BiPAP AVAPS - Sleep Restfully, Inc.
Contents
1. 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 e When using this product IEC 60601 1 1 requirements safety requirements for medical electrical systems must be met e For proper use the power supply must be placed feet down in the upright position e When the device is used with a humidifier position the humidifier so that the water level in the humidifier is lower than you and the humidifier is on the same level or lower than the device e Do not attempt to wear your mask without the device turned on Doing so could result in CO rebreathing Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation 2 User Manual e If you notice any unexplained changes in the performance of the device if it is making unusual or harsh sounds if it and or the power supply has been dropped or mishandled if the enclosure is broken or if water has entered the device discontinue use and contact your home care provider e Repairs and adjustments must be performed by Respironics authorized service personnel only Unauthorized service could cause injury invalidate the warranty or result in costly damage e Periodically inspect electrical cords cables and the power supply device for damage or signs of wear e To avoid electrical shock unplug the device before cleaning e Pins2. 2 To increase or decrease the Flex setting press the HEAT or RAMP button until the correct setting appears You can choose from 1 to 3 NOTE Itis recommended that you start with the minimum setting of 1 which provides the least relief Levels 2 and 3 progressively increase the pressure relief 6 2 2 2 CHANGING THE RISE TIME SETTING Rise time is the time it takes for the device to change from EPAP to IPAP You can adjust the rise time to find the setting that provides you with the most comfort NOTE Ifthe screen shown in Figure 6 9 does not display you cannot adjust this setting Additionally if the Flex feature has been prescribed for you when Flex is enabled the rise time is fixed at a setting of 3 The Rise Time screen will not display and you won t be able to adjust the setting To change the rise time setting complete the following steps 1 From either the Monitoring or Standby screens press the Right User button until you reach this screen The Rise Time Setting screen is shown in Figure 6 9 RISE TIME Figure 6 9 Rise Time Setting Screen 24 User Manual 2 Increase or decrease the rise time setting from 1 to 6 by pressing the HEAT or RAMP button until you find the right setting A setting of 1 is the fastest rise time while 6 is the slowest 6 2 2 3 CHANGING THE RAMP STARTING PRESSURE The device is equipped with an optional ramp feature This feature will reduce the pressure and then gradually increase ramp
3. Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 42 User Manual LiMiTED WARRANTY Respironics Inc warrants that the BIPAP AVAPS system shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of two 2 years from the date of sale by Respironics Inc to the dealer If the product fails to perform in accordance with the product specifications Respironics Inc will repair or replace at its option the defective material or part Respironics Inc will pay customary freight charges from Respironics Inc to the dealer location only This warranty does not cover damage caused by accident misuse abuse alteration 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
4. leak respiratory rate minute ventilation and exhaled tidal volume To access these screens from the Monitoring or Standby screens press the small circular Scroll button located near the RESET button Figure 6 12 shows how to navigate the measured parameter screens Leak Screen ES j 1d Scroll Button Respiratory Rate Screen n 8 Seu Scroll Button Minute Ventilation Screen Minvent q Lom Exhaled Tidal Volume Screen Scroll Button Figure 6 12 Measured Parameter Screen Navigation To return to the Monitoring or Standby Screen from these Measured Parameter screens press the SILENCE button NOTE Ifyou view these screens from the Standby screen each of these screens will display a value of zero because no therapy is being delivered 1 Leak Screen This screen shown in Figure 6 13 shows the average of the leak values for the previous six breaths Figure 6 13 Leak Screen 26 User Manual 2 Respiratory Rate Screen This screen shown in Figure 6 14 shows the average rate of respiration for the previous six breaths Figure 6 14 Respiratory Rate Screen 3 Minute Ventilation Screen This screen shown in Figure 6 15 shows the estimated Exhaled Minute Ventilation the volume of air received on a per minute basis based on the average of the previous six breaths MinVent Figure 6 15 Minute Ventilation Screen NOTE The value shown for Exhaled Minute Venti
5. C to 60 C Relative Humidity 15 to 95 15 to 95 non condensing non condensing Atmospheric Pressure 5600 feet to sea level 83 to 102kPa 11 2 PHYSICAL Dimensions 9 75 L x 6 625 W x 4 4 H 24 8 cm L x 16 8 cm W x 11 2 cm H Weight 4 lbs 1 8 kg 11 3 ELECTRICAL AC Voltage Source 100 to 240 V 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 shock Type BF Applied Part Degree of protection against harmful ingress of water BiPAP AVAPS device Ordinary Equipment IPX0 AC Power Supply Drip Proof IPX1 DC Power Adapter Drip Proof IPX1 Modes of Operation Continuous Electromagnetic Compatibility The BiPAP AVAPS device meets the requirements of EN 60601 1 2 second edition 2001 Fuses There are no user replaceable fuses 11 4 PRESSURE Output 4 to 30 cm H O 38 User Manual 11 5 CONTROL Accuracy Parameter Range Accuracy IPAP 4 to 30 cm H O 5 cm H O EPAP 4 to 25 cm H O 5 cm H O CPAP 4 to 20 cm H O 5 cm H O Breath Rate 0 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
6. SETUP Indicates that the device is in PC therapy mode 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 Spontaneous therapy mode Indicates that the device is in S T therapy mode 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 Tidal Volume is being displayed Indicates that the Estimated Exhaled Tidal Volume is being displayed 4 2 4 BREATHING CIRCUIT CONNECTION Figure 4 6 shows where the circuit tubing connects to the device User Manual Patient Interface 1 Exhalation Port Optional Connection Figure 4 6 Typical Breathing Circuit Connection 13 4 2 5 Rear PANEL Figure 4 7 shows the device s rear panel Communications Connector Port Power Inlets Cord Retainer SmartCard LN Connector G ABA A I Cord Retainer Filter Cap Figure 4 7 Rear Panel NOTE The SmartCard Connector is located on the side of the device WARNING In order to ensure proper protection against
