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Respironics BIPAP Auto SV

1. in en nen riesen 5 1 5 153 SUPBLYING POWER TO THE DEVICE c 57 ntis rt PREDA ERE 5 2 5 154 5 3 ENTERING PROVIDER MODE rrr HE PREX ED RUROR EE ET TEE USER ER USE 5 5 5 1 6 PERFORMANCE VERIFICATION un ehe Di nennen Eee 5 5 5 2 SETTING UP THE DEVICE 5 3 CONNECTING THE PATIENT 5 4 SETTING UP THE SMARTCARD sc urn He E T P UE eo Deoa 5 6 gA t DOWNLOADING DATA innen en seien 5 6 5 2 2 PROGRAMMING A SMARTCARD i unsre ieh REY PER EXE EHE EE EP PAESE 5 6 5 4 3 CHANGING SETTINGS USING 010 eee EPEE A enne enne tenen reset enne 5 6 CHAPTER 6 CHANGING SETTINGS Ans nei ee EE HR C Re PUDE UE CHANGING SETTINGS IN PROVIDER MODE 6 1 1 NAVIGATING SCREENS IN PROVIDER MODE 6 1 2 CHANGING SETTINGS IN PROVIDER MODE 6 2 MONITORING MEASURED PARAMETERS 3 20 6 nenne 6 3 CHANGING SETTINGS IN USER MODE eye vs Provider Manual CHAPTER UAM ID CRT 7 1 7T ALARM INTRODUCTION DEE irie ETE esse nee erregen 7 1 7 1 1 OVERVIEW OF ALARM BEHAVIOR uhren e YER TESE E T EENE 7 1 7 2 SY SEEM rev etre dete een ea neos ue dere ate
2. Apnea Alarm Setting screen is shown in Figure 6 10 This setting enables or disables the audible alert a beeping sound when an apnea is detected Figure 6 10 Apnea Alarm Setting Screen Change the apnea alarm setting by pressing the HEAT and RAMP buttons until the desired setting is reached You can increase or decrease the time from 0 to 40 seconds in 10 second increments 0 disables the apnea alarm 10 means that the alarm sounds if the time between spontaneous breaths exceeds 10 seconds 20 means that the alarm sounds if the time between spontaneous breaths exceeds 20 seconds 30 means that the alarm sounds if the time between spontaneous breaths exceeds 30 seconds 40 means that the alarm sounds if the time between spontaneous breaths exceeds 40 seconds Provider Manual 6 6 10 Patient Disconnect Alarm Setting Screen 11 12 The Patient Disconnect Alarm Setting screen is shown in Figure 6 11 PATIENT SETUP Figure 6 11 Patient Disconnect Alarm Setting Screen This setting enables or disables the audible alert a beeping sound when a large continuous air leak such as mask removal has been detected in the circuit To change the patient disconnect alarm setting press the HEAT and RAMP buttons until the correct setting appears You can increase or decrease the setting between 0 15 and 60 seconds e 0 disables the patient disconnect alarm e 15 means that the alarm sounds after the patient has be
3. RESPIRONICS BiPAP autoSV teses Provider Manual Ihis BiPAP system is covered by one or more of the following patents U S Patent Nos 5 148 802 5 239 995 5 313 937 5 433 193 5 632 269 5 803 065 6 029 664 6 305 374 and 6 539 940 Australian Patent Nos 638054 661575 698519 723681 734319 and 733655 Canadian Patent Nos 2 024 477 2 162 981 and 2 259 795 European Patent No EP0425092 German Patent No 69021681 5 08 and Japanese Patent Nos 2832812 2137336 and 2926392 Other U S and foreign patents pending 2007 Respironics Inc and its affiliates All rights reserved TABLE or CONTENTS 4 1 2 CONTROL BUTTONS 4 1 3 INDICATORS 4 1 4 AUDIBLE ALARMS AND INDICATORS ire rper ee Rete Ere NY eee RP Ae Enea 4 4 4 2 NAVIGATING THE SCREENS ehe I oap nep ror 4 4 4 2 1 EBID Backizokr FOR BUTTONS i arten ie YET 4 5 4 3 PATIENT CIRCUIT CONNECTION anne seinen KEY de PER FERE ET RE FREE XE E Re Y om ERR eap ue 4 5 4 4 REAR PANEL 4 5 SMARTCARD CHAPTER 5 SETUP ERR ERES EFE ERU LEER ERE EB REEF TIEFEN S I PREPARING THE DEVICE anheben ankam einer 5 S E EL INSTALLING EHE ri Pr ERE Er Rr DER Ee EA UE eU rep EXER TERRE LR Cro 5 5 192 ASSEMBLING THE PATIENT CIRCUIT
4. 2 cm H O measured at the patient end of the circuit with a Whisper Swivel and no patient flow he range of values correspond to tenths of seconds e g a setting of 4 indicates a Rise Time of 0 4 seconds Measured at the patient end of circuit with a Whisper Swivel II exhalation device and no patient flow MeasureD PARAMETER ACCURACY Parameter Accuracy Respiratory Rate Greater of 1 BPM or 10 of reading when measured over a four minute period Exhaled Tidal Volume 25 0 15 of reading ml Exhaled Minute 1 0 15 of reading L min Ventilation Leak Rate 5 0 15 of reading L min Provider Manual 12 3 TRIGGERS AND CYCLES Patient Inspired Volume ml Spontaneous Trigger Shape Trigger Volume 6 ml above Vleak Spontaneous Cycle Spontaneous Expiratory Threshold SET e IPAP Maximum of 3 0 seconds CONNECTOR The patient interface port is a 22 mm tapered connector DisPosAL Dispose of this device in accordance with local regulations Pressure Drop Versus FLow For PATIENT Circuits The device automatically compensates for pressure drops associated with a 6 foot 182 9 cm smooth bore tube Additional pressure drops will occur when restrictive elements are added to the patient circuit The following graph shows the additional pressure drop when adding 1 A bacteria filter 2 A bacteria filter and a Respironics Pass over humidifier NOTE Always use a
5. 7 3 PATIENT ALARMS The device has the following patient alarms e Apnea e Patient Disconnect Low Minute Ventilation 7 3 1 APNEA ALARM Figure 7 6 shows the alarm screen ALARM APNEA Figure 7 6 Apnea Alarm Screen The Apnea alarm is a high priority alarm that detects the cessation of spontaneous breathing It occurs when the time between spontaneous breaths exceeds the Apnea alarm time setting 10 20 30 or 40 seconds See Chapter 6 for information on how to set the Apnea alarm time When an apnea alarm occurs APNEA and ALARM flash on the display and the LCD backlight is turned on NOTE setting of zero disables the Apnea alarm This alarm does not automatically reset Press the RESET button to manually reset the alarm 7 3 2 Patient Disconnect ALARM Figure 7 7 shows the alarm screen ALARM PATIENT Figure 7 7 Patient Disconnect Alarm Screen The Patient Disconnect alarm is a high priority alarm It occurs when the patient is disconnected from the device for the time specified in the Patient Disconnect alarm time setting 0 15 or 60 seconds See Chapter 6 for information on how to set the Patient Disconnect alarm time When a patient disconnect alarm occurs PATIENT and ALARM flash on the display and the LCD backlight is turned on NOTE setting of zero disables the Patient Disconnect alarm This alarm does not automatically reset Press the RESET button to manually reset the alarm Provider Manual 7 6
6. 733 Low Minute VENTILATION ALARM Figure 7 8 shows the alarm screen ALARM MinVent Figure 7 8 Low Minute Ventilation Alarm Screen The Low Minute Ventilation alarm is a high priority alarm It occurs when the calculated minute ventilation is less than or equal to the alarm setting See Chapter 6 for information on how to set the Low Minute Ventilation alarm time When a Low Minute Ventilation alarm occurs ALARM and MinVent flash on the display and the LCD backlight is turned on NOTE setting of zero disables the Low Minute Ventilation alarm This alarm does not automatically reset Press the RESET button to manually reset the alarm Provider Manual 7 4 Power ALARMS The device has the following power alarms External Battery Discharged Loss of Input Power Low External Battery AC to DC Power Switchover Battery in Use AC Power Supply This alarm occurs when the external battery is below 9 8 V This alarm does not occur if AC power is available but the Low External Battery alarm remains active The red alarm LED is solid when this alarm occurs and the power failure audible alarm beeps The SILENCE and RESET buttons do not apply to this alarm This alarm occurs when AC and DC power is lost while the device is in the Operate state or AC and DC power is not available when the button is pressed The red alarm LED is solid when this alarm occurs and the power failure audible alarm beeps The SILENCE and RESET
7. nennen rens EEEa ies ansa se ese Ea r eeri E etse tasas Eoi CORGCUITCONE GURATIONS ee an dae oe vex edd eri tee ru Pose aes 10 2 CIRCUITS 85 6 5 rore kae dro e Ee rin PE E e 10 3 Masks EXHALATION PORTS AND RELATED 55 6 eene enne een enn nnne 10 2 LOLA JFIUMIDIBIERS rk ae HEHE ERE PRAVO REIR EE HERE 10 2 10 59 SOFTWARE J 10 2 CHAPTER II OPERATIONAL 410001 nenne teres tsentre reter reren Serner ESEE reesen erns ette anere esenee enn II I Lid SYSTEM VERIFICATION toii eco iot ttv el PORE een IS Ser vete II I 11 2 ALARM VERIFICATION 2 0 r tape Re RACER RE II 2 OHAPTER T3 APPENDIX ERROR CODES APPENDIX INFORMATION Provider Manual 1 1 CHAPTER 1 PACKAGE CONTENTS Encore Pro SmartCard Carrying Case L7 Disposable Ultra fine Filter Reusable Gray User Manual Foam Filters C Filter Cap Provider Manual SW KA 7 Fle
8. Indicates that the Ramp function is in progress or the ramp length setting is being displayed Indicates that the Ramp Starting Pressure is being displayed Indicates that a rise time setting is being displayed Indicates that the Respiratory Rate RR is being displayed The small s on the right side of the display above cm H O indicates that the alphanumeric digits are displaying a time value in seconds Indicates that the device is in Provider mode and not in User mode Indicates that an inspiratory time setting is being displayed Indicates that the Estimated Exhaled Tidal Volume is being displayed Provider Manual 4 1 2 Buttons The control buttons shown in Figure 4 3 are defined below Display Screen Scroll Button Alarm Buttons N Alarm Reset Button Silence Ramp Button Button Pressure On Off Button Heated Humidifier Button Figure 4 3 Control Buttons cy This button starts or stops the device s airflow Press the button in to turn the airflow On This puts the device in the Operate state When the button is in the Off position the device is in the Standby state any ramp in progress is terminated the alarms are reset except for the System Errors alarm and the humidifier is turned off The Pressure On Off button is independent of the display screen Figure 4 4 shows the button s On and Off positions Airflow Airflow On Off x Figure 4 4 Pressure On Off Bu
9. Number 1012865 5 4 2 PROGRAMMING A SMARTCARD 1 Connect a Respironics SmartCard reader writer directly to an IEC60950 Windows compatible computer following the instructions included with the reader writer Remove the SmartCard from the device and insert it into the reader writer 2 Follow the instructions included with your Encore Pro software to program the SmartCard 3 Remove the SmartCard from the reader writer If desired write the patient s name on the front of the card 5 4 3 CHANGING SETTINGS USING SMARTCARD To change the settings in the device using a programmed SmartCard 1 Make sure the device is plugged in Insert the programmed SmartCard into the slot on the right side of the device symbol side facing up When the Monitoring or Standby screen displays CARD this indicates that the card is inserted correctly 2 Turn the airflow on to verify the new prescription setting card can now be removed or you can leave the card in the device to record device usage Once the prescription settings have been transferred to the device they will be deleted from the SmartCard Provider Manual CHAPTER 6 CHANGING SETTINGS This chapter describes the settings that can be changed when the BiPAP autoSV device is in the Provider and User modes 6 1 CHANGING SETTINGS IN PROVIDER MODE Accessing the Provider mode setup level unlocks additional settings that cannot be changed while in User mode When in Provider mode SETUP
10. U 30 dip in for 25 cycles 30 dip in for 25 cycles 596 U 596 U gt 95 dip in U for 5 sec 295 dip in U for 5 sec Mains power quality should be that of a typical home or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in atypical hospital or home environment NOTE U is the a c mains voltage prior to application of the test level Provider Manual B 2 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test LeveL CompLiance LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3Vrms d 1 2 P 150 kHzto 80 MHz IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3V m d 124P 80MHzto 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3P 800 210 2 5 GHz Where P is the maximum output power rating
11. User Serviceable Parts If you need product support call the Respironics Customer Service department at 1 724 387 4000 or 1 800 345 6443 You can also use the following address 3 6 SERVICE Respironics 1001 Murry Ridge Lane Murrysville PA 15668 Visit the Respironics web site at www respironics com Provider Manual CHAPTER 4 CONTROLS AND DisPLAYS This chapter describes the control panel and displays the patient circuit connections and the rear panel connections 4 1 CONTROLS AND DisPLAYS AC Power High Priority Indicator Green Alarm LED Red Low Medium Priority Indicator Green Alarm LED Yellow Display Screen Pressure On Off Scroll Button Button Alarm Reset Button User Al Buttons arm Heated Humidifier Button Silence Ramp Button Button Figure 4 1 The Control Panel Figure 4 1 illustrates the control panel The control panel includes e display screen where all device settings appear Control buttons e Alarm indicators e Power indicators 4 1 1 DisPLAY SCREEN The display screen shows operating parameters instructions and messages A backlight activates when the user buttons are pressed and remains on until there are no buttons pressed for one minute Figure 4 2 shows the display screen ALARM PATIENT HEAT RAMP SETUP APNEA LIGHT START CARD RR m am m ERASE HOURS RISETIME 38 a8 a8 IPAP IPAP EPAP BP ax Min Figure 4 2 Display Screen Provider
12. X M RESPIRONICS 1001 Murry Ridge Lane Respironics Deutschland Murrysville PA 15668 Gewerbestrasse 17 1040272 USA 82211 Herrsching Germany 0123 JR 3 1 07
