface when in Text mode You can choose English EN German DE French FR Spanish ES Italian IT or Brazilian Portuguese BR You can also turn off 0 text mode which means the device will display the Icon Mode on the interface Note Both Icon Mode and English Text Mode are shown throughout this guide for your reference 10 User Manual Info Screen From the Home screen highlight Info or the icon 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 Back Oximetry Status alll Device Settings Monitor Params Phone in Therapy hours Days gt 4 Large leak AHI Periodic breathing 90 EPAP Average PS Back Info Screen Text Mode Info Screen Icon Mode Note The screen will only show a few lines at a time As you rotate the wheel to toggle over different options the screen will slide up and down
11. is highlighted If you choose Back or the icon 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 Note Your device will either display in Text Mode or Icon Mode Examples will be shown in both modes Starting the Device 1 Supply power to the device 2 The Home screen will appear shown below Therapy Bi Flex Home Screen Text Mode Home Screen Icon Mode Note In Text Mode shown above will either display a blank screen or it will show Bi Flex or Rise time depending on how the provider set up the device In Mode FLEX shown above will either display blank screen or it will show FLEX depending on the provider settings Note The SD card icon will display next to Info or the 1 icon 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 me with the mask 4 Turn the wheel to toggle between the options Highlight Therapy or the 1 icon Press the wheel to turn on the airflow and begin therapy The Monitor Pressure screen will appear described in detail in the next section Note If the Auto on feature is enabled the device will automatically turn the airflow on whenever you apply the interface mask to your airway and begin to b
12. until the user acknowledges it No action is needed 15 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 apply power to the device The backlights on the buttons do not light Why IT HAPPENED There is no power at the outlet or the device is unplugged WHAT 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 supply 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 The airflow does not turn on There may be a problem with the blower Make sure the device is powered correctly Make sure Therapy or the 1 icon is highlighted when pressing the control w
13. 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 e 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 Contact your home care provider 18 User Manual Specifications Environmental Operating Temperature 5 to 35 C 41 to 95 F Storage Temperature 20 to 60 C 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 x 10 cm 7 Lx 5 5 W x 4
14. 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 AHI AHI The device accumulates individual Apnea Hypopnea indices AHI 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 CSR During any given night the device recognizes the percentage of time the patient was experiencing period 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 EPAP 90 3 During any given night the device recognizes the 90 EPAP Expiratory
15. 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 IEC 10651 6 Homecare Ventilatory Support 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 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 Minimum Alarm Sound Level 45 dB A Pressure Accuracy Pressure Increments 4 0 to 25 0 cm H O in 0 5 cm H O increments Pressure Stability Static Dynamic Dynamic lt 10 cm H O 2 10 0 to 25 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 Control Accuracy Parameter Range Accuracy Breath Rate 4 to 30 BPM greater of 1 BPM or 10 of s
16. Positive Airway Pressure achieved by the Auto Algorithm 90 EPAP 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 EPAP would be 11 cm H O This screen displays the average of these individual nightly values of 90 EPAP 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 Average PS 5 1 This screen displays the average of the Pressure Support values over 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 Device Alerts There are three types of alarms e High Priority Require immediate response by the operator e Medium Priority Require prompt response by the operator Low Priority Require operator awareness These alarms alert you to a change in the device status Additionally the device also displays informational messages and confirmation alerts that notify you of conditions that need attention but are not alarm conditions Audible and Visual Alarm Indicators When an alarm conditi
17. accordingly If the text is too long to completely fit on the screen it will scroll horizontally across the screen when highlighted e Oximetry SpO2 This screen displays the Oximetry parameters Note This option is only shown when an optional Oximetry module is attached Status This displays information sent from a peripheral SD card _ modem all etc If two peripherals are attached two lines will appear with corresponding icons Note This will not display if no peripherals are being used e Device Settings HH This screen allows you to view the current device settings Maximum pressure min EPAP max BPM PS min and PS max will display e Monitor Parameters STH This screen displays all available measured therapy parameters The following will display Estimated Patient Pressure in cm H O Leak in LPM Minute Ventilation in LPM Tidal Volume in ml Respiratory Rate in BPM and the pulse oximetry measurement if available on the device Example shown below cmH O m MinVent 4 0 6 6 Vte RR SpO 200 10 98 Note This screen will only display if the blower is on Phone in This screen displays the total therapy hours for the device the total blower hours RQ 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 gt 4 This screen also displays a compliance check number Q used by your h