7. State The state of the device when the device and the airflow are both on OSA Obstructive Sleep Apnea Pressure Control PC This is an optional bi level mode which responds to your inhalation by increasing the pressure The length of the inhalation is controlled by the device If you do not start inhaling within a set time the device will automatically start inhalation User Manual Ramp A feature that may increase patient comfort when therapy is started The ramp feature reduces the pressure and then gradually increases ramps the pressure to the prescription setting so you can fall asleep more comfortably Respiratory Rate RR The patients rate of respiration Rise Time The time it takes for the device to change from EPAP to IPAP You can adjust this time for your comfort Spontaneous S This is a bi level mode which responds to both your inhalation and exhalation by increasing pressure when you start to inhale and decreasing pressure when you start to exhale There is no automatic delivery of a breath if you do not inhale Spontaneous Timed This is an optional bi level mode which responds to both your S T inhalation and exhalation by increasing pressure when you start to inhale and decreasing pressure when you start to exhale If you do not start inhaling within a set time the device automatically starts inhalation When the device starts inhalation it controls the time of inhalation a
8. 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 ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P 150 kHz to 80 MHz d 124P 80 MHzto 800 MHz d 22 3NP 800 MHzto 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field 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 ay 5 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 excee
9. iii 5 5 PLUGGING THE DEVICE Nino ad li 55 8 USING AG POWER nee nennen nenne ESEE REEERE 57532 USING DE POWER iiir iiU reri ee ro o o CHAPTER 6 OPERATING THE DEVICE 6 1 STARTING THE DEVICE 6 2 CHANGING THE DEVICE SETTINGS 6 2 1 CHANGING THE HUMIDIFIER SETTING 6 2 2 NAVIGATING THE USER DISPLAY SCREENS esee eee enne enne enne nnne 25 6 2 2 1 CHANGING THE FLEX SETTING cccssssecsssscessssecsesssscsseccesssnecsesssussenecessnsesssseessneess 24 6 2 2 2 CHANGING THE RISE TIME SETTING eese enne enne nnne nne nene 24 6 2 2 3 CHANGING THE RAMP STARTING PRESSURE eese en ener 25 6 2 2 4 CHANGING THE LED BACKLIGHT SETTING eese eene ener entere 25 6 3 MONITORING MEASURED PARAMETERS 525 anie entrer YER SP EH EPRE Ure EE EFE ERR e oe PR HE REP NE PAPAE ESTEER 26 CHAPTER 7 ALARMS asien tiae tpe re be tele tested te te E be ted evi io dud ee ee desti e EE be Re EE 28 TI INTRODUCTION TO ALARMS 4er ne nen dadas 28 7 2 WHAT TO Do WHEN AN ALARM OCCURS eiii esee set dese dde ote ded nado so edo aa deu aede dee hn daa esa ds 29 73 ALARM TABLES uie eei ae Or ee eroe E c rump eere teuer tod 30 7 3 1 HIGH PRIORITY ALARMS nione te ER ee Wa egere ede eee dread 30 7 3 2 MEDIUM PRIORITY EARMS ertet ne en d e EE EHE Fe eee LER e TE OT rE RE 31 7 3 3 LOW PRIORITY ALARM Sd 31 CHAPTER 8 TROUBLESHOOTING in NN 32 CHAPTER 9 CLEANING AND MAINTENANCE iin ai
10. number ready when you call The mask feels uncomfortable to wear This could be due to improper headgear adjustment or improper mask fitting Check the headgear adjustment as described in the headgear instructions Refer to your mask instructions to make sure the mask is properly fitted If the problem continues contact your home care provider for a refitting or a different size mask Runny nose Nasal reaction to the air flow Call your health care professional The devices display is erratic The device or power supply has been dropped or mishandled or the device or power supply is in an area with high EMI emissions Unplug the device and the power supply Relocate the device to an area with lower EMI emissions User Manual 33 Problem Why It Happened What To Do A SmartCard error occurs The SmartCard is not inserted properly It may be inserted upside down or backwards Remove the SmartCard and reinsert it so that the printed side of the card is facing up and the end with the arrow goes into the device first If the error message appears again contact your home care provider or Respironics for directions on having your device serviced Please have your serial number ready when you call 34 User Manual CHAPTER 9 CLEANING AND MAINTENANCE This chapter provides information on how to clean and maintain your system 9 1 CL
11. 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 2 2 CAUTIONS The device may only be operated at temperatures between 41 E 5 C and 95 F 35 C e A properly installed undamaged reusable foam inlet filter is required for proper operation e Do not immerse the device or allow any liquid to enter the enclosure or the inlet filter e Condensation may damage the device Always allow the device to reach room temperature before use NOTE Additional warnings cautions and notes are located throughout this manual 2 3 INTENDED Use The BiPAP AVAPS device is intended to provide noninvasive ventilation for pediatric patients 7 years or older gt 40 lbs 18 2 kg and adult patients gt 66 lbs 30 kg with respiratory insufficiency or obstructive sleep apnea This device may be used in the hospital or home NOTE The device is intended for use with nasal masks and full face masks as recommended by Respironics NOTE The device is to be used only on th
12. of the setting seconds Ramp Duration Rise Time 0 to 45 minutes 1 to 6 10 of the setting er xx Limited to 25 cm H O when using the Bi Flex feature in S mode 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 2 cm H O measured at the patient end of the circuit with a Whisper Swivel II and no patient flow kkk The 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 11 6 MEASURED PARAMETER ACCURACY Parameter Accuracy Respiratory Rate minute period Greater of 1 BPM or 10 of reading when measured over a four Exhaled Tidal Volume 25 0 15 of reading ml Exhaled Minute Ventilation 1 0 15 of reading L min Leak Rate 5 0 15 of reading L min 11 7 DisPosAL Dispose of this device in accordance with local regulations User Manual 39 APPENDIX A EMC INFORMATION GUIDANCE AND MaNurAcTURER s DECLARATION ELECTROMAGNETIC EMISSIONS This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Emissions Test RF emissions CISPR 11 RF emissions CIS
13. to exhaust CO from the patient circuit Do not block or seal the ports on the exhalation device 3 Attach the headgear to the mask See the instructions that came with your headgear User Manual 17 5 4 COMPLETE SETUP Figure 5 7 shows the completed breathing circuit setup Patient Interface Exhalation Port q 1 Filt Breathing ilter a a Circuit Optional Connection Figure 5 7 Complete Breathing Circuit 5 5 PLUGGING THE Device IN You can use AC or DC power to operate the device WARNING The DC power option is not intended as a battery backup when using AC power WARNING For proper use the power supply must be placed feet down in the upright position as shown in Figure 5 8 5 5 1 Using AC Power Complete the following steps to operate the device using AC power 1 Plug the pronged end of the AC power supply s cord into an electrical outlet 2 The external AC power supply features a cord retainer to provide strain relief for the AC power cord Wrap the cord around the AC power supply cord retainer using the wire tie supplied with your power supply WARNING Never plug the AC power supply into an outlet that is controlled by a wall switch WARNING Route the wires to avoid tripping 18 User Manual 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 as shown in Figure 5 8 The power cord ha