13. and If the condition Malfunctioning Remove power Have the device Regulation Red flash cm H20 e e e a for 0 5 device from the device serviced by either High flash seconds the unit Restore power an authorized cycles to EPAP If the alarm service After 3 seconds if continues to representative or the condition occur call your Respironics continues a high health care priority alarm is professional generated but the unit still operates If the condition is still detected after 10 seconds the unit shuts down Pressure Red flash Press the RESET Check for the Regulation ALARM and ee e Operates E AK button to reset following dirty inlet Low cm H20 98 the alarm filters blocked air flash intake excessive Check for the leak in patient following dirty circuit inlet filters blocked air intake the alarm excessive leak in continues have patient circuit If the device alarm continues serviced by either call your health an authorized care professional service representative or Respironics Low Red flash ALARM and ee e Operates Excessive leak Press the RESET Check for the Pressure cm H20 or blockage button to reset following dirty inlet Support flash the alarm filters blocked air intake excessive Check for the leak in patient following dirty circuit inlet filters blocked air intake If the alarm excessive leak in continues have patient circuit If the device alarm continues Serviced by e
14. appears in the top right corner of the display To temporarily access the Provider mode while the device is in User mode simultaneously press the Right User button and the SILENCE button and hold for at least 2 seconds NOTE does not matter whether you press the Right User button or the SILENCE button first An audible indicator sounds when you have successfully accessed the Provider mode To exit Provider Mode press the SILENCE button 6 1 1 NAVIGATING SCREENS IN PROVIDER MODE Figure 6 1 shows how to navigate the Provider mode screens using the Left and Right User keys The parameter symbol and setting will flash NOTE When changing any setting in the Provider mode except for the EPAB IPAP Min IPAP Max and Ramp Start Pressure settings once a maximum setting is reached it will roll over back to the minimum setting and likewise once a minimum setting is reached it will roll over back to the maximum setting for that parameter For example the minimum Humidifier setting is 1 and the maximum is 5 Once the Humidifier setting is increased to 5 if increased again it will roll over to 1 Or once the Humidifier setting is decreased to 1 if decreased again it will roll over to 5 EPAP Setting Screen u De Right User Left User Button meme Ramp Start Pressure Fight User Left Usar une Setting Screen Only displayed if the Ramp Length IPAP Min Setting Screen setting is greater than zero
15. buttons do not apply to this alarm This alarm occurs when the external battery is below 10 3 V It is a medium priority alarm When this alarm occurs the yellow LED and the DC power LED flash upon detection When the alarm is reset or the battery is replaced the yellow LED goes away and the DC power LED stops flashing but remains on to indicate that DC power is being used The medium priority audible alarm sounds This alarm automatically resets when the external battery is replaced Additionally you can press the RESET button to reset this alarm however the alarm will reoccur unless the external battery is replaced This alarm occurs when the device switches from AC to DC power It is a low priority alarm When this alarm occurs the yellow LED and the DC power LED flash upon detection When the alarm is reset the yellow LED goes away and the DC power LED stops flashing but remains on to indicate that DC power is being used The low priority audible alarm sounds This alarm automatically resets when AC power is restored Additionally you can use the RESET button to manually reset this alarm This alarm occurs only upon startup to notify the user that battery power is being used This is a low priority alarm When this alarm occurs the yellow LED turns on and the DC power LED flashes upon detection and stops when AC power is provided or the alarm is reset The low priority audible alarm sounds This alarm automatically resets when AC pow
16. manometer to verify patient mask pressure Pressure Drop Versus Flow for Patient Circuits Bacteria Filter Bacteria Filter and Respironics Passover Humidifier 10 9 8 97 I B6 8 55 54 ES lee 3 2 gem 1 rg 0 4 a i 0 20 40 60 80 100 120 140 160 180 Flow LPM Figure 12 1 Pressure Drop Versus Flow for Patient Circuits Provider Manual 12 4 Maximum Pressure Drop ron PATIENT Disconnect ALARM The Patient Disconnect alarm relies on a fixed relationship between the patient pressure settings and the open circuit flow of the patient circuit The alarm should work properly if your circuit is less restrictive than the circuit parameters shown below Most Restrictive Circuit for Patient Disconnect Alarm a zd 9 18 20 21 23 25 27 29 Pressure cmH20 Figure 12 2 Most Restrictive Circuit for Patient Disconnect NOTE You must verify that the Patient Disconnect Alarm operates properly with the prescribed patient pressures and circuit Provider Manual APPENDIX A ERROR Copes This appendix lists the definitions for the displayed error codes For more information about each error and how to service the device see the BiPAP autoSV Service Manual SYSTEM ERRORS Display Description Provider User Action EO No error For all system errors Exx El NM M RUM perform the following actions Remove power from
17. may be adversely affected by Electromagnetic fields exceeding the level of 10 V m in the test conditions of EN 60601 1 2 Operation of high frequency diathermy equipment Defibrillators or short wave therapy equipment Radiation e g x ray CT Magnetic fields e g MRI Do not use the device at room temperatures above 95 F 35 C If the device is used at room temperatures above 95 F 35 C the temperature of the airflow may exceed 106 F 41 C which could cause thermal irritation or injury to the patient s airway Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of the air coming out of the device Do not use antistatic or electrically conductive hoses or tubing with the device When the device is used with an external humidifier position the humidifier so that the water level in the humidifier is lower than the patient and the humidifier is on the same level or lower than the device Use only Respironics approved humidifiers with the BiPAP autoSV If you detect any unexplained changes in the performance of the device if the device is dropped or mishandled if water is spilled into the enclosure or if the enclosure is broken seek the assistance of Respironics or an authorized service center Do not open the BiPAP autoSV enclosure There are no user serviceable parts inside Repairs and internal servicing should only be perf
18. normalize patient ventilation during sleep disordered breathing events Refer to Figure 3 2 Note When EPAP z IPAPMin z IPAP Max this is equivalent to traditional CPAP therapy EPAP IPAP Min IPAP Max The device delivers minimum pressure support determined by the EPAP and IPAP Min controls The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events Figure 3 3 illustrates the automatic adjustment of IPAP during a sleep disorder breathing event and during normal breathing Note When EPAP IPAP Min z IPAP Max this is equivalent to traditional bi level therapy Pressure IPAP max EPAP IPAP min Target Flow h 4 4 ree dee eee ep eee Mee A A Figure 3 2 CPAP Therapy with Automatic Pressure Support Provider Manual Pressure IPAP max IPAP min m EPAP u TU Flow Target Flow Time RTT HY Time Figure 3 3 Bi Level Therapy with Automatic Pressure Support 3 2 2 Back up Breath Rate CONTROLS In addition to the pressure controls the device may be configured to deliver machine triggered breaths if the patient does not spontaneously breathe at a determined rate Back up breaths are machine triggered machine cycled breaths The Rate and Time Insp controls are
19. 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 states do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranties including any warranty of merchantability or fitness for the particular purpose are limited to two years Some states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from state to state To exercise your rights under this warranty contact your local authorized Respironics Inc dealer or contact Respironics Inc at 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 1 724 387 4000 9
20. pressure sensor out of range Rise rate range failure Invalid array index failure Reserved for future use Reserved for future use Reserved for future use Occluded flow sensor Invalid error code Provider Manual 4 CARD ERRORS Display Description Provider User Action Unable to write to SmartCard The SmartCard is inserted upside down or backwards Remove the card and reinsert properly Otherwise the card is damaged and should be replaced C2 C3 The SmartCard is corrupt or Perhaps the card is intended for another not supported by this device device Erase or reprogram the card If the error continues to occur replace the card The SmartCard contains a Remove the card Exit the parameter screen prescription and was inserted Then reinsert the card while the device was in a parameter screen C5 The SmartCard was inserted Remove the card Exit the calibration mode while the device was in Then reinsert the card calibration mode C6 SmartCard is corrupt Erase or reprogram the card If the error continues to occur replace the card C7 SmartCard presence lost Remove card and reinsert Otherwise the card is damaged and should be replaced C8 Unable to read from the The card is inserted upside down Remove the SmartCard card and reinsert properly Otherwise the card is damaged and should be replaced C9 C10 SmartCard is corrupt Erase or reprogra
21. ree 7 3 72221 SYSTEM ERROR ALARM eas 7 3 7 33 CARD ERROR ALARM eres vue 7 3 712 4 PRESSURE REGULATION HIGH ALARM een ersehen 7 4 7424 PRESSURE REGULATION LOW ALARM 5565 tires interrete reine 7 4 7 2 5 LOW PRESSURE SUPPORT ALARM anni nennen reinen 7 2 6 PRESCRIPTION COMPLETE ALARM 7 3 PATIENT ALARMS nennen 7 3 1 APNEA ALARM 7 322 PATIENT DISCONNECT ALARM sn eher 7 353 L w MINUTE VENTILATION ALARM nl seeieigesnninehpesbep e RR cire hehe er Ehre 7 6 734 POWER ATL RMS nei seen ale EE 7 7 7 5 ALARM SUMMARY TABLES TE 7 8 CHAPTER 8 CLEANING AND MAINTENANCE 8 1 BU CLEANING THE DEVICE Mann MS Dro eques eie EE EE EE 8 1 8 1 1 CLEANING AND DISINFECTION FOR MULTIPLE 5 8 eene eene 8 1 8 2 CLEANING OR REPLACING THE INLET FILTERS eese 9 8 1 8 2 MAINTENANCE kann erh EE 8 4 CARRYING CASE iet ertet er XO Fee FERRE eee peu E Ae repe xe eek RUN CHAPTER 9 ADDING SUPPLEMENTAL OXYGEN 9 1 ADDING SUPPLEMENTAL OXYGEN 9 2 SUPPLEMENTAL OXYGEN CONCENTRATIONS CHAPTER I0 CIRCUITS AND ACCESSORIES
22. the device provides Do not connect any equipment to the device unless recommended by Respironics or the health care professional Verify that an exhalation port is present to exhaust CO from the circuit If circuit accessories other than those recommended by Respironics are connected to the device then pressure must be verified Use of these accessories may alter the pressure received reducing the effectiveness of treatment Ihe device should be used only with masks and accessories recommended by Respironics or with those recommended by the health care professional or respiratory therapist See Chapter 10 for approved patient circuits A mask should not be used unless the device is turned on and operating properly The exhalation port s associated with the mask should never be blocked In the event of a power failure or machine malfunction remove the mask Explanation of the Warning The device is intended to be used with special masks or connectors that have exhalation ports to allow a continuous flow of air out of the mask When the device is turned on and functioning properly new air from the device flushes the exhaled air out through the mask exhalation port However when the device is not operating enough fresh air will not be provided through the mask and exhaled air may be rebreathed Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation Provider Manual Operation of the device
23. the Operate state NOTE Thelights will always be on when the airflow is off and the device is in Standby Figure 6 14 LED Backlight Setting Screen To change the LED backlight setting press the HEAT or RAMP button until the correct setting appears 1 means the lights are on while 0 means the lights are off 14 Access Level Setting Screen The Access Level Setting screen is shown in Figure 6 15 Figure 6 15 Access Level Setting Screen This screen allows you to select Provider mode or User mode access Press the HEAT and RAMP buttons to select the appropriate access level 0 indicates that the device is in User mode and 1 indicates that the device is in Provider mode This is the last screen in the Provider mode Press the SILENCE button to exit the settings menu or continue pressing the Right and Left User buttons as shown in Figure 6 1 to navigate to other Provider mode screens Provider Manual 6 8 6 2 Monitorinc MEASURED PARAMETERS You can view additional measured parameters from the Monitoring screen by pressing the small circular Scroll button located near the RESET button Figure 6 16 shows how to navigate the measured parameters screens NOTE You can also view these screens from the Standby screen but when you do so each of these screens displays a value of zero because the device is not delivering therapy Leak Screen Respiratory Rate Screen Scroll Button Minute Ventilation Screen Scroll Bu
