BiPAP Auto Bi-Flex
Contents
1. RESPIRONICS BiPAP Auto Bi Flex USER MANUAL 2009 Respironics Inc and its affiliates All rights reserved Table of Contents IRI MI R S 2 ulvejgcii seeni A EAEE R A E N EEA a GE 2 bari Serriera ea E E L A R N E NA E N RRA 2 S Up R EE T RE SE S 3 Comtrraindications E EE E E 3 SYMIDOM SY E E E EAE 3 System CONTEMES asstat T 4 SEE ON EI A EN E O E E O 4 Control Buttons 5 Available Theta pies e raia REN ARN AE NE 5 Installlirig the Air FilGGRS scs csssscssssssescuscitssacesescassasscsadpacaesessssesedscsbgaacevenueonigtosseerusdesasuogeuseudpoaecbasunsbsstubdosecufeodesuienes 6 Connecting the Breathing Circuit Where to Place the DEeVvice et ettet rtt ert erre ttbi eene RaR Supplying AC Power to the Device tie tit rettet che te ER PARE obe IR XX EAR t SERERE ee ERG ede 7 Navigating the Device Screens ie ende tse c i e eH ER HERR He ERE Dee Rs REESE RET d cu 7 endure 7 Deleg 8 AESA Setup Screen Xll g r nIP T C 11 Troubl shootiNg m 14 ACCESSOMIGS aS 15 Traveling AES 16 e n A PPIl 12. 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 Respironics interface with a separate exhalation device such as the Whisper Swivel II Respironics 1 83 m 6 ft flexible tubing 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 Note If required connect a bacteria filter to the device air outlet and then connect the flexible tubing to the outlet of the bacteria filter Note The bacteria filter is recommended to protect the patient care provider and equipment from the transference of a virus or bacteria through the breathing circuit Note 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 necessar
3. 400 msec Note 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 Note This same setting is also available under the Rise time screen Humidifier This displays the humidifier setting This will only display if the humidifier is attached Please refer to the humidifier manual if using a humidifier Ramp Start This displays the ramp starting pressure You can increase or decrease the ramp starting pressure in 0 5 cm H O increments This is only available if Ramp time has been set to gt 0 and min EPAP gt 4 cm H O This will not display if your provider enabled Split night on your device SYSTEM ONE resistance i lt This setting allows you to adjust the level of air pressure relief based on the specific Respironics mask Each Respironics mask may have a System One resistance control setting Contact your home care provider if you cannot find this resistance setting for your mask If your provider has locked the resistance setting into place you can view the setting but cannot change it and the screen will display a lock symbol If your provider has disabled resistance you will not see this setting Auto on You can enable this feature if you want the device to automatically turn the airflow on whenever you apply the interface mask to your airway Auto off You can enable this feature if you want
4. Ramp would only be useful if you wake in the middle of the night Bi Flex Rise time Screen From the Home screen highlight the Bi Flex or Rise time option and press the wheel The following screen will appear Note This screen will either display a blank screen or it will show Bi Flex or Rise time depending on the provider settings Back Bi Flex Rise time Bi Flex demo Rise time demo Flex Screen Bi 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 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 Note This same setting is also available under the Setup screen Rise time Rise time is the time it takes for the device to change from EPAP to IPAP This screen allows you to adjust the rise time so you can find the desired setting This is only available if Bi Flex has been disabled 1 sets RiseTime to 1 200 msec 2 sets Rise Time to 2 300 msec 3 sets RiseTime to 3 400 msec
5. as e e Additionally the backlights on the buttons will provide a high priority flashing pattern consisting of a continuous bright to off two flash pattern indicated in the following table as 00 00 Medium Priority These alerts require prompt operator response The alert signal consists of a medium priority sound which is a continuous one beep pattern indicated in the following table as Additionally the backlights on the buttons will provide a medium priority flashing pattern consisting of a continuous bright to dim one flash pattern indicated in the following table as 0 Alert Summary Table The following table summarizes the alerts ALERT AUDIBLE VISUAL Device AcTION PossiBLE PATIENT ACTION INDICATOR INDICATOR Cause Service Required eo oo 00 00 The device enters Device failure Press either the wheel or ramp Screen displays the Safe state in button to silence the alert Service required which the device Remove the power supply cord indicating that power remains on from the device to remove power service is required but the airflow is Plug the cord back into the disabled device s power inlet to restore power If the alert continues to occur contact your home care provider Mask Alert e o 09 Alert present until The breathing Turn off airflow Check your Screen displays action is taken circuit is breathing circuit connections Mask alert disconnected and reconnect the tubing if it has or there
6. charge e g air conditioning humidification conductive floor coverings non synthetic clothing discharging one s body to the frame of the equipment or system or to earth or a large metal object and bonding oneself by means of a wrist strap to the equipment or system or to earth Adding a Humidifier You can use the Heated humidifier or the Passover humidifier with your device They are available from your home care provider A humidifier may reduce nasal dryness and irritation by adding moisture to the airflow CAUTION For safe operation the humidifier must always be positioned below the breathing circuit connection at the mask and the air outlet on the device The humidifier must be level for proper operation Note Refer to the humidifier s instructions for complete setup information Using the SD Card The BiPAP Auto Bi Flex 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 remove 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 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 Pl