14. your home care provider Several screens appear initially during this step a The first screen that appears is the Self Test screen shown in Figure 6 1 This is the internal test performed by the device ALARM PATIENT HEAT RAMP SETUP APNEA LIGHT START CARD LEAK u un MinVent Ye 1 II cm 1 1121 12 H20 PCPAPS T AVAPS BPM ERASE HOURS RISE TIME FLEX 0880 080898 8888 Vy IPAP IPAP EPAP BPM Ti Max Min Figure 6 1 Self Test Screen RR b The next screen displays the software version as shown in Figure 6 2 Figure 6 2 Software Version Screen NOTE The version number 1 0 shown in Figure 6 2 is an example Your device may have a higher software version installed C The third screen to appear is the Blower Hours screen which displays the blower hours time meter Figure 6 3 Blower Hours Screen 20 User Manual NOTE With the exception of the o button the control pad is inactive during these first three screens Each of these screens appears for approximately 1 3 seconds d The next screen that appears is the Standby screen shown in Figure 6 4 This indicates that the device is in the Standby state the blower is off PATIENT HEAT SETUP APNEA LIGHT CARD Figure 6 4 Standby Screen 2 Press the O button to put the device into the Operate state and turn on the airflow The Monitoring screen shown in Figure 6 5 appears ALARM PATIENT HEAT RAMP 9880 36 08 a8 Vy IPAP IPAP EPAP Max Min Fi
15. 2 Heated Humidifier are available from your home care provider The humidifiers may reduce nasal dryness and irritation by adding moisture and heat if applicable to the airflow CAUTION For safe operation the humidifier must always be positioned below the circuit connection at the mask and the air outlet on the device The humidifier must be level for proper operation Refer to the humidifier instructions for complete setup information 10 2 ADDING OXYGEN TO THE DEVICE Oxygen may be added to the mask connection Please note the warnings listed below when using oxygen with the device WARNING Ifyou are using oxygen your device must be equipped with the Respironics Pressure Valve Failure to use the Pressure Valve could result in a fire hazard WARNING Oxygen accelerates fires Keep the device and the O containers away from heat open flames any oily substance or other sources of ignition Do not smoke in the area near the device or the O container WARNING When using oxygen with your device the oxygen supply must comply with the local regulations for medical oxygen WARNING When using oxygen with this system turn the device on before turning the oxygen on Turn the oxygen off before turning the device off This will prevent oxygen accumulation in the device User Manual 37 CHAPTER 11 SPECIFICATIONS 11 1 ENVIRONMENTAL Operating Storage Temperature 41 F to 95 F 4 F to 140 F E 5 C to 35 C 20
16. EANING THE DEVICE Before cleaning or performing any routine maintenance always make sure the device is not operating and disconnect the device from the power source NOTE The following cleaning instructions are for the device only To clean the accessories refer to each accessory s instruction sheet CAUTION Do not immerse the device or allow any liquid to enter the enclosure inlet filter or any openings 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 Gently wash the reusable circuit tubing in a solution of warm water and a mild detergent Rinse thoroughly and allow to air dry 9 2 CLEANING OR REPLACING THE INLET FILTERS The device has two removable filters at the air inlet The gray foam filter is washable and reusable The optional white ultra fine filter is disposable The gray foam filter should be cleaned at least once every two weeks under normal usage and replaced with a new one every six months The white ultra fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty Do not attempt to clean the ultra fine filter because this will damage the filter NOTE Dirty inlet filters may cause high operating temperatures and may affect performance Regularly examine the inlet filters as needed for integrity and cleanliness 1 Make sure the device i
17. Medium Priority Indicator Green Alarm LED Yellow Figure 4 4 Alarm and Power Indicators AC Power Indicator The green AC Power LED lights up when the device is connected to AC Power DC Power Indicator The green DC Power LED lights up when the device is connected to DC power High Priority Alarm The red High Priority Alarm LED lights up when a high priority alarm Indicator occurs Low Medium Priority The yellow Low Medium Alarm LED lights up when a medium or low Alarm Indicator priority alarm occurs NOTE All LED indicators temporarily turn on when the device is first plugged in 4 2 3 Display SCREEN The display shows you the measured pressure and displays alarm messages A backlight activates when any of the buttons are pressed and remains on until there are no buttons pressed for one minute Figure 4 5 shows the display screen ALARM PATIENT HEAT RAMP SETUP APNEA LIGHT START CARD m Sil LEAK Bam MinVent Vre ILI Lll A H20 PCPAPS T AVAPS BPM ERASE HOURS RISE TIME FLEX 38 d8 38 Ba ad IPAP IPAP EPAP BPM Ti Max Min Figure 4 5 Display Screen User Manual 11 The information shown on the display screen is defined as follows ALARM APNEA AVAPS BPM CARD cm H O CPAP EPAP ERASE FLEX HEAT HOURS IPAP IPAP Max IPAP Min LEAK LIGHT LPM MinVent ml PATIENT 12 Indicates that the device requires user attention as indicated on the screen Indicates that an apnea alarm has occur
18. O Z O x Oo U n x BiPAP AVAPS User Manual This BiPAP system is covered by one or more of the following patents US Patent Nos 5 148 802 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 2 162 981 and 2 259 795 European Patent Pub No 0425092B 1 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 OF CONTENTS CHAPTER 4 DEVICE CONTROLS AND DISPLAY FEATURES ueerssenssnensensnnnnnnnnnnnnsnnnnnnensnnnnsnennsnnnnnnnsnnnnnnsnnnnnn 9 41 PRESSURE ON OFF BUTTON isch essetis riter ln brennen IER ER ERE SERE ERN ip e consent eo ehe Felt 9 EAE CONTROL PANEL RC 10 42 12 CONTROL BUTTON Si OU Ogre eae reto E EROR 4 2 2 ALARM AND POWER INDICATORS 4 213 DISPLAY SCREEN niri sh 4 2 4 BREATHING CIRCUIT CONNECTION MES REAR PANEL oa TE ex tpe dvds DRE EE EFC EFE e eer ERE PERIERE CHAPTER 5 SETTING UP THE DEVICE nun en ayer oo rica E ee habe IE en REDE een ren 5 IINSTALHNG THE AIR FITER S esnias reor ter PEE 3T ERR Ue eR Ee TERRE YE HEY ER league ERR EROR NE ee CERE Ee FRR UE Fe 5 2 WHERE TO PEACE THE DEVICE nein neben ur ensemble Pv cie 5 3 CONNECTING THE BREATHING CIRCUIT siperi ioes ieir eie ASE XXE E tds cdean EES eE S Eneee tai 5 4 COMPLETE SETUP resini ori E
19. PR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY ELECTROMAGNETIC ENVIRONMENT GUIDANCE COMPLIANCE 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 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 B B This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 ELECTROMAGNETIC ENVIRONMENT GUIDANCE IEC 60601 Test COMPLIANCE LEVEL LeveL 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 envir