24. 4 0 Right User Left User Button Button p Apnea Alarm Setting Screen Right Left User e n Button Button e IPAP Max Setting Screen me 300 Right User Lett User Button Button Ter Patient Disconnect Alarm Right Left User 15 Setting Screen Button Button Breath Rate Setting Screen um Only displayed if IPAP Max is 1 greater than EPAP 8 el I 6 m m Low Minute Ventilation Alarm Right U m n Setting Screen ji Let user 280 g Inspiratory Time am Setting Screen 16 Right User A Lett User Only displayed if Breath Rate Button Button i t OFF or AUTO E n oe Reset Therapy Meter Right User 1590 Setting Screen Button Button Rise Time Setting Screen Only displayed if IPAP Max is B8 Right User Left User greater than EPAP Button Button LED Backlight Right Left User n Setting Screen Button Button Ramp Length Setting Screen LE 0 05 Right xL Left User Button Button Access Level Left User l Setting Screen Button Right User Figure 6 1 Navigating the Provider Mode Screens Provider Manual 6 2 6 1 2 CHANGING SETTINGS IN PROVIDER From each of these screens press the Right User button to access the next one Likewise press the Left User button to access the previous screen 1 EPAP Setting Screen EPAP Setting screen is shown in Figure 6 2 Figure 6 2 EPAP
25. Airflow Turned On IPAP Min Ramp Button Pressed Minimum Pressure Pressure Support EPAP L Pressure Ramp Start Pressure 0 cm H20 Minutes Linear Ramp Ramp Time The minimum pressure support is defined as the lesser of 2 cm H20 and the difference between IPAP Min and EPAP pressure settings Figure 3 7 Ramp Function 3 2 4 Dicirat Auto Trak Sensitivity An important characteristic of the BiPAP autoSV 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 Sensitivity The following sections examine this function in detail by describing the leak tolerance function and sensitivity 3 2 4 1 Leak TOLERANCE A microprocessor monitors the total flow of the patient circuit and calculates patient flow values A Leak Estimation Average and Parabolic The device uses two leak estimation algorithms A conservation of mass algorithm is used to compute the average leak for a given pressure support relationship This average leak is used when large leak variations are present in the system Average leak is a high estimate during EPAP pressure and a low estimate during IPAP pressure A better leak estimate enabled by the digital system is the parabolic leak algorithm Parabolic leak is proportional to the square of the pat
26. ING Do not immerse the device in liquid or allow any liquid to enter the enclosure inlet filter or any opening This may result in equipment damage 1 Unplug the device and clean the front panel and exterior of the enclosure as needed using a cloth dampened with water and a mild detergent Allow the device to dry completely before plugging in the power cord 2 Inspect the device and all circuit parts for damage after cleaning Replace any damaged parts WARNING To clean breathing circuit accessories refer to the cleaning instructions for each accessory 8 1 1 CLEANING AND DISINFECTION FOR MULTIPLE Users WARNING Ifyou are using the device on multiple users discard and replace the bacteria filter each time the device is used on a different person If you are 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 3 100 Isopropyl Alcohol Vinegar 5 acidity Water Chlorine bleach household 5 25 sodium hypochloride 1 to 5 part reduction with water 3 Allow the device to dry completely before plugging in the power cord 8 2 CLEANING OR REPLACING THE INLET FILTERS The device uses two removable filters at the air inlet The gray foam filter is washable and reusable The op
27. Manual 4 2 The information shown on the display screen is defined as follows ALARM APNEA BPM CARD cm H O EPAP ERASE HEAT HOURS IPAP Max IPAP Min LEAK LIGHT LPM MinVent ml PATIENT RAMP RAMP START RISE TIME RR Indicates that the device requires user attention as indicated on the screen Indicates that an apnea alarm has occurred Indicates that a breath rate setting is being displayed This symbol flashes when the device is providing timed backup breaths Indicates that a SmartCard is inserted and detected Indicates that the alphanumeric digits are displaying a pressure value Indicates that an EPAP pressure setting is being displayed Indicates that the user may clear the Therapy Hour Meter Indicates that the humidifier is turned on and or its setting is displayed Indicates that the Therapy Hour Meter is being displayed Indicates that an IPAP maximum pressure setting is being displayed Indicates that an IPAP minimum pressure setting is being displayed Indicates that the Estimated Leak Rate is being displayed Indicates that the control pad LED backlight setting is being displayed or is active Indicates that the value displayed is in liters per minute Indicates that the Estimated Minute Ventilation is being displayed Indicates that the value displayed is in milliliters Indicates that a Patient Disconnect alarm is active or a patient disconnect alarm setting is being displayed
28. QUIPMENT 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 Raten Maximum Power SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER OurPur OF TRANSMITTER m w 150 kHz ro 80 MHz 80 MHz ro 800 MHz 800 MHz ro 2 5 GHz 124 d 1 2 P d 2 3 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 P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Provider Manual LiMiTED WARRANTY Respironics Inc warrants that the BiPAP autoSV system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two 2 years from the date
29. RT CARD LEAK MinVent vel ot RR ERASE HOURS RISETIME 88 a8 BB 55 BPM Figure 5 4 Self Test Screen 2 next screen displays the software version Figure 5 5 Software Version Screen NOTE version number shown in Figure 5 5 is an example your device may have a different software version installed 3 The Blower Hours Screen then appears which displays the Blower Hours Time Meter Figure 5 6 Blower Hours Screen NOTE With the exception of the b button buttons on the control panel are inactive during these first three screens NOTE Each of the first three screens appears for approximately 1 3 seconds 4 The next screen to appear is the Standby screen PATIENT HEAT APNEA LIGHT CARD HOURS Figure 5 7 Standby Screen Provider Manual 5 5 The Standby screen appears when the device is in the Standby state Pressing the 1 button in puts the device in the Operate state The Monitoring screen then appears PATIENT HEAT RAMP APNEA LIGHT CARD cm C 0 020 do 99 898 8888 Figure 5 8 Monitoring Screen Both the Monitoring and the Standby screens display PATIENT APNEA LIGHT and HEAT if these features are enabled Likewise CARD displays if a SmartCard is inserted and SETUP displays if the access level is set to Provider mode The Monitoring screen dis
30. Setting Screen Increase or decrease the EPAP pressure by pressing the HEAT and RAMP buttons until the correct pressure appears You can adjust the pressure from 4 to 25 cm H O in 1 cm H O increments WARNING High EPAP pressures can cause the patient discomfort Carefully evaluate the patient if you set the level above 15 cm H O NOTE Ifthe EPAP is set to less than the ramp start pressure the ramp start pressure automatically sets to the EPAP NOTE If EPAP is greater than IPAP Min then IPAP Min automatically sets to EPAP 2 IPAP Min Setting Screen IPAP Minimum Setting screen is shown in Figure 6 3 Figure 6 3 IPAP Minimum Setting Screen Increase or decrease the IPAP minimum pressure setting by pressing the HEAT and RAMP buttons until the correct pressure appears You can adjust the IPAP minimum setting from 4 0 cm to 30 0 cm in 1 cm H O increments NOTE Ihe IPAP Min value must be equal to or greater than the EPAP value NOTE If the IPAP Min Setting is set greater than IPAP Max setting the IPAP Max automatically sets to IPAP Min Provider Manual 3 IPAP Max Setting Screen IPAP Maximum Setting screen is shown in Figure 6 4 Figure 6 4 IPAP Maximum Setting Screen Increase or decrease the IPAP maximum pressure setting by pressing the HEAT and RAMP buttons until the correct pressure appears You can adjust the IPAP maximum setting from 4 0 cm to 30 0 cm in 1 cm H O increments NOTE The IPAP M
31. URE EPAP Spontaneous Expiratory Threshold FLOW Figure 3 9 Spontaneous Expiratory Threshold Provider Manual 3 7 Maximum IPAP Time IPAP to EPAP A maximum IPAP time of 3 0 seconds acts as a safety mechanism to limit the time spent at the IPAP level during spontaneous breathing Once the time limit is reached the unit automatically cycles off IPAP to the EPAP level Summary The sensitivity criteria for spontaneous breathing can be summarized as follows Spontaneous Trigger to IPAP A transition from EPAP to IPAP occurs when one of the following conditions is met e Patient flow exceeds the shape signal e 6 ml inspired patient volume Cycle to EPAP The transition from IPAP to EPAP occurs when one of the following conditions is met e Spontaneous Expiratory Threshold SET is achieved 3 0 second maximum IPAP time has occurred safety feature 3 3 Access LEVELS There are two levels of access e Provider Mode User Mode 3 3 1 Proviper Mope Access Lever Setup The Provider mode unlocks additional parameters that are not available to the patient This mode is accessed by completing the following steps 1 Plugin the device to power up the device 2 Press the Right User button and the SILENCE button simultaneously for at least two seconds see Figure 3 10 SETUP appears in the top right corner of the display and the EPAP Setting screen will display This indicates that you are now in Provider mod
32. a events e Duration of each use minimum storage capacity is six months When capacity is reached the oldest data is overwritten Using the Respironics SmartCard reader writer and the Encore Pro software you can download and view the usage data Follow the instructions included with the Encore Pro software to download the data J Figure 4 8 Encore Pro SmartCard NOTE Ifthe card is not installed the device usage will not be recorded When a SmartCard is installed CARD appears in the upper right corner of the display screen Provider Manual 5 1 CHAPTER 5 SETUP 5 1 PREPARING THE DEVICE This section contains information on e Installing the air filters e Assembling the patient circuit e Supplying power to the device e Startup 5 1 1 INSTALLING THE AIR FILTERS device uses one or two removable filters at the air inlet The disposable white ultra fine filter is optional You must install the gray foam filter before operating the device The foam filter is washable and reusable For cleaning instructions see Chapter 8 CAUTION A properly installed undamaged foam filter is required for proper operation Communication Port Reusable Gray Foam Filter required Filter Cap P d _ Disposable Ultra fine Filter optional Figure 5 1 Installing the Air Filters To install the air filters complete the following steps I Ifyou are using the optional white ultra fine fi
33. attery peras below 10 3 V the alarm DC power t aim LED flashes Replace or COMINUES 19 RUN recharge the have the device battery If the serviced by either alarm continues 9 authorized to occur contact Seien your health care representative S professional Respironics 52 Yellow solid The device loses Press the RESET None required GWitchofr ee Operates AC power and button to reset witcho DC power switches to the alarm BED Hashes DC power Check AC power Seek a reliable power source Battery Yellow solid ee Operates On startup only Press the RESET None required in Use alarm notifies button to reset DC power the user that the alarm LED flashes battery power is being used AC Power Yellow alarm Unchanged ee Operates The AC power Remove power Have the power Supply LED solid supply is out of from the device supply serviced spec lt 22V or and then restore by Respironics AC power there is power If alarm oran authorized LED flashes defective continues to Service battery sense occur contact representative line on the DC your health care power adapter professional Measured at the external DC power adapter inlet Provider Manual 8 1 CHAPTER 8 CLEANING AND MAINTENANCE 8 1 CLEANING THE DEVICE WARNING To avoid electrical shock always unplug the device power cord from the wall outlet or DC power source before cleaning the device WARN
34. ax value must be equal to or greater than the IPAP Min value 4 Breath Rate Setting Screen The Breath Rate Setting screen is shown in Figure 6 5 NOTE The Breath Rate Setting screen displays only if IPAP Max is greater than EPAP Figure 6 5 Breath Rate Setting Screen Increase or decrease the breath rate by pressing the HEAT and RAMP buttons until the correct setting appears You can adjust the breath rate from 0 to 30 in 1 BPM increments Provider Manual 6 4 5 Inspiratory Time Setting Screen The Inspiratory Time Setting screen is shown in Figure 6 6 NOTE Inspiratory Time Setting screen displays only if Breath Rate is not OFF or AUTO Figure 6 6 Inspiratory Time Setting Screen Increase or decrease the inspiratory time by pressing the HEAT and RAMP buttons until the correct setting is reached You can adjust the inspiratory time from 0 5 to 3 seconds in 0 1 second increments NOTE inspiratory time and breath rate controls are linked so the inspiratory time never exceeds the expiratory time If the breath rate or inspiratory time are set to values that would cause the I E ratio to exceed 1 1 the inspiratory time is automatically reduced to maintain a 1 1 ratio 6 Rise Time Setting Screen The Rise Time Setting screen is shown in Figure 6 7 Rise time is the time it takes for the device to change from EPAP to IPAP This screen allows you to adjust the rise time so you can find the most comfortable sett
