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1. BiPAP AVAPS user manual 31 Silencing an Alarm You can silence an alarm by pressing the Alarm Silence Indicator button This will silence the alarm for one minute An icon will appear on the screen when the alarm is silenced WA 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 expires 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 Note Pressing the Control Wheel resets all alarms Note If the alarm pop up is present you cannot see the Monitor Pressure screen Chapter 3 Device Alarms 32 Alarm Summary Table The following table summarizes all of the high medium and low priority alarms and informational messages Audible Indicator Priority High Ventilator Inoperative Low Pre
2. PHILIPS S SJHMERICA S ALTHCARE AT HOME Respironics Inc 800 545 6026 1001 Murry Ridge Lane ig dense Murrysville PA 15668 USA PHILIPS gal 1105957 R01 M JJB 01 01 2013 BIPAP AVAPS USER MANUAL RESPIRONICS BiPAP AVAPS user manual Table of Contents Chapter 1T Iftroductio na susan ren een 1 Package Cote ES EET ene 1 intended USE casi rare Eee a R E AET 2 Warnings and CALTON asane hunian nia E N a ai 2 AETATIS Sas E A E E EE EEA 2 CAU ONS ei a RE E ENE E T A a NE a e AET aias 5 NOTES 35k airaa Eara ISa a IEI aaia aaas 6 GOMTPAIMGIGATIOMS ERE TE AEA AE O E E EE O OT 6 Patient Preca O ss ae a aaa a N E ER 7 System Overview sagaer RoN DEAA RE REOR ai 7 Control BUTTONS assucaire AE ARA Available Therapy Modes Available Therapy Features How to Contact Philips Respironics Chapter 2 Device Setup Installing the Air Filter Where to Place the Device srssssasinsionsonionscnninenii in india Hann nunnana 15 Connecting the Breathing Circuit sssssssssssssssssessessssssesssssesseseesnssssusenoesossnssssnnstnotnosensnsssnstnetnnesnssssssstnetst 16 Supplying AC Power to the DEVICE eesssscsssscsssscssecsseecessessusecssecessscesseeesseecsutsenseecescesaseessnecesneesasecessees 17 Display SymBOl Sirin o aa aa O E NEN 18 2013 Koninklijke Philips Electronics N V All rights reserved Table of Contents Navigating the Device Screens 45 anois 21 Starting and Stopping th
3. Icon Bar e Measured Parameters Note The Ramp symbol will also appear on the display if Ramp is active Note If an accessory is attached to the therapy device additional symbols may appear on the Monitor Pressure screen Refer to the instructions provided with the accessory for more information BiPAP AVAPS user manual 23 The top of the display shows a group of status symbols The symbols will only appear if the conditions described in the following table exist Symbol Description S The Provider Access symbol indicates the device is in Provider mode AVAPS The AVAPS symbol displays only when the AVAPS therapy feature is enabled by the provider FLEX The Flex symbol displays only when the Bi Flex therapy feature is enabled by the provider 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 by the provider 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 Leakin Ipm Note The measured parameters display one at a time on screen Changing the Comfort Settings Your device is equipped with optional Flex Ramp Time and Rise Time features that your health care professional may prescribe for you From the Main Menu when you highlight the
4. IEC 60601 1 2 Medical Electrical Equipment Part 1 2 General Requirements for Basic Safety and Essential Performance Collateral standard Electromagnetic compatibility Requirements and tests IEC 60601 1 8 Medical Electrical Equipment Part 1 8 General Requirements for Basic Safety and Essential Performance Collateral standard General Requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 11 Medical Electrical Equipment Part 1 11 General Requirements for Basic Safety and Essential Performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10651 6 Lung Ventilators for Medical Use Particular Requirements for Basic Safety and Essential Performance Part 6 Home care ventilatory support devices RTCA DO 160F Section 21 Category M Emission of Radio Frequency Energy Chapter 6 Specifications 46 Electrical AC Power Consumption with 60W power supply AC Power Consumption with 80W power supply DC Power Consumption Fuses Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Ingress Protection Device Drip Proof Device and AC power supply Mode of Operation Pressure Pressure Increments Flex Therapy Feature Control Accuracy Parameter Range 100 to 240 VAC 50 60 Hz 2 1 A 1
5. If the alarm continues contact your home care provider for service Chapter 3 Device Alarms 34 Alarm Priority Audible Indicator Low Input Voltage SD Card Corrupted BiPAP AVAPS user manual i il Device Action Visual Indicators Ventilator Operates A Humidifier shuts down Low Voltage Yellow flashing button or if Icon option is selected Ay Solid yellow button A SD card corrupted Operates or if Icon option is selected ANE Solid yellow button Operates SD card full or if Icon option is selected Ad User Action The alarm is caused when input power at the device either from an AC outlet or battery falls below the acceptable 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 This alarm occurs when a problem exists with the SD card The data may be corrupted Press the Alarm Silence Indicator button to silence the alarm Contact your home care provider with any questions This alarm occurs when the SD card is full Press the Alarm Silence Indicator button to silence the alarm
6. Remove the SD card and replace it Audible Indicator Alarm Priority SD Card Remove and Reinsert Low SD Card Prescription Accepted SD Card Prescription Rejected SD Card Inserted SD Card Removed Visual Indicators Reinsert SD Card or if Icon option is selected NER SD card inserted prescription accepted or if Icon option is selected i mn SD card inserted prescription rejected or if Icon option is selected X SD card inserted or if Icon option is selected SD card removed or if Icon option is selected O Device Action User Action This alarm occurs when the device cannot read the SD card The card may be inserted incorrectly Remove the SD card and reinsert If the alert continues to occur replace the SD card or contact your home care provider This info message will be present for 30 seconds or until the user acknowledges it No action needed This message occurs when the prescription is missing or incorrect It is present for 30 seconds or until the user acknowledges it Contact your home care provider for the correct prescription This message occurs when the SD card is inserted into the device It is present for 30 seconds or until the user acknowledges No action is needed This message occurs when the SD card is removed from the device It is present for 30 seconds or until the user ackn
7. disable 0 this feature Ifthe 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 Note The System One Humidification option is only available ifthe Heated Tubing is removed or has been disabled Humidifier This setting allows you to view and choose the desired humidity setting This will only display if the humidifier is attached Please refer to the humidifier manual if using a humidifier Note The Humidifier option is only available if the Heated Tubing is removed or has been disabled Tubing Type Setting This setting allows you to select the correct size diameter tubing that you are using with the device You can choose either 22 for the Philips Respironics 22 mm tubing or 15 for the optional Philips Respironics 15 mm tubing When using Heated Tubing the device will automatically change this setting to the appropriate tubing type 15H and you will not be able to change it Note If the Heated Tubing is removed the device will default back to the previous tubing type setting 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 selection SYSTEM ONE Resistance This setting allows you to adjust the level of air pressure relief based on th
