BiPAP Pro Bi-Flex
Contents
1. Bi Flex Comfort Feature Bi level mode The device consists of a special comfort feature called Bi Flex When the device is in Bi level with Bi Flex mode 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 In the diagram the bold lines represent Bi Flex in comparison to the dashed line representing normal Bi level therapy 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 Note The patient also has access to this setting if Flex is enabled C Flex Comfort Feature CPAP mode if available The device consists of a special comfort feature called C Flex if CPAP therapy is enabled When C Flex is enabled it enhances patient comfort by providing pressure relief during the expiratory phase of breathing In the diagram the dashed line represents normal CPAP therapy in comparison to the bold line representing C Flex C Flex levels of 1 2 or 3 progressively reflect increased pressure relief C Flex pressure relief is determined by the C Flex setting and the amount of patient flow C Flex returns to the set pressure by the end of exhalation when the airway is most vulnerable to closure Note The patient also has access to this setting if Flex is enabled Ramp Bi level mode The device is eq2. No therapy adjustments are made in response to periodic breathing Flow Limitation The device looks for relative changes in the peak flatness roundness or shape skewness of the inspiratory portion Detection of the airflow waveform These changes are observed both over a short period of time groups of 4 breaths and over a long period of time several minutes Statistical measures are used to help minimize false event detection while allowing the device to be sensitive to even small changes Hypopnea A hypopnea is detected when there is an approximately 40 reduction in airflow from baseline for at least 10 Detection seconds Snore Vibratory snore is detected when a specific frequency is detected during the inspiratory portion of the patient s Detection breath Vibratory snore is disabled at pressures greater than 16 cm H O Cleaning for Multiple Users WARNING If you are using the device on multiple users discard and replace the bacteria filter each time the device is used on a different person If you are using the device on multiple users complete the following steps to clean the device before each new user 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 e DisCide Towelettes e 10 Chlorine Bleach solution 3 Allow the device to dry completely before plugging in the pow
3. 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 A m 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 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 Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz 3 V m 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 d 1 2 P d 12P 80 MHz to 800 MHz d 23 800 MHz to 2 5 GHz 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 strengt
4. 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 COMPLIANCE LeveL ELECTROMAGNETIC ENVIRONMENT Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 V for input output lines 1 kV differential mode 2 kV common mode 1 kV for input output lines 1 kV differential mode 2 kV for common mode LeveL GUIDANCE Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile Discharge ESD If floors are covered with synthetic material the 8 kV air 8 kV air relative humidity should be at least 30 IEC 61000 4 2 Electrical fast 2 kV for power supply lines 2 kV for supply mains 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 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 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 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 Mains power quality should be that of a typical home or hospital environment If the user of
5. the EPAP setting to 25 cm H O Note This screen only displays if Bi level therapy is enabled e EPAP This screen allows you to modify the EPAP setting The initial default setting is 4 cm H O You can adjust the setting from 4 cm H O to the IPAP setting Note This screen only displays if Bi level therapy is enabled e CPAP pres If available on your device this screen displays the current CPAP pressure setting You can adjust the setting from 4 cm H O to 20 cm H O Note This screen only displays if CPAP therapy is enabled e Flex type This screen displays the comfort mode setting and will have different options depending on the therapy mode e If the device is in Bi level mode you can select None or Bi Flex e If the device is in CPAP mode you can select None or C Flex e Flex You can modify the Flex setting on this screen The Flex comfort feature allows you to adjust the level of air pressure relief that the patient feels when exhaling during therapy The setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief Note The patient also has access to this setting if Flex is enabled e 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 Flex has been disabled and the device is in Bi level mode 0 off reduces the Rise Time feature t
6. 7 Verify that the pressure setting matches the pressure displayed on the manometer If the pressure setting does not match the measured value for the device contact Respironics or an authorized service center to have the device serviced Note Output pressures may vary at local altitude and barometric pressure Because of these factors devices may slightly vary in output pressure over the range of the altitude settings 8 Set up the remaining parameters and exit provider mode The unit is ready for patient use 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 RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Flicker emissions Complies IEC 61000 3 3 ELECTROMAGNETIC ENVIRONMENT GUIDANCE The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended
7. BiPAP Pro Bi Flex PROVIDER GUIDE PHILIPS RESPIRONICS IMPORTANT Remove this guide before giving the device to the patient Only medical professionals should adjust pressure settings This guide provides you with instructions on how to access and navigate the provider screens used to modify device settings Refer to the User Manual for more information Note The screens shown throughout this guide are examples only Actual screens may vary slightly Accessing the Provider Mode Screens Accessing provider mode unlocks settings that cannot be modified by the user To access provider mode 1 Supply Power to the device First plug the socket end of the AC power cord into the power supply Then plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch Finally plug the power supply cord s connector into the power inlet on the back of the device Once the device is powered the Home Screen appears shown below Turn the wheel to toggle between the four options and highlight Setup Info Setup Home Screen Note Bi Flex shown above will display as the current Flex mode Once Setup is highlighted press and hold both the Control Wheel and the Ramp Button lt 1 on the device for at least 5 seconds You will hear a quick double beep and the Provider Mode Screen will appear shown below You are now in provider mode Provider Screen Navigating
8. being applied but will dim after 30 seconds of inactivity Show AHI leak PB You can select whether or not the Apnea Hypopnea index System Leak averages and Periodic Breathing averages are displayed on the Patient Info screens 1 turns this option on and 0 turns this option off e Language This feature allows you to choose which language to display on the interface You can choose English EN or Spanish ES Info Screen From the Provider screen highlight Info and press the wheel The following Info screen will appear Back Phone in Compliance VIC Therapy hours Blower hours Days gt 4 Large leak AHI Periodic breathing Reset data Machine hours Back Info Screen Note The screen will only show 4 lines at a time As you rotate the Wheel to toggle over different options the screen will slide up and down accordingly e Phone in This screen displays the total therapy hours for the device the total blower hours and the total number of days used when the sessions were greater than 4 hours since the device was last reset This screen also displays a compliance check number you can use to validate that the data provided to you is the data taken from this screen e Compliance VIC Visual Inspection Check This screen displays the start day and the total number of days used when the sessions were greater than 4 hours This screen also displays a check code number you can use to validate that t
9. er cord Verifying the Pressure WARNING If the device fails to perform within the stated specifications have the system serviced by a qualified Respironics approved service facility If part of your patient setup procedure is to verify actual pressure with a manometer please use the following instructions to ensure that the device is functioning properly You will need the following equipment to verify the pressure Respironics Pressure Calibration Kit includes e Respironics Whisper Swivel II e Respironics O Enrichment Final Assembly e Closed end cap e Respironics flexible tubing e Pressure tubing e Respironics Digital Manometer or equivalent Flexible Tubing Minimum Specifications 0 25 cm H O or better 0 3 cm H O accuracy Whisper Swivel II 02 Enrichment Assembly Pressure Tubing 0 1 cm H O resolution Closed End Cap e Foam filter Manometer To verify the pressure complete the following steps 1 Install the foam filter into the back of the device 2 With the device unplugged connect the system as illustrated in the diagram 3 Turn the manometer on If it does not display a reading of zero adjust the manometer to calibrate it If the manometer has variable settings for devices set it to cm H O 4 Supply power to the device then place the device in provider mode 5 Set the therapy parameters according to the patient specific data 6 Set the device to the specific pressure value for the patient
10. evice 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 e 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 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 e Reset data This screen allows you to erase all 7 and 30 day averages compliance data therapy hours and patient information on the device Make sure that Reset data is highlighted on the info screen Press and hold both the control wheel and the ramp button for at least 5 seconds The device will beep once signifying that the data has been reset Note Machine hours are not erased e Machine hours This screen displays the amount of time that the machine has been active over the life of the device Note Therapy hours and blower hours can be reset for new patients Machine hours are not erased