35. buttons to adjust the settings Pressing and holding the HEAT or RAMP buttons down for at least 2 seconds will change the settings at a faster rate The SILENCE button allows you to exit a Provider or User mode screen e The small circular Scroll button 8 located next to the RESET button allows you to view measured parameters from the Monitoring screen See Chapter 6 for more information e The alphanumeric digits and symbols flash to indicate setting adjustment Provider Manual 4 2 1 LED BackLicHT Buttons The SILENCE RESET RAMP and HEAT buttons can be lit by an LED backlight The LED backlight is on when the device is in the Standby state or when the System Self Test Screen is displayed When the device is in the Operate state the LED backlight is lit according to the setting in the LED backlight screen The LED backlight may flash to indicate an alarm condition as described in Chapter 7 PANEL Inactivity Some screens have timeout periods The screen s timer starts when the screen is initially displayed and is restarted whenever a button is pressed When a screen times out the LCD backlight is turned off and the Monitoring Standby screen is displayed The LCD backlight turns back on when a button is pressed again 4 3 PATIENT Circuit CONNECTION The patient circuit is connected to the breathing circuit connection shown in Figure 4 6 The breathing circuit connection accepts a bacteria filter or a tub
36. concentration will vary depending on the IPAP and EPAP pressures patient breathing pattern and the leak rate Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations Monitor the patient appropriately To prevent an accumulation of oxygen in the device advise the patient to turn the device on before turning on the oxygen Likewise the patient must turn off the oxygen before turning off the device Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide Provider Manual 2 3 2 2 CAUTIONS The device may only be operated at temperatures between 41 5 C and 95 35 e Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter e Do not place the device in or on any container that can collect or hold water Condensation may damage the device Always allow the device to reach ambient temperature before use e the power cable retainer to keep the power cord from being unintentionally disconnected NOTE Additional warnings cautions and notes are located throughout this manual 2 3 INTENDED Use The BiPAP autoSV is intended to provide non invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and or mixed apneas and periodic breathing 2 4 CONTRAINDICATIONS The BiPAP autoSV syste
37. continues contact Respironics to your health care have the device professional serviced MG Red flash ALARM and in Operates The calculated Press the RESET un inVent minute button to reset Ventilation flash ventilation is the alarm less than or equal to the Report the alarm alarm setting 10 your health care professional Continue using your device Provider Manual System ALARMS Alarm LED Indicator i Device Action Possible Patient Action Provider Action Press the RESET Have the device System Red flash ALARM ee roue OMM end Device failure button to reset serviced by either Error flashes and be restarted the alarm an authorized System error Remove power service code Exx from the device representative or displays Restore power If Respironics the alarm continues to occur contact your health care professional A problem exists Press the RESET Confirm that the Card Error Yellow solid enel and ee Operates with the Smart button to reset card is properly card error Card inserted in the alarm Confirm inserted code Cxx the SmartCard that the card is displays connectivity slot properly inserted f the alarm The card may be continues replace inserted upside If the alarm the SmartCard down or continues to backwards occur remove the SmartCard from the device and contact your health care professional Pressure ALARM
38. d in Chapter 11 5 2 SETTING UP THE DEVICE Before using the device on a patient set the prescription 1 change the settings see Chapter 6 2 set the necessary alarms see Chapter 7 3 Verify that the device is not left in Provider mode Provider Manual 5 6 5 3 CONNECTING THE PATIENT NOTE Before connecting the patient to the device check the integrity of the patient circuit exhalation port and alarms 1 Make sure the device is in User mode See Chapter 6 2 the device airflow on by pressing in the 9 button lfoxygen is being used turn on the oxygen flow Make sure you place the Respironics Pressure Valve Part Number 302418 in line with the patient circuit WARNING Always turn the airflow on before turning on the oxygen and always turn the oxygen off before turning off the airflow 4 Place the mask on the patient 5 4 SETTING UP THE SMARTCARD 5 47 Downtoapine Data You can download data from the SmartCard by following the steps below 1 Connect a Respironics SmartCard reader writer directly to an IEC60950 Windows compatible computer following the instructions included with the reader writer Remove the SmartCard from the device and insert it into the reader writer 2 Follow the instructions included with your Encore Pro software to download the data WARNING Any IEC 60950 device must be connected through the 7 pin mini din connector with a Respironics supplied isolation cable Part
39. e NOTE does not matter whether you press the Right User button or the SILENCE button first Display Screen Scroll Button Alarm User Al Buttons arm Pressure On Off Button Reset Button Heated Humidifier Button Silence Ramp Button Button Figure 3 10 Control Panel NOTE device can be configured to remain in Provider mode by changing the Access Level Setting See Chapter 6 for more information Provider Manual 3 8 3 Navigate the screens and change the settings as described in Chapter 6 You can display and modify the following settings in Provider mode e pressure e PAP minimum pressure e PAP maximum pressure e Breath rate Timed inspiration e Rise time e Ramp length e Ramp starting pressure e Apnea alarm enable disable e Patient disconnect alarm enable disable Low minute ventilation alarm enable disable e Therapy hours erase or save e Backlight e Access Level Setting 3 3 2 User Access LeveL To switch the device from Provider mode to User mode change the Access Level Parameter from 1 to 0 in the Access Level Setting screen See Chapter 6 for more information NOTE Ifyou temporarily set the device to Provider mode by pressing the Right User button and the SILENCE button the device will return to User mode when any of the following occurs SILENCE button is pressed Any parameter screen times out You press the Le
40. e 3 6 illustrates breathing intervals when the back up rate is Auto Cycle Inspiration irati EN Expiration 2 IPAP mn i T EL 0000 V EPAP Rise Time gt lt e Inspiratory Time Figure 3 4 Triggering and Cycling when the Back Up Rate is Off Provider Manual Vol mp Time Interval Based on the Rate Setting P cm H20 D gt us un 92 E 92 TA 6 12 18 21 sec 12 18 21 sec S Spontaneously triggered pressure support breaths Patient triggered T Time triggered pressure limited time cycled breath Machine triggered Figure 3 5 Example of Patient Triggered and Machine Triggered Breaths when the Back Up Rate is 4 30 P Ccm H20 Vol ml ta normal breathing interval tb breathing interval that triggers a timed breath te inspiration time of a timed breath IPAP EPAP 100 S Spontaneously triggered pressure support breaths Patient triggered T Time triggered pressure limited time cycled breath Machine triggered Figure 3 6 Breathing Intervals when the Back Up Rate is Auto Provider Manual 3 2 3 Ramp The device is equipped with a linear ramp function When activated the ramp feature reduces the pressure and then gradually increases ramps the pressure to the prescription pressure setting so patients can fall asleep more comfortably Figure 3 7 illustrates how the ramp function works
41. e Source 100 to 240 VAC 50 60 Hz DC Voltage Source 12 VDC when operated with the external DC power adaptor accessory AC Current 1 25 A maximum DC Current 3 0 A maximum Protection against electric shock Class II Degree of protection against electric Type BF Applied Part shock Degree of protection against harmful ingress of water BiPAP autoSV device Ordinary Equipment AC Power Supply Drip Proof IPX1 Reorder number 1012832 DC Power Adapter Drip Proof IPX1 Reorder number 1012975 Modes of Operation Continuous Electromagnetic The BiPAP autoSV device meets the Compatibility requirements of EN 60601 1 2 second edition 2001 Fuses There are no user replaceable fuses PRESSURE Output 4 to 30 cm H O Provider Manual 12 1 12 2 Accuracy Parameter Range Accuracy IPAP Min 4 to 30 cm H O 5 cm H O IPAP Max 4 to 30 cm H O 5 cm H O EPAP 4 to 25 cm H O 5 cm H O Breath Rate 4 to 30 BPM Greater of 1 BPM or 10 of the setting when measured over a 4 minute period Timed Inspiration 0 5 to 3 0 seconds 0 1 10 of the setting seconds Ramp Duration 0 to 45 minutes 10 of the setting Rise Time 1 to 6 25 A Dynamic pressure accuracy is 5 cm H O measured at the patient end of the circuit with a Whisper Swivel II and varying flow conditions Static pressure accuracy is
42. ed humidifier NOTE Refer to the humidifier s instructions for information on how to set up the BiPAP autoSV device with the humidifier 10 5 SOFTWARE Respironics Encore Pro Data Management software for reading compliance data Provider Manual CHAPTER 11 OPERATIONAL VERIFICATION WARNING Ifthe system fails to perform within the specifications stated in Chapter 12 have the system serviced by a qualified Respironics approved service facility 11 1 SvsrEM VERIFICATION The operational verification allows health care professionals to verify that the device is functioning properly Operational verification should be completed before each new patient setup 1 2 3 Connect the 6 35 mm BiPAP test orifice to the outlet port Connect a water column or digital manometer to the pressure pick off port on the test orifice Connect the AC power supply to the device and connect the AC power cord to the appropriate power source If the device being tested is an international device test the device at the voltage for that specific country The AC power LED should illuminate Access the Provider mode Set the parameters to the following EPAP 4cm H O PAP Min 30cm H O e IPAP Max 30cm H O e Rate Auto e Rise Time 1 e Ramp 0 Off e Patient Disconnect 0 Off e Apnea 0 Off e Low Minute Ventilation 0 Off Exit to the Monitoring screen 22 Press the CO button to turn the airflow and
43. ed until the patient s oxygen needs are adequately met Supplemental O2 Flows 21 101 15 L min 100 90 F 80 F s o Oxygen Concentration EF T 1 10 5 20 5 30 5 Pressures 2 600 Tidal Volume Respiratory Rate 20 BPM Figure 9 2 Oxygen Concentration for 600 ml Tidal Volume Supplemental O Flows 21 101 15 L min 100 7 907 80 F g 7f 607 E 50 5 40 E 5 30 M o o 207 107 0 1 1 10 5 20 5 30 5 Pressures cm H20 1000 ml Tidal Volume Respiratory Rate 20 BPM Figure 9 3 Oxygen Concentration for 1000 ml Tidal Volume Provider Manual 10 1 CHAPTER 10 Cincuirs AND CCESSORIES This chapter details the Respironics approved breathing circuit and accessories WARNING Refer to each accessory s instruction sheet for the applicable warnings cautions and notes 10 1 Circuit CONFIGURATIONS WARNING The device requires an intentional leak port either built into the mask or on a separate exhalation device e g Whisper Swivel II Plateau Exhalation Valve PEV or Disposable Exhalation Valve to remove exhaled air from the circuit Therefore specific masks and circuits using an intentional leak port are required for normal operation Ihe pressurized air from the device causes a continuous flow of ai
44. en disconnected for 15 seconds e 60 means that the alarm sounds after the patient has been disconnected for one minute Low Minute Ventilation Alarm Setting Screen Low Minute Ventilation Alarm Setting screen is shown in Figure 6 12 This setting enables or disables the audible alert a beeping sound when a low minute ventilation event is detected MinVent Figure 6 12 Low Minute Ventilation Alarm Setting Screen Change the alarm setting by pressing the HEAT and RAMP buttons until the desired setting is reached You can increase or decrease the setting from 0 to 99 LPM in increments of 1 LPM Reset Therapy Meter Setting Screen The Reset Therapy Meter Setting screen is shown in Figure 6 13 ERASE HOURS Figure 6 13 Reset Therapy Meter Setting Screen This screen displays the number of hours that the device delivered therapy to the patient The decimal point displays if the therapy time is less than 2000 hours Otherwise the decimal point does not display so values between 2000 and 19999 hours can display To erase the totals and go back to zero press and hold the HEAT or RAMP button ERASE displays on the screen Hold the button down until the time changes to zero and ERASE disappears Provider Manual 13 LED Backlight Setting Screen The LED Backlight Setting screen is shown in Figure 6 14 This setting allows you to have the lights behind the buttons turned on or off while the airflow is turned on and the device is in