8. occur contact your home care provider Tubing may be overheating or malfunctioning Alert is present for 30 seconds or until the condition is fixed Turn off airflow and reconnect the heated tubing to the humidifier according to the humidifier instructions If the alert continues to occur contact your home care provider Alert is present for 12 minutes or until the condition is fixed Turn off airflow and reconnect the humidifier to the device according to the humidifier instructions If the alert continues to occur contact your home care provider Troubleshooting 37 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 backlight on the buttons does not light The airflow does not turn on The device display is erratic Why It Happened There is no power at the outlet or the device is unplugged There may be a problem with the blower The device has been dropped or mishandled or the device is in an area with high Electromagnetic Interference EMI emissions 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
9. Battery Adapter Cable when used with the Shielded DC Cord enables the device to be operated from a 12 VDC free standing battery Refer to the instructions supplied with the Shielded DC Cord and adapter cable for information on how to operate the device using DC power Caution When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running The device may not work properly ifconnected while the vehicle s engine is running Caution Only use a Philips Respironics Shielded DC Cord and Battery Adapter Cable Use of any other system may cause damage to the device or vehicle Carrying Case When traveling the carrying case is for carry on luggage only The carrying case will not protect this 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 It may be helpful to bring this manual along with you to help security per sonnel understand the BiPAP AVAPS 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 adapter 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 Note If you are using a humidifier with the device the humidifier should be emptied before
10. Humidifier with or without Heated Tubing SD Cardiidae naa RE R E R a 41 Supplemental Oxygen secssssessccsssccssseecsnsssccssseecsnseecessseccsnscecsnseceessseecsnseecesuscecsnseecsnsnecessneecanseesensneeesneesed 41 ShieldedD Es E E E de EE E sed EEN EDEN rel ane 42 CATS ING Case aenneren a aa ra anaa Eaa E aaiae aaa A EE 42 PAULING TA V Cll sce sveveeatssncedecrecas dress zectes cenasstvecncsssnssvscesasasrostvestesssayestiareesssstoessaneadsctrssvirsessasvusse iecarerreetseriad 42 Chapters Cleaning the Devices issssssssscasssacsssssaqoscttcsnsssazsusedssadeatensceayessossbesansyeesaqoisbansnseesqpiseaconsssaqoeetiavad saes 43 Cleaning or Replacing the Filters cssssssscssinsssscscdnseetanaaniaartainiansacnainiaaaanmvie 43 Cleaning CMS TU DUNG AEE E E ences EE 44 SENICE rager E a N A E NN 44 Chapter 6 Specifications sidan sner deg EET EN ENE andn saaa Elba saini bedaa prada Vatis Chapter 7 EMC Information Limited Wanra Ny oser ns EEN EEN ERS BiPAP AVAPS user manual BiPAP AVAPS user manual 1 Introduction This chapter provides an overview of the device Package Contents The BiPAP AVAPS system may include the following components Some components e g humidifier are optional accessories that may not be packaged with the device Reusable Gray Foam Filter Power Cord O A A Secure Digital SD Card Package Contents User and Provider Manuals Flexible Tub
11. Ramp keys simultaneously for two seconds e From the Information screen select the Monitor Parameters setting The parameters displayed in this screen are described in the following table A sample screen is cmH O K MinVent 4 0 6 6 shown below Vte 200 Press the Wheel to exit the Monitor Parameters screen and return to the previous screen Note The information displayed in the last box shown on the sample screen will vary depending on what accessory is attached to the therapy device This box will be empty as shown here if no accessory is attached Please refer to the instructions included with your accessory for more information Viewing Measured Parameters Several measured parameters can be viewed on screen The following table describes each measured parameter The measured parameters that display on the Monitor Pressure screen only appear one at a time The Setup Parameter Display setting on the Setup screen allows you to choose which measured parameters you want displayed The parameters below appear on both the Monitor Pressure and Monitor Parameters screens Parameter Description Displays the current patient pressure The estimated leak is the average leak value for the last 6 breaths The display is updated at the end of each breath Respiratory Rate RR This is the average of the previous 6 breaths If the mode supports machine triggered breaths this display will be the total breathing rate spontaneous
12. device is contraindicated on patients without a spontaneous respiratory drive If any of the following conditions apply to you consult your physician before using the device Inability to maintain a patent airway or adequately clear secretions At risk for aspiration of gastric contents 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 Epistaxis causing pulmonary aspiration of blood Hypotension When assessing the relative risks and benefits of using this equipment the health care professional should understand that this device can deliver the pressure ranges indicated in the Control Accuracy table in chapter 6 In the event of certain fault conditions a maximum pressure of 40 cm H O is possible BiPAP AVAPS user manual 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 Ear discomfort Conjunctivitis Skin abrasions due to noninvasive interfaces Gastric distention aerophagia System Overview The BiPAP AVAPS device is intended to augment patient breathing by supplying pressurized air through a patient circuit It senses the
13. in the setup menu 0 1 2 3 4 or 5 will now take effect Viewing the Information Screen From the Main Menu when you highlight the Info option and press the Wheel the Information screen below appears You cannot change settings on the Information screen Back Monitor Parameters Therapy Hours 890 1 Blower Hours 890 1 Machine Hours 902 0 Icon View Text View Note The Information screen is only for reference Your home care provider may periodically ask you for this information Note If an accessory is attached to the therapy device additional items may appear on the Information screen Refer to the instructions provided with the accessory for more information The following items appear on the Information screen e Monitor Parameters Displays the available parameters Therapy Hours The device displays the total number of hours that the blower has been on and patient breathing has been detected e Blower Hours Displays the total number of hours that the blower has been on It can be reset by your home care provider This setting allows the provider to track device usage between patients e Machine Hours Displays the total number of hours that the blower has been on This cannot be reset by the home care provider Chapter 2 Device Setup 28 Viewing the Monitor Parameters Screen There are two ways to access the Monitor Parameters screen From the Monitor Pressure screen press the Alarm Silence and