11. f the humidifier is attached e Humidifier This setting allows you to choose the desired humidity setting 0 1 2 3 4 or 5 If the System One humidity control has been disabled the classic style of basic temperature controlled heated humidification will be used and the display will show 0 C1 C2 C3 C4 or C5 for these settings This will only display if the humidifier is attached Please refer to the humidifier manual if using a humidifier e Auto on You can enable or disable this feature if you want the device to automatically turn the airflow on whenever the patient applies the interface mask to their airway e Auto off You can enable or disable this feature if you want the device to automatically turn the airflow off whenever the patient removes the interface mask from their airway e Mask alert You can enable or disable the mask alert setting If this feature is enabled the mask alert will appear on the display screen when a significant mask leak is detected and an audible alert will sound e Humidifier LED Backlight Ramp Backlight You can enable or disable the LED backlight for the humidifier number settings and Ramp button on the device Note If the humidifier is not attached this feature will display as Ramp Backlight and control the LED backlight for the Ramp button only Note If the Humidifier LED Backlight is enabled or disabled the humidifier icon will always remains on if humidifier is attached and heat is
12. for 10 seconds Airway Apnea D During the apnea one or more pressure test pulses are delivered by the device The device evaluates the response of etection the patient to the test pulse s and assesses whether the apnea has occurred while the patient has a clear airway or an obstructed airway The airway is determined to be clear if the pressure test pulse generates a significant amount of flow otherwise the airway is determined to be obstructed RERA RERA Respiratory effort related arousal is defined as an arousal from sleep that follows a 10 second or longer Detection sequence of breaths that are characterized by increasing respiratory effort but which does not meet criteria for an apnea or hypopnea Snoring though usually associated with this condition need not be present The RERA algorithm monitors for a sequence of breaths that exhibit both a subtle reduction in airflow and progressive flow limitation If this breath sequence is terminated by a sudden increase in airflow along with the absence of flow limitation and the event does not meet the conditions for an apnea or hypopnea a RERA is indicated Periodic Breathing A persistent waning and waxing breathing pattern which repeats itself between 30 and 100 seconds The nadir of the breathing pattern is characterized by at least a 40 reduction in airflow from an established baseline flow The pattern must be present for several minutes before it can be identified as periodic breathing
13. ge for this setting is 0 to 45 minutes e If in Bi level mode the device increases the EPAP pressure from the value set on the Ramp Starting Pressure screen to the EPAP pressure setting over the length of time specified here e If in CPAP mode the device increases the CPAP pressure from the value set on the Ramp Starting Pressure screen to the CPAP pressure setting over the length of time specified here Note If the EPAP pressure if in Bi level mode or CPAP pressure if in CPAP mode is set to 4 the minimum setting this screen will not display e Ramp start You can increase or decrease the ramp starting pressure in 0 5 cm H O increments Note This screen will not display if Ramp time has been set to zero Note This screen will not display if the EPAP pressure if in Bi level mode or CPAP pressure if in CPAP mode is set to 4 cm H O Note If the ramp starting pressure is set higher than the EPAP pressure if in Bi level mode or CPAP pressure if in CPAP mode the ramp starting pressure will be decreased automatically by the device to match the EPAP or CPAP pressure e SYSTEM ONE humidification System One humidity control maintains a consistent mask humidity by monitoring and adjusting for changes in room temperature and room humidity You can enable or disable this feature If the System One humidity control has been disabled the classic style of basic temperature controlled heated humidification will be used This will only display i
14. he 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 SEPARATION DisTANCE ACCORDING TO FREQUENCY OF TRANSMITTER RaTeD Maximum Power M OUTPUT OF TRANSMITTER amp 150 kHz To 80 MHz 80 MHz To 800 MHz 800 MHz To 2 5 GHz d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 23 10 3 8 3 8 73 100 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 VV 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 11 Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA PHILIPS REF 1061641 1061633 Rev 03 JR 9 29 2010 EN DOM
15. he data provided to you is the data taken from this screen e Therapy hours The device is capable of recognizing the difference between the time the patient is actually receiving therapy and the time when the blower is simply running This screen displays the average amount of time the patient is actually receiving therapy on the device over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display e Blower hours This screen displays the number of hours that the blower has been active over the life of the device e 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 e Large leak During any given night the device recognizes the percentage of time the patient was experiencing what it deemed to be a large leak Large leak is defined as the level of leak that is so large it is no longer possible to determine respiratory events with statistical accuracy This screen displays the average of these individual nightly values of percentage of time in large leak over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display e AHI The d
