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BiPAP A40 User Manual

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1. PHILIPS eS RON Respironics Inc Respironics Deutschland C 1097811 1001 Murry Ridge Lane Gewerbestrasse 17 Murrysville PA 15668 USA 82211 Herrsching Germany 1077336 R02 edi EC REP JJB 03 22 2012 PHILIPS PEN BIPAP A40 USER MANUAL RESPIRONICS FOR HOME CARE SERVICE PROVIDER USE ONLY Accessing Prescription Setting Screens The information on this page is ONLY for home care service providers Remove this page from the manual before giving the manual to the patient Full and Limited Menu Access Modes The ventilator has two levels of menu access Full and Limited Full Menu Access allows you to alter all available settings Limited Menu access permits the user to alter only those prescription settings that affect patient comfort such as Rise Time or Flex if they are available as part of the prescription Turning the Lock settings off in Full Menu Access mode allows users to modify them See Chapter 5 for more information The ventilator defaults to Full Menu Access mode When the device is in Limited Menu Access mode use the following key sequence to enter Full Menu Access mode 1 From the Standby or Monitor screen press the Down button and the Alarm Indicator Audio Pause button simultaneously for several seconds This temporarily places the device in Full Menu Access mode 2 Ifyou perform this key sequence from the Monitor screen the Main Menu appears If you perform i
2. 27 User Action Press Start Stop button If display is operational Power Off confirmation screen appears Select Right button to shut off device and silence alarm Immediately remove patient from ventilator and connect them to alternate source of ventilation Contact your home care service provider for service Check for blockages or excessive leaks If alarm continues contact your home care service provider Check for blockages in exhalation devices Make sure the exhalation device is clean and functioning properly If the alarm continues contact your home care service provider Move device to cooler location Make sure device is not close to a heat source Make sure cooling vents are not blocked If condition persists contact your home care service provider If using AC power try plugging device into alternate AC power source If loss of power continues switch to DC power by connecting an external battery to the device If there is still no power connect patient to alternate source of ventilation and contact your home care service provider Chapter 3 Ventilator Alarms 28 Low Battery When Battery is Attached AC Power Disconnected When Battery is Attached Stuck Key Replace Detachable Battery Insert SD Card When Oximeter is Attached Audible Priority B Nd sil Info or Q for Info Medium 000 for depending Medium on cause of alarm 3 6 3 Informational Messag
3. Low Battery See Chapter 3 for more information The yellow indicator is for the last available battery source When the device detects that an in use battery s charge is nearly depleted has approximately 10 minutes of charge left the inside of the box surrounding the battery sym bol turns red In addition a high priority alarm message displays indicating Low Battery See Chapter 3 for more information The red indicator is for the last available bat tery source Whenever AC power is applied to the device the detach able battery will recharge as needed If the detachable battery is being recharged the symbol displays BiPAP A40 user manual 5 Viewing and Changing Settings 5 1 Navigating the Menu Screens To navigate through all of the menu screens and settings e Usethe Up Down button to scroll through the menu e Use the Left and Right buttons to perform the actions specified on the on screen buttons 5 2 Using the Keypad Lock Feature Note When Keypad Lock is enabled the Alarm Indicator Audio Pause and Start buttons continue to function normally 1 Access the Keypad Lock feature from the Options menu It is intended to prevent accidental changes to device settings This feature locks the navigation keys Up Down Stop Left and Right 2 If the keypad is locked you must unlock it before you can enter the Menu When you press one of the navigation keys a Keypad Unlock message displays To unloc
4. 15 On 0 0 MinVent RR LE Ratio 0 0 129 1 1 0 s anal p Menua NNITTTNESE according to the maximum Patient Pressure reached during each breath A bar graph displays the current pressure level If enabled alarm status indicators for Audio Pause Apnea and Circuit Disconnect display in the upper right corner 2 The Date Time panel shows the current date and time 3 The Patient Accessory panel displays when an accessory is connected to the device See the Accessories chapter for more information 4 The Status panel displays certain symbols that indicate features being used such as Ramp as well as battery status In Detailed View the same information is shown except instead of displaying the Date and Time panel the screen displays the following measured parameters Patient Pressure Exhaled Tidal Volume Chapter 5 Viewing and Changing Settings 40 Leak Minute Ventilation Respiratory Rate I E Ratio Note When an oximeter is connected the current SpO and Heart Rate readings will only display on the Patient Accessory panel if Detailed View is turned on When Detailed View is turned off only a heart icon displays to indicate that the oximeter is connected and show the data status The data values will not display 5 6 Changing Settings in Provider Menu Access Mode 1 Press the Up key to enter the Menu screens from the Standby or Monitor screens The Main Menu screen appears 2 Choose from the following sel
5. 4 1 Patient Alarms User Settable eee tetettnntnntnntnnnne 22 34 2 System ANI sasvssccesesvccecsvevesttsveecsvesect r 23 3 5 What to Do When An Alarm Occurs eese ttn tent ttnnnttnnn 25 3 6 Alarm Summary Table eese ttt nter nonne ntt notttts nnns 26 3 6 1 Patient Alarms User Settable eene 26 3 6 2 System Alarms isset repite siepe ein means 27 3 6 3 Informational Messages seen tteennt ttn nntetnnnnes 28 Chapter 4 Device Setup te restitit never ei ieer anatina 31 4 1 Installing the Air Filter eese nnn tent tnnt tton tttnttttnntonnts 31 4 2 Where to Place the Device eee estes teen teen esent tte nttto tto nattsnots 32 4 3 Connecting the Breathing Circuit eene 32 4 3 1 Connecting a Non Invasive Circuit ees 32 4 3 2 Connecting an Invasive Circuit eret 32 4 4 Supplying Power to the Device eerte nntttnnnnes 33 44 1 Using AC POWER ado iiec ieseni nesia n padre Tern DSE NASSER 33 44 2 Using beug 34 4 4 3 Device Power Source Indicators eere teentttnns 35 BiPAP A40 user manual Chapter 5 Viewing and Changing Settings ssseccsssescessseecsnseecssssecessseessnseecessneeesnseecsnsnecessneesensesesnees 5 1 Navigating the Menu Screens 5 2 Using the Keypad Lock Feature 5 3 Accessing the Standby Scr
6. Settings section earlier in this chapter for details on each setting Keypad Lock Keypad Backlight LCD Brightness e Screen Saver e Date Format Time Format Month Day e Year Hour Minute 5 9 Display Symbols The following table defines symbols that may appear on screen Symbol Description Apnea alarm enabled AVAPS 1 AVAPS enabled and the AVAPS rate setting e g 1 Circuit Disconnect alarm is enabled External Battery is full and in use ee External Battery is at 80 capacity Eg External Battery is at 60 capacity Chapter 5 Viewing and Changing Settings 54 Description EN External Battery is at 4096 capacity External Battery is at 2096 capacity External Battery has less than 20 minutes left External Battery has less than 10 minutes left Ei External Battery is empty FLEX 1 FLEX enabled and FLEX setting e g 1 Full Menu Access Mode Provider mode Humidifier is connected and Humidifier setting e g 1 Bad humidifier state flashing symbol displays SD Card Inserted SD Card Error Bad memory card inserted Writing to SD Card Note Refer to the instructions included with your detachable battery for descriptions of the detachable battery symbols that appear on screen when the battery is installed in the device EBD 0 BiPAP A40 user manual BiPAP A40 user manual 6 Cleaning and Maintenance 6 1 Cleaning the Ventilator The
7. Use The BiPAP A40 ventilator is intended to provide invasive and non invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg 22 Ibs with Obstructive Sleep Apnea OSA Respiratory Insufficiency or Respiratory Failure It is intended to be used in home institutional hospital and portable applications such as wheelchairs and gurneys It is not intended to be used as a transport ventilator and is not intended for life support Chapter 1 Introduction 1 3 Warnings and Cautions Warnings A warning indicates the possibility of injury to the user or operator Patient Monitoring Personnel Qualifications SD Card Prescription Changes Battery Back up Power Operating and Storage Temperatures BiPAP A40 user manual Prior to placing a patient on the ventilator a clinical assessment should be performed to determine The device alarm settings Needed alternative ventilation equipment e Ifan alternative monitor i e an alarming Pulse Oximeter or Respiratory Monitor should be used BiPAP A40 is a restricted medical device designed for use by Respiratory Therapists or other trained and qualified caregivers under the supervision of a physician This manual serves as a reference The instructions in this manual are not intended to supersede your health care professional s instructions regarding the use of the device The prescription and other device settings should only be changed on t
8. be adjusted when Bi Flex is enabled 2 2 5 Digital Auto Trak An important characteristic of the device is its ability to recognize and compensate for unintentional leaks in the system and to automatically adjust its trigger and cycle algorithms to maintain optimum performance in the presence of leaks This feature is known as Digital Auto Trak The device continuously monitors flow and adjusts the estimate of patient flow as circuit leak changes The compensation provides a better estimate of patient flow to be used to track patient breathing patterns and calculate flow based parameters such as exhaled tidal volume The device continually tracks breathing patterns and automatically adjusts sensitivity thresholds to ensure optimum patient and machine synchrony as breathing patterns change or as circuit leak varies Sensitive Auto Trak is an enhancement to the Auto Trak algorithm that improves patient and machine synchrony for patients with minimal respiratory effort Sensitive Auto Trak refines the baseline trigger and cycle sensitivity thresholds BiPAP A40 user manual 17 2 3 Therapy Event Detection The device monitors breathing and detects apneas hypopneas and other therapy events as available Definition Obstructed Anapnea is detected when there is an 80 reduction in airflow from baseline for at least Airway 10 seconds or if there is no airflow detected for 10 seconds During the apnea one or Apnea more pressure tes
9. test level BiPAP A40 user manual Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical home or hospital environment 71 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 Compliance Electromagnetic Environment Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 JP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands Ra
10. the integrated heated humidifier no patient flow Sound Minimum Alarm Sound Level 60 dB A Note The sound level may be reduced when the device is used in the In Use bag Chapter 9 Technical Specifications 68 Breathing Resistance During Power Fail or Fault Conditions The resistance measurements include the complete system with humidifier outlet bacteria filter and patient circuit Patient Flow Expiratory Resistance Inspiratory Resistance LPM cm H O cm H O 30 lt 1 5 lt 1 5 60 lt 3 7 4 1 Disposal Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC Dispose of this device in accordance with local regulations BiPAP A40 user manual BiPAP A40 user manual 10 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 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions Class A Be mm Voltage fluctuations Flicker Complies emissions 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 establish
11. the ventilator is connected to AC power It cannot be used with a battery External Battery Do not use the same external battery to operate both the ventilator and any other equipment such as power chairs An external battery should only be connected to the ventilator using the Philips Respironics External Battery Cable This cable is fused pre wired and properly terminated to ensure safe connection to a standard deep cycle lead acid battery Use of any other adapter or cable may cause improper operation of the ventilator Cleaning Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter Do not steam autoclave the ventilator Doing so will destroy the ventilator Do not use harsh detergents abrasive cleaners or brushes to clean the ventilator system Notes This product does not contain natural latex rubber or dry natural rubber in patient or operator accessible areas or in the air path or breathing circuit BiPAP A40 user manual 1 4 Contraindications The BiPAP A40 ventilator is not a life support device The device is contraindicated for both invasive use and pediatric use when in AVAPS AE mode If the patient has any of the following conditions consult their health care professional before using the device in a non invasive mode Inability to maintain a patent airway or adequately clear secretions Atrisk for aspiration of gastric contents Diagnosed with acute sinusitis or otitis