14. 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 adapter 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 or D 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 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 Ifthe problem still occurs contact your home care provider for assistance Chapter 3 Device Alarms 38 Problem The Device will not turn off The Ramp feature does not work when you press the Ramp button The airflow is much warmer than usual The airflow pressure feels too high or too low Why It Happened The correct blower off sequence was n
15. mode lt 5 UL gt 95 dip in U_ for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U 795 dip in U_ for 5 sec Compliance Level V contact V for supply mains V for input output lines V differential mode V for common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U_ for 25 cycles lt 5 U 795 dip in U_ for 5 sec NOTE U is the a c mains voltage prior to application of the test level BiPAP AVAPS user manual Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment 51 Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic env
16. operation of the Patient Disconnect alarm with any changes in the patient circuit When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen 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 When using oxygen with this system a Philips Respironics Pressure Valve REF 302418 must be placed at the air outlet port Failure to use the pressure valve could result in a fire hazard Refer to the pressure valve instructions for use for proper use Supplemental oxygen cannot be used with the heated tube accessory The safety pressure valve is not compatible with this set up and could result in a fire hazard If administering fixed flow supplemental oxygen the oxygen concentration may not be constant The inspired oxygen concentration will vary depending on the pressure setting patient breathing pattern and leak rate Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations Appropriate patient monitoring should be implemented in the presence of an open fla
17. service Low Minute Ventilation Low Tidal Volume Patient Disconnect Priority High Audible Indicator Visual Indicators Device Action Red flashing button Operates Apnea or if Icon option is selected Red flashing button Operates Low Minute Vent or if Icon option is selected Aa MinVent Red flashing button Operates Low Tidal Volume or if Icon option is selected AN Vee Red flashing button Operates Patient Disconnect or if Icon option is selected 33 User Action This alarm is generated when an apnea event occurs during therapy Press the Alarm Silence Indicator button to silence the alarm Report the alarm to your home care provider Continue using your device This alarm occurs when the calculated minute ventilation is less than or equal to the alarm setting Press the Alarm Silence Indicator button to silence the alarm Report the alarm to your home care provider Continue using your device Only enabled if AVAPS therapy feature is enabled This alarm occurs when the device is unable to reach the target tidal volume setting Press the Alarm Silence Indicator button to silence the alarm Report the alarm to your home care provider Continue using your device This alarm occurs when the patient circuit is disconnected or has a large leak Press the Alarm Silence Indicator button to silence the alarm Reconnect the patient circuit or fix the leak
18. the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people BiPAP AVAPS user manual BiPAP AVAPS 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 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 w
19. the same time only the highest priority alarm will be active The precedence is in the following order high priority medium priority then low priority When multiple priority alarms are active the highest priority LED light displays and the highest priority audible indicator sounds On the display screen the last highest priority alarm displays Note Informational messages are a lower precedence than alarms and will not display on the screen if any alarm is active Chapter 3 Device Alarms 30 Alarm LED Indicators The Alarm Silence Indicator button lights up as follows whenever an alarm is detected e Red Flashing Indicator High priority alarm is detected Yellow Flashing Indicator Medium priority alarm is detected Yellow Solid Indicator Low priority alarm is detected The Alarm Silence Indicator button does not light up when informational messages display 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 Ventilator Inoperative When a ventilator inoperative alarm occurs a continuous audible indicator sounds The alarm descriptions later in this chapter display this indicator as Power Failure When a power failure occurs a series of beeps s
20. 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 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 will not be provided through the mask and exhaled air may be rebreathed BiPAP AVAPS user manual Patient In the event of a power or device failure audible and visual alarm signals will Circuits activate The device must be disconnected from the patient immediately As is the case with most ventilators with passive exhalation ports when power is lost sufficient air will not be provided through the circuit and exhaled air may be rebreathed At low EPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing Some rebreathing may occur The device does not have an alarm to detect occlusion of the exhalation port Before each use inspect the patient circuit to verify that the port is not occluded Occlusion or partial occlusion can reduce airflow and result in rebreathing of exhaled air Verify the
21. traveling Airline Travel The device is suitable for use on airlines when it is operating from an AC or DC power source Note The device is not suitable for airline use with any modems or humidifiers installed BiPAP AVAPS user manual BiPAP AVAPS user manual 5 Cleaning the Device Follow the instructions below to clean the device If you are using the device on multiple users complete the following steps before each new user Warning Ifyou are using the device on multiple users discard and replace the bacteria filter each time the device is used on a different person 1 Unplug the device before cleaning 2 Clean the outside of the device only Use a cloth with one of the following cleaning agents to clean the exterior of the device e Mild detergent e 70 Isopropyl Alcohol DisCide Towelettes e 10 Chlorine bleach solution 3 Allow the device to dry completely before plugging in the power cord 4 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 1 If the device is operating stop the airflow Disconnect the device from the power source 2 Remove the filter from the enclosure by gently squeezing the filter in the center and pulling it away from the device 3 Examine the filter for cleanli