20. ake sure the device uncomfortable to wear improper headgear adjustment or improper mask fitting usual is away from bedding or curtains that could The device may be operating block the flow of air around the device Make in direct sunlight or neara sure the device is away from direct sunlight heater and heating equipment If the problem persists contact your home care provider The mask feels This could be due to Check the headgear adjustment as described in the headgear instructions Refer to your mask instructions to make sure the mask is properly fitted If the problem continues contact your home care provider for a refitting or a different size mask There is significant air leakage round the mask This could be due to improper headgear adjustment or improper mask fitting Check the headgear adjustment as described in the headgear instructions Refer to your mask instructions to make sure the mask is properly fitted If the problem continues contact your home care provider for a refitting or a different size mask Redness occurs when the mask cushion comes in contact with the skin This could be due to improper mask fitting or improper mask cleaning Be sure to rinse the mask thoroughly after cleaning to remove residue See the mask cleaning instructions for detailed information If the problem continues contact your home care provider for a refitting or a different size mask Redne
21. alarm continues call your home care provider Red Solid ME MN Blank Shuts down Battery is Press the ON OFF sagen discharged button to silence or Power was lost while the unit was providing therapy the alarm Remove the DC power source from the unit Replace the battery and restore power to the unit Or seek a reliable AC power source Restore power If the alarm continues call your home care provider User Manual 7 3 2 Mebium Priority ALARMS Alarm Alarm Display Device Possible Your LED Sound Message Action Cause Action Yellow Flash Operates Battery is nearly Press the RESET discharged button to reset the DC Power alarm Replace the LED Flashes battery If the alarm continues contact your home care provider 7 3 3 Low Priority ALARMS Alarm Alarm Display Device Possible Your LED Sound Message Action Cause Action Yellow Solid ee CARD Operates There is a problem Confirm that the flashes with the SmartCard SmartCard is properly and inserted in the inserted card error SmartCard code Cxx connectivity slot If the alarm continues displays to occur remove the Perhaps the SmartCard from the SmartCard is device and contact inserted upside down your home care or backwards provider Yellow Solid ee Operates The device lost AC Press the RESET power and is now button to reset the DC power operating on DC alarm Check the LED flashe
22. audible alarms are self cancellable This means that the alarm sound stops when the cause of the alarm is corrected The alarm LED indicators are shown in Figure 7 1 High Priority Alarm LED Red Low Medium Priority Alarm LED Yellow Figure 7 1 Alarm LED Indicators In addition to the alarm LED indicators the control panel also contains Alarm Reset and Alarm Silence buttons as shown in Figure 7 2 28 User Manual Figure 7 2 Alarm Buttons 7 2 WHAT ro Do WHEN AN ALARM Occurs The following example applies to most alarm conditions Follow these steps unless otherwise directed by the alarm tables that follow 1 Look at the alarm indicators and listen to the alarm sound Alarm LED Lights Up JAC Power Alarms JDC PC Figure 7 3 Alarm LED Lights Up Note the color of the LED and whether the LED is solid or flashing 2 Look at the display for text ALARM PATIENT APNEA Figure 7 4 Sample Alarm Display ALARM appears at the top of the screen to indicate an alarm Additional codes and symbols may also appear depending on the type of alarm 3 Press the SILENCE button to temporarily silence the alarm for one minute The display returns to the screen that was showing when the alarm occurred 4 Look up the alarm in the alarm tables shown in Section 7 3 and perform the action specified 5 Press the RESET button to clear the alarm User Manual 29 7 3 ALARM TABLES The following tables summariz
23. ce to sale by or on the order of a physician 2 1 WARNINGS e This manual serves as a reference The instructions in this manual are not intended to supersede the instructions of your health care professional e You should read and understand this entire manual before using the device e The device is not intended to provide your total ventilatory requirement e The prescription must only be adjusted by a trained home care provider e Use only the breathing circuit provided by your home care provider e When using a breathing circuit that contains a mask with an integrated exhalation port or a circuit with a separate exhalation device do not tape seal or otherwise block the vent openings e Ifoxygen is used with the device the oxygen flow must be turned off when the device is not in use e Ifyou are using oxygen the device must be equipped with the Respironics Pressure Valve Failure to use the Pressure Valve could result in a fire hazard e Oxygen supports combustion Oxygen should not be used while smoking or in the presence of an open flame e Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air or in the presence of nitrous oxide Do not use the device if the room temperature is 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 irritation to your airway
24. ds 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 User Manual 41 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND Mo Le RF Communications EQUIPMENT AND THIS Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Raten Maximum Power SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER OUTPUT OF TRANSMITTER m w 150 kHz ro 80 MHz 80 MHz ro 800 MHz 800 MHz ro 2 5 GHz d 1 2 P 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
25. e instruction of a trained health care professional WARNING The effectiveness of Bi Flex C Flex or AVAPS therapy has not been established for pediatric patients at this time User Manual 3 2 4 CONTRAINDICATIONS The device should not be used if you have severe respiratory failure without a spontaneous respiratory drive If any of the following conditions apply to you consult your physician before using the device e nability to maintain an open airway or adequately clear secretions e At risk for aspiration of gastric contents Diagnosed with acute sinusitis or otitis media Allergy or hypersensitivity to the mask materials where the risk from allergic reaction outweighs the benefit of ventilatory assistance Epistaxis causing pulmonary aspiration of blood Hypotension 2 5 PRECAUTIONS e Immediately report any unusual chest discomfort shortness of breath or severe headache e If skin irritation or breakdown develops from the use of the mask refer to the mask instructions for appropriate action The following are potential side effects of noninvasive positive pressure therapy Ear discomfort Conjunctivitis Skin abrasions due to noninvasive interfaces Gastric distention aerophagia 4 User Manual CHAPTER 3 INTRODUCTION TO THE DEVICE This chapter contains the following information Definitions for common terms used throughout this manual e An overview of the device e An e