18. aerophagia e Contact your health care professional if symptoms of sleep apnea recur Symbol Key The following symbols may appear on the device and power supply SYMBOL DEFINITION SYMBOL DEFINITION Consult accompanying instructions for use Use only with power supply 1058190 Separate collection for electrical and electronic For Airline Use Complies with RTCA DO 160F equipment per EC Directive 2002 96 EC section 21 category M DC Power Class Double Insulated Type BF Applied Part Drip Proof Equipment For Indoor Use Only OO GR Do not disassemble User Manual 3 System Contents Your BiPAP autoSV Advanced System One includes the following items e Device e Flexible tubing 22 mm optional 15 mm tubing is also available e User manual e Power cord and power supply Carrying case e Side cover panel Reusable gray foam filter SD card e Disposable ultra fine filter Humidifier optional Note If any of these items are missing contact your home care provider System Overview The BiPAP autoSV Advanced System One device is intended to augment your breathing by supplying pressurized air through a circuit It senses the your breathing effort by monitoring airflow in the circuit and adjusts its output to assist in inhalation and exhalation This therapy is known as Bi level ventilation Bi level ventilation provides a higher pressure known as IPAP
19. any of the accessories such as the Link Module or Modem are not installed Refer to the instructions that came with your accessory 2 User Manual 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 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 extension cords with this device Do not place the device directly onto carpet fabric or other flammable materials Do not place the device 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 e 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 using the bacteria filter the device performance may be affected However the device will remain functional and deliver therapy When DC power is ob
20. ation I E State Indication e Ramp Indication Icon Bar Therapy Parameters Note Additional icons may appear if optional accessories are being used such as the oximetry module Refer to the manual that accompanies the accessory for more information The symbols will only appear if the conditions described in the following table exist SYMBOL DESCRIPTION FLEX The Flex symbol displays only when the Bi Flex therapy feature is enabled by the provider A The Apnea Alarm symbol displays only when the Apnea alarm is enabled by the provider The Patient Disconnect symbol displays only when the Patient Disconnect alarm is enabled the provider The SD Card symbol displays when the SD card is present The Timed Breath Indication symbol displays during a machine triggered breath when the Breath Rate setting is not Off dep is displayed above the pressure setting during IPAP Inspiratory Positive Airway Pressure and E is lorE displayed during EPAP Expiratory Positive Airway Pressure The Ramp symbol displays while the Ramp function is active The bottom section of the display shows additional measured parameters which may include e Respiratory Rate RR e Tidal Volume in milliliters ml e Minute Ventilation Min Vent in liters per minute LPM e Leak in LPM Ramp Feature The device is equipped with an optional ramp feature that y
21. can view the setting but cannot change it and the screen will display a lock symbol next to the setting If your provider has disabled resistance you will not see this setting SYSTEM ONE humidification 595 System One humidity control maintains a consistent mask humidity by monitoring and adjusting for changes in room temperature and room humidity You can enable 1 or disable 0 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 Auto on 1 You can enable 1 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 0 this feature e Humidifier LED Backlight Ramp Backlight 0 You can enable 1 or disable 0 the LED backlight for the humidifier number settings and Ramp button on the device Note If the humidifier is not attached this feature will
22. e 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 User Manual 17 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 BiPAP autoSV Advanced System One 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 Contac
23. e 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 Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame e When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen Do not connect the device to an unregulated or high pressure oxygen source Do not use the device near a source of toxic or harmful vapors e 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 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 Periodically inspect electrical cords and cables for damage or signs of wear Discontinue use and replace if damaged
24. e 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 The airflow pressure feels too high or too low 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 the problem continues contact your home care provider The mask feels uncomfortable to wear there is significant air leakage around the mask or you experience other mask related issues This could be due to improper headgear adjustment or improper mask fitting Make sure you are properly fitted with the correct size mask If the problem continues contact your home care provider to be fitted with a different mask You have a runny nose 16 This may be caused by a nasal reaction to the airflow Contact your home care provider User Manual Accessories There are several accessories available for your BiPAP autoSV Advanced System One device such as a humidifier Oximetry