22. 00 to 240 VAC 50 60 Hz 2 0 A 12 VDC 5 0 6 67 A There are no user replaceable fuses Class Il Type BF Applied Part IP22 Continuous 4 0 to 30 0 cm H O in 1 0 cm H O increments Off 1 2 3 Accuracy IPAP 4 30 cm H O 2 5 cm H O EPAP 4 30cmH O 2 5 cm H O CPAP 4 20 cm H O 2 5 cm H O 0 to 30 BPM greater of 1 BPM or 10 of setting 0 5 to 3 seconds 10 of setting 0 1 second Pressure measured at the patient connection port with or without the humidifier no patient flow with Whisper Swivel II BiPAP AVAPS user manual 47 Displayed Parameter Accuracy Parameter Accuracy Resolution Range Estimated Leak Rate 5 15 of reading LPM 1LPM 0 to 200 LPM Exhaled Tidal Volume 25 15 of reading 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 Spontaneous Breathing During Power Failure Conditions Patient Flow LPM Expiratory Resistance cm ae Inspiratory Resistance cm HO Passive Circuit Passive Circuit 30 lt 1 0 lt 1 0 60 lt 2 8 lt 2 8 Noise Minimum Alarm Sound Level 45 dB A Disposal Dispose of the device in accordance with local regulations Chapter 6 Specifications 48 BiPAP AVAPS user manual BiPAP AVAPS user manual 7 EMC Information Guidance and Manufacturer s Declaration Electromagnetic Emissions This device i
23. Comfort option and press the Wheel the Comfort Settings screen below appears gt Back Bi Flex 2 Ramp time 10 Ramp start 4cm H20 Rise time 83 2 10 4 cm H20 83 4 Comfort Icon View Text View Note If no comfort settings are available the Comfort Settings screen displays No Settings Available Note If your home care provider has locked a comfort setting a lock symbol fg appears next to the value You cannot adjust any settings that are locked Chapter 2 Device Setup 24 Flex Setting The Flex comfort setting allows you to adjust the level of pressure relief that you feel during therapy Your home care provider can enable lock 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 from 1 to 3 A setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief Ramp Time Setting This enables you to modify the Ramp time setting in 5 minute increments The range for this setting is 0 to 45 minutes Ramp Start Setting 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 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 Note
24. Ifthe ramp feature is disabled nothing will happen when you press the Ramp button If ramp is enabled on your device after you turn on the airflow you can press the Ramp button on the top of the device Use the Ramp button as often as you like during the night When Ramp is enabled the Ramp icon f appears on the Monitor Pressure screen The Ramp Start pressure setting can be increased or decreased from 4 in increments of 1 to the CPAP setting if in CPAP therapy mode or the EPAP setting for all other therapy modes Rise Time Setting Rise time 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 1 to 6 to find the setting that provides you with the most comfort A setting of 1 is the fastest rise time while 6 is the slowest Note If Flex is enabled the rise time setting will be fixed at 3 Language This feature allows you to choose which language to display on the interface when in Text mode 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 BiPAP AVAPS user manual 25 Setup Screen me From the Main Menu highlight Setup or the m icon and press the wheel The following Setup screen will appear The user can change settings in the Setup menu Back Heated Tube H
25. 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 ventilator 4 Ensure that all connections are secure Important To remove AC power disconnect the power supply cord from the electrical outlet Note See Chapter 4 for instructions on using DC Power Chapter 2 Device Setup Display Symbols The following symbols may display on the device in place of text if the display language selected by your home care provider is Icon Symbol Description Dow DX Alarm Silence Zie a a AVAPS therapy feature HE fake FLEX FLEXa eg foe TT Clear Patient Data in progress BAX Clear Patient Data Failed HES Clear Patient Data Successfully hf _ Humidifier Humidity Level DAA IPAP Z PAP Language EE BiPAP AVAPS user manual m Symbol Description lt Leak K o ee Min Vent No Settings Available O a Patient Disconnect Ramp Start Pressure M D A 0 Reinsert SD Card Reset Therapy Hours D E S VA rap Kol Reset Blower Hours I Chapter 2 Device Setup ro 20 Symbol Description O M SD Card Inserted Writing in Progress SD Card Inserted Writing Successful ig eS al SD Card Inserted Prescription Accepted SD Card Inserted Prescription Rejected A Pe fr Set Parameter Sree E p One e a AA ONE System One Resistance K 2 System One Resistance Lock lt a Pomorie
26. arranty is non transferable by unauthorized distributers of Respironics Inc products and reserves the right to charge dealers for warranty service of failed product not purchased directly from Respironics or authorized distributers 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 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 Limited Warranty 54 BiPAP AVAPS user manual
27. breaths machine breaths The display is updated at the end of each breath Minute Ventilation The estimated Exhaled Minute Ventilation is based on the average of the last 6 MinVent breaths The display is updated at the end of each breath Exhaled Tidal The estimated Exhaled Tidal Volume is obtained by the integration of patient flow Volume Vte The display is updated at the end of each breath Note If an accessory is attached to the therapy device additional parameters may appear on screen Please refer to the instructions included with your accessory for more information BiPAP AVAPS user manual BiPAP AVAPS user manual 3 Device Alarms This chapter describes the ventilator alarms and what you should do if an alarm occurs There are three types of alarms High Priority Require immediate response by the operator e Medium Priority Require prompt response by the operator e Low Priority Require operator awareness These alarms alert you to a change in the ventilator status Additionally the ventilator 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 condition occurs The alarm LED indicator on the Alarm Silence Indicator button lights The audible alarm sounds e A message appears on the screen describing the type of alarm Note If multiple alarms occur at
28. ched and the target tidal volume is not achieved the Low Tidal Volume alarm activates Bi Flex Comfort Feature If enabled the device provides a comfort feature called Bi Flex in S mode only 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 Chapter 1 Introduction 12 Rise Time If enabled the device provides a feature called Rise Time in S S T T and PC modes 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 1 2 3 4 5 or 6 progressively reflect slowed response of the pressure increase that will take place at the beginning of inspiration A setting of 1 is the fastest rise time while a setting of 6 is the slowest 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 Symbols The following symbols ap
29. d TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m Chapter 7 EMC Information 52 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Rated Maximum Power Separation Distance According to Frequency of Transmitter Output of Transmitter m w 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 24P d 1 2 P d 2 3P 2 2 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using