26. e the high priority medium priority and low priority alarms 7 3 1 HIGH Priority ALARMS 30 Alarm Alarm Display Device Possible Your LED Sound Message Action Cause Action Red Flash ALARM and Operates Breathing circuit is Reconnect the circuit PATIENT disconnected or has or fix the leak flash a large leak Red Flash o ALARM and Operates An apnea event Continue nah APNEA occurred durin device Report the flash th g alarm to your home erapy care provider Red Flash 9 7 ALARM and Operates A low minute Press the RESET MinVent ventilation event button to reset the flash occurred during alarm Continue using therapy the device Report the alarm to your home care provider Red Flash ec c ALARM Operates A low tidal Press the RESET and Vre volume event button to reset the flash occurred during alarm Continue using therapy the device Report the alarm to your home care provider Red Flash e e ALARM Shuts down Device failure Press the RESET flashes Blower cannot button to reset the and an error be restarted alarm Remove code Exx power from the unit displays Restore power If the alarm continues contact your home care provider Red Flash e e ALARMand Operates Excessive leak fees the RESET cm H O or blockage utton to reset the flash malfunctioning unit Alarm Check for the following dirty inlet filters blocked air intake excessive leak in the circuit If the
27. e to deliver the prescribed pressure to your nose or nose and mouth depending on which interface has been prescribed for you e An exhalation device to vent exhaled air from the circuit Patient Exhalation Interface Patient Port ud Typical Interface Typical N Exhalation Typ Hi Device onnector Circuit TNT Flexible Tubing i Tubing g Connector n EE ai Circuit with Separate Circuit with Mask with Exhalation Device Integrated Exhalation Port Figure 3 3 Two Typical Breathing Circuits NOTE The exhalation port may be part of the mask or may be part of a separate exhalation device but is required to minimize the potential for CO rebreathing The system senses your breathing effort and changes pressure levels when you inhale and exhale depending on the mode of operation WARNING The device can operate on AC or DC power The DC power option is not intended as a battery backup CAUTION When DC power is obtained from a vehicle battery the device should not be used while the vehicle s engine is running User Manual 7 3 4 SYMBOLS The symbols shown below are used on the device the AC power supply and throughout this manual Meaning 3 5 How ro CONTACT RESPIRONICS Attention consult accompanying documents DC Power Pressure On Off Type BF Applied Part Class II Double Insulated European CE Declaration of Conformity Canadian US Certification Electrostatic Discharge Drip Proof Equipmen
28. ect one end of the circuit tubing to the outlet of the bacteria filter if using one and connect the inlet of the bacteria filter to the large connector on the device as shown in Figure 5 3 If you are not using a bacteria filter connect the end of the circuit tubing directly to the outlet connector on the device NOTE Follow the recommendations of your home care provider for using the optional bacteria filter Circuit Tubing Filter Optional Figure 5 3 Connecting the Tubing to the Outlet 2 Connect the tubing to the mask A Ifyou are using a mask with a built in exhalation port connect the mask s connector to the circuit tubing as shown in Figure 54 16 User Manual Exhalation Port Mask s Connector Flexible Tubing Connector Figure 5 4 Connecting a Mask with a Built In Exhalation Port B Ifyou are using a mask with a separate exhalation device connect the open end of the circuit tubing to the exhalation device as shown in Figure 5 5 Position the exhalation device so that the vented air is blowing away from your face T TW Circuit Exhalation Tubing Port Figure 5 5 Connecting a Exhalation Device Connect the mask s connector to the exhalation device as shown in Figure 5 6 See the mask instructions for complete setup information Mask or Other up Interface Mask Connector Exhalation Port AA NN Figure 5 6 Connecting the Mask WARNING The exhalation device is designed
29. electrical 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 The rear panel contains the following Communications This connector accepts the Respironics Communications cable for computer Connector and external communications or a remote alarm Use only with an IEC 60950 approved computer Power Inlets There are two power inlets on the rear panel one for connecting the external AC power supply and another for connecting the external DC power adapter Filter Cap The filter cap can be removed to inspect the inlet air filters Cord Retainers Two cord retainers are located on the rear panel to provide strain relief for the power cord 14 User Manual CHAPTER 5 SETTING UP THE DEVICE This chapter provides instructions on how to e Install the air filters e Position the device Connect the breathing circuit e Plug the device in using AC or DC power 5 1 INSTALLING THE Air FILTERS CAUTION A properly installed undamaged gray foam filter is required for proper operation The device uses a gray foam filter that is washable and reusable and an optional white ultra fine filter that is disposable One filter of each kind is supplied with the device If your home care provider did not install the inlet air filters you must install at least the gray foam
30. filter before using the device 1 Place the gray foam filter on top of the ultra fine filter if using the ultra fine filter 2 Slide the filters into the air inlet at the rear of the device and push them down into the recess as shown in Figure 5 1 Reusable Gray Foam Filter required Filter Cap Z N T Disposable Ultra fine Filter optional Figure 5 1 Installing the Filters 3 Attach the filter cap as shown in Figure 5 2 Position the cap so that the small opening on the cap is facing down Insert the cap s bottom tabs into the openings below the filter area Snap the cap into place Figure 5 2 Attaching the Filter Cap User Manual 15 NOTE The filter cap should be installed with the air inlet opening at the bottom See Chapter 9 for information about cleaning or replacing the filters 5 2 WHERE TO PLACE THE Device Place the device on its base somewhere within easy reach of where you will use it Make sure that the air inlet on the rear of the device is not blocked Place the device on a hard flat surface If you block the air flow around the device the device may not work properly WARNING Position the humidifier so the water level is lower than you and the humidifier is on the same level or lower than the device See the humidifier instructions for complete setup information 5 3 CONNECTING THE BREATHING CIRCUIT To connect your breathing circuit to the device complete the following steps 1 Conn