7. 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 Respironics Inc 312 Alvin Drive New Kensington PA 15068 USA REF 1061635 1061627 JR 9 17 2009 EN DOM
8. 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 It may be helpful to bring this manual along with you to help security personnel understand the BiPAP Auto Bi Flex device If you are traveling to a country with a line voltage different than the one you are currently using a different power cord or an international plug adaptor may be required to make your power cord compatible with the power outlets of the country to which you are traveling Contact your home care provider for additional information Cleaning the Device WARNING To avoid electrical shock always unplug the power cord from the wall outlet before cleaning the device DO NOT immerse the device in any fluids 1 Unplug the device and wipe the outside of the device with a cloth slightly dampened with water and a mild detergent Let the device dry completely before plugging in the power cord 2 Inspect the device and all circuit parts for damage after cleaning Replace any damaged parts Cleaning or Replacing the Filters Under normal usage you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months The white ultra fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty DO NOT clean the ultra fi
9. 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 Condensation may damage the device If this device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Do not operate the device outside of the operating temperature range shown in the Specifications Do not use extension cords with this device Do not place the device directly onto carpet fabric or other flammable materials Do not place the device in or on any container that can collect or hold water A properly installed undamaged reusable foam inlet filter is required for proper operation Tobacco smoke may cause tar build up within the device which may result in the device malfunctioning Dirty inlet filters may cause high operating temperatures that may affect device performance Regularly examine the inlet filters as needed for integrity and cleanliness Never install a wet filter into the device You must ensure sufficient drying time for the cleaned filter When DC power is obtained from a vehicle battery the device should not be
10. used while the vehicle s engine is running Damage to the device may occur Only use a Respironics DC Power Cord and Battery Adapter Cable Use of any other system may cause damage to the device Contraindications When assessing the relative risks and benefits of using this equipment the clinician should understand that this device can deliver pressures up to 25 cm H O In the event of certain fault conditions a maximum pressure of 35 cm H O is possible Studies have shown that the following pre existing conditions may contraindicate the use of CPAP therapy for some patients Bullous Lung Disease Pathologically Low Blood Pressure Bypassed Upper Airway Pneumothorax Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway Pressure Caution should be used when prescribing CPAP for susceptible patients such as those with cerebral spinal fluid CSF leaks abnormalities of the cribriform plate prior history of head trauma and or pneumocephalus Chest 1989 96 1425 1426 The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit signs of a sinus or middle ear infection Not for use with patients whose upper airways are bypassed Contact your health care professional if you have any questions concerning your therapy Symbol Key The following symbols may appear on the device and power supply SYMBOL DEFINITION SYMBOL DEFINITION Li Consultaccormpanvine inseructions formuse Sd Sep
11. 45 Ramp start 4 0 min EPAP SYSTEM ONE resistance X1 X2 X3 X4 X5 Auto on on off Auto off on off Mask alert on off LED backlight off Back Setup Screen Note The screen will only show 4 lines at a time As you rotate the wheel to toggle over different options the screen will slide up and down accordingly If the text is too long to completely fit on the screen it will scroll horizontally across the screen when highlighted Bi 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 chis 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 Note This same setting is also available under the Bi Flex screen Rise time Rise time is the time it takes for the device to change from EPAP to IPAP This screen allows you to adjust the rise time so you can find the desired setting This is only available if Bi Flex has been disabled 1 sets Rise Time to 1 200 msec 2 sets Rise Time to 2 300 msec 3 sets RiseTime to 3
12. 6 Cleaning or Replacing the Filters 16 Ve DIACONO 16 Ia lc 16 SPOCHICALIONS m 17 BI e e a M 18 Howto Contact RespironiCS seraient e 18 EMC Information Limited Warranty User Manual CAUTION U S federal law restricts this device to sale by or on the order of a physician Intended Use The Respironics BiPAP Auto Bi Flex system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg 66 Ibs It is for use in the home or hospital institutional environment Important The device is to be used only on the instruction of a licensed physician The system can deliver Bi level therapy or Auto Bi level therapy both with and without Bi Flex Your home care provider will make the correct pressure settings according to your health care professional s prescription When set in the Auto Bi level therapy mode the system will monitor your breathing as you sleep and automatically adjust the pressure to meet your needs When in Bi level therapy the system will deliver a continuous set pressure during the night Several accessories are available to make your OSA treatment with the BiPAP Auto Bi Flex system as convenient and comfortable as possible To ensure that you receive the safe effective therapy prescribed fo