30. e Device wn csssescccsseccsnseecssssccsseecsnsescessececsnseecsnsnscenseeecsnseecenaecesneees 21 Monitor Pressure Screens isse aa i 22 Changing the Comfort SettingS ssesccsssssccssssecsnssccsseecsnseecsssecssnseecsnsseccsneecsnseesesseccsnseessneeeeees 23 SOE US CHEE IM ssssicsscvscevsciscosstusscsccecdestecsesctesssstasvtatesseosteaveaveayusiveassesecossvacuves ders eui cua iaeeuasTassbavtossasiesiaaveeess 25 Viewing the Information Screen asussa neisiet 27 Viewing the Monitor Parameter Screen seessssssscsssseccssesccsseecsssessssseeesuseeecsssessnsnessuneessnseeeesuees 28 Viewing Measured Parameters Chapter 3 Device Alar MS pass ai rdl saadanne Audible and Visual Alarm Indicators sssssssssecsssecssessssccssssccsseesssessnsccsnscessesessecessesesececsseecsncessneeesneeess 29 Alarm LED Indicators oiin Anunua nin n a aad 30 Alert Audible INdiCators seesssesssssscsseesssscsssccssscesseesssecssscceseecsssecssseessscesnscesuceesueeesssessseeesseessnsessaes 30 SUPE TAGLINE an Al nassaan A 31 Alarm Message Screens wiisissnissscsacscsuscssssadsasedasscesnavasssacscoeasvanecaatuassscoasavasaaassshaatessaadzseaasstnuadvvnnaadeetes 31 Alarm Summary Table uu sssssssssssecsssescesseecsnseecesseccsnseecsnsseccssseessnseecssusecssnseessnssecssnencsnseecesseeccunseessnasesses 32 THOUDIOSMOOEIING e E E E O EE E E E Chapter 4 ACCESSONIOS siiscscisscaceusigacessiizdesinesguesdessnaistt deers aae iaae uss EEE E EEA iN Adding a
31. e 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 a next to the setting If your provider has disabled resistance you will not see this setting Backlight You can enable or disable the button LED backlight on the device hPa cmH O You can select either hPa or cmH O as the default unit of measure on the device BiPAP AVAPS user manual 27 Humidifier Preheat When using a humidifier the device can preheat the water tank for up to 30 minutes prior to starting therapy In order to activate the preheat mode the blower must be off and a humidifier must be attached From the device Home screen highlight Therapy or the icon then press and hold down the control wheel for 5 seconds You will hear a single beep and the device will now be in preheat mode The humidifier icon 244 will illuminate during this time During the 30 minute preheat you will still be able to use the control wheel to select other menu options from the Home screen If you press the wheel while Therapy or the O icon is highlighted on the Home screen preheat mode will end and the blower will turn on to begin therapy The humidifier number selected
32. ensation Condensation may damage the device If the 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 chapter Chapter 1 Introduction Extension Do not use extension cords with this device Cords Device 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 Operating the device with a dirty filter may keep the system from working properly and may damage the device A dirty inlet filter may cause high operating temperatures that may affect device performance Regularly examine the inlet filter as needed for integrity and cleanliness Placement Do not place the device directly onto carpet fabric or other flammable materials Do not plug the device into an outlet controlled by a wall switch Never install a wet filter into the device You must ensure sufficient drying time for the cleaned filter Cleaning Do not immerse the device in liquid or allow any liquid to enter the enclosure or inlet filter Notes Additional warnings cautions and notes are located throughout this manual Please see the Limited Warranty section of this manual for information on warranty coverage Contraindications The
33. he device is operating One reusable gray foam filter is supplied with your device If your filter is not already installed when you receive the device you must install it before using the device To install the gray foam filter insert it into the filter area Where to Place the Device Place the device upright 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 or air conditioners Chapter 2 Device Setup 16 Connecting the Breathing Circuit To use the system you will need the following accessories in order to assemble the recommended circuit Philips Respironics interface nasal mask or full face mask with integrated exhalation port or Philips Respironics interface with a separate exhalation device such as the Whisper Swivel II Philips Respironics 1 83 m 6 ft 22 mm flexible tubing or the optional 15 mm flexible tubing Philips Respironics headgear for the mask Complete the following steps to connect your breathing circuit to the device 1 Connect the flexible tubing to the air outlet on the side of the device Note If required connect a bacteria filter to the device air o
34. ing 1 8 m x 22 mm optional 15 mm tubing is also available Chapter 1 Introduction Intended Use The BiPAP AVAPS device is intended to provide non invasive ventilatory support to treat adult patients weighing over 66 Ibs 30 kg and pediatric patients 7 years or older and weighing over 40 Ibs 18 kg with Obstructive Sleep Apnea OSA and Respiratory Insufficiency This device may be used in the hospital or home Warnings and Cautions Caution US federal law restricts this device to sale by or on the order of a physician A Warnings A warning indicates the possibility of injury to the user or operator Device Usage This device is not intended for life support The device provides Positive Pressure Ventilation and is indicated for assisted ventilation The device does not provide ventilation with guaranteed V delivery Patients requiring ventilation at a predetermined V are not candidates for Pressure Support ventilation Personnel This manual serves as a reference The instructions in this manual are not Qualifications intended to supersede your health care professional s instructions regarding the use of the device The prescription and other device settings should only be changed on the order of the supervising physician The operator should read and understand this entire manual before using the device Patient The device should be used only with masks and connectors recommended Circuits by Philips Respironics or with
35. ironment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 P IEC 61000 4 6 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz Radiated RF 3 V m d 23P 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts VV according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast an
36. led PC mode is similar to S T mode except that all breaths are machine cycled This is a pressure limited machine or patient triggered time cycled mode Therefore the inspiratory time may be triggered by the patient or by the device but IPAP will be pressure limited with a set cycle time determined by the Inspiratory Time setting BiPAP AVAPS user manual 11 Available Therapy Features If prescribed for you the device provides the following therapy features AVAPS If enabled Average Volume Assured Pressure Support AVAPS is a feature available in the S S T PC and T modes It helps patients maintain a tidal volume V equal to or greater than the target tidal volume Tidal Volume setting in the AVAPS by automatically controlling the pressure support PS provided to the patient The AVAPS feature adjusts PS by varying the IPAP level between the minimum IPAP Min and maximum IPAP Max settings AVAPS averages V and changes the PS value gradually This occurs over several minutes The rate of change is slow so that the patient is not aware of breath to breath pressure changes As patient effort decreases AVAPS automatically increases PS to maintain the target tidal volume The IPAP level will not rise above IPAP Max even if the target tidal volume is not reached Conversely as patient effort increases AVAPS will reduce PS IPAP will not fall below IPAP Min even if the target tidal volume is exceeded If IPAP Max is rea