12. the white disposable filter simply insert the gray foam filter into the filter area Note See Chapter 6 for information on how to clean and replace the air filter Chapter 4 Device Setup 32 4 2 Where to Place the Device Place the device upright on a firm flat surface somewhere within easy reach of where you will use it at a level lower than your sleeping position Make sure the filter area on the back of the device is not blocked by bedding curtains or other items Air must flow freely around the device for the system to work properly Make sure the device is away from any heating or cooling equipment e g forced air vents radiators or air conditioners 4 3 Connecting the Breathing Circuit You will need the following accessories in order to assemble the recommended circuit Philips Respironics interface nasal mask or full face mask with integrated exhalation port or Philips Respironics interface with a separate exhalation device such as the Whisper Swivel II Philips Respironics 22 mm or 15 mm flexible tubing Philips Respironics headgear for the mask 4 3 1 Connecting a Non Invasive Circuit Complete the following steps to connect a non invasive breathing circuit to the device 1 Connect the flexible tubing to the air outlet on the side of the device a If required connect a bacteria filter to the device air outlet and then connect the flexible tubing to the outlet of the bacteria filter b Whe
13. 0 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz and 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into Patient areas Note 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people BiPAP A40 user manual BiPAP A40 user manual Limited Warranty Respironics Inc warrants that the BiPAP A40 system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period oftwo 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 and other defects not related to material or workmanship 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
14. A setting of 1 provides a small amount of pressure relief with higher numbers providing additional relief Select Off to disable the setting The patient also has access to this setting if Flex Lock is off However if Flex is Off the user cannot adjust it AVAPS Select On or Off to enable or disable AVAPS AVAPS Rate If AVAPS is enabled the AVAPS Rate may be adjusted from 0 5 to 5 0 cmH O minute in 0 5 cmH O increments Tidal Volume If AVAPS is enabled or in AVAPS AE mode you can adjust the target tidal volume from 200 to 1500 ml in 10 ml increments IPAP Max Pressure This setting displays if AVAPS is enabled Increase or decrease the setting from 4 to 40 cm H O in increments of 0 5 The IPAP Max Pressure must be equal to or greater than the IPAP Min value IPAP Min Pressure This setting displays if AVAPS is enabled Increase or decrease the setting from 4 to 40 cm H O in increments of 0 5 The IPAP Min Pressure must be equal to or greater than the EPAP value and it must be less than or equal to the IPAP Max Pressure IPAP This setting displays if AVAPS is Off Increase or decrease the Inspiratory Positive Airway Pressure IPAP from 4 to 40 cm H O in increments of 0 5 You cannot set the IPAP setting lower than the EPAP setting IPAP is limited to 25 cm H O when the Flex feature is enabled EPAP Increase or decrease the Expiratory Positive Airway Pressure EPAP from 4 to 25 cm H O in increments of 0 5 Chapte
15. a tasten Er vere 9 1 7 Symbols sss wel 1 8 Traveling with the System VET Altline Travel E 12 1 9 How to Contact Philips Respironics eesssessssecsseecssecssscesseecssecesseccesecesseecsneessees 12 Chapter 2 Therapy Modes and Features 2 1 Device Therapy Modes 2 2 Therapy Features io ricotta a Pa anunua 14 PR P Siasii piaraan NANS ERE R SS 14 2 2 2 Bi Flex Comfort Feature nmesenrenesanmesmnseneniunniasian 15 223 CI 15 2 2A RISE TIME e 16 2012 Koninklijke Philips Electronics N V All rights reserved Table of Contents 225 Digital AUto Trak rennen mean 16 2 3 Therapy Event Detection ee ette eterne ttt notet nnnes 17 2 3 1 Event Detection in Modes with a Back Up Rate 17 Chapter 3 Ventilator Alarms ccssssssscsssecsssccsssccsssecsseccsseccssccesscessuseesuccesuscessecesseecsseccsseessscessseessuceesneceaseesssees 19 3 1 Audible and Visual Alarm INdicators ssscssssssssecsseeeseessseecsscesssscesnsecsneeesneeess 19 3 1 1 Alarm LED Indicators eese nnt nnne tnnt ttn NERE 19 3 1 2 Audible lndicat rs u ncseeassensinsenetsescnnsesenessnnesssadennsssnrentinnserenensandenmnsernest desen 20 3 1 3 Alarm Messages nissan 21 3 2 Silencing an Alarm esee tts ntt no tttts nones 21 3 3 Resetting am Alarm neto tertio trier eee 22 344 Alarm Descriptions iieri crisp epe a iS 22 3
16. act your home care service provider Question Why isn t the airflow turning on Answer Make sure the device is powered correctly Verify that you are not in Standby mode The airflow remains off while in Standby Pressthe Therapy button to ensure that therapy is on If problem persists contact your home care service provider for assistance Chapter 8 Troubleshooting 62 Question Why is the airflow much warmer than usual Answer the air filters may be dirty Clean or replace the air filters The temperature of the air may vary somewhat based on your room temperature Make sure the device is properly ventilated Keep it away from bedding or curtains that could block the flow of air around the device Make sure the device is away from direct sunlight and heating equipment If using the humidifier with the device check the humidifier settings Refer to the humidifier instructions to make sure the humidifier is working properly Question Why does the mask feel uncomfortable An swer This could be due to improper headgear adjustment or improper mask fitting Make sure you are properly fitted with the correct size mask Ifthe problem continues contact your home care service provider to be fitted with a different mask Question Why did my prescription change fail when updated my prescription using the SD card Answer there are three possible error messages that will appear if the prescription change fa
17. an approximately 40 reduction in airflow from Detection baseline for at least 10 seconds Snore Vibration snore is disabled at pressures greater than 16 cmH O in CPAP mode Vibration snore is Detection disabled at IPAP settings greater than 20 cmH O or max pressure support IPAP EPAP greater than or equal to 10 cmH 0O in bi level modes It is also disabled during any machine triggered breaths when EPAP settings are greater than or equal to 10 cmH O Large Leak The level of leak is so large it is no longer possible to determine respiratory events with statistical accuracy 2 3 1 Event Detection in Modes with a Back up Rate If the device is in a mode that delivers its own backup breath S T PC T or AVAPS AE mode then the device will NOT deliver the test pulse Instead it will use the machine back up breath and evaluate it for which if any type of apnea to score Chapter 2 Therapy Modes and Features 18 BiPAP A40 user manual BiPAP A40 user manual 3 Ventilator Alarms There are three types of alarms High Priority Require immediate response by the operator Medium Priority Require prompt response by the operator Low Priority Require operator awareness These alarms alert you to a change in the ventilator status Additionally the ventilator also displays informational messages and confirmation alerts that notify you of conditions that need attention but do not qualify as alarm conditions Note I
18. an or equal to this setting Select Off to disable this alarm or increase or decrease the setting from 1 l min to 99 l min in increments of 1 34 High Respiratory Rate Alarm This setting enables or disables the High Respiratory Rate alarm The alarm activates when the measured respiratory rate reaches or exceeds this setting Select Off to disable this alarm or increase or decrease the setting from 1 BPM to 60 BPM in increments of 1 5 6 2 Changing Options Menu Settings 1 2 From the Main Menu screen use the Up Down key to highlight the Options item Press the Right key to select Options 5 6 2 1 Options Settings The following settings are available on the Options menu 1 Menu Access Select Full or Limited menu access Full menu access allows home care service providers to access all ventilator and prescription settings Limited menu access allows users to access only certain settings and does not allow them to change prescription settings Detailed View Turn Detailed View On or Off using this setting Detailed view displays additional therapy information on the Monitor screen Language Select the Language that the software will appear in English French German etc The information on the screens will display in the language selected here Pressure Units Select the pressure units that will display on the screens You can choose either cm H O or hPa All pressure units on the screens will display in the unit
19. ays follow the instructions included with them 7 1 Humidifier You can use the provided integrated humidifier with your device A humidifier may reduce nasal dryness and irritation by adding moisture to the airflow When the device is in Standby if the integrated humidifier is connected and the humidifier parameter setting is greater than 0 the Left key is labeled Preheat Selecting this key initiates the humidifier preheat function and changes the humidifier icon to the heating active icon Selecting this key again while the preheat function is active ends the pre heat function After the heater plate reaches the desired temperature the Preheat feature automatically shuts off 7 2 SD Card The system comes with an SD card inserted in the SD card slot on the back of the device to record information for the home care service provider Your provider may ask you to periodically remove the SD card and send it to them for evaluation To remove the SD card 1 Select the Safely Remove SD Card option from the main menu 2 After the Remove SD Card confirmation message appears remove the card To write an Event Log to the SD card 1 Access the Setup screen in Full Menu Access mode Chapter 7 Accessories 58 2 Select the Write Event Log to SD Card option from the main menu a While writing is in progress a confirmation box with the message Writing in Progress appears b When writing is complete a co
20. crements of 0 5 cmH O The EPAP Max pressure settings must be equal to or greater than the EPAP Min Pressure value EPAP Min Pressure This setting displays in AVAPS AE mode Increase or decrease the setting from 4 to 25 cmH O in increments of 0 5 cmH O The EPAP Min Pressure must less than or equal to the EPAP Max value BiPAP A40 user manual 20 21 22 23 24 25 26 45 Rise Time Lock Select Off to allow users to adjust their Rise Time setting or On to prevent users from adjusting the setting Rise Time Adjust the rise time from 1 to 6 to find the most comfortable setting for the patient Rise time is the time it takes for the device to change from EPAP to IPAP A lower setting indicates a slower rise time while a higher setting means a faster rise time The patient also has access to this setting if Rise Time Lock is off Ramp Length Disable Ramp by selecting Off or increase or decrease the Ramp Length setting from 5 to 45 minutes in 5 minute increments When you set the ramp length the device increases the pressure from the value set on the Ramp Start Pressure screen to the pressure setting over the length of time specified here Ramp Start Pressure This setting displays in CPAP S T or PC modes Increase or decrease the ramp start pressure in increments of 0 5 from 4 cm H O to the pressure setting The patient also has access to this setting unless the ramp length is set to Off System One Humi
21. cy range 150 kHz to 80 MHz the field strengths should be less than 3 V m Chapter 10 EMC Information 72 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation Distance According to Frequency of Transmitter Power Output of meters Transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Watts outside ISM Bands in ISM Bands d 1 2 P d 2 3 P d ta P d 1 2 P 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 Pis 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 higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 4
