REMstar Auto A-Flex
Contents
1. ati PHILIPS REF 1058282 1057389 R03 JR 9 21 2010 EN DOM Respironics Inc 1001 Murry Ridge Lane Murrysville PA 15668 USA2. Inhalation Exhalation A Exhalation starts and ie pressure level decreases Therapy Pressure A Flex Levels With A Flex C Flex the level of pressure relief at the beginning of exhalation is determined by the A Flex C Flex setting and the amount of patient flow in any one breath Note The patient also has access to this setting if A Flex C Flex is enabled Note A Flex C Flex transitions from no A Flex C Flex at 4 0 cm H O to full A Flex C Flex at 6 cm H O A Flex C Flex is top limited at 20 0 cm H O pressure Ramp 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 When the device is in Auto CPAP therapy pressing the Ramp button lowers the pressure level to the minimum ramp pressure and then increases pressure in a linear fashion to the Auto minimum pressure setting over the set ramp time If patient events are detected during the ramp the Auto CPAP algorithm will treat the events and then continue to ramp as long as the device is not configured for split night therapy or the preset split night time period has expired during split night therapy 1 2 and 3 Time Inhalation Exhalation Air Flow Turned On Ramp Button a Pressed Therapy Pressure Minimum
3. Ramp Pressure Time Event Definitions The REMstar Auto A Flex 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 for 10 seconds Airway Apnea D i 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 wan
4. Setup and press the wheel The following Setup screen will appear Back Mode Auto CPAP Auto max auto min 20 0 Auto min 4 0 auto max CPAP pres 4 0 20 0 Flex type none C Flex A Flex or C Flex Flex 1 2 3 Tubing type lock on off Tubing type 15 22 SYSTEM ONE resistance O X1 X2 X3 X4 X5 Lock SYSTEM ONE on off Ramp time 0 00 0 45 Ramp start 4 0 auto min or CPAP pres SYSTEM ONE humidification on off Humidifier 012345 Auto on on off Auto off on off Mask alert on off Mask fit check on off Humidifier LED Backlight on off Show AHI leak PB on off Split night on off Split night start 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 39 e Mode This screen displays the therapy mode setting You can select CPAP therapy or Auto CPAP therapy CPAP therapy provides one level of output pressure for both the inspiratory and expiratory breathing phases Auto CPAP therapy provides CPAP therapy while automatically adjusting the pressure level when apnea hypopnea flow limitation or snoring events are detected Note The menu options will vary between CPAP mode and Auto CPAP mode e Auto max This screen allows you to modify the Auto Maximum pressure se
5. 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 Mask fit check You can enable or disable the mask fit check setting if it is available on your device If this feature is enabled it allows the patient to check the fit of their mask prior to starting therapy This is done by measuring the amount of leak in the patient circuit Note This screen only displays if Auto CPAP therapy is enabled Note If Split night is enabled Mask Fit Check will be disabled e Humidifier LED Backlight Ramp Backlight You can enable or disable the LED backlight for the humidifier number settings and Ramp button on the device Note If the humidifier is not attached this feature will display as Ramp Backlight and control the LED backlight for the Ramp button only Note If the Humidifier LED Backlight is enabled or disabled the humidifier icon will always remains on if humidifier is attached and heat is being applied but will dim after 30 seconds of inactivity 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 Split night You can enable or disable Split Night on this screen which splits the therapy throughout the night first in CPAP therapy before transitioning
6. to Auto CPAP therapy Note This screen only displays if Auto CPAP therapy is enabled Note If Split night is enabled Ramp start will be disabled Split night start You can modify the Split night settings on this screen shown here Back CPAP pres auto min auto max Duration 120 180 240 Flex type none C Flex C Flex Flex 1 2 3 Ramp time 0 00 0 45 Ramp start 4 0 CPAP pres Back get As T v Split night settings You can adjust the duration which is the amount of time spent in CPAP therapy before transitioning to Auto CPAP therapy You can set it to 120 180 or 240 minutes You can also adjust the CPAP pressure Flex type and setting the ramp time and ramp starting pressure from this screen Note This screen only displays if Split night is enabled and Auto CPAP therapy is enabled Note If Split night is enabled Ramp start will be disabled 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 90 pressure 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
7. 90 Pressure During any given night the device recognizes the 90 Pressure achieved by the Auto Algorithm 90 Pressure is defined as the pressure at which the device spent 90 of the session time at or below For example if the device recognized airflow for 10 hours and 9 hours were spent at or below 11 cm H O and 1 hour was spent above 11 cm H O then the 90 Pressure would be 11 cm H O This screen displays the average of these individual nightly values of 90 Pressure over a 7 day and 30 day time frame provided the device has at least 7 or 30 days of data respectively If the device has only 5 days of data to use for the calculation the 5 day average value will be seen under the 7 day display This screen only displays in Auto CPAP therapy 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 2 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 C Flex Comfort Feature The device consists of a special comfort feature called C Flex When C Fl
8. REMstar Auto A 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 A 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 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 the Pro
9. 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 the 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 ni