37. me Chapter 1 Introduction Operating Do not use this device if the room temperature is warmer than 95 F 35 C If Temperatures the device is used at room temperatures warmer than 95 F the temperature of the airflow may exceed 109 F 43 C 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 Bacteria Filter If the device is used by multiple persons such as rental devices Philips Respironics recommends that a low resistance main flow bacteria filter Part Number 342077 be installed in line between the device and the circuit tubing to prevent device contamination Improperly If you notice any unexplained changes in the performance of the device if it Functioning is making unusual sounds if it has been dropped or mishandled if water is Ventilator spilled into the enclosure or if the enclosure is cracked or broken disconnect the power cord and discontinue use Contact your home care provider The use of accessories transducers and cables other than those specified with the exception of transducers and cables sold by Philips Respironics as replacement parts for internal components may result in increased Emissions or decreased Immunity This device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use i
38. mmerse the device in any fluids or spray the device with water or cleaners Clean the device with a cloth dampened with an approved cleaner 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 A Cautions A caution indicates the possibility of damage to the device Electrostatic Pins of connectors should not be touched Connections should not be Discharge made to these connectors unless ESD precautionary procedures are ESD 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 any of the accessories such as the Link Module or modem are not installed Refer to the instructions that came with your accessory Do not use antistatic or conductive hoses or conductive patient tubing with the device EMC All Medical Electrical Equipment needs special precautions regarding Information EMC and needs to be installed and put into service according to the EMC information provided in Chapter 7 EMC Information Cond
39. ness and integrity Chapter 5 Cleaning the Device 44 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 Philips Respironics supplied filters should be used as replacement filters 5 Reinstall the filter Cleaning the Tubing Clean the flexible tubing before first use and daily Disconnect the flexible tubing from the device For the 15 or 22 mm flexible tubing gently wash the tubing in a solution of warm water and a mild detergent Rinse thoroughly Air dry Note Refer to the humidifier manual for the instructions on how to clean the heated tube Service The device does not require routine servicing BiPAP AVAPS user manual BiPAP AVAPS user manual 6 Specifications Environmental Operating Storage Temperature 41 F to 95 F 5 C to 35 C 4 F to 140 F 20 C to 60 C Relative Humidity 15 to 95 non condensing 15 to 95 non condensing Atmospheric 101 kPa to 77 kPa N A Pressure 0 7500 ft 0 2286 m Physical Dimensions 7 Lx5 5 W x 4 H 18cmx 14 cm x 10 cm Weight Approximately 3 Ibs 1 36 kg Standards Compliance This device is designed to conform to the following standards IEC 60601 1 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance
40. ntaneous Pressure Support A Bi level therapy mode where breaths are patient triggered and patient cycled The device triggers to IPAP Inspiratory Positive Airway Pressure in response to spontaneous inspiratory effort and cycles to EPAP Expiratory Positive Airway Pressure during exhalation The device also cycles a patient triggered breath if no patient exhalation effort is detected for 3 seconds The level of Pressure Support delivered is determined by the difference between the IPAP and EPAP settings PS IPAP EPAP S T Spontaneous Timed Pressure Support A Bi level therapy mode where each breath is patient triggered and patient cycled or machine triggered and machine cycled S T mode is similar to S mode except that the device also triggers machine triggered breaths based on a set breath rate and cycles machine cycled breaths based on a set inspiratory time if the patient does not spontaneously breathe within a set time PC Timed Pressure Support A Bi level therapy mode where breaths are machine triggered and machine cycled T mode provides mandatory pressure assist with bi level pressures The patient s breathing rate has no effect on the machine rate or pressure levels The trigger to IPAP is determined by the breath rate setting and the cycle time is determined by the inspiratory time setting Pressure Control Pressure Support A Bi level therapy mode where each breath is patient or machine triggered and machine cyc
41. o Therapy Blower Off Therapy Blower On Therapy Hours Timed Timed Inspiration ER a ae O Ni O AW Tubing Type Tubing Type Lock Pe Tube Temperature Yes Selection Confirmed BiPAP AVAPS user manual 21 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 or the lt 4 icon on any screen it will take you back to the previous screen Note The screens shown in this manual are examples only Information on your device screens may be different depending on your prescription settings Note Your device will either display in icon mode or text mode Examples will be shown in both modes Starting and Stopping the Device 1 Supply power to the device The first screen to display will be the Philips Respironics logo followed by the screen showing the current software version number The Blower hours screen BD in icon mode will then appear which shows the total blower hours for the device in hours and minutes 2 The Main Menu screen appears shown below ai i Ko Icon View Blower Off Text View Icon View Blower On 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 or the D icon Press the Wheel to turn
42. on the airflow and begin therapy The Monitor Pressure screen will appear described in detail in the next section 5 Verify that the device beeps and the alarm and ramp LEDs light up 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 leak is normal and acceptable Correct large mask leaks or eye irritation from an air leak as soon as possible Chapter 2 Device Setup 22 7 Ifyou 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 Press and hold the Wheel for approximately 2 seconds to turn off therapy and return to the Main Menu 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 Monitor Pressure Screen From the Main Menu if you select Therapy and then press the Wheel the following Monitor Pressure screen appears s t A 20 0 cm H O RR 15 The Monitor Pressure screen displays the following items Pressure e Therapy Mode CPAP S S T T or PC Timed Breath Indicator