16. hs 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 t 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 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 b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m 10 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 T
17. n highlight Setup and press the wheel The following Setup screen will appear BiLevel CPAP EPAP 25 0 4 0 IPAP CPAP pres 4 0 20 0 Flex type None Bi Flex C Flex Flex 1 2 3 Rise time 0 1 2 3 Tubing type lock on off Tubing type 15 22 SYSTEM ONE resistance 0 X1 X2 X3 X4 X5 LockSYSTEMONE on off Ramp time 0 00 0 45 Ramp start 4 0 EPAP CPAP pres SYSTEM ONEhumidification on off Humidifier 012345 Auto on on off Auto off on off Mask alert on off Humidifier LED Backlight on off Show AHI leak PB on off Language EN ES Back Setup Screen Note The screen will only show 4 lines at a time As you rotate the Wheel to toggle over different options the screen will slide up and down accordingly If the text is too long to completely fit on the screen it will scroll horizontally across the screen when highlighted e Mode This screen displays the therapy mode setting You can select Bi level therapy or CPAP therapy if available on your device Bi level therapy provides one level of output pressure during EPAP Expiratory Positive Airway Pressure and a second higher level during IPAP Inspiratory Positive Airway Pressure CPAP therapy provides one level of output pressure for both the inspiratory and expiratory breathing phases Note The menu options will vary between the various modes e IPAP This screen allows you to modify the IPAP setting The initial default setting is 20 cm H O You can adjust the setting from
18. o the lowest setting off 150 msec e 1 sets Rise Time to 1 200 msec e 2 sets Rise Time to 2 300 msec e 3 sets Rise Time to 3 400 msec Note The patient also has access to this setting if Rise time is enabled e Tubing type lock If available on your device this enables you to lock the Tubing type setting if you do not want the patient to change it Note If you lock this setting the device defaults to a setting of 22 and the patient will not see the Tubing type setting e Tubing type If available on your device 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 Respironics 22 mm tubing or 15 for the optional Respironics 15 mm tubing e SYSTEM ONE resistance 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 System One resistance compensation can be turned off by choosing the setting 0 Note The patient also has access to this setting if Lock SYSTEM ONE is off e Lock SYSTEM ONE lt 8 This enables you to lock the System One resistance control setting if you do not want the patient to change it Note If you lock this setting the patient will see a lock icon next to the setting e Ramp time This enables you to modify the Ramp time setting in 5 minute increments The ran
19. the Provider Mode Screens To navigate these display 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 Choose EXIT from the Provider Screen will exit provider mode and the device will return to the Home Screen in the patient mode Note Provider mode will time out after 1 minute of inactivity and automatically exit the provider mode and return to the Home Screen in the patient mode Provider Mode Screen Descriptions The following sections will describe the options available under the 3 choices from the Provider Screen Reminder Setup and Info Reminder Screen From the Provider screen highlight Reminder and press the wheel The following Reminder screen will appear Back Reminder off 30 90 180 270 365 Reminder Reminder Screen e Reminder You can set a reminder on this screen that will let patients know when it is time to perform a certain task such as replacing the mask You can select one of the following settings Off no reminder is set or you can set the device to display a reminder after 30 90 180 270 or 365 days Note You can set a specific patient reminder message using the Encore Pro software and put this message on the SD Card or send it to the patient s device via a modem Setup Screen From the Provider scree
20. uipped with a linear ramp feature that allows patients to reduce the pressure and then gradually increase ramp the pressure to the prescription pressure setting so they can fall asleep more comfortably The diagram illustrates how the ramp feature works Ramp CPAP mode if available The device is equipped with a linear ramp feature that allows patients to reduce the pressure and then gradually increase ramp the pressure to the prescription pressure setting so they can fall asleep more comfortably The diagram illustrates how the ramp feature works Therapy Pressure C Flex Levels 1 2 and 3 EPAP Bi Flex _ Time Exhalation starts and pressure level decreases Time Inhalation Exhalation Airflow Turned On Ramp Button IPAP Pressure ra Pressed CPAP EPAP Pressure Minimum ee Ramp Pressure 0 cm H20 z le Ramp Time gt Minutes Linear Ramp The delta is defined as the lesser of 2 cm H20 and the difference between IPAP and EPAP pressure settings Air Flow Turned On Ramp Button a Pressed Therapy Pressure Minimum Ramp Pressure he Ramp Time gt l Time Event Definitions The BiPAP Pro monitors breathing and detects apneas and hypopneas Definition Obstructed Airway An apnea is detected when there is an 80 reduction in airflow from baseline for at least 10 seconds or if there is no Apnea Clear airflow detected
Download Pdf Manuals
Related Search