22. cycled S T mode is similar to S mode except that the device also will enforce a set minimum breath rate by if necessary providing machine time triggered breaths For these breaths the inspiratory time is also a set value Timed Pressure Support A Bi level therapy mode where breaths are machine triggered and machine cycled T mode provides mandatory pressure assist with bi level pressures The patient s breathing rate has no effect on the machine rate or pressure levels The trigger to IPAP is determined by the breath rate setting and the cycle time is determined by the inspiratory time setting PC Pressure Control Pressure Support A Bi level therapy mode where each breath is patient or machine triggered and machine cycled PC mode is similar to S T mode except that all breaths are machine cycled This is a pressure limited machine or patient triggered time cycled mode The cycle time is determined by the Inspiratory Time setting Chapter 2 Therapy Modes and Features 14 AVAPS AE A novel Bi level therapy mode that provides an automatically adjusting EPAP Pressure Support and back up breath rate In AVAPS AE mode the device monitors the patient s upper airway resistance and automatically adjusts the delivered EPAP required to maintain a patent airway In this mode the AVAPS feature is always enabled This allows the device to automatically adjust Pressure Support to maintain a target tidal volume Refe
23. d in a 2 beep pattern This pattern repeats until the cause of the alarm is corrected or the audible alarm is paused The alarm descriptions later in this chapter display this indicator as 0 BiPAP A40 user manual 21 Informational Messages and Confirmation Audible Indicators When an informational message appears on screen a brief 1 beep audible indicator sounds Additionally when the device detects that a certain action has been completed for example when the Start Stop button is pressed to start therapy or when an SD card is inserted or removed from the device a brief 1 beep audible indicator sounds The alarm descriptions later in this chapter display this indicator as Q Note For the alarm indicators noted throughout this manual each diamond represents an audible beep 3 1 3 Alarm Messages When the ventilator detects an alarm the Alarms and Messages Screen is displayed showing a description of the alarm condition When an alarm message appears it will be highlighted in red if it is a high priority alarm or in yellow if it is a medium or low priority alarm The highlight color matches the alarm LED color on the Alarm Indicator Audio Pause button If an alarm is manually reset by the user the Alarms and Messages screen is removed and the Monitoring Screen is re displayed If the alarm self cancels the Alarms and Messages screen remains displayed but the highlight for the active alarm is removed the LED is unlit a
24. d the ventilator is unable to reach the target tidal volume setting The device continues to operate The alarm will automatically terminate when the target tidal volume is reached 3 4 2 System Alarms 1 Loss of Power This occurs when a complete power failure has occurred and power was lost while the device was providing therapy 2 Ventilator Inoperative Alarm This occurs when the ventilator detects an internal error or a condition that may affect therapy The device will shut down if the cause of the failure indicates that the device cannot deliver therapy 3 Low Battery Alarm This is a high priority alarm that occurs in two stages The medium priority alarm indicates that approximately 20 minutes of operation remain and the high priority alarm indicates that less than 10 minutes of operation remain Actual run time may be more or less than this and varies with battery age environmental conditions and therapy 4 Pressure Regulation Alarm This is a high priority alarm It occurs when the ventilator cannot regulate pressure within an acceptable accuracy The device continues to operate 5 Low Circuit Leak Alarm This is a high priority alarm It occurs when the device detects that the exhalation port is partially or fully occluded 6 High Temperature Alarm This is a high priority alarm It occurs when the device is close to reaching a high temperature limit The device continues to operate 7 AC Power Disconnected Alar
25. device by connecting a nurse call or Connector remote alarm adapter cable to this connector Side Cover If using a humidifier with the device this side cover can be easily removed with the release tab before attaching the humidifier Refer to the Humidifier Manual for more information Detachable If you are using the Philips Respironics Detachable Battery Module attach the Battery Battery Module Module here and insert the battery into the module See the instructions included with Connection the Detachable Battery Module for more information 1 6 1 Control Buttons The figure below shows the display screen and primary control buttons on the device Alarm Indicator Audio Pause Button SIT AVAPS 0 5 Display Screen OMEN gt ng 5 10 15 20 25 30 12 30 2010 06 12 PM wi Pr MenuA TEE Start Stop Button LED 29 Up Down Button Right Button Chapter 1 Introduction 10 Feature Description Display Screen Shows therapy settings patient data and other messages Start Stop Button Pressing this button when the device is off causes the device to enter Standby mode Pressing this button while therapy is being delivered displays a pop up screen that allows you to either turn the device off or return to Standby mode Alarm Indicator Audio Pause Button This button serves two purposes it temporarily silences the audible portion of an alarm and it also act
26. diated RF 3V m 10V m d 1 2 P 80MHzto 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 26 MHz to 2 5 GHz 23 P 800MHzto 2 5 GHz whereP 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 62 amp 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 Over the frequen
27. dification Select On to enable or Off to disable this humidification feature System One humidity control maintains a consistent mask humidity by monitoring and adjusting for changes in room temperature and room humidity Humidifier Increase or decrease this setting from 0 5 in increments of 1 When the setting is 0 the humidifier is off 0 is the lowest humidity setting while 5 is the highest setting Tubing Type Lock Select Off to allow users to change the tubing type in user mode Or select On so users cannot adjust their tubing type Chapter 5 Viewing and Changing Settings 46 27 Tubing Type This setting allows you to select the correct size diameter tubing that you are using with the device Select 22 mm for the Philips Respironics 22 mm tubing or 15 mm for the optional Philips Respironics 15 mm tubing The patient also has access to this setting if Tubing Type Lock is off 28 System One Resistance Lock Select Off to allow users to modify the System One resistance setting Or select On so users cannot adjust their System One resistance 29 System One Resistance Select from 0 5 or Invasive to set the System One resistance Choose 0 to turn System One Resistance compensation off Choose Invasive if you are using an invasive circuit with the device This setting allows you to adjust the level of air pressure relief based on the specific Philips Respironics mask Each Philips Respironics mask may have a Syste
28. e Main Menu screen use the Up Down key to highlight the My Settings item Press the Right key to select My Settings The My Settings screen will appear Follow the general instructions below to navigate and change any of the therapy settings 1 From the My Settings screen use the Up Down button to navigate to the setting you want to change and highlight it To modify a setting once it is highlighted press the Right Modify button Use the Up Down Edit button to scroll through the available settings Press Down to decrease the setting or press Up to increase the setting Once you have chosen the setting you want press the Right OK button to save the new setting Or if you decide not to change the setting press the Left Cancel button You can now either navigate to the next setting you want to change using the Up Down Navigate button or exit the My Settings menu by pressing the Left Finish button to return to the Main Menu You can change the following settings in the My Settings menu if they are enabled by your home care service provider Refer to the Therapy Settings section earlier in this chapter for details about each setting Tubing Type Rise Time Ramp Start Pressure Flex System One Resistance Humidifier BiPAP A40 user manual 53 5 8 2 Options Menu Items in Limited Access Mode The following settings are included in the Options menu when the device is in Limited access mode Refer to the Options
29. e Travel The device is suitable for use on airlines when it is operating from an AC or DC power source Note The device is not suitable for airline use with any modems or humidifiers installed 1 9 How to Contact Philips Respironics To have your device serviced contact Philips Respironics Customer Service department at 1 724 387 4000 or 49 8152 93060 Respironics Inc Respironics Deutschland 1001 Murry Ridge Lane Gewerbestrasse 17 Murrysville PA 15668 USA 82211 Herrsching Germany BiPAP A40 user manual BiPAP A40 user manual 2 Therapy Modes and Features 2 1 Device Therapy Modes Therapy Modes Description CPAP Continuous Positive Airway Pressure CPAP maintains a constant level of pressure throughout the breathing cycle Spontaneous Pressure Support A Bi level therapy mode where breaths are patient triggered and patient cycled The device triggers to IPAP Inspiratory Positive Airway Pressure in response to spontaneous inspiratory effort and cycles to EPAP Expiratory Positive Airway Pressure during exhalation The device also cycles a patient triggered breath if no patient exhalation effort is detected for 3 seconds The level of Pressure Support delivered is determined by the difference between the IPAP and EPAP settings PS IPAP EPAP S T Spontaneous Timed Pressure Support A Bi level therapy mode where each breath is patient triggered and patient cycled or machine triggered and machine
30. e detachable battery power source is lost and the device has switched to an alternate power source If detachable battery power returns the ventilator will beep but no message will appear on the display 3 5 What to Do When An Alarm Occurs Complete the following steps when an alarm occurs 1 Whenever an alarm occurs first always observe the patient and ensure that adequate ventilation and oxygenation if appropriate are available 2 Look at the alarm indicators and listen to the audible Alarm Indicator Audio Pause button red or yellow and whether the LED is solid or flashing 3 Look at the display to check the alarm message that appears on screen and whether it is highlighted in red or yellow 4 Press the Alarm Indicator Audio Pause button to temporarily silence the audible alarm A visual indicator displays ZX Or press the Left Reset button to reset alarm In case of Loss of Power use the Alarm Indicator Audio Pause button to both silence and terminate the alarm 5 Look up the alarm in the alarm descriptions in this chapter to determine the source of the alarm and the appropriate action Chapter 3 Ventilator Alarms 26 3 6 Alarm Summary Table The following tables summarize the high medium and low priority alarms and informational messages 3 6 1 Patient Alarms User Settable Priority Audible Visual Indicators Device User Action Action Circuit High 000 00 Red flashing button Operates Reconnect the pati
31. e that the oximeter is connected and show the data status When the device has Detailed View turned on the panel also displays the current SpO and Heart Rate readings If bad data is being read from the oximeter dashes appear next to the SpO and Heart Rate indicators Note Use only the oximetry device available from Philips Respironics 7 7 Philips Respironics DirectView Software You can use the Philips Respironics DirectView software to download the prescription data from the SD card to a computer DirectView can be used by clinicians to receive and report stored data from the SD card DirectView does not perform any automatic scoring or diagnosing of a patient s therapy data 7 8 Philips Respironics Encore Software You can use the Philips Respironics Encore software to download prescription data from the SD card to a computer Encore can be used by clinicians to receive and report stored data from the SD card 7 9 Carrying Case A carrying case is available for transporting your ventilator When traveling the carrying case is for carry on luggage only The carrying case will not protect the system if it is put through checked baggage 7 10 Detachable Battery and Detachable Battery Module A rechargeable Lithium lon detachable battery is available for the BiPAP A40 device You can connect the battery to the device and recharge it using the Detachable Battery Module See the instructions included with your detachable battery and Detac