43. on the available accessories When using the optional accessories always follow the instructions enclosed with the accessories Adding a Humidifier with or without Heated Tubing You can use the heated humidifier and the heated tube with your device They are available from your home care provider A humidifier and heated tube may reduce nasal dryness and irritation by adding moisture to the airflow Note Refer to the humidifier s instructions for complete setup information SD Card The system 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 re move the SD card and send it to them for evaluation 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 Alarms chapter of this manual for more information on the SD card Contact your home care provider if you have any questions about the SD card Supplemental Oxygen Oxygen may be added anywhere in the patient circuit provided that a pressure valve is used Please note the warnings in Chapter 1 when using oxygen with the device Chapter 4 Accessories 42 Shielded DC Cord The Philips Respironics Shielded DC Cord can be used to operate this device in a stationary recre ational vehicle boat or motor home The Philips Respironics DC
44. ot followed Your home care provider did not prescribe Ramp for you or your pressure is already set to the minimum setting The air filters may be dirty The device may be operating in direct sunlight or near a heater The Tubing type setting may be incorrect BiPAP AVAPS user manual What To Do Select Therapy to go back to the Monitor Pressure screen Push and hold the knob for 2 seconds If Ramp has not been prescribed for you the Ramp feature will not work If your provider has enabled Ramp but the feature stilldoes not work check the pressure setting on your Monitor Pressure screen If the pressure is set to the minimum setting or the starting pressure is the same as the prescribed pressure the Ramp feature will not work Clean or replace the air filters The temperature of the air may vary somewhat based on your room temperature Make sure the device is properly ventilated Keep it 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 Make sure the Tubing type setting 22 or 15 matches the tubing that you are using Philips Respironics 22 or 15 mm tubing If you are using the Heated Tubing this setting will be 15H and you cannot change i
45. ounds in a 1 beep pattern repeating one second on then one second off The alarm descriptions later in this chapter display this indicator as 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 more beeps This indicator continues until the cause of the alarm is corrected or the audible alarm is silenced The alarm descriptions later in this chapter display this indicator as ee eee ee 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 chapter display this indicator as e e Low Priority When a low priority alarm is active a series of beeps sounds in a 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 chapter display this indicator as 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 chapter display this indicator as
46. owledges it No action is needed Chapter 3 Device Alarms 36 Audible Indicator Priority Check Power Info None Alert Humidifier Alert Power Supply Alert Heated Tube Error Alert Humidifier Failure BiPAP AVAPS user manual Visual Indicators The following symbol IE Humidifier LED icon will flash on the device AAA Humidifier LED icon will flash for 30 seconds Sss AAA Humidifier LED icon will slowly flash for 30 seconds AAA Flashing humidifier LED icon VIA Device Action Shuts down Only displayed when both the humidifier and therapy is on Only displayed when incorrect power supply is used with the heated tube Alert present for 30 seconds or until condition is fixed Device operate Humidifier shuts down User Action The power supply voltage is incorrect Make sure that you are using the correct power supply with your device If the alert continues to occur contact your home care provider Humidifier failure Alert is present for 12 minutes or until the condition is fixed Turn off airflow and reconnect the humidifier to the device according to the humidifier instructions If the alert continues to occur contact your home care provider Using wrong power supply Alert is present for 30 seconds or until the condition is fixed You must use the 80W power supply when using the heated tube If the alert continues to
47. patient s breathing effort by monitoring airflow in the patient 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 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 The device can also provide a single pressure level known as CPAP Continuous Positive Airway Pressure 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 Flex comfort feature provides increased pressure relief during the expiratory phase of breathing and the AVAPS feature helps you maintain a target V Several accessories are also available for use with the device Contact your home care provider to purchase any accessories not included with your system Chapter 1 Introduction The figure below illustrates some of the device features described in the table below SD Card Accessory Slot Air Outlet Port SD Card Cover Power Inlet Side Cover Filter Area Feature Description Air Outlet Port Connec
48. pear on the device and power supply Symbol Description La Consult accompanying instructions for use gms ACPowere 8 TE DC Power IP22 Drip Proof Equipment Caution consult accompanying documents ESD Warning Symbol Class II Double Insulated Type BF Applied Part For indoor use only Do not disassemble C2 FE p gt For Airline Use Complies with RTCA DO 160F section 21 category M BiPAP AVAPS user manual R Caution U S federal law restricts this device to sale by or on the order of a ONLY physician 13 Use only with the standard 60W power supply 1091398 not for use with Heated Tubing Use only with the Heated Tubing compatible 80W power supply 1091399 can also be used when Heated Tubing is not in use How to Contact Philips Respironics To have your device serviced contact your home care provider If you need to contact Philips Respironics directly call the Customer Service department at 1 724 387 4000 or 1 800 345 6443 You can also use the following addresses Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 Chapter 1 Introduction 14 BiPAP AVAPS user manual BiPAP AVAPS user manual 2 Device Setup Installing the Air Filter The device uses a gray foam filter that is washable and reusable The reusable filter screens out normal household dust and pollen It must be in place at all times when t
49. s intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The device uses RF energy only for its internal function Therefore its RF emissions CISPR 11 are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in all establishments including domestic establishments CISPR 11 and those directly connected to the public low voltage power supply network Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Flicker Complies emissions IEC 61000 3 3 Chapter 7 EMC Information 50 Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common
50. s necessary the device should be observed to verify normal operation in the configuration in which it will be used Operation of the device may be adversely affected by Electromagnetic fields exceeding the level of 3 V m in the test conditions of EN 60601 1 2 Operation of high frequency diathermy equipment Defibrillators or short wave therapy equipment Radiation e g x ray CT scan Magnetic fields e g MRI Mobile RF communication equipment The use of accessories transducers and cables other than those specified with the exception of transducers and cables sold by Philips Respironics Power Cord 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 This device is activated when the power cord is connected BiPAP AVAPS user manual Maintenance Never operate the device if any of the parts are damaged or if it is not working properly Have any damaged parts replaced before continuing use Electrical cords cables and the power supply device should be periodically inspected for damage or signs of wear Replace any damaged parts before using Repairs and adjustments must be performed by Philips Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly device damage Cleaning To avoid electric shock unplug the device before cleaning it Do not i