45. er is provided Press the RESET button to manually reset this alarm This alarm may indicate two issues depending on which power supply is connected If only the DC power adapter is connected the alarm indicates that the power supply has a defective battery sense line If only the AC power supply is connected of if both the AC power supply and DC power adapter are connected this alarm indicates that the AC power supply is out of specification less than 22 V Press the RESET button to reset the alarm However the AC power LED continues to flash after a manual reset Provider Manual 7 8 7 5 ALARM SUMMARY TABLES The following tables summarize the patient system and power alarm information PATIENT ALARMS Alarm LED Indicator Display Audible Device Action Possible Cause Patient Action Provider Action Message Indicator Apnea Apnea event Press the RESET Verify patient Red flash ALARMand o o Operates occurred button to reset status APNEA during therapy the alarm flash Report the alarm to your health care professional Continue using your device Patient circuit is Press the RESET Reconnect the Patient Red flash ALARM and disconnected or button to reset patient circuit or Disconnect PATIENT eee o peris has a large leak the alarm fix the leak flash Reconnect the If the alarm patient circuit or continues contact correct the leak an authorized service If the alarm representative or
46. ernately occluding and opening the outlet port then occlude the outlet port e Verify that the Apnea alarm occurs in approximately 10 seconds 11 Press the RESET button to clear the alarm 12 Set the Apnea Alarm setting to 0 Off Low Minute VENTILATION ALARM TEST 13 Simulate 6 breaths by alternately occluding and opening the outlet port for 2 seconds each 14 Set the Low Minute Ventilation Alarm setting 10 0 LPM 15 Simulate 1 or 2 breaths by occluding and opening the outlet port e Verify that the Low Minute Ventilation alarm occurs 16 Set the Low Minute Ventilation Alarm setting to 0 0 Off Loss or Input Power ALARM TEST 17 While the device is still operating disconnect the power cord from the device e Verify that a Loss of Input Power alarm sounds Reconnect power to stop the alarm IMPORTANT When testing is complete and before patient use adjust the device to the appropriate patient settings Provider Manual CHAPTER 12 SPECIFICATIONS ENVIRONMENTAL Operating Storage Temperature 41 F 5 C to 95 F 35 C 4 F 20 C to 140 F 60 C Relative Humidity 15 to 9596 15 to 9596 non condensing non condensing Atmospheric Pressure 5600 feet to sea level 83 to 102kPa PHYSICAL Dimensions 9 75 in Lx 6 625 in W x 4 4 in H 24 8 cm L x 16 8 cm W x 11 2 cm H Weight 4 lbs 1 8 kg ELECTRICAL AC Voltag
47. ft User button while the Setting screen is displayed You press the Right User button while the Access Level Setting screen is displayed The following settings can be modified in User mode e Rise time setting e Ramp start pressure setting if enabled e backlight for control buttons enable disable e Humidifier heat setting from the Humidifier Setting screen The following is also true in User mode e The Rise Time Setting screen is only displayed if the IPAP Max is greater than EPAR Ramp Start Pressure Setting screen is only displayed if the Ramp Length setting is greater than zero Provider Manual 3 9 3 4 DEFINITIONS ACRONYMS AND ABBREVIATIONS The following terms appear in this manual APS Automatic Pressure Support BiPAP Bi level Positive Airway Pressure BPM Breaths Per Minute CSA Central Sleep Apnea CPAP Continuous Positive Airway Pressure Cycle The transition from inspiration to expiration EPAP Expiratory Positive Airway Pressure High Priority Alarm Alarm signal indicating a condition that requires immediate attention IPAP Inspiratory Positive Airway Pressure IPAP Max Ihe maximum IPAP setting established by the health care professional IPAP Min The minimum IPAP setting established by the health care professional LCD Liquid Crystal Display LEAK Measured Average Leak LED Light Emitting Diode Low Minute Ventilation A condition in which the patie
48. ge Corrupt real time clock value Real time clock not ticking Unable to queue data to user interface Invalid Built in Self Test call Over pressure condition Operating system not responding to software Insufficient voltage for audible alarm 12V reference out of range 5V reference out of range Bulk voltage out of range 15 reference out of range Railed Flow sensor Blower pressure sensor failure Reserved for future use Unrecognized Main PCA Blower failure Blower speed out of tolerance Motor current high while blower off Buffer overflow Motor current high while blower on Unable to queue data to provide therapy Stuck key Outlet pressure sensor railed Blower pressure sensor railed Provider Manual E61 E62 E63 E64 E65 E66 E67 E68 E69 E70 E71 E72 E73 E74 E75 E76 E77 E78 E79 E80 E81 E82 E83 E84 E85 E86 E87 E88 Real time clock s battery is dead Blower speed exceeded max Internal watchdog failure External watchdog failure Unexpected watchdog reset Reserved for future use Operating system failed initialization Unable to queue data for communications Sampling thread locked Execution thread locked Internal RAM failure Unable to queue data for logging Reserved for future use Reserved for future use Reserved for future use Failure in loss of power battery High pressure condition Low pressure condition Unable to maintain pressure support Barometric pressure sensor failure Barometric
49. gerous reduction in cardiac output The device should not be used in patients who are dehydrated or volume depleted and should be used with extreme care in patients with atrial fibrillation NOTE When assessing the relative risks and benefits the health care professional should understand that the device can be set to deliver pressures up to 30 cm H O Also in the unlikely event of certain fault conditions a maximum static pressure of 40 cm H O is possible Provider Manual 2 4 2 5 PATIENT PRECAUTIONS e following are potential side effects of noninvasive positive pressure therapy Ear or sinus discomfort Conjunctivitis Skin abrasions due to noninvasive interfaces Gastric distention aerophagia Drying of nose mouth or throat Eye irritation Skin rashes Chest discomfort Provider Manual 3 1 CHAPTER 3 INTRODUCTION 3 1 Overview Figure 3 1 BiPAP autoSV Device The device shown in Figure 3 1 is a low pressure electrically driven ventilator system with electronic pressure control The devices pressure controls are adjusted to deliver pressure support for patient ventilatory assistance The device is intended to augment 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 assistance is provided by the administration of tw
50. hat appears when a Pressure Regulation Low alarm occurs This screen is identical to the Pressure Regulation High alarm or Low Pressure Support alarm screens When this screen displays a Pressure Regulation Low alarm the cm H O and ALARM flash and the LCD backlight is turned on Pressing either the SILENCE or RESET button exits this screen and returns to the previous screen 7 2 5 Low Pressure Support ALARM The Low Pressure Support alarm is a high priority alarm that indicates that a low pressure support condition has been detected for 60 seconds This alarm does not reset automatically Press the RESET button to manually reset this alarm Figure 7 4 shows the screen that appears when a Low Pressure Support alarm occurs This screen is identical to the Pressure Regulation High or Low alarm screens The cm H O and ALARM flash and the LCD backlight is turned on Pressing either the SILENCE or RESET button exits this screen and returns to the previous screen 7 2 6 PRESCRIPTION COMPLETE ALARM Figure 7 5 shows the screen that appears when a Prescription Complete alarm occurs Figure 7 5 Prescription Complete Alarm Screen If a prescription only SmartCard is inserted in the device and is successfully written to the device CARD cm H O and ALARM flash and a low priority audible alert sounds Press the RESET button to reset the alarm Remove the SmartCard from the device to exit this screen and return to the previous screen Provider Manual
51. ient pressure therefore the leak estimate is correlated to the changing patient pressure Both algorithms include unintentional circuit leak and are averaged over several breaths B Patient Flow The total circuit flow is comprised of the circuit leak and the patient flow The calculated patient flow is the total flow minus the circuit leak Patient flow is a primary input into the triggering and cycling mechanisms 3 2 4 2 SENsITIVITY An essential feature of the device s triggering function is its ability to effectively sense spontaneous breathing efforts which causes the ventilator to trigger to IPAP and cycle to EPAP Because no preset sensitivity threshold can assure patient and machine synchrony with changing breathing efforts and circuit leaks the device continuously tracks patient breathing patterns and automatically adjusts sensitivity thresholds to ensure optimum sensitivity as breathing patterns change or as circuit leaks change The algorithm used to ensure optimum sensitivity is the Volume Trigger Provider Manual 3 6 Volume Trigger EPAP to IPAP The volume trigger is the method used to trigger IPAP during spontaneous breathing The volume trigger threshold is 6 ml of accumulated patient inspiratory volume When patient effort generates inspiratory flow causing 6 ml of volume IPAP is triggered Shape Trigger EPAP to IPAP The shape trigger is another method used to trigger IPAP during spontaneous breathing This method c
52. ing connector for reusable or disposable tubing Figure 4 6 Breathing Circuit Connection 4 4 Rear PANEL Figure 4 7 shows the rear panel Communications Connector Port AS Cord Retainer AOGA A 7 SmartCard Slot Connector Cord Retainer Filter Cap Figure 4 7 Rear Panel NOTE The SmartCard connector SmartCard slot is located on the side of the device WARNING In order to ensure proper protection against electric shock only communications accessories with an IEC 60601 1 approved power supply may be connected through the SleepLink interface All IEC 950 devices must only be connected to the 7 pin connector with the Respironics Isolation cable Part Number 1012865 Provider Manual 4 6 The rear panel contains the following communications connector that accepts the Respironics Communications Cable for computer and external communications or a remote alarm when available Use only with an IEC 60950 approved computer e Two power inlets one for connecting the external AC power supply and another for connecting the DC power adapter e The filter cap that is removed to inspect the inlet air filters e Two cord retainers that provide strain relief for the power cord 4 5 SMARTCARD The device is delivered with the SmartCard installed The SmartCard records the following data e Date e Time e Leak e Pressure e Tidal volume Peak flow e Apnea events e Hypopne
53. ing for the patient RISE TIME Figure 6 7 Rise Time Setting Screen NOTE The Rise Time Setting screen displays only if IPAP Max is greater than EPAP Increase or decrease the rise time setting from 1 to 6 by pressing the HEAT and RAMP buttons until you find the right setting The rise time of 1 to 6 corresponds to tenths of a second e g a setting of 4 equals 0 4 second rise time 7 Ramp Length Setting Screen The Ramp Length Setting screen shown in Figure 6 8 allows you to change the ramp time RAMP SETUP FU C LL I Figure 6 8 Ramp Length Setting Screen To change the ramp time press the HEAT and RAMP buttons until the correct time appears Ihe setting increases or decreases from 0 to 45 minutes in 5 minute increments If you do not want ramp set the time to zero NOTE Ifthe ramp length is set to zero the ramp settings are complete Go to step 9 Provider Manual 8 Ramp Start Pressure Setting Screen The Ramp Start Pressure Setting screen is shown in Figure 6 9 NOTE This screen displays only if the ramp length setting is greaterr than 0 RAMP SETUP START Li Mm am H20 Figure 6 9 Ramp Start Pressure Setting Screen To change the ramp starting pressure press the HEAT and RAMP buttons until the correct pressure appears The setting increases or decreases in 1 0 cm H O increments The user can adjust the setting from 4 cm H O to the current EPAP pressure setting 9 Apnea Alarm Setting Screen
54. intended to augment patient breathing It is not intended to provide total ventilatory support It may stop operating with power failure or if a fault occurs in the product In the event of a power or device failure audible and visual alarm signals will activate The device must then be disconnected from the patient immediately As is the case with most ventilators with passive exhalation ports when power is lost sufficient air will not be provided through the circuit and exhaled air may be rebreathed At low EPAP pressures the flow through the exhalation port may be inadequate to clear all exhaled gas from the tubing Some rebreathing may occur Monitor the patient appropriately To reduce the risk of contamination you may place a bacteria filter in line between the device and the patient The device does not have an alarm to detect occlusion of the exhalation port Before each use inspect the patient circuit to verify that the port is not occluded Occlusion or partial occlusion can reduce airflow and result in rebreathing of exhaled air Verify the operation of the Patient Disconnect alarm with any changes in the patient circuit Verify that the Patient Disconnect alarm is active if required for medical reasons If the patient has a severe obstructive or restrictive spirometric defect or severe daytime hypercapnia or hypoxia then the device may not be an appropriate treatment method This is due to the level of ventilatory support that