32. ections on the Main Menu screen Safely Remove SD Card This option will appear if an SD card is inserted in the ventilator Select this option when you want to remove the SD card When the Remove SD Card confirmation message appears remove the card If you press the left cancel button or don t remove the card within 30 seconds the confirmation message will close and the ventilator will continue writing to the card Settings and Alarms View and change prescription settings and alarms Options View and change device settings such as Full or Limited Access mode Detailed View Language etc Alarm Log View a list of the 20 most recent alarms that have occurred Event Log View a list of all events that have occurred such as ventilator setting changes ventilator inoperative conditions alarms etc Information View detailed information about the device such as the device s software version and serial number Clear Patient Data This option appears on the Setup screen when the airflow is off and the device is in Standby It allows you to clear all patient data stored in the device memory and the device SD Card if inserted It also clears the Modem SD Card data However this will not clear the alarm log The alarm log must be cleared separately 5 6 1 Changing Device Settings and Alarms 1 From the Main Menu screen use the Up Down key to highlight the Settings and Alarms item 2 Press the Right key to select Settings and Ala
33. een eret teen ttnnnnnts 5 4 Accessing the Setup Screen eee tenente rtttnn tttm 38 5 5 Accessing the Monitor Screen e ettet ttes ttenntttnnnnes 39 5 5 Monitor Screen CONTAIN sasesana 39 5 6 Changing Settings in Provider Menu Access Mode 40 5 6 1 Changing Device Settings and Alarms s 40 5 6 2 Changing Options Menu Settings ente 47 5 6 2 1 Options Settings sirine iisa 47 5 6 3 Viewing the Alarm LOG eerte tte a 50 5 6 4 Viewing the Event LOG assisterer sr nnt tnnt nn Er ENE 50 5 6 5 Viewing Device Information eterne nn tttnnnnes 50 5 7 Updating Prescriptions Using the SD Card 51 5 8 Changing Settings in Limited Menu Access Mode 51 5 8 1 Changing My Settings Menu Items ente 52 5 8 2 Options Menu Items in Limited Access Mode 53 5 9 Display Symbols niter trei prex ue mile iim 53 Chapter 6 Cleaning and Maintenance eese teen ii n 55 6 1 Cleaning the Ventilator eerte nnt nnne tte nnttttnnnnts 55 6 1 1 Cleaning and Disinfection for Multiple Users 55 6 2 Cleaning and Replacing the Air Inlet Filter 56 6 3 Cleaning the Reusable Tubing ertet nnttnnnnnes 56 6 4 SEN VICE csi onere ette ER dE irte ty RE ec Feo ke cel acad eisen Chapter 7 ACCOSSOFICS sssssssssssessessssesssssssesssssssessscsssessnsssseesscsssess
34. en activated and then gradually increase to allow the patient to fall amp PAP asleep s Ramp If ramp is activated with AVAPS enabled orin start a md Ramp Button Pressed AVAPS AE mode it will reduce the maximum pressure support capability to IPAP Min or Pressure Support Min and ramp to the IPAP Max or Pressure Support Max In AVAPS AE mode the EPAP will reduce to the EPAP Min setting but is not ramped and Auto EPAP adjusts the pressure according to the patient s needs During the ramp period the IPAP or pressure support applied will be adjusted by the AVAPS algorithm but will be constrained by the current maximum ramp pressure set point The pressures with exception of EPAP in AVAPS AE mode will then ramp up to the original prescribed settings over the ramp time period Chapter 2 Therapy Modes and Features 16 2 2 4 Rise Time PRESSURE Rise Time If enabled the device provides a feature called Rise Time in S IPAP S T T PC and AVAPS AE modes Rise time is the amount of time it takes the device to change from EPAP the expiratory pressure setting to gt the inspiratory pressure setting a Rise time levels of 1 2 3 4 5 or 6 progressively reflect slowed response of the pressure increase that will take place at the beginning of inspiration A setting of 1 is the fastest rise time while a setting of 6 is the slowest Adjust the rise time to find the most comfortable setting for the patient Rise time cannot
35. ent Disconnect Circuit Disconnect circuit or fix the leak If alarm message continues to occur contact your home care service provider If the device will not exit circuit disconnect switch to an alternate source of ventilation High 000 00 Red flashing button Operates Report the alarm to your Apnea message home care service provider Continue using device High High 000 00 Red flashing button Operates Continue using device If Respiratory High Respiratory Rate alarm continues contact your Rate message home care service provider Low Minute High 000 00 Red flashing Operates Continue using device If Ventilation button Low Minute alarm continues contact your Ventilation message home care service provider Low Tidal High 000 00 Red flashing button Operates Continue using device If Volume Low Vte message alarm continues contact your home care service provider BiPAP A40 user manual 3 6 2 System Alarms Ventilator Inoperative Pressure Regulation Low Circuit Leak High Temperature Loss of Power Priority Audible a o i o a Visual Indicators Red flashing button Ventilator Inoperative message Red flashing button Pressure Regulation message Red flashing button Low Circuit Leak message Red flashing button High Temperature Message Red flashing button Blank screen Device Action Shuts down if can t provide therapy safely Or continues to operate at a limited level
36. erapy by selecting the Right Therapy key Selecting this key starts the airflow and displays the Monitoring screen 5 4 Accessing the Setup Screen 1 There are two ways to access the Setup screen Select Menu from the Standby screen Perform the Provider Menu Access Key Sequence from the Standby screen Settings And Alarms Options 2 You can access the device and therapy settings pesa from this screen The menu options vary based on Information your device setup A sample screen is shown here Navigate BiPAP A40 user manual 5 5 Accessing the Monitor Screen The Monitor screen appears after you press the Therapy key on the Standby screen There are two versions of this screen Simple View and Detailed View Samples of both screens are shown to the right 5 5 1 Monitor Screen Content The Monitor screen is divided into several panels the Monitor panel Date and Time panel Patient Accessory panel if attached and the Status panel In Simple View the Monitor screen displays the following 1 Monitor Panel a b Therapy mode Flex or AVAPS if enabled display next to the therapy mode along with the value setting Patient breath indicator displays below the therapy mode Peak pressure symbol appears on the graph Simple View 39 SIT AVAPS 0 5 amp Hao 0 5 10 15 20 25 30 11 03 2010 Mora GETTE Detailed View SIT AVAPS 0 5 amp Hzo 0 5 10 15 20 25 30 Pressure Vte Leak 12
37. es Message Priority Audible II Start On Battery PT BiPAP A40 user manual Visual Indicators High Priority Red flashing button Low Battery message On Status panel box around battery is red Yellow flashing button AC Power Disconnected message and a box appears around battery in use Solid yellow button Keypad Stuck message Replace Detachable Battery message appears If battery is nearing end of useful life message appears If battery fails message appears and button flashes yellow Solid yellow button Insert SD Card message Visual Indicators Card Error message Start On Battery message Device Action Switches to alternate power source Device Action Operates User Action Switch to an alternate battery or switch to AC power Check AC power adapter and reconnect it if it has become disconnected Make sure device is not connected to an overloaded AC circuit Check the keys to determine if they are lodged in the case If alarm continues place patient on alternate source of ventilation and contact your home care service provider Switch to an alternate battery or AC power source while replacing the current detachable battery Insert an SD card into the ventilator or remove the oximeter User Action Remove SD Card and use another card if available Ensure card meets specifications If condition persists contact your home care service pro
38. etween 1 and 40 BPM 5 6 1 1 Therapy Settings 1 Mode Change the Mode setting to one of the following therapy modes CPAP S S T T PC AVAPS AE 2 Trigger Type The device can be set to trigger breaths based on automatic flow thresholds or specific flow settings Change the Trigger Type to one of the following options Auto Trak Auto Trak Sensitive or Flow Trigger If Flow Trigger is selected then two set points will be available for adjustment Flow Trigger Sensitivity and Flow Cycle Sensitivity Flow Trigger Sensitivity Expiration to Inspiration The Flow Trigger Sensitivity may be adjusted from 1 to 9 l min in 1 l min increments The flow trigger initiates when the patient s inspiratory effort creates a flow equal to or greater than the flow sensitivity setting e Flow Cycle Sensitivity Inspiration to Expiration The Flow Cycle Sensitivity may be adjusted from 10 to 9096 in 196 increments As flow begins to decrease during inspiration if the patient flow is less than the flow cycle set point the device will cycle to expiration 3 CPAP Increase or decrease the CPAP pressure setting from 4 to 20 cm H O in increments of 0 5 BiPAP A40 user manual 10 11 12 43 Flex Lock Select Off to allow users to adjust the Flex setting Or select On so users cannot adjust their Flex setting Flex This setting is not available if AVAPS is enabled Set Flex to 1 2 or 3 to enable the setting
39. f multiple alarms occur at the same time all alarms are processed and displayed but the alarms are ordered first by priority and then by occurrence with the newest highest priority alarms at the top of the list The alarm precedence is in the following order high priority medium priority low priority and informational messages Note Not all alarms are available in every therapy mode some alarms are mode dependent 3 1 Audible and Visual Alarm Indicators When an alarm condition occurs The alarm LED indicator on the Alarm Indicator Audio Pause button lights The audible alarm sounds e A message appears on the screen describing the type of alarm Each of these is described in detail below 3 1 1 Alarm LED Indicators The Alarm Indicator Audio Pause button on the front of the ventilator lights up as follows whenever an alarm is detected Red Flashing Indicator When the device detects a high priority alarm the Alarm Indicator Audio Pause button flashes red Chapter 3 Ventilator Alarms 20 Yellow Flashing Indicator When the device detects a medium priority alarm the Alarm Indicator Audio Pause button flashes yellow Yellow Solid Indicator When the device detects a low priority alarm a solid yellow light appears on the Alarm Indicator Audio Pause button The Alarm Indicator Audio Pause button does not light up when informational messages or confirmation alerts display 3 1 2 Audible Indicators An audible ind
40. hable Battery Module for more information Chapter 7 Accessories 60 7 11 BiPAP A Series Roll Stand There is a roll stand available for use with your BiPAP A40 device Please see the instructions included with your roll stand for more information 7 12 In Use Bag An In Use bag is available for use with your BiPAP A40 device The bag is not for use with the humidifier The bag is designed to attach the ventilator to a wheelchair Please see the instructions included with the in use bag for more information BiPAP A40 user manual BiPAP A40 user manual 8 Troubleshooting This chapter lists some of the problems you may experience with your device and possible solutions to those problems Question Why isn t my device turning on The backlight on the buttons does not light Answer 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 and that 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 you are using an external power source Make sure your DC power cord and battery adapter cable connections are secure Check your battery It may need recharged or replaced Ifthe problem persists check the DC cord s fuse following the instructions supplied with your DC cord The fuse may need to be replaced If the problem still occurs cont
41. he order of the supervising physician The operator should read and understand this entire manual before using the device When making a therapy prescription or alarm setting change with the SD card the health care professional must review and verify any prescription changes before using the device The health care professional is responsible to ensure that the prescription settings are correct and compatible with the patient after using this feature Installing the wrong prescription for a particular patient may result in improper therapy lack of appropriate safety monitoring and injury to the patient The ventilator has a two stage low battery alarm The medium priority alarm indicates that approximately 20 minutes of operation remain and the high priority alarm indicates that less than 10 minutes of operation remain Actual run time may be more or less than this and varies with battery age environmental conditions and therapy Immediately seek an alternate power source when the Low Battery alarm appears Complete power failure and loss of power is imminent Do not use this device if the room temperature is warmer than 35 C 95 F because the temperature of the airflow may exceed 43 C This could cause thermal irritation or injury to the patient s airway Do not use the device while positioned in a warm place such as direct sunlight Device Start Up Make sure the device is working properly at start up when entering s