13. Note 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 Note This same setting is also available under the Setup screen e Bi Flex demo The Bi Flex setting allows you to set the Bi Flex level prior to beginning therapy The Bi Flex demo setting allows you to try out the different Bi Flex settings in real time After a period of time of inactivity the device will stop therapy and will use the last Bi Flex demo setting as the new Bi Flex setting for your device When therapy is again started from the Home screen the device will operate using the new Bi Flex setting If the provider has disabled this feature this setting will not display Rise time demo The Rise time demo setting allows you to try out the different Rise time settings in real time After a period of time of inactivity the device will stop therapy and will use the last Rise time demo setting as the new Rise time setting for your device When therapy is again started from the Home screen the device will operate using the new Rise time setting If the provider has disabled this feature this setting will not display 8 User Manual Setup Screen From the Home screen highlight the Setup option and press the wheel The following Setup screen will appear The user can change settings in the Setup menu Back Bi Flex 1 2 3 Rise time 123 Humidifier 0123
14. arate collection for electrical and electronic panying i C equipment per EC Directive 2002 96 EC User Manual DC Power Class Il Double Insulated Do not disassemble me Type BF Applied Part Me For Indoor Use Only IPX1 Drip Proof Equipment System Contents Your BiPAP Auto Bi Flex system includes the following items Device Side cover panel User manual SD card Carrying case Reusable gray foam filter Flexible tubing Disposable ultra fine filter optional Power cord and power supply Humidifier optional Note If any of these items are missing contact your home care provider System Overview The BiPAP Auto system offers several options in how therapy is delivered so treatment can be personalized to meet your needs The system delivers two different positive pressure levels IPAP Inspiratory Positive Airway Pressure and EPAP Expiratory Positive Airway Pressure Your home care provider will make the correct pressure settings When prescribed for you the device provides several special features to help make your therapy more comfortable The ramp function allows you to lower the pressure when you are trying to fall asleep The air pressure will gradually increase until your prescription pressure is reached You also have the option of not using the ramp feature at all Additionally the Bi Flex comfort feature provides you with pressure relief when you exhale during therap
15. aration 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 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 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 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
16. ction needed Screen displays 30 seconds or until been removed SD card user acknowledges removed SD Card Data single beep Screen displays Alert present until n a Only displayed immediately after Activity Data activity Do user acknowledges therapy is turned off when data is not remove card or data activity transferring to the card complete 12 User Manual Refer to modem instruction manual AUDIBLE VISUAL Device AcTION PossiBLE PATIENT ACTION INDICATOR INDICATOR Cause SD Card Corrupt e o 09 Alert present until A problem Choose yes to reformat Screen displays action is taken exists with the the card Screen displays Corrupt card SD card The Reformatting do not remove inserted reformat data may be card card corrupted If you choose no the alert will disappear and the card will not be reformatted Note Any information on the card will be lost when reformatted Contact your home care provider with any questions SD Card Remove ee 09 Alert present until Device cannot Remove SD card and reinsert and Reinsert Screen displays action is taken read the If the alert continues to occur SD card error SD card A replace with another card or remove and problem may contact your home care provider reinsert exist with the SD card or it is inserted incorrectly Modem Making Call single beep Modem will Alert present for 30 Refer to If modem is making call whil
17. e display its own seconds after call modem therapy is active alert for call icon on the device sequence or until instruction sequence is not displayed Refer to modem user acknowledges manual instruction manual Modem Unsuccessful single beep 09 Alert present for Refer to No action needed Call Modem will 30 seconds or until modem display its own user acknowledges instruction icon on the device manual User Manual 13 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 s no power at the outlet or the device is unplugged What ro 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 pe
18. e enclosure is broken disconnect the power cord and discontinue use Contact your home care provider 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 Periodically inspect electrical cords and cables for damage or signs of wear Discontinue use and replace if damaged 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 Besure 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 2 User Manual Note Please see the Limited Warranty section of this manual for information on warranty coverage Cautions A Caution indicates the possibility of damage to the device Pins of connectors should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic charge e g air conditioning humidification conductive floor coverings non