55. ironment ELECTROMAGNETIC ENVIRONMENT GUIDANCE Group 1 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 COMPLIANCE Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment IEC 60601 Test LeveL ELECTROMAGNETIC ENVIRONMENT GUIDANCE CowPLiANCE LeveL 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 2 kV for power supply lines 2 kV for supply mains Mains power quality should be that of a 1 kV for input output lines 1 kV for input output lines typical home or hospital environment 1 kV differential mode 1 kV differential mode Mains power quality should be that of a 2 kV common mode 2 kV for common mode typical home or hospital environment 596 U 596 U gt 95 dip in for 0 5 cycle 29596 dip in U for 0 5 cycle 40 U 40 U 60 dip in for 5 cycles 6096 dip in U for 5 cycles 70 U 7096
56. ither call your health an authorized care professional Service representative or Respironics inti Press the RESET Remove the Prescription Yellow solid ALARM ee Operates button to reset SmartCard to Complete CARD and Smarncardihas the alarm exit this screen been inserted j cm H20 i and return to the into the device flash Remove the SmartCard from the device previous screen Provider Manual 7 10 Power ALARMS i Audible i Alarm LED Indicator Display m Device Action Possible Cause Patient Action Provider Action Message Indicator Replace the Shuts down The external Pressthe Q p Red solid Blank screen m battery is button to silence battery below 9 8 V the alarm Remove DC power source from the device and replace the battery to restore power Or seek a reliable AC power source Power was lost I Restore power to Loss of Red solid Blank screen h Press the O gt while the il the device Ifthe Shuts down 5 button to silence Input Power device was the alarm alarm continues to providing occur have the therapy Restore power device serviced If the alarm by either an continues to occur authorized service contact your health epresentative or care professional Respironics Low Yellow alarm Battery is nearly Press the RESET the External LED flashes PUE Operat discharged button to reset attery B
57. lash NOTE Pressing the SILENCE button while the silence period is active does not restart the silence period 7 1 1 2 LED Benavior Red Alarm LED The red alarm LED indicates high priority system and patient alarms The LED flashes when a new high priority alarm is detected It changes from flashing to continuous when the alarm sound is silenced or the alarm condition is corrected The LED resumes flashing when the silence period expires or if a new alarm occurs The LED turns off when all high priority alarms with an automatic reset method end and there are no high priority alarms with a manual reset method active Additionally the red LED turns off when you press the RESET button NOTE continuous red LED indicates loss of power or a silenced high priority alarm Yellow Alarm LED The yellow alarm LED indicates medium or low priority system and power alarms The LED flashes when a new medium priority alarm is detected It changes from flashing to continuous when the alarm sound is silenced or if the alarm condition is corrected The LED resumes flashing when the silence period expires or if a new alarm occurs The LED turns off when all medium and low priority alarms with an automatic reset method end and there are no medium or low priority alarms with a manual reset method active Additionally the yellow alarm LED turns off when you press the RESET button 7 1 1 3 DisPLAv BEHAVIOR For high medium and low priority alarm
58. lter place it against the gray foam filter so the soft side of the ultra fine filter touches the gray foam filter When the filters are installed the hard plastic side of the white filter will touch the inside of the device 2 Slide the filters into the air inlet at the rear of the device with the white filter going in first if it s used Push them down into the recess as shown in Figure 5 1 3 Position the cap so that the small opening on the cap is facing down 4 Snap the cap into place See Chapter 8 for information about cleaning or replacing the filters NOTE The filter cap should be installed with the air inlet opening at the bottom 5 1 2 AssEMBLING THE PATIENT CIRCUIT WARNING The exhalation device e g the Whisper Swivel II or exhalation port on masks with an integrated exhalation port is designed to exhaust CO from the patient circuit Do not block or seal the ports on the exhalation device Provider Manual 5 2 1 Assemble the patient circuit according to the configurations presented in Chapter 10 2 If required connect a bacteria filter to the breathing circuit connection shown in Figure 5 2 and connect the patient tubing to the outlet of the bacteria filter e If the bacteria filter is not required connect the patient tubing directly to the breathing circuit connection e Ifa humidifier is to be used connect the inlet to the bacteria filter outlet or to the breathing circuit connection A completed asse
59. m should not be used on patients with the following conditions e Patients without a spontaneous respiratory drive e Existing respiratory failure failure to treat risk of increased work of breathing due either to incomplete reversal of upper airway obstruction or to breathing at high lung volume leading to worsening respiratory failure e Pneumothorax or pneumomediastinum e Emphysematous bullae or a past history of pneumothorax risk of pneumothorax Acute decompensated cardiac failure or hypotension particularly if associated with intravascular volume depletion risk of further hypotension or reduction in cardiac output e Massive epistaxis or previous history of massive epistaxis risk of recurrence e Pneumoencephalus recent trauma or surgery e g pituitary or nasal that may have produced cranio nasopharyngeal fistula risk of entry of air or other material into the cranial cavity Acute sinusitis otitis media or perforated ear drum e Acute or unstable cardiac failure e Nocturnal or resting angina risk of infarction or arrhythmias e Unstable arrhythmias e Severely obtunded or heavily sedated patients e At risk for aspiration of gastric contents e Impaired ability to clear secretions If patients are dehydrated or volume depleted or have persistent atrial fibrillation their cardiac filling pressures may be low In these cases as with any CPAP or ventilatory support use of the device may lead to a dan
60. m the card If the error C100 C101 continues to occur replace the card C103 C105 The SmartCard contains an SmartCard contains a prescription that is unknown prescription not supported by this device Perhaps the card is intended for another device C106 C109 The SmartCard is corrupt Erase or reprogram the card If the error C200 continues to occur replace the card C201 SmartCard contains an The card contains a logging format that is not unknown logging format supported by this device Perhaps the card is intended for another device C202 C207 The SmartCard is corrupt Erase or reprogram the card If the error C300 C303 continues to occur replace the card C400 C414 C500 C506 Provider Manual APPENDIX B EMC INFORMATION Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 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 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 env
61. mbly without humidifier appears in Figure 5 2 Patient Interface Exhalation Port Breathing Filter Circuit Optional Connection Figure 5 2 An Example of a Typical Circuit 5 1 3 SUPPLYING Power TO THE DEVICE WARNING The BiPAP autoSV device can operate on AC or DC power The DC power option is not intended as a battery backup during use of AC power CAUTION When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the device or the vehicle may occur WARNING Route the wires to avoid tripping 5 1 3 1 AC Operation WARNING For proper use the external AC power supply must be placed feet down in the upright position as shown in Figure 5 3 1 Plug the pronged end of the AC power supply s cord into an electrical outlet that is not controlled by a wall switch 2 external AC power supply features cord retainer to provide strain relief for the AC power cord Wrap the cord around the AC power supply s cord retainer using the wire tie supplied with your power supply 3 Leaving a small amount of slack in the cord connect the cord on the other side of the power supply to one of the power inlets on the device The power cord has a locking connector To properly plug the cord in a Pull the locking mechanism back b Push the connector into place c Release the lock 4 Wrap the cord around the device s po
62. n the morning and alternate using the two gray foam filters provided with the system to ensure sufficient drying time for the cleaned filter 6 If the ultra fine filter is dirty or torn replace it 7 Reinstall the filters If you are using the optional white ultra fine filter place it against the gray foam filter so the soft side of the ultra fine filter touches the gray foam filter Slide the filters into the air inlet at the rear of the device and push them into the recess When the filters are installed the hard plastic side of the white filter will touch the inside of the device 8 Reinstall the filter cover 8 3 MAINTENANCE See the BiPAP autoSV Service Manual for recommended periodic maintenance WARNING Electrical cords or cables should be periodically inspected for damage or signs of wear 8 4 CARRYING CASE A carrying case reorder number 1005965 is included with your BiPAP autoSV system The case is designed to hold your device along with your circuit accessories and humidifier When you are travelling the carrying case can be used for carry on luggage only The carrying case will not protect the device if it is put through checked baggage NOTE If travelling with your humidifier make sure you empty the water chamber before placing it in the carrying case Provider Manual 9 1 CHAPTER 9 DDING SUPPLEMENTAL OXYGEN Oxygen may be added at the mask connection Please note the warnings listed below when using
63. nt is not receiving a specified volume of air on a per minute basis Low Priority Alarm Signal indicating an information message LPM Liters Per Minute Medium Priority Alarm Alarm signal indicating a condition that requires operator awareness MinVent Minute Ventilation NPPV Non invasive Positive Pressure Ventilation Operate State The state of the BiPAP autoSV device when the device and the airflow are both on OSA Obstructive Sleep Apnea Ramp A feature that may increase patient comfort when therapy is started The ramp feature will reduce the pressure and then gradually increase ramp the pressure to the prescription pressure setting so patients can fall asleep more comfortably RR Respiratory Rate SET Spontaneous Expiratory Threshold Standby State The state of the BiPAP autoSV device when it is on but the airflow is off T Inspiratory Time Trigger Ihe transition from expiration to inspiration V Exhaled Tidal Volume Provider Manual 3 10 3 5 5 Key following symbols appear on the device label Symbol Meaning DC Power N Attention consult accompanying documents Pressure On Off Type BF Applied Part Class Double Insulated European CE Declaration of Conformity o SP Canadian US Certification AN Electrostatic Discharge IPX1 Drip Proof Equipment A US UL Recognized for Canada and the United States A TUV Safety Standard Compliance 2 No
64. o levels of positive pressure During exhalation pressure is variably positive or near ambient During inspiration pressure is variably positive and always equal to or higher than the expiratory level The device responds reliably to patient flow rates that indicate movement to inhalation or exhalation even in the presence of most normal leaks in the patient circuit Automatic adjustment of this trigger threshold in the presence of leaks makes the system ideal for mask applied ventilation assistance The patient controllable Rise Time feature may enhance patient ventilator synchrony and patient comfort 3 2 OPERATION This section provides information on the following BiPAP autoSV features Pressure Controls Back up Breath Rate Controls Ramp Digital Auto Trak Sensitivity Provider Manual 3 2 3 2 1 Pressure CONTROLS The device contains the following controls which are used to configure positive pressure therapies e EPAP The pressure maintained during expiration e PAP Min The minimum pressure the device can deliver during inspiration e IPAP Max The maximum pressure the device can deliver during inspiration With these controls the device offers the following therapies Control Settings Description EPAP z IPAP Min IPAP Max The device provides CPAP as a base therapy The device may automatically provide pressure support with inspiratory pressures between IPAP Min and IPAP Max to
65. 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 8 should be less than the compliance level in each frequency range P Interference may occur in the vicinity of equipment marked with the following symbol 64 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND Mo LE RF Communications E
66. ontinuously tracks patient inspiratory and expiratory flow and adjusts the spontaneous trigger threshold for optimum sensitivity The shape signal appears as a shadowy image of the patient s actual flow The shape signal functions as a sensitivity threshold at inspiration When the patient s flow rate crosses the shape signal the unit changes pressure levels Figure 3 8 illustrates how the shape signal is superimposed onto the actual waveform to trigger to IPAP The shape signal is created by offsetting the signal from the actual patient flow by 15 LPM and delaying it for a 300 msec period This intentional delay causes the shape signal to be slightly behind the patient s flow rate A sudden change in patient flow will cross the shape signal causing the pressure level to change IPAP PRESSURE EPAP Cycle to EPAP Shape Crossover Signal Point Estimated FLOW Patient Flow Trigger to IPAP Crossover Point Figure 3 8 Shape Signal Tracking the patient s flow pattern with the shape signal provides a sensitive mechanism to trigger to IPAP in response to changing breathing patterns and circuit leaks Spontaneous Expiratory Threshold IPAP to EPAP method used to cycle off IPAP during spontaneous breathing is called Spontaneous Expiratory Threshold SET SET rises in proportion to the inspiratory flow rate on each breath When the SET and the actual patient flow value are equal the unit cycles to EPAP IPAP PRESS