25. e beeps This indicator continues until the cause of the alarm is corrected or the audible alarm is silenced The alarm descriptions later in this manual display this indicator as e Medium Priority When a medium priority alarm is active a series of beeps sounds in a 3 beep pattern This pattern repeats until the cause of the alarm is corrected or the audible alarm is silenced The alarm descriptions later in this manual display this indicator as Low Priority When low priority alarm is active a series of beeps sounds 2 beep pattern This pattern repeats until the cause of the alarm is corrected or the audible alarm is silenced The alarm descriptions later in this manual display this indicator as e e Informational Messages and Confirmation Audible Indicators When an informational message appears on screen a brief 1 beep audible indicator sounds Additionally when the device detects that a certain action has been completed for example when an SD card is inserted or removed from the device a brief 1 beep audible indicator sounds The descriptions later in this manual display this indicator as Silencing an Alarm You can silence an alarm by pressing the Alarm Silence Indicator button This will silence the alarm for one minute If another alarm occurs while the silence period is active the audible alarm portion of the new alarm will not sound until the silence period expires When the silence period expi
26. etting Inspiration time 0 5 to 3 seconds 10 of setting 0 1 second Displayed Parameter Accuracy Parameter Accuracy Resolution Range Estimated Leak Rate 5 15 of reading LPM 1 LPM 0 to 200 LPM Exhaled Tidal Volume 25 15 of reading ml 1 ml 0 to 2000 ml Respiratory Rate greater of 1 BPM or 10 of reading 1 BPM 0 to 60 BPM Exhaled Minute Ventilation 1 15 of reading LPM 1 LPM 0 to 99 LPM User Manual 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 1 724 387 4000 or 49 8152 93060 You can also use the following addresses Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 Respironics Deutschland Gewerbestrasse 17 82211 Herrsching Germany 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 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
27. h the most comfort A setting of 0 is the fastest Rise time while 3 is the slowest This setting will not display if your provider has not enabled Rise time on your device If the provider has locked this feature lock symbol will display next to the setting and you will not be able to change the setting Note This same setting is also available under the Flex Rise time screen e Tubing Type AA 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 Respironics 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 Note If the provider has locked this feature this setting will not display Ramp start wa This displays the Ramp starting pressure You can increase or decrease the Ramp starting pressure from 4 cm H O to the minimum EPAP setting in 0 5 cm H O increments This will only display if your provider has enabled Ramp on your device e SYSTEM ONE resistance K lt This setting allows you to adjust the level of air pressure relief based on the specific Respironics mask Each Respironics mask may 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
28. heel 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 work when you press the Ramp button Your home care provider did not prescribe Ramp for you or your prescription pressure is already set to the minimum setting If Ramp has not been prescribed for you discuss this 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 pressure setting on the Monitor Pressure screen If it 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 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 th
29. ked 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 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 6 User Manual 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
30. module 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 e Adding a Humidifier You can use the System One 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 Note Refer to the humidifier s instructions for complete setup information e Using the SD Card The BiPAP autoSV Advanced System One comes with an SD card inserted in the SD card slot 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 in the device the SD card icon f_ will display next to Info on the Home screen and it will also displa
31. n this button allows you to activate or restart the ramp function This button lights up when therapy is active Alarm Silence Indicator Silences the audible portion of the alarm for a period of time and indicates an alarm condition Button Available Therapy Features If prescribed for you the device provides the following therapy features Bi Flex Comfort Feature If enabled the device provides a comfort feature called Bi Flex The Bi Flex attribute adjusts therapy by inserting a small amount of pressure relief during the latter stages of inspiration and during active exhalation the beginning part of exhalation Bi Flex levels of 1 2 or 3 progressively reflect increased pressure relief that will take place at the end of inspiration and at the beginning of expiration Ramp If enabled the device is equipped with a linear ramp function The Ramp feature will reduce the pressure and then gradually increase ramp the pressure to the prescription pressure setting so patients can fall asleep more comfortably Rise Time If enabled the device provides a feature called Rise Time Rise time is the amount of time it takes the device to change from the expiratory pressure setting to the inspiratory pressure setting Rise time levels of 0 1 2 or 3 progressively reflect slowed response of the pressure increase that will take place at the beginning of inspiration A setting of 0 is the fastest rise time while a setting of 3 is the slo
32. ome 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 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 Days gt 4 X gt 4 This screen displays the cumulative number of device therapy sessions that exceeded 4 hours over a 7 day and 30 day time frame User Manual 11 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