19. ease note the warnings listed below when using oxygen with the device WARNINGS When using oxygen with this system the oxygen supply must comply with local regulations for medical oxygen When using oxygen with this system a Respironics Pressure Valve must be placed in line with the patient circuit after the oxygen source Failure to use the pressure valve could result in a fire hazard When using oxygen with this system turn the device on before turning on the oxygen Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device Do not connect the device to an unregulated or high pressure oxygen source Supplying DC Power to the Device The Respironics DC Power Cord can be used to operate this device in a stationary recreational vehicle boat or motor home The Respironics DC Battery Adapter Cable when used with the DC Power Cord enables the device to be operated from a 12 VDC free standing battery CAUTION When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the device may occur CAUTION Only use a Respironics DC Power Cord and Battery Adapter Cable Use of any other system may cause damage to the device Refer to the instructions supplied with the DC Power Cord and adapter cable for information on how to operate the device using DC power User Manual 15 Traveling with the System When traveling the carrying case
20. ended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 12 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 23 P 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz 3 Vim where P is the maximum output power rating of the transmitter in watts W 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 1 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 and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level ab
21. gen 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 Respironics Pressure Valve must be placed in line with the patient circuit after the oxygen source Failure to use the pressure valve could result in a fire hazard Do not connect the device to an unregulated or high pressure oxygen source Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide Do not use the device near a source of toxic or harmful vapors Do not use this device if the room temperature is warmer than 35 C 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 Contact your health care professional if symptoms of sleep apnea recur 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 th
22. ice w Humidifier 0 5 cm H O lt 0 5 cm H O lt 1 0 cm H O Maximum Flow Rate Test pressures cm H O 4 0 9 0 14 5 20 0 25 0 Measured pressure at the patient 3 9 87 14 2 19 6 24 0 connection port cm H O Average flow at the patient 61 0 102 7 137 5 167 4 146 9 connection port l min Noise Sound Pressure Level 30 dB A This measurement applies to the therapy device with or without the optional Humidifier Sound Power Level 38 dB A User Manual 17 Disposal Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Dispose of this device in accordance with local regulations How to Contact Respironics To have your device serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 or 1 724 387 4000 You can also use the following address Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 18 User Manual EMC Information Guidance and Manufacturer s Declaration Electromagnetic Emissions 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 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 ver
23. ince the device was last reset by the home care provider This screen also displays a compliance number used by your home care provider to validate that the data provided by you is the data taken from this screen This setting only appears if your provider has enabled this feature Compliance VIC Visual Inspection Check This screen displays the start date and the total number of days used when the sessions were greater than 4 hours This screen also displays a check code number used by your home care provider to validate that the data provided by you is the data taken from this screen This setting only appears if your provider has enabled this feature 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 This screen displays the cumulative number of device therapy sessions that exceeded 4 hours over a 7 day and 30 day time frame 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 lea
24. is a come loose Make sure your large air leak mask is on properly before you restart the airflow If the alert continues to occur contact your home care provider to have your mask checked You may need a mask refitting Auto Off single beep Screen displays The airflow shuts The mask has Put your mask back on and turn Auto off off and the device been removed the airflow on to resume therapy enters the Standby state approximately 45 60 seconds after detection Alert present for 30 seconds or until user acknowledges User Manual 11 ALERT AUDIBLE VISUAL Device AcTION PossiBLE PATIENT ACTION INDICATOR INDICATOR Cause Humidifier Alert none 09 Only displayed when Humidifier Alert is present for 12 minutes or Humidifier LED both the humidifier failure until the condition is fixed Turn icon will flash and therapy is on off airflow and reconnect the humidifier to the device according to the humidifier instructions AAA If the alert continues to occur contact your home care provider Patient Reminder single beep Screen displays Only displayed when Message from Your home care provider may message from the therapy transitions the provider seta patient reminder scheduled provider from on to off to pop up at a particular time to Alert present for remind you to replace your mask 6 minutes or until change your filters etc Check u