42. icator sounds whenever a power failure or a high medium or low priority alarm is detected Additionally an audible indicator sounds for informational messages and to confirm that certain actions have occurred for example when an SD card is inserted or removed from the device Ventilator Inoperative Audible Indicator When a ventilator inoperative alarm occurs a continuous audible alarm sounds The alarm descriptions later in this chapter display this indicator as un Power Failure Audible Indicator When a power failure occurs a series of beeps sounds in a 1 beep pattern repeating one second on then one second off The alarm descriptions later in this chapter display this indicator as 0 9 High Priority Audible Indicator When a high priority alarm is detected a series of beeps sound in the following pattern which is repeated twice 3 beeps a pause and then 2 more beeps This indicator continues until the cause of the alarm is corrected or the audible alarm is paused The alarm descriptions later in this chapter display this indicator as 000 00 Medium Priority Audible Indicator When a medium priority alarm is detected a series of beeps sound in a 3 beep pattern This pattern repeats until the cause of the alarm is corrected or the audible alarm is paused The alarm descriptions later in this chapter display this indicator as 0900 Low Priority Audible Indicator When a low priority alarm is detected a series of beeps soun
43. ils when using an SD card Prescription Change Failed Remove the card and have the prescription replaced with a valid prescription Prescription Failed Serial Number Remove the card and have the prescription replaced with the prescription with the correct serial number Prescription Failed Version Remove the card and have the prescription replaced with a prescription in the correct version BiPAP A40 user manual 63 Question Why isn t my detachable battery charging when it is inserted into the Detachable Battery Module and the ventilator is running on AC power Answer the battery may not charge if the device is too hot or too cold or is operating at an ambient temperature outside of the specified valid range Or the device may not have enough power to charge the battery if the humidifier is in use Make sure the device is not too close to a heat source Ensure the cooling air vents are not blocked Bring the ventilator to ambient room temperature Allow the battery to charge while the device is in Standby or while the airflow is on and humidifier is off Use the optional Philips Respironics Detachable Battery Charger to charge your battery Ifthe problem continues contact an authorized service representative or Philips Respironics to have the device serviced Please have the model number and serial number ready when you call If you are a patient please contact your home care service provider Cha
44. it is Functioning making unusual sounds if the device or detachable battery are dropped if water is Ventilator spilled into the enclosure or if the enclosure is cracked or broken discontinue use and contact Philips Respironics or an authorized service center for service If you are a patient please contact your home care service provider Circuit You should not rely on any single alarm to detect a circuit disconnect condition Disconnect The Low Minute Ventilation and Apnea alarms should be used in conjunction with the Circuit Disconnect alarm Test the operation of the circuit disconnect function whenever a change is made to the circuit An increase in circuit resistance can prevent proper operation of some alarms Chapter 1 Introduction Nurse Call and The Nurse Call output of this device is designed only for use with SELV Safety Extra Remote Alarm Low Voltage as described in IEC 60601 1 Do not connect the Nurse Call output of System this device to potentially hazardous voltages as severe injury or death may result The Nurse Call and Remote Alarm features should be considered a back up to the device s alarm system Do not rely solely on the Nurse Call feature When using a remote alarm or nurse call system make sure you fully test the connector and cable by verifying that Annunciated alarms on the ventilator are also annunciated on the remote alarm or nurse call system Disconnecting the remote alarm or nurse call cable fr
45. k the keypad hold the Right button down for 5 seconds Or press the Left Cancel button to cancel the Keypad Unlock action 3 Anaudible indicator sounds when the keypad is successfully unlocked Once the display is unlocked you can enter the Menu as you normally would by pressing the Up button There is a keypad lock inactivity time out period After you have unlocked the keypad as indicated the keypad will re lock after five minutes of inactivity The keypad automatically unlocks if an alarm or informational message occurs and remains unlocked while alarms are active Chapter 5 Viewing and Changing Settings 38 5 3 Accessing the Standby Screen 1 After you press the button the Startup screen appears momentarily indicating the device name and software version SIT AVAPS 0 5 2 The Standby screen then appears shown here It displays the date and time therapy mode a 12 12 2010 patient accessory panel if a patient accessory is 03 50 AM attached a status panel and the soft key panel 3 You can perform the following actions from the Standby screen a Ifahumidifier is connected you can activate ua E the humidifier preheat function by pressing Menu amp the Left Preheat key See the Accessories chapter for more information b Ifan accessory module is attached you can monitor the connection to any attached patient accessory c Access the menu by selecting the Up Menu key d Initiate th
46. m This is a medium priority alarm It occurs when the AC power source was lost and the device has switched to DC battery power The device continues to operate The alarm terminates when the ventilator begins operating from AC power again Chapter 3 Ventilator Alarms 24 8 Keypad Stuck Alarm This is a low priority alarm It occurs when a key becomes lodged inside the case of the device 9 Replace Detachable Battery Alarm The Replace Detachable Battery alarm occurs when the detachable battery is nearing the end of its useful life or a failure in the detachable battery that prevents it from charging or discharging has been detected The alarm can be an informational message or a medium priority alarm The device may continue to operate depending on the condition causing the alarm 10 Insert SD Card Alarm This is a low priority alarm It occurs when a pulse oximeter is connected to the ventilator and there is no SD card inserted in the ventilator The device continues to operate but no oximeter data is recorded on an SD card 11 Card Error Info Message This info message occurs when an unusable SD card is inserted into the ventilator The device continues to operate but data cannot be logged onto the SD card 12 Start On Battery Info Message This info message indicates that the ventilator has started on battery power and no AC power is available The device operator should verify that this is what is wanted 13 Check AC Power Suppl
47. m One Resistance Lock setting The patient also has access to this setting if System One Resistance Lock is off Note When the device is in AVAPS AE mode the invasive option under System One Resistance is not available 30 Circuit Disconnect Alarm This setting enables or disables the circuit disconnect alarm If enabled an audible alarm will sound when a large continuous air leak such as mask removal has been detected in the circuit Select Off to disable the alarm Or choose 15 or 60 seconds Selecting 15 or 60 means that the alarm will sound after the circuit has been disconnected for that amount of time 31 Apnea Alarm This setting enables or disables the apnea alarm If enabled an audible alarm will sound when an apnea is detected Select Off to disable the alarm Or increase or decrease the setting from 10 to 30 seconds in 10 second increments For example a setting of 10 means that the alarm will sound if the time between spontaneous breaths exceeds 10 seconds 32 Low Tidal Volume Alarm Select On to enable or Off to disable the Low Tidal Volume alarm When the alarm is enabled an audible indicator sounds if target tidal volume can t be reached This alarm is only available when AVAPS is enabled or in AVAPS AE mode BiPAP A40 user manual 47 33 Low Minute Ventilation Alarm This setting enables or disables the Low Minute Ventilation alarm The alarm activates when the calculated minute ventilation is less th
48. media Epistaxis causing pulmonary aspiration of blood Hypotension 1 5 Patient Precautions e Immediately report any unusual chest discomfort shortness of breath or severe headache If skin irritation or breakdown develops from the use of the mask refer to the mask instructions for appropriate action e The following are potential side effects of non invasive positive pressure therapy Ear discomfort Conjunctivitis Skin abrasions due to non invasive interfaces Gastric distention aerophagia Chapter 1 Introduction 1 6 System Overview The BiPAP A40 ventilator can provide non invasive or invasive ventilation The device augments patient breathing by supplying pressurized air through a patient circuit It senses the patient s breathing effort by monitoring airflow in the patient circuit and adjusts its output to assist in inhalation and exhalation This therapy is known as Bi level ventilation Bi level ventilation provides a higher pressure known as IPAP Inspiratory Positive Airway Pressure when you inhale and a lower pressure known as EPAP Expiratory Positive Airway Pressure when you exhale The higher pressure makes it easier for you to inhale and the lower pressure makes it easier for you to exhale The device can also provide a single pressure level known as CPAP Continuous Positive Airway Pressure The ventilator can be operated using AC power a detachable battery or an external batte
49. ments including domestic establishments and those directly connected to the public low voltage power supply network that supplies building used for domestic purpose Chapter 10 EMC Information 70 Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Compliance Level 6 kV contact 8 kV air 2 kV for supply mains Not Applicable 1 kV differential mode 2 kV for common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles 596 U gt 95 dip in U for 5 sec NOTE U is the a c mains voltage prior to application of the
50. n using the bacteria filter the device performance may be affected However the device will remain functional and deliver therapy 2 Connectthe tubing to the mask Refer to the instructions that came with your mask 4 3 2 Connecting an Invasive Circuit 1 Connect the flexible tubing to the air outlet on the side of the device a If required connect a bacteria filter to the device air outlet and then connect the flexible tubing to the outlet of the bacteria filter b When using the bacteria filter the device performance may be affected However the device will remain functional and deliver therapy BiPAP A40 user manual 33 2 If using connect an invasive humidifier or Heat Moisture Exchange filter HME An invasive humidifier meeting EN 1SO8185 is recommended 3 Connect the flexible tubing to the humidifier or HME and then place an exhalation device such as the Whisper Swivel Il in line on the patient end 4 Connect a trach adapter to the exhalation device if needed and then attach the patient s trachestomy tube 5 Refer to Chapter 5 to set the System One Resistance setting to Invasive 4 4 Supplying Power to the Device The device can operate on AC or DC power The ventilator accesses power from potential sources in the following order e AC Power External Battery e Detachable Battery Pack 4 4 1 Using AC Power An AC power cord and power supply is included with the device 1 Plug the socket end of the powe
51. nd the audible alarm stops 3 2 Silencing an Alarm When an alarm occurs you can temporarily silence the audible indicator by pressing the Alarm Indicator Audio Pause button The alarm is silenced for 60 seconds and then sounds again if the cause of the alarm has not been corrected Each time you press the Alarm Indicator Audio Pause button another 60 second period is initiated When Audio Pause is active the Alarm Indicator Audio Pause symbol EX appears if you are on the Monitor screen There is also a Pre silence alarm feature You can press the Alarm Indicator Audio Pause button at any time to begin a 60 second silence period If an alarm occurs during that time the audible indicator will not sound until the silence period ends Chapter 3 Ventilator Alarms 22 3 3 Resetting an Alarm The Reset button clears the currently active alarm s from the display and stops the LED and audible alarm indicator This button should be selected after the situation causing the alarm s has been corrected Pressing this button cancels all active alarms and restarts alarm detection The ventilator self cancels certain alarms if the cause of the alarm is corrected shutting off the alarm LED the audible alarm and the alarm background color You can manually reset an alarm by pressing the Left button Reset An active alarm silence function is cancelled when any alarm is manually reset 3 4 Alarm Descriptions This section describes all of the