31. gure 6 5 Monitoring Screen Both the Monitoring and the Standby screens display PATIENT APNEA LIGHT and HEAT if these features are enabled Additionally CARD displays if a SmartCard is inserted The Monitoring screen also displays the actual measured pressure and FLEX if Flex is enabled and AVADS if AVADS is enabled 3 Put on your mask assembly when the air starts to flow 4 Make sure that no air is leaking from your mask into your eyes If it is adjust the mask and headgear until the air leak stops See the instructions that came with your mask for more information NOTE A small amount of mask leak is normal and acceptable Correct large mask leaks or eye irritation from an air leak as soon as possible 5 Ifyou are using the device while sleeping try placing the tubing from the device over your headboard This may reduce tension on the mask 6 Relax Take normal relaxed breaths through your nose NOTE If you are having trouble with your mask see Chapter 8 Troubleshooting for some suggestions User Manual 21 6 2 CHANGING THE Device SETTINGS You can view the following settings and indicators on the display screen Measured pressure e Therapy Mode e SmartCard e Patient alarms Additionally you can view and modify the following settings using the display screens e Humidifier heat gt Hex e Rise Time e Ramp start pressure e LED backlight NOTE When changing any setting except for the Ramp Start Pressure sett
32. 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 M RESPIRONICS 1001 Murry Ridge Lane Respironics Deutschland i 1048888 Murrysville PA 15668 Gewerbestrasse 17 JR 9 20 07 www respironics com 82211 Herrsching Germany 0123
33. ing once a maximum setting is reached the setting rolls back over to the minimum setting and likewise once a minimum setting is reached it rolls back over to the maximum setting provided For example the minimum humidifier setting is 1 and the maximum is 5 Once the humidifier setting is increased to 5 if you press the HEAT button again the setting will go back to 1 Or once the humidifier setting is decreased to 1 if you press the RAMP button again the setting will go back to 5 6 2 1 CHANGING THE HUMIDIFIER SETTING If you are using the REMstar Heated Humidifier with your device you can adjust the humidifier heat setting by completing the following steps 1 From either the Standby or Monitoring screen press and hold the HEAT button for several seconds The Humidifier Setting screen appears as shown in Figure 6 6 PCPAPS T Figure 6 6 Humidifier Setting Screen 2 Press the HEAT button to increase the humidifier setting or press the RAMP button to decrease the setting You can adjust the setting from 1 to 5 The change takes effect immediately as you adjust the setting 3 You can exit this screen by pressing the Left or Right User buttons or the SILENCE button For additional information on using a humidifier with the device see Chapter 10 22 User Manual 6 2 2 NAVIGATING THE User DisPLAY SCREENS You can navigate the rest of the user display screens by pressing the Left and Right User keys You can change the se
34. lation is an estimate 4 Exhaled Tidal Volume Screen This screen shown in Figure 6 16 shows the estimated Exhaled Tidal Volume which is the volume of each breath Figure 6 16 Exhaled Tidal Volume Screen NOTE The value shown for Exhaled Tidal Volume is an estimate User Manual 27 CHAPTER 7 ALARMS This chapter describes the alarms and what you should do if an alarm occurs 7 1 INTRODUCTION TO ALARMS The device provides three alarm levels high medium and low priority High Priority These alarms require immediate response The alarm signal consists of a red LED indicator and a sound that is either a periodic pattern consisting of a two second beep followed by two seconds of silence or a pattern of three beeps a pause and then two more beeps The display has ALARM at the top of the screen The tables in Section 7 3 display these sounds using the following symbols ee e or Medium Priority These alarms require prompt response The alarm signal consists of a yellow LED and a sound that repeats a pattern of three beeps The display has ALARM at the top of the screen The tables in Section 7 3 display these sounds using the following symbols e e Low Priority These alarms require your awareness The alarm signal consists of a yellow LED and a sound that repeats a pattern of two beeps The display has ALARM at the top of the screen The tables in Section 7 3 display these sounds using the following symbols e Some
35. nd automatically decreases the pressure for exhalation within a set time Standby State The state of the device when the device is on but the airflow is off Tidal Volume V The volume of each breath Timed T This is an optional bi level mode in which the device controls both inhalation and exhalation independent of spontaneous breathing 3 2 Whar is BI LEVEL VENTILATION Bi level ventilation with the device helps you to breathe by supplying two levels of air pressure The device provides a higher pressure known as IPAP Inspiratory Positive Airway Pressure when you inhale and a lower pressure known as EPAP Expiratory Positive Airway Pressure when you exhale The higher pressure makes it easier for you to inhale and the lower pressure makes it easier for you to exhale IPAP Pressure EPAP Pressure Rise Time Time Figure 3 1 IPAP and EPAP Breathing Levels You can adjust the Rise Time to make the pressure change more comfortable The device can also provide a single pressure level known as CPAP Continuous Positive Airway Pressure 6 User Manual 3 3 Wuat is THE BIPAP AVAPS Device The device shown in Figure 3 2 supplies air pressure through a breathing circuit Figure 3 2 The BiPAP AVAPS Device A breathing circuit shown in Figure 3 3 consists of e Circuit tubing to deliver air from the device to your interface e g mask A mask or other patient interface devic
36. nt of the display screen User Manual 4 2 CONTROL PANEL The control panel contains the following control buttons and indicators 4 2 1 CONTROL BUTTONS The control buttons on the control panel are shown in Figure 4 3 Display Screen Scroll Pressure On Off Button Button Alarm Reset Button Heated Humidifier Buttons Alarm Button Silence Ramp Button Button Figure 4 3 Control Panel HEAT When the optional REMstar Heated Humidifier has been prescribed this button controls the humidifiers output Follow the instructions included with the humidifier You can also use this button to adjust the settings shown in the user menu screens RAMP When the airflow is turned on and the ramp function is enabled this button lowers the airflow pressure allowing you to fall asleep more easily You can also use this button to adjust the settings shown in the user menu screens Cam Bm Press the left and right user buttons to navigate the display screens SILENCE This button silences the audible portion of an alarm for one minute You can also use this button to exit the user menu screens RESET This button allows you to clear an alarm and reset the device for alarm detection Oo Use this button to scroll through the monitoring parameters 10 User Manual 4 2 2 ALARM AND Power INDICATORS Figure 4 4 shows the device s alarm and power indicators AC Power High Priority Indicator Green Alarm LED Red Low