25. k is defined as the level of leak that is so large it is no longer possible to determine respiratory events with statistical accuracy This screen displays the average of these individual nightly values of percentage of time in large leak over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display If you see a large increase in the percent of time in large leak indicated here contact your home care provider for assistance This screen only displays if your home care provider has enabled it 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 Periodic Breathing 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 respec
26. mprove patient comfort based on patient needs Auto Bi level Delivers spontaneous Bi level therapy while automatically adjusting EPAP and IPAP levels to meet the patient s needs Auto Bi level with Bi Flex Auto Bi level therapy with pressure relief upon exhalation to improve patient comfort based on patient needs User Manual 5 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 optional ultra fine filter provides more complete filtration of very fine particles The gray reusable filter must be in place at all times when the device is operating The ultra fine filter is recommended for people who are sensitive to tobacco smoke or other small particles A reusable gray foam filter is supplied with the device A disposable ultra fine filter is available as an accessory 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
27. n 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 This Icon lights up when the optional humidifier is attached The humidifier number settings are only visible when the humidifier is attached and therapy is active Please refer to the humidifier user manual for more information Control Wheel Push 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 on this button allows you to activate or restart the ramp function This button lights up when therapy is active or during specific alerts Available Therapies The BiPAP Auto Bi Flex device delivers the following therapies Bi level Provides one level of output pressure during EPAP Expiratory Positive Airway Pressure and a second higher level during IPAP Inspiratory Positive Airway Pressure If your health care professional prescribed ramp for you you can press the Ramp button to reduce the pressure and then gradually increase the pressure to the therapeutic pressure setting so that you can fall asleep more comfortably Bi level with Bi Flex Bi level therapy with pressure relief upon exhalation to i
28. ne 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 warm water with a mild detergent Rinse thoroughly to remove all detergent residue Allow the filter to air dry completely before reinstalling it If the foam filter is torn replace it Only Respironics supplied filters should be used as replacement filters 5 If the white ultra fine filter is dirty or torn replace it 6 Reinstall the filters inserting the white ultra fine filter first if applicable CAUTION Never install a wet filter into the device You must ensure sufficient drying time for the cleaned filter Cleaning the Tubing Clean the tubing 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 enclosu
29. ove 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 b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m 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 Rateb Maximum Power SEPARATION DisTANCE ACCORDING TO FREQUENCY OF TRANSMITTER OUTPUT OF TRANSMITTER M Ww 150 kHz ro 80 MHz 80 MHz ro 800 MHz 800 MHz ro 2 5 GHz dz124P dz124P dz 2 JP 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 23 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the sep
30. ptions and voltage variations on power supply input lines IEC 61000 4 11 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 gt 95 dip in U for 5 sec 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 gt 95 dip in U_ for 5 sec 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 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 Alm Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment NOTE U is the a c mains voltage prior to application of the test level User Manual 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 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 recomm
31. r you use only Respironics accessories 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 The operator should read and understand this entire manual before using the device This device is not intended for life support The device should be used only with masks and connectors recommended by Respironics or with those recommended by the health care professional or respiratory therapist A mask should not be used unless the device is turned on and operating properly The exhalation port s associated with the mask should never be blocked Explanation of the Warning The device is intended to be used with special masks or connectors that have exhalation ports to allow continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask exhalation port However when the device is not operating enough fresh air will not be provided through the mask and exhaled air may be rebreathed 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 oxy
32. re or if the enclosure is broken disconnect the power cord and discontinue use Contact your home care provider 16 User Manual Specifications Environmental Operating Temperature 5 to 35 C 41 to 95 F Storage Temperature 20 to 60 C 4 F to 140 F Relative Humidity operating amp storage 15 to 9576 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 H Weight Device with power supply Approximately 1 53 kg 3 37 Ibs Standards Compliance This device is designed to conform to the following standards IEC 60601 1 General Requirements for Safety of Medical Electrical Equipment EN ISO 17510 1 Sleep Apnea Breathing Therapy Devices EN 60601 1 2 Electromagnetic Compatibility IEC 60601 1 Classification Type of Protection Against Electric Shock Class Il Equipment Degree of Protection Against Electric Shock Type BF Applied Part Degree of Protection against Ingress of Water device amp AC power supply Drip Proof IPX1 Mode of Operation Continuous Electrical AC Power Consumption 100 240 VAC 50 60 Hz 2 1 A DC Power Consumption 12 VDC 5 0 A Fuses There are no user replaceable fuses 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 Dev