67. ormed by an authorized service agent Electrical cords and cables should be periodically inspected for damage or signs of wear Replace any damaged parts before using To avoid electrical shock unplug the device before cleaning Pins of connectors identified with the ESD warning symbol should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Precautionary procedures include methods to prevent build up of electrostatic discharge e g air conditioning humidification conductive floor coverings non synthetic clothing discharging one s body to the frame of the equipment or system or to earth or a large metal object and grounding oneself by means of a wrist strap to the equipment or system or to earth If oxygen is used with the device the oxygen flow must be turned off when the device is not in use Explanation of the warning When the device is not in operation and the oxygen flow is left on oxygen delivered into the ventilator tubing may accumulate within the devices enclosure Oxygen accumulated in the ventilator enclosure will create a risk of fire When using oxygen with this system a Respironics Pressure Valve must be placed in line with the patient circuit Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame When administering fixed flow supplemental oxygen the O concentration may not be constant The inspired oxygen
68. oxygen with the device WARNING The oxygen supply must comply with local regulations for oxygen use WARNING When using oxygen with this system a Respironics Pressure Valve Part number 302418 must be placed in line with the patient circuit Place the valve in line with the patient circuit and connect the oxygen as shown here To Controlled Oxygen Source O2 Enrichment Pressure Attachment Valve Figure 9 1 Using the Respironics Pressure Valve WARNING Oxygen should be administered only on the order of a physician WARNING Supplemental oxygen should not be added to the breathing circuit by placing the source where the gas will be entrained through the inlet filter on the rear of the device WARNING Continuous patient monitoring is recommended while administering oxygen Patient monitoring should consist of at a minimum patient observation and pulse oximetry Arterial blood gas measurements should be used when necessary WARNING If administering fixed flow supplemental oxygen the oxygen concentration may not be constant The inspired oxygen concentration will vary depending on the current IPAP pressure and EPAP setting patient breathing pattern and the leak rate Substantial leaks around the mask may reduce the inspired oxygen concentration to less than the expected concentrations shown in section 9 2 Appropriate patient monitoring should be implemented WARNING When using oxygen with this system turn the device on befo
69. plays RAMP if ramp is enabled and the RAMP button has been pressed If fixed timed backup rate is prescribed BPM and will be displayed if the health care professional set the breath rate between 4 30 BPM For more information about the Monitoring Screen and parameters that you can view from here see Chapter 6 5 When in the Standby or Monitoring screens you can modify the Humidifier setting by pressing and holding the HEAT button until the screen below appears Figure 5 9 Figure 5 9 Humidifier Setting Screen You can increase or decrease the humidifier setting from 1 to 5 in increments of 1 The setting changes immediately as you adjust it 5 1 5 ENTERING Provider There are two ways to select Provider mode access 1 temporarily enter Provider mode when the device is in User mode hold down the Right User button and SILENCE button simultaneously for at least 2 seconds SETUP appears in the upper right corner of the screen and the EPAP setting screen displays 2 Once the device is in Provider mode you can configure the device to remain in Provider mode via the Access Level screen as described in Section 6 1 2 IMPORTANT Prescribed therapy settings can only be set in Provider mode To prevent patients from tampering with the settings do not allow them to access Provider mode 5 1 6 PERFORMANCE VERIFICATION After powering up the device and entering Provider mode perform the operational verification as describe
70. possible high priority sounds e High Priority The sound repeats a pattern of three beeps followed by a pause and then two more beeps until the SILENCE or RESET button is pressed The silence period is one minute This pattern is indicated in Section 7 5 as 9 e Loss of Power The sound repeats a pattern of a two second beep followed by a two second pause periodically without user intervention The 1 button silences this alarm The SILENCE and RESET buttons and the LED control panel backlight do not apply to this alarm This pattern is indicated in Section 7 5 as EE Medium Priority Sound medium priority sound repeats a pattern of three beeps every 20 seconds until the SILENCE or RESET button is pressed The silence period is one minute This pattern is indicated in Section 7 5 as Low Priority Sound The low priority sound repeats a pattern of two beeps every 30 seconds until the SILENCE or RESET button is pressed The audible alarm will not reoccur This pattern is indicated in Section 7 5 as Silence Period The silence period for all applicable alarms is one minute When the alarm sound is silenced a flashing LED becomes continuous If the alarm condition is not corrected by the end of the silence period the alarm sound is repeated the LED will flash again If a new high or medium priority alarm condition occurs during this time the appropriate LED flashes New low priority alarms do not cause the LED to f
71. put the device in the Operate state Occlude the outlet of the device for 4 seconds and then open the outlet for 4 seconds Do this several times while observing the manometer reading and the device display e Verify that the screen agrees with the pressure indicated on the manometer To verify the performance of the patient alarms see Section 11 2 Provider Manual 11 2 11 2 ALARM VERIFICATION Keep the test orifice and parameter setups as used in the system verification described in Section 11 1 Patient Disconnect ALARM TEST 1 Set the Apnea Alarm setting to 0 Off 2 Set the Patient Disconnect Alarm setting to 15 sec 3 Exit to the Monitoring screen Remove the test orifice e Verify that the Patient Disconnect Alarm occurs in approximately 15 seconds Press the SILENCE button to silence the alarm and wait for one minute until the alarm sounds again Press the RESET button to clear the alarm Replace the test orifice Do GON seno um Simulate a breathing pattern by occluding and opening the outlet port to correct the alarm condition NOTE The red high priority alarm indicator light will appear solid when the alarm condition has subsided or if the alarm has been silenced The light will remain solid until the alarm has been cleared 8 Setthe Patient Disconnect Alarm setting to 0 Off Apnea ALARM Test 9 Set the Apnea Alarm setting 10 sec 10 Exit to the Monitoring screen Simulate breathing by alt
72. r describes the device alarms how to set them and what corrective actions to take for the alarm conditions 7 1 ALARM INTRODUCTION The device provides three alarm levels high medium and low priority High Priority These alarms require immediate operator response The alarm signal consists of a red LED and a high priority sound Ihe display has ALARM at the top of the screen Medium Priority These alarms require prompt operator response Ihe alarm signal consists of a yellow LED and a medium priority sound The display has ALARM at the top of the screen Low Priority These alarms require operator awareness The alarm signal consists of a yellow LED and a low priority sound The display has ALARM at the top of the screen Some audible alarms are self cancellable This means that the alarm sound stops when the cause of the alarm is corrected See section 7 3 for detailed descriptions of the alarm LEDs and sounds Figure 7 1 identifies the alarm LEDs and buttons on the control panel High Priority Alarm LED Red Low Medium Priority Alarm LED Yellow Alarm Reset Button Alarm Silence Button Figure 7 1 Alarm LEDs and Buttons 7 1 1 Overview or ALARM BEHAVIOR Alarm conditions are signalled in three ways a sound an LED and a display message Each signal type behaves differently depending on the type of alarm Provider Manual 7 2 7 1 1 1 Sounps BEHAVIOR 1 High Priority Sounds There are two
73. r system alarm Indicator occurs Low Medium Priority The yellow Low Medium Priority Alarm LED illuminates when a medium or low priority patient or Alarm Indicator system alarm occurs NOTE All LED indicators temporarily turn on when the device is first plugged in 4 1 4 NupiBLE ALARMS AND INDICATORS Audible alarms and indicators discussed in detail in Chapter 7 can be heard in the following situations e Power Failure An alarm sounds when power is lost High priority system or patient alarms An alarm sounds several times at intervals for a high priority alarm e Medium priority system alarms An alarm sounds three times for a medium priority alarm Low priority system alarms An alarm sounds twice for a low priority alarm e Provider mode An alarm sounds twice when the provider mode is accessed using the key sequence described in Section 3 3 1 e SmartCard activity An alarm sounds once when the SmartCard is inserted or removed e Power on An alarm sounds once when the devices power cord is connected e Confirmation An alarm sounds once when the airflow is turned on when the humidifier parameter screen is entered and when the humidifier is turned on 4 2 NAVIGATING THE SCREENS Note the following when navigating the Provider or User mode screens e The Left and Right User buttons allow you to go to the previous setting or the next setting respectively The HEAT and RAMP buttons operate as up and down
74. r to exhaust from the leak port to flush the exhaled air from the circuit The device should be turned on and the intentional leak port should be checked before using the device The device is intended for use with Respironics approved patient circuits Typical components are Bacteria filter optional 22 mm reusable circuit tubing Exhalation device Respironics patient interface e g mask Respironics Pressure Valve Part Number 302418 required if adding supplemental oxygen Humidifier optional Additional accessories may be added to the circuit to meet specific needs 10 2 Circuits AND ACCESSORIES 1 Reusable or Disposable Circuit Reusable smooth inner lumen circuit tubing and exhalation port Disposable smooth inner lumen circuit tubing and exhalation port 2 Circuit Accessories 6 in 15 2 cm disposable circuit tubing 18 in 45 7 cm disposable circuit tubing 72 in 182 9 cm disposable circuit tubing O enrichment attachment Bacteria filter 3 Accessories DC power adapter Respironics Communication cable Remote alarm Provider Manual 10 2 10 3 Masks ExHALATION PORTS AND RELATED ACCESSORIES 1 Masks e Respironics mask with built in exhalation port or Respironics mask with separate exhalation device 2 Accessories e Disposable headgear e Reusable headgear e Chin strap 10 4 HUMIDIFIERS l Respironics REMstar Heated humidifier 2 Respironics Pass over humidifier 3 Respironics H2 Heat
75. re turning the oxygen on Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device WARNING Oxygen accelerates fires Keep the device and the oxygen container away from heat open flames any oily substance or other sources of ignition Do not smoke in the area near the device or the oxygen 9 1 ADDING SUPPLEMENTAL OXYGEN The delivered oxygen concentration varies with changes in flow in the circuit The following may have an impact on oxygen concentration e Pressure settings e Patient Tidal Volume e Peak Inspiratory Flow Ratio e Respiratory rate e Circuit leak rate e Oxygen flow rate Provider Manual 9 2 To add oxygen to the circuit the oxygen supply must comply with the local regulations for medical oxygen The oxygen flow into the patient circuit cannot exceed 15 L min and the pressure cannot exceed 50 psi 9 2 SuPPLEMENTAL OXYGEN CONCENTRATIONS Figures 9 2 and 9 3 illustrate the potential range of oxygen concentration available to the patient at a given tidal volume supplemental oxygen flow and pressure setting These figures represent bench test results without inadvertent mask leaks when oxygen is administered at the mask Substantial leaks around the mask may reduce the expected oxygen concentration to below the levels shown in Figures 9 2 and 9 3 This guideline may be used as a starting point for initiating oxygen therapy Oxygen flow should be gradually adjust