52. nfirmation box with the message Writing Successful appears c If the write could not happen a confirmation box with the message Writing Failed appears Note The SD card does not need to be installed for the device to work properly Note Use only SD cards available from Philips Respironics For details on updating a prescription using the SD card see Chapter 5 7 3 Supplemental Oxygen Oxygen may be added anywhere in the patient circuit provided that a pressure valve is placed in line between the device and the oxygen source Refer to the oxygen warnings in Chapter 1 when using oxygen with the device 7 4 Nurse Call System You can use an institutional Nurse Call system with your device There are several Philips Respironics cables available to connect a nurse call system to the ventilator Refer to the instructions included with your cable assembly for details 7 5 Remote Alarm Unit You may use a Philips Respironics Remote Alarm unit with your device There is a dedicated adapter cable assembly for connecting the device to the Remote Alarm unit Refer to the instructions included with your Remote Alarm unit and adapter cable assembly for details BiPAP A40 user manual 59 7 6 Oximeter You can connect the recommended oximetry device to the ventilator to monitor SpO and heart rate levels When an oximeter is connected the Patient Accessory panel appears on the Standby and Monitor screens A heart icon will indicat
53. ng capacity Refer to the instructions supplied with the External Battery Cable for detailed information on how to operate the device using an external battery 4 4 2 2 Detachable Battery Philips Respironics offers a detachable Lithium lon battery pack You can connect the detachable battery to the device and recharge the battery using the Philips Respironics Detachable Battery Module Refer to the instructions included with your Detachable Battery Pack and Detachable Battery Module for more information BiPAP A40 user manual 35 Note The Detachable Battery pack will automatically recharge whenever it is connected to the therapy device and the device is running on AC power 4 4 3 Device Power Source Indicators There are many power source indicators on the device and the display screen These indicators are described in detail below 4 4 3 1 AC Power Indicators When AC power is applied to the device and the airflow is off the green AC LED indicator on the Start Stop button lights When AC power is applied and the airflow is on the white AC LED indicator on the Start Stop button lights 4 4 3 2 DC Power Indicators When DC power is applied to the device battery symbols will appear on screen to indicate the battery status The detachable and external battery symbols will only appear on screen if a detachable or external battery is attached to the device The shading in the battery icon indicates the power remaining in the batte
54. nsssscsssssssessussnsesasssssessnssssesssssnsessessneceacesnessees 7 1 Humidifier TI SD CANE e M 57 7 3 Supplemental Oxygen eerte ttt nter tenni tenni not ttts nonis 58 Table of Contents 7 4 Nurse Call System trier trita e einen 58 7 5 Remote Alarm UMitisssicsscssscecsscsccsesconscossescadscsnssicoussttevessdesssay esvettossesseectasdennesdonsecliesens 58 7 6 OXiMeler arne herren arenaen 59 7 7 Philips Respironics DirectView Software sentent 59 7 8 Philips Respironics Encore Software e eeseeeetenntennntnnn 59 pRe quDepercce acccsiadenarecsassiadsenieeneisi avian ania een ledn 59 7 10 Detachable Battery and Detachable Battery Module 59 7 11 BIPAP A Series Roll Stand essen ttenntennnttnnnttnnttnnd 60 PA PASEO Chapter 8 Troubleshooting Chapter 9 Technical Specifications Chapter 10 EMC Information Limited Warranty BiPAP A40 user manual BiPAP A40 user manual 1 Introduction 1 1 Package Contents The BiPAP A40 system may include the following components Some components are optional accessories that may not be packaged with the device Detachable Battery Ventilator Module Secure Digital White Ultra Fine Filter SD Card Reusable Gray Foam Filter amp Power Cord Retainer and Screw 1 2 Intended
55. o weeks and replace it with a new one every six months The white ultra fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty DO NOT clean the ultra fine filter 1 2 If the device is operating stop the airflow Disconnect the device from the power source Remove the filter s from the enclosure by gently squeezing the filter in the center and pulling it away from the device Examine the filter s for cleanliness and integrity 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 or damaged replace it Only Philips Respironics supplied filters should be used as replacement filters If the white ultra fine filter is dirty or torn replace it Reinstall the filters inserting the white ultra fine filter first if applicable 6 3 Cleaning the Reusable Tubing BP w N 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 and air dry 6 4 Service The device does not require routine servicing BiPAP A40 user manual BiPAP A40 user manual 7 Accessories There are several accessories available for your BiPAP A40 device Contact your home care service provider for additional information When using the accessories alw
56. ocal regulations for medical oxygen Do not connect the device to an unregulated or high pressure oxygen source When using oxygen with this system a Philips Respironics Pressure Valve must be placed at the device outlet Failure to use the pressure valve could result in a fire hazard Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame Do not use the device near a source of toxic or harmful vapors When using oxygen with this system turn the device on before turning on the oxygen Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device Explanation of the Warning When the device is not in operation and the oxygen flow is left on oxygen delivered into the tubing may accumulate within the device s enclosure Oxygen accumulated in the device enclosure will create a risk of fire EMC Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual The device should not be used adjacent to or stacked with other equipment For more information contact your home care service provider Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment See the EMC section of this manual for distances to observe between RF Generators and the ventilator to avoid interference Cleaning To avoid electrical sh
57. ock always unplug the power cord from the wall outlet before cleaning the device Never operate the device if any parts are damaged or if it is not working properly Replace damaged parts before continuing use Periodically inspect electrical cords and cables for damage or signs of wear Discontinue use and replace if damaged Repairs and adjustments must be performed by Philips Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly device damage Chapter 1 Introduction Cautions A caution indicates the possibility of damage to the device Electrostatic Do not use antistatic or conductive hoses or conductive patient tubing with the Discharge ESD device Condensation Condensation may damage the device If the device has been exposed to either very hot or very cold temperatures allow it to adjust to room temperature operating temperature before starting therapy A properly installed undamaged gray foam filter is required for proper operation Wash periodically and replace when damaged for proper operation Extension Cords Do not use extension cords with this device Device Placement Do not place the device in or on any container that can collect or hold water Do not place the device directly onto carpet fabric or other flammable materials Do not plug the device into an outlet controlled by a wall switch The heated humidifier can only be used when
58. of measure selected here Chapter 5 Viewing and Changing Settings 48 Breath Indicator Select Patient or Machine to choose whether the breath indicator flashes on screen during a patient triggered breath or a machine triggered breath The default is Machine Keypad Lock Select On to enable or Off to disable the Keypad Lock feature Keypad Backlight Turn the backlight On or Off using this setting Whenever you press the button to begin therapy the keypad backlight temporarily lights up Once therapy is being provided the keypad will be lit according to this Keypad Backlight setting If the setting is On the backlight remains on while therapy is provided If the setting is Off the backlight remains off while therapy is provided Note The Keypad Backlight setting does not turn the Start Stop button on or off 8 10 Screen Brightness Adjust the brightness of the screen backlight from 1 10 with 1 being the dimmest setting and 10 being the brightest Screen Saver You can change the screen saver to reduce power consumption or dim the screen in a dark room The following settings are available Dim The display s backlight is decreased so that the display is still visible but not as bright Breath The display appears as a black screen with only the patient breath indicator and manometer visible Off No screen saver displays and the display s backlight remains lit If enabled the screen saver displa
59. om the ventilator or from the remote alarm or nurse call system results in an alarm notification at the remote alarm Power Cord 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 Only use the power cords and nurse call cables recommended by Philips Respironics with the ventilator Use of power cords and cables not supplied by Philips Respironics may cause overheating or damage to the device Accessories When adding any components to the breathing system the flow resistance and dead space of the added components such as humidifiers and filters should be carefully considered in relation to the potential for adverse effects on the patient s ventilatory management and device alarms The use of accessories transducers and cables other than those specified by Philips Respironics may result in increased emissions or decreased immunity of the device BiPAP A40 user manual Oxygen When administering fixed flow supplemental oxygen the oxygen concentration may not be constant The inspired oxygen concentration will vary depending on the pressures patient flows and circuit leak Substantial leaks may reduce the inspired oxygen concentration to less than the expected value Appropriate patient monitoring should be used as medically indicated such as an alarming pulse oximeter When using oxygen with this system the oxygen supply must comply with l
60. ondition continues contact your home care service provider Replace depleted battery with another or switch to AC power if available Recharge depleted battery Check connection of the detachable battery to ventilator Check the charge available on detachable battery and recharge battery if necessary Chapter 3 Ventilator Alarms 30 BiPAP A40 user manual BiPAP A40 user manual 4 Device Setup 4 1 Installing the Air Filter The device uses a gray foam filter that is washable and reusable and a white ultra fine filter that is disposable The reusable filter screens out normal household dust and pollen while the 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 One reusable gray foam filter is supplied with your device A disposable ultra fine filter may also be included If your filter is not already installed when you receive the 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 with the smooth side facing toward the device 2 Insert the required gray foam filter into the filter area after the ultra fine filter Note If you are not using
61. ore the prescription update started A message appears on the display if errors occur during this process For details on the possible prescription errors refer to Chapter 8 Troubleshooting 5 8 Changing Settings in Limited Menu Access Mode The settings available to users are limited when the device is set to Limited access mode 1 Press the Up key to enter the Menu screens from the Standby or Monitor screens The Main Menu screen appears Choose from the following selections on the Main Menu screen Safely Remove SD Card This option appears if an SD card is inserted in the ventilator Select this option when you want to remove the SD card When the Remove SD Card confirmation message appears remove the card If you press the Left Cancel button or don t remove the card within 30 seconds the confirmation message will close and the ventilator will continue writing to the card My Settings View and change certain prescription settings such as rise time or ramp starting pressure if these settings were enabled by your provider Chapter 5 Viewing and Changing Settings 52 Options View and change certain device settings such as keypad lock or keypad backlighting Alarm Log View a list of the 20 most recent alarms that have occurred Information View detailed information about your device such as the device s software version and serial number 5 8 1 Changing My Settings Menu Items 1 2 From th