33. on occurs e The alarm LED indicator on the Alarm Silence Indicator button lights e The audible alarm sounds A message appears on the screen describing the type of alarm Alarm LED Indicators The Alarm Silence Indicator button lights up as follows whenever an alarm is detected Red Flashing Indicator High priority alarm is detected e Yellow Flashing Indicator Medium priority alarm is detected e Yellow Solid Indicator Low priority alarm is detected The Alarm Silence Indicator button does not light up when informational messages display 12 User Manual Alert Audible Indicators An audible indicator sounds whenever a power failure or a high medium or low priority alarm is detected Additionally an audible indicator sounds for informational messages and to confirm that certain actions have occurred for example when an SD card is inserted or removed from the device e Device Inoperative When a device inoperative alarm occurs a continuous audible indicator sounds The alarm descriptions later in this manual display this indicator as e Power Failure When a power failure occurs a series of beeps sounds a 1 beep pattern repeating one second on then one second off The alarm descriptions later in this manual display this indicator as e e High Priority When a high priority alarm is active a series of beeps sounds in the following pattern which is repeated twice 3 beeps a pause and then 2 mor
34. our home care provider can enable or disable 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 allowing you to fall asleep more comfortably If ramp is enabled on your device after you turn on the airflow press the RAMP 221 button on the top of the device The Ramp icon add will appear on the Monitor Pressure Screen You can use the RAMP button as often as you wish during the night Note If the Ramp feature is disabled and airflow is on nothing will happen when you press the RAMP button 8 User Manual Bi Flex Rise time Screen FLEX 0 From the Home screen highlight Rise time or the FLEX icon and press the wheel The following screen will appear Note This screen will be blank on the Home screen if your provider has not enabled Bi Flex or Rise time on your device Back Bi Flex Rise time Back Flex Screen Text Mode Flex Screen Icon Mode Bi Flex FLEX The Bi 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 lock or disable this feature When your provider enables Bi 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
35. re 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 777 ak Humidifier Icon and 3 1 Number Settings x g ae Control Wheel Push Button Alarm Silence Indicator Ramp Button Zar This figure shows the primary control buttons on the device described in the following table FEATURE DESCRIPTION Display Screen Shows therapy settings patient data and other messages The startup screen is shown temporarily when the unit is first powered Humidifier Icon and This Icon lights up when the optional humidifier is attached and heat is being applied The humidifier Number Settings 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 Turn the wheel to toggle between options on the screen Press the wheel to choose an option Button Primary function is to turn airflow on off Ramp Button When the airflow is o
36. reathe into the interface 5 Verify that the device beeps each time therapy is started If the device does not operate accordingly contact your home care provider as the alarm system may not be fully functional 6 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 7 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 8 From the Home Screen highlight Therapy or the 07 icon press hold the Wheel for approximately 2 seconds to turn off therapy Or from the Monitor Pressure screen press and hold the Wheel for approximately 2 seconds to turn off therapy and return to the Home Screen 9 Verify that the device beeps when therapy is stopped If the device does not operate accordingly contact your home care provider as the alarm system may not be fully functional User Manual 7 Monitor Pressure Screen From the Main Menu if you select Therapy and then press the Wheel the following Monitor Pressure screen appears Example shown here FLEX 2 AAA E 20 0 cmH20 The Monitor Pressure screen displays the following items e Pressure Timed Breath Indic
37. res the alarm s audible alarm is reactivated Touching the Alarm Silence Indicator button while the silence period is active will restart the silence period Alarm Message Screens When an alarm message is activated an alarm screen is displayed showing the text or icon specific to the most recent highest priority alarm Pressing the Control Wheel will reset the alarm and remove the alarm screen from the display Resetting the alarm allows you to return to the previous screen If multiple alarms occur during the same period of time the alarm screen will display the higher priority alarm higher priority alarms take precedence over lower priority alarms Alert Summary Table The following table summarizes all of the high medium and low priority alarms and informational messages VISUAL INDICATORS Device ACTION User ACTION AUDIBLE INDICATOR Loss of High Power PRIORITY Red flashing button Shuts down Remove your mask Press the Alarm Blank screen Silence Indicator button to silence the alarm Check your power connections Make sure there is power at the outlet or power source Restore power to the device If the alarm continues contact your home care provider for service Device High en Red solid button Shuts down Remove your mask Press the Alarm Inoperative Device Inoperative Silence Indicator button to silence the or the following symbol alarm Contact your home care provider for service