76. s the display shows ALARM and the error code or name of the alarm Provider Manual 7 2 System ALARMS The device has several system alarms e System Errors e Errors e Pressure Regulation High e Pressure Regulation Low e Low Pressure Support e Prescription Card Complete 7 2 1 SYSTEM ERROR ALARM The System Error alarm is a high priority alarm It indicates that there is a problem with the device Unlike other high priority alarms the red LED cannot be turned off because the alarm does not stop until the power shuts down and is then restored A System Error screen is shown in Figure 7 2 Figure 7 2 System Error Screen A three digit error code displays on the screen indicating the type of error e g error code 57 displays as E57 A complete list of system error codes can be found in Appendix A When a system error occurs the devices LCD backlight is turned on and the blower and humidifier are off Pressing the RESET button only shuts off the audible alarm 1 2 2 Carp ERROR ALARM The SmartCard Error alarm is a low priority alarm It indicates that a problem exists with the card inserted in the SmartCard connectivity slot Removing the SmartCard automatically resets this alarm Additionally pressing the RESET button stops the alarm until another invalid SmartCard is inserted and detected The Card Error screen is shown in Figure 7 3 Figure 7 3 Card Error Screen An error code and CARD displays on the
77. screen indicating the type of error e g error code 1 displays as C1 A complete list of SmartCard error codes can be found in Appendix A When a card error occurs the devices LCD backlight is turned on Pressing either the SILENCE or RESET button exits this screen and returns to the previous screen Provider Manual 7 4 7 2 3 Pressure REGULATION HicH ALARM The Pressure Regulation High alarm is a high priority alarm It indicates that the outlet pressure is greater than 5 cm H O above the current IPAP setting This alarm does not reset automatically Press the RESET button to manually reset this alarm ALARM cm H20 Figure 7 4 Screen for Pressure Regulation High Alarm Pressure Regulation Low Alarm and Low Pressure Support Alarm NOTE he Pressure Regulation High Alarm Pressure Regulation Low Alarm and Low Pressure Support Alarm all display the same screen When this screen displays a Pressure Regulation High alarm the cm H O and ALARM flash and the LCD backlight is turned on Pressing either the SILENCE or RESET button exits this screen and returns to the previous screen 7 2 4 Pressure REGULATION Low ALARM The Pressure Regulation Low alarm is a high priority alarm that indicates when the patient is not receiving adequate pressure therapy the outlet pressure is 5 cm H O below the current IPAP setting This alarm does not reset automatically Press the RESET button to manually reset this alarm Figure 7 4 shows the screen t
78. the E2 Software corrupt device E3 External RAM failure e Restore power If the error continues to EA FIQ Stack Overflow occur call Respironics E5 FIQ Stack Underflow or an authorized service representative to have the E6 Nested IRQ Stack Overflow PEN E7 Nested IRQ Stack Underflow E8 IRQ Stack Overflow E9 IRQ Stack Underflow E10 Timer Stack Overflow Ell Timer Stack Underflow E12 Service Stack Overflow E13 Service Stack Underflow E14 Thread Stack Overflow E15 Undefined Instruction E16 Unexpected Software Interrupt E17 Microprocessor Prefetch Exception E18 Data Access Exception E19 Reserved Exception E20 Spurious Default Interrupt E21 Spurious Interrupt E22 Corrupt calibration table E23 Invalid zero flow value in calibration table E24 Unrecognized version of calibration table E25 Excessive drift on flow sensor E26 Communications failure with LCD driver chip E27 Excessive drift on outlet pressure sensor E28 Empty calibration table E29 Excessive drift on blower pressure sensor E30 Unrecognized version of parameter storage Provider Manual A 2 E31 E32 E33 E34 E35 E36 E37 E38 E39 E40 E41 E42 E43 E44 E45 E46 E47 E48 E49 E50 E51 E52 E53 E54 E55 E56 E57 E58 E59 E60 Un repairable parameter storage Corrupt parameter storage Excessive parameter storage size Unable to queue data to parameter storage Unable to write to parameter storage Parameter out of range in parameter stora
79. tional white ultra fine filter is disposable Under normal usage clean the gray foam filter at least once every two weeks and replace it with a new one every six months CAUTION Dirty inlet filters may cause high operating temperatures that may affect performance Regularly examine the inlet filters as needed for integrity and cleanliness 1 Ifthe device is operating stop the airflow by pressing the 5 button Disconnect the device from the power source 2 Remove the filter cap by gently pressing in on the sides of the filter cover and pulling the cap out away from the device Figure 8 1 Figure 8 1 Removing the Filter Cover Provider Manual 8 2 3 Remove the filters from the enclosure by gently pulling around the edges of the filters The top filter is the reusable gray foam filter The bottom filter is the optional disposable white ultra fine filter Figure 8 2 Reusable Gray Foam Filter N p Disposable Ultra fine Filter Figure 8 2 Removing the Filters 4 Examine the filters regularly for cleanliness and integrity 5 If needed wash the gray foam filter in warm water with a mild detergent Rinse thoroughly to remove all detergent residue Allow the filter to dry completely before reinstalling it If the foam filter is torn replace it Only Respironics supplied filters should be used as replacement filters CAUTION Never install a wet filter into the device It is recommended that you clean the filter i
80. tton Exhaled Tidal Volume Screen Figure 6 16 Measured Parameter Screen Navigation To return to the Monitoring or Standby Screen from these Measured Parameter screens press the SILENCE button NOTE user also has access to these screens 1 LeakScreen This screen is shown in Figure 6 17 The Estimated Leak is the average leak value for the last six breaths The display is updated at the end of each breath Figure 6 17 Leak Screen Provider Manual 2 Respiratory Rate Screen This screen is shown in Figure 6 18 Ihe Respiratory Rate is the average of the previous six breaths If the mode supports machine triggered breaths this display will be the total breathing rate spontaneous breaths machine breaths The display is updated at the end of each breath Figure 6 18 Respiratory Rate Screen 3 Minute Ventilation Screen This screen is shown in Figure 6 19 The estimated Exhaled Minute Ventilation is based on the average of the last six breaths The display is updated at the end of each breath MinVent Figure 6 19 Minute Ventilation Screen NOTE value shown for Exhaled Minute Ventilation is an estimate The display flashes during transient conditions such as low tidal volumes erratic breathing or rapidly changing leak 4 Exhaled Tidal Volume Screen This screen is shown in Figure 6 20 estimated Exhaled Tidal Volume is obtained by the integration of patient flow The display is
81. tton on the side of the device HEAT When the optional REMstar Heated Humidifier has been prescribed this button controls the humidifier s output Follow the instructions included with the humidifier This button can also be used to adjust the parameters shown in the provider and user menu screens RAMP When the airflow is turned on this button lowers the airflow pressure allowing the patient to fall asleep more easily This button can also be used to adjust the parameters shown in the provider and user menu screens Press the left and right user buttons to navigate the display screens SILENCE button temporarily silences the audible portion of an alarm Additionally it allows you to exit a parameter screen RESET This button acknowledges an alarm and resets the device for alarm detection e Use this button to scroll through the measured monitoring parameters Provider Manual 4 4 4 1 3 INDICATORS The alarm and power indicators shown in Figure 4 5 are described below AC Power High Priority Indicator Green Alarm LED Red Low Medium Priority Alarm LED Yellow Figure 4 5 Alarm and Power Indicators Indicator Green AC Power Indicator The green AC Power LED illuminates when the device is connected to AC power DC Power Indicator The green DC Power LED illuminates when the device is connected to DC power High Priority Alarm The red High Priority Alarm LED illuminates when a high priority patient o
82. updated at the end of each breath Figure 6 20 Exhaled Tidal Volume Screen NOTE The value shown for Exhaled Tidal Volume is an estimate The display flashes during transient conditions Provider Manual 6 10 6 3 CHANGING SETTINGS IN User MoDE With the device in User mode the patient is restricted to viewing the following e Measured pressure e Backlight settings e Humidifier SmartCard and ramp status Patient alarms e Measured Parameters Leak Respiratory Rate Minute Ventilation Exhaled Tidal Volume The patient can change the following settings in User mode e Humidifier heat e Rise time e Ramp start pressure e LED backlight NOTE These settings can also be changed when the device is in Provider mode Detailed instructions for changing these settings are described in Section 6 1 The figure below shows how to navigate the User mode screens using the Left and Right User buttons These screens time out after 60 seconds of inactivity Rise Time Setting Screen G Only displayed if the rise time feature is prescribed RISETIME Right User Left User Button Button Ramp Start Pressure Setting Screen Only displayed if the ramp feature is prescribed Right User Left User Button Button LED Backlight Setting Screen Figure 6 21 Navigating the User Mode Screens NOTE When in User mode SETUP does not appear in the top right corner of the display Provider Manual CHAPTER 7 ALARMS This chapte
83. used to configure back up breaths to one of three selections Control Settings Description Back up Rate OFF No back up breaths are delivered to the patient The initiation of each breath is exclusively controlled by the patient The device triggers to IPAP in response to spontaneous inspiratory effort and cycles to EPAP during exhalation Figure 3 4 illustrates the trigger and cycle concepts Back up Rate 4 30 Time Insp 5 3 This selection ensures that the patient will receive a minimum number of breaths per minute if their spontaneous breathing rate drops below the breath rate specified by the Rate control If the patient fails to initiate an inspiration within the breath period determined by the control the device triggers a timed breath The duration of each breath is controlled by the Time Insp control Figure 3 5 illustrates patient triggered and machine triggered breaths when the back up rate is 4 30 Back up Rate Auto With Auto selected the back up rate and the time of inspiration are automatically determined by the device Spontaneous breaths are used to compute an average breath period and inspiratory period The 2 to3 breaths prior to central apnea may be insufficient to ventilate Thus tidal volumes less than 100 ml are not counted as a breath Timed breaths are delivered in groups of 5 breaths The First Timed breath has separate timing criteria as compared to the subsequent 4 breaths Figur
84. wer cord retainer which provides strain relief for the power cord 5 Ensure that all connections are secure Provider Manual Figure 5 3 Using the External Power Supply NOTE You can plug the cord into either of the power inlets on the back of the device NOTE Ifyou need to disconnect the power cord from the device slide the locking connector back and then remove the power cord 5 1 3 2 DC Operation You can operate the device on DC power by using the Respironics DC power adapter accessory See the DC power adapter instructions for information on how to operate the device using DC power CAUTION When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running Damage to the vehicle may occur CAUTION Only use the Respironics DC power adapter available from your health care professional Use of any other system may cause damage to the device or the vehicle 5 1 4 STARTUP When the power cord is plugged into an AC or DC power source the device sounds a confirmation alarm and the control panel buttons light up NOTE Ifthe alarm does not sound or the buttons do not light up the device requires servicing Additionally if any of the alphanumeric digits shown in Figure 5 4 do not display on the Self Test screen the device requires servicing Provider Manual 5 4 1 The first screen to appear is the Self Test screen ALARM PATIENT HEAT RAMP SETUP APNEA LIGHT STA
85. xible Tubing External AC Power Supply 1 83 m 6 ft x 22 mm i d Provider Manual 1 2 Provider Manual CHAPTER 2 WARNINGS AND CAUTIONS WARNING Indicates the possibility of injury to the patient or the operator CAUTION Indicates the possibility of damage to the BiPAP autoSV device NOTE Places emphasis on an operating characteristic Caution U S federal law restricts this device to sale by or on the order of a physician 2 1 WARNINGS This manual serves as a reference The instructions in this manual are not intended to supersede the instructions of the health care professional The operator should read and understand this entire manual before using the device Long term effects of the treatment of sleep disordered breathing and or Cheyne Stokes Respiration in patients with Congestive Heart Failure CHF or atrial fibrillation have not been documented Therefore caution should be exercised when using this device on a patient with CHF or atrial fibrillation The clinician should assess the relative risk and benefits of the therapy on a case by case basis The device provides positive pressure ventilation and is indicated for assisted ventilation This system does not provide ventilation with guaranteed tidal volume delivery Patients requiring ventilation at predetermined tidal volumes are not candidates for pressure support ventilation This is not a life support ventilator BiPAP autoSV is non continuous ventilator

Respironics BIPAP Auto SV

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