37. onment 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 lt 5 U lt 5 U Mains power quality should be that of a gt 95 dip in U for 0 5 cycle gt 95 dip in U for 0 5 cycle typical home or hospital environment If 40 U 40 U the user of the device requires continued 60 dip in U for 5 cycles 60 dip in U for 5 cycles operation during power mains interruptions 70 U 70 U it is recommended that the device be 30 dip in U for 25 cycles 30 dip in U for 25 cycles powered from an uninterruptible power lt 5 U lt 5 U supply or a battery gt 95 dip in U for 5 sec gt 95 dip in U for 5 sec 6 kV contact 8 kV air 6 kV contact 8 kV air 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 40 User Manual GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC 60601 Test LeveL Conducted RF 3Vrms IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3V m IEC 61000 4 3 80 MHz to 2 5 GHz COMPLIANCE LEVEL NOTE 1 At 80 MHz and 800 MHz the higher
38. red Indicates that the device is operating with AVAPS therapy 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 CPAP pressure setting is being displayed and or the device is in CPAP mode Indicates that an EPAP pressure setting is being displayed Indicates that the user may clear the Therapy Hour Meter Indicates that the C Flex Bi Flex comfort setting is being displayed or is active 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 pressure setting 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 User Manual PC RAMP RAMP START RISE TIME RR SIT
39. rline 35 9 1 CLEANING THE DEVICE seen 35 9 2 CLEANING OR REPLACING THE INLET FILTERS 35 CHAPTER 10 ACCESSORIES eene 55357 10 1 ADDING A HUMIDIFIER scoio oiii Ere A Yorn er ea 37 10 2 ADDING OXYGEN TO THE DEVICE esses eee nennen nnne nennen nennen tenes nenne inneren nennen 37 CHAPTER II SPECIFICATIONS aia 38 YID DNVIRONMENTAE S1 tale rose ete a pet Ree RE ETETES NEVER UE NE E EUN Ye ERU URN E REEL eV E EN EYPU Pe ee EE EPOD RUN 38 E 38 11 4 ELECTRICAL Hase T X 38 THA PRESSURE anne eddie edd Sod eda ede 38 TTS CONTROL ACCURACY een naeh 39 11 6 MEASURED PARAMETER ACCURACY 5 1 pese stc TEE ais 39 ior MT m APPENDIX A EMC INFORMATION CHAPTER 1 PACKAGE CONTENTS Your BiPAP AVAPS device should include the following items If any of these items are missing contact your home care provider Flexible Tubing 6 ft 1 83 m x 22 mm i d Power Cord I et Disposable External AC Power Supply Reusable Ultrafine Filter Gray Foam Filters Filter Cap User Manual User Manual CHAPTER 2 WARNINGS AND CAUTIONS WARNING Indicates the possibility of injury to the user or operator CAUTION Indicates the possibility of damage to the device NOTE Places emphasis on an operating characteristic CAUTION US federal law restricts this devi
40. s 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 Figure 5 8 Plugging in the AC Power Supply NOTE You can plug the cord into either of the power inlets on the back of the device 4 Wrap the cord around the device s power cord retainer which provides strain relief for the power cord 5 Ensure that all connections are secure NOTE Ifyou need to disconnect the power cord from the device slide the locking connector back and then remove the power cord 5 5 2 Usinc DC Power You can operate the device on DC power by using the Respironics DC power adapter accessory See the DC power adapter instructions for more information CAUTION Use only the Respironics DC power adapter available from your home care provider Using any other system may cause damage to the device or the vehicle CAUTION When using DC power 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 User Manual 19 CHAPTER 6 OPERATING THE DEVICE This chapter explains how to start the device and change the device settings 6 1 STARTING THE DEVICE 1 Plugin the device to an AC or DC power source to power up the device A confirmation alarm sounds and the control pad buttons light up NOTE Ifthe alarm does not sound or the buttons do not light up the device requires servicing Call
41. s not operating and disconnect the power cord from the wall outlet or DC source 2 As shown in Figure 9 1 remove the filter cap by gently pressing down on the top panel and pulling the cap out away from the device Figure 9 1 Removing the Filter User Manual 35 3 m N 8 Remove the filters from the enclosure as shown in Figure 9 2 The top filter is the reusable gray foam filter The bottom filter is the optional disposable white ultra fine filter Reusable Gray Foam Filter Disposable Ultra fine Filter Figure 9 2 Removing the Air Filters Check the filters to see if they are dirty or torn If needed wash the foam filter in warm water and a mild detergent Rinse the filter thoroughly to remove all detergent residue Allow the filter to completely dry before reinstalling it If the foam filter is torn replace it If the ultra fine filter is dirty or torn replace it Reinstall the filters with the ultra fine filter on the bottom Slide the filters into the air inlet at the rear of the device and push them down into the recess Replace the filter cap Contact your home care provider to order additional filters NOTE To clean the breathing circuit accessories refer to each accessory s instruction sheet 36 User Manual CHAPTER 10 ACCESSORIES There are several accessories you can use with the device 10 1 ADDING A HUMIDIFIER The REMstar Heated Humidifier REMstar Passover Humidifier and H
42. s power AC power Seek a reliable power At start up only source Provide AC alarm notifies you power if you do not that a battery is want to use a battery being used otherwise no further to provide power action is needed Yellow Solid ee Unchanged Operates The AC power Remove power from supply is out of the device and then AC power spec lt 22V or restore power If alarm LED flashes there is a defective continues to occur battery sense line contact your home on the DC power care provider adapter Yellow Solid ee ALARM Operates The device Remove the CARD and has successfully SmartCard from the cm H O downloaded the device If alarm flash prescription from continues to occur the SmartCard contact your home care provider User Manual 31 CHAPTER 8 TROUBLESHOOTING This chapter describes problems that you may experience with your device or mask and provides possible solutions Problem The device does not operate when you press the b button Why It Happened If the power LED is off there s no power at the outlet or the device is unplugged If the power LED is on the problem is in the device What To Do Check the outlet power and verify that the device is plugged in If the problem continues call your home care provider The air out of the mask is much warmer than The inlet filters may be dirty Clean or replace the inlet air filters as described in Chapter 9 M