51. ssure Alarm High Pressure BiPAP AVAPS user manual Device Action Visual Indicators Red flashing button Blank Shuts down screen Red solid button Shuts down A Ventilator Inoperative or if Icon option is selected A Red flashing button A Low Pressure Operates or if Icon option is selected NE Are Red flashing button High Pressure Operates Ifthe alarm continues for 10 seconds the alarm escalates to a Ventilator Inoperative alarm or if Icon option is selected User Action Remove your mask 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 Remove your mask Press the Alarm Silence Indicator button to silence the alarm Contact your home care provider for service This could be caused by an excessive leak or blockage or a device malfunction Press the Alarm Silence Indicator button to silence the alarm 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 This may be caused by a malfunctioning device Press the Alarm Silence Indicator button to silence the alarm Remove your mask Remove power from the device Restore power If the alarm continues contact your home care provider for
52. t Problem Tube Temperature is turned on in Setup screen but Heated Tubing is not warm Tube Temperature is turned on in Setup screen but Humidifier LED does not stay orange The mask feels uncomfortable to wear there is significant air leakage around the mask or you experiences other mask related issues You have a runny nose Why It Happened Incorrect power supply is being used 60W is used instead of 80W Heated Tubing is attached incorrectly or damaged This could be due to improper headgear adjustment or improper mask fitting This may be caused by a nasal reaction to the airflow 39 What To Do Make sure the 80W power supply is being used This can be confirmed by looking at the power supply for the 60W or 80W symbols This can also be checked by looking at the Humidifier settings under the Setup screen Inspect Heated Tubing for damage and reconnect If the problem continues contact your home care provider 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 Contact your home care provider Chapter 3 Device Alarms 40 BiPAP AVAPS user manual BiPAP AVAPS user manual 4 Accessories There are several accessories available for your BiPAP AVAPS system such as a humidifier Contact your home care provider for additional information
53. t the flexible tubing here Note Heated Tubing should only be connected to the Air Outlet Port of the compatible System One Heated Humidifier and not to the Air Outlet Port of the therapy device SD Card If applicable insert the optional SD card here Accessory Slot 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 your accessory When not using an accessory this cover must be in place on the device Power Inlet Connect the power supply cord here Filter Area A reusable gray foam filter must be placed in the filter area to screen out normal household dust and pollen 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 for more information BiPAP AVAPS user manual Control Buttons The figure below shows the display screen and primary control buttons on the device Humidifier Icon and Number Settings Alarm Silence Indicator Button PHILIPS RESPIRONICS LCD Display Screen BiPAP AVAPS Control Wheel Push Button 2 3 LSE j lay Ramp Button Feature Description Display Screen Shows therapy settings patient data and other messages The startup screen is shown temporarily when the device is first powered Humidifier Icon This Icon lights
54. umi Humidity Level Tube Temperature System One humidi Humidifier Tubing Type System One Resist Back light hPa cmH O Back Icon View Text View 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 The following options appear on the Setup screen Heated Tube Humidification This setting will only display if you are using the heated tube You can enable 1 or disable 0 this feature Humidity Level This setting will only display if you are using the heated tube This setting allows you to choose the desired humidity setting for the humidifier 1 2 or 3 This setting can only be changed from the Setup screen Tube Temperature This setting will only display if you are using the heated tube This setting allows you to choose the desired temperature for the heated tube 0 1 2 3 4 or 5 If you choose zero 0 this will turn off both the humidifier and the heated tube Note When using Heated Tubing the contro wheel can also be used to change this setting Chapter 2 Device Setup 26 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 1 or
55. up different colors when the optional humidifier and or heated tube is attached and heat is being applied White means classic humidification is selected Blue means System One humidification is selected Orange means the heated tube is attached Please refer to the humidifier user manual for more information Humidifier Numbers The humidifier number settings are only visible when the humidifier is attached and therapy is active You can use the control wheel to change the number settings for the humidifier When the heated tube is being used with the humidifier these numbers will control the heated tube temperature setting 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 Pressing the Wheel also resets alarms Ramp Button When the airflow is on this button allows you to activate or restart the ramp function This button lights up when therapy is active or during specific alerts Alarm Silence Indicator Button Silences the audible portion of the alarm for a period of time and indicates an alarm condition Chapter 1 Introduction 10 Available Therapy Modes The table below describes the therapy modes available on the device Therapy Modes CPAP Description Continuous Positive Airway Pressure CPAP maintains a constant level of pressure throughout the breathing cycle Spo
56. utlet and then connect the flexible tubing to the outlet of the bacteria filter Note When using the bacteria filter the device performance may be affected However the device will remain functional and deliver therapy Note When using the optional heated tubing attach the heated tubing to the humidifier s modified air outlet port with the bacteria filter installed in line but at the opposing end of the tubing 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 Warning The exhalation device Whisper Swivel Il or exhalation port on masks with an integrated exhalation port is designed to exhaust CO from the patient circuit Do not block or seal the ports on the exhalation device 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 You must ensure that the entrainment valve is functioning properly BiPAP AVAPS user manual 17 Supplying AC Power to the Device Complete the following steps to supply AC power to the device 1 Plug the socket end of the power cord included into the power supply also included Important When you are using Heated Tubing with the compatible System One Heated Humidifier you must use the 80W power supply 2 Plug the pronged end of the power cord into

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