62. pter 8 Troubleshooting 64 BiPAP A40 user manual BiPAP A40 user manual 9 Technical Specifications Environmental Operating Storage Temperature 5 C to 35 C 41 F to 95 F 20 C to 60 C 4 F to 140 F Relative Humidity 15 to 95 non condensing 15 to 95 non condensing Atmospheric Pressure 101 kPa to 77 kPa approximately N A 0 2286 m 0 7500 ft Physical Dimensions 8 75 W x 7 25 L x4 25 H Weight Approximately 4 4 lbs Standards Compliance This device is designed to conform to the following standards IEC 60601 1 Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests SO 10651 6 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6 Home care ventilatory support devices ISO 10993 1 Biological evaluation of medical devices Part 1 Evaluation and testing Biocompatibility e RTCA DO 160F section 21 category M Emission of Radio Frequency Energy Chapter 9 Technical Specifications 66 Electrical AC Voltage Source 100 to 240 VAC 50 60 Hz 1 2 A DC Power Source 12 VDC 5 0 A External Battery 24 VDC 4 2 A Power Supply Type of Protection Against Electric Shock Class Il To be used with external Class Il power supply only Degree of Protection Against Elec
63. r 5 Viewing and Changing Settings 44 13 14 15 16 17 18 19 Breath Rate Use the Breath Rate setting to establish the minimum rate of mandatory breaths that the ventilator will deliver per minute Increase or decrease the Breath Rate setting in increments of 1 as follows S T and PC modes from 0 to 40 BPM T mode from 4 to 40 BPM AVAPS AE mode Auto or from 0 40 BPM Note Setting the Breath Rate to 0 turns the setting off Inspiratory Time Adjust the Inspiratory Time setting from 0 5 to 3 0 seconds in 0 1 second increments Inspiratory Time is the duration for the inspiratory phase of a mandatory breath Maximum Pressure This setting displays in AVAPS AE mode AVAPS AE limits the pressure delivery to the Maximum Pressure setting Increase or decrease the setting from 6 to 40 cmH O in increments of 0 5 cmH O Pressure Support Max This setting displays in AVAPS AE mode Increase or decrease the setting from 2 to 36 cmH O in increments of 0 5 cmH O The Pressure Support Max Pressure must be equal to or greater than the Pressure Support Min value Pressure Support Min This setting displays in AVAPS AE mode Increase or decrease the setting from 2 to 36 cmH O in increments of 0 5 cmH O The Pressure Support Min Pressure must less than or equal to the Pressure Support Max value EPAP Max Pressure This setting displays in AVAPS AE mode Increase or decrease the setting from 4 to 25 cmH O in in
64. r cord into the power supply 2 Plug the pronged end of the 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 ventilator 4 Ensure that all connections are secure Chapter 4 Device Setup 34 5 There is an accessory clip that can be used to secure the power cord to prevent accidental disconnection Route the cords through the clip and secure the clip to the enclosure of the device using the supplied screw as shown pe e Y N J ZO 8 eg IN IN Note Some devices have a locking type power connector To avoid damage to the connector when disconnecting the power cord pull the connector at its base not the cord to disengage the lock 4 4 2 Using DC Power You can operate the ventilator using an external battery or detachable battery pack 4 4 2 1 External Battery The ventilator can operate from a 12 VDC lead acid battery using the Philips Respironics External Battery Cable This cable is pre wired and properly terminated to ensure safe connection of an external battery to the ventilator Battery operating time depends on the characteristics of the battery and usage of the device Due to a variety of factors including battery chemistry age and use profile the capacity of the external battery as shown on the device display is only an estimate of the actual remaini
65. r to the description of AVAPS in Section 2 2 Therapy Features The required Pressure Support is delivered above the automatic EPAP setting Additionally when the Breath Rate is set to Auto the device will automatically adjust the back up breath rate based on the patient s spontaneous respiratory rate 2 2 Therapy Features If prescribed for you the device provides the following therapy features 2 2 1 AVAPS Average Volume Assured Pressure Support AVAPS is a feature available in the S S T PC and T modes In AVAPS AE mode the AVAPS feature is always enabled AVAPS helps patients maintain atidal volume VT equal to or greater than the target tidal volume Tidal Volume setting by automatically controlling the pressure support PS provided to the patient The AVAPS feature adjusts PS by varying the IPAP level between the IPAP Min and IPAP Max settings or Pressure Support Min and Pressure Support Max in AVAPS AE mode AVAPS will retain the learned PS for the patient so that each time therapy is started the PS will start at the learned PS The AVAPS algorithm in the BiPAP A40 contains an improvement to more accurately achieve and maintain the target tidal volume The muscle effort of a spontaneous breath typically results in a larger tidal volume than a machine breath delivered at the same pressure The new AVAPS algorithm will adjust the pressure slightly on machine delivered breaths to compensate for this difference and
66. rms BiPAP A40 user manual 41 The device settings are listed below along with the therapy modes in which they are available The following settings are common to all therapy modes Therapy Mode System One Resistance Lock Ramp Length e System One Resistance System One Humidification Circuit Disconnect Humidifier Apnea Tubing Type Lock Low Minute Ventilation Tubing Type High Respiratory Rate The settings below are specific to the modes listed in the table Therapy Modes 1 1 1 1 Trigger Type X Auto Trak Auto Trak Sensitive Flow Trigger Flow Trigger Sensitivity Flow Cycle Sensitivity CPAP Flex Lock Flex AVAPS AVAPS Rate Tidal Volume IPAP Max Pressure IPAP Min Pressure Lan LONE x x NNI hm x x I ere x fx Cd Iepeoyme x fx mamoms i L Fressuresupponwax IT Frressuresupponwin II amaes OOOO DIT amines Sid Sid Cid Sd Imemewk 1 X 1 X x x X X X X X X x3 d x x x x x X X X X X gt lt x ee EE 1 4 1 E lt lt X lt Chapter 5 Viewing and Changing Settings 42 Therapy Modes Remme mT x if x x x 1 Only available when AVAPS is enabled 2 AVAPS and Rise Time are not available when Flex is enabled 3 Flex is not available when AVAPS is enabled 4 Inspiratory time is only available in AVAPS AE when the breath rate is set b
67. ry Refer to the Display Symbols table in Chapter 5 for information on each battery symbol Battery External Battery Detachable Battery Chapter 4 Device Setup 36 There are several DC power indicators that will display on screen to indicate which battery is in use if applicable if the batteries are low charging or discharged etc The following table explains all of the DC power indicators DC Power Indicator Battery in Use Indicator Green Fully Charged Battery Indica tor Partially Charged Battery Indicator Yellow Low Battery Indicator Me dium Priority Red Low Battery Indicator Yellow Battery Recharging Symbol d BiPAP A40 user manual Description A black box will appear around the battery that is in use For instance if the external battery is currently in use the symbol appears on screen When a battery is charged to greater than 90 of its capacity all of the bars in the battery symbol will appear in green When a battery symbol is partially charged some of the bars in the battery symbol will appear in green while oth ers will be clear For instance if the external battery is 50 charged the following symbol displays on screen When the device detects that an in use battery s charge is low has approximately 20 minutes of charge left the inside of the box surrounding the battery symbol turns yellow In addition a medium priority alarm message will display indicating
68. ry See Chapter 4 for more information Several accessories are available for use with the device Contact your home care service provider to purchase any accessories not included with your system The following figure illustrates some of the device connectors and features described in the table that follows Detachable Battery Module Connection Nurse Call Accessory Slot Cover Shown Connector SD Card Slot i P m EL Js r 3 3 1 EN DC Power Inlet L AY AC Power Inlet Side Cover Filter Area BiPAP A40 user manual Feature Description Air Outlet Port Connect the flexible tubing here SD Card Slot If applicable insert the optional SD card here Accessory Slot If applicable an optional accessory such as the Broadband Oximetry modem can be with cover installed here Refer to the instructions supplied with your accessory When not using an accessory the cover must be in place on the device AC Power Inlet Connect the AC power adapter here DC Power Inlet Connect an external battery here using the Philips Respironics DC power cord Filter Area A reusable gray foam filter must be placed in the filter area to screen out normal household dust and pollen A white ultra fine filter can also be used for more complete filtration of very fine particles Nurse Call Connect a nurse call or remote alarm system to the
69. s as an alarm indicator See Chapter 3 for more information Up Down Button This button allows you to navigate the display menu and edit device settings Left and Right Buttons These buttons allow you to select display options or perform certain actions specified on screen BiPAP A40 user manual 1 7 Symbols The following symbols appear on the device Symbol Description Start Stop Alarm Indicator Audio Pause For Airline Use Complies with RTCA DO 160F section 21 category M IR e DC Power AC Power Supply connection for the AC DC power supply DC Battery Voltage connection for an external battery Consult accompanying instructions for use Type BF Applied Part Class Il Double Insulated Exposure Protection Separate collection for electrical and electronic equipment per EC Directive 2002 96 EC be SOI OTT a Chapter 1 Introduction 12 1 8 Traveling with the System 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 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 1 8 1 Airlin
70. states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you Accessories and replacement parts including but not limited to circuits tubing leak devices exhaust valves filters and fuses are not covered under this warranty 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 Deutschland Gewerbestrasse 17 82211 Herrsching Germany 49 8152 93060 Limited Warranty 74 BiPAP A40 user manual
71. t from the Standby screen the Setup screen appears 3 Anaudible indicator sounds indicating you are now in Full Menu Access mode 4 Youcan access the Options menu and permanently change the Menu Access setting to Full Otherwise the device will return to Limited mode once you exit the menu screens or if one minute passes without pressing any device buttons Note Chapter 5 provides detailed descriptions of the Full and Limited Menu screens Note Philips Respironics recommends that you set the device back to Limited Menu Access mode before returning it to the patient so patients cannot change their prescription settings Respironics Inc Respironics Deutschland ce 1097811 1001 Murry Ridge Lane Gewerbestrasse 17 Murrysville PA 15668 USA 82211 Herrsching Germany ossis ee EC REP JJB 03 22 2012 BiPAP A40 user manual Table of Contents Chapter 1 Introduction uicti toto te tette teria m dbi E oce due 1 1 1 Package Contents retteretesttos retenu tesic ets essersi obrero ces eet tatata Rs 1 1 2 Intended 1 1 3 Warnings and Cautions iaceret tercer rese a 2 Ere 2 EIU c M a 6 Dc cI 6 1 4 ContraindicatiIOns ds cerent se b br pe NH REN Mut 7 1 5 Patient Precautions 2 ee RREA 7 1 6 System Overview iacere essen 8 16 1 Control BULEtOEIS iecoris ettet rer
72. t pulses are delivered by the device The device evaluates the response Clear Airway of the patient to the test pulse s and assesses whether the apnea has occurred while the Apnea patient has a clear airway or an obstructed airway The airway is determined to be clear Detection 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 Detection 10 second or longer 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 A persistent waning and waxing breathing pattern which repeats itself between 30 and 100 Breathing 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 Hypopnea A hypopnea is detected when there is
73. tandby mode Always verify that the audible tone sounds and the alarm LEDs light red then yellow momentarily Contact Philips Respironics or an authorized service center for service if these indications do not occur at start up See Chapters 4 and 5 for more information about device start up Bacteria Filter Philips Respironics recommends that a main line outlet bacteria filter be used whenever the device is used on multiple patients Therapy Modes The AVAPS AE mode is for non invasive use on adult patients only Features Patient Circuits The ventilator should only be used with patient interfaces e g masks circuits and exhalation ports recommended by Philips Respironics Proper operation of the device including alarms with other circuits has not been verified by Philips Respironics and is the responsibility of the health care professional or respiratory therapist An exhalation port is required Do not block the exhalation port This can reduce airflow and result in rebreathing of exhaled air At low expiratory pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing some rebreathing may occur When using a patient circuit with a full face mask the mask must be equipped with a safety entrainment valve Make sure that the safety entrainment valve is functioning properly with the ventilator Improperly If you notice any unexplained changes in the performance of the device if