10. e Ramp start This displays the ramp starting pressure You can increase or decrease the ramp starting pressure in 0 5 cm H O increments This is only available if Ramp time has been set to gt 0 and auto min or CPAP pressure gt 4 cm H O This will not display if Split night is enabled e SYSTEM ONE humidification System One humidity control maintains a consistent mask humidity by monitoring and adjusting for changes in room temperature and room humidity You can enable or disable this feature If the System One humidity control has been disabled the classic style of basic temperature controlled heated humidification will be used This will only display if the humidifier is attached e Humidifier This setting allows you to choose the desired humidity setting 0 1 2 3 4 or 5 If the System One humidity control has been disabled the classic style of basic temperature controlled heated humidification will be used and the display will show 0 C1 C2 C3 C4 or C5 for these settings This will only display if the humidifier is attached Please refer to the humidifier manual if using a humidifier e 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
11. ex 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 C Flex is enabled A Flex C Flex Comfort Feature The device consists of a special comfort feature called A Flex if Auto CPAP therapy is enabled or C Flex if CPAP therapy is enabled When A Flex C Flex is enabled it enhances patient comfort in three ways 1 by smoothing the transition between the end of inhalation and the beginning of exhalation 2 by providing significant pressure relief during the beginning of exhalation and 3 by reaching an end exhalation pressure of no more than 2 cm H O below the high point of inspiration In the diagram the dashed line represents CPAP pressure in comparison to the bold line representing A Flex C Flex A Flex C Flex levels of 1 2 or 3 progressively reflect increased pressure relief during the beginning of exhalation C Flex Levels 1 2 and 3 Exhalation starts and S pressure level decreases Therapy Pressure Time
12. 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 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 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 3 Vrms d 1 2 P IEC 61000 4 6 150 kHz to 80 MHz d 1 2P 80 MHz to 800 MHz Radiated RF 3 Vi
13. fore 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 power 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 Whisper Swivel I 0 3 cm H O accuracy 0 1 cm H O resolution eee e Foam filter Manometer S 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 sett
14. ght 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 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 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
15. ice 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 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 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 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 When you set the ramp time the device increases the CPAP pressure from the value set on the Ramp Starting Pressure screen to either the CPAP pressure setting if in CPAP mode or the Auto Minimum pressure setting if in Auto CPAP mode over the length of time specified here Note If the CPAP pressure if in CPAP mode or Auto Minimum pressure if in Auto CPAP mode is set to 4 the minimum setting this screen will not display Note If the Ramp time is set to 0 Ramp start will not display
16. ing 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 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 be
17. ings 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 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 10 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 su
18. itable 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 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 6 kV contact 8 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 30 Electrical fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for common mode 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 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
19. 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 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 RY 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 streng
20. ths 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 SEPARATION DisTANCE ACCORDING TO FREQUENCY OF TRANSMITTER M RaTeD Maximum Power OUTPUT OF TRANSMITTER WwW 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz To 2 5 GHz d 1 2P d 1 2 P d 2 3P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 12 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
21. tting The setting you specify here will be the maximum pressure for the device Auto therapy will adjust the CPAP pressure between the Auto Maximum and the Auto Minimum pressure settings Note This screen only displays if Auto CPAP therapy is enabled e Auto min This screen allows you to modify the Auto Minimum pressure setting The setting specified here will be the minimum pressure for the device Auto therapy will adjust the CPAP pressure between the Auto Maximum and the Auto Minimum pressure settings Note This screen only displays if Auto CPAP therapy is enabled e CPAP pres 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 You can select None C Flex or C Flex if in CPAP mode You can select None C Flex or A Flex if in Auto CPAP mode e Flex You can modify the Flex setting 1 2 or 3 on this screen if you enabled Flex 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 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 1 turns the lock on and 0 turns the lock off Note If you lock this setting the dev
22. vider 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 Choosing 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 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 screen highlight
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