33. rsists 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 is highlighted when pressing the control wheel to start airflow If the airflow does not turn on there may be a problem with your device Contact your home care provider for assistance The device s display is erratic The device has been dropped or mishandled or the device is in an area with high Electromagnetic Interference EMI emissions Unplug the device Reapply power to the device If the problem continues relocate the device to an area with lower EMI emissions away from electronic equipment such as cellular phones cordless phones computers TVs electronic games hair dryers etc If the problem still occurs contact your home care provider for assistance The Ramp feature does not work when you press the Ramp button Your home care provider did not prescribe Ramp for you or your CPAP pressure is already set to the minimum setting If Ramp has not been prescribed for you discuss 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 CPAP setting on your Active Displa
34. ser acknowledges your mask a new one may be available Call your provider is the default message The provider may change the message Instant Message single beep Home care Only displayed when Message from Your home care provider may provider will therapy is off the provider send an instant message Contact supply text to be your home care provider with any displayed questions SD Card Prescription single beep Screen displays Alert present for n a Card status can be checked in Accepted SD card inserted 30 seconds or until Status menu prescription user acknowledges accepted SD Card Prescription single beep 09 Alert present for Prescription Contact your home care provider Rejected Screen displays 30 seconds or until missing or for correct prescription SD card inserted user acknowledges incorrect prescription rejected SD Card Inserted e o 09 Alert present until SD card Alert is present until card is Incorrectly Screen displays action is taken inserted removed Remove SD card and SD card inserted incorrectly reinsert correctly If the alert incorrectly continues to occur contact your home care provider SD Card Full ee 09 Alert present until SD card is full Alert is present until card is Screen displays action is taken removed Card status can be SD card full checked in the Status menu Remove SD card and replace SD Card Remove single beep 09 Alert present for SD card has No a
35. te the following steps to operate the device using AC power 1 Plug the socket end of the AC power cord included into the power supply also included 2 Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch 3 Plug the power supply cord s connector into the power inlet on the back of the device 4 Ensure that all connections are secure IMPORTANT To remove AC power disconnect the power supply cord from the electrical outlet WARNING Periodically inspect electrical cords and cables for damage or signs of wear Discontinue use and replace if damaged CAUTION Do not use extension cords with this device Navigating the Device Screens Turn the wheel to toggle between options and settings on the screen Press the wheel to choose an option or setting that is highlighted If you choose Back on any screen it will take you back to the previous screen Note The screens shown throughout this manual are examples only Actual screens may vary slightly Examples are for reference only Starting the Device 1 Supply power to the device 2 The Home screen will appear shown below Home Screen Note Bi Flex shown above will either display a blank screen or it will show Bi Flex or Rise time depending on the provider settings 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
36. the device to automatically turn the airflow off whenever you remove the interface mask from your airway Mask alert You can enable or disable the mask alert setting If this feature is enabled the mask alert will appear on the display screen when a significant mask leak is detected and an audible alert will sound Refer to the Device Alerts section for more information about the mask alert LED backlight You can enable or disable the LED backlight for the humidifier icon and settings on the device User Manual 9 Info Screen From the Home screen highlight the Info option 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 Status alll Phone in Compliance VIC Therapy hours Days gt 4 Large Leak AHI Periodic breathing 90 pressure Back Info Screen Note The screen will only show 4 lines at a time As you rotate the wheel to toggle over different options the screen will slide up and down accordingly Status This displays information sent from a peripheral SD card modem etc If two peripherals are attached two lines will appear with corresponding icons e Phone in This screen displays the total therapy hours for the device the total blower hours and the total number of days used when the sessions were greater than 4 hours s
37. tively 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 10 User Manual 9076 Pressure During any given night the device recognizes the 9076 Pressure achieved by the Auto Algorithm 9076 Pressure is defined as the pressure at which the device spent 9076 of the session time at or below For example if the device recognized airflow for 10 hours and 9 hours were spent at or below 11 cm H O and 1 hour was spent above 11 cm H O then the 90 Pressure would be 11 cm H O This screen displays the average of these individual nightly values of 9076 Pressure over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display Each average will display 2 numbers The first number shown is the IPAP average while the second number shown is the EPAP average This screen only displays if you are in Auto Bi level therapy Device Alerts High Priority These alerts require immediate operator response The alert signal consists of a high priority sound which is a continuous two beep pattern indicated in the following table