43. ss occurs when the mask cushion accessory comes in contact with the skin Irritation or allergic reaction to the mask material Use a barrier between your skin and the mask such as 3M s Microfoam or Squibb s Duoderm Refer to your mask instructions for additional information 32 User Manual Problem Why It Happened What To Do Sore or dry eyes The mask may not be positioned correctly or the mask is not properly fitted Check the headgear adjustment as described in the headgear instructions Refer to your mask instructions to make sure the mask is properly fitted If the problem continues contact your home care provider for a refitting or a different size mask There are unexplained changes in the performance of the device The device or power supply has been dropped or mishandled or water has been spilled onto or into the device or the power supply Discontinue use Contact your home care provider or Respironics for directions on how to have your device serviced Please have the serial number ready when you call A patient disconnect alarm occurs The tubing has become disconnected from the system Press the RESET button to reset the alarm Reconnect the tubing If the alarm continues the device may not be operating correctly Contact your home care provider or Respironics for directions on having the device serviced Please have your serial
44. t UL Recognized for Canada and the United States TUV Safety Standard Compliance No User Serviceable Parts To have your device serviced contact your home care provider If you need to contact Respironics directly call the Respironics Customer Service department at 1 800 345 6443 USA or Canada only or 1 724 387 4000 You can also use the following address Respironics 1001 Murry Ridge Lane Murrysville PA 15668 Visit Respironics web site at www respironics com User Manual CHAPTER 4 DEVICE CONTROLS AND DisPLAY FEATURES Figure 4 1 shows the location of the device s alarm power indicators control panel Pressure On Off button and the breathing circuit connection Alarm and Power Indicators Control Panel Breathing Circuit Connection Pressure On Off Button 5 Figure 4 1 Device Front and Top 4 1 Pressure On OrF BUTTON The devices Pressure On Of O button located on the side of the device starts and stops the device s airflow e To turn the airflow on press the button in as shown in Figure 4 2 This puts the device in the Operate state e To turn the airflow off press the button again This puts the device in the Standby state Airflow Airflow On Off N Figure 4 2 Pressure Button On Off Positions When the device is in Standby any ramp in progress is terminated the alarms are reset except for the System Errors alarm and the humidifier is turned off The O button is independe
45. the pressure to the prescription pressure setting so you can fall asleep more comfortably NOTE Ihe ramp feature is not prescribed for all users If the screen shown in Figure 6 10 does not appear on your display you cannot adjust this setting To change the ramp starting pressure setting complete the following steps 1 From either the Monitoring or Standby screens press the Right User button until the Ramp Start Setting screen appears as shown in Figure 6 10 Figure 6 10 Ramp Start Setting Screen 2 Press the HEAT or RAMP button to increase or decrease the ramp starting pressure as needed You can adjust the setting from 4 0 cm H O to your EPAP or CPAP setting 6 2 2 4 CHANGING THE LED BACKLIGHT SETTING When airflow is turned on and the device is in the Operate state you can turn the control pad lighting behind the buttons on or off using the LED backlight setting NOTE The lights are always on when the airflow is off and the device is in Standby To change the LED backlight setting complete the following steps 1 From either the Monitoring or Standby screens press the Right User button until the LED Backlight Setting screen appears as shown in Figure 6 11 Figure 6 11 LED Backlight Setting Screen 2 Press the HEAT or RAMP button to select a new setting A setting of 1 means the light is on while 0 means the light is off User Manual 25 6 3 MONITORING MEASURED PARAMETERS You can view four measured parameters
46. ttings on any of the display screens by pressing the HEAT and RAMP buttons to increase or decrease the setting You can exit any of the user display screens by pressing the SILENCE button Figure 6 7 shows how to navigate the user display screens using the right and left user buttons Flex Setting Screen i Only displayed if the Flex feature is prescribed for you FLEX Right User Left User Button Button Rise Time Setting Screen Only displayed if you can adjust the rise time setting RISE TIME Right User Left User Button Button Ramp Start Pressure Setting Screen Only displayed if the ramp feature is prescribed for you Right User Left User Button Button LED Backlight Setting Screen Figure 6 7 Navigating the User Display Screens User Manual 23 6 2 2 1 CHANGING THE FLEX SETTING The Flex setting allows you to adjust the level of air pressure relief that you feel when you exhale during therapy WARNING The effectiveness of Bi Flex C Flex or AVAPS therapy has not been established for pediatric patients at this time NOTE he Flex feature is not prescribed for all users If the screen shown in Figure 6 8 does not appear on your display you cannot adjust this setting To change the Flex setting complete the following steps 1 From either the Monitoring or Standby screens press the Right User button The Flex Setting screen appears as shown in Figure 6 8 FLEX Figure 6 8 Flex Setting Screen
47. xplanation of the symbols used on the device and throughout this manual e Contact information 3 1 DEFINITIONS The following terms appear throughout this manual Apnea A condition marked by the cessation of spontaneous breathing AVAPS Average Volume Assured Pressure Support A therapy feature that automatically adjusts the pressure support level of the patient to provide a consistent tidal lung volume to the patient BPM Breaths Per Minute CPAP Continuous Positive Airway Pressure EPAP Expiratory Positive Airway Pressure Exhaled Tidal Volume V The exhaled volume of each breath FLEX A therapy feature that provides pressure relief during exhalation to improve patient comfort High Priority Alarm An alarm signal indicating a condition that requires immediate attention IPAP Inspiratory Positive Airway Pressure LED Light Emitting Diode LEAK The amount of airflow leak detected by the device Low Minute Ventilation A condition in which you are not receiving a specified volume of air on a per minute basis Low Priority Alarm An alarm signal indicating an informational message Low Tidal A condition in which the average volume over several breaths is less Volume than expected Medium Priority Alarm An alarm signal indicating a condition that requires operator awareness Minute Ventilation MinVent The volume of air received by the patient on a per minute basis Operate
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