74. throughout the night the algorithm will learn the correct amount of pressure adjustment to apply to machine triggered breaths If IPAP Max is reached and the target tidal volume is not achieved the Low Tidal Volume alarm activates if enabled BiPAP A40 user manual 15 2 2 1 1 AVAPS Rate The AVAPS Rate setting allows you to adjust the maximum rate at which the pressure support automatically changes to achieve the target tidal volume The actual rate may be less than this maximum setting depending on how far the current estimated tidal volume is from the target tidal volume A higher rate allows the AVAPS algorithm to change pressure support faster to meet the target tidal volume It can be set from 0 5 cmH O per minute to 5 0 cmH O per minute in increments of 0 5 cmH O per minute 2 2 2 Bi Flex Comfort Feature If enabled the device provides a comfort feature called Bi Flex in S mode only The Bi Flex attribute adjusts therapy by inserting a small amount of IPAP EX EAE T v E pressure relief during the latter stages of inspiration and during active exhalation the beginning part of Epap exhalation Bi Flex levels of 1 2 or 3 progressively reflect increased pressure relief that will take place at the end of inspiration and at the beginning of Bi Flex 5 gt expiration Time 2 2 3 Ramp The device is equipped with an optional ramp sw Ramp Time i feature The ramp feature is designed to offer ee lower pressures wh
75. tric Shock Type BF Applied Part Degree of Protection against Ingress of Water Drip Proof IP22 Mode of Operation Continuous SD Card and SD Card Reader Use only SD cards and SD card readers available from Philips Respironics including the following SanDisk Card Reader Writer SanDisk ImageMate REF SDDR 99 A15 Control Accuracy Parameter Range Accuracy IPAP 4 40 cm H O 2 5cm H O EPAP 4 25cm H O 2 5cm H O CPAP 4 20 cm H O 2 5 cm H O 0 to 40 BPM greater of 1 BPM or 10 of setting 0 5 to 3 seconds 10 of setting 0 1 second Specifications listed are based on using a standard patient circuit Philips Respironics 15 or 22 mm tubing Whisper Swivel Il Pressure measured at the patient connection port with or without the integrated heated humidifier no patient flow BiPAP A40 user manual 67 Displayed Parameter Accuracy Parameter Accuracy Resolution Range 20 of reading 10 of reading Exhaled Minute Ventilation Calculation based on 0 1 LPM 0 to 25 LPM Exhaled Tidal Volume and Respiratory Rate Estimated Patient Pressure 2 5 cmH O 0 1 cmH O 0 to 40 cm H O E Ratio Calculation based on 9 9 1 to 1 9 9 Inspiratory time and Expiratory time Displayed parameter accuracies are based on ambient bench top conditions at an altitude of nominally 380 meters All flow based parameters are expressed in volumetric flow Pressure measured at the patient connection port with or without
76. ttings and system settings You can use the Up Down buttons to scroll through the information You can also view the Information screen by holding the Down key for 5 seconds when in the Monitor screen This causes the detailed view of the Monitor Screen and the Information Screen to be displayed temporarily BiPAP A40 user manual 51 5 7 Updating Prescriptions Using the SD Card You can update the patient s prescription using the SD Card The prescription update can occur either when the ventilator is off or on 1 Insert an SD Card with a valid prescription into the device A Change Prescription message appears on the display Select Yes to start the prescription update process Select No to cancel the prescription update process and return to the previous display Select Page to review the entire prescription Select Cancel to cancel the prescription update process and return the screen to the initial state before the prescription update started Once the entire prescription has been reviewed a screen displays with the option to Cancel or OK the changes Select OK to complete the prescription update and display the Prescription Change confirmation screen Select Cancel to cancel the prescription update process and return the screen to the initial state before the prescription update started If the SD card is removed at any time during the prescription update the process aborts and the screen returns to the initial state bef
77. ventilator alarms and informational messages 3 4 1 Patient Alarms User Settable 1 Circuit Disconnect Alarm This is a high priority alarm It occurs when the breathing circuit is disconnected or has a large leak The device continues to operate The alarm will automatically terminate when the circuit is reconnected or the leak is fixed 2 Apnea Alarm This is a high priority alarm It occurs when the patient has not triggered a breath within the time specified in the apnea alarm setting The device continues to operate The alarm will automatically terminate when two consecutive patient breaths are detected that meet the apnea alarm time setting 3 High Respiratory Rate Alarm This is a high priority alarm It occurs when the respiratory rate is greater than the High Respiratory Rate alarm setting The device continues to operate The alarm will automatically terminate when the measured respiratory rate is less than the High Respiratory Rate alarm setting 4 Low Minute Ventilation Alarm This alarm is a high priority alarm It occurs when the patient s minute ventilation is less than the Low Minute Ventilation alarm setting The device continues to operate The alarm will automatically terminate when the calculated minute ventilation is greater than the Low Minute Ventilation alarm setting BiPAP A40 user manual 23 5 LowTidal Volume Alarm This is a high priority alarm It occurs when AVAPS is enabled or in AVAPS AE mode an
78. ventilator s exterior surface and the exterior of the detachable battery pack compartment and battery pack if using should be cleaned before and after each patient use and more often if needed 1 Unplug the device and clean the front panel and exterior of the enclosure as needed using a clean cloth dampened with water and a mild detergent 2 Inspect the device and tubing for damage after cleaning Replace any damaged parts 3 Allow the device to dry completely before plugging in the power cord 6 1 1 Cleaning and Disinfection 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 When using the device on multiple users complete the following steps to clean and disinfect the device before each new user 1 Unplug the device before disinfecting 2 Disinfect the outside of the device only Use a cloth with one of the following cleaning agents to clean the exterior of the device Hydrogen Peroxide 396 91 Isopropyl Alcohol Vinegar 596 acidity Water Chlorine bleach household 5 25 sodium hypochlorite 1 to 5 part reduction with water Chapter 6 Cleaning and Maintenance 56 3 DisCide Towelettes Allow the device to dry completely before plugging in the power cord 6 2 Cleaning and Replacing the Air Inlet Filter Under normal usage you should clean the gray foam filter at least once every tw
79. vider Check battery status Connect to AC power source as soon as possible Message Audible Priority Check AC Power Supply Info Battery Disconnected Battery Discharging Stopped Due to Temperature Battery Not Charging Due to Temperature Battery Not Charging Battery Depleted Detachable Battery Disconnected Visual Indicators Check AC Power Supply message Batt Disconnected message Batt Discharge Stopped Temp message Batt Not Charging Temp message Detach Battery Not Charging message External Battery Depleted message Detachable Batt Disconnected message and a box appears around battery in use Device Action Switches to alternate power source 29 User Action Connect ventilator to a battery and remove AC power Replace the AC power supply If condition persists contact your home care service provider Check the connection to the battery if not an intentional disconnection Move device to cooler location Make sure device is not close to a heat source Make sure cooling vents are not blocked If condition persists contact your home care service provider Make sure device is not close to a heat source Make sure cooling vents are not blocked Move device to a cooler location If device is too cold allow it to warm up If condition persists contact your home care service provider Replace the battery or find an alternate power source If c
80. y Hours This setting displays the total time the patient receives therapy You can reset this value Chapter 5 Viewing and Changing Settings 50 5 6 3 Viewing the Alarm Log 1 From the Main Menu screen use the Up Down key to highlight the Alarm Log item 2 Press the Right key to select Alarm Log The alarm log displays the alarms in chronological order with the most recent events displayed first It lists the 20 most recent alarms or messages that appeared on the device display The alarm log can be cleared when in Full Menu access mode but not when the device is in Limited Menu access mode Press the Right Clear key to clear the alarm log Note Depending on how many alarms have occurred the alarm log may be up to 4 pages long 5 6 4 Viewing the Event Log 1 From the Main Menu screen use the Up Down key to highlight the Event Log item 2 Press the Right key to select Event Log The event log displays a list of all events that have occurred in chronological order with the most recent events displayed first The event log is available in Full Menu access mode but not in Limited Menu access mode 3 If desired press the Right Clear key to clear the event log 5 6 5 Viewing Device Information 1 From the Main Menu screen use the Up Down key to highlight the Information item 2 Press the Right key to select Information The Information screen provides you with a summary of the current prescription settings device se
81. y Info Message This info message occurs when the AC power input to the ventilator is incorrect The device continues to operate but therapy may not start 14 Battery Disconnected Info Message This info message occurs when the battery is disconnected from the ventilator while operating The device continues to operate on AC power 15 Battery Discharging Stopped Due to Temperature Info Message This info message occurs when the detachable battery becomes overheated while providing power for the device The device continues to operate The battery is not used and the power source is switched to the next available power source BiPAP A40 user manual 25 16 Battery Not Charging Due to Temperature Info Message This info message occurs when the detachable battery becomes too hot while charging or the device was in too cold or hot an environment before charging started The device continues to operate Battery charging stops until the battery cools or warms sufficiently 17 Battery Not Charging Info Message This info message occurs when the device has detected a condition that prevents the battery from accepting a charge The device continues to operate Battery charging stops 18 Battery Depleted Info Message This info message occurs when the external battery is fully depleted The device continues to operate using the detachable battery if it is available 19 Detachable Battery Disconnected Info Message This info message occurs when th
82. ys after 5 minutes of no keypad activity Pressing any button on the device will exit the screen saver Additionally any alarm or informational message will also exit the screen saver Date Format Select either mm dd yyyy or dd mm yyyy as the date format that will display on the device screens BiPAP A40 user manual 49 11 Time Format Select either an AM PM time format hh mm AM or 24 Hour time format hh mm For example 2 49 PM or 14 49 12 Month The month defaults to the current month The adjustable range is from 1 January 12 December 13 Day The day defaults to the current day The adjustable range is from 1 31 The maximum value is based on the selected month 14 Year The year defaults to the current year The adjustable range is from 2000 2099 15 Hour The hour defaults to the current hour The adjustable range is from 12 AM 12 PM or 0 23 depending on the selected Time Format 16 Minute The minute defaults to the current minute The adjustable range is from 0 59 17 Blower Hours Displays the number of hours that the blower has been active since the last time this value was reset You can reset this value to zero if desired e g each time you give the device to a new patient Note The Machine Hours displayed on the Information screen indicates the total number of hours that the blower has been working over the life of the device This value cannot be reset 18 Therap

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