38. wheel to toggle between the four options Highlight Therapy Press the wheel to turn on the airflow and begin therapy The Therapy screen will appear which will show the current pressure setting being delivered 5 Make sure that no air is leaking from your mask into your eyes If necessary adjust the mask and headgear until the air leak stops See the instructions provided with your mask for more information Note A small amount of mask leak is normal and acceptable Correct large mask leaks or eye irritation from an air leak as soon as possible 6 If you are using the device in a bed with a headboard try placing the tubing over the headboard This may reduce tension on the mask 7 Press the wheel again to turn off therapy and return to the Home screen User Manual 7 Ramp Feature The device is equipped with an optional ramp feature that your home care provider can enable or disable This feature reduces the air pressure when you 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 button on the top of the device You can use the RAMP button as often as you wish during the night Note If the ramp feature is disabled nothing will happen when you press the RAMP button Note If in Auto mode there is no ramp at minimum pressure when starting
39. y Several accessories are also available for use with your BiPAP Auto device Contact your home care provider to purchase any accessories not included with your system SD Card Accessory Slot Air Outlet Port Power Inlet Filter Area This figure illustrates some of the device features described in the following table Device FEATURE DESCRIPTION Air Outlet Port Connect the flexible tubing here conical 22 mm SD Card Accessory Slot If applicable insert the optional accessory SD card here SD Card Cover If applicable the optional accessories such as a Link Module or Modem can be installed here Refer to the instructions supplied with the accessory When not using an accessory this cover must be in place on the device Power Inlet Connect the power cord here Filter Area A reusable gray foam filter must be placed in the filter area to screen out normal household dust and pollens An optional 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 Controls Buttons __LCD Display Screen Humidifier Icon amp Number Settings 1 Control Wheel Push Button Ramp Butto
40. y Refer to the instructions that came with your headgear Where to Place the Device Place the device on a firm flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position Make sure the filter area on the back of the device is not blocked by bedding curtains or other items Air must flow freely around the device for the system to work properly Make sure the device is away from any heating or cooling equipment e g forced air vents radiators air conditioners CAUTION Do not place the device directly onto carpet fabric or other flammable materials CAUTION Do not place the device in or on any container that can collect or hold water 6 User Manual Supplying AC Power to the Device CAUTION Condensation may damage the device If this device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy Do not operate the device outside of the operating temperature range shown in the Specifications WARNING Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture WARNING This device is activated when the power cord is connected 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 Comple
41. y screen If CPAP is set to the minimum setting 4 0 cm H O or the starting pressure is the same as the prescribed pressure the Ramp feature will not work Make sure that the ramp time setting is gt 0 The airflow is much warmer than usual The air filters may be dirty The device may be operating in direct sunlight or near a heater Clean or replace the air filters The temperature of the air may vary somewhat based on your room temperature Make sure that the device is properly ventilated Keep the device away from bedding or curtains that could block the flow of air around the device Make sure the device is away from direct sunlight and heating equipment If using the humidifier with the device check the humidifier settings Refer to the humidifier instructions to make sure the humidifier is working properly If the problem continues contact your home care provider 14 User Manual Accessories There are several accessories available for your BiPAP Auto Bi Flex system such as a humidifier or a modem Contact your home care provider for additional information on the available accessories When using optional accessories always follow the instructions enclosed with the accessories CAUTION Pins of connectors should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic
42. y 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 emissions Complies IEC 61000 3 3 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 IEC 60601 Test LeveL 6 kV contact 8 kV air CoMPLIANCE LEVEL X6 kV contact X8 kV air 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 3076 Electrical fast Transient burst 2 kV for power supply lines 1 kV for input output lines 2 kV for supply mains 1 kV for input output lines Mains power quality should be that of a typical home or hospital environment 2 kV common mode IEC 61000 4 4 Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical IEC 61000 4 5 home or hospital environment 2 kV for common mode Voltage dips short interru
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