38. ss than or equal or the following symbol to the alarm setting Press the Alarm Silence Indicator button to silence the MinVent alarm Report the alarm to your home care provider Continue using your device Patient High c ee Red flashing button Operates This alarm occurs when the patient Disconnect Patient Disconnect circuit is disconnected or has a large or the following symbol leak Press the Alarm Silence Indicator button to silence the alarm Reconnect the patient circuit or fix the leak If the alarm continues contact your home care provider for service 14 User Manual ALARM PRIORITY AUDIBLE VISUAL INDICATORS Device ACTION User ACTION INDICATOR Low Input Medium ee Yellow flashing button Device Operates The alarm is caused when input power Voltage Low Voltage Humidifier shuts at the device either from an AC outlet or the following symbol down or battery falls below the acceptable 4 limit for 10 seconds Press the Alarm Silence Indicator button to silence the alarm If the device is plugged into a wall outlet unplug the device and then plug it back in If the alarm continues to occur contact your home care provider for service If you are using a battery replace the battery or plug the device into an AC outlet If the alarm continues contact your home care provider for service SD Card Low Solid yellow button Operates This alarm occurs when a problem Corrupted SD card corrupted
39. t your home care provider for additional information Airline Travel The device is suitable for use on airlines when the device is operating from an AC or DC power source Home Cleaning e 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 e 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 performance 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
40. tained 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 Respironics DC Power Cord and Battery Adapter Cable Use of any other system may cause damage to the device 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 Contraindications The device should not be used if you have severe respiratory failure without a spontaneous respiratory drive If any of the following conditions apply to you consult your physician before using the device e Inability to maintain an open airway or adequately clear secretions e At risk for aspiration of gastric contents e Diagnosed with acute sinusitis or otitis media Allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance e Epistaxis causing pulmonary aspiration of blood Hypotension Patient Precautions e Immediately report any unusual chest discomfort shortness of breath or severe headache If skin irritation or breakdown develops from the use of the mask refer to the mask instructions for appropriate action The following are potential side effects of noninvasive positive pressure therapy e Ear discomfort Conjunctivitis e Skin abrasions due to noninvasive interfaces e Gastric distention
41. te exhalation device such as the Whisper Swivel II Respironics 22 mm flexible tubing 1 83 m 6 ft or optional Respironics 15 mm tubing 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 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 CAUTION When using the bacteria filter 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 bloc
42. ts 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 or Deutschland Gewerbestrasse 17 82211 Herrsching Germany 49 8152 93060 PHILIPS Respironics Inc Respironics Deutschland REF 1070826 1001 Murry Ridge Lane Gewerbestrasse 17 ee Murrysville PA 15668 USA 82211 Herrsching Germany 0123 JR 10 15 2010 REP EN INTL
43. west Providers should adjust the rise time to find the most comfortable setting for the patient Rise time cannot be adjusted when Bi Flex is enabled User Manual 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 an optional 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 reusable gray foam filter and the optional disposable ultra fine filter is supplied with the device 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 using 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 Respironics interface nasal mask or full face mask with integrated exhalation port or entrainment valve or Respironics interface with a separa
44. with higher numbers providing additional relief If the provider has disabled this feature this setting will not display If the provider has locked this feature a lock symbol will display next to the setting and you will not be able to change the setting Note This same setting is also available under the Setup screen Rise time _4 The Rise time comfort feature is the time it takes for the device to change from EPAP to IPAP If Rise time is prescribed for you you can adjust the Rise time from 0 to 3 to find the setting that provides you with the most comfort A setting of 0 is the fastest Rise time while 3 is the slowest This setting will not display if your provider has not enabled Rise time on your device If the provider has locked this feature a lock symbol will display next to the setting and you will not be able to change the setting Note This same setting is also available under the Setup screen Setup Screen From the Home screen highlight Setup or the icon and press the wheel The following Setup screen will appear The user can change settings in the Setup menu Back Bi Flex 1 23 FLEX 12 3 Rise time 012 3 L 01 2 3 Tubing Type 15 22 AJ 15 22 Ramp start 4 EPAP Min 4 SYSTEM ONE resistance 0 X1 X2 X X4 X5 Ke X1 X2 X3 X4 X5 SYSTEM ONE humidification on off Ke l 0 Humidifier 012345 wu 01 2 3 4 5 Auto on on off 1 1 0 Humidifier
45. y 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 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 setup 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 Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen Do not connect the device to an unregulated or high pressure oxygen source e Supplying DC Power to the Devic
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